L 144/92
EN
Official Journal of the European Union
5.6.2023
(3)
Germany is of the opinion that the agreement presented in the CA document does not make it mandatory to assign biocidal products used for the disinfection of surfaces in the veterinary health care area exclusively to product-type 2.
In their opinion, the CA document provides the possibility to assign, to product-type 2, biocidal products for general surface disinfection in veterinary health care area when the products are used both in human and veterinary clinics, while the biocidal product is not intended to be used in the human medical area.
Germany is of the opinion that it is not the purpose of the efficacy guidance and the CA document to establish a description of the product-type, as such a description is established in Annex V to Regulation (EU) No 528/2012.
For those reasons, Germany considers the use in veterinary healthcare as appropriate for product-type 3 for the biocidal product.
(4)
As no agreement was reached in the coordination group, on 24 August 2022 Germany referred the unresolved objection to the Commission, pursuant to Article 36(1) of Regulation (EU) No 528/2012.
It thereby provided the Commission with a detailed statement of the matter on which Member States were unable to reach agreement and the reasons for their disagreement.
That statement was forwarded to the Member States concerned and to the applicant.
(5)
Article 2(1) of Regulation (EU) No 528/2012 states that a list of the types of biocidal products covered by that Regulation and their descriptions is set out in Annex V to that Regulation.
(6)
Article 19(1), point (a), of Regulation (EU) No 528/2012 provides that one of the conditions for granting an authorisation is that the active substances contained in the biocidal product are included in Annex I to that Regulation or approved for the relevant product-type and any conditions specified for those active substances are met.
(7)
Annex V to Regulation (EU) No 528/2012 provides that product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, includes products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs; usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities; products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil; products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials; products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
Annex V to Regulation (EU) No 528/2012 provides that product-type 3, veterinary hygiene, includes products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function; products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
(8)
After having carefully examined all the available information, the Commission concurs with the views of Germany that the use of the biocidal product should be assigned to product-type 3 as described in Annex V to Regulation (EU) No 528/2012, as the product is to be used for disinfection in the veterinary health care area, including veterinary clinics and operating rooms, surfaces, equipment and objects for companion animals.
Product-type 3 includes products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function, products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
Therefore, as the biocidal product is intended to be used for disinfection in the veterinary health care area, it should be considered as a disinfectant used for veterinary hygiene purposes.
(9)
The CA document reflects the agreement reached by the Commission services and competent authorities for the implementation of Regulation (EU) No 528/2012 to harmonise practices on the allocation of the product-types for disinfectants used in the medical area and in veterinary health care.
The CA document indicates that it is feasible to assign to product-type 2 biocidal products for disinfection of surfaces in veterinary practices or hospitals associated with examination and operation/treatment of the animals, whereas products for specific veterinary hygiene purposes (e.g., products with specific claims against a target organism only relevant in the veterinary area) should be assigned to product-type 3.
The CA document thus provides for flexibility on the allocation of such products to either product-type 2 or product-type 3 and does not preclude the allocation of the biocidal product to product-type 3.