Commission Implementing Regulation (EU) 2026/1737 of 16 July 2026 granting a Union authorisation for the biocidal product family BPF THO TM Desana in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Data as of 2026-08-06 · 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-0036217-0000 is hereby granted to Thonhauser GmbH for the making available on the market and use of the biocidal product family ‘BPF THO TM Desana’ in accordance with the summary of the product characteristics set out in the Annex. The Union authorisation is valid from 6 August 2026 until 31 July 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 BPF THO TM Desana Product type(s) PT04: Food and feed area Authorisation number EU-0036217-0000 R4BP asset number EU-0036217-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name BPF THO TM Desana 1.2. Product type(s) Product type(s) PT04: Food and feed area 1.3. Authorisation holder Name and address of the authorisation holder Name Thonhauser GmbH Address Perlhofgasse 2/1 2372 Giesshübl Austria Authorisation number EU-0036217-0000 R4BP asset number EU-0036217-0000 Date of the authorisation 6 August 2026 Expiry date of the authorisation 31 July 2036 1.4. Manufacturer(s) of the product Name of manufacturer Thonhauser GmbH Address of manufacturer Perlhofgasse 2/1 2372 Giesshübl Austria Location of manufacturing sites Thonhauser GmbH Industriepark Pischelsdorf 3435 Zwentendorf Austria 1.5. Manufacturer(s) of the active substance(s) Active substance Active chlorine released from sodium hypochlorite Name of manufacturer Donau Chemie AG Address of manufacturer Am Heumarkt 10 1030 Wien Austria Location of manufacturing sites Donau Chemie AG Klagenfurter Straße 17 9371 Brückl Austria 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 (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 19 - 25 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 2,5 - 3,3 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 1,5 - 15,5 % (w/w) Sodium hydroxide Sodium hydroxide Non-active substance 1310-73-2 215-185-5 0 - 6 % (w/w) Sodium chlorate Sodium chlorate Non-active substance 7775-09-9 231-887-4 0 - 0,68 % (w/w) 2.2. Type(s) of formulation Formulation type(s) SL Soluble concentrate 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) 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 (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 25 - 25 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 3,3 - 3,3 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 15,5 - 15,5 % (w/w) Sodium chlorate Sodium chlorate Non-active substance 7775-09-9 231-887-4 0 - 0,68 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements 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 P234: Keep only in original packaging. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER. P310: Immediately call a doctor. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P405: Store locked up. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local/regional/national/international regulations. P501: Dispose of container to hazardous or special waste collection point, in accordance with local/regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #1 – Bacteria, yeasts, fungi – professional users – disinfection of inner surfaces (disinfection after cleaning) - indoor Product type PT04: Food and feed area Where relevant, an exact description of the authorised use --- Target organism(s) (including development stage) Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Field(s) of use indoor use Hard surface disinfection (non-porous) in food processing area and food consumption areas (e.g. kitchens, canteens, restaurants) via concentrate. Application method(s) Method: CIP (cleaning in place) Detailed description: --- Application rate(s) and frequency Application Rate: Application solution: 3,78 % (w/w) biocidal product in water, corresponding to 0,126 % (w/w) active chlorine Number and timing of application: Application frequency: max. once per day (Annual use frequency must comply with national regulatory requirements) Category(ies) of users professional Pack sizes and packaging material 1 kg bottle (HDPE) 2 kg bottle (HDPE) 6 kg jerry can (HDPE) 20 kg jerry can (HDPE) 25 kg jerry can (HDPE) closure: screw cap with safety seal (HDPE) 250 kg barrel (HDPE) closure: bung closure with plug (PP) 1000 kg IBC (HDPE) 1200 kg IBC (HDPE) closure: screw cap (HDPE) Abbreviations: HDPE (high-density polyethylene), PP (polypropylene) 4.1.1. Use-specific instructions for use Disinfection of small scale beverage dispensing installations. Use only in semi-closed process (pressure process): disinfection step in closed system, preparation of in-use solution and discharge: non-closed process. Safeguard taps during disinfection procedure. Pre-clean the surfaces and lines before disinfection including rinsing with water. 1. PREPARE SOLUTION: Always rinse the cleaning container. Fill cleaning container with lukewarm water (up to 35°C) and add the biocidal product (135 ml of biocidal product in 4.5 l water). Use solution for a maximum of 1 hour. Use dispensing taps, manual or electrical drum pumps or measuring beaker for transfer. 2. SHAKE: SOLUTION VIOLET: Close and shake container. Pull a sample of the original solution. Freshly prepared solution is PURPLE. 3. CONNECT CLEANING CONTAINER: Attach tap head of the beverage container under the CO 2 pressure onto the cleaning container. 4. AUTHORISATION HOLDER shall PROVIDE INFORMATION on filling the lines on the label of the product. 5. AUTHORISATION HOLDER shall PROVIDE INFORMATION on pre-cleaning step on the label of the product. 6. DISINFECTION STEP: After that fill lines once more with fresh solution to complete disinfection step – leave in lines for 15 minutes in order to allow the product to take effect for the contact time needed. 7. RINSING: Rinse treated pipes with drinking water after application e.g. 1000 ml water per meter for 7 mm lines. Check the rinsing by means of pH test strips: The pH value of the rinsing water must correspond to the pH value of the fresh water. Always drain disinfection solution and rinse the system with water before maintenance and repair duties. Keep bystanders away. 4.1.2. Use-specific risk mitigation measures During mixing and loading, application and post-application step: Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374, or equivalent, during product handling phase (glove material to be specified by the authorisation holder within the product information) (N-78). Wear chemical resistant goggles (consistent with EN 166, or equivalent). Wear a protective coverall (type 4, EN 14605, or equivalent) (similar to N-10). Wear suitable protective footwear meeting the requirements of European standard EN 13832, or equivalent (similar to N-79). For draining the lines use a hose or a deep narrow pail close to the tap. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749 (N-386). Personal protective equipment (PPE) is stated 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 (N-7). See Section 6 for the full texts of the European standards and legislation cited. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 4.2. Use description Table 2 Use #3 – Bacteria, yeasts, fungi – industrial users - CIP (cleaning in place) disinfection (terminal disinfection after cleaning) - indoor Product type PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Field(s) of use indoor use Hard surface disinfection (non-porous) in food production and processing industry area (including (non)alcoholic beverages, dairy industry, meat industry) via concentrate. Application method(s) Method: CIP (cleaning in place) Detailed description: --- Application rate(s) and frequency Application Rate: Application solution: 3,78 % (w/w) biocidal product in water, corresponding to 0,126 % (w/w) active chlorine Number and timing of application: Application frequency: max. once per day (Annual use frequency must comply with national regulatory requirements) Category(ies) of users industrial Pack sizes and packaging material 1 kg bottle (HDPE) 2 kg bottle (HDPE) 6 kg jerry can (HDPE) 20 kg jerry can (HDPE) 25 kg jerry can (HDPE) closure: screw cap with safety seal (HDPE) 250 kg barrel (HDPE) closure: bung closure with plug (PP) 1000 kg IBC (HDPE) 1200 kg IBC (HDPE) closure: screw cap (HDPE) Abbreviations: HDPE (high-density polyethylene), PP (polypropylene) 4.2.1. Use-specific instructions for use Disinfection of beverage dispensing installations. Pre-clean the surfaces and lines before disinfection including rinsing with water. Automated dosing: Add the biocidal product automatically via dosing pump from drum or container to the CIP (cleaning in place) tank pre-filled with the required amount of dilution water. 1. PREPARE SOLUTION: Fill CIP tank with lukewarm water (up to 35°C) and add the biocidal product (3 % (v/v), i.e. 3 l biocidal product in 100 l water) automatically. Freshly prepared solution is PURPLE. Use solution for a maximum of 1 hour. 2. AUTHORISATION HOLDER shall PROVIDE INFORMATION on filling the lines on the label of the product. 3. AUTHORISATION HOLDER shall PROVIDE INFORMATION on pre-cleaning step on the label of the product. 4. DISINFECTION STEP: After that fill lines once more with fresh solution to complete disinfection step – leave in installation for 15 minutes in order to allow the product to take effect for the contact time needed. 5. RINSING: Rinse treated pipes with drinking water after application. Check the rinsing by means of pH test strips: The pH value of the rinsing water must correspond to the pH value of the fresh water. Always drain disinfection solution and rinse the system with water before maintenance and repair duties. Keep bystanders away. 4.2.2. Use-specific risk mitigation measures During automated mixing and loading, application and post-application step: Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374, or equivalent, during product handling phase (glove material to be specified by the authorisation holder within the product information) (N-78). Wear chemical resistant goggles (consistent with EN 166, or equivalent). In case CIP system is not fully closed or during repair tasks: Wear a protective coverall (type 4, EN 14605, or equivalent) (similar to N-10). Wear suitable protective footwear (EN 13832, or equivalent) (similar to N-79). Wear respiratory protective equipment (RPE) protecting against particles with an assigned protection factor (APF) of at least 4. At least a filtering half mask (FFP1, EN 149 or equivalent) or a half/quarter mask (EN 140 or equivalent) or a full-face mask (EN 136 or equivalent) with a particle filter/P1 (EN 143 or equivalent) is required. Filter type (code letter, colour) to be specified by the authorisation holder within the product information. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749 (N-386). Personal protective equipment (PPE) is stated 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 (N-7). See section 6 for the full titles of the European Standards and legislation cited. