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Proposed Draft Guidelines for Dietary Supplements (Agenda Item 7)[7]

42. The Committee had an exchange of views on the opportunity of proceeding with work on Dietary Supplements in view of the difficulty to reach consensus on the approach to be followed. The Delegation of the United States, supported by the Delegation of the United Kingdom and Japan, did not agree with the development of the guidelines as the provisions therein were inconsistent with their national regulations and would unnecessarily restrict consumer access to dietary supplements. Some delegations however stressed the need for international guidelines as these products were widely traded and should be regulated. Other delegations, although not opposed to the development of guidelines, pointed out that several issues remained to be addressed and that further scientific data would be needed. The Delegation of Canada emphasized the importance of applying risk assessment methodology if maximum levels of intake were to be established. The Delegation of the Netherlands stressed the need for a safety based approach in setting upper limits.

43. The Committee agreed to concentrate on safety considerations based on scientific evidence and proceeded with the consideration of the text, with the understanding that some questions could not yet be settled.


44. Some delegations felt that the Preamble was not necessary and should be deleted, as the promotion of balanced diets concerned nutrition policy and was therefore outside the Scope. Other delegations and the Observer from Consumers International felt that the importance of a balanced diet should be highlighted as it was essential to place the guidelines in their proper context. The Committee retained the Preamble with an amendment to the first sentence to make it more general.

45. The Committee did not accept the proposal of the Delegation of India to indicate that "However people who do not have access to balanced diets may need vitamins and minerals supplements to safeguard their health".


46. The Committee discussed the opportunity of referring to "dietary supplements". It was suggested to establish a distinction between food supplements intended for general use and dietary supplements for specific dietary purposes. The Observer from the EC indicated that "dietary" applied only to foods for special dietary uses in the EC Directive and that confusion should be avoided between these two categories of products.

47. The Committee agreed to refer to "Vitamins and Minerals Supplements" in the scope, the title and throughout the text as it would clarify that the guidelines did not apply to other nutrients.

48. Some delegations indicated that supplements were regulated as drugs in their legislation. After an exchange of views on the applicability of the guidelines, the Committee agreed to amend the second paragraph to clarify that the classification of supplements was left to national legislation and the guidelines did not apply where supplements were regulated as drugs.

2. Definitions

49. The Committee deleted current sections 2. Definitions and 3. Nutrients to replace them with new sections as proposed by the Delegation of Germany.

Section 2.1

50. Some delegations pointed out that other nutrients might be included in the supplements, and it was clarified that they derived their nutritional relevance primarily from minerals and/or vitamins. The Committee did not agree to include a maximum level of energy to distinguish supplements from other products such as fortified foods, as the definition was sufficiently explicit.

51. The different forms of presentation were mentioned in the definition without any reference to "pharmaceutical dosage" which could create confusion on the nature of the product.

52. The Committee agreed to specify that supplements were used when the intake of food was insufficient to meet vitamins and minerals requirements or when the consumers considered that their diet required supplementation.

Section 2.2

53. While recognizing that supplements were regulated as drugs in some countries, the Committee agreed that for the purpose of the Guidelines, they were considered as foods.

Section 2.3

54. The Committee agreed to indicate that supplements could also be used for specific dietary purposes.

3. Composition

Section 3.1

55. Some delegations were in favour of a positive list while other delegations stressed that no comprehensive list could be established and that no limitations should be set except on the basis of safety; moreover, an "adequate intake" was not clearly defined. The Committee agreed that only vitamins/provitamins and those minerals which were recognized as essential on a scientific basis should be included. The Committee did not come to an agreement on the proposal of the Delegation of Germany concerning recommendations for intake, which was left in square brackets. The Delegation of France expressed the view that toxicological and nutritional aspects should be distinguished when safety limits were considered, and the Committee should primarily address nutritional concerns.

56. The Committee agreed to refer to nutrient selection criteria (3.1.2), to limitations of use for health protection reasons (3.1.3) and to the suitability of nutrients for specific purposes on the basis of scientific data (3.1.4).

Section 3.2

57. In section 3.2.1, the Committee could not agree on a minimum level set and left "15% of the recommended daily intake" square brackets.

58. In section 3.2.2, some delegations were opposed to the definition of a maximum level of 100% of the recommended daily intake. The Committee agreed to a proposal by the Delegations of the United Kingdom and Canada referring to a safe level set on the basis of risk assessment, taking into account all sources of the nutrients in the diet, as well as nutrient interaction. Both proposals were put in square brackets for further consideration.

59. In section 3.2.3, it was agreed that when a narrow margin existed between the RDA and the adverse level, different maximum limits might be established at the national level.

8. Labelling

60. The Committee agreed to refer to the name of the product instead of "commercial name".

61. In section 8.3, the Committee agreed that the label should indicate "the biologically active part of the vitamins and minerals". As it was suggested that "recommended daily intake" be replaced by "nutrient reference value", the current wording was retained in square brackets for further comments.

62. The Committee agreed that section 8.4 should only mention recommendations for use while section 8.5 should refer to a warning statement when a risk of toxicity existed.

Status of the Proposed Draft Guidelines for Vitamins and Minerals Supplements

63. The Delegation of the United States, supported by other delegations, pointed out that since there was no consensus on many aspects of the Guidelines and further detailed consideration of the proposals put forward at the session would be required, the text should be returned to Step 3 for additional comments on the amended version. Several delegations however noted that significant progress had been made through extensive discussion and that guidelines were urgently needed.

64. The Committee agreed to forward the Proposed Draft Guidelines to the Commission for adoption at Step 5 (see Appendix V). The Delegations of Australia, Canada, Japan, Netherlands, New Zealand, United States and United Kingdom objected to this decision.

[7] CL 1995/18-NFSDU and CX/NFSDU 96/6 (comments of Cuba, Denmark, France, Germany, Malaysia, Spain, European Federation of Associations of Health Product Manufacturers), CX/NFSDU 96/6-Add 1 (Consumers for Health Choice), CRD 6 (Canada, Thailand)

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