¹ Generally, the term “sports nutrition” in this article covers nutritional substances used by athletes to gain some additional benefit from training.Google Scholar

² Proposal for a Regulation on Food Intended for Infants and Young Children and on Food for Special Medical Purposes, at 17, SEC (2011) 762 final, Impact Assessment (June 20, 2011) [hereinafter Impact Assessment].Google Scholar

³ Id. The presented groups of consumers are defined as follows: “Bodybuilders” are people who are engaged in the sport of bodybuilding, which entails building up muscle through a combination of weight training and increased calorific intake. “Athletes” include all professional sportspeople, excluding bodybuilders. “Recreational users” are people who do sports on the weekends and fitness enthusiasts. “Lifestyle users” include people who use sports nutrition products for purposes other than sports or exercise.Google Scholar

⁴ Id. at 62.Google Scholar

⁵ Richard B. Kreider et al., ISSN Exercise & Sport Nutrition Review: Research & Recommendations, 7 J. Int'l Soc'y Sports Nutrition 1 (2010); Ron J. Maughan et al., The Use of Dietary Supplements by Athletes, 25 J. Sports Sci. 103 (2007).Google Scholar

⁶ Kreider et al., supra note 5.Google Scholar

⁷ Ron J. Maughan et al., Dietary Supplements, 22 J. Sports Sci. 96 (2004); Williams, Melvin H., Dietary Supplements and Sports Performance: Introduction and Vitamins, 1 J. Int'l Soc'y Sports Nutrition 1 (2004); Williams, Melvin H., Dietary Supplements and Sports Performance: Minerals, 2 J. Int'l Soc'y Sports Nutrition 43 (2005).Google ScholarPubMed

⁸ See Directive 2002/46 of the European Parliament and of the Council of 10 June 2002, 2002 O.J. (L 183) 51, recital 13 (EC) [hereinafter Food Supplements Directive] (discussing the approximation of the laws of the Member States relating to food supplements).Google Scholar

⁹ See Case 174/82, Officier van Justitie v. Sandoz, 1983 E.C.R. 2445, para. 11; Case C-192/01, Comm'n v. Denmark, 2003 E.C.R. I-9693, para. 43; Case C-24/00, Comm'n v. France, 2004 E.C.R. I-1277, para. 50; Case C-446/08, Solgar Vitamin's France v. Ministre de l'Économie, des Finances et de l'Emploi, 2010 E.C.R. I-3973, para. 36.Google Scholar

¹⁰ Basturk Taner et al., The Effects of the Recommended Dose of Creatine Monohydrate on Kidney Function, 4 Nephrology Dialysis Transplantation Plus 23 (2011).Google Scholar

¹¹ Lowery, Lonnie M. & Devia, Lorena, Dietary Protein Safety and Resistance Exercise: What Do We Really Know?, 6 J. Int'l Soc'y Sports Nutrition 1 (2009).Google ScholarPubMed

¹² Maughan et al., supra note 5, at 104. Notably, the authors refer to online sales as by far the most problematic when it comes to consumers’ protection because “internet selling has effectively removed most of the national controls that might protect the consumer.” Id. at 110. It is worth mentioning that the question of sales by mail order has indeed been approached specifically by the ECJ in Case C-497/03, Comm'n v. Austria (Oct. 28, 2004). The case originated from the prohibition on the sale of food supplements by mail order, laid down in Austrian national law. The ECJ stated that such measure had equivalent effect to a quantitative restriction on imports, while the aim of protecting consumers against health risks and misrepresentation, which was put forward in order to justify such a prohibition, could have been achieved by more lenient means.Google Scholar

¹³ Regulation 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims Made on Foods, 2006 O.J. (L 404) 9, recitals 1 and 14 [hereinafter Health Claims Regulation].Google Scholar

¹⁴ Food Supplements Directive, supra note 8, at recitals 11 and 13.Google Scholar

