May 2012: Application from Lallemand for the authorisation of Vitamin D2 yeast concentrate under the Novel Food Regulation (EC) 258/97. Under evaluation.
This is an application from Lallemand to market a yeast (Saccharomyces Cerevisiae) containing an enhanced level of vitamin D2 as a nutritional food ingredient and food supplement ingredient in Europe. The applicant intends that the novel food, which is treated with UV to enhance the of vitamin D2 present, will be used primarily in the leavening of bread and in food supplements.
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 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 period and the discussion of this application by the committee at its meetings between April and August the Committee has formulated a positive opinion on this Vitamin D2 yeast concentrate.
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.