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"
Date: 2000-10-19
Institutions: European Economic and Social Committee
Subjects: approximation of laws, consumer protection, food substitute, health policy, human nutrition, processed food product

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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

The proposal for a directive sets out to regulate within
1.1.
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
are concentrated sources of nutrients, marketed in pre-pack-
aged dose form as capsules, tablets, powder or similar and
sometimes combined with other ingredients, carrier substances
or flavourings. The broad range of food supplements on the
market includes many nutrients such as amino acids or certain
fatty acids, as well as vitamins, minerals, plant extracts and
other substances.

These shortcomings in terms of definition, labelling
1.5.
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.

1.6.
The Commission’s proposal on approximation of legal
requirements for food supplements defines these as nutrients
alone or in combination marketed in dose form. This limits
the scope of the directive to vitamins and minerals contained
in positive lists (Annexes I and II),
thus excluding use
of unauthorised substances of this substance class. Other
ingredients (other nutrients, plant extracts) are not subject to
the provisions of the directive but for now will continue to be
governed by the laws of individual states.

In past decades nutritional advice was given to combat
1.2.
general malnutrition and vitamin deficiency diseases, but today
the accent is on improving health (fitness, wellness) and
preventive measures to reduce risk factors in particular target
groups, e.g. the elderly. The market for such products is
expanding rapidly, lacks transparency and differs considerably
between Member States.

1.7.
For permitted vitamins and minerals, maximum levels
are to be laid down on the basis of a scientific risk assessment,
as well as minimum levels to guarantee the intended purpose
of the product. Stricter observation of nutrition recommen-
dations (reference values) is intended to ensure safety in the
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,
which is causing more and more consumers to increase their
use of these products. The role of electronic commerce in
this connection is growing, but without consumers being
adequately informed and protected.

In some Member States people traditionally treat food
1.4.
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
from the market, on the grounds that they were effectively
medicines but did not fulfil the more stringent legal require-
ments applicable to medicines.

1.8.
The labelling, presentation and advertising of products
must not refer to properties of preventing or curing diseases.
Labelling must provide information about the recommended
daily intake in relation to portions of the preparation, a
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.

1.9.
The label must indicate the amount of nutrients per
recommended daily portion and per single dose both in
numerical form using the units specified in Annex I, and as a
percentage of the reference values.

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1.10.
To permit effective surveillance, manufacturers are to
provide a model of the label to the competent authority when
they start selling their product. This also applies to importers,
if the product is manufactured in a third country.

for nutritional intake have existed in some Member States
since January 2000.

2. General comments

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
authorities and consumers. The Committee espouses the
Commission’s concern to give top priority to consumer health
protection, safety and public information. It is pleased to
note that the Commission explicitly includes the European
Economic Area (EEA) in its proposal.

2.2.
The Commission clearly defines food supplements as
foods, although in some countries these products are not
immediately recognisable as such. As foods they are not
governed by the provisions of pharmaceuticals legislation.

The scope of the directive is initially restricted to the
2.3.
substance class of vitamins and minerals, classed as ‘essential’
in the Scientific Committee for Food’s Report on Nutrient and
Energy Intakes for the European Community (31st series).
this approach is not
However,
ambitious enough, since it only covers a small part of the food
supplements available. Steps should be taken as soon as
possible to widen the scope of the directive to include lists of
substances which have an adequate effectiveness and safety
record.

the Committee feels that

2.4.
The title of the directive, with its reference to laws
relating to food supplements, suggests a broader range of
substances,
regulation of which would then be dispro-
portionately slow as a result of the time required for implemen-
tation and transitional periods. The Committee therefore calls
on the Commission to provide regulations for other substances
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
consumer information.

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
(Directive
90/496/EEC), but which the Committee feels should be
brought up to date as soon as possible by the EU’s Scientific
Committee for Food (SCF), particularly as new reference values

reference to rules

that already exist

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
vitamins and minerals, flavourings, colourings and sweeteners,
are particularly attractive to children.

2.7.
Consumption of food supplements should be monito-
red and subject to general status reports, so that prompt and
effective action can be taken if negative effects (e.g. overdose)
are reported.

By analogy with food law, advertisers should not be
2.8.
allowed to make assertions and promises giving the impression
that the product can cure, alleviate or prevent diseases (1). This
seems to the Committee to be justified, as scientific studies on
the effect of individual substances — e.g. in preventing disease
— have not always produced conclusive results, whilst for
some high-risk individuals an overdose can actually increase
the risk of disease.

2.9.
Advertisements often attribute to food supplements
health-promoting or cosmetic effects (prevention of hair loss,
ageing of the skin, etc.), but such claims are not covered by the
ban on claims relating to the prevention or cure of diseases.
The Commission is therefore called upon to draw up rules for
health claims as soon as possible.

2.10.
The members of the Committee fear that many
products from third countries do not always meet single
market requirements and are too rarely checked by supervisory
bodies. This problem is even more acute in the sphere of
electronic commerce. The scope of
this directive should
therefore be broadened to cover products sold over the Internet
or by mail order (2), which hitherto have in some cases been
subject only to national rules.