¹⁵ Health Claims Regulation, supra note 13, at recital 15.Google Scholar

¹⁶ Id. at recital 17.Google Scholar

¹⁷ Id.; see also Kreider et al., supra note 5, at 4–7.Google Scholar

¹⁸ Health Claims Regulation, supra note 13.Google Scholar

¹⁹ Kreider et al., supra note 5, at 5-6; Maughan et al., supra note 5, at 104.Google Scholar

²⁰ Kathryn Froiland et al., Nutritional Supplement Use Among College Athletes and Their Sources of Information, 14 Int'l J. Sport Nutrition & Exercise Metabolism 104 (2004).Google Scholar

²¹ See Regulation 178/2002 of the European Parliament and of the Council of 28 January 2002, 2002 O.J. (L 31) 1 (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).Google Scholar

²² Id. at art. 5(1).Google Scholar

²³ Id. at art. 6.Google Scholar

²⁴ Id. at art. 7.Google Scholar

²⁵ Id. at art. 8.Google Scholar

²⁶ Id. at arts. 9–10.Google Scholar

²⁷ Id. at art. 18.Google Scholar

²⁸ Id. at art. 14(1). See van der Meulen, Bernd, The Core of Food Law, 3 Eur. Food & Feed L. Rev. 117 (2012). In Case C-636/11, Karl Berger v. Freistaat Bayern, Apr. 11, 2013, para. 35, the ECJ stated that if a foodstuff does not fulfill the food safety requirements under article 14(5), it prejudices the interests of consumers, the protection of whom, as stated in article 5, is one of the objectives of food law.Google Scholar

²⁹ See Regulation 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the Provision of Food Information to Consumers, amending Regulations 1924/2006 and 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC, and Commission Regulation 608/2004, 2011 O.J. (L 304) 18.Google Scholar

³⁰ Regulation 178/2002, supra note 21, at art. 14(9).Google Scholar

³¹ Consolidated Version of the Treaty on the Functioning of the European Union, Oct. 26, 2012, 2012 O.J. (C 326) 47 [hereinafter TFEU]. This rule, often referred to as the “principle of mutual recognition,” is traced back to the renowned Case 120/78, Rewe-Zentral AG v. Bundesmonopolverwaltung für Branntwein (Cassis de Dijon), 1979 E.C.R. 649, available at http://curia.europa.eu/. According to the ECJ, this principle can be defined as follows: There is no valid reason why products should not be introduced into one of the Member States provided that they have been lawfully produced and marketed in any other Member State; the sale of such products may not be subject to legal prohibition on the marketing set by the national rules. Id. at para. 14. Therefore, such products can be sold in other Member States with no additional restrictions, omitting those justified under the above-mentioned article 36 of the TFEU, which shall be discussed further.Google Scholar

³² Regulation 1925/2006 of the European Parliament and of the Council, Dec. 20, 2006, 2006 O.J. (L 404) 26, On the Addition of Vitamins and Minerals and of Certain Other Substances to Foods (EC) [hereinafter Fortified Foods Regulation].Google Scholar

³³ Directive 2009/39 of the European Parliament and of the Council, May 6, 2009, 2009 O.J. (L 124) 21, On Foodstuffs Intended for Particular Nutritional Uses (EC) [hereinafter Dietetic Foods Framework Directive].Google Scholar

³⁴ Food supplements under article 2(a) are defined as:Google Scholar

Food Supplements Directive, supra note 8, at art. 2(a). “Nutrients” are defined as vitamins and minerals. Id. at art. 2(b).Google Scholar

³⁵ Id. at art. 4(1).Google Scholar

³⁶ Id. at art. 4(2).Google Scholar

³⁷ Id. at art. 4(3).Google Scholar

³⁸ Id. at art. 4(4).Google Scholar

³⁹ See Commission Directive 2008/84, Aug. 27, 2008, 2008 O.J. (L 253) 1 (EC) (laying down specific purity criteria on food additives other than colors and sweeteners).Google Scholar