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use --- 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions: 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 or ambulance for medical assistance. Information to Healthcare personnel and 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 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 INHALED: Move to fresh air and keep at rest in a comfortable position for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. Information to Healthcare personnel and doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. (Add phone number of POISON CENTRE, if nationally required) Emergency measures to protect the environment: Avoid spillage of product to soil, surface water or groundwater. Collect spillage by means of a suitable material (absorbents and binders: sawdust, kieselgur (diatomite), sand, universal binder). 5.4. Instructions for safe disposal of the product and its packaging For containment: Scoop absorbed substance into closing containers. Do not use metal containers. Methods for cleaning up: Small quantities of liquid spill: take up in non-combustible absorbent material and shovel into container for disposal. Large spills: contain released substance, pump into suitable containers. Do not use metal containers. Disposal: Dispose of contents or container to hazardous or special waste collection point in accordance with local, national and international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and local authority requirements. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 8 months N-372: Store at temperatures not exceeding 20°C. N-267: Avoid sources of heat (radiator, direct sunlight), and open windows. N-27: Protect from frost. Store in dry, cool, well-ventilated area. Keep in original container. 6. OTHER INFORMATION If professional users are workers under Framework Directive 89/391/EEC and Directive 89/656/ECC, training is to be provided by employers to ensure appropriate handling of the product and the PPE required. With respect to the “Category(ies) of user(s)” note: Professionals (including industrial users) means trained professionals if this is required by national legislation. Note for notifications of products according to Art. 17(6) of Regulation (EU) No 528/2012: For potassium hydroxide (KOH) and sodium hydroxide (NaOH), the grouping concept applies. Products pertaining to the BPF contain either potassium hydroxide (KOH), sodium hydroxide (NaOH) or a combination of both substances. However, independent of how these substances are combined within the biocidal products, the concentration (single or combined) is at minimum 7,5 % (w/w) and at maximum 15,5 % (w/w). Meta SPC 1: Contains only KOH, cf. to concentrations in the composition table. Meta SPC 2: Contains only KOH, cf. to concentrations in the composition table. Meta SPC 3: Grouping applies. Both pH regulators shall be used together. The minimum content of the potassium hydroxide shall be 1,5 % (w/w). The maximum content of potassium hydroxide shall be 5 % (w/w). The minimum content of sodium hydroxide shall be 5 % (w/w), the maximum content of sodium hydroxide shall be 6 % (w/w). The total content of pH regulators in the formulation should be in the range of 7.5 and 10 The full titles of the EN standards referenced in sections use specific risk mitigation measures are: EN ISO 374-1:2016+A1:2018 Protective gloves against dangerous chemicals and micro-organisms. EN 166 Personal eye protection - Specifications; English version of DIN EN 166 EN 14605 Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN 13832-1 Footwear protecting against chemicals - Part 1: Terminology and test methods EN 13832-2 Footwear protecting against chemicals - Part 2: Requirements for limited contact with chemicals EN 13832-3 Footwear protecting against chemicals - Part 3: Requirements for prolonged contact with chemicals EN 140:1998 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking EN 149:2001 + A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking EN 143:2000 Respiratory protective devices - Particle filters - Requirements, testing, marking Full titles of the cited EU legislation: 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 , ELI: http://data.europa.eu/eli/dir/1998/24/oj ). Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work ( OJ L 330, 16.12.2009, p. 28 , ELI: http://data.europa.eu/eli/dir/2009/148/oj ). Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products ( OJ L 178, 8.6.2020, p. 7 , ELI: http://data.europa.eu/eli/reg/2020/749/oj ). 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) TM DESANA TM DESANA 1.0 TM SCHANKANLAGENREINIGER TM PINKOBELLO TM DESANA CIP TM CIP 100 TM CIP 722 TM DESANA BLC TM BLC TM PURPLE REIN TM PURPLE CLEAN TM DESANA PST TM DESANA CLEAN Authorisation number EU-0036217-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 25 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 3,3 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 15,5 % (w/w) Sodium chlorate Sodium chlorate Non-active substance 7775-09-9 231-887-4 0,68 % (w/w) 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC: meta SPC2 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) 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 (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 25 - 25 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 3,3 - 3,3 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 7,5 - 7,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H290: May be corrosive to metals. 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 P234: Keep only in original packaging. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER. P310: Immediately call a doctor. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P405: Store locked up. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local/regional/national/international regulations. P501: Dispose of container to hazardous or special waste collection point, in accordance with local/regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #1– Bacteria, yeasts, fungi – professional users – disinfection of inner surfaces (disinfection after cleaning) - indoor Product type PT04: Food and feed area Where relevant, an exact description of the authorised use --- Target organism(s) (including development stage) Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Field(s) of use indoor use Hard surface disinfection (non-porous) in food processing area and food consumption areas (e.g. kitchens, canteens, restaurants) via concentrate. Application method(s) Method: CIP (cleaning in place) Detailed description: --- Application rate(s) and frequency Application Rate: Application solution: 3,78 % (w/w) biocidal product in water, corresponding to 0,126 % (w/w) active chlorine Number and timing of application: Application frequency: max. once per day (Annual use frequency must comply with national regulatory requirements) Category(ies) of users professional Pack sizes and packaging material 1 kg bottle (HDPE) 2 kg bottle (HDPE) 6 kg jerry can (HDPE) 20 kg jerry can (HDPE) 25 kg jerry can (HDPE) closure: screw cap with safety seal (HDPE) 250 kg barrel (HDPE) closure: bung closure with plug (PP) 1000 kg IBC (HDPE) 1200 kg IBC (HDPE) closure: screw cap (HDPE) Abbreviations: HDPE (high-density polyethylene), PP (polypropylene) 4.1.1. Use-specific instructions for use Disinfection of small scale beverage dispensing installations. Use only in semi-closed process (pressure process): disinfection step in closed system, preparation of in-use solution and discharge: non-closed process. Safeguard taps during disinfection procedure. Pre-clean the surfaces and lines before disinfection including rinsing with water. 1. PREPARE SOLUTION: Always rinse the cleaning container. Fill cleaning container with lukewarm water (up to 35°C) and add the biocidal product (135 ml of biocidal product in 4.5 l water). Use solution for a maximum of 1 hour. Use dispensing taps, manual or electrical drum pumps or measuring beaker for transfer. 2. SHAKE: SOLUTION VIOLET: Close and shake container. Pull a sample of the original solution. Freshly prepared solution is PURPLE. 3. CONNECT CLEANING CONTAINER: Attach tap head of the beverage container under the CO 2 pressure onto the cleaning container. 4. AUTHORISATION HOLDER shall PROVIDE INFORMATION on filling the lines on the label of the product. 5. AUTHORISATION HOLDER shall PROVIDE INFORMATION on pre-cleaning step on the label of the product. 6. DISINFECTION STEP: After that fill lines once more with fresh solution to complete disinfection step – leave in lines for 15 minutes in order to allow the product to take effect for the contact time needed. 7. RINSING: Rinse treated pipes with drinking water after application e.g. 1000 ml water per meter for 7 mm lines. Check the rinsing by means of pH test strips: The pH value of the rinsing water must correspond to the pH value of the fresh water. Always drain disinfection solution and rinse the system with water before maintenance and repair duties. Keep bystanders away. 4.1.2. Use-specific risk mitigation measures During mixing and loading, application and post-application step: Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374, or equivalent, during product handling phase (glove material to be specified by the authorisation holder within the product information) (N-78). Wear chemical resistant goggles (consistent with EN 166, or equivalent). Wear a protective coverall (type 4, EN 14605, or equivalent) (similar to N-10). Wear suitable protective footwear meeting the requirements of European standard EN 13832, or equivalent (similar to N-79). For draining the lines use a hose or a deep narrow pail close to the tap. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749 (N-386). Personal protective equipment (PPE) is stated 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 (N-7). See Section 6 for the full texts of the European standards and legislation cited. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 4.2. Use description Table 2 Use #3 – Bacteria, yeasts, fungi – industrial users - CIP (cleaning in place) disinfection (terminal disinfection after cleaning) - indoor Product type PT04: Food and feed area Where relevant, an exact description of the authorised use --- Target organism(s) (including development stage) Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Field(s) of use indoor use Hard surface disinfection (non-porous) in food production and processing industry area (including (non)alcoholic beverages, dairy industry, meat industry) via concentrate. Application method(s) Method: CIP (cleaning in place) Detailed description: --- Application rate(s) and frequency Application Rate: Application solution: 3,78 % (w/w) biocidal product in water, corresponding to 0,126 % (w/w) active chlorine Number and timing of application: Application frequency: max. once per day (Annual use frequency must comply with national regulatory requirements) Category(ies) of users industrial Pack sizes and packaging material 1 kg bottle (HDPE) 2 kg bottle (HDPE) 6 kg jerry can (HDPE) 20 kg jerry can (HDPE) 25 kg jerry can (HDPE) closure: screw cap with safety seal (HDPE) 250 kg barrel (HDPE) closure: bung closure with plug (PP) 1000 kg IBC (HDPE) 1200 kg IBC (HDPE) closure: screw cap (HDPE) Abbreviations: HDPE (high-density polyethylene), PP (polypropylene) 4.2.1. Use-specific instructions for use Disinfection of beverage dispensing installations. Pre-clean the surfaces and lines before disinfection including rinsing with water. Automated dosing: Add the biocidal product automatically via dosing pump from drum or container to the CIP (cleaning in place) tank pre-filled with the required amount of dilution water. 