Noria Distribution ("Noria") is a French company that markets food supplements in the European Union. However, criminal proceedings were commenced against Noria for marketing food supplements containing vitamins and minerals that exceeded the maximum permitted amounts under French law.
Directive 2002/46/EC (the "Food Supplements Directive") is the principal legal text that applies to food supplements and was transposed into French law by Decree No 2006-352 of 20 March 2006. An inter-ministerial order dated 9 May 2006 (the "Order"), adopted in accordance with the Decree, lists vitamins and minerals that can be used in the manufacture of food supplements and their maximum daily doses. Although Noria did not substantially contest the acts it was accused of committing, it claimed the Order, which served as the basis of the criminal proceedings, contravened European Union law. Consequently, the Tribunal de Grande Instance de Perpignan referred the following questions to the CJEU:
- 'Do Directive 2002/46 … and Community principles of free movement of goods and of mutual recognition preclude the laying down of national legislation such as the order of 9 May 2006 which refuses any mutual recognition procedure so far as concerns food supplements based on vitamins and minerals from another Member State by excluding the application of a simplified procedure in respect of products lawfully marketed in another Member State that are based on nutrients [whose values exceed the limits set] by the order of 9 May 2006?
- Does Directive 2002/46, in particular in Article 5, as well as the principles resulting from Community case-law on the provisions relating to the free movement of goods, permit the maximum daily doses 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?
- Does Directive 2002/46, as well as the principles resulting from Community case-law on the provisions relating to the free movement of goods, permit the doses to be set [in the light of] solely national scientific opinions even though recent international scientific opinions [conclude in favour of] higher doses in identical conditions of use?’
The First Question
The CJEU answered the first question in the affirmative – the Order did not comply with the Food Supplements Directive or the principles of free movement of goods and mutual recognition.
The CJEU emphasised that as long as the European Commission had not set maximum amounts of nutrients used in the manufacture of food supplements, Member States remained competent to adopt national legislation setting those amounts, provided that they complied with the principles of free movement of goods in Articles 34 and 36 of the Treaty on the Functioning of the European Union ("TFEU") and the criteria in Articles 5(1) and 5(2) of the Food Supplements Directive, including the requirement for a risk assessment based on generally accepted scientific data.
However, the legislation at issue created a barrier to trade within the EU and constituted a measure having an effect equivalent to a quantitative restriction within the meaning of Article 34 TFEU. Such measures could be justified if they complied with the requirements of Article 36 TFEU, as interpreted by the CJEU. CJEU case law had previously established:
- national rules must provide for a mechanism for economic operators to obtain authorisation to market food supplements, including vitamins and minerals in doses exceeding those authorised. That procedure must be readily accessible, completed within a reasonable time and, if the applicant is refused, the decision must be challengeable before national courts; and
- an application to obtain authorisation to market such supplements may be refused by the competent national authorities only if those supplements pose a genuine risk to public health.
Although the French legislation did provide a mechanism for mutual recognition, it did not provide any procedure authorising food supplements lawfully manufactured or marketed in another Member State, whose nutrient content exceeded the maximum doses permitted in France. Consequently, the restriction imposed by the French legislation could not be justified under Article 36 TFEU.
The Second Question
The CJEU explained that in addition to complying with Articles 34 and 36 TFEU, maximum amounts of vitamins and minerals must be based on the criteria set out in Articles 5(1) and 5(2) of the Food Supplements Directive. Specifically:
(1) Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account:
- upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;
- intake of vitamins and minerals from other dietary sources.
(2) When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population."
The CJEU held that the maximum amounts referred to in Article 5 of the Food Supplements Directive must be set on a case-by-case basis taking into account all of the elements in Articles 5(1) and 5(2). In particular, the upper safe levels must be established after a comprehensive scientific assessment of the risks for public health, based on relevant scientific data, not general or hypothetical considerations. It was for the national courts to assess whether the method of setting those amounts complies with those requirements. However, a method that sets maximum amounts solely on the basis of the nutritional needs of the population or without taking into account those elements, was not compatible with Article 5 of the Food Supplements Directive or the principle of free movement of goods.
The Third Question
The CJEU held that by requiring the assessment to be based on "generally accepted scientific data", Article 5(1)(a) of the Food Supplements Directive intended the assessment to be carried out on the basis of reliable scientific data, regardless of whether it was national or international.1 The assessment was subject to the same requirements as those deriving from the CJEU's case law concerning the existence of a real risk for public health alleged by a Member State to justify a measure prohibiting the marketing of a food supplement, in accordance with Article 36 TFEU. In such cases, the CJEU had held that the existence of the risk must be shown in each case in light of national nutritional habits and the results of international scientific research.
An assessment could not be carried out without regard to recent and reliable international scientific data available at the time of the assessment.
The Noria case highlights the issues faced by manufacturers, importers and distributers of food supplements, who wish to market food supplements into more than one EU Member State. Economic operators must ensure that their products comply with the maximum amount of the relevant vitamins or minerals that apply in each Member State they wish to market their product in. However, difficulties may arise where a company wishes to market a product in another Member State given divergent national laws that set the maximum amounts.
This lack of harmonisation was recognised in the European Commission's Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs, published in June 2006.2 In particular, it recognised that the application of divergent maximum permitted levels of vitamins and minerals in Member States was "causing serious problems to the free circulation of the products concerned in the European market. The maximum levels for vitamins and minerals have not been set in [the Food Supplements Directive], but have to be established by the Commission through the Regulatory Committee as an implementing measure".
A number of responses were received following the publication of the Discussion Paper, but according to the Commission's website "…no proposal has not yet been presented due to the complex nature of the issue and the divergent views that were expressed. All the available data on the potential effects on economic operators and consumers of the setting of maximum amounts of vitamins and minerals in foods, including food supplements, will be taken into account. Every effort will be made to ensure that the maximum amounts set will take into account the concerns expressed by all interested parties."
As maximum amounts of vitamins and minerals present in food supplements that are consumed per daily dose remains to be harmonised, the Mutual Recognition Regulation (Regulation (EC) No. 764/2008) will apply. The Mutual Recognition Regulation sets out the rules and procedures that must be followed by national competent authorities when taking or intending to take certain decisions which would hinder free movement of a product lawfully marketed in another Member State, and subject to the principle of free movement of goods under Article 28 TFEU (including prohibiting placing a product on the market) .
It would appear from the CJEU's judgment that despite the adoption of the Mutual Recognition Regulation, there remains hurdles to the free movement of food supplements within the EU. The CJEU's judgment will be welcomed by manufacturers, importers and distributors of food supplements, but it be interesting to see how the Tribunal de Grande Instance de Perpignan applies the judgment and whether French law will be changed as a result.