Scientific Documents

Safety of ‘Lipid extract from Euphausia superba' as a novel food ingredient Safety of ‘Lipid extract from Euphausia superba' as a novel food ingredient [1]

Summary (30 KB)

Opinion (276 KB)

This summary, published on 26 June 2009, replaces the earlier version published on 13 February 2009[2].

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on the safety of ‘Lipid extract from Euphausia superba' as food ingredient.

The novel food ingredient is an oil obtained by extraction of the crustacean Euphausia superba (Antarctic Krill) with acetone. Proteins and krill material are removed from the lipid extract by filtration. The acetone and residual water are removed by subsequent evaporation steps. The name proposed is Neptune Krill Oil (NKO™).

One of the main features of NKO™ is the low content of triglycerides and the high content of phospholipids (38 - 50 g/100g). Another characteristic property is the high content of polyunsaturated fatty acids, in particular eicosapentaenoic acid (EPA, C20:5n-3; 15 - 19 g/100g) and docosahexaenoic acid (DHA, C22:6n-3; 7-16 g/100g). The major amounts of these fatty acids are present in phospholipids. Compositional data on major components of NKO™ as well as on minor components (e.g. unsaponifiable matter) have been provided and a broad spectrum of potential contaminants has been analysed. The parameters presented sufficiently characterise the product and demonstrate its consistency and stability.

The applicant reviewed data on absorption, distribution and elimination, data from toxicity studies and data from clinical human studies performed with the major components of NKO™, i.e. phospholipids, EPA and DHA, and with the carotenoid astaxanthin.

The toxicological data provided for NKO™ are limited to a repeat-dose study (six months) conducted with C57BL/6 nude congenic mice (B6NU-T heterozygotes) in order to examine potential effects of oral, topical and topical/oral administration of NKO™ on UVB radiation- induced skin cancer. The animals treated orally received a diet containing 16.6 % NKO™. According to the study report, the histopathological examination of selected organs and tissues revealed no relevant differences between the treatment and control group, which received soybean oil. Body weight development, haematology, clinical chemistry and urine analyses as well as organ weight determinations were not performed.

Twenty-five healthy male and female volunteers consumed six 1g NKO™ gel capsules (6 g of NKO™ daily) for a period of two months. Haematology and clinical chemistry analyses were performed at baseline, and after 1 and 2 months. One female withdrew from the study due to a known salt intolerance. Two other females withdrew because of rapidly increasing greasiness of their facial skin. No adverse effects were reported in the remaining 22 subjects.

In a trial designed to examine the effect of NKO™ on the clinical course of hyperlipidaemia, 120 patients (mean age 51 years) were administered up to 3 g NKO™/day for a period of
12 weeks, with one group continuing for an additional 90 days with a consumption of 500 mg NKO™/day. No adverse effects were reported.

The effects of NKO™ on the premenstrual syndrome and on dysmenorrhea were examined in a clinical trial. Seventy female adults of reproductive age consumed either NKO™ or fish oil (during the first month of the trial two 1 g capsules once daily; during the second and third month of the trial two 1 g capsules once daily for 8 days prior to menstruation and 2 days during menstruation). No adverse effects were reported by the subjects during the trial.

The effects of NKO™ on markers of chronic inflammation were examined in a clinical trial in which 300 mg NKO™/day or 300 mg of placebo were administered to 90 subjects. The subjects ranging from 50 to 68 years were diagnosed with cardiovascular disease or rheumatoid arthritis and osteoarthritis, and were reported to have C-reactive protein levels of > 1.0 mg/dL. No adverse effects associated with the consumption of NKO™ were reported. 

NKO™ contains residual protein (0.8 - 3.0 g/100 g), the nature of which has not been further elucidated. In accordance with the, all products containing NKO™ must be labelled as “contains crustaceans and fish”. For food supplements, the applicant proposed the following additional warning to be put on all products containing NKO™: “Persons with coagulopathy or who are taking anticoagulants or other medications should discuss their situation with their doctor and submit to tests before taking nutritional supplements”.

The applicant provided data on the use of Antarctic krill as human food and data on the sales of capsules containing NKO™ outside the EU.

The food groups to which NKO™ is intended to be added and the maximum levels of DHA and EPA proposed by the applicant are in accordance with the Commission Decision of 5 June 2003 on the use of oil rich in DHA from the microalga Schizochytrium.

The maximum use levels of EPA and DHA as proposed by the applicant and food consumption data obtained from the National Diet and Nutrition Survey (NDNS) program in the United Kingdom were used as a basis to estimate the daily intakes of EPA and DHA. Mean estimated daily intakes of EPA and DHA range from 210 mg/person/day for children to
363 mg/person/day for male adults. The 97.5th percentile intakes range from 490 mg/person/day for children to 976 mg/person/day for male adults.

The toxicological and clinical data provided for NKO™ are limited. However, in combination with the data available for the main constituents, they support the safety of the novel food ingredient under the proposed conditions of use.

The Panel concludes that the lipid extract from Euphausia superba (Antartic Krill, NKO™) as a novel food ingredient is safe under the specified conditions of use.