July 2008: Application from CBC Co. Ltd., for the authorisation of Touchi extract under the Novel Food Regulation (EC) 258/97. Authorised August 2011.
Touchi extract (TE) is a protein-rich powder obtained from the fermentation of small soybeans with Aspergillus oryzae. The ingredient contains an alpha-glucosidase inhibitor and is intended to be consumed by those who wish to slow the breakdown of carbohydrates. TE is similar to black bean sauce that has been on the market in the European Union for many years. One portion of black bean sauce contains 15g of fermented black beans, which corresponds to 4.5g of the novel food ingredient on extraction. TE is intended to be marketed as a food supplement and a tea/soup style formulation at levels that would not exceed 4.5g per daily serving/dose.
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
Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP). Following an initial public consultation on the application and the discussion of this application by the ACNFP at its meetings between July and November 2008, the Committee has formulated a positive initial opinion on this Touchi extract ingredient.
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.