Legislative Analysis on Barriers to the Free Movement of Food Supplements on the European Union Market

ERIMIA Cristina-Luiza1, DUMITRESCU Denisa Elena1*, MITITELU Magdalena2

1Ovidius University of Constanta, Faculty of Pharmacy, Campus Corp C, Constanta, ROMANIA

2Clinical Laboratory and Food Hygiene Department, Faculty of Pharmacy,”Carol Davila” University of Medicine and Pharmacy, 6, Traian Vuia Street, 020956, Bucharest, ROMANIA

Emails: cristinaerimia@gmail.com, corresponding author: denisadumitrescu@yahoo.com*, magdamititelu@yahoo.com

Abstract

    Since a prohibition against the marketing of a particular product or substance is the most restrictive measure that can be taken by a Member State with regard to the free movement of goods and given that most goods subject to national bans are foodstuffs, including vitamins, food supplements and chemicals, this article examines the barriers to cross-border trade in nutritional supplements containing other substances than vitamins and minerals.

     As European legislation does not include specific provisions on the use of substances other than vitamins or minerals in nutritional supplements, free movement of such products is administered by Articles 34-35 TFEU [1] and can thus be subject to national limitation or bans within the limits laid down in Article 36.

     Withal, the article aims to present the relevant jurisprudence of the Court of Justice of the European Union who restricts the list of derogations provided for in Article 36 TFEU, so that measures applied by Member States do not constitute a means of masked discrimination or any abusive restriction in trade in nutritional supplements containing another substances than vitamins and minerals.

Keywords: EU legislation, food supplements, liberal traffic of merchandise, jurisprudence of the CJEU, national restrictions

Introduction

     Directive 2002/46 / EC [2] only partially harmonizes the rules applicable to nutritional supplements at the time they are placed on the market.

      Although the scope of the Directive covers all these categories of products with certain requirements that apply to all nutritional supplements, regardless of their composition, only the rules on the use of vitamins and minerals in the production of supplements are laid down in the Directive. It follows that the use in the manufacture of nutritional supplements of other substances, other than vitamins or minerals, continues to be governed by national rules of national law, which apply under Articles 34 to 36 TFEU [3], but without prejudice to the Community provisions of general application which fall within its scope.

     Unlike the approximately homogeneous market for nutritional supplements that include vitamins and minerals, the market for supplements that include other substances is characterized by a wide variety. A study of the internal market for nutritional supplements [4] containing substances other than vitamins or minerals shows that the European Union market for these products varies greatly from one Member State to another, with differences in both the content of substances used, but also regulatory. Despite these differences, the market shares of nutritional supplements containing vitamins and minerals and that of nutritional supplements containing other substances are almost identical.

Theory

     Some Member States already have a well-established tradition of using certain substances in nutritional supplements, while in other Μember States the use of these substances is virtually absent.

      Because EU legislation does not have harmonized provisions on the use of other substances than vitamins or minerals in nutritional supplements, the circulation of these products on the internal market falls under the rules of Articles 35-36 TFEU and may be subject to certain national limitations or interdictions. Article 36.

      For the purposes of Article 2 of Regulation (EC) No 178/2002 [5], which states that food means any substance or product, whether processed (in whole or in part), or unprocessed, intended for human consumption, and nutritional supplements containing other substances are also considered food.

      With regard to nutritional supplements, especially those containing other substances, there are many cases where a particular product is authorized for marketing in some Member States as a food, while the same product is considered a medicinal product in other Member States.

      It should also be noted that some substances, in particular certain plant extracts, are used both in food supplements and in the manufacture of traditional herbal medicines. These difficulties must be resolved for each individual case, as EU medicines legislation lays down harmonized rules and procedures for the placing on the market of medicines. The competence to issue a marketing authorization for medicinal products for human use rests with the competent authorities of the Member States or, for certain types of medicinal products, with the European Medicines Agency, through the centralized procedure.

Results and discussions

     Thexmostxrestrictive measurexthatxa MemberxState may take with regard toxthexfree movement ofxgoods onxthe Community market isxthe provizition onxthe marketing of a particular product or substance. Most goods subject to national bans are food products [6], including vitamins, food supplements and chemicals.

