G/SPS/N/EU/168  
 
7 July 2016  
(16-3636)  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 Consumers Directorate-
General 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S 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: Annexes to "Draft Commission Regulation amending 
Annexes II, III and V to Regulation (EC) No 39 6/2005 of the European Parliament and of 
the Council as regards maximum residue levels for bitertanol, tebufenpyrad and 
chlormequat in or on certain products (Text with EEA relevance)"  Language(s): 
English  Number of pages: 26 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_2693_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_2693_01_e.pdf  
6. Description of content: These notified annexes to the draft Regulation set proposed 
maximum residue levels for bi tertanol, tebufenpyrad and chlormequat in or on certain 
products in Annex II and V to Regulation (EC) No 396/2005. MRLs for these substances in certain commodities are changed: either in creased or lowered. Higher MRLs are set to 
accommodate new uses in the European Union and in third countries which export those 
commodities to the European Union. Lower MRLs are set after updating the limit of 
determination and/or deleting old uses which are not authorized any more in the European Union or for which there is not enough data for an MRL to be set. 
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 st andard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text) CAC/MRL 1: Maximum Resi due Limits (MRLs) for 
Pesticides 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    G/SPS/N/EU/168 
 
- 2 - 
 
  [ ] 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 reasoned 
opinions on the review of the existing maximum residue levels for bitertanol, 
tebufenpyrad and chlormequat. Based on these opinions the Regulation (EC) No 396/2005 should therefore be amended following a risk analysis approach. 
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/LexUriServ/LexUriServ.do?uri=CONSLEG:2005R0396:20120101:EN:PDF  
 Reasoned opinions published by the European Food Safety Authority on the setting of 
MRLs for bitertanol, tebufenpyrad and chlormequat: https://www.efsa.europa.eu/sites/default/fil es/scientific_output/f iles/main_documents
/4386.pdf : MRLs for bitertanol 
https://www.efsa.europa.eu/sites/default/fil es/scientific_output/f iles/main_documents
/4469.pdf : MRLs for tebufenpyrad 
https://www.efsa.europa.eu/sites/default/fil es/scientific_output/f iles/main_documents
/4422.pdf : MRLs for chlormequat  
(available in English) 
10. Proposed date of adoption (dd/mm/yy) : February 2017 
Proposed date of publication (dd/mm/yy) : February 2017 
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 
[ ] Trade facilitating measure   
12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 5 September 2016 
Agency or authority designated to hand le 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 Consumers, 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 Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
European Commission  
DG Health and Consumers, 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