A New Australian Standard for Squalene and Shark Liver Oil Sourced and Manufactured in Australia – AS 5380:2023

From Peter Nichols


Both Squalene and Shark Liver Oil are health food supplement products that are typically sold in bottles of soft gel capsules to retail consumers (like Omega 3 fish oil etc.) globally. No Standard (or benchmark specification) for marine derived Squalene or the Diacylglycerol Ether/Alkoxyglycerol (DAGE/AKG) containing fraction derived from Shark Liver Oil had existed in Australian or global reference publications such as US Pharmacopoeia, British Pharmacopoeia or other forms.  Retail items presented to consumers as ‘Squalene’ and ‘Shark Liver Oil’ are available in store and online in Australia and the world. These items usually state they are genuine material and are Australian sourced and manufactured, yet clearly are NOT.  Yet there is only one Australian producer of Australian sourced and manufactured product, and that company (Ocean Oils Pty Ltd) sells no product in Australia.


Australia’s Therapeutic Goods Administration (TGA) had accepted that there is no Standard for Squalene or Shark Liver Oil in Australia.  The TGA and other organizations (ACCC, AMCL, Australian Trade Commission, others) did not have the resources to produce a relevant standard.  Given the lack of and clear need for an Australian Standard for these materials, interaction and then collaboration with Standards Australia occurred from 2020 and has seen the recent publication of this new Australian Standard (AS 5380:2023) that aims to ensure appropriate quality, safety and guidance information for industry and consumer alike. This project was initially proposed and fully supported by a key NZ scientist in this field (Mr Laurence Eyres, NZ Oils and Fats Group) who attended the World Congress of Fats and Oils in Sydney in February 2020, and then visited CSIRO Hobart.


The CSIRO Hobart team has worked closely with Ocean Oils, including with the initial R&D funded by FRDC in the 1990’s and 2000’s. Over three decades, CSIRO has undertaken research and analysis work on the Squalene and DAGE/AKG fraction. CSIRO was involved with the initial isolation and determination of these marine lipids derived from well managed and sustainable fisheries and has built a wealth of knowledge in this field. In 2018-19, CSIRO assisted Ocean Oils in the drafting of an ’Australian Standard’ / ‘Compositional Guideline’ for both genuine quality Australian Squalene and Australian DAGE/AKG.  This undertaking included CSIRO results pertinent to determine product provenance with the results obtained using compound specific-stable isotope analysis (CSIA). This work was published in 2022 and demonstrated that Australian and New Zealand Squalene and Shark Liver Oil could be distinguished from oils derived from other locations around the world.  Work then continued with the SA team through 2021-2023 to further progress and publish in June 2023 the new Australian Standard – AS 5380:2023 Squalene and Shark Liver Oil.


Revill, A. T.  et al. (2022) Using compound-specific carbon stable isotope analysis of squalene to establish provenance and ensure sustainability for the deep-water shark liver oil industry. Sustainability. 14, 9228. ,

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