Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/1707 20.6.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1707 of 19 June 2024 granting a Union authorisation for the biocidal product family ‘STERI-PEROX’ 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...
Official Journal EN of the European Union L series 2024/1707 20.6.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1707 of 19 June 2024 granting a Union authorisation for the biocidal product family ‘STERI-PEROX’ 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 2012concerning the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph, thereof,
Whereas:
(1) On 27 January 2017, Veltek Associates Inc. Europe submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘STERI-PEROX’ of product-type 2, 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-GQ029577-18 in the Register for Biocidal Products.
(2) ‘STERI-PEROX’ contains hydrogen peroxide as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 2.
(3) On 27 February 2023, 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 2 October 2023, the Agency submitted to the Commission its opinion(2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘STERI-PEROX’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.
(5) The opinion concludes that ‘STERI-PEROX’ is a biocidal product family within the meaning of Article 3(1), point (s), 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) and (6) of that Regulation.
(6) On 20 October 2023, 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 ‘STERI-PEROX’.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
(1) OJ L 167, 27.6.2012, p. 1, http://data.europa.eu/eli/reg/2012/528/oj.
(2) ECHA opinion of 14 September 2023 on the Union authorisation of ‘STERI-PEROX’ (ECHA/BPC/393/2023), https://echa.europa.eu/ opinions-on-union-authorisation.
ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj 1/12EN OJ L, 20.6.2024
HAS ADOPTED THIS REGULATION:
Article 1 A Union authorisation with authorisation number EU-0031643-0000 is granted to Veltek Associates Inc. Europe for the making available on the market and use of the biocidal product family ‘STERI-PEROX’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 10 July 2024until 30 June 2034.
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, 19 June 2024.
For the Commission The President Ursula VON DER LEYEN 2/12 ELI: http://data.europa.eu/eli/reg_impl/2024/1707/ojEN OJ L, 20.6.2024 ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY STERI-PEROX® Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals Authorisation number EU-0031643-0000 R4BP asset number EU-0031643-0000 PART I FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name Name STERI-PEROX®
1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals
1.3. Authorisation holder Name Veltek Associates Inc. Europe Name and address of the authorisation holder Address Rozengaard 1940 8212DT Lelystad NL Authorisation number EU-0031643-0000 R4BP asset number EU-0031643-0000 Date of the authorisation 10 July 2024 Expiry date of the authorisation 30 June 2034
1.4. Manufacturer(s) of the product Name of manufacturer Veltek Associates, Inc.
Address of manufacturer 15 Lee Blvd. PA19355 Malvern United States (the) Location of manufacturing sites 15 Lee Blvd. PA19355 Malvern United States (the)
ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj 3/12EN OJ L, 20.6.2024
1.5. Manufacturer(s) of the active substance(s) Active substance Hydrogen peroxide Name of manufacturer Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) Address of manufacturer One Commerce Square 2005 Market Street Suite 3200 PA 19103 Philadelphia United States (the) Location of manufacturing sites Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) site 1 PeroxyChem Bayport Plant, 12000 Bay Area Blvd TX 77507 Passadena United States
(the)
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 (%) Hydrogen perox active substance 7722-84-1 231-765-0 6,4 - 6,4 % (w/w) ide
2.2. Type(s) of formulation Formulation type(s) AL Any other liquid
XX diverse: Ready to Use Wipe PART II.
SECOND INFORMATION LEVEL - META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier Identifier Meta SPC 1 - Wipes
1.2. Suffix to the authorisation number Number 1-1
1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals 4/12 ELI: http://data.europa.eu/eli/reg_impl/2024/1707/ojEN OJ L, 20.6.2024
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 (%) Hydrogen perox active substance 7722-84-1 231-765-0 6,4 - 6,4 % (w/w) ide
2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) XX Diverse: Ready to Use Wipe
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H319: Causes serious eye irritation.
Precautionary statements P264: Wash face and hands thoroughly after handling.
P280: Wear eye protection/face protection.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rin sing.
P337+P313: If eye irritation persists: Get medical advice.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1.
1.1 – Industrial use – Wipe - Indoors - Meta SPC 1 Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of - the authorised use Target organism(s) (including develop Scientific name: no data ment stage) Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data Field(s) of use indoor use Disinfectant of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. Not for use in medical areas. Disinfectant for use in manufacturing facilities including the clean room areas found in the pharmaceutical,bio pharmaceutical, medical device and diagnostic product manufacturing facilities.
ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj 5/12EN OJ L, 20.6.2024 Application method(s) Method: Wiping
Detailed description: - Application rate(s) and frequency Application rate: 30,5 cm x 30,5 cm wipe – 32,5 ml per wipe. 7,5 ml is freely available per wipe. 1 wipe = 7,5 ml per m2 Dilution (%): The product is ready to use.
Number and timing of application:
Frequency: 3 applications per day.
Contact time: 10 minutes
Use temperature: room temperature Category(ies) of users industrial Pack sizes and packaging material Wipe is composed of 100% continuous filament polyester fibre.
Pack sizes are detailed below:
Sterile (gamma irradiated) or non-sterile
Wipes:
12 x 12 inches (30,5 cm x 30,5 cm). 20 wipes per pack. 10 packs per case.
Reclosable (peel and seal) low density polyethylene (opaque) bags.
12 x 12 inches (30,5 cm x 30,5 cm). Individual wipe. 100 packs per case.
Low density polyethylene (opaque) bags.
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 See general directions for use
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 directions for use
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use Apply away from eyes and face. Pre-clean surface before application.
Only use wet wipes. Remove one or two wipes at a time. Wipe article thoroughly to ensure it is visibly wet. Allow surface to remain wet for 10 minutes (bactericidal and yeasticidal uses). Discard wipe after use. Close the package after opening.
5.2. Risk mitigation measures During application only the user of the product can be present in the room.
6/12 ELI: http://data.europa.eu/eli/reg_impl/2024/1707/ojEN OJ L, 20.6.2024 During application and for re-entry, the airborne hydrogen peroxide levels may not exceed the AEC inhalation limit of 1,25 mg/m3 (or a lower relevant national reference value). A calibrated sensor shall be used to establish that the airborne hydrogen peroxide levels are not exceeded.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
Prevent entry to sewers and public waters. Notify authorities if product enters sewers or public waters.
5.4. Instructions for safe disposal of the product and its packaging
Waste disposal recommendation: Dispose in a safe manner in accordance with local/national regulations. Ecology -
waste materials: Avoid release to the environment.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Keep in a cool, well-ventilated place. Reseal package between uses to retain moisture.
Store in original container. Protect from frost. Do not store at temperatures high than 40°C.
Shelf-life = 2 years
6. OTHER INFORMATION
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) STERI-PEROX® Market area: EU 6% WIPE Authorisation number EU-0031643-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen per active sub 7722-84-1 231-765-0 6,4 oxide stance
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier Identifier Meta SPC2 - Liquid
ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj 7/12EN OJ L, 20.6.2024
1.2. Suffix to the authorisation number Number 1-2
1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals
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 (%) Hydrogen perox active substance 7722-84-1 231-765-0 6,4 - 6,4 % (w/w) ide
2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H319: Causes serious eye irritation.
Precautionary statements P264: Wash face and hands thoroughly after handling.
P280: Wear eye protection/face protection.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rin sing.
P337+P313: If eye irritation persists: Get medical advice.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1.
2.1 - Industrial use – Liquid spraying - Indoors - Meta SPC 2 Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: no data stage) 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 8/12 ELI: http://data.europa.eu/eli/reg_impl/2024/1707/ojEN OJ L, 20.6.2024 Field(s) of use indoor use Disinfectant of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. Not for use in medical areas. Disinfectant for use in manufac turing facilities including the clean room areas found in the pharma ceutical, biopharmaceutical, medical device and diagnostic indus tries.
Application method(s) Method: spraying
Detailed description: - Application rate(s) and frequency Application rate: 60 ml product per m2 Dilution (%): The product is ready to use.
Number and timing of application:
Frequency: 3 applications per day.
Contact time: 10 minutes for bacteria and yeasts, 20 minutes for fungi
Use temperature: room temperature Category(ies) of users industrial Pack sizes and packaging material 473 ml bottle (sterile only).
946 ml bottle (sterile only).
Trigger spray attachment is supplied separately.
Packaging materials:
Bottles Bottles are made of high density polyethylene (opaque). A separate hand sprayer has polypropylene dip tube. The bottle cap is polypro pylene, the induction seal is polypropylene. Bottles are provided with a polyethylene sprayer separately within bags, the sprayers are not connected to the bottles and are supplied separately. The sterile ver sions are individually double-bagged and bags are heat-sealed shut.
Optional quadruple bagging is available. Distributors distribute sealed cases, not individual customers.
4.1.1. Use-specific instructions Pre-clean surface before application. Unwrap and apply trigger to bottle. Pre-clean surface before application. Direct the spray onto the surface from a distance of 15-20 cm away. Thoroughly wet surface with product and allow to take effect for a minimum of 10 minutes (bactericidal, yeasticidal uses) and 20 minutes (for fungicidal uses). Allow surface to air dry, or after the required contact time has been achieved, wipe dry with sterilised cloth or wipe, if necessary.
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 See general directions for use
ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj 9/12EN OJ L, 20.6.2024
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 directions for use
4.2. Use description Table 2.
2.2 - Industrial use – Liquid Soaking – Indoors – Meta SPC 2 Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of - the authorised use Target organism(s) (including develop Scientific name: no data ment stage) 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
Scientific name: no data
Common name: Bacterial spores
Development stage: no data Field(s) of use indoor use Disinfectant of hard non-porous inanimate surfaces, materials and equip ment which are not used for direct contact with food or feeding stuffs. Not for use in medical areas. Disinfectant for use in manufacturing facilities including the clean room areas found in the pharmaceutical, biopharma ceutical, medical device and diagnostic industries.
Application method(s) Method: Soaking
Detailed description: - Application rate(s) and frequency Application rate: - Dilution (%): The product is ready to use.
Number and timing of application:
Frequency: 3 applications per day
Contact time: 10 minutes (bactericidal, yeasticidal), 20 minutes (fungici dal), 60 minutes (sporicidal)
Use temperature: room temperature Category(ies) of users industrial
Pack sizes and packaging material Bottles:
473 ml bottle (sterile only) 946 ml bottle (sterile only).
Bottles are made of high density polyethylene (opaque). The bottle cap is polypropylene, the induction seal is polypropylene. The sterile versions are individually double-bagged and bags are heat-sealed shut. Optional quad ruple bagging is available.
3,79 litres (sterile and non-sterile) 10/12 ELI: http://data.europa.eu/eli/reg_impl/2024/1707/ojEN OJ L, 20.6.2024 Containers made of high density polyethylene (opaque) with a moulded carrying handle and small screw-capped pouring spout moulded towards the top edge. Polypropylene screw cap with liner covers the pouring opening, the induction seal is polypropylene. All bottle caps are screw caps and able to be re-applied onto the bottle.
Distributors distribute sealed cases, not individual containers. The sterile versions are individually double-bagged and bags are heat-sealed shut.
Optional quadruple bagging is available.
Drum:
200 litres (sterile only) High Density polyethylene (opaque). Blow moulded, closed head. Molded integral top ring. Double bagged and shrink wrapped to secure it.
For secure dispensing after opening, the 200 litres drum has a 5 centimeter top-mounted polypropylene screw cap having a one-way directional dip tube attached to a length of 0,95 cm Santoprene® 73A FDA rubber tubing to connect to a peristaltic non-product contact dispensing pump of the customer’s choice – not supplied. The pump and tubing remain attached and ready for dispensing during the entire use period. There are no fittings for adding material back into the drum.
4.2.1. Use-specific instructions Pre-clean surface before application. immerse item in a basin with product and allow to remain in the basin for a minimum of 10 minutes (bactericidal, yeasticidal uses), 20 minutes (fungicidal uses) or 60 minutes (sporicidal use).
After the required contact time has been achieved, allow surface to air dry, or wipe dry with sterilised cloth or wipe, if necessary. Only use dipping bath once.
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 See general directions for use
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 directions for use
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use Use with adequate ventilation and apply away from eyes and face.
5.2. Risk mitigation measures During application only the user of the product can be present in the room.
During application and for re-entry, the airborne hydrogen peroxide levels may not exceed the AEC inhalation limit of 1,25 mg/m3 (or a lower relevant national reference value). A calibrated sensor shall be used to establish that the airborne hydrogen peroxide levels are not exceeded.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj 11/12EN OJ L, 20.6.2024
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
Prevent entry to sewers and public waters. Notify authorities if product enters sewers or public waters.
5.4. Instructions for safe disposal of the product and its packaging
Waste disposal recommendations: Dispose in a safe manner in accordance with local or national regulations.
Ecology – waste materials: Avoid release to the environment
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Keep in a cool, well-ventilated place. Reseal package between uses to retain moisture.
For the liquid discard 60 days after opening Store in original container. Protect from frost. Do not store at temperatures higher than 40°C.
Shelf-life = 2 years
6. OTHER INFORMATION
Trade name: STERI-PEROX® 6%
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) STERI-PEROX Market area: EU 6% Authorisation number EU-0031643-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen perox active sub 7722-84-1 231-765-0 6,4 ide stance 12/12 ELI: http://data.europa.eu/eli/reg_impl/2024/1707/oj