UK stands by EVM in vitamin, mineral response

The discussion paper was published in June and a deadline of September 30 was given for member states to revert with responses to a number of questions. The UK government's response was informed by two meetings of Food Standards Agency (FSA) stakeholders.

The UK has carried out considerable work in the are of vitamin and mineral levels, which are pertinent to two pieces of EU legislation: the 2002 Food Supplements Directive and the impending EU regulation on fortified foods. The EVM was established in 1998 and in 2003 published a risk assessment on safe levels of vitamins and minerals in food supplements and fortified foods.

"The FSA and UK stakeholders… support the approach taken by the internationally recognised UK EVM in setting safe upper limits and guidance levels for intakes of vitamins and minerals, and recommend that this approach should also be used in setting maximum levels of vitamins and minerals in fortified foods and food supplements,"​ said the UK government response.

In the interests of "absolute clarity"​ in the language used, EFSA's expression 'tolerable upper limit' and EVM's 'safe upper level' (or, where evidence is weak, 'guidance level') were said to "essentially have the same meaning"​.

The UK government also said that FSA officials would welcome the opportunity to present the work of the EVM to the commission and member states.

In September 2005, in the absence of proposals from the EC, the UK proposed a two-tier approach whereby common safe maximum levels would be set across the EU by EFSA to facilitate intra community trade, but that members states should be able to set higher levels at a national level, where there was evidence that dietary levels were lower than those used by the EC, or where a higher dose is supported by expert opinion.

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 publication of the discussion document caused dismay from some quarters that the UK's work and perspective was being overlooked, since its two-tier approach was omitted from the annex. Some other, stricter, proposals 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 UK government provided responses to the specific questions raised by the discussion document.

In instances where there is not yet any scientifically established tolerable upper intake level for a nutrient, but where there are indications that there may be adverse effects, the upper intake level should be "the highest level considered to be safe (without risk of adverse effects)"​ - equivalent to the guidance levels set by the EVM.

The expertise of the UK's national scientific advisory committees was offered in facilitating such a review.

The UK reported two divergent views from stakeholders on whether maximum levels need be set for those for which the risk of adverse events, even at high levels, seems to be extremely low or non-existent.

Some held that there was no reason to set levels in these cases, while others supported a risk categorisation approach to establish where levels should be set. Others said levels should be set be set since "the absence of evidence of an adverse effect is not equivalent to evidence of the absence of an adverse effect."​

Moreover, consumers may feel more confident if levels were set for all​ vitamins and minerals, and this may help facilitate trade.

The UK government took a view that a risk-based approach is needed, should be build on the FAO/WHO and EVM approach, and should comprise a review mechanism so that the levels can be amended as new data become available.

On the question as to whether maximum levels should be set for food supplements and fortified foods separately, it said that this is an "extremely complex issue"​ and it is difficult to allocate contributions from the two sources. The UK would welcome a wider EU discussion on the feasibility of allocating levels and the factors that would need to be considered - including the difficulty of predicting dietary changes and market development, the onus on the consumer to interpret information, and the requirement to have a monitoring system.

It also noted that evidence from the UK National Diet and Nutrition Survey suggest that those who consume supplements are also more likely to have a diet naturally high in vitamins and minerals. Results of a survey of diet and nutrition of low income consumers in the UK, including vitamin and mineral intakes from food and supplements, are expected this autumn.

Another pertinent issue was whether intake of different population groups should be taken into account when setting maximum levels.

While saying that clarification is needed on what different population groups are, it said that the varying needs of different sectors of the population should be borne in mind when considering how fortified foods and supplements can be used to improve the nutritional adequacy of diets.

Particular consideration should be given to children, and the needs of subgroups could be addressed by more targeted labelling, allowing consumers to make in informed choice, or individual dietary advice from qualified health professionals.

The full response from the UK government is available online​.