1 
 REGULATIONS GOVERNING THE MANAGEMENT OF THE REVIEW , REGISTRATION 
AND ISSUANCE OF PERMIT DOCUMENTS FOR FOOD AND RELATED PRODUCTS  
  
 
Chapter I  
General Provisions  
 
Article 1  
The Regulations are enacted pursuant to the provisions of Article 21 Paragraph 5 of 
the Act Governing Food  Safety and  Sanitation  (hereafter referred to as “the Act”) . 
 
Article 2 
The term “review and registration” herein stated refer to the process of review , test, 
and registration and the issuance of permit documents .  
The registration referred in the preceding paragraph shall include the following 
information based on the product classification and characteristics:  
1. Product name in Chinese and foreign language,  
2. Ingredients,  
3. Packaging,  
4.  Name and address of the manufacturer,  
5. Name and address of the applicant,  
6. Validity period of the permit  document , 
7. Other registration information  designated by the central competent authority . 
 
Article 3 
A food business operator applying for review and registration  with the central 
competent authority shall complete an application form, pay the due review , test, 
and certificate fees, and attach  following documents or information to the 
application form  based on the product classification and characteristics : 
1. Table of ingredient content, specifications, test method, certificate of analysis, 
nutrients analysis report , and manufacturing process  summary ; 
2. Complete technical information ; 
3. Labels, packaging, Chinese labeling, user instruction , sample, and photo of the 
actual product ; 
4. An application filed for imported product review and registration  shall  be 
attached with the official substantiating documents certifying that the original 2 
 manufacturer is legally established or registered. If the document s are 
photocopies of the original , they shall be attested as true copies of the original by 
a notary public in the country of origin ; 
5. A contract manufacturer is required to provide the original copy of the 
manufacturing contract ; 
6. Photocopy of the applicant’s company registration or business registration 
certificate;  
7. Other essential documents and information specified by the central competent 
authority.  
The foregoing d ocuments or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by 
a registered translation agency.  
 
Article 4     
Applicant applying for review and registration  shall  claim the permit document 
within two months after the central competent authority approves the application 
through review  procedure and issues a notification letter advising the permit 
document issuance. Failure of applicant to claim the permit document within the 
deadline shall co nstitute the abandonment of application; whereupon, the central 
competent authority is entitled to process the nullification of the issued permit 
document .  
 
Article 5  
Permit document s issued on applications filed pursuant to the provisions of Article 
21 Paragraph s 1 and 2  of the Act shall have a validity period ranging from one to 
five years  subject to the announcement made by the central competent authority 
based on the product classification and characteristics .  
Where a n extension shall be required, a pertinent application form complete with the 
permit document and the documents or information herein prescribed in Article 3 
shall  be filed with the central competent authority for extension approbation  within 
three months before expir ation . The applicant shall  pay the review  fee when filing a n 
extension application. The maximum validity period of the extended  permit 
document shall be five years . Where issuance of a new certificate shall be necessary, 
a certificate processing fee shall be collected.  
 
  3 
 Article 6 
In the event of  amendment  in the registered information of the permit document , an 
application form complete  with the permit document and the documents or 
information herein prescribed in Article 3 shall  be filed with the central competent 
authority for amendment of registration records. The applicant shall  pay the review  
fee when filing an application. Where issuance of a new certificate shall be necessary, 
a certificate processing fee shall be collected . 
 
Article 7  
In the event of permit document ownership transfer, an application form complete 
with the documents or information herein prescribed in Article 3 shall  be filed with 
the central competent authority for the transfer registration  and a n review  fee shall 
be collected . Additionally, if the permit document is a certificate , a certificate 
processing fee  shall be collected.   
 
Article 8 
In the event of the defacement or loss of a  permit document , an application form and 
the documents or information herein prescribed in Article 3 shall  be filed with the 
central competent authority for replacement or reissuance. The applicant shall  pay 
the review  fee and certificate processing fee. Where application is filed due to 
defacement, the original permit document shall  be surrendered for destructio n. 
The new permit  document  issued under the replacement or reissuance application as 
referred in the preceding paragraph shall bear the same expiration date as the 
original permit  document . 
 
Artic le 9  
For products that have already obtained permit documents , if the manufacture or 
importation of a product is officially banned under the Act, the original permit 
document issued for which shall be nullified.  
      
Article 10  
A food business operator applying for the cancellation of its permit document  shall 
submit the application form complete with the permit document and related 
documents or information to the central competent authority for annulment . Upon 
due approval, the central competent authority shall issue an official announcement 
declaring the permit document null and void.  
 
 4 
 Article 11  
A food business operator applying for the review and registration and the permit 
document replacement, re -issuance, extension, transf er, or cancellation, or 
amendment of registered information shall process the required procedure within 
two months after receiving the official notice of document submission for test or 
supplementary information from the central competent authority.  Where 
circumstances shall require, the food business operator may apply for a one -month 
extension period. Failure to submit documents within the prescribed deadline is 
subject to rejection with no further notice . 
 
Article 12  
Regarding the review and registration matters defined in the Regulations, the 
application form format, information to be contained in the application form, 
documents or information to be attached to the application form, and the official 
permit document format are subject to the discretion of the central competent 
authority.  
 
Chapter II  
 Review and Registration of  Infant  Formula  and Follow -up Infant Formula  
 
