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“There is an urgent need for a fresh approach dealing with the EU’s immovable commitment to harmonise maximum levels for vitamins and minerals”

New research aims to end EU’s vitamin safety blockade

By Shane Starling+

Last updated on 27-Nov-2013 at 12:06 GMT2013-11-27T12:06:16Z

Dr Carrie Ruxton:
Dr Carrie Ruxton: "...what is an acceptable upper limit for vitamin D intake in sunny Greece may be too low for rainy Scotland.”

Just commissioned research aims to to help resolve the stalemate that exists in the EU over maximum permitted levels (MPLs) for vitamins and minerals with a novel approach.

The Alliance for Natural Health International (ANH-I) has engaged Dutch research organization TNO to conduct the research into a model it said was required because existing models were outdated or inappropriate.

It chose TNO over Newcastle and Wageningen Universities due to its, “systems biology approach and track record in dealing with complex issues of this nature,” Robert Verkerk, PhD, ANH-I executive and scientific director told us.

The challenge with MPLs is constructing unified safe levels across diverse populations comprising more than 500 million living in the European Union’s 28 member states.

The 6-month research project will be submitted for peer review in May next year. It will retain an overall unified level setting approach, but will also seek specific outputs for some nutrients and molecular forms.

“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.

“There is an urgent need for a fresh approach dealing with the EU’s immovable commitment to harmonise maximum levels for vitamins and minerals."

“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.”

Scotland-based nutritionist Dr Carrie Ruxton backed the model and its, “criticism of rigid harmonisation.”

“For example, what is an acceptable upper limit for vitamin D intake in sunny Greece may be too low for rainy Scotland,” she noted.

Modelling makeover

The ANH-I said the most high profile models under consideration by the European Commission, member states and other stakeholders were not going to get the harmonisation job done.

One, led by the European Federation of Associations of Health Product Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA), was almost a decade old, ANH-I said.

The other, presented by the German food safety agency, BfR has been widely criticised among more liberal EU member states for being overly risk-obsessed and restrictive.

Dr Verkerk: "Thrilled"

“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,” Dr Verkerk said.

“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.”

He added: “The science has moved on a long way since the other models and approaches were originally proposed.”

MPL reader

EU MPLs were set to be finalised in 2009 under the nutrition and health claims regulation (NHCR) but have stalled over disparate views and methodologies about what ‘safe’ is among a great variety of vested interests.

Trade groups have attacked the idea that nutrients like vitamin C, calcium, magnesium, beta-carotene and zinc at high doses in supplements such as multivitamins as well as functional foods may be under threat by restrictive MPLs.

In the UK, Sweden and Ireland, vitamin C, for example, can be sold at levels of 1000mg or more in food supplements, whereas a conservative approach may see limits set as low as 60mg, a level closer to existing norms in places like Germany and some eastern European countries.

Under risk management principles, high dose supplements are permitted accompanied by warnings if there are special population sub-groups who should not consume them such as, in some cases, children and pregnant women.

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