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

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 holder
Name
Kanters Special Products B.V.
Address
De Stater 32 5737 RV Lieshout Netherlands (the)
Authorisation number
EU-0034622-0000
R4BP asset number
EU-0034622-0000
Date of the authorisation
23 October 2025
Expiry date of the authorisation
30 September 2035
1.3.    Manufacturer(s) of the product
Name of manufacturer
Kanters Special Products B.V.
Address of manufacturer
De Stater 32 5737 RV Lieshout Netherlands (the)
Location of manufacturing sites
Kanters Special Products B.V. De Stater 32 5737 RV Lieshout Netherlands (the)
1.4.    Manufacturer(s) of the active substance(s)
Active substance
Hydrogen peroxide
Name of manufacturer
Kemira Rotterdam B.V.
Address of manufacturer
Botlekweg 175 3197 KA Rotterdam Netherlands (the)
Location of manufacturing sites
Kemira 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 name
IUPAC name
Function
CAS number
EC number
Content (%)
Hydrogen peroxide
Hydrogen peroxide
Active substance
7722-84-1
231-765-0
49,4 % (w/w)
Phosphoric acid
Phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,0113 % (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 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
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/m 2 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, 1 000 litres, 1 150 kilogram and 1 200 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-1 200 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 m 3 .
—
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 type
PT03: Veterinary hygiene
Target 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/m 2 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, 1 000 litres, 1 150 kilogram and 1 200 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-1 200 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 m 3 .
—
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 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
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/m 2 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, 1 000 litres, 1 150 kilogram and 1 200 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-1 200 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 m 3 .
—
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  ( 1 )
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/m 3 ) 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/m 3 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.
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
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

Schedules & Appendices

Cite this act
