Commission Implementing Regulation (EU) 2023/754 of 12 April 2023 granting a Union authorisation for the single biocidal product ‘Arche Chlorine’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/754of 12 April 2023granting a Union authorisation for the single biocidal product Arche Chlorine 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 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 7 December 2018, Arche Consortia 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 single biocidal product named "Arche Chlorine" of product-types 2 and 5, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-UQ045679-98 in the Register for Biocidal Products.(2)"Arche Chlorine" contains active chlorine released from chlorine as the active substance included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 5.(3)On 27 November 2020, 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 5 July 2021, the Agency submitted to the Commission its opinionECHA opinion of 16 June 2021 on the Union authorisation of the single biocidal product "Arche Chlorine" (ECHA/BPC/281/2021), https://echa.europa.eu/it/opinions-on-union-authorisation., the draft summary of the biocidal product characteristics ("SPC") of "Arche Chlorine" and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "Arche Chlorine" is a single biocidal product within the meaning of Article 3(1), point (r), 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) of that Regulation.(6)On 30 July 2021, 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)On 7 March 2022, Germany requested the Commission to adjust the terms and conditions of the Union authorisation of the single biocidal product "Arche Chlorine" for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 on the grounds of public policy referred to in Article 37(1), point (b), and the protection of health and life of humans referred to in Article 37(1), point (c), of that Regulation. In their request, the German authorities referred to the national rules of the German Drinking Water Ordinance (TrinkwV)Trinkwasserverordnung in der Fassung der Bekanntmachung vom 10. März 2016 (Bundesgesetzblatt I S. 459), zuletzt geaendert durch Artikel 1 der Verordnung vom 22. September 2021 (Bundegesetzblatt I S. 4343). TrinkwV.pdf (gesetze-im-internet.de) establishing a systematic set of rules to ensure healthy and clean drinking water by regulating the required quality of water, and the substances, methods and procedures to be used for the treatment of drinking water; imposing obligations on water treatment plants and setting rules on the enforcement of those obligations. Based on the rules established by the TrinkwV, certain norms and common practices have developed which are well established in the sector of drinking water treatment in Germany.(8)Germany explained in more detail that parts of the description of use 2 (disinfection of drinking water at drinking water suppliers), use 3 (disinfection of water in reservoirs) and use 4 (disinfection of water in collective systems) of the SPC do not fully correspond to the rules of the TrinkwV. In particular, the application methods and application rates and frequency for those uses would need to be adapted to meet the requirements of the list of treatment substances and disinfection processes according to paragraph 11 of the TrinkwV.(9)The Commission, having regard to Article 2(7) of Regulation (EU) No 528/2012, considers that the request made by Germany to adjust the conditions of the Union authorisation of the single biocidal product "Arche Chlorine" for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 is justified on the grounds of public policy in the supply of drinking water and the protection of health and life of humans pursuant to Article 37(1), points (b) and (c), respectively, of that Regulation. The TrinkwV implements in Germany Council Directive 98/83/ECCouncil Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32)., which sets a legal framework to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean. That Directive sets essential quality standards at Union level and allows Member States to implement additional requirements and higher standards when transposing it into their national laws. The particular rules chosen by Germany to transpose the provisions of Directive 98/83/EC into national law are in place since 2001 and are implemented and relied upon by the drinking water treatment sector in Germany. Products for the disinfection of drinking water made available on the German market should therefore not interfere with that system and should comply with the rules established in the TrinkwV.(10)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for "Arche Chlorine" with the adjustments of the SPC as requested by Germany for its territory for the uses 2, 3 and 4 in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012.(11)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION: