Commission Implementing Regulation (EU) 2022/2330 of 28 November 2022 granting a Union authorisation for the single biocidal product 'Christiansen LD Bednet' 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 3 June 2016, Christiansen SARL submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a single biocidal product named ‘Christiansen LD Bednet’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Denmark had agreed to evaluate the application. The application was recorded under case number BC-GK024706-40 in the Register for Biocidal Products.

(2) ‘Christiansen LD Bednet’ contains permethrin 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-type 18.

(3) On 7 December 2020, 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 5 July 2021, the Agency submitted its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Christiansen LD Bednet’ and the final assessment report on the single biocidal product, to the Commission in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Christiansen LD Bednet’ is a single biocidal product within the meaning of Article 3(1), point (r), of Regulation (EU) No 528/2012, that is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

(6) On 22 July 2021, 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) The Agency recommends authorising the product only for indoor use because of identified risks for the freshwater and sediment compartments, together with risk mitigation measures to protect the environment. Those measures ensure that the product would have no environmental impact.

(8) On 12 October 2021, the Biocidal Products Committee amended the evaluating competent authority’s report of the active substance permethrin to implement the conclusions of its environment working group regarding the persistency of that substance.

(9) As permethrin has not yet formally been identified as a candidate for substitution in accordance with Article 10(5) of Regulation (EU) No 528/2012, no comparative assessment pursuant to Article 23 of that Regulation is required to be performed, and the authorisation of the product may be granted for a maximum period of 10 years. No additional risk mitigation measure were considered necessary to take into account that permethrin has been found to be persistent.

(10) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Christiansen LD Bednet’.

(11) The Commission also considers that, as the exposure assessment for human health and for the environment was conducted based on a maximum size of the biocidal product, the terms and conditions of the authorisation should include that no biocidal product of a greater size should be made available on the market.

(12) 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-0026815-0000 is granted to Christiansen SARL for the making available on the market and use of the single biocidal product ‘Christiansen LD Bednet’ subject to 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 19 December 2022 to 30 November 2032.

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 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) ECHA opinion of 18 June 2021 on the Union authorisation of the biocidal product ‘Christiansen LD Bednet’ (ECHA/BPC/285/2021), https://echa.europa.eu/it/opinions-on-union-authorisation