B6 Concern Shakes EU Upper Limits Initiative


The controversial process in Europe of setting upper safe levels for vitamins and minerals in Europe has moved a step nearer with the publication by the European Union's Scientific Committee on Food (SCF) of opinions on 13 nutrients including vitamins A, B1, B2, B6 and B12; and minerals such as manganese, selenium and magnesium. In some cases, no upper limit was recommended, indicating no level of toxicity had been ascertained or that the existing data were inconclusive.

Although overall the recommendations have met with lukewarm approval across Europe, the proposed level of 25mg/day for vitamin B6 has been widely criticised. The industry was hoping the SCF would recommend a level closer to 100mg/day.

The proposed 25mg/day is still 2.5 times greater than the level recommended by the UK's Food Standards Agency's Expert Group on Vitamins and Minerals (EVM), whose findings will be considered by the SCF when final upper limits are set. However, it is still far below the 200mg/day toxicity limit found in scientific studies.

The president of the UK-based Health Food Manufacturers Association, Maurice Hanssen, said he was more concerned with the way these figures may be interpreted in the next two years than with the levels themselves.

"I have a problem with the political process that follows the issuing of figures," he said. "There is an idea known as the precautionary principle that takes a safe level of nutrient use and then divides it to make it even safer. This is semi-enshrined in European Commission regulations. So whereas most of the results are not surprising, the way in which they are interpreted may be. It may become necessary to mount a massive campaign against the inappropriate use of the precautionary principle."

Derek Shrimpton, PhD, an observer to the EVM and the European Federation of Health Product Manufacturers' (EHPM) scientific advisor, said there remained many grey areas in the process of setting upper limits.

"The idea of USLs is not that they should be guidelines but that they should never be exceeded," Shrimpton said. "Where there is no identified risk, they will have to decide what the upper formulation level is, and I would hope they would set it at a level that doesn't inconvenience anybody."

Whilst accepting most of the published limits as being reasonable, the EHPM will continue to push for maximum levels. Regulatory Affairs Director Pedro de Azua said, "We are trying to show the EC that in countries, such as the UK, where people have been taking high levels of vitamins and minerals for a long time, there is no health hazard."

Theo van Rooij, chairman of the Natural and Health Products Association in The Netherlands (NPN), said they were looking to the next phase of the negotiations.

"That is when the Germans or the French might say you have to be very close to the RDA," he pointed out. "The onus really is on the companies and trade associations. If you want a nutrient on the Annex and you want USLs set at levels that meet existing needs and are not dangerous, then the science must be presented to the SCF in the next three years. That is the bottom line."

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