COMMISSION IMPLEMENTING DECISION (EU) 2024/2950

of 29 November 2024

postponing the expiry date of the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 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 14(5) thereof,

After consulting the Standing Committee on Biocidal Products,

Whereas:

(1) N,N-diethyl-meta-toluamide was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-type 19, subject to the conditions set out in that Annex.

(2) In accordance with Article 86 of Regulation (EU) No 528/2012, N,N-diethyl-meta-toluamide was deemed to have been approved under that Regulation on the date of its inclusion in Annex I to Directive 98/8/EC of the European Parliament and of the Council. That approval was to expire on 31 July 2022.

(3) On 26 January 2021, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 (‘the application’).

(4) On 4 June 2021, the evaluating competent authority of France informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

(5) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.

(6) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(7) Commission Implementing Decision (EU) 2021/2146 (3) postponed the expiry date of the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 to 31 January 2025, in order to allow sufficient time for the examination of the application.

(8) On 26 June 2024, the evaluating competent authority informed the Commission that it expects to submit the renewal assessment report to the Agency in the third quarter of 2025.

(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalise the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for the preparation and submission by the Agency of its opinion, and the time needed for the Commission to decide whether the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 may be renewed, the expiry date should be postponed to 31 January 2027.

(10) After the further postponement of the expiry date of the approval, N,N-diethyl-meta-toluamide remains approved for use in biocidal products of product-type 19 subject to the conditions set out in Annex I to Directive 98/8/EC,

HAS ADOPTED THIS DECISION:

Article 1

The expiry date of the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 set out in Annex I to Directive 98/8/EC is postponed to 31 January 2027.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

Done at Brussels, 29 November 2024.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 167, 27.6.2012, p. 1

, ELI:

http://data.europa.eu/eli/reg/2012/528/oj

(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (

OJ L 123, 24.4.1998, p. 1

, ELI:

http://data.europa.eu/eli/dir/1998/8/oj

(3) Commission Implementing Decision (EU) 2021/2146 of 3 December 2021 postponing the expiry date of approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 (

OJ L 433, 6.12.2021, p. 23

, ELI:

http://data.europa.eu/eli/dec_impl/2021/2146/oj

ELI: http://data.europa.eu/eli/dec_impl/2024/2950/oj

ISSN 1977-0677 (electronic edition)