BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Directive 2007/5/EC included captan as an active substance in Annex I to Council Directive 91/414/EEC. 

(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. 

(3) The approval of the active substance captan, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 November 2024. 

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

(5) The applicants submitted the supplementary dossiers 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 complete 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 the Authority and the Commission on 4 December 2017. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of captan. 

(7) The Authority communicated the draft renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority made the supplementary summary dossier available to the public. 

(8) On 24 July 2020, the Authority communicated to the Commission its conclusion on whether captan can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that captan does not meet the criteria for the determination of endocrine disrupting properties set in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009. 

(9) The Commission presented a draft renewal report on 14 July 2022 and the draft Regulation on 13 October 2022 to the Standing Committee on Plants, Animals, Food and Feed. 

(10) Some Member States requested to explore the possibility to refine the assessment for certain non-target species for field uses. The rapporteur Member State conducted such assessment and the Authority was requested to analyse that assessment. In the absence of agreed harmonised values for regulatory purposes, in 2024 the Authority did not consider the information available as sufficienty robust to demonstrate a significant variation of the level of risk to those non-target species compared to the one identified in the EFSA Conclusion. 

(11) In March 2024, the Standing Committee on Plants, Animals, Food and Feed endorsed a compendium which lists techniques and pesticide application equipment, which include innovations used in precision agriculture, and are recognised by risk managers as reducing exposure of the environment to pesticides. That compendium sets a harmonised sound basis for risk managers to select particular application equipment which leads to the reduction of exposure as risk mitigation measures. Consequently, while acknowledging the Authority's assessment of the literature studies, the Standing Committee considered that the risk mitigation measures leading to the refined risk assessment could be considered appropriate and achieving the reduction of exposure necessary to protect wild mammals, bees, and the aquatic environment. Taking into account the new information, the Commission presented a revised draft renewal report to the Standing Committee on Plants, Animals, Food and Feed on 24 June 2024. 

(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 both versions of the renewal report. The Commission also shared the further assessment for certain non-target species for field uses with further refinements provided by the rapporteur Member State with the applicants and the other Member States. The applicants submitted their comments on both versions of the renewal report and on the further assessment provided by the rapporteur Member State. Those comments 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 captan that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of captan. 

(14) It is however necessary to provide for certain conditions and restrictions, 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. It is, in particular, appropriate that the use of plant protection products containing captan be restricted to uses outside flowering of the crop and when no flowering weeds are present in the rows of the treated crops. Furthermore, for outdoor applications on orchards (e.g., apples, cherries), in order to ensure the protection of non-target organisms, in particular wild mammals, aquatic organisms and bees, only certain uses should be authorised. Those are uses via pesticide application equipment that increases the precision and accuracy of the application 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 practices, therefore, minimises the drift to areas outside the target surface of the crop (e.g. canopy), shall be authorised. 

(15) In order to increase confidence in the regulatory decision making, the applicants should submit information and exposure data demonstrating that the pesticide application equipment (e.g., emission shields, shielded sprayers, hooded sprayers, tunnel sprayers, sensor-controlled sprayers) used on orchards 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. 

(16) It is further appropriate to require further confirmatory information as regards 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. 

(17) Taking into account the Opinion of the Risk Assessment Committee of the European Chemicals Agency of 14 September 2023, which proposed to classify captan as toxic to reproduction Category 2 and as STOT-RE Category 1, it is also appropriate to require further confirmatory information concerning the relevance of metabolites THPI and THPAM that may occur in groundwater. 

(18) Furthermore, it is also appropriate to require further confirmatory information as regards the storage stability of captan in high acidic content matrices to confirm the existing applicable maximum residue level for strawberries. 

(19) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(20) Commission Implementing Regulation (EU) 2023/918 extended the approval period of captan to 15 November 2024 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 the renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date. 

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