2.11.
The statement to the effect that a high-quality diet
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

(1) Such claims are also increasingly to be found in sections of the

media devoted to subjects such as lifestyle and fitness.

(2) See ESC opinion (OJ C 169, 16.6.1999, p. 36) on electronic

commerce.

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declare natural foods to be inadequate ensures that food
supplements will not come to be seen as a substitute for the
normal diet. This is very welcome in the interests of protecting
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
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
(Directive 89/398/EEC).

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
when it would be advisable to obtain independent nutritional
advice (dietetics consultation). Governments, public health
services, doctors and producers of food supplements have a
information
role to play here. This supplier-independent
should not play down the importance of diet and lifestyle in
promoting health, and it should not discourage people from
seeking nutritional advice.

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
reason it welcomed the introduction of the question of dietary
patterns in the White Paper and encouraged the future
authority to deal with ‘nutritional aspects’.

3. Comments on individual articles

3.1.1.
The explanation of ‘dose form’ in Article 2(c) should
be expressed in more general terms: ‘... such as pills, powders,
liquids and other similar forms.’

Article 3

The Committee points out that supervisory bodies
3.2.
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.

Articles 4 and 5

To be consistent, ‘vitamins and minerals’ should also
3.3.
be replaced here by general terms such as ‘nutrients’, ‘permitted
substances’ etc.

Article 5(1)(b)

3.4.
The Committee regards Article 5 as crucial to approxi-
mating the Member States’ laws on food supplements. Introdu-
cing maximum amounts, using reference values and intakes
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
difference between the reference value and the upper safe
level’.

Article 2

Article 5(3)

3.1.
The definition of these products as nutrients alone or
in combination is true of vitamins and minerals as micro-
nutrients, but does not fit food supplements that are not
nutritional in character. However, bioactive substances such
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
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
be extended.

(1) See ESC opinion of May 2000 (OJ C 169, 16.6.1999, p. 26).

3.5.
The SCF should establish the lists of minimum and
maximum amounts, and purity criteria as quickly as possible
so as to avoid a long period of legal uncertainty after the
directive enters into force. This would ultimately result in
lower product safety.

Article 6

The Committee welcomes the requirement for labelling
3.6.
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
the consumer against being misled.

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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
confused with the trade name. The directive should therefore
stipulate that the name appear ‘on the label’ and include the
word ‘supplement’.

Article 6(2)

In addition,

3.8.
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
misled (1).

Article 6(3)(b)

The following should be added: ‘..., with reference to

3.9.
specific population groups where appropriate’.

3.13.
The Committee welcomes the ban on advertising
statements to the effect that a diet without food supplements
is inadequate. However, since it is scientifically proven that
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 8(2)

3.14.
The Commission is urged to find a way of providing
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
benchmark or to require a statement of the price per single
dose.

3.15.
would make it easier to read labels.

Standardising dose units and abbreviations (Annex I)

Article 6(3)(c)

3.10.
priate to needs’.

The word ‘diversified’ should be replaced by ‘appro-

Article 10

Article 6(4)

3.11.
preparation is a food supplement’.

The statement should be worded positively:

‘This

Under existing legislation, ingredients produced using
3.12.
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
beneficial to health, consumers have a fundamental interest in
knowing whether the foodstuffs concerned have been pro-
duced using gene technology.

(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
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
not mentioned in the action plan, the Committee calls on the
Commission to launch consultation on health claims and common
practices in different Member States with a view to harmonising
the relevant Community legislation.’

The notification requirement is intended to facilitate
3.16.
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
be without a notification procedure. This system should
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.

Article 15(b)

3.17.

1 June 2004 should be changed to 1 June 2003.

4. Conclusion

The Committee is glad that this draft directive harmon-
4.1.
ises the law on food supplements in the Community,
in
particular remedying shortcomings in consumer health protec-
tion, food safety and consumer information, and so dismantles
barriers to trade.

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4.2.
The definitions of the scope of the directive should,
however, be worded in such a way that the directive can be
extended as quickly and easily as possible in accordance with
a timetable to include other food supplements.

4.5.
Advertising statements concerning health-promoting
properties should better reflect requirements for the prevention
of misleading information (health claims).

4.3.
There is an urgent need for a uniform scientific basis
for preparing the data that must be established or taken into
account for substances on the positive list (maximum levels,
upper
in Directive
90/496/EEC must also be updated, completed and accepted by
all the Member States.

reference values

levels). The

safe

4.6.
It seems necessary specifically to include in the scope
of the directive products sold by mail order or over the
Internet.

4.7.
The notification requirement should apply to all Mem-
ber States without exception, and the authorities must be
better equipped to provide effective surveillance.

4.4.
Once the directive enters into force, steps must be
taken to avoid any legal uncertainty with regard to the lists of
minimum and maximum amounts, and purity criteria.

4.8.
The Committee points out that the general public
should receive more information about when it makes sense
to take food supplements and in which cases nutritional advice
should be sought.

Brussels, 19 October 2000.

The President

of the Economic and Social Committee

Göke FRERICHS