It also gained EU PARNUTS (foods for particular nutritional uses) approval which, combined with the Novel Foods go-ahead, means Neptune’s NKO ingredient can be formulated into:
- Dietary Supplements
- Functional Foods
- Diet Meal Replacements
- Dietary Foods for Special Medical Purposes
While Neptune was unavailable for comment before publication, the Canadian company said in a statement the approvals meant NKO was ready for “immediate commercialisation at a clinically proven effective daily dose in all 27 European countries.” "NKO's strong clinically proven benefits for cardiovascular health will now lead Neptune's further expansion in the European omega-3 market, which is currently dominated by cardiovascular health applications with 80 per cent of all omega-3 fatty acids targeting heart benefits," said Neptune’s corporate development and investor relations manager, Dr Toni Rinow.
The European omega-3 market is growing at 24 per cent and forecast to be valued at $1.6bn by 2014, according to some market estimates.
"This opens the door for NKO to gain a leadership position in both dietary supplements and functional food markets, achieving targets unmet by other omega-3 products and krill competition," added Neptune chief scientific officer, Tina Sampalis,
The approval
The European Food Safety Authority (EFSA)’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found the krill ingredient extracted from the crustacean Euphausia superba (Antarctic Krill), had no safety issues.
NDA noted that while the data backing NKO itself was limited, when taken 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.”
NDA noted NKO was low in triglycerides and high in phospholipids (38-50g/100g) as well as being particularly high in EPA (eicosapentaenoic acid – 15-19g/100g) and DHA (docosahexaenoic acid – 7-16g/100g).
Neptune’s submission included data on absorption, distribution and elimination, toxicity studies and clinical human studies “performed with the major components of NKO, i.e. phospholipids, EPA and DHA, and with the carotenoid astaxanthin.”
NDA noted a number of trials involving the major components of NKO – no adverse effects were reported.
Labelling
In accordance with the Labelling Directive 2003/89/EC, all products containing NKO must be labelled as “contains crustaceans and fish”.
Neptune suggested the following warning for food supplement products: “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”.
In addition, NDA noted that 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.”
There was no threat that the mean estimated daily intakes at 97.5th percentile intakes of 490 mg/person/day for children to 976 mg/person/day for male adults would be exceeded.
Europe's Novel Foods regulation (EC No 258/97) was introduced in May, 1997 and requires any food or ingredient not commonly consumed in the EU prior to May 1997 to undergo safety assessment before it can be sold across the EU's 27-member bloc.
It is a notoriously long-winded and unpopular process that has been much criticised by industry for stalling innovation, but the European Commission has mooted that it will be simplified or streamlined or both.