Applications for review and registration of infant formula and follow-up infant formula shall submit the application form, along with the following documents and information as well as product samples, to the central competent authority, and pay the related fees, while the provisions in Article 3 do not apply:
1.Original table of ingredient content of the product: The table shall be issued by the original manufacturer and dated within the past one year and contain the detailed name and net quantity of contents of all the raw materials and food additives.
2.Original product specification: The product specification shall be issued by the original manufacturer and dated within the past one year and contain the hygiene and nutrients specification of the product. Its calories and nutrients shall meet the specifications set out in Schedule 1; if it contains nutrients other than those in Schedule 1, scientific evidence or other references shall be provided for the nutrients.
3.Original hygiene and nutrients analysis report: The report shall be the original issued by the original manufacturer or accreditation of food testing institution by the central competent authority and dated within the past one year.
4.The applicant is required to submit the original substantiating document verifying the product is for sale in a market outside the territory of Taiwan and a product sample, or a trial report of the product with a valid sample size of more than 20 subjects.
5.Manufacturing process summary.
6.Certification document verifying that the original manufacturer is legally established or registered;
(1.Domestic manufacturer: Carbon copy of the factory registration certificate.
(2.Foreign manufacturer: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin and dated within the past two years, shall be provided. The certificate shall specify the name and address of the manufacturer, its business activities, categories of products, hygienic status of the factory, and full name of the government agency issuing the certificate with official stamp or authorized signature. If the certificate verifying the legitimacy of the original manufacturer is a copy of the original, the document shall be a certified true copy of the original by a notary public in the country of origin.
7.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.
8.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required.
9.Two copies each of the physical or color drafts of the Chinese 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
10.The applicant shall submit a carbon copy of its company registration or business registration certificate.
11.Where the complete sample is available to the market in different packaging specifications, forms or materials, the applicant is required to submit one sample for each option.
12.Where the product is intended to be re-packed in new containers for sale in Taiwan, the applicant shall submit the following documents:
(1.The manufacturer’s original re-packing certificate or the original document of consent to product re-packing for imported products.
(2.The domestic re-packing facility’s factory registration certificate in carbon copy. Food re-packing, processing or manufacturing shall be listed in the scope of business stated on the factory registration certificate.
(3.The original copy of the hygiene and nutrition analysis report on the re- packed product issued within the past one year by the original manufacturer or accreditation of food testing institution by the central competent authority.
(4.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instructions of the re-packed products; 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 specification, form, and materials may be submitted
(5.Where the re-packed product sample is available in different packaging specifications, forms and materials, the applicant is required to submit one sample for each option.
13.Other essential documents and information specified by the central competent authority.
The foregoing documents or information in languages other than English and Chinese must be accompanied with English or Chinese translations provided by a registered translation agency.
The permit documents issued on the applications filed in compliance with Paragraph 1 and approved pursuant to the Act shall be valid for five years.

• Schedule 1.pdf

Applications for extension of the permit document for infant formula and follow-up infant formula shall submit an application form within three months prior to the expiry date of permit, along with the following documents, information and product sample, to the central competent authority, and pay the related fees, while the provisions in Article 5 do not apply:
1.Original permit document.
2.The original certificate or document of consent to renewal of the product manufacturing agreement, or original table of ingredient content issued by the original manufacturer based on the content of originally issued permit within the past one year.
3.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.
4.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required.
5.Two copies each of the physical or color drafts of the product labels in Chinese, containers 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 specification, form, and materials may be submitted
6.Description of product usage: The report issued or signed by the original manufacturer describing the situations of domestic and overseas consumer usage of the product in the last five years, and the content of which shall at least include the sales situations, adverse reactions reported domestically and overseas, and the latest results of inspection imposed on the original manufacturer by the competent authorities or its entrusted institution.
7.Original hygiene and nutrients specifications issued by the original manufacturer within the past one year.
8.Original hygiene and nutrients analysis report of the batches of production within the past year issued by the original manufacturer or accreditation of food testing institution by the central competent authority. The original analysis report of the latest batch of production shall be provided in case there is no production within the past year.
The foregoing documents or information in languages other than English and Chinese must be accompanied with English or Chinese translations provided by a registered translation agency.
The permit document issued on the applications for extension filed in compliance with Paragraph 1 and approved pursuant to the Act shall be valid for five years. If it is necessary to reissue a new permit document, a certificate processing fee shall be collected.
In case that, within one year of the amendment and implementation of these Regulations on November 30, 2023, the applicant is unable to provide a description of domestic and overseas usage in the past five years as specified in Paragraph 1 Subparagraph 6, the submission of overseas sales certificates and the product, or trial usage reports with a sample size of twenty or more subjects may be accepted as a substitute.

