Commission Implementing Regulation (EU) 2023/1041 of 24 May 2023 granting a Union authorisation for the biocidal product ‘TWP 094’ 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 12 November 2018, TROY CHEMICAL COMPANY BV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product named TWP 094 of product-type 8, 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-QN044827-14 in the Register for Biocidal Products.

(2) TWP 094 contains 3-Iodo-2-propynyl butylcarbamate (IPBC) 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 8.

(3) On 7 January 2022, 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 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of TWP 094 and the final assessment report on the biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that TWP 094 is a biocidal product within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

(6) On 18 August 2022, 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 Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for TWP 094.

(8) In its opinion, the Agency states that the authorisation holder is to complete a long-term storage test at ambient temperature for TWP 094 and provide a test on persistent foaming and a test on the degree of dissolution and dilution stability for the soluble concentrate formulation type of the product as a condition in the authorisation. The results of the long-term storage test should confirm the shelf life of the biocidal product of one year granted based on an accelerated storage stability test and the submitted interim results of a long-term storage stability test at ambient temperature. The information to be provided on persistent foaming and degree of dissolution and dilution stability should confirm the technical properties of the product for the formulation type soluble concentrate of the product.

(9) The Commission agrees with the opinion of the Agency and considers that the submission of the results of the test and the information for the soluble concentrate formulation type should be a condition relating to the making available on the market and use of the biocidal product TWP 094 pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.

(10) 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-0028968-0000 is hereby granted to TROY CHEMICAL COMPANY BV for the making available on the market and use of the biocidal product TWP 094 subject to compliance with 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 June 2023 to 31 May 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, 24 May 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) ECHA opinion of 16 June 2022 on the Union authorisation of TWP 094 (ECHA/BPC/348/2022), https://echa.europa.eu/opinions-on-union-authorisation