Synthetic dihydrocapsiate (extension of use). EC No.173

May 2014: Application from Ajinomoto Co., Inc., Japan to extend the use of synthetic dihydrocapsiate for use in food supplements under the Novel Food Regulation (EC) 258/97. Applicaiton status Authorised.

Background

Dihydrocapsiate is a capsinoid and occurs naturally in edible pungent (hot) and non-pungent chilli peppers. The applicant states that capsinoids are able to enhance energy expenditure and fat oxidation. Capsinoids are chemical analogues of capsaicin which is the hot component creating the sensation of 'hotness' in chilli peppers, while capsinoids are virtually non-pungent.

Sourcing of large quantities of dihydrocapsiate from chilli peppers is not sustainable because of the relatively small amounts that are contained in and can be extracted from chilli peppers. Ajinomoto therefore intends to produce dihydrocapsiate synthetically. Ajinomoto’s synthetic dihydrocapsiate was authorised in November 2012 to be added to a range of foods. Ajinomoto has applied to the UK requesting to extend the use of this novel ingredient to include use in food supplements.

Legal Backgroud

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

In May 2014, Ajinomoto Co. Inc. submitted an application to the UK Competent Authority to extend the uses of its synthetic Dihydrocapsiate (DHC) to include use in food supplements in accordance with Article 4 of Regulation (EC) 258/97.

In June 2014 the Food Standards Agency issued its initial assessment report, having obtained expert advice from the Advisory Committee on Novel Foods and Processes (ACNFP), the committee that advises the Agency on all novel food issues. This report concluded that the application for extension of use of DHC meets the criteria for acceptance of a novel food, as defined in Article 3(1) of the Regulation.

The Committee 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.