The company's proprietary omega-3 canola oil — sold under the human nutrition brand Nutriterra — was developed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and Aussie agricultural chemical firm Nufarm (of which Nuseed is a subsidiary).
Genetically engineered to contain convert oleic acid to DHA, the canola oil is meant to be a sustainable alternative to fish oil.
Specifically, Nuseed wants to obtain non-regulated status for its canola oil, and to this end, has provided information from field trials and laboratory analyses that the product will not be a plant pest and as such, should not fall under Animal and Plant Health Inspection Service (APHIS) regulations.
Nuseed has commenced clinical trial work in North America to further demonstrate the safety and efficacy of its canola oil, and to clinically support its marketing claims so as to strengthen its entry into the world's largest supplement and fortified food market.
The company hopes to gain approval for both consumption and cultivation of the canola oil by 2019.
Benita Boettner, Nuseed's global lead of commercial strategy, told NutraIngredients-Asia: "There are no specific hurdles for Nuseed's application. The US and Canada have clear and rigorous regulatory systems, and (in the US) our file is under review and progressing to our expectations.
"(In Canada) as with the US, our file is currently under review and we are in dialogue with the relevant agencies."
Sustainable and scalable
Nuseed applied for regulatory approval in Australia last year, and its product was approved for consumption in the country in March this year.
Food Standard Australia New Zealand (FSANZ) approved it forhuman consumption within Australia, and the Australian Office of Gene Technology Regulator announced that it had also been approved for cultivation and use for animal feed purposes.
Boettner said, "Our omega-3 programme is very much motivated by a goal of contributing to the sustainability of healthy ocean ecosystems and the judicious use of natural resources.
"Additionally, our oil has a unique omega-3 profile that will provide consumer benefits to both the nutraceutical and fortified food sectors. Nutriterra's essential nutrients deliver a scalable and accessible solution for long-chain and short-chain omega-3s.
"We will also address the dreaded 'fishy burp' associated with many fish oil capsules, which affects a large percentage of nutraceutical users."
Indeed, Nuseed has estimated that a single hectare of its omega-3 canola oil can match the omega-3 yield of 10,000kg of wild caught fish.
When it came to commercial activity involving manufacturers and finished products, however, Boettner said she could not comment on Nuseed's market approach or industry discussions, as it was still "in pre-commercial activity".
Approval in APAC?
Apart from Australia and North America, Nuseed has set its sights on APAC, where it expects approvals between 2021 and 2023, with more to follow in 2024 and beyond.
From 2021 to 2023, the firm is aiming to achieve regulatory approval in China, Japan and South Korea, as well as throughout South East Asia, particularly in Vietnam, Thailand, the Philippines, and Indonesia.
It is also eyeing the UK, and several countries in Europe and South America. The regulatory approvals for APAC (apart from Australia where the it is currently cultivated), South America, Europe and the UK will be for consumption and market access, allowing the canola oil to be used in finished products.
Boettner said, "Our applications for human consumption are guided by those countries with the greatest need, where the daily intake of vital omega-3 nutrients is lowest, and where a scalable source of omega-3 can have the greatest impact on consumer health."