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Dr. Rath Health Foundation

Responsibility for a healthy world Dr. Rath Research Institute 100+ Studies Published In PubMed

Analysis of ECJ judgement on legal challenge to Food Supplements Directive

July 2005 – The European Court of Justice (ECJ) handed down its ruling on the legal challenge to the EU Food Supplements Directive (FSD) on the 12th July. Consisting of a 139 paragraph assessment of the case, the ECJ’s judgment concluded that:

Examination of the question referred to the Court has revealed no factor of such a kind as to affect the validity of Articles 3, 4(1) and 15(b) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.

Almost immediately, the world’s media responded by announcing that the European Court had confirmed its decision to tighten rules on the sale of vitamin and minerals.

But was this response fully borne out by the text of the judgment? And what happens next?

Concessions?

Clearly, the FSD was not invalidated by the ECJ, and as such any products that do not comply with it will now be prohibited from 1st August. Nevertheless, some observers believe that the ECJ’s judgment contains some important concessions, and that as a result the vast majority of vitamin and mineral food supplements will not now be banned on this date. This belief is essentially based upon the wording of four particular paragraphs of the judgment.

The first of these four paragraphs, paragraph 63, reads as follows:

63. It must be stated, at the outset, that if the various recitals in the preamble to Directive 2002/46 are read together, it is apparent that the directive concerns food supplements containing vitamins and/or minerals derived from a manufacturing process using ‘chemical substances’ (11th recital), and not food supplements whose ingredients include ‘amino acids, essential fatty acids, fibre and various plant and herbal extracts’ (6th recital), whose conditions for use consequently remain ‘until … specific Community rules are adopted’ within the scope of ‘national rules’, ‘without prejudice to the provisions of the Treaty’ (8th recital).

This paragraph, and the context in which it is placed, has been suggested by some as inferring that the ECJ has interpreted the Directive as applying only to those food supplements that are manufactured from chemical substances, and not to natural forms of vitamins and minerals normally found in the diet.

Paragraphs 72 and 73, meanwhile, concern the claim that the procedure for having additional forms of vitamins and minerals added to the positive lists lacks transparency, and read as follows:

72. In that regard, a measure which, like that at issue in the main actions, includes a prohibition on marketing products containing substances not included on the positive lists laid down in the applicable legislation must be accompanied by a procedure designed to allow a given substance to be added to those lists and the procedure must comply with the general principles of Community law, in particular the principle of sound administration and legal certainty.

73. Such a procedure must be accessible in the sense that it must be expressly mentioned in a measure of general application which is binding on the authorities concerned. It must be capable of being completed within a reasonable time. An application to have a substance included on a list of authorised substances may be refused by the competent authorities only on the basis of a full assessment of the risk posed to public health by the substance, established on the basis of the most reliable scientific data available and the most recent results of international research. If the procedure results in a refusal, the refusal must be open to challenge before the courts (see, by analogy, Case C‑24/00 Commission v France [2004] ECR I‑1277, paragraphs 26, 27 and 36, and Case C‑95/01 Greenham and Abel [2004] ECR I‑1333, paragraphs 35, 36 and 50).

These two paragraphs, and the case law cited in them, have been suggested by some to infer that the process of adding substances to the positive lists will now be a much simpler, less time consuming and more affordable process than was previously the case, and that the burden of proof for showing an ingredient to be unsafe will now lie with the regulator and not the manufacturer.

There have also been suggestions that the ECJ appear to have clarified the criteria that vitamins and minerals must satisfy in order to gain entry to the positive lists. Paragraph 85 of the judgment appears to be key in this respect, and reads as follows:

85. On the contrary, it is clear from the 9th recital to Directive 2002/46 that the criterion that the vitamin or mineral be normally found in, and consumed as part of, the diet is the only relevant criterion for the purposes of the list in Annex I to the directive. As the claimants in Case C‑154/04 have observed, although the proposal for the directive mentioned at paragraph 37 of this judgment provided for a second criterion, namely that the vitamins and minerals in question should be ‘considered essential nutrients’, as is shown by the 7th recital in the preamble to the proposal, that criterion is no longer included in the 9th recital to Directive 2002/46. As regards the list in Annex II to the directive, it is apparent from the 11th recital that the only relevant criteria are those relating to the safety and bioavailability of the chemical substance in question.

So what are we to make of all this, and how likely is it that the European Commission will agree to these interpretations of the judgment?

The Standing Committee on the Food Chain and Animal Health (re. paragraph 63 of the judgment)

In October 2002, at the request of the UK authorities, the European Commission’s Standing Committee on the Food Chain and Animal Health met in order to discuss the status of naturally occurring sources of vitamins and minerals in relation to the Directive. After some consideration they agreed that ingredients that naturally contain a nutrient can be included in food supplements. They specified however that these nutrients would have to be declared in the list of ingredients of the product, and that the natural content of a nutrient in such a food supplement would contribute to the total quantity of that nutrient with respect to any restriction on nutrient levels and to declared amounts in nutrition labelling. As such, and by way of an example, sales of cod liver oil capsules would continue to be unaffected by the Directive so long as they comply with any restrictions upon nutrient dosage levels that might later be set.

Nevertheless, the Committee do not appear to have made any suggestion that this exemption should be extended to include the natural forms of nutrients themselves, in isolation, rather than simply the food sources that contain them. As such it would appear to be somewhat unlikely that the European Commission would agree to interpret paragraph 63 of the ECJ’s judgment in such a way as to exempt natural forms of vitamins and minerals from the Directive.

Finally, it should be noted that the phrase “chemical substance” appears several times in the ECJ’s judgment, and looking at each occurrence in context it seems unlikely that the phrase was used to refer to synthetic varieties of nutrients only.

Dossiers and the positive lists (re. paragraphs 72-73 of the judgment)

The text of the Directive contains two Annexes, which have become known as the “positive lists”. Annex I specifies the general classes of vitamins and minerals which may be contained in food supplements, whilst Annex II lists their specific forms. For example, Annex I shows that vitamin C can be used in food supplements, whilst Annex II lists L-ascorbic acid, sodium-L-ascorbate, calcium-L-ascorbate, potassium-L-ascorbate and L-ascorbyl 6-palmitate as the only forms of vitamin C that will be permitted.

These positive lists of permitted vitamins and minerals are arguably the most contentious aspect of the Directive. Significantly therefore, on 5 April, 2005, the ECJ’s Advocate General described the procedure by which vitamins and minerals could be added to the positive lists as being "as transparent as a black box." At that time it was generally believed that to have a vitamin or mineral added to the positive lists was a difficult and expensive process that would require the manufacturer to spend up to £250,000 per ingredient in order to prove that it was safe. However, paragraph 73 of the ECJ’s judgement appears to have clarified this procedure in such a way as to require the authorities to prove that a nutritional ingredient is unsafe, rather than, as was previously assumed, the manufacturer having to prove that it is safe.

The wording of paragraph 73 is by no means a precedent in European law, as its conclusions are already supported by a significant amount of case-law. For example, the relevant sections of Case C‑24/00 (Commission v France), as cited in paragraph 73 of the ECJ’s judgment, read as follows:

26. First, such legislation must make provision for a procedure enabling economic operators to have that nutrient included on the national list of authorised substances. The procedure must be one which is readily accessible and can be completed within a reasonable time, and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts (see to that effect Case Commission v France, cited above, paragraph 9).

27. Secondly, an application to obtain the inclusion of a nutrient on the national list of authorised substances may be refused by the competent national authorities only if such substance poses a genuine risk to public health (see Commission v Denmark, paragraph 46).

36. As is clear from paragraph 26 of this judgment, a procedure which requires prior authorisation, in the interest of public health, for the addition of a nutrient authorised in another Member State complies with Community law only if it is readily accessible and can be completed within a reasonable time and if, when it is refused, the refusal can be challenged before the courts.

Similarly, the relevant sections of Case C‑95/01 (Greenham and Abel), as also cited in paragraph 73 of the ECJ’s judgment, read as follows:

35. First, such rules must make provision for a procedure enabling economic operators to have a nutrient included on the national list of authorised substances. The procedure must be one which is readily accessible and can be completed within a reasonable time, and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts (see to that effect Case C-344/90 Commission v France [1992] ECR I-4719, paragraph 9, and today's judgment in Case C-24/00 Commission v France [2004] ECR I-0000, paragraph 26).

36. Secondly, an application to obtain the inclusion of a nutrient on the national list of authorised substances may be refused by the competent national authorities only if such substance poses a genuine risk to public health (see Commission v Denmark, cited above, paragraph 46).

50. Having regard to all those considerations, the reply to the question referred must be that Articles 28 EC and 30 EC must be interpreted as meaning that they do not preclude a Member State from prohibiting the marketing without prior authorisation of foodstuffs lawfully manufactured and marketed in another Member State, where nutrients such as vitamins or minerals have been added thereto other than those whose use has been declared lawful in the first Member State, provided that certain conditions are satisfied.

