41. The Chairman recalled that the last Session of the CAC (June 1997) discussed this issue and agreed to return the Proposed Draft to Step 3 for further comments and consideration by the CCNFSDU, including a fundamental reconsideration of the need for the Guidelines, and invited the Committee to exchange views on the fundamental question raised.
42. The Committee considered the matter and recognized that two approaches existed to this question. Several countries and the Observer from CI were in favour of further elaboration of these Guidelines without delay as vitamin and mineral supplements were widely marketed and the unregulated usage of some supplements might harm the health of consumers. Moreover, since national legislation could not always address the problems and trade barriers already existed, it was essential to provide an international reference in the framework of the Codex and to ensure fair trade practices. Some delegations pointed out that a clear distinction should be established between vitamins and minerals for therapeutic purposes, and dietary supplements which should be classified as foods and therefore within the mandate of the Committee.
43. The Delegation of Canada, supported by the United States strongly objected to further elaboration of the guidelines as this would interfere with the trade of products which could benefit certain consumers, as recent scientific data indicate that diet may not be sufficient to meet the requirements for some nutrients of some population subgroups; in addition, many consumers felt that the consumption of vitamin and minerals was a right, and products which were safe and presented no health risk should be freely available. The Delegation stressed that, since the attitude and perception of consumers greatly differed from one country to another, the regulation of supplements should be left to national authorities.
44. The Committee was reminded that in some countries vitamin and/or mineral supplements were regulated as pharmaceuticals or therapeutic goods entirely and in some countries it depended on the amount of dosage in excess of the RDI. It was therefore considered necessary first to solve the key principles of the problem. The Delegation of South Africa, supporting the written comments of Australia, stated that as the Guidelines would not apply to those countries where supplements were regulated as drugs, they would have a limited effect on the current situation in South Africa.
45. The Committee had an extensive debate on the basis for the establishment of upper limits in the light of currently available scientific evidence; some delegations supported a science based risk model approach for developing upper safe limits while other delegations stressed that decision should be based essentially on nutritional considerations. It was also noted that official authorities had to address questions related to unsubstantiated claims, control and monitoring of products, which should be taken into account when discussing the establishment of limits.
46. The Chairman proposed that in order to facilitate consensus, efforts should be made to combine the different approaches as it should be possible to integrate both safety and nutrition concerns on the following basis: the establishment of a science based risk assessment model to develop safe upper limits, taking into account all sources of nutrients and adequate safety factors to make recommendations for vitamin and mineral daily intake for vitamin and mineral supplements. The Committee could not come to a conclusion at this stage but agreed to continue its discussions at the next session in the light of the above proposal and the issues raised during the debate.
47. The Secretariat drew the attention of the Committee to the Joint FAO/WHO Expert Consultation on Human Vitamin and Mineral Requirements, currently being held in Bangkok (21-30 September 1998). The intention of the Consultation was to review the full scope of food-based vitamin and minerals requirements, including their role in normal human physiology and metabolism and in deficiency disease conditions and it might provide the basis for the solution of this issue.
48. The Observer from the EC indicated that the question of dietary supplements was currently under consideration in the EC, where no legislation existed as yet, and informed the Committee that a paper on this matter had been prepared by the EC services. This paper provided a neutral and objective presentation on the issues that should be considered on this subject and aimed to help understand the rational behind the different approaches. The Observer pointed out that this paper currently discussed had been developed in the EU context but that it might be further developed in the international context with the participation of interested countries; it would be useful to study in depth the principles justifying each particular position in order to find a common ground for discussion. The Committee agreed that, before proceeding further in the elaboration of the Guidelines a discussion paper, taken as a basis the above mentioned paper, should be prepared jointly by Canada, USA and the EC on the issues raised above.
STATUS OF THE PROPOSED DRAFT GUIDELINES ON VITAMIN AND MINERAL SUPPLEMENTS
49. The Committee decided to retain the Proposed Draft Guidelines for Vitamin and Mineral Supplements at Step 4 and agreed to consider a discussion paper prepared by Canada, the United States and the EC at its next session in order to facilitate consideration of this issue.