Opinion of the Advocate General — ECLI:EU:C:2016:961
Date: 2016-12-15
Language of the case: French
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: France

Summary — Judgment of the Court (First Chamber), 27 April 2017 1. Approximation of laws — Food supplements – Directive 2002/46 — Definition of minimum and maximum amounts of vitamins and minerals used for the manufacture of food supplements — Conferred power of the Commission — Lack of regulation — Competence of the Member States — Limits (European Parliament and Council Directive 2002/46, Art. 5(4)) 2. Free movement of goods — Quantitative restrictions — Measures having equivalent effect — National legislation not providing for a procedure for the placing on the market of food supplements with a nutrient content exceeding the maximum limits set by that legislation — Food supplements lawfully manufactured or marketed in another Member State — Unlawful — Justification — Protection of public health — Absence (Arts 34 TFEU and 36 TFEU; European Parliament and Council Directive 2002/46) 3. Approximation of laws — Food supplements – Directive 2002/46 — Setting maximum amounts of nutrients which can be used for the manufacture of food supplements — Setting on a case-by-case basis — Elements to be taken into account — Determination by the national court (European Parliament and Council Directive 2002/46, Art. 5(1) and (2)) 4. Approximation of laws — Food supplements — Directive 2002/46 — Definition of minimum and maximum amounts of vitamins and minerals used for the manufacture of food supplements — Scientific assessment of risks prior to the establishment of upper safe limits carried out solely on the basis of national scientific opinions — Unlawful (European Parliament and Council Directive 2002/46, Art. 5(1)(a)) 1. See the text of the decision. (see para. 16) 2. The provisions of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements and those of the TFEU relating to the free movement of goods must be interpreted as precluding legislation of a Member State, such as that at issue in the main proceedings, which does not provide for a procedure for the placing on the market of that Member State of food supplements whose content in nutrients exceeds the maximum daily doses set by that legislation and which are lawfully manufactured or marketed in another Member State. 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). The legislation at issue in the main proceedings creates a barrier to trade within the European Union, since a food supplement whose nutrient content exceeds the maximum limits set by that legislation cannot be marketed in France, even if that food supplement is lawfully manufactured or marketed in another Member State. That legislation therefore constitutes a measure having an effect equivalent to a quantitative restriction for the purposes of Article 34 TFEU. 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). 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). 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). Consequently, in so far as the legislation at issue in the main proceedings prohibits the marketing of food supplements whose content in nutrients exceeds the upper limits set by that legislation without providing for any procedure for the placing on the market of that type of food supplement, and that even if they are lawfully manufactured or marketed in another Member State, that legislation does not comply with the requirement referred to in paragraph 22 of the present judgment and cannot, therefore, be justified under Article 36 TFEU. (see paras 18-23, 27, 28, operative part 1) 3. The provisions of Directive 2002/46 and those of the TFEU relating to the free movement of goods must be interpreted as meaning that the maximum amounts referred to in Article 5 of that directive must be set on a case-by-case basis and taking into account all of the elements in Article 5(1) and (2) of that directive, in particular of the upper safe levels established, with respect to the nutrients at issue, after a comprehensive scientific assessment of the risks for public health, based not on general or hypothetical considerations, but on relevant scientific data. It is for the referring court to assess whether the method for the setting of those amounts at issue in the main proceedings complies with those requirements. (see para. 42, operative part 2) 4. The provisions of Directive 2002/46 and those of the TFEU relating to the free movement of goods must be interpreted as precluding that the scientific assessment of the risks referred to in Article 5(1)(a) of that directive, prior to the establishment of upper safe limits which must in particular be taken into account in order to set the maximum amounts referred to in Article 5 thereof, be carried out solely on the basis of national scientific opinions, even though recent international scientific opinions concluding in favour of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue. In that regard, it should be noted that, in accordance with Article 5(1)(a) of that directive, the setting of those maximum amounts must in particular take account of upper safe levels of vitamins and minerals after a scientific risk assessment based on ‘generally accepted scientific data’. It cannot therefore be inferred from that wording that that assessment can be carried out on the sole basis of national scientific data, since international scientific data are also available. By requiring that that assessment be based on ‘generally accepted scientific data’, Article 5(1)(a) of Directive 2002/46 intends that assessment to be carried out on the basis of reliable scientific data, regardless of whether they are national or international. Therefore, if recent and reliable international scientific data are available on the date on which the scientific assessment of risks provided for in Article 5(1)(a) of Directive 2002/46 is carried out, that assessment cannot be carried out without having regard to those data. (see paras 44, 45, 47, 50, 51, operative part 3)