BAKGRUNN (fra kommisjonsoforodningen)

(1) For the active substances 1,4-dimethylnaphthalene, difluoroacetic acid (DFA), fluopyram and flupyradifurone, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. 

(2) As regards 1,4-dimethylnaphthalene, an application was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRL in potatoes. In addition, the applicant submitted information, previously unavailable during the review of the MRLs for this substance conducted pursuant to Article 12 of Regulation (EC) No 396/2005, on the nature of the residue in processed commodities for potatoes and on analytical methods for products of animal origin. 

(3) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the Member State concerned evaluated that application and forwarded the evaluation report to the Commission. In the evaluation report, the Member State assessed the livestock dietary burden taking into account the livestock intake of commodities produced from potatoes and proposed lowering some of the existing MRLs for 1,4-dimethylnaphthalene in products of animal origin from mammals and raising the MRLs for that substance in ‘commodities from poultry’ and ‘bird eggs’. 

(4) The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report. It examined 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. 

(5) As regards the previously unavailable information submitted by the applicant on the nature of the residue in processed commodities for potatoes and on analytical methods for products of animal origin, the Authority concluded that these data gaps were sufficiently addressed. 

(6) Therefore, for potatoes and products of animal origin, the requirement to submit additional information should be deleted from Annex II to Regulation (EC) No 396/2005. 

(7) As regards the modifications to the MRLs for 1,4-dimethylnaphthalene in potatoes, swine fat, swine others, ‘commodities from bovine’, sheep muscle, sheep fat, sheep liver, sheep edible offals (other than liver and kidney), sheep others, goat muscle, goat fat, goat liver, goat edible offals (other than liver and kidney), goat others, ‘commodities from equine’, ‘commodities from poultry’, ‘milk’ and ‘bird eggs’ requested by the applicant, 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 the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it 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. 

(8) In its reasoned opinion, the Authority did not recommend specific MRLs for the categories ‘edible offals (other than liver and kidney)’ of the various groups of animal products. 

(9) To ensure that those MRLs are established at a realistic level, it is appropriate to set them at the highest MRL applicable to one of the products within that same product group. 

(10) In its reasoned opinion, the Authority did not recommend specific MRLs for the group ‘commodities from other farmed terrestrial animals’. 

(11) Since those MRLs are usually set at the same values as for the ruminant species group with the lowest MRLs, it is appropriate to set those MRLs at the same level as the MRLs for the group ‘commodities from bovine’.

(12) As regards fluopyram, an application was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRL for fluopyram in pumpkin seeds. 

(13) For that application, a Member State made a request to use the fast-track procedure, provided for in the Technical Guidelines on the MRL setting procedure, to set an MRL based on residue trials on rapeseeds/canola seeds. 

(14) The Authority assessed residue trials on rapeseeds/canola seeds in the framework of the review of the existing MRLs for fluopyram and gave a reasoned opinion on the proposed MRL. That opinion relies on the current scientific and technical knowledge on the subject. As it is appropriate to extrapolate from the residue trials on rapeseeds/canola seeds to pumpkin seeds, in line with the Technical Guidelines on extrapolation of MRL, it is unnecessary to request the Authority to provide a reasoned opinion on pumpkin seeds specifically. 

(15) It is therefore appropriate to set the MRL for fluopyram in pumpkin seeds at 0,4 mg/kg on the basis of the residue trials performed on rapeseeds/canola seeds. 

(16) As regards DFA and flupyradifurone, two applications were submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs for ‘citrus fruits’, cherries (sweet), ‘cane fruits’, ‘other small fruits and berries’, ‘leafy brassica’, ‘herbs and edible flowers’, sunflower seeds, barley, maize/corn, common millet/proso millet, oat, rye, wheat, sugar beet roots, chicory roots and honey. Those applications also requested setting import tolerances for those substances used in Australia, Brazil and the United States on other citrus fruits, macadamias, ‘stone fruits’, avocados, mangoes, papayas, asparagus, sesame seeds, sunflower seeds, barley, maize/corn, common millet/proso millet, oat, rye and wheat pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005. The applicants provided data showing that the uses of DFA and flupyradifurone on those crops that are authorised in Australia, Brazil and the United States lead to residues exceeding the MRLs set in Regulation (EC) No 396/2005 and that higher MRLs are needed to avoid trade barriers when importing these crops. 

