EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/961_Rev8  
[…](2024) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for thiacloprid in or 
on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the E uropean 
Parliament and of the Council as regards maximum residue levels for thiacloprid 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) , point (a) and Article 18(1)  thereof , 
Whereas:  
(1) For the active substance thiacloprid , maximum residue levels ( ‘MRLs ’) were set in 
Annex  II to Regulation (EC) No  396/2005.  The European Food Safety Authority (the 
‘Authority’) reviewed these MRLs in accordance with Article 12 of Regulation (EC) 
No 396/2005  and recommended MRLs which it found to be safe  for consumer s2. 
Commission Regulation (EU) 201 5/12003 included these MRLs in Annex II to 
Regulation (EC) No  396/2005.  
(2) In 2020, t he approval of this active substance was not renewed4 on the basis of 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council5, in 
view of the critical concerns identified by the Authority in the conclusions of the peer 
review  in relation to the contamination of groundwater with potential carcinogenic 
metabolites of thiacloprid6 and its cl assification, in accordance with Regulation (EC) 
No 1272/2008  of the European Parliament and of the Council7, as toxic for 
 
1 OJ L 70, 16.3.2005, p. 1 , http://data.europa.eu/eli/reg/2005/396/2024 -02-26. 
2 EFSA (European Food Safety Authority), 2014. Reasoned opinion on the review of the existing 
maximum residue levels  (MRLs) for thiacloprid according to Article 12 of  Regulation (EC) 
No 396/2005. EFSA Journal 2014;12( 3):3617. 
3 Commission Regulation (EU) 2015/1200 of 22 July 2015 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 amidosulfuron, fenhexamid, kresoxim -methyl, thiacloprid and trifloxystrobin in or on certain 
products  (OJ L 195, 23.7.2015, p. 1 ).  
4 Commission Implementing Regulation (EU) 2020/23 of 13 January 2020 concerning the non -renewal 
of the approval of the active substance thiacloprid, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council concerning the placing of plant protection products on 
the market  and amending the Annex to Commission Implementing Regulation  (OJ L 8, 14.1.2020, p.  8). 
5 Regulation (EC) No 1107/2009 of the Euro pean Parliament and of the Council of 21 October 2009 
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 ). 
6 EFSA (European Food Safety Authority), 201 9. Conclusion on pesticides peer review .  Peer review of 
the pesticide risk assessment of the active substance thiacloprid. EFSA Journal 2019;17(3 ): e05595 .  
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives EN 2  EN reproduction category 1B . Since the substance did not fulfil the approval criteria , the 
Authority did not consider it necessary to finalise the assessment of the possible 
endocrine disrupt ing properties of thiacloprid  on the basis of the most recent  criteria in 
points  3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 . The Authority 
noted, however,  that thiacloprid was considered to meet the criteria for endocrine 
disrupting properties set out in 20138 and the WHO definition for endocrine 
disruptors9, since it causes adverse  effects on the reproductive and endocrine system 
through an endocrine  mode of action.  
(3) All existing authorisations for plant protection products containing thiacloprid  have 
been revoked. It is therefore appropriate to delete the existing MRLs set out for th is 
active substance in Annex II of Regulation (EC) No 396/2005 in accordance with 
Article  17 of that Regulation in conjunctio n with Article  14(1) , point (a) thereof. In 
view of the new toxicological reference values, in particular a lower acute reference 
dose, as proposed in the conclusion of the peer review, the Commiss ion requested the 
Authority to provide a reasoned opinion  under Article 43 of Regulation (EC) No 
396/2005  containing  a short -term (acute) dietary risk  assessment for th e MRLs that are 
based on non -EU uses, being those that are based on import tolerance r equests and 
those that are based on Codex maximum residue limits (‘CXLs’)  set in 2007 .  
(4) In its statement10, the Authority identified a risk for consumers concerning the MRLs 
for peaches and sweet peppers/bell peppers . It is therefore appropriate to lower the 
MRLs for those products to the product -specific limits of determination (‘ LOD s’). For 
the MRLs for papayas  and tea , which  were derived from import tolerances , and for the 
MRLs f or quinces, medlars, loquats/Japanes e medlars, apricots, cherries (sweet), 
plums, strawberries, “cane fruits”, “other small fruits and berries”, kiwis, potatoes, 
tomatoes, aubergines/eggplants, “cucurbits with edible peel”, melons, watermelons, 
rapeseeds/canola seeds, mustards seeds, rice, w heat, “animal (swine, bovine, sheep, 
horse, and other farm animals) products from tissues (muscle, liver, kidney and edible 
offal)”, poultry (muscle, liver and edible offal), milk and eggs , which  are based on  
CXLs , the Authority did not identi fy an acute  risk for the consumers but concluded 
that further consideration by risk managers was required .  
(5) The risk assessment carried out by the Authority was based on  existing  toxicological 
reference values . As these toxicological reference values  were established before the 
most recent  Union  criteria on endocrine disruptors were adopted , the y do not 
necessarily reflect endocrine -related  effects . Furthermore,  endocrine -related effects 
frequently occur at low -dose levels  and endocrine disruptor subs tances often do not 
have a safe threshold11. As a result,  there remain  reasonable grounds for concern that 
the MRLs that are based on non -EU uses have potentially harmful effects on human  
 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, 
p. 1–1355 )  
8 EFSA  (European Food Safety Authority ) Scientific Committee, 2013. Scientific Opinion on the hazard 
assessment of endocrine disruptors: scientific  criteria for identification of endocrine disruptors and 
appropriateness of existing test methods for assessing  effects mediated by these substances on human 
health and the envi ronment. EFSA Journal 2013;11(3):3132,84 . 
9 WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2002. Global 
Assessment of the State -of-the-science of Endocrine Disruptors.  WHO/PCS/EDC/02.2 .  
10 EFSA ( European Food Safety Authority ) 2023 ; Statement on the short -term (acute) dietary risk  
assessment and evaluation of confirmatory data for certain  maximum residue levels (MRLs) for 
thiacloprid . EFSA Journal 2023;21(3):7888 . 
11 EFSA (European Food Safety Authority ) 2010;  Scientific report of the Endocrine Active Substances 
Task Force. EFSA Journal 2010;8(11):1932 . EN 3  EN health  and are inconsistent with the high level of consumer protecti on in the Union . 
The Commission has  therefore  requested the Authority to carry out  an additional  
assessment for thiacloprid  taking into account the most recent criteria for endocrine 
disruptors .  
(6) Pending the conclusion of th is additional risk assessment by the Authority, and given 
the available pertinent information  with regard to  potentially harmful effects on human 
health, it is appropriate to  provisionally  lower the MRLs that are based on non -EU 
uses. These MRLs will be reviewed once the assessment by the Authority is 
concluded .  
(7) The Commission consulted the European Union reference laboratories for residues of 
thiacloprid  as regards the need to adapt certain LODs . Those laboratories proposed 
product specific LODs that are  analytically achievable for all products .  
(8) 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.  
(9) Regulation (EC) No  396/2005 should therefore be amended acco rdingly.  
(10) 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 re quirements 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,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es II and V  to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth day following th at of its publication in 
the Official Journal of the European Union . 
It shall apply from [ Office of Publication s: please insert date 6 months after date of entry into 
force ]. 
This Regulation shall be binding in its entirety and directly applicable in all M ember States.  
Done at Brussels,  
 For the Commission  
The President  
 Ursula VON DER LEYEN