Article 1 3 
Applicat ions for review and registration  of infant  formula  and follow -up infant 
formula  shall submit the application  form, along with the following documents  and 
information as well as product samples , to the central competent authority , and pay 
the related fees , while the provisions in Article 3 do not apply:  
1. Original table of ingredient content  of the product : The table  shall be issued by 
the original manufacturer and dated within the past one year and contain the 
detailed name and net quantity of contents of all the raw materials and food 
additive s.    
2. Original product specification : The product specification shall be issued by the 
original manufacturer and dated within the past one year and contain the 
hygiene and nutrients specification of the product.  Its calories and nutrients 
shall  meet the specifications set out in Schedule 1; if it contains nutrients other 
than those in Schedule 1, scientific evidence or other references shall  be provided 
for the nutrients.  5 
 3. Original hygiene and nutrients analysis report : The report shall be the  original 
issued by the original man ufacturer or accreditation of food  testing institution  
by the central competent authority and dated within the past one year.   
4. The applicant is required to submit the original substantiating document  
verifying the product  is for sale in a market  outside the territory of Taiwan  and a 
product sample, or a trial report  of the product with a  valid sample size of more 
than 20 subjects.  
5. Manufacturing process summary . 
6. Certification document verifying  that the original manufacturer is legally 
established or registered;  
(1) Domestic manufacturer: C arbon copy of the factory registration certificate . 
(2) Foreign manufactur er: The o riginal official certificate issued by a competent 
government agency responsible for product hygiene and safety or factory 
licensing in the country of origin and dated within the past two years, shall 
be provided. The certificate shall  specify the name and address of the 
manufacturer, its business activities, categories of products, hygienic status 
of the factory , and full name of the government agency issuing the certificate 
with official stamp or authorized signature . If the certificate  verifying the 
legitimacy of the original manufacturer is a copy of the original, the 
document shall  be a certified true copy of the original by a notary public in 
the country of origin . 
7. In cases of authorized  sales, the original certificate of authorization  issued by the 
original manufacturer or distributor is required . 
8. In case s of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer is required.  
9. Two copies each of the  physical or color drafts of the Chinese label, container or 
outer packaging, and user instruction s; the above items shall be attached 
separately  for different packaging specifications, forms, and materials;  if the 
contents of the user instruction s are the same , the user instruction of any 
specification s, form s, and materials may be submitted    
10. The applicant shall submit a carbon copy of its company registration or business 
registration certificate .  
11. Where the complete sample is available to the market in different packaging 
specifications, forms or materials, the applicant is required to submit one sample 
for each option.  6 
 12. Where the product is intended to be re -packed in new containers for sale  in 
Taiwan , the applicant shall submit the following documents:  
(1) The manufacturer’s original re-pack ing certificate or the original document 
of consent to product re-pack ing for imported products . 
(2) The domestic re-pack ing facility’s factory registration certificate in carbon 
copy . Food re -packing, processing or manufacturing shall be listed in the 
scope of business stated on the factory registr ation certificate.  
(3) The original copy of the hygiene and nutrition analysis report on the re -
packed product issued within the past one year by the original manufacturer 
or accreditation of food testing institution  by the central competent authority.  
(4) Two copies each of the  physical or color drafts of the Chinese label, container 
or outer packaging, and user instructions  of the re -packed products ; the 
above items shall be attached separ ately for different packaging 
specifications, forms, and materia ls; if the contents of the user instruction s 
are the same,  the user instruction of any specification, form, and materials 
may be submitted   
(5) Where the re -packed product sample is available in different packaging 
specifications, forms and materials, the  applicant is required to submit one 
sample for each option.   
13.  Other essential documents and information specified by the central competent 
authority.  
The foregoing documents or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by 
a registered translation agency.  
The p ermit  document s issued on the applications filed in compliance with 
Paragraph 1 and approved pursuant to the Act shall be valid for five years.  
 
Article 14 
Applica tions for extension of the  permit document  for infant  formula and follow -up 
infant formula shall submit an application  form within three months prior to the 
expiry date of permit , along with the following documents, information and product 
sample, to the central competent authority , and  pay t he related fees , while the 
provisions in Article 5 do not apply:  
1. Original  permit  document . 7 
 2. The original certificate or document of consent to renewal of the product 
manufacturing agreement, or original table of ingredient content  issued by the 
original manufacturer  based on the content of original ly issued permit within  
the past one year . 
3.  In cases of authorized  sales, the original certificate of authorization  issued by the 
original manufacturer or distributor  is required . 
4. In case s of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer  is required . 
5. Two copies each of the  physical or color drafts of the product labels  in Chinese , 
containers or outer packaging, and user instructions; the above items shall be 
attached separately  for different packaging specifications, forms, and materials;  
if the contents of the user instructions are the same , the user instruction of any 
specification, form, and materials may be submitted    
6.  Description of product usage: The report issued or signed by the original 
manufacturer describing the situations of domest ic and overseas consumer 
usage of the product in the last five years, and the content of which shall  at least 
include the sales situations, adverse reactions reported domestically and 
overseas, and the latest results of inspection imposed on the original 
manufacturer by the competent authorities  or its entrusted institution.  
7.  Original hygiene and nutrients specification s issued by the original 
manufacturer within the past one year.  
8. Original hygiene and nutrients analysis r eport of the batches of production 
within the past year issued by the original manufacturer or accreditation of food 
testing institution  by the central competent authority .  The original analysis 
report of the latest batch of production shall be provided in case there is no 
production within the past year.  
The foregoing documents or information in languages other than English an d 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
The permit document issued on the applications for extension filed in compliance 
with Paragraph 1 and approved pursuant to the Act shall be vali d for five years. If it 
is necessary to reissue a new permit document , a certificate processing fee shall be 
collected . 
In case that, within one year of the amendment and implementation of these 
Regulations on Nove mber 3 0, 2023, the applicant is unable to provide a description 8 
 of domestic and overseas  usage in the past five years as specified in Paragraph 1 
Subparagraph 6, the submission of overseas sales certificates and the product, or 
trial usage reports with a sample size of  twenty or more subjects may be accepted as 
a substitute.  
 
