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| 食品與相關產品查驗登記及許可文件管理辦法 |
Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products |
| 第 一 章 總則 |
Chapter I General Provisions |
| 第 1 條 |
Article 1 |
| 本辦法依食品安全衛生管理法（以下簡稱本法）第二十一條第五項規定訂定之。 |
The Regulations are enacted pursuant to the provisions of Article 21 Paragraph 5 of the Act Governing Food Safety and Sanitation (hereafter referred to as “the Act”). |
| 第 2 條 |
Article 2 |
| 本辦法所稱查驗登記，指審查、檢驗、登載及核發許可文件之程序。 |
The term “review and registration” herein stated refer to the process of review, test, and registration and the issuance of permit documents. |
| 前項許可文件之登載內容，依產品類別及特性，包括下列事項： |
The registration referred in the preceding paragraph shall include the following information based on the product classification and characteristics: |
| 一、中文及外文品名。 |
1.Product name in Chinese and foreign language, |
| 二、原料成分。 |
2.Ingredients, |
| 三、包裝。 |
3.Packaging, |
| 四、製造廠名稱及地址。 |
4.Name and address of the manufacturer, |
| 五、申請廠商名稱及地址。 |
5.Name and address of the applicant, |
| 六、許可文件有效期間。 |
6.Validity period of the permit document, |
| 七、其他中央主管機關指定之事項。 |
7.Other registration information designated by the central competent authority. |
| 第 3 條 |
Article 3 |
| 食品業者向中央主管機關申請查驗登記時，應填具申請書，繳納審查費、檢驗費、證書費，並依產品類別及特性，分別檢附下列文件、資料： |
A food business operator applying for review and registration with the central competent authority shall complete an application form, pay the due review, test, and certificate fees, and attach following documents or information to the application form based on the product classification and characteristics: |
| 一、產品成分含量表、規格表、檢驗方法、檢驗成績書、營養成分分析表、製程作業重點資料。 |
1.Table of ingredient content, specifications, test method, certificate of analysis, nutrients analysis report, and manufacturing process summary; |
| 二、完整技術性資料。 |
2.Complete technical information; |
| 三、標籤、包裝、中文標示、說明書、樣品、實物照片。 |
3.Labels, packaging, Chinese labeling, user instruction, sample, and photo of the actual product; |
| 四、申請輸入查驗登記者，原製造廠依法設立或登記之證明文件。所出具之證明文件為影本，應經原產國公證單位簽證與正本相符。 |
4.An application filed for imported product review and registration shall be attached with the official substantiating documents certifying that the original manufacturer is legally established or registered. If the documents are photocopies of the original, they shall be attested as true copies of the original by a notary public in the country of origin; |
| 五、委託製造者，其委託證明文件正本。 |
5.A contract manufacturer is required to provide the original copy of the manufacturing contract; |
| 六、申請廠商公司登記或商業登記證明文件影本。 |
6.Photocopy of the applicant’s company registration or business registration certificate; |
| 七、其他中央主管機關指定之文件、資料。 |
7.Other essential documents and information specified by the central competent authority. |
| 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。 |
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. |
| 第 4 條 |
Article 4 |
| 申請查驗登記，經中央主管機關審查通過後，應於接獲通知後二個月內領取許可文件；屆期未領者，視同放棄，並由中央主管機關逕予廢止許可文件。 |
Applicant applying for review and registration shall claim the permit document within two months after the central competent authority approves the application through review procedure and issues a notification letter advising the permit document issuance. Failure of applicant to claim the permit document within the deadline shall constitute the abandonment of application; whereupon, the central competent authority is entitled to process the nullification of the issued permit document. |
| 第 5 條 |
Article 5 |
| 依本法第二十一條第一項及第二項規定向中央主管機關申請之許可文件，其有效期間為一年至五年，由中央主管機關依產品類別及特性公告之。 |
Permit documents issued on applications filed pursuant to the provisions of Article 21 Paragraphs 1 and 2 of the Act shall have a validity period ranging from one to five years subject to the announcement made by the central competent authority based on the product classification and characteristics. |
| 前項有效期間屆滿需展延者，應於期滿前三個月內，填具申請書，檢附許可文件及第三條所定文件、資料，向中央主管機關申請展延，並繳納審查費。每次核定展延之期間，不得超過五年；其應換發新證者，並應繳納證書費。 |
Where an extension shall be required, a pertinent application form complete with the permit document and the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for extension approbation within three months before expiration. The applicant shall pay the review fee when filing an extension application. The maximum validity period of the extended permit document shall be five years. Where issuance of a new certificate shall be necessary, a certificate processing fee shall be collected. |
| 第 6 條 |
Article 6 |
| 許可文件之登記事項有變更者，應填具申請書，檢附許可文件及第三條所定文件、資料，向中央主管機關申請變更登記，並繳納審查費；其應換發新證者，並應繳納證書費。 |
In the event of amendment in the registered information of the permit document, an application form complete with the permit document and the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for amendment of registration records. The applicant shall pay the review fee when filing an application. Where issuance of a new certificate shall be necessary, a certificate processing fee shall be collected. |
| 第 7 條 |
Article 7 |
| 許可文件持有人移轉時，應填具申請書，檢附第三條所定文件、資料，向中央主管機關申請移轉登記，並繳納審查費；其許可文件為證書者，另應繳納證書費。 |
In the event of permit document ownership transfer, an application form complete with the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for the transfer registration and an review fee shall be collected. Additionally, if the permit document is a certificate, a certificate processing fee shall be collected. |
| 第 8 條 |
Article 8 |
| 許可文件有污損或遺失者，應填具申請書，檢附第三條所定文件、資料，向中央主管機關申請換發或補發，並繳納審查費、證書費。污損之許可文件，應同時繳銷。 |
In the event of the defacement or loss of a permit document, an application form and the documents or information herein prescribed in Article 3 shall be filed with the central competent authority for replacement or reissuance. The applicant shall pay the review fee and certificate processing fee. Where application is filed due to defacement, the original permit document shall be surrendered for destruction. |
| 前項換發或補發之許可文件，其有效期間，同原許可文件。 |
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 original permit document. |
| 第 9 條 |
Article 9 |
| 原取得許可文件之產品，經依本法規定公告禁止製造或輸入者，應廢止其原許可文件。 |
For products that have already obtained permit documents, if the manufacture or importation of a product is officially banned under the Act, the original permit document issued for which shall be nullified. |
| 第 10 條 |
Article 10 |
| 食品業者得填具申請書，檢附許可文件及有關文件、資料，向中央主管機關申請廢止許可；經中央主管機關核定後廢止，並公告之。 |
A food business operator applying for the cancellation of its permit document shall submit the application form complete with the permit document and related documents or information to the central competent authority for annulment. Upon due approval, the central competent authority shall issue an official announcement declaring the permit document null and void. |
| 第 11 條 |
Article 11 |
| 食品業者申請查驗登記及許可文件之換發、補發、展延、移轉、廢止、登記事項變更，經中央主管機關通知送驗或補送文件者，應於二個月內辦理，必要時得申請延期一個月；屆期未補正者，其申請案得逕予駁回。 |
A food business operator applying for the review and registration and the permit document replacement, re-issuance, extension, transfer, or cancellation, or amendment of registered information shall process the required procedure within two months after receiving the official notice of document submission for test or supplementary information from the central competent authority. Where circumstances shall require, the food business operator may apply for a one-month extension period. Failure to submit documents within the prescribed deadline is subject to rejection with no further notice. |
| 第 12 條 |
Article 12 |
| 本辦法所定查驗登記事項，其申請書格式、申請書應載明之事項、申請案應檢附之文件、資料及許可文件格式，由中央主管機關定之。 |
Regarding the review and registration matters defined in the Regulations, the application form format, information to be contained in the application form, documents or information to be attached to the application form, and the official permit document format are subject to the discretion of the central competent authority. |
| 第 二 章 嬰兒與較大嬰兒配方食品查驗登記 |
Chapter II Review and Registration of Infant Formula and Follow-up Infant Formula |
| 本條文有附件 第 13 條 |
Article 13 |
| 申請嬰兒與較大嬰兒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： |
Applications for review and registration of infant formula and follow-up infant formula 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: |
| 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。 |
1.Original table of ingredient content of the product: 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 additives. |
| 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；其熱量及營養素，應符合附表一所定之規格；其含有附表一以外營養素者，應就該營養素，提具科學實證或其他採用引據。 |
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. Its calories and nutrients shall meet the specifications set out in Schedule 1; if it contains nutrients other than those in Schedule 1, scientific evidence or other references shall be provided for the nutrients. |
| 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。 |
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. |
| 四、販售證明及產品，或試用報告：國外之販售證明及產品，或有效樣本數二十人以上之試用報告。 |
4.The applicant is required to submit the original substantiating document verifying the product is for sale in a market outside the territory of Taiwan and a product sample, or a trial report of the product with a valid sample size of more than 20 subjects. |
| 五、製程作業重點資料。 |
5.Manufacturing process summary. |
| 六、原製造廠依法設立或登記之證明文件： |
6.Certification document verifying that the original manufacturer is legally established or registered; |
| （一）國內製造者：工廠登記證明文件影本。 |
(1.Domestic manufacturer: Carbon copy of the factory registration certificate. |
| （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。 |
(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. |
| 七、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。 |
7.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 八、委託製造者，其受託製造廠出具之受託製造證明正本。 |
8.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required. |
| 九、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。 |
9.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instructions; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specifications, forms, and materials may be submitted |
| 十、申請廠商公司登記或商業登記證明文件影本。 |
10.The applicant shall submit a carbon copy of its company registration or business registration certificate. |
| 十一、完整樣品：有不同包裝規格、型態或材質者，各別檢附之。 |
11.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. |
| 十二、申請產品於國內再分裝者，並檢附下列文件及樣品： |
12.Where the product is intended to be re-packed in new containers for sale in Taiwan, the applicant shall submit the following documents: |
| （一）輸入之產品，原製造廠出具分裝證明或同意文件正本。 |
(1.The manufacturer’s original re-packing certificate or the original document of consent to product re-packing for imported products. |
| （二）國內分裝工廠之工廠登記證明文件影本，且該文件應登載有關食品分裝、加工或製造項目。 |
(2.The domestic re-packing facility’s factory registration certificate in carbon copy. Food re-packing, processing or manufacturing shall be listed in the scope of business stated on the factory registration certificate. |
| （三）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分裝產品衛生及營養成分分析表正本。 |
(3.The original copy of the hygiene and nutrition analysis report on the re- packed product issued within the past one year by the original manufacturer or accreditation of food testing institution by the central competent authority. |
| （四）分裝產品中文標籤、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。 |
(4.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instructions of the re-packed products; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specification, form, and materials may be submitted |
| （五）分裝後樣品：不同分裝規格、型態、材質者，各別檢附之。 |
(5.Where the re-packed product sample is available in different packaging specifications, forms and materials, the applicant is required to submit one sample for each option. |
| 十三、其他中央主管機關指定之文件、資料。 |
13.Other essential documents and information specified by the central competent authority. |
| 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。 |
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. |
| 第一項申請案經審核符合本法規定者，核發有效期間為五年之許可文件。 |
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. |
| 第 14 條 |
Article 14 |
| 申請嬰兒與較大嬰兒配方食品查驗登記許可展延，應於期滿前三個月內，填具申請書，檢附下列文件、資料及產品，並繳納費用，向中央主管機關提出，不適用第五條規定： |
Applications for extension of the permit document for infant formula and follow-up infant formula shall submit an application form within three months prior to the expiry date of permit, along with the following documents, information and product sample, to the central competent authority, and pay the related fees, while the provisions in Article 5 do not apply: |
| 一、原許可文件。 |
1.Original permit document. |
| 二、原製造廠最近一年內出具依原許可內容繼續製造之證明或同意文件正本，或產品成分含量表正本。 |
2.The original certificate or document of consent to renewal of the product manufacturing agreement, or original table of ingredient content issued by the original manufacturer based on the content of originally issued permit within the past one year. |
| 三、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。 |
3.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 四、委託製造者，其受託製造廠出具之受託製造證明正本。 |
4.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required. |
| 五、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。 |
5.Two copies each of the physical or color drafts of the product labels in Chinese, containers or outer packaging, and user instructions; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instruction of any specification, form, and materials may be submitted |
| 六、原製造廠出具或簽署之產品最近五年國內、外使用情形說明；其內容至少應包括產品上市情形、國內、外不良反應通報、原製造廠最近一次經政府機關或其委託機構稽查情形。 |
6.Description of product usage: The report issued or signed by the original manufacturer describing the situations of domestic and overseas consumer usage of the product in the last five years, and the content of which shall at least include the sales situations, adverse reactions reported domestically and overseas, and the latest results of inspection imposed on the original manufacturer by the competent authorities or its entrusted institution. |
| 七、原製造廠最近一年內，出具之產品衛生及營養成分規格表正本。 |
7.Original hygiene and nutrients specifications issued by the original manufacturer within the past one year. |
| 八、原製造廠或中央主管機關認證之食品檢驗機構，出具最近一年內生產批次之產品衛生及營養成分分析表正本；最近一年內無生產者，應出具最近生產批次之分析表正本。 |
8.Original hygiene and nutrients analysis report of the batches of production within the past year issued by the original manufacturer or accreditation of food testing institution by the central competent authority. The original analysis report of the latest batch of production shall be provided in case there is no production within the past year. |
| 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。 |
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. |
| 第一項展延申請案，經審核符合本法規定者，核發有效期間五年之許可文件；其應換發新證者，並應繳納證書費。 |
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. |
| 本辦法中華民國一百十二年十一月三十日修正發布後一年內，申請案件未能依第一項第六款提供最近五年國內、外使用情形說明者，得以國外之販售證明及產品，或有效樣本數二十人以上試用報告替代之。 |
In case that, within one year of the amendment and implementation of these Regulations on November 30, 2023, the applicant is unable to provide a description of domestic and overseas usage in the past five years as specified in Paragraph 1 Subparagraph 6, the submission of overseas sales certificates and the product, or trial usage reports with a sample size of twenty or more subjects may be accepted as a substitute. |
| 第 15 條 |
Article 15 |
| 申請嬰兒與較大嬰兒配方食品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： |
Applications for amendment of the permit document for infant formula and follow- up infant formula shall 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 6 do not apply: |
| 一、原許可文件。 |
1.Original permit document. |
| 二、變更涉及產品中文標籤、容器或外包裝及說明書者，其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。 |
2.Two copies each of the physical or color drafts of the Chinese labels, container or outer packaging, and user instructions of the product that are involved in amendment; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instructions of any specifications, forms, and materials may be submitted. |
| 除前項規定外，依申請變更之項目，另應檢附下列文件、資料或樣品︰ |
In addition to the foregoing requirements, the following documents, information or sample shall be additionally submitted according to the application of amendment: |
| 一、產品名稱變更：產品為輸入者，其原製造廠出具產品名稱變更之證明或同意文件正本。 |
1.Product name change: The certificate or document of consent to change of the product name issued by the original manufacturer for imported products. |
| 二、許可文件持有廠商名稱、地址或負責人變更： |
2.Change of name, address or person-in-charge of the manufacturer holding the permit document: |
| （一）許可文件持有廠商公司登記或商業登記證明文件影本。 |
(1.Photocopy of company registration or business registration certificate of the manufacturer holding the permit document. |
| （二）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。 |
(2.A complete list of product items shown on the permit document held by the manufacturer. The list is required to contain the registration numbers, Chinese names of the product items and expiry date of the permit document. |
| 三、原製造廠名稱變更： |
3.Change of the original manufacturer’s name: |
| （一）國內製造者︰工廠登記證明文件影本。 |
(1.Domestic manufacturer: Carbon copy of the factory registration certificate. |
| （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。 |
(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. |
| （三）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。 |
(3.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 product items, and expiry date of the permit document. |
| 四、原製造廠門牌整編： |
4.Building number adjustment of the original manufacturer’s address: |
| （一）國內製造者︰政府機關所出具，足資證明門牌整編之文件影本。 |
(1.In cases of domestic manufacturers: The applicant shall submit a photocopy of the documents issued by a competent government agency certifying the address building number adjustment. |
| （二）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。 |
(2.In cases of foreign manufacturers: The original certificate issued by a competent government agency of the country of origin 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. |
| （三）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。 |
(3.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 the product items, and expiry dates of the permit document. |
| 五、第十三條第一項第二款之產品規格變更： |
5.Amendment of the product specifications set forth in Subparagraph 2, Paragraph 1 of Article 13: |
| （一）原製造廠最近一年內出具之變更合理性評估報告，包括變更內容前後對照表。 |
(1.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year (including a chart of comparison of the content before and after the amendment). |
| （二）第十三條第一項第一款及第二款規定之文件，並依變更之規格項目，檢附同條項第三款規定之文件。 |
(2.The documents set forth in Subparagraphs 1 and 2, Paragraph 1 of Article 13, attaching those set forth in Subparagraph 3 of the same Article and Paragraph, based on the amended items of specifications. |
| 六、包裝規格、型態、材質變更： |
6.Amendment to the packaging specification, form and material: |
| （一）產品為輸入者，其原製造廠出具包裝變更之證明或同意文件正本。 |
(1.For imported product items, the original manufacturer’s certificate or document of consent to the change of packaging in original copy shall be submitted. |
| （二）型態或材質變更者，檢附樣品。 |
(2.Product samples are required if changes involve product forms or materials. |
| （三）產品為須再分裝者，檢附第十三條第一項第十二款規定之文件及樣品。 |
(3.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents and sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations. |
| 七、中文標籤、容器或外包裝及說明書變更： |
7.Amendment of the Chinese label, container or outer packaging, and user instructions of the product: |
| （一）變更前後對照表。 |
(1.A chart of comparison of the content before and after the amendment. |
| （二）產品為輸入者，檢附原製造廠出具中文標籤、容器或外包裝及說明書變更之證明或同意文件正本。 |
(2.For imported product items, the original manufacturer’s certificate or document of consent to the amendment of the Chinese label, container or outer packaging, and user instructions in original copy. |
| （三）營養標示變更： |
(3.For amendment to the nutrition facts: |
| 1.原製造廠最近一年內出具之變更合理性評估報告。 |
A.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year. |
| 2.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之營養成分分析表正本。 |
B.The original copy of the nutrition analysis report issued by the original manufacturer or accreditation of food testing institution by the central competent authority within the past one year. |
| 3.第十三條第一項第一款及第二款規定之文件。 |
C.The documents set forth in Subparagraphs 1 and 2, Paragraph 1 of Article 13. |
| 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。 |
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. |
| 製造廠更換、遷移或增列者，其申請程序、文件、資料與樣品之檢附，及費用之繳納，準用第十三條申請查驗登記新案之規定辦理。 |
For the application process and the submission of documents and information, product samples, and related fees in case of change, relocation or expansion of the manufacturer, the provisions of Article 13 on new registration applications shall apply mutatis mutandis. |
| 辦理第一項變更應換發新證者，並應繳納證書費。 |
If it is necessary to reissue a new permit document, a certificate processing fee shall be collected. |
| 第二項第五款產品規格變更及第七款第三目營養標示變更，以產品成分及含量均未變更者為限。 |
For the product specifications as set forth in Subparagraph 5 of Paragraph 2 and the nutrition facts in Item 3 of Subparagraph 7, amendment shall be limited to cases where neither the product composition nor the content has been amended. |
| 第 16 條 |
Article 16 |
| 嬰兒與較大嬰兒配方食品之中文標籤、容器或外包裝及說明書之變更，有下列情形之一者，免辦理變更申請： |
Applications for the amendment of Chinese label, container or outer packaging, and user instructions of the infant and follow-up formula are exempted in one of the following situations: |
| 一、圖樣或顏色更改。 |
1.Amendment of patterns or colors. |
| 二、原核准圖文依比例縮小或放大。 |
2.Proportionate reduction or enlargement of the approved images and texts. |
| 三、原核准圖文位置移動。 |
3.Movement of the position of the approved images and texts. |
| 四、原核准文字之字體更改。 |
4.Amendment of the fonts of the approved text. |
| 前項標籤、容器或外包裝及說明書，刊載本法以外其他相關機關規定之內容者，其變更應依各該法規規定辦理。 |
The amendment in the preceding paragraph of the Chinese labels, container or outer packaging and user instructions which contain the content stipulated by relevant authorities other than those specified in this Act shall be subject to the provisions of respective regulations. |
| 許可文件持有人，應就第一項免辦變更之事項，作成書面紀錄，並妥善保存。 |
For items exempted from amendment applications as set forth in the first paragraph, the permit holder shall produce a written record for retention. |
| 第 17 條 |
Article 17 |
| 申請嬰兒與較大嬰兒配方食品查驗登記許可文件持有人移轉者，受讓人應填具申請書，檢附下列文件、資料，並繳納審查費及證書費，向中央主管機關提出，不適用第七條規定： |
Applications for transference of the permit document for infant formula and follow- up infant formula, 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: |
| 一、讓與人同意讓與之證明文件正本。 |
1.Transferor’s certificate or document of consent to transfer of permit document ownership in original copy. |
| 二、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。 |
2.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 三、委託製造者，其受託製造廠出具之受託製造證明正本。 |
3.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required. |
| 四、原許可文件。 |
4.Original permit document. |
| 五、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。 |
5.Two copies each of the physical or color drafts of the Chinese labels, container or outer packaging, and user instruction of the product; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instructions of any specifications, forms, and materials may be submitted. |
