Commission Implementing Regulation (EU) 2025/1977of 1 October 2025granting a Union authorisation for the single biocidal product Aqua-Clean in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)

Commission Implementing Regulation (EU) 2025/1977 of 1 October 2025 granting a Union authorisation for the single biocidal product Aqua-Clean in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 31 January 2017, Kanters Special Products B.V. submitted an application to the European Chemicals Agency (the Agency) in accordance with Article 43(1) of Regulation (EU) No 528/2012, for Union authorisation of the single biocidal product Aqua-Clean of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-PT029767-00 in the Register for Biocidal Products. (2) Aqua-Clean contains hydrogen peroxide as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4. (3) On 29 August 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. (4) On 21 March 2025, the Agency submitted to the Commission its opinion Opinion of 27 February 2025 on the Union authorisation of the single biocidal product Aqua-Clean (ECHA/BPC/463/2025), https://echa.europa.eu/opinions-on-union-authorisation. , the draft summary of the biocidal product characteristics (SPC) of Aqua-Clean and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012. (5) The opinion concludes that Aqua-Clean is a single biocidal product within the meaning of Article 3(1), point (r), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation. (6) On 15 April 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the single biocidal product Aqua-Clean. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0034622-0000 is hereby granted to Kanters Special Products B.V. for the making available on the market and use of the single biocidal product Aqua-Clean in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 23 October 2025 until 30 September 2035.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 1 October 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT Aqua-Clean Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area Authorisation number: EU-0034622-0000 R4BP asset number: EU-0034622-0000

1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s)Aqua-Clean 1.2. Authorisation holder Name and address of the authorisation holderNameKanters Special Products B.V.AddressDe Stater 32 5737 RV Lieshout Netherlands (the)Authorisation numberEU-0034622-0000R4BP asset numberEU-0034622-0000Date of the authorisation23 October 2025Expiry date of the authorisation30 September 2035 1.3. Manufacturer(s) of the product Name of manufacturerKanters Special Products B.V.Address of manufacturerDe Stater 32 5737 RV Lieshout Netherlands (the)Location of manufacturing sitesKanters Special Products B.V. De Stater 32 5737 RV Lieshout Netherlands (the) 1.4. Manufacturer(s) of the active substance(s) Active substanceHydrogen peroxideName of manufacturerKemira Rotterdam B.V.Address of manufacturerBotlekweg 175 3197 KA Rotterdam Netherlands (the)Location of manufacturing sitesKemira Rotterdam B.V. Moezelweg 151 3198 LS Europoort Rotterdam Netherlands (the)
2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hydrogen peroxideHydrogen peroxideActive substance7722-84-1231-765-049,4 % (w/w)Phosphoric acidPhosphoric acidNon-active substance7664-38-2231-633-20,0113 % (w/w) 2.2. Type(s) of formulation SL Soluble concentrate
3. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H412: Harmful 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. P260: Do not breathe vapours. P264: Wash hands thoroughly after handling. 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 gloves. 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. P312: Call a POISON CENTER/doctor if you feel unwell. P363: Wash contaminated clothing before reuse. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents in accordance with local/regional/national/international regulations. P501: Dispose of container in accordance with local/regional/national/international regulations. 4. AUTHORISED USE(S) 4.1. Use description Table 1 Use #1 – Disinfection of hard surfaces and equipment in industrial, institutional and plant cultivation areas (PT2) Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsTarget organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use Indoor use Disinfection of hard surfaces and equipment in industrial and institutional areas (non-healthcare areas) and in rooms intended for plant cultivation (disinfection for general hygiene purposes only). Application method(s) Method: open system: immersion spraying Detailed description: Application rate(s) and frequency Application Rate: Spraying: 18 ml/m2 of diluted product. Immersion: Use sufficient liquid resulting in objects to be completely immersed. Dilution (%): 15 Number and timing of application: Contact time: 15 minutes Frequency: 1 × per cycle in empty housing (1 × per 6-12 weeks) Category(ies) of users Industrial Professional Pack sizes and packaging material Jerrycan, High Density Polyethylene (HDPE), screw cap: 4 litres, 5 litres, 10 litres, 20 litres, 20 kilogram and 24 kilogram. Barrel, High Density Polyethylene (HDPE), screw cap: 200 litres and 250 kilogram. Intermediate bulk container (IBC), High Density Polyethylene (HDPE), screw cap with integrated safety valve: 975 litres, 1000 litres, 1150 kilogram and 1200 kilogram. 4.1.1. Use-specific instructions for use For use at room 20 °C Only for use on non-porous surfaces. Disinfection of hard surfaces and equipment in industrial and institutional areas (non-healthcare areas): Dilute the product to 15 % (150 ml of product, add water up to 1 l). Keep surface wet or keep objects immersed during complete contact time of 15 minutes. Wipe dry or let it air dry. Cover the bath with a lid while disinfection occurs. Immersion baths can only be used once. Rinse treated surfaces/equipment/pipes/machinery with drinking water after application.

