Commission Implementing Regulation (EU) 2026/355 of 18 February 2026 renewing the approval of the active substance pyrimethanil 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

Renewal of the approval of the active substance

Article 1

The approval of the active substance pyrimethanil, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force and date of application

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 April 2026.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Pyrimethanil CAS No: 53112-28-0 CIPAC No: 714 N-(4,6-dimethylpyrimidin-2-yl) aniline ≥ 975 g/kg The following impurities shall not exceed the following levels in the technical material: — cyanamide: 0,5 g/kg; — aniline: 4 g/kg; — acetylacetone: 0,1 g/kg. 1 May 2026 30 April 2041 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyrimethanil, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bystanders and residents, ensuring that drift reduction measures are applied, where necessary; — the protection of aquatic organisms, bees and other pollinators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicity of the metabolite M605F004, including its conjugates, and the metabolite M605F007, to confirm the relevant residue definitions for risk assessment; (2) the effect of water treatment processes on the residues of pyrimethanil or its metabolites present in water abstracted for the production of drinking water, in accordance with the EFSA and ECHA Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water; (3) the degradation of pyrimethanil in soil, including where relevant the identification and characterisation of metabolites. If the information indicates the relevance of the metabolite U2, soil, surface water, sediment and groundwater exposure and risk assessment for the metabolite U2 shall be provided. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1.2 and 3 by 11 March 2028. ( 1 )   Further details on the identity and specification of the active substance are provided in the renewal report.

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 135 on pyrimethanil is deleted; (2) in Part B, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘179 Pyrimethanil CAS No: 53112-28-0 CIPAC No: 714 N-(4,6-dimethylpyrimidin-2-yl) aniline ≥ 975 g/kg The following impurities shall not exceed the following levels in the technical material: — cyanamide: 0,5 g/kg; — aniline: 4 g/kg; — acetylacetone: 0,1 g/kg. 1 May 2026 30 April 2041 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyrimethanil, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bystanders and residents, ensuring that drift reduction measures are applied, where necessary; — the protection of aquatic organisms, bees and other pollinators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicity of the metabolite M605F004, including its conjugates, and the metabolite M605F007, to confirm the relevant residue definitions for risk assessment; (2) the effect of water treatment processes on the residues of pyrimethanil or its metabolites present in water abstracted for the production of drinking water, in accordance with the EFSA and ECHA Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water; (3) the degradation of pyrimethanil in soil, including where relevant the identification and characterisation of metabolites. If the information indicates the relevance of the metabolite U2, soil, surface water, sediment and groundwater exposure and risk assessment for the metabolite U2 shall be provided. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1.2 and 3 by 11 March 2028.’ ( 1 )   Further details on the identity and specification of the active substance are provided in the renewal report.