Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses). A wide range of nutrients and other ingredients 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.
Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic action. Therefore their use is not intended to treat or prevent diseases in humans or to modify physiological functions.
In the EU, food supplements are regulated as foods. Harmonised legislation regulates the vitamins and minerals, and the substances used as their sources, which can be used in the manufacturing of food supplements. For ingredients other than vitamins and minerals, the European Commission has established harmonised rules to protect consumers against potential health risks and maintains a list of substances which are known or suspected to have adverse effects on health and the use of which is therefore controlled.
In May 2018, the EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) adopted guidance on the evaluation of sources of nutrients and bioavailability of nutrient from the sources.
In December 2017, EFSA published the Summary report on Dietary Reference Values for nutrients. Earlier in 2017, EFSA published the Overview on Tolerable Upper Intake Levels as derived by the Scientific Committee on Food (SCF) and the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
2012-2021 EFSA carries out the safety assessments of six substances used as ingredients in food supplements, for which safety concerns were raised either by the EC or Member States, namely: Ephedra species, Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille), Hydroxyanthracene derivatives, Cathechins from green tea, Monacolins from red yeast rice and alpha-lipoic acid (thioctic acid) and the risk of insulin autoimmune syndrome (Hirata’s disease).
2018 The mandate of the EFSA NDA Panel is broadened to include the assessment of nutrient sources and requests for safety assessment under Art. 8 of Regulation (EC) No 1925/2006.
2010 The EFSA NDA Panel publishes an opinion laying down the general principles for establishing Dietary Reference Values (DRV) and started the review of DRVs for macro and micronutrients established by the Scientific Committee on Food in 1993.
2006 EFSA and the Scientific Committee on Food (SCF) compile all opinions identifying possible adverse health effects of individual micronutrients at intakes in excess of dietary requirements and, where possible, establish tolerable upper intake levels (UL) for different population groups.
Between 2005 and 2009, EFSA carried out a comprehensive assessment of substances that are permitted to be used as sources of vitamins and minerals in food supplements in the EU. The assessment included both the evaluation of the safety of a nutrient source at the intake levels suggested by the applicant, and the bioavailability of the nutrient from the source i.e. the effectiveness with which the mineral or vitamin is released into the body.
Companies wishing to market a nutrient source not included in the permitted list have to submit an application to the European Commission. Under Directive 2002/46/EC, EFSA then prepares a scientific opinion to support the European Commission’s evaluation of the request. Based on EFSA’s work, the European Commission reviews and updates the list of vitamin or mineral substances that may be used in food supplements.
If a substance intended to be used in food supplements does not have a history of safe use in the EU before 1997, EFSA is requested to provide a scientific opinion on its safety according to Regulation (EC) No 2015/2283 on novel foods.
Moreover, EFSA has performed a comprehensive evaluation of the possible adverse health effects of individual micronutrients at intakes exceeding the dietary requirements and, where possible, established tolerable upper intake levels (ULs) for different population groups. ULs represent the highest level of chronic daily intake of a nutrient that is not likely to pose a risk of adverse health effects to humans. The ULs defined by EFSA and by the former Scientific Committee on Food (SCF) are used as a reference in EFSA’s evaluations of the safety of nutrient sources added to food supplements. Throughout this work EFSA provides support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.
For all substances added to foods, including food supplements, that are claimed to have an effect on the nutritional or health status of consumers, EFSA carries out an assessment in line with Regulation (EC) No 1924/2006 on nutrition and health claims.
Under the circumstances described in Art. 8 of Regulation 1925/2006, i.e. “…where a substance other than vitamins or minerals … is added to foods … under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected … under normal conditions … and/or would otherwise represent a potential risk to consumers…”, EFSA may be requested by the European Commission to assess the available information to support a decision on the safety of the substance. Based on EFSA’s assessment the European Commission may decide to include the specific substance in a list of substances whose use in foods in the EU is prohibited, restricted or under scrutiny (see Annex III of Regulation (EC) No 1925/2006).
According to the EU General Food Law Regulation (EC) No 178/2002, food supplements are considered as foodstuffs. Responsibility for the safety of these products lies with the food business operator placing the product on the market.
