G/SPS/N/EU/525  
 
13 December 2021  
(21-9298) 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 Par liament and of the Council as 
regards maximum residue levels for fluoride ion, oxyfluorfen, pyroxsulam, quinmerac and 
sulfuryl fluoride in or on certain products (Text with EEA relevance) . Language(s):  
English . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EU/21_7731_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EU/21_7731_01_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EU/21_7731_02_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EU/21_7731_03_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EU/21_7731_04_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for fluoride ion, oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride in certain 
food commodities. MRLs for these substances in certain commodities are changed: either 
increased or lowered. Lower MRLs are set after updating the limits of determination and/or 
deleting old uses which are not authorised any more in the European Union or for wh ich a 
human health concern may not be excluded. Some residue definitions have been updated.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory f rom 
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 sulfuryl fluoride 
(218). The list of Codex MRLs is available at: https://www.fao.org/fao -who-
codexalimentar ius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=218 . 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  G/SPS/N/EU/525  
 
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  [ ] 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 the reasoned 
opinion o n the review of the existing maximum residue levels for oxyfluorfen, pyroxsulam, 
quinmerac and sulfuryl fluoride (and its metabolite fluoride ion). Based on this 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 a mending 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 oxyfluorfen according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2020;18(10):6269.  
https://www.efsa.europa.eu/en/efsajournal/pub/626 9 
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for pyroxsulam according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2020;18(10):6260.  
https://www.efsa.europa.eu/en/efsajournal/pub/6260  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for quinmerac according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2020;18(10):6257.  
https://www.efsa.europa.eu/en/efsajournal/pub/6257  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for sulfuryl fluoride according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2021;19(1):6390.  
https://www.efsa.europa.eu/en/efsajournal/pub/6390  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 30 April 2022  
Proposed date of publication (dd/mm/yy) : 30 June 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Twenty days after publication in 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 a nd/or (dd/mm/yy) : 11 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  G/SPS/N/EU/525  
 
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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 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