⁴⁰ Study undertaken for D.G. Sanco, European Commission. European Advisory Servs., The Use of Substances with Nutritional or Physiological Effect Other than Vitamins and Minerals in Food Supplements, at 9-10 (2007), http://ec.europa.eu/food/safety/docs/labelling_nutrition-supplements-2007_a540169_study_other_substances_en.pdf.Google Scholar

⁴¹ Characteristics and Perspectives of the Market for Food Supplements Containing Substances Other Than Vitamins and Minerals, COM (2008) 824 final (Dec. 5, 2008), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2008:2976:FIN:EN:PDF [hereinafter Characteristics and Perspectives].Google Scholar

⁴² European Advisory Servs., supra note 40.Google Scholar

⁴³ Characteristics and Perspectives, supra note 41.Google Scholar

⁴⁴ Id. at 11–12.Google Scholar

⁴⁵ Case C-88/07, Comm'n v. Spain, 2009 E.C.R. I-1353, para. 28; Food Supplements Directive, supra note 8, at recital 8.Google Scholar

⁴⁶ Id.; see also European Advisory Servs., supra note 40, at 58.Google Scholar

⁴⁷ Food Supplements Directive, supra note 8, arts. 5(1) & (4).Google Scholar

⁴⁸ Id. art. 5(2).Google Scholar

⁴⁹ Id. art. 5(3). These, however, have not yet been laid down. See Case C-137/13, Herbaria Kräuterparadies GmbH v. Freistaat Bayern, Op. of AG Sharpston, May 8, 2014, para. 46.Google Scholar

⁵⁰ Case C-446/08, Solgar Vitamin's France v. Ministre de l'Économie, des Finances et de l'Emploi, 2010 E.C.R. I-3973, paras. 21–24. Earlier, the Court expressed that article 11(2) of the Food Supplements Directive operates in a similar way to the above-mentioned article 14(9) of the Food Law Regulation and permits national rules to apply in the absence of specific EU rules. See Case C-319/05, Comm'n v. Germany, 2007 E.C.R. I-9811, para. 84.Google Scholar

⁵¹ Solgar Vitamin's France, Case C-446/08 at para. 32.Google Scholar

⁵² Id. at para. 35; see also Case 104/75, Criminal Proceedings Against Adriaan de Peijper, 1976 E.C.R. I-613, 635; Case 272/80, Criminal Proceedings Against Frans-Nederlandse Maatschappij voor Biologische Producten BV, 1981 E.C.R. I-3277, para. 12; Case 174/82, Officier van Justitie v. Sandoz, 1983 E.C.R. 2445, paras. 16–17; Case C-192/01, Comm'n v. Denmark, 2003 E.C.R. I-9693, para. 42; Case C-24/00, Comm'n v. France, 2004 E.C.R. I-1277, para. 49.Google Scholar

⁵³ Solgar Vitamin's France, Case C-446/08 at para. 36; see also Denmark, Case C-192/01 at para. 43; France, Case C-24/00 at para. 50.Google Scholar

⁵⁴ Sandoz, Case 174/82 at paras. 16–17; Case C-42/90, Criminal proceedings against Jean-Claude Bellon, 1990 E.C.R. I-4863, paras. 10–11; Case C-400/96, Criminal Proceedings Against Jean Harpegnies, 1998 E.C.R. I-5121, para. 29; Denmark, Case C-192/01 at para. 42; France, Case C-24/00 at paras. 49–50; Solgar Vitamin's France, Case C-446/08 at para. 48.Google Scholar