| 六、產品須再分裝者，檢附第十三條第一項第十二款第一目至第四目之文件。 |
6.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents set forth in Article 13 Paragraph 1 Subparagraph 12 Items 1-4 of the Regulations. |
| 七、產品成分含量表影本。 |
7.Photocopy of the table of product ingredient content. |
| 八、申請廠商公司登記或商業登記證明文件影本。 |
8.Photocopy of the applicant’s company registration or business registration certificate. |
| 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。 |
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. |
| 第 18 條 |
Article 18 |
| 嬰兒與較大嬰兒配方食品查驗登記許可文件污損或遺失，其申請換發或補發者，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，不適用第八條規定： |
Applications for reissuance or replacement the permit document for infant formula and follow-up infant formula 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: |
| 一、申請廠商公司登記或商業登記證明文件影本。 |
1.The applicant shall submit the photocopy of the applicant’s company registration or business registration certificate. |
| 二、換發者，繳銷之原許可文件。 |
2.For replacement application, the applicant shall submit the originally issued permit document. |
| 三、補發者，原許可文件作廢之切結聲明。 |
3.For re-issuance application, the applicant shall submit a statement that declares the original permit document null and void. |
| 前項換發或補發之許可文件，其有效期間，同原許可文件。 |
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 original permit document. |
| 第 三 章 特定疾病配方食品查驗登記 |
Chapter III Review and Registration of Formula for Certain Disease |
| 本條文有附件 第 19 條 |
Article 19 |
| 本章所稱特定疾病配方食品，指因病人生理功能失調，致無法進食、消化、吸收或代謝一般食品或食品中特定營養成分，或醫學上認定有其他特殊營養需求，且不易透過日常飲食調整所獲取，而依據其適用對象特別加工或配製之食品。 |
Formula for certain disease referred to in this chapter is intended for the dietary management of patients who have impaired capacity to ingest, digest, absorb or metabolize ordinary foods or certain nutrients, or who, for any medically-proven reason, have special dietary requirements that cannot be easily met with re-balancing daily diet. The food products in this category are processed or formulated according to the needs of the target users. |
| 前項特定疾病配方食品，其範圍如下： |
The scope of formula for certain disease as referred in the preceding paragraph is as follows: |
| 一、可作為單一營養來源之營養完整配方食品： |
1.Nutritionally complete food that may be used as the single source of nutrients: |
| （一）營養均衡完整配方食品：指以均衡營養為基礎，供應病人維持生理所需之基礎熱量及營養素；其營養素規格，除供一歲至十八歲病人使用者外，應符合附表二規定。 |
(1.Nutritionally complete food with balanced formula: The products in this category are designed to maintain caloric and nutritional sustenance of patients. The various nutrients contained in the product shall comply with the regulations provided in the Schedule 2, except for formulae for patient children aged one to eighteen. |
| （二）營養調整完整配方食品：指依病人需求增減特定營養素，供應病人維持生理所需之基礎熱量及營養素。該特定營養素，應具科學實證；其他營養素，準用附表二規定。 |
(2.Nutritionally complete food with customized formula: The products in this category are designed to maintain caloric and nutritional sustenance of patients by delivering complete nutrition with added or reduced nutrients to meet the patients’ specific needs. The nutrient addition or reduction shall be based on scientific evidence. For other nutrients, the regulations provided in Schedule 2 shall apply mutatis mutandis. |
| 二、不可作為單一營養來源之營養補充配方食品︰ |
2.Nutrition supplement formula food that may not be used as the single source of nutrients: |
| （一）營養調整補充配方食品：指依病人特定營養需求，作為部分營養補充使用，並符合下列條件者： |
(1.Nutrition adjusted supplementary formula food: The products in this category are designed to be used as part of nutritional supplement for patients of specific nutritional needs and meet the following requirements: |
| 1.補充之特定營養素，應具科學實證，其他營養素每一百大卡應可達附表二之下限值，且每日建議攝取量不得超過食品添加物使用範圍及限量暨規格標準最高限量規定。 |
A.The specific nutrients to be supplemented shall be based on scientific evidence. For the non-customized nutrition portion of the product, every serving size (100 Kcal) shall reach the lower limit as specified in Schedule 2. The recommended daily nutrition allowance for the product shall not exceed the maximum allowance specified in the Standards for Specification, Scope, Application and Limitation of Food Additives. |
| 2.特定補充營養素以外之其他營養素，每一百大卡未達附表二之下限值者，應於國內進行臨床人體食用研究後，證明該產品使用者，依建議之飲食攝取方式及內容可達營養需求。 |
B.Where the non-customized nutrition portion of the product under application per 100 Kcal does not reach the lower limit as specified in Schedule 2, a domestic clinical study on the product is required to prove that the users of such product will be able to meet the nutritional requirements by following the recommended diet. |
| （二）特殊單素配方食品：指為供特定疾病營養或代謝所需，而具有單素且該單素符合下列規定之配方食品： |
(2.Special modular formula food: The products in this category are designed to deliver a specific nutrient or ingredient to meet the nutritional needs deriving from specific illness or metabolic needs and contain the element meeting the following requirements: |
| 1.所含單素之來源食品添加物，屬同一類別營養素之營養添加劑。 |
A.The source food additives containing the modular formula are the nutritional additives within the same domain of nutrients. |
| 2.有科學證據證明該單素為特定疾病營養或代謝所需不可或缺者。 |
B.There is scientific evidence that this element is essential for the nutritional needs deriving from specific illness or metabolic needs. |
| 前項食品，得依口味調整或加工之必要，併同使用其他食品原料或食品添加物。 |
The products as referred in the preceding paragraph may use other food ingredients or additives to meet the flavoring or processing requirements. |
| 第 20 條 |
Article 20 |
| 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： |
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: |
| 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。 |
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. |
| 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。 |
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. |
| 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。 |
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. |
| 四、製程作業重點資料。 |
4.Manufacturing process summary. |
| 五、原製造廠依法設立或登記之證明文件： |
5.Certification document verifying that the original manufacturer is legally established or registered: |
| （一）國內製造者：工廠登記證明文件影本。 |
(1.Domestic manufacturer: Carbon copy of the factory registration certificate. |
| （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。 |
(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. |
| 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。 |
6.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 七、委託製造者，其受託製造廠出具之受託製造證明正本。 |
7.In cases of entrusted manufacturing, the original certificate of the entrusted manufacturing issued by the entrusted manufacturer is required. |
| 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。 |
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. |
| 九、申請廠商公司登記或商業登記證明文件影本。 |
9.The applicant shall submit a carbon copy of its company registration or business registration certificate. |
| 十、完整樣品，其有不同包裝規格、型態或材質者，各別檢附之。 |
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. |
| 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。 |
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. |
| 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： |
12.All applicants, except for nutritionally complete food with balanced formula, are required to submit the following: |
| （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。 |
(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. |
| （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。 |
(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. |
| （三）產品設計原理。 |
(3.The mechanism behind the product design. |
| （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。 |
(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. |
| （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。 |
(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. |
| 十三、特定疾病用之高蛋白質食品，應提供蛋白質效率（Protein Efficiency Ratio, PER）、蛋白質經消化率修正的胺基酸評分值（Protein Digestibility Corrected Amino Acid Score, PDCAAS）或其他國際間認可之蛋白質測定方法。 |
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. |
| 十四、其他中央主管機關指定之文件、資料。 |
14.Other essential documents and information specified by the central competent authority. |
| 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。 |
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. |
| 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。 |
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. |
| 第 21 條 |
Article 21 |
| 中央主管機關為前條申請案之審查，得召開專家會議；必要時，並得指定申請廠商到會陳述或答覆。 |
The central competent authority may convene an expert review meeting for reviewing the applications filed in accordance with the preceding Article, and when necessary, may demand the presence of the applicant for presentations or questioning. |
| 召開前項會議時，中央主管機關應通知申請廠商限期檢送指定之文件、資料；屆期未檢送或檢送不完備者，其申請案得逕予駁回。 |
For the convening of the meeting referred to in the preceding paragraph, the central competent authority shall notify the applying company to submit necessary documents and information within the designated time. Failure of submission or submission of incomplete documents and information within the designated time may result in the rejection of application with no further notice. |
| 第 22 條 |
Article 22 |
| 申請特定疾病配方食品查驗登記許可展延，應於期滿前三個月內，填具申請書，檢附下列文件、資料及產品，並繳納費用，向中央主管機關提出，不適用第五條規定： |
Applications for extension of the permit document for formula for certain disease shall submit an application form within three months prior to the expiry date of permit, along with the following documents, information and product sample, to the central competent authority, and pay the related fees, while the provisions in Article 5 do not apply: |
| 一、原許可文件。 |
1.Original permit document. |
| 二、原製造廠最近一年內出具依原許可內容繼續製造之證明或同意文件正本，或產品成分含量表正本。 |
2.The original certificate or document of consent to renewal of the product manufacturing agreement, or original table of ingredient content issued by the original manufacturer based on the content of originally issued permit within the past one year. |
| 三、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。 |
3.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 四、委託製造者，其受託製造廠出具之受託製造證明正本。 |
4.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required. |
| 五、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。 |
5.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 instructions are the same, the user instructions of any specification, form, and materials may be submitted. |
| 六、原製造廠最近一年內，出具之產品衛生及營養成分規格表正本。 |
6.Original hygiene and nutrients specifications issued by the original manufacturer within the past one year. |
| 七、原製造廠或中央主管機關認證之食品檢驗機構出具最近一年內生產批次之產品衛生及營養成分分析表正本；最近一年內無生產者，應出具最近生產批次之分析表正本。 |
7.Original hygiene and nutrients analysis report of the batches of production within the past year issued by the original manufacturer or accreditation of food testing institution by the central competent authority. The original analysis report of the latest batch of production shall be provided in case there is no production within the past year. |
| 八、臨床人體食用研究報告，其曾檢附或屬營養均衡完整配方者免附。 |
8.Clinical study report for the product under application (applications for nutritionally complete food with balanced formula or with attached clinical study report already is exempted from the requirement). |
| 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。 |
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. |
| 第一項展延申請案，經審核符合本法規定者，核發有效期間五年之許可文件；其應換發新證者，並應繳納證書費。 |
The permit document issued on the extension applications 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. |
| 第 23 條 |
Article 23 |
| 申請特定疾病配方食品查驗登記事項變更，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： |
Applications for amendment of the permit document for certain disease shall 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 6 do not apply: |
| 一、原許可文件。 |
1.Original permit document. |
| 二、變更涉及產品中文標籤、容器或外包裝及說明書者，其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。 |
2.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instruction that are involved in amendment; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instructions are the same, the user instructions of any specification, form, and materials may be submitted. |
| 除前項規定外，依申請變更之項目，另應檢附下列文件、資料或樣品︰ |
In addition to the foregoing requirements, the following documents, information or sample shall be additionally submitted according to the application of amendment: |
| 一、產品名稱變更：產品為輸入者，其原製造廠出具產品名稱變更之證明或同意文件正本。 |
1.Product name change: The certificate or document of consent to change of the product name issued by the original manufacturer for imported products. |
| 二、許可文件持有廠商名稱、地址或負責人變更： |
2.Change of name, address or person-in-charge of the manufacturer holding the permit document: |
| （一）許可文件持有廠商公司登記或商業登記證明文件影本。 |
(1.Photocopy of the company registration or business registration certificate of the manufacturer holding the permit document. |
| （二）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。 |
(2.A complete list of product items shown on the permit document held by the manufacturer. The list is required to contain the registration numbers, Chinese names of the product items, and expiry date of the permit document. |
| 三、原製造廠名稱變更︰ |
3.Change of the original manufacturer’s name: |
| （一）國內製造者︰工廠登記證明文件影本。 |
(1.Domestic manufacturer: Carbon copy of the factory registration certificate. |
| （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。 |
(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. |
| （三）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。 |
(3.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 the product items, and expiry date of the permit document. |
| 四、原製造廠門牌整編： |
4.Building number adjustment of the original manufacturer’s address: |
| （一）國內製造者︰政府機關出具，足資證明門牌整編之文件影本。 |
(1.In cases of domestic manufacturers: The applicant shall submit a photocopy of the official certificate issued by a competent government agency certifying the building number adjustment. |
| （二）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。 |
(2.In cases of foreign manufacturers: The original official certificate issued by a competent government agency of the country of origin in its full title certifying the address 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. |
| （三）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。 |
(3.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 the product items, and expiry date of the permit document. |
| 五、第二十條第一項第二款之產品規格變更： |
5.Amendment of the product specifications as set forth in Article 20, Paragraph 1, Subparagraph 2: |
| （一）原製造廠最近一年內出具之變更合理性評估報告，包括變更內容前後對照表。 |
(1.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year (including a chart of comparison of the content before and after the changes). |
| （二）第二十條第一項第一款及第二款規定之文件，並依變更之規格項目，檢附同條項第三款規定之文件。 |
(2.The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 and 2, attaching those set forth in Subparagraph 3 of the same Article and Paragraph, based on the amended items of specifications. |
| 六、包裝規格、型態、材質變更： |
6.Amendment to the packaging specification, form and material: |
| （一）產品為輸入者，其原製造廠出具包裝變更之證明或同意文件正本。 |
(1.For imported product items, the original manufacturer’s certificate or document of consent to the change of packaging in original copy shall be submitted. |
| （二）型態或材質變更者，應檢附樣品。 |
(2.Product samples are required if changes involve product forms or materials. |
| （三）產品為須再分裝者，檢附第十三條第一項第十二款規定之文件及樣品。 |
(3.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents or sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations. |
| 七、中文標籤、容器或外包裝及說明書變更： |
7.Amendment of Chinese label, container or outer packaging, and user instructions of the product: |
| （一）變更前後對照表。 |
(1.A chart of comparison of the content before and after the changes. |
| （二）產品為輸入者，檢附原製造廠出具中文標籤、容器或外包裝及說明書變更之證明或同意文件正本。 |
(2.For imported product items, the original manufacturer’s certificate or document of consent to the amendment of Chinese label, container or outer packaging, and user instructions in original copy shall be submitted. |
| （三）營養標示變更者： |
(3.For amendment to the nutrition facts label (with no changes of the product ingredients and content): |
| 1.原製造廠最近一年內出具之變更合理性評估報告。 |
A.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year; |
| 2.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之營養成分分析表正本。 |
B.The original copy of the nutrition analysis report issued by the original manufacturer or accreditation of food testing institution by the central competent authority within the past one year. |
| 3.第二十條第一項第一款及第二款規定之文件。 |
C.The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 and 2. |
| 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。 |
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. |
| 製造廠更換、遷移或增列者，其申請程序、文件、資料與樣品之檢附，及費用之繳納，除第二十條第一項第十二款第五目之報告免檢附外，準用第二十條申請查驗登記新案之規定辦理。 |
For the application process, attachment of documents and information and product samples, and fee payment in cases of change, relocation or expansion of the manufacturer, except for the exemption provided for the clinical report under Article 20, Paragraph 1, Subparagraph 12, Item 5, the provisions of Article 20 on new case applications shall apply mutatis mutandis. |
| 辦理第一項變更應換發新證者，並應繳納證書費。 |
If it is necessary to reissue a new permit document, a certificate processing fee shall be collected. |
| 第二項第五款產品規格變更及第七款第三目營養標示變更，以產品成分及含量均未變更者為限。但因應本辦法修正，調整產品配方微量營養素之成分或含量者，不在此限。 |
For the product specifications as set forth in Subparagraph 5 of Paragraph 2 and the nutrition facts in Item 3 of Subparagraph 7, amendment shall be limited to cases where neither the product composition nor the content has been amended. This does not apply to cases where the ingredients or content of the micronutrients in the product formula are adjusted in accordance with the revisions to the regulations. |
| 第 24 條 |
Article 24 |
| 特定疾病配方食品之中文標籤、容器或外包裝及說明書之變更，有下列情形之一者，免辦理變更申請： |
Applications for the amendment of the Chinese label, container or outer packaging, and user instructions of the food formula for specific diseases are exempted in one of the following situations: |
| 一、圖樣或顏色更改。 |
1.Amendment of patterns or colors. |
| 二、原核准圖文依比例縮小或放大。 |
2.Proportionate reduction or enlargement of the approved images and texts. |
| 三、原核准圖文位置移動。 |
3.Movement of the position of the approved images and texts. |
| 四、原核准文字之字體更改。 |
4.Amendment of the fonts of the approved text. |
| 前項標籤、容器或外包裝及說明書，刊載本法以外其他相關機關規定之內容者，其變更應依各該法規規定辦理。 |
The amendment in the preceding paragraph of the Chinese labels, container or outer packaging and user instructions which contain the content stipulated by relevant authorities other than those specified in this Act shall be subject to the provisions of respective regulations. |
| 許可文件持有人，應就第一項免辦變更之事項，作成書面紀錄，並妥善保存。 |
For items exempted from modification applications as set forth in the first paragraph, the permit holder shall produce a written record for retention. |
| 第 25 條 |
Article 25 |
| 申請特定疾病配方食品查驗登記許可文件持有人移轉者，受讓人應填具申請書，檢附下列文件、資料，並繳納審查費及證書費，向中央主管機關提出，不適用第七條規定： |
Applications for transference of the permit document for formula for certain disease, 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: |
| 一、讓與人同意讓與之證明文件正本。 |
1.Transferor’s certificate or document of consent to transfer of permit document ownership in original copy. |
| 二、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。 |
2.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 三、委託製造者，其受託製造廠出具之受託製造證明正本。 |
3.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required. |
| 四、原許可文件。 |
4.Original permit document. |
| 五、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。 |
5.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 instructions are the same, the user instructions of any specification, form, and materials may be submitted. |
| 六、產品須再分裝者，檢附第十三條第一項第十二款第一目至第四目之文件。 |
6.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents set forth in Article 13 Paragraph 1 Subparagraph 12 Items 1-4 of the Regulations. |
| 七、產品成分含量表影本。 |
7.Photocopy of the table of product ingredient content. |
| 八、申請廠商公司登記或商業登記證明文件影本。 |
8.Photocopy of the applicant’s company registration or business registration certificate. |
| 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。 |
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. |
| 第 26 條 |
Article 26 |
| 特定疾病配方食品查驗登記許可文件污損或遺失，其申請換發或補發者，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，不適用第八條規定： |
Applications for reissuance or replacement the permit document for formula for certain disease 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: |
| 一、申請廠商公司登記或商業登記證明文件影本。 |
1.The applicant shall submit the photocopy of the applicant’s company registration or business registration certificate. |
| 二、換發者，繳銷之原許可文件。 |
2.For replacement application, the applicant shall submit the originally issued permit document. |
| 三、補發者，原許可文件作廢之切結聲明。 |
3.For re-issuance application, the applicant shall submit a statement that declares the original permit document null and void. |
| 前項換發或補發之許可文件，其有效期間，同原許可文件。 |
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 original permit document. |
| 第 四 章 食品添加物查驗登記 |
Chapter IV Review and Registration of Food Additives |
| 第 27 條 |
Article 27 |
| 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： |
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: |
| 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。 |
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. |
| 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。 |
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. |
| 三、檢驗方法：前款檢驗項目之檢驗方法。 |
3.Test method: the test method used on the test requirement in the preceding paragraph. |
| 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。 |
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. |
| 五、製程作業重點資料。 |
5.Essential information of the manufacturing process of the original manufacturer. |
| 六、原製造廠依法設立或登記之證明文件： |
6.Certification document that that the original manufacturer is legally established or registered: |
| （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。 |
(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 |
| （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。 |
(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. |
| 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。 |
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. |
| 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。 |
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. |
| 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。 |
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. |
| 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。 |
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. |
| 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。 |
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. |
| 十二、衛生管理相關人員文件： |
12.Documents of hygiene management personnel: |
| （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。 |
(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. |
| （二）國外製造者：申請廠商之管理衛生人員在職證明文件。 |
(2.Foreign manufacturer: The employment certification documents of the hygiene management personnel of the applying company. |
| 十三、其他中央主管機關指定之文件、資料。 |
13.Other essential documents and information specified by the central competent authority. |
| 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。 |
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. |
| 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。 |
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. |
| 第 28 條 |
Article 28 |
| 申請食品添加物查驗登記許可展延，應於期滿前三個月內，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，不適用第五條規定： |
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: |
| 一、原許可文件。 |
1.Original permit document. |
| 二、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。 |
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. |
| 三、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。 |
3.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer within the past one year is required. |
| 四、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。 |
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. |
| 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。 |
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. |
| 第一項展延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；其應換發新證者，並應繳納證書費。 |
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. |
| 第 29 條 |
Article 29 |
| 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： |
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: |
| 一、產品名稱變更： |
1.Changes of the product name: |
| （一）原許可文件。 |
(1.Original permit document. |
| （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。 |
(2.In cases of imported products, the original document issued by the manufacturer certifying the amendment of the name of product. |
| 二、包裝規格、型態、材質變更： |
2.Changes of packaging specifications, forms, and materials: |
| （一）原許可文件。 |
(1.Original permit document. |
| （二）原製造廠出具包裝變更之證明或同意文件正本。 |
(2.The original document or consent document issued by the manufacturer certifying the amendment of packaging. |
| 三、許可文件持有廠商名稱、地址或負責人變更： |
3.Change of the name, address or person in charge of the manufacturer holding the permit document: |
| （一）原許可文件。 |
(1.Original permit document. |
| （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。 |
(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. |
| （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。 |
(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. |
| 四、原製造廠名稱變更： |
4.Amendment of the name of the original manufacturer: |
| （一）原許可文件。 |
(1.Original permit document. |
| （二）國內製造者︰工廠登記證明文件影本。 |
(2.Domestic manufacturer: A copy of the factory registration certificate. |
| （三）國外製造者︰製造廠所出具廠名變更之證明文件正本。 |
(3.Foreign manufacturer: An original document issued by the manufacturer certifying the change of its name. |
| （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。 |
(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. |
| 五、原製造廠門牌整編： |
5.Building number adjustment of the original manufacturer: |
| （一）原許可文件。 |
(1.Original permit document. |
| （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。 |
(2.Domestic manufacturer: The applicant shall submit a photocopy of the official certificate issued by a competent government agency certifying the building number adjustment. |
| （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。 |
(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. |
| （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。 |
(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. |
| 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。 |
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. |
| 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。 |
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. |
| 辦理第一項變更應換發新證者，並應繳納證書費。 |
If it is necessary to reissue a new permit document, a certificate processing fee shall be collected. |
| 第 30 條 |
Article 30 |
| 申請食品添加物查驗登記許可文件持有人移轉者，受讓人應填具申請書，檢附下列文件、資料，並繳納審查費及證書費，向中央主管機關提出，不適用第七條規定： |
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: |
| 一、原許可文件。 |
1.Original permit document. |
| 二、讓與人同意讓與之證明文件正本。 |
2.Transferor’s certificate or document of consent to transfer of permit document ownership in original copy. |
| 三、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。 |
3.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. |
| 四、委託製造者，其委託證明文件正本。 |
4.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing is required. |
| 五、產品中文標籤、容器或內外包裝材質說明文件及包裝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；輸入者應另附原文標籤。 |
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. |
| 六、產品成分含量表影本。 |
6.A copy of the table of product ingredient content. |
| 七、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。 |
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. |
| 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。 |
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. |
| 第 31 條 |
Article 31 |
| 食品添加物查驗登記許可文件污損或遺失，其申請換發或補發者，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，不適用第八條規定： |
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: |
| 一、申請廠商公司登記或商業登記證明文件影本。 |
1.The photocopy of the applicant’s company registration or business registration certificate. |
| 二、換發者，繳銷之原許可文件。 |
2.For replacement application, the permit document originally issued. |
| 三、補發者，原許可文件作廢之切結聲明。 |
3.For reissuance application, the applicant’s affidavit that declares the original permit document null and void. |
| 前項換發或補發之許可文件，其有效期間，同原許可文件。 |
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. |
| 第 五 章 附則 |
Chapter V Supplementary Provisions |
| 第 32 條 |
Article 32 |
| 本辦法所定申請案件，食品業者得至衛生福利部食品藥物管理署建置之食品線上申辦平臺辦理；其文件、資料，得以掃描上傳。 |
Applications in accordance with the provisions of the Regulations may be filed by the food industry operators on the web platform of Taiwan Food and Drug Administration, the Ministry of Health and Welfare, with the documents and information scanned and uploaded. |
| 許可文件展延、查驗登記內容變更、移轉及換發之申請案件，食品業者依前項規定辦理後，應將原許可文件正本寄送中央主管機關登載用印或繳銷。 |
After completion of applications by food business operators for permit document extension, amendment of registration contents, document transference or document replacement pursuant to provisions in the preceding paragraph, the original permit document shall be sent to the central competent authority for registration or cancellation. |
| 第 33 條 |
Article 33 |
| 中華民國一百十二年十一月三十日修正發布之下列規定，自發布後一年施行： |
The following provisions of these Regulations shall take effect one year after the promulgation of the amendment on November 30, 2023. |
| 一、第十三條第一項第三款、第十五條第二項第五款第二目、第二十條第一項第三款、第二十二條第一項第七款與第二十三條第二項第五款第二目之衛生分析表正本。 |
1.Article 13 Paragraph 1 Subparagraph 3, Article 15 Paragraph 2 Subparagraph 5 Item 2, Article 20 Paragraph 1 Subparagraph 3, Article 22 Paragraph 1 Subparagraph 7, Article 23 Paragraph 2 Subparagraph 5 Item 2, which provide original hygiene analysis report related provisions. |
| 二、第十四條第一項第七款與第八款及第二十二條第一項第六款。 |
2.Article 14 Paragraph 1 Subparagraphs 7 and 8, and Article 22 Paragraph 1 Subparagraph 6. |
| 第 34 條 |
Article 34 |
| 本辦法除前條另定施行日期者外，自發布日施行。 |
Except for provisions with separate enforcement dates as stipulated in the preceding Article, these Regulations shall come into effect from the date of promulgation. |
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| 食品安全衛生管理法行政罰行為數認定標準 |
Criteria for Determining the Number of Administrative Penalty of the Act Governing Food Safety and Sanitation |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法（以下簡稱本法）第五十五條之一規定訂定之。 |
These Criteria are prescribed in accordance with Article 55-1 of the Act Governing Food Safety and Sanitation (hereinafter “the Act”). |
| 第 2 條 |
Article 2 |
| 依本法有不得製造、加工、調配、包裝、運送、貯存、販賣、輸入、輸出、作為贈品或公開陳列特定物品之義務而違反者，依下列基準判斷其行為數： |
Any person who has the obligations not to manufacture, process, prepare, package, transport, store, sell, import, export, present as a gift or publicly display certain articles under the Act and violates such obligations, the number of administrative penalty shall be determined pursuant to the following criteria: |
| 一、不同日之行為。 |
1. Acts in different days. |
| 二、不同品項之物品。 |
2. Articles under different items. |
| 三、不同場所之行為或物品。 |
3. Acts or articles in different sites. |
| 四、受侵害對象之個數。 |
4. The number of the infringed parties. |
| 五、限期改善之期限。 |
5. The deadline to make corrections within a prescribed time period. |
| 六、其他經主管機關認定之事項。 |
6. Others matters designated by the competent authority. |
| 第 3 條 |
Article 3 |
| 實施違反本法第二十八條廣告限制規定之行為者，依下列基準判斷其行為數： |
Any person whose acts violate the advertisement restrictions under Article 28 of the Act, the number of administrative penalty shall be determined pursuant to the following criteria: |
| 一、不同品項之產品。 |
1. Products under different items. |
| 二、不同版本之廣告。 |
2. Advertisements of different versions. |
| 三、不同刊播媒介之個數。 |
3. The number of different publishing and broadcasting media. |
| 四、不同日之刊播。 |
4. Publishing and broadcasting in different days. |
| 第 4 條 |
Article 4 |
| 判斷前二條之行為數時，應斟酌下列各款情事： |
When determining the number of administrative penalty under the preceding two Articles, the circumstances specified in the following subparagraphs shall be taken into consideration: |
| 一、違反之動機及目的。 |
1. The motive and intent of violation. |
| 二、違反之手段。 |
2. The means of violation. |
| 三、違反義務之影響程度。 |
3. The impact degree of obligation violation. |
| 四、違反義務所致之所生危害及損害。 |
4. The harm and damage caused by obligation violation. |
| 第 5 條 |
Article 5 |
| 依本法有應作為之義務而不作為，其違法狀態持續者，以主管機關裁處行政罰之行政處分送達行為人時，為一行為。 |
Any person who has the obligation to act under the Act but fails to act, and such violation persists, it shall be regarded as one and single act when the administrative disposition made by the competent authority in imposing an administrative penalty serves upon the actor. |
| 前項經主管機關裁處並於行政處分送達後，違反義務人仍不作為者，為另一違反義務之行為。 |
If such actor continues not to act after the above administrative disposition by the competent authority serves, it shall be regarded as another act. |
| 第 6 條 |
Article 6 |
| 依本法有容忍主管機關進入製造、加工、調配、包裝、運送、貯存、販賣場所執行現場查核及抽樣檢驗之義務而規避、妨礙或拒絕者，以同一日相同行政目的之查核或檢驗要求所為規避、妨礙或拒絕，為一行為。依不同法規所為相同內容之查核或檢驗要求，亦同。 |
Any person who has the obligations to endure the entering the place of manufacturing, processing, preparation, packaging, transportation, storage and sales, performing on-site examination and conducting sampling and testing by the competent authority under the Act but evades, impedes or refuses to do so, it shall be regarded as one and single act if such evading, impediment or refusal pertains toexamination or test requests for the same administrative purpose in same day. This Article shall apply to examination or test requests regarding the same content pursuant to different laws or regulations. |
| 第 7 條 |
Article 7 |
| 本標準自發布日施行。 |
These Criteria shall be implemented from the date of promulgation. |
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| 食品安全衛生管理法施行細則 |
Enforcement Rules of the Act Governing Food Safety and Sanitation |
| 第 1 條 |
Article 1 |
| 本細則依食品安全衛生管理法（以下簡稱本法）第五十九條規定訂定之。 |
These Enforcement Rules are prescribed in accordance with the provisions of Article 59 of the Act Governing Food Safety and Sanitation (hereinafter referred to as “this Act”). |
| 第 2 條 |
Article 2 |
| 本法第三條第二款所定嬰兒與較大嬰兒配方食品，包括嬰兒配方食品、較大嬰兒配方輔助食品及特殊醫療用途嬰兒配方食品。 |
The term “infant and follow-up formula” prescribed in subparagraph 2 of Article 3 of this Act shall include infant formula, follow-up infant formula and infant formula for special medical purposes. |
| 第 3 條 |
Article 3 |
| 本法第三條第三款所稱中央主管機關之准用許可字號，指下列情形之一： |
The term “approval number granted by central competent authority” referred to in subparagraph 3 of Article 3 of this Act shall mean one of the following circumstances: |
| 一、依本法第八條第三項規定完成登錄，取得之登錄字號及產品登錄碼。 |
1. The registration number and product registration code obtained from the completion of registration under paragraph 3 of Article 8 of this Act. |
| 二、依本法第十八條所定食品添加物使用範圍及限量暨規格標準附表一食品添加物使用範圍及限量所定之編號。 |
2. The code prescribed in the Standards for Scope, Application and Limitation of Food Additives of the Appendix 1 of the Standards for Specification, Scope, Application and Limitation of Food Additives under Article 18 of this Act. |
| 三、依本法第二十一條第一項規定，取得之查驗登記許可字號。 |
3. The registration approval number as stated in Paragraph 1 of Article 21 of this Act. |
| 第 4 條 |
Article 4 |
| 本法第八條第五項所稱衛生安全管理系統，指本法第八條第一項或第二項規定之食品良好衛生規範準則或食品安全管制系統準則。 |
The term “sanitation and safety management systems” referred to in Paragraph 5 of Article 8 of this Act shall mean the regulations on good hygiene practice for foods or the regulations on food safety control system as stated in Paragraph 1 or 2 of Article 8 of this Act. |
| 第 5 條 |
Article 5 |
| 本法第十五條第一項第三款所稱有毒，指食品或食品添加物含有天然毒素或化學物品，而其成分或含量對人體健康有害或有害之虞者。 |
The term “toxic” referred to in subparagraph 3, paragraph 1 of Article 15 of this Act shall mean foods or food additives which contain natural toxins or chemicals and the ingredients or contents of which are harmful to human health or may possibly harm the human health. |
| 第 6 條 |
Article 6 |
| 本法第十五條第一項第四款所稱染有病原性生物者，指食品或食品添加物受病因性生物或其產生之毒素污染，致對人體健康有害或有害之虞者。 |
The items that are contaminated by pathogenic organisms referred to in subparagraph 4, paragraph 1 of Article 15 of this Act shall mean foods or food additives contaminated by pathogenic organisms, or toxins derived from said pathogenic organisms, which are harmful to human health or may possibly harm human health. |
| 第 7 條 |
Article 7 |
| 本法第二十二條第一項第一款及第二十五條第一項所定品名，其標示應依下列規定辦理： |
The labelling for the product names prescribed in subparagraph 1, paragraph 1 of Article 22 and paragraph 1 of Article 25 of this Act shall be handled in accordance with the following provisions: |
| 一、名稱與食品本質相符。 |
1. The product names shall conform to the nature thereof. |
| 二、經中央主管機關規定者，依中央主管機關規定之名稱；未規定者，得使用中華民國國家標準所定之名稱或自定其名稱。 |
2. The names of those that are stipulated by the central competent authority shall be set in accordance with the stipulated names provided; whereas names that are not stipulated by the central competent authority may either be set in accordance with National Standards of the Republic of China (CNS) or by their own. |
| 第 8 條 |
Article 8 |
| 本法第二十二條第一項第三款所定淨重、容量，應以法定度量衡單位或其代號標示之，並依下列規定辦理： |
The net weight and capacity prescribed in subparagraph 3, paragraph 1 of Article 22 of this Act shall be labelled using the legal units of measurement or their symbols and shall be handled in accordance with the following provisions: |
| 一、內容物中液汁與固形物混合者，分別標明內容量及固形量。但其為均勻混合且不易分離者，得僅標示內容物淨重。 |
1. Those ingredients that are a mixture of liquid and solid materials shall indicate their respective contents; whereas those ingredients which are a homogeneous mixture that are hard to separate may merely indicate the net weight thereof. |
| 二、內容物含量，得視食品性質，註明最低、最高或最低與最高含量。 |
2. Depending on the nature of the foods, the contents may be indicated as minimum quantity, maximum quantity, or both the minimum and maximum quantities. |
| 第 9 條 |
Article 9 |
| 本法第二十二條第一項第四款所定食品添加物名稱，應以食品添加物使用範圍及限量暨規格標準附表一食品添加物使用範圍及限量所定之品名，或一般社會通用之名稱標示之，並依下列規定辦理： |
The name of food additives prescribed in subparagraph 4, paragraph 1 of Article 22 of this Act shall be labelled in accordance with the food additive items prescribed in the Standards for Scope, Application and Limitation of Food additives of the Appendix 1 of the Standards for Specifications, Scope, Application and Limitation of Food Additives or the names commonly known by society, and shall be handled in accordance with the following provisions: |
| 一、屬甜味劑、防腐劑、抗氧化劑者，應同時標示其功能性名稱。 |
1. Sweeteners, preservatives and antioxidants shall indicate the names of their respective functions. |
| 二、屬複方食品添加物者，應標示各別原料名稱。 |
2. Food additive combinations shall indicate the name of each material. |
| 食品中之食品添加物係透過合法原料之使用而帶入食品，且其含量明顯低於直接添加於食品之需用量，對終產品無功能者，得免標示之。 |
The labelling of the food additives is not required when the food additives contained in foods were made through legalized materials and the contents of which are apparently below the normal amount as added to the foods and do not provide functions thereof. |
| 第 10 條 |
Article 10 |
| 本法第二十二條第一項第五款及第二十四條第一項第五款所稱製造廠商，指下列各款情形之一者： |
The term “manufacturer” referred to in subparagraph 5, paragraph 1 of Article 22 and subparagraph 5, paragraph 1 of Article 24 of this Act shall mean one of the following circumstances: |
| 一、製造、加工、調配製成終產品之廠商。 |
1. Those businesses that manufacture, process or prepare the end products. |
| 二、委託製造、加工或調配者，其受託廠商。 |
2. Those businesses that are entrusted to manufacture, process or prepare products. |
| 三、經分裝、切割、裝配、組合等改裝製程，且足以影響產品衛生安全者，其改裝廠商或前二款之廠商。 |
3. For those products made through the repacking process such as sub packaging, cutting, assembling or combining, and that are enough to affect the sanitation and safety of the product, the repacking factory or businesses referred to in the two previous subparagraphs. |
| 前項製造廠商之標示，應依下列規定辦理： |
The labelling of the manufacturers referred to in the preceding paragraphs shall be handled in accordance with the following provisions: |
| 一、輸入食品或食品添加物之製造廠商名稱、地址，以中文標示之。但難以中文標示者，得以國際通用文字或符號標示之。 |
1. Name and address of the manufacturer of imported foods or food additives shall be labelled in Chinese. For those names that are hard to recognize in Chinese, they may be labelled in commonly known characters or symbols. |
| 二、食品或食品添加物係由同一公司所屬之工廠製造，且其設立地皆屬同一國家者，製造廠商得以總公司或所屬製造工廠擇一為之；其名稱、地址及電話，應與標示之總公司或工廠一致。但其設立地屬不同國家者，仍應以實際製造工廠標示之。 |
2. Where the foods or food additives are manufactured by the factory belonging to the same company and registered under the same country, the labelling of the manufacturer can be either the head company or the manufacturing factory. The name, address and telephone number shall be labelled as of the head company or factory; when the registered place of the factory is different from that of the company’s, the manufacturing factory that engaged in the actual manufacturing process shall be on the label. |
| 三、前項第三款之改裝廠商，以「改裝製造廠商」標示之。 |
3. The repacking factory referred to in the preceding subparagraph 3 shall be labelled as “repacking manufacturer.” |
| 第 11 條 |
Article 11 |
| 本法第二十二條第一項第五款、第二十四條第一項第五款、第二十六條第四款及第二十七條第四款所稱國內負責廠商，指對該產品於國內直接負法律責任之食品業者。 |
The responsible domestic company referred to in subparagraph 5, paragraph 1 of Article 22, subparagraph 5, paragraph 1 of Article 24, subparagraph 4 of Article 26 and subparagraph 4 of Article 27 of this Act shall mean food businesses that are responsible for the liability of the products. |
| 本法第二十二條第一項第五款及第二十四條第一項第五款所稱應標示製造廠商或國內負責廠商名稱、電話號碼及地址，屬輸入之食品或食品添加物，指應標示國內負責廠商之名稱、電話號碼及地址，並得另標示國外製造廠商之名稱、電話號碼及地址；屬國內製造之食品或食品添加物，指應標示製造廠商之名稱、電話號碼及地址，或標示國內負責廠商之名稱、電話號碼及地址，或二者均標示。 |
Name, telephone number and address of the manufacturer or that of the responsible domestic company of the imported foods or food additives referred to in subparagraph 5, paragraph 1 of Article 22 and subparagraph 5, paragraph 1 of Article 24 shall mean the labelling of the names, telephone number and address of the responsible domestic company and the names, telephone number and address of the foreign manufacturer can also be labelled in addition. For those foods or food additives manufactured domestically, the labelling thereof shall be either the name, telephone number or address of the manufacturer or that of the responsible domestic company or both. |
| 第 12 條 |
Article 12 |
| 本法第二十二條第一項第六款所稱原產地（國），指製造、加工或調配製成終產品之國家或地區。 |
The country of origin referred to in subparagraph 6, paragraph 1 of Article 22 of this Act shall mean the country or region where the end products are manufactured, processed or prepared. |
| 前項原產地（國）之標示，應依下列規定辦理： |
The labelling of the country of origin referred to in the preceding paragraph shall be handled in accordance with the following provisions: |
| 一、輸入食品之原產地（國），依進口貨物原產地認定標準認定之。 |
1. The Country of Origin of imported goods shall be determined in accordance with the Regulations Governing the Determination of Country of Origin of an Imported Good. |
| 二、輸入食品依進口貨物原產地認定標準，屬不得認定為實質轉型之混裝食品，應依各食品混裝含量多寡由高至低標示各別原產地（國）。 |
2. Where the food product is not an assorted product of substantial transformation based on the Regulations Governing the Determination of Country of Origin of an Imported Good, the labelling of which shall be the respective country of origin based on the volume of contents it possesses. |
| 三、中文標示之食品製造廠商地址足以表徵為原產地（國）者，得免為標示。 |
3. Where the address of the manufacturer in Chinese can obviously represent the country of origin, the labelling may be exempted. |
| 第 13 條 |
Article 13 |
| 本法第二十二條第一項第七款所定有效日期之標示，應印刷於容器或外包裝之上，並依習慣能辨明之方式標明年月日。但保存期限在三個月以上者，其有效日期得僅標明年月，並以當月之末日為終止日。 |
The labelling of the expiry date prescribed in subparagraph 7, paragraph 1 of Article 22 of this Act shall be printed on the container or package and the year, month and day shall be marked in a way that is customarily decipherable. However, for products of which the shelf life is 3 months or longer, the expiry date may be marked with the year and month only and the last date of that month shall be the expiry date. |
| 第 14 條 |
Article 14 |
| 本法第二十四條第一項第一款所定品名，其為單方食品添加物者，應以食品添加物使用範圍及限量暨規格標準附表一食品添加物使用範圍及限量所定之品名，或中央主管機關公告之通用名稱標示之；其為複方食品添加物者，得自定其名稱。 |
Where the product names prescribed in subparagraph 1, paragraph 1 of Article 24 of this Act is for a single food additive, it shall be labelled in accordance with the food additive items prescribed in the Standards for Scope, Application and Limitation of Food additives of the Appendix 1 of the Standards for Specifications, Scope, Application and Limitation of Food Additives or the names commonly known prescribed by the central competent authority in a public announcement; whereas when the product name is for food additive combinations, the names may be set by their own. |
| 依前項規定自定品名者，其名稱應能充分反映其性質或功能。 |
Product names set by their own in accordance with the preceding paragraph shall be sufficient to reflect the nature or function of the product. |
| 本細則中華民國一百零六年七月十三日修正施行前，經中央主管機關查驗登記，取得許可文件之食品添加物，其品名未能符合前二項規定者，應於一百零七年七月一日前，依本法第二十一條第一項規定申請品名變更登記；一百零八年一月一日以後製造者，應以變更後之品名標示於容器或外包裝。 |
Food additive that has been registered with the central competent authority and received a permit document prior to the amendment of this Enforcement Rules on 13th July 2017, the product name of which is unable to comply with the two preceding paragraphs shall apply for a change of the product name in accordance with paragraph 1 of Article 21 of this Act before 1st July 2018. The changed product name shall be labeled on the container or package from 1st January 2019. |
| 第 15 條 |
Article 15 |
| 本法第二十四條第一項第三款所定食品添加物名稱，應以食品添加物使用範圍及限量暨規格標準附表一食品添加物使用範圍及限量所定之品名，或中央主管機關公告之通用名稱標示之。 |
The food additive names prescribed in subparagraph 3, paragraph 1 of Article 24 shall be labelled in accordance with the food additive items prescribed in the Standards for Scope, Application and Limitation of Food additives of the Appendix 1 of the Standards for Specifications, Scope, Application and Limitation of Food Additives or the names commonly known prescribed by the central competent authority in a public announcement. |
| 第 16 條 |
Article 16 |
| 本法第二十四條第一項第四款所定淨重、容量，應以法定度量衡單位或其代號標示之。 |
The net weight and capacity prescribed in subparagraph 3, paragraph 1 of Article 24 of this Act shall be labelled using the legal units of measurement or their symbols. |
