G/SPS/N/EU/79  
 
26 May 2014  
(14-3131)  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): Entire fresh 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: Commission Regulation (EU) amending Annex II to 
Regulation (EC) No 1333/2008 of the Europe an Parliament and of the Council and the 
Annex to Commission Regulation (EU) No 231/2012 as regards the removal of montan 
acid esters (E 912) (Text with EEA relevance)  Language(s): English  Number of 
pages: 5 
http://members.wto.org/crnattachments/2014/sps/EEC/14_2462_00_e.pdf  
6. Description of content: A program for the re-evaluation of these food additives is laid 
down in Commission Regulation (EU) No 257/2010. Interested business operator(s) and 
any other interested party shall submit the data related to the re-evaluation of a food 
additive within the period set by EFSA in its calls for data. Where the information necessary for the completion of the re-evaluation of a particular food additive is not 
provided, the food additive may be removed from the Union list. 
EFSA launched public calls for scientific data on montan acid esters (E 912) in 
February 2012. No data on toxicokinetics and reproductive and developmental toxicity of 
montan acid esters were available. The available data on short-term and subchronic 
toxicity, genotoxicity and chronic toxicity and carcinogenicity of montan acid esters were 
limited. No data on the usage was submitted. Based on these limitations EFSA concluded that the safety of montan acid esters as a food additive could not be evaluated. 
Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended by removing 
montan acid esters (E 912) from the Union list of authorised food additives as the 
absence of recent scientific evidence no longer justifies its inclusion in the list. At the 
same time, the additives should be removed from Commission Regulation 231/2012 
laying down its specifications. 
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/79 
 
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  8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available:     
10. Proposed date of adoption (dd/mm/yy) : End of July 2014 
Proposed date of publication (dd/mm/yy) : End of July 2014 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : Twenty days following 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 and/or (dd/mm/yy) : 25 July 2014 
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 G6-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. Texts 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 Consumers, Unit G6-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