BAKGRUNN (fra kommisjonsforordningen)

(1) The maximum residue levels (‘MRLs’) for dithianon are set out in Part A of Annex III to Regulation (EC) No 396/2005. 

(2) The Authority has submitted a reasoned opinion on the review of the existing MRLs for dithianon in accordance with Article 12(1) of Regulation (EC) No 396/2005. The Authority noted that the mutagenicity potential of the metabolite 1,4-naphthoquinone remains uncertain, pending the submission of additional studies fulfilling the previously identified data gap. Therefore, the values of the acceptable daily intake (ADI) and acute reference dose (ARfD) of 1,4-naphthoquinone are considered provisional and all MRLs for dithianon above the limits of determination (LODs) require further consideration by risk managers. As the missing data is to be submitted as part of the ongoing procedure for the renewal of the approval of dithianon, the MRLs should be reconsidered and revised by risk managers following the finalisation of that procedure. 

(3) Additionally, the Authority identified an exceedance of the ARfD of dithianon for apples and pears. The Authority consulted the Member States and requested them to report potential fall-back Good Agricultural Practices (GAPs) for apples and pears, authorised in Member States or third countries and already evaluated at Member State level, which would not lead to an unacceptable risk for consumers. Fall-back GAPs for apples and pears were identified that do not lead to exceedances of the ARfD of dithianon. It is therefore appropriate to lower the MRLs for dithianon on apples and pears to the values identified by the Authority in Part A of Annex III to Regulation (EC) No 396/2005.

(4) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs for dithianon. Those laboratories proposed product-specific LODs that are analytically achievable. 

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

(6) Annex III to Regulation (EC) No 396/2005 should therefore be amended accordingly. 

(7) A reasonable period should be allowed to elapse before the new MRLs for dithianon become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs. 

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