Article 1 5 
Applica tions  for amendment of the permit document for infant  formula and follow -
up infant formula shall submit an application form, along with the following 
documents or information, to the central competent authority, and pay the related 
fees, while the provisions in Article 6 do not apply:  
1. Original permit document .  
2. Two copies each of the physical or color drafts of the Chinese labels, container or 
outer packaging, and user instructions of the product that are involved in 
amendment ; the above items shall be attached separately  for different packaging 
specifications, forms, and materials; if the contents of the user instructions  are 
the sam e, the user instructions of any specifications, forms, and materials may be 
submitted.    
In addition to the foregoing requirements, the follow ing documents , information  or 
sample shall be additionally submitted according to the application of amendment :  
1. Product name change:  The certificate or document of consent to change of the 
product name issued by the original manufacturer for imported products.  
2. Change of name, address or person -in-charge of the manufacturer holding the 
permit document :  
(1) Photocopy of c ompany registration or business registration certificate of the 
manufacturer holding the permit document . 
(2) A complete list of product  item s shown on the permit document held by the 
manufacture r. The list is required to contain the registration numbers, 
Chinese names of the product items and expiry date of the permit document . 
3. Change of the original manufacturer’s name:  
(1) Domestic manufacturer : Carbon copy of the factory registration certificate.  
(2) Foreign manufacturer: T he original official certificate issued by a competent 
government agency responsible for product hygiene and safety or factory 
licensing in the country of origin and dated within the past two years, shall 
be provided. The certificate shall specify the name  and address of the 
manufacturer, its business activities, categories of products, hygienic status 9 
 of the factory, and full name of the government agency issuing the certificate 
with official stamp or authorized signature . If the certificate  verifying the 
legitimacy of the original manufacturer is a copy of the original, the 
document shall  be a certified true copy of the original by a notary public in 
the country of origin . 
(3) A complete list of product items of the original manufacturer  shall be 
provided . The list is required to contain the registration numbers, Chinese 
names of product items, and expiry date of the permit document . 
4. Building number adjustment of the original manufacturer’s address:  
(1) In cases of domestic manufacturers : The applicant shall submit a photocopy 
of the documents issued by a competent government agency certifying the 
address building number adjustment . 
(2) In cases of foreign manufacturers: The original certificate issued by a 
competent government agency of the country of origin in its full title 
certifying the building number adjustment, whereas the certificate submitted 
is a photocopy, the document shall be notarized as a true copy of the original 
by a notary public in the country of origin.  
(3) A complete list of product items of the original manufacturer  shall be 
provided . The list is required to contain the registration numbers, Chinese 
names of the product items , and expiry dates of the permit document . 
5. Amendment  of the product specifications set forth in Subparagraph 2, 
Paragraph 1 of Article 13:  
(1) The e valuation report on the rationale of amendment  issued by the original 
manufacturer within the past one year (including a chart of comparison of 
the content before and after the amendment ). 
(2) The documents set forth in Subparagraphs 1 and 2, Paragraph 1 of Article 13,  
attaching those set forth in Subparagraph 3 of the same Article and 
Paragraph, based on the amended items of specifications.  
6. Amendment  to the packaging specification, form and material:  
(1) For imported product items, the original manufacturer’s certificate or 
document of consent to the change of packaging in original copy shall be 
submitted . 
(2) Product samples are required if changes involve product forms or materials . 10 
 (3) Where the product will be re -packed in new containers for sale, the 
applicant shall submit the documents and sample set forth in Article 13 
Paragraph 1 Subparagraph 12 of t he Regulations.  
7. Amendment  of the Chinese label, container or outer packaging, and user 
instructions  of the product:  
(1)  A chart of comparison of the content before and after the amendment . 
(2) For imported product items, the original manufacturer’s certificate or 
document of consent to the amendment  of the Chinese label, container or 
outer packaging, and user instructions  in original copy.   
(3) For amendment  to the nutrition facts :  
A. The evaluation report on the rationale of amendment  issued by the 
original manufacturer within the past one year.  
B. The original copy of the nutrition analysis report issued by the original 
manufacturer or accreditation of food testing institution  by the central 
competent authority within the past one year.  
C.  The documents set forth in Subparagraphs 1 and 2 , Paragraph 1 of 
Article 13.  
The foregoing d ocuments or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by 
a registered translation agency.  
For the application process and the submission of documents and information, 
product samples, and related fees in case of change, relocation or expansion of 
the manufacturer, the provisions of Article 13 on new registration applications 
shall apply mutatis mutandis.  
If it is necessary to reissue a new permit document , a certificate processing fee 
shall be collected . 
For the product specifications as set forth in Subparagraph 5 of Paragraph 2 and 
the nutrition facts in Item 3 of Subparagraph 7, amendment  shall be limited to 
cases where neither the product composition nor the content has been amended . 
 
Article 16 
Applica tions  for the amendment  of Chinese label, container or outer packaging, and 
user instruction s of the infant and follow -up formula  are exempted in one of the 
following situations:  11 
 1.  Amendment  of patterns or colors.  
2.  Proportionate reduction or enlargement of the approved images and texts.  
3.  Movement of the position of the approved images and texts.  
4.  Amendment  of the fonts of the approved text.  
The amendment  in the preceding paragraph of the Chinese labels, container or outer 
packaging and u ser instructions which contain the content stipulated by relevant 
authorities other than those specified in this Act shall be subject to the provisions of 
respective regulations.  
For items exempted from amendment  applications as set forth in the first para graph, 
the permit holder shall produce a written record for retention.  
 
Article 1 7 
Application s for transfer ence  of the permit document for infant  formula  and follow -
up infant formula , the transferee is required to submit an application form, along 
with the following documents  or information , to the central competent authority  for 
review , and pay the review  and certificate processing  fees, while the provisions in 
Article 7 do not apply:  
1. Transferor’s certificate or document of consent to transfer of permit document 
ownership in original copy . 
2. In case s of authorized  sales, the original certificate of authoriz ation issued by the 
original manufacturer or distributor  is required . 
3. In case s of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer  is required . 
4. Original permit document . 
5. Two copies each of the physical or color drafts of the Chinese label s, container or 
outer packaging , and user instruction  of the product ; the above items shall be 
attached separately  for different packaging specifications, forms, and materials; 
if the contents of the user instructions  are the sam e, the user instruction s of any 
specification s, form s, and materials may be submitted.  
6. Where the product will be re -packed in new containers for sale, the applicant 
shall submit the documents set forth in Article 13 Paragraph 1 Subparagraph 12 
Items 1-4 of the Regulations . 
7. Photocopy of the table of product ingredient content . 12 
 8. Photocopy of the applicant’s company registration or business registration 
certificate.  
The foregoing d ocuments or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
 
Article 18 
Applications for reissuance  or replace ment  the permit document for infant  formula  
and follow -up infant  formula  review and registration  due to  defacement or loss , the 
applicant is required to submit an application form , along with the following 
documents or information , to the central competent authority , and pay the related 
fees, while the provisions in Article 8 do not apply:  
1. The applicant shall submit the p hotocopy of the applicant’s company 
registration or business registration certificate . 
2. For replacement application, the applicant shall submit the originally issued 
permit document . 
3. For re -issuance application, the applicant shall submit a statement that declares 
the original permit document null and void.  
The new permit document issued under the replacement or reissuance  application as 
referred in the preceding paragraph shall bear the same expiration date as the 
original permit document . 
 