1. PREPARE SOLUTION: Fill CIP tank with lukewarm water (up to 35°C) and add the biocidal product (3 % (v/v), i.e. 3 l biocidal product in 100 l water) automatically. Freshly prepared solution is PURPLE. Use solution for a maximum of 1 hour. 2. AUTHORISATION HOLDER shall PROVIDE INFORMATION on filling the lines on the label of the product. 3. AUTHORISATION HOLDER shall PROVIDE INFORMATION on pre-cleaning step on the label of the product. 4. DISINFECTION STEP: After that fill lines once more with fresh solution to complete disinfection step – leave in installation for 15 minutes in order to allow the product to take effect for the contact time needed. 5. RINSING: Rinse treated pipes with drinking water after application. Check the rinsing by means of pH test strips: The pH value of the rinsing water must correspond to the pH value of the fresh water. Always drain disinfection solution and rinse the system with water before maintenance and repair duties. Keep bystanders away. 4.2.2. Use-specific risk mitigation measures During automated mixing and loading, application and post-application step: Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374, or equivalent, during product handling phase (glove material to be specified by the authorisation holder within the product information) (N-78). Wear chemical resistant goggles (consistent with EN 166, or equivalent). In case CIP system is not fully closed or during repair tasks: Wear a protective coverall (type 4, EN 14605, or equivalent) (similar to N-10). Wear suitable protective footwear (EN 13832, or equivalent) (similar to N-79). Wear respiratory protective equipment (RPE) protecting against particles with an assigned protection factor (APF) of at least 4. At least a filtering half mask (FFP1, EN 149 or equivalent) or a half/quarter mask (EN 140 or equivalent) or a full-face mask (EN 136 or equivalent) with a particle filter/P1 (EN 143 or equivalent) is required. Filter type (code letter, colour) to be specified by the authorisation holder within the product information. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749 (N-386). Personal protective equipment (PPE) is stated 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 (N-7). See section 6 for the full titles of the European Standards and legislation cited. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use --- 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions: 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 or ambulance for medical assistance. Information to Healthcare personnel and 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 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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. Information to Healthcare personnel and doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. (Add phone number of POISON CENTRE, if nationally required) Emergency measures to protect the environment: Avoid spillage of product to soil, surface water or groundwater. Collect spillage by means of a suitable material (absorbents and binders: sawdust, kieselgur (diatomite), sand, universal binder). 5.4. Instructions for safe disposal of the product and its packaging For containment: Scoop absorbed substance into closing containers. Do not use metal containers. Methods for cleaning up: Small quantities of liquid spill: take up in non-combustible absorbent material and shovel into container for disposal. Large spills: contain released substance, pump into suitable containers. Do not use metal containers. Disposal: Dispose of contents or container to hazardous or special waste collection point in accordance with local, national and international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and local authority requirements. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 8 months N-372: Store at temperatures not exceeding 20°C. N-267: Avoid sources of heat (radiator, direct sunlight), and open windows. N-27: Protect from frost. Store in dry, cool, well-ventilated area. Keep in original container. 6. OTHER INFORMATION If professional users are workers under Framework Directive 89/391/EEC and Directive 89/656/ECC, training is to be provided by employers to ensure appropriate handling of the product and the PPE required. With respect to the “Category(ies) of user(s)” note: Professionals (including industrial users) means trained professionals if this is required by national legislation. Note for notifications of products according to Art. 17(6) of Regulation (EU) No 528/2012: For potassium hydroxide (KOH) and sodium hydroxide (NaOH), the grouping concept applies. Products pertaining to the BPF contain either potassium hydroxide (KOH), sodium hydroxide (NaOH) or a combination of both substances. However, independent of how these substances are combined within the biocidal products, the concentration (single or combined) is at minimum 7,5 % (w/w) and at maximum 15,5 % (w/w). Meta SPC 1: Contains only KOH, cf. to concentrations in the composition table. Meta SPC 2: Contains only KOH, cf. to concentrations in the composition table. Meta SPC 3: Grouping applies. Both pH regulators shall be used together. The minimum content of the potassium hydroxide shall be 1,5 % (w/w). The maximum content of potassium hydroxide shall be 5 % (w/w). The minimum content of sodium hydroxide