Commission Implementing Regulation (EU) 2026/1410 of 26 June 2026 granting a Union authorisation for the biocidal product family Prisman Händedesinfektion in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

ANNEXSupplementary provisions

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Prisman Händedesinfektion Product type(s) PT01: Human hygiene Authorisation number EU-0034420-0000 R4BP asset number EU-0034420-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name Prisman Händedesinfektion 1.2. Product type(s) Product type(s) PT01: Human hygiene 1.3. Authorisation holder Name and address of the authorisation holder Name Schuelke & Mayr GmbH Address Robert-Koch-Str. 2 22851 Norderstedt DE Authorisation number EU-0034420-0000 R4BP asset number EU-0034420-0000 Date of the authorisation 6 August 2026 Expiry date of the authorisation 30 September 2035 1.4. Manufacturer(s) of the product Name of manufacturer Prisman Chemie GmbH Address of manufacturer Otto-Hahn-Ring 6-18 64653 Lorsch Germany Location of manufacturing sites Prisman Chemie GmbH site 1 Otto-Hahn-Ring 6-18 64653 Lorsch Germany 1.5. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer Stockmeier Chemie GmbH & Co. KG Address of manufacturer Am Stadtholz 37 33609 Bielefeld Germany Location of manufacturing sites INEOS Solvents Germany GmbH Römerstraße 733 47443 Moers Germany 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,1 - 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0 - 0,5 % (w/w) 2.2. Type(s) of formulation Formulation type(s) AL Any other liquid PART II SECOND INFORMATION LEVEL META SPC(S) 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier meta SPC1 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #1 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #2 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #3 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #4 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #5 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #6 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. Product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #7 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #7.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #7.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #7.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #7.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #7.1.: as required (typically 25 applications per day) Use #7.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #8 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #8.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry. Use #8.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #8.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #8.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #8.1.: as required (typically 25 applications per day) Use #8.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #9 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #10 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #10.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use # 10.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #10.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #10.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #10.1.: as required (typically 25 applications per day) Use #10.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 21 Authorisation number EU-0034420-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,5 % (w/w) 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier meta SPC2 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #11 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #12 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #13 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #14 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #15 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #16 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: as required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #17 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Field of use description: #Use 17.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).or in industrial areas, e.g. pharma or food production industry #Use 17.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: #Use 17.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) #Use 17.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 17.1.: as required (typically 25 applications per day) #Use 17.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #18 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #18.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #18.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #18.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #18.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 18.1.: as required (typically 25 applications per day) #Use 18.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #19 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #20 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #20.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #20.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #20.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #20.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #20.1.: as required (typically 25 applications per day) Use #20.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.11. Use description Table 11 Use #21 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.12. Use description Table 12 Use #22 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.12.2. Use-specific risk mitigation measures --- 4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.13. Use description Table 13 Use #23 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.13.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.14. Use description Table 14 Use #24 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.14.2. Use-specific risk mitigation measures --- 4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 22 Authorisation number EU-0034420-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,5 % (w/w) 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier meta SPC3 1.2. Suffix to the authorisation number Number 1-3 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #25 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #26 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #27 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #28 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #29 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #30 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: as required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #31 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #31.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #31.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #31.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #31.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #31.1.: as required (typically 25 applications per day) Use #31.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #32 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #32.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #32.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #32.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #32.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #32.1: as required (typically 25 applications per day) Use #32.2: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #33 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #34 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #34.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Use #34.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #34.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #34.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #34.1.: as required (typically 25 applications per day) Use #34.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 23 Authorisation number EU-0034420-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier meta SPC4 1.2. Suffix to the authorisation number Number 1-4 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #35 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #36 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #37 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #38 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #39 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #40 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #41 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #41.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #41.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #41.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #41.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 41.1.: as required (typically 25 applications per day) #Use 41.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #42 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #42.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #42.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #42.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #42.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #42.1.: as required (typically 25 applications per day) Use #42.