Plant cultivation areas: Pre-clean the surface or object which should be disinfected. Remove excess water before disinfection. Dilute the product to 15 % (150 ml of product, add water up to 1 l). Keep surface wet or keep objects immersed during complete contact time of 15 minutes. Cover the bath with a lid while disinfection occurs. Immersion baths can only be used once. Rinse treated surfaces/equipment/pipes/machinery with drinking water after application. Small containers (4 l-24 kg) will be handled by manual pouring into a suitable application device (backpack sprayer, trolley sprayer, bucket). Drums and intermediate bulk containers (200 l-1200 kg) will be handled by hand-pump to fill the sprayer or bucket. 4.1.2. Use-specific risk mitigation measures For mixing and loading: Wear protective chemical resistant gloves (EN 374) during product handling phase. Use eye protection (chemical goggles) (EN166) during handling of the product. Use of respiratory protective equipment (RPE) providing a protection factor of 10 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 gas filter is required. (EN 12941). Wear a protective coverall (at least type 4, EN 14605) which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). For spraying: Spraying is only allowed in the downward or horizontal direction. The flow rate of the backpack sprayer must not exceed 0,3 l/min. The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory. Use only in rooms with a volume ≥ 300 m3. Provide ventilation of 3 air changes per hour (industrial ventilation or keeping windows and doors open). The use respiratory protective equipment (RPE) (EN 12941) providing a protection factor of 10. At least a powered air purifying respirator with helmet/hood/mask (TH2/TM2), or a full mask with filter B-P2 is required. For dipping/Immersion: The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory. The use of respiratory protective equipment (RPE) (EN 12941) providing a protection factor of 4 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH2/TM2), or a full mask with filter B-P2 is required. Cleaning equipment (spraying/dipping uses) Wear the same PPE and RPE needed for application. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards. 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 See general instructions. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions. 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 instructions. 4.2. Use description Table 2 Use #2 – Disinfection of hard surfaces and equipment in stables used for animal husbandry (PT3) Product typePT03: Veterinary hygieneTarget organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use Indoor use Disinfection of hard non-porous surfaces and equipment used for animal husbandry. Application method(s) Method: open system: immersion spraying Detailed description: Application rate(s) and frequency Application Rate: Spraying: 18 ml/m2 of diluted product. Keep surface wet during the complete contact time. Immersion: Use sufficient liquid resulting in objects to be completely immersed. Dilution (%): 25 Number and timing of application: Contact time: 15 minutes Frequency: 1 × per cycle when cleaning spaces (1 × per 6-12 weeks) Category(ies) of users Industrial Professional Pack sizes and packaging material Jerrycan, High Density Polyethylene (HDPE), screw cap: 4 litres, 5 litres, 10 litres, 20 litres, 20 kilogram and 24 kilogram. Barrel, High Density Polyethylene (HDPE), screw cap: 200 litres and 250 kilogram. Intermediate bulk container (IBC), High Density Polyethylene (HDPE), screw cap with integrated safety valve: 975 litres, 1000 litres, 1150 kilogram and 1200 kilogram. 4.2.1. Use-specific instructions for use For use at 10 °C Only use in empty animal housing. Pre-clean the object/surface which should be disinfected. Remove excess of water before disinfection. Dilute the product to 25 % (250 ml product, add water up to 1l). Keep surface wet or keep objects submerged during complete contact time of 15 min. Cover the bath with a lid while disinfection occurs Immersion bath can only be used once. Rinse treated surfaces/equipment/pipes/machinery with drinking water after application. Small containers (4 l-24 kg) will be handled by manual pouring into a suitable application device (backpack sprayer, trolley sprayer, bucket). Drums and intermediate bulk containers (200 l-1200 kg) will be handled by hand-pump to fill the sprayer or bucket. 4.2.2. Use-specific risk mitigation measures For mixing and loading: Wear protective chemical resistant gloves (EN 374) during product handling phase. Use eye protection (chemical goggles) (EN166) during handling of the product. Use of respiratory protective equipment (RPE) providing a protection factor of 10 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 gas filter is required. (EN 12941). Wear a protective coverall (at least type 4, EN 14605) which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). For spraying: Spraying is only allowed in the downward or horizontal direction. The flow rate of the backpack sprayer must not exceed 0,3 l/min. The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory.