⁵⁵ TFEU arts. 34–35.Google Scholar

⁵⁶ Solgar Vitamin's France, Case C-446/08 at para. 48.Google Scholar

⁵⁷ Sandoz, Case 174/82 at para. 18; Case C-247/84, Criminal Proceedings Against Léon Motte, 1985 E.C.R. I-3887, para. 23; Case C-304/84, Criminal Proceedings Against Claude Muller, 1986 E.C.R. I-1511, para. 23; Case C-178/84, Comm'n v. Germany, 1987 E.C.R. I-1227, para. 28; Bellon, Case C-42/90 at para. 14; Harpegnies, Case C-400/96 at para. 34; Denmark, Case C-192/01 at para. 45; France, Case C-24/00 at para. 52; Solgar Vitamin's France, Case C-446/08 at para. 54.Google Scholar

⁵⁸ Food Supplements Directive, supra note 8, at art. 5(1)(a).Google Scholar

⁵⁹ Solgar Vitamin's France, Case C-446/08 at para. 49.Google Scholar

⁶⁰ Id. Google Scholar

⁶¹ Id. at para. 61.Google Scholar

⁶² Id. at para. 65.Google Scholar

⁶³ Denmark, Case C-192/01 para. 49; France, Case C-24/00 at para. 56; Solgar Vitamin's France, Case C-446/08 at para. 67.Google Scholar

⁶⁴ Case C-157/96, Queen v. Ministry of Agric., Fisheries & Food, 1998 E.C.R. I-2211, para. 63; Denmark, Case C-192/01 at para. 49; France, Case C-24/00 at para. 56; Solgar Vitamin's France, Case C-446/08 at para. 67.Google Scholar

⁶⁵ Case C-236/01, Monsanto Agricoltura Italia SpA v. Presidenza del Consiglio dei Ministri, 2003 E.C.R. I-8105, para. 106; Denmark, Case C-192/01 at para. 49; France, Case C-24/00 at para. 56; Solgar Vitamin's France, Case C-446/08 at para. 67.Google Scholar

⁶⁶ Case E-3/00, EFTA Surveillance Auth. v. Norway, 2001 EFTA Ct. Rep. 73, para. 29.Google Scholar

⁶⁷ Id.; Denmark, Case C-192/01 at para. 50; Solgar Vitamin's France, Case 446/08 at para. 68.Google Scholar

⁶⁸ EFTA Surveillance Auth., Case E-3/00 at para. 30; Monsanto Agricoltura Italie, Case C-236/01 at para. 113; Denmark, Case C-192/01 at para. 51; Solgar Vitamin's France, Case C-446/08 at para. 69.Google Scholar

⁶⁹ EFTA Surveillance Auth., Case E-3/00 at paras. 31–32; Denmark, Case 192/01 at paras. 52–53; Solgar Vitamin's France, Case C-446/08 at para. 70.Google Scholar

⁷⁰ Solgar Vitamin's France, Case C-446/08 at para. 73. The Court, however, acknowledged that after the upper safe limits have been established, the possibility of setting such maximum amounts at a level significantly lower than those limits cannot be excluded if the setting of those amounts can be justified by the criteria set in articles 5(1) and (2) and that it complies with the principle of proportionality. Such assessments should be carried out by the national courts on a case-by-case basis.Google Scholar

⁷¹ Food Supplements Directive, supra note 8, at art. 6(2).Google Scholar

⁷² Id. at art. 6(3).Google Scholar

⁷³ Id. at arts. 8–9.Google Scholar

⁷⁴ Id. at art. 9(1).Google Scholar

⁷⁵ Article 1(1) refers to fortified foods as an “addition of vitamins and minerals and of certain other substances to foods,” with “other substance” meaning “substance other than a vitamin or a mineral that has a nutritional or physiological effect.” Fortified Foods Regulation, supra note 32, at arts. 1(1) & 2(2).Google Scholar

⁷⁶ Id. at recital 8.Google Scholar

⁷⁷ Case C-41/02, Comm'n v. Netherlands, 2004 E.C.R. I-11375, para. 15.Google Scholar

⁷⁸ Case E-3/00, EFTA Surveillance Auth. v. Norway, 2001 EFTA Ct. Rep. 73, para. 1.Google Scholar

