Lycopene from Blakeslea trispora. EC No. 48

October 2003: Application from Vitatene to approve lycopene from Blakeslea trispora as a novel food ingredient. Authorised October 2006.

Background

Solvent extracted lycopene from tomatoes is approved for use as an additive (E160d) and is used as an ingredient in a range of foods and dietary supplements. Synthetic lycopene is also used as a food ingredient, but is not permitted for use as a colour additive. Blakeslea trispora is a fungus that synthesises large quantities of carotenoids. Vitatene proposes to market lycopene, derived from the fungus Blakeslea trispora, for use as a nutritional food ingredient and dietary supplement in the EU. Approval is sought under Regulation (EC) No 258/97 concerning novel foods and novel food ingredients.

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

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 period and the discussion of this application at the 20 November 2033 and 4 February 2004 meetings of the ACNFP, the Committee has now formulated an initial opinion on this novel food ingredient.

In October 2006 Vitatence was granted authorisation to market its Lycopene from Blakeslea trispora, in the EU by Commission Decision 2006/721/EC.

Application Files