EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11226/2021 Rev.01  
[…](2022) 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 clothianidin and 
thiamethoxam 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 European 
Parliament and of the Council as regards maximum residue levels for clothianidin and 
thiamethoxam 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) an d Article 49(2) thereof,  
Whereas:  
(1) For clothianidin and thiamethoxam  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) 
396/20052 and recommended MRLs which it found safe for consumers. Commission 
Regulation (EU) 2016/1563 included these MRLs in Annex II to Regulation (EC) No 
396/2005. Some of these MRLs were based on Codex maximum residue limits 
(CXLs) and  had already been included in Annex II to Regulation (EC) No 396/2005 
through earlier amendments4.  
(2) On 11 July 20155 the Codex Alimentarius Commission (CAC)  adopted a new set 
CXLs for clothianidin and thiamethoxam. As they were found to be safe for 
                                                 
1 OJ L 70, 16.3.2005,  p. 1. 
2 EFSA (European Food Safety Authority), 2014. Reasoned opinion on the review of the existing 
maximum residue levels  (MRLs) for clothianidin and thiamethoxam according to Article 12 of  
Regulation (EC) No 396/2005. EFSA Journal 2014;12(12):3918, 120 pp. doi:10.2903/j.efsa.2014.3918  
3 Commission Regulation (EU) 2016/156 of 18 January 2016 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 boscalid, clothianidin,  thiamethoxam, folpet and tolclofos -methyl in or on certain products, OJ L 31, 
6.2.2016, p.  1.  
4 Commission Regulation (EU) No  441/2012 of 24  May 2012 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 bifenazate, bifenthrin, boscalid, cadusafos, chlorantraniliprole, chlorothalonil, clothianidin, 
cyproconazole, deltamethrin, dicamba, difenoconazole, dinocap, etoxazole, fenpyroximate, 
flubendiamide, fludioxonil, glyp hosate, metalaxyl -M, meptyldinocap, novaluron, thiamethoxam, and 
triazophos in or on certain products , OJ L 135, 25.5.2012, p.  4  
5 ftp://ftp.fao.org/codex/reports/reports_2015/REP1 5_PRe.pdf . Joint FAO/WHO food standards 
programme Codex Alimentarius Commission. Appendices III and IV. Thirty -Eight Session. Geneva, 
Switzerland, 6 -11 July 2015 . 
  
EN 2  EN consumers in the Union6 by the Authority, Commission Regulation (EU) 
No 2017/6717 included them in Regulation (EC) No  396/2 005.  
(3) Clothianidin and thiamethoxam were included in Annex I to Directive 91/414/EEC on 
1 August 2006 and 1 February 2007, respectively, and, therefore, before the entry into 
force of Regulation (EU) No 1107/2009. The most recent risk assessments8,9 for be es 
from the exposure to these substances conducted by the Authority under Regulation 
(EC) No 1107/2009 found that, due to their intrinsic properties, the exposure from 
outdoor use of clothianidin and thiamethoxam leads to unacceptable risks for bees, or 
such risks could not be excluded based on the available data. Therefore, Commission 
Implementing Regulations (EU) 2018/78410 and 2018/78511 restricted, the approval of 
clothianidin and thiamethoxam, respectively, to uses in permanent greenhouses only 
and requi red that the resulting crops stayed within a permanent greenhouse during 
their entire life cycle.  
(4) Following the adoption of these restrictions, all applications for the renewal of the 
approval of the active substances clothianidin and thiamethoxam were wi thdrawn. 
Therefore, the approval of clothianidin expired on 31 January 2019 and the approval 
of thiamethoxam expired on 30  April  2019.  
(5) In the light of the Authority’s risk assessment for bees and of all the available 
pertinent information, there is curren tly no evidence that would allow any outdoor 
uses for clothianidin and thiamethoxam to be considered as safe for bees. Producers of 
the substances can however, at any time, submit additional information, as provided in 
Articles 7 of Regulation (EC) No 1107 /2009, demonstrating the safety for bees of 
outdoor uses of clothianidin and thiamethoxam. That information, if submitted, would 
be reviewed within the time period provided for in that Regulation. To date, no such 
information has been submitted.  
(6) Adverse e ffects of clothianidin and thiamethoxam on bees are directly linked to the 
intrinsic properties of those substances. Therefore,  the risks for bees from outdoor uses 
of these substances are unlikely to be limited to the Union.  
(7) There is a substantial body o f evidence showing that active substances which are 
neonicotinoids, such as clothianidin and thiamethoxam, play an important role in the 
decline of bees and other pollinators worldwide. The Intergovernmental Science -
Policy Platform on Biodiversity and Ecos ystem Services on pollinators, pollination 
                                                 
