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Spain adopts decree with a detailed list of substances that may be used in the preparation of food supplements
On 27 March 2017, Spain published in its Official Journal the Royal Decree 130/2018, of 16 March, which modifies Royal Decree 1487/2009, of 26 September, relating to food supplements (i.e., Real Decreto 130/2018, de 16 de marzo, por el que se modifica el Real Decreto 1487/2009, de 26 de septiembre, relativo a los complementos alimenticios, hereinafter, R.D. 130/2018). As a novelty, R.D. 130/2018 includes a detailed list of substances other than vitamins and minerals that may be used in the preparation of food supplements.
‘Food supplements’ are defined in Article 2(a) 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 (as last amended by Commission Regulation (EU) 2017/1203) as “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities”. Directive 2002/46/EC only harmonises, at the EU level, the rules on labelling and on authorised vitamins and minerals and their forms. Important aspects in the marketing of food supplements, such as maximum and minimum levels of vitamins and minerals or the use of other substances, such as botanical extracts, essential fatty acids or fibre, are not harmonised at EU level.
Recitals 6 to 8 of Directive 2002/46/EC describe the original plan of the EU legislator. It acknowledged that there is a wide range of nutrients and other ingredients that might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts. As a first stage, Directive 2002/46/EC laid down specific rules for vitamins and minerals used as ingredients of food supplements. It was planned that specific rules concerning nutrients, other than vitamins and minerals, or other substances with a nutritional or physiological effect used as ingredients of food supplements would be laid down at a later stage, provided that adequate and appropriate scientific data about them became available. Until such specific EU rules are adopted, national rules concerning nutrients or other substances with nutritional or physiological effects used as ingredients of food supplements apply.
In accordance with Article 4(8) of Directive 2002/46/EC, the European Commission (hereinafter Commission), submitted, on 5 December 2008, a report to the Council of the EU and the European Parliament on the use of substances other than vitamins and minerals in food supplements. In that report, the Commission points out that, “in general terms, despite certain limitations, mutual recognition is a useful instrument for facilitating the free movement of the products concerned”. The Commission concluded that it did not consider it opportune to lay down specific rules for substances other than vitamins or minerals for use in food supplements. However, since substances other than vitamins or minerals, including substances derived from plants, are now being added to ordinary foodstuffs and not only to food supplements, the Commission does not rule out the possibility, at a later state, of carrying out supplementary analysis to the report, examining the conditions for the addition of these substances to foodstuffs in general.
Therefore, the principle of mutual recognition is extremely relevant for the marketing of food supplements in the EU. This means that a food supplement containing a certain substance may be lawfully placed on the market in one EU Member State and would subsequently have to be accepted by other EU Member States that still maintain more restrictive national legislation. However, the mutual recognition principle does not apply if the authorities of an EU Member State can successfully invoke the protection of health and life of humans as a reason to deny the marketing. However, this may only take place under strict conditions, including an in-depth risk assessment based on the most reliable scientific data available and on the basis of the most recent results of international research, which must show that there is a risk to health associated with a product, as well as proportionality.
In R.D. 130/2018, Spain argues that the conclusions of the Commission’s 2008 report, which indicated that mutual recognition was sufficient, were not shared by many EU Member States. In fact, in the absence of a perspective of harmonisation at the EU level, EU Member States have opted to establish lists of substances that may be used in the elaboration of food supplements. Substances other than vitamins and minerals are indeed subject to legislation at the national level. For instance, in Belgium, the Ministerial Decree of 19 February 2009 on the production and placing on the market of food supplements containing substances other than nutrients and plant or plant preparations (i.e., Arrêté ministériel du 19 février 2009 relatif à la fabrication et au commerce de compléments alimentaires contenant d’autres substances que des nutriments et des plantes ou des préparations de plantes), lists three substances (i.e., choline, carnitine, ubiquinone) for which the use in food supplements is subject to conditions. Italy lists various other substances, including caffeine, carnitine, creatine, lycopene, flavonoids and some enzymes, in the Health Ministry’s revised list (of November 2007) of nutrients and substances with a nutritional or physiological effect (i.e., Ministero della Salute: Altri nutrienti e altre sostanze ad effetto nutritivo o fisiologico, revisione novembre 2017). France has adopted an Order on 26 September 2016 establishing a list of substances authorised in food supplements for nutritional or physiological purposes (i.e., caffeine, carnitine, creatine, lycopene) and the conditions for their use (i.e., Arrêté du 26 septembre 2016 établissant la liste des substances à but nutritionnel ou physiologique autorisées dans les compléments alimentaires et les conditions de leur emploi, Version consolidée au 29 janvier 2018).
