As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety.

For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed.

Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use.

Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website.

As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process. The substances on the list for which Tilleke & Gibbins has advised clients—djulis seed extract, 2′-fucosyllactose/difucosyllactose (2′-FL/DFL), lacto-n-tetraose (LNT), 6′-sialyllactose sodium salt (6′-SL), 3′-sialyllactose sodium salt (3′-SL), and the 5-HMO blend (comprising 2′-FL/DFL, LNT, 6′-SL, 3′-SL, and one additional human milk oligosaccharide (HMO))—reflect the broad range of innovative food ingredients that food manufacturers and pioneers have seen successfully pass the Thai FDA’s assessment process.

Increased Transparency, but No General Authorization

While the publication of the list provides useful insight into substances that have been reviewed by the Thai FDA, businesses should be aware that the publication of a substance on the list does not constitute a general market authorization allowing any company to use that substance.

Under the current regulatory framework, approvals issued by the Thai FDA are generally applicant- and substance-specific, and the approval documentation issued by the authority remains an essential component of the regulatory dossier used to support the registration of food products containing the approved substance. The approval is granted exclusively to the company that submitted the safety assessment dossier, and the approval documentation remains an essential part of the regulatory dossier supporting the registration of food products containing the approved ingredient.

Consequently, third parties cannot rely solely on the published list as a legal basis for using the substance or registering food products containing that substance. A company intending to use the substance must still satisfy the applicable regulatory requirements and possess the relevant approval documentation where required.

Exclusivity Period for Novel Food Safety Assessments

Recognizing the significant investment required to generate the scientific data supporting a novel food safety assessment, the Thai FDA is now surveying food business operators on whether a formal period of regulatory exclusivity should be introduced. The public survey proposes exclusivity periods of 5 or 10 years, while also inviting comments on alternative timeframes. The objective is to provide innovators with sufficient time to recover their investment before competitors can rely on the same regulatory approval.

The survey also illustrates the distinction between regulatory exclusivity and protection under Thailand’s Trade Secrets Act B.E. 2545 (2002). While confidential safety data may qualify for trade secret protection if the statutory requirements are met, regulatory exclusivity operates independently by preventing competitors from relying on an applicant’s regulatory approval for a defined period.

The development is particularly noteworthy because it builds upon the Thai FDA’s existing framework for protecting confidential regulatory information. In the pharmaceutical sector, the Thai FDA has established procedures governing the submission and protection of marketing authorization dossiers through the electronic Common Technical Document (eCTD) system. These procedures implement the confidentiality obligations under the Trade Secrets Act, ensuring that confidential commercial and technical information contained in marketing authorization dossiers continues to receive legal protection throughout the regulatory process.

The consideration of a formal exclusivity regime for novel foods therefore represents a logical evolution of the Thai FDA’s broader regulatory policy. While the existing framework protects confidential information from unauthorized disclosure, a formal exclusivity regime would provide an additional layer of protection by preventing competitors from relying on an applicant’s regulatory approval for a defined period. This would further strengthen incentives for innovation by recognizing the commercial value of applicant-generated safety data.

The publication of the novel food list and the survey on exclusivity signal the Thai FDA’s intention to improve transparency while preserving incentives for innovation by continuing to recognize applicant-specific approvals and potentially introducing a formal data exclusivity period.

Implications for Food Business Operators

These announcements provide valuable regulatory insight for food manufacturers, importers, and product developers. In particular, the list offers visibility into ingredients that have previously undergone review by the Thai FDA and may help businesses assess potential ingredient sourcing options and product development strategies.

However, companies intending to use a listed substance should consider carefully whether they are legally entitled to rely on the relevant approval documentation and whether the proposed use falls within the scope of the approved conditions. In many cases, a business seeking to use an already approved substance would need to source the ingredient from the approved manufacturer or supplier and rely on the corresponding approval documentation associated with that substance.

The publication may also assist businesses in evaluating potential regulatory pathways for ingredients that have not yet been assessed, as it provides insight into the categories of substances that have previously been accepted by the Thai FDA.

As for the exclusivity period survey, it represents a significant step toward formalizing data exclusivity for novel foods in Thailand and could strengthen incentives for innovation by providing greater certainty over the commercial value of proprietary safety data.

Key Takeaways

Overall, these promising developments involving the Thai FDA enhance transparency, provide businesses with greater visibility into the authority’s prior assessments, and point to a potentially more predictable regulatory framework for novel food ingredients in Thailand.

While it will continue to be important to conduct careful regulatory due diligence before developing, importing, sourcing, or registering food products containing novel food ingredients in Thailand, proactive food businesses should consider how this development may affect their products, supply chain arrangements, and regulatory strategy.