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On March 13, 2025, the Taiwan Food and Drug Administration (TFDA) released the draft of Principles for Safety Assessment of Novel Food Ingredients (hereafter referred to as the Draft Principles). Stakeholders are encouraged to submit opinions within 60 days following the announcement.
The Draft Principles is established based on the Guidelines for the Application of Non-Traditional Food Ingredients, further clarifying the regulations on the safety assessment of novel food ingredients. Notably, it adds provisions for novel food ingredients produced using genetically modified microorganisms (GMOs) but free of GMOs or transgenes in the final ingredients. The key provisions of the Draft Principles are summarized below:
Definition of Novel Food Ingredients
A novel food ingredient meets either of the following criteria:
1. The ingredient had no sufficient history of safe consumption in Taiwan before December 31, 1999, or its intended use differs from traditional consumption patterns. (A sufficient safe consumption history requires widespread intake for food purposes and does not include use in medicine, cosmetics, or oral hygiene products.)
2. The ingredient is modified from a traditional food ingredient through non-traditional breeding, propagation, or novel food processing technologies, leading to changes in composition, chemical structure, or physical form. (This does not apply to food ingredients in foods regulated under existing frameworks, such as genetically modified foods or irradiated foods.)
Safety Assessment Process
1. Business submits a questionnaire
The food business submits a questionnaire to the TFDA along with supporting documentation to determine whether the ingredient falls within the scope of novel food ingredients (details specified in Appendix 1 of the Draft Principles).
2. TFDA reviews the scope
The TFDA reviews the submitted documents to assess whether the ingredient falls within the scope.
3. Business provides mandatory documentation
If the ingredient falls within the scope, the business must submit a safety assessment dossier, including the following mandatory documentation (details specified in Appendix 2 of the Draft Principles):
Applicant information
Ingredient details
Intake information
Toxicology test information (tests must follow internationally recognized methods and guidelines)
Labeling and usage instructions
Regulatory information on approval or rejection in other countries
Evidence confirming that the ingredient does not contain genetically modified microorganisms (GMMs) or transgenes if it is produced using GMMs (as specified in Appendix 3 of the Draft Principles)
Any additional information if required by the TFDA to assess safety
4. Authorities review and determine results
The TFDA conducts an initial evaluation and submits its findings to the Ministry of Health and Welfare for further document review and committee assessment. If the ingredient passes the safety assessment, it will be officially announced for use.
ChemLinked Notes
In Taiwan, ingredients that have not been assessed and confirmed as safe by the authorities cannot be used in foods. If a food business intends to use such an ingredient, a prior application must be submitted for a safety assessment. Only ingredients that pass this assessment may legally be used in food production and sales. With technological advancements and growing international trade, the number of novel food ingredients is steadily increasing. Established regulations for the safety assessment of novel food ingredients ensure their safety while fostering innovation and growth within the food industry.
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