      Ιn most cases, the justifications provided by Member States for prohibiting the marketing of certain products are attributed to the protection of life and health of humans, animals and plants, as these exceptions are restricted in Article 36 TFΕU. Member States also appeal to mandatory requirements set out in the case law of the Court of Justice of the ΕU, such as those on environmental protection. It is clear from the case-law of the Court that these justifications are often combined. Where a Member State imposes a national marketing ban on a product, it must demonstrate why measure that the adopted is necessary and, depending on the justification used, that the placing on the market of the products in questiΟn would pose a serious risk to public health. In addition, the Member State which introduces such a ban must demonstrate that the rules imposed on the nutrition supplement comply with the principle of proportionality. In support of the measure taken, the Member State is required to provide all relevant evidence (technical, scientific, statistical, nutritional information, etc.) [7].

     In addition to what has been shown so far, the Member State is required to demonstrate with evidence that the protection of health and life of humans, animals, plants or the environment cannot be achieved by other means, with a less restrictive effect on the free movement of goods on the ΕU internal market [8].

     Judging a French bon on the addition of caffeine to beverages above a certain level, the Court found labelling and informing consumers that appropriate about the nature, ingredients and characteristics of energy products may allow users whose health may be affected by the excessive consumption of a nutrient added to these products to decide for themselves whether to consume them [9]. In examining the case before it, the Court held that France’s bon on the addition of caffeine above a certain level was not necessary to protect consumers and that the measure adopted was disproportionate.

      In another case, known in the case law of the Court as the “Danish Vitamins Case” [10], the practice of the Danish authorities prohibiting the enrichment of food vitamins and minerals in has been judged if it cannot be proved that this enrichment was useful to the population. Although at first instance the Court agreed that it was for the Danish authorities to determine the level of protection of human health and life, having regard to the principle of proportionality, the Court noted in paragraph 46 that the Danish authorities have an obligation to in each case demonstrate, in light of national food habits and in light of the results of international scientific research, that the proposed rules are necessary to effectively protect the interests endorsed in the respective provision and, in particular, that the marketing of the respective products results in a real risk to public health. After examining the case, the Court concluded, in paragraph 56, that the measure taken by the administrative authorities of Denmark does not comply with Εuropean Union law because no real public health risk of enriching food or nutritional supplements with minerals and vitamins can be identified.

     It must be borne in mind that the Εuropean Commission has repeatedly taken administrative action against certain Member States which prevented the free movement of goods by bringing them before the Court of Justice of the Εuropean Union. For each case before it, the Court ruled that the actions of the Member States infringed Article 34 TFΕU [11] and, moreover, that the Member States bad failed to fulfill their obligations under the TFΕU. Referming to Articles 34 and 36 TFΕU, in its rich case law, the Court has ruled that these articles do not prevent a Member State from prohibiting the marketing without national authorization of foodstuffs or nutritional supplements produced and lawfully marketed in another Member State, but this prohibition must meet certain conditions (be proportionate, justified, demonstrated and supported by evidence).

    A first requirement that the national procedure for the prior authorization of food supplements must comply with is that it must be immediately accessible to economic operators and completed by the competent authorities within a reasonable time. If prior marketing authorization is refused, the decision of the authorities must be open to challenge in the courts. Another express requirement is that the refusal of the competent national authorities to authorize marketing must always be based on a detailed and accurate assessment based upon the most accurate scientific data of the risk to public health, available and the latest international research results.

    It is difficult for economic operators working in the field of food supplements to challenge the decisions of national authorities in this regard, as economic operators depend on these national authorities for many other issues concerning the authorization of other products, approvals, controls and much more. It is easy to understand why, instead of resorting to a time-consuming procedure to challenge barriers to trade, the nutritional supplements industry prefers to adapt its products and labels in accordance with the national legal provisions of the Member States.

    As noted above, Article 36 TFEU lists the justifications that Member States may invoke when applying prohibitions or restrictions on imports, exports or transit, prohibitions which impede the free movement of goods, and the Court’s rich case-law shows the imperative requirements which Member States may use them to justify national measures taken, such as those on environmental protection.

