Commission Implementing Regulation (EU) 2023/2704 of 28 November 2023 granting a Union authorisation for the single biocidal product GHC Chlor

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 10 December 2018, GHC Gerling, Holz & Co. Handels GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘GHC Chlor’ of product-types 2 (disinfectants and algaecides not intended for direct application to humans or animals) and 5 (drinking water) as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-EN045705-33 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference single biocidal product ‘Arche Chlorine’, recorded in the Register under case number BC-UQ045679-98.

(2) ‘GHC Chlor’ 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 3 August 2021, the Agency submitted to the Commission its opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘GHC Chlor’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.

(4) In its opinion, the Agency concludes that the differences, proposed by GHC Gerling, Holz & Co. Handels GmbH, between the same biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of Arche Chlorine and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

(5) On 15 June 2023, 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.

(6) The Commission also 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 also applies for the uses 2, 3 and 4 of ‘GHC Chlor’. This adjustment is justified in recitals 7 to 9 of Commission Implementing Regulation (EU) 2023/754 (5) granting a Union authorisation for the single biocidal product ‘Arche Chlorine’ in accordance with Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘GHC Chlor’ 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.

(8) The expiry date of this authorisation is aligned to the expiry date of the reference single biocidal product ‘Arche Chlorine’.

(9) 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-0027044-0000 is granted to GHC Gerling, Holz & Co. Handels GmbH for the making available on the market and use of the same single biocidal product ‘GHC Chlor’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

For the territory of the Federal Republic of Germany, adjustments to the terms and conditions apply for the uses 2, 3 and 4 of ‘GHC Chlor’ as laid down in the summary of product characteristics in the Annex.

The Union authorisation is valid from 20 December 2023 until 30 April 2033.

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, 28 November 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

(3) ECHA opinion of 3 August 2021 on the Union authorisation of the same single biocidal product ‘GHC Chlor’ (https://echa.europa.eu/opinions-on-union-authorisation).

(4) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

(5) 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 (OJ L 100, 13.4.2023, p. 83).