Commission Implementing Regulation (EU) 2023/2087 of 28 September 2023 granting a Union authorisation for the biocidal product family ‘Lysoform IPA Surface’ 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 products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 25 November 2022, Lysoform Dr Hans Rosemann 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 a same biocidal product family, as referred to in Article 1 of that Regulation, named ‘Lysoform IPA Surface’, for product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-DP082158-26 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’, recorded in the Register under case number BC-GX025200-35.

(2) The same biocidal product family ‘Lysoform IPA Surface’ contains propan-2-ol 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 31 March 2023, the Agency submitted to the Commission its opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lysoform IPA Surface’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4) The opinion concludes that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’ and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

(5) On 31 March 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 concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘Lysoform IPA Surface’.

(7) The expiry date of this authorisation is aligned to the expiry date of the reference biocidal product family ‘Lyso IPA Surface Disinfection’.

(8) 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-0030790-0000 is hereby granted to Lysoform Dr Hans Rosemann GmbH for the making available on the market and use of the same biocidal product family ‘Lysoform IPA Surface’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 19 October 2023 until 30 November 2030.

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 September 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 for ‘Lysoform IPA Surface’, 31 March 2023, 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).