DHA-rich algal oil (infant and follow on formula). EC No.156

September 2013 : Application from DSM Nutritional Products for the authorisation of DHA-rich algal oil from microalgae Schizochytrium sp, under the Novel Food Regulation (EC) 258/97. Authorised.


This application is to extend the use of a docosahexaenoic acid (22:6(n-3), DHA) rich algal oil from the microalgae Schizochytrium sp. This is the sixth full application made for oils rich in polyunsaturated fatty acids obtained from the microalgae Schizochytrium sp. This oil, which is rich in the fatty acid docosahexaenoic acid (DHA) is obtained from another strain of the species and differs from previous applications in that it is proposed for use, primarily, in infant and follow on formula. DHA that is currently used in infant formula is typically obtained from fish (tuna) oil or using a DHA rich oil from Crypthecodinium cohnii. 

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

The application for DHA and EPA for infant formula was assessed by the UK under Regulation 258/97 (EC). The application was accepted in September 2013 and was reviewed by the Committee to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage.

The Committee completed its assessment and published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation.