Commission Implementing Regulation (EU) 2026/2116 of 8 September 2026 granting a Union authorisation for the biocidal product family Christeyns Peracetic Acid Biocidal Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
In force
Version historyWe hold this version only; in force from 2026-09-08.
Data as of 2026-10-15 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0035834-0000 is hereby granted to Christeyns NV for the making available on the market and use of the biocidal product family ‘Christeyns Peracetic Acid Biocidal Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 15 October 2026 until 30 September 2036.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Christeyns Peracetic Acid Biocidal Product Family Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene Authorisation number EU-0035834-0000 R4BP asset number EU-0035834-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name Christeyns Peracetic Acid Biocidal Product Family 1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene 1.3. Authorisation holder Name and address of the authorisation holder Name Christeyns NV Address Afrikalaan 182 9000 Gent BE Authorisation number EU-0035834-0000 R4BP asset number EU-0035834-0000 Date of the authorisation 15 October 2026 Expiry date of the authorisation 30 September 2036 1.4. Manufacturer(s) of the product Name of manufacturer Christeyns N.V. Address of manufacturer Afrikalaan 182, 9000 Gent, Belgium Location of manufacturing sites Christeyns N.V. site 1 Afrikalaan 182, 9000 Gent Belgium Name of manufacturer Christeyns France S.A. Address of manufacturer Rue de la Maladrie 31 44124 Vertou France Location of manufacturing sites Christeyns France S.A. site 1 Rue de la Maladrie 31 44124 Vertou France Name of manufacturer Christeyns UK Address of manufacturer Rutland Street BD4 7EA Bradford United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sites Christeyns UK site 1 Rutland Street BD4 7EA Bradford United Kingdom of Great Britain and Northern Ireland (the) Name of manufacturer Christeyns Italia S.R.L Address of manufacturer Via Aldo Moro, 30 20060 Pessano Con Bornago, Milan Italy Location of manufacturing sites Christeyns Italy site 1 Via Aldo Moro, 30 20060 Pessano Con Bornago, Milan Italy Name of manufacturer Pliwa Hygiene GmbH Address of manufacturer Pliwastraße 2 34323 Malsfeld Germany Location of manufacturing sites Pliwa Hygiene GmbH Pliwastraße 2 34323 Malsfeld Germany 1.5. Manufacturer(s) of the active substance(s) Active substance Peracetic acid Name of manufacturer Christeyns N.V. Address of manufacturer Afrikalaan 182, 9000 Gent, Belgium Location of manufacturing sites Christeyns N.V. site 1 Afrikalaan 182, 9000 Gent Belgium Active substance Peracetic acid Name of manufacturer Christeyns France S.A. Address of manufacturer Rue de la Maladrie 31 44124 Vertou France Location of manufacturing sites Christeyns France S.A. site 1 Rue de la Maladrie 31, Pl de la Vertonne 44124 Vertou France 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,008 - 15 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1 - 25,7 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 0,8 - 18,2 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 0 - 2,8 % (w/w) Ethanol ethanol Non-active substance 64-17-5 200-578-6 0 - 4,68 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0 - 7,68 % (w/w) Propan-2-ol Non-active substance 67-63-0 200-661-7 0 - 0,9 % (w/w) Phosphoric acid phosphoric acid Non-active substance 7664-38-2 231-633-2 0 - 0,23 % (w/w) Alcohol Ethoxylated Isotridecanol, ethoxylated Non-active substance 69011-36-5 931-138-8 0 - 4 % (w/w) Dodecylbenzenesulfonic acid 4-(tridecan-3-yl)benzene-1-sulfonic acid Non-active substance 85536-14-7 287-494-3 0 - 2,7 % (w/w) Amines, C12-14 (even nummers)-alkyldimethyl, N-oxides Amines, C12-14 (even nummers)-alkyldimethyl, N-oxides Non-active substance 308062-28-4 931-292-6 0 - 2,142 % (w/w) 2.2. Type(s) of formulation Formulation type(s) AL Any other liquid SL Soluble concentrate Impregnated wipes PART II. SECOND INFORMATION LEVEL META SPC(S) 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC: Meta SPC 1 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,0125 - 0,0125 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,49 - 1,49 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,4 - 1,4 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 0,8 - 0,8 % (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 H290: May be corrosive to metals. H412: Harmful to aquatic life with long lasting effects. Precautionary statements P102: Keep out of reach of children. P234: Keep only in original packaging. P273: Avoid release to the environment. P390: Absorb spillage to prevent material damage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 1.1 – PT2 hard non-porous surface disinfection, trigger spraying and wiping Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: viruses (limited spectrum virucidal activity) Common name: bacteria Common name: yeasts Field(s) of use indoor use Small hard non-porous surfaces, non-healthcare. General public: houses (incl. bathrooms) Professional users: institutions, workplaces, hotels, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses. Application method(s) Method: - Trigger spraying (and wiping to spread the disinfectant) and wiping (trigger spray into the wipe) Detailed description: The product is ready-to-use. Apply by trigger spraying (and wiping to spread the disinfectant). Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature For professional users: Contact time: 15 minutes in dirty conditions against bacteria, yeasts and viruses (limited spectrum) for trigger spray (and wiping to spread the disinfectant), and with wiping (trigger spray into the wipe) against bacteria and yeast after 5 minutes contact time in dirty conditions. For general public (non-professional): Contact time: 15 minutes in dirty conditions against bacteria and yeasts for trigger spray (and wiping to spread the disinfectant), and with wiping (trigger spray into the wipe) against bacteria and yeast after 5 minutes contact time in dirty conditions. Number and timing of application: Frequency: Up to 5 applications/day (general public), Up to 19 applications/day (professional users) Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE=High Density Polyethylene) 5 L refill cans (HDPE) with screw caps (HDPE) (for professional users only) 4.1.1. Use-specific instructions for use Trigger spraying and wiping of hard non-porous surfaces Trigger spray: Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Wiping (trigger spray into the wipe): The product can also be sprayed on a wipe and then applied on the surface. Assure that the surface is completely wet and remains wet during the required contact time. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Comply with the instructions for use 4.1.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 1.2 – PT4 hard non-porous surface disinfection, trigger spraying and wiping Product type PT04: Food and feed area Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: viruses Common name: bacteria Common name: yeasts Field(s) of use indoor use Small hard non-porous surfaces General public: kitchens Professional users: large-scale kitchens, restaurants, food & beverage industry, feed industry Application method(s) Method: Trigger spraying (and wiping to spread the disinfectant) and wiping (trigger spray into the wipe) Detailed description: The product is ready-to-use. Apply by trigger spraying (and wiping to spread the disinfectant). Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. Contact time: 15 minutes in dirty conditions against bacteria, yeasts and viruses for trigger spray (with wiping to spread the disinfectant), and with wiping (trigger spray into the wipe) against bacteria and yeast after 5 minutes contact time in dirty conditions. Number and timing of application: Frequency: Up to 5 applications/day (general public), Up to 19 applications/day (professional users) Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) (for professional users only) 4.2.1. Use-specific instructions for use Trigger spraying and wiping of hard non-porous surfaces Trigger spray: Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Wiping (trigger spray into the wipe): The product can also be sprayed on a wipe and then applied on the surface. Assure that the surface is completely wet and remains wet during the required contact time. Treated surfaces or objects that may come into contact with food, feed, drinks and ingredients thereof should be rinsed with potable water after disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Comply with the instructions for use 4.2.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 3 months Keep out of reach of children and non-target animals/pets. 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. 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) Chriox Spray Market area: EU Desinfectant Détartrant Market area: EU Authorisation number EU-0035834-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,0125 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,49 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,4 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 0,8 % (w/w) 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC: Meta SPC 2 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,009 - 0,009 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 2,87 - 2,87 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 0,8 - 0,8 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 0,24 - 0,24 % (w/w) Ethanol ethanol Non-active substance 64-17-5 200-578-6 4,68 - 4,68 % (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 H319: Causes serious eye irritation. H290: May be corrosive to metals. H412: Harmful to aquatic life with long lasting effects. Precautionary statements P234: Keep only in original packaging. P264: Wash hands thoroughly after handling. P273: Avoid release to the environment. P280: Wear protective clothing. Wear protective gloves. Wear eye/face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313: If eye irritation persists: Get medical advice. P337+P313: If eye irritation persists: Get medical attention. P390: Absorb spillage to prevent material damage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 2.1 – PT2 hard non-porous surface disinfection, trigger spraying and wiping Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use indoor use Small hard non-porous surfaces Hospitals, institutions, hotels, workplaces, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Trigger spraying (and wiping to spread the disinfectant) and wiping (trigger spray into the wipe) Detailed description: The product is ready-to-use. Apply by trigger spraying (and wiping to spread the disinfectant). Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. PT2 healthcare: Surfaces must be pre-cleaned before disinfection. Routine use: Against bacteria and yeasts after 5 minutes in clean conditions with wiping (trigger spray into the wipe). Special use: against fungi after 15 minutes contact time in clean conditions with wiping (trigger spray into the wipe). PT2 non-healthcare: Routine use: Against bacteria and yeasts after 5 minutes in clean conditions with wiping (trigger spray into the wipe). Routine use: against bacteria and yeasts after 5 minutes contact time in dirty conditions with trigger spray (with wiping to spread the liquid). Special use: against fungi after 15 minutes contact time in clean conditions with wiping (trigger spray into the wipe) . Special use: also against fungi after 15 minutes contact time in dirty conditions with trigger spray (with wiping to spread the liquid). Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.1.1. Use-specific instructions for use Trigger spraying and wiping of hard non-porous surfaces Trigger Spray: Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Wiping (trigger spray into the wipe): The product can also be sprayed on a wipe and then applied on the surface. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. 4.1.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). Keep unprotected people away from treated surfaces until dry. Hygiene measures: Wash hands after handling the product. 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 First aid instructions IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. 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: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 2.2 – PT4 hard non-porous surface disinfection, trigger spraying and wiping Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use indoor use Small hard non-porous surfaces Large-scale kitchens, restaurants, food & beverage industry, feed industry Application method(s) Method: Trigger spraying (and wiping to spread the disinfectant) and wiping (trigger spray into the wipe) Detailed description: The product is ready-to-use. Apply by trigger spraying (and wiping to spread the disinfectant). Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. Routine use: against bacteria and yeasts after 5 minutes in dirty conditions for trigger spray (with wiping to spread the liquid). Routine use: Against bacteria and yeasts after 5 minutes in clean conditions with wiping (trigger spray into the wipe). Special use: against fungi after 15 minutes in dirty conditions for trigger spray (with wiping to spread the liquid). Special use: against fungi after 15 minutes contact time in clean conditions with wiping (trigger spray into the wipe). Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.2.1. Use-specific instructions for use Trigger spraying and wiping of hard non-porous surfaces Trigger spray: Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Wiping (trigger spray into the wipe): The product can also be sprayed on a wipe and then applied on the surface. Assure that the surface is completely wet and remains wet during the required contact time. Treated surfaces or objects that may come into with food, feed, drinks and ingredients thereof should be rinsed with potable water after disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. 4.2.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). Keep unprotected people away from treated surfaces until dry. Hygiene measures: Wash hands after handling the product. 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 First aid instructions IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. 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: If symptoms occur call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 3 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. 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) Proglass Désinfectant Market area: EU Resolutions Détergent Désinfectant Toutes Surfaces Market area: EU Phago’Soft Market area: EU Authorisation number EU-0035834-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,009 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 2,87 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 0,8 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 0,24 % (w/w) Ethanol ethanol Non-active substance 64-17-5 200-578-6 4,68 % (w/w) 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier Meta SPC: Meta SPC 3 1.2. Suffix to the authorisation number Number 1-3 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,014 - 0,014 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,48 - 1,48 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,2 - 1,2 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 2,8 - 2,8 % (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 H315: Causes skin irritation. H318: Causes serious eye damage. H290: May be corrosive to metals. H412: Harmful to aquatic life with long lasting effects. Precautionary statements P234: Keep only in original packaging. P264: Wash hands thoroughly after handling. P273: Avoid release to the environment. P280: Wear eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P321: Specific treatment (see on this label). P332+P313: If skin irritation occurs: Get medical attention. P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. P390: Absorb spillage to prevent material damage. