DRAFT AMENDMENT OF THE “REGULATIONS GOVERNING THE MANAGEMENT OF THE 
REVIEW , REGISTRATION , AND PERMIT ISSUANCE OF FOOD AND RELATED PRODUCTS ” 
*THE NAME OF THE REGULATIONS HAS BEEN CHANGED TO THE “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 Sanitation.  
 
Article 2 
The term “review and registration” herein stated refer to the examination, inspection, 
and registration of related matters and the issuance of permit docu ments .  
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.  
 
Article 3 
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 the following documents or information  to 
the application form : 
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 ; 
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 legit imacy 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 ; 
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 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  
Permit document s issued on applications filed pursuant to the provisions of Article  
21 Paragraph 1 of the Act shall have a validity period ranging from one to five years  
subject to the announcement made by the central competent authority based on the  
product classification and characteristics . Where a n extension shall be required, a 
pertinent application form complete with the permit document and the documents 
or information herein prescribed in Article 3 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.  Article 6 
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 amendment of registration records. The applicant should pay the 
examination fee when filing an application. Where issuance of a new certificate shall 
be necessary, a ce rtificate processing fee shall be collected.  
 
Article 7  
In the event of permit document ownership transfer, an application form complete 
with the documents or information herein prescribed in Article 3 should be filed 
with the central competent authority for the transfer registration. An examination fee 
and a certificate processing fee shall be collected.  
 
Article 8 
In the event of the defacement or loss of a  permit document , an application form 
complete with a statement of reason for application and the d ocuments 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 defac ement, the 
original permit document should be surrendered for destruction; where application 
is filed due to loss, an application for the nullification of the original permit 
document should be filed.  
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   
Where the manufacture or importation of a product is officially banned under th e 
Regulations , the original permit document issued for which shall be nullified.  
      
Article 10  
A food business operator applying for the cancellation of its permit document for 
reasons of its own may submit a statement of reasons and the pertinent application 
form complete with the permit document and related documents or information to 
the central competent authority for cancellation. 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 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 shall 
constitute abandonment of application; whereupon, the central competent authority 
is entitle d to conclude the case.  
 
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.  
Where the review and registration matters referred in the preceding paragraph 
involve marks and standard drawi ngs, such matters shall be subject to the definition 
of the central competent authority pursuant to the product classification.  
 
Chapter II. Review and Registration of Formula for Infants and Toddlers  
 
Article 1 3 
An applicant for  review and registration  of a formula for infants and toddlers 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 I ngredient 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.   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 , a 
product sample, as well as  a product review 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 : Carbon 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 .  
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 produc t 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;   
(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 authority 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 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 sp ecification,  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.   
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 . 
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 a formula for infants and 
toddlers shall submit an application for extension , 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.  
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 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.  
5. The original substantiating document verifying the product is for sale in a 
market outside the territory of Taiwan,  a product sample, as well as a product 
review of the product with a  valid sample size of more than 20 subjects .   
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 . 
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.  
 
Article 1 5 
Applicants seeking to modify the infant and toddler 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.  
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 : 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 certificate shall s pecify the name and address of the 
manufacturer, its business activities, categories of products, hygienic status 
of the factory, and full name of t he government agency issuing the certificate 
with official stamp or authorized signature ; 
(3) A complete lis t 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 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 fac tory, and full name of t he government agency issuing the certificate 
with official stamp or authorized signature ; 
(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 Article 
13. 
 
Article 16 
Where an application for ownership transfer of a registered permit document for an 
infant and toddler 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 related 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 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 i ngredient 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 an infant and toddler 
formula  review and registration , 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 ; 
3. For reissuance application, the applicant shall submit a statement that declares 
the original permit document null and void.  
 
Chapter III. Review and Registration of a Disease -Specific Formula  
 
Article 18  
Disease -specific formulae are 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 with re -balancing da ily diet. The products in 
this category are processed or formulated according to the needs of the target users. 
The products include:  
1. Nutritionally complete food with balanced formula :  
(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 imitating a customized diet 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 be scienti fically proven . The other nutrition 
portion of the product shall comply with the regulations provided in the 
Schedule.  
2. Nutrition supplement formula food :  
(1) Nutrition supplement formula  food  that cannot be used as the single source 
of nutrients :  
A. The products in this category are designed to be used as nutrition 
supplement for patients of specific dietary needs. The nutrient addition 
or reduction shall be scientifically proven. 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) for 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 trial 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 single -nutrient 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 dietary needs deriving from  specific illness  
or metabolic needs . The ingredients shall be limited to those allowed for 
special dietary foods. The products in this category may use food material or 
additives to meet the flavoring or processing requirements.   
 
Article 1 9 Applicants for review and registration of a disease -specific 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 I ngredient 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 F inal 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.  
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 th e factory, and full name of the government agency issuing the certificate 
with official stamp or authorized signature.  
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:   
(1) Information on the specific nutritional requirement for intended product 
users that would otherwise not be met without the product due to illness or 
medical conditions, along with supporting documents ; 
(2) Information on why the intended users cannot otherwise meet the specific 
nutritional requirement described in the preceding subparagraph from the 
daily diet, along with supporting document s;  
(3) The mechanism behind the product design;  
(4) Information on how  the intended use and quantity of intake of the product 
help the users to achieve the objectives described in subparagraphs (1) and (2) 
of this paragraph, along with supporting documents;   
(5) Where a clinical trial for the produ ct has been conducted 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 arti cle, 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.  
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 a disease -specific formula shall 
submit an application form , along with the following documents, information, 
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 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 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.  
5. Original N utrients Analysis Report : The report shall be the original issued by the 
origi nal manufacturer or the inspection body approved by the central competent 
authority and dated within three years.  
6. Clinical trial report for the product under application (applications for 
nutritionally complete food  with balanced formula is exe mpted from the 
requirement)  
Documents in languages other than English and Chinese must be accompanied with 
English or Chinese translations provided 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.  
For products with a permit document issued prior to the amendment of the 
Regulations on _________ (date), 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 trial report for the product, th e existing permit may be extended up 
to December 31, 2022. All applicants 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 21 
Applicants seeking to modify the disease -specific for mula product 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. 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 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  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 : The applicant shall su bmit 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 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 t he government agency issuing the certificate 
with official stamp or authorized signature ; 
(3) A complete list of product it ems 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: T he applicant shall submit a photocopy of the 
manufacturer’s factory registration certificate ; 
(2) Foreign manufacturer: T he 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 t he government  agency issuing the certificate 
with official stamp or authorized signature ; 
(3) A complete list of product items of the original manufacturer. The 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 manufacturer’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 : 
(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 Eng lish or Chinese translations provided by a registered translation agency . 
The change of product manufacturer shall be subject to the provisions of Article 
19. 
 
Article 22 
Where an application for ownership transfer of a registered permit document for a 
disease -specific formula product  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 related 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 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 ; 
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 i ngredient 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 a disease -specific 
formula review and registration , 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 ; 
3. For reissuance application, the applicant shall submit a statement that declares 
the original permit document null and void.  
 
Chapter I V. Supplementary Provisions  
 
Article 2 4 
The Regulations shall take effect immediately upon promulgation.  
 
  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 low 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)  4. α-TE indicates  ”α-Tocopherol Equivalent ”. 
5. NE indicates  “Niacin Equivalent ”. 
6. The maximum value for niacin from nicotinamide is 100mgNE/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.