Reference COD/2000/0080
Title Food supplements: approximation of the laws of the member States
Legal basis CE095
Number of TEC dossier T06805
Subject(s) 3.10.10- foodstuffs, foodstuffs legislation
4.60.02- consumer information, publicity, labelling
4.60.04- consumer health, food safety
Stage reached Awaiting Council 2nd reading 

Stages in the procedure
Events Documents: references Dates of publication
  Source reference Equivalent references of document  in Official Journal
Initial proposal  CE COM(2000)0222    C5-0234/2000 08/05/2000 C311 31-OCT-00 207(E)
Opinion of ESC  CES CES1212/2000    19/10/2000 C014 16-JAN-01 042
Report tabled PE A5-0025/2001 PE293.684 24/01/2001
EP opinion 1st reading PE T5-0079/2001    14/02/2001 C276 01-OCT-01 052 126
Modified proposal  CE COM(2001)0159    C5-0119/2001  19/03/2001 C180 26-JUN-01 248(E)
Council common position  CSL 12394/2/2001    C5-0640/2001 03/12/2001
Commission assessment  CE SEC(2001)1975    07/12/2001
Recommendation for 2nd reading tabled PE A5-0044/2002 PE312.624 20/02/2002
EP decision (second reading)  PE T5-0103/2002    13/03/2002
Agents in procedure - European Parliament
Committee Rapporteur Political group
Environment, public health, consumers (responsible) MÜLLER Emilia Franziska PPE-DE
Industry, external trade, research... ** (opinion) THORS Astrid  ELDR
Legal affairs, internal market (opinion)    
Agents in procedure - European Commission and Council of the Union
European Commission DG DG Health and consumer protection
Council of the Union Employment and social policy
Internal market

13/03/2002 - EP VOTE 2nd READING
 The European Parliament adopted the recommendation by Mrs Emilia MÜLLER
(EPP-ED, D) subject to one amendment. (Please refer to the text dated

 The committee adopted the draft recommendation for 2nd reading (codecision
procedure) by Emilia Franziska MÜLLER (EPP-ED, D) broadly approving the
Council's common position subject to some minor changes. One key amendment
adopted sought to lengthen the period for the submission of safety dossiers to
36 months (rather than 18 months as stated in the proposal) after the
directive's entry into force. MEPs felt the extra time was crucial to give
small companies longer to comply with the directive.
It should be pointed out that a considerable minority of MEPs from different
political groups took the view that the common position should be rejected.
They argued that, given the different cultures in the Member States and the
fact that an absence of legislation had so far caused no problems, there was
no need for a directive in this area.

 The Commission is of the opinion that the common position is a carefully
balanced compromise, in particular on the issue of the criteria to be used for
setting maximum levels for vitamins and minerals in these products. It is in
line with the basic principles of food law, namely that food should be safe
and properly labelled so that consumers can make an informed choice from a
wide range of safe products.
The Commission included in the modified proposal those amendments adopted in
first reading by the European Parliament that were acceptable. Those
amendments remain in the common position in a way that should be satisfactory
to the EP.
There are three main differences between the modified proposal and the common
1) in the common position, the issue of setting maximum limits for vitamins
and minerals in food supplements is resolved by providing the scientific risk
assessment and intakes from other sources will be primarily factors to be
taken into account for the safety of these products, and that in the overall
exercise the reference intakes for the population will be given due
consideration. While this differs from the Commission proposal, supported by
the Parliament, that the reference intakes be taken into account only in the
case of some nutrients, the Commission can accept the common position because
it strengthens the process of establishing safe maximum levels for vitamins
and minerals in food supplements;
2) Article 4.8 of the common position requires the Commission to submit to the
European Parliament and the Council, within 5 years from the entry into force
of the Directive, a report on the advisability of establishing specific rules
on other nutrients or substances with a nutritional or physiological effect,
accompanied by any proposals for appropriate legal measures. The Commission
can accept the request to submit a report on the subject within a specified
time limit while maintaining the right of initiative to propose appropriate
3) Article 4.6 of the common position is new. It foresees a transnational
period during which vitamins and minerals and certain of their forms that are
not listed in the Annexes but are currently in food supplements marketed in
some Member States, may continue to be used until their evaluation by the
Scientific Committee for Food and eventual insertion in the Annexes. It was
introduced to give effect to an amendment of the European Parliament that was
not acceptable in its original form. The Commission supports this new position.

