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Document 32025R0534
Commission Implementing Regulation (EU) 2025/534 of 21 March 2025 amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product Bioquell HPV-AQ
Commission Implementing Regulation (EU) 2025/534 of 21 March 2025 amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product Bioquell HPV-AQ
Commission Implementing Regulation (EU) 2025/534 of 21 March 2025 amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product Bioquell HPV-AQ
C/2025/1679
OJ L, 2025/534, 25.3.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/534/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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Official Journal |
EN L series |
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2025/534 |
25.3.2025 |
COMMISSION IMPLEMENTING REGULATION (EU) 2025/534
of 21 March 2025
amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’
(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 (1), and in particular Article 50(2) thereof,
Whereas:
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(1) |
On 14 July 2022, Commission Implementing Regulation (EU) 2022/1226 (2) granted a Union authorisation, under number EU-0027469-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the single biocidal product ‘Bioquell HPV-AQ’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that single biocidal product. |
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(2) |
On 24 January 2023 and 24 April 2024, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), notifications of administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’, recorded in the register for biocidal products under case numbers BC-EE084020-66 and BC-VW094451-98. The notified proposed changes concern the addition of active substance manufacturers and formulators of biocidal products, a change of the manufacturer name from ‘Ecolab SNC’ to ‘Ecolab Europe GmbH’ to align with other Ecolab biocidal product authorisations and the addition of one packaging size within the packaging range assessed during the evaluation. |
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(3) |
On 10 March 2023 and 20 May 2024 (4), the Agency submitted to the Commission in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met. |
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(4) |
On 29 April 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013. |
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(5) |
The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ to introduce the administrative changes requested by Ecolab Deutschland GmbH. |
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(6) |
Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘Bioquell HPV-AQ’ as set out in the Annex to Implementing Regulation (EU) 2022/1226 remains unchanged. |
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(7) |
In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/1226 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in 2024, the summary of biocidal product characteristics in that Annex, should also include some minor editorial and layout changes. |
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(8) |
Implementing Regulation (EU) 2022/1226 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2022/1226 is replaced by the text set out in the Annex to this Regulation.
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, 21 March 2025.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2022/1226 of 14 July 2022 granting a Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ (OJ L 189, 18.7.2022, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2022/1226/oj).
(3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).
(4) ECHA Opinion No UAD-C-1650176-34-00/F and UAD-C-1732722-38-00/F of 10/03/2023 and 20/05/2024 on the administrative change of the Union authorisation of the single biocidal product ‘Bioquell HPV-AQ’, https://echa.europa.eu/opinions-on-applications-for-union-authorisation.
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT
Bioquell HPV-AQ
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-0027469-0000
R4BP asset number: EU-0027469-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
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Trade name(s) |
Bioquell HPV-AQ |
1.2. Authorisation holder
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Name and address of the authorisation holder |
Name |
Ecolab Deutschland GmbH |
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Address |
Ecolab Allee 1 40789 Monheim am Rhein DE |
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Authorisation number |
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EU-0027469-0000 |
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R4BP asset number |
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EU-0027469-0000 |
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Date of the authorisation |
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7 August 2022 |
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Expiry date of the authorisation |
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31 July 2032 |
1.3. Manufacturer(s) of the product
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Name of manufacturer |
Ecolab Europe GmbH |
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Address of manufacturer |
Richtistrasse 7 8304 Walliselen Switzerland |
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Location of manufacturing sites |
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1.4. Manufacturer(s) of the active substance(s)
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Active substance |
Hydrogen peroxide |
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Name of manufacturer |
Evonik Peroxide Spain |
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Address of manufacturer |
Beethoven 15, Sobreatico 08021 Barcelona Spain |
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Location of manufacturing sites |
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Active substance |
Hydrogen peroxide |
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Name of manufacturer |
Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) |
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Address of manufacturer |
Creavis, Rellinghauser Straße 1-11 45128 Essen Germany |
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Location of manufacturing sites |
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Active substance |
Hydrogen peroxide |
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Name of manufacturer |
Evonik Peroxid GmbH |
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Address of manufacturer |
Industriestrasse 1 A-9721 Weissenstein Austria |
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Location of manufacturing sites |
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Active substance |
Hydrogen peroxide |
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Name of manufacturer |
Evonik Operations GmbH |
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Address of manufacturer |
Creavis, Rellinghauser Straße 1-11 45128 Essen Germany |
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Location of manufacturing sites |
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2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Hydrogen peroxide |
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active substance |
7722-84-1 |
231-765-0 |
35 % (w/w) |
2.2. Type(s) of formulation
HN Hot fogging concentrate
3. HAZARD AND PRECAUTIONARY STATEMENTS
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Hazard statements |
H272: May intensify fire; oxidiser. H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. |
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Precautionary statements |
P220: Keep away from clothing or other combustible materials. P261: Avoid breathing vapours. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves/protective clothing/eye protection. P301+P312: IF SWALLOWED: Call a Poison Center or doctor/physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water. P332+P313: If skin irritation occurs: Get medical attention. P362+P364: Take off contaminated clothing and wash it before reuse. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor/physician.. P312: Call a POISON CENTER/doctor if you feel unwell. P370+P378: In case of fire: Use water to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents to waste in accordance with applicable local, national and international regulations. |
4. AUTHORISED USE(S)
4.1. Use description
Table 1
Surface disinfection in small (0,25 m3 - 4 m3) enclosures
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Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area |
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Where relevant, an exact description of the authorised use |
- |
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Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: bacteria spores Development stage: no data Scientific name: no data Common name: Mycobacteria Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Scientific name: no data Common name: bacteriophage Development stage: no data |
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Field(s) of use |
indoor use Hard, non-porous surfaces in small (0,25 m3 to 4 m3) sealed enclosures by vapourisation, 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. |
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Application method(s) |
Method: vapourisation Detailed description: Vapourisation with Bioquell Hydrogen Peroxide Vapour system followed by microcondensation – to deliver the disinfectant to surfaces in closed systems.Temperature range: room temperatureHumidity range: 10 % - 80 % |
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Application rate(s) and frequency |
Application rate: 100 g/m3 of undiluted product, contact time of 35 minutes (after diffusion). 0 Number and timing of application: Users should carry out decontaminations in line with their requirements and operating procedures |
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Category(ies) of users |
professional |
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Pack sizes and packaging material |
75 ml, 150 ml, 500 ml, 950 ml, 1 000 ml, 2 000 ml, 5 000 ml, 20 L, and 25 L. Bottles are constructed of HDPE |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
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 directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Only recycle completely emptied packaging. Dispose of any residual product in accordance with EWC 160903
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Do not store at temperatures above 35 °C
Shelf life 18 months.
4.2. Use description
Table 2
Surface disinfection within large (> 4 m3) enclosures
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Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area |
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Where relevant, an exact description of the authorised use |
- |
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Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Mycobacteria Development stage: no data Scientific name: no data Common name: Bacteria spores Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Scientific name: no data Common name: bacteriophages Development stage: no data |
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Field(s) of use |
indoor use Hard, non-porous surfaces in large (> 4 m3) sealed enclosures by vapourisation, 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 |
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Application method(s) |
Method: vapourisation Detailed description: Vapourisation with Bioquell Hydrogen Peroxide Vapour system followed by micro condensation – to deliver the disinfectant to surfaces in closed systems.Temperature range: Room temperatureHumidity range:10 % - 80 % |
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Application rate(s) and frequency |
Application rate: 10g/m3 of undiluted product, contact time of 35 minutes (after diffusion) 0 Number and timing of application: Users should carry out decontaminations in line with their requirements and operating procedures. |
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Category(ies) of users |
professional |
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Pack sizes and packaging material |
75 ml, 150 ml, 500 ml, 950 ml, 1 000 ml, 2 000 ml, 5 000 ml, 20 L, and 25 L. Bottles are constructed of HDPE. |
4.2.1. Use-specific instructions
See general directions for use
4.2.2. Use-specific risk mitigation measures
See general directions for use
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 directions for use
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Only recycle completely emptied packaging. Dispose of any residual product in accordance with EWC 160903
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Do not store at temperatures above 35 °C. Shelf life 18 months.
5. GENERAL DIRECTIONS FOR USE (1)
5.1. Instructions for use
Surfaces must be pre-cleaned and dry before disinfection and cupboard doors and drawers should be opened for the process to be effective.
Users should carry out decontaminations in line with their requirements and operating procedures.
For disinfection of pre-cleaned animal cages/racks within biomedical and animal laboratory facilities, disinfection can only take place on thoroughly cleaned non-porous surfaces (PT3), when possible use automated washing machines.
Do not mix with detergents or other chemicals. Undiluted.
Bioquell HPV-AQ is to be used with a Bioquell vaporisation module as a disinfectant for surfaces and other inanimate objects in enclosures.
Seal the enclosure (e.g. with tape) to ensure no leakage of the vapourised active substance outside the enclosure prior to initiating a cycle.
Refer to the Bioquell HPV-AQ Labelling insert prior to running a cycle.
At the end of the dwell period, the aeration phase is activated which removes the hydrogen peroxide. The aeration phase is deactivated by the user when the enclosure has been confirmed to be less than or equal to 1,25 mg/m3 (0,9 ppm) using an independent calibrated low-level hydrogen peroxide sensor.
Biological validation should be performed for enclosures to be disinfected. Where environmental conditions within an enclosure are well controlled, a protocol for disinfection of the enclosure should be made and used thereafter. Validated quantitative chemical indicators can be used in place of biological indicators for routine disinfection.
Biological or chemical indicators shall be placed in the enclosure to validate the cycle.
Users should not carry out manual cleaning operations (for example sweeping) immediately post-decontamination.
5.2. Risk mitigation measures
No person or animals are allowed to be present in a room during treatment.
Treated areas may not be entered until the concentration of hydrogen peroxide is ≤ 0,9 ppm (1,25mg/m3).
The professional user may only enter the room in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m3 ) considering RPE with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves, eye protection, coverall) must be worn.
Use a calibrated sensor to confirm the enclosure is ≤ 0,9 ppm (1,25 mg/m3) prior to re-entry.
When opening the container and preparing contents wear suitable personal protective equipment (gloves, eye protection, coverall).
Wash hands after use.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Possible exposure effects:
Skin – chemical burn – transient, non-permanent whitening of the skin
Eyes – potential for permanent damage
Inhalation - irritation of the throat and nose
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor:
Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
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.
5.4. Instructions for safe disposal of the product and its packaging
Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets ...) nor down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from Frost. Do not store at temperatures above 35 °C.
Shelf life 18 months.
6. OTHER INFORMATION
Bioquell HPV-AQ is not intended for use as a terminal sterilant / disinfectant for medical devices.
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
ELI: http://data.europa.eu/eli/reg_impl/2025/534/oj
ISSN 1977-0677 (electronic edition)