EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10617/2018 Rev. 1 
[…](2018) XXX  draft 
 
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annex II to Regulatio n (EC) No 396/2005 of the Europea n Parliament and of 
the Council as regards maximum res idue levels for acetamiprid i n certain products 
(Text with EEA relevance) 
  
EN 2  EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the Europea n Parliament and of 
the Council as regards maximum re sidue levels for acetamiprid i n 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 Pa rliament and of the 
Council of 23 February 2005 on maximum residue levels of pestic ides in or on food and feed 
of plant and animal origin and amending Council Directive 91/41 4/EEC1, and in particular 
Article 14(1)(a) thereof, 
Whereas: (1) For acetamiprid, maximum residue levels (MRLs) were set in Anne x II to Regulation 
(EC) No 396/2005.  
(2) In the context of a procedure for the authorisation of the use of a plant protection 
product containing the active substance acetamiprid on table ol ives and olives for oil 
production, an application was submitted in accordance with Art icle 6(1) of 
Regulation (EC) No 396/2005 for mod ification of the existing MR Ls. 
(3) Such an application was also subm itted for the use of acetamipr id on barley and oat.  
(4) In accordance with Article 8 of Regulation (EC) No 396/2005, th ose applications were 
evaluated by the Member States concerned and the evaluation rep orts were forwarded 
to the Commission. 
(5) The European Food Safety Authority ('the Authority') assessed t he applications and 
the evaluation report s, examining in particular the risks to th e consumer and, where 
relevant, to animals and gave a reasoned opinion on the propose d MRLs
2. The 
Authority forwarded that opinion to the applicant, the Commissi on and the Member 
States and made it available to the public. 
(6) The Authority concluded in its r easoned opinion that all requir ements with respect to 
data were met and that the modifications to the MRLs requested by the applicant were 
acceptable with regard to consumer safety on the basis of a con sumer exposure 
assessment for 27 specific European consumer groups. The Author ity took into 
account the most recent information on the toxicological proper ties of the substances. 
Neither the lifetime exposure to these substances via consumpti on of all food products 
                                                 
1 OJ L 70, 16.3.2005, p. 1. 
2 EFSA scientific reports available online: http://www.efsa.europa.eu : 
Reasoned opinion on the focussed assessment of certain existing  MRLs of concern for acetamiprid and 
modification of the existing MRLs for table olives, olives for oil production, barley and oats. EFSA 
Journal 2018;16(5):5262.  
EN 3  EN that may contain them, nor the short-term exposure due to high consumption of the 
r e l e v a n t  p r o d u c t s  s h o w e d  t h a t  t h e r e  i s  a  r i s k  t h a t  t h e  a c c e p t a b le daily intake or the 
acute reference dose is exceeded. 
(7) In the context of the procedure for the renewal of the approval  of the active substance 
acetamiprid in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council3, the Authority submitted a conclusion on the peer 
review of the pesticide risk ass essment concerning that active substance4, where new 
toxicological endpoints were proposed . These endpoints were agreed by the Standing 
Committee on Plants, Animals, Food and Feed on 13 December 20175.  
(8) In accordance with Article 43 of Regulation (EC) No 396/2005, t he Commission 
requested the Authority to assess the risks the current MRLs fo r acetamiprid may pose 
to consumers in the light of the  lower acute reference dose (AR fD). 
(9) The Authority identified in its reasoned opinion6 consumer intake concerns for apples, 
pears, peaches, head cabbages, Chinese cabbages, kales, lettuce s, escaroles, spinaches, 
purslanes, chards and celeries. Member States were consulted to  report potential fall-
back Good Agricultural Practices (GAPs) that would not lead to an unacceptable risk 
for consumers. Member States identified fall-back GAPs for all concerned products 
except for Chinese cabbages, kales and celeries, for which the MRLs should be set at 
the relevant limit of determination. 
(10) Through the World Trade Organisation, the trading partners of t he Union were 
consulted on the new MRLs and their  comments have been taken in to account. 
(11) Regulation (EC) No 396/2005 should therefore be amended accordi ngly. 
(12) A reasonable period should be allowed to elapse before the modi fied MRLs become 
applicable in order to permit Member States, third countries an d food business 
operators to prepare themselves to meet the new requirements wh ich will result from 
the modification of the MRLs. 
(13) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex II to Regulation (EC) No 396/2005 is amended in accordanc e with the Annex to this 
Regulation. 
                                                 
3 Regulation (EC) No 1107/2009 of the European Parliament and of  the Council of 21 October 2009 
concerning the placing of plant protection products on the mark et and repealing Council 
Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
4 Conclusion on the peer review of the pesticide risk assessment  of the active substa nce acetamiprid.  
EFSA Journal 2016;14(11):4610. 
5 Review report for the active s ubstance acetamiprid (SANTE/1050 2/2017 Rev. 4). 
6 Reasoned opinion on the focussed assessment of certain existin g MRLs of concern for acetamiprid and 
modification of the existing MRLs for table olives, olives for oil production, barley and oats. EFSA 
Journal 2018;16(5):5262.  
EN 4  EN Article 2 
This Regulation shall enter into force on the twentieth day fol lowing 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].   
However, for acetamiprid in olives for oil production, table ol ives, barley and oat, it shall 
apply from [Office of Publication: please insert date of entry into force] . 
This Regulation shall be binding i n its entirety and directly a pplicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President   Jean-Claude JUNCKER