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No harmonisation of bioactives needed, says Europe

February 24, 2009

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No further harmonisation of bioactive and botanical ingredients used in food and nutritional products across the European Union is necessary at this stage, according to a European Commission report.

The report on the use of ingredients other than vitamins and minerals in food supplements, published earlier this month, said adding ingredients such as Omega 3 and probotics to the Food Supplements Directive was not required because a number of new laws should be capable of solving the majority of issues that may arise about the use of such ingredients in member states.

These laws included regulations covering Nutrition and Health Claims, Fortification, Novel Food and the Mutual Recognition.

Trade body The European Federation of Associations of Health Product Manufacturers said the new mutual recognition regulation, in force from May 2009, would play a particularly important role now that these substances were to remain subject to different national rules. According to the mutual recognition principle, ingredients lawfully marketed in one EU member state should be accepted in all other EU markets.

Brussels-based EHPM said companies manufacturing botanicals and bioactive substances should familiarise themselves with the regulation, as it could be the key to countering restrictions placed on their products in the various EU member state markets.

"The annexes of the Commission report highlight the most important other ingredients used, which should make it very difficult for member states to deny their existence in food supplements," said EHPM Chairman Peter van Doorn. "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."

The European Botanical Forum said more effort was still needed to ensure botanical supplement products marketed in one European Union member state were accepted for sale in all.

"The Commission's report recognises the importance and variety of use of other ingredients, including botanicals, in food supplements across the EU," said EBF chairman Manfred Ruthsatz. "They are used almost as much as vitamins and minerals in some member states.

"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. While national authorities and industry are aware of the principle of mutual recognition, how it is applied in practice is a grey area depending on the different member state interpretations, so companies tend not to take it up.

"Now that a regulation has been put in place, the procedure will be much clearer, so it is important for companies to recognise and familiarise themselves with this valuable tool."

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