1 
 Amendment of Regulations for Application of 
Health  Food Permit (Draft)  
 
Promulgated on May 29, 1999.  
Amended on October 30, 2006.  
Amended on August 29, 2012.  
Amended on January 28, 2014.  
Amended on January 21, 2016.  
Amended on December 25, 2020.  
Scheduled to be amended on October 19, 2023 
 
Article 1  These Regulations are set forth pursuant to the paragraph 5 of Article 7 of the Health 
Food Control Act (hereinafter referred to as "Act").  
 
Article 2  Applicants applying for new registration of health food products under Subparagraph 
1of Paragraph 1 of Article 3 of the Act shall submit an application form, the following documents, information, and samples to the central competent authority, and pay the 
review fees:  
1. Specifications and quantity of ingredients, along with their sources of supplies, 
issued by the manufacturer.
 
2. Safety assessment report: Health food products classified as Category 1 in the 
health food safety assessment method, unless demanded by the central competent 
authority, may be exempted f rom this requirement, but the safety related literature 
shall be attached.  
3. Health care effect assessment report.  
4. Test plan and result report on the stability of the product and its health care effect ingredient . 
5. Product nutrient analysis report.  
6. Product sanitary test report.  
7. Identification report of the i ngredients  with health care effects of the product and 
the test ing method.  
8. Product manufacturing process documents and information provided by the 
product manufacturer.  
9. Documentary  evidence provided by the manufacturer to demonstrate compliance 
with Standard of Good Manufacturing Practice for Health Food. 
10. In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is r equired. 
11. In cases of authorized sales, the original certificate of authorization issued by the 
original manufacturer or distributor is required.  2 
 12. The physical or color drafts of the Chinese label, container or outer packaging, 
and user instructions;  the above items shall be attached separately for different 
packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specifications, forms, and materials may be submitted . 
13. Summar y of information for health food registration . 
14. The applicant shall submit a carbon copy of its company registration or business registration certificate.  
15. Certification document verifying that the original manufacturer is legally established or regi stered : 
(1) Domestic manufacturer: Carbon copy of the factory registration certificate.  
(2) Foreign manufacturer: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin shall be provided. The certificate shall specify full name of the government agency issuing the certificate with official stamp or authorized signature. If the certificate verifying the legitimacy of the original manufacturer is a copy of the original, the document 
shall be a certified true copy of the original by a notary public in the country 
of origin.  
16. Other relevant research reports and literature.  
The foregoing documents or information in languages other than English and Chines e 
must be accompanied with English or Chinese translations provided by a registered translation agency. 
Article 3  For applications for new registration of health food whose products fall under Subparagraph 2 of Paragraph 1 of Article 3 of the Act, the appl ication shall comply 
with the provisions of the preceding Article, except for the exemption of documents and information mentioned in Subparagraphs 2, 3, and 16 of Paragraph 1 of the preceding Article.  
 
Article 4  For applications filed under the preceding two articles, each case shall be limited to a 
single health care effect or specification  standards . 
 
Article 5  The c entral competent authority, after receiv ing the application for registration, shall 
conduct a preliminary review of the documents and inform ation submitted by the 
applicants . On-site inspections may be conducted by the central competent authority 
when deemed necessary.  
If the docu ments and information  as mentioned above  are incomplete, the applicants  
shall, within one month after receiving the notice of the central competent  authority, 3 
 submit the suppl ementary documents and information, but can apply to expa nd for 
one-month extension if necessary. The supplementary docu ments and information 
are submitted with one time only. Without submitting  the supplementary documents 
and information wi thin the time limit results in the re jection of the application. 
The applicants  with unwil ling to accept the rejection of the preliminary review can 
take relief by one of the following manners: 
1. Propose the re -examination with reasons to the central authority within six months 
following the date of the preliminary review result notice. According to the 
Administrative Appeal Act, the applicant with unwilling to accept the rejection of re-examination can propose an appeal. 
2. Accord ing to the Administrative Appeal  Act, the applicant
 with unwilling to 
accep t the rejection of the preliminary revi ew can propose an appeal direc tly 
within thirty days following the date of the preliminary review result  notice. 
The re -examination shall not be accepted if an appeal has been proposed in 
accordance with subparagraph 2 of the preceding paragraph prior to re -examination 
has been proposed in accordance with subparagraph 1 of the preceding paragraph, or have been proposed. 
 
Article 6  Applications  for reg istration  filed in accordance with the provisions of Article 2 and 
having passed the preliminary review, an application for secondary review  shall, 
within fifteen da ys from the da te following the preliminary review result  notice, be 
filed to the central competent authority with the fee for the secondary review  paid and 
suppl ementary documents and information specified in amended Article 2 according 
to the preliminary review  opinions stated in the notification letter. Failure to inc lude 
the secondary review  fee payment and/or the doc uments and information within the 
specified period shall lead to the rejection of the application.  
For applications submitted under Article 3, the provisions of the preceding paragraph shall apply mutatis  mutandis if the central competent authority determines that 
secondary review  is necessary.  
 
Article 7  For applications filed in accordance with provisions in the preceding Article for secondary review, the Health Food Review Committee of the Food and Dru g 
Administration of the Ministry of Health and Welfare shall review the application documents and information and call meetings to review the safety, health care effect, package, label and product information of the product, and provide review opinions.  
 The Review Committee in the preceding paragraph consists of a certain number of 
members who are appointed by the Director -General of the Food and Drug 
Administration of the Ministry of Health and Welfare.  4 
  
Article 8  For the secondary review, the central com petent authority may conduct  an on- site 
inspection if it is considered necessary.  
 The central competent authority should verify the review in accordance with the 
provisions in relevant regulations and Paragraph 1 of the preceding Article and noti fy 
the ap plicants of the result of the secondary review. 
 
Article 9  If the central competent authority considers documents and information submitted for secondary review are incomplete and more supplementary documents as well as information are required, the appli cants  shall, within one month after receiving the 
notice, submit the supplementary documents and information, but can apply to expand for one -month extension if necessary. The supplementary documents and 
information are submitted with one time only. Without submitting the supplementary documents and information within the time limit results in the rejection of the application.  
 
Article 10  If the product analysis is considered necessary for applying registration, the applicant shall, within one month follow ing the date of the notice from the central competent 
authority, pay the testing fee and submit enough quantity of samples with original package to the analytical institution indicated by central competent authority for testing. Without paying the testing fee or submitting the samples within the time limit will result in the rejection of the application.  
  
Article 11 The applicants with unwilling to accept the decisions made by the central competent 
authority in accordance with Article 6, paragraph 2 of Art icle 8, Article 9, or the 
preceding Article for the application can take relief by one of the following manners:  
1. Propose  the re-examination with reasons to the central
 author ity within  six 
months following the date of the s econdary review  result notice. Acco rding to 
the Ad ministrative Appeal  Act, the applicants with unwilling to accept the 
rejection of re-examination can propose an appeal. 
 
2. According to the Administrative Appeal Act, the applicants with unwilling to 
accept the rejection of the seconda ry review can propose an appeal directly within 
thirty days following the date of the secondary review result notice.  
The re-examination shall not be accepted if an appeal has been proposed in 
accordance with subparagr aph 2 of the preceding pa ragraph befor e re-examination 
has been proposed in accordance with subparagr aph 1 of the preced ing paragraph, or 
both have  been pr opos ed. 5 
  
Article 12  If an application for product registration is accepted, the central competent authority 
shall issue a health food permit upon payment of a permit fee by the applicants. The 
permit shall  be valid for five years and be extended within three months prior to 
expiration. The original  permit shall autom atically become invalid if applica tion for  
extension is not proposed within the time limit or the permit is disagr eed with 
expansion. 
 The registered contents of the aforementioned permit include the following items:  
1. Product names in Chi nese and Englis h. 
2. Nam e and address of the applicant  and responsible person.  
3. Name and ad dress of the manufacturer . 
4. Ingredients and appearance of the product.  
5. Ingredients  and quantities related to the health care effects or quality control of the 
product.  
6. Health care effects and descriptions of the product.  
7. Packaging specifications  and materials.  
8. Expiration date, storage methods and conditions  of the product.  
9. Content displayed on the Chinese labels, outer packaging, and product 
instructions.  
10. Other re gistration items designated by the central health competent authority.  
 
