Nutrients in Food Supplements: the European Court of Justice Rules on Boundaries of National Legislation Imposing Maximum Amounts

07 June 2017

Francesca Lotta

On 27 April 2017, the Court of Justice of the European Union issued a judgement upon request of the Tribunal de Grande Instance of Perpignan (France) for a preliminary ruling under Article 267 TFEU, made by decision of 5 August 2015.

The request concerned the interpretation of Directive (EC) 2002/46 on the approximation of laws of the Member States relating to food supplements and Articles 28 and 30 of the Treaty on the Functioning of the European Union (TFEU) on the free movement of goods.

The question arose in the context of a criminal proceeding brought against Noria Distribution SARL (“Noria Distribution”) for putting on sale or sold food supplements not authorised in France because they exceeded the maximum daily doses of vitamins and minerals which may be used for the manufacture of such food supplements, as set forth in the inter-ministerial order of 9 May 2006 on nutrients (“Order”).

Background of the case

Noria Distribution, a French company that markets food supplements in the European Union, is prosecuted in France for having sold food supplements containing vitamins and minerals in quantities exceeding the maximum daily doses provided in the Order. The Company does not substantially contest the violation of French Law, but it claims that the Order on which the criminal proceeding is based is not compatible with the European Law.

According to Article 5 of Decree No 2006/352 transposing Directive (EC) 2002/46 under French Law ("Decree"), vitamins and minerals can be used in the manufacture of food supplements only under the conditions set forth in an implementing inter-ministerial Order. The Order provides a positive list of vitamins and minerals that can be used in the manufacture of food supplements and establishes the maximum daily doses that must not be exceeded in the context of that use. It follows that food supplements with content of nutrients exceeding the limit set forth in the Decree, cannot be legally placed in the French market even though they are legally sold in other European Member States. Although the Decree provides a simplified "mutual recognition" procedure, this shall not apply to food supplements containing vitamins and minerals.

Question referred to the Court

The Tribunal de Grande Instance of Perpignan, unsure on the conformity of national legislation with Directive (EC) 2002/46, decided to stay the proceeding and refer to the Court a request for preliminary ruling. In particular, the referring Court inquires:

  1. whether Directive (EC) 2002/46 and Community principles of free movement of goods and of mutual recognition shall be interpreted as precluding national legislation which does not foresee a simplified mutual recognition procedure for food supplements containing vitamins and minerals;
  2. whether Article 5 of Directive (EC) 2002/46 and Community principles of free movement of goods must be interpreted as precluding that the maximum amount is set in proportion to the recommended daily allowances, basically as multiples of reference intakes, and if vitamins and minerals can be grouped for that purpose depending on the level of risk they present;
  3. whether Directive (EC) 2002/46 and Community principles of free movement of goods shall be interpreted as precluding that the scientific assessment of the risk related to the maximum amount of vitamins and minerals is carried out solely on the basis of national scientific opinions.

Findings of the Court

As to the first question, the Court of Justice of the European Union ("CJEU") observes that until the adoption by the European Commission of an act setting forth the maximum amount of vitamins and minerals to be used in foodstuffs, Member States remain competent to adopt the legislation concerning these amounts. However, in the exercise of that competence, they shall comply with the rules concerning the free movement of goods, as well as with principles laid down in Article 5(1) and (2) of Directive (EU) 2002/46, including the requirement for a risk assessment based on generally accepted scientific data.

According to the CJEU, the French Decree constitutes a measure having an effect equivalent to a quantitative restriction, since it prohibits the marketing of food supplements exceeding the maximum limits of nutrients even if they are lawfully manufactured or marketed in another Member State. According to the CJEU's case law, measures having equivalent effect to a quantitative restriction are justified when two requirements are fulfilled. First, national rules provide a procedure enabling economic operators to obtain the authorisation to market food supplements non-compliant with these limits and the procedure is: easily accessible; can be completed within a reasonable time; and, in case of refusal, the decision can be challenged before the courts. Secondly, the application to obtain the authorisation to market those food supplements may be refused by the competent national authorities only if those supplements pose a genuine risk to public health.

Since the French legislation forbids the marketing of food supplements whose content in nutrients exceeds the upper limits set by the legislation without providing a procedure of mutual recognition, the restriction does not seem justified under the European Law.

With reference to the second question, concerning the method used to set maximum amounts of vitamins, the CJEU affirms that it shall be based on a scientific risk assessment based on generally accepted scientific data and it must be carried out on a case-by-case basis. It follows that a method which consists of setting those amounts without taking into account all of these elements, is not compatible with rules on free movement of goods.

Finally, addressing the third question, the CJEU points out that by requiring that the assessment is based on “generally accepted scientific data”, Article 5(1) of Directive (EC) 2002/46 intends that the assessment shall be based on reliable scientific data, regardless of whether they are national or international. It follows that if recent and reliable international scientific data are available on the date on which the scientific assessment of risks is carried out, that assessment cannot be made without having regard to those data.

Comment

In the case at issue, the Court of Justice provides a new ruling on boundaries of national legislation which provides measures having an effect equivalent to a quantitative restriction to free circulation of goods. According to the Court, these measures are not generally forbidden provided that they are based substantively on a full risk assessment based on up-to-date science and, procedurally, on a system that allows a Member State to verify whether a genuine risk to public health actually exists.

Addressing the first question, the Court confirms the findings of the Solgar decision (C-233/10), where it stated that maximum amounts of vitamins and minerals shall be based on generally accepted scientific data and on risk assessment, as generally required by Regulation (EC) 178/2002 for all measures concerning food safety.

Dealing with the procedural requirement, the Court clarifies the meaning of "mutual recognition procedure", that it shall not be intended as a procedure according to which Member States automatically recognize and authorize the import of any food supplements, but as a procedure that allows Member States to verify whether a genuine risk to public health exists. In the light of this, Member States are required to provide a procedure for repeating the assessment when importers are able to present new scientific evidence that could lead to a reconsideration of the original restriction.

This decision confirms that the lack of harmonization in sensitive matters – such as food supplements – still leads to the creation of barriers to free circulation of goods even though Regulation 764/2008/EC ("Mutual Recognition Regulation") has clarified the procedure which national authorities shall follow before they can restrict goods which are lawfully marketed in other Member States. This has been clearly pointed out by the EU Commission itself in the document "Upgrading the Single Market: more opportunities for people and business" where the Commission has highlighted that "National regulations and practices continue to create barriers (…)While these problems occur in many industrial sectors, they are particularly present in the fields of construction, foodstuffs, food supplements and fertilisers. This translates into lost business opportunities, less competition and higher prices for consumers".

Even though the referring Court has not yet provided a decision on the case at issue, the ruling of the CJEU has led the Italian Ministry of Health to revise the maximum levels of vitamins (Vitamin D, Vitamin B12 and Vitamin K) allowed in food supplements, bringing legal levels in line with the European Food Safety Authority opinions and international safety data.