03/12/2001 - COMMON POSITION
 In general, the Council has followed the Commission's amended proposal. It has
accepted - either in whole or in substance - the sixteen amendments adopted at
first reading by the European Parliament as set out by the Commission in its
amended proposal.
The other European Parliament amendments which were not incorporated into the
Commission's amended proposal have also been omitted by the Council. However,
the idea expressed in 3 amendments according to which some vitamins and
substances currently marketed but not covered in the Annex should undergo
scientific evaluation, has been taken into account to some extent.
The main innovations introduced by the Council relate to:
1) the setting of quantities of food supplments: Article 5 ensure a balanced
approach guaranteeing both the safety of such supplements and due regard for
reference intakes of the population;
2) authorisation of the placing on the market of existing food supplements not
listed in Annex I or II: Article 4(6) and (7), in conjunction with Article 15
on the text's entry into force, aims to allay the concern of participants in
this market by laying down clear procedures and time limits for all current
supplements not listed in Annexes I or II to the text, thereby reassuring both
industry and the consumer;
3) the revision of the Directive: Article 4(8) establishes an amendment
procedure after a period of 5 years, which will enable the Commission usefully
to take stock of the implementation of the Directive, particularly with regard
to its scope, and to propose amendments if necessary.
Furthermore, the Council has considered that the obligation to provide
information when a product is placed on the market is ultimately the
responsibility of the Member States.
Lastly, it has introduced a clause providing for the possibility of the
participation of the Standing Committee on Foodstuffs in order to specify the
procedures for implementing Articles 7 and 8 on labelling, presentation and
advertising of food supplements.
The Council considers that the common position responds to a large extent to
the basic wishes expressed by the European Parliament, while at the same time
taking sufficient account of the concern expressed by Member States, inter
alia with regard to public health and/or Community harmonisation. The Council
considers that the common position achieves a good balance between the
prerequisites for the proper functioning of the single market and consumer

 The Presidency concluded that its compromise proposals for a common position
on the Directive relating to food supplements did not meet with a sufficient
degree of agreement. The Council will therefore revert to this issue at one of
its next sessions.

 The amended proposal accepts, in total or in part, 16 of the 38 amendments
proposed by the European Parliament at first reading.
The Commission can accept the amendments which aim to:
- specify that the ingredients of food supplements may be some substances that
nutritional function (e.g. vitamins, minerals, amino acids, fatty acids) or
physiological one (e.g. fibre and various plant and herbal extracts);
- propose to include on the label a statement to the effect that food
supplements should be stored out of reach of children;
- proposes to delete Article 6(4) that would result in the vast majority of
food supplements bearing in mind the statement "This is not a medicinal
The Commission can in principle accept the amendments which aim in particular
- underline that specific rules on vitamins and minerals laid down in the
future directive should be applicable to food supplements containing vitamins,
minerals and other ingredients. Otherwise it would be very easy to avoid
applying these rules by adding just a small quantity of another ingredient to
a food supplement containing vitamins or minerals. On the other hand, in the
absence of specific Community rules concerning other ingredients relevant
national rules may continue to apply, without prejudice to the provisions of
the Treaty;
- state in a recital that that priority should be given to the evaluation by
the Scientific Committee for Food of Substances  that are not included in
Annex II of the proposal but which are used in the manufacture of products
currently marketed in some Member States;
- propose some principles for the adoption of purity criteria for vitamin
preparations and mineral substances listed in Annex II;
- take into account requirements of children and adults when setting maximum
levels for vitamins and minerals.

