Directive 2002/46/EC, which harmonises European Community legislation on food supplements was published in the Official Journal of the European Communities (L183/51) on 12 July 2002. We are required to introduce national measures to implement these provisions by 31 July 2003 and I am writing to invite your comments on the draft Regulations.
A copy of the draft Regulations and the draft Regulatory Impact Assessment (RIA) outlining the estimated cost to businesses were enclosed with the letter. You can find the Directive on the: European Commission's website
The Regulations implement Directive 2002/46/EC and introduce measures, in England,
to meet the following objectives:
introduce into legislation, for the first time, a definition of the term 'food supplement';
introduce into legislation, for the first time, a list of the vitamins and minerals that may be used in food supplements together with a list of the permitted chemical forms (sources) of these vitamins and minerals - the so-called 'positive lists';
prohibit the sale of vitamin or mineral supplements unless these compositional requirements are met, subject to a transitional provision in most cases;
prohibit the sale of a food supplement to the ultimate consumer unless it is in a pre-packaged form;
introduce mandatory labelling requirements for food supplements in addition to those applied to most foodstuffs by the existing Food Labelling Regulations 1996 (as amended); and prohibit the sale of food supplements that do not comply with these requirements; and
make provision as to responsibilities for enforcement; create offences and penalties and apply certain provisions of the Food Safety Act 1990. The Regulations also provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (OJ No. L186, 30.6.89, p.23) on the official control of foodstuffs.
The Regulations must be implemented in UK law by 31 July 2003 and will come into force on 1 August 2005 with the exception of the provisions relating to Schedule 1, which we propose will come into force on 31 July 2004.
These new Regulations would apply to England only. Separate parallel legislation is being prepared in Scotland, Wales and Northern Ireland.
The Directive offers Member States a number of areas of flexibility when transposing the provisions of the Directive; these are as follows:
Article 4 of the Directive contains a derogation allowing MS to permit, subject to the conditions set out in Regulation 5(4), the continued use of vitamins and minerals not on the 'positive lists' until 31 December 2009. The FSA intends to make use of this derogation, which will apply to all those products that fulfil the conditions set out in Regulation 5(4) except for those that contain any of the substances listed in Schedule 1.
Article 10 of Directive 2002/46/EC allows Member States to require the manufacturer or the person placing a food supplement product on the market to notify the competent authority of that by forwarding to it a model of the label used for the product. The FSA do not intend to require the manufacturer or the person placing a food supplement product on the market to notify them. They consider that this would provide little benefit to consumers and would place additional burden on industry and Government resources.
Article 15 of the Directive requires Member States to bring into force laws, regulations and administrative provisions necessary to prohibit trade in products which do not comply with the Directive from 1 August 2005 at the latest. The FSA does intend to implement the provisions of Article 15 in order to prohibit trade in non-compliant products (other than those in Schedule 1) from the latest date allowed, that is 1 August 2005.
The FSA is also proposing to prohibit the use of two substances - chromium picolinate and menadione - in food supplements (Regulation 5(1) and Schedule 1) with effect from 31 July 2004. This provision has been added due to concern about the safety of these substances, as highlighted by reviews carried out by the Food Standards Agency's Expert Group on Vitamins and Minerals (EVM) whose draft report is currently out to consultation (available on the Agency website at: www.food.gov.uk/news/newsarchive/88275).
Substances are included on this list in Schedule 1 as a precautionary measure and will remain there subject to further testing and the submission of evidence in support of their safety, after which they may be removed, if appropriate.
The EVM also highlighted concerns over germanium and vanadium. Germanium is currently subject to a voluntary ban on its use in supplements in the UK. Given that this arrangement appears to be effective, we propose to continue to support the voluntary arrangement and, at present, do not plan to include germanium in Schedule 1.
The use of vanadium in supplements is not currently controlled in the UK and the FSA are considering whether they should take action; options would include a voluntary ban or a statutory ban (inclusion in Schedule 1). The FSA would welcome comments on germanium and vanadium, as well as any additional data in support of the safe use of either of these products which may be available.
Comments are required by 15 January 2003.