as a Novel

Abstract

relevance is unclear and therefore the Panel considers the dose level of 450 mg/kg bw per day to be the NOAEL in rats. This is more than 50 fold higher than the proposed use level. No treatment-related adverse effect was observed in one human study using the NFI at the proposed use level for six months. The Panel concludes that the novel food ingredient, CSO, is safe under the proposed uses and use levels. seed oil to three groups of 10 male and 10 female Wistar Crl:WI (Han) rats for 13 weeks. A group of 10 rats per sex received the vehicle (1 % carboxymethylcellulose in water with 5 % Tween 80) and served as the negative control. Two additional groups of five male and five female animals were administered the high dose or vehicle for 13 weeks, and received a standard rodent diet for four weeks thereafter (recovery group). Rats were housed in groups of five of the same sex. During the study, the following parameters were monitored: clinical condition, functional observation, body weight, food consumption, ophthalmic examination, haematology, blood chemistry, urinalysis, organ weight, macropathology and histopathological investigations.