December 2013: Application from Technology Crops International for the authorisation of refined Buglossoides oil under the Novel Food Regulation (EC) 258/97. Status: Authorised under Regulation (EC) 258/97.
The applicant’s intention is to market refined oil from Buglossoides arvensis seeds as a novel food ingredient to be incorporated into a range of foods (including, dairy products, breakfast cereals, food supplements, foods for weight control diets and foods for special medical purposes). The applicant states in its application that the oil could be consumed by people looking to increase their intake of long-chain omega-3 fatty acids, who are unwilling or unable to consume fish oils. This might include vegetarians, for example.
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 Buglossoides arvensis was assessed by the UK under Regulation 258/97 (EC). The application was sent in June 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. It was authorised under Commission Implementing Decision (EU) 2015/1290.