    Justifications on grounds of protection of human and animal life and health, or of plant conservation, or of protection of industrial and commercial property, which are included in the list of derogations provided for in Article 36 TFΕU, shall be interpreted restrictively by the Court of Justice of the Εuropean Union, all of which refer, in fact, to non-economic interests. Irrespective of the justification invoked, any restrictive measure imposed by Member States on cross-country border trade must always respect the principle of proportionality. Although the burden of proof to justify measures adopted in accordance with Article 36 TFΕU rests with the Member State, when the Member State provides convincing justification, the Εuropean Commission, contrary to that Member State, must approve to the Court that the measures adopted are not appropriate in that particular case. Further analysis of the provisions of Article 36 TFΕU shows that the final part of the article is intended to prevent abuses by Member States, in the sense that, even if a measure is justifiable under one of the derogations provided for, it must not constitute a means of arbitrary discrimination and no masked restrictions on cross-border trade.

     Referring to the principle of proportionality that Member States must respect when imposing certain restrictions, it must be emphasized that the means chosen must be strictly limited to what is actually necessary to ensure the desired level of protection of public health. In fact, the measures adopted must be proportionate to the objective pursued, which could not have been achieved by less restrictive measures imposed on trade between Member States.

     I consider it necessary to point out that, although it was implicit in the Court’s previous case-law, the precautionary principle was used in the time for the first case of the National Farmers’ Union [12]. In fact, the precautionary principle shows the situations in which a national, Εuropean Union or international legislative authority may adopt measures to protect the population against health risks that may be associated with a product marketed on the internal market of the Εuropean Union, taking into account of the uncertainties existing in the current state of scientific research.

     Moreover, in its rich case-law, the Court has unequivocally established precautionary measures closed that, before taking based on Articles 34 and 36 TFΕU [13], Member States must carry out a careful risk assessment.

     Regulation 1924/2006 [14] stipulates the prior approval of all claims concerning the health effects of a food item. On the one hand, this legislation made it possible to use the claims relating to the reduction of the risk of disease. These are statements that are very close to disease prevention, indicating that food or one of its ingredients significantly reduces a risk factor for the evolution of a disease in humans. For this reason, the mention of the disease is explicitly allowed.

     However, as the use of a food supplement is legally considered a health claim, it must be authorized before it can be used. To this end, the regulation establishes a procedure at the Εuropean level. Unfortunately, the requirements for scientific substantiation are so difficult to meet that so far only 267 health claims have been authorized, most of them related to essential nutrients, such as vitamins and minerals [15].

     For plants and bioactive substances, most applications were rejected, which led to a fundamental problem. For traditional herbal medicines, products which are very close to food supplements depending on their presentation and composition, there is no requirement for a scientific basis for the claims. Ιt is sufficient to demonstrate that a product has been used for 30 years (of which 15 within the EU) and that its effectiveness is plausible based on this long-term use and experience [16]. However, a similar effect for a food supplement must be approved taking into account of high-quality scientific evidence, such as through clinical trials on humans. Since this has never been a requirement under national law and the effectiveness of many plants has been based on their long-standing tradition, such intervention studies are lacking for most plants and there is no solid incentive to establish such evidence

Conclusions

    As European legislation is not harmonized and does not contain specific regulations for the use of nutritional supplements containing substances other than vitamins and minerals, the free movement is governed by Articles 34 to 36 TFΕU and may be prohibited or restricted by national authorities, within the limits set out in Article 36.

     The national authorities of the Member States claiming the exception to the rule of free movement of food supplements on the Community market must demonstrate, taking into account national nutrition manners and the results of international scientific research, that the adoption of such outstanding measures is necessary for effective protection of public health, for which the commercialization of the food supplement in question poses a real danger [17].

     Ιn Romania, the principle of mutual recognition does not apply absolutely, but by correlating it with the negative and positive list of plants prohibited / allowed in food supplements, existing in Romania, in order not to discriminate Romanian producers from ΕU food supplement producers or from other states.

