Formula for certain disease referred to in this chapter is intended for the dietary management of patients who have impaired capacity to ingest, digest, absorb or metabolize ordinary foods or certain nutrients, or who, for any medically-proven reason, have special dietary requirements that cannot be easily met with re-balancing daily diet. The food products in this category are processed or formulated according to the needs of the target users.
The scope of formula for certain disease as referred in the preceding paragraph is as follows:
1.Nutritionally complete food that may be used as the single source of nutrients:
(1.Nutritionally complete food with balanced formula: 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 2, except for formulae for patient children aged one to eighteen.
(2.Nutritionally complete food with customized formula: 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 based on scientific evidence. For other nutrients, the regulations provided in Schedule 2 shall apply mutatis mutandis.
2.Nutrition supplement formula food that may not be used as the single source of nutrients:
(1.Nutrition adjusted supplementary formula food: The products in this category are designed to be used as part of nutritional supplement for patients of specific nutritional needs and meet the following requirements:
A.The specific nutrients to be supplemented shall be based on scientific evidence. For the non-customized nutrition portion of the product, every serving size (100 Kcal) shall reach the lower limit as specified in Schedule 2. 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 Additives.
B.Where the non-customized nutrition portion of the product under application per 100 Kcal does not reach the lower limit as specified in Schedule 2, a domestic clinical study 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 modular formula food: The products in this category are designed to deliver a specific nutrient or ingredient to meet the nutritional needs deriving from specific illness or metabolic needs and contain the element meeting the following requirements:
A.The source food additives containing the modular formula are the nutritional additives within the same domain of nutrients.
B.There is scientific evidence that this element is essential for the nutritional needs deriving from specific illness or metabolic needs.
The products as referred in the preceding paragraph may use other food ingredients or additives to meet the flavoring or processing requirements.

• Schedule 2 Nutritional Value for a Nutritionally Complete Food with Balanced Formula.pdf

Applications for review and registration of formula for certain disease shall submit the application form, along with the following documents and information as well as product samples, to the central competent authority, and pay the related fees, while the provisions in Article 3 do not apply:
1.Original table of ingredient content: 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 additive.
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.
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.Manufacturing process summary.
5.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.
6.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.
7.In cases of entrusted manufacturing, the original certificate of the entrusted manufacturing issued by the entrusted manufacturer is required.
8.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instructions of the product; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instruction are the same, the user instruction of any specifications, forms, and materials may be submitted.
9.The applicant shall submit a carbon copy of its company registration or business registration certificate.
10.Where the complete sample is available to the market in different packaging specifications, forms or materials, the applicant is required to submit one sample for each option.
11.Where the product is intended to be re-packed in new containers for sale in Taiwan, the applicant shall submit the documents and sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations.
12.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 documents.
(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.Clinical human consumption report: In case of subsequent or concurrent applications for multiple products of different pigments, flavors or sweeteners, while keeping the other ingredients identical and maintaining the same nutritional specifications with no influence on safety, the report of one of the products will suffice for application.
13.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 indicators.
14.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.

The central competent authority may convene an expert review meeting for reviewing the applications filed in accordance with the preceding Article, and when necessary, may demand the presence of the applicant for presentations or questioning.
For the convening of the meeting referred to in the preceding paragraph, the central competent authority shall notify the applying company to submit necessary documents and information within the designated time. Failure of submission or submission of incomplete documents and information within the designated time may result in the rejection of application with no further notice.

Applications for extension of the permit document for formula for certain disease shall submit an application form within three months prior to the expiry date of permit, along with the following documents, information 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 Chinese label, container or outer packaging, and user instructions 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 specification, form, and materials may be submitted.
6.Original hygiene and nutrients specifications issued by the original manufacturer within the past one year.
7.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.
8.Clinical study report for the product under application (applications for nutritionally complete food with balanced formula or with attached clinical study report already is exempted from the requirement).
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 extension applications 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.

Applications for amendment of the permit document for certain disease 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 label, container or outer packaging, and user instruction 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 specification, form, 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 the 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 the 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 official certificate 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 product items of the original manufacturer shall be provided. The list is required to contain the registration numbers, Chinese names of the product items, and expiry date of the permit document.
5.Amendment of the product specifications as set forth in Article 20, Paragraph 1, Subparagraph 2:
(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 changes).
(2.The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 and 2, 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 or sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations.
7.Amendment of Chinese label, container or outer packaging, and user instructions of the product:
(1.A chart of comparison of the content before and after the changes.
(2.For imported product items, the original manufacturer’s certificate 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 to the nutrition facts label (with no changes of the product ingredients and content):
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 Article 20, Paragraph 1, Subparagraphs 1 and 2.
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, attachment of documents and information and product samples, and fee payment in cases of change, relocation or expansion of the manufacturer, except for the exemption provided for the clinical report under Article 20, Paragraph 1, Subparagraph 12, Item 5, the provisions of Article 20 on new case 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. This does not apply to cases where the ingredients or content of the micronutrients in the product formula are adjusted in accordance with the revisions to the regulations.

Applications for the amendment of the Chinese label, container or outer packaging, and user instructions of the food formula for specific diseases 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 modification 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 formula for certain disease, 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 label, container or outer packaging, and user instructions 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 specification, form, 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 formula for certain disease review and registration due to defacement or loss, the applicant is required to submit an application form, along with the following documents or information, to the central competent authority, and 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.