Chapter III  
 Review and Registration of Formula for Certain Disease  
 
Article 19  
Formula  for certain disease  referred to in this chapter  is intended for the dietary 
management of patients who have impaired capacity to ingest, digest, absorb or 
metabolize ordinary foods or certain nutrients, or who, for any medically -proven 
reason, have special dietary requirements that cannot be easily met wi th re -
balancing daily diet. The food products in this category are processed or formulated 
according to the needs of the target users.  
The scope of formula  for certain disease  as referred in the preceding paragraph  is as 
follows : 
1. Nutritionally complete  food that may be used as the single source of nutrients:  13 
 (1)  Nutritionally complete food with balanced formula : The products in this 
category are designed to maintain caloric and nutritional sustenance of 
patients . The  various nutrients contained in the product shall comply with 
the regulations provided in the Schedule  2, except for formulae for patient 
children aged one to eight een.  
(2) Nutritionally complete food with customized formula : The products in this 
category are designed to maintain caloric and nutritional sustenance of 
patients by delivering complete nutrition with added or reduced nutrients to 
meet the patients’ specific needs. The nutrient addition or reduction shall be 
based o n scientific evidence.  For other nutrients, the regulations provided in 
Schedule 2 shall apply mutatis mutandis.   
2. Nutrition supplement formula food  that may not be used as the single source of 
nutrients:  
(1) Nutrition  adjusted s upplement ary formula  food : The products in this 
category are designed to be used as part of nutrition al supplement for 
patients of specific nutritional  needs  and meet the following requirements:  
A. The specific nutrients to be supplemented  shall be based on scientific 
evidence . For the non -customized nutrition portion of the product, every 
serving size (100 K cal) shall reach the lower limit as specified in Schedule 
2. The recommended daily nutrition allowance for the product shall not 
exceed the maximum allowance specif ied in the Standards for 
Specification, Scope, Application and Limitation of Food Additive s. 
B. Where the non-customized nutrition  portion of the product under 
application per 100 Kcal does not reach the lower limit as specified in 
Schedule 2,  a domestic clinical study  on the product is required to prove 
that the users of such product will be able to meet the nutritional 
requirements by following the recommended diet.   
(2) Special modular formula  food : The products in this category are designed to 
deliver a specific nutrient or ingredient to meet the nutritional needs 
deriving from specific illness  or metabolic needs  and contain the element 
meet ing the following requirements:  
A.  The source food additives containing the  modular formula are the 
nutrit ional  additives within the same domain of nutrients.  
B.   There is scientific evidence that this element is es sential for th e 
nutritional needs deriving from specific illness or metabolic needs . 14 
 The products as referred in the preceding paragraph  may use other food  
ingredients  or additives to meet the flavoring or processing requirements.   
 
Article 20 
Applicat ions for review and registration of formula  for certain disease  shall submit 
the application form, along  with the following documents and information  as well as 
product samples , to the central competent authority , and pay the related fees , while 
the provisions in Article 3 do not apply : 
1. Original table of ingredient content : The  table  shall be issued by the original 
manufacturer and dated within the past one year and contain the detailed name 
and net quantity of contents of all the raw materials and food additive.     
2.  Original product specification: The product specification shall be issued by the 
original manufacturer and dated within the past one year and contain the 
hygiene and nutrients specification of the product.  
3. Original hygiene and nutrients analysis report: The report shall be the original 
issued by the original manufacturer or accreditation of food testing institution  
by the central competent authority and dated  within the past one year.    
4. Manufacturing process summary.  
5. Certification document verifying that the original manufacturer  is legally 
established or registered :  
(1) Domestic manufacturer: Carbon copy of the factory registration certificate.  
(2) Foreign  manufacturer : The original official certificate issued by a competent 
government agency responsible for product hygiene and safety or factory 
licensing in the country of origin and dated within the past two years, shall 
be provided. The certificate shall specify the name and address of the 
manufacturer, its business activities, categor ies of products, hygienic status 
of the factory, and full name of the government agency issuing the certificate 
with official stamp or authorized signature.  If the certificate  verifying the 
legitimacy of the original manufacturer is a copy of the original,  the 
document shall  be a certified true copy of the original by a notary public in 
the country of origin . 
6. In cases of authorized  sales, the original certificate of authorization  issued by the 
original manufacturer or distributor is required.  
7. In case s of entrusted manufacturing, the original certificate of the entrusted 
manufacturing issued by the entrusted manufacturer  is required . 15 
 8. Two copies each of the physical or color drafts of the Chinese label, container or 
outer packaging, and user instructions of the product ; the above items shall be 
attached separately  for different packaging specifications, forms, and materials ; 
if the contents of the user instruction  are the same, the user instruction of any 
specification s, form s, and materials may be submitted.    
9. The applicant shall submit a carbon copy of its company registration or business 
registration certificate.  
10. Where the complete sample is available to the market in different packaging 
specifications, forms or materials, the applicant is required to submit one sample 
for each option.  
11. Where the product is intended to be re -packed in new containers for sale  in 
Taiwan , the applicant shall submit the documents and sample set forth in Article 
13 Paragraph 1 Subparagraph 1 2 of the Regulations.  
12. All applicants, except for nutritionally complete food with balanced formula, are 
required to submit the following:   
(1) Information on the specific nutritional requirement for intended product 
users that would otherwise not be met without the product due to illness or 
medical conditions, along with supporting documents . 
(2) Information on why the intended users cannot otherwise meet the specific 
nutritional requirement described in the preceding subparagraph from the 
daily diet, along with supporting document s. 
(3) The mechanism behind the product design . 
(4) Information on how the intended use and quantity of intake of the product 
help the users to achieve the objectives described in subparagraphs (1) and (2)  
of this paragraph, along with supporting documents . 
(5) Clinical human consumption report: In case of subsequent or concurrent 
applications for multiple products of different pigments, flavors or 
sweeteners , while keeping the other ingredients identical a nd maintaining 
the same nutritional specifications with  no influence on safety, the report of 
one of the products will suffice for application.  
13. For high -protein disease -specific formulas, the applicant is required to provide 
information on the Protein Efficiency Ratio (PER), Protein Digestibility 
Corrected Amino Acid Score (PDCAAS) or other internationally -recognized 
protein determination indicators.   16 
 14.  Other essential documents and information specified by the central competent 
authority.  
The foregoing documents or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
The permit documents issued on the applications filed in compliance with 
Paragraph 1 and approved pursuant to the Act shall be valid for five years.  
 
Article 2 1  
The central competent authority may convene an expert review meeting for 
reviewing the applications filed in accordance with the preceding  Article, and when 
necessary, m ay demand the presence of the applicant for presentations or 
questioning.  
For the convening of the meeting referred to in the preceding paragraph, the central 
competent authority shall notify the applying company to submit necessary 
documents and information within the designated time. Failure of submission or 
submission of incomplete documents and information within the designated time 
may result in the rejection of application with no further notice.  
 
