Foodlaw-Reading

Dr David Jukes, The University of Reading, UK

Providng access to food law since May 1996

..... ..... ..... ..... ..... .....
Last updated: 9 July, 2024

Food Supplements

Providing access to the EU and UK legislation

On this page:

  • Summary - Brief details of the chronology of developments linked to this topic
  • EU Legislation - Listing of Regulations covering the topic
  • UK Legislation - Listing of Regulations covering the topic

Summary

The addition of vitamins and minerals to food is related to this topic but is covered on a separate page. For details, see: Fortified Foods

The approach to food supplements and the imposition of legal controls by Member States has historically followed quite different routes. These have varied from strict controls placing significant limits on their use by some Member States to an approach where controls were limited or absent allowing manufacturers much greater freedom but subject to over-riding controls requiring the production of safe products.

In establishing EU controls on food supplements it was important to establish a uniform legal definition. When the legislation was adopted in 2002, by Directive 2002/46, the following defintion was used:

"food supplements" means 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

The Directive established detailed controls relating to 'nutrients', which are defined as vitamins and minerals, when sold as food supplements. The permitted vitamins and minerals are listed (Annex I), as are their sources (Annex II).

In addition, as indicated in the definition, the controls apply to 'other substances with a nutritional or physiological effect'. These have not been listed or subject to detailed controls although the Directive considered that this might be needed in the future. The Commission published a report in December 2008 on the market for supplements with these other substances (suggesting that there were over 400 such substances) but no further legislation has been forthcoming.

All food supplements have to be marketed using the term 'food supplements' and must comply with certain additional labelling requirements. Member States may still operate certain national rules where these are considered necessary for consumer protection. For example, Article 10 allows Member States to operate a notification requirement prior to the placing of food supplements on the market.

As foods, food supplements are subject to the general controls on food information imposed by Regulation 1169/2011 (see Food Labelling) and to the restrictions on nutrition and health claims imposed by Regulation 1924/2006 (see Nutrition and Health Claims).

For the Commission's page on this topic, see: Food Supplements.

EU Law

Additional information can be found on the European Commission's page: Food supplements

Framework Directive:

For a consolidated version, see: Directive 2002/46/EC (version from September 2022)

Guidance:

UK Legislation

Brexit: Prior to the IP Completion Day (31 December 2020), the legal requirements given in the EU Regulations listed above still applied to the UK. Since IP Completion Day, the EU Regulations above have been incorporated into UK legislation but with amendments to correct deficiencies. Information on this is given below. For more details of the process of incorporating EU legislation into UK law, see the separate page: UK Food Law: EU Legislation as Amended for the UK. Provisions for the enforcement of the controls (originally the EU Regulations but now as amended) have been provided in the UK Regulations listed below. For Northern Ireland, EU rules still apply.

Guidance (from Department of Health and Social Care):

UK Legislation: with links to legislation.gov.uk

Note: Since the European controls were published as a Directive, all legal requirements were already contained in UK legislation. The following UK Regulations contain both the technical requirements and the enforcement provisions.

Guidance

Nutrition Legislation Information Sheet. This document, published by the Department of Health and Social Care, is intended to help food businesses comply with nutrition legislation - one section relates to food supplements. (Originally published in 2014, this is a pdf version of the updated DHSC web page from November 2022).

[Provided under the Open Government Licence. The original publication accessed from: ]

 

This page was first provided on 8 January 2021
To go to main Foodlaw-Reading Index page, click here.