The reference EU legislation in the area of food supplements is Directive 2002/46/EC, which establishes harmonised lists of the vitamins and minerals substances used in the manufacture of food supplements and the labelling requirements for these products. EFSA provides scientific opinions to support the evaluations carried out by the European Commission.
The directive lays down the rules applicable only to the use of vitamins and minerals in the manufacture of food supplements. The use of substances other than vitamins or minerals in the manufacture of food supplements may be governed by national rules or may be subject to other specific EU legislation.
The latter is the case for:
- substances without a history of safe use in the EU before 1997, which are assessed under Regulation (EC) No 2015/2283 on novel food;
- sources of vitamins, minerals and additional substances proposed for use in the manufacture of food supplements that may also be assessed under Regulation (EC) No 1925/2006 on fortification of foods or Regulation (EC) No 609/2013 on foods for specific groups;
- substances added to food supplements to perform certain technological functions, for example to colour, to sweeten or to preserve, that are assessed as food additives under Regulation (EC) No 1333/2008.
The addition of nutrients or other substances to fortify a food does not fall within the definition of food supplement and it is addressed by Regulation (EC) 1925/2006.
Finally, as with all the other food products, food supplements may contain additives (e.g. sweeteners, colours, coating agents). In the EU, only food additives that are specifically authorised for use in this food category according to Regulation (EC) No 1333/2008 can be added to food supplements.
1. Who is responsible for the safety of food supplements and for monitoring these products in the EU?
Because food supplements are considered as food, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a food supplement placed on the market is safe.
Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. Once the product is on the market, the competent authority of the Member State may monitor its use in that territory.
2. Which ingredients are authorised for use in food supplements?
Annex I of Directive 2002/46/EC lays down a list of vitamins and minerals that may be added for nutritional purposes to food supplements (e.g. vitamin C, calcium). Annex II of the same directive contains a list of substances that are authorised as source of the vitamins and minerals listed in Annex I (e.g. sodium-L-ascorbate as a source of vitamin C, calcium lactate as a source of calcium).
The use of ingredients other than vitamins and minerals (e.g. botanicals) in the manufacture of food supplements may also be authorised under other specific legislations depending on the nature of the substance (e.g. novel foods, substances for the fortification of food, foods for specific groups).
Substances not falling in the above categories may still be found in food supplements present on national markets subject to provisions in the specific national legislations.
In addition to the substances added for nutritional purposes, food supplements may also contain food additives, i.e. substances added to the products for technological reasons (e.g. coating agents for tablets, sweeteners). The list of food additives that are permitted for use in food supplements can be found in Regulation (EC) No 1333/2008.
3. What are the maximum and minimum levels of vitamins and minerals allowed in EU food supplements?
There are at present no binding maximum and minimum levels for the ingredients of food supplements defined in the European Union. Directive 2002/46/EC envisages the maximum and minimum levels being defined in consultation between the European Commission, Members States and interested stakeholders. Due to the complex nature of the issue and the divergent views expressed by the parties involved, this process is ongoing and no final conclusion has been reached. The activities of EFSA in establishing tolerable upper intake levels (ULs) of individual micronutrients for different population groups provide support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.
4. What are the labelling requirements for food supplements on the EU market?
Directive 2002/46/EC sets out specific labelling requirements for food supplements. These include:
- the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances;
- the portion of the product recommended for daily consumption;
- a warning not to exceed the stated recommended daily dose;
- a statement to the effect that food supplements should not be used as a substitute for a varied diet;
- a statement to the effect that the products should be stored out of the reach of young children.
In addition, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.
5. Are there substances that are prohibited or restricted for use in food supplements?
The European Commission, on its own initiative or on the basis of information provided by the Member States and following an assessment by EFSA, may take a decision to include a certain substance in a list of substances whose use in foods is prohibited, restricted or under scrutiny. This may happen when the addition of a substance in food products increases its exposure to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers. This procedure is defined in art. 8 of Regulation (EC) No 1925/2006 and the substances whose use in foods is prohibited, restricted or under scrutiny are listed in its Annex III.