Commission Implementing Regulation (EU) 2025/834 of 5 May 2025 granting a Union authorisation for the single biocidal product Chlorine in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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 44(5), first subparagraph, thereof,

Whereas:

(1) On 20 December 2018, CGV Chlorgas Vertriebs GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a single biocidal product named ‘Chlorine’ of product-types 2 and 5, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Slovenia had agreed to evaluate the application. The application was recorded under case number BC-EQ047299-18 in the Register for Biocidal Products.

(2) ‘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 8 November 2021, 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 1 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘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 ‘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 3 August 2022, 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 4 April 2023, Germany sent a request to the Commission to adjust the terms and conditions of the Union authorisation of the single biocidal product ‘Chlorine’ for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 for use 1 (disinfection of public swimming pools) and use 3 (disinfection of drinking water at the water suppliers and their water distribution systems) on the grounds of protection of the environment, public policy and the protection of health and life of humans as referred to in Article 37(1), points (a) to (c), of that Regulation. The request concerning the adjustments to use 1 (disinfection of swimming pools) was withdrawn by Germany on 8 May 2024.

(8) In its request for the adjustments to use 3 (disinfection of drinking water at the water suppliers and their water distribution systems), Germany refers to the German Ordinance on the Quality of Water Intended for Human Consumption, Trinkwasserverordnung- TrinkwV (‘TrinkwV’) (3) establishing a systematic set of rules to ensure healthy and clean drinking water by regulating the 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 TrinkwV, certain well-established norms and common practices have developed in the drinking water treatment sector in Germany. Germany explained in more detail that the description of use 3 of the SPC does not fully correspond to the rules of the TrinkwV. In particular, the application method and application rate and frequency of use would need to be adapted to meet the requirements of the ‘List of Permissible Treatment Agents and Disinfection Methods’ according to Section 20 of the TrinkwV.

(9) The Commission, having regard to Article 2(7) of Regulation (EU) No 528/2012, providing that nothing in that Regulation is to prevent Member States from restricting or banning the use of biocidal products in the public supply of drinking water, considers that the request made by Germany to adjust the conditions of the Union authorisation of the single biocidal product ‘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 transposes Directive (EU) 2020/2184 of the European Parliament and of the Council (4) into German law. That Directive 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 also sets essential quality standards at Union level and allows Member States to implement additional requirements and higher standards where the protection of human health within its national territory or part of it so requires. The TrinkwV is in force in Germany since 2001 and its requirements have been relied upon by the drinking water treatment sector in Germany since then. Products for the disinfection of drinking water made available on the German market should comply with the rules established by the TrinkwV.

(10) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the single biocidal product ‘Chlorine’ with the adjustments of the SPC as requested by Germany for its territory for use 3 of the SPC 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:

Article 1

A Union authorisation with authorisation number EU-0028952-0000 is hereby granted to CGV Chlorgas Vertriebs GmbH for the making available on the market and use of the single biocidal product ‘Chlorine’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

For the territory of Germany, adjustments to the terms and conditions apply for use 3 of ‘Chlorine’ as laid down in the summary of product characteristics in the Annex.

The Union authorisation is valid from 26 May 2025 until 30 April 2035.

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, 5 May 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) ECHA opinion of 9 June 2022 on the Union authorisation of ‘Chlorine’ (ECHA/BPC/340/2022), https://echa.europa.eu/opinions-on-union-authorisation.

(3) German Ordinance on the Quality of Water Intended for Human Consumption – Verordnung über die Qualität von Wasser für den menschlichen Gebrauch (Trinkwasserverordnung – TrinkwV) in the version of the Second Ordinance for the Revision of the Drinking water Ordinance (Zweite Verordnung zur Novellierung der Trinkwasserverordnung vom 20. Juni 2023 (Bundesgesetzblatt I Nr. 159), https://www.gesetze-im-internet.de/englisch_trinkwv/englisch_trinkwv.pdf.

(4) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1, ELI: http://data.europa.eu/eli/dir/2020/2184/oj).