(1)

Commission Directive 2005/3/EC (2) included S-metolachlor as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

According to Article 78(3) of Regulation (EC) No 1107/2009, 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 (4).

(3)

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

(4)

Applications for the renewal of the approval of S-metolachlor were submitted to Germany, the rapporteur Member State and France, to the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) 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 applications were 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 Authority and the Commission on 6 September 2018.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 29 September 2022, given that all areas of the assessment, except for endocrine disrupting properties, had been completed and that several critical areas of concern had been identified, the Commission invited the Authority to provide the results of the risk assessment of the active substance S-metolachor, including its conclusion as to whether S-metolachlor can be expected to meet the approval criteria set out in Article 4 of Regulation (EC) No 1107/2009 excluding the full assessment of endocrine disrupting properties.

(9)

On 3 February 2023, the Authority communicated to the Commission its conclusion (6) on whether S-metolachlor can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(10)

The Authority identified several critical areas of concerns. First of all, it concluded that there is a potential for S-metolachlor and its relevant herbicidally active metabolites to be present in groundwater above the parametric drinking water limit of 0,1 μg/L, based on monitoring data and that, in addition, these metabolites are predicted to be above 0,1 μg/L in all scenarios for all representative uses based on groundwater modelling. Furthermore, the Authority found a high potential for groundwater exposure above the parametric drinking water limit of 0,1 μg/L for metabolites which are toxicologically relevant due to concerns or data gaps concerning genotoxicity and/or carcinogenicity. Finally, the Authority also identified a high risk to earthworm-eating mammals from secondary poisoning.

(11)

Pursuant to Article 14 of Implementing Regulation (EU) No 844/2012, the Commission presented a draft renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed, for examination in May 2023. The draft renewal report was finalised by the Standing Committee on 12 July 2023.

(12)

The Commission invited the applicants to submit their comments on the conclusions of the Authority. Furthermore, in accordance with Article 14(1), third paragraph, of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicants submitted their comments which have been carefully examined.

(13)

However, despite the arguments put forward by the applicants, the concerns regarding the active substance could not be eliminated.

(14)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product containing S-metolachlor that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of that active substance.

(15)

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

(16)

Member States should be given sufficient time to withdraw authorisations for plant protection products containing S-metolachlor.

(17)

For plant protection products containing S-metolachlor, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should at the latest, expire on 23 July 2024.

(18)

Commission Implementing Regulation (EU) 2023/918 (7) extended the approval period of S-metolachlor to 15 November 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval has been taken ahead of the expiry of that extended approval period, this Regulation should start to apply earlier than that date.

(19)

This Regulation does not prevent the submission of a further application for the approval of S-metolachlor pursuant to Article 7 of Regulation (EC) No 1107/2009.

(20)

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