COMMISSION IMPLEMENTING DECISION (EU) 2023/686
of 24 March 2023
not granting a Union authorisation for the single biocidal product “Insecticide Textile Contact”
(notified under document C(2023) 1853)
(Only the French text is authentic)
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 24 April 2016, DAKEM submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named “Insecticide Textile Contact” of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-JR023293-31 in the Register for Biocidal Products.
(2) “Insecticide Textile Contact” contains permethrin, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 18.
(3) On 5 December 2019, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the evaluating competent authority submitted an assessment report and the conclusions of its evaluation to the Agency. Prior to the submission to the Agency, on 7 October 2019, DAKEM was given the opportunity to provide written comments on the assessment report and the conclusions, in accordance with Article 44(1), second subparagraph, of Regulation (EU) No 528/2012. The evaluating competent authority took due account of the comments received from DAKEM when finalising its evaluation. During the Agency’s opinion-forming process on that assessment report, it was updated by the evaluating competent authority and, on 25 May 2020, DAKEM was given the opportunity to provide comments on the updated assessment report and the draft opinion of the Agency before the final opinion was adopted by the Biocidal Products Committee of the Agency on 17 June 2020.
(4) On 2 July 2020, the Agency submitted to the Commission its opinion (2) on the application for Union authorisation of “Insecticide Textile Contact” in accordance with Article 44(3) of Regulation (EU) No 528/2012. The Agency concludes in that opinion that the biocidal product “Insecticide Textile Contact” does not meet the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.
(5) According to the opinion of the Agency, the intended use of the biocidal product “Insecticide Textile Contact” is considered to lead to unacceptable risks for non-professional users, namely for adults applying the product and for general public exposed to the treated articles, and to unacceptable risks for the environment, namely for surface water and sediment, and, therefore, the product does not meet the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.
(6) The Commission concurs with the opinion of the Agency and considers that the “Insecticide Textile Contact” does not meet the conditions laid down in Article 19(1)(b), points (iii) and (iv), of Regulation (EU) No 528/2012. It is therefore appropriate to not grant a Union authorisation for “Insecticide Textile Contact”.
(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
A Union authorisation is not granted to DAKEM for the making available on the market and use of the single biocidal product “Insecticide Textile Contact”.
Article 2
This Decision is addressed to DAKEM, 69 rue Victor Hugo, 92400 Courbevoie, France.
Done at Brussels, 24 March 2023.
For the Commission
Stella KYRIAKIDES
Member of the Commission
(1)
OJ L 167, 27.6.2012, p. 1
.
(2) ECHA opinion of 17 June 2020 on the Union authorisation of the biocidal product “Insecticide Textile Contact” (ECHA/BPC/263/2020), https://echa.europa.eu/de/opinions-on-union-authorisation
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