Commission Implementing Regulation (EU) 2024/2186 of 3 September 2024 renewing the approval of the active substance captan 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 captan, as specified in Annex I to this Regulation, is renewed subject to the conditions laid down in that Annex.

Amendment 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 Captan CAS No 133-06-2 CIPAC No 40 N-[(trichloromethyl)thio]cyclohex-4-ene–1,2 -dicarboximide ≥ 930 g/kg perchloromethylmercaptan: ≤ 5 g/kg folpet: ≤ 10 g/kg carbon tetrachloride: ≤ 0,1 g/kg 1 November 2024 31 October 2039 For outdoor uses the following conditions shall apply: — only uses outside flowering of the crop and when no flowering weeds are present in the rows of the treated crops may be authorised, — Member States shall require that applications in orchards (e.g. apples, cherries) are only done with application equipment that increases the precision and accuracy of the application (e.g. emission shields, shielded sprayers, hooded sprayers, tunnel sprayers, sensor-controlled sprayers), and, while maintaining the application rate on the target surfaces, achieves an average reduction of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional application equipment and practice. 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 captan, and in particular Appendices I and II thereto, shall be taken into account. In addition, risk mitigations such as no-spray buffer zones from field margins, shall be required, when appropriate, by the Member States on the basis of their risk assessment to protect bees and aquatic organisms. In this overall assessment Member States shall pay particular attention to: — the compliance with the technical specification of the active substance contained in the plant protection product for which applications for authorisation are submitted, — the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment taking into account the high skin sensitising potential of the active substance, — the protection of bystanders and residents ensuring that conditions of use include adequate risk mitigation measures taking into account the high skin sensitising potential of the active substance. In addition, Member States may set monitoring requirements when granting authorisations, in order to supplement the monitoring under Directives 2000/60/EC  ( 2 ) and 2009/128/EC  ( 3 ) of the European Parliament and of the Council. Within two years from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the effect of water treatment processes on the nature of residues of captan’s metabolites THPI and THPAM present in ground water, when it is abstracted for drinking water; (2) the relevance of metabolites THPI and THPAM that may occur in groundwater, taking into account the proposal of classification of captan as toxic to reproduction Category 2 and as STOT-RE Category 1 in the Opinion of the Risk Assessment Committee of the European Chemicals Agency of 14 September 2023; (3) the storage stability of captan in high acid content matrices, in compliance with the relevant OECD Test Guideline; and Furthermore, within 18 months from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority: (4) information and exposure data demonstrating that the pesticide application equipment used on orchards increases the precision and accuracy of the application and achieves a reduction of exposure of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional equipment and practices. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( OJ L 327, 22.12.2000, p. 1 , ELI: http://data.europa.eu/eli/dir/2000/60/oj ). ( 3 )   Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides ( OJ L 309, 24.11.2009, p. 71 , ELI: http://data.europa.eu/eli/dir/2009/128/oj ).

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 145 on captan 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 ‘170 Captan CAS No 133-06-2 CIPAC No 40 N-[(trichloromethyl)thio]cyclohex-4-ene–1,2 -dicarboximide ≥ 930 g/kg perchloromethylmercaptan: ≤ 5 g/kg folpet: ≤ 10 g/kg carbon tetrachloride: ≤ 0,1 g/kg 1 November 2024 31 October 2039 For outdoor uses the following conditions shall apply: — only uses outside flowering of the crop and when no flowering weeds are present in the rows of the treated crops may be authorised, — Member States shall require that applications in orchards (e.g. apples, cherries) are only done with application equipment that increases the precision and accuracy of the application (e.g. emission shields, shielded sprayers, hooded sprayers, tunnel sprayers, sensor-controlled sprayers), and, while maintaining the application rate on the target surfaces, achieves an average reduction of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional application equipment and practice. 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 captan, and in particular Appendices I and II thereto, shall be taken into account. In addition, risk mitigations such as no-spray buffer zones from field margins, shall be required, when appropriate, by the Member States on the basis of their risk assessment to protect bees and aquatic organisms. In this overall assessment Member States shall pay particular attention to: — the compliance with the technical specification of the active substance contained in the plant protection product for which applications for authorisation are submitted, — the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment taking into account the high skin sensitising potential of the active substance, — the protection of bystanders and residents ensuring that conditions of use include adequate risk mitigation measures taking into account the high skin sensitising potential of the active substance. In addition, Member States may set monitoring requirements when granting authorisations, in order to supplement the monitoring under Directives 2000/60/EC  ( 2 ) and 2009/128/EC  ( 3 ) of the European Parliament and of the Council. Within two years from 24 September 2024 , the applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the effect of water treatment processes on the nature of residues of captan’s metabolites THPI and THPAM present in ground water, when it is abstracted for drinking water; (2) the relevance of metabolites THPI and THPAM that may occur in groundwater, taking into account the proposal of classification of captan as toxic to reproduction Category 2 and as STOT-RE Category 1 in the Opinion of the Risk Assessment Committee of the European Chemicals Agency of 14 September 2023; (3) the storage stability of captan in high acid content matrices, in compliance with the relevant OECD Test Guideline; and Furthermore, within 18 months from 24 September 2024 , the applicant shall submit to the Commission, the Member States and the Authority: (4) information and exposure data demonstrating that the pesticide application equipment used on orchards increases the precision and accuracy of the application and achieves a reduction of exposure of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional equipment and practices. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( OJ L 327, 22.12.2000, p. 1 , ELI: http://data.europa.eu/eli/dir/2000/60/oj ). ( 3 )   Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides ( OJ L 309, 24.11.2009, p. 71 , ELI: http://data.europa.eu/eli/dir/2009/128/oj ).’