Commission Implementing Regulation (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family Lactic acid based products – CID Lines NV 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 48(1), point (a), thereof,

Whereas:

(1) On 26 July 2022, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Lactic acid-based products – CID Lines NV’ by Commission Implementing Regulation (EU) 2022/1391 (2). In Annex I to Implementing Regulation (EU) 2022/1391 the authorisation holder was required to conduct a long-term storage stability test at ambient temperature of ‘Lactic acid-based products – CID Lines NV’ in commercial packaging in which the products in the family will be made available on the market and to submit the results of the test to the Agency by 1 March 2023.

(2) The authorisation holder provided the required data on 28 February 2023 to the European Chemicals Agency (ECHA), recorded under the case number BC-RC051007-54. The evaluating competent authority of Belgium submitted the conclusions of its evaluation to ECHA on 9 March 2023.

(3) On 30 June 2023, ECHA submitted the opinion of the Biocidal Products Committee (3) to the Commission concluding that the submitted data confirms the shelf life of 2 years for the products of the biocidal product family ‘CID Lines – Lactic acid-based products’, except for the packaging Wipe 4, 2L (105 wipes) from meta SPC 7 for which a two-year shelf life could not be confirmed.

(4) The Commission concurs with the opinion of ECHA and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Lactic acid-based products – CID LINES NV’.

(5) Since the shelf life of 2 years could not be confirmed for the packaging Wipe 4, 2L (105 wipes) of the biocidal product family, the conditions of Article 19 of Regulation (EU) No 528/2012 are not met for this packaging type for the duration of the shelf life.

(6) The packaging Wipe 4, 2L (105 wipes) should therefore be removed from the entry ‘Pack sizes and packaging material’ in tables 13, 14, 15, 16, 17 and 18 of meta SPC 7 in Annex II to Implementing Regulation (EU) 2022/1391.

(7) On 4 August 2023, the Commission informed the authorisation holder of its intention to amend the Union authorisation for the biocidal product family ‘Lactic acid-based products – CID Lines NV’ and gave the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. In its response received on the same day, the authorisation holder agreed with the intended amendment of the authorisation for the packaging Wipe 4, 2L (105 wipes) in meta SPC 7 for which a two-year shelf life could not be confirmed.

(8) In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the Register of Biocidal Products, Annex II to Implementing Regulation (EU) 2022/1391 should be replaced in its entirety.

(9) Implementing Regulation (EU) 2022/1391 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Implementing Regulation (EU) 2022/1391 is replaced by the text in the Annex to this Regulation.

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, 8 December 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Implementing Regulation (EU) 2022/1391 of 26 July 2022 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ (OJ L 211, 12.8.2022, p. 1).

(3) Opinion of the evaluation of post authorisation conditions for the Union authorisation of Lactic acid based products – CID Lines NV’. ECHA/BPC/384/2023 of 7 June 2023.