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Australian Food Agency is Ready to Approve Cultured Meats, Are You?

This past August, Cellular Agriculture Australia (CAA), a non-profit organization, founded in 2020, that aims to promote cellular agriculture in Australia through awareness, education, research, and advocacy, published a 2022 White Paper.[1] The Paper asserts that Australia is well-positioned to become a global leader in cellular agriculture; however, research and commercialization are still in their early stages compared to other fast-growing industries (e.g., renewable energy and autonomous vehicles).

Despite early times for the cellular agriculture industry, the food authority in Australia, Food Standards Australia New Zealand (FSANZ)[2] is ready to approve foods made with this new technology, often referred to as “cultured meat” or “cell-based meat” products.[3] It is, therefore, worth taking a closer look at the local food regulatory landscape to help strategize market entry. While we continue to keep a close eye on how global authorities work out the appropriate approach to regulate cell-based meat alternatives, let’s turn to Australia – keeping in mind that products acceptable in Australia are also acceptable in New Zealand, given that FSANZ is a joint food regulatory body recognized by both Australia and New Zealand. 

FSANZ considers “cell-based meat” to be food produced using animal cell culture technology, where meat is produced from animal cells using a combination of biotechnology, tissue engineering, molecular biology, and synthetic processes.[4] Importantly, FSANZ has confirmed that the existing food regulatory framework in Australia, e.g., the Australia New Zealand Food Standards Code (“Food Code”)[5] is equipped to deal with foods involving the use of new technologies. Specifically, depending on product composition, FSANZ takes the position that cell-based meat is subject to pre-market approval requirements under the Food Code. For instance, novel foods are non-traditional foods that require assessment by FSANZ to establish their safety before they are added to the food supply.[6] Given that cell-based meats emerged in recent years, thus having no history of traditional human consumption, filing a novel food application under the Food Code (Standard 1.5.1)[7] is necessary before the product can be placed on the market.

The above being said, a specific cell-based meat product may trigger the regulatory requirements across different Standards of the Food Code. Therefore, a case-by-case analysis must be performed to determine the specific Standards that one needs to apply for approval. For example, if a cell-based meat uses genetic modification technologies, Standard 1.5.2 of the Food Code -- Food Produced Using Gene Technology[8] should be taken into account when examining the regulatory procedures for the product. Further, the substances used during the manufacture of cell-based meat production, such as processing aids, vitamins, and minerals, are governed by separate Standards in the Food Code and should be reviewed and taken into account when preparing a dossier seeking approval of the finished cell-based meat.



FOOTNOTES

[1] White Paper, ‘Cellular Agriculture: An Opportunity to Diversify Australia’s Food System’, released by CAA in August 2022, at https://cellularagricultureaustralia.org/.

[2] Food Standards Australia New Zealand (FSANZ) is an independent statutory agency established by the Food Standards Australia New Zealand Act 1991. See more details about FSANZ at https://www.foodstandards.gov.au/about/Pages/default.aspx.

[3] Different names have been used for cultured meat, such as cell-based meat, lab-grown meat, synthetic meat, clean meat, cultivated meat, slaughter-free meat, etc.

[4] https://www.foodstandards.gov.au/consumer/generalissues/Pages/Cell-based-meat.aspx.

[5] https://www.foodstandards.gov.au/code/Pages/default.aspx. FSANZ developed the Australia New Zealand Food Standards Code to provide the requirements for foods sold in Australia and New Zealand. This article refers to the approval in Australia for cultured meat; however, once such approval is obtained, the product is also regarded as acceptable in New Zealand given that FSANZ is a joint food regulatory body recognized by both Australia and New Zealand.

[6]https://www.foodstandards.gov.au/industry/novel/Pages/default.aspx#:~:text=Novel%20foods%20are%20non-traditional%20foods%20that%20require%20assessment,%E2%80%93%20Novel%20Foods%20in%20the%20Food%20Standards%20Code.

[7] https://www.legislation.gov.au/Series/F2015L00403.

[8] https://www.legislation.gov.au/Series/F2015L00404

© 2023 Keller and Heckman LLPNational Law Review, Volume XII, Number 301
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About this Author

David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China
Partner

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

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Jenny Li, Keller Heckman, China Food, Drug Regulation, Shanghai, International Trade
Legal Consultant

Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.

86-21-6335-1000
Chen Hu , Keller Heckman, Scientist, Food Chemistry, Regulatory Compliance, Shanghai
Scientist

Chen Hu joined Keller and Heckman in April 2009. He provides technical assistance in the area of food, food packaging, and chemical control, in matters related to regulatory compliance in Asian-Pacific regions.

Mr. Hu works closely with government authorities and trade associations in various phases of regulatory development. Mr. Hu has prepared and submitted hundreds of Chinese applications for registration of food packaging materials, food additives, new food ingredients, and new chemical substances. He is experienced in auditing plant...

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Eric Gu, Keller Heckman, China, Shanghai, Food packaging lawyer, Additives regulations Attorney
Associate

Eric Gu advises domestic and foreign clients on the requirements and regulations for a variety of consumer products, including foods, food additives, food packaging materials, drugs, cosmetics, medical devices, and associated labeling, with a focus on China, Japan, Korea, Thailand, and other Asian countries.

Prior to joining Keller and Heckman, Mr. Gu worked as an attorney in law firms in Shanghai and New York and acquired deep understanding of both China and U.S. laws and practice. While attending the University of Wisconsin Law School, Mr. Gu...

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Yin Dai, Keller Heckman, Multi national Food Companies Regulation, Paralegal, Shanghai, China,
Paralegal

Yin Dai joined Keller and Heckman in 2013.  She is a paralegal in the food and drug practice area. She monitors developments impacting the regulations of food, food packaging, drugs and medical devices throughout Asia.  Ms. Dai assists multi-national food and chemical companies in product stewardship and compliance matters, especially in China, Japan, Korea, Thailand, and other ASEAN countries.  She also participates in the clearance for new food related materials in China and other Asian countries.

Prior to joining Keller and Heckman, Ms. Dai...

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