(1)

Commission Directive 2004/58/EC (2) included desmedipham as an active substance in Annex I to Council Directive 91/414/EEC (3).

(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 (4).

(3)

The approval of the active substance desmedipham, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2020.

(4)

An application for the renewal of the approval of desmedipham was submitted 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 applicant submitted the supplementary dossiers required 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 renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 21 December 2016.

(7)

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

(8)

On 10 January 2018, the Authority communicated to the Commission its conclusion (6) on whether desmedipham can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Authority identified specific concerns. In particular, it was not possible to exclude exposure of consumers and/or livestock to residues containing free and/or conjugated aniline (classified as mutagen category 2 and carcinogen category 2) and consumer exposure to residues containing 4-aminophenol (classified as mutagen category 2) via animal commodities. In addition, the Authority concluded that a high long-term risk to mammals was identified for all representative uses, except for insectivorous mammals when the use pattern includes only one application. A high long-term risk for birds was identified for the representative uses in sugar beet/fodder beet, when the use pattern includes two or three applications.

(10)

Furthermore, the Authority also concluded that the assessment of endocrine disrupting properties could not be completed based on the available information.

(11)

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

(12)

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

(13)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product 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 the active substance desmedipham in accordance with Article 20(1)(b) of that Regulation.

(14)

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

(15)

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

(16)

For plant protection products containing desmedipham, 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 1 July 2020.

(17)

Commission Implementing Regulation (EU) 2019/707 (7) extended the approval period of desmedipham to 31 July 2020 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on the non-renewal of the approval has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

(18)

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

(19)

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