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 examination, 
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 
Unless otherwise provided by these Regulations , a food business operator applying 
for review and registration  with the central competent authority shall complete an 
application form, pay the due examination,  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 ; 2 
 4. An application filed for imported product review and registration  shall  be 
attached with the official substantiating documents certifying that the original 
manufacturer is the legitimate manufacturer ; if the  substantiating document 
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 ; 
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 . 
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 applications in the first paragraph, the food business operator shall  file 
applications at the online application platform of the Food and Drug 
Administration of the Ministry of Health and Welfare (hereinafter referred to as 
the online platform), with the documents and attachments scanned and uploaded 
and the original copies retained with the applicant.  
 
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 examination procedure and issues a notification letter advising the permit 
document issuance. Failure of applicant to claim the permit document within the 
deadline sha ll constitute the abandonment of application; whereupon, the central 
competent authority is entitled to process the nullification of the issued permit 
document .  
 
Article 5  
Unless otherwise provided by these Regulations , 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 
classif ication 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 3 
 shall  be filed with the central competent authority for extension approbation  within 
three months before expiration . The applicant shall  pay the examination 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 certific ate shall be necessary, a 
certificate processing fee shall be collected.  
 
Article 6 
Unless otherwise provided by these Regulations , in the event of changes 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 examination fee when filing an application. Where 
issuance of a new certificate shall be necessary, a certificate processing fee shall be 
collected.  
 
Article 7  
Unless otherwise provided by these Regulations , 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 examination fee shall be collected . Additionally, if the 
permit document is a certificate , a certificate processing fee  shall be collected.   
 
Article 8 
Unless otherwise provided by these Regulations , 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 re -issuance. The applicant shall  pay the examination fee and certificate 
processing fee. Where application is filed due to defacement, the original permit 
document shall  be surrendered for d estructio n. 
The new permit  document  issued under the replacement or re -issuance application as 
referred in the preceding paragraph shall bear the same expiration date as the original 
permit  document . 
 
Article 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.  
      4 
 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.  
 
Article 11  
A food business operator applying for the review and registration and the permit 
document replacement, re -issuance, extension, transfer, 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 f rom 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 
Applicant s 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:   
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 5 
 and nutrients specification of the product.  Its energy  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.  
3. Original hygiene and nutrients analysis report : The report shall be the original 
issued by the original manufacturer or a food  testing institution accredited 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. Original official certificate verifying  the legitimacy of the original manufacturer .  
(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 certif icate 
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 case s of authorized sales, the original certificate of authorized  sales 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 product label, outer 
box packaging  and user instruction ; for those who apply for different packaging 
specifications, forms , and materials, the above items shall  be attached separately ; 
if the contents of the user instruction  are the sam e, the user instruction  of any 
specification form , and materials may be submitted.   
10. The applicant shall submit a carbon copy of its company registration or business 
registration certificate .  6 
 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.  
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 registration certificate.  
(3) The original copy of the hygiene and nutrition analysis report on the re -packed 
sample issued within the past one year by the original manufacturer or a food 
testing institution accredited by the central competent authority.  
(4) Two copies each of the physical or color draf ts of the Chinese label  of the re -
packed product , outer box packaging and user instruction ; for those who 
apply for different packaging specifications, forms , and materials, the above 
items shall  be attached separately; if the contents of the user instruction  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.  
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 specified in Paragraph 1 and 
filed and reviewed pursuant to the Regulations shall be valid for five years.  
 
Article 14 
Applicants seeking to extend a 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 : 
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 case s of authorized  sales, the original certificate of authorized  sales 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 Chinese product label, outer 
box packaging and user instruction ; for those who apply for different packaging 
specifications, forms , and materials, the above items shall  be attached separately; 
if the contents of the user instruction  are the same, the user instruction of any 
specification, form , and materials may be submitted.  
6.  Description of product usage: The report issued or sig ned by the original 
manufacturer describing the situations of domestic 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; in case the above is not provided  within one year after th e amendment 
and promulgation of the Regulations on _______, 20__ , 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 can be used as substitute to meet the requirement.  
7.  Original hygiene and nutrients specification  issued by the original manufacturer 
within the past one year.  
8. Original hygiene and nutrients analysis report  of the latest batch of production 
issued by the original manufacturer or a food  testing institution  accredited by the 
central competent authority .   
The foregoing documents or information in languages other than English and Chinese 
must be accompanied wit h English or Chinese translations provided by a registered 
translation agency.  
The p ermit  document s issued on the extension applications specified in Paragraph 1 
and filed and reviewed pursuant to the Regulations shall be valid for five years. If it 
is necessary to re-issue a new permit document , a certificate processing fee shall be 
collected . 8 
  
