July 2009: Application from William Wrigley Jr. Company for the authorisation of magnolia bark extract under the Novel Food Regulation (EC) 258/97. Authorised October 2011.
The magnolia bark extract (MBSE) is obtained from the bark of the plant Magnoliae officinalis. This plant is native to the mountains of China and has been used for centuries as part of traditional Asian remedies. The applicant intends to incorporate MBSE into two confectionary products (chewing gum and a limited number of mint confectionery products) at a maximum use level of 0.2% for its perceived breath freshening properties. t be rigorously assessed for safety.
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 Magnolia Bark Extract was assessed by the UK under Regulation 258/97 (EC). The application was accepted in July 2009 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 was authorised using an acceptance letter from the UK.