November 2014: Application from Amino Up Chemical Company Ltd for Oligonol® under the Novel Food Regulation (EC) 258/97. Passed to the EU under Regulation (EC) 2015/2283.
This page detials on an application from Amino Up Chemical Company Ltd for Oligonol.
The applicant’s Oligonol® is made by an oligomerisation reaction that cleaves the polyphenols present in a combined extract of lychee fruit and green tea into monomers and low molecular weight oligomers. Oligonol® is composed mainly of monomeric flavan-3-ols, as well as procyanidins formed from the condensation of these monomeric units.
The applicant proposes to incorporate Oligonol® into a range of different foods including dairy products, confectionery, cereals, bakery wares, non-alcoholic beverages and foods for particular nutritional uses and food supplements. Oligonol® is intended to serve as another source of dietary polyphenols which the applicant states have been associated with lowered risk of many chronic diseases such as cardiovascular disease, cancer and chronic inflammation.
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: Passed to the EC
The application for Oliginol was assessed by the UK under Regulation 258/97 (EC). The application was accepted in November 2014: 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 a number of assessments and after reviewing requested information positive opinion. This was shared with other member states who raised reasoned saftey concerns. As a result, the application was not completed prior to the 1st of January 2018 and was passed to the EU under regulation (EC) 2015/2283.