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Risk assessment

Safety Assessment RP1411 Schizochytrium sp. oil rich in DHA and EPA

This section summarises outcome of assessment of an application under the assimilated regulation 2015/2283 EU for Schizochytrium sp. oil rich in DHA and EPA as a novel ingredient in meat and fish analogues.


An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in January 2022 from DSM Nutritional Products, Switzerland (“the applicant”). The application is for the authorisation of the proposed extension of use of Schizochytrium sp. oil rich in DHA and EPA as a novel food in two additional food categories.

The novel food is an algal oil that is rich in docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), which is intended to be used as a food ingredient and as an ingredient in food supplements. The novel food is manufactured by heterotrophic fermentation of Schizochytrium sp. algae, which produce oils predominantly comprised of triglycerides (DHA and EPA).

Schizochytrium sp. oil rich in DHA and EPA (hereafter “DHA-O”) is currently authorised as a novel food in the UK (assimilated Commission Implementing Regulation (EU) 2017/2470). This new application is an extension of the intended uses of DHA-O, seeking to use the novel food within two new food categories: meat analogues and fish analogues.

To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the extension of use of the food is safe, and not putting consumers at a nutritional disadvantage.

The FSA and FSS concluded that the applicant had provided sufficient information to assure the proposed extension of use for DHA-O, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods was not considered to be nutritionally disadvantageous.

The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinion of the FSA and FSS.

Safety assessment