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, 
inspection, 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, inspection, 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, method of inspection, certificate of 
analysis, nutrition facts,  and essential information of the manufacturing process ; 
2. Complete technical information ; 
3. Labels, packaging, Chinese labeling, product description, sample, and photo of 
the actual product ; 2 
 4. An application filed for imported product review and registration  should 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 origi nal, the 
document should 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 . 
Documents 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  should 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 shall 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 
classification and characteristics .  
Where a n extension shall be required, a pertinent application form complete with the 
permit document and the documents or informa tion herein prescribed in Article 3 
should be filed with the central competent authority for extension approbation  
within three months before expiration . The applicant should 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 certificate shall be 
necessary, a certificate processing fee shall be collected.  
 3 
 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 should be filed with the central competent authority for a mendment of registration 
records. The applicant should 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 should 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 should be filed with the central competent authority 
for replacement or re -issuance. The applicant should pay the examination fee and 
certificate processing fee. Where application is filed due to defacement, the original 
permit document should be surrendered for destructio 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.  
      
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 4 
 due approval, the central competent authority shall issue an official announcement 
declaring the permit docum ent 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 proce dure within 
two months after receiving the official notice of document submission for inspection 
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 will 
result in the rejection of the application . 
 
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 
An applicant for review and registration  of infant  formula  and follow -up infant 
formula  is required to submit an application and the following documents, 
information and samples to the central competent authority  for review , and should 
pay t he related fees:   
1. Original Ingredient List: The list shall be issued by the original manufacturer 
and dated within one year and contain the detailed name and net quantity of 
contents of all the raw materials and food additive.     
2. Original P roduct Specification : The specification shall be issued by the original 
manufacturer and dated within one year and contain the sanitary and nutrients 
specification of the product.  
3. Original N utrients Analysis Report : The report shall be the original issued by the 
original manufacturer or the inspection body approved by the central competent 
authority and dated within one year.   5 
 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. The applicant  is required to submit the 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: 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  bear the full name of the government 
agency and specify the name and address of the manufacturer, its business 
activities, categories of products, hygienic status of the factory , as well as the 
official stamp or authorized signature  of the government agency . If the 
certificate  verifying the legitimacy of the original manufacturer is a copy of 
the original, the docu ment should be a certified true copy of the original by a 
notary public in the country of origin . 
7. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  
8. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and m aterial. However, if the product s in different 
specifications, forms and materials have identical user instructions,  the applicant 
does not need to submit replicate copies.   
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 under review is intended to be repacked in new containers 
for sale  in Taiwan , the applicant shall submit the following documents:  
(1) The manufacturer’s original repacking certificate or the original document of 
consent to product repacking  for imported products;   6 
 (2) The domestic repacking facility’s factory registration certificate in carbon 
copy . Food repacking, processing or manufacturing shall be listed in the 
scope of business stated on the factory registration certificate.  
(3) Where the competent central authori ty deems necessary, the applicant may be 
required to submit the original copy of the nutrition analysis on the repackaged 
sample issued by an inspection body approved by the competent central authority 
within one year.  
(4) If the repacked product on the ap plication will be available in different 
packaging specifications, forms and materials, the applicant is required to 
submit two copies of Chinese product label, box packaging, and user 
instructions for each specification, particular and material. However, if the 
product s in different specifications, forms and materials have identical user 
instructions,  the applicant does not need to submit replicate copies.  
(5) Where the repacked product sample is available in different packaging 
specifications, forms and materials, the applicant is required to submit one 
sample for each option.   
12.  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.  
Permit  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  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 should pay t he related fees : 
1. The original  permit  document ; 
2. The original certificate or document of consent to renewal of the product 
manufacturing agreement, or original  product ingredient list issued by the 
original manufacturer  based on the content of original ly issued permit within  
one year ;  
3. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  7 
 4. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and material. However, if the product s in different 
specifications, forms and materials use identical user instructions,  the applicant 
does not need to submit replicate copies.  
5. 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 produc t with a valid sample size of more than 20 subjects .   
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.  
Permit  document s issued on the foregoing 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 reissue a new permit document , a certificate 
processing fee shall be collected . 
 
Article 1 5 
Applicants seeking to modify the infant  formula  and follow -up infant  formula 
review and registration shall submit an application for modification , along with the 
following documents  and information, to the central competent authority , and 
should pay the related fees : 
1. Original permit document;  
2. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  
3. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and material. However, if the product s in different 
specifications, forms and materials use identical user instructions,  the applicant 
does not need to submit replicate copies.  
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.  8 
 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 registra tion 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 : The applicant shall submit a photocopy of the 
manufacturer’s 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 certi ficate 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 should 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. Change of the original manufacturer’s  address : 
(1) Domestic  manufacturer: T he applicant shall submit a photocopy of the 
manufacturer’s 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 coun try 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 a gency 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 9 
 document should 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 dates of the permit document . 
5. 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 ;  
(2) Product samples are required if changes involve forms  or materials;  
(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 1 1 of the Regulations .  
 6. Change of Chinese label, box packaging, and user instruction of the product:  
(1) 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 ;  
(2) For m odification to the nutrition facts label , the original copy of the nutrition 
facts table issued by the original manufacturer or a n inspection body 
approved by the central competent authority within one year  shall be 
submitted.  
Documents in languages other than English and Chinese must be accompanied 
with English or Chinese translations provided by a registered translation agency.  
The change of product manufacturer shall be subject to the provisions of Artic le 
13. 
If it is necessary to reissue a new permit document , a certificate processing fee 
shall be collected . 
 
