Chapter IV Review and Registration of Food Additives
Article 27
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.
Article 28
Applications for extension of the permit document for food additive permit document shall submit an application form within three months prior to the expiry date of permit, along with the following documents, information, to the central competent authority, and shall pay the related fees, while the provisions in Article 5 do not apply:
1.Original permit document.
2.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor within the past one year is required.
3.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer within the past one year is required.
4.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.
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.
Article 29
Applications for amendment of the permit document for food additives shall submit an application form, along with the following documents and information to the competent authority, and shall pay the related fees, while the provisions in Article 6 do not apply:
1.Changes of the product name:
(1.Original permit document.
(2.In cases of imported products, the original document issued by the manufacturer certifying the amendment of the name of product.
2.Changes of packaging specifications, forms, and materials:
(1.Original permit document.
(2.The original document or consent document issued by the manufacturer certifying the amendment of packaging.
3.Change of the name, address or person in charge of the manufacturer holding the permit document:
(1.Original permit document.
(2.A copy of the company registration or business registration certificate of the applicant, in which the business scope, in the case of importers, shall include the import of food additives, and in case of domestic manufacturers, shall include the food additive manufacturing, processing, formulation, re- packing, etc.
(3.The complete list of the licensed products of the manufacturer holding the license, specifying the license number, the Chinese name of the product and the validity period of the permit document.
4.Amendment of the name of the original manufacturer:
(1.Original permit document.
(2.Domestic manufacturer: A copy of the factory registration certificate.
(3.Foreign manufacturer: An original document issued by the manufacturer certifying the change of its name.
(4.The complete list of the licensed products of the original manufacturer, specifying the license number, the Chinese name of the product and the validity period of the permit document.
5.Building number adjustment of the original manufacturer:
(1.Original permit document.
(2.Domestic manufacturer: The applicant shall submit a photocopy of the official certificate issued by a competent government agency certifying the building number adjustment.
(3.Foreign manufacturer: The original official certificate issued by a competent government agency 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.
(4.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 products, and expiry date of the permit document.
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, and related fees in case of change, relocation, or expansion of the manufacturer, the provisions of Article 27 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.
Article 30
Applications for transference of the permit document for food additive, 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.Original permit document.
2.Transferor’s certificate or document of consent to transfer of permit document ownership in original copy.
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 is required.
5.Color photos of the product with clearly legible label in Chinese, the descriptions of container or the 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 separately for each one of the specifications, types, and materials; for products imported from overseas, the labels in original foreign languages shall be attached.
6.A copy of the table of product ingredient content.
7.A photocopy of the applicant’s company registration or business registration certificate. For the listing of its business items, the importer shall include the import of food additives; the domestic manufacturer shall include the manufacturing, processing, formulation and re-packing of food additives.
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.
Article 31
Applications for reissuance or replacement the permit document for food additive 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 photocopy of the applicant’s company registration or business registration certificate.
2.For replacement application, the permit document originally issued.
3.For reissuance application, the applicant’s affidavit 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 permit document originally issued.