EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10552/2021 Rev. 3  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for methoxyfenozide, 
propoxur, spinosad and thiram in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for methoxyfenozide, 
propoxur, spinosad and thiram 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) , Article 18(1)(b ) and Article 49(2) thereof,  
Whereas:  
(1) For methoxyfenozide and spinosad, maximum residue levels ( MRLs ) were set in 
Annex II to Regulation (EC) No 396/2005. For propoxur and thiram , MRLs were set , 
in Annex II and Part B of Annex III  to Regulation (EC) No 396/2005 , depending on 
the product.   
(2) For methoxyfenozide , in the context of the  procedure for the  renewal of the approval 
of that active substance in accordance with Regulation (EC) No 1107/2009  of the 
European Parliament and of the Council2, the European Food Safety Authority  (‘the 
Authority ’) published a conclusion on the peer review of  the risk assessment of  that 
active substance3, confirming the existing acceptable daily intake (ADI)  and 
establishing a lower acute reference dose ( ARfD).   
(3) In accordance with Article 43 of Regulation (EC) No  396/2005, the Commission 
requested the Authority  to provide a reasoned opinion,  assess ing the risks that the 
current MRLs for methoxyfenozide  may pose to consumers , in light of the above -
mentioned lower  ARfD.  
(4) In its reasoned opinion4, the  Authority identified  unacceptable risks concerning the 
current MRLs  for oranges, grapefruits, mandarins, pears, peaches, apples, tomatoes 
and broccoli . Member States were consulted  and requested  to report potential fall -back 
Good Agricultural Practices (GAPs) that would not lead to an unacceptable risk for 
consumers. Member States identified  such a fall-back  GAP  only for tomatoes. The 
Authority then performed an exposure calculation considering t he residue data of the 
                                                 
1 OJ L 070, 16.3.2005 , p. 1.  
2  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) . 
3 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of t he 
active substance methoxyfenozide. EFSA Journal 2017;15(9):4978.  
4 European Food Safety Authority; Focused assessment of certain existing MRLs of concern for 
methoxyfenozide. EFSA Journal 2020;18(12):6330.  EN 2  EN fall-back GAP for tomatoes and the peeling factor for citrus fruits  established during 
the peer review of the substance . Notwithstanding that, f or citrus fruits  (oranges, 
grapefruits, mandarins ), the Authority nevertheless explained that the existing MRLs 
are safe w hen using the peeling factor  established during the peer review . For all other 
concerned products , the MRLs should be set at the r elevant limit of determination  
(LOD) . 
(5) For propoxur,  the Commission requested the Authority , in accordance with Article 43 
of Regulation (EC) No 396/2005, to assess toxicological properties, derive 
toxicological reference values and evaluate the existing MRLs , as t he substance was 
never assessed in the EU  and findings were recently reported . In its reasoned opinion5, 
the Authority could not derive EU toxicological reference values  for propoxur  and, 
therefore, could not conclude on the safety of the MRLs for consumers . The Authority 
concluded that further consideration from risk managers was require d. From a risk 
management perspective, in the absence of such data, for all products, a risk for 
consumers cannot be excluded. As uses for this substance are no longer authorised in 
the Union , the MRLs should be set in Annex V  to Regulation (EC) No 396/200 5 at the 
LOD.  
(6) For spinosad, the Authority submitted , in the context of the  procedure for the  renewal 
of ap proval  of that active substance  in accordance with Regulation (EC) 
No 1107/2009, a conclusion on the peer review  of the risk assessment  of that active  
substance6, establishing , for the first time , an ARfD.   
(7) In accordance with Article 43 of Regulation (EC) No  396/2005, the Commission 
requested the Authority to assess the risks that the current MRLs for spinosad  may 
pose to consumers in the light of th at new ARfD.  
(8) The Authority identified in its reasoned opinion7 consumer risks  for sweet peppers/bell 
peppers, lettuces, escaroles/broad -leaved endives, spinaches, chards /beet leaves  and 
witloofs /Belgian endives . Member States were consulted  and requested  to report 
potential fall -back GAPs  that would not lead to an unacceptable risk for consumers. 
Member States identified fall -back GAPs for all  concerned products . The Authority 
therefore recommended lowering the MRLs for those products. For those products 
MRLs should be set at the level identified by the Authority.  
(9) For thiram,  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20058. Thiram  is no longer 
approved in the Union and all authoris ations for  plant protection products containing  
this substance have been revoked. In accordance with Article 17 of Regulation (EC) 
No 396/2005 in conjunction with Article 14(1)(a) thereof, the MRLs set out for thiram 
in Annex II and part B of Annex III to Regulation (EC) No 396/2005 should therefore 
be deleted. The Authority also assessed the existing import tolerances for thiram but , 
in the absence of toxicological data for its metabolite M1,  the Authority  could not 
finalise the consumer risk assessment  and concluded that further consideration by risk 
                                                 
5 European Food Safety Authority; Reasoned opini on on the toxicological properties and maximum 
residue levels for propoxur. EFSA Journal 2021;19(1):6374.  
6 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance spinosad. EFSA Journal 2018;1 6(5):5252.  
7 European Food Safety Authority; Focused assessment of certain existing MRLs of concern for 
spinosad. EFSA Journal 2021;19(2):64 04. 
8 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for thiram according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2021;19(1):6391 . EN 3  EN managers was required . From a risk management perspecti ve, in the absence of such 
data and taking into account the reasons for the non -renewal of the approval of thiram,  
for all products, a risk for consumers cannot be excluded and  MRLs should be set  in 
Annex V to Regulation (EC) No  396/2005 at the LOD .  
(10) 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 l imits 
(‘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.  
(11) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . As regards several substances, 
those laboratories concluded that for certain commodities technical development 
requires the setting of specific LODs . 
(12) 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.  
(13) 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.  
(14) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(15) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should prov ide 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.  
(16) 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.  
(17) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II , III and V  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 produced in the Union or imported into the Union 
before  [Office of Publications: please insert date 6  months after entry into force of this 
Regulation ], except for methoxyfenozide in pear s, peaches, apples and broccoli,  for propoxur 
on all commodities and for thiram on all commodities . 
Article 3  
This Regulation shall enter into force on the twentieth day following that of it s publication in 
the Official Journal of the European Union .  EN 4  EN 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  
Ursula VON DER LEYEN