Overview of Approved GMM-Derived Ingredients in Taiwan, Including HMOs, Astaxanthin and trans-Resveratrol

The global synthetic biology industry is developing rapidly, with the manufacturing technology of raw materials based on genetically modified microorganisms becoming increasingly mature. Several new food raw materials have successively obtained market approval in regions such as Europe, America, Australia, New Zealand, and Canada.

Since 2020, Taiwan Food and Drug Administration has gradually released usage restrictions and labeling regulations for six new food raw materials produced from genetically modified microorganisms, including three 2′-fucosyllactose, astaxanthin, Ganoderma microsporum globulin-like protein concentrate, and trans-resveratrol. CIRS Group has compiled key information on these 6 products for industry reference.

Product 1: 2′-fucosyllactose

• Date of issue: December 16, 2020
• Document No.: Wei-Shou-Shi-Zi No.1091303448
• Purity: 2′ - fucosyllactose ≥90%
• Production strain: Genetically modified Escherichia coli (BL21 (DE3) #1540
• Scope of use: Limited to infant and follow-on formulas and milk powder or similar products for children under seven years old
• Usage limit: 1.2 g/L, calculated based on the state of ready-to-eat or prepared according to label instructions

Product 2: 2′-fucosyllactose

• Date of issue: June 16, 2021
• Document No.: Wei-Shou-Shi-Zi No.1101301211
• Purity: 2′ - fucosyllactose ≥94%
• Production strain: Genetically Modified Escherichia coli K-12 DH1 MDO MAP1001d
• Scope of use: Limited to infant and follow-on formulas and milk powder or similar products for children under seven years old
• Usage limit: 1.2 g/L, calculated based on the state of ready-to-eat or prepared according to label instructions

Product 3: 2′-fucosyllactose

• Date of issue: June 1, 2023
• Document No.: Wei-Shou-Shi-Zi No.1121300951
• Purity: 2′ - fucosyllactose ≥94%
• Production strain: Genetically Modified Escherichia coli K-12 MG1655 INB000846
• Scope of use: Limited to infant and follow-on formulas and milk powder or similar products for children under seven years old
• Usage limit: 1.2 g/L, calculated based on the state of ready-to-eat or as prepared according to label instructions

Product 4: Astaxanthin

• Date of issue: March 11, 2021
• Document No.: Wei-Shou-Shi-Zi No. 1101300104
• Purity: Total carotenoids ≥95%; astaxanthin ≥ 80%
• Production strain: Genetically modified Escherichia coli Ast12
• Scope of use: Children under twelve years old, pregnant women, nursing mothers, and those taking medications related to liver or metabolic diseases should avoid consumption
• Usage limit: Daily consumption limit is 2 mg based on astaxanthin

Product 5: Ganoderma microsporum globulin-like protein concentrate

• Date of issue: February 16, 2022
• Document No.: Wei-Shou-Shi-Zi No. 1111300075
• Purity: Content of ganoderma microsporum globulin-like protein is 5.5 ± 1.5 mg/mL
• Production strain:Genetically modified Pichia pastoris Ey72
• Scope of use: Children under twelve years old, pregnant women, nursing mothers, and individuals with allergies should avoid consumption
• Usage limit: Daily consumption limit is 6 mg based on ganoderma microsporum globulin-like protein

Product 6: trans-Resveratrol

• Date of issue: June 29, 2023
• Document No.: Wei-Shou-Shi-Zi No.1121301256
• Purity: Trans-resveratrol ≥98% (on a dry weight basis)
• Production strain: Genetically modified Saccharomyces cerevisiae EFSC4687
• Scope of use: For adult use only; pregnant and nursing women should avoid consumption; those taking medication should consult a physician before use
• Usage limit: Daily consumption limit is 150 mg

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, ensuring the safety of such food ingredients for consumption. For more interpretations of the new operating principles, you can click on the Regulatory Compliance for Novel Food Ingredients in Taiwan: Definitions, Documentation, and Approval Process to learn more.

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.