Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products 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.
中文原文 食品與相關產品查驗登記及許可文件管理辦法第29條
申請食品添加物查驗登記事項變更者,應填具申請書,檢附下列文件、資料,並繳納費用,向中央主管機關提出,不適用第六條規定:
一、產品名稱變更:
(一)原許可文件。
(二)產品為輸入者,其原製造廠出具產品名稱變更之證明文件正本。
二、包裝規格、型態、材質變更:
(一)原許可文件。
(二)原製造廠出具包裝變更之證明或同意文件正本。
三、許可文件持有廠商名稱、地址或負責人變更:
(一)原許可文件。
(二)申請廠商公司登記或商業登記證明文件影本。
其營業項目之登載,輸入者應包含食品添加物之進口;國內製造者應包含食品添加物之製造或加工、調配、改裝。
(三)許可文件持有廠商之所有許可產品清冊,並載明許可字號、產品中文名稱及許可文件有效期限。
四、原製造廠名稱變更:
(一)原許可文件。
(二)國內製造者︰工廠登記證明文件影本。
(三)國外製造者︰製造廠所出具廠名變更之證明文件正本。
(四)原製造廠之所有許可產品清冊,並載明許可字號、產品中文名稱及許可文件有效期限。
五、原製造廠門牌整編:
(一)原許可文件。
(二)國內製造者︰政府機關出具,足資證明門牌整編之文件影本。
(三)國外製造者︰出產國政府機關以全銜出具,足資證明門牌整編之文件;其為影本者,經原產國公證單位簽證與正本相符。
(四)原製造廠之所有許可產品清冊,並載明許可字號、產品中文名稱及許可文件有效期限。
前項文件、資料,以非英文之外文記載者,應檢附立案翻譯社出具之中文或英文譯本。
製造廠更換、遷移或增列者,其申請程序、文件與資料之檢附,及費用之繳納,準用第二十七條申請查驗登記新案之規定辦理。
辦理第一項變更應換發新證者,並應繳納證書費。

English translation for reference only; the Chinese text prevails. Not legal advice.