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C 14/42 EN Official Journal of the European Communities 16.1.

2001

Opinion of the Economic and Social Committee on the ‘Proposal for a Directive of the European
Parliament and of the Council on the approximation of the laws of the Member States relating to
food supplements’

(2001/C 14/10)

On 23 June 2000 the Council decided to consult the Economic and Social Committee, under Articles 43
and 198 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 5 October 2000. The rapporteur
was Mr Jaschick.

At its 376th plenary session (meeting of 19 October 2000) the Economic and Social Committee adopted
the following opinion by 96 votes to one, with no abstentions.

1. Introduction 1.5. These shortcomings in terms of definition, labelling
and other requirements are now to be remedied for the
protection and information of consumers and in the interests
of free movement of goods in the Community.
1.1. The proposal for a directive sets out to regulate within
the Member States the marketing of products offered as
supplements to the normal diet and which have hitherto been
described as food supplements. All the products in question 1.6. The Commission’s proposal on approximation of legal
are concentrated sources of nutrients, marketed in pre-pack- requirements for food supplements defines these as nutrients
aged dose form as capsules, tablets, powder or similar and alone or in combination marketed in dose form. This limits
sometimes combined with other ingredients, carrier substances the scope of the directive to vitamins and minerals contained
or flavourings. The broad range of food supplements on the in positive lists (Annexes I and II), thus excluding use
market includes many nutrients such as amino acids or certain of unauthorised substances of this substance class. Other
fatty acids, as well as vitamins, minerals, plant extracts and ingredients (other nutrients, plant extracts) are not subject to
other substances. the provisions of the directive but for now will continue to be
governed by the laws of individual states.

1.2. In past decades nutritional advice was given to combat
general malnutrition and vitamin deficiency diseases, but today 1.7. For permitted vitamins and minerals, maximum levels
the accent is on improving health (fitness, wellness) and are to be laid down on the basis of a scientific risk assessment,
preventive measures to reduce risk factors in particular target as well as minimum levels to guarantee the intended purpose
groups, e.g. the elderly. The market for such products is of the product. Stricter observation of nutrition recommen-
expanding rapidly, lacks transparency and differs considerably dations (reference values) is intended to ensure safety in the
between Member States. case of substances that easily produce overdose and damage to
health.

1.3. Possible health-promoting effects or cosmetic claims
are clearly pointed up in advertising for food supplements, 1.8. The labelling, presentation and advertising of products
which is causing more and more consumers to increase their must not refer to properties of preventing or curing diseases.
use of these products. The role of electronic commerce in Labelling must provide information about the recommended
this connection is growing, but without consumers being daily intake in relation to portions of the preparation, a
adequately informed and protected. warning that this amount should not be exceeded, and an
indication that food supplements are not a substitute for an
adequate diet. It is therefore forbidden to state that adequate
nutrients cannot be obtained from the diet.
1.4. In some Member States people traditionally treat food
supplements as (over-the-counter) medicines; food authorities
have also often been obliged, in view of the concentration of
nutrients or active ingredients to withdraw these products 1.9. The label must indicate the amount of nutrients per
from the market, on the grounds that they were effectively recommended daily portion and per single dose both in
medicines but did not fulfil the more stringent legal require- numerical form using the units specified in Annex I, and as a
ments applicable to medicines. percentage of the reference values.
16.1.2001 EN Official Journal of the European Communities C 14/43

1.10. To permit effective surveillance, manufacturers are to for nutritional intake have existed in some Member States
provide a model of the label to the competent authority when since January 2000.
they start selling their product. This also applies to importers,
if the product is manufactured in a third country.

2.6. Another urgent need is for age to be taken into
account, as, for example, the needs of small children are
significantly less than those of adults, whilst effervescent
tablets for example, sometimes containing high doses of
2. General comments
vitamins and minerals, flavourings, colourings and sweeteners,
are particularly attractive to children.

2.1. The initiative aimed at regulating these products at
Community level is to be welcomed both from the point of
view of producers and distributors and from that of food 2.7. Consumption of food supplements should be monito-
authorities and consumers. The Committee espouses the red and subject to general status reports, so that prompt and
Commission’s concern to give top priority to consumer health effective action can be taken if negative effects (e.g. overdose)
protection, safety and public information. It is pleased to are reported.
note that the Commission explicitly includes the European
Economic Area (EEA) in its proposal.
2.8. By analogy with food law, advertisers should not be
allowed to make assertions and promises giving the impression
2.2. The Commission clearly defines food supplements as that the product can cure, alleviate or prevent diseases (1). This
foods, although in some countries these products are not seems to the Committee to be justified, as scientific studies on
immediately recognisable as such. As foods they are not the effect of individual substances — e.g. in preventing disease
governed by the provisions of pharmaceuticals legislation. — have not always produced conclusive results, whilst for
some high-risk individuals an overdose can actually increase
the risk of disease.

