G/SPS/N/EU/696  
23 November 2023  
(23-7913) Page: 1/2 
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 Codes: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 
1008); Foodstuffs of animal origin (HS Codes: 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 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 benomyl, carbendazim and thiophan ate‐methyl in or on 
certain products (text with EEA relevance) . Language(s):  English . Number of pages:  28 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13743_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13743_01_e.pdf  
https://members.wto.or g/crnattachments/2023/SPS/EEC/23_13743_02_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13743_03_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13743_04_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the update of existing 
MRLs for benomyl, carbendazim and thiophanate ‐methyl in certain food commodities. MRLs 
for these substances in certain commodities are changed. Lower MRLs are set after 
deleting old uses which are not authorised any more in the European Union or for which a 
human health concern may not be excluded.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/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 tex t): Codex Maximum Residue Limits for pesticide 
carbendazim (72) in some commodities.  Codex MRLs list is available at 
https://www.fao.org/fao -who-codexalimentarius/codex -
texts/dbs/pestres/pesticides/en/  
[ ] 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  G/SPS/N/EU/696  
 
- 2 - 
 
  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 approvals of carbendazim and thiophanate ‐methyl for their 
use in plant protection products were not renewed. In addition, the European Food Safety 
Authority published reasoned opinions on the modification of the existing maximum 
residue (MRLs) for carbendazim and thiophanate ‐methyl. B ased on the above, 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 opinions published by the European Food Safety Authority on the setting of 
MRLs for carbendazim and thiophanate -methyl . European Food Safety Authority; 
Reasoned opinion on the  review of the existing maximum residue levels (MRLs) for 
thiophanate -methyl and carbendazim according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2014;12(12):3919. https://doi.org/10.29 03/j.efsa.2014.3919  
− European Food Safety Authority; Conclusion on the peer review of the pesticide risk 
assessment of the active substance thiophanate -methyl. EFSA Journal 
2018;16(1):5133. https://doi.org/10.2903/j.efsa.2 018.5133  
− European Food Safety Authority; Reasoned opinion on the toxicological properties and 
maximum residue levels (MRLs) for the benzimidazole substances carbendazim and 
thiophanate -methyl. EFSA Journal 2021;19(8):6773 . 
https://doi.org/10.2903/j.efsa.2021.6773  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 2 June 2024  
Proposed date of publication (dd/mm/yy) : 2 July 2024  
11. Proposed date of entry into force: [X]  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 in the Official Journal of the European Union and  apply 
6 months thereafter.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 22 January 2024  
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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu