Omega-3, probiotics, plant extracts not ruled by Supplements Directive, says EC

By Shane Starling

- Last updated on GMT

Related tags Food supplements Mutual recognition European union

Adding nutrients such as some herbal extracts, omega-3s, probiotics, glucosamine and more to the Food Supplements Directive (FSD) is impractical and unworkable, the European Commission has stated.

In a long-awaited document on the matter sent to Member States and the European Parliament last week, the EC said nutrients other than the vitamins and minerals already regulated by the FSD did not enjoy the same consistency of use throughout the bloc.

They should therefore continue to be governed under varying national and EU regulations and institutions.

Because of the regularity with which such nutrients are added to food supplements there was momentum to have them regulated under the FSD.


But in its 13-page document on the matter the EC concluded: “Laying down specific rules applicable to substances other than vitamins and minerals for use in food supplements is not justified.”

It added that, a proposal for harmonisation in this area could only be limited to some substances, thus restricting its usefulness.”

These “other nutrients” ​that also include L-carnitine, conjugated linoleic acid (CLA) and coenzymeQ10, will continue to come under the remit of the fortified foods directive; the Novel Foods regulation; PARNUTS (foods for particular nutritional purposes); the nutrition and health claims regulation as well as precedents established in the European Court of Justice (ECJ).

The idea of mutual recognition, whereby, in principle, products OK’d in one Member State should be accepted by all Member States, was also highlighted as a mechanism that would facilitate the free trade of non-VMS products without amendment to the FSD.

“If companies and national regulatory authorities both have a clear understanding of the mutual recognition regulation, it should go a long way towards breaking down EU barriers to trade,” ​said European Federation of Associations of Health Product Manufacturers (EHPM) chairman Peter van Doorn.

The mutual recognition regulation is due to take full effect in the EU from May, 2009.

However the Commission added that, given the increasing level of food fortification with these substances, a revision of its current position was a possibility at some point in the future.


Patrick Coppens, the secretary general of the Belgium-based European Botanical Forum (EBF) and the European Responsible Nutrition Alliance (ERNA), said the EC’s position had been expected as it was not feasible at this point in time to bring the nutrients within the FSD.

“Ideally these substances would be brought into the FSD so there was legal certainty but this is not the worst result and the principle of mutual recognition should ensure free trade in products containing these nutrients,”​ he told

“The EC is being pragmatic about this and the result is there will be little change in market conditions. They have decided it is better not to regulate at this stage.”

EHPM welcomed the EC position and noted it demonstrated the “adequacy of the current legal framework”.

“We understand the complexities involved in harmonising these ingredients and agree that the newly implemented laws should be given a chance,”​ Van Doorn said.


The EBF emphasized the importance of herb use in food supplements.

“They are used almost as much as vitamins and minerals in some Member States,”​ said EBF chairman, Manfred Ruthsatz.

“It needs to be appreciated that for European companies to be competitive they need to be able to sell across their domestic market, which is the EU.”

He added: “…we hope that all of the laws currently in existence will be used as intended and preserve the place of botanical food supplements alongside medicinal products,”​ said EBF chairman Manfred Ruthsatz.

To view the EC document in 22 languages click here​.

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