DHA Rich Microalgal Oil. EC No. 88

January 2008: Application from Martek Biosciences Corporation, for the extension of use of a DHA-rich algal oil from the microalgae Schizochytrium sp under the novel food Regulation (EC) 258/97. Authorised October 2009.

Background

The ACNFP first considered an application for the authorisation of this DHA-rich oil as a novel food ingredient in 2001-02. The UK Competent Authority submitted a favourable initial opinion to the Commission in June 2002 and the product was authorised in 2003, albeit with a reduction in the number of food categories. Martek Biosciences Corporation has now applied for authorisation for the use of this novel food ingredient in a wider range of food categories (bakery products, bread and rolls, nutrition bars, non-alcoholic beverages, milk based drinks and dairy analogue drinks).

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

Following an initial public consultation period and the discussion of this application by the ACNFP at its meetings between January 2008 and July 2008, the Committee has formulated a positive initial opinion. In October 2009 Martek Biosciences Corporation was granted authorisation to extend the use of their DHA-rich oil in the EU by Commission Decision 2009/778/EC.