According to Taiwan’s Principles for Safety Assessment of Novel Food Ingredients, which came into effect on January 27, 2026, food ingredient that lacks a sufficient history of safe food consumption in Taiwan before December 31, 1999, or traditional food ingredient whose composition, chemical structure or form has been changed by non-traditional technologies, may need to undergo safety assessment by the Taiwan Food and Drug Administration (TFDA). Only after passing the review and being publicly announced can these ingredients be legally used in food production.
For non-local companies of food ingredient, nutrition, functional food, botanical extract, fermentation-derived ingredient, microbial ingredient and bio-manufacturing, the key market entry concernis often not only whether the finished product can be imported into Taiwan, but also whether the ingredient itself is permitted for food use. If an imported food product contains a novel food ingredient that has not been assessed or approved by TFDA, the product may face compliance risks such as delayed market entry, shipment return or destruction.
REACH24H provides Taiwan novel food ingredient application and compliance support, including ingredient classification, application feasibility assessment, safety assessment dossier preparation, toxicology data gap analysis, GMM-related documentation, TFDA communication support and post-market food compliance review.
What Is a Novel Food Ingredient in Taiwan?
To protect consumer safety while supporting food industry innovation, Taiwan regulates food ingredients that lack sufficient food consumption history or involve non-traditional technologies. Under Taiwan’s Principles for Safety Assessment of Novel Food Ingredients, novel food ingredients mainly fall into the following two categories.
Type 1: Ingredients without sufficient safe food use history in Taiwan
This refers to food ingredients that had no sufficient history of safe food consumption in Taiwan before December 31, 1999, or ingredients whose intended use differs from traditional food consumption experience.
Examples may include human milk oligosaccharides (HMOs), astaxanthin, trans-resveratrol and other food ingredients that have no established history of safe consumption in Taiwan.
Type 2: Traditional food ingredients changed by non-traditional technologies
This refers to traditional food ingredients produced through non-traditional breeding, propagation or novel food processing technologies, resulting in changes to food composition, chemical structure or form.
This category does not include foods already regulated under separate rules, such as genetically modified foods or irradiated foods.
What is “sufficient safe food use history”?
It refers to an ingredient that has been widely consumed as food in Taiwan for general dietary purposes, with evidence of common consumption and without causing health hazards. Records of usage solely for medical, pharmaceutical, cosmetic or oral hygiene applications, such as traditional Chinese medicinal materials and toothpaste, shall not be accepted as evidence to verify the ingredient’s history of food consumption.
Which Products May Need Taiwan Novel Food Ingredient Application?
The following types of ingredients may require TFDA novel food ingredient safety assessment before entering the Taiwan market.
Main categories that may require an application
New botanical or herbal extracts: New plant species, rare plants, or extracts produced using novel extraction processes such as high-purity extraction or structural modification. Examples may include certain mushroom or fungal extracts, new-source inulin, green coffee bean extract and specific plant polysaccharides.
Probiotics and microbial-related ingredients: New strains, probiotics cultivated through non-traditional technologies, or ingredients produced using genetically modified microorganisms where the final ingredient does not contain the microorganism or transgene. These ingredients may also require additional GMM documentation.
New marine or animal-derived ingredients: Marine organism extracts, animal-derived proteins, polysaccharides or other ingredients without a traditional food use history in Taiwan.
Traditional ingredients processed by non-traditional technologies: Traditional food ingredients that have undergone novel breeding, fermentation, enzymatic hydrolysis, high-pressure processing or other technologies that significantly change their composition, chemical structure or form.
Innovative ingredients used in functional or health food products.
Food ingredients introduced into Taiwan for the first time.
Situations that usually do not require novel food ingredient application
Novel food ingredient application is usually not required for:
Traditional food ingredients widely consumed as ordinary foods, such as common vegetables and fruits;
Food ingredients already announced or recognized by TFDA as usable food ingredients, which can be checked through the TFDA Food Ingredient Integration Query Platform;
Ordinary packaged finished foods, provided that the formulation does not contain ingredients requiring separate safety assessment;
Foods already regulated under other frameworks, such as genetically modified foods or irradiated foods.
If you are not sure whether your ingredient falls within the scope of Taiwan novel food ingredients, it is recommended to conduct a preliminary regulatory assessment or submit the official TFDA questionnaire before preparing a full safety assessment dossier. This can help avoid unnecessary testing, duplicated dossier work or incorrect pathway selection.
Taiwan Novel Food Ingredient Application Process and Timeline
Taiwan adopts a stepwise approach: classification first, safety assessment second.
Step 1: Preliminary feasibility assessment
The applicant should first complete the official “Questionnaire for Determining Whether an Ingredient Is a Novel Food Ingredient” and prepare supporting documents for TFDA review. TFDA will use the submitted information to determine whether the ingredient falls within the scope of novel food ingredients.
