EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11228/2017 Rev. 1  
[…](2017) 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 
lambda -cyhalothrin in or on certain products  
(Text with EEA relevance)   EN 2  EN 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 
lambda -cyhalothrin in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Havi ng regard to Regulation (EC) No 396/2005 of the European Parl iament and of the 
Council of 23 February 2005 on maximum residue levels of pesticides in or on fo od and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and in pa rticular 
Article  14(1)(a)  and Article 49(2) thereof,   
Whereas:  
(1) For lambda -cyhalothrin  maximum residue levels (MRLs) were set in Part B of 
Annex III to Regulation (E C) No 396/2005.  
(2) For lambda -cyhalothrin  the European Food Safety Authority, (the Authority ), 
submitted a reasoned opinion on the review of the existing MRLs in accordance with 
Article 12of Regulation (EC) No 396/2005  in conjunction with Article  12(1) 
thereo f2. The Authority subsequently submitted a conclusion on the peer review of 
lambda -cyhalothrin3, in which the analytical endpoints of the substanc e were 
updated. In accordance with Article 43 of Regulation (EC) No 396/2005 the 
Commission requested the Auth ority  to revise the assessment of  lambda -cyhalothrin  
taking into account the new endpoints . On 2 December 2015, the Authority 
submitted a  reasoned opinion on the revision of the review of the existing MRLs for 
lambda -cyhalothrin4. The residue definition  of lambda -cyhalothrin covers also t he 
substance gamma -cyhalothrin . The Commission asked the Authority , in accordance 
with Article 43 of Regulation (EC) No 396/2005,  to review the MRLs for lambda -
cyhalothrin, taking into account also the possible uses of gamm a-cyhalothrin. On 26 
July 2017 t he Authority submitted a reasoned opinion on the f ocused review on the 
existing MRLs  for lambda -cyhalothrin  in light of the unspecific residue definition5.  
                                                 
1 OJ L 070, 16.3.2005, p. 1.  
2 European Food Safety Authority, 2014. Reasoned opinion on the review of the existing maximum 
residue levels   (MRLs) for lambda -cyhalothrin according to Article 12 of   Regulation (EC) No 
396/2005. EFSA Journal 2014;12(1):3546.  
3 European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment 
of the active substance lambda -cyhalothrin. EFSA Journal 2014;12(5):3677.  
4  EFSA (European Food Safety Authority), 2015.  Reasoned opinion on the revision of the review of the 
existing maximum residue levels for lambda -cyhalothrin. EFSA Journal  2015;13(12):4324.  
5 EFSA (European Food Safety Authority), 2017 . Reasoned opinion on the focused review of the existing 
maximum residu e levels for lambda -cyhalothrin in light of the unspecific residue definition and the 
existing good agricultural practices for the substance gamma -cyhalothrin. EFSA journal 
2017;15(7):4930.  EN 3  EN (3) The Authority proposed to change the residue definition for all pro ducts . It identified 
a risk for consumers concerning the  MRLs for kale and rice . It is therefore 
appropriate to lower these MRLs. The Authority  concluded that concerning the 
MRLs for peaches, apricots, cane fruit, other small fruits and berries, bananas, 
onions, shallots, cucumbers, escarole  (broad -leaf endive), cress, land cress, rocket, 
leaves and sprouts of Brassica spp ., fresh herbs, Chinese cabbages, leeks, oats, hops, 
spices and commodities with high acid content 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 . The 
Authority  also concluded that concerning the MRLs for sunflower seeds, soya beans 
and tea no information was available and that further consideration by risk managers 
was required. The MRLs for these products should be set at the specific limit of 
determination  or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) 
No 396/2005 . 
(4) 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 s hould  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.  
(5) The Commission consulted the European Union reference laboratories for residues of 
pesticide s 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 sp ecific limits of determination.  
(6) Based on the reasoned o pinions 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.  
(7) 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.  
(8) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(9) 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.  
(10) A reasonable perio d 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.  
(11) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee on Plants, Animals, Food and Feed , EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes I I and III  to Regulation (EC) No 396/2005 are amended in accordance w ith the 
Annex to this Regulation.  
Article 2  
As regards the active substance  lambda -cyhalothrin  in and on all products except kale and rice  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products w hich were produced before [ Office of Publication please insert 
date 6 months after entry into force of this Regulation ]. 
 
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 [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 Pre sident  
Jean -Claude JUNCKER