Updated risk management model for setting maximum levels published

An updated version of the risk management model reviewed in the European Commission’s Orientation Paper on maximum and minimum levels for vitamins and minerals has been published this month.

Available in the November 2 edition of peer review journal ‘Food Science and Technology Bulletin: Functional Foods’, the model has been updated using the latest data from the UK and Ireland.

It was devised by a scientific team led by Professor David P Richardson, and it’s methodology is supported by industry association, the European Responsible Nutrition Alliance (ERNA) which hopes that it will play a key role in the EU-wide setting of maximum vitamin and mineral levels.

“We fully support Professor Richardson’s risk management model,” said Gert Krabichler, Chair of ERNA. “We hope it will serve as an appropriate model for the European Commission when it develops its proposal for setting maximum levels in fortified foods and food supplements in the coming months.”

The model is based on a system of categorizing nutrients into three risk groups: those with no evidence of risk; those with a low risk of exceeding the upper level, and those with a potential risk of exceeding the upper level.

Professor Richardson said: “We have found that when using the latest data from mature markets such as the UK and Ireland where food supplements and fortified foods co-exist in the market, the model’s methodology has remained sound. The maximum safe levels derived from it are flexible enough to be applied in all Member States and in different communities.”

Last year on request of the European Commission, the European Food Safety Authority (EFSA) concluded its series of scientific opinions on tolerable upper intake levels for 29 nutrients; specified numerical upper intake levels for 16, and gave qualitative risk assessments for the others where the existing data was insufficient.

These results have been included in the Commission’s Orientation Paper, as well as results from the Institute of Medicine (IOM) in the USA and the UK Expert Group on Vitamins and Minerals (EVM).

Highlighting the importance of taking into account all three risk assessments in setting maximum levels especially in the absence of an EFSA upper intake level, Professor Richardson pointed out that the model takes into account nutrients from all sources; characterises risk using a ‘Population Safety Index’ (PSI); uses both quantitative and qualitative data, and reflects current market practices in Europe including food fortification.

He said: “The broad principles set out in the orientation paper are pragmatic and sensible, and they provide a good foundation for a risk management model that primarily takes into account the protection of health of consumers, facilitation of consumer choice, opportunities for product innovation and avoidance of barriers to trade.”


The European Responsible Nutrition Alliance (ERNA) is made up of major European food supplement manufacturers and suppliers, all working towards a common European approach to food supplements that reflects the interests of both the consumers and the industry.

Reference of the publication: David P. Richardson. Risk management of vitamins and minerals: a risk categorisation model for the setting of maximum levels in food supplements and fortified foods. Food Science and Technology Bulletin: Functional Foods 4 (6) 51-66. 2007 (DOI: 10.1616/1476-2137.14996

For more information about ERNA email Patrick Coppens, Secretary General, at [email protected], tel + 32 2 209 11 50, or visit www.erna.org

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