EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11316/2021  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for abamectin in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for abamectin 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/EEC1, and in particular 
Article  14(1)(a)  and Article 49(2) thereof,  
Whereas:  
(1) For abamectin , maximum residue levels ( MRLs ) were set in Annex II to Regulation 
(EC) No 396/2005 .  
(2) During the review of those MRLs in accordance with Article 12 of Regulation (EC) 
No 396/2005, the European Food Safety Authority ("the Authority") , identified  in its 
reasoned opinion2 some information as unavailable for certain products. The available 
information was sufficient for the Authority to propose MRLs that are safe for 
consumers and the data gaps were indicated in Annex II of that Regulation specifying 
the date by which the missing information was to be submitted to the Authority in 
support of the proposed MRLs .  
(3) The applicant submitted the missing data together  with a request based on Article 6 of 
Regulation (EC) 396/2005  to modify the existing MRLs for abamectin in certain 
products.    
(4) In accordance with Article 8 of Regulation (EC) No 396/2005, the application  was 
evaluated by the Member State  conc erned and the evaluation report  was forwarded to 
the Commission.  
(5) The Aut hority assessed the application  and the evaluation report, examining in 
particular risks to consumers and, where relevant, to animals.  
(6) On 23 January 2020 , the Authority published a reason ed opinion on  the e valuation of 
the confirmatory data submitted followi ng the MRL review under Article 12  of 
                                                 
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 (MRLs) for abamectin according to Article 12 of Regulation (EC) No 396/2005 . EFSA Journal 
2014;12(9):3823 .  
EN 2  EN Regulation (EC) No  396/2005  and on the  request to  modif y the existing maximum 
residue levels for abamectin in various commodities3.  
(7) For almo nds, hazelnuts/cobnuts, walnuts , currants (black, red and white), gooseberries 
(green, red and yellow), papayas and  witloofs/Belgian endives  information concerning 
residue trials was not submitted by the applicant . The Authority concluded that  the 
data gap was thus not sufficiently addressed  and that risk managers may co nsider 
setting or keeping those MRLs at the limit of determination (LOD). Therefore, for 
these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 
396/2005 at the LOD . It is therefore appropriate to amend the Anne x II and to delet e 
the reference  concerning additional information from that Annex.  
(8) For quinces, medlars, loquats/Japanese medlars, the applicant proposed to derive an 
MRL based on an alternative Good Agricultural Practices (GAP ). This use and the 
residue trials were already assessed  in a previous reasoned opinion4. The Authority 
concluded that the residue data were sufficient to support lower MRL proposals for 
those products. Therefore, for those products, MRLs in Annex II to Regulation (EC) 
No 396/2005 should be set at the level identified by the Authority.  
(9) For celery leaves, beans with pods and peas with pods, Authority concluded that 
residue data were sufficient to support the MRL for those products. Therefore, for 
these products, MRLs should be set in Annex II to R egulation (EC) No 396/2005 at 
the level requested by the applicant.  
(10) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 applications 
for import tolerances were submitted for abamectin used in the United States on  
certain products.  
(11) The ap plicant state s that the authorised uses of abamectin on such crops in th at countr y 
lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and 
that higher MRLs are necessary to avoid trade barriers for the importation of those 
crops.  
(12) In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were 
evaluated by the Member State concerned and the evaluation report was forwarded to 
the Commission.  
(13) The Authority assessed the applications and the evaluation report, examin ing in 
particula r risks  to consumer s and, where relevant, to animals .  
(14) On 10 July 2020, the Auth ority published a reason ed opinion on setting of import 
tolerances for abamectin in various crops5.  
(15) As regards modifications to MRLs requested by the applicant for avocados, cresses 
and other sprouts and shoot, land cresses, Roman rocket/rucola, baby leaf crops 
(including brassica species), o ther lettuces and salad plants, purslanes, Florence 
fennels and  cotton seeds, the Authority concluded, that all requirements with respect to 
completeness of data submission were met and that the modifications to the MRLs 
requested by the applicant were acceptable with regard to consumer safety on the basis 
                                                 