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #43 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #44 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #44.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #44.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #44.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #44.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #44.1.: as required (typically 25 applications per day) Use #44.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.11. Use description Table 11 Use #45 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.12. Use description Table 12 Use #46 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.12.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.13. Use description Table 13 Use #47 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.13.2. Use-specific risk mitigation measures --- 4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.14. Use description Table 14 Use #48 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.14.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 24 Authorisation number EU-0034420-0004 1-4 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier meta SPC5 1.2. Suffix to the authorisation number Number 1-5 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 5 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,1 - 63,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #49 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.2. Use description Table 2 Use #50 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.3. Use description Table 3 Use #51 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: 2 x 5 mL per disinfection, corresponding to 2 x 2,76 g a.s. Contact time 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.4. Use description Table 4 Use #52 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses,: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.5. Use description Table 5 Use #53 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.6. Use description Table 6 Use #54 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE): 36 months 4.7. Use description Table 7 Use #55 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #55.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #55.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #55.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #55.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #55.1.: as required (typically 25 applications per day) Use #55.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.8. Use description Table 8 Use #56 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #56.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #56.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #56.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #56.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #56.1.: as required (typically 25 applications per day) Use #56.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.9. Use description Table 9 Use #57 Surgical hand rub - professional user – bacteria, yeasts, fungi – pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Bactericide, yeasticide, fungicide: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 4.10. Use description Table 10 Use #58 Hygienic/surgical hand rub - professional user – bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #58.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #58.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #58.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #58.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #58.1.: as required (typically 25 applications per day) Use #58.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: HDPE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Händedesinfektion Hand Disinfection Désinfection Des Mains Rankos Dezinfekuojamos Disinfezione Delle Mani Roku Dezinfekcija Käte Desinfektsioon Dezynfekcja Rąk Dezinfectarea Mâinilor дезинфекция на ръцете Hånddesinfektion Käsidesinfektio αντισηψία των χεριών Dezinfekciju Ruku Rankų Dezinfekcija Handdesinfektion Dezinfekcia Rúk Desinfección De Las Manos Dezinfekce Rukou Kézfertőtlenítés PRISMAN Händedesinfektion PRISMAN Hand Disinfection PRISMAN Désinfection Des Mains PRISMAN Rankos Dezinfekuojamos PRISMAN Disinfezione Delle Mani PRISMAN Roku Dezinfekcija PRISMAN Käte Desinfektsioon PRISMAN Dezynfekcja Rąk PRISMAN Dezinfectarea Mâinilor PRISMAN дезинфекция на ръцете PRISMAN Hånddesinfektion PRISMAN Käsidesinfektio PRISMAN αντισηψία των χεριών PRISMAN Dezinfekciju Ruku PRISMAN Rankų Dezinfekcija PRISMAN Handdesinfektion PRISMAN Dezinfekcia Rúk PRISMAN Desinfección De Las Manos PRISMAN Dezinfekce Rukou PRISMAN Kézfertőtlenítés Innocid Händedesinfektion HD-i50 Innocid HD-i50 Hand Disinfection Innocid HD-i50 Désinfection Des Mains Innocid HD-i50 Rankos Dezinfekuojamos Innocid HD-i50 Disinfezione Delle Mani Innocid HD-i50 Roku Dezinfekcija Innocid HD-i50 Käte Desinfektsioon Innocid HD-i50 Dezynfekcja Rąk Innocid HD-i50 Dezinfectarea Mâinilor Innocid HD-i50 дезинфекция на ръцете Innocid HD-i50 Hånddesinfektion Innocid HD-i50 Käsidesinfektio Innocid HD-i50 αντισηψία των χεριών Innocid HD-i50 Dezinfekciju Ruku Innocid HD-i50 Rankų Dezinfekcija Innocid HD-i50 Handdesinfektion Innocid HD-i50 Dezinfekcia Rúk Innocid HD-i50 Desinfección De Las Manos Innocid HD-i50 Dezinfekce Rukou Innocid HD-i50 Kézfertőtlenítés SunSept Händedesinfektion SunSept Hand Disinfection • SunSept Désinfection Des Mains SunSept Rankos Dezinfekuojamos SunSept Disinfezione Delle Mani SunSept Roku Dezinfekcija SunSept Käte Desinfektsioon SunSept Dezynfekcja Rąk SunSept Dezinfectarea Mâinilor SunSept дезинфекция на ръцете SunSept Hånddesinfektion SunSept Käsidesinfektio SunSept αντισηψία των χεριών SunSept Dezinfekciju Ruku SunSept Rankų Dezinfekcija SunSept Handdesinfektion SunSept Dezinfekcia Rúk SunSept Desinfección De Las Manos SunSept Dezinfekce Rukou SunSept Kézfertőtlenítés Authorisation number EU-0034420-0005 1-5 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,1 % (w/w) 1. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier meta SPC6 1.2. Suffix to the authorisation number Number 1-6 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 6 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 - 63,14 % (w/w) 2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. EUH208: Contains Isoeugenol. May produce an allergic reaction. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #59 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.1.2. Use-specific risk mitigation measures --- 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.2. Use description Table 2 Use #60 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.3. Use description Table 3 Use #61 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #61.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #61.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #61.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec. Use #61.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: Use #61.1.: as required (typically 25 applications per day) Use #61.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.4. Use description Table 4 Use #62 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) HD1 Authorisation number EU-0034420-0006 1-6 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 % (w/w) 1. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier meta SPC7 1.2. Suffix to the authorisation number Number 1-7 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 7 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 7 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 - 63,14 % (w/w) 2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #63 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.1.2. Use-specific risk mitigation measures --- 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.2. Use description Table 2 Use #64 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.3. Use description Table 3 Use #65 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #65.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #65.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #65.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec. Use #65.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: Use #65.1.: as required (typically 25 applications per day) Use #65.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds. Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: — The authorisation number; — The trade name of the biocidal product; — The identity and content of each active ingredient; — The instructions for use, including the incorporation time required for the biocidal action; — The information according to CLP. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 4.4. Use description Table 4 Use #66 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping – indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub disinfection product for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 125, 500 1 000 ml Packaging: HDPE Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Canister: 5, 10, 20, 30 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials Drum: 220 l Packaging: HDPE Closure: HDPE, LDPE, PP or a combination of these materials IBC: 1 000 l Packaging: HDPE with steel frame Closure: HDPE, LDPE, PP or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: 36 months 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) HD2 Authorisation number EU-0034420-0007 1-7 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 % (w/w) 1. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier meta SPC8 1.2. Suffix to the authorisation number Number 1-8 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 8 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 8 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 8 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #67 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #68 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #69 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #70 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #71 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #72 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: as required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #73 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #73.1 .: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #73.2 .: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #73.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #73.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #74 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #74.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry. Use #74.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #74.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #74.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #74.1.: as required (typically 25 applications per day) Use #74.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #75 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #76 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #76.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #76.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- Application rate(s) and frequency Application Rate: Use #76.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #76.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #76.1.: as required (typically 25 applications per day) Use #76.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed. Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans. Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 21 Authorisation number EU-0034420-0008 1-8 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,5 % (w/w) 1. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier meta SPC9 1.2. Suffix to the authorisation number Number 1-9 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 9 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 9 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #77 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #78 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #79 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #80 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #81 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #82 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: as required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #83 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use #Use 83.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) or in industrial areas, e.g. pharma or food production industry #Use 83.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: #Use 83.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) #Use 83.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 83.1.: as required (typically 25 applications per day) #Use 83.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #84 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #84.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #84.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #84.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #84.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 84.1.: as required (typically 25 applications per day) #Use 84.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures -- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #85 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #86 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #86.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #86.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #86.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #86.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #86.1.: as required (typically 25 applications per day) Use #86.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.11. Use description Table 11 Use #87 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.12. Use description Table 12 Use #88 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 4.12.2. Use-specific risk mitigation measures --- 4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.13. Use description Table 13 Use #89 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.13.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.14. Use description Table 14 Use #90 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 4.14.2. Use-specific risk mitigation measures --- 4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 22 Authorisation number EU-0034420-0009 1-9 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1-Tetradecanol Tetradecan-1-ol Non-active substance 112-72-1 204-000-3 0,5 % (w/w) 1. META SPC 10 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 10 identifier Identifier meta SPC10 1.2. Suffix to the authorisation number Number 1-10 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 10 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 10 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 10 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #91 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #92 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #93 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and limited spectrum virucidal activity: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #94 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #95 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #96 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #97 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #97.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #97.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #97.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #97.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #97.1.: as required (typically 25 applications per day) Use #97.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #98 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #98.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #98.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #98.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #98.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #98.1: as required (typically 25 applications per day) Use #98.2: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #99 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #100 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #100.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). Use #100.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #100.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #100.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #100.1.: as required (typically 25 applications per day) Use #100.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 10 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 23 Authorisation number EU-0034420-0010 1-10 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1. META SPC 11 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 11 identifier Identifier meta SPC11 1.2. Suffix to the authorisation number Number 1-11 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 11 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 11 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 - 75 % (w/w) 2.2. Type(s) of formulation of the meta SPC 11 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #101 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases). Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #102 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #103 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #104 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #105 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.6. Use description Table 6 Use #106 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #107 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #107.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #107.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #107.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #107.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 107.1.: as required (typically 25 applications per day) #Use 107.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #108 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #108.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #108.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #108.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #108.