1 
 Regulations Governing the Labeling of Formula for Certain Disease  
 
1. The Regulations are established under the provisions of Article 22 Paragraph 1 
Subparagraph 10 of the Act Governing  Food Safety and Sanitation.  
 
2. Formula for certain disease shall have container or external packaging  labeled with the 
following information, as required in addition to general information o n regulations of 
prepackaged food requirements : 
(1) The applicable subjects.  
(2) Storage instructions before and after the package is opened.  
(3) Usage and dosage instructions.  
(4) Warning statement: "This product is a formula food for certain disease, and it is 
not suitable for the general population and must be taken under the instruction of 
a doctor or registered dietitian" , or the synonyms . Text shall appear bold and be 
distinct from the background color . 
(5) Warning statement: "Increasing dosage will not help improve this type of disease", 
or the synonyms . 
(6) Warning statement: "This product is not for intravenous use",  or the synonyms . 
(7) Tube -feeding formulas must specify the osmotic pressure.  
(8) Other p recautions  related to  nature thereof  and characteristics  of product . 
 
3. In addition to the foregoing  requirements, different categories shall have the following 
additional information printed on the container or package:  
(1) Nutritionally complete food with balance  formula :  
 All products must specify the percentage calories  of protein , fat and 
carbohydrate,  fiber , lactose and nutrient content  with lower limits on the 
Schedule  in Regulations Governing the Management of the Review, 
Registration and Issuance of Permit Documents for Food and Related 
Products . 
 (2) Nutritionally complete food with  customized formula :  
A. All products must specify the percentage calories  of protein , fat and 
carbohydrate,  fiber , lactose and nutrient content  with lower limits on the 
Schedule  in Regulations Governing the Management of the Review, 2 
 Registration and Issuance of Permit Documents for Food and Related 
Products . 
B. Products with adjusted nutrients/ingredients must specify the “ increas ed”, 
“reduced” or “ eliminate d” nutrient/ingredient , or the synonyms . 
 (3) Nutrition adjusted supplement ary formula  food :  
A. All products must specify the percentage calories  of protein , fat and 
carbohydrate,  fiber , lactose and nutrient content  with lower limits on the 
Schedule  in Regulations Governing the Management of the Review, 
Registration and Issuance of Permit Documents  for Food and Related 
Products . 
B. Products with nutrients/ingredients adjusted must specify the “ increas ed”, 
“reduced” or “ eliminate d” nutrient/ingredient , or the synonyms . 
C. Where a product does not contain the essential fatty acids, such must be stated 
on the product (e.g. “This product does not contain the essential fatty acids.”). 
Where a product does not contain one of the essential fatty acids, Linoleic acid  
(LA) or α-Linolenic acid ( ALA), such must be stated on the product (e.g. “This 
product does not contain Linoleic acid, an essential fatty acid” or “This 
product does not contain α -Linolenic acid, an essential fatty acid”).  
D. “This product should not be used as th e sole source of nutrients”  label in bold . 
(4) Special modular formula  food : 
A. Products with a specific nutrient or ingredient  must specify the nutrient  and 
nutrient content on the label.  
B. “This product should not be used as the sole source of nutrients”  label in bold . 
4. The label of the two foregoing requirements  with particularity  is set  after approv ing 
the application through examination procedure . In the event of changes in the 
information of the label , the application of modification according to Regulations 
Governing the Management of the Review, Registration and Issuance of Permit 
Documents for Food and Related Products  shall be submitted for appr oval .