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 TM ) 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.
© European
SUMMARYFollowing 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". The novel food (NF) rapeseed protein isolate (Isolexx TM ) is an aqueous protein-rich extract from rapeseed press cake originating from the two Brassicaceae species, Brassica napus L. and Brassica rapa L., both so-called canola varieties. Canola varieties are characterised by their low content of erucic acid (≤ 2 % by mass in the oil) and glucosinolate content of below 30 μmol/g in the air-dried, oil-free meal. The albumin napin and the globulin cruciferin, are the two major storage proteins and represent the majority of proteins in rapeseed. The results from batch testing of twelve production batches showed compliance with the specifications as proposed by the applicant. The Panel considers that the information provided on the composition, specifications and stability and production process of the NF does not raise safety concerns.The applicant intends to market the NF essentially for the same food products, at similar concentrations and for corresponding purposes, as soy protein isolates, namely: a) as a source of protein, for example, in meal replacements (formula diets), protein drinks (including "dairy analogues")...