In its decision of 29 April 2010 in, Solgar et al (C-446/08), the Court of Justice of the European Union (CJEU) took the opportunity to specify the extent of the Member States’ competence regarding the regulation of the manufacture of food supplements6 in respect of certain areas not yet regulated by the Commission.
The Ministry of Economy, Finance and Industry made an order fixing the list of vitamins and minerals which could be used in the manufacture of food supplements, as well as the authorised Maximum Daily Amounts7. Several food supplement manufacturers as well as the Syndicat de la Diététique et des Compléments Alimentaires (Dietary/Food Supplements Syndicate) brought proceedings to have the order annulled on the grounds of an abuse of power, in particular as a result of the non-compliance of this order with Directive 2002/46/EC of the European Parliament and the Council of 10 June 2002 relating to the harmonisation of laws of the Member States regarding food supplements 8(Directive 2002/46/EC).
Article 5 of Directive 2002/46/EC provides that maximum and minimum quantities of vitamins and minerals in the composition of food supplements are to be laid down by the Commission9. However, regulation of this area was never adopted despite the time limit laid down for transposition of the Directive expiring on 31 July 2003. The result of this is that a ‘product compliant with the Directive’ remains impossible to define in any uniform way across the European Union10.
By a decision of 17 December 2007, a joint sitting of the 1st and 6th sub-sections of the Conseil d’Etat (Council of State) referred two preliminary issues relating to the interpretation of Directive 2002/46/CE11 to the CJEU, namely:
- whether the Member States have the authority to adopt regulation relating to maximum amounts of vitamins and minerals present in food supplements whilst awaiting adoption of a regulatory act by the Commission which is responsible for defining these amounts; and
- to make a ruling on the extent of the Member States’ competence in this regard.
The CJEU has already ruled that, in the absence of specific European regulation, national rules may be applied without prejudice to the provisions of the treaty12. In the case of a loophole, the CJEU therefore considers that the Member States have the authority to adopt regulations relating to the maximum and minimum amounts of nutrients in the absence of any regulation by the Commission.
The question then is what margin for manoeuvre the Member States have in the preparation of such national regulation?
Article 5 of Directive 2002/46/CE lays down the three criteria for the fixing of the maximum and minimum amounts of nutrients present in food supplements:
- upper safety limits;
- intake of vitamins and minerals from other dietary sources; and
- reference intakes for the population. It is clear on studying the CJEU’s decision that the three criteria are considered to be elements which guarantee a uniformity within the EU.
The CJEU was first asked to make a ruling as to whether or not a duty falls on the Member States to be guided by the criteria set out above, particularly the requirement to evaluate risks based on generally accepted scientific data13. The CJEU stated in this regard that, in exercising their authority, the Member States must above all respect the EU law14. A duty therefore falls upon them to comply with the requirements of Article 5, particularly regarding the evaluation of risks.
The CJEU then had to consider the possibility that the Member States may fix the maximum amount of a nutrient that may be used in the manufacture of food supplements at zero, without having recourse to the procedure provided for by Article 12 of Directive 2002/46/EC (known as the Safeguard Procedure). The question related particularly to fluoride, which was mentioned in Schedule I of Directive 2002/46/EC as capable of being used in the manufacture of food supplements. The French government considered that it had the right to fix such value at zero as fluoride presents recognised dangers and levels of intake from other food sources are impossible to determine with any precision15. The manufacturers argued that fixing a zero level would amount to a prohibition on the use of fluoride in the manufacture of food supplements which would result in the restriction of the scope of application of the Directive16.
The CJEU based its reasoning on established case law under which it falls on Member States, in the absence of harmonisation and insofar as there remain uncertainties in the current state of scientific knowledge, to decide on the level of protection required for the health of its citizens, taking into account the requirements of free movement of goods within the EU17. The CJEU also recalled that Article 5 of Directive 2002/46/EC provides that maximum and minimum amounts of vitamins and minerals are fixed according to intakes from other dietary sources. The CJEU inferred from that the possibility for a Member State to fix the maximum value at zero, where such amounts are not otherwise regulated by the Commission.
The CJEU was also required to rule on the possibility of a Member State fixing a maximum amount of nutrient for the population as a whole, where it wished to protect a population at risk particularly by the use of appropriate labelling18. The Council of State raised particularly the issue that such labelling might dissuade ‘at risk’ groups of population from consuming the nutrients in question even though a small amount could in fact be beneficial to them. The CJEU considered that the fact that appropriate labelling might dissuade the group of consumers to which it is addressed from taking a nutrient which might be beneficial in small doses was not a relevant argument for fixing the maximum amounts of the nutrient. It added that appropriate labelling does in fact contribute to a guarantee of a high level of protection for consumers. The CJEU also recalled that, in exercising their power of appraisal with regard to the protection of public health, the Member States must respect the principle of proportionality (i.e. that the means used should be strictly necessary to safeguard public health)19. It therefore referred back to the national court the question of whether appropriate labelling constitutes an adequate measure to ensure protection of the health of people at risk and whether this objective could not be achieved by measures which were less restrictive of trade within the EU.
Finally, the question was posed as to whether maximum amounts of nutrients may be fixed when, in the absence of recognised health risks, upper safety limits have not been fixed for such nutrients. More generally, the Council of State wondered whether it would be possible to fix such maximum amounts at a level considerably below the upper safety limits of these nutrients.
Once again basing its arguments on Article 5 of Directive 2002/46/EC, the CJEU held that the Directive must be interpreted as being opposed to the fixing of maximum amounts of nutrients where, in the absence of established health, upper safety limits had not been established. However, it considered that such a measure might be justified under the principle of precaution, which permits the adoption of restrictive measures provided that such measures are objective and non-discriminatory. This is the case where a scientific assessment of risks reveals that uncertainty persists as to the existence of real dangers to health20. Once upper safety limits have been established, the fixing of maximum amounts of nutrients at a level considerably lower than those limits is allowed if it can be justified by the taking into account of the criteria of Article 5 and is in accordance with the principle of proportionality. The CJEU referred assessment of whether these criteria are fulfilled back to the national court.
In the absence of European regulations adopted by the Commission, the CJEU has therefore provisionally granted the Member States significant room for manoeuvre with regard to the regulation of the manufacture of food supplements whilst awaiting uniformity across the EU which should reconcile protection of public health and free movement of goods.