BAKGRUNN (fra kommisjonsforordningen)

(1) For the active substances azoxystrobin, flonicamid, isofetamid, mefentrifluconazole, metazachlor, and pyrimethanil, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. Quartz sand was included temporarily in Annex IV to that Regulation. 

(2) As regards azoxystrobin, an application requesting a modification of the existing MRL for hops was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005. As regards flonicamid, such an application was submitted for Chinese cabbages/pe-tsai, kales and kohlrabies. As regards isofetamid, such an application was submitted for lettuces and salad plants (except lettuces). As regards mefentrifluconazole, such an application was submitted for citrus fruits, hazelnuts/cobnuts, pistachios, strawberries, other small fruits and berries, table olives, kaki/Japanese persimmons, other root and tuber vegetables except sugar beets, tomatoes, sweet peppers/bell peppers, aubergines/eggplants, cucurbits with edible peel, cucurbits with inedible peel, flowering brassica, Brussel sprouts, head cabbages, Roman rocket/rucola, baby leaf crops, spinaches, herbs and edible flowers, beans (without pods), peas (without pods), cardoons, celeries, Florence fennels, globe artichokes, rhubarbs, pulses, linseeds, poppy seeds, soyabeans, mustard seeds, gold of pleasure seeds, olives for oil production, hops, swine liver, and swine, others. As regards metazachlor, such an application was submitted for leeks and honey. As regards pyrimethanil, such an application was submitted for table grapes, garlic, and honey. In addition, as regards pyrimethanil, the applicant submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005 on analytical methods for honey.

(3) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. 

(4) The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports. It examined in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs. It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. 

(5) As regards flonicamid in 'leafy brassica, others', as it is appropriate to extrapolate residue data from the residue trials on kales to 'leafy brassica, others', as confirmed by the technical guidelines on extrapolation of MRLs, it is unnecessary to request the Authority to provide a reasoned opinion on those crops specifically. It is therefore appropriate to set the MRL for flonicamid in 'leafy brassica, others' at 0,5 mg/kg on the basis of the residue trials performed on kales. 

(6) As regards mefentrifluconazole in lentils, lupins/lupini beans and ‘pulses, other’, the Authority concluded that further consideration by risk managers was required concerning whether to establish the new MRL at the level of 0,2 mg/kg, as derived by the Authority based on the assessment of the residue trials on dry peas, or at the level of 0,15 mg/kg, as derived by the Authority based on the combined assessment of the residue trials on dry beans and dry peas. As the Authority concluded that both limits would be safe for consumers, and in order to ensure that the proposed MRL reliably covers the uses in accordance with Good Agricultural Practices for peas, it is appropriate to set the MRLs for mefentrifluconazole in lentils, lupins/lupini beans and ‘pulses, other’ at the higher level of 0,2 mg/kg. 

(7) As regards mefentrifluconazole, the Authority concluded that the data submitted by the applicant for hazelnuts, beans and soyabeans were insufficient to set new MRLs. Therefore, no modifications are proposed for those MRLs. 

(8) As regards the previously unavailable information submitted by the applicant on analytical methods for pyrimethanil in honey, the Authority concluded that the new method provided is adequately validated. Therefore, the requirement to submit additional information on analytical methods for pyrimethanil in honey should be deleted from Annex II to Regulation (EC) No 396/2005. 

(9) As regards all the other modifications to MRLs for azoxystrobin, flonicamid, isofetamid, mefentrifluconazole, metazachlor, and pyrimethanil 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 these 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. 

(10) Based on the reasoned opinion 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. 

(11) Quartz sand was temporarily included in Annex IV to Regulation (EC) No 396/2005 pending the finalisation of its evaluation under Council Directive 91/414/EEC4 or Regulation (EC) No 1107/2009 of the European Parliament and of the Council5 , and pending the review of MRLs for that active substance pursuant to Article 12 of Regulation (EU) No 396/2005. In the context of application for renewal of the approval of this active substance under Regulation (EC) No 1107/2009, the Authority issued a conclusion on the peer review of the pesticide risk assessment of quartz sand6 . Based on that conclusion, no MRLs are required for quartz sand. Therefore, it is appropriate to keep this substance in Annex IV to Regulation (EC) No 396/2005 and delete the footnote referring to its temporary inclusion. 

(12) Regulation (EC) No 396/2005 should therefore be amended accordingly. 

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