This guide was drafted by a multidisciplinary working group under the overall co-ordination of the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC).
Definition
Food supplements are defined 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” in 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 [1]. Herbal food supplements are defined as a type of food supplement that contain plants, parts of plants or plant-derived preparations, and are available as single-entity or combination products. They can be purchased from any food business operator permitted to market food, including pharmacies, non-pharmacy outlets, health food stores, supermarkets and internet sites.
Note: plants, parts of plants or plant-derived preparations can also be found in the composition of herbal medicinal products and traditional herbal medicinal products. These products are covered by the medicinal products regulatory framework and are outside the scope of this document.
Purpose of food supplements
According to the European Food Safety Authority (EFSA), food supplements are intended to help the consumer maintain an adequate intake of certain nutrients, supplement the normal diet or 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 [2]. According to European legislation2, in the European Union (EU), any claims made for foods (including food supplements) concerning health benefits or properties related to the prevention, treatment or cure of human diseases3 must have been authorised by the European Commission (EC) after an EFSA evaluation. In addition to the above mentioned provisions, the European Court of Justice has often ruled that “products which are presented as having therapeutic or prophylactic properties with respect to human diseases should be covered by the legislation on medicinal products.” [3].
Legislation
In the EU, food supplements are covered by the food legislation framework. They also come under 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 [1], that lays down both additional mandatory labelling requirements and other conditions, and the following:
- General requirements for food safety, responsibilities for producers and obligations for traceability, information provision and recall of harmful products (Regulation (EC) No 178/2002) [4]
- Preparation and hygiene of foodstuffs based on the principles of Hazard Analysis and Critical Control Points (HACCP) (Regulation (EC) No 852/2004) [5]
- Food labelling with the aim of adequately informing the consumer about the composition, properties and use of foodstuffs (Regulation (EU) No 1169/2011) [6]
- Use of nutrition and health claims that require prior authorisation (Regulation (EC) No 1924/2006) [7]
- Conditions for the use of additives (Regulation (EC) No 1333/2008) [8]
- Maximum levels for residues and contaminants (Regulation (EC) No 369/2005 and Regulation (EC) No 1881/2006) [9-10]
- Approval of novel foods and food ingredients not on the European market before 15 May 1997 (Regulation (EU) No 2015/2283) [11]
Some EU member states may have national laws and regulations in addition to the EU legislation listed above. National laws may differ considerably among countries, not only in terms of design and scope, but also in terms of content (e.g. lists with ingredients that are permitted or prohibited, maximum levels of ingredients, specific labelling requirements and various other conditions of use), and the resulting variety in regional, national, European and international legal regulations makes it difficult to compare food supplement regulations and provisions [3].
Some non-EU member states also have national regulations in place and these may differ from the EU legislation mentioned above. For instance, North Macedonia maintains lists of plants that are either prohibited (around 250) or permitted (around 1700) in the manufacture of food supplements [12]. In Türkiye, new regulations introduced in 2023 list, among other things, health claims that may be used in food and food supplement labelling, promotion or advertising [13]. It should also be noted that some non-EU Eastern European countries (e.g. Armenia, Georgia and Ukraine) have a different class of products which is equivalent to food supplements. These are referred to as “biologically active supplements” and have the same regulatory status as food supplements but with certain differences. For example, they are not only designed for oral administration, but can be administered parenterally (e.g. as injections), topically (e.g. ointments and creams), through inhalation, etc. The standards on which national regulations and manufacturing controls for biologically active supplements are based are much lower than in the EU. Therefore, although the legislation in these non-EU countries considers that biologically active supplements are equivalent to food supplements, higher health risks may nonetheless be associated with their use.
In conclusion, although (unlike medicinal products) food supplements and herbal food supplements do not have to undergo a marketing authorisation procedure prior to their commercialisation, they are subject to legal provisions under both food and food supplement legislation covering their composition, safety, labelling and advertisement. Indeed, the EU General Food Law [4] establishes that only safe food can be put on the market and that this safety is the responsibility of food business operators. Moreover, food supplements are controlled by national competent authorities based on risk assessment criteria, through product sampling and analysis, checking the labelling and advertising materials and inspecting manufacturing facilities. For consumer protection purposes, food supplements that do not meet all applicable requirements are taken off the market and necessary actions are taken by authorities [14].
Source: Herbal Food Supplements Guide by the European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe
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