First, the prior authorisation procedure must be readily accessible and capable of being completed within a reasonable time and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts. Secondly, refusal to authorise marketing must be based on a detailed assessment of the risk to public health, based on the most reliable scientific data available and the most recent results of international research.

Moreover, it should also be noted that many of the cases cited in the above two rulings themselves, such as Case C-192/01(Commission v Denmark), and Case C-344/90 (Commission v France), come to similar conclusions. Paragraph 46 of Case C-192/01(Commission v Denmark), for example, unequivocally places the burden of proof on the authorities to show that a risk to public health exists, rather than on manufacturers to show that their products are safe:

46. Furthermore, since Article 30 EC provides for an exception, to be interpreted strictly, to the rule of free movement of goods within the Community, it is for the national authorities which invoke it to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary to give effective protection to the interests referred to in that provision and, in particular, that the marketing of the products in question poses a real risk to public health (see, to that effect, Sandoz, paragraph 22; Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 40; Beer purity law, cited above, paragraph 46; and Case C-228/91 Commission v Italy [1993] ECR I-2701, paragraph 27).

Taking all of the above into account it would therefore appear possible that the European Commission might be prepared to agree to either a simplification, or at least a clarification, of the application process for having a nutrient added to the national lists of authorized substances. Nevertheless, such an outcome can by no means be guaranteed, and could even require the claimants to initiate further legal action in order to achieve it.

New entry requirements to the positive lists? (re. paragraph 85 of the judgment)

As previously stated, paragraph 85 of the judgment appears to be concluding that for a vitamin and mineral to be added to Annex I it need only be shown to be normally found in, and consumed as part of, the diet. If this interpretation is correct, then minerals such as boron and vanadium, which are not currently included in Annex I, could no longer be excluded from it, as they are clearly constituents of normal food.

Similarly, paragraph 85 also appears to clarify the entry requirements to Annex II of the directive, and states that the only relevant criteria are those relating to the safety and bioavailability of the substance in question.

Of course, safety and bioavailability are relative concepts, and as such it is notable that the judgment does not clarify the degree to which either will be required.

For example, are we to take “safety” as meaning 100 percent totally safe, for everybody, of any age, at any time, in any dosage, and regardless of any physical or medical conditions that might be present?

With regard to defining “bioavailability” however the judgment’s lack of clarity is perhaps helpful, as one would only have to show that the substance in question had at least some degree of bioavailability, no matter how small, in order to be defined as “bioavailable”.

As such, the main issue would once again appear to concern safety, which means that the key factor remains whether or not the European Commission will choose to agree that the burden of proof should rest with the authorities, rather than the manufacturers.

Conclusion

Clearly, whilst it is remains possible that the legal challenge could eventually result in some aspects of the Directive becoming slightly less restrictive, for the time being it will be enacted in exactly the same format as was agreed by the European Parliament. Moreover, and despite the Directive having supposedly been necessary in order to harmonize the European market, it is already clear that significant differences between the types of supplements that can be purchased across the 25 EU Member States will continue to exist. Germany, for example, along with the majority of European Member States, has thus far not given derogation to any non-positive list forms of nutrients, whilst by way of contrast the UK has given derogation to a total of 505 such substances. As such, the availability of vitamin and mineral supplements and information about the positive health benefits of natural remedies will continue to be restricted throughout most countries in the European Union, and may yet become more restricted still.

The next major battle looming on the horizon, and arguably the most important one of all, concerns the permitted dosages that can be contained in vitamin and mineral supplements. The 505 forms of non-positive list vitamins and minerals will be of very little use to consumers in the UK, for example, if the maximum permitted amounts of them that can be contained in supplements ends up being little more than the RDAs.

There therefore remains an urgent need for us all to continue to campaign against restrictions upon our rights to purchase and receive information about the health benefits of vitamins, minerals and other natural substances. As such, participation in initiatives such as the Foundation’s EU Referendum campaign and anti-Codex activities remain essential cornerstones in the building of a New Global Healthcare System.

Based on scientific breakthroughs in the areas of vitamin research and cellular health, it is already possible that cardiovascular disease, cancer, Aids and other common diseases will be largely unknown in future generations if this New Global Healthcare System is implemented now. Clearly therefore there is no time for delay, as not only our own health, but also that of future generations, depends upon it.