shall be 5 % (w/w), the maximum content of sodium hydroxide shall be 6 % (w/w). The total content of pH regulators in the formulation should be in the range of 7.5 and 10 The full titles of the EN standards referenced in sections use specific risk mitigation measures are: EN ISO 374-1:2016+A1:2018 Protective gloves against dangerous chemicals and micro-organisms. EN 166 Personal eye protection - Specifications; English version of DIN EN 166 EN 14605 Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN 13832-1 Footwear protecting against chemicals - Part 1: Terminology and test methods EN 13832-2 Footwear protecting against chemicals - Part 2: Requirements for limited contact with chemicals EN 13832-3 Footwear protecting against chemicals - Part 3: Requirements for prolonged contact with chemicals EN 140:1998 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking EN 149:2001 + A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking EN 143:2000 Respiratory protective devices - Particle filters - Requirements, testing, marking Full titles of the cited EU legislation: 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 , ELI: http://data.europa.eu/eli/dir/1998/24/oj ). Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work ( OJ L 330, 16.12.2009, p. 28 , ELI: http://data.europa.eu/eli/dir/2009/148/oj ). Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products ( OJ L 178, 8.6.2020, p. 7 , ELI: http://data.europa.eu/eli/reg/2020/749/oj ). 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) TM DESANA 1.1 TM DESANA NOP TM LINE CLEANER TM DC 7 TM PINK PROOF Authorisation number EU-0036217-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 25 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 3,3 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 7,5 % (w/w) 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier Meta SPC: meta SPC3 1.2. Suffix to the authorisation number Number 1-3 1.3. Product type(s) Product type(s) 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 (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 19 - 19 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 2,5 - 2,5 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 1,5 - 5 % (w/w) Sodium hydroxide Sodium hydroxide Non-active substance 1310-73-2 215-185-5 5 - 6 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H290: May be corrosive to metals. 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 P234: Keep only in original packaging. P260: Do not breathe mist. P260: Do not breathe vapours. P260: Do not breathe spray. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER. P310: Immediately call a doctor. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P390: Absorb spillage to prevent material damage. P391: Collect spillage. P405: Store locked up. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local/regional/national/international regulations. P501: Dispose of container to hazardous or special waste collection point, in accordance with local/regional/national/international regulations. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #1– Bacteria, yeasts, fungi – professional users – disinfection of inner surfaces (disinfection after cleaning) - indoor Product type PT04: Food and feed area Where relevant, an exact description of the authorised use --- Target organism(s) (including development stage) Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Field(s) of use indoor use Hard surface disinfection (non-porous) in food processing area and food consumption areas (e.g. kitchens, canteens, restaurants) via concentrate. Application method(s) Method: CIP (cleaning in place) Detailed description: --- Application rate(s) and frequency Application Rate: Application solution: 3,78 % (w/w) biocidal product in water, corresponding to 0,0958 % (w/w) active chlorine Number and timing of application: Application frequency: max. once per day (Annual use frequency must comply with national regulatory requirements) Category(ies) of users professional Pack sizes and packaging material 1 kg bottle (HDPE) 2 kg bottle (HDPE) 6 kg jerry can (HDPE) 20 kg jerry can (HDPE) 25 kg jerry can (HDPE) closure: screw cap with safety seal (HDPE) 250 kg barrel (HDPE) closure: bung closure with plug (PP) 1000 kg IBC (HDPE) 1200 kg IBC (HDPE) closure: screw cap (HDPE) Abbreviations: HDPE (high-density polyethylene), PP (polypropylene) 4.1.1. Use-specific instructions for use Disinfection of small scale beverage dispensing installations. Use only in semi-closed process (pressure process): disinfection step in closed system, preparation of in-use solution and discharge: non-closed process. Safeguard taps during disinfection procedure. Pre-clean the surfaces and lines before disinfection including rinsing with water. 1. PREPARE SOLUTION: Always rinse the cleaning container. Fill cleaning container with lukewarm water (up to 35°C) and add the biocidal product (135 ml of biocidal product in 4.5 l water). Use solution for a maximum of 1 hour. Use dispensing taps, manual or electrical drum pumps or measuring beaker for transfer. 2. SHAKE: SOLUTION VIOLET: Close and shake container. Pull a sample of the original solution. Freshly prepared solution is PURPLE. 3. CONNECT CLEANING CONTAINER: Attach tap head of the beverage container under the CO 2 pressure onto the cleaning container. 4. AUTHORISATION HOLDER shall PROVIDE INFORMATION on filling the lines on the label of the product. 5. AUTHORISATION HOLDER shall PROVIDE INFORMATION on pre-cleaning step on the label of the product. 