2.3. The scope of the directive is initially restricted to the
substance class of vitamins and minerals, classed as ‘essential’
in the Scientific Committee for Food’s Report on Nutrient and 2.9. Advertisements often attribute to food supplements
Energy Intakes for the European Community (31st series). health-promoting or cosmetic effects (prevention of hair loss,
However, the Committee feels that this approach is not ageing of the skin, etc.), but such claims are not covered by the
ambitious enough, since it only covers a small part of the food ban on claims relating to the prevention or cure of diseases.
supplements available. Steps should be taken as soon as The Commission is therefore called upon to draw up rules for
possible to widen the scope of the directive to include lists of health claims as soon as possible.
substances which have an adequate effectiveness and safety
record.

2.10. The members of the Committee fear that many
products from third countries do not always meet single
2.4. The title of the directive, with its reference to laws market requirements and are too rarely checked by supervisory
relating to food supplements, suggests a broader range of bodies. This problem is even more acute in the sphere of
substances, regulation of which would then be dispro- electronic commerce. The scope of this directive should
portionately slow as a result of the time required for implemen- therefore be broadened to cover products sold over the Internet
tation and transitional periods. The Committee therefore calls or by mail order (2), which hitherto have in some cases been
on the Commission to provide regulations for other substances subject only to national rules.
as soon as possible and, for a transitional period, to take action
together with the Member States to harmonise labelling and
advertising regulations for these products and to prevent
distortions of competition, damage to health and misleading 2.11. The statement to the effect that a high-quality diet
consumer information. appropriate to needs should normally be sufficient for proper
nutrition, particularly in the light of modern conditions of
production, is of key importance. The ban on using advertising
to elevate food supplementation above natural nutrition or to
2.5. The Committee explicitly welcomes the fact that the
Commission has limited the amount of permitted substances
in food supplements (maximum amounts), while providing for
a minimum dose to guarantee efficacy. The draft directive
makes reference to rules that already exist (Directive (1) Such claims are also increasingly to be found in sections of the
90/496/EEC), but which the Committee feels should be media devoted to subjects such as lifestyle and fitness.
brought up to date as soon as possible by the EU’s Scientific (2) See ESC opinion (OJ C 169, 16.6.1999, p. 36) on electronic
Committee for Food (SCF), particularly as new reference values commerce.
C 14/44 EN Official Journal of the European Communities 16.1.2001

declare natural foods to be inadequate ensures that food 3.1.1. The explanation of ‘dose form’ in Article 2(c) should
supplements will not come to be seen as a substitute for the be expressed in more general terms: ‘... such as pills, powders,
normal diet. This is very welcome in the interests of protecting liquids and other similar forms.’
consumers’ health. It follows, therefore, that food supplements
are not strictly necessary, but the market need not be
unnecessarily restricted, if there is felt to be a demand or a
need for these products for specific population groups, such Article 3
as the elderly or for use under specific circumstances, e.g.
pregnancy and breastfeeding. The indications for dietary foods
intended for particular nutritional uses are not affected by this 3.2. The Committee points out that supervisory bodies
(Directive 89/398/EEC). must have adequate staff and technical facilities so that
Member States can carry out their task of ensuring that food
supplements containing the permitted substances comply with
the directive.
2.12. The general public should, however, receive more
information about the situations in which use of food sup-
plements can be useful, how their use should be limited and Articles 4 and 5
when it would be advisable to obtain independent nutritional
advice (dietetics consultation). Governments, public health
services, doctors and producers of food supplements have a
role to play here. This supplier-independent information 3.3. To be consistent, ‘vitamins and minerals’ should also
should not play down the importance of diet and lifestyle in be replaced here by general terms such as ‘nutrients’, ‘permitted
promoting health, and it should not discourage people from substances’ etc.
seeking nutritional advice.

Article 5(1)(b)
2.13. In its comments on the White Paper on Food Safety,
the ESC (1) underlined that EU food policy must focus not only
safety (point 2.1.7), but on nutrition and diet as well. For this 3.4. The Committee regards Article 5 as crucial to approxi-
reason it welcomed the introduction of the question of dietary mating the Member States’ laws on food supplements. Introdu-
patterns in the White Paper and encouraged the future cing maximum amounts, using reference values and intakes
authority to deal with ‘nutritional aspects’. from diet, while also setting minimum levels, ensures a high
level of safety and protection against being misled. However,
it is essential when setting minimum and maximum levels that
certain age groups, especially small children, are taken into
account. The Committee suggests the following wording for
Article 5(1)(b), after the comma: ‘where there is only a small
3. Comments on individual articles difference between the reference value and the upper safe
level’.