| 第 17 條 |
Article 17 |
| 本法第二十四條第一項第六款所定有效日期之標示，應印刷於容器或外包裝之上，並依習慣能辨明之方式標明年月日。但保存期限在三個月以上者，其有效日期得僅標明年月，並以當月之末日為終止日。 |
The labelling of the expiry date prescribed in subparagraph 6, paragraph 1 of Article 24 of this Act shall be printed on the container or package and the year, month and day shall be marked in a way that is customarily decipherable. However, for products of which the shelf life is 3 months or longer, the expiry date may be marked with the year and month only and the last date of that month shall be the expiry date. |
| 第 18 條 |
Article 18 |
| 本法第二十四條第一項第八款所稱原產地（國），指製造、加工或調配製成終產品之國家或地區。 |
The country of origin referred to in subparagraph 8, paragraph 1 of Article 24 of this Act shall mean the country or region where the end products are manufacture, processed or prepared. |
| 前項原產地（國）之標示，應依下列規定辦理： |
The labelling of the country of origin referred to in the preceding paragraph shall be handled in accordance with the following provisions: |
| 一、輸入食品添加物之原產地（國），依進口貨物原產地認定標準認定之；其產品經於我國進行產品之分類、分級、分裝、包裝、加作記號或重貼標籤者，不得認定為實質轉型，仍應標示實際製造、加工或調配製成終產品之國家或地區。 |
1. The Country of Origin of imported goods shall be determined in accordance with the Regulations Governing the Determination of Country of Origin of an Imported Good; whereas the products cannot be determined as a substantial transformation because of classification, categorizations, sub-packaging, packaging, marking or relabeling in our country, the labelling shall still be set as the country or region where the end products are manufactured, processed or prepared. |
| 二、中文標示之食品添加物製造廠商地址足以表徵為原產地（國）者，得免為標示。 |
2. Where the address of the manufacturer in Chinese can obviously represent the country of origin, the labelling may be exempted. |
| 第 19 條 |
Article 19 |
| 有容器或外包裝之食品、食品原料、食品添加物及食品添加物原料之標示，應依下列規定辦理： |
The labelling of pre-packaged foods, food raw materials, food additives and their raw materials shall be handled in accordance with the following provisions: |
| 一、標示字體之長度及寬度各不得小於二毫米。但最大表面積不足八十平方公分之小包裝，除品名、廠商名稱及有效日期外，其他項目標示字體之長度及寬度各得小於二毫米。 |
1. The length and width of the characters marked on the labels shall not be less than two millimeters. However, where the area of the largest surface of a package is less than 80 square centimeters, the length and width of characters for all items other than the name of the product, the company name, and expiry date, may be less than two millimeters. |
| 二、在國內製造者，其標示如兼用外文時，應以中文為主，外文為輔。 |
2. Where the products are domestically manufactured and their labels are in a foreign language, the labelling text in Chinese shall be primary and the labelling text in the foreign language is only supplementary. |
| 三、輸入者，應依本法第二十二條及第二十四條規定加中文標示，始得輸入。但需再經改裝、分裝或其他加工程序者，輸入時應有品名、廠商名稱、日期等標示，或其他能達貨證相符目的之標示或資訊，並應於販賣前完成中文標示。 |
3. Where the products are imported from overseas, the importer is allowed to import such products when a Chinese label is added in accordance with the provisions of Article 22 and 24 of this Act. However, where products need to be repackaged, sub-packaged or go through other processing procedure, such products shall label the product name, manufacturer name, and date, or have other labels or information for proof of the authenticity of the items at the time of importation, and the labelling in Chinese shall be completed prior to the sale of the products. |
| 第 20 條 |
Article 20 |
| 本法第二十五條第一項所稱散裝食品，指陳列販賣時無包裝，或有包裝而有下列情形之一者： |
The bulk foods referred to in paragraph 1 of Article 25 of this Act shall mean that the product is without a package while vending or with a package but meets one of the following circumstances: |
| 一、不具啟封辨識性。 |
1. Does not have unpackaged identifiability. |
| 二、不具延長保存期限。 |
2. Could not extend the shelf life. |
| 三、非密封。 |
3. Is not sealed. |
| 四、非以擴大販賣範圍為目的。 |
4. The purpose of selling is no more than vending in a small area. |
| 第 21 條 |
Article 21 |
| 依本法第二十六條公告之食品器具、食品容器或包裝，應依下列規定標示： |
The food utensils, food containers and packages prescribed in Article 26 of this Act shall be labelled in accordance with the following provisions: |
| 一、標示之位置：以印刷、打印、壓印或貼標於最小販賣單位之包裝或本體上，標示內容並應於販賣流通時清晰可見。經中央主管機關規定者，其主要本體之材質名稱及耐熱溫度二項標示，應以印刷、打印或壓印方式，標示於主要本體上。 |
1. The position of labels: labels shall be printed, stamped, pressed or marked on the package or object of the smallest unit of the vending products. The labeled content shall be clearly visible at the time of distribution and marketing. For those products prescribed by the central competent authority, the name of materials and thermal resistance temperature of its major part shall be printed, stamped or pressed on the object. |
| 二、標示之方式：其以印刷或打印為之者，以不褪色且不脫落為準。 |
2. The method of labelling: if the labelling is made by way of printing or stamping, the ink shall sustain fading and shall not peel off. |
| 三、標示之日期：依習慣能辨明之方式標明年月日或年月；標示年月者，以當月之末日為終止日，或以當月之末日為有效期間之終止日。 |
3. Labelling of Date: the labelling of the date shall consist of the year, month and day and date shall be marked in a way that is customarily decipherable. Where the labelling of the date consists of only the year and month, the last day of that month shall be regarded as the last expiry date or date of the shelf life. |
| 四、標示之字體：其長度及寬度，各不得小於二毫米。 |
4. Font of Labelling: the length and width of the characters marked on the labels shall not be less than two millimetres. |
| 第 22 條 |
Article 22 |
| 食品用洗潔劑之標示，應依下列規定辦理： |
The labelling of food cleansers shall be handled in accordance with the following provisions: |
| 一、標示之位置：以印刷、打印、壓印或貼標於最小販賣單位之包裝上，標示內容並應於販賣流通時清晰可見。 |
1. The position of labels: labels shall be printed, stamped, pressed or marked on the package of the smallest unit of the vending products. The labeled content shall be clearly visible at the time of distribution and marketing. |
| 二、標示之方式：其以印刷或打印為之者，以不褪色且不脫落為準。 |
2. The method of labelling: if the labelling is made by way of printing or stamping, the ink shall sustain fading and shall not peel off. |
| 三、標示之日期：依習慣能辨明之方式標明年月日或年月；標示年月者，以當月之末日為終止日，或以當月之末日為有效期間之終止日。 |
3. Labelling of Date: the labelling of the date shall consist of the year, month and day and date shall be marked in a way that is customarily decipherable. Where the labelling of the date consists of only the year and month, the last day of that month shall be regarded as the last expiry date or date of the shelf life. |
| 四、標示之字體：其長度及寬度，各不得小於二毫米。 |
4. Font of Labelling: the length and width of the characters marked on the labels shall not be less than two millimetres. |
| 五、輸入者，應依本法第二十七條規定加中文標示，始得輸入。但需再經改裝、分裝或其他加工程序者，輸入時應有品名、廠商名稱、日期等標示，或其他能達貨證相符目的之標示或資訊，並應於販賣前完成中文標示。 |
5. Where the products are imported from overseas, the importer is allowed to import such products when a Chinese label is added in accordance with the provisions of Article 27 of this Act. However, where products need to be repackaged, sub-packaged or go through other processing procedure, such products shall label the product name, manufacturer name, and date, or have other labels or information for proof of the authenticity of the items at the time of importation, and the labelling in Chinese shall be completed prior to the sale of the products. |
| 第 23 條 |
Article 23 |
| 本法第二十六條第一款及第二十七條第一款所定品名，應與產品本質相符。 |
The product name prescribed in subparagraph 1 of Article 26 and subparagraph 1 of Article 27 of this Act shall conform to the nature thereof. |
| 第 24 條 |
Article 24 |
| 本法第二十六條第三款及第二十七條第三款所定淨重、容量，應以法定度量衡單位或其代號標示之。 |
The net weight and capacity prescribed in subparagraph 3 of Article 26 and subparagraph 3 of Article 27 of this Act shall be labelled using the legal units of measurement or their symbols. |
| 第 25 條 |
Article 25 |
| 本法第二十六條第五款及第二十七條第五款所稱原產地（國），指製造、加工或調配製成終產品之國家或地區。 |
The country of origin referred to in subparagraph 5 of Article 26 and subparagraph 5 of Article 27 of this Act shall mean the country or region where the end products are manufacture, processed or prepared. |
| 前項原產地（國）之標示，應依下列規定辦理： |
The labelling of the country of origin referred to in the preceding paragraph shall be handled in accordance with the following provisions: |
| 一、輸入產品之原產地（國），依進口貨物原產地認定標準認定之；其產品經於我國進行產品之分類、分級、分裝、包裝、加作記號或重貼標籤者，不得認定為實質轉型，仍應標示實際製造、加工或調配製成終產品之國家或地區。 |
1. The Country of Origin of imported goods shall be determined in accordance with the Regulations Governing the Determination of Country of Origin of an Imported Good; whereas the products cannot be determined as a substantial transformation because of classification, categorizations, sub-packaging, packaging, marking or relabeling in our country, the labelling shall still be set as the country or region where the end products are manufactured, processed or prepared. |
| 二、中文標示之製造廠商地址足以表徵為原產地（國）者，得免為標示。 |
2. Where the address of the manufacturer in Chinese can obviously represent the country of origin, the labelling may be exempted. |
| 第 26 條 |
Article 26 |
| 本法第二十七條第二款所稱主要成分或成分，指食品用洗潔劑中具消毒、清潔作用者。 |
The “main ingredients” or “ingredients” referred to in subparagraph 2 of Article 27 of this Act shall mean the ingredients that are contained in the food cleansers and the function of which is to disinfect or clean. |
| 第 27 條 |
Article 27 |
| 食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑專供外銷者，其標示事項得免依本法第二十二條、第二十四條、第二十六條及第二十七條規定辦理。 |
Where the foods, food additives, food utensils, food containers, packages or food cleansers are exclusive for export, the labelling based on Article 22, 24, 26, and 27 of this Act may be exempted. |
| 第 28 條 |
Article 28 |
| 本法第四十條所定檢驗方法、檢驗單位及結果判讀依據，其內容如下： |
The method of test, testing unit and the evidence used in interpreting the results prescribed in Article 40 of this Act, with the content as follows: |
| 一、檢驗方法：包括方法依據、實驗流程、儀器設備及標準品。 |
1. The method of test: including the basis of the method adopted, experiment procedure, instruments and equipment for the test and standard materials. |
| 二、檢驗單位：包括實驗室名稱、地址、聯絡方式及負責人姓名。 |
2. Testing Unit: including the name, address, contact information and responsible person of the laboratory. |
| 三、結果判讀依據：包括檢體之抽樣方式、產品名稱、來源、包裝、批號或製造日期或有效日期、最終實驗數據、判定標準及其出處或學理依據。 |
3. Evidence used in interpreting the results: including the sampling method of the specimens, product names, source, package, batch number or manufacturing date or expiry date, data of finalized experiment, interpreting standard and its source or academic reference. |
| 第 29 條 |
Article 29 |
| 食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑，經依本法第五十二條第一項第一款至第三款規定沒入銷毀或通知限期消毒、改製或採行安全措施者，其範圍及於相同有效日期或批號之產品；未標示有效日期或批號無法辨識者，其範圍及於全部產品；其為來源不明而無法通知限期消毒、改製或採行安全措施者，沒入銷毀之。 |
Where foods, food additives, food utensils, food containers, food packages or food cleansers are confiscated, destroyed or are notified to be disinfected, reconditioned or remedied with safety measures within a set period in accordance with the provisions of subparagraphs 1 to 3, paragraph 1 of Article 52 of this Act, the scope of such confiscation, destruction, disinfection, reconditioning or remedies shall be extended to the finished products of the same expiry date, and shall be extended to all finished products on which no expiry date is marked or the expiry date is unintelligible. Products that are of unknown origin and cannot be notified to be disinfected, reconditioned or remedied with safety measures within a set time period shall be confiscated and destroyed. |
| 第 30 條 |
Article 30 |
| 經營食品、食品添加物、食品器具或食品容器輸出之業者，為應出具證明文件之需要，得向主管機關申請辦理檢驗或查驗；其符合規定者，核發衛生證明、檢驗報告或自由銷售證明等外銷證明文件。 |
To meet the requirements of documentary proof, those engaging in the export of foods, food additives, food utensils or food containers may apply to the competent authority for an inspection and examination. Those that comply with the regulations shall be approved with the issuance of an export proof document such as sanitary certificate, test report or certificate of free sales and manufacture. |
| 第 31 條 |
Article 31 |
| 本細則除第二十二條自發布後一年施行外，自發布日施行。 |
Other than Article 22 is implemented one year after promulgation, these Enforcement Rules shall be implemented as of its being promulgated. |
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| 食品安全衛生管理法第四十四條第一項罰鍰裁罰標準 |
|
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法（以下簡稱本法）第四十四條第二項規定訂定之。 |
These Standards are prescribed in accordance with Paragraph 2, Article 44 of the Act Governing Food Safety and Sanitation (hereinafter “the Act”). |
| 第 2 條 |
Article 2 |
| 本標準適用於依本法第四十四條第一項規定所為罰鍰之裁罰。 |
These Standards are applicable to fines imposed in accordance with Paragraph 1, Article 44 of the Act. |
| 本條文有附件 第 3 條 |
Article 3 |
| 違反本法第八條第一項規定者，其罰鍰之裁罰基準，規定如附表一。 |
The Standards for fines imposed for violation of Paragraph 1, Article 8 of the Act are provided in Appendix 1. |
| 違反本法第八條第二項規定者，其罰鍰之裁罰基準，規定如附表二。 |
The Standards for fines imposed for violation of Paragraph 2, Article 8 of the Act are provided in Appendix 2. |
| 本條文有附件 第 4 條 |
Article 4 |
| 違反本法第十五條第一項第一款、第二款、第六款、第八款、第九款或第十六條第二款至第四款規定者，其罰鍰之裁罰基準，規定如附表三。 |
The Standards for fines imposed for violation of Subparagraph 1, 2, 6, 8 or 9, Paragraph 1, Article 15 or Subparagraphs 2 to 4, Article 16 of the Act are provided in Appendix 3. |
| 違反本法第十五條第一項第三款、第七款、第十款或第十六條第一款規定者，其罰鍰之裁罰基準，規定如附表四。 |
The Standards for fines imposed for violation of Subparagraph 3, 7 or 10, Paragraph 1, Article 15 or Subparagraph 1, Article 16 of the Act are provided in Appendix 4. |
| 違反本法第十五條第一項第四款規定者，其罰鍰之裁罰基準，規定如附表五。 |
The Standards for fines imposed for violation of Subparagraph 4, Paragraph 1, Article 15 of the Act are provided in Appendix 5. |
| 違反本法第十五條第一項第五款或第十五條第四項規定者，其罰鍰之裁罰基準，規定如附表六。 |
The Standards for fines imposed for violation of Subparagraph 5, Paragraph 1, Article 15 or Paragraph 4, Article 15 of the Act are provided in Appendix 6. |
| 本條文有附件 第 5 條 |
Article 5 |
| 經主管機關依本法第五十二條第二項規定，命其回收、銷毀而不遵行者，其罰鍰之裁罰基準，規定如附表七。 |
The Standards for fines imposed for incompliance with order by the competent authority to recover or destruction in accordance to Paragraph 2, Article 52 of the Act are provided in Appendix 7. |
| 本條文有附件 第 6 條 |
Article 6 |
| 違反中央主管機關依本法第五十四條第一項所為禁止其製造、販賣、輸入或輸出之公告者，其罰鍰之裁罰基準，規定如附表八。 |
The Standards for fines imposed for violation of the public announcement by the central competent authority to ban the manufacture, sale, import or export in accordance to Paragraph 1, Article 54 of the Act are provided in Appendix 8. |
| 第 7 條 |
Article 7 |
| 主管機關為審議裁處罰鍰案件之違規事實及額度，得邀請學者專家及機關代表組成審議小組為之。 |
To review and determine the facts of violations and the amounts of fines to be imposed, the competent authority may invite scholars, experts and representatives from authorities to form a review committee. |
| 第 8 條 |
Article 8 |
| 裁罰時，違法行為數之認定，應依食品安全衛生管理法行政罰行為數認定標準辦理。 |
When a fine is imposed, the number of administrative penalty shall be determined in accordance to the Criteria for Determining the Number of Administrative Penalty of the Act Governing Food Safety and Sanitation. |
| 第 9 條 |
Article 9 |
| 本標準自發布日施行。 |
These Standards shall be implemented from the date of promulgation. |
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| 一般食品衛生標準 |
Sanitation Standards for General Foods |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法（以下簡稱本法）第十七條及第十五條第二項規定訂定之。 |
This Standard is prescribed in accordance with the provisions of Article 17 and the second paragraph of Article 15 of the Act Governing Food Safety and Sanitation (herein referred to as "this Act"). |
| 第 2 條 |
Article 2 |
| 食品衛生，除法規另有規定外，應符合本標準。 |
For foods which have their own sanitation standards, those standards shall be applied to the respective foods. |
| 第 3 條 |
Article 3 |
| 販賣之食品，應具正常且合理可接受之性狀、風味及色澤，不得有因衛生不良、品質不佳或製程品管不當所導致之變色、異常氣味或風味、異常之凝結或沉澱、污染、肉眼可見霉斑、異物或蟲體、寄生蟲等情形。 |
Foods being sold shall have normal and reasonable acceptable traits, flavor and color. No discoloration, off odor or flavor, abnormal clot or precipitate, contamination, visible moldy, foreign matter, insects or parasite can be permitted; because of bad hygiene, poor quality or improper processing process control. |
| 第 4 條 |
Article 4 |
| 食品中之重金屬、真菌毒素、其他污染物質及毒素，除另有規定外，應符合「食品中污染物質及毒素衛生標準」之規定。 |
The maximum levels of metals, mycotoxins, other contaminants and toxins in foods, except as foods which have their own sanitation standards, shall meet the “Sanitation Standard for Contaminants and Toxins in Food”. |
| 第 5 條 |
Article 5 |
| （刪除） |
(Delete) |
| 第 6 條 |
Article 6 |
| 食品用水之規定： |
Water for food production: |
| 一、食用冰塊、飲料、包裝飲用水及盛裝飲用水之原料水，應符合環境主管機關所訂「飲用水水質標準」之規定。 |
1. Water used in the production of food grade ice cubes, beverage, bottled and packaged drinking water shall meet the requirement of “Drinking Water Quality Standards” set by the competent environmental authorities. |
| 二、包裝飲用水及盛裝飲用水之溴酸鹽含量應為 0.01 mg/L 以下。 |
2. The maximum levels of bromate in bottled and packaged drinking water shall not be more than 0.01 mg/L. |
| 第 7 條 |
Article 7 |
| 有容器或包裝之液態飲料，其咖啡因含量之規定： |
The caffeine contents of packed beverages: |
| 一、茶及可可飲料，咖啡因含量不得超過 500 mg/L 。 |
1. Caffeine contents of tea and cocoa shall not exceed 500 mg/L. |
| 二、茶、咖啡及可可以外之飲料，咖啡因含量不得超過 320 mg/L 。 |
2. The beverages other than tea, coffee and cocoa, caffeine contents shall not exceed 320 mg/L. |
| 第 8 條 |
Article 8 |
| 嬰兒配方食品、較大嬰兒配方輔助食品、特殊醫療用途嬰兒配方食品及嬰兒穀物類輔助食品等專供十二個月以下嬰兒食用之食品，不得含有農藥殘留超過0.01ppm，如農藥檢驗之定量極限大於或小於0.01ppm時，則以定量極限為準。 |
Infant formula, follow-up infant formula, infant formula for special medical purposes and cereal based foods for infants not more than 12 months of age, residue pesticide shall not be more than 0.01 ppm. This limit will reference to pesticides minimum detectable level, when this level is greater or less than 0.01 ppm. |
| 違反本條規定者，另依違反本法第十五條第一項第五款規定論處。 |
That violation of this Article shall be sanctioned in accordance with violation subparagraphs 5 of paragraph 1 of Article 15 of this Act. |
| 第 9 條 |
Article 9 |
| 本標準自中華民國一百零八年一月一日施行。 |
This Standard shall be implemented at release date. |
| 本標準中華民國一百零九年十二月十日修正發布條文，自一百十年七月一日施行。 |
The amended articles shall apply form 1 July 2021. |
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| 不適合兒童長期食用之食品廣告及促銷管理辦法 |
Regulations Governing Advertisement and Promotion of Food Products Not Suitable for Long-term Consumption by Children |
| 第 1 條 |
Article 1 |
| 本辦法依食品安全衛生管理法（以下簡稱本法）第二十八條第三項規定訂定之。 |
This set of Regulations is enacted pursuant to Article 28 Paragraph 3 of the Act Governing Food Safety and Sanitation (“the Act”). |
| 第 2 條 |
Article 2 |
| 本辦法所稱不適合兒童長期食用之食品，指具有下列各款情形之一，不適合未滿十二歲兒童長期食用之零食、糖果、飲料、冰品及直接供應飲食之場所所供應之食品： |
The food products not suitable for long-term consumption by children as herein stated refer to the snacks, candies, drinks, ice products and the food products sold by the food suppliers for direct consumption, which are not suitable for long-term consumption by children under 12 years of age and contain one of the following nutritional contents: |
| 一、脂肪所占熱量為總熱量百分之三十以上。 |
1.Calories from fats accounting for more than 30% of the total calories; |
| 二、飽和脂肪所占熱量為總熱量百分之十以上。 |
2.Calories from saturated fats accounting for more than 10% of the total calories; |
| 三、鈉含量每份四百毫克以上。 |
3.Sodium content higher than 400 milligram (400 mg) per serving; |
| 四、額外添加糖所占熱量為總熱量百分之十以上。 |
4.Calories from added sugar accounting for more than 10% of the total calories. |
| 第 3 條 |
Article 3 |
| 前條所列食品，其廣告及促銷不得以下列方式為之： |
It is specified that the above-defined food products are banned from being advertised and promoted by the following practices: |
| 一、十七時至二十一時，於兒童頻道刊播廣告。 |
1.Advertise on a dedicated TV channel for children from 5 pm to 9 pm; |
| 二、以可取代正餐飲食之表示或表徵為廣告。 |
2.Advertise the food products by showing or implying that it can be a replacement of a regular meal; |
| 三、對兒童以贈送、加購玩具或以玩具為獎勵等方式為促銷。 |
3.Promote the food products with toys that are given as free gifts, with additional price or as an encouragement. |
| 前項第一款所稱兒童頻道，指衛星廣播電視事業執照申請書或境外衛星廣播電視事業許可申請書之頻道節目屬性欄位中，勾選為「兒童」者。 |
The “dedicated TV channel for children” in Paragraph 1 indicates the TV channel operators who identified the nature of their channels’ programme as “for children” on the application form of Satellite Broadcasting & Television License or Foreign Satellite Broadcasting & Television Permit. |
| 第 4 條 |
Article 4 |
| 違反本辦法規定者，應依本法第四十五條規定處罰之。 |
Violators of the Regulations are subjected to penalties as set forth in Article 45 of the Act. |
| 第 5 條 |
Article 5 |
| 本辦法自中華民國一百零五年一月一日施行。 |
This set of Regulations takes effect from January 1, 2016. |
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| 天然食用色素衛生標準 |
Sanitation Standard for Natural Edible Colorants |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法第十七條規定訂定之。 |
This Standard is prescribed in accordance with the provisions of Article 17 of the Act Governing Food Safety and Sanitation. |
| 第 2 條 |
Article 2 |
| 萃取天然食用色素之溶劑來源，包括： |
The source of solvent to be used for extraction of natural edible colorants includes: |
| 一、水、乙醇、植物油或其他食品原料。 |
1. Water, ethanol, vegetable oil or other food raw materials. |
| 二、加工助劑衛生標準准用之溶劑。 |
2. Solvents permitted by Sanitation Standard for Processing Aids. |
| 第 3 條 |
Article 3 |
| 添加賦形劑或其他添加物之天然食用色素，其所添加者，限於食品添加物使用範圍及限量暨規格標準所載品名別，或其他可供食用之食品原料。 |
The natural edible colorants with excipients or other additives added are limited to the product names listed in the Scope and Application Standard of Food Additives, or other food raw materials. |
| 本條文有附件 第 4 條 |
Article 4 |
| 天然食用色素之來源、主成分及規格，應符合附表之規定。 |
The sources, major component and specifications standard of natural edible colorants shall comply with the requirements of the Appendix table. |
| 第 5 條 |
Article 5 |
| 本標準自中華民國一百十三年一月一日施行。 |
This Standard shall be implemented from 1 January, 2024. |
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| 加工助劑衛生標準 |
Sanitation Standard for Processing Aids |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法第十八條之一規定訂定之。 |
The Standards are prescribed in accordance with the provisions of Article 18-1 of the Act Governing Food Safety and Sanitation. |
| 第 2 條 |
Article 2 |
| （刪除） |
(Deleted) |
| 第 3 條 |
Article 3 |
| 加工助劑之使用量應以可達使用目的之最小量為原則，並應儘可能於終產品中降低其殘留量，且該殘留量不應對消費者健康造成危害。 |
The quantity of the substance used as processing aid shall be limited to the lowest achievable level necessary to accomplish its desired technological purpose. Residues or derivatives of the substance remaining in food should be reduced to the extent reasonably achievable and should not pose any health risk. |
| 本條文有附件 第 4 條 |
Article 4 |
| 使用附表一之加工助劑應符合該表列載之使用規定。 |
The use of processing aids shall meet appendix 1. |
| 本條文有附件 第 5 條 |
Article 5 |
| 附表一列載之加工助劑規格應符合附表二之規定。 |
The specification of processing aids shall meet appendix 2. |
| 第 6 條 |
Article 6 |
| 本標準自發布日施行。 |
The Standards shall be implemented from the date of promulgation. |
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| 有機農業促進法 |
Organic Agriculture Promotion Act |
| 第 一 章 總則 |
Chapter 1 General Principles |
| 第 1 條 |
Article 1 |
| 為維護水土資源、生態環境、生物多樣性、動物福祉與消費者權益，促進農業友善環境及資源永續利用，特制定本法。 |
The Act is established for maintaining water and soil resources, ecological environment, biodiversity, animal welfare and consumer interests, and promoting agricultural operation that is eco-friendly and sustainable use of resources. |
| 第 2 條 |
Article 2 |
| 本法所稱主管機關：在中央為行政院農業委員會；在直轄市為直轄市政府；在縣（市）為縣（市）政府。 |
The term "competent authority" used in this Act is the Council of Agriculture of the Executive Yuan at the central level; the municipal/county/city governments at the local level. |
| 第 3 條 |
Article 3 |
| 本法用詞，定義如下： |
The terms used in this Act shall be defined as the following: |
| 一、農產品：指利用自然資源、農用資材及科技，從事農作、林產、水產、畜牧等生產或加工後供食用之物或其他經中央主管機關公告之物。 |
1.Agricultural product: Any product which is produced or processed as food by utilizing natural resources, agricultural materials and technology, including cultivation, forestry, aquaculture, and animal husbandry or any product promulgated by the Central Competent Authority. |
| 二、農產品經營者：指生產、加工、分裝、進口、流通或販賣農產品者。 |
2.Operator: Any individual or legal entity who engages in the production, processing, packaging, importing, distribution or sale of agricultural products. |
| 三、有機農業：指基於生態平衡及養分循環原理，不施用化學肥料及化學農藥，不使用基因改造生物及其產品，進行農作、森林、水產、畜牧等農產品生產之農業。 |
3.Organic agriculture: Any farming practice including cultivation, forestry, aquaculture, and animal husbandry without using chemical fertilizer, chemical pesticide, and genetically modified organism (GMO) and derived products, based on the principle of ecological balance and nutrient cycle. |
| 四、有機農產品：指農產品生產、加工、分裝及流通過程，符合中央主管機關訂定之驗證基準，並經依本法規定驗證合格，或符合第十七條第一項規定之進口農產品。 |
4.Organic agricultural product: Any agricultural product that is produced, processed, packaged and distributed in accordance with the certification standard established by the Central Competent Authority and certified under this Act, or any imported agricultural product approved in accordance with Article 17 paragraph 1 of this Act. |
| 五、有機轉型期農產品：指農產品生產、加工、分裝及流通過程，於轉型為有機農產品之期間內，符合中央主管機關訂定之驗證基準，並經依本法規定驗證合格者。 |
5.Organic in-conversion agricultural product: Any agricultural product that is undergoing conversion to organic, during which the product is required to be produced, processed, packaged and distributed in accordance with the certification standard established by the Central Competent Authority and certified under this Act. |
| 六、有機農產品標章：指證明為有機農產品所使用之標章。 |
6.Organic mark: The mark used to indicate the agricultural product to be organic. |
| 七、標示：指農產品於陳列販賣時，於農產品本身、裝置容器、內外包裝所為之文字、圖形、記號或附加之說明書。 |
7.Labeling: Words, graphics, symbols or additional instruction affixed to agricultural products, the containers or packaging of agricultural products when displayed or for sale. |
| 八、認證機構：指經中央主管機關審查許可，具有執行本法所定認證業務資格之機構或法人。 |
8.Accreditation body: An institution or legal entity who is reviewed and permitted by the Central Competent Authority and with the qualification to conduct accreditation activities prescribed by this Act. |
| 九、認證：指經認證機構與機構、學校或法人以私法契約約定，由認證機構就其是否具經營本法所定驗證業務資格者，予以審查之過程。 |
9.Accreditation: The process in which the accreditation body evaluates whether an institution, school or legal entity is qualified to provide certification services prescribed by this Act under a contract. |
| 十、驗證機構：指經認證合格，得經營驗證業務之機構、學校或法人。 |
10.Certification body: An institution, school or legal entity who is accredited by the accreditation body to provide certification services. |
| 十一、驗證：指驗證機構與農產品經營者以私法契約約定，由驗證機構就特定農產品之生產、加工、分裝及流通過程是否符合本法規定，予以審查之過程。 |
11.Certification: The process in which the certification body verifies whether the production, processing, packaging or distribution of a specific agricultural product is in compliance with this Act under a contract with the respective operator. |
| 第 二 章 有機農業推廣 |
Chapter 2 Promotion of Organic Agriculture |
| 第 4 條 |
Article 4 |
| 主管機關應推廣採用農藝、生物、機械操作及使用天然資源之農業生產管理系統，並排除合成化學物質、基因改造生物及其產品之使用，以符合友善環境要求之有機農業。 |
The competent authority shall promote the agricultural production management system which adopts the approach of agronomical, biological, and machinery operation and uses natural resources, excluding synthetic chemicals and GMO and derived products, in order to fulfill the eco-friendly requirement of organic agriculture. |
| 前項主管機關應推廣之有機農業，包含未經第三條第十一款驗證之友善環境耕作。 |
The above organic agriculture that competent authority shall promote includes eco-friendly farming, despite it not certified as mentioned in subparagraph 11 of Article 3. |
| 主管機關推廣有機農業，應秉持產銷均衡原則，以謹慎合理態度進行新科技之研發及應用，提升農產品經營者生產技術及產品品質，促進有機農產品普及並廣為宣導社會大眾瞭解，取得消費者之信任，促使農民願意主動從事有機農業。 |
The competent authority shall uphold the principle of balancing supply and demand in promotion of organic agriculture by proceeding with the development and implementation of new technology prudently and reasonably, improving production techniques of the operator and product quality, making the organic agricultural products accessible to consumers, enhancing the understanding, and gaining consumer trusts. All these efforts are for the purpose of making farmers willing to engage in organic agriculture. |
| 第 5 條 |
Article 5 |
| 中央主管機關為促進農業永續發展，應設任務編組，並諮詢相關機關（構）、團體意見，以發展有機國家為目標，每四年提出有機農業促進方案，報請行政院核定後實施。 |
To promote the sustainable development of agriculture, the Central Competent Authority shall set up the consultant board, consult related authorities (institutions) and organizations on its path toward a country with full organic adoption. The Organic Agriculture Promotion Program shall be revised every four years and implemented after approved by the Executive Yuan. |
| 前項有機農業促進方案之內容如下： |
Contents of the Organic Agriculture Promotion Program are as follow: |
| 一、有機農業生產面積目標、占全國農業生產面積之比例及分年預算配置。 |
1.The target organic agricultural production area, its proportion of total arable land, and the annual budget allocation. |
| 二、有機農業前瞻發展規劃及現況調查。 |
2.Forward-looking development plan and current status survey for organic agriculture. |
| 三、有機農業生產、行銷及有機農產品驗證之輔導。 |
3.Counseling for organic agricultural production, marketing, and product certification. |
| 四、轉型有機農業生產與維護生態保育之獎勵及補貼。 |
4.Incentives and subsidies for conversion to organic agriculture and environment preservation. |
| 五、有機農業與有機農產品之農法技術、科技研發及人才培育。 |
5.Improvement of agricultural practices, research and development of agricultural technologies, and personnel training for organic agriculture and organic agricultural products. |
| 六、各級機關（構）、學校與消費者對有機農產品及有機食農教育之推廣。 |
6.Promotion of organic agricultural products and organic food and agricultural education for authorities (institutions) at all levels, schools, and consumers. |
| 七、相關民間團體辦理有機農業推廣工作之輔導。 |
7.Counseling relevant civil groups for the promotion of organic agriculture. |
| 八、其他促進有機農業發展之工作。 |
8.Other tasks that facilitate the development of organic agriculture. |
| 主管機關為推廣有機農業，應寬列預算，並每四年滾動檢討調升幅度，以達全國農業有機化為目標，配合辦理前項各款工作。 |
In promotion of organic agriculture, the competent authority shall allocate ample budget, which will be raised every four years on a rolling review of the rate of increase, for conducting tasks mentioned in the previous paragraph, in pursuance of full organic adoption. |
| 第二項第四款獎勵及補貼之辦法，由中央主管機關依比例原則定之。 |
The Central Competent Authority shall establish the standard on the principle of proportionality for issuing incentives and subsidies mentioned in subparagraph 4 of paragraph 2. |
| 第 6 條 |
Article 6 |
| 直轄市、縣（市）主管機關應視其轄區條件逐年檢討及開發設置有機農業促進區，並鼓勵民間合作生產或共同運銷組織參與設置。 |
The Local Competent Authorities shall review the districts of their jurisdiction annually and locate suitable areas to establish organic agricultural promotion zones while encouraging civil production cooperatives or collaborative marketing organizations to participate in the establishment. |
| 公有土地或國營事業土地可供農業使用者，應優先設置有機農業促進區。 |
Public land or lands of state-owned enterprises suitable for agricultural production shall be prioritized for the establishment of organic agricultural promotion zones. |
| 主管機關應優先輔導或補助建構有機農業促進區基礎公共工程設施及產銷設施（備）。 |
The competent authority shall prioritize in providing assistance or subsidies on public infrastructure and marketing facilities (equipment) in organic agricultural promotion zones. |
| 直轄市、縣（市）主管機關得對依第一項規定設置之有機農業促進區內尚未採用有機農業生產之農民予以輔導轉型，並得要求其採取必要措施，避免妨礙毗鄰土地有機農業生產。 |
The Local Competent Authorities may provide assistance to farmers in organic agricultural promotion zones established under paragraph 1 who have not yet adopted organic agricultural production and require them to take necessary measures to avoid the impediment of organic agricultural production at neighboring lands. |
| 第 7 條 |
Article 7 |
| 主管機關得對農產品經營者依本法驗證所需費用、技術提升、行銷通路擴展、產銷設施（備）、資材、資金貸款及其他與有機農業發展相關事項給予適當協助，並得獎勵有機農業之留種、育種及種苗生產；就前條有機農業促進區之農產品經營者，得優先予以協助、獎勵。 |
The competent authority may provide proper assistance to operators on the certification fees, the technology upgrade, marketing channel expansion, production-marketing facilities (equipment), materials, fund loan and other organic agriculture related matters in accordance with this Act as well as incentives for seed reserving, breeding, and seedling production of organic agriculture; the operators in organic agricultural promotion zones of the previous paragraph may be prioritized in receiving assistance and incentives. |
| 農產品經營者承租公有土地或國營事業土地作有機農業使用，應給予土地租金優惠。 |
The operator who rents public lands or lands of state-owned enterprises for organic agricultural production shall be provided with a rental discount. |
| 前項農產品經營者承租公有土地或國營事業土地並依第三條第十一款通過驗證者，其土地租期應給予十年以上二十年以下之保障，不受國有財產法第四十三條有關租期之限制。 |
For the operator who rents public lands or lands of state-owned enterprises under the previous paragraph for organic agricultural production and has been certified according to subparagraph 11 of Article 3, the land lease shall be guaranteed for a period from 10 years up to 20 years and free from the restriction of the lease period stipulated in Article 43 of National Property Act. |
| 第二項之租金優惠、前項之租期保障及相關土地承租履約管理事項之辦法，由中央主管機關會商公有土地或國營事業土地管理機關及相關部會定之。 |
The regulations governing the rental discount mentioned in paragraph 2, guaranteed land lease period in the previous paragraph, and matters concerning lease management shall be established by the Central Competent Authority after it consult with the management authority of public lands or state-owned enterprises lands and relevant departments. |
| 第 8 條 |
Article 8 |
| 主管機關應設置網路平臺，整合驗證機構驗證資料、有機農業生產、行銷及可用於有機農產品之資材、種苗、進口審查合格有機農產品等相關資訊，供公開查詢。 |
The competent authority shall establish online platforms to integrate certification data from certification bodies and information about organic farming, marketing, materials permitted for organic production, seedlings, qualified organic imports, and other relevant information for public query. |
| 第 9 條 |
Article 9 |
| 主管機關應輔導相關機關（構）、團體或企業優先採用在地有機農產品。 |
The competent authority shall encourage relevant authorities (institutions), organizations or enterprises for preferential use of local organic agricultural products. |
| 主管機關應輔導機關（構）、團體或企業成立農民市集，提供銷售有機農產品之管道。 |
The competent authority shall counsel authorities (institutions), organizations or enterprises to establish farmers' market to provide the channels for selling organic agricultural products. |
| 主管機關得輔導有機農產品經營者設置網路資訊平臺，提供消費者直接向生產者購買之管道。 |
The competent authority may assist operators in establishing online platforms to provide consumers with direct channels to purchase from producers. |
| 第 10 條 |
Article 10 |
| 主管機關應進行有機農業科技技術研發，提供資訊及人員培訓。 |
The competent authority shall devote to organic agriculture technology research and development, the provision of information and personnel training. |
| 主管機關應鼓勵所屬人員參加有機農業相關教育訓練。 |
The competent authority shall encourage its personnel to participate in organic agriculture related training. |
| 中央主管機關應參與國際組織及國際合作，進行有機農業相關資訊、技術、人員之交流。 |
The Central Competent Authority shall participate in international organizations and international cooperation affairs to carry out the exchange of information, technology and personnel related to organic agriculture. |
| 第 三 章 認證及驗證機構管理 |
Chapter 3 Management of Accreditation Body and Certification Body |
| 第 11 條 |
Article 11 |
| 機構、法人經營認證業務者，應檢附相關文件，向中央主管機關申請許可，並於取得認證機構許可證明文件後，始得為之；許可事項有變更者，亦同。 |
Any institution or legal entity shall not engage the following accreditation activities until submitting the documents to apply for and obtaining the permission from the Central Competent Authority and any amendments thereto. |
| 前項許可證明文件之有效期間不得超過五年；期滿前一年得向中央主管機關申請許可展延，每次展延期間不得超過五年。 |
The validity of the certificate of the aforementioned permission shall not exceed 5 years; the application for accreditation renewal shall be submitted to the Central Competent Authority one year prior to expiration. The validity of renewed certificate shall not exceed 5 years. |
| 認證機構之認證業務如下： |
The accreditation tasks conducted by accreditation bodies are the following: |
| 一、受理及審查申請認證之案件。 |
1.Accepting and reviewing accreditation applications. |
| 二、與認證合格者簽訂認證契約。 |
2.Signing accreditation contracts with those who are accredited. |
| 三、依認證合格之驗證業務類別發給驗證機構認證證書。 |
3.Issuing accreditation certificates to the certification bodies in the qualified scope. |
| 四、對經其認證合格之驗證機構所經營驗證業務實施評鑑。 |
4.Assessing the accredited certification bodies through examining their certification activities. |
| 五、其他與認證有關之業務。 |
5.Other tasks related to accreditation activities. |
| 認證機構經營認證業務，應遵守下列事項，並應接受中央主管機關之監督及查核，不得規避、妨礙、拒絕或提供不實資料： |
Accreditation bodies shall be subject to supervision by the Central Competent Authority and shall not evade from, impede, or refuse such supervision or provide false data. The accreditation bodies shall comply with the following: |
| 一、於中央主管機關許可之國家或地區受理申請認證之案件。 |
1.Accepting accreditation applications from the countries or areas approved by the Central Competent Authority. |
| 二、擬訂認證基準，報中央主管機關核定；其修正、廢止，亦同。 |
2.Establishing and submitting accreditation standards to the Central Competent Authority for approval. The amendments or abolishment of which are included. |
| 三、依中央主管機關核定之認證基準審查申請認證之案件，並依認證基準對驗證機構所經營驗證業務實施評鑑。 |
3.Reviewing accreditation application and assessing the certification bodies in accordance with accreditation standards approved by the Central Competent Authority. |
| 四、保存有關經營認證業務之紀錄五年以上，並報中央主管機關備查。 |
4.Retaining records related to accreditation tasks for at least 5 years and notifying the Central Competent Authority for the record. |
| 五、協助並配合中央主管機關查核經其認證合格之驗證機構。 |
5.Assisting and coordinating with the Central Competent Authority on examining accredited certification bodies. |
| 六、驗證機構未能繼續經營驗證業務者，認證機構應協調其他驗證機構承接其驗證業務。 |
6.For certification bodies unable to provide certification services, the accreditation bodies shall coordinate among certification bodies for their certification business to be taken over. |
| 第一項申請許可及變更許可之資格、程序、應檢附文件、許可要件、第二項申請展延應檢附文件、第三項第三款認證證書應記載事項、前項認證機構之監督、管理、查核認證機構之程序、方法、認證基準應包括事項、經營認證業務紀錄之項目、申報備查之文件及其他應遵行事項之辦法，由中央主管機關定之。 |
The Central Competent Authority shall establish regulations to stipulate the eligibility, procedure, required documents, and criteria for the application of permission and its amendment specified in paragraph 1; required documents for renewal application specified in paragraph 2; the items that shall be described in the certificates specified in subparagraph 3 of paragraph 3; the procedures and methods for supervising, managing, examining the accreditation bodies, the required coverage of accreditation standards, the required items related to the accreditation tasks to be recorded, and the notification documents specified in the above paragraph; and other relevant requirements. |
| 第 12 條 |
Article 12 |
| 機構、學校、法人經營驗證業務者，應經認證機構認證合格，並由認證機構依其經營驗證業務類別發給認證證書後，始得為之。 |
Any institution, school, or legal entity shall not engage in the certification activities until being accredited by an accreditation body and receiving the accreditation certificate in the qualified scope. |
| 驗證機構之驗證業務如下： |
The certification activities of certification bodies are the following: |
| 一、與農產品經營者簽訂契約，依驗證基準驗證農產品經營者之農產品。 |
1.Signing contracts with operators to certify their agricultural products in accordance with the certification standards. |
| 二、製發有機農產品、有機轉型期農產品驗證證書，及管理經其驗證通過之農產品經營者使用有機農產品標章。 |
2.Issuing certificates of organic agricultural products and organic in-conversion agricultural products and controlling the organic marks used by the certified operators. |
| 三、依契約查驗農產品。 |
3.Inspecting agricultural products according to the contracts. |
| 四、其他經中央主管機關公告與驗證有關之業務。 |
4.Other certification related activities promulgated by the Central Competent Authority. |
| 前項第一款之驗證基準、農產品類別、品項，由中央主管機關定之。 |
The Central Competent Authority shall establish the certification standards, categories, and items of agricultural products mentioned in subparagraph 1 of the above paragraph. |
| 驗證機構經營第二項驗證業務，應依中央主管機關公告之項目、方式及期間，保存相關資料及紀錄；中央主管機關得隨時查核之，驗證機構不得規避、妨礙、拒絕或提供不實資料、紀錄。 |
The certification bodies engaging in the aforementioned certification activities shall retain the data and records according to the items, methods and periods promulgated by the Central Competent Authority. The certification bodies shall provide those data and records when requested by the Central Competent Authority. The certification bodies shall not evade, impede, or refuse the examination or provide false data or records. |
| 第 13 條 |
Article 13 |
| 驗證機構與農產品經營者得就農產品生產、加工、分裝或流通過程約定實施驗證之範圍。 |
The certification bodies may sign agreements with operators to determine the scope of certification in production, processing, packaging, or distribution of agricultural products. |
| 驗證機構經營驗證業務，中央主管機關得公告其收費上限。 |
The Central Competent Authority may promulgate the upper limit for certification service fee. |
| 農產品經營者因與其簽約之驗證機構之認證終止、解除認證契約、解散或其他原因未能繼續經營驗證業務，應於中央主管機關公告期間內，改與其他驗證機構簽訂契約。該農產品經營者之有機農產品或有機轉型期農產品，於中央主管機關公告期間內，仍視為驗證合格。 |
When a certification body is unable to provide certification services due to revocation of accreditation, termination of accreditation contract, dismissal, or any other causes, the contracted operator shall sign a new contract with another certification body within the period specified by the Central Competent Authority. The status of organic agricultural products or organic in-conversion agricultural products remains certified during the above specified period. |
| 第 14 條 |
Article 14 |
| 認證機構與驗證機構之認證契約、驗證機構與農產品經營者簽訂之契約，中央主管機關得公告其應記載或不得記載之事項。 |
The Central Competent Authority may promulgate mandatory or prohibitory items in the contracts between the accreditation bodies and certification bodies as well as between the certification bodies and operators. |
| 違反前項公告之契約條款無效，除去該部分，契約亦可成立者，該契約之其他部分，仍為有效。但對當事人之一方顯失公平者，該契約全部無效。 |
Provisions of the contract that violate the above items are null and void. Other parts of the contract that stand without the above null and void parts may still be effective. But, if the contract is unconscionable to one of the parties, then the entire contract shall be rendered null and void. |
| 中央主管機關公告應記載之事項，雖未記載於契約，仍構成契約之內容。 |
Provisions promulgated by the Central Competent Authority but not specified in contracts shall still constitute a part of the contract. |
| 第 四 章 有機農產品管理 |
Chapter 4 Management of Organic Agricultural Products |
| 第 15 條 |
Article 15 |
| 中央主管機關應公告有機農產品與有機轉型期農產品之生產、加工、分裝、流通及販賣過程可使用之物質。 |
The Central Competent Authority shall promulgate the substances allowed to be used in production, processing, packaging, distribution and sale of organic agricultural products and organic in-conversion agricultural products. |
| 除前項物質以外，農產品經營者不得使用含有基因改造產品、化學農藥、化學肥料、動物用藥品或其他合成化學品等禁用物質。 |
Except for the aforementioned substances, operators shall not use prohibited substances such as GMO and derived products, chemical pesticides, chemical fertilizers, animal drugs, and other synthetic chemical substances. |
| 農產品經營者應確保其生產、加工、分裝、流通、販賣之有機農產品及有機轉型期農產品，未含有前項所定禁用物質。 |
Operators shall ensure the organic agricultural products and organic in-conversion agricultural products they produced, processed, packaged, distributed, and sold contain no prohibited substances as stated in the previous paragraph. |
| 第 16 條 |
Article 16 |
| 農產品之生產、加工、分裝及流通過程，經驗證合格者，始得以有機名義販賣、標示、展示或廣告。 |
Agricultural products shall be certified to be organic throughout their production, processing, packaging, and distribution before they can be sold, labelled, displayed or advertised as organic. |
| 農產品之生產、加工、分裝及流通過程，經有機轉型期農產品驗證合格者，始得以有機轉型期名義販賣、標示、展示或廣告。 |
Agricultural products shall be certified to be organic in conversion throughout their production, processing, packaging, and distribution before they can be sold, labelled, displayed or advertised as organic in-conversion agricultural products. |
| 自本法施行滿一年之次日起，法人、商號、農場、非法人團體、畜牧場等非自然人之農產品經營者，不得以有機為其名稱之全部或一部分。但其販賣之農產品均經驗證合格者，或均依第十七條第一項第二款規定審查合格者，不在此限。 |
The day after the anniversary date of the implementation of this Act, any non-natural operator, such as a legal entity, business, farm, unincorporated body, and ranch shall not use the term "organic", as a whole or a part of its name, unless all agricultural products sold are certified or reviewed qualified according to subparagraph 2 of paragraph 1 of Article 17. |
| 第 17 條 |
Article 17 |
| 進口農產品符合下列規定之一者，始得以有機名義販賣、標示、展示或廣告： |
Imported agricultural products shall meet one of the following conditions before they can be sold, labelled or advertised as organic: |
| 一、經我國認證合格之境內或境外驗證機構，於認證證書記載之地區、國家境內實施之有機農產品驗證合格。 |
1.Certified by a domestic or foreign certification body accredited by ROC, given that the certification activities are performed within the territory prescribed on the accreditation certificate. |
| 二、有機同等性之國家或世界貿易組織會員有機認證合格之驗證機構，於該國或會員境內驗證合格，並由進口業者向中央主管機關申請審查合格，取得同意文件。 |
2.Certified by a certification body accredited by a country or member of World Trade Organization that is in organic equivalence with ROC, given that the certification activities are performed within the territory of the accrediting country or WTO member, reviewed qualified by the Central Competent Authority at the request of the importer, and issued with an approval document. |
| 前項第二款所定有機同等性之國家或世界貿易組織會員，應與我國完成簽訂雙邊有機同等性相互承認之條約、協定或其他官方約定文件後，由中央主管機關公告之。 |
Countries or members of WTO with organic equivalence defined in subparagraph 2 of the previous paragraph shall sign the mutual organic equivalence recognition treaty, agreement, or other official documents with ROC. After signing, the countries or members shall be promulgated by the Central Competent Authority. |
| 第一項第二款進口有機農產品之申請要件、審查程序、資料保存、標示方式、管理及其他相關事項之辦法，由中央主管機關定之。 |
The Central Competent Authority shall establish the regulations to stipulate the application requirement, the review procedures, the data to retain, the labeling, the management, and other relevant items, as described in subparagraph 2 of paragraph 1. |
| 第 18 條 |
Article 18 |
| 有機農產品及有機轉型期農產品之容器或包裝，應以中文及通用符號，明顯標示下列事項： |
The container or packaging of organic agricultural products and organic in-conversion agricultural products shall be notably indicated in Chinese and common symbols with the following items: |
| 一、品名。屬有機農產品者，應一併標示有機文字；屬有機轉型期農產品者，應一併標示有機轉型期文字。 |
1.Product name. For organic agricultural products, the term “organic” shall be indicated; for organic in-conversion agricultural products, the term “organic in-conversion” shall be indicated. |
| 二、原料名稱。其為二種以上混合物時，應依其含量多寡由高至低分別標示之。但單一原料製成且與前款品名完全相同者，得免標示原料名稱。 |
