August 2010: Application from Ametis JSG, Russia for the authorisation of Taxifolin under the Novel Food Regulation (EC) 258/97. Authorised 10th Novemeber 2017.
In August 2010, Ametis JSC made a request to the UK to place faxifolin-rich extract on the Union market as a novel food ingredient. Taxifolin or (2R,3R) trans-dihydroquercetin is a flavanone extracted from the wood of dahurian larch (Larix gmelinii). It is has been marketed in Russia and the US for 15-20 years as a food supplement. The applicant is sought an authorisation to market taxifolin in a range of food products.
Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).
One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.
Application Status: Authorised
The application for taxifolin-rich extract us was assessed by the UK under Regulation 258/97 (EC). The application was accepted in August 2010 and was reviewed by the Committee to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage.
The Committee completed its assessment and published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation. It is authorised under commission implementing decision (EU) 2017/2079.