Article 2 Article 5(3)

3.5. The SCF should establish the lists of minimum and
3.1. The definition of these products as nutrients alone or maximum amounts, and purity criteria as quickly as possible
in combination is true of vitamins and minerals as micro- so as to avoid a long period of legal uncertainty after the
nutrients, but does not fit food supplements that are not directive enters into force. This would ultimately result in
nutritional in character. However, bioactive substances such lower product safety.
as secondary plant products, dietary fibre, hormone-type
substances, co-enzymes, etc. have, in particular, become the
focus of scientific interest and are increasingly being sold by
the industry in the form of concentrates with reference to the Article 6
health-promoting effects of eating the foods in question. The
definition of food supplement products should therefore be
worded in such a way that the scope of the directive can easily 3.6. The Committee welcomes the requirement for labelling
be extended.
of food supplements, which will provide consumers with
comprehensive information on possible health risks or inadvis-
able practices. In particular the ban on claiming that a
substance can cure or prevent disease and the requirement to
give doses and warnings are major contributions to protecting
(1) See ESC opinion of May 2000 (OJ C 169, 16.6.1999, p. 26). the consumer against being misled.
16.1.2001 EN Official Journal of the European Communities C 14/45

Article 6(1) Article 7

3.7. However, the wording with regard to the name under
which products are sold is too general; this could easily be 3.13. The Committee welcomes the ban on advertising
confused with the trade name. The directive should therefore statements to the effect that a diet without food supplements
stipulate that the name appear ‘on the label’ and include the is inadequate. However, since it is scientifically proven that
word ‘supplement’. such diet must be put together carefully the words ‘an adequate
and diversified diet’ should be replaced by ‘a high-quality diet
appropriate to needs’.
Article 6(2)

Article 8(2)
3.8. In addition, the Commission must without delay
examine the rules and practices relating to health claims
applied in the Member States so that further provisions can
if necessary be added to provide protection against being 3.14. The Commission is urged to find a way of providing
misled (1). consumers with real price comparisons, given the multiplicity
of products and their different compositions. It might be
possible to give nutrients per 100 g as a general, standard
Article 6(3)(b) benchmark or to require a statement of the price per single
dose.

3.9. The following should be added: ‘..., with reference to
specific population groups where appropriate’.
3.15. Standardising dose units and abbreviations (Annex I)
would make it easier to read labels.
Article 6(3)(c)

Article 10
3.10. The word ‘diversified’ should be replaced by ‘appro-
priate to needs’.

3.16. The notification requirement is intended to facilitate
Article 6(4) surveillance of food supplements by the authorities. Although
under the ‘tell and do’ principle consumer protection measures
can only be taken when a product is already on the market,
there are at least more surveillance options than there would
3.11. The statement should be worded positively: ‘This be without a notification procedure. This system should
preparation is a food supplement’. therefore apply to all Member States; the Committee thinks it
would be too difficult to evaluate particular reasons for
Member States not needing to meet this requirement.
3.12. Under existing legislation, ingredients produced using
gene technology need only be labelled if the product contains
residues of modified protein. However, in the case of food
supplements which, clearly, are presented as particularly Article 15(b)
beneficial to health, consumers have a fundamental interest in
knowing whether the foodstuffs concerned have been pro-
duced using gene technology.
3.17. 1 June 2004 should be changed to 1 June 2003.

(1) ESC Opinion on the White Paper on Food Safety: ‘Often health
claims are made on packaging or in advertising of products
without proper scientific documentation, causing improper use
and creating unjustified expectations. For this reason, food 4. Conclusion
supplements and fortified foods (point 105 of the White Paper)
and herbal products too, should be regulated at EU level as soon
as possible, harmonising their definition, labelling and advertising
(particularly for claims related to well-being and health). Since
health claims are not currently regulated at Community level and 4.1. The Committee is glad that this draft directive harmon-
not mentioned in the action plan, the Committee calls on the ises the law on food supplements in the Community, in
Commission to launch consultation on health claims and common particular remedying shortcomings in consumer health protec-
practices in different Member States with a view to harmonising tion, food safety and consumer information, and so dismantles
the relevant Community legislation.’ barriers to trade.
C 14/46 EN Official Journal of the European Communities 16.1.2001

4.2. The definitions of the scope of the directive should, 4.5. Advertising statements concerning health-promoting
however, be worded in such a way that the directive can be properties should better reflect requirements for the prevention
extended as quickly and easily as possible in accordance with of misleading information (health claims).
a timetable to include other food supplements.
4.6. It seems necessary specifically to include in the scope
of the directive products sold by mail order or over the
4.3. There is an urgent need for a uniform scientific basis Internet.
for preparing the data that must be established or taken into
account for substances on the positive list (maximum levels,
upper safe levels). The reference values in Directive 4.7. The notification requirement should apply to all Mem-
90/496/EEC must also be updated, completed and accepted by ber States without exception, and the authorities must be
all the Member States. better equipped to provide effective surveillance.

4.8. The Committee points out that the general public
4.4. Once the directive enters into force, steps must be should receive more information about when it makes sense
taken to avoid any legal uncertainty with regard to the lists of to take food supplements and in which cases nutritional advice
minimum and maximum amounts, and purity criteria. should be sought.

Brussels, 19 October 2000.

The President
of the Economic and Social Committee
Göke FRERICHS