14/02/2001 - EP VOTE 1st READING
 The European Parliament adopted the report by Mr Emilia Franziska MÜLLER
(EPP/ED, D), however, the text was subject to numerous amendments. The
amendments call for:
- ingredients such as amino acids, fatty acids and herbal extracts, which can
also contribute to good health and are already available on the market, to be
brought within the scope of the Directive;
- the labelling of products covered by this Directive to always include the
words 'food supplement' and the name of the category of the nutrients
characterising the product and/or the ingredients characterising the product;
- warnings to be carried against exceeding the recommended amount for daily
consumption; if there are health risks this must be explained on then package
leaflet or appear on the product itself;
- products to carry warnings stating that they may be taken by pregnant women
or children under the age of one only with the agreement of a doctor or health
- excessive doses which could harm the user must be avoided;
- certain minerals to be included in Annex I of the directive, such as boron,
nickel and tin, when evidence can be provided of their usefulness in food
Lastly, the Parliament calls for certain vitamin and mineral substances
marketed in the EU to undergo scientific evaluation.

 The committee adopted the report by Emilia Franziska MÜLLER (EPP-ED, D)
broadly approving the proposal under the codecision procedure (1st reading),
subject to a number of amendments. It sought to include extra vitamins and
minerals and their chemical compounds in the list of substances which could be
used in the manufacture of food supplements, arguing that there was clear
evidence of their usefulness. The other amendments concerned provisions on
labelling to ensure consumers were properly informed, adequate purity and
quality requirements, and binding notification procedures. Lastly, the
committee wanted to ensure that disputes were resolved within specific
deadlines and that the Scientific Committee for Food was required to publish
guidelines for the criteria, procedure and timetable it adopted when assessing
substances so that applicants seeking approval for products were treated
openly and fairly and without unnecessary delay.

 PURPOSE : to present a Directive on the approximation of the laws of the
Member States relating to food supplements.
CONTENT : a wide range of products, known under the term food supplements,
diet integrators or others, have been marketed in Community Member States for
a number of years. The national rules applicable to them may differ
substantially. This has led to obstacles to intracommunity trade that the
application of the principle of mutual recognition did not succeed in
overcoming. For a number of years now, there have been many comments received
from Member States and other interested parties which emphasised the need to
adopt Community rules on these products marketed as foodstuffs.
The products in question are usually concentrated sources of nutrients and
other ingredients, alone or in combination and marketed in dose form. These
ingredients include, among others, vitamins, minerals, amino acids, essential
fatty acids, fibre, various plant and herbal extracts. The task of covering
products containing all these ingredients would be enormous and very
complicated. It has therefore been decided for practical reasons to deal at
this stage in detail with products containing vitamins and minerals. The
measures may be amended in the future to cover in detail products containing
other nutrients and/or ingredients.
Furthermore, there is an important range of vitamins and mineral supplements
on the market. They vary from single nutrient products of variable nutrient
levels to multi-nutrient products also of variable nutrient levels for
individual nutrients. Prevalence of one or the other product is determined by
consumer preferences and differs from one Member State to another. Thus, the
choice must be made exempt of any risks health by ensuring that products
appropriate and correct information about these products through labelling.
Ensuring that food is safe and providing adequate and clear information on the
label have been two fundamental principles of Community food law.
Another very important element regarding the safety of these products is the
maximum levels of minerals they contain. These levels should therefore be
stipulated in order to ensure their safety. Upper safe intake levels for some
nutrients  (e.g. vitamins A, D, B6 and folic acid, iron, selenium, zinc) may
be close to amounts that are recommended as population reference intakes
(PRI). Therefore, for these few nutrients the PRIs should be taken into
account when setting maximum levels in food supplements. On the other hand,
the setting of a minimum level of vitamins and minerals in these products is
desirable in order to guarantee that food supplements contain a significant
amount that would justify the intended purpose of the product. Once the
principles for setting maximum and minimum limits have been agreed the
adoption of specific limits or each nutrient, based on the opinion of the
Scientific Committee for Food (SCF), is a technical matter and should be
delegated to the Commission.
It should be noted that excess intake of some vitamins and minerals may cause
undesirable or adverse effects. Hence, the need to ensure the safety of these
products which includes  labelling the products with clear instructions about
the use of the product, in particular the quantity to be consumed. Asit is,
food supplements are excluded from the scope of Directive 90/496/EEC on
nutrition labelling. Therefore, the specific relevant rules must be
stipulated. These products contain hardly any significant amounts of energy,
protein, carbohydrate or fat and, therefore their declaration in the
nutritional labelling would be irrelevant. Their nature and intended use,
however, as sources of vitamins and minerals would justify that labelling for
these nutrients should be compulsory.