Regulatory Compliance for Novel Food Ingredients in Taiwan: Definitions, Documentation, and Approval Process

On January 27, 2026, Taiwan released the “Guidelines for Safety Assessment of Novel Food Ingredients”, which clarify the definition, required submission materials, and regulatory procedures for novel food ingredients in Taiwan. The guidelines also specify documentation requirements for ingredients produced using genetically modified microorganisms (GMMs), ensuring the safety of such food ingredients for consumption. Based on a detailed review of the guidelines, CIRS Group summarizes the key points below.

Issued Documents Include:

• Guidelines for Safety Assessment of Novel Food Ingredients (main text)
• Appendix I: Questionnaire for Determining Whether a Substance Is an Novel Food Ingredient
• Appendix II: Safety Assessment Dossier for Novel Food Ingredients
• Appendix III: Required Materials for Products Produced Using Genetically Modified Microorganisms but Not Containing the Microorganisms or Recombinant DNA in the Final Product

Definition

1. Substances that, before December 31, 1999, had insufficient history of safe consumption in Taiwan, or are intended to be consumed in a manner different from traditional usage.
2. Traditional food ingredients that have undergone non-traditional breeding, propagation, or novel processing technologies resulting in changes in composition, chemical structure, or form (excluding regulated foods such as GMMs or irradiated foods).

Required Safety Assessment Documentation

1. Applicant information;
2. Detailed ingredient information (including name, source, composition, specifications, processing flowchart, stability, storage conditions, intended food categories, and usage levels)
3. Dietary exposure data (including recommended use, estimated intake, target consumers, excluded populations, and consumption history in Taiwan or abroad)
4. Toxicological data;
5. Labeling and usage instructions;
6. Regulatory status in other countries (approval or rejection);
7. Other relevant safety information

Detailed Toxicological Testing Requirements

* Including microbial gene mutation analysis, in vitro mammalian cell genotoxicity analysis, and in vivo animal genotoxicity analysis.

** If the raw material has been approved for food use in fewer than two countries among the United States, Canada, Europe, New Zealand/Australia, and Northeast Asia, a 90-day feeding toxicity study is required, along with GLP (Good Laboratory Practice) certification documents.

Additional Data Required for Novel Food IngredientsProduced Using GMMs

(1) Basic information on the microorganism (including scientific name, taxonomic classification and other names, source of the microorganism, and identification data of the production strain);

(2) Construction method of the genetically modified microorganism (including description of the inserted gene, vector or plasmid, as well as the insertion site and copy number of the transgene);

(3) Stability test report of the transgene in the genetically modified microorganism (including test methods for genetic stability and stability of gene expression products, results from at least three batches, and conclusions);

(4) Description of the process for removing genetically modified microorganisms and transgenes from the final product;

(5) Test report confirming the absence of genetically modified microorganisms and transgene fragments in the final product (including test methods, results from at least three batches, and conclusions);

(6) Locations of R&D or production of the genetically modified microorganism, manufacturing sites of raw materials, and the subsequent disposal method of the genetically modified microbial cells removed from the final product.

Safety Assessment Process for Novel Food Ingredients

Applicants may first submit a questionnaire and supporting documents for review by the Taiwan Food and Drug Administration to determine whether the ingredient qualifies as a novel food ingredient.

• If it is determined to be a novel food ingredient, the applicant must provide the required documents in Annex 2 for safety assessment by the TFDA.
• If genetically modified microorganisms are involved, additional documents in Annex 3 must also be submitted. The GMO Review Panel will first confirm that the final product does not contain the microorganism or transgene before initiating the safety assessment.

About CIRS Food Division

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, U.S. GRAS notices, EU novel food applications, health food registration, and food for special medical purposes (FSMP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.