Article 16 
Where an application for ownership transfer of a registered permit document for 
infant  formula  and follow -up infant 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:  10 
  
1. Transferor’s certificate or document of consent to transfer of permit document 
ownership in original copy;  
2. For imported product items, the original manufacturer’s certificate or document 
of consent in original copy;  
3. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  
4. Original permit document ;  
5. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and material. However, if the products in different 
specifications, forms and materials use identical user instructions, the applicant 
does not need to submit replicate copies . 
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 (11) 
A-D of the Regulations;  
7. Photocopy of the ingredient list;  
8. Photocopy of the applicant’s  company registration or business registration 
certificate.  
Documents in languages other than English and Chinese must be accompanied with 
English or Chinese translations provided by a registered translation agency.  
 
Article 17 
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 should 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 ; 11 
 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.  
 
Chapter III. Review and Registration of Formula for Certain Disease  
 
Article 18  
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 , 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 reduction shall have scientific evidence base . The other nutrition 
portion of the product shall comply with the regulations provided in the 
Schedule.  
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 12 
 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 contain nutritional values equal to or no less 
than 5% of the dietary reference intakes (DRIs) fo r citizens (except 
fluorine). 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 does not meet the reference intakes provided in Paragraph 
18-2-(1)-A, a domestic clinical study  on the product is required to prove 
that the users of such product will be able to meet the nutritional 
requi rements 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 category  of nutrients or ingredients.  
B.   The element  shall be limited to those allowed for special dietary foods.  
C.  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 1 9 
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 Ingredient List: The list shall be issued by the original manufacturer 
and dated within one year and contain the detailed name and net quantity of 
contents of all the raw materials and food additive.     
2.  Original Final Product Specification: The final product specification shall be the 
original issued by the original manufacturer and dated within one year and 
contain the sanitary and nutrients specification of the final product.  13 
 3. Original Nutrients  Analysis Report: The nutrients  analysis report shall be the 
original issued by the original manufacturer or the inspection body approved by 
the central competent authority and dated within one year.   
4. Manufacturing process  summary.  
5. Original official certificate verifying the legitimacy of the original manufacturer :  
(1) Domestic manufacturer: The applicant shall submit a 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 or iginal manufacturer is a copy of the original, the 
document should be a certified true copy of the original by a notary public in 
the country of origin . 
6. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  
7. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and m aterial. However, if the product s in different 
specifications, forms and materials use identical user instructions,  the applicant 
does not need to submit replicate copies.   
8. The applicant shall submit a carbon copy of its company registration or business  
registration certificate.  
9. 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.  
10. 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 1 1 of the Regulations.  
11. All applicants, except for nutritionally complete food with balanced formula, are 
required to submit the following:   14 
 (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 docu ments ; 
(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) Where a clinical study  for the product has been c onducted in a site outside of 
the territory of Taiwan, the applicant is required to submit documents that 
prove ethnic insensitivity of the product. Where the product under 
application fits the description provided in Paragraph 2 Subparagraph (1) -B 
of the preceding article, a domestic study report is required . 
12. 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 indicato rs.  
13.  Other essential documents.  
Documents in languages other than English and Chinese must be accompanied with 
English or Chinese translations provided by a registered translation agency.  
The central competent authority may call an expert advisory consultation meeting 
for the purpose of reviewing the application  specified in Paragraph 1 . Where 
necessary, the applicant may be required to attend the meeting to do a presentation 
or answer questions.  
The permit document issued on applications specified in Paragraph 1 and filed and 
reviewed pursuant to the Regulations shall be valid for five years.  
 
Article 20 
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, information, product sample, to the central 
competent authority , and pay the related fees :  15 
 1. Original permit document ; 
2. The original certificate or document of  consent to renewal of the product 
manufacturing agreement, or original product ingredient list issued by the 
original manufacturer based on the content of originally issued permit within 
one year.  
3. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  
4. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user  instructions for each 
specification, form and material. However, if the product s in different 
specifications, forms and materials use identical user instructions,  the applicant 
does not need to submit replicate copies.  
5. Original Nutrients Analysis Repor t: The report shall be the original issued by the 
original manufacturer or the inspection body approved by the central competent 
authority and dated within three years.  
6. Clinical study  report for the product under application (applications for 
nutritionally complete food  with balanced formula is exempted from the 
requirement)  
Documents in languages other than English and Chinese must be accompanied with 
English or Chinese translations p rovided by a registered translation agency.  
Permit 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 reissue 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. All appli cants who seek to extend the permit document 
then will need to ensure conformity to all requirements provided in the Paragraph 1  
by December 31, 2021.  
 
