Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products 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.
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27條
申請食品添加物查驗登記新案，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，不適用第三條規定：
一、產品成分含量表正本：原製造廠最近一年內出具，並載明所有成分名稱及含量百分比。
二、產品規格表正本：原製造廠最近一年內出具，並載明鑑別、純度及定量檢驗項目之規格。
三、檢驗方法：前款檢驗項目之檢驗方法。
四、檢驗成績書正本：原製造廠最近一年內出具，就第二款之項目，自行或委託檢驗者。
五、製程作業重點資料。
六、原製造廠依法設立或登記之證明文件：
（一）國內製造者：工廠登記證明文件影本；其屬免辦工廠登記者，得以載明有關食品添加物製造或加工、調配、改裝營業項目之公司或商業登記文件，及轄管工業主管機關發給之免辦工廠登記證明文件替代之。
（二）國外製造者︰出產國管理產品衛生安全或核發製造廠證照之政府機關最近五年內，以全銜出具，並載明製造廠名稱、地址、營業項目、產品種類、工廠衛生狀況，經該政府機關或其主管官員戳記或簽章；其為影本者，經出產國公證單位簽證與正本相符。
七、獲授權販售者，其原製造廠或經銷商最近一年內出具之授權證明正本。
八、委託製造者，其受託製造廠最近一年內出具之受託製造證明正本。
九、產品中文標籤、容器或內外包裝材質說明文件及標示內容可清晰辨識之產品彩色照片；其申請不同包裝規格、型態、材質者，每一規格、型態、材質均應分別檢附之；輸入者應附原文標籤，國外未販售者免附。
十、國內製造者，原料內非屬香料之單方食品添加物，其查驗登記許可證影本；其他原料，其來源為食品業者之證明文件。
十一、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。
十二、衛生管理相關人員文件：
（一）國內製造者：經直轄市、縣（市）主管機關備查在案之原製造廠衛生管理人員證明文件影本。
（二）國外製造者：申請廠商之管理衛生人員在職證明文件。
十三、其他中央主管機關指定之文件、資料。
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。
第一項申請案經審核符合本法規定者，核發有效期間五年之許可文件。
一、產品成分含量表正本：原製造廠最近一年內出具，並載明所有成分名稱及含量百分比。
二、產品規格表正本：原製造廠最近一年內出具，並載明鑑別、純度及定量檢驗項目之規格。
三、檢驗方法：前款檢驗項目之檢驗方法。
四、檢驗成績書正本：原製造廠最近一年內出具，就第二款之項目，自行或委託檢驗者。
五、製程作業重點資料。
六、原製造廠依法設立或登記之證明文件：
（一）國內製造者：工廠登記證明文件影本；其屬免辦工廠登記者，得以載明有關食品添加物製造或加工、調配、改裝營業項目之公司或商業登記文件，及轄管工業主管機關發給之免辦工廠登記證明文件替代之。
（二）國外製造者︰出產國管理產品衛生安全或核發製造廠證照之政府機關最近五年內，以全銜出具，並載明製造廠名稱、地址、營業項目、產品種類、工廠衛生狀況，經該政府機關或其主管官員戳記或簽章；其為影本者，經出產國公證單位簽證與正本相符。
七、獲授權販售者，其原製造廠或經銷商最近一年內出具之授權證明正本。
八、委託製造者，其受託製造廠最近一年內出具之受託製造證明正本。
九、產品中文標籤、容器或內外包裝材質說明文件及標示內容可清晰辨識之產品彩色照片；其申請不同包裝規格、型態、材質者，每一規格、型態、材質均應分別檢附之；輸入者應附原文標籤，國外未販售者免附。
十、國內製造者，原料內非屬香料之單方食品添加物，其查驗登記許可證影本；其他原料，其來源為食品業者之證明文件。
十一、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。
十二、衛生管理相關人員文件：
（一）國內製造者：經直轄市、縣（市）主管機關備查在案之原製造廠衛生管理人員證明文件影本。
（二）國外製造者：申請廠商之管理衛生人員在職證明文件。
十三、其他中央主管機關指定之文件、資料。
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。
第一項申請案經審核符合本法規定者，核發有效期間五年之許可文件。