Criminal proceedings against Noria Distribution SARL.
Date: 2017-04-27
16


First of all, it should be noted that, so long as, in accordance with Article 5(4) of Directive 2002/46, the Commission has not laid down the maximum amounts of nutrients which may be used in the manufacture of food supplements, the Member States remain competent to adopt legislation relating to those amounts, on the understanding that, in the exercise of that competence, those Member States are required to comply with Articles 34 and 36 TFEU and to be guided by the criteria laid down in Article 5(1) and (2) of Directive 2002/46, including the requirement for a risk assessment based on generally accepted scientific data (see, to that effect, judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraphs 24 and 32).
17


In that regard, it should be recalled that that the free movement of goods between Member States is a fundamental principle of the TFEU which finds its expression in the prohibition, set out in Article 34 TFEU, of quantitative restrictions on imports between Member States and all measures having equivalent effect (see judgments of 2 December 2004, Commission v Netherlands, C‑41/02, EU:C:2004:762, paragraph 38, and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 73).
18


The prohibition on measures having an effect equivalent to restrictions set out in Article 34 TFEU covers all commercial rules enacted by the Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Union trade (see, inter alia, judgments of 11 July 1974, Dassonville, 8/74, EU:C:1974:82, paragraph 74; of 5 March 2009, Commission v Spain, C‑88/07, EU:C:2009:123, paragraph 82, and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 74).
21


According to the Court’s case-law, rules of a Member State which prohibit the marketing, in that State, of foodstuffs whose content in nutrients exceeds the maximum amount set by those rules, such foodstuffs being lawfully manufactured and/or marketed in the another Member State, can be justified, as a measure having equivalent effect to a quantitative restriction within the meaning of Article 34 TFEU, in so far as they comply with the requirements of Article 36 TFEU, as interpreted by the Court (see, to that effect, judgment of 5 February 2004, Greenham and Abel, C‑95/01, EU:C:2004:71, paragraph 34).
22


First, such rules must make provision for a procedure enabling economic operators to obtain the authorisation to market food supplements including nutrients in doses exceeding those authorised. 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, judgments of 5 February 2004, Commission v France, C‑24/00, EU:C:2004:70, paragraph 26; of 5 February 2004, Greenham and Abel, C‑95/01, EU:C:2004:71, paragraph 35, and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 81).
23


Secondly, an application to obtain the authorisation to market those supplements may be refused by the competent national authorities only if those supplements pose a genuine risk to public health (see, to that effect, judgments of 5 February 2004, Commission v France, C‑24/00, EU:C:2004:70, paragraph 27; of 5 February 2004, Greenham and Abel, C‑95/01, EU:C:2004:71, paragraph 36, and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 82).
31


In that regard, it should be recalled that, as well as having to be carried out in compliance with Articles 34 and 36 TFEU, setting the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements must be based on the criteria in Article 5(1) and (2) of Directive 2002/46 (see judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraphs 32 and 63).
32


According to Article 5(1)(a) thereof, those amounts are set per daily portion of consumption as recommended by the manufacturer, taking into account the 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 (see judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraph 64).
33


It follows therefrom that setting the maximum amounts referred to in Article 5 of Directive 2002/46 must in particular be based on consideration of the upper safe limits established, for the vitamins and minerals concerned, following a scientific assessment of the risks to human health based on the relevant scientific data and not on purely hypothetical considerations (see judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraph 65).
34


Therefore, setting maximum amounts for vitamins and minerals which may be used in the manufacture of food supplements where, in the absence of a proven risk to human health, upper safe limits have not been established for those nutrients after such a scientific assessment, does not satisfy that requirement (see judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraph 66).
35


After the upper safe limits have been established, the possibility of setting maximum amounts at a level significantly lower than those limits cannot be excluded if the setting of those maximum amounts can be justified by taking into account the criteria in Article 5(1) and (2) of Directive 2002/46 and that it complies with the principle of proportionality (see judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraph 71).
37


Furthermore, the assessments leading to setting maximum amounts of nutrients which may be used in the manufacture of food supplements must be carried out on a case-by-case basis (see, to that effect, judgments of 23 September 2003, Commission v Denmark, C‑192/01, EU:C:2003:492, paragraph 46; of 5 February 2004, Greenham and Abel, C‑95/01, EU:C:2004:71, paragraph 40; of 5 February 2004, Commission v France, C‑24/00, EU:C:2004:70, paragraph 53; of 2 December 2004, Commission v Netherlands, C‑41/02, EU:C:2004:762, paragraph 47, and of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraphs 55 and 72).
38


Finally, it should be noted that, according to the Court’s case-law, although the criterion of the nutritional need of the population of a Member State can play a role in its detailed assessment of the risks which the addition of nutrients to foodstuffs may pose for public health, the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 36 TFEU, of the marketing of foodstuffs lawfully manufactured and/or marketed in other Member States (see judgments of 5 February 2004, Greenham and Abel, C‑95/01, EU:C:2004:71, paragraph 46; of 2 December 2004, Commission v Netherlands, C‑41/02, EU:C:2004:762, paragraph 69, and of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraph 60).
48


Furthermore, the assessment referred to in that provision is subject to the same requirements as those deriving from the Court’s case-law where it concerns 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 that regard, the Court has in particular held that the existence of such a risk must be shown in each case in the light of national nutritional habits and in the light of the results of international scientific research (see judgments of 23 September 2003, Commission v Denmark, C‑192/01, EU:C:2003:492, paragraph 46; of 5 February 2004, Commission v France, C‑24/00, EU:C:2004:70, paragraph 53; and of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraph 55).
49


In that context, the Court has also held, first, that such a measure can be adopted only if the alleged real risk for public health appears to be sufficiently established on the basis of the latest scientific data available at the date of the adoption of that measure (see judgments of 23 September 2003, Commission v Denmark, C‑192/01, EU:C:2003:492, paragraph 48; of 5 February 2004, Commission v France, C‑24/00, EU:C:2004:70, paragraph 55; of 2 December 2004, Commission v Netherlands, C‑41/02, EU:C:2004:762, paragraph 49; and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 89), and, secondly, that the evaluation of that risk must be carried out on the basis of the most reliable scientific data available and the most recent results of international research (see judgment of 5 February 2004, Greenham and Abel, C‑95/01, EU:C:2004:71, paragraph 47).