Regulation  for The Use Restriction  and Labeling 
Requirement  of the Ganoderma microsporum  Globulin -like 
Protein Concentrate  Produced by Genetically M odified  
Pichia pastoris  Ey72  as a Food Ingredient  
MOHW Food No.1 111300075 , 16 February  2022 
Article 1  
The regulation  is prescribed in accordance with the provisions of Paragraph 
2 of Article 1 5-1 and Subparagraph 10 of Paragraph 1 of Article 22 of the 
Act Governing Food Safety and Sanitation . 
 
Article 2 
The Ganoderma microsporum  globulin -like protein concentrate  referred to 
herein is produced by fermentation process using genetically modified 
Pichia pastoris  Ey72 . The fermentation broth  is concentrated  via 
sequen tial steps including membrane filtration, concentration, membrane 
separation, mixing with water, sodium chloride and legal  food additives,  
sterile filtration  etc. The final Ganoderma microsporum  globulin -like 
protein concentrate  shall not contain any genetical ly modified 
microorganism and its transgenes.  
 
Article 3  
For use as a food ingredient,  the Ganoderma microsporum  globulin -like 
protein concentrate  produced by Pichia pastoris  Ey72  shall comply with  
the following requirements : 
1. The detection  result of g enetically modified microorganism  and its 
transgenes  by real -time quantitative polymerase chain reaction  (qPCR ) 
shall be negative . 
2. The content of the Ganoderma microsporum  globulin -like protein 
shall be 5.5±1.5 mg/mL . 
3. The daily intake of the Ganoderma microsporum  globulin -like protein  shall not exceed  6 mg. 
4. The container or external packaging of  the Ganoderma microsporum  
globulin -like protein concentrate  produced by  Pichia pastoris  Ey72  
shall be display ed one of the following information: “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 genetic ally modified microorganism and its transgenes ”. Final 
products containing the protein concentrate  as one of its ingredients  
are exempted from this labeling requirement . 
 
Article 4  
The labelling of food products containing the 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.  
 
 