Use only in rooms with a volume ≥ 300 m3. Provide ventilation of 3 air changes per hour (industrial ventilation or keeping windows and doors open). The use of respiratory protective equipment (RPE) (EN12941) providing a protection factor of 20. At least a powered air purifying respirator with helmet/hood/mask (TH2/TM2), or a full mask with filter B-P2 is required. Animals must be kept away from treated areas until surfaces are dry. For dipping/Immersion: The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory. The use of respiratory protective equipment (RPE) (EN12941) providing a protection factor of 10 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH2/TM2), or a full mask with filter B-P2 is required. Animals must be kept away from treated areas until surfaces are dry. Cleaning equipment (spraying/dipping uses) Wear the same PPE and RPE needed for application. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards. 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 See general instructions. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions. 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 instructions. 4.3. Use description Table 3 Use #3 – Disinfection of hard surfaces, machinery, (drinking-) equipment and in pipelines in animal housing and food and feed industry (PT4). Product typePT04: Food and feed areaTarget organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Field(s) of use Indoor use Coarse spraying or submerging of drinking equipment (animal water bowls) and other equipment (scoops, shovels, hard furniture and cutlery used for preparation of food and feed). Only use in empty animal housing. Coarse spraying of surfaces in kitchens of restaurants and in food and feed industry. Filling or CIP of (drinking water) pipelines in animal housings and pipelines and machineries in kitchens of restaurants, hospitals and in food and feed industry. Application method(s) Method: open system: immersion spraying CIP of (drinking) water pipelines – Filling Detailed description: Application rate(s) and frequency Application Rate: Spraying: Product shall be diluted to 15 % (150 ml of product, add water up to 1 l). Use 18 ml/m2 of diluted product. Immersion: Product shall be diluted to 15 % (150 ml of product, add water up to 1 l). Use sufficient liquid resulting in objects to be completely immersed. CIP: Product shall be diluted to 3 % or 15 %. Filling: Product shall be diluted to 3 % or 15 %. Use sufficient liquid resulting in completely filled pipes (no air bubbles remaining). Dilution: 15 % (Spraying/Immersion), 3-15 % (CIP/ Filling)

