Vitamins and minerals in supplements and fortified foods update 10 July 2006

The Commission wants responses to its paper by 30 September 2006, and the two stakeholder meetings will be used to inform the Agency�s position.

Under the Food Supplements Directive there are provisions for the European Commission to set maximum levels for vitamins and minerals in food supplements.

A separate regulation also allows maximum levels to be set for the addition of vitamins and minerals to food (fortification).

After the EC consultation ends on 30 September, the Commission plans to publish proposals to set these levels within two years, and these will then form the basis of discussions with Member States.

The first stakeholder meeting is being held at the Agency's London headquarters on 25 July, with a follow-up one planned for 4 September.

There will be video links to the FSA offices in Scotland, Wales and Northern Ireland, and the following stakeholder representatives have been invited:

• supplements industry and other trade organisations (British Retail Consortium, Food and Drink Federation etc)
• health organisations and NGOs (British Medical Association, British Dietetic Association etc)
• consumer groups (Which? National Consumer Council, Consumers for Health Choice etc)
• independent scientific committee members (Scientific Advisory Committee on Nutrition and the Committee on Toxicity)
• FSA officials and colleagues from other Government departments (Cabinet Office, Department of Trade and Industry, Department of Health, DEFRA etc).

Numbers are restricted but should you be interested in attending then please contact the Agency at supps_consult@foodstandards.gsi.gov.uk or by fax at 020 7276 8564. Confirmation of attendance will then be issued.

If you want to respond to the EC discussion document direct, you can find further details on the European Commission website.

At its open meeting in Cardiff on 13 July, the FSA Board will be asked to agree both the engagement strategy with stakeholders, and that some important principles should underpin the Agency's discussions with them.

These are:

• consumers should have the right to make an informed choice unless their safety is compromised
• an evidence base is necessary to ensure consumer safety is safeguarded
• there is a need for ongoing monitoring of supplements in the 'market place' to continue to inform the evidence base
• the evidence base needs to take into account the risk assessment by scientific experts

Expert advice

In May 2003, the Agency published new advice on vitamins and minerals that could have possible harmful effects if taken in too high a dose.

This advice follows the publication of the most comprehensive review of the safety of vitamins and minerals ever undertaken in Europe. It was carried out by the Expert Group on Vitamins and Minerals (EVM), an independent expert advisory committee.

The Agency has been discussing with companies the use of substances (vitamins and minerals) in food supplements that are not on a �positive list� in the Food Supplements Directive, and for which safety dossiers were not submitted to the European Commission before a deadline of 12 July 2005.

The positive list of vitamin and minerals in the Directive covers those substances that have been assessed for safety and are therefore permitted for sale in the EU. Companies were able to submit dossiers on the safety of substances not on this list for assessment by the European Food Safety Authority (EFSA).

Products containing these substances were allowed to remain on sale pending the outcome of this assessment and a decision by member states at the EC Standing Committee.

The UK had been given to understand by the European Commission (EC) that there was some flexibility in the 12 July deadline for submitting dossiers, but the EC subsequently established that this was not legally the case

The Agency received 46 dossiers covering 44 substances after the 12 July deadline. Twenty two of these substances are already listed in the Directive, or covered in dossiers, submitted by other companies before the deadline of 12 July.

Seven substances are not used by the companies and another seven are out of the scope of the directive.

There are six substances whose sale is prohibited by the Food Supplements Directive and regulations in the UK.

If companies wished to use these substances in the future then they would need to comply with the procedures for adding new substances to the positive lists in the Food Supplements Directive, and dossiers would need to be submitted for assessment by EFSA.

The Agency is discussing the status of the two remaining substances with the companies concerned.