Open AccessSafety of oil from Schizochytrium limacinum (strain FCC ‐3204) for use in food supplements as a novel food pursuant to Regulation ( EU ) 2015/2283
Author(s) -
Turck Dominique,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst Karen Ildico,
Kearney John,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Pelaez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Cubadda Francesco,
Frenzel Thomas,
Hein Marina,
Marchelli Rosangela,
NeuhäuserBerthold Monika,
Poulsen Morten,
Maradona Miguel Prieto,
Schlatter Josef Rudolf,
van Loveren Henk,
Turla Emanuela,
Knutsen Helle Katrine
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6345
Subject(s) - food science , food safety , european commission , docosahexaenoic acid , biology , population , microbiology and biotechnology , european union , biochemistry , fatty acid , environmental health , business , medicine , polyunsaturated fatty acid , economic policy
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 the safety of Schizochytrium sp. oil as a novel food ( NF ) pursuant to Regulation ( EU ) 2015/2283. Schizochytrium sp. is a single‐cell microalga. The strain FCC ‐3204, used by the applicant (Fermentalg), belongs to the species Schizochytrium limacinum . The NF , an oil rich in docosahexaenoic acid ( DHA ), is obtained from microalgae after enzymatic lysis. The applicant proposed to increase the use level of the NF as a food supplement, from 250 mg DHA /day (currently authorised for the general population, excluding pregnant and lactating women) to 3 g DHA /day for adults, excluding pregnant and lactating women. S. limacinum was attributed the qualified presumption of safety ( QPS ) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF . No toxicological studies were performed with the NF . However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF , the production process, the composition of the NF and the absence of viable cells in the NF , the Panel considers there are no concerns with regard to toxicity of the NF . The Panel considers that the data provided by the applicant are not sufficient to conclude on the safety of the NF at the proposed uses (3 g DHA /day as a food supplement) in adults. However, in 2012, the Panel concluded that supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population. The Panel concludes that the NF is safe for the use in food supplements at the maximum intake level of 1 g DHA /day for the target population (adults, excluding pregnant and lactating women).