Food Law News - UK - 2005

FSA Letter, 4 January 2005

PARNUTS - EC Food Supplements Directive 2002/46/EC

The FSA letter is to remind people that the Food Supplements Directive 2002/46/EC will come into effect under UK law on 1 August 2005 , and apply the provisions of this Directive with respect to the sale of food supplements after this date.

The Food Supplements Directive 2002/46/EC, came into force in July 2002 and the UK government was required by British and EU law to implement it by the end of July 2003. This was done by a set of food supplement regulations for England approved by the House of Commons on 3 July 2003 .

One of the provisions of this directive is for positive lists of nutrients and their ingredient sources that can be included in food supplements. The first list covers the vitamins and minerals that may be used in food supplements (eg 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 from the European Food Safety Authority.

The following information is intended to assist companies by clarifying what is required to submit safety data on nutrients in order for products to remain on the market. The requirements for companies who wish to use an ingredient in the UK after 1 August 2005 that is not yet included in Annex 2 are that a product containing that ingredient must have been on the market on 12 July 2002 and that a dossier has been submitted to the EU authorities. 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 at

Administrative guidance on the submission of dossiers is available on the European Commission's web site at

The UK will allow products, which meet these criteria, to remain on the market until 1 January 2010 providing EFSA has not given an unfavourable opinion.

The process for submission is for a company to present a dossier to the appropriate authority within one member state the competent authority in the UK is the Food Standards Agency (FSA). The Member State will then forward the dossier to the European Commission who will forward this to European Food Safety Authority (EFSA). EFSA will carry out the safety assessment on the information provided in the dossier and will ask additional questions of the petitioner (if required) before providing an opinion. The deadline for submission of dossiers in the UK to the FSA is 12 June 2005 . If an ingredient is not included in Annex 2 of the Directive and a dossier has not been submitted then it must be removed from formulation by 31st July 2005.

Further information on derogation and dossier submission is also available from the Food Standards Agency in the form of draft guidance notes, which can be accessed at:

These guidance notes will be updated early in 2005 following comments received from stakeholders and the final version will be placed on the Agency's web site.

See also UK News Item: 20 September 2004

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