2.Ingredients. Those containing more than one ingredient shall be accordingly indicated in a descending order of proportion; in the case of a product containing single ingredient represented by the product name, the product is exempted from ingredient indication. |
| 三、農產品經營者名稱、地址及電話號碼。但進口之有機農產品，應標示其進口業者之名稱、地址及電話號碼。 |
3.The name, address, and telephone number of the operator. In the case of organic products being imported, the name, address, and telephone number of the importer shall be indicated instead. |
| 四、原產地（國）。但已標示製造廠或驗證場所地址，且足以表徵原產地（國）者，不在此限。 |
4.Origin (country). However, those with the address of the manufacturing plant or certification site that can represent the origin indicated are exempted. |
| 五、驗證機構名稱。 |
5.Name of the certification body. |
| 六、驗證證書字號。符合第十七條第一項第二款規定之進口有機農產品者，應標示同意文件之字號。 |
6.Certificate number. Organic agricultural products imported in accordance with subparagraph 2 of paragraph 1 of Article 17 shall be indicated with the number of approval document. |
| 七、其他經中央主管機關公告應標示事項。 |
7.Other items required to be indicated promulgated by the Central Competent Authority. |
| 因面積、材質或其他因素難以標示前項所定事項者，中央主管機關得公告免一部之標示，或以其他方式標示。 |
In case of difficulty to label the items mentioned in the previous paragraph due to the limited package surface area, material, or other conditions, the Central Competent Authority may promulgate conditions for exemption or alternative indication methods. |
| 第一項各款之標示事項有變更者，應自變更事實發生之日起三個月內更換原有標示。 |
For any changes to the subject matter being indicated according to the paragraph 1, the label shall be updated within three months of the occurrence of the changes. |
| 第 19 條 |
Article 19 |
| 農產品經營者販賣散裝之有機農產品及有機轉型期農產品，應於陳列販賣處以告示牌展示品名及原產地（國），並展示有機農產品及有機轉型期農產品驗證證書影本；符合第十七條第一項第二款規定之進口有機農產品者，應展示同意文件影本。 |
Operators selling organic agricultural products and organic in-conversion agricultural products in bulk package shall display the name, the origin (country) of the products on site with billboards, with a duplicate copy of the certificate of organic certification or organic in-conversion certification presented. Those selling organic agricultural products imported under subparagraph 2 of paragraph 1 of Article 17 shall present a duplicate copy of the approval document. |
| 前項品名及原產地（國）之展示，準用前條第一項第一款及第四款規定。 |
The aforementioned disclosure of product name and origin (country) is subject to provisions in subparagraph 1 and 4 of paragraph 1 of the pervious article. |
| 前二項及前條標示、展示之事項、方式及其他應遵行事項之辦法，由中央主管機關定之。 |
The Central Competent Authority shall establish the regulations governing the items, methods, and other requirements regarding indication and display specified in the above 2 subparagraphs and the previous article. |
| 第 20 條 |
Article 20 |
| 經依本法驗證合格之農產品，始得使用有機農產品標章。 |
Only agricultural products certified as organic under this Act are allowed to be labeled with organic mark. |
| 前項有機農產品標章之規格、圖式、使用規定及其他應遵行事項之辦法，由中央主管機關定之。 |
The Central Competent Authority shall establish regulations to stipulate the specification, design, use condition, and other requirements regarding the above organic mark. |
| 第 21 條 |
Article 21 |
| 以有機或有機轉型期名義所為之農產品廣告，其接受委託刊播者，應自刊播廣告之日起六個月內，保存委託刊播者之姓名或名稱、國民身分證統一編號或營利事業統一編號、住居所、營業所或事務所、電話及託播內容資料；主管機關得要求提供，接受委託刊播者不得規避、妨礙、拒絕或提供不實資料。 |
Those entrusted to disseminate advertisement about organic agricultural products or organic in-conversion agricultural products shall retain the following records for 6 months from the date of the first broadcast: the entruster’s name, personal identification number or business registration number, residence, the address of the residence or office, the telephone number, and the content of dissemination. When requested for provision by the competent authority, the entrustee shall not evade, impede, refuse, or provide false data. |
| 第 22 條 |
Article 22 |
| 主管機關得派員攜帶證明文件進入涉及有機或有機轉型期農產品生產、加工、分裝、貯存、販賣或其他相關場所及運輸工具，執行檢查、抽樣檢驗或要求農產品經營者提供相關資料、紀錄；任何人不得規避、妨礙、拒絕或提供不實資料、紀錄。 |
The competent authority may assign staff with proof of identity to enter the premise concerning production, processing, packaging, storing, selling, and other operations as well as transporting vehicles related to organic agricultural products or organic in-conversion agricultural products to examine, sample for test, or acquire data or records from operators. Any subject shall not evade, impede, refuse, or provide false data or records. |
| 第 23 條 |
Article 23 |
| 有機農產品及有機轉型期農產品之檢驗，由中央主管機關準用中央衛生福利主管機關依食品安全衛生管理法所定檢驗方法為之。中央衛生福利主管機關未定檢驗方法者，得依國際間認可之方法為之。 |
For testing of organic agricultural products and organic in-conversion agricultural products, the Central Competent Authority shall refer to the test methods established in Act Governing Food Safety and Sanitation by the Central Competent Authority of Health and Welfare. For the test methods not been established by the Central Competent Authority of Health and Welfare, other international recognized test methods can be referred to. |
| 前項檢驗，中央主管機關得委任所屬檢驗機關（構）或委託其他機關（構）、學校、團體辦理。 |
The Central Competent Authority may appoint its affiliated testing authorities (institutions) or entrust other authorities (institutions), schools, or organizations for the above testing. |
| 第 24 條 |
Article 24 |
| 農產品經營者對檢驗結果有異議者，得於收到通知後十五日內，繳納檢驗費用，向原抽樣檢驗機關申請複驗，並以一次為限。 |
Dissident for the result of testing, the operator may apply for a retest to the original sampling authority and pay the retest fees within 15 days on receiving the notice, and is limited to once. |
| 受理前項複驗者，應於七日內通知原檢驗者就原檢體複驗之。但檢體已變質或無適當方法可資保存者，得不受理之。 |
Upon accepting the retest application, the sampling authority shall notify the original testing body to conduct a retest of the original specimen within 7 days. The authority may refuse the retest application if the specimen has deteriorated or could not be preserved properly. |
| 第 25 條 |
Article 25 |
| 有機農產品及有機轉型期農產品，經檢出含有第十五條第二項所定禁用物質或有其他不符本法規定情形者，主管機關得令農產品經營者或所有人將農產品禁止移動、下架、回收或為其他適當處置。 |
When the organic agricultural products and organic in-conversion agricultural products tested contain the prohibited substances specified in paragraph 2 of Article 15 or any other matters violating the provision of this Act, the competent authorities may prohibit the operator or owner from transporting the agricultural products and order them to withdraw or recall the product from the market, or take other appropriate measures. |
| 第 26 條 |
Article 26 |
| 主管機關對於檢舉查獲違反本法規定者，應對檢舉人身分資料保守秘密，並應給予獎勵。 |
The competent authority shall keep the identification of those reporting a potential violation of this Act confidential, and those enable the identification of such violation shall be ewarded. |
| 前項檢舉、獎勵之方式及其他相關事項之辦法，由中央主管機關定之。 |
The Central Competent Authority shall establish regulations governing the reporting, rewarding and other relevant matters prescribed in the previous paragraph. |
| 第 五 章 罰則 |
Chapter 5 Penalties |
| 第 27 條 |
Article 27 |
| 有下列情形之一者，處新臺幣六十萬元以上六千萬元以下罰鍰： |
Under any of the following circumstances, a subject is fined from NTD600,000 up to NTD60,000,000: |
| 一、違反第十一條第一項規定，未經中央主管機關許可，經營認證業務，或未經中央主管機關依第十一條第二項規定許可展延而經營認證業務。 |
1.Violation of paragraph 1 of Article 11, engaging in accreditation activities without the permission of the Central Competent Authority or engaging in accreditation activities without the renewal permission of the Central Competent Authority in accordance with paragraph 2 of Article 11. |
| 二、認證機構違反中央主管機關依第三十三條第一項規定所為停止受理新申請認證案件之處分。 |
2.Violation of the suspension of accepting new accreditation applications imposed on accreditation bodies by the Central Competent Authority under paragraph 1 of Article 33. |
| 第 28 條 |
Article 28 |
| 違反第十二條第一項規定，未經認證機構認證合格並取得認證證書，經營驗證業務者，處新臺幣三十萬元以上三千萬元以下罰鍰。 |
Violating paragraph 1 of Article 12 by engaging in certification activities without accredited by an accreditation body and obtaining a corresponding certificate is fined from NTD300,000 up to NTD30,000,000. |
| 第 29 條 |
Article 29 |
| 有下列情形之一者，處新臺幣二十萬元以上二百萬元以下罰鍰，並得按次處罰： |
Under any of the following circumstances, a fine from NTD200,000 up to NTD2,000,000 is applicable to each individual violation: |
| 一、違反第二十條第一項規定，未經驗證合格，使用有機農產品標章。 |
1.Violation of paragraph 1 of Article 20, labeling organic mark on uncertified products. |
| 二、違反主管機關依第三十二條第二項規定所為停止使用有機農產品標章之處分。 |
2.Violating the suspension of the usage of organic mark imposed by the Central Competent Authority under paragraph 2 of Article 32. |
| 第 30 條 |
Article 30 |
| 有下列情形之一者，處新臺幣十萬元以上一百萬元以下罰鍰，並得按次處罰： |
Under any of the following circumstance, a fined from NTD100,000 up to NTD1,000,000 is applicable to each individual violation: |
| 一、違反第十二條第四項規定，規避、妨礙或拒絕主管機關之查核，或提供不實資料、紀錄，或未依中央主管機關公告之項目、方式及期間，保存相關資料及紀錄。 |
1.Violation of paragraph 4 of Article 12, evading, impeding, or refusing the examination by the competent authority, or providing false data and records, or failing to retain relevant data and records in accordance with the items, methods, and time periods promulgated by the Central Competent Authority. |
| 二、違反第二十一條規定，未保存資料，或規避、妨礙或拒絕提供資料，或提供不實之資料。 |
2.Violation of Article 21, failing to retain data, evading, impeding, or refusing to provide data or providing false data. |
| 三、違反第二十二條規定，規避、妨礙或拒絕主管機關進入場所、運輸工具、執行檢查、抽樣檢驗，或未提供相關資料或紀錄，或提供不實之資料或紀錄。 |
3.Violation of Article 22, evading, impeding or refusing the staffs of the competent authority entering the premise or transporting vehicles for the purpose of conducting examination, or sampling specimen for testing, or failing to provide relevant data or records, or providing false data or records. |
| 四、違反主管機關依第三十四條規定所為之處置。 |
4.Failing to comply with the proceedings by the Central Competent Authority under Article 34. |
| 第 31 條 |
Article 31 |
| 農產品經營者有下列情形之一者，處新臺幣六萬元以上六十萬元以下罰鍰，並得按次處罰： |
Under any one of the following circumstances, an operator is subject to a fine from NTD60,000 up to NTD600,000 for each individual violation: |
| 一、違反第十五條第二項規定，使用禁用物質。 |
1.Violation of paragraph 2 of Article 15, using the prohibited substances. |
| 二、違反第十五條第三項規定，其有機農產品及有機轉型期農產品含有禁用物質。但農產品經營者證明其已採取必要之防護措施，且經主管機關認定為鄰田污染者，不罰。 |
2.Violation of paragraph 3 of Article 15, the organic agricultural products and organic in-conversion agricultural products containing the prohibited substances; however, operators validating that they have taken necessary prevention measures, and their fields are identified by the competent authority to be contaminated by adjacent farms, are exempted from penalties. |
| 三、違反第十六條第一項、第二項或第十七條第一項規定，其農產品未經驗證合格，或未經進口審查合格，以有機名義或其他足使他人誤認之方法，而販賣、標示、展示或廣告。 |
3.Violation of paragraph 1 and 2 of Article 16 or paragraph 1 of Article 17, agricultural products not certified or imports not reviewed qualified being sold, labeled, displayed, or advertised as organic or in a misleading way. |
| 四、違反第十六條第三項規定，非自然人之農產品經營者以有機為其名稱之全部或一部分，且其農產品未經驗證合格或未依第十七條第一項第二款規定審查合格。 |
4.Violation of paragraph 3 of article 16, non-natural person operator using the term “organic” as whole or a part of its name without having all its product certified or reviewed qualified under subparagraph 2 of paragraph 1 of Article 17. |
| 五、違反主管機關依第三十二條第二項規定所為停止以有機名義販賣、標示、展示或廣告之處分。 |
5.Violating the suspension of selling, labeling, displaying, or advertising products as organic imposed by the Central Competent Authority under paragraph 2 of Article 32. |
| 農產品經營者依委託人或定作人之指示，生產、加工、分裝或流通農產品，而有前項各款所定情形之一者，以委託人或定作人為處罰對象。 |
Operators in the above situations in production, processing, packaging, or distribution under the instruction of an entruster or client shall inflict penalties on the entruster or client instead. |
| 第 32 條 |
Article 32 |
| 農產品經營者有下列情形之一，應令其限期改正；屆期不改正者，處新臺幣三萬元以上三十萬元以下罰鍰，並得按次處罰： |
Under any of the following circumstances, operators shall be order to correct within a specified period; a fine from NTD30,000 up to NTD300,000 is applicable to those unable to comply in time and to each individual violation. |
| 一、未依第十八條第一項規定標示或標示不實，或未依第十八條第三項規定，於變更事實發生之日起三個月內更換原有標示。 |
1.Not labeling in accordance with paragraph 1 of Article 18, making false labeling, or not updating the label within 3 months of the date when a change to the subject matter indicated occurs in accordance with paragraph 3 of Article 18. |
| 二、未依第十九條第一項規定展示品名、原產地、有機農產品或有機轉型期農產品驗證證書影本、同意文件影本，或未依第十九條第二項準用第十八條第一項第一款及第四款規定，展示品名、原產地（國）。 |
2.Violation of paragraph 1 of Article 19, not displaying the product name, origin, a duplicate copy of the certificate of organic certification or organic in-conversion certification, or a duplicate copy of the approval document; violation of paragraph 2 of Article 19, which directly refers to subparagraph 1 and 4 of paragraph 1 of Article 18, not displaying the product name or origin (country). |
| 三、違反第十九條第三項所定辦法有關標示、展示之事項、方式之規定。 |
3.Violation of paragraph 3 of Article 19 regarding the items and methods of labeling and displaying. |
| 四、違反第二十條第二項所定辦法有關標章規格、圖式或使用之規定。 |
4.Violation of paragraph 2 of Article 20 regarding the specification, design, and usage of organic marks. |
| 有前項各款情形之一者，主管機關並得令三個月以上一年以下期間，停止其使用有機農產品標章或以有機名義販賣、標示、展示或廣告。 |
For any one of the above circumstances, the competent authority shall suspend the operators’ usage of organic mark, selling, labeling, displaying, and advertising products as organic for a period from 3 months up to 1 year. |
| 第 33 條 |
Article 33 |
| 認證機構有下列情形之一者，得按其情節輕重，予以警告，或令二個月以上二年以下期間，停止其受理新申請認證案件之處分： |
Under any of the following circumstances, the Central Competent Authority shall warn the accreditation bodies according to the severity, or impose a penalty of suspending the accreditation bodies to accept new accreditation applications for a period from 2 months up to 2 years: |
| 一、違反第十一條第四項規定，規避、妨礙、拒絕接受中央主管機關之查核或提供不實資料。 |
1.Violation of paragraph 4 of Article 11, accreditation bodies evading, impeding, or refusing the supervision by the Central Competent Authority, or providing false data. |
| 二、違反第十一條第四項第一款規定，於中央主管機關許可以外之國家或地區受理申請認證之案件。 |
2.Violation of subparagraph 1 of paragraph 4 of Article 11, accreditation bodies accepting accreditation applications from countries or areas not permitted by the Central Competent Authority. |
| 三、違反第十一條第四項第二款規定，未將擬訂、修正或廢止之認證基準報中央主管機關核定。 |
3.Violation of subparagraph 2 of paragraph 4 of Article 11, accreditation bodies failing to report the formulation, amendment or abolishment of accreditation standards to the Central Competent Authority. |
| 四、違反第十一條第四項第三款規定，未依中央主管機關核定之認證基準審查申請認證之案件或對驗證機構所經營驗證業務實施評鑑。 |
4.Violation of subparagraph 3 of paragraph 4 of Article 11, accreditation bodies failing to review accreditation applications or assess certification activities performed by the certification body in accordance with standards approved by the Central Competent Authority. |
| 五、違反第十一條第四項第四款規定，未保存有關經營認證業務之紀錄五年以上、保存不實紀錄，或未報中央主管機關備查。 |
5.Violation of subparagraph 4 of paragraph 4 of Article 11, failing to retain records related to accreditation task for at least 5 years, keeping false records, or failing to notify the Central Competent Authority for the record. |
| 六、違反第十一條第四項第五款規定，不配合中央主管機關查核經其認證合格之驗證機構。 |
6.Violation of subparagraph 5 of paragraph 4 of Article 11, accreditation bodies failing to comply with the Central Competent Authority on examining the certification bodies they accredited. |
| 七、違反第十一條第四項第六款規定，於驗證機構未能繼續經營驗證業務時，未協調其他驗證機構承接其驗證業務。 |
7.Violation of subparagraph 6 of paragraph 4 of Article 11, accreditation bodies failing to coordinate with other certification bodies to take over the certification tasks when one certification body is unable to continue the certification business. |
| 八、違反第十一條第五項所定辦法有關認證機構之監督、管理、經營認證業務紀錄之項目或申報備查文件之規定。 |
8.Violation of paragraph 5 of Article 11, regarding the supervision and management of accreditation bodies, the required items related to the accreditation tasks to be recorded, and the notification documents specified in the above paragraph. |
| 認證機構於三年內，經中央主管機關依前項規定停止受理新申請認證業務二次後，再有前項各款情形之一者，中央主管機關應廢止其許可，並得令二年以上五年以下期間，禁止其依第十一條第一項規定，申請許可。 |
If an accreditation body has been suspended from accepting new applications by the Central Competent Authority under the above paragraph twice in the previous 3 years, another violation specified in the previous paragraph shall result in Central Competent Authority abolishing the permission and prohibit accreditation body to apply for permission under paragraph 1 of Article 11 for a period from 2 years up to 5 years. |
| 依前項規定廢止許可之認證機構，自廢止之日起，其與驗證機構簽訂之認證契約，由中央主管機關繼受；各該驗證機構並應於中央主管機關公告之期間內，與其他認證機構簽訂認證契約，其與中央主管機關之認證契約同時終止。 |
For accreditation body revoked in accordance with the above paragraph, the Central Competent Authority shall assume the accreditation body’s contracts signed with the certification bodies; those certification bodies shall enter into an accreditation contract with other accreditation bodies within the period designated by the Central Competent Authority, and the accreditation contracts with the Central Competent Authority will thereby be terminated at the same time. |
| 第 34 條 |
Article 34 |
| 農產品廣告中所涉農產品，有第三十一條或第三十二條所定情形之一者，除依本法規定處罰外，並得為下列處置： |
For agricultural products appearing in advertisements and meeting circumstances specified in Article 31 or Article 32, aside from penalties prescribed by this Act, the following proceedings also apply: |
| 一、令委託刊播廣告者於原刊播之同一篇幅、時段刊播一定次數之更正廣告，其內容應載明表達歉意及排除錯誤之訊息。 |
1.Enforcing the advertiser to order the broadcast of corrective advertising on the same page or timeslots of the original broadcast that shall extend apology and corrective message. |
| 二、令受委託刊播廣告者停止刊播、回收原刊播廣告資料。 |
2.Enforcing the broadcaster to suspend the broadcast and withdraw advertising materials. |
| 第 35 條 |
Article 35 |
| 有第二十九條至第三十二條所定情形之一者，除依規定處罰外，並得公布其違規情節、農產品之名稱、農產品經營者姓名、地址、法人或團體之名稱、事務所或營業所、管理人或代表人之姓名及農產品抽樣地點、日期。 |
For situations specified between Article 29 and 32, aside from imposing penalties under the relevant regulations, the administrator may announce the details of violations, the product name, the name and address of operators, the name of its affiliated legal entities, organizations, firm offices, or business premise, the name of its manager or representative, and the site and date the agricultural product sampled. |
| 第 36 條 |
Article 36 |
| 本法所定之處罰，除對認證機構及驗證機構之處罰，由中央主管機關為之外，由直轄市、縣（市）主管機關為之。 |
The penalties established by this Act, except those targeting accreditation bodies and certification bodies, which are imposed by the Central Competent Authority, are carried out by the municipality or county (city) government. |
| 第 六 章 附則 |
Chapter 6 Supplementary Provisions |
| 第 37 條 |
Article 37 |
| 本法施行前，經中央主管機關依農產品生產及驗證管理法第六條第一項公告之有機同等性國家，自本法施行後一年內，未與我國完成簽訂雙邊有機同等性相互承認之條約、協定或其他官方約定文件者，由中央主管機關廢止其同等性認可公告。 |
For countries promulgated by the Central Competent Authority as organic equivalent under paragraph 1 of Article 6 of Agricultural Production and Certification Act prior to the implementation of this Act, if they fail to reach mutual organic equivalence with ROC by signing a bilateral treaty, agreement, or official document within one year of the implementation of this Act, the Central Competent Authority shall abolish the equivalence recognition. |
| 依前項規定廢止同等性認可公告之國家認證之驗證機構，於廢止同等性認可公告生效前，其驗證合格之農產品，經中央主管機關審查合格後輸入者，於廢止同等性認可公告生效後，仍得以有機名義販賣、標示、展示或廣告。 |
For certification bodies of a country with equivalence recognition abolished under the previous paragraph, agricultural products certified by them and reviewed qualified by the Central Competent Authority prior to the abolishment are allowed to be sold, labeled, displayed, or advertised as organic, even after the abolishment enters into effect. |
| 第 38 條 |
Article 38 |
| 本法施行前已依農產品生產及驗證管理法及其相關規定認證之有機農產品驗證機構，於本法施行之日起十八個月內，視為已依本法認證合格，得依農產品生產及驗證管理法有機農產品相關規定辦理驗證業務。 |
Prior to the implementation of this Act, the certification bodies that have been accredited to conduct certification activities under the Agricultural Production and Certification Act and other relevant regulations shall retain their accredited status for 18 months after the implementation of this Act. During which the certification bodies may conduct certification activities under Agricultural Production and Certification Act. |
| 本法施行前已依農產品生產及驗證管理法及其相關規定驗證合格之有機農產品，於本法施行之日起十八個月內，其有機農產品驗證證書效期尚未屆滿者，視為已依本法驗證合格。 |
Prior to the implementation of this Act, the organic agricultural products that have been certified under the Agricultural Production and Certification Act shall be deemed certified under this Act for up to 18 months after the implementation of this Act, given that the certificate of organic certification is within its valid period. |
| 第 39 條 |
Article 39 |
| 無本國機構或法人擔任認證機構時，中央主管機關得公告自行或指定機構、法人於一定期間擔任認證機構。 |
In the absence of domestic institutions or legal entities serving as accreditation bodies, the Central Competent Authority may promulgate itself, other designated institutions, or legal entities as the accreditation body for a limited period. |
| 無本國機構、學校或法人擔任驗證機構時，中央主管機關得公告指定機構、學校或法人於一定期間擔任驗證機構。 |
In the absence of domestic institutions, schools or legal entities serving as certification bodies, the Central Competent Authority may promulgate institutions, schools, or legal entities as the certification body for a limited period. |
| 第 40 條 |
Article 40 |
| 除本法另有規定外，自本法施行之日起，農產品生產及驗證管理法有關有機農產品之規定，不再適用。 |
Unless otherwise stipulated in this Act, the provisions of Agricultural Production and Certification Act relating to organic agricultural production no longer apply from the implementation date of this Act. |
| 第 41 條 |
Article 41 |
| 本法施行細則，由中央主管機關定之。 |
Enforcement rules for this Act shall be established by the Central Competent Authority. |
| 第 42 條 |
Article 42 |
| 本法自公布後一年施行。 |
This Act shall enter into force one year after the date of promulgation. |
| |
|
| 食用牛羊脂衛生標準 |
Sanitation Standard for Edible Tallow |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法第十七條規定訂定之。 |
This Standard is prescribed in accordance with the provisions of Article 17 of the Act Governing Food Safety and Sanitation. |
| 第 2 條 |
Article 2 |
| 食用牛羊脂之原料來源，應符合食品安全衛生管理法之規定，並來自屠宰時健康之牛或羊所取得之清潔完整且可供食用之脂肪組織，及帶骨或肌肉之脂肪部分熬製而成之食用牛羊脂。 |
The raw materials of edible tallow shall meet the “Act Governing Food Safety and Sanitation”, obtained by rendering the clean, sound, fatty tissues, attendant muscles and bones of bovine animals and/or sheep (Ovis aries) in good health at the time of slaughter and fit for human consumption. |
| 第 3 條 |
Article 3 |
| 食用牛羊脂應具良好色澤（灰白色至淡黃色），不得有異味或酸敗氣味。 |
Edible tallow shall have good color (off white to pale yellow), no off odor or flat-sour spoilage flavor. |
| 第 4 條 |
Article 4 |
| 食用牛羊脂之酸價，應為 2.5 mg KOH/g fat 以下。其衛生安全，應另符合食品安全衛生管理法所定之其他相關標準。 |
Edible tallow shall have acid value not more than 2.5 mg KOH/g fat. The products shall be in accordance with the other relevant standards set from the “Act Governing Food Safety and Sanitation”. |
| 第 5 條 |
Article 5 |
| 本標準自發布日施行。 |
This standard shall be implemented from the date of promulgation. |
| |
|
| 食用豬脂衛生標準 |
Sanitation Standard for Pork Fat |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法第十七條規定訂定之。 |
This Standard is prescribed in accordance with the provisions of Article 17 of the Act Governing Food Safety and Sanitation. |
| 第 2 條 |
Article 2 |
| 食用豬脂之原料來源，應符合食品安全衛生管理法之規定，並來自健康豬隻所取得之乾淨且可供食用之組織。但不包括內臟器官、腦、脊髓及粗血管。 |
The raw materials of pork fat shall meet the “Act Governing Food Safety and Sanitation”, obtaining from swine fatty tissues in good health, clean and fit for human consumption. The tissues for raw materials do not include viscera, brains, spinal marrow and large blood vessels. |
| 第 3 條 |
Article 3 |
| 食用豬脂應具良好色澤，不得有異臭或酸敗氣味。 |
Pork fat shall have good color, no off odor or flat-sour spoilage flavor. |
| 第 4 條 |
Article 4 |
| 食用豬脂之酸價，應為 2.0 mg KOH／g fat 以下；惟經精製程序（脫酸、脫色或脫臭等）之精製食用豬脂，其酸價應為1.3mgKOH／gfat以下。其衛生安全，應另符合食品安全衛生管理法所定之其他相關標準。 |
Pork fat shall have acid value not more than 2.0 mg KOH/g fat. The refined pork fats, which have the process for refining, bleaching and deodorization, shall have acid value not more than 1.3 mg KOH/g fat. Both of them shall be in accordance with the other relevant standards set from the “Act Governing Food Safety and Sanitation”. |
| 第 5 條 |
Article 5 |
| 本標準自發布日施行。 |
This standard shall be implemented from the date of promulgation. |
| |
|
| 食品工廠建築及設備設廠標準 |
The Establishment Standards of Construction and Equipment of a Food Factory |
| 第 一 章 通則 |
Chapter I: General Provisions |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法第十條第二項規定訂定之。 |
These standards are set forth in accordance with the second paragraph of Article 10 of Act Governing Food Safety and Sanitation. |
| 第 2 條 |
Article 2 |
| 食品工廠建築及設備之設置，除法令另有規定外，依本標準之規定。 |
Unless otherwise stipulated by law, the construction of buildings and equipment of the food factories shall be made in accordance with the regulations of these standards. |
| 第 3 條 |
Article 3 |
| 本標準所定之食品工廠，應依法辦理工廠登記。 |
The food factories prescribed by these standards refer to factories that should apply for factory registration. |
| 第 4 條 |
Article 4 |
| 食品工廠設廠，應符合第二章之規定，下列專業食品工廠並應符合第三章之相關規定： |
The construction of food factories should conform to the regulations prescribed in Chapter 2; and the following specialized food factories should conform to regulations prescribed in Chapter 3. The relevant regulations for specialized food factories: |
| 一、罐頭食品工廠。 |
(1) Canned food factories |
| 二、冷凍食品工廠。 |
(2) Frozen food factories |
| 三、蜜餞醃漬工廠。 |
(3) Candied fruit factories |
| 四、飲料工廠。 |
(4) Beverage factories |
| 五、醬油工廠。 |
(5) Soy sauce factories |
| 六、乳品工廠。 |
(6) Dairy product factories |
| 七、食用油脂工廠。 |
(7) Edible oil factories |
| 八、脫水蔬果工廠。 |
(8) Dehydrated vegetable and fruit factories |
| 九、餐盒食品工廠。 |
(9) Lunch box food factories |
| 十、速食麵工廠。 |
(10) Instant noodle factories |
| 十一、食品添加物工廠。 |
(11) Food additive factories |
| 前項專業食品工廠之類別，參考中華民國行業標準分類及經濟部工業產品分類認定。 |
The classifications of the preceding specialized factories are made in reference with Taiwan’s Standard Occupational Classification and Industrial Category and Classification, Ministry of Economic Affairs. |
| 第 二 章 食品工廠之基本共同標準 |
Chapter II: The Universal Basic Standards for Food Factories |
| 第 5 條 |
Article 5 |
| 食品工廠之廠區環境應符合下列規定： |
The environment of food factories should conform to the following regulations: |
| 一、廠區內應築有通暢之排水溝，空地應舖設混凝土、柏油或予以綠化，不得有塵土飛揚，環境應隨時保持清潔，地面應隨時清掃、保持清潔。 |
1.The factory premises should be constructed with unobstructed gutters, the open space paved with concrete, asphalt or green covering and free from flying dust. The environment should be kept clean always with the ground being swept regularly to maintain cleanliness. |
| 二、排水系統應經常清理，保持暢通，不得有異味。 |
2.The drainage system should be cleaned up regularly to keep it unobstructed and free from foul smell. |
| 三、禽畜、寵物等應予管制，並有適當的措施以避免污染食品。 |
3.Livestock, pets, etc., should be kept under control and appropriate measures should be taken to avoid contaminating the food. |
| 四、員工宿舍應與作業場所完全隔離並分別設置出入口。 |
4.The staff dormitories should be completely isolated from the operating site and be constructed with separate entrance doors. |
| 五、應實施病媒防治措施。 |
5.Vector control measures should be implemented. |
| 第 6 條 |
Article 6 |
| 食品工廠包括辦公室、原料處理場、加工或調理場、檢驗或研究室、包裝室、倉庫、機電室、鍋爐室、修護室、更衣室、洗手消毒室、餐廳、員工休息室、員工宿舍及廁所等。凡使用性質或清潔程度要求不同之場所，應個別設置或有效隔離及管理，其建築並應符合下列規定： |
The food factories should include an office, raw material preparation site, processing or dressing site, inspection room or laboratory, packaging room, warehouse, electrical room, boiler room, maintenance room, changing rooms, hand washing and sterilizing room, restaurant, staff rest rooms, staff dormitories and toilets, etc. For sites with different applications and cleanliness requirements, they should be constructed individually or isolated effectively and managed, and their buildings should conform to the following regulations: |
| 一、牆壁與支柱：原料處理場、加工或調理場等建築物之牆壁與支柱面應為白色或淺色，離地面至少一公尺以內之部分應使用非吸收性、不透水、易清洗之材料舖設，其表面應平滑無裂縫並經常保持清潔。 |
1. Walls and pillars: The walls and pillars of raw material preparation sites, processing, dressing and other buildings should be in white or light-colored, the section at least one meter above the ground should be paved with non-absorbent, water impermeable and easily-washable material, and its surface should be smooth with no cracks and kept clean regularly. |
| 二、地面：原料處理場、加工或調理場、內包裝室建築物之地面，應採非吸收性、不透水且耐酸鹼、耐磨之材料舖設。地面應有良好之排水斜度及排水系統。 |
2. Floor: The building’s surface of raw material preparation, processing, dressing and indoor packaging sites should be paved with non-absorbent, water impermeable, acid/alkali resistant and wear resistant material. The floor should feature an appropriate drainage gradient and water discharge system. |
| 三、樓板或天花板：應為白色或淺色、易清掃、可防止灰塵積儲之構築。食品暴露之正上方樓板或天花板不得有結露現象，並保持清潔、良好維修之狀態。 |
3. Floor slab or ceiling: It should be in white or light-colored to ease cleaning, constructed to avoid dust accumulation. Condensation is not allowed on the floor slab or ceiling directly above the exposed food, and it should be kept clean and maintained in good condition. |
| 四、光線：食品工廠之廠房除倉庫以外，其他各項建築物應有足夠的光線，工作台面或調理台面應保持二百勒克斯以上，機器設備台面應保持一百勒克斯以上，使用之光源應不致改變食品之顏色。 |
4. Light: Except for warehouses, all other buildings of food factories should be able to get adequate light; the work table or dressing table should maintain more than 200 lux, and the machinery and equipment table should maintain more than 100 lux. The light source used should not be able to change the color of food. |
| 五、通風：廠房建築物應通風良好，視需要裝設風扇、抽風機等有效換氣設備，且通風口應有防止病媒侵入之設施。如有密閉之加工室或包裝室，則應有空調設備。 |
5.Ventilation: The factory buildings should be well-ventilated, and installed with fans, exhaust fans and other effective ventilation equipment if necessary. The air vents should be equipped with facilities to prevent the intrusion of disease vectors. Any confined processing room or packaging room should be installed with air conditioning facilities. |
| 六、出入口、門窗及其他孔道：應以非吸收性、易清洗、不透水堅固材料製作，並應設置防止病媒侵入之設施。 |
6. Entrances, doors, windows and other channels: They should be made of durable non-absorbent, easily-washable, water impermeable and durable materials, and equipped with facilities to prevent the intrusion of disease vectors. |
| 七、排水系統：應有完整暢通之排水系統，排水溝應有攔截固體廢棄物之設施，出口處並應有防止病媒侵入之設施。 |
7.Water drainage system: There should be a complete unobstructed water drainage system and the gutters equipped with intercepting facilities to intercept solid wastes, and the exit equipped with facilities to prevent the intrusion of disease vectors. |
| 八、倉庫：原料倉庫及成品倉庫應分別設置或予獨立，庫內地面應較庫外為高，並採用不透水材料建築，庫內所設之棧板須足以配合存貨及生產作業之需要。 |
8.Warehouse: The raw material warehouse and finished product warehouse should be constructed separately or independently, the floor at warehouse interior higher than warehouse exterior, and constructed with water impermeable material, and the warehouse interior prepared with sufficient pallets to cope with inventory and production operation needs. |
| 九、廁所： |
9. Toilet: |
| （一）廁所之設置地點應防止污染水源。 |
(1) The toilet construction site should be prevented from contaminating the water source. |
| （二）廁所不得正面開向食品作業場所，但如有緩衝設施及有效控制空氣流向以防止污染者，不在此限。 |
(2)The toilet entrance should not face directly towards the food processing site, but such restriction does not apply if it is constructed with a buffer facility to control airflow effectively and to prevent contamination. |
| （三）應有良好之通風、採光、防蟲、防鼠等設施，並備有流動自來水、清潔劑、烘手器或擦手紙巾等之洗手、乾手設施及垃圾桶。 |
(3)It should be equipped with ventilation, day lighting, anti-pest, anti-rodent and other facilities, as well as running tap water, detergent, hand washing and drying facilities with hand dryers or paper towels, and trash bins. |
| （四）應有如廁後應洗手之標示。 |
(4)It should be installed with a sign to remind users to wash their hands after visiting the toilet. |
| 十、更衣室：食品工廠視其需要得設置更衣室，更衣室應設於加工調理場旁適當位置並與食品作業場所隔離，不同性別之更衣室應分開，室內應備有更衣鏡、潔塵設備及數量足夠之個人用衣物櫃及鞋櫃等。 |
10.Changing room: There is a need for food factories, depending on requirements, to construct changing rooms at appropriate locations adjacent to the processing/dressing site but isolated from the food processing site. Changing rooms should be separated by gender, and equipped with mirrors, dust cleaning equipment, and sufficient personal lockers, shoe cabinets, etc. |
| 十一、洗手消毒室：食品工廠視其需要得設置洗手消毒室，其應與加工調理場或內包裝室相鄰，並設置數量足夠之洗手及乾手設施。 |
11.Hand sterilizing room: There is a need for food factories, depending on requirements, to set up a hand sterilizing room. It should be adjacent to the processing/dressing or indoor packaging room, and installed with sufficient hand washing and drying facilities. |
| 十二、冷凍設備應有安全設施設置。 |
12. The safety facilities installations are required for freezing refrigeration equipment. |
| 第 7 條 |
Article 7 |
| 食品工廠之機器設備設計及機器設備材質應符合下列規定： |
The mechanical design and material of machinery and equipment in food factories shall meetconform to the following requirements: |
| 一、機器設備設計：用於食品或食品添加物產製用機器設備之設計和構造應能防止危害食品或食品添加物品質衛生，易於清洗消毒，並容易檢查。應有使用時可避免潤滑油、金屬碎屑、污水或其他可能引起污染之物質混入產品之結構。 |
1.Design of mMachinery and equipment design: The design and structure of the machinery and equipment used for production of food or food additives should prevent hazards from deteriorating the quality and hygiene of food or food additives and should permit easy cleaning, sterilization and inspection. Moreover, the structural design should safeguard products against contamination of lubricants, metal filings, wastewater, or other contaminants. |
| 二、機器設備材質：所有用於食品或食品添加物處理區及可能接觸食品或食品添加物之設備與器具，應由不會產生或溶出毒素、無臭味或異味、非吸收性、耐腐蝕且可承受重複清洗和消毒之材料製造，同時應避免使用會發生接觸腐蝕的材料。 |
2.Materials of mMachinery and equipment material: The equipment and utensils used in the food or food additive processing section or likely to have contact with food or food additives should be made of materials incapable of producing or dissolving and generating toxins and bad or unpleasant odors; moreover, materials should be non-absorbent and corrosion-resistant and capable of withstanding repeated washing and sterilization procedures. The use of materials which produce contact corrosion shall also be avoided. |
| 第 三 章 專業食品工廠之生產設備、檢驗設備及基本設施標準 |
Chapter III. Production and Inspection Equipment Standards and Basic Facility Requirements Standards ofor Food Factories |
| 第 8 條 |
Article 8 |
| 罐頭食品工廠應具備下列生產及檢驗設備： |
The canned food factories should possess the following production and inspection equipment are required for canned food factories: |
| 一、生產設備： |
1.Production equipment: |
| （一）穩定熱能來源：蒸氣主管壓力應維持在六公斤／平方公分以上。 |
(1)Stable heat source: The main steam supply pipe pressure shall be maintained at 6kg/cm2 or above. |
| （二）封蓋設備：封蓋設備應能確保封蓋之安全性，其種類應符合產品之需要設置。 |
(2)Capping equipment: The capping equipment should be able to ensure safety cap sealing and the type used should be able to conform to product needs. |
| （三）殺菌設備。 |
(3)Disinfection equipment |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）定溫保溫箱。 |
(1)Constant temperature incubator |
| （二）罐頭真空測定器及耐壓測定器（金屬罐裝罐頭食品工廠必備）。 |
(2)Can vacuum tester and pressure resistance tester (essential for metal canned food factories) |
| （三）pH 測定器或試紙。 |
(3)pH meter or litmus paper |
| （四）捲封測微器（金屬罐裝罐頭食品工廠必備）。 |
(4)Closed volume micrometer (essential for metal canned food factories) |
| （五）耐壓強度測定裝置（殺菌袋裝罐頭食品工廠必備）。 |
(5)Compressive strength measuring device (essential for retort pouch canned food factories) |
| 罐頭食品工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for canned food factories depending on the production and inspection needs: |
| 一、生產設備： |
1.Production equipment: |
| （一）原料洗滌設備。 |
(1)Raw material washing equipment |
| （二）殺菁設備（附冷卻設備）。 |
(2)Blanching equipment (equipped with cooler) |
| （三）調理台及調理工具。 |
(3)Dressing table and dressing tools |
| （四）脫氣設備。 |
(4)Degassing equipment |
| （五）清洗消毒設備。 |
(5)Cleaning and sterilizing equipment |
| （六）殺菌後冷卻設備。 |
(6) Post-disinfection cooling equipment |
| （七）填充液調配設備。 |
(7) Filling solution preparation equipment |
| （八）批號及日期標示設備。 |
(8)Batch number and date labeling equipment |
| （九）空罐（瓶）噴洗設備。 |
(9) Empty can (bottle) spray washing equipment |
| （十）冷凍（藏）庫。 |
(10)Freezer (refrigerator) |
| （十一）線上真空檢測器或打檢棒。 |
(11)In-process vacuum leak detector or vacuum probe. |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）固定之開罐器。 |
(1)Fixed can opener |
| （二）秤量器。 |
(2) Weighing scale |
| （三）溫度計。 |
(3) Thermometer |
| （四）糖度計。 |
(4) Glucose meter |
| （五）餘氯測定器或試紙。 |
(5) Residual chlorine analyzer or litmus paper |
| （六）給水裝置及洗滌等設備。 |
(6)Water supply device and washing equipment |
| （七）袋內殘留空氣量測定裝置。 |
(7)Measuring device for residual air in bag |
| （八）罐頭檢漏設備。 |
(8)Can leak detection device |
| （九）尖頭型鐵皮厚度測微器。 |
(9)Point micrometer |
| 第 9 條 |
Article 9 |
| 冷凍食品工廠應具備凍結之生產設備。 |
The following freezing equipment are required for production processes in frozen food factories. |
| 冷凍食品工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for a frozen food factoriesy depending on the production and inspection needs: |
| 一、生產設備 |
1.Production equipment: |
| （一）原料洗滌設備。 |
(1)Raw material washing equipment |
| （二）殺菁及冷卻設備。 |
(2)Blanching and cooling equipment |
| （三）冷凍車：其溫度應能維持品溫在攝氏負十八度以下。 |
(3)Cold storage vehicle: If it is available, Tthe temperature of the food should be maintained at below -18°C. |
| （四）清洗消毒設備。 |
(4)Cleaning and sterilizing equipment |
| （五）金屬或其他異物檢出設備。 |
(5)Metal or and foreign matter detector |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）餘氯測定器或試紙。 |
(1)Residual chlorine analyzer or litmus paper |
| （二）微生物檢驗設備。 |
(2)Microbiological testing equipment |
| （三）產品品溫測定儀器。 |
(3)Product temperature testing instrument |
| （四）秤量器。 |
(4)Weighing scale (sensitivity below 1mg) |
| （五）氧化酵素測定設備、pH測定器或試紙、糖度計。 |
(5)Oxidase detection device, pH meter or litmus paper, glucose meter |
| （六）藥物殘留測定儀器。 |
(6)Drug residue detection device |
| （七）揮發性鹽基態氮定量裝置。 |
(7)Volatile basic nitrogen (VBN) determination device |
| （八）粗脂肪定量裝置。 |
(8)Crude fat quantitative determination device |
| （九）組織胺定量裝置。 |
(9)Histamine quantitative determination device |
| 第 10 條 |
Article 10 |
| 蜜餞醃漬工廠應具備下列基本設施及檢驗設備： |
The following basic facilities and inspection equipment are required for candied fruit factories: |
| 一、基本設施： |
1.Basic facilities: |
| （一）加工及包裝場所如為密閉者，應有空氣調節設備。 |
(1)If the processing and packaging sites are confined spaces, they should be equipped with air conditioning equipment. |
| （二）鹽漬池應為遮蓋設施，糖漬槽或缸桶等均應設在室內並有遮蓋設施。 |
(2) The pickled pool should be a covered facility, and the pickled tank or barrels should be set up indoors and equipped with covers. |
| （三）需用曬場乾燥者，其曬場應以不透水材料構築。 |
(3)If a drying field is needed in drying, it should be constructed of water-impermeable material. |
| （四）二重釜、湯煮桶、糖漬槽或桶、匙槳、盤、刀、叉等用具，宜為不銹鋼材質，未產蜜餞之工廠免設。 |
(4)Steam-jacketed kettle, soup cooking barrels, candied tanks or barrels, paddles, plates, knives, forks and other utensils may should be made of stainless steel to the extent possible. These can be exempted for factories not manufacturing candied fruits. |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）糖度計或糖度折射計（未產蜜餞之工廠免設）。 |
(1)Glucose meter or glucose refractometer (can be exempted for factories not manufacturing candied fruits) |
| （二）鹽度計。 |
(2)Salinity meter |
| 蜜餞醃漬工廠視需要得具備下列檢驗設備： |
The following inspection equipment are optional for candied fruit factories depending on the production and inspection needs: |
| 一、餘氯測定器或試紙。 |
1.Residual chlorine analyzer or litmus paper |
| 二、二氧化硫定量裝置。 |
2.Sulfur dioxide quantitative determination device |
| 三、溫度計。 |
3.Thermometer |
| 四、pH 測定器或試紙。 |
4.pH meter or litmus paper |
| 五、秤量器。 |
5.Weighing scale |
| 第 11 條 |
Article 11 |
| 飲料工廠應具備下列生產設備： |
The following production equipment are required for beverage factories: |
| 一、一般飲料工廠： |
1.General beverage factoriesmanufacturing plants: |
| （一）充填設備。 |
(1) Filling machine |
| （二）過濾設備。 |
(2) Filter |
| （三）殺菌設備。 |
(3) Disinfect equipment |
| 二、果蔬汁飲料工廠： |
2.Fruit and vegetable juice factoriesmanufacturing plants: |
| （一）充填設備。 |
(1)Filling machine |
| （二）精濾機、離心機或均質機。 |
(2)Fine filter, centrifuge or homogenizer |
| （三）殺菌設備。 |
(3)Disinfection equipment |
| 飲料工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for beverage factories depending on the production and inspection needs: |
| 一、生產設備： |
1.Production eEquipment : |
| （一）一般飲料工廠： |
(1)General beverage factoryies: |
| 1.容器洗滌消毒設備。 |
A.Container washing and sterilizing equipment |
| 2.貯水槽：其容量應足供當日加工用水量。 |
B.Water reservoir: Its capacity should be sufficient to meet daily processing needs. |
| 3.不銹鋼調和器及不銹鋼槽。 |
C.Stainless steel blender and stainless steel tank |
| 4.瓶裝飲料檢查設備、浸水槽及燈光透視檢查台。 |
D.Bottled water inspection equipment, dip tank and lighting fluoroscopy unit, etc. |
| 5.瓶裝飲料自動裝瓶機及打蓋機。 |
E.Bottled drink automatic filling and capping machines |
| 6.罐裝飲料動力封蓋機。 |
F.Canned drink power cap sealing machine |
| 7.碳酸氣混合機。 |
G.Carbonated mixer |
| 8.冷凍機。 |
H.Freezer (essential for carbonated drink factories) |
| （二）果蔬汁飲料工廠： |
(2)Fruit and vegetable juice factories: |
| 1.容器洗滌消毒設備。 |
A.Container washing and sterilizing equipment |
| 2.洗滌槽或迴轉式洗滌機。 |
B.Washing tank or rotary washing machine |
| 3.破碎機。 |
C.Crusher |
| 4.榨汁機。 |
D.Juicer |
| 5.冷卻設備。 |
E.Cooling equipment |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）顯微鏡。 |
(1)Microscope |
| （二）微生物檢驗設備。 |
(2)Microbiological testing equipment |
| （三）定溫保溫箱。 |
(3)Constant temperature incubator |
| （四）pH 測定器或試紙。 |
(4)pH meter or litmus paper |
| （五）糖度計或糖度折射計（包裝飲用水及礦泉水工廠除外）。 |
(5)Glucose meter or glucose refract meter (excluding packaged drink and mineral water factories) |
| （六）秤量器。 |
(6)Weighing scale |
| （七）餘氯測定器或試紙。 |
(7)Residual chlorine analyzer or litmus paper |
| （八）離心分離器及真空測定器。 |
(8)Centrifugal separator and vacuum tester |
| （九）壓力測定器。 |
(9)Pressure detector |
| （十）濁度及色度測定設備。 |
(10) Turbidity and color determination equipment |
| 第 12 條 |
Article 12 |
| 醬油工廠應具備下列檢驗設備： |
The following inspection equipment are required for soy sauce factories: |
| 一、pH 測定器或試紙。 |
1.pH meter or litmus paper |
| 二、秤量器。 |
2.Weighing scale |
| 三、食鹽測定或分析設備或鹽度計。 |
3. Salt detector, analyzer, orand salinity meter |
| 四、酸度檢驗設備。 |
4. pH testing equipment |
| 五、餘氯測定器或試紙。 |
5. Residual chlorine analyzer or litmus paper |
| 醬油工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for soy sauce factories depending on the production and inspection needs: |
| 一、生產設備： |
1.Production equipment: |
| （一）原料選別設備（使用經選別之原料者得免設置）。 |
(1)Raw material sorting equipment (can be exempted for factories using pre-screened raw materials) |
| （二）蒸煮設備。 |
(2)Steam cooker |
| （三）炒麥設備（不加麥者免設）。 |
(3)Wheat frying equipment (can be exempted for factories not using wheat additive) |
| （四）混合設備。 |
(4)Blender |
| （五）製麴設備。 |
(5)Koji making equipment |
| （六）食鹽溶解設備。 |
(6)Salt dissolving equipment |
| （七）發酵設備。 |
(7)Fermentation equipment |
| （八）壓榨設備。 |
(8)Compressing equipment |
| （九）過濾設備。 |
(9)Filtering equipment |
| （十）澄清槽。 |
(10)Settling tank |
| （十一）殺菌設備或加熱調煮設備。 |
(11)Disinfection or heating/cooking equipment |
| （十二）噴洗瓶設備（重複性使用之玻璃瓶裝醬油工廠必備）。 |
(12)Spray washer (essential required for soy sauce factories that package product in reusable glass bottles) |
| （十三）充填設備（包括封瓶機）。 |
(13)Filling equipment (including capping machine) |
| 二、檢驗設備 |
2.Inspection equipment |
| （一）無菌室、無菌箱或微生物培養室。 |
(1)Sterile room, sterile container or microbial incubator |
| （二）總氮測定裝置。 |
(2) Total nitrogen measuring device |
| （三）氨基態氮測定設置。 |
(3)Amino nitrogen determination equipment |
| （四）水份測定器。 |
(4)Moisture detector |
| （五）色度分析設備或比色板。 |
(5)Color analyzer or color disc |
| 第 13 條 |
Article 13 |
| 乳品工廠應具備下列基本設施及檢驗設備： |
The following basic facilities, production and inspection equipment are required for dairy product factories: |
| 一、基本設施： |
1.Basic facilities |
| （一）乳品工廠貯乳、加工、分裝、或調配等過程必需在調理場內進行，所有之加工設備必須具備優良之衛生條件，乳液或乳粉流經之管道，及與乳液或乳粉接觸之設備，應為內壁光滑、無針孔、無直角、無狹縫之不銹鋼製品。 |
(1)Milk storage, processing, repacking, dressing and other treatments of dairy product factories should be done within the factories. All processing equipment must meet excellent sanitation conditions; the flowing channels of milk emulsion and powered milk, and the equipment that the milk emulsion or powered milk gets in touch with, should be made of stainless steel with smooth interior walls that are free from pinholes, right angles and slits. |
| （二）乳品工廠應具備供應冷卻水（或其他冷卻液）之設備，此等設備並應與加工調理場隔離（乳粉調配除外）。 |
(2)The dairy product factories should possess cooling water supply (or other cooling fluid) equipment and should be isolated from the processing/dressing site (excluding powered milk blending). |
| （三）收乳及貯乳設備（非使用生乳為原料之乳製品除外）：秤量設備、儲乳槽、乳桶洗滌殺菌設備、牛乳幫浦、過濾器或雜質離心分離機、乳液冷卻設備、具冷卻設備之貯乳槽、生乳檢查設備（包括酒精試驗、沉澱物檢查器及取樣工具等）一套、冷藏運輸車。 |
(3)Milk collection and milk storage equipment (excluding dairy products made from raw milk as the raw material): Weighing equipment, milk storage tank, milk barrel washing and disinfection equipment, milk pump, filter or impurity centrifugal machine, milk cooling equipment, milk storage tank with cooling effect, a set of raw milk inspection equipment (including alcohol testing, precipitate tester, sampling equipment, etc.), cold storage vehicles. |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）生乳取樣器（乳粉調配除外）。 |
(1)Raw milk sampler (excluding powdered milk blending) |
| （二）酸度滴定裝置或滴定管。 |
(2)Acidic titration device and burette |
| （三）生乳比重計（乳粉調配除外）。 |
(3)Raw milk densometer (excluding powered milk blending) |
| （四）溫度計。 |
(4) Thermometer |
| （五）水分測定用乾燥器（生產廠必備）。 |
(5)Dryer for detecting moisture (essentialrequired for production factoriesyplants) |
| （六）秤量器。 |
(6)Weighing scale |
| （七）餘氧測定器（乳粉調配或製造必備）。 |
(7)Residual oxygen analyzer (essential for powdered milk blending or manufacturing) |
| （八）藥物殘留檢驗設備。 |
(8)Drug residue testing instruments |
| 乳品工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for dairy product factories depending on the production and inspection needs: |
| 一、生產設備 |
1.Production equipment |
| （一）鮮乳及調味乳處理工廠： |
(1)Fresh milk and flavored milk processing factories: |
| 1.牛乳幫浦。 |
A.Milk pump |
| 2.均質機。 |
B.Homogenizer |
| 3.乳脂肪分離機。 |
C.Milk fat separator |
| 4.洗瓶機（包括殺菌設備）及裝瓶機或自動紙器包裝機。 |
D.Bottle washing machine (including disinfection equipment), bottle filling machine or automatic paper packing machine |
| 5.成品低溫（攝氏七度以下凍結點以上）貯存室（保久乳除外）。 |
E.Low-temperature (below 7°C and above freezing point) storage room for finished products (excluding enduring milk) |
| （二）濃縮乳（奶水及煉乳）製造： |
(2)Concentrated milk (milk and condensed milk) production plants: |
| 1.均質機。 |
A.Homogenizer |
| 2.預熱設備。 |
B.Pre-heat equipment |
| 3.濃縮設備。 |
C.Enrichment equipment |
| 4.冷卻設備。 |
D.Cooling equipment |
| 5.調合處理設備。 |
E.Blending and processing equipment |
| 6.牛乳幫浦。 |
