G/SPS/N/EU/533  
20 December 2021  
(21-9496) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -
General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Cereals (HS Code( s): 1001, 1002, 1003, 1004, 1005, 1006, 1007, 
1008), foodstuffs of animal origin (HS Code(s): 0201, 0202, 0203, 0204, 0205, 0206, 
0207, 0208, 0209, 0210) and certain products of plant origin, including fruit and 
vegetables.  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Regulation amending Annex II to 
Regulation (EC) No 396/2005 of the Eu ropean Parliament and of the Council as regards 
maximum residue levels for 2,4 -D, azoxystrobin, cyhalofop -butyl, cymoxanil, 
fenhexamid, flazasulfuron, florasulam, fluroxypyr, iprovalicarb and silthiofam in or on 
certain products (Text with EEA relevance) . Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7884_04_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7884_03_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7884_02_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7884_01_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7884_00_e.pdf  
6. Description of content:  Following the evaluation of confirmatory data, the proposed 
draft Regulation amends the existing MRLs for 2,4 -D, azoxystrobin, cyhalofop -butyl, 
cymoxanil,  fenhexamid, flazasulfuron, florasulam, iprovalicarb and silthiofam in certain 
food commodities and keeps the existing MRLs for fluroxypyr.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from anima l/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Maximum Residue Limits for 2,4 -D, 
azoxystrobin and fenhexamid. The list of Codex MRLs is available at: 
http://www.fao.org/fao -who-codexalimentar ius/codex -
texts/dbs/pestres/pesticides/en  G/SPS/N/EU/533  
 
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  [ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The European Food Safety Authority published reasoned 
opinions on the evaluat ion of confirmatory data following the review of the existing 
maximum residue levels for 2,4 -D, azoxystrobin and fenhexamid. Based on these 
opinions, Regulation (EC) No 396/2005 should be amended accordingly.  
9. Other relevant documents and language(s) in which these are available:  
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/EEC"  
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
Reasoned opinion published by the European Food Safety Authority on the eva luation of 
confirmatory data following the review of MRLs for 2,4 -D. 
https://www.efsa.europa.eu/en/efsajournal/pub/6910    
Reasoned opinion published by the European Food Safety Authority on the evaluation of 
confirmatory data following the review of MRLs for azoxystrobin.  
https://www.efsa.europa.eu/en/efsajournal/pub/6231     
Conclusion published by the  European Food Safety Authority on the peer review of the 
pesticide risk assessment of cyhalofop -butyl.  
https://www.efsa.europa.eu/en/efsajournal/pub/3943   
Reasoned opinion publ ished by the European Food Safety Authority on the evaluation of 
confirmatory data following the review of MRLs for cymoxanil.  
https://www.efsa.europa.eu/en/efsajournal/pub/5823     
Reasoned opinion published by the European Food Safety Authority on the evaluation of 
confirmatory data following the review of MRLs for fenhexamid.  
https://www.efsa.europa. eu/en/efsajournal/pub/6910    
Conclusion published by the European Food Safety Authority on the peer review of the 
pesticide risk assessment of flazasulfuron.  
https://www.efsa.eu ropa.eu/en/efsajournal/pub/4575    
Conclusion published by the European Food Safety Authority on the peer review of the 
pesticide risk assessment of florasulam.  
https://www.efsa.europa.eu/en/efsajournal/pub/3984    
Reasoned opinion published by the European Food Safety Authority on the evaluation of 
confirmatory data following the review o f MRLs for fluroxypyr.  
https://www.efsa.europa.eu/en/efsajournal/pub/5816    
Reasoned opinion published by the European Food Safety Authority on the evaluation of 
confirmatory da ta following the review of MRLs for iprovalicarb.  
https://www.efsa.europa.eu/en/efsajournal/pub/6910    
Conclusion published by the European Food Safety Authority on the peer review of the 
pesticide risk assessment of silthiofam.  
https://www.efsa.europa.eu/en/efsajournal/pub/4574  (available in English)  
10. Proposed date of adoption (dd/mm/yy) : July 2022 
Proposed date of publication (dd/mm/yy) : September 2022  G/SPS/N/EU/533  
 
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  11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : This Regulation shall enter into force on the twentieth day 
following that of its publication i n the Official Journal of the European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 February 2022  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu