G/SPS/N/EU/713  
24 January 2024  
(24-0536) 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 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 and 
III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for cyproconazole and spirodiclofen in or  on certain 
products (Text with EEA relevance) . Language(s):  English . Number of pages:  47 
https://members.wto.org/crnattachments/2024/SPS/EEC/24_00716_00_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_00716_01_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_00716_02_e.pdf  
https://member s.wto.org/crnattachments/2024/SPS/EEC/24_00716_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review and update 
of existing MRLs for cyproconazole and spirodiclofen in certain food commod ities. MRLs for 
these substances in certain commodities are lowered. 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 as the approval of the use  of the active 
substance has expired.  
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 text) : Codex Maximum Residue Limits for cyproconazole 
and spirodiclofen  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) :  G/SPS/N/EU/713  
 
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  [ ] None  
Does this proposed regulation confor m 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 opinion 
on the existing MRLs for cyproconazole an d spirodiclofen. Based on the opinions, 
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 E uropean Union sets MRLs f or the commodity under consideration; (ii) that the 
current EU MRL is lower than the CXL; and (iii) that the CXL is acceptable to the 
European  Union with respect to its policy objective of ensuring a high level of consumer 
protection, including aspects on supporting data and extrapolations.  
Where the E uropean  Union considers that a proposed CXL is not acceptable, it makes a 
reservation to the Codex Committee on Pesticide Residues (CCPR). Reservations made by 
the E uropean  Union, concerning some of the active  substances envisaged by the draft 
Regulation, are listed in the relevant CCPR reports:  
http://www.fao.org/fao -who-codexalimenta rius/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/l egal-content/EN/ALL/?uri=CELEX%3A32005R0396  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for cyproconazole according to Article 12 of Regulation (EC) 
No 396/2005; EFSA Journal 2021;19(3):6483  
https://doi.org/10.2903/j.efsa.2021.6483  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue l evels for spirodiclofen according to Article 12 of Regulation (EC) 
No 396/2005; EFSA Journal 2021;19(11):6908  
https://doi.org/10.2903/j.efsa.2021.6908  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 23 August 2024  
Proposed date of publication (dd/mm/yy) : 23 September 2024  
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 its 
publication in the Official 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) : 24 March 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  G/SPS/N/EU/713  
 
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  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