Article 1 5 
Applicants seeking to modify the infant  formula  and follow -up infant  formula review 
and registration shall submit an application  form , along with the following documents  
or information, to the central competent authority , and pay the related fees : 
1. Original permit document . 
2. Two copies each of the physical or color drafts of the Chinese product label, outer 
box packaging and user instruction  when changes are involved; for those who 
apply for different packaging specifications, forms , and materials, the above items 
shall  be attached separately; if the contents of the user instruction  are the same, 
the user instruction of any specification, form , and materials may be submitted.  
In addition to the foregoing requirements, the following documents , information  or 
sample shall be additionally submitted according to the application of modification :  
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 of 
the factory, and full name of the government agency issuing the certificate 
with official stamp or authorized sign ature . 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 . 9 
 (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. Address 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 government agency certifying 
the address building number adjustment . 
(2) In cases of foreign manufacturers : The original official certificate issued by a 
competent government agency certifying the address 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 publ ic 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. Change of the product specifications (with no changes of the product ingredients 
and content):  
(1) The e valuation report on the rationale of changes issued by the original 
manufacturer within the past one year (including a chart of comparison of the 
content before and after the changes ). 
(2) The documents set forth in Article 13, Paragraph 1 Subparagraphs 1 to 3.  
6. Modification 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 . 
(3) Where the product will be re -packed in new containers for sale, the applicant 
shall s ubmit the documents and sample set forth in Article 13 Paragraph 1 
Subparagraph 12 of the Regulations.  
7. Change of Chinese label, box packaging, and user instruction of the product:  
(1)  A chart of comparison of the content before and after the change s. 10 
 (2) For imported product items, the original manufacturer’s certificate or 
document of consent to the change of Chinese label, box packaging , and user 
instruction in original copy shall be submitted . 
(3) For m odification to the nutrition facts label  (with no changes of the product 
ingredients and content ):  
A. The evaluation report on the rationale of changes issued by the original 
manufacturer within the past one year, and the original copy of the 
nutrition analysis report issued by the original manufactur er or a food  
testing institution  accredited by the central competent authority within 
the past one year.  
B.  The documents set forth in Article 13, Paragraph 1 Subparagraphs 1 to 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.  
In cases of change, moving, or adding of the manufacturer , the application process, 
documents and information, product samples, and related fees shall mutatis 
mutandis to  the provisions of Article 13.   
If it is necessary to re-issue a new permit document , a certificate processing fee 
shall be collected . 
 
Article 16 
Applications f or the change of Chinese label, box packaging, and user instruction of  
the product  are exempted , if only the following situations are involved:  
1.  Change 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.  Change of the fonts of the approved text.  
5.  Changes of marks not governed by the Regulations.  
For the above modifications, the holder of the permit document shall retain a written 
record.  
 
Article 1 7 
Where an application for ownership transfer of a regis tered permit document for 
infant  formula  and follow -up infant formula is filed, the transferee is required to 11 
 submit an application form, along with the following documents  or information , to 
the central competent authority  for review , and pay the examination  and certificate 
processing  fees:  
 
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 authorized  sales 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 product label, outer 
box packaging and user instruction ; for those who apply for different packaging 
specifications, forms , and materials, the above items shall  be attached separately; 
if the c ontents of the user instruction  are the same, the user instruction 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 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 18 
For applications to re-issue or replace 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 :  
1. The applicant shall submit the p hotocopy of the applicant’s company registration 
or business registration certificate . 12 
 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 re -issuance 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 :  
(1)  Nutritionally complete food with balanced formula that may be used as the 
single source of nutrients: 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  that may be used as the 
single  source of nutrients:  
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 redu ction shall have scientific evidence base . The other nutrients shall 
mutatis mutandis to the regulations provided in Schedule 2.  
2. Nutrition supplement formula food :  
(1) Nutrition  adjusted s upplement ary formula  food  that cannot be used as the 
single source of nutrients : The products in this category are designed to be 13 
 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 have scientific evidence 
base . 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 specified in the Standards for 
Specification, Scope, Application and Limitation of Food Additive.  
B. Where the non-customized nutrition  portion of the product under 
application per 100 Kcal does not reach the lower limit a s 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  that cannot be used as the single source of 
nutrients:  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 element  shall be a single nutritional additives within the domain of 
food additives.  
B.   There is scientific evidence that this element is es sential for the nutritional 
needs deriving from specific illness or metabolic  needs . 
The products as referred in the preceding paragraph  may use other food  
ingredients  or additives to meet the flavoring or processing requirements.   
 