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #108.1.: as required (typically 25 applications per day) Use #108.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #109 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #110 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Field(s) of use indoor use Use #110.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #110.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #110.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1,9 g a.s. Contact time: 60 sec. (in total) Use #110.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #110.1.: as required (typically 25 applications per day) Use #110.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.11. Use description Table 11 Use #111 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.12. Use description Table 12 Use #112 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.12.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging -- 4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.13. Use description Table 13 Use #113 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. 4.13.2. Use-specific risk mitigation measures --- 4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.14. Use description Table 14 Use #114 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas. (e.g. in case of diseases/special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time. The product is restricted to adult use only. 4.14.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. Avoid disinfection in the presence of children <6 years. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 11 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed. Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans. Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 24 Authorisation number EU-0034420-0011 1-11 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 75 % (w/w) 1. META SPC 12 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 12 identifier Identifier meta SPC12 1.2. Suffix to the authorisation number Number 1-12 1.3. Product type(s) Product type(s) PT01: Human hygiene 2. META SPC 12 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 12 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,1 - 63,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 12 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12 Hazard statements H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. Precautionary statements P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local and national regulations. P501: Dispose of container in accordance with local and national regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #115 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.2. Use description Table 2 Use #116 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activit)y - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 4.2.2. Use-specific risk mitigation measures --- 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.3. Use description Table 3 Use #117 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.3.2. Use-specific risk mitigation measures --- 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.4. Use description Table 4 Use #118 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) Category(ies) of users industrial Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. 4.4.2. Use-specific risk mitigation measures --- 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.5. Use description Table 5 Use #119 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area. Do not use near domestic animals. In case of skin dryness, use appropriate skin care lotion. Use is restricted for adults only. 4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 4.6. Use description Table 6 Use #120 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) Category(ies) of users general public (non-professional) Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. The product is restricted to adult use only. 4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE) and bag/sachet (PE): 6 days 4.7. Use description Table 7 Use #121 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #121.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #121.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #121.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #121.2.: : 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #121.1.: as required (typically 25 applications per day) Use #121.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.7.2. Use-specific risk mitigation measures --- 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.8. Use description Table 8 Use #122 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #122.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry. Use #122.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #122.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #122.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #122.1.: as required (typically 25 applications per day) Use #122.2.: as required (typically 4 applications per day) Category(ies) of users industrial professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.8.2. Use-specific risk mitigation measures --- 4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.9. Use description Table 9 Use #123 Surgical hand rub - professional user - bacteria, yeasts, fungi - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Field(s) of use indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Bactericide, yeasticide, fungicide: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.9.2. Use-specific risk mitigation measures --- 4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 4.10. Use description Table 10 Use #124 Hygienic/surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Fungi Common name: fungi Development stage: vegetative cells Scientific name: Tuberculosis bacteria Common name: Tuberculosis bacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable Field(s) of use indoor use Use #124.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #124.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - Application rate(s) and frequency Application Rate: Use #124.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #124.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total) Number and timing of application: Frequency: Use #124.1.: as required (typically 25 applications per day) Use #124.2.: as required (typically 4 applications per day) Category(ies) of users professional Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time. Surgical hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time. Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions. 4.10.2. Use-specific risk mitigation measures --- 4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight. Store at room temperature in the original container. Shelf life: Bottle (PE), bag/sachet (PE): 6 days 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 12 5.1. Instructions for use Application technique: Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers. Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action. Step 3: Open fingers and rub the finger webs. Reverse and repeat action. Step 4: Rub palm to palm with fingers interlocked (5 times). Step 5: Rub thumb of each hand using a rotating movement. Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely. Do not use the product together with other products. Always read the label or leaflet before use and follow all the instructions provided. Keep out of reach of children and non-target animals/pets. Avoid contact to eyes. Do not eat, drink or smoke when using this product. Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time. 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects: None. First aid instructions: General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur. If medical advice is needed, have product container or label at hand. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. IF SWALLOWED: Rinse mouth. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE. Emergency measures to protect the environment: Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents). Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. In case of contamination of soil or water bodies notify the competent authorities. Beware of the explosion danger. Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks). Use non-sparking tools and explosion-proof equipment. Take precautionary measures against static discharge. Ensure electrical continuity by bonding and grounding (earthing) all equipment. 5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements. Avoid (direct) release (of undiluted product) to the environment/sewage system. Do not empty into drains. Dilute spills with water and mop up. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage --- 6. OTHER INFORMATION Recommendation for professional use: P280 Wear eye protection Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family. With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Schülke® 25 Authorisation number EU-0034420-0012 1-12 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,1 % (w/w)

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