Commission Implementing Regulation (EU) 2025/524 of 20 March 2025 granting a Union authorisation for the biocidal product family Sodium hypochlorite Liquid disinfectant biocidal product family 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 14 December 2018, Reckitt Benckiser Production 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 biocidal product family named ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ of product-types 2 and 4, 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-NB046342-57 in the Register for Biocidal Products.

(2) ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ contains sodium hypochlorite 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 4.

(3) On 22 July 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 23 August 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ 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 ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ 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 12 September 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 28 June 2023, in the meeting of the Standing Committee on Biocidal Products (the ‘Standing Committee’), concerns were expressed about the dietary risk assessment conducted by the evaluating competent authority and endorsed in the Agency’s opinion for the products of product-type 4. Those concerns related to the risk that the general public may be exposed to chlorate residues via the consumption of food in contact with disinfected surfaces and that that risk could only be mitigated by the introduction of a rinsing step after application of those products, while non-professional users cannot be expected to effectively implement such a risk mitigation measure.

(8) The applicant agreed to remove the use of the product as disinfectant for hard non-porous surfaces in the food and feed area by non-professional users of product-type 4 from the SPC and informed the Commission accordingly on 31 August 2023.

(9) On 27 September 2023, the Standing Committee endorsed the introduction of a rinsing step after the disinfection of hard non-porous surfaces in the food and feed area for product-type 4 only for professional users to comply with the chlorate limit values set out in Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) and removal of the affected product-type 4 uses for non-professional users from the SPC.

(10) Except for the feasibility of the rinsing step to be performed by the non-professional users after the use of the product as disinfectant for hard non-porous surfaces in the food and feed area of product-type 4, the Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ excluding the use as disinfectant for hard non-porous surfaces in product-type 4 for non-professional users.

(11) In its opinion, the Agency recommends that the authorisation holder provides a test to determine whether the quantity of product delivered by the spray used to apply the products of meta-SPC F is always the same before and after two years of storage to ensure that the effective dose applied does not change after storage as a condition in the authorisation. 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 ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ in products of meta-SPC F 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 existing data.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0029289-0000 is hereby granted to Reckitt Benckiser Production for the making available on the market and use of the biocidal product family ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ 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.

The Union authorisation is valid from 13 April 2025 until 31 March 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, 20 March 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 19 August 2022 on the Union authorisation of ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ (ECHA/BPC/349/2022), https://echa.europa.eu/opinions-on-union-authorisation.

(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj).