Commission Implementing Regulation (EU) 2026/355

law://eu/reg/2026/355@2026-11-12

Contents

Article 1Renewal of the approval of the active substance#

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.

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

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

Article 3Entry into force and date of application#

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 May 2026.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
PyrimethanilCAS No: 53112-28-0CIPAC No: 714	N-(4,6-dimethylpyrimidin-2-yl) aniline	≥ 975 g/kgThe 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.

Annex II

(1)in Part A, entry 135 on pyrimethanil is deleted;

(2)in Part B, the following entry is added:^noteNoCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘179PyrimethanilCAS No: 53112-28-0CIPAC No: 714N-(4,6-dimethylpyrimidin-2-yl) aniline≥ 975 g/kgThe following impurities shall not exceed the following levels in the technical material:

(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.

—cyanamide: 0,5 g/kg;

—the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;

—aniline: 4 g/kg;

—the protection of bystanders and residents, ensuring that drift reduction measures are applied, where necessary;

—acetylacetone: 0,1 g/kg.

—the protection of aquatic organisms, bees and other pollinators.

1 May 202630 April 2041For 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:Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: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.’

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

Commission Implementing Regulation (EU) 2026/355

Commission Implementing Regulation (EU) 2026/355

Article 1Renewal of the approval of the active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

Connections

Key facts

History · 1 version

Article 1Renewal of the approval of the active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II