February 2001: Application from OmegaTech for approval of DHA Gold, a DHA-rich oil. Authorised June 2003.
An application was recieved from OmegaTech for approval of DHA Gold, a DHA-rich oil. The full version of this dossier was placed on the UK competent authority website on 14th February 2001. During the course of the evaluation the UK Competent Authority sought further information to clarify certain aspects of the dossier. The application was prepared according to the European Commission's guidelines. DHA-Gold was identified as belonging to class 2.2 ('complex novel food from a non-GM source', 'the source of the novel food has no history of use in the community').
DHA (docosahexaenoic acid) rich oil is produced via an algal fermentation process using microalgae from the genus Schizochytrium, a member of the kingdom Chromista, which includes the golden algae. Schizochytrium sp. has previously been assessed in the United States and was given GRAS (Generally Recognised As Safe) clearance as a nutritional food ingredient. In the United States, a daily intake of up to 1.5g of DHA was recommended (DHA-rich oil contains 35-45% DHA). Prior to this, the microalgae achieved GRAS status to be used in chicken feed at levels of incorporation of up to 2.8% for broilers and 4.7% in layers).
There is evidence to suggest that each of the components of the oil is already present to a significant degree in the human food chain. The production strain of microalgae used for DHA Gold has been developed using conventional improvement techniques of the wild type strain and no recombinant DNA technology was used.
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
Following an initial public consultation and the discussion of this application at the 14 March 2001, 13 March and 16 May 2002 meetings of the ACNFP, the UK Competent Authority have formulated an initial opinion on this novel food ingredient. In June 2003 OmegaTech was granted authorisation to market DHA-rich oil in the EU by Commission Decision 2003/427/EC.