In this context, the elaboration in Spain of a national list of substances that may be used in food supplements has been considered necessary in order to ensure consumer protection, without undermining the competitiveness of national food companies in the EU market. Since the publication of R.D. 1487/2009, Spanish legislation on food supplements has focused on the use of vitamins and minerals as ingredients for their manufacture. Spain considers its legislation no longer sufficient, since today there are an estimated 400 different substances for the manufacture of these supplements. About 50 other substances, divided into eight new categories of ingredients for food supplements, have been introduced by R.D. 1487/2009: 1) Fatty acids; 2) Amino acids (and their salts of Na, K, Ca, Mg and HCl) and other nitrogen compounds; 3) Dipeptides and peptides; 4) Coenzymes; 5) Flavonoids and carotenoids; 6) Nucleotides; 7) Polysaccharides and oligosaccharides; and 8) Other substances (e.g., glucosamine (as sulfate or hydrochloride), wheat germ, pollen and brewer’s yeast). For these substances, maximum daily doses have been established and in some cases, warning messages need to be labelled like “not be consumed by pregnant or lactating women, nor by children” when astaxanthin of crustaceans and fish (category 5: flavonoids, carotenoids) are used.
In preparing R.D. 130/2018, Spain has taken the reports of the Scientific Committee for Food (SCF) and the European Food Safety Authority (EFSA) into account, as well as other bodies of recognised scientific authority. The safety of the substances and the doses established in R.D. 130/2018 have been evaluated by the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (i.e., the Comité Científico de la Agencia Española de Consumo, Seguridad Alimentaria y Nutrición), except for those that have traditionally been considered as dietetic or have been traditionally consumed in Spain, like royal jelly (i.e., jalea real, a honey bee secretion).
R.D. 1487/2009 has incorporated a new additional provision to expressly address mutual recognition: “The requirements of this royal decree shall not apply to food supplements legally manufactured or marketed in other Member States of the European Union, or products originating in the countries of the European Free Trade Association (EFTA) which are contracting parties to the Agreement on the European Economic Area (EEA), or to those States which have a Customs Association agreement with the European Union”. In this context, it should be stressed that, since 13 May 2009, refusals of mutual recognition are subject to the conditions laid down in Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State.
Besides the matter of ‘other substances’ in food supplements, there are two other major areas of regulation on food supplements in the EU that have not been harmonised: 1) Botanical substances; and 2) Maximum amounts of vitamins and minerals. ‘Other substances’ introduced by Spain’s R.D. 130/2018, do not specifically include permitted botanical substances in food supplements. Botanical preparations have a wide variety of applications and can fall under different regulatory regimes, depending on their intended use and presentation (e.g., as food supplements or medicines). The use of botanicals in food supplements may be subject to legislation at EU Member State level. Some EU Member States like Belgium, France and Italy have adopted lists of prohibited and/or authorised plants and plant parts in their legislation. Germany has developed a reference guide for authorities and food business operators. Most EU Member States do not have specific regulations on the use of botanicals. The second contentious matter is that of the maximum amounts of vitamins and minerals. Article 5 of Directive 2002/46/EC provides that maximum amounts of vitamins and minerals present in food supplements, per daily portion of consumption as recommended by the manufacturer, shall be set, taking the following into account: 1) 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; and 2) Intake of vitamins and minerals from other dietary sources. However, such EU harmonised minimum and maximum levels of vitamins and minerals have not yet been adopted.
In the absence of harmonisation, national rules and guidance apply in certain EU Member States, including 1) In the UK, Safe Upper Levels for Vitamins and Minerals of May 2003 by the Expert Group on Vitamins and Minerals; 2) In France, Decree of 6 May 2006 on nutrients to be used in the production of food supplements (i.e., Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires, Version consolidée au 17 avril 2018); 3) In Belgium, Royal Decree of 3 March 1992 on the placing on the market of nutrients and foods with added nutrients (i.e., Arrêté Royal du 3 mars 1992 concernant la mise dans le commerce de nutriments et de denrées alimentaires auxquelles des nutriments ont été ajoutés, modifié par A.R. du 24 avril 2014); and 4) In Italy, daily levels of vitamins and minerals allowed in food supplements by the Ministry of Health, revision of May 2017 (i.e., Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentary, revisione maggio 2017). This tendency for EU Member States to ‘do it alone’, with restrictive individual maximum levels for vitamins and minerals in food supplements, may reportedly eliminate the therapeutic effect of vitamin supplements and have long-term negative impacts on consumers’ health.
Besides the matter of ‘other substances’ in food supplements, which has now been addressed in Spain, the use of botanical substances in food supplements and maximum amounts of vitamins and minerals in the EU are increasingly regulated by EU Member States, due to the lack of EU harmonisation. Clearly, this piecemeal approach does not do the EU Single Market justice. Only a coordinated approach and harmonised rules on the relevant issues would allow for the necessary degree of trade facilitation intended by EU law. All interested stakeholders should carefully analyse the relevant rules in EU Member States and reach out to relevant interlocutors in view of increased harmonisation efforts.