G/SP S/N/EU/82  
 
20 June 2014   
(14-3589) 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; ICS numbers should be provided in 
addition, where applicable): Aluminium lakes of INS 101 Riboflavins and INS 120 
Carmines  
4. Regions or countries likely to be affected, to the extent r elevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Commission Regulation amending Annex II to 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards 
the use of aluminium lakes of riboflavins (E 101) and cochineal, carminic acid, carmines 
(E 120) in certain food categories and Annex to Regulation (EU) No 231/2012 as regards 
the specifications for riboflavins (E 101) (Text with EEA relevance)   Language(s): 
English   Number of pages: 4+8 
http://members.wto.org/crnattachments/2014/sps/EEC/14_2794_00_e.pdf  
http://members.wto.org/crnattachments/2014/sps/EEC/14_2794_01_e.pdf  
6. Description of content: The European Food Safety  Authority in its opinion of 
22 May 2008 lowered the tolerable weekly intake (TWI) for aluminium and the 
conditions of use f or food additives containing aluminium, including aluminium lakes 
were amended by Commission Regulation (EU) No 380/2012 in order to ensure that the 
revised TWI was not exceeded.  
Applications for authorisation of the use of aluminium lakes of riboflavins (E 101) and 
the extension of use of aluminium lakes of cochineal, carminic acid, carmines (E 120) to 
certain specific foods were received and considered with a special attention to a possible 
exposure to aluminium in order not to undermine Regulation (EU) No 380/2012. It is not 
expected that the considered authorisations would have a significant impact on the total 
exposure to aluminium. Therefore, it is appropriate to authorise the requested uses and 
to modify the specifications for INS 101 with regard to the use of aluminium lakes of 
colours.  
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/82  
 
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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 STAN 192 -1995 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Anima l 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: There is a Codex General Standard for Food additives 
(CS 192-1995). However, this standard has not established any rules/limits for 
aluminium coming from aluminium lakes of colours. General information on aluminiu m 
lakes of colours and the reference to the JECFA's PTWI of 2 mg/kg bw for aluminium is 
contained in the JECFA's Combined Compendium of Food Additive Specifications.  
9. Other relevant documents and language(s) in which these are available:     
10. Propos ed date of adoption (dd/mm/yy) : August 2014  
Proposed date of publication (dd/mm/yy) : August 2014  
11. Proposed date of entry into force: [ ]  Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days after publication.  
[X] Trade facilitating measure   
12. Final date for comments: [ ]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fa x number and e -mail address 
(if available) of other body:   
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