EN
5.6.2023
Official Journal of the European Union
L 144/91
COMMISSION IMPLEMENTING DECISION (EU) 2023/1084 of 1 June 2023 on the unresolved objections regarding the conditions for granting an authorisation for the biocidal product A-Quasan in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2023) 3447) (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 36(3) thereof,
Whereas:
(1)
On 15 June 2021, the company Menno Chemie-Vertrieb GMBH (‘the applicant’) submitted an application to the competent authority of the Netherlands for the mutual recognition in sequence, in accordance with Article 33 of Regulation (EU) No 528/2012, of the national authorisation of the biocidal product A-Quasan (‘the biocidal product’) already granted in Germany.
The biocidal product, containing benzoic acid as active substance, has been authorised as a disinfectant of product-type 3, veterinary hygiene, to be used for disinfection in the veterinary healthcare area, including veterinary clinics and operating rooms, surfaces, equipment, and objects for companion animals.
(2)
On 24 October 2021, the Netherlands referred objections to the coordination group indicating that the biocidal product does not meet the condition laid down in Article 19(1), point (a), of Regulation (EU) No 528/2012 for the use in operating rooms in the veterinary healthcare area, as such use corresponds to product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and benzoic acid is not approved for that product-type.
To support their position, the Netherlands referred to the Guidance on the Biocidal Products Regulation Volume II Efficacy - Assessment and Evaluation (Parts B+C) (‘the efficacy guidance’) of the European Chemicals Agency, version of April 2018 (2), which indicates in its chapter 5.4.3.1 that biocidal products applied for general disinfection of surfaces in the medical area (medical practices, hospitals) as well as of surfaces in veterinary practices associated with examination and operation/treatment of the animals are assigned to producttype 2, whereas products for specific veterinary hygiene purposes (e.g. products with specific claims against a target organism only relevant in the veterinary area) are considered to be in product-type 3.
The efficacy guidance follows the note for guidance CA-May15-Doc8.3 (3) (‘the CA document’) presented by the Commission services and agreed by the competent authorities of the Member States for the implementation of Regulation (EU) No 528/2012.
(1) OJ L 167, 27.6.2012, p. 1.
(2) European Chemicals Agency, Guidance on the Biocidal Products Regulation, Volume II Efficacy - Assessment and Evaluation (Parts B +C), Version 3.0, April 2018 https://echa.europa.eu/documents/10162/23036412/bpr_guidance_assessment_evaluation_part_vol_ii_ part_bc_en.pdf/950efefa-f2bf-0b4a-a3fd-41c86daae468 (3) European Commission, Health and Food Safety Directorate General, Safety of the food chain, Pesticides and Biocides - Note for Guidance, Assignment of products used for general disinfection in veterinary practices or hospitals to product type 2 or 3 under the BPR, May 2015 https://circabc.europa.eu/ui/group/e947a950-8032-4df9-a3f0-f61eefd3d81b/library/0015a899-662d-4b86-ab1d-d73b42bf1888/ details