Date: 2025-10-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2025/2027 of 9 October 2025 amending Implementing Regulation (EU) No 540/2011 as regards the approval period of the active substance penthiopyrad
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Regulation (EU) 2025/2027, dated 9 October 2025, amends Implementing Regulation (EU) No 540/2011 concerning the approval period of the active substance penthiopyrad. The amendment is due to the applicant no longer supporting the renewal of approval for the substance. This regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Amendment to Implementing Regulation (EU) No 540/2011:**
* The Annex to Implementing Regulation (EU) No 540/2011 is amended.
* In Part B, row 57, for 'Penthiopyrad,' the approval expiration date is replaced by '31 October 2025'.
* **Entry into Force:**
* The regulation takes effect twenty days after its publication in the Official Journal of the European Union.
* The regulation is binding in its entirety and directly applicable in all Member States.
**Impact Analysis**
**Member States**
* **Impact:** Must withdraw authorizations for plant protection products containing penthiopyrad.
* **Action Required:** Implement the new expiration date for penthiopyrad by 31 October 2025, giving sufficient time to withdraw authorizations.
**Applicant of Active Substance Penthiopyrad**
* **Impact:** Active substance Penthiopyrad is no longer supported.
* **Action Required:** No action is required, as applicant confirmed they are no longer supporting the renewal of approval for the active substance penthiopyrad.
Key Entities Referenced
Implementing Regulation (EU) No 540/2011: Regulation being amended, concerning the list of approved active substances for plant protection products.
Commission Implementing Regulation (EU) 2025/2027: The primary subject: a regulation amending approval period of the active substance penthiopyrad.
penthiopyrad: The active substance whose approval period is being amended.
European Commission: The issuer of the regulation
Official Journal EN
of the European Union L series
2025/2027 10.10.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/2027
of 9 October 2025
amending Implementing Regulation (EU) No 540/2011 as regards the approval period of the active
substance penthiopyrad
(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).
(2) Commission Implementing Regulation (EU) No 1187/2013(3) approved the active substance penthiopyrad until
30 April 2024. Penthiopyrad is listed in Part B of the Annex to Implementing Regulation (EU) No 540/2011.
(3) Application for the renewal of the approval of the active substance penthiopyrad was submitted in accordance with
Commission Implementing Regulation (EU) 2020/1740(4). On 19 January 2023, the rapporteur Member State
informed the co-rapporteur Member States, the Commission and the Authority that they had assessed the
admissibility pursuant to Article 8 of Implementing Regulation (EU) 2020/1740, and in particular the completeness
and the timeliness, of the application and concluded that it was admissible.
(4) Commission Implementing Regulation (EU) 2025/787(5) extended the approval period of the active substance
penthiopyrad until 31 October 2027, pending the remaining steps in the procedure for renewal of the approval of
that active substance.
(5) The applicant confirmed on 13 March 2025 that they no longer support the application for renewal of the approval
for the active substance penthiopyrad.
(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) No 1187/2013 of 21 November 2013 approving the active substance penthiopyrad, in
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 313,
22.11.2013, p. 42, ELI: http://data.europa.eu/eli/reg_impl/2013/1187/oj).
(4) 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).
(5) Commission Implementing Regulation (EU) 2025/787 of 24 April 2025 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances 1,4-dimethylnaphthalene, amidosulfuron, bentazone, bixafen,
clomazone, fenoxaprop-P, fludioxonil, fluoxastrobin, flutolanil, fluxapyroxad, gibberellic acid, gibberellins, halauxifen-methyl,
mecoprop-P, paraffin oil, penthiopyrad, pirimiphos-methyl, propamocarb, propyzamide, prothioconazole, rimsulfuron, sedaxane and
sulfoxaflor (OJ L, 2025/787, 25.4.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/787/oj).
ELI: http://data.europa.eu/eli/reg_impl/2025/2027/oj 1/3EN
OJ L, 10.10.2025
(6) Therefore, the extension of the approval period of penthiopyrad 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 penthiopyrad.
(7) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(8) 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, 9 October 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/2027/ojEN
OJ L, 10.10.2025
ANNEX
In the Annex to Implementing Regulation (EU) No 540/2011, in Part B, in row 57, ‘Penthiopyrad’, in the sixth column,
‘Expiration of approval’, the date is replaced by ’31 October 2025’.
ELI: http://data.europa.eu/eli/reg_impl/2025/2027/oj 3/3