The safety assessment of microalgae-derived products as novel foods by the European Food Safety Authority

Recent advancements in food research alongside the growing interest in new sources with enhanced nutritional value have led to an increasing development of food products derived from microalgae. Some of these products fall under the category of novel foods (NFs) in the European Union (EU) and their safety must be evaluated by the European Food Safety Authority (EFSA) before being authorised on the EU market. By August 2024, EFSA had evaluated eleven NFs derived from microalgae, including oils rich in docosahexaenoic acid (DHA) from Schizochytrium spp., whole biomass of the microalga Euglena gracilis and its derivative beta-glucan polymer (paramylon), ethanolic extract from Phaeodactylum tricornutum and oleoresin rich in astaxanthin from Haematococcus pluvialis. One of the key scientific requirements for the safety assessment of these products is the characterisation of the microalga strain, including its unambiguous taxonomic identification at species level and pathogenicity. The "Qualified Presumption of Safety" (QPS) status of the microalgae also plays a significant role in determining the safety assessment approach to be applied. Other relevant requirements comprise a thorough chemical characterisation (e.g., biotoxins, undesirable substances, heavy metals) together with microbiological and nutritional characterisation of the product, description of the manufacturing process and a toxicological and allergenicity assessment. By illustrating examples of NF that consist of, are isolated from or are produced by microalgae we highlight the main requirements needed for their safety assessment alongside the challenges encountered. Taking into account the continuous evolution of the microalga sector leading to innovative products, we also extend these requirements to the safety assessment of microalgal proteins, considering potential future mandates to assess algae-derived proteins as NFs by EFSA.