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L 98/2

EN

Official Journal of the European Union
11.4.2023

5

The applicant submitted the supplementary dossiers 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 Authority and the Commission on 15 October 2019.

7

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant 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 30 March 2022, the Authority communicated to the Commission its conclusion 6 on whether oxamyl can be expected to meet the approval criteria provided for in Article 4 of Regulation EC No 1107/2009.

9

In its conclusion, the Authority identified a number of concerns. In particular, it concluded that there is a high risk for all the representative uses assessed to exceed the acceptable operator exposure level AOEL for operators even with the use of personal protective equipment PPE.

10

Furthermore, the preliminary acute consumer dietary risk assessment indicated a large exceedance of the acute reference dose ARfD for all the representative uses on all edible crops. In addition, the consumer risk assessment through drinking water indicated that the theoretical maximum daily intake TMDI from the groundwater metabolite IN-D2708 exceeded the acceptable daily intake ADI for adults, children and infants in all representative uses and that the TMDI from the groundwater metabolite IN-A2213 exceeded the ADI for infants in all representative uses.

11

The Commission presented a renewal report concerning the approval of oxamyl as well as a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 13 October 2022 and 8 December 2022
respectively.

12

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with Article 141, third subparagraph, of Implementing Regulation EU No 844/2012, the Commission invited the applicant to submit comments on the renewal report.

13

Despite the arguments put forward by the applicant, 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, 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 oxamyl.

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 oxamyl.

17

For plant protection products containing oxamyl, 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 30 September 2023.

18

Commission Implementing Regulation EU 2023/116 7 extends the approval period of oxamyl to 31 October 2023 in order to allow the renewal process to be completed before the expiry of the approval period.
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 earlier than that date.

6 EFSA Journal 2022;205:7296.
7 Commission Implementing Regulation EU 2023/116 of 16 January 2023 amending Implementing Regulation EU No 540/2011 as regards the extension of the approval period of the active substance oxamyl OJ L 15, 17.1.2023, p. 15.