N°64 - Ingrédients /Extraits végétaux Herbal supplements: a wait- The regulatory framework for herbal supplements is changing. Amongst the future prospects, the harmonization of the lists of plants authorized in Europe and the publication of a list of health claims. Still, there will be no real progress as to the subject of botanical claims by the next European Commission elections (September 2019). In the meantime, 2,000 claims may still be used. Food supplements are highly regulatedproducts positioned between the foodthat feeds and the medicine that heals.15. Nevertheless, operators should remain vigi-lant as to this list which is not updated and hasno legal value. It is highly recommended to check Defi ned by Directive 2002/46/EC, transposed the indications and substances directly on the into the French legislation by Decree 2006-32, Téléicare electronic registration website, as the food supplements are products at the crossroads DGCCRF often makes updates on this website. of different regulations. Indeed, we must take into account the laws related to foodstuffs (safety, A negative list consumer information...), food supplements (defi nition, safety of composition, labelling...) In France, there is also a negative list of plants and those related to agricultural raw materials. that are included in list B of the French Phar- 108 macopoeia. The plants in this list have poten- Herbal supplements: lack of tial adverse effects that are stronger than their harmonization across the EU expected therapeutic benefi t. Some of the plants featuring in this list are also present in the Decree The plants and plant-based preparations autho- on Plants, which means that the food supple- rized for use in food supplements are not harmo- ments containing these plants may be sold only nized across the |EU. by pharmacists In France, the Decree of 24 June 2014 (known as the “Decree on Plants”) lays down the list Future prospects? containing the 540 plants authorized for use in food supplements and their conditions of use One of the future prospects for herbal supple- (substance to be monitored, maximum doses, ments is the harmonization of the plants autho- precautions for use). It is important to make surerized for use. Work has already been done and that a given product does not fall within the defi -published in 2014: the BelFrIt List, which has no nition of a medicinal product as the plant pre- regulatory or legal value. This list, which includes parations for which a well-established use has 1,029 plants and 11 mushrooms, is the result of been defi ned by the EMA (European Medicines a close collaboration between France, Belgium Agency) cannot be used under such conditions and Italy in an attempt to reach a common of use - the product would then be reclassifi ed vision on the use of plants in food supplements. because of its function. This initiative is being promoted at European As to the plants absent from the Decree on level. However, it is currently diffi cult to reach a Plants, but which are on the positive list of anotherconsensus among all Member States. Member State (Belgium, Italy...), it is possible toThe European Commission is using a backdoor use such plants in a food supplement by way strategy for the assessment and harmonization of mutual recognition and therefore registration of plants at European level. Indeed, over the past under Article 16. The DGCCRF (French General year, applications for the evaluation of a subs- Directorate for Fair Trading, Consumer Affairs tance or ingredient containing a substance falling and Fraud Control) has also made available on its under the scope of the procedure laid down in website a list of 889 plants eligible under ArticleArticle 8 of Regulation (EC) 1925/2006 have ■ / Juillet - Août - Septembre 2018 / N°64 / L’Actualité des Ingrédients Fonctionnels & Santé