Applications for amendment of the permit document for infant formula and follow- up infant formula shall submit an application form, along with the following documents or information, to the central competent authority, and pay the related fees, while the provisions in Article 6 do not apply:
1.Original permit document.
2.Two copies each of the physical or color drafts of the Chinese labels, container or outer packaging, and user instructions of the product that are involved in amendment; 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 instructions of any specifications, forms, and materials may be submitted.
In addition to the foregoing requirements, the following documents, information or sample shall be additionally submitted according to the application of amendment:
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 company registration or business registration certificate of the manufacturer holding the permit document.
(2.A complete list of product items 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 manufacturer: Carbon copy of the factory registration certificate.
(2.Foreign manufacturer: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin and dated within the past two years, shall be provided. The certificate shall specify the name and address of the manufacturer, its business activities, categories of products, hygienic status of the factory, and full name of the government agency issuing the certificate with official stamp or authorized signature. If the certificate verifying the legitimacy of the original manufacturer is a copy of the original, the document shall be a certified true copy of the 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.Building number adjustment of the original manufacturer’s address:
(1.In cases of domestic manufacturers: The applicant shall submit a photocopy of the documents issued by a competent government agency certifying the address building number adjustment.
(2.In cases of foreign manufacturers: The original certificate issued by a competent government agency of the country of origin in its full title certifying the building number adjustment, whereas the certificate submitted is a photocopy, the document shall be notarized as a true copy of the original by a notary public in the country of origin.
(3.A complete list of product items of the original manufacturer shall be provided. The list is required to contain the registration numbers, Chinese names of the product items, and expiry dates of the permit document.
5.Amendment of the product specifications set forth in Subparagraph 2, Paragraph 1 of Article 13:
(1.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year (including a chart of comparison of the content before and after the amendment).
(2.The documents set forth in Subparagraphs 1 and 2, Paragraph 1 of Article 13, attaching those set forth in Subparagraph 3 of the same Article and Paragraph, based on the amended items of specifications.
6.Amendment to the packaging specification, form and material:
(1.For imported product items, the original manufacturer’s certificate or document of consent to the change of packaging in original copy shall be submitted.
(2.Product samples are required if changes involve product forms or materials.
(3.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents and sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations.
7.Amendment of the Chinese label, container or outer packaging, and user instructions of the product:
(1.A chart of comparison of the content before and after the amendment.
(2.For imported product items, the original manufacturer’s certificate or document of consent to the amendment of the Chinese label, container or outer packaging, and user instructions in original copy.
(3.For amendment to the nutrition facts:
A.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year.
B.The original copy of the nutrition analysis report issued by the original manufacturer or accreditation of food testing institution by the central competent authority within the past one year.
C.The documents set forth in Subparagraphs 1 and 2, Paragraph 1 of Article 13.
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.
For the application process and the submission of documents and information, product samples, and related fees in case of change, relocation or expansion of the manufacturer, the provisions of Article 13 on new registration applications shall apply mutatis mutandis.
If it is necessary to reissue a new permit document, a certificate processing fee shall be collected.
For the product specifications as set forth in Subparagraph 5 of Paragraph 2 and the nutrition facts in Item 3 of Subparagraph 7, amendment shall be limited to cases where neither the product composition nor the content has been amended.

Applications for the amendment of Chinese label, container or outer packaging, and user instructions of the infant and follow-up formula are exempted in one of the following situations:
1.Amendment of patterns or colors.
2.Proportionate reduction or enlargement of the approved images and texts.
3.Movement of the position of the approved images and texts.
4.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 amendment applications as set forth in the first paragraph, the permit holder shall produce a written record for retention.

Applications for transference of the permit document for infant formula and follow- up infant formula, 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, while the provisions in Article 7 do not apply:
1.Transferor’s certificate or document of consent to transfer of permit document ownership in original copy.
2.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.
3.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required.
4.Original permit document.
5.Two copies each of the physical or color drafts of the Chinese labels, container or outer packaging, and user instruction of the product; 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 instructions of any specifications, forms, and materials may be submitted.
6.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents set forth in Article 13 Paragraph 1 Subparagraph 12 Items 1-4 of the Regulations.
7.Photocopy of the table of product ingredient content.
8.Photocopy of the applicant’s company registration or business registration certificate.
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.

Applications for reissuance or replacement the permit document for infant formula and follow-up infant formula review and registration due to defacement or loss, the applicant is required to submit an application form, along with the following documents or information, to the central competent authority, and pay the related fees, while the provisions in Article 8 do not apply:
1.The applicant shall submit the photocopy of the applicant’s company registration or business registration certificate.
2.For replacement application, the applicant shall submit the originally issued permit document.
3.For re-issuance application, the applicant shall submit a statement that declares the original permit document null and void.
The new permit document issued under the replacement or reissuance application as referred in the preceding paragraph shall bear the same expiration date as the original permit document.