19.1.2023
EN
Official Journal of the European Union
L 17/57
(6)
As regards azoxystrobin, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for rapeseeds/canola seeds and linseeds.
As regards prosulfocarb, such an application was submitted for herbs and edible flowers.
As regards sedaxane, such an application was submitted for potatoes.
(7)
In accordance with Article 8 of Regulation (EC) No 396/2005, all those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.
(8)
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 (7).
It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public.
(9)
As regards azoxystrobin in linseeds, the Authority concluded that the submitted data was insufficient to modify the existing MRL.
Therefore, it is not appropriate to modify that MRL.
(10)
As regards all other modifications to MRLs requested by the applicants for azoxystrobin, prosulfocarb and sedaxane, the Authority concluded that all requirements with respect to completeness of data submission were 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 shortterm exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.
(11)
As regards prosulfocarb in herbs and edible flowers, the Authority had previously identified, in the framework of the review of the existing MRLs for prosulfocarb according to Article 12 of Regulation (EC) No 396/2005 (8), that some information on residue trials was unavailable.
Therefore, Commission Regulation (EU) No 777/2013 (9) required further residue data to confirm the tentative MRL of 0,05 mg/kg for that active substance in those products.
In the framework of the new application requesting the modification of the MRLs for prosulfocarb in herbs and edible flowers, new uses and new residue trials were submitted and the Authority concluded that these data were sufficient for the uses under consideration and to support a new higher MRL.
Therefore, it is appropriate to modify the MRL and to delete the respective footnote in Regulation (EC) No 396/2005 highlighting the need for additional data.
(12)
Based on the on the scientific report and 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 Article 14(2) of Regulation (EC) No 396/2005.
(13)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(14)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
(7) EFSA scientific reports are available online: http://www.efsa.europa.eu Reasoned Opinion on the modification of the existing maximum residue levels for azoxystrobin in rapeseeds and linseeds.
EFSA Journal 2022;20(1):7051.
Reasoned Opinion on the modification of the existing maximum residue levels for prosulfocarb in herbs and edible flowers.
EFSA Journal 2022;20(5):7334.
Reasoned Opinion on the modification of the existing maximum residue level for sedaxane in potatoes.
EFSA Journal 2022;20 (6):7371.
(8) EFSA scientific reports are available online: http://www.efsa.europa.eu Reasoned Opinion: Review of the existing maximum residue levels (MRLs) for prosulfocarb according to Article 12 of Regulation (EC) No 396/2005.
EFSA Journal 2011; 9(8):2346.
(9) Commission Regulation (EU) No 777/2013 of 12 August 2013 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for clodinafop, clomazone, diuron, ethalfluralin, ioxynil, iprovalicarb, maleic hydrazide, mepanipyrim, metconazole, prosulfocarb and tepraloxydim in or on certain products (OJ L 221, 17.8.2013, p. 1).