Commission Implementing Decision (EU) 2024/2460 of 16 September 2024 postponing the expiry date of the approval of metofluthrin for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-09-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, insecticide, market approval








L_202402460EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2460


17.9.2024







            COMMISSION IMPLEMENTING DECISION (EU) 2024/2460
of 16 September 2024
         
postponing the expiry date of the approval of metofluthrin for use in biocidal products of product-type 18 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)


Metofluthrin 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 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 April 2021 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.












(2)


On 25 October 2019, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of metofluthrin for use in biocidal products of product-type 18 (‘the application’).












(3)


On 15 October 2020, the evaluating competent authority of Ireland 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.












(4)


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.












(5)


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.












(6)


Commission Implementing Decision (EU) 2021/327 (3) postponed the expiry date of the approval of metofluthrin for use in biocidal products of product-type 18 (‘the approval’) to 31 October 2023, in order to allow sufficient time for the examination of the application.












(7)


Commission Implementing Decision (EU) 2023/1086 (4) postponed again the expiry date of the approval to 31 October 2024 due to the need of the evaluating competent authority to assess additional data requested from the applicant.












(8)


On 13 February 2024 the evaluating competent authority informed the Commission that an additional extension of the approval is needed due to delays in the evaluation of the application. The evaluating competent authority submitted the renewal assessment report to the Agency on 7 March 2024.












(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 the preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval, the expiry date should be postponed to 30 April 2026.












(10)


After the further postponement of the expiry date of the approval, metofluthrin remains approved for use in biocidal products of product-type 18 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 metofluthrin for use in biocidal products of product-type 18 set out in Implementing Decision (EU) 2023/1086 is postponed to 30 April 2026.


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, 16 September 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) 2021/327 of 23 February 2021 postponing the expiry date of approval of metofluthrin for use in biocidal products of product-type 18 (OJ L 64, 24.2.2021, p. 10, ELI: http://data.europa.eu/eli/dec_impl/2021/327/oj).

(4)  Commission Implementing Decision (EU) 2023/1086 of 2 June 2023 postponing the expiry date of the approval of metofluthrin for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 144, 5.6.2023, p. 96, ELI: http://data.europa.eu/eli/dec_impl/2023/1086/oj).


ELI: http://data.europa.eu/eli/dec_impl/2024/2460/oj
ISSN 1977-0677 (electronic edition)