Article 2 2 
Applica tions for extension of the  permit document for formula  for certain disease 
shall submit an application form  within three months prior to the expiry date of 
permit , along with the following documents, information and product sample, to the 
central competent authority, and pay the related fees , while the provisions in Article 
5 do not apply:  
1. Original permit document . 
2. The original certificate or document of consent to renewal of the product 
manufacturing agreement, or original table of ingredient content  issued by the 
original manufacturer based on the content of originally issued permit within 
the past one year.  
3. In case s of authorized sales, the original certificate of authorization  issued by the 
original manufacturer or distributor  is required . 
4. In case s of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer  is required.  17 
 5. Two copies each of the physical or color drafts of the Chinese label, container or 
outer packaging, and user instructions of t he product ; the above items shall be 
attached separately  for different packaging specifications, forms, and materials; 
if the contents of the user instructions  are the same , the  user  instruction s of any 
specification, form, and materials may be submitted.  
6. Original hygiene and nutrients specification s issued by the original 
manufacturer within the past one year.  
7.  Original hygiene and nutrients analysis r eport of the batches of production 
within the past year issued by the original manufacturer or accreditation of food 
testing institution  by the central competent authority .  The original analysis 
report of the latest batch of production shall be provided in case there is no 
production within the past year.  
8. Clinical study report for the product un der application (applications for 
nutritionally complete food with balanced formula or with attach ed clinical 
study report already  is exempted from the requirement) . 
The foregoing d ocuments  or information in languages other than English and 
Chinese must be  accompanied with English or Chinese translations provided by a 
registered translation agency.  
The permit document issued on the extension applications filed in compliance with 
Paragraph 1 and approved pursuant to the Act shall be valid for five years. If it is 
necessary to reissue a new permit document , a certificate processing fee shall be 
collected . 
 
Article 2 3 
Applica tions  for amendment of the permit document for  certain disease  shall submit 
an application form, along with the following documents or information, to the 
central competent authority, and pay the related fees , while the provisions in Article 
6 do not apply:   
1. Original permit document . 
2. Two copies each of the physical or color drafts of the Chinese  label, container or 
outer packaging , and user instruction  that are involved in amendment ; the 
above items shall be attached separately  for different packaging specifications, 
forms, and materials ; if the contents of the user instruction s are the same, the 
user instruction s of any specification, form , and materials may be submitted.  18 
 In addition to the  foregoing  requirements, the following documents , information or 
sample shall be additionally submitted according to the application of amendment :  
1. Product name change:  The certificate or document of consent to change of the 
product name issued by the original manufacturer for imported products.  
2. Change of name, address  or person -in-charge of the manufacturer holding the 
permit document:  
(1) Photocopy of the c ompany registration or business registration certificate of 
the manufacturer holding the permit document . 
(2) A complete list of product items shown on the permit document held by the 
manufacturer. The list is required to contain the registration numbers, 
Chinese names of the product items , and expiry date of the permit document . 
3. Change of the original manufact urer’s name:  
(1) Domestic manufacturer : Carbon copy of the factory registration certificate.  
(2) Foreign manufacturer: The original official certificate issued by a competent 
government agency responsible for product hygiene and safety or factory 
licensing  in the country of origin and dated within the past two years, shall 
be provided. The certificate shall specify the name and address of the 
manufacturer, its business activities, categories of products, hygienic status 
of the factory, and full name of the government agency issuing the certificate 
with official stamp or authorized signature . If the certificate  verifying the 
legitimacy of the original manufacturer is a copy of the original, the 
document shall  be a certified true copy of the original by a notary public in 
the country of origin . 
(3) A complete list of product items of the original manufacturer  shall be 
provided . The list is required to contain the registration numbers, Chinese 
names of the product items , and expiry date of the permit document . 
4. Building number adjustment of the original manufacturer’s address : 
(1) In cases of domestic manufacturers : The applicant shall submit a photocopy 
of the official certificate issued by a competent go vernment agency certifying 
the building number adjustment . 
(2) In cases of foreign manufacturers : The original official certificate issued by a 
competent government agency of the country of origin in its full title 
certifying the address building number adjustment, whereas the certificate 19 
 submitted is a photocopy, the document shall  be notarized as a true copy of 
the original by a notary public in the country of origin . 
(3) A complete list of product items of the ori ginal manufacturer  shall be 
provided . The list is required to contain the registration numbers, Chinese 
names of the product items, and expiry date of the permit document . 
5.  Amendment  of the product specifications as set forth in Article 20, Paragraph 1, 
Subparagraph 2:  
(1) The e valuation report on the rationale of amendment  issued by the original 
manufacturer within the past one year (including a chart of comparison of 
the content before and after the change s). 
(2) The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 and 2, 
attaching those set forth in Subparagraph 3 of the same Article and 
Paragraph, based on the amended  items of specifications.  
6. Amendment  to the packag ing specification, form and material:  
(1) For imported product items, the original manufacturer’s certificate or 
document of consent to the change of packaging in original copy shall be 
submitted . 
(2) Product samples are required if change s involve product form s or material s. 
(3) Where the product will be re -packed in new containers for sale, the 
applicant shall submit the documents or sample set forth in Article 13 
Paragraph 1 Subparagraph 1 2 of the Regulations.  
 7. Amendment  of Chinese label, container or outer packaging, and user 
instruction s of the product:  
(1) A chart of comparison of the content before and after the changes . 
(2) For imported product items, the original manufacturer’s certificate or 
document of consent to t he amendment  of Chinese label, container or outer 
packaging, and user instruction s in original copy shall be submitted . 
(3) For amendment  to the nutrition facts label (with no changes of the product 
ingredients and content):  
A.  The evaluation report on the rationale of amendment  issued by the 
original manufacturer within the past one year ; 20 
 B. The original copy of the nutrition analysis report issued by the original 
manufacturer or accreditation of food testing institution  by the central 
competent authority within the past one year.  
C.  The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 
and 2. 
The foregoing d ocuments or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by 
a registered translation agency.  
For the application process, attachment of documents and information and 
product samples, and fee payment in cases of change, relocation or expansion of 
the manufacturer, except for the exem ption provided for the clinical report 
under Article 20, Paragraph 1, Subparagraph 12, Item 5, the provisions of Article 
20 on new case applications shall apply mutatis mutandis.  
If it is necessary to reissue a new permit document , a certificate processing  fee 
shall be collected . 
For the product specifications as set forth in Subparagraph 5 of Paragraph 2 and 
the nutrition facts in Item 3 of Subparagraph 7, amendment  shall be limited to 
cases where neither the product composition nor the content has been amend ed. 
This does not apply to cases where the ingredients or content of the 
micronutrients in the product formula are adjusted in accordance with the 
revisions to the regulations.  
 
Article 2 4 
Applications for the amendment  of the Chinese label, container or outer packaging, 
and user instructions of the food formula for specific diseases are exempted in one of 
the following situations:  
1.  Amendment  of patterns or colors.  
2.  Proportionate reduction or enlargement of the approved images and texts.  
3.  Movement of the position of the approved images and texts.  
4.  Amendment  of the fonts of the approved text.  
The amendment  in the preceding paragraph of the Chinese labels, container or outer 
packaging and user instructions which contain the content stipulated by relevant 
authorities other than those specified in this Act shall be subject to the provisions of 
respective regulations.  21 
 For items exempted from modification applications as set forth in the first paragraph, 
the per mit holder shall produce a written record for retention.  
 
