The regulation approves the use of strain WZU477 of the microalgae Schizochytrium sp. in oil form as a novel food for use in infant formula and follow-on formula and follows the European Food Safety Authority’s (EFSA) positive assessment in August 2020.
Oil from Microalgae Schizochytrium sp
“The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the Microalgae Schizochytrium sp,” the entry states.
“Authorised on 16 May 2021, this inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
“During the period, the novel food is authorised for placing on the market within the Union only by Progress Biotech unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Progress Biotech bv.”
Extension of use
Formed in 2014, Progress Biotech, a Dutch-based biotech firm provides a range of DHA algal oils for use in food and dietary supplement products that are mainly based on its propriety Schizochytrium strain.
In evaluations carried out by EFSA, the authority highlighted the oil’s mixture of triglycerides containing polyunsaturated fatty acids (PUFA) in which docosahexaenoic acid (DHA) represented more than 40% of total fatty acids.
While August 2020’s application was an extension of use for infant and follow-on formula, Schizochytrium sp. oil has been authorised as a food supplement (250 milligrams per day (mg/day) for the general population and 450 mg/day for pregnant and lactating women.
Progress Biotech said of the EU’s approval that it was a, “recognition of the uncompromised approach to quality and service enabling it to deliver such high-quality products to the market.”