36. The Committee recalled that its last session had agreed that a discussion paper should be prepared by a Drafting Group[8] in order to facilitate further consideration of the Proposed Draft Guidelines, which had been returned to Step 4. In order to progress more efficiently the Chairman invited the Committee to structure the discussion in the following way:
37. The Delegation of the United States introduced the discussion paper which included a wide range of issues such as Description of the Covered Products, consideration of Positive and Negative Lists, Maximum and Minimum Levels, Purity Criteria, Good Manufacturing Practices (GMPs), Labelling, Packaging and Marketing and pointed out the wide range and the diversity of opinions surrounding the elaboration of provisions to address those issues.
38. The Committee had an extensive debate on the need for the elaboration of Guidelines. The Delegation of Canada strongly objected to the elaboration of the Guidelines and indicated that worldwide guidelines were not appropriate to address this very complex issue and suggested to leave the matter of regulation to national authorities. The Delegation stated that in Canada these products were currently classified as drugs and that the mandate of Codex was to develop guidelines or related texts for foods. This view was supported by the Delegations of India, Kenya and some other delegations. The Delegation of India expressed the view that the promotion of vitamin and mineral supplements will effect good dietary practices. The Delegation of the USA stressed the importance of consumer choice and access to vitamin and mineral supplements; however the importance of a balanced diet was not questioned.
39. The Delegation of Malaysia supported by several other delegations stressed the fact that those products were widely placed on the market, sometimes with a very high dosage of vitamins and minerals and in order to avoid misleading consumers, it was necessary to regulate them and to develop general guidelines.
40. Some Delegations who supported the elaboration of guidelines suggested to develop them on the basis of RDI indicating different values for upper limits, while some other delegations and the Observer of IADSA favoured further development on the guidelines setting safe upper limits based on sound scientific risk assessment.
41. The Committee agreed to proceed with further elaboration of the guidelines and decided to consider the Proposed Draft Guidelines in conjunction with the Discussion paper section by section and made the following changes.
Preamble
42. The Committee deleted the current Preamble and reworded it as proposed in CRD 17. The term dietary supplements was replaced with vitamin and mineral supplements. The Delegation of India pointed out that natural foods provided many more nutritive substances than just vitamins and minerals.
Section 1. Scope
43. The Committee agreed to insert a sentence to the effect that these guidelines apply to vitamin and mineral supplements which are regulated as foods and substituted the word regulations by authorities in the second paragraph. The Committee accepted the proposal by the Delegation of India to amend the first sentence by referring to supplementation if and when necessary, and decided to put this amendment in square brackets.
44. The Committee included a new sentence in square brackets specifying that foods for special dietary uses were not covered by the Scope and agreed that it should be discussed further at the next session.
Section 2. Definitions
45. The Committee amended the second sentence of the Definitions to read Vitamins and minerals are concentrated sources of those nutrients alone or in combination, marketed in capsules, tablets, powders, solutions etc, not in a conventional food form and they do not provide a significant amount of energy and put it in square brackets.
46. The Committee took out Section 2.2 as the content of this section was already covered by the amended Scope.
47. It was agreed to put Section 2.3 in square brackets as proposed by the Delegation of the USA.
Section 3. Composition
48. The Committee agreed that supplements should contain substances of nutritive value proven by scientific data, instead of indispensability in Section 3.1.1 and deleted the end of the sentence in square brackets, since the levels of use were addressed in section 3.2.
49. Section 3.1.2 was amended to reflect that criteria such as safety and bioavailability were essential in the selection of sources and the reference to FAO/WHO or Pharmacopoeias and national legislation was placed in square brackets.
50. The Committee edited Section 3.1.3 for clarification purposes and decided to put it in square brackets.
Section 3.2 Contents of Vitamins and Minerals
51. The Committee had an extensive debate on the reference to the percentage of RDI for minimum and maximum levels of nutrients and was unable to reach a consensus at this stage, therefore decided to keep both nutritional and risk assessment approaches open for further comments and consideration. 52. The Committee agreed to delete the alternative Section 3.2.1 which was placed in square brackets, replaced the bracketed alternative wording of Section 3.2.2 by the wording of Section 3.2.2 proposed in CRD 17 and put both options in square brackets.
Sections 4, 5 Food Additives, Contaminants and 6 Hygiene.
53. The Committee accepted the proposal of the Chairman and deleted Sections 4, 5 and 6 as those Sections were more relevant in Codex Standards but not in guidelines and the numbering of Sections was changed accordingly.
Former Section 8 Labelling (new Section 5)
54. To be consistent with previous decisions the Committee substituted the reference to dietary supplements with vitamin and mineral supplements in Section 8.1; agreed to delete the reference to the Guidelines on Nutrition Labelling; and put Section 8.2 in square brackets for further consideration.
55. The Committee had an extensive debate on the declaration of vitamins and minerals. Several delegations supported reference to the biologically active part of vitamins and minerals as bioavailability was referenced as one of the criteria in Section 3 while other delegations indicated that the meaning of this wording was not clear enough. As a compromise the Committee agreed to amend the former Section 8.3 as proposed by the Observer of the EC and including the references to amounts of vitamins and minerals by units of weight, the amount per portion of the product and the percentage of the NRV mentioned and retained it in square brackets.
56. The Committee agreed to accept the proposal of the Delegation of Malaysia to specify that supplements should not replace a balanced diet and that the supplements should be taken on the basis of qualified advice and put it in square brackets.
Status of the Proposed Draft Guidelines on Vitamin and Mineral Supplements
57. The Committee agreed to return the Proposed Draft Guidelines, as amended during the session, to Step 3 for further comments and consideration by next session of the Committee (see Appendix IV).
