The setting of maximum levels for vitamins and minerals forms part of two pieces of European legislation: the 2002 Food Supplements Directive; and the EU regulation on fortified foods that is currently making its way through the rule-making process.
On June 6, the EC published a discussion document requesting comments on a number of technical aspects relating to setting the maximum level. The FSA's input is intended to ensure that the UK's position is taken into account in on-going deliberations; there have been some fears it has been ignored to date, which could have a catastrophic effect on the country's supplements industry.
In the absence of earlier communication from the EC on how it planned to go about setting these levels, in September 2005 the FSA put forward a proposal for a two-tier system that provided for warning labels on products exceeding the maximum levels, at the discretion of individual member states.
A voluntary agreement with UK manufacturing associations was already in place since May 2004 that high-dose products carry warnings of possible adverse effects.
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.
In September the FSA also set four principals that should form the basis of discussions over maximum levels: "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 marketplace to continue to support the evidence base; the evidence base needs to take into account the risk assessment by scientific experts."
At the time of its publication, the June discussion document elicited dismay from some in the UK, since it did not include the two-tier system in its annex while other, stricter approaches were included.
However a letter from EC Commissioner Markos Kyprianou to Austin Mitchell, MP, said that models included in the annex were intended only as examples of different approaches that can be used.
"The Commission will consider with utmost care all existing national rules and data in the exercise of establishing maximum amounts of vitamins and minerals in food supplements. In particular, the UK Expert group on Vitamins and Minerals (EVM) report [drawn up by the FSA in 2003] will constitute a valuable source of scientific information," he wrote.
Moreover, he pointed out that the EVM report was used to inform the Danish budget and the ERNA-EHPM' models, both of which were included in the model.
The FSA held two meetings with stakeholders to discuss what its response should be, on July 25 and September 4.
While the FSA's full draft response it not presently available, a spokesperson for the FSA told NutraIngredients.com that the board requested only minor changes in the response to the question on vitamins aimed at specific population groups, to include children.
The deadline for comments to be sent to the EC is September 30, and the EC has said that it plans to publish proposals within two years, which will form the basis of discussions with member states.