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Date: 12-Nov-2024 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2024/2848 of 11 November 2024 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances fenpyrazamine and flumetralin

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

What it means

  • Commission Implementing Regulation (EU) 2024/2848 amends Implementing Regulation (EU) No 540/2011 to revise the approval periods for the active substances fenpyrazamine and flumetralin.
  • The regulation shortens the previously extended approval periods for these substances because the applicants no longer support the renewal of their approvals.

Key Changes

  • The expiration date for fenpyrazamine's approval is changed from 31 May 2026 to 15 January 2025.
  • The expiration date for flumetralin's approval is changed from 11 May 2026 to 15 January 2025.
  • This amendment is made because the applicants for renewal of approval for both fenpyrazamine and flumetralin have withdrawn their support for the applications.

Impact Analysis

Stakeholders Impacted

  • Applicants: The companies that originally applied for renewal of the approvals for fenpyrazamine and flumetralin will no longer be able to market these substances for plant protection in the EU.

Suggested Action Items

  • Monitor further communications from the European Commission and national regulatory bodies regarding the implementation of this regulation.

Key Entities Referenced

European Commission: The executive branch of the European Union responsible for proposing and implementing legislation. Regulation (EC) No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market. Implementing Regulation (EU) No 540/2011: Commission Implementing Regulation regarding the list of approved active substances under Regulation (EC) No 1107/2009. This regulation is being amended by the current regulation. Commission Implementing Regulation (EU) 2023/2592: Commission Implementing Regulation that previously extended the approval period of fenpyrazamine. Commission Implementing Regulation (EU) 2023/1757: Commission Implementing Regulation that previously extended the approval period of flumetralin. Fenpyrazamine: An active substance used in plant protection products. Flumetralin: An active substance used in plant protection products. Member States: The individual countries that are part of the European Union.
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Official Journal EN of the European Union L series 2024/2848 12.11.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/2848 of 11 November 2024 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances fenpyrazamine and flumetralin (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC(1), and in particular Article 17, first subparagraph, thereof, Whereas: (1) Active substances approved under Regulation (EC) No 1107/2009 are listed in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011(2) and active substances approved under Regulation (EC) No 1107/2009 as candidates for substitution are listed in Part E of that Annex. (2) The active substance fenpyrazamine is listed in Part B of the Annex to Implementing Regulation (EU) No 540/2011 while the active substance flumetralin is listed in Part E of that Annex. (3) Commission Implementing Regulation (EU) 2023/2592(3) extended the approval period of the active substance fenpyrazamine until 31 May 2026 and Commission Implementing Regulation (EU) 2023/1757(4) extended the approval period of the active substance flumetralin until 11 May 2026, pending the remaining steps in the procedure for the renewal of the approval of those active substances. (4) For the active substance fenpyrazamine, on 30 July 2024and for the active substance flumetralin, on 30 April 2024, the respective applicants confirmed that they no longer support the applications for the renewal of the approvals. (5) Therefore, the extension of the approval periods of these active substances is no longer justified. Consequently, a new expiry date should be set at the earliest possible date, while giving Member States sufficient time to withdraw their authorisations for the plant protection products containing those active substances. (6) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. (1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj. (2) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1, ELI: http://data. europa.eu/eli/reg_impl/2011/540/oj). (3) Commission Implementing Regulation (EU) 2023/2592 of 21 November 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-naphthylacetamide, 1-naphthylacetic acid, 2-phenylphenol (incl. its salts such as sodium salt), 8-hydroxyquinoline, amidosulfuron, bifenox, dicamba, difenoconazole, diflufenican, dimethachlor, esfenvalerate, etofenprox, fenoxaprop-P, fenpropidin, fenpyrazamine, fluazifop P, lenacil, napropamide, nicosulfuron, paraffin oils, paraffin oil, penconazole, picloram, prohexadione, spiroxamine, sulphur, tetraconazole and tri-allate (OJ L, 2023/2592, 22.11.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2592/oj). (4) Commission Implementing Regulation (EU) 2023/1757 of 11 September 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, eugenol, fludioxonil, flufenacet, flumetralin, fosthiazate, geraniol, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad, thymol, and tritosulfuron (OJ L 224, 12.9.2023, p. 28, ELI: http://data.europa.eu/eli/ reg_impl/2023/1757/oj). ELI: http://data.europa.eu/eli/reg_impl/2024/2848/oj 1/3EN OJ L, 12.11.2024 (7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: Article 1 The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation. 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, 11 November 2024. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2024/2848/ojEN OJ L, 12.11.2024 ANNEX The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part B, in row 25, fenpyrazamine, in the sixth column, ‘Expiration of approval’, the date is replaced by ‘15 January 2025’; (2) in Part E, in row 1, flumetralin, in the sixth column, ‘Expiration of approval’, the date is replaced by ‘15 January 2025’. ELI: http://data.europa.eu/eli/reg_impl/2024/2848/oj 3/3

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