EN  EN
EUROPEAN
COMMISSION 
Brussels, XXX
SANTE 2017/10094 Rev. 0 
[…](2016) XXX  draft 
COMMISSION REGULATION (EU) …/… 
of XXX
amending Annexes II and III to Regulation  (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for 2-phenylphenol, 
bensulfuron-methyl, dimethachlor and lufenuron in or on certain products 
(Text with EEA relevance) EN 2   ENCOMMISSION REGULATION (EU) …/… 
ofXXX
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for 2-phenylphenol, 
bensulfuron-methyl, dimethachlor and lufenuron in or on certain products 
(Text with EEA relevance) 
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/EEC
1, and in particular 
Article 14(1)(a) and Article 49(2) thereof,
Whereas:(1) For 2-phenylphenol maximum residue levels (MRLs) were set Annex II to 
Regulation (EC) No 396/2005. For dilmethachlor and lufenuron MRLs were set in Annex II and Part B of Annex III to that Regulation. For bensulfuron-methyl MRLs were not yet set before. 
(2) For 2-phenylphenol the European Food Safety Authority, hereinafter "the Authority", 
submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005
2. It proposed to change the residue 
definition for plant products and recommended lowering the MRLs for pears, for muscle, fat, liver and kidney from swine, bovine and equine, and for milk from cattle and horse. 
(3) For bensulfuron-methyl the Authority submitted a reasoned opinion on the existing 
MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005
3. It 
recommended raising or keeping the existing MRLs. 
(4) For dimethachlor the Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article 12(1) of Regulation (EC) No 396/20054. It recommended 
raising or keeping the existing MRLs. 
(5) For lufenuron the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20055. It proposed to 
1 OJ L 070, 16.3.2005, p. 1. 
2 European Food Safety Authority ; Reasoned opinion on the review of the existing maximum residue 
levels for 2-phenylphenol according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2017;15(1):4696. 
3 European Food Safety Authority ; Reasoned opinion on the review of the existing maximum residue 
levels for bensulfuron-methyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2016;14(10):4596. 
4 European Food Safety Authority ; Reasoned opinion on the review of the existing maximum residue 
levels for dimethachlor according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2016;14(11):4632. EN 3   ENchange the residue definition all products and recommended lowering the MRLs for 
citrus fruits, pome fruits, cherries sweet, plums, table grapes, wine grapes, figs, kaki/Japanese persimmons, kiwi fruits, potatoes, tomatoes, sweet peppers/bell peppers, cucumbers, courgettes and soya bean. For other products it recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for apricot, peaches, strawberries, gherkins, lamb's lettuces/corn salads, lettuces, escaroles/broad leaved endives, cresses and other sprouts and shoots, land cresses, roman rocket/rucola, red mustards, baby leaf crops (including Brassica  species), liver 
and kidney from swine, bovine, sheep, goat, equine and poultry liver, 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 w ill be reviewed; the review will take into 
account the information available within two years from the publication of this Regulation.
(6) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or Codex maximum residue limits (CXLs) exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.
(7) 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. 
(8) 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. 
(9) 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. 
(10) Regulation (EC) No 396/2005 should therefore be amended accordingly. (11) 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. 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. 
(12) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee on Plants, Animals, Food and Feed, 
                          
5 European Food Safety Authority ; Reasoned opinion on the review of the existing maximum residue 
levels for lufenuron according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2017;15(1):4652. EN 4   ENHAS ADOPTED THIS REGULATION: 
Article 1 
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation. 
Article 2 
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were lawfully produced before [ Office of Publications 
please insert date of application of this Regulation ]. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
theOfficial Journal of the European Union .
It shall apply from [Office of Publication: please insert date 6 months after entry into force] .
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President 
Jean-Claude JUNCKER