Thailand: A Rising Market in Asia for Alternative Proteins
In December 2024, Aleph Farms took a step down the alternative protein regulatory pathway and submitted a food application in Thailand to seek approval for its cultivated beef [1]. This submission represents a significant milestone as Thailand officially initiates the assessment process for cultivated meat.
Alternative proteins marketed in Thailand are primarily regulated by the Thai Food and Drug Administration (Thai FDA) via its existing novel food framework. Thai FDA published [2] an application form for the safety assessment of novel foods along with a preliminary checklist, particularly for those obtained by cell culture technology.
The Notification of the Ministry of Public Health (No.376) B.E 2559 (2016) Re: Novel food [3] sets forth general requirements for novel foods, which mandates that all novel foods must obtain pre-market approval from the authority before they can be commercialized. In addition, based on Thai FDA’s guidelines concerning safety assessment for novel foods [4], the National Center for Genetic Engineering and Biotechnology (BIOTEC) is the key agency responsible for evaluating the safety and compliance of cultivated meat products.
Notably, BIOTEC developed a comprehensive guideline [5] specifically addressing the safety assessment criteria for foods derived from animal cell culture. This guideline has been incorporated into Thai FDA’s safety guidelines for novel foods [6], serving as a critical resource for enterprises preparing application dossiers for cultivated meat approval.
The BIOTEC’s guideline outlines key data requirements for safety assessment, covering identity and source of cell lines, production process, toxicological study data (in case of non-genetically and genetically modified cells), allergen information, etc. Further, it provides detailed guidance and interpretations to help industry meet these data requirements. For example, it explicitly states that components of cell culture media must be free from mutagenic substances, carcinogens, and heavy metals. Thailand joins Singapore, the United States, Israel, Australia, South Korea, etc., as markets that have now opened a regulatory pathway for industry to consider when strategizing market entry plans [7].
Notably, Thai FDA has looked into other areas of alternative protein products, such as plant-based proteins. In May 2024, it published a draft standard for plant-based proteins that seemingly bans certain meat and cheese-related labeling terms for vegan analogues [8]. Interested stakeholders should closely monitor its development as aspects of this could expand to labeling of cultured meat products.
We will continue to report regulatory updates on alternative proteins in Thailand and other countries across Asia. Please sign up for our newsletters here. Keller and Heckman represents the food industry, including alternative protein companies around the world, on various regulatory matters. If you have any questions about the food application process or need any assistance in better understanding the regulatory landscape of alternative proteins in Asia, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] https://aleph-farms.com/journals/aleph-farms-submits-first-ever-application-for-cultivated-meat-in-thailand/
[2] https://food.fda.moph.go.th/media.php?id=686841546284343296&name=CultureMeat.pdf
[3] https://food.fda.moph.go.th/media.php?id=509390438113878016&name=No.376_Re_Novel_food.pdf
[4] https://food.fda.moph.go.th/media.php?id=517516718898290688&name=212_NovelFood.pdf
[5] https://www.biotec.or.th/biosafety/images/document/guideline/culturemeat_GL.pdf
[6] https://food.fda.moph.go.th/media.php?id=470856744084578304&name=9.3.pdf
[7] For more detailed insights on alternative proteins in other markets, please refer to our previous CRM - Special Focus on Alternative Proteins, available at: https://www.khlaw.com/CRM
[8] https://www.greenqueen.com.hk/thailand-labelling-ban-plant-based-meat-cheese-alternative-protein/