WORLD TRADE
ORGANIZATIONG/SPS/N/EEC/68
16 December 1998
(98-5072)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
If applicable, name of local government involved:           
2. Agency responsible:   European Commission – Directorate General for Industry
3. Products covered (tariff item number(s) as specified in national schedules deposited
with the WTO.  ICS numbers may be provided in addition, where applicable):   Dietary
foods for special medical purposes
4. Title and number of pages of the notified document:   Draft Commission directive on
dietary foods for special medical purposes, III/5318/98 – Rev.2 (15 pages)
5. Description of content:   The present draft includes a clear definition and categorization of
products covered, specific labelling provisions appropriate to their specific nature and
provisions for the notification to the competent authorities by manufacturers or importerswhen these products are put onto the market.  It also includes provisions for the minimum
and maximum levels of vitamins.  These levels, which are within scientifically recognized
safety limits, take into account the fact that the products are intended for persons with a
limited, impaired or disturbed capacity to digest, absorb, metabolise or excrete ordinary
food or certain nutrients and that they are to be used under medical supervision.  They alsotake into account that needs among intended users are very different and that the industry,
working in close co-operation with the medical profession, should dispose of a range of
levels that will allow it to cater for these different needs and to innovate on the basis of
scientific and technological progress.
6. Objective and rationale:  Public health
7. An international standard, guidelin e or recommendation does not exist [    ].
If an international standard, guideline or  recommendation exists, whenever possible,
identify deviations:   Yes, in Codex.  Deviations regard some compositional criteria that are
included in Annex (vitamins and minerals).
8. Relevant documents and language(s) in which these are available:  III/5318/98 – Rev.2
9. Proposed date of adoption:  March 1999
10. Proposed date of entry into force:  20 days after adoption
11. Final date for comments:  4 February 1999
Agency or authority designated to handle comments:   European Community Enquiry
Point
12. Texts available from:  National enquiry point [  X ] or address, telefax number and
E-mail address (if available) of other body:            