TNO commissioned to develop new vitamin safety approach

The Dutch independent research organisation, TNO, has been contracted to develop a new approach to determining maximum safe levels of vitamins and minerals for European consumers. The outcome of the research is intended to add to the two existing approaches that have been under consideration by the European Commission since 2007. One was developed nearly 10 years ago by two food supplement industry associations, while the second, proposed by the German government’s food safety watchdog, BfR, has been criticised widely for being unnecessarily restrictive and draconian.

ANH-Intl has been at the forefront of critiquing these existing approaches, and in 2010 published two scientific papers in the peer – reviewed journal Toxicology [1,2] that exposed their weaknesses.

Robert Verkerk PhD, first author of the critiques, executive director of ANH-Intl and lead commissioner of the research project, said: “There is an urgent need for a fresh approach dealing with the EU’s immovable commitment to harmonise maximum levels for vitamins and minerals.” He continued, “While the issue has historically been complicated by great variations in approach taken by different national authorities in individual EU member states, a robust scientific approach has previously been missing. This is the challenge we’re now passing to TNO.”

ANH-Intl has sought funding for the research from a diverse range of European stakeholders, including companies and individual practitioners. The pilot project will span 6 months, with the aim of not only developing a generalised approach, but also providing specific outputs for a limited range of vitamins and minerals, including different molecular forms of each. Subject to general and scientific acceptance of the approach to be proposed by TNO, further research will be necessary to establish maximum values for all the vitamin and mineral forms authorised for use in the EU.

Dr Verkerk believes that the results of the new research will prove vital to the European Commission’s forthcoming proposals on MPLs. “We’re thrilled that the TNO scientists agree that a risk/benefit approach is far preferable to the existing risk‐only ones”, commented Dr Verkerk.

Explaining the nature of TNO’s remit further, Dr Verkerk said, “The risk-only approaches tend to push maximum levels extremely low, in an attempt to ensure a near-zero risk of any kind of adverse effect, however mild and transient, in the most sensitive individuals. This is the case even if it means significant benefits are ruled out for the vast majority. By characterising and categorising risks and benefits, and doing this for individual forms of nutrients, risks can be managed far more proportionately. This will likely mean significantly higher maximum levels than those proposed by the existing approaches which ignore benefit and differences between nutrient form.”

Verkerk added, “The science has moved on a long way since the other models and approaches were originally proposed. While everyone appears agreed the approach should be science based, it’s also crucial it takes into account the most recent scientific developments. TNO is a trusted research organisation with a great reputation for independent science – and it’s also well regarded by both the European Commission and the European Food Safety Authority. We’re confident the output from TNO will go a long way toward providing a valid approach that will then be agreed by scientific consensus.”

The main output from the research project will be an article detailing the proposed approach, which is intended to

Be submitted to a peer-reviewed journal at the end of May 2014.

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