G/SPS/N/EU/255  
 
20 April 2018  
(18-2476) 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 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): Food products  
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 Annex II 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 Cochineal, Carminic acid, 
Carmines (E 120) (Text with EEA relevan ce). Language(s): English.  Number of 
pages:  6 
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2141_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2141_01_e.pdf  
6. Description of content: The text amends the title and the specifications for Cochineal, 
Carminic  acid, Carmines (E 120) as a follow up to the recommendations made in the EFSA 
opinion re -evaluating safety of this food additive.  Annex II to Regulation 
(EC) No 1333/2008 (Union list of food additives approved for use in foods and conditions 
of use) and t he 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 te rritory 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  
Does this proposed regulation conf orm to the relevant international standard?  
[ ] Yes   [X] No  G/SPS/N/EU/255  
 
- 2 - 
 
  If no, describe, whenever possible, how and why it deviates from the 
international standard: The proposed regulation further aligns the specifications in 
certain aspects with the JECFA specifica tions (e.g. introducing the purity criteria and 
aligning with the limits for total ash, protein, matter insoluble in dilute ammonia and 
microbiological criteria) on the other hand it deviates as regards the limits for toxic 
elements (arseni c, lead, mercury  and cadmium), amendment of the title of the food 
additive and inclusion of 4 -aminocarminic acid in the specifications as a follow up to the 
recommendations made in the scientific opinion of EFSA.  
9. Other relevant documents and language(s) in which these are available: 
Scientific  Opinion on the re -evaluation of cochineal, carminic acid, carmines (E 120) as a 
food additive (European Food Safety Authority, EFSA Journal 2015;13(11):4288 [66 pp.]  
http://www.efsa.europa.eu/en/efsajournal/pub/4288   
10. Proposed date of adoption (dd/mm/yy) : August 2018  
Proposed date of publication (dd/mm/yy) : August 2018  
11. Proposed date of entry  into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 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 t he 
notification and/or (dd/mm/yy) : 19 June 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