EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/961_Rev2  
[…](2023) 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 thiacloprid 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 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)(a) and Article 49 (2) thereof , 
Whereas:  
(1) For thiacloprid , maximum residue levels ( ‘MRLs ’) were set in Annex  II to Regulation 
(EC) No  396/2005.  
(2) According  to Commission Implementing Regulation (EU) 2020/232, the approval of 
the active substance  thiacloprid  was not renewed , following the critical concerns 
identified by the European Food Safety Authority (the ‘Authority’) in relation to the 
contamination of groundwater with metabolites of thiacloprid3. Additionally, 
thiacloprid is classified in accordance with Regulation (EC)  No 1272/2008  of the 
European Parliament and of the Council4 as toxic for reproduction category  1B.  
(3) All authorisations for plant protection products containing  the active substance  
thiacloprid  have been revoked , due to the human  health risk emanating fro m the use of 
thiacloprid and the contamination of groundwater . It is therefore appropriate to delete 
the existing MRLs  based on the good agricultural practices related to those 
authorisations  set for th is substance in Annex II of Regulation (EC) No 396/200 5 in 
accordance with Article  17 of that Regulation in conjunction with Article 14(1)(a) 
thereof .  
(4) In accordance with Article 43 of Regulation (EC) No  396/2005, the Commission 
requested the Authority to provide a reasoned opinion, assessing the risks that the 
 
1 OJ L 70, 16.3.2005, p. 1.  
2 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). 
3 European Food Safety Authority Conclusion on the peer review of the pesticide risk assessment of the 
active substa nce thiacloprid. EFSA Journal 2019;17(3):5595.  
4  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 
67/54 8/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, p. 
1).  
EN 2  EN current MRLs based on import tolerances and Codex MRLs (CXLs) for thiacloprid 
may pose to consu mers considering the most recent consumption data available .  
(5) The Authority concluded that t he MRLs set for thiacloprid residues in papayas  and tea  
were derived from import tolerances , which had been supported by data and are 
considered safe for consumers5. These MRLs should  therefore  be maintained  in 
accordance with Article 3 (2)(g) of Regulation (EC) No 396/2005.  
(6) For thiacloprid residues in quinces, medlars, loquats/Japanese medlars, apricots, 
cherries (sweet), plums, strawberries, cane fruits, other sm all fruits and berries, kiwis, 
potatoes, tomatoes, aubergines/eggplants, cucurbits with edible peel, melons, 
watermelons, rapeseeds/canola seeds, mustards seeds, rice, wheat, animal (swine, 
bovine, sheep, horse, and other farm animals) products from tissue s (muscle, liver, 
kidney and edible offal), poultry (muscle, liver and edible offal), milk and eggs , the 
existing MRLs correspond to the CXL  values and the Authority concluded that are 
considered safe for consumers5; they should therefore also be maintained according to 
the principles of Article 14(2)(e) of Regulation (EC) No  396/2005 .  
(7) The Authority identified a health risk a risk for consumers concerning the MRLs for 
peaches and sweet peppers/bell peppers5. It is therefore appropriate to lower the MRLs 
for those products to the product specific  LOD s. 
(8) For thiacloprid residues based on non-longer  authorised good agricultural practices in 
the EU , it is appropriate to lower the respective MRLs set in Annex II to Regulation 
(EC) No 396/2005 to the  product -specific  limit of determination (‘LOD’)  in 
accordance with Article  14(1)(a)  of Regulation (EC) No 396/2005 , in conjunction with 
Article  17 of that Regulation.  
(9) The Commission consulted the European Union refere nce 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 .  
(10) 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.  
(11) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(12) To allow for the normal marketing, processing and consumption of products, this 
Regulation should not  apply to any products, which have been produced in the Union 
or imported into the Union before the new MRLs become applicable and for which a 
high level of consumer protection is maintained.  This is the case for all products, 
except peaches and sweet peppers/bell peppers.   
(13) 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.   
(14) 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 T HIS REGULATION:  
 
5  European Food Safety Authority Statement on the short -term (acute) dietary risk assessment and 
evaluation of confirmatory data for certain maximum residue leve ls (MRLs) for thiacloprid . EFSA 
Journal 2023;21(3):7888.   
EN 3  EN Article 1  
Annex  II to Regulation (EC) No  396/2005 is 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 whic h were produced in the Union or imported  into the Union 
before [ Office of Publication s: please insert date 6   months after  the date of entry into force  of 
this Regulation ], except for peaches and sweet peppers/bell peppers . 
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 s: please insert date 6 months after the date of entry 
into force  of this  Regulation ]. 
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