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 3.1 – PT2 hard non-porous surface disinfection, trigger spraying Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small hard non-porous surfaces Hospitals, institutions, hotels, workplaces, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Trigger spraying Detailed description: The product is ready-to-use. Apply by trigger spraying. Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature PT2 healthcare: Surfaces must be pre-cleaned before disinfection. Routine use: against bacteria and yeasts after 5 minutes in clean conditions. Special use: against fungi and viruses after 15 minutes contact time in clean conditions. PT2 non-healthcare: Routine use: against bacteria and yeasts after 5 minutes in dirty conditions Special use: against fungi and viruses after 15 minutes in dirty conditions Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.1.1. Use-specific instructions for use Trigger spraying of hard non-porous surfaces Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. 4.1.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: The use of eye protection according to EN166 or equivalent during handling of the product is mandatory. Wear protective chemical resistant gloves according to EN374 or equivalent during handling of the product is mandatory. See section 6 for the full titles of the European Standard and Council Directive. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user. Hygiene measures: Wash hands after handling the product. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 3.2 – PT4 hard non-porous surface disinfection, trigger spraying Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small hard non-porous surfaces Large-scale kitchens, restaurants, food & beverage industry, feed industry Application method(s) Method: Trigger spraying Detailed description: The product is ready-to-use. Apply by trigger spraying. Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. Routine use: against bacteria and yeasts after 5 minutes in dirty conditions . Special use: against fungi and viruses after 15 minutes in dirty conditions. Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.2.1. Use-specific instructions for use Spray the product directly onto the hard non-porous surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. Treated surfaces or objects that may come into contact with food, feed, drinks and ingredients thereof should be rinsed with potable water after disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. 4.2.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: The use of eye protection according to EN166 or equivalent during handling of the product is mandatory. Wear protective chemical resistant gloves according to EN374 or equivalent during handling of the product is mandatory. See Section 6 for the full titles of the European Standards and Council Directive. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user. Only for treatment of small surfaces (up to 0,5m 2 ). 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 3.3 – PT2 toilet bowl disinfection, trigger spraying Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small hard non-porous surfaces Hospitals, institutions, hotels, workplaces, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Trigger spraying Detailed description: The product is ready-to-use. Apply by trigger spraying. Surfaces must be pre-cleaned before disinfection. Spray enough liquid to keep the surface wet during the required contact time. Place a warning sign during disinfection. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. Routine use: against bacteria and yeasts after 5 minutes contact time in clean conditions. Special use: also against fungi and viruses after 15 minutes contact time in clean conditions. Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.3.1. Use-specific instructions for use Toilet bowl disinfection by trigger spraying Spray the product directly onto the surface to be treated and let dry or scrub off after the required contact time. If necessary, scrub the product over the surface with a toilet brush to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between applications and the next use of the treated surface. Place a warning sign during disinfection. 4.3.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: The use of eye protection according to EN166 or equivalent during handling of the product is mandatory. Wear protective chemical resistant gloves according to EN374 or equivalent during handling of the product is mandatory. See section 6 for the full titles of the European Standards and Council Directive. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 12 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 166 - Eye protection against chemicals EN 374 - Protective gloves against dangerous chemicals and micro-organisms Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Nettoyant Désinfectant Sanitaire Market area: EU Hygiasan Market area: EU Phago’Sanit Market area: EU Axisurf Biofilm3D Market area: EU Authorisation number EU-0035834-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,014 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,48 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,2 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 2,8 % (w/w) 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier Meta SPC: Meta SPC 4 1.2. Suffix to the authorisation number Number 1-4 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,034 - 0,034 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 3,22 - 3,22 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,16 - 1,16 % (w/w) Propan-2-ol Non-active substance 67-63-0 200-661-7 0,9 - 0,9 % (w/w) Phosphoric acid phosphoric acid Non-active substance 7664-38-2 231-633-2 0,23 - 0,23 % (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 H411: Toxic to aquatic life with long lasting effects. H290: May be corrosive to metals. Precautionary statements P102: Keep out of reach of children. P234: Keep only in original packaging. P273: Avoid release to the environment. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 4.1 – PT2 hard non-porous surface disinfection, trigger spraying and wiping Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Common name: bacterial spores Common name: Mycobacteria Field(s) of use indoor use Small hard non-porous surfaces Hospitals, institutions, hotels, workplaces, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Trigger spraying (with wiping to spread the liquid) and wiping (trigger spray into the wipe) Detailed description: The product is ready-to-use. Apply by trigger spraying (and wiping). Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature For professional users: PT2 healthcare: Routine use: against bacteria, yeasts, fungi, and mycobacteria after 5 minutes contact time in dirty conditions with wiping (trigger spray into the wipe). Special use: For trigger spray (with wiping to spread the liquid) against viruses (limited spectrum virucidal activity already after 5 minutes) after 15 minutes, and against mycobacteria after 5 minutes in dirty conditions. Against bacterial spores after 15 minutes in clean conditions. PT2 non-healthcare: Routine use: Against bacteria, yeast, fungi, and mycobacteria after 5 minutes contact time in dirty conditions with wiping (trigger spray into the wipe). Routine use: against bacteria, yeasts, limited spectrum virucidal activity and mycobacteria after 5 minutes contact time in dirty conditions for trigger spray (with wiping to spread the liquid). Special use: against bacterial spores, fungi and full spectrum viruses after 15 minutes in dirty conditions for trigger spray (with wiping to spread the liquid). For general public (non-professional): PT2 healthcare: Routine use: against bacteria, yeasts, fungi, and mycobacteria after 5 minutes contact time in dirty conditions with wiping (trigger spray into the wipe). Special use: For trigger spray (with wiping to spread the liquid) against viruses after 15 minutes, and against mycobacteria after 5 minutes in dirty conditions. Against bacterial spores after 15 minutes in clean conditions. PT2 non-healthcare: Routine use: Against bacteria, yeast, fungi, and mycobacteria after 5 minutes contact time in dirty conditions with wiping (trigger spray into the wipe). Routine use: against bacteria, yeasts, and mycobacteria after 5 minutes contact time in dirty conditions for trigger spray (with wiping to spread the liquid). Special use: against bacterial spores, fungi and viruses after 15 minutes in dirty conditions for trigger spray (with wiping to spread the liquid). Number and timing of application: Frequency: Professional users: Up to 19 applications/day. General public: Up to 5 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) (for professional users only) 4.1.1. Use-specific instructions for use Trigger spraying and wiping of hard non-porous surfaces Trigger spray: Spray the product directly onto the surface to be treated, spread the product with a wipe or cloth and let dry or wipe off after the required contact time. Wiping (trigger spray into the wipe): The product can also be sprayed on a wipe and then applied on the surface. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. In case of heavy soiling, first clean the surface before applying as above. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Comply with the instructions for use. 4.1.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 4.2 – PT3 hard non-porous surface disinfection, trigger spraying Product type PT03: Veterinary hygiene Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small hard non-porous surfaces Disinfection of hard non-porous surfaces by trigger spraying (animal housing, cages). Application method(s) Method: Trigger spraying (and wiping to spread the disinfectant) Detailed description: The product is ready-to-use. Apply by trigger spraying and wiping. Surfaces must be pre-cleaned before disinfection. Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use: against bacteria, yeasts, viruses and fungi after 30 minutes in clean conditions. Number and timing of application: Frequency: Professional users: Up to 19 applications/day. General public: Up to 5 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) (for professional users only) 4.2.1. Use-specific instructions for use Trigger spraying of open surfaces Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Only for use on non-porous surfaces. Comply with the instructions for use. 4.2.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). The product should not be used in the presence of animals. 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 4.3 – PT4 hard non-porous surface disinfection, trigger spraying and wiping Product type PT04: Food and feed area Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Common name: bacterial spores Common name: Mycobacteria Field(s) of use indoor use Small hard non-porous surfaces Large-scale kitchens, restaurants, food & beverage industry, feed industry, Application method(s) Method: Trigger spraying (and wiping to spread the disinfectant) and wiping (trigger spray into the wipe) Detailed description: The product is ready-to-use. Apply by trigger spraying and wiping. Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature Routine use: Against bacteria, yeast, fungi, and mycobacteria after 5 minutes contact time in dirty conditions with wiping (trigger spray into the wipe). Routine use: against bacteria, yeasts, viruses and mycobacteria after 5 minutes in dirty conditions for trigger spray (with wiping to spread the liquid). Special use: against bacterial spores, fungi and viruses after 15 minutes in dirty conditions for trigger spray (with wiping to spread the liquid). Number and timing of application: Frequency: Professional users: Up to 19 applications/day. General public: Up to 5 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) (for professional users only) 4.3.1. Use-specific instructions for use Trigger spraying and wiping of hard non-porous surfaces Trigger spray: Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Wiping (trigger spray into the wipe): The product can also be sprayed on a wipe and then applied on the surface. Assure that the surface is completely wet and remains wet during the required contact time.For use in clean conditions, surfaces must be pre-cleaned before disinfection. Treated surfaces or objects that may come into contact with food, feed, drinks and ingredients thereof should be rinsed with potable water after disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Comply with the instructions for use. 4.3.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Only for treatment of small surfaces (up to 0,5m 2 ). 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 12 months Keep out of reach of children and non-target animals/pets. 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. 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) Phago’Spore Market area: EU Axisurf Consult Market area: EU AIRANDE H2O2 Solution 3 Market area: EU NOSOSOL 3.25% Market area: EU Multi-Prop H2O2 Market area: EU Authorisation number EU-0035834-0004 1-4 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,034 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 3,22 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,16 % (w/w) Propan-2-ol Non-active substance 67-63-0 200-661-7 0,9 % (w/w) Phosphoric acid phosphoric acid Non-active substance 7664-38-2 231-633-2 0,23 % (w/w) 1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier Meta SPC: Meta SPC 5 1.2. Suffix to the authorisation number Number 1-5 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,014 - 0,014 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,48 - 1,48 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,2 - 1,2 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 2,8 - 2,8 % (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 H290: May be corrosive to metals. H315: Causes skin irritation. H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. EUH208: Contains cineole. May produce an allergic reaction. Precautionary statements P234: Keep only in original packaging. P264: Wash hands thoroughly after handling. P273: Avoid release to the environment. P280: Wear eye protection/gloves. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P321: Specific treatment (see on this label). P332+P313: If skin irritation occurs: Get medical attention. P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. P390: Absorb spillage to prevent material damage. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 5.1 – PT2 hard non-porous surface disinfection, trigger spraying Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small hard non-porous surfaces Professional: hospitals, institutions, hotels, workplaces, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Trigger spraying Detailed description: The product is ready-to-use. Apply by trigger spraying. Spray enough liquid to keep the surface wet during the required contact time Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature PT2 Healthcare: Surfaces must be pre-cleaned before disinfection. Routine use: against bacteria and yeasts after 5 minutes in clean conditions. Special use: also, against fungi and viruses after 15 minutes in clean conditions. PT2 non-healthcare: Routine use: against bacteria and yeasts after 5 minutes in dirty conditions. Special use: against fungi and viruses after 15 minutes in dirty conditions. Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.1.1. Use-specific instructions for use Trigger spraying of hard non-porous surfaces Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. 4.1.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Only for treatment of small surfaces (up to 0,5m 2 ). The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: The use of eye protection according to EN166 or equivalent during handling of the product is mandatory. Wear protective chemical resistant gloves according to EN374 or equivalent during handling of the product is mandatory. See Section 6 for the full titles of the European Standard and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 5.2 – PT4 hard non-porous surface disinfection, trigger spraying Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small hard non-porous surfaces Professional: large-scale kitchens, restaurants, food & beverage industry, feed industry Application method(s) Method: Trigger spraying Detailed description: The product is ready-to-use. Apply by trigger spraying. Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. Routine use: against bacteria and yeasts after 5 minutes contact time in dirty conditions. Special use: against fungi and viruses after 15 minutes contact time in dirty conditions. Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.2.1. Use-specific instructions for use Trigger spraying of hard non-porous surfaces Spray the product directly onto the surface to be treated and let dry or wipe off after the required contact time. If necessary, wipe the product over the surface with a wipe or cloth to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. Treated surfaces or objects that may come into contact with food, feed, drinks and ingredients thereof should be rinsed with potable water after disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. 4.2.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Only for treatment of small surfaces (up to 0,5m 2 ). The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: The use of eye protection according to EN166 or equivalent during handling of the product is mandatory. Wear protective chemical resistant gloves according to EN374 or equivalent during handling of the product is mandatory. See Section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 5.3 – PT2 toilet bowl disinfection, trigger spraying Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Field(s) of use indoor use Small surfaces Professional: hospitals, institutions, hotels, workplaces, buildings, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Trigger spraying Detailed description: The product is ready-to-use. Apply by trigger spraying. Surfaces must be pre-cleaned before disinfection. Spray enough liquid to keep the surface wet during the required contact time. Place a warning sign during disinfection. Application rate(s) and frequency Application Rate: ca.20 mL/m 2 Use at room temperature. Routine use: against bacteria and yeasts after 5 minutes contact time in clean conditions. Special use: also against fungi and viruses after 15 minutes contact time in clean conditions. Number and timing of application: Frequency: Up to 19 applications/day Application rate of ca. 20 ml / m 2 is equivalent to 17 strokes/m 2 Category(ies) of users professional Pack sizes and packaging material 750 ml flasks with trigger spraying device inside (HDPE) 5 L refill cans (HDPE) with screw caps (HDPE) 4.3.1. Use-specific instructions for use Toilet bowl disinfection by trigger spraying: Spray the product directly onto the surface to be treated and let dry or scrub off after the required contact time. If necessary, scrub the product over the surface with a toilet brush to spread it out. Assure that the surface is completely wet and remains wet during the required contact time. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Place a warning sign during disinfection. 4.3.2. Use-specific risk mitigation measures Ensure that application is carried out in well-ventilated areas. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Only for treatment of small surfaces (up to 0,5m 2 ). The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: The use of eye protection according to EN166 or equivalent during handling of the product is mandatory. Wear protective chemical resistant gloves according to EN374 or equivalent during handling of the product is mandatory. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 12 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 166 - Eye protection against chemicals EN 374 - Protective gloves against dangerous chemicals and micro-organisms Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) NETTOYANT Désinfectant & détartrant Eucalyptus Market area: EU Authorisation number EU-0035834-0005 1-5 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,014 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,48 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,2 % (w/w) L-(+)-lactic acid (2S)-2-hydroxypropanoic acid Non-active substance 79-33-4 201-196-2 2,8 % (w/w) 1. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier Meta SPC: Meta SPC 6 1.2. Suffix to the authorisation number Number 1-6 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 2,4 - 2,4 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 7,3 - 7,3 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 16,2 - 16,2 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,5 - 0,5 % (w/w) Alcohol Ethoxylated Isotridecanol, ethoxylated Non-active substance 69011-36-5 931-138-8 4 - 4 % (w/w) Dodecylbenzenesulfonic acid 4-(tridecan-3-yl)benzene-1-sulfonic acid Non-active substance 85536-14-7 287-494-3 2,7 - 2,7 % (w/w) 2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements H272: May intensify fire; oxidiser. H290: May be corrosive to metals. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H410: Very toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P234: Keep only in original packaging. P260: Do not breathe mist/vapours/spray. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing. Wear protective gloves. Wear eye/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. 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. P310: Immediately call a POISON CENTER or doctor/physician. P363: Wash contaminated clothing before reuse. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 6.1 – PT2 hard non-porous surface disinfection, low-pressure spraying/foaming, 0,5-2 % (v/v) dilutions Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacterial spores Common name: viruses Common name: bacteria Common name: yeasts Field(s) of use indoor use Non-food industry (e.g. pharmaceuticals, cosmetics) Application method(s) Method: low-pressure foaming Detailed description: Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: 0,5 % (v/v) dilution against bacteria and yeasts after 5 minutes contact time in clean* and 15 minutes contact time in dirty conditions at 20 o C. Special use : 2 % (v/v) dilution against viruses after 5 minutes in clean* conditions and against Bacterial spores after 10 minutes in clean* conditions at 20 o C. *Surfaces must be cleaned before disinfection. Special use: 0,8 % (v/v) dilution against bacteria and yeasts after 5 minutes contact time in dirty conditions at 10°C (for use in refrigerators). Number and timing of application: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC (Intermediate Bulk Container) HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.1.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.1.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (according to EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : — Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Do not apply in rooms smaller than 100 m 3 . For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Respiratory equipment when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,5 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Special Use (2 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation 3 ACH or ≥ 300 m3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. Special Use (0,75-0,8 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 6.2 - PT4 hard non-porous surface disinfection, low-pressure spraying/foaming, 0,5-2 % (v/v) dilutions Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacterial spores Common name: viruses Common name: fungi Common name: bacteria Common name: yeasts Common name: bacteriophages Field(s) of use indoor use Food, beverages and feed industry Dairy industry Breweries Application method(s) Method: low-pressure foaming Detailed description: Spray enough liquid to keep the surface wet during the required contact time. Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: PT4 general food industry: 0,5 % (v/v) dilution against bacteria and yeasts after 5 minutes in clean* and 15 minutes contact time in dirty conditions at 20 o C. For breweries: Routine use: At 0,75 % (v/v) dilution against bacteria and yeast after 5 minutes contact time in clean conditions at 20 o C. Special use for PT4 general industry and breweries: 2 % (v/v) dilution against viruses after 5 minutes in clean* conditions and against bacterial spores after 10 minutes in clean* conditions at 20 o C. Special use: 0,8 % (v/v) dilution against bacteria and yeasts after 5 minutes contact time in dirty conditions at 10°C (for use in refrigerators). For uses on dairy farms and in dairy industry: Routine use: 0,5 % (v/v) against bacteria, yeast and bacteriophages after 5 minutes contact time at 20 o C in milk conditions. Special use: 2 % (v/v) against fungi after 15 minutes contact time at 20 o C in clean* and milk conditions. * Surfaces must be cleaned before disinfection. Number and timing of application: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.2.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.2.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size > 100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . m 3 For re-entry, the undercut of AECinhalation of 0.5 mg peracetic acid/m 3 and 1.25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use and dairy industry (0.5 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Routine Use (0.75-0.8 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Special Use (2 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation 3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 6.3: PT2 Disinfection of objects and equipment by dipping, 0,5-2 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacterial spores Common name: viruses Common name: bacteria Common name: yeasts Field(s) of use indoor use Non-food industry Application method(s) Method: Dipping Detailed description: The disinfection bath (liquid) can be used only once and should be replaced after each use. Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 l) Routine use: 0,5 % (v/v) dilution against bacteria and yeasts after 5 minutes in clean* and 15 minutes contact time in dirty conditions at 20 o C. Special use: 2 % (v/v), against viruses after 5 minutes contact time and 10 minutes for bacterial spores in clean* conditions at 20 o C. Special use: 0,8 % (v/v) dilution against bacteria and yeasts after 5 minutes contact time in dirty conditions at 10°C (for use in refrigerators). * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 19 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.3.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.3.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size > 100-300 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.4. Use description Table 4 Use 6.4: PT4 Disinfection of objects and equipment by dipping, 0,5-2 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteriophages Common name: bacterial spores Common name: viruses Common name: fungi Common name: bacteria Common name: yeasts Field(s) of use indoor use Food, beverages and feed industry Dairy industry Breweries Application method(s) Method: Dipping Detailed description: The disinfection bath (liquid) can be used only once and should be replaced after each use. Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25L) PT4 General Food Industry Routine use: 0,5 % (v/v) dilution against bacteria and yeasts after 5 minutes in clean* and 15 minutes contact in dirty conditions at 20 o C. For breweries: Routine use: At 0,75 % (v/v) dilution against bacteria and yeast after 5 minutes contact time in clean* conditions. Special use for PT4 general industry and breweries: 2 % (v/v) against viruses after 5 minutes contact time and after 10 minutes against bacterial spores in clean* conditions at 20 o C. Special use: 0,8 % (v/v) dilution against bacteria and yeasts after 5 minutes contact time in dirty conditions at 10°C for use in refrigerators. For uses on dairy farms and in dairy industry: Routine use: 0,5 % (v/v) against bacteria, yeast and bacteriophages after 5 minutes contact time at 20 o C in milk conditions. Special use: 2 % (v/v) against fungi after 15 minutes contact time in milk conditions. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 19 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.4.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Treated objects that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.4.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. See Section 6 for the full titles of the European Standards and Council Directive. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size > 100m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 12 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 374 - Protective gloves against dangerous chemicals and micro-organisms EN 14387 - Respiratory protective devices - Gas filters and combined filters for use as replaceable components in unassisted respiratory protective devices (RPD) with the exception of escape devices EN 166 - Eye protection against chemicals EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with spray-tight (Type 4) connections, including items providing protection to parts of the body only (Type PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Mida Chriox F2 Market area: EU Peroxybac Foam Market area: EU Peroxybac Foam GA Market area: EU IF Fulldes Oxy Foam Market area: EU CCL PAA Foam 2.4% Market area: EU Perosan 2.4 % Foam Market area: EU Hydrosan PE Schaum Market area: EU Celacide PAA-Foam Market area: EU Brush foam 2 Market area: EU Mida agrifoam 2 Market area: EU Mida agriox F2 Market area: EU SynQ Red Des Market area: EU OxyFoam Market area: EU Peroxyfoam 2 Market area: EU Perronac F Market area: EU Farnax Delta F Market area: EU Azliox F Market area: EU Oxy Brosse F Market area: EU Antisept 36 Market area: EU Foodclean Des 40 Market area: EU LABAZ OXY CLEAN F Market area: EU PERADOX F Market area: EU PRO CLEAN PAF Market area: EU TOP CLEAN PAF Market area: EU Authorisation number EU-0035834-0006 1-6 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 2,4 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 7,3 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 16,2 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,5 % (w/w) Alcohol Ethoxylated Isotridecanol, ethoxylated Non-active substance 69011-36-5 931-138-8 4 % (w/w) Dodecylbenzenesulfonic acid 4-(tridecan-3-yl)benzene-1-sulfonic acid Non-active substance 85536-14-7 287-494-3 2,7 % (w/w) 1. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier Meta SPC: Meta SPC 7 1.2. Suffix to the authorisation number Number 1-7 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 2,8 - 2,8 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 7,8 - 7,8 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 18 - 18 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,48 - 0,48 % (w/w) Amines, C12-14 (even nummers)-alkyldimethyl, N-oxides Amines, C12-14 (even nummers)-alkyldimethyl, N-oxides Non-active substance 308062-28-4 931-292-6 2,14 - 2,14 % (w/w) 2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements H272: May intensify fire; oxidiser. H290: May be corrosive to metals. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H410: Very toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P234: Keep only in original packaging. P260: Do not breathe mist/vapours/spray. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing. Wear gloves. Wear eye/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. 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. P310: Immediately call a POISON CENTER or doctor. P363: Wash contaminated clothing before reuse. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 7.1 – PT2 hard non-porous surface disinfection, low-pressure spraying/foaming, 0,5 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Non-food industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry, non-food warehouses Application method(s) Method: Low-pressure foaming Detailed description: Surfaces should be cleaned before disinfection. Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: 0,5 % (v/v) against bacteria and yeasts after 5 minutes contact time in clean conditions at room temperature. Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.1.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.1.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Routine use (0,5 % (v/v) dilution): Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. In rooms ≥ 100 m 3 and ventilation 3 ACH or ≥ 300 m 3 and ventilation 1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. See section 6 for the full references to the titles of the European Standards and the Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 7.2 – PT3 hard non-porous surface disinfection, low pressure spraying/foaming, 0,5 % (v/v) dosage Product type PT03: Veterinary hygiene Target organism(s) (including development stage) Common name: viruses Common name: bacteria Common name: yeasts Field(s) of use indoor use Farms – empty animal housings – animal transport vehicles Application method(s) Method: Low-pressure foaming Detailed description: Surfaces should be cleaned before disinfection. The product should not be used in the presence of animals. Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: 0,5 % (v/v) against bacteria, yeasts and viruses after 5 minutes in clean conditions. Number and timing of application: Frequency: 1 application/day Category(ies) of users professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.2.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. Foam enough liquid to keep the surface wet during the required contact time. Only for use on non-porous surfaces. 4.2.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Do not use near livestock. Only use in empty animal housing. Keep unprotected people away from the treated room/vehicle. If it is necessary to be present for the bystander, wear same PPE as the professional user. Do not apply in rooms smaller than 100 m 3 . For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Routine use (0.5 % (v/v) dilution): Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. In rooms ≥ 100 m 3 and ventilation 3 ACH or ≥ 300 m 3 and ventilation 1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 7.3 – PT4 hard non-porous surface disinfection, low pressure spraying/foaming, 0,5 % (v/v) dosage. Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Food, beverages and feed industry Application method(s) Method: Low-pressure foaming Detailed description: Surfaces should be cleaned before disinfection. Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: 0,5 % (v/v) against bacteria and yeasts after 5 minutes in clean conditions at room temperature. Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.3.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. Foam enough liquid to keep the surface wet during the required contact time. 4.3.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m). Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Routine use (0,5 % (v/v) dilution): Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.4. Use description Table 4 Use 7.4: PT2 Disinfection of objects and equipment by dipping, 0,5 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Non-food industry (e.g. pharmaceuticals, cosmetics), non-healthcare industry. Application method(s) Method: Dipping Detailed description: Surfaces should be cleaned before disinfection. Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 L) Routine use: 0,5 % (v/v) against bacteria and yeasts after 5 minutes contact time in clean conditions at room temperature. Number and timing of application: Frequency: Up to 15 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.4.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.4.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.5. Use description Table 5 Use 7.5: PT4 Disinfection of objects and equipment by dipping, 0,5 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Food, beverages and feed industry Application method(s) Method: Dipping Detailed description: Surfaces should be cleaned before disinfection. Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 l) Routine use: 0,5 % (v/v) against bacteria and yeasts after 5 minutes contact time in clean conditions at room temperature Number and timing of application: Frequency: Up to 15 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.5.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Treated objects that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.5.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 18 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 374 - Protective gloves against dangerous chemicals and micro-organisms EN 14387 - Respiratory protective devices - Gas filters and combined filters for use as replaceable components in unassisted respiratory protective devices (RPD) with the exception of escape devices EN 166 - Eye protection against chemicals EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with spray-tight (Type 4) connections, including items providing protection to parts of the body only (Type PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Mida Chriox F3 Market area: EU Brush foam3 Market area: EU Mida agrifoam3 Market area: EU Mida agriox F3 Market area: EU SynQ Red Des Oxifoam ELC Market area: EU Peroxyfoam3 Market area: EU Perakyll FELC Market area: EU Perronac FELC Market area: EU Farnax Delta FELC Market area: EU Azliox FELC Market area: EU Oxy Brosse FLC Market area: EU Ökoron 13 Market area: EU Antisept 34 Market area: EU Foodclean Des 41 Market area: EU VITAFOR PERA F Market area: EU PERADOX FELC Market area: EU PRO CLEAN PAFELC Market area: EU TOP CLEAN PAFELC Market area: EU Authorisation number EU-0035834-0007 1-7 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 2,8 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 7,8 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 18 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,48 % (w/w) Amines, C12-14 (even nummers)-alkyldimethyl, N-oxides Amines, C12-14 (even nummers)-alkyldimethyl, N-oxides Non-active substance 308062-28-4 931-292-6 2,14 % (w/w) 1. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier Meta SPC: Meta SPC 8 1.2. Suffix to the authorisation number Number 1-8 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 4,9 - 4,9 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 23 - 23 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 8 - 8 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,48 - 0,48 % (w/w) 2.2. Type(s) of formulation of the meta SPC 8 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements H272: May intensify fire; oxidiser. H290: May be corrosive to metals. H302: Harmful if swallowed. H312: Harmful in contact with skin. H332: Harmful if inhaled. H314: Causes severe skin burns and eye damage. H410: Very toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P234: Keep only in original packaging. P260: Do not breathe mist/vapours/spray. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing. Wear protective gloves. Wear eye/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER/doctor. 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. P310: Immediately call a POISON CENTER or doctor/physician. P362+P364: Take off contaminated clothing and wash it before reuse. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 8.1: PT2 Cleaning-in-place (CIP), 0,3-2 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: Mycobacteria Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Common name: viruses Field(s) of use indoor use Non-Food Industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry Application method(s) Method: Cleaning-in-place Detailed description: Application rate(s) and frequency Application Rate: depending on size and characteristics of system. Use at room temperature. Routine use: - against bacteria and yeasts at 0,3 % (v/v) in clean conditions* after 5 minutes or at 0,5 % (v/v) in dirty conditions after 15 minutes. Special uses: - against bacterial spores and viruses at 2 % (v/v) after 5 minutes in clean conditions*, - against fungi at 2 % (v/v) and against mycobacteria at 1 % (v/v) after 15 minutes in clean conditions*. *Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.1.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.1.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 8.2: PT4 Cleaning-in-place (CIP), 0,3-4,8 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: Mycobacteria Common name: bacteria Common name: yeasts Common name: fungi Common name: bacteriophages Common name: bacterial spores Common name: viruses Field(s) of use indoor use Food, beverages and feed industry Dairy industry Dairy farms: the inside of milking systems and milking robots Breweries Application method(s) Method: Cleaning-in-place Detailed description: Use at room temperature Application rate(s) and frequency Application Rate: depending on characteristics of system. Use at room temperature Routine use PT4 general: — against bacteria and yeasts at 0.3 % (v/v) in clean* after 5 minutes or at 0.5 % (v/v) and dirty conditions after 15 minutes. For breweries: Routine use: against bacteria and yeast at 0,5 % (v/v) after 5 minutes in clean conditions* Special uses for PT4 general industry and breweries: — against bacterial spores and viruses at 2 % (v/v) after 5 minutes in clean conditions*, — against fungi at 2 % (v/v) and against mycobacteria at 1 % (v/v) after 15 minutes in clean conditions*. For uses on dairy farms and in the dairy industry: Routine use: at 0,3 % (v/v) against bacteria, yeasts and bacteriophage after 5 minutes in milk conditions. Special uses: — against fungi at 2 % (v/v) after 15 minutes in milk conditions. — against bacterial spores at 4,8 % (v/v) after 10 minutes and at 0,8 % (v/v) after 60 minutes in milk conditions. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.2.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use. 4.2.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).. The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Rinse treated surfaces/equipment/ pipes/machinery with drinking water after application. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 8.3 – PT2 hard non-porous surface disinfection, low-pressure spraying, 0,5-2 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: Mycobacteria Common name: bacterial spores Common name: viruses Common name: fungi Common name: yeasts Common name: bacteria Field(s) of use indoor use Non-food, non-healthcare (e.g. pharmaceuticals, cosmetics) industry and warehouses Application method(s) Method: Low-pressure spraying Detailed description: Use at room temperature Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: — against bacteria and yeasts at 0,5 % (v/v) after 5 minutes in clean* and after 15 minutes dirty conditions. Special uses: — against bacterial spores and viruses at 2 % (v/v) after 5 minutes in clean conditions*, — against fungi at 2 % (v/v) and against mycobacteria at 1 % (v/v) after 15 minutes in clean conditions*. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.3.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Cleaning of equipment can be done with water. Between application of the biocidal product and the next use of the product, no interval is required if the appropriate PPE is worn based on the use of the product. For re-entry without PPE, it should be ensured that the air concentration for hydrogen peroxide has dropped below the appropriate limit value, i.e. below 1.25 mg/m3 (0.9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide with technical and organizational measures (e.g. sensor, defined ventilation period). 4.3.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . m 3 For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,5 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Special Use (0.8-1 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. Special Use (2 % (v/v) dilution): Apply only in rooms of at least 100 m 3 with ventilation rate of at least 10 ACH or 300 m 3 with ventilation rate of at least 3 ACH. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.4. Use description Table 4 Use 8.4 – PT3 hard non-porous surface disinfection, low-pressure spraying, 0,5-5 % (v/v) dosage Product type PT03: Veterinary hygiene Target organism(s) (including development stage) Common name: fungi Common name: viruses Common name: yeasts Common name: bacteria Field(s) of use indoor use Farms – empty animal housings & transportation vehicles Application method(s) Method: Low-pressure spraying Detailed description: Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use for disinfection of animal transport vehicles and stables: — 0,5 % (v/v) product dilution against bacteria, yeasts and viruses after 5 minutes in clean conditions*. Special use for disinfection of stables: — 5 % (v/v) against fungi in clean conditions with 30 minutes contact time. * Surfaces must be cleaned before disinfection. Animals should not be present during disinfection. Number and timing of application: Frequency: 1 application/day Category(ies) of users professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.4.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. Only for use on non-porous surfaces. 4.4.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Keep unprotected people away from the treated room/vehicle. If it is necessary to be present for the bystander, wear same PPE as the professional user. Do not apply in rooms smaller than 100 m 3 . m 3 For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Routine use (0,5 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Special Use (5 % (v/v) dilution): Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Do not touch treated surface until they are dried. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.5. Use description Table 5 Use 8.5– PT4 hard non-porous surface disinfection, low-pressure spraying, > 0,5-4,8 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacterial spores Common name: Mycobacteria Common name: viruses Common name: fungi Common name: bacteria Common name: bacteriophages Common name: yeasts Field(s) of use indoor use Food, beverages and feed industry Breweries Dairy industry Dairy farms: the inside of milking systems and milking robots Application method(s) Method: Low-pressure spraying Detailed description: Application rate(s) and frequency Application Rate: 0,25 l/m 2 Use at room temperature PT4 general industry: Routine use: against bacteria and yeasts at 0,5 % (v/v) in clean* after 5 minutes and dirty conditions after 15 minutes. For breweries: Routine use: against bacteria and yeast at 0,5 % (v/v) after 5 minutes in clean conditions* Special uses for PT4 general industry and breweries: — against bacterial spores and viruses at 2 % (v/v) after 5 minutes in clean conditions*, — against fungi at 2 % (v/v) and against mycobacteria at 1 % (v/v) after 15 minutes in clean conditions*, For uses on dairy farms and in the dairy industry: Routine use: — at 0,5 % (v/v) against bacteria, yeasts and bacteriophages after 5 minutes. Special uses — against fungi at 2 % (v/v) after 15 minutes. — against bacterial spores at 4,8 % (v/v) after 10 minutes and at 0,8 % (v/v) after 60 minutes. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.5.1. Use-specific instructions for use Low-pressure foaming or spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Cleaning of equipment can be done with water. Between application of the biocidal product and the next use of the product, no interval is required if the appropriate PPE is worn based on the use of the product. For re-entry without PPE, it should be ensured that the air concentration for hydrogen peroxide has dropped below the appropriate limit value, i.e. below 1.25 mg/m3 (0.9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide with technical and organisational measures (e.g. sensor, defined ventilation period). 4.5.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . m 3 For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,5 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Special Use (0.8-1 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. Special Use (2 % (v/v) dilution): Apply only in rooms of at least 100 m 3 with ventilation rate of at least 10 ACH or 300 m 3 with ventilation rate of at least 3 ACH. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: - Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. Special Use (4.8 % (v/v) dilution): Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Do not touch treated surface until they are dried. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.6. Use description Table 6 Use 8.6 - PT2 Whole room fogging Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Non-food Industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry Application method(s) Method: fogging Detailed description: Application rate(s) and frequency Application Rate: 5,02 ml/m 3 Fogging: dry fogging Room size : 30 -150 m 2 Contact time after diffusion: 4h Temperature: room temperature RH: 40-80% Ready-to-use product Droplet size: < 5 μm Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.6.1. Use-specific instructions for use Whole room Fogging (dry fogging) Mixing and loading: Fill the fogging equipment with undiluted product. Application: Place the fogging equipment into the room and place the plug into the socket. Adjust the settings of the equipment to the product and room volume (Dosage: 5,02 ml/m 3 ). Switch on the equipment and leave the room. The equipment allows for some time to leave the room before it starts fogging. Close all doors and windows tightly. The equipment is switched off automatically after the required application time. Required contact time: 4 hours after diffusion Cleaning of equipment can be done with water. The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable “standard room”, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. 4.6.2. Use-specific risk mitigation measures Mixing and loading: Keep unprotected people away during mixing and loading. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application: During the diffusion, keep the room closed and do not enter in. Treatment should be conducted with no human or animals present. — All gaps present in the room (e.g. window frame) from where fog may leak must be sealed beforehand. — Ensure that access to the vapor-treated area is denied during the whole procedure with a warning sign. — The professional user shall enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m 3 ) wearing mandatory the following Personal protective equipment (PPE): Respiratory protective equipment (RPE) with Assigned Protection Factor (APF) 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves, eye protection, coverall). A built-in meter (calibrated sensor) must be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value for airborne hydrogen peroxide. Unprotected persons or animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m 3 (0,9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.7. Use description Table 7 Use 8.7 - PT4 Whole room fogging Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Food, beverages and feed industry and warehouses Application method(s) Method: fogging Detailed description: Application rate(s) and frequency Application Rate: 5,02 ml/m 3 Fogging: dry fogging Room size: 30 -150 m 3 Contact time after diffusion: 4h Temperature: room temperature RH: 40-80% Ready-to-use product Droplet size: < 5 μm Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.7.1. Use-specific instructions for use Whole room Fogging (dry fogging) Mixing and loading: Fill the fogging equipment with undiluted product. Application: Place the fogging equipment into the room and place the plug into the socket. Adjust the settings of the equipment to the product and room volume (Dosage: 5,02 ml/m 3 ). Switch on the equipment and leave the room. The equipment allows for some time to leave the room before it starts fogging. Close all doors and windows tightly. The equipment is switched off automatically after the required application time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Required contact time: 4 hours after diffusion. Cleaning of equipment can be done with water. The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable “standard room”, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. 4.7.2. Use-specific risk mitigation measures Mixing and loading: Keep unprotected people away during mixing and loading. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application: During the diffusion, keep the room closed and do not enter in. Treatment should be conducted with no human or animals present. — All gaps present in the room (e.g. window frame) from where fog may leak must be sealed beforehand. — Ensure that access to the vapor-treated area is denied during the whole procedure with a warning sign. — The professional user shall enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m 3 ) wearing mandatory the following Personal protective equipment (PPE): Respiratory protective equipment (RPE) with Assigned Protection Factor (APF) 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective quipment (gloves, eye protection, coverall).e- A built-in meter (calibrated sensor) must be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value for airborne hydrogen peroxide. Unprotected persons or animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m 3 (0,9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide. Rinse treated surfaces/equipment/ pipes/machinery with drinking water after application. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.8. Use description Table 8 Use 8.8: PT2 Disinfection of objects and equipment by dipping: 0,5-2 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Common name: viruses Field(s) of use indoor use Industry, non-healthcare (e.g. pharmaceutical, cosmetic) industry Application method(s) Method: Dipping Detailed description: The disinfection bath(liquid) can be used only once and should be replaced after each use. Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 l) Use at room temperature Routine use: against bacteria and yeasts at 0,5 % (v/v) in clean conditions after 5 minutes and dirty conditions after 15 minutes. Special uses: — against bacterial spores and viruses at 2 % (v/v) after 5 minutes in clean conditions. — against fungi at 2 % (v/v) after 15 minutes in clean conditions. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Routine use: Up to 15 applications/day Special use: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.8.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Treated objects that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.8.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. — Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.9. Use description Table 9 Use 8.9: PT4 Disinfection of objects and equipment by dipping, 0,5-4.8 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: Mycobacteria Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Common name: bacteriophages Common name: viruses Field(s) of use indoor use Food, beverages and feed industry Dairy industry Dairy farms: the inside of milking systems and milking robots Breweries Application method(s) Method: Dipping Detailed description: The disinfectant solution can be used only once. Replace the solution after each use. Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 L) Use at room temperature PT4 general industry: Routine use: against bacteria and yeasts at 0,5 % (v/v) in clean conditions* after 5 minutes and in dirty conditions after 15 minutes contact time For breweries: Routine use: against bacteria and yeasts at 0,5 % (v/v) after 5 minutes in clean conditions* Special uses for PT4 general industry and breweries: — against bacterial spores and viruses at 2 % (v/v) after 5 minutes in clean conditions*. — against fungi at 2 % (v/v) and against mycobacteria at 1 % (v/v) after 15 minutes in clean conditions*. * Surfaces must be cleaned before disinfection. For uses on dairy farms and in the dairy industry: Routine use: - at 0,5 % (v/v) against bacteria, yeasts and bacteriophages after 5 minutes. Special uses: — against fungi at 2 % (v/v) after 15 minutes. — Against bacterial spores 0,8 % (v/v) after 60 minutes or at 4,8 % (v/v) after 10 minutes. Number and timing of application: Frequency: Routine use: 15 applications/day Special use: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.9.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Treated objects that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.9.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size 30-100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Special Use (4,8 % (v/v) dilution): Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.10. Use description Table 10 Use 8.12: PT4 Milking cluster disinfection by automatic flushing Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacterial spores Common name: bacteriophages Common name: fungi Common name: bacteria Common name: yeasts Field(s) of use indoor use Dairy farms: Milking cluster disinfection Application method(s) Method: Flushing Detailed description: Application rate(s) and frequency Application Rate: 1 litre disinfection solution per milking cluster Use at room temperature Routine use (daily): — at 0,5 % (v/v) against bacteria, yeasts and bacteriophages after 5 minutes in milk conditions. Special uses: — against fungi at 2 % (v/v) after 15 minutes. — against bacterial spores at 0,8 % (v/v) after 60 minutes or at 4,8 % (v/v) after 10 minutes. Number and timing of application: Frequency: Routine use: 2-3 times per day for traditional milking systems, 170-280 times per day for milking robots Special use: 1 application/day Category(ies) of users professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.10.1. Use-specific instructions for use Milking cluster disinfection Mixing and loading: Open containers manually. Load the product into the CIP system of the milking installation or the milking robot. Application: Dose automatically into the milking cluster. Allow the required contact time at the corresponding temperature. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. There are no precautions to be taken to avoid the development of resistance. 4.10.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Rinse treated surfaces/equipment/ pipes/machinery with drinking water after application. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.11. Use description Table 11 Use 8.13 – PT2 Laundry disinfection Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Common name: Mycobacteria Field(s) of use indoor use Laundry disinfection for Hospitals, Institutions, Hotels Application method(s) Method: Dosing in System Detailed description: See “Use specific instructions for use” Application rate(s) and frequency Application Rate: 4 l water / kg laundry — 0,4 g/l Select Power + 2,0 ml/l formula 555 10 minutes 70°C for bacteria, yeasts, fungi and mycobacteria — 0,4 g/l Select Power + 4,0 ml/l formula 555 10 minutes 70°C for viruses Number and timing of application: Frequency: — Washing streets: up to 1200 applications/day (automatic) — Tumbler washing machines: up to 24 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.11.1. Use-specific instructions for use Laundry disinfection Mixing and loading: Open containers manually. Load the product into the dosing system of the washing machine. Application: Dose automatically into the washing machine, during the main wash cycle when the required temperature has been reached. Allow the required contact time at the corresponding temperature. No interval is required between application of the biocidal product or between application and the next use of the product. 4.11.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Shelf-life: 24 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 374 - Protective gloves against dangerous chemicals and micro-organisms EN 14387 - Respiratory protective devices - Gas filters and combined filters for use as replaceable components in unassisted respiratory protective devices (RPD) with the exception of escape devices EN 166 - Eye protection against chemicals EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with spray-tight (Type 4) connections, including items providing protection to parts of the body only (Type PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Mida Chriox 5 Market area: EU Personril Market area: EU Peracid Asepsis Market area: EU Peracide Market area: EU Albi Blan Professional Market area: EU Blue Line Blanchiment Désinfectant Market area: EU Mega 8 Blanchissant Détachant désinfectant Market area: EU NESTOR Agent de Blanchiment Désinfectant Market area: EU Phago’Germyl CIP Market area: EU Bali Market area: EU Symphonie Activateur Market area: EU Techline Agent de Blanchiment Désinfectant Market area: EU Oxybac 5 Market area: EU Oxybac GA Market area: EU Mevibac S3 Market area: EU Peracide Gan 5 Market area: EU Oxybac H2O Market area: EU Perac H2O Market area: EU Oxydrink Market area: EU Pearl Chemicals peracetic acid 5% Market area: EU Peracide Gan H5 Market area: EU Star-Perox Water Market area: EU Perac 5 Market area: EU Peroxybac GA Market area: EU Perac GA Market area: EU Serbonet Forte Market area: EU Star-Perox PcTc Market area: EU Sana Guard 3 Market area: EU San OxyBross Market area: EU San OxyClean Market area: EU RobOxy Active Market area: EU San OxyRobot Market area: EU San OxyDrink Market area: EU San OxyWater Market area: EU Oxy Brosse Market area: EU Peracetic acid 5% Market area: EU Perac 5S Market area: EU IF Fulldes Oxy Market area: EU Peal Chemicals peracetic acid 5 Market area: EU Perosan 5 Market area: EU Perapearl 5 Market area: EU FREEHYGIENE PAA5 Market area: EU Ox-San Market area: EU Ox-virin Market area: EU Synthevir Market area: EU WTP PAA5+ Market area: EU Peroxi-gene PAA5+ Market area: EU HYDRO.CLEANSE+ Market area: EU Hydrex 7110+ Market area: EU Hydrex 4203+ Market area: EU FOSSE PERACETIC ACID 5+, Market area: EU Lubrox P+ Market area: EU CSI Hydrex 7110+ Market area: EU Hydrosan Cinq Market area: EU Celacide PAA5 Market area: EU Robo Brush Market area: EU Mida Agriox 5 Market area: EU Caldic perazijnzuur 5CH Market area: EU SynQ Red Des Oxi+ Market area: EU PeroxySa5 Market area: EU Perakyll 5 Market area: EU Perronac 5 Market area: EU Farnax Delta 5 Market area: EU Azliox 5 Market area: EU Ökoron 11 Market area: EU Antisept 32 Market area: EU HSHox5 Market area: EU LABAZ OXY CLEAN 5 Market area: EU AQUA-OXIDES LIGHT5 Market area: EU ALG 500 Market area: EU VITAFOR PERA Market area: EU PERADOX 5 Market area: EU PRO CLEAN PA5 Market area: EU TOP CLEAN PA5 Market area: EU Peracid Asepsis Combo Market area: EU Authorisation number EU-0035834-0008 1-8 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 4,9 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 23 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 8 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,48 % (w/w) 1. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier Meta SPC: Meta SPC 9 1.2. Suffix to the authorisation number Number 1-9 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 4,9 - 4,9 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 22,5 - 22,5 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 6,7 - 6,7 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 7,68 - 7,68 % (w/w) 2.2. Type(s) of formulation of the meta SPC 9 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements H242: Heating may cause a fire. H290: May be corrosive to metals. H302: Harmful if swallowed. H312: Harmful in contact with skin. H332: Harmful if inhaled. H314: Causes severe skin burns and eye damage. H410: Very toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P234: Keep only in original packaging. P235: Keep cool. P260: Do not breathe mist/vapours/spray. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing. Wear protective gloves. Wear eye/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER/doctor. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER/doctor. 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. P310: Immediately call a POISON CENTER or doctor/physician. P362+P364: Take off contaminated clothing and wash it before reuse. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P403: Store in a well-ventilated place. P410: Protect from sunlight. P420: Store separately. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 9.1: PT2 Cleaning-in-place (CIP), 0,25-2 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacterial spores Common name: viruses (limited spectrum virucidal activity) Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use indoor use Non-Food Industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry Application method(s) Method: Cleaning-in-place Detailed description: Application rate(s) and frequency Application Rate: depending on characteristics of system. Use at room temperature Routine use: 0,25 % (v/v) against bacteria and yeasts after 5 minutes in clean conditions Special use: 2,0 % (v/v) against fungi after 15 minutes, 2 % (v/v) against bacterial spores and 1 % (v/v) against limited spectrum virucidal activity after 5 minutes in clean conditions. Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.1.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.1.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Only automated mixing and loading is allowed. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 9.2: PT4 Cleaning-in-place (CIP), 0,25-2 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteriophages Common name: bacterial spores Common name: viruses Common name: bacteria Common name: fungi Common name: yeasts Field(s) of use indoor use Food, beverages and feed industry Dairy farms: the inside of milking systems and milking robots Dairy industry Application method(s) Method: Cleaning-in-place Detailed description: Application rate(s) and frequency Application Rate: depending on characteristics of system. Use at room temperature Routine use PT4 General: 0,25 % (v/v) against bacteria and yeasts after 5 minutes in clean conditions*. Special use PT4 General: 2,0 % (v/v) against fungi after 15 minutes, 2 % (v/v) against bacterial spores and 1 % (v/v) against viruses after 5 minutes in clean conditions*. For uses on dairy farms and in the dairy industry: Routine use: 0,25 % (v/v) against bacteria and yeasts after 5 minutes in milk conditions. Special use: 2,0 % (v/v) against fungi after 15 minutes and against bacteriophages at 0,3 % (v/v) after 5 minutes contact time in milk conditions. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.2.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.2.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Only automated mixing and loading is allowed. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 30 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 15 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 374 - Protective gloves against dangerous chemicals and micro-organisms EN 14387 - Respiratory protective devices - Gas filters and combined filters for use as replaceable components in unassisted respiratory protective devices (RPD) with the exception of escape devices EN 166 - Eye protection against chemicals EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with spray-tight (Type 4) connections, including items providing protection to parts of the body only (Type PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Mida Chriox TS5 Market area: EU Peroxybac DC Market area: EU Hydrosan CD Market area: EU Celacide PAA5Trace Market area: EU Brush CD Market area: EU Mida Agriox TS5 Market area: EU SynQ Red Des OxiCD Market area: EU PeroxySaCD Market area: EU Perakyll CD Market area: EU Perronac CD Market area: EU Farnax Delta CD Market area: EU Azliox CD Market area: EU Oxy Brosse Cond Market area: EU HSHoxCD Market area: EU LABAZ OXY CLEAN Market area: EU PERADOX CD Market area: EU PRO CLEAN PACD Market area: EU TOP CLEAN PACD Market area: EU Authorisation number EU-0035834-0009 1-9 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 4,9 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 22,5 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 6,7 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 7,68 % (w/w) 1. META SPC 10 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 10 identifier Identifier Meta SPC: Meta SPC 14 1.2. Suffix to the authorisation number Number 1-10 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 0,034 - 0,034 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 3,22 - 3,22 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,16 - 1,16 % (w/w) Propan-2-ol Non-active substance 67-63-0 200-661-7 0,9 - 0,9 % (w/w) Phosphoric acid phosphoric acid Non-active substance 7664-38-2 231-633-2 0,23 - 0,23 % (w/w) 2.2. Type(s) of formulation of the meta SPC 10 Formulation type(s) Impregnated wipes 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statements H411: Toxic to aquatic life with long lasting effects. H290: May be corrosive to metals. Precautionary statements P102: Keep out of reach of children. P234: Keep only in original packaging. P273: Avoid release to the environment. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 14.1: PT2 hard non-porous surface disinfection, wet wipes Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Small hard non-porous surfaces Institutions, workplaces, buildings, hotels, hospitals, non-food industry (e.g. pharmaceuticals, cosmetics), warehouses Application method(s) Method: Wiping Detailed description: The product is ready-to-use Apply by wiping Application rate(s) and frequency Application Rate: 1 wipe / 0,5 m 2 Use at room temperature. Use against bacteria, yeasts after 5 minutes in dirty conditions. Number and timing of application: Frequency: Professional users: Up to 19 applications/day. General public: Up to 5 applications/day Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 100 wipes/pack PET/PE white flowpack 12 PET / 100 PE with lid, reclosable. Impregnation rate: 5,26 g/wipe (263 %) Wipes: 200x200mm unfolded; 110x200mm folded; 100 % PET; 50g; color white 4.1.1. Use-specific instructions for use Wet wipes Mixing and loading: Not applicable, the product is ready-to-use. Application: Wipe over the hard non-porous surface to be disinfected, leave for the indicated contact time and let dry. Make sure to wet the surface completely. Only wet wipes are efficacious. For use in clean conditions, surfaces must be pre-cleaned before disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Comply with the instructions for use. 4.1.2. Use-specific risk mitigation measures Only for treatment of small surfaces (up to 0,5m 2 ). Ensure that application is carried out in well-ventilated areas. 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 14.2 – PT4 hard non-porous surface disinfection, wet wipes Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use Indoors. Small hard non-porous surfaces Large-scale kitchens, restaurants, food, beverages and feed industry Application method(s) Method: Wiping Detailed description: The product is ready-to-use. Apply by wiping. Application rate(s) and frequency Application Rate: 1 wipe / 0,5 m 2 Use at room temperature. Routine use: against bacteria and yeasts after 5 minutes in dirty conditions. Number and timing of application: Frequency: Professional users: Up to 19 applications/day. General public: Up to 5 applications/day Category(ies) of users professional general public (non-professional) Pack sizes and packaging material 100 wipes/pack PET/PE white flow pack 12 PET / 100 PE with lid, resealable. Impregnation rate: 5,26 g/wipe (263 %) Wipes: 200x200mm unfolded; 110x200mm folded; 100 % PET; 50g; color white 4.2.1. Use-specific instructions for use Wet wipes Mixing and loading: Not applicable, the product is ready-to-use. Application: Wipe over the hard non-porous surface to be disinfected, leave for the indicated contact time and let dry. Make sure to wet the surface completely. Only wet wipes are efficacious. For use in clean conditions, surfaces must be pre-cleaned before disinfection. Treated surfaces or objects that may come into contact with food, feed, drinks and ingredients thereof should be rinsed with potable water after disinfection. No interval is required between applications of the biocidal product or between application and the next use of the treated surface. Comply with the instructions for use. 4.2.2. Use-specific risk mitigation measures Only for treatment of small surfaces (up to 0,5m 2 ). Ensure that application is carried out in well-ventilated areas. 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 If medical advice is needed, have product container or label at hand. First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 10 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 12 months Keep out of reach of children and non-target animals/pets. 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. 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) Phago’wipes Spore Market area: EU AIRANDE H2O2 Solution 3 Flow-Wipes Market area: EU NOSO-WIPES 3.25% Market area: EU Lingettes Multi-Prop H2O2 Market area: EU Authorisation number EU-0035834-0010 1-10 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,034 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 3,22 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 1,16 % (w/w) Propan-2-ol Non-active substance 67-63-0 200-661-7 0,9 % (w/w) Phosphoric acid phosphoric acid Non-active substance 7664-38-2 231-633-2 0,23 % (w/w) 1. META SPC 11 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 11 identifier Identifier Meta SPC: Meta SPC 11 1.2. Suffix to the authorisation number Number 1-11 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 14,9 - 14,9 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 25,7 - 25,7 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 13,1 - 13,1 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,96 - 0,96 % (w/w) 2.2. Type(s) of formulation of the meta SPC 11 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statements H242: Heating may cause a fire. H290: May be corrosive to metals. H302: Harmful if swallowed. H311: Toxic in contact with skin. H332: Harmful if inhaled. H314: Causes severe skin burns and eye damage. H410: Very toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P234: Keep only in original packaging. P235: Keep cool. P260: Do not breathe mist/vapours/spray. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing. Wear protective gloves. Wear eye/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER or doctor. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER or doctor. 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. P310: Immediately call a POISON CENTER or doctor/physician. P361+P364: Take off immediately all contaminated clothing and wash it before reuse. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P410: Protect from sunlight. P420: Store separately. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 11.1: PT2 Cleaning-in-place (CIP), 0,05-1 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: Mycobacteria Common name: viruses Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use indoor use Non-Food Industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry Application method(s) Method: Cleaning-in-place Detailed description: Application rate(s) and frequency Application Rate: depending on characteristics of system. Use at room temperature. Routine use: 0,05 % (v/v) against bacteria and yeasts after 5 minutes in clean conditions* and 15 minutes in dirty conditions. Special uses: 0,8 % (v/v) against fungi in clean conditions* and 1 % (v/v) in dirty conditions after 15 minutes. At 1 % (v/v) against viruses after 5 minutes, 0,1 % (v/v) against mycobacteria after 10 minutes in clean conditions*. * Surfaces must be cleaned before disinfection. Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.1.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.1.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 100m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 11.2: PT4 Cleaning-in-place (CIP) – 0,05-1 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: viruses Common name: Mycobacteria Common name: bacterial spores Common name: bacteriophages Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use indoor use Food, beverages and feed industry Dairy farms: the inside of milking systems and milking robots Dairy industry Breweries Application method(s) Method: Cleaning-in-place Detailed description: Surfaces must be cleaned before disinfection Application rate(s) and frequency Application Rate: depending on characteristics of system. Use at room temperature. Routine use PT4 General: 0,05 % (v/v) against bacteria and yeasts after 5 minutes in clean conditions* and 15 minutes in dirty conditions. For breweries: Routine use: against bacteria and yeasts at 0,10 % (v/v) after 5 minutes in clean conditions*. Special use for PT4 General and Breweries: 0,8 % (v/v) against fungi in clean conditions and 1 % (v/v) in dirty conditions after 15 minutes contact time. At 1 % (v/v) against viruses after 5 minutes, 0,1 % (v/v) against mycobacteria after 10 minutes in clean conditions*. * Surfaces must be cleaned before disinfection For uses on dairy farms and in the dairy industry: Routine use: 0,1 % (v/v) against bacteria, yeasts and bacteriophages after 5 minutes in milk conditions. Special use: 1,0 % (v/v) against fungi and at 0,4 % (v/v) against bacterial spore after 15 minutes contact time in milk conditions. Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.2.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.2.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Rinse treated surfaces/equipment/ pipes/machinery with drinking water after application. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 11.3 – PT2 hard non-porous surface disinfection, low-pressure spraying, 0,1-1,5 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: yeasts Common name: bacteria Common name: fungi Common name: Mycobacteria Field(s) of use indoor use Non-food industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry, non-food warehouses Application method(s) Method: Low-pressure spraying Detailed description: Application rate(s) and frequency Application Rate: 0,25 l/m 2 Use at room temperature. Routine use: Against bacteria and yeasts at 0,1 % (v/v) after 5 minutes contact time in clean conditions* and at 0,25 % (v/v) after 15 minutes in dirty conditions. Special use: Against fungi at 1,5 % (v/v) in dirty conditions and 1 % (v/v) in clean conditions* after 15 minutes contact time. Against mycobacteria at 0,1 % (v/v) after 10 minutes in clean conditions*. * Surfaces must be cleaned before disinfection Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.3.1. Use-specific instructions for use Low-pressure spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. Between application of the biocidal product and the next use of the product, no interval is required if the appropriate PPE is worn based on the use of the product. For re-entry without PPE, it should be ensured that the air concentration for hydrogen peroxide has dropped below the appropriate limit value, i.e. below 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide with technical and organisational measures (e.g. sensor, defined ventilation period). 