G/SPS/N/EU/686  
30 October 2023  
(23-7294) 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):  Meat and edible meat offal (HS code(s): 02); Cereals (HS code(s): 10)  
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 III to 
Regulation (EC) No. 396/2005 of the European Parliament and of the Council as regards 
maximum residue levels for dithianon in or on certain products (Text with EEA relevance) . 
Language(s):  English . Number of pages:  32 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13209_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13209_01_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_13209_02_e.pdf  
https://member s.wto.org/crnattachments/2023/SPS/EEC/23_13209_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for dithianon in certain food commodities. MRLs for these substances in certain 
commodities are lowered. Lower MRLs are set after deleting old uses which are not 
authorised any more in the European Union.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/pl ant 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 dithianon in some 
commodities. CODEX MRLs LIST is available at https://www.fao.org/fao -who-
codexalimentarius/cod ex-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  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  G/SPS/N/EU/686  
 
- 2 - 
 
  If no, describe, whenever possible, how and why it deviates from the 
international standard:   
The European Food Safety Authority published reasoned opinio n on the existing MRLs for 
dithianon. Based on the opinion, Regulation (EC) No. 396/2005 should be amended 
following a risk analysis approach.  
The current EU policy is to align EU MRLs with CXLs if the following conditions are fulfilled: 
(i) that the EU se ts MRLs for the commodity under consideration; (ii) that the current EU 
MRL is lower than the CXL; and (iii) that the CXL is acceptable to the EU with respect to its 
policy objective of ensuring a high level of consumer protection, including aspects on 
supporting data and extrapolations.  
Where the EU considers that a proposed CXL is not acceptable, it makes a reservation to 
the Codex Committee on Pesticide Residues (CCPR). Reservations made by the EU, 
concerning some of the active substances envisaged by th e draft Regulation, are listed in 
the relevant CCPR reports:   
http://www.fao.org/fao -who-codexalimentarius/committees/committee/ related -
meetings/en/?committee=CCPR  
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  
European Food Safety Authority; Reasoned opinion on the review of the existing maximum 
residue levels for dithianon according to Article 12 of Regulation (EC) No. 396/2005; EFSA 
Journal 2023;2 1(1):7731: https://www.efsa.europa.eu/en/efsajournal/pub/7731  
(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 Of ficial Journal of the European Union and apply six 
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) : 29 December 2023  
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