On Feb 16, 2022, Taiwan FDA sets the use restriction and labeling requirement for Ganoderma microsporum globulin-like protein concentrate as a food ingredient produced by genetically modified Pichia pastoris Ey72.
Requirements of the ingredient
As revealed by Taiwan FDA’s notice1, Ganoderma microsporum globulin-like protein concentrate is produced by the fermentation process using genetically modified Pichia pastoris Ey72. The fermentation broth is concentrated via sequential steps including membrane filtration, concentration, membrane separation, mixing with water as well as sodium chloride and legal food additives, sterile filtration, etc. The final Ganoderma microsporum globulin-like protein concentrate shall not contain any genetically modified microorganism and its transgenes.
Use restriction
When using the ingredient, it shall meet the following requirements:
The detection result of genetically modified microorganism and its transgenes by real-time quantitative polymerase chain reaction (qPCR) shall be negative.
The content of the Ganoderma microsporum globulin-like protein shall be 5.5±1.5 mg/mL.
The daily intake of the Ganoderma microsporum globulin-like protein shall not exceed 6 mg.
Labeling requirements
One of the following information shall be displayed on the container or external packaging of the Ganoderma microsporum globulin-like protein concentrate produced by Pichia pastoris Ey72:
“The Ganoderma microsporum globulin-like protein concentrate is produced by genetically modified microorganism” or
“The Ganoderma microsporum globulin-like protein concentrate is produced by genetically modified microorganism, but ultimately does not contain any genetically modified microorganism and its transgenes”.
Final products containing the protein concentrate as one of its ingredients are exempted from this labeling requirement above.
Food products containing Ganoderma microsporum globulin-like protein concentrate produced by Pichia pastoris Ey72 shall bear the following warning statement: Children under twelve years old, pregnant women, lactating women and people with allergies shall avoid consuming.
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