Commission Implementing Regulation (EU) 2025/831 of 5 May 2025 granting a Union authorisation for the biocidal product family AWPF Calcium Hypochlorite BPF 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 13 December 2018, Innovative Water Care Europe SAS 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 ‘AWPF Calcium Hypochlorite BPF’ of product-types 2, 4 and 5, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-WK046289-14 in the Register for Biocidal Products.

(2) ‘AWPF Calcium Hypochlorite BPF’ contains active chlorine released from calcium hypochlorite as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 4 and 5.

(3) On 23 June 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 4 November 2021, the Agency submitted its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘AWPF Calcium Hypochlorite BPF’ 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 ‘AWPF Calcium Hypochlorite BPF’ 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(6) of that Regulation.

(6) On 22 November 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 14 July 2022, Germany sent a request to the Commission to adjust the terms and conditions of the Union authorisation of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 for use 1 in meta SPC 1, 2 and 3 (Disinfection of swimming pools and spas – professional user), use 4 (Disinfection of drinking water for human consumption in public distribution systems and portable devices – professional) and use 5 (Disinfection of drinking water for human consumption in public distribution systems and portable devices (automated feeder) – industrial user) on the grounds of the 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. On 8 May 2024, Germany withdrew the request concerning the adjustments to use 1 in meta SPC 1, 2 and 3 (Disinfection of swimming pools and spas – professional user).

(8) In its request for the adjustments to uses 4 and 5 in meta SPC 1, 2 and 3, Germany refers to the German Ordinance on the Quality of Water Intended for Human Consumption, Trinkwasserverordnung (TrinkwV) (3) 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 TrinkwV, certain well-established norms and common practices have been developed in the drinking water treatment sector in Germany. Germany explained that for the disinfection of drinking water, part of the description of uses 4 and 5 in meta-SPCs 1, 2 and 3 of ‘AWPF Calcium Hypochlorite BPF’ does not fully correspond to the rules of the TrinkwV. For uses 4 and 5 in meta-SPC 1, 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 Section 20 of the TrinkwV. For uses 4 and 5 in meta-SPC 2 and 3, the minimum concentration of active chlorine by weight in the biocidal product is not met and the anti-scaling agent, pigment and processing-aid are not mentioned in the list of authorised treatment substances and disinfection processes of Section 20 of the TrinkwV, which means that the products cannot be allowed in the territory of Germany for the disinfection of drinking water.

(9) The Commission, also 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 biocidal product family ‘AWPF Calcium Hypochlorite BPF’ 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 in the TrinkwV.

(10) In its opinion, the Agency recommends that the authorisation holder conducts a long-term storage stability test of a product in meta-SPC 4 in the commercial packaging in which the products are to be made available on the market, as a condition in the authorisation. The test should address the relevant physical, chemical and technical properties of that product both prior to and after storage to confirm a shelf life of 12 months. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on the existing data.

(11) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘AWPF Calcium Hypochlorite BPF’ with the adjustments of the SPC as requested by Germany for its territory for the uses 4 and 5 in meta-SPCs 1, 2 and 3 in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012.

(12) 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-0027464-0000 is granted to Innovative Water Care Europe SAS for the making available on the market and use of the biocidal product family ‘AWPF Calcium Hypochlorite BPF’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

For the territory of Germany, adjustments to the terms and conditions apply for the uses 4 and 5 in meta-SPCs 1, 2 and 3 as laid down in the summary of product characteristics in Annex II.

The Union Authorisation is valid from 26 May 2025 to 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 6 October 2021 on the Union authorisation of ‘AWPF Calcium Hypochlorite BPF’ (ECHA/BPC/289/2021), https://echa.europa.eu/bpc-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).