Brussels, 10 January 2003

Dear Mr Hasslberger,

Commissioner Byrne has asked me to thank you for your electronic mail of 12 December 2002 regarding Directive 2002/46/EC on food supplements and, in particular, the list of vitamin and mineral substances approved for use in food supplements.

Your letter raises concerns regarding the safety of three substances authorised for use in food supplements and included in Annex II of this Directive: sodium hydroxide, potassium hydroxide and calcium oxide. These substances have been evaluated by the Scientific Committee for Food and approved by the Council for use in the manufacture of foods since well before the adoption of the Directive on food supplements. These same substances have been evaluated for use in foods by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), convened under the auspices of the Food and Agriculture Organisation and the World Health Organisation and appear in the list of food additives included in the Codex Alimentarius Standard 192-1995. They have been safely utilised in foods for over 30 years.

The manufacture of foods requires the use of a wide range of nutritional substances adapted to the different chemical environments associated with their manufacturing processes. These ingredients are utilised in the necessary amounts as determined by the particularities of the individual product. These amounts are usually very small. In addition to level of addition, there is a significant qualitative difference in that these substances when utilised as ingredients of foods, must meet specific quality specifications (i.e. the form must be “food grade”), including purity criteria.
Therefore, I cannot accept the allegations you are making regarding the potential safety risk associated with the use of these substances in food supplements. Indeed, the primary objective of European food legislation is to ensure the highest level of consumer protection. The Directive on food supplements is fully in line with this objective.

In line with the provisions of the Directive, the Commission will put forward proposals to update the list of substances appearing in the Annexes of the Directive on food supplements when requests for substances to be added have been evaluated by the European Food Safety Authority.

I hope that the above explanations have addressed your concerns and help to place the issue you raised in the right perspective.

Sincerely yours,


Cc. A. Bardenhewer (Cabinet D. Byrne)
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