⁷⁹ Case C-24/00, Comm'n v. France, 2004 E.C.R. I-1277, para. 58.Google Scholar

⁸⁰ Fortified Foods Regulation, supra note 32, at art. 3(1). Notably, both Annexes cover essentially the same substances as the Annexes of the Food Supplements Directive, namely vitamins, minerals, and their compositions, thus leaving out all other substances.Google Scholar

⁸¹ Id. at art. 8(2).Google Scholar

⁸² Addition of Vitamins and Minerals, Eur. Comm'n (Jan. 7, 2015), http://ec.europa.eu/food/safety/labelling_nutrition/vitamins_minerals/index_en.htm.Google Scholar

⁸³ Commission Regulation 2015/403 of Mar. 11, 2015, Amending Annex III to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as Regards Ephedra Species and Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille), 2015 O.J. (L 67) 4.Google Scholar

⁸⁴ Fortified Foods Regulation, supra note 32, at recital 6.Google Scholar

⁸⁵ Id. at recital 7.Google Scholar

⁸⁶ Case C-95/01, Criminal Proceedings Against John Greenham & Léonard Abel, 2004 E.C.R. I-1333, para. 46; Case C-41/02, Comm'n v. Netherlands, 2004 E.C.R. I-11375, para. 61; Case C-192/01, Comm'n v. Denmark, 2003 E.C.R. I-9693, para. 54; Case C-24/00, Comm'n v. France, 2004 E.C.R. I-1277, para. 60; Case C-446/08, Solgar Vitamin's France v. Ministre de l'Économie, des Finances et de l'Emploi, 2010 E.C.R. I-3973, para. 60; Joined Cases C-211/03, C-299/03, and C-316/03 to C-318/03, HLH Warenvertriebs & Orthica, 2005 E.C.R. I-5141, para. 69. It must be observed that the EFTA Court adopted an analogical position in EFTA Surveillance Auth. v. Norway. Case E-3/00, EFTA Surveillance Auth. v. Norway, 2001 EFTA Ct. Rep. 73, para. 28. Furthermore, as might be perceived in both EFTA and ECJ cases, this position applies not only in respect to fortified foods, but to food supplements as well.Google Scholar

⁸⁷ Case 216/84, Comm'n v. France, 1988 E.C.R. I-793, para. 16; Case C-17/93, Criminal Proceedings Against J.J.J. Van der Veldt, 1994 E.C.R. I-3537, para. 19; France, 2004 E.C.R. para. 75; Solgar Vitamin's France, 2010 E.C.R. para. 51.Google Scholar

⁸⁸ Van der Veldt, Case C-17/93 at para. 19; Case C-319/05, Comm'n v. Germany, 2007 E.C.R. I-9811, para. 95; Solgar Vitamin's France, Case C-446/08 at para. 51.Google Scholar

⁸⁹ Fortified Foods Regulation, supra note 32, at art. 5.Google Scholar

⁹⁰ Id. at art. 6.Google Scholar

⁹¹ Id. at art. 6(5)(a).Google Scholar

⁹² Id. at art. 17(3).Google Scholar

⁹³ See Lalor, Fiona & Wall, Patrick G., Health Claims Regulations: Comparison Between USA, Japan and European Union, 113 Brit. Food J. 298 (2011).Google Scholar

⁹⁴ Health Claims Regulation, supra note 13, at recital 10.Google Scholar

⁹⁵ See id. at arts. 2(2)(4) & (5) (supplying definitions of nutrition and health claims).Google Scholar

⁹⁶ Id. at art. 1(2)(d).Google Scholar

⁹⁷ An example of nutrition and health claims on a sports nutrition product, a BCAA complex: “BCAA complex is a source of Vitamin B6, which contributes to: the regulation of hormonal activity; normal energy-yielding metabolism; the reduction of tiredness and fatigue; normal functioning of the immune system and nervous systems; normal protein and glycogen metabolism; normal red blood cell formation.” BCAA Complex, Scitech Nutrition, http://www.sciteconline.com/language/en/products/scitec_nutrition/bcaas/bcaa_complex (last visited Aug. 13, 2015).Google Scholar

