Date: 2025-05-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2025/910 of 20 May 2025 concerning the non-renewal of the approval of the active substance flufenacet, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulations (EU) No 540/2011 and (EU) 2015/408
Issued by European Commission
· Directorate-General for Health and Food Safety
## Report on Commission Implementing Regulation (EU) 2025/910 concerning the non-renewal of approval of flufenacet
**1. Executive Summary:**
This report analyzes Commission Implementing Regulation (EU) 2025/910 of 20 May 2025, which concerns the non-renewal of the approval of the active substance flufenacet within the European Union. This regulation amends Implementing Regulation (EU) No 540/2011 and (EU) 2015/408. The core purpose is to prohibit the use of flufenacet in plant protection products due to identified risks to human health (endocrine disruption, toxicity of a metabolite) and the environment (groundwater contamination). Key provisions include the non-renewal of flufenacet's approval, the removal of flufenacet from the list of approved substances and candidates for substitution, and a timeline for Member States to withdraw authorizations for products containing flufenacet.
**2. Introduction:**
This report provides an overview of Commission Implementing Regulation (EU) 2025/910, based on the text provided. The purpose of this report is to inform affected industries about the key aspects of this regulation.
**3. Policy Overview:**
This is an amendment to existing regulations: Commission Implementing Regulation (EU) No 540/2011 and (EU) 2015/408.
* **Core Objective(s):** The primary objective, as stated in the provided text, is the non-renewal of the approval of the active substance flufenacet. This aims to protect human health and the environment from the potentially harmful effects of flufenacet and its metabolites.
**4. Background and Rationale:**
This amendment is driven by concerns raised by the European Food Safety Authority (EFSA) regarding flufenacet. The main reasons for the non-renewal, according to the text, include:
* **Endocrine Disruptor:** Flufenacet meets the criteria to be identified as an endocrine disruptor for the thyroid.
* **Groundwater Contamination:** The flufenacet metabolite trifluoroacetic acid (TFA) has the potential to contaminate groundwater at levels exceeding the statutory limit. TFA may also be classified as toxic for reproduction.
* **High Risk to Algae:** EFSA identified a high risk to algae in most relevant scenarios.
* **Lack of data on certain metabolites:** The assessment of relevance of metabolites of flufenacet other than TFA in groundwater and the assessment of risks to consumers could not be finalized due to the lack of data on exposure to certain metabolites.
**5. Key Provisions / Changes:**
This regulation introduces the following changes to the existing regulatory framework:
* **Non-Renewal of Approval:** The approval of flufenacet as an active substance is not renewed. This means that flufenacet can no longer be used in plant protection products within the EU after the transitional periods.
* **Amendment to Implementing Regulation (EU) No 540/2011:** Flufenacet is removed from Part A of the Annex to Implementing Regulation (EU) No 540/2011, which lists approved active substances. This directly reflects the non-renewal decision.
* **Amendment to Implementing Regulation (EU) 2015/408:** Flufenacet is removed from the Annex to Implementing Regulation (EU) 2015/408, which lists candidates for substitution. With flufenacet no longer approved, its status as a candidate for substitution becomes irrelevant.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this regulation include:
* **Manufacturers and distributors of plant protection products containing flufenacet:** They will be required to cease production and sales of affected products.
* **Farmers and agricultural businesses:** They will need to find alternative plant protection solutions.
* **Member State authorities:** They are responsible for withdrawing authorizations for plant protection products containing flufenacet and enforcing the regulation.
* **The public:** Potentially benefits from reduced exposure to a harmful substance.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The European Commission, the European Food Safety Authority (EFSA), and Member State authorities are the key bodies involved in implementing this regulation. The Standing Committee on Plants, Animals, Food and Feed also played a role in the decision-making process.
* **Timelines:**
* Member States must withdraw authorizations for plant protection products containing flufenacet by **December 10, 2025**.
* Any grace period granted by Member States for the disposal, storage, placing on the market, and use of existing stocks must expire by **December 10, 2026**.
**8. Expected Outcomes / Impact of Changes:**
The intended outcomes of these changes are:
* **Reduced risk to human health:** By eliminating flufenacet, the regulation aims to prevent potential endocrine disruption and exposure to the toxic metabolite TFA.
* **Improved environmental protection:** The regulation seeks to prevent groundwater contamination by TFA and mitigate risks to non-target organisms, particularly algae.
* **Shift towards alternative plant protection products:** Farmers will need to adopt alternative pest control methods, potentially promoting the use of more sustainable solutions.
**9. Conclusion:**
Commission Implementing Regulation (EU) 2025/910 represents a significant regulatory action concerning the active substance flufenacet. The non-renewal of its approval, driven by concerns regarding human health and environmental risks, will have a direct impact on the agricultural sector and require affected industries to adapt their practices. The regulation's timelines for withdrawal of authorizations and grace periods provide a framework for this transition. This regulation underscores the EU's commitment to a high level of protection of both human health and the environment.
Key Entities Referenced
flufenacet: Active substance whose approval is not renewed.
European Union: A political and economic union of member states located primarily in Europe.
Official Journal EN of the European Union L series 2025/910: Official publication documenting EU legislation.
21.5.2025: Date of the Official Journal.
COMMISSION IMPLEMENTING REGULATION (EU) 2025/910: EU regulation concerning the non-renewal of approval of flufenacet.
20 May 2025: Date of the Commission Implementing Regulation (EU) 2025/910.
Regulation (EC) No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
European Parliament: One of the legislative branches of the European Union.
Council: Refers to the Council of the European Union, a legislative body.
Commission Implementing Regulations (EU) No 540/2011: Commission Implementing Regulation regarding the list of approved active substances.
EU 2015/408: Commission Implementing Regulation establishing a list of candidates for substitution.
Treaty on the Functioning of the European Union: Treaty defining the scope of the EU's powers.
Article 20(1): Article within Regulation (EC) No 1107/2009.
Article 78(2): Article within Regulation (EC) No 1107/2009.
Commission Directive 2003/84/EC: Directive including flufenacet as an active substance.
Annex I to Council Directive 91/414/EEC: Annex listing active substances, including flufenacet.
Council Directive 91/414/EEC: Council Directive concerning the placing of plant protection products on the market.
Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011: Part of the Annex listing approved active substances.
15 June 2025: Original expiry date of the approval of flufenacet.
Poland: Rapporteur Member State for the renewal application.
France: Co-rapporteur Member State for the renewal application.
Article 1 of Commission Implementing Regulation (EU) No 844/2012: Article related to the submission of renewal application.
Commission Implementing Regulation (EU) No 844/2012: Regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances.
Article 17 of Commission Implementing Regulation (EU) 2020/1740: Article related to the procedure for the renewal of flufenacet.
Commission Implementing Regulation (EU) 2020/1740: Regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances.
Article 6 of Implementing Regulation (EU) No 844/2012: Article related to the supplementary dossiers.
European Food Safety Authority (the Authority): Agency responsible for providing scientific advice on food and feed safety.
7 June 2017: Date when the draft renewal assessment report was submitted.
29 August 2024: Date when the Authority communicated its conclusion.
Article 4 of Regulation (EC) No 1107/2009: Article defining the approval criteria.
trifluoroacetic acid (TFA): Metabolite of flufenacet.
Directive 2006/118/EC: Directive on the protection of groundwater against pollution and deterioration.
Annex I to Directive 2006/118/EC: Annex related to groundwater limit.
Article 3(32) of Regulation (EC) No 1107/2009: Article related to toxicologically relevant metabolites.
Commission Regulation (EU) No 546/2011: Regulation implementing Regulation (EC) No 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products.
Regulation (EC) No 1907/2006: Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Regulation (EC) No 1272/2008: Regulation on classification, labelling and packaging of substances and mixtures.
German authorities: Submitted a proposal for harmonised classification and labelling of TFA.
Guidance document on the assessment of the relevance of metabolites in groundwater: Document used for the assessment of metabolites in groundwater.
Standing Committee on Plants, Animals, Food and Feed: Committee consulted by the Commission.
4 December 2024: Date when the Commission presented a renewal report.
Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012: Article related to the applicant's comments on the renewal report.
Commission Implementing Regulation EU 2015/408: Regulation concerning candidates for substitution.
Article 46 of Regulation (EC) No 1107/2009: Article regarding grace periods.
Commission Implementing Regulation (EU) 2023/1757: Regulation extending the approval period of flufenacet.
Article 7 of Regulation (EC) No 1107/2009: Article related to the application for approval.
Article 1: Article of the current regulation concerning the nonrenewal of flufenacet.
Article 2: Article of the current regulation concerning amendment to Implementing Regulation EU No 540/2011.
Article 3: Article of the current regulation concerning amendment to Implementing Regulation EU 2015/408.
Article 4: Article of the current regulation concerning transitional measures.
10 December 2025: Date by which Member States shall withdraw authorizations.
Article 5: Article of the current regulation concerning the grace period.
10 December 2026: Date by which any grace period shall expire.
Article 6: Article of the current regulation concerning entry into force.
Brussels: Location where the regulation was adopted.
Ursula VON DER LEYEN: President of the Commission.
Official Journal EN
of the European Union L series
2025/910 21.5.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/910
of 20 May 2025
concerning the non-renewal of the approval of the active substance flufenacet, in accordance with
Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending
Commission Implementing Regulations (EU) No 540/2011 and (EU) 2015/408
(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 2003/84/EC(2) included flufenacet as an active substance in Annex I to Council
Directive 91/414/EEC(3).
(2) 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 flufenacet, as set out in Part A of the Annex to Implementing Regulation (EU)
No 540/2011, expires on 15 June 2025.
(4) An application for the renewal of the approval of the active substance flufenacet was submitted to Poland, the
rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission
Implementing Regulation (EU) No 844/2012(5)within the time period provided for in that Article. That Regulation
continues to apply for the purposes of the procedure for the renewal of the approval of flufenacet, pursuant to
Article 17 of Commission Implementing Regulation (EU) 2020/1740(6).
(5) The applicant submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member
State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of
Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member
State.
(1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.
(2) Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet,
iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (OJ L 247, 30.9.2003, p. 20, ELI: http://
data.europa.eu/eli/dir/2003/84/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 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) 2020/1740 of 20 November 2020 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, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20,
ELI: http://data.europa.eu/eli/reg_impl/2020/1740/oj).
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OJ L, 21.5.2025
(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur
Member State and submitted it to the Authority and the Commission on 7 June 2017. In that draft renewal
assessment report, the rapporteur Member State proposed to not renew the approval of flufenacet.
(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the
draft renewal assessment report to the applicant and to the Member States for comments and launched a public
consultation on it. The Authority forwarded the comments received to the Commission.
(8) On 29 August 2024, the Authority communicated to the Commission its conclusion(7)on whether flufenacet can be
expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(9) The Authority identified several concerns. In particular, it concluded that flufenacet meets the criteria to be identified
as an endocrine disruptor for the thyroid (T)-modality for humans and non-target organisms and that it has not been
demonstrated that the exposure of humans and non-target organisms to that active substance in a plant protection
product, under realistic proposed conditions of use, is negligible.
(10) The Authority also identified a potential for the flufenacet metabolite trifluoroacetic acid (‘TFA’) to contaminate
groundwater at levels that significantly exceed the statutory limit of 0,1 μg/l, provided for in point 1 of Annex I to
Directive 2006/118/EC of the European Parliament and of the Council(8), under all relevant groundwater
assessment scenarios for all representative uses assessed. That limit applies to toxicologically relevant metabolites as
defined in Article 3(32) of Regulation (EC) No 1107/2009, and in accordance with point 2.5.1.2. (i) of Part A of the
uniform principles for evaluation and authorisation of chemical plant protection products set in the Annex to
Commission Regulation (EU) No 546/2011(9).
(11) Regarding the intrinsic toxicological properties of this metabolite, it is noted that some of the registrants of TFA and
its salts under Regulation (EC) No 1907/2006 of the European Parliament and of the Council(10) updated their
registration dossiers to indicate that those substances fulfil the criteria for classification as toxic for reproduction
category 2 under Regulation (EC) No 1272/2008 of the European Parliament and of the Council(11). Furthermore,
the German authorities submitted a proposal for harmonised classification and labelling of TFA as toxic for
reproduction category 1B under Regulation (EC) No 1272/2008. Finally, in accordance with the applicable Guidance
document on the assessment of the relevance of metabolites in groundwater(12), metabolites leaching into
groundwater which qualify for classification under Regulation (EC) No 1272/2008 due to their reproductive toxicity,
regardless of the category, are considered to be toxicologically relevant. Based on those elements, the Commission
considers TFA to be a toxicologically relevant metabolite with a high potential to contaminate groundwater.