(17) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the Member States concerned evaluated those applications and forwarded the evaluation reports to the Commission. In the evaluation report, the Member State assessed the livestock dietary burden taking into account the livestock intake of commodities produced from those crops and proposed raising some of the existing MRLs for DFA and flupyradifurone in products of animal origin. 

(18) 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 its reasoned opinions to the applicants, the Commission and the Member States and made them available to the public. 

(19) In its reasoned opinion, the Authority concluded that the data submitted by the applicants concerning flupyradifurone and DFA in grapefruit and oranges were insufficient to set new MRLs. Concerning flupyradifurone in lemons, limes, mandarins, macadamias, blueberries, ‘cane fruits’, avocados, asparagus, barley, maize/corn, wheat, sugar beet roots, and chicory roots and for DFA in grapefruit, oranges, blackberries, raspberries, ‘other small fruits and berries’, ‘herbs and edible flowers’, barley, common millet/proso millet, wheat and honey, the Authority concluded that the existing MRL values do not need to be changed. 

(20) As regards DFA in rotational crops, the Authority concluded that further consideration by risk managers was required concerning the need to set MRLs taking into consideration not only the direct treatment on those crops but also residues expected to be taken up via roots. As studies show that in rotational crops the uptake of residues of DFA from soil, stemming from preceding crops, cannot be fully avoided, it is appropriate to set MRLs that are reflecting both direct treatment and such uptake of residues from soil. This is relevant for Chinese cabbages/pe-tsai, kales, ‘leafy brassica, others’, sesame seeds, sunflower seeds, maize/corn, oat, rye, sugar beet roots and chicory roots. 

(21) As regards flupyradifurone in kales, the Authority concluded that further consideration by risk managers was required concerning the possibility to lower the existing MRL, in accordance with the applicant request, based on the new residue trials submitted. As the new residue trials provided for flupyradifurone in kales are based on the same Good Agricultural Practices as the existing MRL, it is appropriate to lower the MRL from 5 mg/kg to 4 mg/kg based on the most recent and complete data provided. 

(22) As regards flupyradifurone in sunflower seeds, the Authority concluded that further consideration by risk managers was required concerning whether to establish the new MRL at the level of 0,8 mg/kg, as derived by the Authority based on the assessment of the residue trials on sunflower seeds submitted by the United States, or at the MRL of 0,7 mg/kg, which is in force in the exporting country, the United States. 

(23) In accordance with the Technical Guidelines on the MRL setting procedure, an MRL established in the framework of an import tolerance application should not exceed the one approved in the exporting country. 

(24) Therefore, it is appropriate to set the MRL at the level established in United States (0,7 mg/kg). 

(25) As regards the modifications to the MRLs for DFA in lemons, limes, mandarins, ‘citrus fruits, others’, macadamias, ‘stone fruits’, ‘cane fruits’, avocados, mangoes, papayas, “leafy brassica”, asparagus, sesame seeds, sunflower seeds, maize/corn, oat, rye, sugar beet roots, chicory roots, swine fat, swine liver, sheep fat, goat fat, and poultry fat and for flupyradifurone in ‘citrus fruits, others’, ‘stone fruits’, ‘cane fruits’, ‘other small fruits and berries’ (except blueberries), mangoes, papayas, ‘leafy brassica’, ‘herbs and edible flowers’, sesame seeds, sunflower seeds, common millet/proso millet, oat, rye, ‘commodities from swine’ (except swine muscle), and honey requested by the applicants, the Authority concluded that all the data requirements had been met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them nor the short-term exposure due to high consumption of relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded. 

(26) Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of that article. 

(27) In addition, due to a clerical mistake, the MRL for DFA in ‘herbal infusions from any other parts of the plant’ was deleted by Commission Regulation (EU) 2021/1842. Therefore, it is appropriate to correct Annex II to Regulation (EC) No 396/2005 by reinstating the previously established MRL for DFA in ‘herbal infusions from any other parts of the plant’ at the level of 0,1 mg/kg. 

(28) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. 

(29) Regulation (EC) No 396/2005 should therefore be amended and corrected accordingly. 

(30) For all active substances covered by this Regulation, in order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been placed on the market in the Union before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. 

(31) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which result from the amendments. 

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