Draft Regulations Governing the Labeling whic h shall 
be labeled of Infant and Follow -up Formula  
1. The Regulations are established under the provisions of Article 22 
Paragraph 1 Subparagraph 10 of the Act Governing Food Safety and 
Sanitation . 
2. Infant and Follow -up formula  shall have container or external packaging 
labeled with the following information, as required in addition to general 
information of the packaged food requirem ents:  
(1)  Products with iron content less than 1 m illigram per 100  kilocalories 
shall  be labeled with the warning statement "For infants , Additional 
Iron May Be Necessary ", or the synonyms . 
(2) Products with iron content of 1 m illigram  per 100 kilocalories or 
more sh all be labeled with the warning statement "Infant Formula 
With Iron ", or the synonyms . 
(3)  Instructions of storage before and after opening.  
(4)  Directions for product preparation and amount of using . 
i. Products in powder form shall be labeled with the weight of a 
spoonful filled with the attached measuring spoon, and the amount 
of the product and water required for preparation.  
ii. Concentrated products in liquid form  shall be labeled  with the 
warning statement "Must be p repare with water b efore feeding" or 
the synonyms , and the amount of the product and water required 
for preparation.  
(5) The warning statement "Prepare and dilute with water that has been 
boiled and then cooled to warm  and in totally sterilized containers 
only", or the synonyms.  
(6)  The warning statement "Inappropriate preparation will cause health 
hazard of the baby" , or the synonyms . 
(7) Products in liquid form shall be labeled with the warning statement 
"Shake the bottle till the solution is evenly mixed before feeding" , or                                                                          
the synonyms . 
(8)  The warning statement "From the age over six months , infant sh all 
receive complementary foods in addition to the formula ", or the 
synonyms . 
(9) The warning statement "User  shall follow t he advice of health care 
worker  and nutritionists to determine whether the need for infant 
formula  and the proper method of use ", or the synonyms . 
(10) The recognized label shall be clearly printed on the container or 
external packaging . The image  and specifications are regulated in the 
Appendix.  
(11)  Infant formula in liquid form shall be labeled with the warning 
statement, “For hospital use only”.  
3. In addition to  the foregoing requirements, the container or external 
packaging  shall be labeled with the following information depending on 
the product categories : 
(1) Infant formula:  
i. The phrase  "infant formula" sh all be labeled . 
ii. A statement of the superiority of breastfeeding sh all be labeled . 
iii. The baby's weight sh all be added in th e feeding table.  
(2) Follow -up infant formula:  The phrase "follow -up infant formula " 
shall be labeled . 
(3) Infant formula for special medical purposes : The characteristics of 
the products and applicable users.  
4. Phrases like “humanized” , “matern alized” or other similar phrases 
suggesting superiority to breast milk sh all not be labeled  on the container 
or external packaging  of infant and follow -up formula. Nor sh all there have 
pictures of infant s or phrases and pictures  which may idealize the use of 
produ ct. 
5. The label  contents  specified in Articles 2 and 3 shall follow the specifics 
approved by registration review of the products. For any changes,                                                                          
applications sh all be filed in accordance with the Regulations Governing 
the Management of the Review, Registration and Issuance of Permit 
Documents for F ood and Related Product s. The changes can be made only 
with the approval granted.  
6. If the labeling of the product does not comply with this regulation, and 
appears to be false, exaggerated or misleading,  it shall be fined in 
accordance with the relevant regulations of this law.  
                                                                           
 
Image and Specifications of the recognized label  on 
the container or external packaging  of Infant  and 
Follow -up Formula : 
 
 
1. Image : 
  
2. Specifications:  
(1) The words  of the image  "Breast milk is  the best food  for your baby" 
and " Ministry of Health and Welfare cares for you" shall be printed 
using at least font size 8 . 
(2) The image shall be printed using CMYK colors: green (Y100C60) 
and orange (Y100M60).  
(3) The size  of the image may be determined by the user, but shall not be 
smaller  than 3 cm (height) × 3 cm (width).  
Appendix