3 European Food Safety Authority; Reasoned opinion on evaluation of confirmatory data following the 
Article 12  MRL review and modification of the existing maximum r esidue levels for abamectin in 
various commodities . EFSA Jour nal 2020;18(1 ):5989 . 
4  European Food Safety Authority ; Reasoned opinion on the modification of the existing MRLs 
forabamectin in various crops. EFSA Journal 2015;13(7):4189 . 
5 European Food Safety Authority; Reasoned opinion on setting of import tolerance s for abamectin in 
various crops . EFSA Journal 2020;18(7):6173 .  
EN 3  EN of a consum er exposure assessment for 27 specific European consumer groups. The 
Authority took into account the most recent information on the toxicological 
properties of the substance. Neither the lifetime exposure to the substance via 
consumption of all food produc ts that may contain them, nor the short -term exposure 
due to high consumption of the relevant products showed that there is a risk that the 
acceptable daily intake or the acute reference dose is exceeded.  Therefore, for these 
products, MRLs should be set i n Annex  II to Regulation (EC) No 396/2005 at the level 
requested by the applicant.   
(16) In the context of the procedure for the renewal of the approval of th e active substance  
abamectin  in accordance with Regulation (EC) No 1107/2009 of the Europea n 
Parliament  and of the Council6, the Authority published a conclusion on the peer 
review of the risk asse ssment7 of that active substance . The Authority  proposed , based 
on the developmental neurotoxicity studie s, that a lower acceptable daily intake (ADI) 
and acute r eference dose (ARfD)  should be established .   
(17) On  3 February 2021  and i n accordance with Article 43 of Regulation (EC) No 
396/2005, the Commission requested the Authority to provide a reasoned opinion 
assessing the risks  on certain  existing  MRLs for abamectin  that may pose to 
consumers in light of th e lower ADI and ARfD.   
(18) On 6 October 2021 , the Authority published a reasoned opinion on the focussed 
assessment of certain existing maximum residues levels of concern for abamectin8.  
(19) For apples, pears  and escaroles/broad -leaved endives , the Authority identified 
unacceptable risks concerning the current MRLs . Member States were consulted and 
requested to report potential fall -back GAPs which would lead to safe MRLs for 
consumers.  For apples and pears,  a fall-back GAP could not proposed by the Member 
States.  Supporting data w as not available for the GAP reported for escaroles/broad -
leaved endives. Therefore, no MRL could be derived for apples, pears and 
escaroles/broad -leaved endives. Therefore, for these pro ducts, it is appropriate to set 
the MRLs in Annex II to Regulat ion (EC) No  396/2005 at the LOD.  
(20) For strawberries,  tomatoes, cucumbers, courgettes, lamb's lettuces/corn salads, 
lettuces, chervil and parsley , the Authority identified unacceptable risks concerning 
the current MRLs. Member States were consulted and requested to report potential 
fall-back GAPs which would lead to safe MRLs for consumers.  Member States 
identified such GAP s for strawberries, tomatoe s, cucumbers, courgettes, lamb's 
lettuces/corn salads, lettuces, chervil and parsley. The Authority therefore 
recommended lowering the MRLs for those products. Therefore, for these products, 
MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level 
identified by the Authority.  
(21) For sweet peppers/bell peppers,  the Authority identified unacceptable risks  for 
consumers  with the current MRLs. Member States were consulted and requested to 
report potential fall-back  GAPs  which would lead to safe MRLs for consumers . The 
Authority concluded that although Member States identified a fall -back GAP for sweet 
                                                 
6 Regulation (EC) No 1107/2009 of the European Parliament and of the Council  concerning the placing 
of plant protection products on the market and repealing Council Directives 79/117/EEC and 
91/414/EEC  (OJ L 309 24.11.2009, p. 1) . 
7 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance abamectin. EFSA Journal 2020;18(8):6227 . 
8 European Food Safety Authority; Focused assessment of certain existing MRLs of concern for 
abamectin. EFSA Journal 2021;19(10):6842 .  
EN 4  EN peppers/bell peppers, some information was not available and that further 
consideration by risk managers was required. As there is no risk for cons umers, the 
MRLs for sweet peppers/bell peppers should be set in  Annex II to Regulation (EC) 
No 396/2005 at the level identified by the Authority. This MRL will be reviewed; the 
review will take into account the information available within two years from t he 
publication of this Regulation.  
(22) The Commission consulted the European Union reference laboratories for residues of 
pesticides on the need to adapt certain LOD s. For abamectin,  those laboratories 
proposed product specific LODs that are analytically feasible . 
(23) 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.  
(24) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(25) In order to allow for the  normal marketing, processing and consumption of products, 
this Regulation should not apply to products which have been produced in the Union 
or imported into the Union  before the modifi ed MRLs  start applying and for which 
information shows that a high lev el of consumer protection is maintained . This is the 
case for all products  except for apples, pears, strawberries, tomatoes, sweet 
peppers/bell peppers, cucumbers, courgettes, lamb's lettuces/corn salads, lettuces, 
escaroles/broad -leaved endives, chervil a nd parsley . 
(26) 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 adapt  themselves to meet the new requirements which will result from th e 
modification of the MRLs.  
(27) 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 accordance with the Annex to this 
Regulation.  
Article 2 
As regards active substance  abamectin in and on all products  except apples, pears , 
strawberries, tomatoes, sweet peppers/bell peppers , cucumbers, courgettes,  lamb's 
lettuces/corn salads, l ettuces, escaroles/broad -leaved endives , chervil and parsley , 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 U nion or imported into the U nion before  [Office of 
Publications: 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 fr om [Office of Publication: please insert date 6 months after entry into force] .  
EN 5  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
The President  
Ursula VON DER LEYEN