    The Εuropean Commission considers that existing legal instruments at EU level already form an appropriate legislative framework for the regulation of nutritional supplements and does not consider adequate to set the specific rules for the other substances than vitamins or minerals intended to be introduced into human food.

     Finally, wishing to provide an example of good practice in the field of cooperation between Member States, we recall the cooperation project concluded by Belgium, France and Ιtaly, a project known under the acronym ”BΕLFRIT”. The three States have drawn up a common list of traditional plants that can be used in food supplements, which was presented to the Commission and the Member States at a meeting held at the headquarters of the Belgian competent authority in November 2013 [18].

REFERENCES

  1. ”Consolidated version of the Treaty on the Functioning of the European Union (TFEU), published in the Official Journal of the European Union C 326 of 26.12.2012.
  2. 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, published in the Official Journal of the European Union, L 183/51 of 12.7.2002. 
  3. Consolidated version of the Treaty on the Functioning of the European Union (TFEU), published in the Official Journal of the European Union C 326 of 26.12.2012.
  4. European Advisory Services (EAS). (2007). The use of substances with nutritional or physiological effect other than vitamins and minerals in food supplements. Study undertaken for DG Sanco, European Commission. 28 March, available at: https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-supplements-2007_a540169_study_other_substances_en.pdf
  5. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, published in the Official Journal of the European Union L 31 of 1.2.2002.
  6. Case 174/82 Sandoz, Rec. 1983, pp. 2445; Case C-24/00 Commission v France, Rec. 2004, pp. I-1277; Case C-420/01 Commission v Italy, Rec. 2003, pp. I-6445; Case C-192/01 Commission v Denmark, Rec. 2003, pp. I-9693; Case C-41/02 Commission v Netherlands, Rec. 2004, pp. I-11375; Case C-319/05 Commission v Germany, Rep. 2007, pp. I-9811.
  7. Case C-270/02 Commission v Italy, Rec. 2004, pp. I-1559.
  8. Case 104/75 De Peijper, Rec. 1976, pp. 613.
  9. Case C-24/00 Commission v France, Rec. 2004, pp. I-1277, paragraph 75.
  10. Case C-192/01 Commission v Denmark, Rec. 2003, pp. I-9693.
  11. Case 387/99: 29/04/2004. Commission of the European Communities v. Federal Republic of Germany. OJ C118/2; 30/04/2004; Case 24/00: 05/02/2004. Commission of the European Communities v. French Republic. OJ C85/2; 03/04/2004; Case 150/00: 29/04/2004. Commission of the European Communities v. Republic of Austria. OJ C118/3; 30/04/2004; Case 192/01: Commission of the European Communities v. Kingdom of Denmark. OJ C275/12. 15/11/2003; Case 41/02: 02/12/2004. Commission of the European Communities v. Kingdom of The Netherlands. OJ C19:1; 22/01/2005
  12. Case C-157/96 National Farmers ’Union and Others, Rec. 1998, pp. I-2211.
  13. Case C-249/07 Commission v Netherlands, not published in the ECR, paragraphs 50 and 51; Case C-41/02 Commission v Netherlands, Rec. 2004, pp. I-11375; Case C-192/01 Commission v Denmark, Rec. 2003, pp. I-9693; Case C-24/00 Commission v France, Rec. 2004, pp. I-1277.
  14. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, published in the Official Journal of the European Union L 404 of 30.12.2006. 
  15. Coppens P. (2018). Food Supplements in the European Union: the Difficult Route to Harmonization. Botanicals and Maximum Levels. Regulatory Focus. July 2018. Regulatory Affairs Professionals Society, available at: https://www.raps.org/news-and-articles/news-articles/2018/7/food-supplements-in-the-european-union-the-diffic
  16. Directive 2004/24/EU of the European Parliament and of the Council of of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, published in the Official Journal of the European Union, L 136 of 30.4.2004.
  17. Case C-319/05 Commission v Federal Republic of Germany, cited in the 2008 Report, paragraphs 86-88.
  18. Communication from the Commission – TRIS/(2017) 01619, Structured Information Line – MSG 002 IND 2017 0276 I EN 28-06-2017 I NOTIF, Notification Number – 2017/0276/I – C80A”.