Article 25 
Application s for transfer ence  of the permit document  for formula  for certain disease , 
the transferee is required to submit an application form, along with the following 
documents or information, to the central co mpetent authority for review , and pay 
the review  and certificate processing  fees, while the provisions in Article 7 do not 
apply:   
1. Transferor’s certificate or document of consent to transfer of permit document 
ownership in original copy . 
2. In case s of authorized  sales, the original ce rtific ate of authorization  issued b y the 
original manufacturer or distributor  is required.  
3. In case s of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer  is required.  
4. Original permit document . 
5. Two copies each of the physical or color drafts of the Chinese label, container or 
outer packaging , and user instruction s of the product ; the above items shall be 
attached separately  for different packaging specifications, forms, and materials ; 
if the contents of the user instruction s are the same, the user instruction s of any 
specification, form , and materials may be submitted . 
6. Where the product will be re -packed in new containers for sale, the applicant 
shall submit the documents set forth in Article 13 Paragraph 1 Subparagraph 12 
Items 1-4 of the Regulations . 
7. Photocopy of the table of product ingredient content . 
8. Photocopy  of the applicant’s company registration or business registration 
certificate.  
The foregoing d ocuments  or information  in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
 
Article 2 6 
Applications for reissu ance  or replace ment  the permit document for formula  for 
certain disease  review and registration  due to  defacement or loss , the applicant is 22 
 required to submit an application form, along with the following documents or 
information, to the central competent authority , and pay the related fees , while the 
provisions in Article 8 do not apply:  
1. The applicant shall submit the p hotocopy of the applicant’s company 
registration or business registration certificate . 
2. For replacement application, the applicant shall submit the originally issued 
permit document . 
3. For re -issuance application, the applicant shall submit a statement that declares 
the original permit document null and void.  
The new permit document issued under the replacement or reissuance application as 
referred in the preceding paragraph shall bear the same expiration date as the 
original permit document.  
 
Chapter IV  
Review and Registration of Food Additives  
 
Article 2 7  
Applica tions for review and registration of food additives  shall submit an 
application form to the central competent authority with fees paid and the following 
documents and materials attached , while the provisions in Article 3 do not apply : 
1.  Original table of ingredient content : The table shall be issued by the original 
manufacturer within the past one year  and contain the names and content 
percentages of all the ingredients.  
2.  Original product specification: The product specification shall be issued by the 
original manufacturer within the past one year  and contain the specifications of 
the test requirement such as identification, purity and quantification.  
3.  Test m ethod: the test method used on the test requirement in the preceding 
paragraph.  
4.  The origi nal copy of the certificate of analysis: The analysis shall be issued by 
the original manufacturer or an entru sted inspection body  withi n the past one 
year on the requirement specified in the Paragraph 2.  
5.  Essential information of the manufacturing process of the original manufacturer . 
6.  Certification document that that the original manufacturer is legally established 
or registered : 23 
 (1) Domestic manufacturer : photocopy of the factory registration certificate; or, 
in case of an exemption from factory registration, the certificate of company 
or business registration listing the business files of food additive 
manufactur ing, processing, formulation, re-packing , etc., and the certificate 
issued by the competent authority on the exemption from factory 
registration  
(2) Foreign manufacturer : The original certificate issued in its full name by a 
competent government agency in charge of product hygiene and safety or 
factory licensing in the country of origin and dated within the past five 
years, shall be provided. The certificate shall specify the name and address 
of the manufacturer, its business scope, categories of products, and hygien ic 
status of the factory, and full name of the government agency issuing the 
certificate with official stamp or authorized signature . If the certificate  
verifying the legitimacy of the original manufacturer is a copy of the 
original, the document shall be a certified true copy of the original by a 
notary public in the country of origin . 
 7.  In cases of authorized sales, the original certificate of authorization issued by 
the original manufacturer or distributor within the past one year is required.  
 8. In cases of entrusted manufacturing, the original of the entrusted 
manufacturing certificate issued by the entrusted manufacturer within the past 
one year  is required.  
9.  Color photos of the produc t w ith clearly legible label  in Chinese , the 
descriptions of the container or inner and outer packaging materials, and the 
labeling on the container or outer packaging ; for applications for different 
packaging specifications, forms , and materials, color photos to the above effect 
shall  be attac hed for each one of the specifications, types, and materials; for 
products imported from overseas, the labels in original foreign languages shall  
be attached unless the product is not sold in an overseas market.  
 10. In cases of domestic manufacturers , a copy of the review and registration license 
for single food additives that are not spices in ingredients ; and the certificate of 
sources from the food industry for other ingredients . 
 11.  A copy of the company registration or business registration certific ate of the 
applicant, in which the business activities , in the case of importers, shall  include 
the import of food additives, and in cases of domestic manufacturers , shall  
include the food additive manufacture, processing, formulation, re-packing , etc.  
12.  Documents of hygiene management personnel:  24 
 (1) Domestic manufacturer : photocopy of the certification document of the 
manufacturer's hygiene management personnel that has been verified and 
filed by the municipal or county (city) competent authority.  
(2) Foreign manufacturer : The employment certification documents of the 
hygiene management personnel of the appl ying company . 
13. Other essential documents and information specified by the central competent 
authority.  
 The foregoing documents or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by 
a registered translation agency.  
 The permit document issued on the applications filed in compliance with 
Paragraph 1 and approved pursuant to the Act shall be valid for five years.  
 
