. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/274 
8 November 2005 
 (05-5224) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
 
If applicable, name of local government involved:   
2. Agency responsible:  Commission of the European Co mmunities. Health & Consumer 
Protection Directorate-General  Directorate E – Food Safety: Plant Health, Animal Health 
and Welfare, International questions.  
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 supplements (foodstuffs aiming to supplement the normal diet consisting 
on concentrated sources of nutrients or substa nces with a nutritional effect). CN 2106, 2936 
and 3044. ICS 67.220  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Member States of the European Communiti es (EC) and third countries exporting the 
products concerned to the EC.  
5. Title, language and number of pa ges of the notified document:  Draft Commission 
Directive amending the Annexes to Directive 2002/46/EC of the European Parliament and 
of the Council as regards the inclusion of certa in substances (5 pages available in English, 
French and Spanish).  This measur e has also been notified under TBT.  
6. Description of content:   
It is proposed to add: Boric acid, Calcium-L-me thylfolate and Sodium borate, to the list of 
forms of vitamins and minerals  that may be used for the manufacture of food supplements 
Further background:   
In G/SPS/N/EEC/87 (16 J une 2000) the EC notified Directive 2002/46/EC of the European 
Parliament and of the Council of 10 June 2002 on the approximation of the laws of the 
Member States relating to food supplements  (O. J. L183, 12/07/2002 pp. 51-57) that set EC 
rules for food supplements containing vitamins and minerals. Only vitamins and minerals 
listed in Annex I, in the forms listed in A nnex II, may be used fo r the manufacture of food 
supplements. Since 2002, additional substances have been evaluated and are proposed to be 
included in the Annex.  
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   
To facilitate trade G/SPS/N/EEC/274 
Page 2  
 
 8. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:   
European Commission Document SANCO/ 2005/02845 Draft Commission Directive 
amending the Annexes to Directive 2002/46/EC of the European Parliament and of the 
Council as regards the inclusion of certain subs tances  (Available in English, French and 
Spanish). When adopted it will be publishe d in the Official Journal available at: 
http://europa.eu.int/eur-lex/lex/JOIndex.do?ihmlang=en   
Directive 2002/46/EC of the European Parliame nt and of the Council of 10 June 2002 on the 
approximation of the laws of the Member Stat es relating to food s upplements (O.J. L183, 
12/07/2002 pp: 51 – 57) can be downloaded from: 
http://europa.eu.int/eur-lex/pri /en/oj/dat/2002/l_183/l_18320020712en00510057.pdf  
10. Proposed date of adoption:  January 2006  
11. Proposed date of entry into force:  20 days after publication in the Official Journal of the 
European Union  
12. Final date for comments:  45 days from date of notification  
Agency or authority designated to handle co mments:  [ X ] EC notification authority, 
[   ] EC enquiry point, or address, fax number and E-mail address (if available) of other body:   
13. Texts available from:  [   ] EC notificati on authority, [ X ] EC enquiry point, or 
address, fax number and E-mail address (if available) of other body: