DHA rich algal oil and a related DHA and EPA rich oil (extension of use). EC No. 147

January 2013 and April 2013: Application from DSM Nutritional Products to extend the authorisation of two algal oils under the Novel food Regulation (EC) 258/97. Under evaluation.

Background

These applications are to extend the use of a docosahexaenoic acid (22:6(n-3), DHA) rich algal oil from the microalgae Schizochytrium sp. and a related DHA and eicosapentaenoic (20:5(n-3), EPA) rich oil from a different strain of the same source organism.

As the Committee has issued positive opinions for these oils in the past, both the opinions are in the form of letters which informs the European Commission and other Member States that the ACNFP accepts the applicant’s rationale for extending the uses.

Extending the use of these oils will not lead to consumption at levels which exceed the European Food Safety Authority’s (EFSA’s) tolerable upper intake level of EPA and DHA of 5g/day, which was set in June 2012, and the applicant’s requests follow the publication of two positive EFSA opinions earlier this year which endorse a cause and effect relationship between dietary intake of EPA and DHA and the reduction of blood pressure and blood triglycerides . These opinions are likely to result in the authorisation of health claims which will be restricted to high dose food supplements.

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