Food Law News - UK - 2005

FSA News Item, 1 March 2005

PARNUTS - Vitamins and minerals for use in food supplements: dossiers submitted

The Food Supplements Directive 2002/46/EC came into force in July 2002 and was implemented in England by the Food Supplements ( England ) Regulations 2003. The directive and these regulations apply from 1 August 2005 .

One of the provisions of this directive is for lists of nutrients and their sources that can be included in food supplements. The first list covers the vitamins and minerals that may be used in food supplements (such as vitamin C, calcium, iron). It excludes six minerals (tin, silicon, nickel, boron, cobalt, and vanadium) that are currently used in food supplements on sale in the UK .

The second list covers the chemical forms (sources) of those vitamins and minerals that may be used. These lists can be added to following a favourable opinion on individual nutrients or nutrient sources from the European Food Safety Authority (EFSA) after consideration of a dossier containing safety data.

The requirements for companies who wish to use an ingredient in the UK after 1 August 2005 that is not yet included in Annexe 2 of the directive are:

Only one dossier is required per nutrient or nutrient source for assessment by EFSA.

The UK will give derogation for nutrients and nutrient sources where a dossier has either been submitted to the UK or to another EU Member State.

The Food Standards Agency has granted derogation for the nutrient sources listed in the table below allowing them to continue to be used in food supplements in accordance with Article 4 (6)(a) and (b) of Directive 2002/46/EC. These products (used by any operator) are allowed to remain on the market until 31 December 2009 providing EFSA has not given an unfavourable opinion. The table will continue to be updated as further dossiers are received.

Guidance on the information to be included in dossiers (SCF/CS/ADD/NUT/21 Final 12 July 2001) issued by the former Scientific Committee on Food (SCF) is available here.

Administrative guidance on the submission of dossiers is available on the European Commission's website.

Information regarding opinions which have been requested from EFSA can be found on their website.

Dossiers submitted to the UK and granted derogation by the UK under Directive 2002/46/EC on food supplements

  1. Albion: Calcium amino acid chelate
  2. Albion: Magnesium amino acid chelate
  3. Albion: Iron amino acid (with additional information provided as a stand-alone dossier on bisglycinate)
  4. Albion: Manganese amino acid chelate
  5. Albion: Zinc amino acid chelate
  6. Albion: Copper amino acid chelate
  7. Albion: Chromium amino acid chelate
  8. Solgar: UK Ltd Boric acid
  9. Wassen International Ltd: Sodium borate
  10. Zila Nutraceuticals Inc: Calcium ascorbate/threonate
  11. InterHealth Nutraceuticals Inc: Chromium polynicotinate
  12. InterHealth Nutraceuticals Inc: Zinc monomethionine
  13. Wassen UK, Lallemand and Lesaffre France: Selenium-enriched yeast
  14. Health Food Manufacturers' Association: Calcium sulphate

Dossiers submitted to a Member State and granted derogation by the UK will appear in a separate list as information is received.

To go to main Foodlaw-Reading Index page, click here.