Novel Foods
The Novel Foods Regulation (EC) No 2015/2283 is a key legislative framework designed to ensure the safety and proper labeling of new and innovative food products entering the European market. This regulation applies to foods and ingredients that have not been significantly consumed by humans in the EU before May 15, 1997. By requiring thorough safety assessments and compliance with stringent standards, the regulation aims to protect consumer health, foster innovation in the food industry, and facilitate the introduction of novel, beneficial products to the European market.
regulatory support
Elements Advisory can support you with:
Strategic advice
Communication with EFSA and Member states
Preparation of the technical dossier
Risk assessments
Drafting GRAS conclusion for US FDA