Therefore, it has not been demonstrated that, in the light of the current scientific and technical knowledge, flufenacet
would not have harmful effects on groundwater or any unacceptable effect on the environment.
(7) EFSA (European Food Safety Authority), 2024. Peer review of the pesticide risk assessment of the active substance flufenacet (EFSA
Journal 2024;22(9):8997, https://doi.org/10.2903/j.efsa.2024.8997).
(8) Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater
against pollution and deterioration (OJ L 372, 27.12.2006, p. 19, ELI: http://data.europa.eu/eli/dir/2006/118/oj).
(9) Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products Text with
EEA relevance (OJ L 155, 11.6.2011, p. 127, ELI: http://data.europa.eu/eli/reg/2011/546/oj).
(10) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396,
30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).
(11) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
(12) Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council
Directive 91/414/EEC (document Sanco/221/2000 – rev.10 of 25 February 2003, https://food.ec.europa.eu/system/files/2016-10/
pesticides_ppp_app-proc_guide_fate_metabolites-groundwtr.pdf).
2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/910/ojEN
OJ L, 21.5.2025
(12) The Authority also identified a high risk to algae for 8 out of 9 relevant scenarios for all representative uses of
flufenacet. As one scenario is considered by the Authority to be acceptable, such identification does not lead to the
conclusion that flufenacet does not satisfy the renewal criteria.
(13) Furthermore, the Authority concluded that the assessment of relevance of metabolites of flufenacet other than TFA in
groundwater and the assessment of risks to consumers could not be finalised due to the lack of data on exposure to
certain metabolites.
(14) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants,
Animals, Food and Feed on 4 December 2024.
(15) The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in
accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, the Commission
invited the applicant to submit comments on the renewal report. The applicant submitted its comments, which have
been carefully examined and taken into due consideration.
(16) Despite the arguments put forward by the applicant, the concerns regarding the active substance flufenacet could not
be eliminated.
(17) Consequently, it has not been established with respect to one or more representative uses of at least one plant
protection product containing flufenacet that the approval criteria provided for in Article 4 of Regulation (EC)
No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance flufenacet
in accordance with Article 20(1), point (b), of that Regulation.
(18) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(19) Commission Implementing Regulation (EU) 2015/408(13)listed flufenacet as a candidate for substitution. In the light
of the non-renewal of the approval of flufenacet that listing is no longer relevant. Accordingly, flufenacet should be
removed from the Annex to Implementing Regulation (EU) 2015/408.
(20) Member States should be given sufficient time to withdraw authorisations for plant protection products containing
flufenacet.
(21) For plant protection products containing flufenacet, where Member States grant any grace period in accordance with
Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 18 months from the date of entry into
force of this Regulation.
(22) Commission Implementing Regulation (EU) 2023/1757(14) extended the approval period of flufenacet to 15 June
2025 in order to allow the renewal process to be completed before the expiry of the approval period of that active
substance. However, given that a decision on the non-renewal of the approval is taken ahead of the expiry date of
that extended approval period, this Regulation should apply earlier than that date.
(23) This Regulation does not prevent the submission of another application for the approval of flufenacet pursuant to
Article 7 of Regulation (EC) No 1107/2009.
(13) Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC)
No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and
establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18, ELI: http://data.europa.eu/eli/reg_impl/2015/408/oj).
(14) 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).
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OJ L, 21.5.2025
(24) 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 the approval of the active substance
The approval of the active substance flufenacet 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 65, on flufenacet, is deleted.
Article 3
Amendment to Implementing Regulation (EU) 2015/408
The entry for flufenacet is deleted from the Annex to Implementing Regulation (EU) 2015/408.
Article 4
Transitional measures
Member States shall withdraw authorisations for plant protection products containing flufenacet as an active substance by
10 December 2025.
Article 5
Grace period
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by
10 December 2026.
Article 6
Entry into force
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, 20 May 2025.
For the Commission
The President
Ursula VON DER LEYEN
4/4 ELI: http://data.europa.eu/eli/reg_impl/2025/910/oj