FOOD SUPPLEMENTS (VITAMINS AND MINERAL
SUPPLEMENTS)
(21294)
8525/00
COM(00) 222
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Draft Council Directive on the approximation of the laws of the
Member States relating to food supplements.
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| Legal base:
| Article 95 EC; co-decision; qualified majority voting
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| Document originated:
| 8 May 2000 |
| Forwarded to the Council:
| 11 May 2000 |
| Deposited in Parliament:
| 5 June 2000 |
| Department: |
Health |
| Basis of consideration:
| EM of 28 June 2000 |
| Previous Committee Report:
| None, but see paragraph 4.7 below
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| To be discussed in Council:
| No date set |
| Committee's assessment:
| Politically important |
| Committee's decision:
| Not cleared; awaiting further information
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Background
4.1 Council Directive 79/112/EEC[25]
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[26],
sets out more detailed conditions for nutritional labelling.
4.2 However, according to the Commission,
the second of these 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. It has accordingly put forward 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.
The current proposal
4.3 In the introduction to its proposal,
the Commission says that, although a varied diet should ideally
provide all the necessary nutrients, changes in life styles and
dietary habits may in practice lead to inadequate intakes, and
that consequently recent scientific research has suggested that
health benefits may arise from the intake of recommended levels
of these nutrients. It also points to the increased consumer demand
for nutritional supplements, and their subsequent proliferation
on the market. It goes on to suggest that, although it would not
be right to restrict consumer choice in this area, it is desirable
to ensure that the products in question are safe, and that appropriate
and accurate information is provided on the label, over and above
that provided for more generally in Council Directive 79/112/EEC.
4.4 Against this background, the Commission
is proposing:
- that only those vitamins and supplements normally
consumed as part of the diet, and considered essential by the
Scientific Committee on Food (SCF), should be allowed in food
supplements;
- that these should be set out in a "positive"
list;
- that, as with other Community legislation on
foods for infants and particular nutritional uses, there should
also be a "positive" list for the different chemical
forms of a nutrient that can be used in the manufacture of foods,
based on their safety and bioavailability;
- that, on safety grounds, provision should be
made for the maximum levels of vitamins and minerals in food supplements
when used in accordance with the manufacturer's instructions,
having regard to the intake of those nutrients from the normal
diet, and to the upper safe limits already established by scientific
risk assessment;
- that minimum levels should also be set, in order
to ensure that a supplement contains amounts sufficient to justify
its intended purpose;
- that, in each case, the actual maximum and minimum
levels would be set by the Commission, based on the advice of
the SCF, and that the Commission should also be able, where necessary,
to revise the composition of the "positive" lists;
- that labels should contain information about
the amount of ingredients, clear instructions about the use of
the product and recommended quantity, coupled with warnings about
exceeding the latter;
- that manufacturers should be prohibited from
using "fanciful" names, which could confuse or mislead
the consumer;
- that manufacturers should similarly be forbidden
to use misleading claims about the effect of their product in
treating disease, or to suggest that a varied and adequate diet
cannot provide a sufficient quantity of nutrients;
- that, in order to facilitate effective monitoring,
manufacturers or importers placing a product on the market in
a Member State should notify the competent authority (though the
Member State would not have to impose this requirement in cases
where it can demonstrate to the Commission that it was not necessary
for monitoring purposes).
4.5 The Commission is proposing that Member
States should make the necessary legislative provision by 31 May
2002, so as to permit trade in products complying with the proposed
Directive from 1 June 2002. A prohibition on trade in products
not complying would not, however, come into force until 1 June
2004.
The Government's view
4.6 In her Explanatory Memorandum of 28
June 2000, the Parliamentary Under-Secretary of State at the Department
of Health (Ms Gisela Stuart) points 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 goes on
to say that in most other Member States these products are subject
to a more restrictive regulatory régime, and that, as a
consequence, consumers in this country enjoy access to a relatively
wide selection of products.
4.7 Against this background, the Minister
says that the Government's overall objective in relation to this
proposal will be to ensure that any restriction on this range
of products is justified on health, rather than trade, grounds.
She points out that a safety-based approach to setting maximum
limits was advocated by the Government in its response to the
Green Paper[27]
and subsequent discussion document issued by the Commission in
1997, and believes that the current proposal is consistent with
this objective. However, she adds that the Government will be
looking closely at the proposed "positive" list to ensure
that it accurately reflects the composition of products already
in the market place, and can readily be updated to take account
of advances in science and technology. She also suggests that,
while the safety of the substances which would currently be included
is not in question, the "potential for an adverse impact
on choice" is not yet clear.
4.8 As regards labelling, the Minister says
that the Government is pressing for mandatory nutritional labelling
of all foods, and therefore supports this aspect of the proposal.
It will, however, consider carefully whether the other additional
labelling measures, and the proposed notification system, are
justified. In the latter case, it has also noted that the proposed
arrangement is not a prior approval system, and that it need not
be imposed if there are other means of monitoring the range of
products in the market place.
4.9 Finally, the Minister says that interested
parties are currently being consulted on the proposals, following
which a detailed Regulatory Impact Assessment will be prepared.
In the meantime, she suggests that the costs to industry would
depend on the degree to which the "positive" list reflects
nutrients used in products on the market, and that, although the
labelling provisions would entail "significant" costs
to industry, these would be offset to some degree by the proposed
extended transitional period. She also says that the Commission's
Explanatory Memorandum does not give an assessment of the financial
implications of the proposal, and that the Government will be
pressing for such details when negotiations begin.
Conclusion
4.10 In principle, we welcome a move
towards providing more information to consumers on food supplements,
though we note — and share — the Government's concern
over the need to avoid an unduly prescriptive approach, which
might hinder the development of new products. When the Minister
provides the Regulatory Impact Assessment which she has promised,
we would be interested to see what is said on this point in response
to the consultation exercise which the Government is currently
conducting. Similarly, we would also 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 are not clearing the document.
25 OJ No. L 33, 8.2.79, p.1. Back
26
OJ No. L 276, 6.10.90, p.40. Back
27 (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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