G/SPS/N/EU/260  
 
20 June 2018  
(18-3868) 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 practic able: 
[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 bromuconazole, carboxin, fenbutatin oxide, 
fenpyrazamine and pyridaben in or on certain products (Text with EEA relevance) . 
Language(s): English.  Number of pages: 5+ Annexes  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_3194_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/ EEC/18_3194_01_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_3194_02_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_3194_03_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_3194_04_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_3194_05_e.pdf  
6. Description of content: The proposed draft Regulation concerns the review of existing 
MRLs for bromuconazole, carboxin, fenbutatin oxide, fenpyrazamine and pyridaben 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 which a human health concern may not be excluded. The residue definition for  
some substances has also been updated.  
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.  G/SPS/N/EU/260  
 
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  8. Is there a relevan t 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 fenbutatin oxide.  
The list of Codex MRLs is available at: http://www.fao.org/fao -who-
codexalimentarius/codex -texts/dbs/pestres/pesticides/en/  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquati c 
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 a reasoned 
opinion on the review of the existing maximum residue levels for fenbutatin oxide in which 
it does not recommend to maintain CXL values as toxicologica l data for the active 
substance and its metabolite, di -hydroxy fenbutatin oxide, were not provided and the risk 
to consumers could not be assessed. Commission Implementing Regulation (EU) 
No 486/2014 provided for the withdrawal of the approval of fenbutati n oxide as the further 
confirmatory information for this active substance required by Commission Directive 
2011/30/EU had not been submitted. All existing national authorisations for plant 
protection products containing fenbutatin oxide have been revoked.  
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 ori gin and amending Council Directive 91/414/EEC"  
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
"Reasoned opinion on the review of the ex isting maximum residue levels for 
bromuconazole according to Article 12 of Regulation (EC) No 396/2005". EFSA 
Journal  2017;15(9):4986.  
http://onlinelibrary.wiley.c om/doi/10.2903/j.efsa.2017.4986/epdf  
"Reasoned opinion on the review of the existing maximum residue levels for carboxin 
according to Article 12 of Regulation (EC) No 396/2005". EFSA Journal 2017;15(10):5019.  
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.5019/epdf  
"Reasoned opinion on the review of the existing maximum residue levels for fenbutatin 
oxide according to Article 12 of Regulation (EC) No 396/200 5". EFSA 
Journal  2017;15(12):5091.  
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.5091/epdf  
"Reasoned opinion on the review of the existing maximum residue  levels for 
fenpyrazamine according to Article 12 of Regulation (EC) No 396/2005". EFSA 
Journal  2017;15(12):5072.  
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa .2017.5072/epdf  
"Reasoned opinion on the review of the existing maximum residue levels for pyridaben 
according to Article 12 of Regulation (EC) No 396/2005". EFSA Journal 2017;15(11):5054.  
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.5054/epdf  (available in English)  
10. Proposed date of adoption (dd/mm/yy) : January 2019  
Proposed date of publ ication (dd/mm/yy) : March 2019  
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  G/SPS/N/EU/260  
 
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  12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 19 August 2018  
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