Article 13  The review of specifications and quantities the ingredient s mentioned in Article 2 
shall be based on the following supporting documents and information provided by the applicants, depending on the nature of the case:
 
1. Acceptance reports for ingr edient quality control or sanitary test. 
2. In case of ingredient extracted or concentrated , the processes of manufacturing are 
required.  
3. The process  of manufacturing and test reports  for the ingredient with health care 
effect . 
4. In case of the ingredi ents that are edible  Chinese medicine , the origin 
identification reports are required.  
5. In case of the microbial ingredients , the s ource certification and species 
identification reports are required ; in case of those  that are lactobacillus , the strain 
identification reports are required . 
 
Article 14.  The target of assessment , test, analys is, and identification reports under Article 2 is 
limited to products on the factory production line.  
 6 
 Article 15  The safety assessment report and health care effect assessment report mentioned in 
Article 2 shall be conducted by a third party other than the ingredient research and development unit  according to the health food safety assessment methods and health 
food health care effect assessment methods announced by the central competent authority.  
 
Article 16  The stability test report, nutrient analysis report, sanitary test  report, and identification 
report of the ingredients  with health care effects of the product  mentioned in Article 2 
shall be produced on the basis of  at least three batches of products from the factory 
production line and within their expiration date.  
 For the aforementioned reports, at least two batches of testing should be conducted within the past three years.
 
 
Article 17  The ingredient  stability te st report stated in Article 2 in which the test indicators are 
the ingredients  with health care effects of the product , but if those  cannot be 
determined, the quality control ingredients shall be selected as the test indicators.  
 For applications filed under Article 3, the specifications specified by the central 
competent authority shall be used as the testing indicators mentioned in the preceding Paragraph.
 
 
Article 18  The nutrient analysis report mentioned in Article 2 shall include the calorific value and nutrients required by the regulations for packaged food nutrition labeling.  
 Article 19  The product sanitary test  report mentioned in Article 2 shall provide sufficie nt 
evidence to demonstrate that the product meets the various standards established unde r the Act Governing Food Safety and Sanitation.
 
 
Article 20  The identification report of the ingredients  with health care effect of the product 
mentioned in Article 2 shall include qualitative and quantitative test results of the ingredients  with health ca re effects of the product .
 
 For applications filed under Article 3, the results of the aforementioned identification 
results shall comply with the health food specification standards established by the 
central competent authority.  
 The testing methods used for the identification in the preceding two paragraphs shall 
prioritize the methods announced or recommended by the central competent authority. If other methods are used, scientific evidence and comparative explanatory documents and information shall be provided demonstrating that they are non- inferior 
or superior to the announced or recommended test ing methods. 7 
  The submission of the identification reports mentioned in the first and second 
paragraphs shall be accompanied by the standard operating procedures and relevant 
documents and validation  of the test ing methods. 
 In cases the provisions of the latter part of Subparagraph 1 of Paragraph 1 of Article 3 of this Act apply, the identification report for each ingredient with the respective 
health care eff ect shall be submitted."
 
 
Article 21  The manufacturing process documents and information mentioned in Article 2 shall include the preparation and processing procedures, as well as the processi ng 
conditions of the ingredients.  
 For processes involving extr action, the extraction method and solvents used shall be 
specified, and for concentration processes, the degree of concentration shall be 
indicated.
 
 
Article 22  The documentary evidence provided by the manufacturer to demonstrate compliance 
with Standard of Good Manufacturing Practice for Health Food mentioned in Article 
2 shall include process control documents, quality control documents, quality control engineering diagrams, and other documents and information proving compliance with the Standard of Good Manufacturing Practice for Health Food .  
 For imported products, the aforementioned documents and information may be substituted with official certification issued by the country of origin, confirming compliance with their respective good manufacturing pra ctices standards.  
 For domestically produced products manufactured by pharmaceutical companies, a certificate issued by the central competent authority, indicating the eligibility to produce food products, shall be provided.
 
