COMMISSION IMPLEMENTING REGULATION (EU) 2022/1226
of 14 July 2022
granting a Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product
1. ADMINISTRATIVE INFORMATION
1.1.
Trade name(s) of the product
Trade name(s) |
Bioquell HPV-AQ |
1.2.
Authorisation holder
Name and address of the authorisation holder |
Name |
Ecolab Deutschland GmbH |
Address |
Ecolab Allee 1, 40789 Monheim am Rhein Germany |
|
Authorisation number |
EU-0027469-0000 |
|
R4BP asset number |
EU-0027469-0000 |
|
Date of the authorisation |
7.8.2022 |
|
Expiry date of the authorisation |
31.7.2032 |
1.3.
Manufacturer(s) of the product
Name of manufacturer |
Ecolab SNC |
Address of manufacturer |
153 Quai de Rancy, Bonneuil-sur-Marne, 94380 Paris France |
Location of manufacturing sites |
153 Quai de Rancy, Bonneuil-sur-Marne, 94380 Paris France 53 Royce Close, SP10 3TS Andover United Kingdom Unit E4, Eastway Business Park, Ballysimon Road, V94 K267 Limerick Ireland |
1.4.
Manufacturer(s) of the active substance(s)
Active substance |
Hydrogen peroxide |
Name of manufacturer |
Evonik Peroxide Spain |
Address of manufacturer |
Beethoven 15, Sobreatico, 08021 Barcelona Spain |
Location of manufacturing sites |
C/ Afueras s/n La Zaida, 50784 Zaragoza Spain |
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 |
|
Active Substance |
7722-84-1 |
231-765-0 |
35,0 |
2.2.
Type of formulation
3. HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
May intensify fire; oxidiser Harmful if swallowed. Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Harmful to aquatic life with long lasting effects. |
Precautionary statements |
Keep away from clothing and other combustible materials. Avoid breathing vapours. Do not eat, drink or smoke when using this product. Avoid release to the environment. Wear protective gloves/protective clothing/eye protection. IF SWALLOWED: Call a Poison Centre or doctor/physician if you feel unwell. Rinse mouth. IF ON SKIN: Wash with plenty of water. If skin irritation occurs: Get medical attention. Take off contaminated clothing. And wash it before reuse. IF INHALED: Remove person to fresh air and keep comfortable for breathing. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. Call a POISON CENTER/doctor if you feel unwell. In case of fire: Use water to extinguish. Store in a well-ventilated place. Keep container tightly closed. Store locked up. Dispose of contents to waste in accordance with applicable local, national and international regulations. |
4. AUTHORISED USE(S)
4.1.
Use description
Product type |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants) |
Where relevant, an exact description of the authorised use |
- |
Target organism(s) (including development stage) |
Common name: Bacteria Development stage: Common name: bacteria spores Development stage: Common name: Mycobacteria Development stage: Common name: Fungi Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Common name: bacteriophage Development stage: |
Field(s) of use |
Indoor Hard, non-porous surfaces in small (0,25 m3 to 4 m3) sealed enclosures by vaporisation, with prior cleaning. PT2 – clean conditions in, for example, isolators, pass-through chambers, cabinets, material airlocks, cupboards, filling lines, emergency vehicles. PT3 – pre-cleaned animal cages/racks within biomedical and animal laboratory facilities PT4 – clean conditions in, for example, aseptic filling lines, storage containers. |
Application method(s) |
Method: vaporisation Detailed description: Vaporisation with Bioquell Hydrogen Peroxide Vapour system followed by micro condensation – to deliver the disinfectant to surfaces in closed systems. Temperature range: room temperature Humidity range: 10 %-80 % |
Application rate(s) and frequency |
Application Rate: 100 g/m3 of undiluted product, contact time of 35 minutes (after diffusion). Dilution (%): 0 Number and timing of application: Users should carry out decontaminations in line with their requirements and operating procedures |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
75 ml, 150 ml, 500 ml, 950 ml, 1 000 ml, 2 000 ml, 5 000 ml and 25 L. Bottles are constructed of HDPE |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
Product type |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants) |
Where relevant, an exact description of the authorised use |
- |
Target organism(s) (including development stage) |
Common name: Bacteria Development stage: Common name: Mycobacteria Development stage: Common name: Bacteria spores Development stage: Common name: Fungi Development stage: Common name: Yeasts Development stage: Common name: Viruses Development stage: Common name: bacteriophages Development stage: |
Field(s) of use |
Indoor Hard, non-porous surfaces in large (> 4 m3) sealed enclosures by vaporisation, with prior cleaning. PT2 – clean conditions in, for example hospitals, clean rooms, aseptic processing facilities, laboratories, nursing homes, research facilities, schools, cruise ships, emergency vehicles, veterinary hospitals (excluding animal housing), laboratories in veterinary institutions PT3 – pre-cleaned animal cages/racks within biomedical and animal laboratory facilities. PT4 – clean conditions in, for example, aseptic filling lines, food production facilities, storage containers |
Application method(s) |
Method: vaporisation Detailed description: Vaporisation with Bioquell Hydrogen Peroxide Vapour system followed by micro condensation – to deliver the disinfectant to surfaces in closed systems. Temperature range: Room temperature Humidity range:10 %-80 % |
Application rate(s) and frequency |
Application Rate: 10 g/m3 of undiluted product, contact time of 35 minutes (after diffusion Dilution (%): 0 Number and timing of application: Users should carry out decontaminations in line with their requirements and operating procedures. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
75 ml, 150 ml, 500 ml, 950 ml, 1 000 ml, 2 000 ml, 5 000 ml and 25 L. Bottles are constructed of HDPE. |