Transposition of Directive 2002/46/EC on Food Supplements

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 we 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 are attached.

The Regulations implement Directive 2002/46/EC and introduce measures, in Scotland, 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 are due to 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. Similar but separate legislation will apply in England, Wales and Northern Ireland.

The Directive offers Member States (MS) a number of areas of flexibility when transposing the provisions of the Directive; these are as follows:

1. 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.

We intend 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.

2. Article 10 of Directive 2002/46/EC allows MS 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.

We do not intend to require the manufacturer or the person placing a food supplement product on the market to notify us. We consider that this would provide little benefit to consumers and would place additional burden on industry and Government resources.

3. Article 15 of the Directive requires MS 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.

We do 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.

Chromium Picolinate and Menadione
You will note that we also propose 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.

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.

Germanium and Vanadium
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 we are considering whether we should take action; options would include a voluntary ban or a statutory ban (inclusion in Schedule 1). We would welcome your 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.

Consultation Process
We would like to invite you to comment on both the draft Regulations and on the draft RIA. The RIA aims to assess the impact, in terms of costs, benefits and risks of the forthcoming regulation and how it will affect your business or organisation.

In particular it would be very helpful if manufacturers could provide us with additional information regarding the likely costs incurred in implementing this EU Directive into national legislation.

We would be grateful for your comments or views no later than 21 February 2003.

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Data protection form (Word)

Data protection form (pdf)

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk