Nařízení Komise (EU) 2019/90 ze dne 18. ledna 2019, kterým se mění přílohy II, III a V nařízení Evropského parlamentu a Rady (ES) č. 396/2005, pokud jde o maximální limity reziduí pro bromukonazol, karboxin, fenbutatinoxid, fenpyrazamin a pyridaben v některých produktech a na jejich povrchu (Text s významem pro EHP.)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EECOJ L 70, 16.3.2005, p. 1 . , and in particular Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,

Annexes II, III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

OJ L 70, 16.3.2005, p. 1 .

(1) For bromuconazole, carboxin, fenpyrazamine and pyridaben maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. For fenbutatin oxide MRLs were set in Annex II and in Part B of Annex III to that Regulation.

(2) For bromuconazole, the European Food Safety Authority (the Authority) submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for bromuconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(9):4986. . It concluded that concerning the MRLs for rye, wheat, bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney), poultry (muscle, fat, liver), milk (cattle, sheep, goat, horse) and birds eggs, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(3) For carboxin, the Authority submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for carboxin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(10):5019. . It proposed to change the residue definition and concluded that concerning the MRLs for all commodities some information was not available and that further consideration by risk managers was required. As a risk for consumers cannot be excluded, the Authority recommended reducing the MRLs for plant and animal commodities to the relevant limit of determination (LOD). These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(4) For fenbutatin oxide, the Authority submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fenbutatin oxide according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(12):5091. . Commission Implementing Regulation (EU) No 486/2014Commission Implementing Regulation (EU) No 486/2014 of 12 May 2014 withdrawing the approval of the active substance fenbutatin oxide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 138, 13.5.2014, p. 70 ). provides for withdrawing the approval of fenbutatin oxide, as the further confirmatory information for this active substance required by Commission Directive 2011/30/EUCommission Directive 2011/30/EU of 7 March 2011 amending Council Directive 91/414/EEC to include fenbutatin oxide as active substance and amending Commission Decision 2008/934/EC (OJ L 61, 8.3.2011, p. 14 ). has not been submitted.

(5) For fenpyrazamine, the Authority submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fenpyrazamine according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(12):5072, Modification of the existing maximum residue levels for fenpyrazamine in lettuces, salad plants, spinaches and similar leaves. EFSA Journal 2018;16(4):5231. . For apricots, cherries, plums, table grapes, wine grapes, strawberries, blackberries, dewberries, raspberries (red and yellow), blueberries, tomatoes, sweet peppers/bell peppers, aubergines/eggplants, cucumbers, gherkins and courgettes, the Authority recommended keeping the existing MRLs and it recommended increasing the MRL for peaches. The Authority concluded that concerning the MRL for almonds, some information was not available and that further consideration by risk managers was required. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(6) For pyridaben, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for pyridaben according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(11):5054. . It recommended lowering the MRLs for grapefruits, oranges, lemons, limes and mandarins and strawberries and keeping the existing MRLs for cucumbers, gherkins and courgettes. The Authority concluded that concerning the MRLs for apples, pears, quinces, medlars, loquats/Japanese medlars, apricots, peaches, tomatoes, aubergines/eggplants, beans with pods, bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney) and milk (cattle, sheep, goat, horse), some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRLs for plums, table grapes, wine grapes, currants (black, red and white), gooseberries (green, red and yellow) and sweet peppers/bell peppers, no information was available and that further consideration by risk managers was required. The MRLs for these products should be set at the specific LOD.

(7) As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or CXLs exist, MRLs should be set at the specific LOD or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.

(8) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.

(9) Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(10) 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.

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

(12) 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 produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.

(13) 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.

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

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 13 August 2019 .

European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for bromuconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(9):4986.

Article 1 Article 1

Article 2 Article 2

Article 3 Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 13 August 2019 .

European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for carboxin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(10):5019.

European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fenbutatin oxide according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(12):5091.

Commission Implementing Regulation (EU) No 486/2014 of 12 May 2014 withdrawing the approval of the active substance fenbutatin oxide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 138, 13.5.2014, p. 70 ).

Commission Directive 2011/30/EU of 7 March 2011 amending Council Directive 91/414/EEC to include fenbutatin oxide as active substance and amending Commission Decision 2008/934/EC (OJ L 61, 8.3.2011, p. 14 ).

European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for fenpyrazamine according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(12):5072, Modification of the existing maximum residue levels for fenpyrazamine in lettuces, salad plants, spinaches and similar leaves. EFSA Journal 2018;16(4):5231.

European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for pyridaben according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(11):5054.

HAS ADOPTED THIS REGULATION: