5.8.2022
EN
Official Journal of the European Union
L 205/209
(10)
For fluroxypyr, such information concerning analytical methods, storage stability, pre-harvest interval and residue trials for apples and onions was submitted by the applicant.
Additional information on the analytical method used in the residue trials for thyme was also submitted by the applicant.
The Authority concluded that these data gaps were sufficiently addressed (10), (11).
Therefore, for these products, the MRLs in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority and the requirement to submit additional information should be deleted from that Annex.
The Authority concluded that the data gap concerning the analytical method for garlics and shallots has been addressed, however for leeks, cereals, herbal infusions from flowers and sugar canes it has not been addressed and that further risk management consideration is needed.
It also concluded that the data gaps concerning storage stability and metabolism for swine (muscle, fat, liver, kidney, edible offals), bovine (muscle, fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, goat, horse) were only partially addressed and that further risk management consideration is needed.
In the Final Review report (12) for this substance, it was concluded that the available data was sufficient to also address these data gaps.
Therefore, for these products, MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex.
(11)
For iprovalicarb, such information concerning crop metabolism on lettuces, escaroles/broad-leaved endives and roman rocket/rucola was not submitted and the Authority concluded that the data gap previously identified was thus not addressed (13) and that risk managers may consider replacing those MRLs with the LOD.
Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the specific LOD and to delete the requirement to submit additional information from that Annex.
(12)
For silthiofam, such information concerning analytical methods for barley, rye and wheat was submitted by the applicant and the Authority concluded that this data gap was sufficiently addressed (14).
Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirements to submit additional information should be deleted from that Annex.
(13)
The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs.
Those laboratories concluded that for certain products technical development permits the setting of lower LODs.
(14)
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.
(15)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(16)
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional measure for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.
(17)
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 will result from the modification of the MRLs.
(10) European Food Safety Authority; Evaluation of confirmatory data following the Article 12 MRL review for fluroxypyr.
EFSA Journal 2019;17(9):5816.
(11) European Food Safety Authority; Modification of the existing maximum residue levels for fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers.
EFSA Journal 2020;18(10):6273.
(12) SANCO/11019/2011 rev.5, ‘Final Review report for the active substance fluroxypyr finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 17 June 2011 in view of the approval of fluroxypyr as active substance in accordance with Regulation (EC) No 1107/2009’, 23 March 2017, https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/activesubstances/?event=as.details&as_id=734 (13) European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-D, fenhexamid and iprovalicarb.
EFSA Journal 2021;19(10):6910.
(14) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance silthiofam.
EFSA Journal 2016;14(8):4574.