Regulation s for Manufacture /Import License of Feed and Feed 
Additives  (Draft)  
Article 1  
This set of regulations  is prescribed  according to Section s 10.2 and 11.3 of the Feed 
Control Act (hereinafter “the Act ”) 
 
Article 2  
2.1 For the license to ma nufacture and/or process feed/ additives according to Section  
10.1 of the Act, the application shall be submitted to the central competent authority 
along with the following infor mation or objects and, upon subsequent notice of the 
central competent authority, provide the fee receipt, t wo copies of the list for lab tests, 
and four 300- gram samples of the feed/ additive  before the deadline . 
2.1.1 Four photocopies of the applicant’s ID paper . Non-natural -person applicants 
shall submit four photocopies of the certificate of incorporation or registration.    
2.1.2 Four photocopies of  registration certificate for the feed/additive factory.  
2.1.3 Two copies each of product description, i ngredient specification , manufacture 
flowchart , testing  method and the test  report, formulation basis, and reference material 
or literature . Such documents are  not required for feed/additive  for which national 
standards already exist.   
2.1.4 Two photos of the feed/additive package or container , if any.   
2.1.5 For reuse -entity applicants, four copies of the one-time or general -purpose 
permit, or the industrial waste disposal plan.  
2.1.6 For applicants that are publ ic/private waste clearance/di sposal  entities, four 
copies of the waste clearance/disposal permit, its attached list  and appendices .   
2.1.7 For feed in the animal -fat category, t he proof of raw material source , and one 
color photo of the material . 
2.1.8 For feed used as  mineral supplement s, two copies of proof of raw material 
source .  
2.1.9 For feed additives containing peptide, protein, or nucleic acid  that are produced 
with genetically modified (GM) or molecular biotechnology, the characteristics  of the 
GM additive s, safety  assessment , a list of relevant research papers and such papers .  
2.1.10 For feed/additives claiming  special benefits, two copies of post -feeding test 
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 report about the benefit .  
2.1.11  Four copies of the affidavit stating that the entity name and/or trademark are 
not a likeness, duplicate, counterfeit, or imitation  of any existing entity name or 
trademark.   
2.1.12 Other information or objects specified by the central competent authority.  
2.2 For the license to repackage feed or additives according to Section  10.1 of the Act, 
applicants shall submit the application to the central competent authority along with 
the following information or objects and, upon subsequent notice of the central  
competent authority, provide the fee receipt, two copies of the list for lab tests, and four 300- gram samples of the feed or additive.  
2.2.1 Two photocopies of manufacture/ import license registration for feed and 
additives.  
2.2.2 Two copies of written consent by the holder of  the registration described in 
Section 2.2.1. 
2.2.3 Information or objects specified in Sections 2.1.1~2.1.4, 2.1.11, and 2.1.12. 
However, t he formulation basis and reference material in Section 2.1.3 are not 
required.   
 
Article 3  
For the  license to import feed/additives according to Section  11.1 of the Act, the 
application shall be submitted  to the central competent authority along with the 
following information or objects and, upon subsequent notice of the central competent 
authority, provide the fee receipt, two copies of the list for lab tests, and four 
300-gram samples of the feed or additive  before the deadline.  
3.1 Four photocopies of the applicant’s ID paper . Non- natural -person applicants shall 
submit four photocopies of the certificate of incorporation or registration.    
3.2 Four photocopies of registration certificate for feed sale.  
3.3 Two copies each of product description, ingredient  specification , man ufacture 
flowc hart, testing  method and the test report, formulation basis, and reference 
literature . Such documents are not required for feed/additives for which national 
standards already exist.  
3.4 Two photos of the feed/additive package or container , if any.  
3.5 One original and three photocopies of notarized/certified Power of Attorney (POA) 
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 by the foreign supplier and manufacture/sales permit issued by the exporting country; 
if the foreign supplier is not the original manufacturer, additional documents are 
required: one original and two photocopies of notarized/certified POA by the original 
manufacturer to the supplier. No need to submit such a POA if the manufacturer has been verified by the central competent authority to be officially recognized by the 
exporting country.  
3.6 For feed in the animal -fat category, the proof of raw material source, and one 
color photo of the material . 
3.7 For feed additives containing  peptide, protein, or nucleic acid that are produced 
with genetically modified (GM) or molecular biotechnology, the characteristics  of the 
GM additive s, safety  assessment , a list of relevant research papers and such papers  
listed .   
3.8 For feed/additives claiming special benefits, two copies of post -feeding test report 
about the benefit.  
3.9 Four copies of the affidavit sta ting that the entity name and /or trademark are not  a 
likeness, duplicate, counterfeit, or imitation  of any existing entity name or trademark . 
3.10 Other information or objects specifi ed by the central competent authority.  
 
