DHA and EPA-rich Algal Oil. EC No. 128

April 2011: Application from Martek Biosciences Corporation, for the authorisation of DHA and EPA-rich algal oil (DHA-O) under the Novel Food Regulation (EC) 258/97. Authorised July 2012.

Background

Martek has previously gained approval for docosahaexanoic acid (DHA)-rich oil produced from Schizochytrium sp. as a nutritional ingredient. Martek has now developed an improved strain, from another species of Schizochytrium microalgae which produces an oil rich in both DHA and eicosapentaenoic acid (EPA). The applicant intends to market its DHA and EPA-rich oil, known as DHA-O at similar use levels and in similar food categories to those currently approved for its DHA-rich oil. Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. 

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

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 ACNFP at its meetings between January 2011 and December 2011 the Committee has formulated a positive opinion on this DHA and EPA-rich oil. The UK's initial opinion was forwarded by the European Commission to Member States for a 60 day period to comment or provide reasoned objections. On 6 July 2012 the Agency wrote to the applicatn informing them that DHA and EPA-rich oil may now be marketed in the European Union.