Number and timing of application: Contact time spraying & immersion: 15 minutes Contact time filling & CIP: 15 % product for 15 min or 3 % product for at least 12 hours Frequency: 1 × per cycle in empty housing (1 × per 6-12 weeks) Category(ies) of users industrial professional Pack sizes and packaging material Jerrycan, High Density Polyethylene (HDPE), screw cap: 4 litres, 5 litres, 10 litres, 20 litres, 20 kilogram and 24 kilogram. Barrel, High Density Polyethylene (HDPE), screw cap: 200 litres and 250 kilogram. Intermediate bulk container (IBC), High Density Polyethylene (HDPE), screw cap with integrated safety valve: 975 litres, 1000 litres, 1150 kilogram and 1200 kilogram. 4.3.1. Use-specific instructions for use For use at 20 °C Only use in empty animal housing. Only for use on non-porous surfaces. For spraying/immersion: Dilute the product to 15 % (150 ml product, add water up to 1 l). Spraying is only allowed in the downward or horizontal direction. Keep surface wet or keep objects submerged during complete contact time, cover the bath with a lid while disinfection occurs; Contact time: 15 minutes. For CIP: Use an automated dosing system for application. Connect the piping system to the automated dosing equipment and adjust to 3 % product dilution; Contact time: at least 12 hours with a 3 % product dilution, or 15 minutes with a 15 % product dilution For filling: Use sufficient liquid (3 % diluted product resulting in completely filled pipes (no air bubbles remaining); Contact time: at least 12 hours with a 3 % product dilution, or 15 minutes with a 15 % product dilution Rinse treated surfaces/equipment/pipes/machinery with drinking water after application. Small containers (4 l-24 kg) will be handled by manual pouring into a suitable application device (backpack sprayer, trolley sprayer, bucket). Drums and intermediate bulk containers (200 l-1200 kg) will be handled by hand-pump to fill the sprayer or bucket. 4.3.2. Use-specific risk mitigation measures Mixing and loading Wear protective chemical resistant gloves (EN 374) during product handling phase. The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory. Use of respiratory protective equipment (RPE) providing a protection factor of 10 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 gas filter is required. (EN 12941). Wear a protective coverall (at least type 4, EN 14605) which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information). For spraying: The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory. Use only in rooms with a volume ≥ 300 m3. Provide ventilation of 3 air changes per hour (industrial ventilation or keeping windows and doors open). The use of respiratory protective equipment (RPE) (EN 12941) providing a protection factor of 10 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH2/TM2), or a full mask with filter B-P2 is required.

For dipping/Immersion: The use of eye protection (chemical goggles) (EN166) during handling of the product is mandatory. The use of respiratory protective equipment (RPE) (EN12941) providing a protection factor of 4 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH2/TM2), or a full mask with filter B-P2 is required. Maintenance equipment (CIP, filling): Wear eye protection (chemical goggles) (EN166) during maintenance of circuit system/dosing pumps. Cleaning equipment (spraying/dipping uses): Wear the same PPE and RPE needed for application. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards. 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 See general instructions. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions. 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 instructions. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses. 5.1. Instructions for use See use-specific instruction for use. 5.2. Risk mitigation measures Unprotected persons and animals shall be kept away from treated areas during application. No access of third parties during application / treatment. Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid measures: After inhalation: 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. After skin contact: 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. After eye contact: 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. After swallowing: 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. Information for doctor: The eyes should also be rinsed repeatedly on the way to the doctor. Accidental release measures: Personal precautions, protective equipment and emergency procedures:

Keep people at a distance and stay on the windward side. Keep away from ignition sources. Ensure adequate ventilation. Use personal protection equipment. Keep unprotected persons away. Environmental precautions: Dilute with plenty of water. Do not allow to enter sewers/surface or ground water. Methods and material for containment and cleaning up: Send for recovery or disposal in suitable receptacles. Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Use neutralising agent. Dispose contaminated material as waste according to instructions. Ensure adequate ventilation. 5.4. Instructions for safe disposal of the product and its packaging Waste treatment methods Small amounts may be diluted with plenty of water and washed away. Dispose of bigger amounts in accordance with Local Authority requirements. Rinse packaging before disposal. Empty containers/packaging may not be used for other purposes. Dispose of as hazardous waste. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Uncleaned packaging: Disposal must take place according to official regulations. Recommended cleansing agents: Water, if necessary together with cleansing agents. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store this product in a well-ventilated place. Do not expose container to sunlight. Shelf life: 2 years in HDPE packaging. 6. OTHER INFORMATION The following personal protective equipment (PPE) is stipulated 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. EN 374 – Protective gloves against dangerous chemicals and micro-organisms EN 166 – Eye protection against chemicals EN 12941 – Respiratory protective devices – Powered filtering devices incorporating a loose fitting respiratory interface 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]) Please be aware of the European reference value of 1,25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) was used for the risk assessment for the biocidal product. Please be aware that relevant lower national limit values may apply. With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.