Safety of paramylon as a novel food pursuant to Regulation (EU) 2015/2283

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Margarita Aguilera Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Miguel Prieto MaradonaRosangela Marchelli, Monika Neuhäuser-Berthold, Morten Poulsen, Josef Rudolf Schlatter, Henk van Loveren, Reinhard Ackerl, Helle Katrine Knutsen, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel)

Research output: Contribution to journalArticleResearch


Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Paramylon is a linear, unbranched beta-1,3-ᴅ-glucan polymer that is isolated from the single-cell microalga Euglena gracilis. The NF consists of at least 95% beta-glucan and minor amounts of protein, fat, ash and moisture. The applicant proposed to use the NF in food supplements, as a food ingredient added to a number of food categories and in foods for total diet replacement for weight control. In 2019, E. gracilis was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’, which includes food products based on microbial biomass of the microalga. Based on the information provided, E. gracilis is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns. No adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day. In view of the QPS status of the source of the NF, supported by the manufacturing process, compositional data and lack of toxicity observed in the toxicity studies, the Panel has no safety concerns and concludes that the NF, i.e. paramylon, is safe under the proposed uses and use levels.

Original languageEnglish
Article numbere07995
Pages (from-to)e07995
JournalEFSA Journal
Issue number5
Publication statusPublished - 26 May 2023


  • algae
  • beta-glucan
  • Euglena gracilis
  • novel food
  • paramylon
  • safety


Dive into the research topics of 'Safety of paramylon as a novel food pursuant to Regulation (EU) 2015/2283'. Together they form a unique fingerprint.

Cite this