EAS Clarifies Borderline Between EU and National Rules for Food Supplements

“Despite food supplement rules being harmonised across the EU, companies wanting to market food supplement products have to comply with a complex combination of EU and national laws,” said EAS Scientific and Regulatory Affairs Manager Efi Leontopoulou.

1/25/2011 --- Food supplement companies struggling to navigate the fine line between European Union (EU) regulation and national rules for food supplements in Europe can get clarity at an upcoming workshop from international food policy consultancy EAS.

The one-day session, titled “Building a Regulatory Strategy for Marketing Food Supplements in Europe: The key steps to a successful product launch”, will take place in Brussels on 17 March, with EAS regulatory experts advising companies on how to avoid common pitfalls to a successful regulatory strategy in the wake of the EU’s food supplement harmonisation process.

It covers mandatory and optional harmonised rules; the borderline between what is harmonised and what is not in terms of vitamins, minerals, herbs and other substances; how to use the principle of mutual recognition to break down national trade barriers; challenges with novel foods and the European Commission’s proposal to amend the novel food regulation; health claims and product labelling compliance.

“Despite food supplement rules being harmonised across the EU, companies wanting to market food supplement products have to comply with a complex combination of EU and national laws,” said EAS Scientific and Regulatory Affairs Manager Efi Leontopoulou, “Manufacturers still often face having to reformulate their products depending on the EU countries they are launching in, especially, for example, when it comes to ingredients such as herbs, amino acids and other bioactive  substances, which many are unaware are still regulated at the national level. It is therefore essential for companies to develop a good knowledge of the pan-European regulatory environment to avoid pitfalls to marketing products in the EU.”

The workshop is limited to 25 attendees to ensure participants have the chance to be given clear advice on their specific regulatory issues, with the afternoon session dedicated to the controversial issue of health claims.

“The EU Nutrition and Health Claims Regulation is one of the major hurdles for the future marketing food supplements in Europe,” said Stefanie Geiser EAS-Italy Regulatory Affairs Manager. “A first ban on a wide range of generic article 13 health claims foreseen for 2011 has been delayed to an extent, although companies wanting to maximise this delay must ensue their products are in line with existing national provisions. At our workshop we will provide recommendations on how to best benefit from this period, present the new expected timelines for the article 13 transition period for different claims, give an update on the European Food Safety Authority’s evaluation results for article 13.5 and article 14 claims, and clarify its EFSA claims substantiation standards.”