Article 2 1 16 
 Applicants seeking to modify the formula  for certain disease  review and registration 
shall su bmit 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. A contract manufacturer is required to provide the original copy of the 
manufacturing  contract.  
3. If the product on the application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and material. However, if the product s in different 
specifications, forms and materials use ident ical user instructions,  the applicant 
does not need to submit replicate copies.   
In addition to the requirements  in the preceding paragraph , the following 
documents , information or sample shall be additionally submitted according to the 
application of modi fication:  
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 : The applicant shall submit a photocopy of the 
manufacturer’s factory registration certificate;  
(2) Foreign manufacturer: The original official certificate issued by a competent 
government agency responsible for product hygiene and safety or facto ry 
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 17 
 legitimacy of the original manufacturer is a copy of the original, the 
document should 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. Change of the original manufacturer’s address:  
(1) Domestic manufacturer: The applicant shall submit a photocopy of the 
manufacturer’s 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 bu siness 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 should 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. T he list is 
required to contain the registration numbers, Chinese names of the product 
items, and expiry date of the permit document . 
5. Modification to the packag ing specification, form and material:  
(1) For imported product items, the original manufacture r’s certificate or 
document of consent to the change of packaging in original copy shall be 
submitted ;   
(2) Product samples are required if such change involve s product form  or 
material;  
(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 1 of the Regulations.  
 6. Change of Chinese label, box packaging, and user instruction of the product:  18 
 (1) 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 ;  
(2) For modification to the nutrition fact s label, the original copy of the nutrition 
facts table issued by the original manufacturer or an inspection body 
approved by the central competent authority within one year shall be 
submitted.  
Documents in languages other than English and Chinese must be  accompanied 
with English or Chinese translations provided by a registered translation agency.  
The change of product manufacturer shall be subject to the provisions of Article 
19. 
If it is necessary to reissue a new permit document , a certificate processing fee 
shall be collected . 
 
Article 22 
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 
authority for review , and should 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. For imported product items, the original manufacturer’s certificate or document 
of consent in original copy;  
3. A contract manufacturer is required to provide the original copy of the 
manufacturing contract.  
4. Original permit document;  
5. If the product on t he application will be available in different packaging 
specifications, forms and materials, the applicant is required to submit two 
copies of Chinese product label, box packaging, and user instructions for each 
specification, form and material. However, if the product s in different 
specifications, forms and materials use identical user instructions,  the applicant 
does not need to submit replicate copies;  19 
 6. Where the product will be re -packed in new containers for sale, the applicant 
shall submit the docu ments set forth in Article 13 Paragraph 1 Subparagraph 11 
A-D of the Regulations;  
7. Photocopy of the ingredient list;  
8. Photocopy of the applicant’s company registration or business registration 
certificate.  
Documents in languages other than English and Chinese must be accompanied with 
English or Chinese translations provided by a registered translation agency.  
 
Article 2 3 
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 should pay the related fees:   
1. The applicant shall submit the p hotocopy of the applic ant’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 origi nal 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 I V. Supplementary Provisions  
 
Article 2 4 
The Regulations shall take effect immediately upon promulgation.  
 
  20 
 Schedule  
Nutritional Value for a Nutritionally Complete F ood  
with Balance d Formula   
Nutrient  Unit of 
measurement  Per 1500  Cal 
Lower Limit  Upper Limit  
Protein  Percentage value  10 25 
Fat Percentage value  20 35 
Carbohydrate  Percentage value  45 65 
Vitamin  A μg RE 412.5  3000  
Vitamin D μg 7.5 50 
Vitamin E mg α-TE 9 1000  
Vitamin K μg 78.75  - 
Vitamin C mg 75 2000  
Vitamin B1 mg 0.79 - 
Vitamin B2 mg 0.9 - 
Vitamin B6 mg 1.125  80 
Vitamin B12 μg 1.8 - 
Niacin  mg NE 11.25  35 
Choline  mg 315 3500  
Pantothenic acid  mg 3.75 - 
Folic acid  μg 300 1000  
Biotin  μg 22.5 - 
Calcium  mg 750 2500  
Phosphorus  mg 600 3000  
Magnesium  mg 247.5  700 
Zinc  mg 10.125  35 
Iron mg 7.5 40 
Iodine  μg 105 1000  
Selenium  μg 41.25  400 
Fluorine  mg - 10 
 
Footnote:  
1. The upper and lower limits  of nutrients on the Schedule indicate the margin of error 
allowed for the stated value versus actual value.  
2. RE indicates  “Retinol Equivalent ”. 
3. Vitamin D shall be measured by the quantity of vitamin D3 (Cholecalciferol)  21 
 4. α-TE indicates  ”α-Tocopherol Equivalent ”. 
5. NE indicates  “Niacin Equivalent ”. 
6. The maximum value for niacin from nicotinamide is 100  mg NE/1500 Kcal.  
7. Copper, manganese, chromium, molybdenum, sodium 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.  
 
 
 