Select Committee on European Scrutiny Eighth Report


COM(00) 222

Draft Council Directive on the approximation of the laws of the Member States relating to food supplements.

Legal base: Article 95 EC; co-decision; qualified majority voting
Department: Health
Basis of consideration: SEM of 1 March 2001
Previous Committee Report: HC 23-xxiv (1999-2000), paragraph 4 (12 July 2000)
To be discussed in Council: Following receipt of European Parliament opinion
Committee's assessment: Politically important
Committee's decision: Cleared


  17.1  Council Directive 79/112/EEC[38] sets out general provisions on the harmonisation of the laws of the Member States on the labelling, presentation and advertising of foodstuffs for sale to the final consumer. As such, it was seen principally as a means of facilitating intra-Community trade, and covers such matters as the need to avoid misleading labelling, the particulars which must be shown on the label, including ingredients, and provisions governing the date showing when the foodstuff concerned should be consumed. A further measure, Council Directive 90/496/EEC,[39] sets out more detailed conditions for nutritional labelling.

  17.2  However, according to the Commission, the second of these measures does not apply to food supplements, and although reference is made in the earlier Directive to such supplements, the term is not adequately defined. The Commission also believes that the increasing demand for products of this kind, coupled with the wide range now on the market and the different national rules which apply to them, make it desirable for there to be Community legislation in this area.

  17.3  It therefore put forward in May of this year the current proposal for a Council Directive governing the sale of vitamins and mineral supplements, leaving the possibility of further measures in the future covering other nutritional supplements, such as amino acids, essential fatty acids, fibre, and plant and herbal extracts. In particular, it is proposing:

    —  that only essential vitamins and supplements, normally consumed as part of the diet, should be allowed in food supplements;

    —  that these should be set out in a "positive" list;

    —  that maximum and minimum levels should be set for vitamins and minerals in food supplements;

    —  that labels should contain information about the amount of ingredients, clear instructions about the use of the product and recommended quantity;

    —  that manufacturers should be prohibited from using "fanciful" or misleading names; and

    —  that those placing a product on the market should notify the Member State's competent authority (though the Member State would not have to impose this requirement where it was not necessary for monitoring purposes).

  17.4  In her Explanatory Memorandum of 28 June 2000, the Parliamentary Under-Secretary of State at the Department of Health (Ms Gisela Stuart) pointed out that, although manufacturers must comply with the general safety and labelling requirements laid down in food safety legislation, the UK has no specific legislation controlling the sale of supplements sold as foods. She added that in most other Member States these products are subject to a more restrictive regulatory regime, and that, as a consequence, consumers in this country enjoy access to a relatively wide selection of products.

  17.5  Against this background, the Minister said that the Government's overall objective was to ensure that any restriction on this range of products is justified on health, rather than trade, grounds. She pointed out that a safety-based approach to setting maximum limits was advocated by the Government in its response to the Green Paper[40] and subsequent discussion document issued by the Commission in 1997, but that the Government would be looking closely at the proposed "positive" list to ensure that it accurately reflected the composition of products already in the market place. The Minister also said that the Government was pressing for mandatory nutritional labelling of all foods, and therefore supported this aspect of the proposal. It would, however, consider carefully whether the other additional labelling measures, and the proposed notification system, were justified.

  17.6  In the conclusion to our Report of 12 July 2000, we said that we welcomed in principle a move towards providing more information to consumers on food supplements, though we shared the Government's concern over the need to avoid an unduly prescriptive approach. We also noted that the Minister had promised to let us have a Regulatory Impact Assessment, and we said that we would be interested at that stage to see what was said on this point in response to the Government's consultation exercise. Similarly, we said we would like to know how the Commission responds to the Government's request for more information on the wider financial implications of the proposal. In the meantime, we did not clear the document.

Supplementary Explanatory Memorandum of 1 March 2001

  17.7  In her Supplementary Explanatory Memorandum of 1 March 2001, the Minister provides a summary Regulatory Impact Assessment, which suggests that the 30,000 vitamin and mineral supplement products on the UK market are worth about £500 million a year, and that re-labelling costs could amount to some £10 million (though she adds that this is a maximum figure, because many products would be scheduled for re-labelling for other reasons during the transitional period). She puts reformulation costs at up to £4 million, but points out that in some cases, particularly for small businesses relying on unusual ingredients, this might not be a practical proposition, and products will be discontinued. Small specialist retailers also stand to lose "significant" amounts of business if a wide range of specialist products is no longer available. In addition, industry estimates notification costs at £500 per product for the 15,000 new products launched each year.

  17.8  As regards the financial implications at Community level, the Minister says that the Commission has not provided an assessment, but that it takes the view that any costs will be more than offset by the benefits of establishing a single market in these products.

  17.9  The Minister also summarises the results of the Government's consultation exercise. She says that responses from all sectors (consumers, industry, trade organisations and enforcement groups) were "broadly supportive", particularly as regards the adoption of a safety-based approach to setting upper limits. She adds that the main concern was that the proposed positive lists were unnecessarily restrictive, and could have a negative effect on consumer choice and costs to industry. Views on the labelling proposals and on notification were said to be"mixed": consumer groups favour more label information, particularly warnings, and believe compulsory notification would provide useful information, whilst industry respondents on the whole find the current proposals excessive and see compulsory notification as an unnecessary burden.


  17.10  We are grateful to the Minister for this further information. Whilst it is clear that some reservations remain over this proposal, we believe that the main parameters for the discussions in the Council have been clearly established, as have the views of the Government. We are therefore clearing the document.

38  OJ No. L 33, 8.2.79, p.1. Back

39  OJ No. L 276, 6.10.90, p.40. Back

40  (18083) 8150/97; see HC 155-ii (1997-98), paragraph 1 (22 July 1997) and HC 155-v (1997-98), paragraph 2 (5 November 1997). Back

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