BAKGRUNN (fra kommisjonsforordningen)

(1) For the active substances fenazaquin and propamocarb, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For the active substance mepiquat, MRLs were set in Part A of Annex III to that Regulation.
(2) As regards fenazaquin, an application for import tolerances for use of that substance on hops in the United States, was submitted to the Member State concerned pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005. The applicant provided evidence that the uses of fenazaquin on hops authorised in the United States would lead to residues that exceed the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs would be needed to avoid trade barriers when importing that crop.
(3) As regards propamocarb, an application requesting a modification of the existing MRLs for honey was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005.
(4) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. The Commission forwarded the applications, the evaluation reports, and the supporting dossiers to the European Food Safety Authority (the ‘Authority’).
(5) The Authority assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs. It forwarded its reasoned opinions to the applicants, the Commission and the Member States and made them available to the public.
(6) As regards mepiquat, temporary MRLs were set for cultivated fungi by Commission Regulation (EU) 2019/503 and for oyster mushrooms by Commission Regulation (EU) 2019/1791, to be revised considering new information to be submitted by 31 December 2022, to address a cross-contamination that affected untreated cultivated fungi with straw lawfully treated with mepiquat.
(7) An application requesting a modification of the existing temporary MRLs for mepiquat in cultivated fungi and oyster mushrooms was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005.
(8) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, that application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report, and the supporting dossiers to the Authority.
(9) The Authority assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLs. It forwarded its reasoned opinion to the applicant, the Commission and the Member States and made it available to the public.
(10) As regards the modification to the temporary MRL for mepiquat in cultivated fungi requested by the applicant, the Authority assessed the monitoring data provided with the application and those deriving from the Union monitoring programme, which showed that the existing MRL is sufficient to account for the residue uptake in cultivated fungi.
(11) It is therefore appropriate not to modify the existing temporary MRL for mepiquat in cultivated fungi.
(12) As regards the modification to the temporary MRL for mepiquat in oyster mushrooms requested by the applicant, the Authority assessed the monitoring data provided with the application and those deriving from the Union monitoring programme and concluded that further consideration by risk managers was required concerning whether to establish the new MRL at the level of 1 mg/kg, as derived by the Authority based on the 95th percentile of the data population, or at the level of 3 mg/kg, as derived by the Authority based on 95th percentile of the data population at the 95% confidence level.
(13) As pursuant to Commission Regulation (EU) No 283/2013 temporary MRLs proposals based on monitoring data are to cover the 95th percentile of the data population at the 95 % confidence level, it is appropriate to set the temporary MRL for mepiquat in oyster mushrooms at the level of 3 mg/kg.
(14) It is appropriate to continue to monitor the levels of mepiquat in cultivated fungi and oyster mushrooms and to review those MRLs based on monitoring data submitted to the Commission by 31 December 2030.
(15) As regards all the other modifications to MRLs for fenazaquin, mepiquat and propamocarb requested by the applicants, the Authority concluded that all data requirements had been met and that such modifications were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of those substances. Neither the lifetime exposure to those substances via consumption of all food products that may contain them nor the short-term exposure due to high consumption of the relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded.
(16) Based on the opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the proposed modifications to the MRLs are acceptable.
(17) Regulation (EC) No 396/2005 should therefore be amended accordingly.
(18) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,