Article 4  
Regarding the application  for license (hereinafter “application”) described in Articles 
2 and 3, if the  applicant -- after being notified to pay the fee, and/or provide complete 
and accurate information / samples -- fails to fully rectify the issue before a deadline, 
the central competent author may disregard the application, or review the application 
simply based on currently available information.  
 
Article 5  
The application will be denied in any of the following situations: 
5.1 The feed/additive listed in the application has not yet been declared by the central 
competent authority for use as feed/additive according to Section  3.1 or Section 3-1.1 
of the Act; or has been declared by the central competent authority according to 
Section  20.1 of the Act as a substance prohibited from use in feed or additives.  
5.2 Test result s show  that feed/additive  listed in the application is  incompliant with 
applicable national standards , or in the absence of applicable national standards , 
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 incompliant with ingredient specifications approved by the central competent 
authority.   
5.3 The factory making the feed/additive liste d in the application is incompliant with 
the factory establishment standards in Section  9.2 of the A ct, or has not been 
registered according to law.  
5.4 The label on the feed/additive package or container fails to comply with the 
requirements of Article 14 of the Act.  
5.5 The applicant is not eligible  for feed /additive manufacture license registration 
(hereinafter “manufacture registration” ) or import license  registration (hereinafter 
“import  registration ”) according to Section  25.2 of the Act.   
5.6 For the mineral supplements described in Article 2, the raw material supplier  has 
not obtained  import  registration , manufacture registration or the license is not for 
feed/ food.   
5.7 For additives containing peptide, protein, or nucleic acid that are  produced with 
GM or molecular biotechnology, failure to pass the safety assessment test.  
5.8 For feed/additi ves claiming special benefits, failure to deliver said benefits or 
necessity for animal growth  after reviews . 
5.9 The company name or trademark is found to be a likeness, duplicate, counterfeit 
or imitation  of existing ones. 
5.10 The application contains deficiency or mistakes that cannot be rectified, or 
failure to rectify according to Article 4.   
 
Article 6  
6.1 For applications described in Articles 2, 3, and 9, the central competent authority 
may invite experts or scholars from relevant a uthorities, legal entities, schools or 
organizations to assist in the review. When necessary, the authority may send officials to inspect the domestic/overseas site of feed/additive factory or supplier.  
6.2 For the application approved according to Article 2 or 3, a manufacture or import  
registration  shall  be issued  by the central competent authority.   
  
Article 7  
A manufacture registration shall contain the following information:  
7.1 The registration number,  
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 7.2 Categories, descriptions, commercial names of the feed/additive, and scope of the 
license of registration ,  
7.3 Name of the feed manufacturer; non- natural -person manufacturer shall list its 
name, and the name of the person -in-charge , or the representative,  
7.4 Name and address of the factory,  
7.5 Ingredi ents and their content levels,  
7.6 Target species  and life stages , and  
7.7 Description of feed appearance, and the package/container.  
 
