The European Directive on Food Supplements was approved in March 2002 by the EU Parliament and at the end of May 2002 the EU Council It was published in the Official Journal of the EU on the 12th of July. The final text can be found at:
- Member States have up to one year of time from the date of publication to work out and publish their respective national laws to implement the provisions of the directive.
- Manufacturers have up to 36 months to submit dossiers to obtain approval for the numerous substances (approximately 300) that are sources of vitamins and/or minerals are already on the market in various Member States but which are missing from the Annexes of the directive. Any substances that either receive a negative response on their dossier or for which no dossier could be submitted by the end of the 36 months "grace period" must be removed from the market.
- The EU Scientific Committee for Foods (SCF) is reviewing the published literature to determine the "maximum safe levels" of each vitamin and mineral. The opinions of the SCF on some of the vitamins and minerals already reviewed can be found at:
After completion of this review by the SCF, the EU Commission and the Council will on the basis of the SCF opinions, and taking into account other factors that have not been made public, - decide the maximum allowed dosages for each one of the vitamins and minerals permitted in food supplements.
- Meanwhile, other directives that will have a definite impact on natural health products are being discussed by the EU Parliament and the Council.
The procedural steps and the publicly available documents with regard to these directives can be found on the EU Commission's website:
Traditional Herbal Medicinal Products:
Revision of Community Pharmaceutical legislation:
Watch out for more information on these legislative developments to come soon.