Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 27 條｜Food and Drug Administration｜Regulation｜In Force
第 四 章｜衛生福利部｜v1.0
Effective Date: 2024-11-30｜Last Amended: 2023-11-30
Applications for review and registration of food additives shall submit an application form to the central competent authority with fees paid and the following documents and materials attached, while the provisions in Article 3 do not apply: 1.Original table of ingredient content: The table shall be issued by the original manufacturer within the past one year and contain the names and content percentages of all the ingredients. 2.Original product specification: The product specification shall be issued by the original manufacturer within the past one year and contain the specifications of the test requirement such as identification, purity and quantification. 3.Test method: the test method used on the test requirement in the preceding paragraph. 4.The original copy of the certificate of analysis: The analysis shall be issued by the original manufacturer or an entrusted inspection body within the past one year on the requirement specified in the Paragraph 2. 5.Essential information of the manufacturing process of the original manufacturer. 6.Certification document that that the original manufacturer is legally established or registered: (1.Domestic manufacturer: photocopy of the factory registration certificate; or, in case of an exemption from factory registration, the certificate of company or business registration listing the business files of food additive manufacturing, processing, formulation, re-packing, etc., and the certificate issued by the competent authority on the exemption from factory registration (2.Foreign manufacturer: The original certificate issued in its full name by a competent government agency in charge of product hygiene and safety or factory licensing in the country of origin and dated within the past five years, shall be provided. The certificate shall specify the name and address of the manufacturer, its business scope, categories of products, and 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 within the past one year is required. 8.In cases of entrusted manufacturing, the original of the entrusted manufacturing certificate issued by the entrusted manufacturer within the past one year is required. 9.Color photos of the product with clearly legible label in Chinese, the descriptions of the container or inner and outer packaging materials, and the labeling on the container or outer packaging; for applications for different packaging specifications, forms, and materials, color photos to the above effect shall be attached for each one of the specifications, types, and materials; for products imported from overseas, the labels in original foreign languages shall be attached unless the product is not sold in an overseas market. 10.In cases of domestic manufacturers, a copy of the review and registration license for single food additives that are not spices in ingredients; and the certificate of sources from the food industry for other ingredients. 11.A copy of the company registration or business registration certificate of the applicant, in which the business activities, in the case of importers, shall include the import of food additives, and in cases of domestic manufacturers, shall include the food additive manufacture, processing, formulation, re-packing, etc. 12.Documents of hygiene management personnel: (1.Domestic manufacturer: photocopy of the certification document of the manufacturer's hygiene management personnel that has been verified and filed by the municipal or county (city) competent authority. (2.Foreign manufacturer: The employment certification documents of the hygiene management personnel of the applying company. 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 document issued on the applications filed in compliance with Paragraph 1 and approved pursuant to the Act shall be valid for five years.