There are two separate pieces of EU legislation that deal with maximum levels of vitamins and minerals: the 2002 food supplements directive (2002/46/EC), which came into effect in August and provides for maximum levels to be set for supplements via the Standing Committee; and the EU regulation on fortified foods, on which the EU Parliament voted favourably in mid-May.
Chris Whitehouse, managing director of the Whitehouse Consultancy, said: “The phoney war is over and the real battle now commences over the setting of maximum permitted levels for food supplements.”
For supplements, maximum levels are expected to be in place by 2007, and a similar timescale is in place for fortified foods subject to approval by the Council, which is expected within weeks. It will apply from six months after its publication in the Official Journal of the European Communities.
It makes sense, according to the paper, to consider the issues surrounding maximum levels for both types of products in tandem.
“...The considerations for setting maximum levels for vitamins and minerals are inevitably interrelated. In particular, the distribution of these nutrients in the two broad categories of food products, food supplements and fortified foods, have to be considered together if we are to have a clear picture of the overall food offering,” it said.
However this is not necessarily a given. Amongst the issues still to be hammered out on maximum levels, it asks whether separate limits must be set for supplements and fortified foods in order to safeguard public health and the expectations of food business operators, or whether there are any alternatives.
It also asks what upper safe levels should be taken into account for those nutrients for which there is not yet scientifically established tolerable upper intake, and whether there is any need at all to set maximum levels for vitamins and minerals for which available data indicates extremely low or non-existent risk, even at high levels.
The difficulties of obtaining reliable current data on vitamin and mineral intake from dietary sources across all EU member states is highlighted. Since surveys used to collect such data may be expensive, inaccurate or out of date, it asks for indications of the best sources of such data at EU level.
Moreover, should data only refer to some member states, can this be reasonably applied across the whole bloc, and should the intake of different populations groups, who may have different intakes or nutritional needs, be taken into account?
Another point raised is to what extent population reference intakes and recommended daily allowances should be taken into account when setting the maximum levels.
And it's not just maximum levels that are up for debate, either; minimum amounts are also envisaged – for fortified foods, at least – in order for the claim to be viable. But the questions remain as to whether these minimum amounts should be linked to the amounts required for labelling purposes for both foods and supplements. It also asked whether there should be different minimum amounts for specific foods or different categories of foods.
The report presents a number of models for the setting of maximum vitamin and mineral levels in foods, from the French Agency of Food Safety, the Danish Institute of Food and Veterinary Research, the German federal Institute for Risk Assessment, ILSI Europe, and the European Responsible Nutrition Alliance with the European Federation of Associations of Health Product Manufacturers.
Whitehouse expressed concern at the German model, which he described as “very worrying” since, if adopted, it could lead to very restrictive upper limits being set.
“The time is coming for a big push to get across industry's message that maximum levels should be set only on the basis of safety and not be risk-managed downwards for political reasons and to placate the Germans.”
The opinion of the UK's Food Standards Agency, as expressed in the EVM report, was notably absent from the annex, which Whitehouse said indicated the government agency has “failed completely to get its message across in Europe”.
In an open board meeting held last September, the Food Standards Agency advised health ministers to negotiate with European officials for a two-tier system that would allow the UK to keep its high-dose vitamin supplements on the market subject to advisory statements about high doses on product labels.
