02 May 2017 - Authored by:Eveline Van Keymeulen
On 27 April 2017, the Court of Justice of the European Union (CJEU) issued a judgment on the interpretation of Directive 2002/46/EC on food supplements (Directive) (case C-672/15). The CJEU ruled that the Directive and the provisions on the free movement of goods in the Treaty on the Functioning of the European Union (TFEU) preclude national legislation that does not provide for a mutual recognition procedure for the placing on the market of food supplements whose content in nutrients exceeds the national maximum daily doses and that are lawfully manufactured or marketed in another member state. Furthermore, the CJEU held that member states must set maximum daily doses for nutrients on a case-by-case basis after a comprehensive scientific assessment of the risk for public health. This must be based not only on national data, but also on available international scientific data.
The Directive lays down rules for the placing on the market of food supplements (concentrated sources of nutrients or other substances with a nutritional or physiological effect marketed under a dosage form) in the EU. In particular, the Directive sets out lists of vitamins and minerals that may be used in the preparation of food supplements. Until the European Commission lays down harmonised maximum and minimum amounts for these nutrients, the member states may fix national amounts provided that, when exercising this competence, they comply with the principle of the free movement of goods and are guided by the criteria set out in Article 5(1) and (2) of the Directive, including the requirement for a risk assessment based on “generally accepted scientific data”.
Article 5(1) of the Directive requires that maximum amounts of vitamins and minerals be set per daily portion of consumption as recommended by the manufacturer, taking into account (i) the upper safe levels of vitamins and minerals established by scientific risk assessment based on “generally accepted scientific data” (considering, as appropriate, the varying degrees of sensitivity of different consumer groups), and (ii) the intake of vitamins and minerals from other dietary sources. In addition, Article 5(2) states that, when the maximum levels are set, due account should be taken of reference intakes of vitamins and minerals for the population.
In France, Decree 2006-352 on food supplements (Decree), transposing the Directive into French law, allows the use of vitamins and minerals in food supplements under conditions laid down by ministerial order(s). An implementing inter-ministerial order of 9 May 2006 relating to nutrients that may be used in the manufacture of food supplements (Order) sets out the positive list of vitamins and minerals and their forms, as well as their maximum daily doses. In addition, the Decree provides for a ‘simplified’ mutual recognition procedure for food supplements containing substances with a nutritional or physiological effect that are not included in the order(s) but that have been legally manufactured or marketed in another member state. This procedure does not, however, apply to food supplements containing vitamins or minerals.
Facts and referred questions
The preliminary ruling request stems from French criminal proceedings against Noria Distribution SARL (Noria) for having marketed food supplements containing vitamins and minerals in quantities exceeding the maximum daily doses set out in the Order, among other allegations. Noria did not contest the allegations but it claimed that the Order breaches EU law.
The District Court of Perpignan referred a preliminary ruling request to the CJEU asking the following questions:
- whether the absence under French law of a ‘simplified’ mutual recognition procedure for food supplements lawfully marketed in another member state whose content in nutrients exceeds the maximum daily doses set out in the Order is compatible with the Directive and the TFEU principle of the free movement of goods (first question);
- whether the Directive and the principle of the free movement of goods allow the maximum amounts of vitamins and minerals to be set in proportion to the recommended daily allowances by adopting a value equal to three times the recommended daily allowances for nutrients presenting the least risk, a value equal to the recommended daily allowances for nutrients presenting a risk of the upper safe level being exceeded and a value below the recommended daily allowances or even zero for nutrients involving the most risk (second question); and
- whether, in setting those maximum amounts, account should be taken not only of national but also of international scientific research concluding in favour of setting higher safe levels (under identical conditions of use) (third question).
Findings of the CJEU
On the first question, the CJEU reminded that member states remain competent to set maximum amounts of nutrients which may be used in food supplements, provided that they comply with the principle of the free movement of goods and are guided by the criteria laid down in Article 5(1) and (2) of the Directive, including the requirement for a risk assessment based on generally accepted scientific data.
In the CJEU’s view, the French legislation constitutes a measure having an effect equivalent to a quantitative restriction (Article 34 TFEU), since a food supplement whose nutrient content exceeds the national maximum limits cannot be marketed in France even if that food supplement is lawfully manufactured or marketed in another member state. For said restriction to be justified (Article 36 TFEU), a national authorisation procedure must be in place for food supplements including nutrients in excess of national maximum limits that is readily accessible, able to be completed within a reasonable time, and subject to judicial review in case of refusal – such refusal being justified only where there is a genuine risk to public health. Since the French legislation provides for a mutual recognition procedure for certain food supplements, but not for those with nutrients whose content exceeds the national maximum daily doses, the restrictions imposed by French law cannot be justified under Article 36 TFEU.
Regarding the second question, the CJEU did not respond on the merits, leaving it to the referring court to determine whether the method used by France to set maximum amounts of vitamins and minerals complies with EU law. However, the CJEU set out the relevant requirements for the referring court to make this determination. In particular, the CJEU held that national maximum amounts of vitamins and minerals must be set on a case-by-case basis and taking into account, among other things, the upper safe levels established after a comprehensive scientific assessment of the risks for public health based on relevant scientific data, and not on general or hypothetical considerations. Setting maximum amounts without taking into account all Article 5(1) and (2) criteria, on the sole basis of the nutritional needs of the population concerned or without carrying out a case-by-case analysis, is not compatible with the Directive or with the principle of the free movement of goods.
With respect to the third question, the CJEU held that the setting of maximum amounts of vitamins and minerals must take account of upper safe levels of these nutrients determined after a scientific risk assessment based on “generally accepted scientific data”, regardless of whether those data are national or international data. Therefore, if recent and reliable international scientific data are available on the date on which the scientific risk assessment is carried out, the assessment cannot be carried out without having regard to those data.
This post was originally co-authored by Marco de Morpurgo & Patricia Carmona Botana.