6 Scientific support for preparing an EU position in the 47th Session of the Codex Committee  on Pesticide 
Residues (CCPR). EFSA Journal 2015;13(7):4208 [178 pp.].  
7 Commission Regulation (EU) 2017/671 of 7 April 2017 amending Annex II to Regulation (EC) No 
396/2005 of the European Parliament and of the Council as regards maximum residue levels fo r 
clothianidin and thiamethoxam in or on certain products (OJ L  97, 8.4.2017, p. 9 ). 
8 European Food Safety Authority; Peer review of the pesticide risk assessment for bees for the active 
substance clothianidin considering the uses as seed treatments and g ranules . EFSA Journal 
2018;16(2):5177.  
9 European Food Safety Authority; Peer review of the pesticide risk assessment for bees for the active 
substance thiamethoxam  considering the uses as seed treatments and granules . EFSA Journal 
2018;16(2):5179 . 
10 Commi ssion Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin  
(OJ L 132, 30.5.2018, p.  35). 
11 Commission Implementing Regulation (EU) 2018/785 of 29 May 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance 
thiamethoxam  (OJ L 132, 30.5.2018, p.  40).  
EN 3  EN and food production concluded in its 2016 assessment report12 that neonicotinoids 
(such as clothianidin and thiamethoxam) have adverse effects on bees and other 
pollinators. The impact of neonicotinoids on wildlife  has been assessed by the 
International Union for Conservation of Nature (IUCN) Task Force on Systemic 
Pesticides since 2012. The Worldwide Integrated Assessment of the Impact of 
Systemic Pesticides on Biodiversity and Ecosystems (WIA) has examined 1,121 
scientific studies and results indicate that pollinator populations are highly vulnerable 
to the existing levels of pollution with neonicotinoids and are likely to have large -scale 
and wide ranging negative biological and ecological impacts13. A recent revie w of the 
existing scientific knowledge corroborated this conclusion indicating that 
neonicotinoid use is driving the decline of pollinator population in different world 
regions14.  
(8) Since the ban on outdoor uses of clothianidin and thiamethoxam in the Union,  several 
countries outside the Union have also restricted the use of clothianidin and 
thiamethoxam to protect pollinators, including bees15,16,17. Other countries are 
currently re -evaluating their approval of these active substances18,19,20.   
(9) Regulation (EC) No  396/2005 establishes in accordance with the general principles 
laid down in Regulation (EC) No 178/200221 provisions related to maximum residue 
levels of pesticides residues in or on food and feed of plant and animal origin. In 
accordance with Article 5(1) of the latter Regulation, food law shall pursue one or 
more of the general objectives of a high level of  protection of human life and health 
and the protection of consumers’ interests, including fair practices in food trade, taking 
                                                 
