. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/273 
8 November 2005 
 (05-5226) 
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):  Foodstuffs for particular nutritional uses (i.e. foodstuffs which, owing to their 
special composition or manufacturing process, ar e clearly distinguishable from foodstuffs for 
normal consumption, which are suitable for their claimed nutritional purposes and which are 
marketed in such a way as to indicate such suitability) . CN Headings 2104, 2106. ICS: 
67.040, 677.220.20 and 67.2300  
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 p ages of the notified document:  European Commission 
Document SANCO/2005/02844 - Draft Commission Directive amending the Annex to Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific 
nutritional purposes as regards the inclusion of certain substances  (Available in English, 
French and Spanish).  This measur e has also been notified under TBT.  
6. Description of content:   
It is proposed to enlarge the EC list of chemical substances that may be used in the 
manufacture of foods for partic ular nutritional uses (FPNU).  
Substance  Category of food  
  All FPNU  FSMP  
calcium-L-methylfolate x  magnesium L-aspartate  x boric acid x  
sodium borate x  
creatine monohydrate x   
 
FSMP: Foods for special medical purposes. 
FPNU: Dietary foods for particular nutritional uses including FSMP’s but excluding infant formulae, follow-on formulae, processed cereal-based 
foods and baby foods intended for infants and young children. 
 G/SPS/N/EEC/273 
Page 2  
 
 Further background:
   
In G/SPS/N/EEC/80 (6 April 2000) the EC notified Commission Directive 2001/15/EC of 15 
February 2001 on substances that may be added for specific nutritional purposes in foods for 
particular nutritional uses  (O.J. L52, 22/02/2001 pp. 19-5) that specifies certain categories of 
substances and mentions for each of them the chemical substances that may be used in the 
manufacture of FPNU.  
In G/SPS/N/EEC/229 (23 December 2003) the EC  notified Commission Directive 2004/5/EC 
of 20 January 2004 amending Directive 2001/15/EC  to include certain substances in the 
Annex (O.J. L14, 21/01/2004 pp.: 19 -20) 
Since 2004, additional substances have been evaluated and the measure proposed hereby 
includes them in the annex to Directive 2001/15/EC.   
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 
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/2005/02844 - Draft Commission Directive 
amending the Annex to Directive 2001/15/EC as re gards the inclusion of certain substances 
(Available in English, French and Spanish). When adopted it will be published in the Official 
Journal available at:  http://europa.eu.int/eur-lex/lex/JOIndex.do?ihmlang=en   
A consolidated text of Directiv e 89/398/EEC is available at:  
http://europa.eu.int/eur-lex/e n/consleg/pdf/1989/en_1989L0398_do_001.pdf   
The consolidated text of Directive 2001/15/EC is available at 
http://europa.eu.int/eur-lex/e n/consleg/pdf/2001/en_2001L0015_do_001.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: