G/SPS/N/EU/202  
 
6 March 2017  
(17-1338) 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 it em number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable): Food products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading part ners   
[ ] Specific regions or countries:   
5. Title of the notified document: Draft Commission Regulation amending Annexes II 
and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council 
and the Annex to Commission Regulation (EU ) No 231/2012 as regards the removal of 
calcium sorbate (E 203) (Text with EEA relevance) . Language(s): English . Number of 
pages: 20 
http://members.wto.org/crnattachments/2 017/SPS/EEC/17_1180_00_e.pdf  
http://members.wto.org/crnattachments/2017/SPS/EEC/17_1180_01_e.pdf  
6. Description of content: The proposed measure removes calcium sorbate (E 203) from 
the Union list of authorised food additives in Regulation (EC) No 1333/2008, since due to 
the absence of appropriate genotoxicity data it is not possible to assess the risk posed 
by the use of this substance as a food additive to human health.  Therefore, the inclusion 
of this substance in the Union list of authorised food additives can no longer be justified. 
Annexes II and III to Regulation (EC) No 1333/2008 (authorised uses and use levels for 
food additive) and the Annex to Regulation (EU) No  231/2012 (specifications for food 
additives) are amended accordingly.  
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 General Stan dard For Food Additives – 
Codex  Stan 192 -1995 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :   
[ ] International Plant Protection Convention (e.g.  ISPM number) :   
[ ] None  G/SPS/N/EU/202  
 
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  Does this proposed regulation conform to the relevant international s tandard?   
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard: The Codex Alimentarius Standard for food additives includes 
provisions for the use of calcium sorbate as a food additive in several foo d categories. In 
the European Union calcium sorbate (E 203) is authorised as a preservative in a variety 
of foods, as well as in food colour preparations and food flavourings, in accordance with 
Annexes II and III to Regulation (EC) No 1333/2008. Article 3 2(1) of Regulation (EC) 
No 1333/2008 provides that all food additives that were already permitted in the Union 
before 20 January 2009 are subject to a new risk assessment by the European Food 
Safety Authority (EFSA). On 30 June 2015 EFSA delivered a Scient ific Opinion on the re -
evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate 
(E 203) as food additives. The opinion stated that there was a lack of genotoxicity data 
on calcium sorbate. Consequently EFSA was not able to confirm t he safety of calcium 
sorbate as a food additive and concluded that this substance should be excluded from 
the group Acceptable Daily Intake (ADI) defined for sorbic acid (E 200) and potassium 
sorbate (E 202). On 10 June 2016 the European Commission launche d a public call for 
genotoxicity data on calcium sorbate (E 203). However, by the closure date of the call 
(25 November 2016) no business operator committed to providing the requested data. 
Without those data EFSA cannot complete the re -evaluation of the s afety of calcium 
sorbate as a food additive and consequently it cannot be determined whether this 
substance still fulfils the conditions pursuant to Article 6(1) of Regu lation (EC) 
No 1333/2008 for inclusion in the Union list of approved food additives. It  is therefore 
appropriate to remove calcium sorbate (E 203) from the Union list of approved food 
additives.  
9. Other relevant documents and language(s) in which these are available: 
Scientific Opinion on the re -evaluation of sorbic acid (E 200), potassium  sorbate (E 202) 
and calcium sorbate (E 203) as food additives (European Food Safety Authority, EFSA 
Journal 2015;13(6):4144, http://www.efsa.europa.eu/en/efsajournal/pub/4144  
10. Proposed  date of adoption (dd/mm/yy) : Foreseen for September 2017.  
Proposed date of publication (dd/mm/yy) : Foreseen for September 2017.  
11. Proposed date of entry into force: [ ]  Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days after publication i n 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) : 5 May 2017  
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 Brusse ls 
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/202  
 
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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