EU Commission recommends "proportionate" approach to upper safe levels

The European Commission has issued a belated orientation paper on Upper Safe Levels (USLs) for food supplement nutrient levels that offers hope to concerned parties in high-dose havens like Sweden, the UK and the Netherlands by indicating exemptions may be granted to certain nutrients without safety concerns.

"For some nutrients extremely low or non-existent toxicity, even at very high doses of administration, is indicated from existing evidence available from observational studies," the Commission stated, adding, "…the position not to establish maximum amounts for nutrients for which there are no evident safety concerns would seem a proportionate approach, which would also be in line with the principles of better regulation."

Member States would not be able to establish their own levels "for those vitamins and minerals for which no limits have been set at EU level."

The document suggests vitamins B1, B2, B12, K as well as biotin, panthothenic acid and chromium (III) may not require USLs but recommends a formal review system if new evidence comes to light.

The Belgium-based European Responsible Nutrition Alliance (ERNA) welcomed the thrust of the paper. "It is a balanced view that takes both the legal aspects and scientific elements into account," said chairman, Gert Krabichler. "It emphasises the safety approach and reflects the legal interpretation of the Food Supplements Directive and the Fortified Foods Regulation."

Belgium-based regulatory expert, Chris Whitehouse, of the Whitehouse Consultancy, praised the document for:

  1. endorsing a case-by-case approach
  2. rejecting an over-application of the precautionary principle
  3. acknowledging previously ignored EVM (UK) and IOM (US) reports
  4. rejecting RDA/PRIs

But he warned overtures to total nutrient intakes when food sources were considered as well as a rejection of minor adverse effects could lead to restrictive USLs being established. He also called for a review of nutrients such as B6 for which a low USL of 25mg has already been established.

"The paper could have been worse: it acknowledges some key arguments, it rightly rejects an RDA based approach, but is worrying particularly in relation to the possible sharing of limits with fortified foods and in relation to supplements which might have very minor reversible effects in some population groups," he said. "It seems to either misunderstand or misrepresent the fact that there are many examples of legal food products which are accepted as safe but which have minor and reversible effects."

The setting of USLs was written into the Food Supplements Directive which has been law across the European Union's 27 Member States since 2002. ?The current paper takes into account more than 50 formal stakeholder comments submitted after a previous paper was published in mid-2006.

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