MARIE-EVE DANIEL, AMÉLIE DENIS

Nutraveris, Scientifi c and Regulatory Expertise,
18c rue du Sabot, 22440, Ploufragan, France

Abstract

After several years of work at national and European levels, the new expected French law on botanical in food supplements will be published by the end of this year and should be applicable in 2014.
The current French regulatory specifications on botanicals usable or not in foods will therefore disappear: only 148 authorized botanicals which involved regular resorts to mutual recognition principle, which slows down the commercialization of food supplements based on botanicals in France.
With the new French law, not less than 600 botanicals will be authorized in food supplements with their specific conditions of use. Nevertheless, companies responsible for the commercialization of that kind of products on the French market will be invited to offer more guarantees on the quality and safety of their ingredients: characterization, identification and management of risks, post-market monitoring will be new specific constraints but for a genuine breakthrough in the simplification of the commercialization of herbal preparations on the French market.

A French text on botanicals in food supplements has been expected for several years. 

After a lot of work at national level, a draft law has been notified by France at the European level in December 2012 and has been presented to the Standing Committee on the Food Chain and Animal Health (SCFCAH) in February. European Commission and other Member States could make some comments by April 2nd. French Authorities would now take into account those comments to prepare the final text for a publication before the end of this year. It is expected to be applicable in 2014 depending on the date of publication.

CURRENT REGULATORY CONTEXT IN FRANCE
There are already some French technical regulations concerning botanicals usable or not in foods, including food supplements.
A list from French pharmacopeia is used as a negative list, because it includes botanicals for which possible adverse effects are higher than benefits, so it is a proof of safety risks that may lead French Authorities to refuse the commercialization of a product with one of the botanicals from this list.
Since 2008, there is also a French positive list of 148 botanic ...