 
Article 23  For products manuf actured in different manufacturing factories and at different stages, 
the documents and information mentioned in the preceding Article shall be provided separately by the respective manufacturing factories. For products manufactured in different sections o f the same manufacturer , a site plan of the factory area shall also 
be provided.  
 Article 24  The physical or color drafts of the Chinese label, container or outer packaging, and user instructions  mentioned in Article 2 shall comply with the provisions of t his Act 
or the Act Governing Food Safety and Sanitation regarding their content and labeling requirements.  
 The size of the printed diagrams or drafts shall match the physical counterparts and include legible and clear texts.  8 
  
Article 25  The relevant resea rch reports and literature mentioned in Article 2 shall demonstrate 
scientific reliability and accuracy.  
 Article 26  Applications for extension of the health food permit shall submit an application form within three months prior to the expiry date of permi t, along with the following 
documents and information, to the central competent authority, and pay the related fees:  
1. Original permit.  
2. The original certificate or document of consent to renewal of the product manufacturing agreement issued by the original manufacturer based on the content of originally issued permit within the past one year.  This requirement is exempted 
if the permit holder is the same as the manufacturer.  
3. The physical or color drafts of the Chinese label, container or outer packagi ng, 
and user instructions; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specifications, forms, and materials may be submitted.  
4. In cases of entrusted manufacturing, the original certificate of entrusted 
manufacturing issued by the entrusted manufacturer is required. 
5. In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.  
6. Other re gistration items designated by the central health competent authority.
 
No applications for extension shall be accepted  after the expiration of the permit. 
Instead, applications for new registration should be filed under the provisions of 
Article 2 or Article 3. Applications for a new registration within six months after the expiration, however, may be waived of the requirement for secondary review under 
Article 6 and the following documents and information may be exempted:
 
1. For applications filed under the provisions of Article 2: Documents and 
information mentioned in Subparagraphs 2, 3, 4, and 15 of Paragraph 1 of Article 2. 
2. For applicants filed under the provisions of Article 3: Documents and inform ation 
mentioned in Subparagraph 4 of Paragraph 1 of Article 2.  
Where applications filed under the preceding Paragraph are approved, the applicants 
shall be issued a new permit and a new permit number by the central competent authority.  
 
Article 27  Applicat ions for amendment of the health food permit shall submit an application form, 9 
 along with the following documents or information, to the central competent authority, 
and pay the related fees:  
1. Original permit.  
2. Summary of information for health food re gistration  after the amendment . 
In addition to the foregoing requirements, the following documents and information shall be additionally submitted according to the application of amendment : 
1. Product name in Chinese or English change: The certificate or d ocument of 
consent to change of the product name issued by the original manufacturer for imported products.  
2. Change of n ame and address of the applicant and responsible person :  
(1) Photocopy of the company registration or business registration certifica te of 
the manufacturer holding the permit.  
(2) A complete list of health food product s shown on the permit held by the 
manufacturer. The list is required to contain the registration numbers, Chinese names of the products, and expiry date of the permit.
 
3. Expansion or change  of manufacturer : Documents and information mentioned in 
Subparagraphs 1, 4 to 12, and 15 of Paragraph 1 of Article 2.  
4. Relocation of the manufacturer : Documents and information mentioned in 
Subparagraphs 4, 9 and 15 of Paragraph 1 of Article 2.  
5. Change of the original manufacturer’s name:  
(1) Document mentioned in Subparagraph 15 of Paragraph 1 of Article 2.  
(2) A complete list of health food product s of the original manufacturer shall be 
provided. The list is required to contain the  registration numbers, Chinese 
names of the products, and expiry date of the permit.  
6. Building number adjustment of the original manufacturer’s address : 
(1) In cases of domestic manufacturers: The applicant shall submit a photocopy of the official certif icate issued by a competent government agency certifying the 
building number adjustment.  
(2) In cases of foreign manufacturers: The original official certificate issued by a competent government agency of the country of origin in its full title certifying the address building number adjustment, whereas the certificate 
submitted is a photocopy, the document shall be notarized as a true copy of the original by a notary public in the country of origin.  
(3) A complete list of health food product s of the origina l manufacturer shall be 
provided. The list is required to contain the registration numbers, Chinese names of the products, and expiry date of the permit.  
7. Change  of ingredients  of color, flavoring agents or sweeteners while other 
ingredients remain  uncha nged and the product safety is not affected: Documents 10 
 and information mentioned in subparagraphs 1, 5, and 7 of Paragraph 1 of Article 
2. 
8. Amendment to the packaging specification, form and material (including inner packaging, outer packaging, packaging quantity, and trademark):
 
(1) For imported product s, the original manufacturer’s certificate or document of 
consent to the change of packaging in original copy shall be submitted.  
(2) The physical or color drafts of the Chinese label, container or outer p ackaging, 
and user instructions; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specifications, forms, and materi als may be submitted.  
(3) For change  to the inner packaging, product stability test report. 
(4) For change  to the packaging  materials, the supporting documents 
demonstrating compliance with the sanita tion standard for food utensils, 
containers and packag es.
 
