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Fields of Expertise: Botanicals, Food Ingredient, Food Additives, Novel Food, New Dietary Ingredient (NDI), Generally Recognized As Safe (GRAS), Health Claims, Safety, Toxicology, Food Regulation.

Author's details: Jérôme LE BLOCH has been, since 2011, a member of the Health claim and Food safety department in Nutraveris, and is now at the head of this department. He obtained his master degree in Biochemistry from Rennes I University (France) in 2006, and his Ph. D in nutrition and metabolism from Nantes University (France) in 2011. His thesis was focused on the nutritional management of metabolic syndrome and associated metabolic disorders by niacin (vitamin B3) and omega 3 fatty acids. In Nutraveris, he manages scientific projects aiming to substantiate the safety or efficacy of ingredient from the nutrition and health market. This covers health claim, novel food, NDI/GRAS or food additive applications, in Europe and in the US. Nutraveris is the leading European consulting company on the nutrition and health market, with both the scientific and regulatory expertise.

Abstract: Polyphenols are commonly found in botanicals and explain at least in part the beneficial health effects of plants. For instance, among the most well-know polyphenols, curcumin is involved in the anti-inflammatory and anti-arthritic properties of turmeric (Curcuma longa L.), whereas the main bioactives of green tea (Camellia sinensis L.) are polyphenols, and notably epigallocatechin gallate (EGCG). Due to their nutritional or therapeutic benefits, polyphenols have been well-studied. However, the regulatory aspects of the use of polyphenols for human nutrition must be considered. Polyphenols and plant extracts may be considered in Europe as Novel Foods, i.e. ingredient which have not been consumed in Europe before the 15 May 1997. Novel foods can be authorized only after the evaluation of a scientific application by the European Food Safety Authority (EFSA) and the publication of a regulation indicating the conditions of uses and the main characteristics of the ingredient by the European Commission. Even if polyphenols are consumed daily through fruits and vegetables, purified polyphenols may be considered as novel foods. This has been the case for instance of Ecklonia cava phlorotannins, purified EGCG from green tea leaves, or flavonoids from licorice. In the US, the situation is identical, with GRAS or NDI applications needed for these compounds. The purpose of this conference will be to answer the following questions: What are the main criteria that define whether a polyphenol is novel or not? What are the various regulatory procedures to follow to obtain an authorization for a purified polyphenol? If the ingredient is novel, what are the main information to present in a novel food application and what are the main steps to put a purified polyphenol on the market? And finally, what are the similarities and differences between US and EU procedures?