EHPM Welcomes EU Commission Report on Use of Bioactive and Botanical Ingredients in Food Supplements

The report, which was sent to all Member States and the European Parliament last week, states that no further harmonisation of bioactive and botanical ingredients used in food and nutritional products is necessary at this stage.

10/12/08 The European Commission’s report on the use of ingredients other than vitamins and minerals in food supplements shows their widespread use across the EU and the adequacy of the current legal framework, trade organisation the European Federation of Associations of Health Product Manufacturers (EHPM) has said.

The report, which was sent to all Member States and the European Parliament last week, states that no further harmonisation of bioactive and botanical ingredients used in food and nutritional products is necessary at this stage, as a number of new laws, such as those for Nutrition and Health Claims, Fortification, Novel Food and the Mutual Recognition should be capable of solving the majority of issues that may arise.

EHPM said that the report’s conclusions reflected its own assessment of the current variety of national approaches, adding that its clear description of the legal framework will be a significant help to supplement companies arguing for market access in cases of borderline issues or mutual recognition.

“The Report recognises the importance and variety of the use of other ingredients in food supplements across the EU, although the situation varies among the different Member States,” said EHPM Chairman Peter van Doorn. “We understand the complexities involved in harmonising these ingredients and agree that the newly implemented laws should be given a chance.”

The Commission report makes reference to the issue of the borderline between medicines and food supplements, and lays out the current European Court of Justice (ECJ) rulings that apply in the case of classification issues.

EHPM highlighted the role that the new mutual recognition Regulation could play now that these substances will remain subject to different national rules. The trade organisation said that companies manufacturing botanicals and bioactive substances should familiarise themselves with the mutual recognition Regulation, as it could be the key to countering restrictions placed on their products in the various EU Member State markets. Ingredients lawfully marketed in one EU member state should, according to the mutual recognition principle, be accepted in all other EU markets.

“The annexes of the Commission report highlights the most important other ingredients used, which should make it very difficult for Member States to deny their existence in food supplements,” said Mr 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.”