⁹⁸ Health Claims Regulation, supra note 13, at art. 1(5).Google Scholar

⁹⁹ Id. at recital 17.Google Scholar

¹⁰⁰ Lalor & Wall, supra note 93, at 307.Google Scholar

¹⁰¹ Health Claims Regulation, supra note 13, at art. 6.Google Scholar

¹⁰² Id. at art. 3. For example, that the use of nutrition and health claims shall not be false or misleading, give rise to doubt about the safety of other foods, etc.Google Scholar

¹⁰³ Id. at art. 5. For example, that the nutrient or other substance, present in food, has been scientifically shown to have a beneficial nutritional or physiological effect, is contained in due quantity, etc.Google Scholar

¹⁰⁴ According to recital 16, the Regulation takes as a benchmark an average consumer, who is reasonably well-informed, reasonably observant, and circumspect, taking into account social, cultural, and linguistic factors, as interpreted by the Court of Justice. Id. at recital 16.Google Scholar

¹⁰⁵ For example, “high protein,” “source of vitamins/minerals,” “source of omega-3 fatty acids,” etc.Google Scholar

¹⁰⁶ Id. at art. 8(1).Google Scholar

¹⁰⁷ These include: a statement indicating the importance of a varied and balanced diet, the pattern of consumption required to obtain the claimed beneficial effect, a statement addressed to persons who should avoid using the food, and an appropriate warning for products that are likely to present a health risk if consumed to excess.Google Scholar

¹⁰⁸ According to the latter, health claims are classified into three types: “function” health claims (related to growth, development, and functions of the body, psychological and behavioral functions, and slimming or weight-control) under art. 13(1), risk of disease reduction claims, and children development and health claims under arts. 14(1)(a) and (b), respectively. Health Claims, Eur. Comm'n, http://ec.europa.eu/food/food/labellingnutrition/claims/health_claims_en.htm (last visited Aug. 13, 2015).Google Scholar

¹⁰⁹ Case C-609/12, Ehrmann AG v. Zentrale zur Bekämpfung unlauteren Wettbewerbs eV, paras. 25–30 (Apr. 10, 2014), http://curia.europa.eu/.Google Scholar

¹¹⁰ Generally, in case of non-compliance, the products in question may not be marketed after 31 July 2009. Health Claims Regulation, supra note 13, at art. 28(1). However, derogations are possible in cases of certain trademarks, brand names, or fancy names that may be construed as nutrition or health claims according to article 1(3). Id. at art. 1(3). Products bearing such marks or names may continue to be marketed until 19 January 2022 pursuant to article 28(2). Id. at art. 28(2). The ECJ stated, though, that this provision applies only to food, bearing a mark/name, which must be considered a nutrition or health claim within the meaning of the Regulation and which, in that form, existed before 1 January 2005. Case C-299/12, Green - Swan Pharmaceuticals CR, a.s. v. Státní zemêdêlská a potravináêská inspekce, üstední inspektorát, para. 37 (July 18, 2013), http://curia.europa.eu/. At the same time, with regard to trademarks and brand names and their relationship to common commercial communications under article 1(2) of the Health Claims Regulation, the Court held that such communication may constitute a trade mark or brand name, provided that it is protected by the applicable legislation, which is for the national court to ascertain. Health Claims Regulation, supra note 13, at art. 1(2) para. 32.Google Scholar

¹¹¹ Case C-544/10, Deutsches WeintoreG v. Land Rheinland-Pfalz, 2012 E.C.R. I-526, para. 26.Google Scholar

