Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products Article 20
Applications for review and registration of formula for certain disease shall submit the application form, along with the following documents and information as well as product samples, to the central competent authority, and pay the related fees, while the provisions in Article 3 do not apply:1.Original table of ingredient content: The table shall be issued by the original manufacturer and dated within the past one year and contain the detailed name and net quantity of contents of all the raw materials and food additive.2.Original product specification: The product specification shall be issued by the original manufacturer and dated within the past one year and contain the hygiene and nutrients specification of the product.3.Original hygiene and nutrients analysis report: The report shall be the original issued by the original manufacturer or accreditation of food testing institution by the central competent authority and dated within the past one year.4.Manufacturing process summary.5.Certification document verifying that the original manufacturer is legally established or registered:(1.Domestic manufacturer: Carbon copy of the factory registration certificate.(2.Foreign manufacturer: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin and dated within the past two years, shall be provided. The certificate shall specify the name and address of the manufacturer, its business activities, categories of products, 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.6.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.7.In cases of entrusted manufacturing, the original certificate of the entrusted manufacturing issued by the entrusted manufacturer is required.8.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instructions of the product; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instruction are the same, the user instruction of any specifications, forms, and materials may be submitted.9.The applicant shall submit a carbon copy of its company registration or business registration certificate.10.Where the complete sample is available to the market in different packaging specifications, forms or materials, the applicant is required to submit one sample for each option.11.Where the product is intended to be re-packed in new containers for sale in Taiwan, the applicant shall submit the documents and sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations.12.All applicants, except for nutritionally complete food with balanced formula, are required to submit the following:(1.Information on the specific nutritional requirement for intended product users that would otherwise not be met without the product due to illness or medical conditions, along with supporting documents.(2.Information on why the intended users cannot otherwise meet the specific nutritional requirement described in the preceding subparagraph from the daily diet, along with supporting documents.(3.The mechanism behind the product design.(4.Information on how the intended use and quantity of intake of the product help the users to achieve the objectives described in subparagraphs (1) and (2) of this paragraph, along with supporting documents.(5.Clinical human consumption report: In case of subsequent or concurrent applications for multiple products of different pigments, flavors or sweeteners, while keeping the other ingredients identical and maintaining the same nutritional specifications with no influence on safety, the report of one of the products will suffice for application.13.For high-protein disease-specific formulas, the applicant is required to provide information on the Protein Efficiency Ratio (PER), Protein Digestibility Corrected Amino Acid Score (PDCAAS) or other internationally-recognized protein determination indicators.14.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 documents 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20條
申請特定疾病配方食品查驗登記新案，應填具申請書，檢附下列文件、資料及樣品，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，並載明所有原料、食品添加物之詳細名稱及含量。
二、產品規格表正本：原製造廠最近一年內出具，並載明產品之衛生及營養成分規格。
三、衛生及營養成分分析表正本：原製造廠或中央主管機關認證之食品檢驗機構最近一年內出具。
四、製程作業重點資料。
五、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。
（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二年內，以全銜出具，並載明製造廠名稱、地址、營業項目、產品種類、工廠之衛生狀況，經該政府機關或其主管官員戳記或簽章；其為影本者，經原產國公證單位簽證與正本相符。
六、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。
七、委託製造者，其受託製造廠出具之受託製造證明正本。
八、產品中文標籤、容器或外包裝及說明書之實體或彩色擬稿各二份；其包裝規格、型態、材質不同者，分別檢附之；說明書內容相同者，得檢送任一規格、型態、材質者之說明書。
九、申請廠商公司登記或商業登記證明文件影本。
十、完整樣品，其有不同包裝規格、型態或材質者，各別檢附之。
十一、產品須再分裝者，檢附第十三條第一項第十二款之文件及樣品。
十二、除營養均衡完整配方食品者外，應另檢附下列文件、資料：
（一）產品適用對象因疾病或醫療狀況導致特定營養素或成分需求之說明及佐證資料。
（二）前目特定營養需求難以日常飲食達成之說明及佐證資料。
（三）產品設計原理。
（四）產品使用方式及食用量可達成第一目及第二目特定需求之說明及佐證資料。
（五）臨床人體食用研究報告：先後或同時申請複數產品，其添加不同色素、香料或甜味劑，而其他成分及營養成分規格相同，無影響產品安全之虞者，得以其中一產品之報告為代表。
十三、特定疾病用之高蛋白質食品，應提供蛋白質效率（ProteinEfficiencyRatio,PER）、蛋白質經消化率修正的胺基酸評分值（ProteinDigestibilityCorrectedAminoAcidScore,PDCAAS）或其他國際間認可之蛋白質測定方法。
十四、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，並載明所有原料、食品添加物之詳細名稱及含量。
二、產品規格表正本：原製造廠最近一年內出具，並載明產品之衛生及營養成分規格。
三、衛生及營養成分分析表正本：原製造廠或中央主管機關認證之食品檢驗機構最近一年內出具。
四、製程作業重點資料。
五、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。
（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二年內，以全銜出具，並載明製造廠名稱、地址、營業項目、產品種類、工廠之衛生狀況，經該政府機關或其主管官員戳記或簽章；其為影本者，經原產國公證單位簽證與正本相符。
六、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。
七、委託製造者，其受託製造廠出具之受託製造證明正本。
八、產品中文標籤、容器或外包裝及說明書之實體或彩色擬稿各二份；其包裝規格、型態、材質不同者，分別檢附之；說明書內容相同者，得檢送任一規格、型態、材質者之說明書。
九、申請廠商公司登記或商業登記證明文件影本。
十、完整樣品，其有不同包裝規格、型態或材質者，各別檢附之。
十一、產品須再分裝者，檢附第十三條第一項第十二款之文件及樣品。
十二、除營養均衡完整配方食品者外，應另檢附下列文件、資料：
（一）產品適用對象因疾病或醫療狀況導致特定營養素或成分需求之說明及佐證資料。
（二）前目特定營養需求難以日常飲食達成之說明及佐證資料。
（三）產品設計原理。
（四）產品使用方式及食用量可達成第一目及第二目特定需求之說明及佐證資料。
（五）臨床人體食用研究報告：先後或同時申請複數產品，其添加不同色素、香料或甜味劑，而其他成分及營養成分規格相同，無影響產品安全之虞者，得以其中一產品之報告為代表。
十三、特定疾病用之高蛋白質食品，應提供蛋白質效率（ProteinEfficiencyRatio,PER）、蛋白質經消化率修正的胺基酸評分值（ProteinDigestibilityCorrectedAminoAcidScore,PDCAAS）或其他國際間認可之蛋白質測定方法。
十四、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。