May 2016: Application from Calanus AS, for the authorisation of oil from Calanus finmarchicus under the Novel Food Regulation (EC) 258/97. Status: Authorised
Calanus finmarchicus is an herbivorous copepod (miniature shrimp) and one of the most common species of zooplankton found in the North Atlantic Ocean. A characteristic of marine copepods is their ability to generate large lipid stores – primarily in the form of wax esters or triglycerides. The applicant intends that the oil will be marketed in the form of food supplements and it is one of an increasing number of oils rich in the polyunsaturated fatty acids Docosahexaenoic acid and Eicosapentaenoic acid (DHA and EPA).
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 Calanus finmarchicus was assessed by the UK under Regulation 258/97 (EC). The application was accepted in May 2016 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.