Commission Implementing Regulation (EU) 2024/2198 of 4 September 2024 renewing the approval of the active substance folpet 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 folpet, 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 November 2024.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Folpet CAS No: 133-07-3 CIPAC No: 75 N-[(trichloromethyl)thio]phthalimide ≥ 940 g/kg The following impurities shall not exceed the following levels in the technical material: — (trichloro(chlorosulfanyl) methane) (PCMM): 2 g/kg — carbon tetrachloride: 2 g/kg — captan: 3 g/kg — carbon disulphide: 2,5 g/kg 1 November 2024 31 October 2039 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 folpet, 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 aquatic organisms, ensuring a minimum of 95 % spray drift reduction next to water bodies such as that provided by a 20 m no spray buffer zone unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift; — the protection of operators (use of PPE for operators during mixing, loading and application) and workers (use of workwear and protective gloves for re-entry activities); and — the protection of bystanders and residents, ensuring that conditions of use include the adequate risk mitigation measures, such as drift reduction equipment, with the aim of minimising exposure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information to determine the levels of phthalic acid deriving from the use of folpet taking into account the background levels of phthalic acid in wheat and barley during residue field trials for the uses listed in Appendix II of the renewal report only. The applicant shall submit to the Commission, the Member States and the Authority this information by 25 March 2025. ( 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 Commission Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 146 on folpet 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 ‘172 Folpet CAS No: 133-07-3 CIPAC No: 75 N-[(trichloromethyl)thio]phthalimide ≥ 940 g/kg The following impurities shall not exceed the following levels in the technical material: — (trichloro(chlorosulfanyl) methane) (PCMM): 2 g/kg — carbon tetrachloride: 2 g/kg — captan: 3 g/kg — carbon disulphide: 2,5 g/kg 1 November 2024 31 October 2039 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 folpet, 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 aquatic organisms, ensuring a minimum of 95 % spray drift reduction next to water bodies such as that provided by a 20 m no spray buffer zone unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift; — the protection of operators (use of PPE for operators during mixing, loading and application) and workers (use of workwear and protective gloves for re-entry activities); and — the protection of bystanders and residents, ensuring that conditions of use include the adequate risk mitigation measures, such as drift reduction equipment, with the aim of minimising exposure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information to determine the levels of phthalic acid deriving from the use of folpet taking into account the background levels of phthalic acid in wheat and barley during residue field trials for the uses listed in Appendix II of the renewal report only. The applicant shall submit to the Commission, the Member States and the Authority this information by 25 March 2025. ( 1 )   Further details on the identity and specification of the active substance are provided in the renewal report.’