Article 8  
An import registration  shall contain the following information:  
8.1 The  registration  number,  
8.2 Categories, descriptions, commercial names of the feed/additive, and scope of the 
registration license,  
8.3 Name and address of the feed vendor; non- natural -person vendor shall list its 
name, the person -in-charge or representative, and the primary office or sales venue,  
8.4 Name and address of foreign supplier or manufacturer,  
8.5 Ingredients and their content levels , 
8.6 Target  species and life stages , and  
8.7 Description of feed appearance, and the package/container.  
 
Article 9  
9.1 Application for extension of m anufacture/import registration  (license)  according 
to Section  12.1 of the Act shall be submitted to the central competent authority one to 
four months before it expires , along with the following documents:  
9.1.1 The original manufacture/import  registration , 
9.1.2 For extension of import registration , the original and one photocopy of 
notarized/certified Power of Attorney (POA) from the foreign supplier; if the foreign 
supplier is not the original manufacturer, additional documents are required: the 
original  and one photocopy of notarized/certified POA by the original manufacturer to 
the supplier. No need to submit such a POA if the manufacturer has been verified by the central competent authority to be officially recognized by the exporting country.  
9.1.3 For reuse -entity applicants, two copies of the one -time or general -purpose 
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 permit, or the industrial waste disposal plan.  
9.1.4 For applicants that are public/private waste clearance and/or disposal entities,  
two copies of the waste clearance/ disposal permit , its attached list and appendices.  
9.2 Once approved by the central competent authority, the license extension applied 
for in Section 9.1 shall last for no more than four years, and shall be noted as so on 
the manufacture/import  registration . When the reg istration license runs out of space 
for such notes, the applicant shall pay a fee and surrender the original license for a  
replacement  manufacture/import  registration .  
 
Article 10  
The categories, descriptions, ingredients, and target species  and life stag es of animals 
on the manufacture/import  registration  must not change ; for changes to other items on 
the registration , the following procedure shall be  followed:  
10.1 Regarding the manufacture license, application  for changes to the manufacturer, 
person- in-charge or representative, name or address of the factory shall be submitted 
within one month of the fact of change, along with relevant document proof.  
10.2 Regarding the import registration, a pplication s for changes to name/address of 
the forei gn supplier /factory  shall be submitted within three months after  the fact of 
change, along with the document proof s described in Section 3.5. However, for  a 
change of the country of  manufacturing fac tory, stipulations in Article 3  may be 
applicable.  
10.3 Application for changes to commercial name, appearance, package/container of 
feed/additive s shall be submitted one month prior to the change, along with two 
photos of the package/container.   
10.4 If the content of  feed/additive listed on the manufacture/im port registration is 
rendered incompliant with Section 4.2 of the Act due to a change of applicable 
national standards, the application shall be submitted upon notice of the central 
compet ent authority . 
 
Article 11  
If a manufacture/import registration is defaced, damaged or lost,  application for a 
renewed/re- issued regis tration  shall be submitted to the central competent authority , 
along with explanation and fee payment . In exchange for a re -issued registration , the 
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 original  registration  shall be surrender ed and annulled.  
 
Article 12  
Entities delegating importation tasks to other feed vendors according to Section  11.2 of 
the Act  shall enter  – batch by batch -- the name and tax ID of the delegated party on the  
joint review and customs clearance p latform instituted by central competent authorities . 
 
Article 13  
13.1 Documents  or information required under this set of Regulations shall be submitted 
along with the  Chinese or English-language  translation if originally prepared in a third 
language . 
13.2 Supporting documents or information required under these Regulations – if issued 
by a foreign government or a power of attorney (POA) produced in a foreign country – 
shall be  duly authenticated by the Republic of China’s embassy, consulate, representative 
office or other institutions authorized by the Ministry of Foreign Affairs. Documents 
issued by authorities in Hong Kong, Macau or Mainland China, or a POA produced in 
Hong Kong, Macau or Mainland China, shall be certified by an organization established 
or designated, or a private organization entrusted,  by Executive Yuan.   
 
Article 14  
This set of Regulations shall enter into force on the date of its promulgation. 
 
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