An overview of the European Food Supplements legislation as part of a realistic integrated approach to food safety
EXPO MILANO 2015 gives a ‘global portrait’ of Food in the World: Food as ‘nutritional tales’ and also as a ‘pleasure’. But the main objective of EXPO is to foster research and development and innovation in how to think about, and regulate, food in all its aspects today and for the future.
European citizens need to have access to safe and wholesome food of the highest standard. A series of food incidents in late 1990s draw attention to the need to establish general principles and requirements, specific and technical rules concerning food and feed law at Union level. Accordingly, the European Commission (‘Commission’) developed an integrated approach of food safety ‘from farm to table’, primarily set out in its White Paper on Food Safety. It covers all sectors of the food chain, including feed production, primary production, food processing, storage, transport and retail sale. But the approach of the Commission needs to have a complementary link with the supplement legislation, as we suggest with the ‘overview’, that we consider as an important part of the European food safety policy.
The EU General Food Regulation from 2002 is considered as the foundation of food and feed law. Its set up an overarching and coherent framework for the development of food and feed legislation and to this end it lays down general principles, requirements and procedures that underpin decision making in matters of food and feed safety, covering all stages of food and feed production and distribution. It also has set up an independent Agency responsible for scientific advice and support, the European Food Safety Agency (EFSA). Moreover, it creates the main procedures and tools for the management of emergencies and crises as well as the Rapid Alert System for Food and Feed (RASFF).
Food supplements are an important part of the make up of many foods eaten by Europeans. So the Commission, at the end of the Nineties, proposed to the EU legislator, the Council, to adopt a Directive on the approximation of the laws of the Member States in relation to food supplements.
Vitamins and minerals may be added to foods voluntarily by food manufacturers, or must be added as nutritional substances as provided for by specific Community law. They may also be added for technological purposes as additives, colourings, flavourings, preservatives or other uses including authorised oenological practices and processes provided for by relevant EU law.
The objective of the harmonised rules of Directive 2002/46/EC  on food supplements is to protect consumers against potential health risks from those products. With respect to the safety of food supplements, Annex I of the Directive lays down a harmonised list of vitamins and minerals that may added for nutritional purposes as food supplements. Annex II contains a list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.
Directive 2006/37/EC has amended Annex II to Directive 2002/46/EC. The changes have been made after the full consultation of the European Food Safety Authority (EFSA) to evaluate the food safety aspects. Thus the amendments follow on from thorough scientific evaluations. In addition the risks identified by EFSA have been subjected to the risk management process in the Commission and the Member States via the Standing Committee on Food Chain and Animal Health. The evaluation of health and safety is and on-going process based on the European system for the management of food health and safety which includes thorough science and rigorous risk management. For this reason and considering the ‘nature’ of exclusive competence of the EU in relation to food safety, the Commission has continued to legislate with ‘ad hoc’ Regulations.
Commission Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods represents a ‘milestone’ of the EU legislation for this kind of supplements.
The Commission stated that: ‘Since the objective of this Regulation, namely to ensure the effective functioning of the internal market as regards the addition of vitamins and minerals and certain other substances to foods whilst providing a high level of consumers protection, cannot be sufficiently achieved by the Member States, and can therefore be better achieved at [EU] level, the [EU] may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty’.
The Regulation is based on the assumption that there is a wide range of nutrients and other ingredients that my be used in food manufacturing, including trace elements, amino acids, essential fatty acid, fibre, various plants and herbal extracts.
Beside food safety another important consideration for EU food law is the free movement of goods. The addition of additives to specific food (as opposed to the authorisation of the use of particular additives) is regulated in Member States on the basis of differing national rules that can impede the free movement of these products, and can create unequal conditions of competition and thus have a direct impact on the functioning of the internal market. For this to be avoided Community rules harmonising national provisions relating to the addition of vitamins and minerals and of certain other substances to foods were needed.
This Regulation aims to regulate the addition of vitamins and minerals to foods and the use of certain other substances or ingredients containing substances other than vitamins or minerals that are added to foods or used in the manufacture of foods under conditions that result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers. In the absence of specific rules regarding prohibition or restriction of use of substances or ingredients containing substances other than vitamins or minerals under this Regulation or under other specific EU provisions, relevant national rules may apply without prejudice to the provision of the Treaty.
The Commission underlines that: ‘an adequate and varied diet can, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities such as those established and recommended by generally acceptable scientific data’, and ‘…however, surveys show that this ideal situation is being achieved neither for all vitamins and minerals nor by all groups of the population across the Community. Foods to which vitamins and minerals have been added appear to make an appreciable contribution to the intake of these nutrients and as such may be considered to make a positive contribution to overall intakes’.
But the main purpose of the Commission is to regulate manufacture and to protect consumers. In fact, food to which vitamins and minerals are added are in most cases promoted by manufacturers and may be perceived by consumers as products having a nutritional, physiological or other health advantages over similar or other products without such nutrients added. This may induce consumer choices that may be otherwise undesirable.
To counter these potentially undesirable effects, the Commission considered it appropriate to impose some restrictions on the products to which vitamins and minerals can be added, in addition to those that would be result naturally from technologically considerations or become necessary for safety reasons when maximum limits of vitamins and minerals in such products are set. 
Commission Regulation (EC) No 1925/2006 sets out: rules on requirements, conditions, restrictions and EU Scrutiny for the addition of vitamins and minerals; purity criteria; labelling; substances restricted and restricted; EU Register; free movement of goods; notification procedure; safety measures.
The rules on food supplements are one element in an ever more complex body of laws being set by the EU to ensure a high level of food safety and a single market in which foodstuffs can move freely between different Member States.
The irony is that just as the EU is on the cusp of completing the project to harmonise EU food law in a way that allows the free movement of foodstuffs, the average consumer seems to be demanding local food and to know the origin of all foods.
 White paper on Food Safety, COM(1999)719 final, 12 January 2000. The same year the European Commission also adopted the White Paper on Environmental Liability, COM(2000) 66 final, 9 February 2000.
 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, OJ L31, 1.2.2002, p.1.
 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, OJ L 183, 12.7.2002, p.51.
 The list has been amended by subsequent Directives and Regulations.
 Commission Directive 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances, OJ L 94, 1.4.2006, p.32.
 The Amendments has concerned the Section ‘Vitamins’ (Folate replaced Folic Acid) and the Section ‘Minerals (Ferrous Bisglycinate).
 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, OJ L 404, 30.12.2006, p.26.
 Since detailed rules on food supplements containing vitamins and minerals have been introduced by Directive 2002/46/EC, Regulation (EC) No 1925/2006 should not apply to food supplements.
 Recital 7 of Regulation (EC) No 1925/2006.
 Recital 14 of Regulation 1925/2006 reads as follows: ‘Excessive intakes of vitamins and minerals may result in adverse health effects and it is therefore necessary to set maximum amounts for them when they are added to foods, as the case may be’.