6. DISINFECTION STEP: After that fill lines once more with fresh solution to complete disinfection step – leave in lines for 15 minutes in order to allow the product to take effect for the contact time needed. 7. RINSING: Rinse treated pipes with drinking water after application e.g. 1000 ml water per meter for 7 mm lines. Check the rinsing by means of pH test strips: The pH value of the rinsing water must correspond to the pH value of the fresh water. Always drain disinfection solution and rinse the system with water before maintenance and repair duties. Keep bystanders away. 4.1.2. Use-specific risk mitigation measures During mixing and loading, application and post-application step: Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374, or equivalent, during product handling phase (glove material to be specified by the authorisation holder within the product information) (N-78). Wear chemical resistant goggles (consistent with EN 166, or equivalent). Wear a protective coverall (type 4, EN 14605, or equivalent) (similar to N-10). Wear suitable protective footwear meeting the requirements of European standard EN 13832, or equivalent (similar to N-79). For draining the lines use a hose or a deep narrow pail close to the tap. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749 (N-386). Personal protective equipment (PPE) is stated 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 (N-7). See Section 6 for the full texts of the European standards and legislation cited. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 4.2. Use description Table 2 Use #3 – Bacteria, yeasts, fungi – industrial users - CIP (cleaning in place) disinfection (terminal disinfection after cleaning) - indoor Product type PT04: Food and feed area Where relevant, an exact description of the authorised use --- Target organism(s) (including development stage) Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Field(s) of use indoor use Hard surface disinfection (non-porous) in food production and processing industry area (including (non)alcoholic beverages, dairy industry, meat industry) via concentrate. Application method(s) Method: CIP (cleaning in place) Detailed description: --- Application rate(s) and frequency Application Rate: Application solution: 3,78 % (w/w) biocidal product in water, corresponding to 0,0958 % (w/w) active chlorine Number and timing of application: Application frequency: max. once per day (Annual use frequency must comply with national regulatory requirements) Category(ies) of users industrial Pack sizes and packaging material 1 kg bottle (HDPE) 2 kg bottle (HDPE) 6 kg jerry can (HDPE) 20 kg jerry can (HDPE) 25 kg jerry can (HDPE) closure: screw cap with safety seal (HDPE) 250 kg barrel (HDPE) closure: bung closure with plug (PP) 1000 kg IBC (HDPE) 1200 kg IBC (HDPE) closure: screw cap (HDPE) Abbreviations: HDPE (high-density polyethylene), PP (polypropylene) 4.2.1. Use-specific instructions for use Disinfection of beverage dispensing installations. Pre-clean the surfaces and lines before disinfection including rinsing with water. Automated dosing: Add the biocidal product automatically via dosing pump from drum or container to the CIP (cleaning in place) tank pre-filled with the required amount of dilution water. 1. PREPARE SOLUTION: Fill CIP tank with lukewarm water (up to 35°C) and add the biocidal product (3 % (v/v), i.e. 3 l biocidal product in 100 l water) automatically. Freshly prepared solution is PURPLE. Use solution for a maximum of 1 hour. 2. AUTHORISATION HOLDER shall PROVIDE INFORMATION on filling the lines on the label of the product. 3. AUTHORISATION HOLDER shall PROVIDE INFORMATION on pre-cleaning step on the label of the product. 4. DISINFECTION STEP: After that fill lines once more with fresh solution to complete disinfection step – leave in installation for 15 minutes in order to allow the product to take effect for the contact time needed. 5. RINSING: Rinse treated pipes with drinking water after application. Check the rinsing by means of pH test strips: The pH value of the rinsing water must correspond to the pH value of the fresh water. Always drain disinfection solution and rinse the system with water before maintenance and repair duties. Keep bystanders away. 4.2.2. Use-specific risk mitigation measures During automated mixing and loading, application and post-application step: Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374, or equivalent, during product handling phase (glove material to be specified by the authorisation holder within the product information) (N-78). Wear chemical resistant goggles (consistent with EN 166, or equivalent). In case CIP system is not fully closed or during repair tasks: Wear a protective coverall (type 4, EN 14605, or equivalent) (similar to N-10). Wear suitable protective footwear (EN 13832, or equivalent) (similar to N-79). Wear respiratory protective equipment (RPE) protecting against particles with an assigned protection factor (APF) of at least 4. At least a filtering half mask (FFP1, EN 149 or equivalent) or a half/quarter mask (EN 140 or equivalent) or a full-face mask (EN 136 or equivalent) with a particle filter/P1 (EN 143 or equivalent) is required. Filter type (code letter, colour) to be specified by the authorisation holder within the product information. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749 (N-386). Personal protective equipment (PPE) is stated 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 (N-7). See section 6 for the full titles of the European Standards and legislation cited. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage --- 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use --- 5.2. Risk mitigation measures --- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions 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 or ambulance for medical assistance. Information to Healthcare personnel and 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 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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. Information to Healthcare personnel and doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. (Add phone number of POISON CENTRE, if nationally required) Emergency measures to protect the environment: Avoid spillage of product to soil, surface water or groundwater. Collect spillage by means of a suitable material (absorbents and binders: sawdust, kieselgur (diatomite), sand, universal binder). 5.4. Instructions for safe disposal of the product and its packaging For containment: Scoop absorbed substance into closing containers. Do not use metal containers. Methods for cleaning up: Small quantities of liquid spill: take up in non-combustible absorbent material and shovel into container for disposal. Large spills: contain released substance, pump into suitable containers. Do not use metal containers. Disposal: Dispose of contents and container to hazardous or special waste collection point in accordance with local, national and international requirements. Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and local authority requirements. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 8 months N-372: Store at temperatures not exceeding 20°C. N-267: Avoid sources of heat (radiator, direct sunlight), and open windows. N-27: Protect from frost. Store in dry, cool, well-ventilated area. Keep in original container. 6. OTHER INFORMATION If professional users are workers under Framework Directive 89/391/EEC and Directive 89/656/ECC, training is to be provided by employers to ensure appropriate handling of the product and the PPE required. With respect to the “Category(ies) of user(s)” note: Professionals (including industrial users) means trained professionals if this is required by national legislation. Note for notifications of products according to Art. 17(6) of Regulation (EU) No 528/2012: For potassium hydroxide (KOH) and sodium hydroxide (NaOH), the grouping concept applies. Products pertaining to the BPF contain either potassium hydroxide (KOH), sodium hydroxide (NaOH) or a combination of both substances. However, independent of how these substances are combined within the biocidal products, the concentration (single or combined) is at minimum 7,5 % (w/w) and at maximum 15,5 % (w/w). Meta SPC 1: Contains only KOH, cf. to concentrations in the composition table. Meta SPC 2: Contains only KOH, cf. to concentrations in the composition table. Meta SPC 3: Grouping applies. Both pH regulators shall be used together. The minimum content of the potassium hydroxide shall be 1,5 % (w/w). The maximum content of potassium hydroxide shall be 5 % (w/w). The minimum content of sodium hydroxide shall be 5 % (w/w), the maximum content of sodium hydroxide shall be 6 % (w/w). The total content of pH regulators in the formulation should be in the range of 7.5 and 10 The full titles of the EN standards referenced in sections use specific risk mitigation measures are: EN ISO 374-1:2016+A1:2018 Protective gloves against dangerous chemicals and micro-organisms. EN 166 Personal eye protection - Specifications; English version of DIN EN 166 EN 14605 Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN 13832-1 Footwear protecting against chemicals - Part 1: Terminology and test methods EN 13832-2 Footwear protecting against chemicals - Part 2: Requirements for limited contact with chemicals EN 13832-3 Footwear protecting against chemicals - Part 3: Requirements for prolonged contact with chemicals EN 140:1998 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking EN 149:2001 + A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking EN 143:2000 Respiratory protective devices - Particle filters - Requirements, testing, marking Full titles of the cited EU legislation: 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 , ELI: http://data.europa.eu/eli/dir/1998/24/oj ). Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work ( OJ L 330, 16.12.2009, p. 28 , ELI: http://data.europa.eu/eli/dir/2009/148/oj ). Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products ( OJ L 178, 8.6.2020, p. 7 , ELI: http://data.europa.eu/eli/reg/2020/749/oj ). 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) TM DESANA VERIFY TM DESANA 2.0 TM SUPER 7 TM PINK BLC TM PURPLE BLC TM SCHANKREIN TM DC77 TM COLOUR CLEAN TM DESANA PINK Authorisation number EU-0036217-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 19 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 2,5 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 5 % (w/w) Sodium hydroxide Sodium hydroxide Non-active substance 1310-73-2 215-185-5 5 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) TM DESANA 2.1 TM SMART CIP TM PINK CIP TM PURPLE CIP TM CIP 911 TM SMART CIP BLC TM SMART CIP COLOUR Authorisation number EU-0036217-0004 1-3 Common name IUPAC name Function CAS number EC number Content (%) Sodium hypochlorite solution (14 % (w/w)) Sodium hypochlorite Releaser 7681-52-9 231-668-3 19 % (w/w) Active chlorine released from sodium hypochlorite Active chlorine released from sodium hypochlorite Active substance 2,5 % (w/w) Potassium hydroxide Potassium hydroxide Non-active substance 1310-58-3 215-181-3 1,5 % (w/w) Sodium hydroxide Sodium hydroxide Non-active substance 1310-73-2 215-185-5 6 % (w/w)
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