Article 20 
Applicants 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 : 
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.  14 
 3. Original hygiene and nutrients analysis report: The report shall be the origina l 
issued by the original manufacturer or a food  testing institution  accredited by the 
central competent authority and dated  within the past one year.    
4. Manufacturing process summary.  
5. Original official certificate verifying the legitimacy of the original manufacturer :  
(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 o riginal by a notary public in the country 
of origin . 
6. In case s of authorized sales, the original certificate of  authorized  sales 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 . 
8. Two copies each of the physical or color drafts of the Chinese product label, outer 
box packaging and user instruction ; for those who apply for different packaging 
specifications, forms, and materials, the above items shall  be attached separately; 
if the contents of the user instruction  are the same, the user instruction of any 
specification, form, and materials may be su bmitted.   
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:   15 
 (1) Information on the specific nutritional requirement for intended product users 
that would other wise 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 study : In cases of products with the same nutritional specifications  
and no influence on safety , but different pigments, flavors or sweeteners, one 
copy of the report may  be attached in 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 ind icators.  
14.  Other essential documents.  
For applications, under the same nutritional specifications and no influence on safety , 
changing pigments, flavors or sweeteners of approved products , the clinical study in 
Paragraph 1, Subparagraph 12, Item 5  may be exempted . 
The d ocuments or information  specified in Paragraph 1 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 specified in Paragraph 1 and filed 
and reviewed pursuant to the Regulations 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, 
may 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 applicant t o make payment for the review 
expenses and to submit necessary documents and information within the designated 16 
 time. Failure to make payment , to submit documents and/or information  not 
completed within the designated time may result in the rejection of application with 
no further notice.  
 
Article 2 2 
Applicants seeking to extend a 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, info rmation  and product sample, to the central 
competent authority, and pay the related fees:  
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 authorized sales issued by 
the original manufacturer or distributor  is requi red. 
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 Chinese product label, outer 
box packaging and user  instruction ; for those who apply for different packaging 
specifications, forms, and materials, the above items shall  be attached separately; 
if the contents of the user instruction  are the same, the  user  instruction of any 
specification, form, and materials may be submitted.  
6. Original hygiene and nutrients specification  issued by the original manufacturer 
within the past one year.  
7.  Original hygiene and nutrients analysis report of the latest batch of  production 
issued by the original manufacturer or a food  testing institution inspection body  
accredited by the central competent authority.  
8. Clinical study report for the product under application (applications for 
nutritionally complete food with balanced formula or with attaching 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.  17 
 The p ermit documents issued on the extension applications specified in Paragraph 1 
and filed and reviewed pursuant to the Regulations shall be valid for five years.  If it 
is necessary to re-issue a new permit document , a certificate processing fee shall be 
collected . 
For products with a permit document issued prior to the amendment of the 
Regulations on April 10, 2019, in the  event that the product is determined to be non -
conforming to the criteria and requirements herein or that the applicant fails to submit 
a clinical study  report for the product, the existing permit may be extended up to 
December 31, 2022. Applicants who di d not apply for an extension before December 
31, 2021, shall not apply for another extension.  
 
