Safety of oil from Schizochytrium sp. (strain ATCC 20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283.
Résumé
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. The NF which is the subject of the application
is an oil rich in docosahexaenoic acid (DHA) that is produced by the microalgae Schizochytrium sp.
(strain ATCC-20889). The applicant proposed to add the NF in infant formulae (IF) and follow-on
formulae (FOF) at use levels in accordance with Regulation (EU) No 609/2013. The evidence provided
by the applicant does not demonstrate to which species the strain Schizochytrium sp. ATCC 20889
belongs. As the source organism of the NF is not characterised at species level, no assessment for
inclusion in the Qualified Presumption of Safety (QPS) list can be performed by EFSA. Marine biotoxins
(including cyanotoxins) in the NF were below their limits of quantification. However, since it is
unknown to which species the strain Schizochytrium sp. ATCC 20889 belongs, the concern that this
strain has the potential to produce other toxins remains. No toxicological studies with the NF were
provided by the applicant. Toxicological studies are available with DHA-rich algal oils produced from
other strains of Schizochytrium sp. However, the Panel considers that those toxicological studies
cannot be used to establish the safety of the oil produced by the strain which is under assessment in
this application (Schizochytrium sp. ATCC 20889). Therefore, based on the information provided by the
applicant, the Panel concludes that the safety of the NF has not been established.
Domaines
Sciences du Vivant [q-bio]
Fichier principal
EFSA Journal - 2022 - - Safety of oil from Schizochytrium sp strain ATCC 20889 for use in infant and follow‐on formula.pdf (1.63 Mo)
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