For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it.

This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market.

Thai FDA Food Safety Evaluation Framework

Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety.

The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements to support food product registration, and it remains tied to the applicant’s company alone. Other companies cannot rely on the public list as a basis for using the same substance without consent (an authorization letter) from the original approval holder.

This exclusivity creates a concrete regulatory challenge for third-party food companies that wish to incorporate the same food substance, even though it has already been evaluated and approved for another entity.

The Thai FDA expressly recognizes two pathways for such companies to use a previously approved novel food substance.

Two Pathways for Third-Party Use

The two pathways differ in cost, timing, and the degree of dependence they create on the original approval holder. The choice between them is often a consequential commercial decision for a company seeking to use an already-approved novel food substance in Thailand.

• Pathway 1: Consent from the original applicant. If a client of the approved company wishes to use a food substance that has already passed a safety evaluation, it must obtain consent from the company that originally submitted the safety assessment. Specifically, the third party must present a copy of the applicant’s approval notification certificate to support its own product registration application, together with the consent letter. This pathway effectively requires a commercial relationship—through a supply agreement, licensing arrangement, or other contractual mechanism—with the approved manufacturer or importer.
• Pathway 2: Independent safety assessment. The second pathway is much more time-consuming, requiring the third party to submit its own safety assessment for the same substance. It may do so by filing a request with a certified safety evaluation unit recognized by the Thai FDA—such as BIOTEC or the Nutrition Institute of Mahidol University—and submitting the evaluation report, along with supporting documentary evidence, for the Thai FDA’s consideration. Although available in principle, this route demands significant investment in time, costs, and regulatory effort, as the applicant must compile a complete safety dossier that may need to include original research data.

The practical effect is that the original applicant gains a significant first-mover advantage, both commercially and from a regulatory standpoint. Competitors must either negotiate access to the original approval documentation or invest in a separate safety assessment—a dynamic that becomes especially consequential where the underlying safety data is proprietary or expensive to replicate.

No “Substantial Equivalence” Shortcut

Importantly, Thailand’s novel food regime does not recognize any concept of “substantial equivalence” that would allow a subsequent applicant to rely on another party’s prior approval as the basis for its own market authorization. Each company must either obtain the consent and documentation of the original applicant or pursue an entirely independent safety assessment. The absence of any referencing mechanism raises the barrier to entry for later participants and, in effect, treats safety evaluation outcomes as proprietary to the applicant—giving first movers in the novel food ingredient market an advantage that functions much like an intellectual property right.

Strategic Considerations for Food Companies

For food companies operating in or seeking to enter the Thai market, applicant-tied approvals call for careful planning around novel food ingredients. Companies that plan to use novel food substances in their product formulations should first check whether the desired substance has already been approved. If it has, they should establish early and robust commercial relationships with the approved manufacturer or importer. Supply agreements with those approval holders should also contain explicit provisions on the right to reference and use the Thai FDA approval documentation, including representations as to the continuing validity of the approval and obligations to provide any updated documentation required for regulatory submissions.

Where commercial terms with existing approval holders are unworkable, or where a company wants to establish its own proprietary market position, pursuing an independent safety assessment—though resource-intensive—remains a viable route. Companies taking this path should engage early with Thai FDA-recognized safety evaluation units and prepare comprehensive safety dossiers well in advance of anticipated product launch timelines.

Conclusion

The Thai FDA’s novel food safety evaluation regime presents a regulatory landscape of considerable complexity for industry participants. The applicant-tied approval model creates competitive advantages for first movers and significant barriers for those who follow. Thailand’s novel food approval system offers no mechanism for subsequent applicants to reference prior approvals without the original applicant’s consent. Food companies therefore need to adapt their market entry strategies through proactive supplier engagement, contractual planning, or investment in independent safety assessments to navigate this distinctive regulatory environment effectively.