BAKGRUNN (fra kommisjonsforordningen)

(1) For the active substance flonicamid, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For the active substances clopyralid and difenoconazole, MRLs were set in Part A of Annex III to that Regulation. For chitosan, fat distillation residues, hydrolysed proteins, and lavandulyl senecioate no specific MRLs were set, nor were those substances included in Annex IV to that Regulation, so the default value laid down in Article 18(1), point (b), thereof applies. 

(2) As regards clopyralid, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for honey and other apiculture products. As regards difenoconazole, such an application was submitted for rye and wheat. As regards flonicamid, such an application was submitted for potatoes, lettuces and salad plants, spinaches and similar leaves, beans (without pods), cardoons, celeries, Florence fennels and rhubarbs. 

(3) 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’). 

(4) 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.

(5) As regards the MRLs for difenoconazole in wheat and rye, the Authority concluded that further consideration by risk managers was required as the overall chronic exposure was considered provisional pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and animals and the impact of isomerisation on the toxicity of difenoconazole. Since wheat and rye are minor contributors to the overall chronic exposure, and as the Authority confirmed that exceedances are not to be expected even assuming a possible shift in the ratio of its isomers, it is appropriate to establish the new MRL for difenoconazole in wheat and rye at the level of 0.1 mg/kg proposed by the Authority. 

(6) As regards all the other proposed modifications to MRLs for clopyralid, difenoconazole and flonicamid 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. 

(7) 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. 

(8) Chitosan is approved as a basic substance by Commission Implementing Regulation (EU) 2022/456. Fat distillation residues and hydrolysed proteins have been renewed as low-risk active substances by Commission Implementing Regulations (EU) 2023/1755 and 2024/821, respectively. Lavandulyl senecioate has been approved as a low-risk active substance by Commission Implementing Regulation (EU) 2020/646 The conditions of use of those substances are not expected to lead to the presence of residues in food or feed commodities that may pose a risk to the consumer and, therefore, no MRLs are required. It is therefore appropriate to include those substances in Annex IV to Regulation (EC) No 396/2005. 

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

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