The Regulations are enacted pursuant to the provisions of Article 21 Paragraph 5 of the Act Governing Food Safety and Sanitation (hereafter referred to as “the Act”).

The term “review and registration” herein stated refer to the process of review, test, and registration and the issuance of permit documents.
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 designated by the central competent authority.

A food business operator applying for review and registration with the central competent authority shall complete an application form, pay the due review, test, and certificate fees, and attach following documents or information to the application form based on the product classification and characteristics:
1.Table of ingredient content, specifications, test method, certificate of analysis, nutrients analysis report, and manufacturing process summary;
2.Complete technical information;
3.Labels, packaging, Chinese labeling, user instruction, sample, and photo of the actual product;
4.An application filed for imported product review and registration shall be attached with the official substantiating documents certifying that the original manufacturer is legally established or registered. If the documents are photocopies of the original, they shall be attested as true copies 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 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.

Applicant applying for review and registration shall claim the permit document within two months after the central competent authority approves the application through review procedure and issues a notification letter advising the permit document issuance. Failure of applicant to claim the permit document within the deadline shall constitute the abandonment of application; whereupon, the central competent authority is entitled to process the nullification of the issued permit document.

Permit documents issued on applications filed pursuant to the provisions of Article 21 Paragraphs 1 and 2 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 an extension shall be required, a pertinent application form complete with the permit document and the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for extension approbation within three months before expiration. The applicant shall pay the review fee when filing an 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.

In the event of amendment 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 shall be filed with the central competent authority for amendment of registration records. The applicant shall pay the review fee when filing an application. Where issuance of a new certificate shall be necessary, a certificate processing fee shall be collected.

In the event of permit document ownership transfer, an application form complete with the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for the transfer registration and an review fee shall be collected. Additionally, if the permit document is a certificate, a certificate processing fee shall be collected.

In the event of the defacement or loss of a permit document, an application form and the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for replacement or reissuance. The applicant shall pay the review fee and certificate processing fee. Where application is filed due to defacement, the original permit document shall be surrendered for destruction.
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.

For products that have already obtained permit documents, if the manufacture or importation of a product is officially banned under the Act, the original permit document issued for which shall be nullified.

A food business operator applying for the cancellation of its permit document shall submit the application form complete with the permit document and related documents or information to the central competent authority for annulment. Upon due approval, the central competent authority shall issue an official announcement declaring the permit document null and void.

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 test 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 is subject to rejection with no further notice.

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.