Food supplement companies hoping to market products containing ingredients other than vitamins and minerals across the European Union, must ensure their business strategies take into account national rules now that harmonisation is unlikely, EAS has said.
Commenting on the European Commission’s recently published opinion that the use of ‘other ingredients’ (e.g. herbal ingredients, amino acids, ginseng, essential fatty acids, enzymes, and pre- and probiotics) should not be harmonised across the EU, EAS Scientific and Regulatory Affairs Manager Efi Leontopoulou said that national rules will remain essential when it comes to introducing these substances on the EU market, for the forseeable future.
The consultancy is holding a one-day workshop on 2 April 2009, which will lead participants through the regulatory process for launching supplements in the EU, 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 longterm product strategies.
“With all of the EU legislative changes in recent years, we’ve found that many companies are still unclear on which areas are harmonised and which are not,” said Ms Leontopoulou. “Navigating these national rules can be a very complex process due to the widely differing regulations in the 27 Member States. Denmark and France, for example, are already working on the development of lists to clarify the conditions for using other substances, while Latvia on the other hand recently deleted its list with of specific restrictions for plants.”
The workshop, titled ‘Building a Regulatory Strategy for Marketing Food Supplements in Europe: The key steps to a successful product launch’, also covers the practical impact of the EU Claims Regulation; labelling do’s and don’ts; key areas of opportunity and concern for herbs and other bioactive substances, and the future impact of steps towards EU harmonisation on businesses.
It will be presented by the EAS expert regulatory team, made up of Scientific and Regulatory Affairs Manager, Efi Leontopoulou; Katarina Wagner, Regulatory Affairs Manager, Nutritional Products; Elodie Lebastard, Food Law Adviser; Pieter Lagae, Regulatory Adviser; and Stefanie Geiser, Regulatory Affairs Manager of the EAS Italy office.
Ms Leontopoulou said: “The aim is to help companies not only develop a multicountry strategy to overcome regulatory challenges, but also to put this into practice. With the right combination of knowledge, flexibility and strategic thinking, it’s quite possible to market a range of food supplement products across the EU.”