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Breaking News on Supplements & Nutrition - Europe

EC shifting against high-dose vitamins and

minerals: HFMA
By Shane Starling, 22-Dec-2008

Related topics: Dosage forms, Minerals, Vitamins & premixes

The UK-based Health Food Manufacturers Association (HFMA) has warned the European Commission
may severely restrict maximum levels of vitamins and minerals in food supplements, after an industry
meeting with the European Commission.

The UK and some of the more liberal member states of the European Union have long pushed for maximum
permitted levels (MPLs) to be set high, and based on negotiations that have dragged on for many years, it
seemed the European Commission’s committees were favouring such a stance.

But with MPLs to be finalised in February, 2009, the use of nutrients such as vitamin C, calcium, magnesium,
beta-carotene, zinc and nickel at high doses in supplements such as multivitamins as well as functional foods
may be under threat if the EC has indeed changed its position.

In the UK, 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.

Jeopardy

HFMA chairman John Redman contacted NutraIngredients to air his organisation’s concerns after the meeting
that occurred between major UK-based health food chain, Holland & Barrett, and Robert Madelin, the director
general of DG Sanco Health & Consumer Protection at the EC.

He said 100s of products containing 11 micronutrients being used at high doses in the UK, and some of them in
other markets such as the Netherlands and Sweden, were in serious jeopardy.

Madelin told Holland & Barrett representatives emphasis was being placed on minor and reversible side-effects,
with risk management models such as those forwarded by the European trade groups, EHPM (European
Federation of Associations of Health Product Manufacturers) and ERNA (European Responsible Nutrition
Alliance), losing favour.

“Alarm bells are ringing,” Redman said. “What we are concerned about is that contrary to what we were led to
believe before, the EC has indicated it will not consider any potencies that may result in minor and reversible
side-effects. More alarming was the fact Madelin said the EC considers the loss of higher potency substances a
fair price to pay for harmonisation in the EU.”

He added: “It’s a strange way for the EC to change position, via a meeting such as this, rather than via some
sort of public statement, but we are concerned and will react accordingly. If not for the Holland & Barrett
meeting we may have been none the wiser. The potential for consumer unrest is high.”

The HFMA and other aligned groups would increase lobbying efforts to ensure the principles of risk management
are followed, he said, with the HFMA putting a lobbying toolkit together to assist companies and other
organisations.

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.

Flip?

Redman pointed to EU discussion papers in 2006 and 2007 which “broadly endorsed” the EHPM/ERNA approach
to risk management, and said he “no idea” what had caused the change in DG Sanco’s position.

“It even flies in the face of a legal opinion that EHPM has sourced where protection is offered to the UK position
and which we have shared with both DG Sanco and the UK Food Standards Agency (FSA).”

It is estimated the UK specialist supplements market is worth more than €100m.

Across Europe levels for minerals and vitamins differ radically from country to country. A study by the
Association of the European Self-Medication Industry (AESGP) found Belgium, for example, had maximum
levels which varied between 1.5 and three times the recommended daily allowance (RDA) with a minimum level
of 1.5 per cent RDA.

By comparison Denmark varied on the maximum level from 1.8 to 1300 times RDA, and a higher minimum
level of 30 to 33 per cent of RDA. Some countries had no minimum level, including Estonia, which had a
maximum level inline with RDA.
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1z1 2008-12-23 21:54