Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat-killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently described and does not raise safety concerns. The information provided on the composition of the NF is sufficient and does not raise safety concerns. The applicant proposed to use the NF as a food supplement in the form of capsules, tablets or powder. The target population for the NF is the general population above 3 years of age. The maximum proposed daily use levels are 3 g/day for children from 3 years to less than 10 years of age and 6 g/day thereafter. Taking into account the composition of the NF and the proposed use levels, the consumption of the NF is not nutritionally disadvantageous. No relevant toxicological information was provided. The Panel considers that given the qualified presumption of safety (QPS) status for production purposes of Yarrowia lipolytica and the fact that the production process of the NF does not raise safety concerns, no toxicological studies are needed for the safety assessment of the NF. The Panel concludes that the NF, Yarrowia lipolytica yeast biomass, is safe under the proposed conditions of use.

Safety of selenium‐enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283

“…In its opinion on the safety of Y. lipolytica yeast biomass, the Panel concluded that taking into account the composition and the proposed conditions of use, the consumption of Y. lipolytica yeast biomass is not nutritionally disadvantageous (EFSA NDA Panel, 2019). This conclusion was based on the nutritional analysis of Y. lipolytica biomass (which comprised information on the protein content, amino acid composition, carbohydrates, fibre, fatty acids, vitamins and minerals) and the proposed conditions of use (i.e.…”

“…This conclusion was based on the nutritional analysis of Y. lipolytica biomass (which comprised information on the protein content, amino acid composition, carbohydrates, fibre, fatty acids, vitamins and minerals) and the proposed conditions of use (i.e. up to 3 g/day for children from 3 to 9 years of age and up to 6 g/day thereafter) (EFSA NDA Panel, 2019).…”

Safety of chromium‐enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283

“…The EFSA NDA Panel has previously favourably assessed the safety of Y. lipolytica yeast biomass as a novel food (EFSA NDA Panel, ).…”

“…As noted in the previous safety assessment of Y. lipolytica (EFSA NDA Panel, ), the Panel reiterates that in order to monitor the efficacy of the heat treatment and to guarantee that there are no viable Y. lipolytica cells remaining in the dried biomass, testing for the presence of viable yeast cells has to be carried out immediately after the heat treatment (see also Specifications, Table ).…”

“…In its opinion on the safety of Y. lipolytica yeast biomass, the Panel concluded that, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous (EFSA NDA Panel, 2019). This conclusion was based on the nutritional analysis of the NF (which comprised information on the protein content, amino acid composition, carbohydrates, fibre, fatty acids, vitamins and minerals in the NF) and the proposed conditions of use (i.e.…”