If TFDA determines that the ingredient can be used as a food ingredient and does not require novel food ingredient safety assessment, the applicant does not need to prepare a full safety assessment dossier.
Step 2: Safety assessment dossier preparation and submission
If the ingredient is determined to be a novel food ingredient and the applicant intends to use it in food, the applicant should prepare the “Novel Food Ingredient Safety Assessment Data Sheet” and the required supporting documents, including ingredient details, dietary intake information and toxicological data.
If the ingredient is produced using genetically modified microorganisms, but the final product does not contain the microorganism or transgene, the applicant should also prepare additional documents for GMM-derived ingredients.
Step 3: TFDA technical review and external assessment
After acceptance, TFDA will conduct an administrative and technical review of the dossier. During the review, TFDA may request supplementary information. The case may also be submitted for external safety assessment and further review by the relevant food safety and nutrition advisory committee.
Step 4: Official announcement and approval
After the review is completed and the ingredient is considered safe for food use, the Ministry of Health and Welfare will decide whether to approve the ingredient and proceed with the relevant public notice and announcement procedures. Once officially approved, the ingredient may be legally used in food production in Taiwan under the approved conditions.
Estimated timeline
For planning purposes, the official review period is commonly estimated at approximately six months. A practical project timeline, including preliminary feasibility assessment and dossier preparation, is usually around 8–12 months. If the case involves supplementary information requests, expert committee review or GMM-related review, the timeline may be extended.
REACH24H Taiwan Novel Food Ingredient Application Services
REACH24H provides one-stop support for Taiwan novel food ingredient application and compliance projects.
Application feasibility assessment: Assist with the official questionnaire, prepare supporting documents and support TFDA preliminary review.
Full dossier preparation: Draft and review ingredient details, safety assessment documents and required appendices.
Toxicology compliance guidance: Review existing toxicological data, identify toxicology data gaps and coordinate with GLP-compliant laboratories where additional testing is needed.
Application process support: Support application submission, follow up with TFDA and expert review progress, and assist with responses to supplementary information requests.
Post-market compliance support: Provide labeling compliance review, food additive-related compliance assessment and other food product compliance support after ingredient approval. For broader product-level compliance, companies may also refer to REACH24H’s Global Food Compliance Service.
Why Choose REACH24H
With more than a decade of experience in food regulatory compliance, REACH24H has supported thousands of food companies worldwide in entering target markets, including Fortune Global 500 companies. We also work with embassies, consulates, business associations, and industry organizations as a trusted market access service provider.
Decades of Food Compliance Expertise
Our food compliance team combines expertise in food science, toxicology, chemistry, biology, nutrition, and regulatory affairs. REACH24H also has toxicology professionals with credentials such as DABT, ERT, and DCST, enabling us to support safety assessment, dossier preparation, and technical responses during the NHC review process.
Global Service Network & Local Presence
Equipped with a dedicated local office in Taiwan and backed by 9 global branches and 300+ in-house regulatory specialists, we have served over 15,000 enterprises including 103 Fortune Global 500 firms, delivering responsive, customized cross-border regulatory support for Asia-Pacific and global market access.
Proven GMM & Novel Food Compliance Experience
We have extensive experience assisting clients with the registration of novel food ingredients and food additives derived from genetically modified microorganisms (GMMs). Our team maintains in-depth expertise in GMM-specific safety evaluation and official dossier requirements.
FAQ
A: The key date is December 31, 1999. If the ingredient lacks asufficient history of safe food consumption in Taiwan before that date, or if its intended use differs from traditional food use, it may fall under Type 1 novel food ingredients. In addition, if a traditional ingredient is changed by non-traditional technologies in a way that alters its composition, chemical structure or form, it may fall under Type 2 novel food ingredients.
Companies should first complete the official questionnaire and submit supporting documents to TFDA for classification before preparing a full safety assessment dossier.
A: Common issues include:
Submitting a full safety assessment dossier without first completing the classification questionnaire;
Toxicology reports that do not meet GLP requirements;
Insufficient explanation of how a novel process changes the ingredient’s composition or structure;
Inadequate evidence showing that a GMM-derived final ingredient does not contain the production microorganism or transgene;
Inconsistencies between different sections of the dossier.
Official References and Useful Links
For companies preparing Taiwan novel food ingredient applications, the following official resources may be useful:
Related Food Compliance Services
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Planning to launch a new food ingredient in Taiwan? REACH24H can help you determine whether your ingredient falls within the scope of Taiwan novel food ingredients, assess the required application pathway, prepare safety assessment documents and support communication with TFDA.