12 IPBES (2016). The assessment report of the Intergovernmental Science -Policy  Platform on Biodiversity 
and Ecosystem Services on pollinators, pollination and food production. S.G. Potts, V. L. Imperatriz -
Fonseca, and H. T. Ngo (eds). Secretariat of the Intergovernmental Science -Policy Platform on 
Biodiversity and Ecosystem Services , Bonn, Germany. 552 pages. 
https://doi.org/10.5281/zenodo.3402856 . 
13 IUCN SSC CEM Task Force on Systemic Pesticides . Worldwide Integrated Assessment . Peer reviewed 
scientific journal articles compiled  in Environmental Science and Pollution Research” volume 22, issue 
1, January  2015  
14 Neonic Insecticides and Invertebrate Species Endangerment,  Pierre Mineau . Module in Earth Systems 
and Environmental Sciences . 2021 . 
https://www.sciencedirect.com/science/article/pii/B9780128211397001264 . 
15 Health Canada’s Pest Management Regulatory Agency . Re-evaluation Decision RVD2019 -05, 
Clothianidi n and Its Associated End -use Products: Pollinator Re -evaluation . Pest Management 
Regulatory Agency 11 April 2019 ISSN: 1925 -0886.  
16 Re-evaluation Decision RVD2019 -04, Thiamethoxam and Its Associated End -use Products: Pollinator 
Re-evaluation . Pest Manageme nt Regulatory Agency 11 April 2019 ISSN: 1925 -0886 . 
17 Ministerio de Ganaderí a, Agricultura y Pesca de Paraguay. Resolución N° 503/019 DGSA Modificación 
de etiquetas para los Productos Fitosanitarios a base de los ingredientes activos Clotianidina, 
Imidaclo prid, Tiametoxan y Clorpirifos . December  2019 . 
18 Australian Pesticides and Veterinary Medicines Authority. Reconsideration of Neonicotinoid Approvals 
and Registrations. Commonwealth of Australia Gazette  No. APVMA 23, November  2019.   
19 New Zealand Environmental Protection Authority. Application to decide whether there are grounds for 
reassessment of the neonicotinoids clothianidin, thiamethoxam, imidacloprid, thiacloprid, and 
acetamiprid (APP203949). December  2019.  
20 United States Enviro nmental Protection Agency. Proposed Interim Registration Review Decision Case 
Numbers 7620 and 7614. Docket Numbers EPA -HQ-OPP-2011 -0865 and EPA -HQ-OPP-2011 -0581 . 
January  2020.  
21 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety.  OJ L 31, 1.2.2002, p. 1 .  
EN 4  EN into account, where appropriate, the protection of animal health and welfare, plant 
health and the environment.  
(10) There is growing  worldwide concern that the decline of pollinators is a serious threat 
to global biodiversity, the environment and sustainable development, as well as to 
maintaining agricultural productivity and food security. According to the Convention 
on Biological Div ersity’s  International Initiative for the Conservation and Sustainable 
Use of Pollinators22, pollination is one of the most important mechanisms in the 
maintenance and promotion of biodiversity and, in general, life on earth. Many 
ecosystems, including agr o-ecosystems and two thirds of major food crops depend on 
pollinators for quality or yield. The Food and Agriculture Organization of the United 
Nations (FAO) calls for actions to address the drivers of pollinator decline for the sake 
of sustainable global food production23. Highly dependent on pollination, foods such 
as fruits, vegetables, nuts and seeds are the main dietary contributors of micronutrients 
necessary to prevent the risk of some non -communicable diseases in humans2425. 
Therefore, pollinators are important to ensure diversity in diet  and to reduce the threat 
to biodiversity in the global environment.   
(11) As the decline in pollinators is an issue of international concern, Union measures need 
to be adopted to protect pollinator populations worldwide, in cluding bees, from the 
risks of active substances, such as the neonicotinoids clothianidin and  thiamethoxam. 
Preserving the pollinator population within the Union only would be insufficient to 
reverse the worldwide decline of pollinator populations and its  effects on biodiversity, 
agricultural production and food security, also in the Union.  
(12) In accordance with Article 3(d) of Regulation (EC) No 396/2005, MRLs for 
clothianidin and thiamethoxam were based on Good Agricultural Practices (GAPs) as 
defined in Ar ticle 3(a) of that Regulation, which took into account, in particular, 
considerations of efficiency to combat plant pests, and protection of the environment 
and public health in the context of the authorisation of the use of plant protection 
products conta ining those substances. The MRLs resulting from these GAPs were 
subsequently considered and found safe for consumers in the Union. It is now 
appropriate to complement the regulatory response to date by better integrating within 
it environmental considerati ons taking into account in particular whether the GAPs 
used in the past as a basis for setting MRLs ensure a sufficient protection of the 
environment, based on current knowledge. GAPs involving outdoor uses of 
clothianidin and thiamethoxam are not acceptab le, in light of current scientific and 
technical knowledge, due to their effects on bees. Given the global nature of pollinator 
decline, there is a need to ensure that also commodities imported into the Union do not 
contain residues resulting from GAPs bas ed on outdoor uses of clothianidin and/or 
thiamethoxam, in order to avoid the transfer of adverse effects on bees from food 
production in the Union to production of food in other parts of the world that is then 
                                                 
