EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the safety of “ r apeseed protein isolate ” as a Novel Food ingredient

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of a “rapeseed protein isolate” (Isolexx™) as a novel food ingredient (NF) in the context of Regulation (EC) No 258/97. The NF is an aqueous extract with at least 90 % protein, isolated from rapeseed press cake originating from so-called canola varieties.

The applicant intends to market the NF for the same food products, at similar concentrations and for corresponding purposes, as soy protein isolates. Total protein intake of "heavy" adult consumer may be estimated as the mean + 2 SD, i.e. 2.2 g/kg bw per day. The age group of 4 - 6 years is estimated to have the highest protein intake on a per kg bw basis with a mean and 95th percentile intake of up to 3 and up to 4.73 g/kg bw per day, respectively.

A significant part of these estimated intakes could come from rapeseed protein. The Panel considers that the risk of sensitisation to rapeseed cannot be excluded and that it is likely that rapeseed trigger can allergic reactions in mustard allergic subjects. The biological value of rapeseed and soy protein, determined by the PDCAAS, appears to be similar.

The Panel notes the source and nature of the novel food, the absence of a nutritional disadvantage at the proposed uses and use levels, the low concentrations of potentially adverse components in the NF, and the absence of toxicologically relevant effects in subchronic studies with rats conducted with rapeseed protein isolates with similar compositions.

The Panel concludes that rapeseed protein isolate is safe under the proposed uses and use levels.