4.3.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading: Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m). Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,1 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH: No RPE is needed. Routine use (0.25 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation 3 ACH or ≥ 300 m 3 and ventilation 1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. Special Use (1 % (v/v) dilution): Do not touch treated surface until they are dried. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Apply only in rooms of at least 100 m 3 with ventilation rate of at least 10 ACH or 300 m 3 with ventilation rate of at least 3 ACH. In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. Special Use (1,5 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 is mandatory. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.4. Use description Table 4 Use 11.4 – PT2 Disinfection of objects and equipment by dipping, > 0,1-1,5 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: fungi Common name: Mycobacteria Common name: bacteria Common name: yeasts Field(s) of use indoor use Non-food industry, non-healthcare (e.g. pharmaceuticals, cosmetics) industry, non-food warehouses Application method(s) Method: Dipping Detailed description: Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 l) Use at room temperature. Routine use: Against bacteria and yeast at 0,1 % (v/v) after 5 minutes contact time in clean conditions* and at 0,25 % (v/v) after 15 minutes in dirty conditions. Special use: Against fungi at 1 % (v/v) in clean conditions* and at 1,5 % (v/v) in dirty conditions after 15 minutes contact time. Against mycobacteria at 0,1 % (v/v) after 10 minutes in clean conditions*. * Surfaces must be cleaned before disinfection Number and timing of application: Frequency: Routine use: Up to 15 applications/day Special use: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.4.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Treated objects that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.4.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading: Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application (dipping)(1,5 % (v/v)) Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.5. Use description Table 5 Use 11.5 – PT4 hard non-porous surface disinfection, low-pressure spraying, 0,1-1,5 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacterial spores Common name: bacteriophages Common name: Mycobacteria Common name: fungi Common name: yeasts Common name: bacteria Field(s) of use indoor use Food, beverages and feed industry Dairy farms: the inside of milking systems and milking robots Dairy industry Breweries Application method(s) Method: - Low-pressure spraying Detailed description: Application rate(s) and frequency Application Rate: 0.25 l/m 2 Use at room temperature. Routine use PT4 General: Against bacteria and yeasts at 0,1 % (v/v) after 5 minutes in clean conditions* and at 0,25 % (v/v) against bacteria and yeast after 15 minutes in dirty conditions. For breweries: Routine use: 0,2 % (v/v) against bacteria and yeast after 5 minutes contact time in clean conditions*. Special use PT4 General and breweries: Against fungi at 1,5 % (v/v) in dirty conditions and at 1 % (v/v) in clean* conditions after 15 minutes contact time. At 0,1 % (v/v) against mycobacteria after 10 minutes in clean* conditions * Surfaces must be cleaned before disinfection For uses on dairy farms and in the dairy industry: Routine use: 0,1 % (v/v) against bacteria, yeasts and bacteriophage after 5 minutes in milk conditions. Special use: 1,0 % (v/v) against fungi and at 0,4 % (v/v) against bacterial spores after 15 minutes contact time in milk conditions. Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.5.1. Use-specific instructions for use Low-pressure spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain wet during the required exposure time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. Between application of the biocidal product and the next use of the product, no interval is required if the appropriate PPE is worn based on the use of the product. For re-entry without PPE, it should be ensured that the air concentration for hydrogen peroxide has dropped below the appropriate limit value, i.e. below 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide with technical and organizational measures (e.g. sensor, defined ventilation period). 4.5.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading: Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Do not use near livestock. Only use in empty animal housing. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . m 3 For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organizational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,1 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH: No RPE is needed. Routine use (0,2 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: No RPE is needed. Routine use (0,25 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. In rooms ≥ 300 m 3 and ventilation ≥10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. Special Use (1 % (v/v) dilution): Do not touch treated surface until they are dried. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Apply only in rooms of at least 100 m 3 with ventilation rate of at least 10 ACH or 300 m 3 with ventilation rate of at least 3 ACH. In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. Special Use (1,5 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 is mandatory. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.6. Use description Table 6 Use 11.6 – PT4 Disinfection of objects and equipment by dipping, 0,1-1,5 % (v/v) dosage - Meta SPC 11 Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: Mycobacteria Common name: bacterial spores Common name: bacteriophages Field(s) of use indoor use Food, beverages and feed industry Dairy farms: the inside of milking systems and milking robots Dairy industry Breweries Application method(s) Method: - Dipping Detailed description: Application rate(s) and frequency Application Rate: depending on dipping bath size (1-25 l) Use at room temperature. Routine use PT4 General: Against bacteria and yeasts at 0,1 % (v/v) after 5 minutes in clean conditions* and at 0,25 % (v/v) after 15 minutes in dirty conditions. For breweries: Routine use: 0,2 % (v/v) against bacteria and yeast after 5 minutes contact time in clean conditions. Special use PT4 General and Breweries: Against fungi at 1 % (v/v) in clean conditions and at 1,5 % (v/v) in dirty conditions after 15 minutes contact time. At 0,1 % (v/v) against mycobacteria after 10 minutes in clean conditions. * Surfaces must be cleaned before disinfection For uses on dairy farms and in the dairy industry: Routine use: 0,1 % (v/v) against bacteria, yeasts and bacteriophage after 5 minutes in milk conditions. Special use: 1,0 % (v/v) against fungi after and at 0,4 % (v/v) against bacterial spores after 15 minutes contact time and in milk conditions. Number and timing of application: Frequency: Routine use: Up to 15 applications/day. Special use: 1 application/day. Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.6.1. Use-specific instructions for use Disinfection of objects by dipping Mixing and loading: Open containers manually. Transfer the required amount of product to the dipping bath and add water. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Immerse the objects in the dipping bath during the required contact time. The disinfection bath (liquid) can be used only once and should be replaced after each use. Treated objects that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.6.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >100m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading: Use of respiratory protective equipment (RPE) providing a protection factor of 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. providing a protection factor of at least Special use (1-1,5 % (v/v) dilution): Do not touch treated surface until they are dried. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 11 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 9 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 374 - Protective gloves against dangerous chemicals and micro-organisms EN 14387 - Respiratory protective devices - Gas filters and combined filters for use as replaceable components in unassisted respiratory protective devices (RPD) with the exception of escape devices EN 166 - Eye protection against chemicals EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with spray-tight (Type 4) connections, including items providing protection to parts of the body only (Type PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Mida Chriox 15 Market area: EU Puresan Asepsis Market area: EU Pearl Chemicals peracetic acid 15 Market area: EU Perosan 15 Market area: EU PERAPEARL15 Market area: EU FREEHYGIENE PAA15 Market area: EU Peracetic acid 15 % Caldic Market area: EU WTP PAA15+ Market area: EU Peroxi-gene PAA15+ Market area: EU FOSSE PERACETIC ACID 15+ Market area: EU Hydrosan Stabil Market area: EU Celacide PAA15 Market area: EU Brush 15 Market area: EU Mida Agriox 15 Market area: EU Caldic perazijnzuur 15CH Market area: EU SynQ Red Des OxiStrong Market area: EU PeroxySa15 Market area: EU Perronac 15 Market area: EU Farnax Delta 15 Market area: EU Azliox 15 Market area: EU Oxy Brosse 15 Market area: EU Ökoron 12 Market area: EU Antisept 33 Market area: EU Foodclean Des 43 Market area: EU Foodclean Des 47 Market area: EU HSHox15 Market area: EU LABAZ OXY CLEAN 15 Market area: EU AQUA-OXIDES SUPER 15 Market area: EU ALG 600 Market area: EU VITA-DIS PERA Market area: EU PERADOX 15 Market area: EU PRO CLEAN PA15 Market area: EU TOP CLEAN PA15 Market area: EU Authorisation number EU-0035834-0011 1-11 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 14,9 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 25,7 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 13,1 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,96 % (w/w) 1. META SPC 12 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 12 identifier Identifier Meta SPC: Meta SPC 12 1.2. Suffix to the authorisation number Number 1-12 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 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 (%) Peracetic acid Active substance 79-21-0 201-186-8 15 - 15 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 20,6 - 20,6 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 18,2 - 18,2 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,96 - 0,96 % (w/w) 2.2. Type(s) of formulation of the meta SPC 12 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12 Hazard statements H242: Heating may cause a fire. H290: May be corrosive to metals. H302: Harmful if swallowed. H311: Toxic in contact with skin. H332: Harmful if inhaled. H314: Causes severe skin burns and eye damage. H410: Very toxic to aquatic life with long lasting effects. EUH071: Corrosive to the respiratory tract. Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P234: Keep only in original packaging. P235: Keep cool. P260: Do not breathe mist/vapours/spray. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing. Wear protective gloves. Wear eye/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER/doctor. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER/doctor. 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. P310: Immediately call a POISON CENTER/doctor. P361+P364: Take off immediately all contaminated clothing and wash it before reuse. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P410: Protect from sunlight. P420: Store separately. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 12.1: PT2 Cleaning-in-place (CIP) – 0,04-1,5 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Field(s) of use indoor use Non-Food Industry, non-health care (e.g. pharmaceuticals, cosmetics) industry Application method(s) Method: Cleaning-in-place Detailed description: Application rate(s) and frequency Application Rate: depending on characteristics of system. Routine use: 0,04 % (v/v) against bacteria and yeasts after 5 minutes at 20 o C in clean* and dirty conditions. Special uses: — 1 % (v/v) against fungi after 15 minutes in clean* and dirty conditions — against bacterial spores at 1 % (v/v) after 10 minutes contact time at 60°C and at 1,5 % (v/v) after 15 minutes at 40 o C in clean* and dirty conditions * Surfaces must be cleaned before disinfection Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.1.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.1.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size > 100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.2. Use description Table 2 Use 12.2: PT4 Cleaning-in-place (CIP), 0,04-1,5 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Field(s) of use indoor use Food, beverages and feed industry Application method(s) Method: Cleaning-in-place Detailed description: Application rate(s) and frequency Application Rate: depending on characteristics of system. Routine use: 0,04 % (v/v) against bacteria and yeasts after 5 minutes contact time in clean* and dirty conditions at 20 o C. Special use: — 1 % (v/v) against fungi after 15 minutes contact time at 20 o C in clean* and dirty conditions — against bacterial spores at 1 % (v/v) after 10 minutes contact time at 60°C and at 1,5 % (v/v) after 15 minutes at 40 o C in clean* and dirty conditions * Surfaces must be cleaned before disinfection Number and timing of application: Frequency: Up to 20 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.2.1. Use-specific instructions for use Cleaning-In-Place (CIP) Mixing and loading: Open containers manually. Load the product into the dosing system of the CIP installation. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean the system. Any detergent used for cleaning should be rinsed with clean water. Treat piping systems and equipment by means of a circulating pump system as usual in a CIP system. The product is dosed automatically. Cleaning of equipment can be done with water. Between application of the biocidal product and the next use of the product, no interval is required if the appropriate PPE is worn based on the use of the product. For re-entry without PPE, it should be ensured that the air concentration for hydrogen peroxide has dropped below the appropriate limit value, i.e. below 1.25 mg/m3 (0.9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide with technical and organizational measures (e.g. sensor, defined ventilation period). 4.2.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Rinse treated surfaces/equipment/ pipes/machinery with drinking water after application. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.3. Use description Table 3 Use 12.3 – PT2 hard non-porous surface disinfection, low-pressure spraying, 0,05-2 % (v/v) dosage Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Field(s) of use indoor use Non-food industry, non healthcare (e.g. pharmaceuticals, cosmetics) industry Application method(s) Method: Low-pressure spraying Detailed description: Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: 0,05 % (v/v) against bacteria and yeasts after 5 minutes in clean* and dirty conditions at 20 o C. Special uses: — 2 % (v/v) against fungi after 15 minutes at 20 o C in clean* and dirty conditions. * Surfaces must be cleaned before disinfection Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.3.1. Use-specific instructions for use Low-pressure spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: Thoroughly pre-clean surfaces and materials. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. Between application of the biocidal product and the next use of the product, no interval is required if the appropriate PPE is worn based on the use of the product. For re-entry without PPE, it should be ensured that the air concentration for hydrogen peroxide has dropped below the appropriate limit value, i.e. below 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value for airborne hydrogen peroxide with technical and organizational measures (e.g. sensor, defined ventilation period). 4.3.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading: Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Do not apply in rooms smaller than 100 m 3 . Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user m 3 For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,05 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: No RPE is needed. Special Use (1 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 100 m 3 with ventilation rate of at least 10 ACH or 300 m 3 with ventilation rate of at least 3 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 or 20 is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. Special Use (1,5 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Special Use (2 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.4. Use description Table 4 Use 12.4 – PT4 hard non-porous surface disinfection, low-pressure spraying, 0,05-2 % (v/v) dosage Product type PT04: Food and feed area Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: bacterial spores Field(s) of use indoor use Food, beverages and feed industry Application method(s) Method: Low-pressure spraying Detailed description: Application rate(s) and frequency Application Rate: 0,25 l/m 2 Routine use: 0,05 % (v/v) against bacteria and yeasts after 5 minutes in clean* and dirty conditions at 20 o C. Special uses: — against fungi at 2 % (v/v) after 15 minutes contact time in clean* and dirty conditions at 20 o C. * Surfaces must be cleaned before disinfection Number and timing of application: Frequency: 1 application/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.4.1. Use-specific instructions for use Low-pressure spraying Mixing and loading: Open containers manually. Small containers are transferred manually into reservoirs or dilution vessels, while large containers are pumped into reservoirs via a pump. Application: For use in clean conditions, surfaces must be pre-cleaned before disinfection. Thoroughly pre-clean surfaces and materials. Any detergent used for cleaning should be rinsed off with clean water. Remove excess water. Apply the diluted product on the surface to be disinfected by means of foaming or spraying with the aid of low-pressure foaming or spraying equipment. When disinfecting, use as much liquid so that the surfaces remain completely wet during the required exposure time. Treated surfaces or materials that may come into contact with food, drinks and ingredients thereof should be rinsed thoroughly with potable water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.4.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Manual mixing and loading: Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Application Only horizontal and downward spraying is allowed with a lance sprayer (> 1m).Do not use near livestock. Only use in empty animal housing. Keep unprotected people away from treated surfaces until dry. If it is necessary to be present for the bystander, wear same PPE as the professional user Do not apply in rooms smaller than 100 m 3 . For re-entry, the undercut of AECinhalation of 0,5 mg peracetic acid/m 3 and 1,25 mg hydrogen peroxide/m 3 or relevant lower national reference values shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period). Respiratory protection when needed: Use of respiratory protective equipment (RPE) according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. Routine use (0,05 % (v/v) dilution): In rooms ≥ 100 m 3 and ventilation ≥3 ACH or ≥ 300 m 3 and ventilation ≥1 ACH: Use of respiratory protective equipment (RPE) with APF of at least 4 is mandatory. In rooms ≥ 100 m 3 and ventilation ≥10 ACH or ≥ 300 m 3 and ventilation ≥3 ACH: No RPE is needed. Special Use (1 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 100 m 3 with ventilation rate of at least 10 ACH or 300 m 3 with ventilation rate of at least 3 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 or 20 is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). In rooms ≥ 100 m 3 and ventilation 10 ACH or ≥ 300 m 3 and ventilation 3 ACH: Use of respiratory protective equipment (RPE) with APF of at least 20 is mandatory. In rooms ≥ 300 m 3 and ventilation 10 ACH: Use of respiratory protective equipment (RPE) with APF of at least 10 is mandatory. Special Use (1,5 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Special Use (2 % (v/v) dilution): Do not touch treated surface until they are dried. Apply only in rooms of at least 300 m 3 with ventilation rate of at least 10 ACH. Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of respiratory protective equipment (RPE) providing a protection factor of at least 20 is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 4.5. Use description Table 5 Use 12.5 – PT2 Laundry disinfection in washing machines Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Common name: Mycobacteria Field(s) of use indoor use Laundry disinfection for hospitals, institutions, hotels Application method(s) Method: Dosing in system Detailed description: Application rate(s) and frequency Application Rate: 4-5 l water at in-use concentration / kg laundry — Main wash:10 minutes at 70°C, 1:4 liquor ratio — 0,12 g/l Majestic excellent + 0,9 ml/l formula 652 against bacteria, yeasts, mycobacteria and fungi — 0,12 g/l Majestic excellent + 2,0 ml/l formula 652 against viruses — Pre-wash: 5 minutes at 20°C and Main wash:10 min. at 60°C, 1:5 liquor ratio — 0,12 g/l Select Power + 1,0 ml/l formula 652 against bacteria, yeasts, mycobacteria and fungi — 0,12 g/l Select Power + 1,8 ml/l formula 652 against viruses — Main wash:15 minutes at 40°C, 1:5 liquor ratio — 4 g/l Selox micran + 6 ml/l formula 652 against bacteria, yeasts, viruses and mycobacteria — Pre-wash: 5 minutes at 20°C and Main wash:10 min. at 60°C, 1:4 liquor ratio — 0,5 g/l PureSan Power + 0,25 ml/l PureSan Ultra + 1,5 ml/l formula 652 against bacteria, yeasts, mycobacteria, fungi and viruses — Pre-wash: 5 minutes at 20°C and Main wash:10 min. at 60°C, 1:4 liquor ratio — 0,25 ml/l Osmaflux Solis + 1,33 ml/l formula 652 against bacteria, yeasts, mycobacteria, fungi and viruses Number and timing of application: Frequency: — Washing streets: up to 1200 applications/day (automatic) — Tumbler washing machines: up to 24 applications/day Category(ies) of users industrial professional Pack sizes and packaging material 10 - 20 - 30 - 60 - 220 litre blue HDPE vessels with vented screw caps 1000 litre opaque white IBC HDPE with screw cap (top, HDPE) and tap (bottom, HDPE) 4.5.1. Use-specific instructions for use Laundry disinfection Mixing and loading: Open containers manually. Load the product into the dosing system of the washing machine. Application: Dose automatically into the washing machine, during the main wash cycle when the required temperature has been reached. Allow the required contact time at the corresponding temperature. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. 4.5.2. Use-specific risk mitigation measures Use in well-ventilated places. Avoid breathing vapours. The following personal protective equipment is mandatory. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work: Hand protection: Chemical resistant PVC/Nitril rubber gloves (to European standard EN 374 or equivalent). Thickness: 0,4 mm. Penetration time: >480 min (level 6). The selection of specific gloves for a specific application and time of use in a working area, should also take into account other factors on the working space, such as (but not limited to): other chemicals that are possibly used, physical requirements (protection against cutting/drilling, skill, thermal protection), and the instructions/specification of the supplier of gloves. Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Never return unused material to original container. When handling product, avoid contact with eyes, skin and clothing. Use specific risk mitigation measures for human health: Mixing and loading: Keep unprotected people away during mixing and loading. Mixing and loading can only be performed in rooms of at least 100 m 3 . Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). The use of eye protection (chemical goggles) according to EN166 or equivalent during handling of the product is mandatory. Wear a protective coverall (at least type 4) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). Automated mixing and loading in room size >100 m 3 : Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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, thereafter call a POISON CENTRE. 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Collect all waste in suitable and labelled containers and dispose according to local legislation. 4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 12 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Shelf-life: 24 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. The full titles of the EN standards referenced in sections where risk mitigation measures are listed should be stated in section 6 as: EN 374 - Protective gloves against dangerous chemicals and micro-organisms EN 14387 - Respiratory protective devices - Gas filters and combined filters for use as replaceable components in unassisted respiratory protective devices (RPD) with the exception of escape devices EN 166 - Eye protection against chemicals EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with spray-tight (Type 4) connections, including items providing protection to parts of the body only (Type PB [4]). Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). 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) Peracid Forte Market area: EU Ultimate Forte Market area: EU Peracid Forte Combo Market area: EU Sanoxy Forte Combo Market area: EU Authorisation number EU-0035834-0012 1-12 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 15 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 20,6 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 18,2 % (w/w) Sulphuric Acid Sulfuric Acid Non-active substance 7664-93-9 231-639-5 0,96 % (w/w) 1. META SPC 13 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 13 identifier Identifier Meta SPC: Meta SPC 13 1.2. Suffix to the authorisation number Number 1-13 1.3. Product type(s) Product type(s) PT03: Veterinary hygiene 2. META SPC 13 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 13 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,019 - 0,019 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,05 - 1,05 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 2 - 2 % (w/w) 2.2. Type(s) of formulation of the meta SPC 13 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 13 Hazard statements H412: Harmful to aquatic life with long lasting effects. H290: May be corrosive to metals. Precautionary statements P273: Avoid release to the environment. P234: Keep only in original packaging. P390: Absorb spillage to prevent material damage. P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use 13.1 – PT3 Teat dipping after milking Product type PT03: Veterinary hygiene Where relevant, an exact description of the authorised use Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Field(s) of use indoor use outdoor use Disinfection of teats after milking by dipping Dairy farms Application method(s) Method: Manual dipping using a dip cup Detailed description: Application rate(s) and frequency Application Rate: 5 ml per animal per treatment at 5 minutes contact time and 30 o C. The product is ready-to-use Number and timing of application: Frequency: Up to 3 applications/day Category(ies) of users professional Pack sizes and packaging material 10 - 25 – 220 Litres HDPE vessels with vented screw caps 1000 Litres IBC with screw cap (top) and tap (bottom) 4.1.1. Use-specific instructions for use Teat dipping after milking Mixing and loading: The product is ready-to-use. A no-spill dip cup should be used for manual teat dipping. The product must be brought to a temperature above 20 °C before use. The lower reservoir is filled with the RTU product and the dip cup is screwed on top. Squeeze the lower reservoir to move the disinfectant into the upper reservoir to make sure that it’s sufficiently filled before dipping. Application: Dip each teat in the upper reservoir of the dip cup after milking. Leave the product on the teats until next milking. Make sure that the full length of the teat (3-5 cm) is immersed into the disinfectant. Top up with fresh disinfectant as needed. Allow to take effect for the indicated contact time by keeping animals standing up. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. Cleaning of equipment can be done with water. No interval is required between application of the biocidal product or between application and the next use of the product. See section 6 for the full titles of the European Standards and Council Directive. 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 First aid instructions IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging Dispose of in accordance with relevant local regulations. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See General Directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 13 5.1. Instructions for use See use-specific instructions for use. Inform the authorisation holder if the treatment is ineffective 5.2. Risk mitigation measures Access to bystanders / animals should be restricted during application. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Environmental precautions Prevent liquid from entering sewers or surface waters. 5.4. Instructions for safe disposal of the product and its packaging See specific to the use, the instructions for safe disposal of the product and its packaging. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Storage conditions: Store in original container, at room temperature. Keep away from heat and direct sunlight. Protect from frost. Shelf-life: 12 months 6. OTHER INFORMATION Professionals (including industrial, professionals) mean trained professional if this is required by national legislation. Please be aware of the European reference value of 1,25 mg/m 3 for hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product family (please be aware that relevant lower national limit values may apply). Please be aware of the European reference value of 2 mg/m 3 (STEL) for phosphoric acid (CAS No.: 7664-38-2) which was used for the risk assessment for the biocidal product family. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 13 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Mida Agri 833 PO Market area: EU Authorisation number EU-0035834-0013 1-13 Common name IUPAC name Function CAS number EC number Content (%) Peracetic acid Active substance 79-21-0 201-186-8 0,019 % (w/w) Hydrogen peroxide Non-active substance 7722-84-1 231-765-0 1,05 % (w/w) Acetic acid Ethanoic acid Non-active substance 64-19-7 200-580-7 2 % (w/w)
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