Use high dose labels or suffer EU consequences, industry warned

The Food Standards Agency conducted a survey of the UK supplements market, and found that high dose advisory labels are only now starting to appear on packaging - despite a voluntary agreement with UK manufacturing associations having been reached in May 2004 that high-dose products carry warnings of possible adverse effects.

"If the use of the advisory statements are not achievable under a voluntary basis, then it may be difficult to demonstrate the feasibility of this option in discussions at an EU levels, and other options may need to be considered to ensure that public health is protected, as well as consumer choice maintained,"​ said the agency in a food survey information sheet.

It is a stark warning that failure to self-regulate could lead to the matter being wrested out of industry's hands.

However the survey did show that the majority of companies contacted said they were either in the process of adding advisory statements or had already done so. Most reported 90 per cent compliance, and that rate of adopting the statements was said to depend on how fast products sell, and product turnover in individual outlets.

The 2002 Food Supplements Directive (2002/46/EC) came into effect in August and provides for maximum levels to be set for supplements, still to be set by the standing committee.

The UK, together with The Netherlands, is currently one of the most liberal markets for high dose vitamins and minerals. High dose products account for 12 to 15 per cent of the £220m UK vitamin and mineral market, and the UK industry would suffer a severe blow if the EU legislation were to proscribe the sale of high dose products.

The UK government moved to pre-empt the standing committee as early as 2003, when the independent Expert Group on Vitamins and Minerals (EMV) published a report on recommended safe intake levels, providing an evidence-based risk assessment to underpin and inform the FSA's approach.

Since the industry advised at that time that there were a good many products on the market exceeding the levels set by EMV, the voluntary advisory statement system was put forward and agreed upon the following year.

In September 2005, the FSA Board said that it supported the option to establish common maximum safe upper levels across the bloc in the interests of intra-community trade. But it proposed a second tier of national guidance levels in individual member states so that, subject to national discretion, products exceeding the limits could continue to be sold so long as they carried the warning labels.

However the latest indications are that the European Commission is veering towards a more restrictive approach. A discussion document published last month included in its annex position statements from several quarters - including that of the German Federal Institute for Risk Assessment - but omitted the FSA's opinion as expressed in the EVM report.

Industry lobbyist Chris Whitehouse of the Whitehouse Consultancy described the German model as "very worrying" since, if adopted, it could lead to very restrictive upper limits being set.

The findings of the recent survey will be used to inform future discussions on setting maximum levels for vitamins and minerals in supplements.

The EU regulation on fortified foods, on which the EU Parliament voted favourably in mid-May, will deal with maximum vitamin and mineral levels in foods. Discussions on levels for supplements will most likely have a bearing on this piece of legislation too.