¹¹² Id. at para. 34. Therefore, a health claim may cover a description such as “easily digestible,” accompanied by a reference to the reduced content of substances frequently perceived by consumers as being harmful. Id. at para. 41.Google Scholar

¹¹³ The product in question contained a following statement on its packaging: “The preparation also contains calcium and vitamin D3, which help to reduce a risk factor in the development of osteoporosis and fractures.” Id. at para. 11. The national court asked whether a reduction of disease risk claim must necessarily expressly state that the consumption of a category of food, a food or one of its constituents significantly reduces a risk factor in the development of a human disease. Id. at para. 21. The ECJ gave a negative answer and stated that it is sufficient that that claim may simply give the average consumer the impression that the reduction of a risk factor is significant. Id. at para. 24.Google Scholar

¹¹⁴ Health Claims Regulation, supra note 13, at art. 10(3).Google Scholar

¹¹⁵ Commission Implementing Decision of Jan. 24, 2013, Adopting Guidelines for the Implementation of Specific Conditions for Health Claims Laid Down in Article 10 of Regulation 1924/2006 of the European Parliament and of the Council, 2013 O.J. (L 22) 25, annex.Google Scholar

¹¹⁶ Id. Google Scholar

¹¹⁷ For example, claims suggesting that health could be affected by not consuming the food or making reference to the rate or amount of weight loss, etc. Health Claims Regulation, supra note 13, at art. 12.Google Scholar

¹¹⁸ Id. at art. 4.Google Scholar

¹¹⁹ Opinion on the setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006. European Food Safety Authority, final (Feb. 25, 2008), http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/nda_op_ej644_nutrient%20profiles_en%2C3.pdf Google Scholar

¹²⁰ See, e.g., relevant health claims on glutamine, carnitine, whey protein, BCAA, creatine, etc. For detailed information see EU Register on Nutrition and Health Claims, Eur. Comm'n, http://ec.europa.eu/nuhclaims/?event=search (last visited Aug. 13, 2015).Google Scholar

¹²¹ Art. 1(2) defines dietetic foods as “[f]oodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.” Dietetic Foods Framework Directive, supra note 33, at art. 1(2).Google Scholar

¹²² Id. at art. 1(3)(b).Google Scholar

¹²³ Case C-107/97, Criminal Proceedings Against Max Rombi and Arkopharma SA, 2000 E.C.R. I-3367, paras. 37–39.Google Scholar

¹²⁴ Dietetic Foods Framework Directive, supra note 33, at art. 2(1).Google Scholar

¹²⁵ Id. at art. 2(2).Google Scholar

¹²⁶ Id. at art. 3(1).Google Scholar

¹²⁷ See Max Rombi, Case C-107/97 at para. 42 (“It is for the national court alone to ascertain whether the products at issue … are actually suitable for the nutritional purposes that Arkopharma claims they are, that is, whether they do facilitate weight loss or are, in the case of sportsmen, performance-enhancing.”). Consequently, the only way for national authorities to treat such products as normal foods is to establish that they are not suitable for the nutritional purposes claimed by the manufacturer or that they do not fulfill the particular nutritional requirements of one of the categories of persons referred to in article 1(3). Dietetic Foods Framework Directive, supra note 33, at art. 1(3) para. 43.Google Scholar

¹²⁸ As a substance with nutritional/physiological effect. See European Advisory Servs., supra note 40.Google Scholar

¹²⁹ Id. Google Scholar

¹³⁰ Currently, L-carnitine is not granted an authorization for health claims related to weight-reduction. The main reason for this is the lack of scientific substantiation on such claimed effect of this product. Supra note 120. Still, such health claims may potentially become possible in case of proper scientific substantiation in the future.Google Scholar

¹³¹ Case C-107/97, Criminal Proceedings Against Max Rombi and Arkopharma SA, 2000 E.C.R. I-3367, paras. 37–39.Google Scholar

¹³² This category first appeared in Directive 89/398/EEC and reappeared later in Directive 2009/39/EC as a category, for which specific provisions, laid down by a specific directive, should have been developed over the years.Google Scholar

¹³³ Dietetic Foods Framework Directive, supra note 33, at art. 2(2).Google Scholar

¹³⁴ European Advisory Servs., supra note 40, at 71.Google Scholar

¹³⁵ Dietetic Foods Framework Directive, supra note 33, at art. 9(2).Google Scholar

¹³⁶ Id. at art. 9(3).Google Scholar

¹³⁷ Case C-270/02, Comm'n v. Italy, 2004 E.C.R. I-1559, para. 26; Case C-24/00, Comm'n v. France, 2004 E.C.R. I-1277, para. 76.Google Scholar

¹³⁸ See Meisterernst, Andreas, Foods for Particular Nutritional Uses—Death Sentence Passed for Sound Reasons?, 6 Eur. Food & Feed L. Rev. 315 (2011).Google Scholar

¹³⁹ Impact Assessment, supra note 2, at 13.Google Scholar

¹⁴⁰ Report of the Scientific Committee on Food on Composition and Specification of Food Intended to Meet the Expenditure of Intense Muscular Effort, Especially for Sportsmen (Feb. 28, 2001), http://ec.europa.eu/food/fs/sc/scf/out64_en.pdf. The report covered a wide range of sports nutrition, mentioned in the introductory part of this article.Google Scholar

¹⁴¹ Meisterernst, supra note 138, at 319.Google Scholar

¹⁴² Id. at 317–18.Google Scholar

¹⁴³ Id. at 315.Google Scholar

¹⁴⁴ Proposal for a Regulation on Food Intended for Infants and Young Children and on Food for Special Medical Purposes, COM (2011) 353 final (Jan. 28, 2012).Google Scholar

¹⁴⁵ Impact Assessment, supra note 2.Google Scholar

¹⁴⁶ Proposal for a Regulation on Food Intended for Infants and Young Children and on Food for Special Medical Purposes, supra note 144, at 14.Google Scholar

¹⁴⁷ Id. at 8.Google Scholar

¹⁴⁸ Impact Assessment, supra note 2, at 4.Google Scholar

¹⁴⁹ Id. at 17.Google Scholar

¹⁵⁰ Id. Google Scholar

¹⁵¹ “‘Food suitable for people with digestion disorders' (indication of suitability) and 'food that facilitates digestion' (health claim).” Meisterernst, supra note 138.Google Scholar

¹⁵² Impact Assessment, supra note 2, at 13.Google Scholar

¹⁵³ Id., at 14.Google Scholar

¹⁵⁴ Roethenbaugh, Gary, ESSNA Welcomes “Dramatic Changes” in EU law Covering Sports Nutrition, (June 14, 2013), http://www.triathlonbusiness.com/2013/industry-news/essna-welcomes-dramatic-changes-in-eu-law-covering-sports-nutrition/.Google Scholar

¹⁵⁵ Regulation 609/2013 of the European Parliament and of the Council of June 12, 2013, On food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control, Repealing Council Directive 92/52, Commission Directives 96/8, 1999/21, 2006/125, and 2006/141, Directive 2009/39 of the European Parliament and of the Council and Commission Regulations 41/2009 and 953/2009, 2013 O.J. (L 181) 35.Google Scholar

¹⁵⁶ Id. at recital 32.Google Scholar

¹⁵⁷ Id. Google Scholar

¹⁵⁸ Id. at recital 33.Google Scholar

¹⁵⁹ Id. at art. 13. As of late August 2015, however, the report has not yet been submitted.Google Scholar

¹⁶⁰ Id. at recital 11.Google Scholar

¹⁶¹ Impact Assessment, supra note 2, at 36–39.Google Scholar

¹⁶² The Regulation, with some exceptions, will apply from July 20, 2016. Regulation 609/2013, supra note 155, art. 22.Google Scholar