22 https://www.cbd.int/doc/decisions/cop -14/cop -14-dec-06-en.pdf . 
23 FAO. 2019. The State of the World’s Biodiversity for Food and Agriculture, J. Bélanger & D. Pilling 
(eds.). FAO Commission on Genetic Resources for Food and Agriculture Assessments. Rome. 572 pp.  
24 Effects of decreases of animal pollinators on human nutrition and global health: a modelling analysis . 
MR Smith, GM Singh, D Mozaffarian, SS Myers. The Lancet 386, Issue 10007; 2015 . 
25 Communication from the Commiss ion to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions. Europe’s Beating Cancer Plan. 
COM (2021) 44.   
EN 5  EN imported into the Union.26 This is appropriate  to ensure that all products produced or 
consumed in the Union are free from clothianidin and thiamethoxam and the 
production is not associated with pollinator mortality. In view of this, CXLs based on 
GAPs that do not achieve the appropriate level of prot ection of the Union should no 
longer be provided for as MRLs pursuant to Regulation (EC) No 396/2005.  
(13) Furthermore, all authorisations for plant protection products containing clothianidin 
and/or thiamethoxam in the Union have been revoked. It is therefore appropriate to 
delete the corresponding MRLs set out in Annex II of Regulation (EC) No 396/2005, 
in accordance with Article  17 of that Regulation in conjunction with Article  14(1)(a).  
(14) Therefore, taking into account all the factors relevant to the matter un der consideration 
in accordance with Article 14(2), read in the light of Article 11 TFEU, all the current 
MRLs for clothianidin and/or thiamethoxam as set out by Regulation (EC) 
No 396/2005 should be lowered to the Limit of Determination (LODs).  
(15) The Commis sion consulted the European Union reference laboratories on analytically 
achievable LODs specific to each product. Those LODs should be listed in Annex  V 
in accordance with Article  18(1)(b) of Regulation (EC) No  396/2005.  
(16) Through the World Trade Organisat ion, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(17) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(18) In order to allow for the normal marketing, processing and consumpti on of products, 
this Regulation should provide for a transitional arrangement for products which have 
been produced in or imported into the Union before the modification of the MRLs and 
for which information shows that for such products complying with the existing MRLs 
a high level of consumer protection is maintained.  
(19) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit operators in third countries, especially in least developed 
and developing count ries, and food business operators to prepare themselves to meet 
the new requirements which will result from the modification of the MRLs. Such 
adaptation of agricultural practices can be reasonably expected to be achieved after 
two growing seasons.  
(20) In orde r to meet  the needs of international trade, applications for import tolerances for 
clothianidn or thiamethoxam maybe be submitted pursuant to Article 7 of Regulation 
(EC) No  396/2005 and should provide relevant information to demonstrate that the 
GAPs appl ying for the specific uses of the active substances are safe for pollinators. 
That information, if submitted, would  be assessed on a case by case basis within the 
time period provided for in that Regulation . In the context of the assessment of a 
request fo r an import tolerance, if an applicant provides scientific evidence that the use 
of these neonicotinoids does not adversely impact pollinators, if all requirements are 
met, an import tolerance could  be set by the Commission   
(21) 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:  
                                                 
26 Communication from the Commission to the European Parliament, the Council, the European  
Economic and Social Committee and the Committee of the Regions. A Farm to Fork Strategy for a fair, 
healthy and environmentally -friendly food system. COM (2020) 381 .  
EN 6  EN Article 1  
Annexes II and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulati on. 
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 Publication: please insert date [36 months] after entry into force ].  
 
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: please insert date [36 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