52000AE1183

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

1.1. 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 are concentrated sources of nutrients, marketed in pre-packaged 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.

1.2. In past decades nutritional advice was given to combat 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.

1.3. 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.

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 from the market, on the grounds that they were effectively medicines but did not fulfil the more stringent legal requirements applicable to medicines.

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.

1.6. 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.

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 recommendations (reference values) is intended to ensure safety in the case of substances that easily produce overdose and damage to health.

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.

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.

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.

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 Energy Intakes for the European Community (31st series). However, the Committee feels that this approach is not 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.

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 disproportionately slow as a result of the time required for implementation 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 reference to rules that already exist (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 for nutritional intake have existed in some Member States since January 2000.

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 monitored and subject to general status reports, so that prompt and effective action can be taken if negative effects (e.g. overdose) are reported.

2.8. By analogy with food law, advertisers should not be 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 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 supplements 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 role to play here. This supplier-independent information 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(3) 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

Article 2

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.

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

3.2. The Committee points out that supervisory bodies 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

3.3. To be consistent, "vitamins and minerals" should also 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 approximating the Member States' laws on food supplements. Introducing 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 5(3)

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

3.6. The Committee welcomes the requirement for labelling of food supplements, which will provide consumers with comprehensive information on possible health risks or inadvisable 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.

Article 6(1)

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)

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 misled(4).

Article 6(3)(b)

3.9. The following should be added: "..., with reference to specific population groups where appropriate".

Article 6(3)(c)

3.10. The word "diversified" should be replaced by "appropriate to needs".

Article 6(4)

3.11. The statement should be worded positively: "This preparation is a food supplement".

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 beneficial to health, consumers have a fundamental interest in knowing whether the foodstuffs concerned have been produced using gene technology.

Article 7

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. Standardising dose units and abbreviations (Annex I) would make it easier to read labels.

Article 10

3.16. The notification requirement is intended to facilitate 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

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

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.

4.3. 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 safe levels). The reference values in Directive 90/496/EEC must also be updated, completed and accepted by all the Member States.

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.

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

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 Member States without exception, and the authorities must be better equipped to provide effective surveillance.

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

(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.

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

(4) 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."