Article 2 8 
Applica tions for extension of the  permit document  for food additive permit 
document shall submit an application form within three months prior to the expiry 
date of permit, along with the following documents, information, to the central 
competent authority, and shall  pay the related fees , while the provisions in Article 5 
do not apply:  
1. Original permit document . 
2.  In cases of authorized sales, the original certificate of authorization issued by 
the original manufacturer or distributor within the past one year is required.  
3. In cases of entrusted manufacturing, the original certificate of entrusted 
manufacturing issue d by the entrusted manufacturer within the past one year is 
required.  
4. In cases of domestic manufacturers , a copy of the review  and registration license 
for single food additives that are not spices in ingredients ; and the certificate of 
sources from the  food in dustry for other  ingredients . 
The foregoing documents or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
The permit document issued on the  applications for extension filed in compliance 
with Paragraph 1 and approved pursuant to the Act shall be valid for five years. If it 
is necessary to reissue a new permit document , a certificate processing fee shall be 
collected .  25 
 Article 29 
Applica tions  for amendment of the permit document  for food additives shall submit 
an application  form , along with the following documents and information to the 
competent authority, and shall  pay the related  fees, while the provisions in Article 6 
do not apply:  
1.  Changes  of the product name:  
(1) Original permit document.  
(2) In cases of imported products, the original document issued by the 
manufacturer certifying the amendment  of the name of product.  
2.  Changes  of packaging specifications, forms, and materials:  
(1) Original permit document . 
(2) The original document or consent document issued by the manufacturer 
certifying the amendment  of packaging . 
3. Change of the name, address or person in charge of the manufacturer holding 
the permit document:  
(1) Original permit document . 
(2) A copy of the company registration or business registration certificate of the 
applicant, in which the business scope, in the case of importers, shall  include 
the import of food additives, and in case of domestic manufacturers, shall  
include the food additive manufactur ing, processing, formulation, re-
packing , etc.   
(3) The complete list of the licensed products of the manufacturer holding the 
license, specifying the license number , the Chinese name of the product and 
the validity per iod of the permit document.  
4. Amendment  of the name of the original manufacturer:  
(1) Original permit document . 
(2)  Domestic manufacturer : A copy of the factory registration certificate.  
(3)  Foreign manufacturer : An original document issued by the manufacturer 
certifying the change of its name.  
(4) The complete list of the licensed products of the original manufacturer, 
specifying the license number , the Chinese name of the product and the 
validity period of the permit document.  
5. Building number adjustment of the original manufacturer:  26 
 (1) Original permit document . 
(2) Domestic manufacturer : The applicant shall submit a photocopy of the 
official certificate issued by a competent government agency certifying the 
building number adjustment . 
(3) Foreign manufacturer : The original official certificate issued by a competent 
government agency  in its full title  certifying the building number 
adjustment , whereas the certificate submitted is a photocopy, the document 
shall be notarized as a true copy of the  original by a notary public in the 
country of origin.  
(4) A complete list of product items of the original manufacturer shall be 
provided. The list is required to contain the registration numbers, Chinese 
names of product s, and expiry date of the permit document.  
The foregoing documents or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
For the application  process and the submission of documents a nd information, and 
related fees in case of change, relocation,  or expansion of the manufacturer, the 
provisions of Article 27 on new registration applications shall apply mutatis 
mutandis.  
If it is necessary to reissue  a new permit document, a certificate  processing fee shall 
be collected.  
 
Article 3 0 
Application s for transfer ence  of the permit document for food additive, the 
transferee is required to submit an application form, along with the following 
documents or information, to the central competent authority for review, and pay 
the review  and certificate processing  fees, while the pro visions in Article 7 do not 
apply:  
1.  Original permit document . 
2.  Transferor’s certificate or document of consent to transfer of permit document 
ownership in original copy.  
3.  In cases of authorized  sales, the original certificate of authoriz ation issued by the 
original manufacturer or distributor is required.  
4.  In cases of entrusted manufacturing, the original certificate of entrusted 
manufacturing is required.  27 
 5.  Color photos of the product with clearly legible label in Chinese, the 
descriptions of container or the inner and outer packaging materials, and the 
labeling on the container or outer packaging; for applications for different 
packaging specifications, forms, and materials, color photos to the above effect 
shall be attached se parately for each one of the specifications, types, and 
materials; for products imported from overseas, the labels in original foreign 
languages shall be attached.  
6.  A copy of the table of product ingredient content . 
7.  A photocopy of  the applicant’s company registration or business registration 
certificate . For the listing of its business items, the importer shall include the 
import of food additives; the domestic manufacturer shall include the 
manufactur ing, processing, formulation a nd re -packing  of food additives.  
The foregoing documents or information in languages other than English and 
Chinese must be accompanied with English or Chinese translations provided by a 
registered translation agency.  
 
Article 3 1  
Applications for reissuance  or replace ment  the permit document for food additive 
review and registration  due to  defacement or loss , the applicant is required to 
submit an application form, along with the following documents or information, to 
the central competent authority, and pay the related f ees, while the provisions in 
Article 8 do not apply:  
1. The p hotocopy of the applicant’s company registration or business registration 
certificate.  
2.  For replacement application, the permit document originally issued.  
3.  For reissuance application, the applicant’s affidavit that declares the original 
permit document null and void.  
The new permit document issued under the replacement or reissuance application as 
referred in the preceding paragraph shall bear the same expiration date as the permit 
document originally issued.  
 
 
  28 
 Chapter V  
Supplementary Provisions  
 
Article 3 2 
Applications in accordance with the provisions of the Regulations may be filed by 
the food industry operators on the web platform of Taiwan Food and Drug 
Administration, the Ministry of Health and Welfare, with the documents and 
information scanned and upl oaded.  
After completion of applications by food business operators for permit document 
extension, amendment of registration contents, document transfer ence  or document 
replacement pursuant to provisions in the preceding paragraph, the original permit 
document shall be sent to the central competent authority for registration or 
cancellation.  
 
Article 3 3  
The following provisions of these Regulations shall take effect one year after the 
promulgation of the amendment on Nove mber 3 0, 2023. 
1. Article 13 Paragraph 1 Subparagraph 3, Article 15 Paragraph 2 Subparagraph 5 
Item 2, Article 20 Paragraph 1 Subparagraph 3, Article 22 Paragraph 1 
Subparagraph 7, Article 23 Paragraph 2 Subparagraph 5 Item 2, which provide 
original hygiene  analysis report related provisions.  
2. Article 14 Paragraph 1 Subparagraphs 7 and 8, and Article 22 Paragraph 1 
Subparagraph 6.  
 
Article 34  
 Except for provisions with separate enforcement dates as stipulated in the preceding 
Article, these Regulations shall come into eff ect from the date of promulgation.  
 
