WORLD TRADE  
ORGANIZATION   
G/SPS/N/EU/1 
12 December 2011  
 (11-6439) 
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, 
Directorate E Safety of the Food Chain 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Food additives 
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 as regards 
the conditions of use and the use levels  for aluminium-containing food additives 
Language(s):  English  Number of pages:  49 
http://members.wto.org/crnattach ments/2011/sps/EEC/11_4170_00_e.pdf  
http://members.wto.org/crnattach ments/2011/sps/EEC/11_4170_01_e.pdf  
6. Description of content:  This Regulation concerns Annex II (Community list of food 
additives approved for use in foods and c onditions of use) to Regulation (EC) 
No. 1333/2008.  The European Food Safety Au thority (EFSA), in its opinion of 22 May 
2008, recommended to lower the tolerable weekly  intake (TWI) for aluminium to 1 mg/kg 
body weight/week.  In addition, EFSA considers that the revised TWI is generally exceeded 
for high consumers, especially children, in a significant part of the Union.  EFSA considers 
that the major route of exposure to aluminium compounds for the general population is through food, including food additives.  Annex II authorises the use of aluminium containing food additives and the use of some colours that may contain aluminium in the 
form of lakes in a wide number of foodstuffs , in general without any indication of the 
maximum concentration levels of aluminium coming from the lakes.  It is therefore appropriate to amend the current  conditions of use and reduce the use levels for aluminium-
containing food additives, including aluminium lakes, to ensure that the revised TWI is not exceeded.  
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/1 
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  8. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) General Standard for Food Additives CODEX STAN 192-1995 
adopted in 1995, revised in 1997, 1999, 2001, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010 and 2011. 
[ ] 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 conform to the relevant international standard?   
 [X] 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:  When 
adopted, it will be published at the Official Journal available at http://eur-lex.europa.eu  
(available in English). 
10. Proposed date of adoption (dd/mm/yy) :  March 2012 
Proposed date of publication (dd/mm/yy) :  April 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  On the 20th day following its publication in the Official Journal of the 
European Union.  Provisions on aluminiu m containing food additives shall apply from 
1 February 2014.  Provisions on aluminium lakes of colours shall apply from 1 August 
2014.  Provisions on labelling of the aluminiu m content of lakes of food colours for 
business to business shall a pply from 1 February 2013. 
[ ] Trade facilitating measure   
12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  10 February 2012 
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 Consumers, Unit G6 - Multilateral International Relations 
Rue Froissart 101 B 1049 Brussels Tel:  +(322) 29 68185/59922 
Fax:  +(322) 29 98090 
E-mail:  sps@ec.europa.eu  G/SPS/N/EU/1 
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  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:  +(322) 29 68185/59922 
Fax:  +(322) 29 98090 E-mail:  sps@ec.europa.eu