9. Amendment of Chinese label, container or outer packaging, and user instructions of the product:  
(1) The physical or color drafts of the Chinese label, container or outer packaging, and user instructions; the above items shall be attached separately fo r different 
packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specifications, forms, and materials may be submitted.  
(2) For imported products, the original manufacturer’s cer tificate or document of 
consent to the amendment of Chinese label, container or outer packaging, and user instructions in original copy shall be submitted. 
(3) For amendment of  the nutrition facts label (with no changes of the product 
ingredients and conte nt):
 
A. The assessment  report on the rationale of amendment issued by the 
original manufacturer within the past one year;  
B. Documents and informati on mentioned in subparagraphs 1 and 5 of 
Paragraph 1 of Article 2.  
10. Amendment  of product expiration date, storage method, and conditions: Stability 
test plan and report of the product and the ingredient of  health care effect.  
 
Article 28  Applications for the amendment of the Chinese label, container or outer packaging, and user instructions of health food products are exempted in one of the following situations:  
1. Amendment of patterns or colors.  11 
 2. Proportionate reduction or enlargement of the approved images and texts.  
3. Movement of the position of the approved images and texts.  
4. Amendment of the fonts of the approved text.  
 The amendment in the preceding paragraph of the Chinese labels, container or outer 
packaging and user instructions which contain the content stipulated by relevant authorities other than those specified in this Act shall be subject to  the provisions of 
respective regulations.  
 For items exempted from modification applications as set forth in the first paragraph, the permit holder shall produce a written record for retention.
 
 
Article 29  Applications for transference of the permit, the transferee is required to submit an application form, along with the following documents or information, to the central competent authority for review, and pay the review and certificate processing fees:  
1. Original permit.  
2. Summary of information for he alth food registration .. 
3. Transferor’s certificate or document of consent to transfer of permit document ownership in original copy. 
4. Certificate or document of  the manufacturer  in original copy granting permission 
to the transferee to sell the product s. 
5. The physical or color drafts of the Chinese label, container or outer packaging, and user instructions; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instruction s are the same, the user instruction of any specifications, forms, and 
materials may be submitted.  
6. The applicant shall submit a carbon copy of its company registration or business registration certificate.
 
 
Article 30  Applications for reissuance or repl acement the permit due to defacement or loss, the 
applicant is required to submit an application form, along with the following documents or information, to the central competent authority, and pay the related fees:  
1. For replacement application, the appl icant shall submit the originally issued 
permit.  
2. 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 reissuance application as referred in the preceding paragraph shall bear the same expiration date as the original permit document.
 12 
  
Article 31  For applications submitted following the provisions of Articles 26, 27, 29 or the 
preceding Article, if the central competent authority notifies the applicants to submit 
supplementary documents and information, the applicants  shall submit th ose within 
one month. An extension of one month may be requested. If the applicants  still fails 
to submit the demanded supplementary documents and information  within the 
specified period, the application shall be rejected.  
 
Article 32  For applications submitted following the provisions of Articles 26, 27, 29 or Article 
30, documents and information in languages other than English and Chinese must be 
accompanied with English or Chinese translations provided by a registered translation 
agency.  
 Where issuance of a new certificate shall be necessary  under the provisions of 
Articles 26, 27, 29, or Article 30, a certificate processing fee shall be collected.  
Article 33  Applications in accordance with the provisions of the Regulations may be filed by the food industry operators on the web platform of Taiwan Food and Drug Administration, the Ministry of Health and Welfare, with the documents and information scanned and uploaded.  
 After completion of applications by applicants for permit extension, amendment of registration contents, permit transference or permit replacement pursuant to provisions in the preceding paragraph, the original permit shall be sent to the  central 
competent authority for registration or cancellation.  
 
Article 34  These amendatory r egulations shall come into effect from the date of promulgation.