Commission Opinion on Other Ingredients Offers a Wide Range of Solutions for Supplement Sector

The Commission’s opinion cited that harmonisation of these ingredients would not be appropriate at this point because rules could only be introduced for a few substances due to the vastly differing national markets; and because there are existing legal instruments that may over time result in harmonization, such as the fortified foods and novel foods regulations and the recently adopted mutual recognition regulation.

11/03/09 The European Commission’s opinion for no EU harmonisation of substances other than vitamins and minerals used in food  supplements has a number of implications for the sector, a food policy consultant has said. Pieter Lagae, Regulatory Adviser at international food and nutrition policy consultancy EAS, said in a podcast interview that while the opinion means vastly differing regulations would remain in place in the 27 Member States, harmonisation would in reality be difficult to achieve.

“Entering all EU markets with one formula due to EU harmonisation of other substances would be the easiest option for  manufacturers, because harmonisation could be the way forward into markets which are currently reluctant to accept, for example, herbal extracts, and it would entail more transparency and legal certainty for companies,” said Mr Lagae. “However, the scientific demands for EU-wide rules could also result in harmonisation for only a minimum number of substances.”

Other substances are ingredients with a nutritional or physiological effect for which no harmonised legal framework exists, such as amino acids, ginseng,essential fatty acids, enzymes, and pre- and probiotics. They do not include vitamins and minerals, which are already harmonised by the EU Food Supplement Directive, food additives, processing aids and flavourings.

The Commission’s opinion cited that harmonisation of these ingredients would not be appropriate at this point because rules could only be introduced for a few substances due to the vastly differing national markets; and because there are existing legal instruments that may over time result in harmonization, such as the fortified foods and novel foods regulations and the recently adopted mutual recognition regulation.

In response to the opinion EAS is holding a final session of its popular one-day workshop on 2 April 2009, which will lead participants through the regulatory process for launching supplements in the EU. The event covers the entire stepby- step process from notification strategies to the rules and status for vitamins, minerals and other ingredients across Europe as well as novel food requirements, with EAS experts giving tips on future regulatory developments for mid- and long-term product strategies.

Mr Lagae said: “The reason the workshop is so popular is because being confronted with unclear restrictions or a simple no for your product can be very challenging. And companies will know from experience that this may happen in countries with either a case by case assessment or even a detailed procedure. “Our workshop helps companies develop a multi-country strategy to overcomeregulatory challenges. We limit participation to the first 25 in order to maximise the value to the individuals and allow thorough discussion on strategies/ways to market a range of products across the whole of the EU.”