(1)

Commission Directive 2006/74/EC (2) included pyrimethanil 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 pyrimethanil, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2026.

(4)

An application for the renewal of the approval of the active substance pyrimethanil was submitted to Czech Republic, the rapporteur Member State, and Austria, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

(5)

The applicants submitted the supplementary dossier required 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.

(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 31 August 2017. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of pyrimethanil.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicants 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 16 December 2019, the Authority requested additional information from the applicants on the endocrine disrupting properties of pyrimethanil pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012. The applicants submitted information to allow the Authority to conclude the assessment as regards whether the scientific criteria for the determination of endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation (EU) 2018/605 (6), are met.

(9)

In September 2022, the rapporteur Member State made an updated draft renewal assesment report available to the Authority, the Member States and the Commission. In that report, the rapporteur Member State considered the additional information regarding the criteria to identify endocrine disrupting properties and proposed renewing the approval of pyrimethanil.

(10)

On 3 September 2024, the Authority communicated to the Commission its conclusion (7) indicating that, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing pyrimethanil can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(11)

The Commission presented a renewal report to the Standing Committee on Plants, Animals, Food and Feed on 1 October 2025 and a draft of this Regulation on 10 December 2025.

(12)

The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicants submitted their comments, which have been carefully examined and taken into due consideration.

(13)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance pyrimethanil that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(14)

It is therefore appropriate to renew the approval of pyrimethanil.

(15)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions and restrictions.

(16)

It is, in particular, appropriate to set maximum limits for cyanamide, aniline, and acetylacetone, which are toxicologically relevant impurities that might be present in the technical material as manufactured, to ensure that the active substance pyrimethanil used in plant protection products does not lead to any harmful effects on human health.

(17)

Based on the findings of the risk assessment, it is also necessary to require Member States to pay particular attention to the protection of operators, bystandars, residents, aquatic organisms, bees and pollinators when carrying out assessments for the authorisation of plant protection products containing pyrimethanil. Member States shall impose, where appropiate, the use of personal protective equipment to reduce the exposure of operators, and other risk mitigation measures to reduce the exposure of bystandars, residents, aquatic organisms, bees and pollinators.

(18)

Provisional residue definitions for the consumer risk assessment for certain commodities of plant or animal origin, as well as for certain processed commodities, have been established due to a data gap on the toxicity of metabolites of pyrimethanil that may be present in those commodities: metabolite M605F004 and its conjugates and metabolite M605F007. The applicants should provide further information on the toxicity of the metabolite M605F004, including its conjugates, and of the metabolite M605F007, so that definitive residue definitions can be set in relation to the commodities concerned.

(19)

In addition, in order to increase the confidence in the conclusion that the metabolite U2 is present in soil in an amount that does not trigger the need for its identification according to the data requirements for active substances (8), and that, therefore, the subsequent soil, surface water, sediment and groundwater exposure and risk assessment for the metabolite U2 is not needed, the applicants should provide confirmatory information on the degradation of pyrimethanil in soils.

(20)

Finally, given that new scientific and technical knowledge on the assessment of the potential effects of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water has been developed during the evaluation process which was not available at the time of the submission of the supplementary dossier for pyrimethanil, notably a Guidance Document (9), the applicants should provide confirmatory information on the effects of water treatment processes on residues of pyrimethanil or its metabolites that may occur in water abstracted for the production of drinking water.

(21)

It is therefore appropriate to renew the approval of pyrimethanil, subject to the conditions set out in the Annex to this Regulation. Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(22)

Commission Implementing Regulation (EU) 2025/99 (10) extended the approval period of pyrimethanil to 30 June 2026, 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 renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

(23)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,