Commission Implementing Regulation (EU) 2024/2777 of 31 October 2024 concerning the non-renewal of approval of the active substance tritosulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011
Date: 2024-10-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product, withdrawal from the market








L_202402777EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2777


4.11.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2777
of 31 October 2024
         
concerning the non-renewal of approval of the active substance tritosulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011
(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 20(1) and Article 78(2) thereof,

Whereas:







(1)


Commission Directive 2008/70/EC (2) included Tritosulfuron as an active substance in Annex I to Council Directive 91/414/EEC (3).












(2)


According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).












(3)


The approval of the active substance tritosulfuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 July 2025.












(4)


An application for the renewal of the approval of tritosulfuron was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.












(5)


On 14 July 2023 the European Food Safety Authority communicated its Conclusions of the risk assessment for tritosulfuron. The Authority did not identify any specific risks but did conclude that several parts of the risk assessment could not be finalised.












(6)


On 8 May 2024, the applicant informed the Commission of their decision to withdraw the application for the renewal of approval of tritosulfuron.












(7)


It is therefore appropriate not to renew the approval of the active substance tritosulfuron in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009.












(8)


Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.












(9)


Member States should be provided with sufficient time to withdraw authorisations.












(10)


For plant protection products containing tritosulfuron, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should be as short as possible and not exceed 12 months from the date of entry into force of this Regulation.












(11)


Commission Implementing Regulation (EU) 2023/1757 (6) postpones the expiry of tritosulfuron to 15 July 2025 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision has been taken ahead of this extended expiry date, this Regulation should apply as soon as possible.












(12)


This Regulation does not prevent the submission of a new application for the approval of the active substance tritosulfuron pursuant to Article 7 of Regulation (EC) No 1107/2009.












(13)


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

Non-renewal of approval of active substance

The approval of the active substance tritosulfuron is not renewed.


Article 2

Amendment to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 186, on tritosulfuron, is deleted.


Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing tritosulfuron as active substance by 7 May 2025.


Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 7 November 2025.


Article 5

Entry into force

This Regulation shall enter into force on the third 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, 31 October 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.

(2)  Commission Directive 2008/70/EC of 11 July 2008 amending Council Directive 91/414/EEC to include tritosulfuron as an active substance (OJ L 185, 12.7.2008, p. 40, ELI: http://data.europa.eu/eli/dir/2008/70/oj).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/414/oj).

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 amending 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).

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26, ELI: http://data.europa.eu/eli/reg_impl/2012/844/oj).

(6)  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/2024/2777/oj
ISSN 1977-0677 (electronic edition)