 
  29 
 Schedule 1 
 
(1) Energy  and Nutritional Value for Infant Formula  
Item Unit of Measurement  Lower limit  Upper limit  
Energy  Kcal/100ml  60 70 
Protein  g/100 kcal  1.8 3 
Fat g/100 kcal  4.4 6 
Linoleic acid  mg/100 kcal  300 - 
Alpha -linolenic acid  mg/100 kcal  50 - 
Carbohydrate  g/100 kcal  9 14 
Vitamin A  μg RE/100 kcal  60 180 
Vitamin D 3 μg/100 kcal  1 2.5 
Vitamin E  mg α-TE/100 kcal  0.5 - 
Vitamin K  μg/100 kcal  4 - 
Vitamin B 1 μg/100 kcal  60 - 
Vitamin B 2 μg/100 kcal  80 - 
Niacin  mg/100 kcal  0.3 - 
Vitamin B 6 μg/100 kcal  35 - 
Vitamin B 12 μg/100 kcal  0.1 - 
Pantothenic acid  mg/100 kcal  0.4 - 
Folic acid  μg/100 kcal  10 - 
Vitamin C  mg/100 kcal  10 - 
Biotin  μg/100 kcal  1.5 - 
Iron mg/100 kcal  0.45 - 
Calcium  mg/100 kcal  50 - 
Phosphorus  mg/100 kcal  25 - 
Magnesium  mg/100 kcal  5 - 
Sodium  mg/100 kcal  20 60 
Chlorine  mg/100 kcal  50 160 
Potassium  mg/100 kcal  60 180 
Manganese  μg/100 kcal  1 - 
Iodine  μg/100 kcal  10 - 
Selenium  μg/100 kcal  1 - 
Copper  μg/100 kcal  35 - 
Zinc  mg/100 kcal 0.5 - 
Choline  mg/100 kcal  7 - 
Inositol  mg/100 kcal  4 - 
L-carnitine  mg/100 kcal  1.2 - 
 
 30 
 Notes:  
1.  The permissible margin of error of the values of energy and nutri tion label  in infant 
formula shall fall within the range between the upper limit and the lower limit 
specified in (1) of this Schedule.  
2.  The content of trans fat (acid) shall not exceed 3% of fat.  
3.  The ratio of linoleic acid to α -linolenic acid shall  be between 5 and 15.  
4. The ratio of calcium to phosphorus shall  be between 1 an d 2. 
5.  RE indicates “Retinol Equivalent”.  
6.  α-TE indicates ”α -Tocopherol Equivalent”.  
7.  Niacin refers to nicotinic acid and nicotinamide.  
8.  Retinol content s shall be provided by preformed retinol, while any content s of 
carotenoid s should  not be included in the calculation and declaration of vitamin A 
activity.  
9.  The composition of infant formula for special medical purposes shall comply with 
the provisions in (1) of this Schedule, except for adjustments based on empirical 
evidence to cope with diseases, disorders or other medical conditions; nutrients like 
chromium and molybdenum may be taken in consideration based on the following 
regulations:  
 
Item  Unit of Measurement  Lower limit  Upper limit  
Chromium  μg/100 kcal  1.5 - 
Molybdenum  μg/100 kcal  1.5 - 
 
 
  31 
 (2) Energy  and Nutritional Value for Follow -up Infant Formula  
Item  Unit  of Measurement  Lower limit  Upper limit  
Energy  Kcal/100ml  60 85 
Protein  g/100 kcal  1.8 4.5 
Fat g/100 kcal  3 6 
Linoleic acid  mg/100 kcal  300 - 
Vitamin A  µg RE/100 kcal  75 225 
Vitamin D  μg/100 kcal  1 3 
Vitamin E  mg α-TE/100 kcal  0.5 - 
Vitamin K 1 μg/100 kcal  4 - 
Vitamin B 1 μg/100 kcal  40 - 
Vitamin B 2 μg/100 kcal  60 - 
Niacin  mg/100 kcal  0.25 - 
Vitamin B 6 μg/100 kcal  45 - 
Vitamin B 12 μg/100 kcal  0.15 - 
Pantothenic acid mg/100 kcal  0.3 - 
Folic acid  μg/100 kcal  4 - 
Vitamin C  mg/100 kcal  8 - 
Biotin  μg/100 kcal  1.5 - 
Iron mg/100 kcal  1 2 
Calcium  mg/100 kcal  90 - 
Phosphorus  mg/100 kcal  60 - 
Magnesium  mg/100 kcal  6 - 
Sodium  mg/100 kcal  20 85 
Chlorine  mg/100 kcal  55 - 
Potassium  mg/100 kcal  80 - 
Iodine  μg/100 kcal  5 - 
Zinc  mg/100 kcal  0.5 - 
Notes:  
1. The permissible margin of error of the values of energy  and nutri tion label in 
follow -up infant formula shall fall within the range between the upper limit and the 
lower limit specified in ( 2) of this Schedule.  
2.  Reference may be made to the limits specified for infant formula in cases of 
nutrients with no upper limit specified in the Schedule.  
3.  Each gram of protein shall  contain no less than 0.015 mg of vitamin B 6. 
4.  The ratio of calcium to phosphorus shall  be between 1 .2 and 2.  
5.  RE indicates “Retinol Equivalent”.  
6.  α-TE indicates ”α -Tocopherol Equivalent”.  
7.  Niacin refers to nicotinic acid and nicotinamide.   32 
 Schedule 2  
Nutritional Value for a Nutritionally Complete F ood  
with Balance d Formula   
Nutrient  Unit of 
Measurement  Per 100 Kcal  Suggested daily 
intake  
Lower Limit  Upper Limit  
Protein  Percentage value  10 25 
Fat Percentage value  20 35 
Carbohydrate  Percentage value  45 65 
Vitamin  A μg RE 27.5 3000  
Vitamin D μg 0.5 50 
Vitamin E mg α-TE 0.6 1000  
Vitamin K μg 5.25 - 
Vitamin C mg 5 2000  
Vitamin B1 mg 0.053 - 
Vitamin B2 mg 0.06 - 
Vitamin B6 mg 0.075 80 
Vitamin B12 μg 0.12 - 
Niacin  mg NE 0.75 35 
Choline  mg 21 3500  
Pantothenic acid  mg 0.25 - 
Folic acid  μg 20 1000  
Biotin  μg 1.5 - 
Calcium  mg 50 2500  
Phosphorus  mg 40 3000  
Magnesium  mg 16.5 700 
Zinc  mg 0.675 35 
Iron mg 0.5 40 
Iodine  μg 7 1000  
Selenium  μg 2.75 400 
Fluorine  mg - 10 
Notes :  
1. The permissible margin of error of the values of nutri tion label shall fall within the range 
between the upper limit and the lower limit specified in this Schedule.  
2. RE indicates  “Retinol Equivalent ”. 
3. α-TE indicates  ”α-Tocopherol Equivalent ”. 
4. NE indicates  “Niacin Equivalent ”. 
5. The upper limit of the suggested daily intake for niacin from nicotinamide is 100 mg.  
6. Copper, manganese, chromium, molybdenum, sodium, potassium, and chloride may be 
added to the product as nutrients in a proper amount pursuant to the provisions of the 
Standards for Specification, Scope, Application and Limitation of Food Additive s.