Article 2 3 
Applicants seeking to modify the formula  for certain disease  review and registration 
shall submit an application form, along with the following documents or information, 
to the central competent authority , and pay the related fees : 
1. Original permit document . 
2. Two copies each of the physical or color drafts of the Chinese  product  label, outer 
box packaging and user instruction  when changes are involved; for those who 
apply for different packaging specifications,  forms , and materials, the above items 
shall  be attached separately; if the contents of the user instruction  are the same, 
the user instruction of any specification, form , and materials may be submitted.  
In addition to the  foregoing  requirements, the following documents , information or 
sample shall be additionally submitted according to the applicatio n of modification:  
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 ite ms 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 manufacturer’s name:  
(1) Domestic manu facturer : Carbon copy of the factory registration certificate.  18 
 (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 or igin. 
(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. Address 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 government agency certifying 
the address building number adjustment . 
(2) In cases of foreign manufacturers : The original official certificate issued by a 
competent government agency certifying the address 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 date of  the permit document . 
5.  Change of the product specifications (with no changes of the product ingredients 
and content ): 
(1) The e valuation report on the rationale of changes 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 to 3.  
6. Modification 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 . 19 
 (2) Product samples are required if change s involve product form s or material s. 
(3) Where the product w ill 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. Change of Chinese label, box packaging, and user instruction 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 the change of Chinese label, box packaging, and user 
instruction in original copy shall be su bmitted . 
(3) For modification to the nutrition facts label (with no changes of the product 
ingredients and content):  
A.  The evaluation report on the rationale of changes issued by the original 
manufacturer within the past one year, and the original copy of the 
nutrition analysis report issued by the original manufacturer or a food  
testing institution  accredited by the central competent authority within 
the past one year.  
B.  The documents set fo rth in Article 20, Paragraph 1, Subparagraphs 1 to 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.  
In cases of change, moving, or adding of the manufacturer, the application process, 
documents and information, product samples, and related fees , except that the 
clinical study under Article 20, Paragraph 1, Subparagraph 12, Item 5 is exempted,  
shall muta tis mutandis to the pr ovisions of Article 1 9.  
If it is necessary to re-issue a new permit document , a certificate processing fee 
shall be collected . 
 
Article 2 4 
Applications f or the change of Chinese label, box packaging, and user instruction of 
the product  are exempted , if only the following situations are involved:  
1.  Change 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.  20 
 4.  Change of  the fonts of the approved text.  
5.  Changes of marks not governed by the Regulations.  
For the above modifications, the holder of the permit document shall retain a written 
record.  
 
Article 25 
Where an application for ownership transfer of a registered permit document for 
formula  for certain disease  is filed, the transferee is required to submit an application 
form, along with the following documents or information, to the central competent 
auth ority for review , and pay the examination  and certificate processing  fees:  
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 authorized  sales 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 product label, outer 
box packaging and user instruction ; for those who apply for different packaging 
specifications, forms , and materials, the above items shall  be attached separately; 
if the c ontents of the user instruction  are the same, the user instruction 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 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 21 
 For applications to re -issue or replace the permit document for formula  for certain 
disease  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:   
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 re -issuance 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  
An applica nt applying f or 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:  
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 requir ement such as identification, purity and quantification.  
3.  Test m ethod  : the test method used on the test requirement in the preceding 
paragraph.  
4.  The original copy of the certificate of analysis: The analysis shall be issued by the 
original manufacturer or an entrusted testing institution within the past one year 
on the requirement specified in the Paragraph 2.  
5.  Essential information of the manufacturing process of the original manufacturer . 22 
 6.  The official substanti ating documents certifying that the original manufacturer  is 
the legitimate registration manufacturer : 
(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 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 five 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 n ame 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 case s of authorized  sales, the original certificate of authorized  sales issued by 
the original manufacturer or distributor  is required.  
 8. In cases of entrusted manufacturing, the original of the entrusted manufacturing 
certificate issued by the entrusted manufacturer is required.  
9.  Color photos of the product with the Chinese label, the descriptions of the inner 
and outer packaging materia ls, and the labeling on the outer packaging are all 
clearly identifiable; for applications for different packaging specifications, forms , 
and materials, color photos to the above effect shall  be attached for each one of 
the specifications, types, and mater ials; 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 fo od 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 certificate 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.  23 
 12.  Documents of hygiene management personnel:  
(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 certification documents o f the hygiene 
management personnel of the applicant.  
13. Other essential documents.  
 The foregoing documents or information in languages other than English and 
Chinese must be accompanied with an English or Chinese translation provided 
by a registered translation agency.  
 The p ermit documents issued on the applications specified in Paragraph 1 and 
filed and reviewed pursuant to the Regulations shall be valid for five years.  
 
Article 2 8 
Applicants seeking to extend the 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:  
1. Original permit document . 
2.  In case s of authorized  sales, the original certificate of authorized  sales 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. In cases of domestic manufacturers , a copy of the review  and registration license 
for single food additives that are not s pices 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 an English or Chinese translation provided by a r egistered 
translation agency.  
The permit documents issued on the applications for extension specified in Paragraph 
1 and filed and reviewed pursuant to the Regulations shall be valid for five years. if 
the certificate shall  be renewed, a certificate fee shall be paid.  
 
Article 29 24 
 Applicants seeking to modify registered items on a 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:  
1.  Change of the product  name : 
(1) Original permit document.  
(2) In cases of imported products, the original document issued by the 
manufacturer certifying the change of the name of product.  
2.  Change of packaging specifications, forms, and materials:  
(1) Original permit document . 
(2) The original document or consent document issued by the manufacturer 
certifying the change 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 period of the permit document.  
4. Change 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. Address building number adjustment of the original manufacturer:  
(1) Original permit document . 25 
 (2) Domestic manufacturer : The applicant shall submit a photocopy of the official 
certificate issued b y a competent government agency certifying the address 
building number adjustment . 
(3) Foreign manufacturer : The original official certificate issued by a competent 
government agency certifying the address building number adjustment . 
(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 Engli sh and Chinese 
must be accompanied with an English or Chinese translation provided by a registered 
translation agency.  
In cases of change, moving, or adding of the manufacturer, the application process, 
documents and information, product samples, and relat ed fees shall mutatis mutandis 
to  the provisions of Article 27.  
If it is necessary to renew a new permit document, a certificate processing fee shall be 
collected.  
 
Article 3 0 
Where an application for ownership transfer of a registered permit document for  food 
additive formula is filed, 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 examination  and certificate processing  fees:  
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 authorized sales issued by 
the original manufacturer or di stributor is required.  
4.  In cases of entrusted manufacturing, the original of the manufacturing contract . 
In cases of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer is required.  
5.  The Chinese product label, the description document of the inner and outer 
packaging materials, and the color photo of the product with the content of the 
packaging label clearly identifiable; those who apply  for different packaging 
specifications, forms , and materials, each specification, form , and material shall  
be attached separately; The importer shall  attach the original label . 26 
 6.  A copy of the table of ingredient content . 
7.  A photocopy of  the applicant’s company registration or business registrat ion 
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, and re -packing  of food additives.  
The foregoing documents or information in languages other than English and Chinese 
must be accompanied with an English or Chinese translation provided by a registered 
translation agency.  
 
Article 3 1  
For applications to re -issue or replace the permit document for food additive 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:  
1. The applicant shall sub mit 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 reissuance 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 re -issuance application as 
referred in the preceding paragraph shall bear the same expiration date as the original 
permit document.  
 
  27 
 Chapter V Supplementary Provisions  
 
Article 3 2 
For applications filed in accordance with the provisions in Chapters II to IV of the 
Regulations, including their uploading and retention, the provisions of Article 3, 
Paragraph 3 shall apply mutatis mutandis.  
The application in the preceding paragraph, except for reissuance due to document 
loss, shall  have the original permit document sent to the central competent authority 
for registration or cancellation.  
 
Article 3 3  
The Regulations shall take effect immediately upon promulgation.  
The Regulations amended and promulgated on ______, 20_____, shall take effect 
immediately upon promulgation,  except that Article 13 Paragraph 1 Subparagraph 3, 
Article 15 Paragraph 2 Subparagraph 5 Item 2, Article 20 Paragraph 1 Subparagraph 
3, Article 2 2 Paragraph 1 Subparagraph 7 , Article 2 3 Paragraph 2 Subparagraph 5 Item 
2, which provide original hygiene  analysis report  related provisions , and Article 14 
Paragraph 1 Subparagraphs 7 and 8, and Article 2 2Paragraph 1 Subparagraph 6  shall  
take effect  one year after the date of promulgation.   
 
 
  28 
 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 - 
Notes:  29 
 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 and 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  shall  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, excep t 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 - 
 
 
  30 
 (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.  
  31 
 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 maximum value for niacin from nicotinamide is 100  mg NE/1500 Kcal.  
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.