F.Milk pump |
| 7.空罐清洗及殺菌設備。 |
G.Empty can washing and disinfection equipment. |
| 8.奶水及煉乳自動裝罐封罐機。 |
H.Milk and condensed milk automatic filling and sealing machines |
| （三）乳粉製造： |
(3)Powdered milk manufacturing plants: |
| 1.牛乳幫浦。 |
A.Milk pump |
| 2.乳脂肪分離機。 |
B.Milk fat separator |
| 3.均質機。 |
C.Homogenizer |
| 4.貯乳槽。 |
D.Milk storage tank |
| 5.乳液預熱設備。 |
E.Milk emulsion pre-heat equipment |
| 6.濃縮設備。 |
F.Enrichment equipment |
| 7.乾燥製粉設備。 |
G.Milk powder making machine |
| 8.集粉處理設備。 |
H.Powder collection and processing equipment |
| 9.乳粉貯槽。 |
I.Powdered milk storage tank |
| 10. 添加物混合設備。 |
J.Additive mixer |
| 11. 空罐殺菌、清潔設備。 |
K.Empty can disinfection and cleaning equipment |
| 12. 乳粉自動充填、封蓋設備。 |
L.Automatic powered milk filling and sealing equipment |
| 13. 即溶奶粉相關設備。 |
M.Machinery relating to Iinstant milk powder related equipmentproduction |
| （四）醱酵乳製造： |
(4)Fermentation milk production plants: |
| 1.牛乳幫浦。 |
A.Milk pump |
| 2.乳脂肪分離機。 |
B.Milk fat separator |
| 3.醱酵液調和槽。 |
C.Broth blending tank |
| 4.醱酵槽。 |
D.Fermenter |
| 5.均質機。 |
E.Homogenizer |
| 6.稀釋調合設備。 |
F.Dilution blending equipment |
| 7.洗瓶機及裝瓶機、或紙器包裝機、或其他容器包裝設備。 |
G.Bottle washing and filling machines, paper packing machine or other container packing machine |
| 8.菌種管制設備。 |
H.Bacteria culture control equipment |
| 9.成品低溫（攝氏七度以下凍結點以上）貯存室。 |
I.Low-temperature storage room for finished products (below 7°C and above freezing point) |
| （五）乳粉調配： |
(5)Powdered milk blending plants: |
| 1.空調設備（調配及包裝場所必備）。 |
A.Air-conditioning equipment (essential for blending and packaging sites) |
| 2.真空吸塵設備。 |
B.Vacuum cleaner |
| 3.充氮設備或脫氧劑等同等設備替代之。 |
C.Nitrogen filling equipment, deoxidant or equipment with equivalent effect |
| 4.檢重機。 |
D.Weight inspection machine |
| 5.金屬或其他異物檢出設備。 |
E.Metal or foreign matter detector |
| 6.空罐殺菌或清潔設備。 |
F.Empty can disinfection and cleaning equipment |
| 7.乳粉自動充填、封蓋設備。 |
G.Powdered milk automatic filling and sealing equipment |
| 8.秤量設備。 |
H.Weighing equipment |
| 9.攪拌混合設備。 |
I.Mixing equipment |
| 10. 篩粉機。 |
J.Screening machine |
| 11. 儲粉設備或容器。 |
K.Powder storage equipment or container |
| 二、檢驗設備： |
2.Inspection equipment |
| （一）微生物檢驗設備。 |
(1)Microbiological analysis equipment |
| （二）餘氯測定器或試紙。 |
(2)Residual chlorine analyzer or litmus paper |
| （三）體細胞數測定設備。 |
(3)Somatic cell count equipment |
| 第 14 條 |
Article 14 |
| 食用油脂工廠應具備下列基本設施： |
The following basic facilities are required for edible oil factories: |
| 一、溶劑提油廠應設置溶劑貯桶及其貯藏場所，溶劑廠應有防爆裝置、滅火器、消防砂等消防設備。 |
1.Oil solvent extraction factories should construct solvent storage tanks and their storage site, and be equipped with anti-explosion devices and fire equipment such as fire extinguishers and fire sand, etc. |
| 二、內包裝室：生產小包裝（三公斤以下包裝）產品工廠，應獨立設置內包裝室，並裝設紗窗、紗門或空氣簾、空氣清淨器相關設備，必要時設置殺菌裝置。（無生產小包裝者得免設置）。 |
2.Indoor packaging room: Factories producing small packages (less than 3 kg packs) of products should construct independent indoor packaging room equipped with screen windows, screen doors or air curtains, air purifying equipment and disinfection devices installations where necessary (The requirement does not apply to plants that do not manufacture products in small packages.). |
| 三、動物性油脂工廠應設有攝氏零度以下之凍藏庫。 |
3.Animal fat factories should construct cold storage warehouse of temperature below the zero point. |
| 四、各種食用油貯槽宜為不銹鋼材質，並有原料貯槽或原料儲存專區及成品貯槽。 |
4.All edible oil storage tanks should be made of stainless steel whenever possible. Raw Designated material storage tanks or material storage areasshelves and finished-product storage tanks shall be made available. |
| 食用油脂工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for edible oil factories depending on the production and inspection need: |
| 一、生產設備 |
1.Production equipment: |
| （一）大豆油工廠： |
(1)Soybean oil factories: |
| 1.原油煉製廠： |
A.Crude soybean oil refineries: |
| （1）篩別機。 |
a.Screening machine |
| （2）乾燥機。 |
b.Dryer |
| （3）粉碎機。 |
c.Crusher |
| （4）壓扁機。 |
d.Flattening machine |
| （5）烘焙機。 |
e.Baking machine |
| （6）提油機（附 Miscella 蒸餾器、脫脂粕之脫溶劑器、溶劑蒸氣回收器）。 |
f.Oil extraction machine (built-in with Miscella distiller, desolventizer for defatted meal, solvent vapor collector) |
| 2.精製油煉製： |
B.Refined oil manufacturing plants: |
| （1）精製大豆油工廠： |
a.Refined soybean oil factories: |
| 離心分離機。 |
Centrifuge |
| 脫色相關設備。 |
Bleaching equipment |
| 壓濾機。 |
Pressure filter |
| 真空幫浦。 |
Vacuum pump |
| 預熱相關設備。 |
Pre-heat equipment |
| 脫臭相關設備。 |
Deodorizing equipment |
| 冷卻相關設備。 |
Cooling equipment |
| （2）大豆沙拉油工廠：同精製大豆油工廠，另宜設置冷凍室、脫臘設備及氮氣充填設備。 |
b.Soybean oil factories: Soybean oil factory equipment requirements include those identical to refined soybean oil factories. Additional installation of requirements are freezer, dewaxing equipment and nitrogen filling equipment is recommended. |
| （二）動物油脂工廠： |
(2)Animal fat factories: |
| 1.熱炸法原油煉製廠： |
A.Hot fried soybean refineries: |
| （1）切（碎）肉機。 |
a.Slicing (shredding) machine. |
| （2）炸油鍋。 |
b.Frying pan. |
| （3）油壓機。 |
c.Hydraulic machine. |
| （4）冷卻槽。 |
d.Cooling tank. |
| 2.精製動物油脂廠：同精製大豆油工廠。 |
B.Refined animal fat factories: Same as the various equipment required for refined soybean factories. |
| （三）人造奶油（Margarine） 、脂肪抹醬（Fat spreads） 及烤酥油（Shortening）工廠： |
(3) Margarine, fat spread and shortening oil factories: |
| 1.一貫作業人造奶油、脂肪抹醬及烤酥油工廠： |
A.Margarine, fat spread and shortening oil integrated production plants: |
| （1）同精製大豆油工廠。 |
a.The equipment requirements include those identical refined soybean oil factories. |
| （2）乳化槽（間接加熱式）。 |
b.Emulsifying tank (indirect heating manner) |
| （3）殺菌設備。 |
c.Disinfection equipment |
| （4）急冷捏和機（附設冷凍機）。 |
d.Rapid cold quenching machine (built-in with freezer) |
| （5）計量器。 |
e.Quantifier |
| 2.購用精製油為原料之加工廠：同一貫作業人造奶油、脂肪抹醬及烤酥油工廠。 |
B.Processing factories using refined oil as the raw material: The equipment requirements are identical to those of margarine, fat spread and shortening oil integrated production plants. |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）原油煉製廠：應能化驗酸價等項之儀器、器具及化學藥品外，另應購置秤量器、乾燥箱及乾燥器。 |
(1)Crude soybean oil refineries: The refineries are required to have instruments, equipment and chemicals needed to perform acidity test and other analyses. Additional equipment requirements include weighing scale, oven and dryer. |
| （二）精製油煉製廠：除應具備原油煉製廠檢驗設備外，尚應能化驗碘價、過氧化價及顏色等，其主要設備如下： |
(2)Refined oil refineries: In addition to inspection equipment for crude oil refineries, equipment needed to perform iodine value, peroxide value, and color tests are required. A main equipment list is provided below: |
| 1.顏色測定器。 |
A.Color measuring device |
| 2.秤量器。 |
B.Weighing scale |
| 3.恆溫箱。 |
C.Incubator |
| 4.乾燥箱。 |
D.Oven |
| （三）溶劑提油廠應購置溶劑殘留測定器。 |
(3)The solvent oil extraction plants should possess solvent residue detection device. |
| （四）人造奶油、脂肪抹醬及烤酥油工廠： |
(4)Margarine, fat spread and shortening oil factories: |
| 1.一貫作業人造奶油、脂肪抹醬及烤酥油工廠：應具有精製油煉製廠檢驗設備外，尚應能檢驗融點、凍點、大腸桿菌、雜菌、含皂份等項，其主要設備如下： |
A.Margarine, fat spread and shortening oil integrated production factories: The inspection equipment requirements for these factories include those identical to refined oil refineries. Additional equipment requirements are instruments needed to perform melting point, freezing point, E. coli, bacteria, saponification value tests. The A main equipment are listed ais followsprovided below: |
| （1）細菌培養、檢驗設備或其快速試驗器材（器具、儀器或設備）。 |
a.Bacterial culture, testing equipment or rapid bioassay devices (apparatus, instrument and equipment) |
| （2）無菌室、無菌箱或微生物培養室（烤酥油工廠得免設置）。 |
b.Sterile room, sterile container or microbial incubator (not required for shortening oil factories) |
| （3）融點、凍點測定裝置。 |
c.Melting point, freezing point detection device |
| 2.購用精製油為原料之加工廠：同本款第一目原油煉製廠檢驗設備之規定及本款第四目之一之一貫作業人造奶油、脂肪抹醬及烤酥油工廠檢驗設備（1） 至（3） 之各種設備。 |
B.Processing factories using refined oil as the raw material: The inspection equipment requirements include those of crude soybean oil refineries as provided in Subparagraph (1) of this Paragraph, the inspection equipment requirements for margarine, fat spread and shortening oil factories as provided in Items (a) to (c) of Subparagraph (4)A. |
| 第 15 條 |
Article 15 |
| 脫水蔬果工廠應具備下列檢驗設備： |
The following inspection equipment are required for dehydrated vegetable and fruit factories: |
| 一、水分或水活性測定設備。 |
1.Moisture or water activity measuring equipmentmeter |
| 二、秤量器。 |
2.Weighing scale |
| 脫水蔬果工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection requirements are optional for dehydrated vegetable and fruit factories depending on the production and inspection needs: |
| 一、生產設備： |
1.Production equipment |
| （一）蔬菜工廠： |
(1)Dehydrated vegetable factories: |
| 1.洗滌機。 |
A.Washing machine |
| 2.殺菁機。 |
B.Blanching machine |
| 3.除頭尾機。 |
C.Head and tail cutting machine |
| 4.切條或切片機。 |
D.Slitting or slicing machine |
| 5.熱風、冷凍或其他乾燥設備。 |
E.Hot-air drying, freeze-drying or other drying equipment |
| 6.磨粉機（製粉工廠必備）。 |
F.Powder grinding machine (essential for powder making factories) |
| 7.包裝設備。 |
G.Packaging equipment |
| （二）果實工廠： |
(2)Dehydrated fruit factories: |
| 1.去皮器具。 |
A.Peeling equipment |
| 2.除芯器具。 |
B.Decoring equipment |
| 3.批次糖漬設備或連續糖漬設備。 |
C.Batch candied equipment or continuous candied equipment |
| 4.洗滌機或容器。 |
D.Washing machine or container |
| 5.切角機。 |
E.Corning cutting machine |
| 6.磨粉機（製粉工廠必備）。 |
F.Powder grinding machine (essential for powder making factories) |
| 8.殺菁機。 |
G.Slicer H.Blanching machine |
| 9.熱風、冷凍或其他乾燥設備。 |
I.Hot-air drying, freeze-drying or other drying equipment |
| 10. 包裝設備。 |
J.Packaging equipment |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）餘氯測定器或試紙。 |
(1)Residual chlorine analyzer or litmus paper |
| （二）糖度計或糖度折射計。 |
(2)Glucose meter and glucose refract meter |
| （三）pH測定器或試紙。 |
(3)pH meter or litmus paper |
| （四）灰分測定裝置。 |
(4)Ash measuring device |
| （五）乾燥箱。 |
(5)Oven |
| 第 16 條 |
Article 16 |
| 餐盒食品工廠應具備下列基本設施及檢驗設備： |
The following basic facilities and inspection equipment are required for lunch box food factories: |
| 一、基本設施： |
1.Basic facilities: |
| （一）原料處理場。 |
(1)Raw material preparation site |
| （二）加工調理場。 |
(2)Processing/dressing site |
| （三）冷凍庫、冷藏庫。 |
(3)Freezer/ and refrigerator |
| （四）包裝場所：產品之配膳包裝應有獨立或專用之場所與設備。 |
(4)Packaging site: The meal distribution and packaging of the products should be done using an independent or specialized site and equipment. |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）微生物檢驗設備。 |
(1)Microbiological inspection equipment |
| （二）一般品質檢驗設備（測中心溫度之不銹鋼探針溫度計及餘氯測定器或試紙等）。 |
(2)General quality inspection equipment (stainless steel probe thermometer for detecting internal temperature, residual chlorine analyzer or litmus paper, etc.) |
| 餐盒食品工廠視需要得具備下列生產設備： |
The following production equipment are optional for lunch box food factories industries depending on the production needs: |
| 一、洗米煮飯設備或其他主食加工設備。 |
1.Rice washing, cooking and other staple food processing equipment |
| 二、切菜切肉機及專用刀具。 |
2.Specialized vegetable and meat cutting tools |
| 三、煎、煮、炒、油炸等烹飪設備。 |
3.Frying, cooking, stir frying, deep frying and other food processing equipment |
| 四、輸送帶或不銹鋼調理台。 |
4.Conveyor belt or stainless-steel dressing table |
| 五、食品器具容器洗滌消毒設備。 |
5.Food container washing and sterilizing equipment |
| 六、刀具砧板保管箱設備。 |
6. Knife and cutting board storage cabinet |
| 七、洗滌（熱水或蒸汽）設備。 |
7.Washingers (hot-water or steam) equipment |
| 八、加工調理場在發生蒸汽、熱氣、煙臭或油炸等油脂加熱處理之機器或設備上應裝設排氣罩裝置（含抽油煙設備）。 |
8. The machines or equipment that would generate steam, hot air, fumes or frying oil while treating with the heating oil in the processing/dressing site should be installed with exhaust hood devices (including smoke exhaust equipment). |
| 九、包裝作業場所應有空氣過濾及換氣設施。 |
9. The packaging site should be installed with filter or ventilation facilities. |
| 十、成品應有適當之運送設備及運送專用車輛。 |
10.The finished products should be delivered by appropriate transportation equipment or specialized vehicles. |
| 第 17 條 |
Article 17 |
| 速食麵工廠應具備下列生產設備： |
The following production equipment are required for instant noodle factories: |
| 一、麵條製造設備。 |
1.Noodle manufacturing making equipment |
| 二、連續式油炸設備或蒸麵乾燥機。 |
2.Continuous deep frying equipment or noodle steaming and drying machines |
| 速食麵工廠視需要得具備下列生產及檢驗設備： |
The following production and inspection equipment are optional for instant noodle factories depending on the production and inspection needs: |
| 一、生產設備 |
1.Production equipment: |
| （一）鍋爐。 |
(1)Boiler |
| （二）蒸煮機。 |
(2)Cooker |
| （三）冷卻設備。 |
(3)Cooling equipment |
| （四）包裝設備。 |
(4) Packaging equipment |
| （五）金屬或其他異物檢出設備。 |
(5)Metal or foreign matter detector |
| 二、檢驗設備： |
2.Inspection equipment: |
| （一）水份測定設備。 |
(1)Moisture detector |
| （二）秤量器。 |
(2)Weighing scale |
| （三）粗脂肪測定設備。 |
(3)Crude fat determination equipment |
| （四）油脂性質檢驗設備（含水份、酸價、過氧化價、碘價、總極性化合物等）。 |
(4)Oil nature inspection equipment (moisture content, acid value, peroxide value, iodine value and total polar compounds, etc.) |
| 第 18 條 |
Article 18 |
| 食品添加物工廠應具備下列基本設施及檢驗設備： |
The following basic facilities and inspection equipment are required for food additive factories: |
| 一、味精工廠 |
1.Monosodium glutamate (MSG) factories: |
| （一）基本設施： |
(1)Basic facilities: |
| 1.應具備從基本原料至結晶味精一貫作業之整套設備（包括原料處理場、發酵工廠、麩酸工廠、精製工廠及包裝室等）。 |
A.These factories should possess a full set of integrated operation from basic raw materials until crystallization of MSG (including raw material preparation site, fermentation plant, glutamine acid plant, refining plant, packaging room, etc.). |
| 2.自結晶罐排出之味精中間製品，應以密閉式之脫水機、輸送機、乾燥機、篩選機等連貫設備完成作業。 |
B.The intermediate product discharged from crystallization cans should be processed completely using confined coherent equipment including dewatering machine, conveyor, dryer, screening machine, etc. |
| 3.微生物培養室及設備。 |
C.Microbial culture room and equipment. |
| 4.包裝室，其設施應符合本標準第六條相關規定，包裝室外應有洗手設備。 |
D.The packaging room should conform to relevant regulations prescribed in Article 6 of these standards, and come with hand washing equipment. |
| （二）檢驗設備： |
(2)Inspection equipment: |
| 1.麩酸測定器或自動化學分析儀。 |
A.Glutamic acid analyzer or automatic chemical analyzer |
| 2.秤量器。 |
B.Weighing scale |
| 3.pH 測定器或試紙。 |
C.pH meter or litmus paper |
| 4.總氮測定裝置。 |
D.Total nitrogen detection equipment |
| 5.氨基態氮測定裝置。 |
E.Amino nitrogen measuring device |
| 6.微生物檢驗設備。 |
F.Microbiological testing equipment |
| 二、除味精工廠外之食品添加物工廠應具備下列檢驗設備： |
2.The following inspection equipment are requiredments for apply to all food additive factories with the exception of monosodium glutamate (MSG) factories: |
| （一）秤量器（感度在一毫克以下）。 |
(1)Weighing scale (sensitivity below 1mg) |
| （二）pH 測定器或試紙。 |
(2)pH meter or litmus paper |
| （三）水分測定器。 |
(3)Moisture detector |
| 食品添加物工廠視需要得具備下列生產設備及檢驗設備： |
The following production and inspection equipment are optional for food additive factories depending on the production and inspection needs: |
| 一、味精工廠之檢驗設備： |
1.Inspection equipment for MSG factories: |
| （一）餘氯測定器或試紙。 |
(1)Residual chlorine analyzer or litmus paper |
| （二）顯微鏡。 |
(2)Microscope |
| （三）水分或水活性測定設備。 |
(3)Moisture or water activity measuring equipmentmeter |
| （四）保溫箱。 |
(4) Incubator |
| （五）乾燥箱。 |
(5)Oven |
| （六）光電比色計。 |
(6)Photoelectric colorimeter |
| （七）粒度篩別機。 |
(7)Granularity screening machine |
| （八）菌體量測定器。 |
(8)Biomass measuring device |
| 二、除味精工廠外之食品添加物工廠： |
2.Food additive factories other than MSG factories: |
| （一）生產設備： |
(1)Production equipment: |
| 1.粉碎機。 |
A.Crusher |
| 2.篩粉機。 |
B.Screening machine |
| 3.混合或煉合機。 |
C.Mixer |
| 4.乾燥機或乾燥箱。 |
D.Dryer or oven |
| 5.噴霧、送風、乾燥設備。 |
E.Mist sprayer, air blower, and drying equipment |
| 6.集粉處理設備。 |
F.Powder collection and processing equipment |
| 7.攪拌及混合設備。 |
G.Stirring and blending equipment |
| 8.過濾設備。 |
H.Filtering equipment |
| 9.加熱反應設備。 |
I.Heating reactors |
| 10. 濃縮設備。 |
J.Concentration equipment |
| 11. 電解設備。 |
K.Electrolysis device |
| 12. 溶解設備。 |
L.Dissolving equipment |
| 13. 儲存設備。 |
M.Storage device |
| 14. 充填設備。 |
N.Filling equipment |
| 15. 金屬或其他異物檢出設備。 |
O.Metal or foreign matter detector |
| （二）檢驗設備： |
(2)Inspection equipment |
| 1.光電比色計。 |
A.Photoelectric colorimeter |
| 2.氣相層析儀。 |
B.Gas chromatography |
| 3.液相層析儀。 |
C.Liquid chromatography |
| 4.分光光度計。 |
D.Spectrophotometer |
| 5.微生物檢驗設備。 |
E.Microbiological testing equipment |
| 6.比重計。 |
F.Hydrometer |
| 7.原子吸收光譜儀。 |
G.Atomic absorption spectrophotometer |
| 8.濁度計。 |
H.Turbidimeter |
| 9.導電度計。 |
I.Electrical conductivity meter |
| 10. 比旋光度計。 |
J.Polarimeter |
| 11. 折射計。 |
K.Refractometer |
| 第 19 條 |
Article 19 |
| 本標準第八條至第十八條專業食品工廠未設應具備之基本設施、生產設備或檢驗設備者，應提出合理說明及相關文件。 |
Food factories that fail to meet the basic facility, production equipment or inspection equipment requirements provided in Article 8 to Article 18 in the Standards are required to submit a statement explaining the reason(s) and provide supporting documents. |
| 第 四 章 附則 |
Chapter IV. Supplementary Provisions |
| 第 20 條 |
Article 20 |
| 本標準自發布日施行。 |
These standards shall be implemented from the date of promulgation. |
| |
|
| 食品中污染物質及毒素衛生標準 |
Sanitation Standard for Contaminants and Toxins in Food |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法第十七條規定訂定之。 |
This Standard is prescribed in accordance with the provision of Article 17 of the Act Governing Food Safety and Sanitation. |
| 第 2 條 |
Article 2 |
| 本標準所稱之污染物質，係指食品於製造、加工、調配、包裝、運送、貯存、販賣中產生或污染者，或因環境之污染，非有意添加而存在於食品者，但不包括蟲體碎片、毛髮或其他外來異物。 |
The contaminants in this standard shall mean the substance not intentionally added to food, which present in food as a result of production or pollution during the manufacturing, processing, preparing, packaging, transportation, storage, or selling, or as a result of environmental contamination. It does not include insect fragments, hairs and other extraneous matters. |
| 本標準所稱之毒素，包括真菌毒素、海洋生物毒素及植物天然毒素。 |
The toxins in this standard include the mycotoxins, marine bio-toxins and natural toxins in plant origin. |
| 本標準之訂定範圍，不包括農藥、動物用藥及加工助劑之殘留，亦不包括食品中之原子塵或放射能污染物、多氯聯苯及戴奧辛之限量及食品中微生物之衛生標準所規範之微生物及其毒素。 |
The scope of this standard does not include the residues of pesticides, veterinary drugs and processing aids; the tolerance of atomic dust and radioactivity contamination, polychlorinated biphenyl and dioxins; and the microorganisms and microbial toxins that are within the sanitation standard for microbiological in foods. |
| 本條文有附件 第 3 條 |
Article 3 |
| 食品中之重金屬限量，應符合附表一之規定。 |
The maximum levels of metals in food shall meet the standard on Appendix 1. |
| 本條文有附件 第 4 條 |
Article 4 |
| 食品中之真菌毒素限量，應符合附表二之規定。 |
The maximum levels of mycotoxins in food shall meet the standard on Appendix 2. |
| 本條文有附件 第 5 條 |
Article 5 |
| 食品中所含其他污染物質及毒素之限量，應符合附表三之規定。 |
The maximum levels of other contaminants and toxins in food shall meet the standard on Appendix 3. |
| 第 6 條 |
Article 6 |
| 本標準自中華民國一百零八年一月一日施行。 |
This standard shall be implemented from 1 January, 2019. |
| 本標準中華民國一百零九年六月十七日修正發布之第三條附表一、第四條附表二、第五條附表三，自一百十年一月一日施行。 |
The articles of this standard amended on 17th June 2020 shall apply form 1 January 2021. |
| 本標準中華民國一百十年二月四日修正發布之第五條附表三，自一百十年七月一日施行。 |
The articles of this standard amended on 4 February 2021 shall apply form 1 July 2021. |
| 本標準中華民國一百十一年五月三十一日修正發布之第五條附表三，自一百十三年一月一日施行。 |
The articles of this standard amended on 31 May 2022 shall apply form 1 July 2024. |
| 本標準中華民國一百十三年三月二十八日修正發布之第三條附表一，自一百十三年七月一日施行。 |
The articles of this standard amended on 28 March 2024 shall apply form 1 July 2024. |
| |
|
| 食品中原子塵或放射能污染容許量標準 |
Standards for the Tolerance of Atomic Dust and Radioactivity Contamination in Foods |
| |
|
| 食品中微生物衛生標準 |
Sanitation Standard for Microorganisms in Foods |
| 第 1 條 |
Article 1 |
| 本標準依食品安全衛生管理法（以下簡稱本法）第十七條規定訂定之。 |
This standard is prescribed in accordance with the provisions of Article 17 of the Act Governing Food Safety and Sanitation (herein referred to as "this Act"). |
| 第 2 條 |
Article 2 |
| 本標準之訂定範圍，包括食品微生物及其毒素或代謝物，不包括真菌及其毒素。 |
The scopes of this standard include food microorganisms and their toxins or metabolites, but do not include fungi and mycotoxins. |
| 本條文有附件 第 3 條 |
Article 3 |
| 食品中之微生物及其毒素或代謝物限量，應符合附表之規定。 |
The limits for food microorganisms and their toxins or metabolites shall meet the requirements in the table in Annex. |
| 第 4 條 |
Article 4 |
| 食品有本法第十五條第一項第四款及本法施行細則第六條規定情事者，依違反本法第十五條第一項規定辦理。 |
Non-compliant under the jurisdiction of subparagraphs 4 of paragraph 1 of Article 15 of this Act and Article 6 of Rules for the Implementation of this Act, shall be sanctioned in accordance with violating Article 15 of this Act. |
| 第 5 條 |
Article 5 |
| 本標準自中華民國一百十年七月一日施行。 |
This standard shall be implemented from July 1, 2021. |
| |
|
| 食品及其相關產品回收銷毀處理辦法 |
Regulations of recall and destruction for food and related products |
| 第 1 條 |
Article 1 |
| 本辦法依食品安全衛生管理法（以下簡稱本法）第五十二條第三項規定訂定之。 |
This regulation is prescribed in accordance with the provisions of Paragraph 3 of Article 52 of the Act Governing Food Safety and Sanitation (hereinafter referred to as “the Act”). |
| 第 2 條 |
Article 2 |
| 食品及其相關產品（以下簡稱物品）之回收銷毀作業，由各該物品之製造、加工、調配、販賣、運送、貯存、輸入、輸出食品業者（以下簡稱責任廠商）為之。 |
The recall and destruction procedure for food and relevant products (hereinafter referred to as “products”) shall be carried out by the food industries (hereinafter referred to as “Responsible Manufacturers”) dealing with the manufacturing, processing, distribution, selling, storing, importing and exporting of the food or articles. |
| 第 3 條 |
Article 3 |
| 責任廠商執行物品之回收銷毀作業，應以書面或其他足以查證方式訂定物品回收銷毀程序之計畫書，其內容應包括下列資料： |
Responsible Manufacturers shall perform article recall and destruction in written form or other action plans for such recall and destruction procedures that can be verified, including: |
| 一、回收物品之品名、包裝、型態或可供辨識之特徵或符號。 |
1.product Name, package and form of recalled products or other identifiable features or signs; |
| 二、回收物品所標示之日期、批號或代號等識別資料與編號。 |
2.identification, lot number, code or other identifiable information or number specified on recalled products; |
| 三、回收物品完整之產銷紀錄，其內容包括物品之名稱、重量或容量、批號、受貨者之名稱及地址、出貨日期及數量。 |
3.complete production and sales record of recalled products, including name, weight or capacity, lot number, name and address of consignee, delivery date and quantity; |
| 四、回收物品之負責廠商名稱、地址及電話。 |
4.title, address and telephone number of the Responsible Manufacturer for recalled products; |
| 五、回收之原因及其可能產生之危害。 |
5.reasons for the recall and nature of the potential hazard; |
| 六、回收物品之總量。 |
6.total quantity of recalled products; |
| 七、回收物品在銷售通路中之產品總量。 |
7.total quantity of recalled products in distribution; |
| 八、回收物品之配銷資料紀錄。 |
8.distribution record of recalled products; |
| 九、採行之回收措施，包括回收層面、停止銷售該物品之指示及其他應執行之行動、回收執行完成之期限等。 |
9.recall measures to be adopted, including the level of recall, instructions to end sale of the products and other performed actions, expiry date of recall implementation, etc.; |
| 十、後續之消毒、改製或改正等安全措施。 |
10.subsequent safety measures, such as disinfection, reconditioning or corrections; |
| 十一、對消費者所需提出之警示及其內容。 |
11.alert issued to consumers and the contents thereof; |
| 十二、回收物品為應銷毀者，應於回收計畫中明訂銷毀程序；銷毀程序有污染環境之虞，應依環保相關法規進行銷毀。 |
12.recalled products that should be destroyed shall be expressed on the recall project; any environmental contamination in the destruction procedure shall be destroyed pursuant to the relevant regulations of environment protection; |
| 十三、其他經主管機關指定執行回收銷毀事項。 |
13.other matters regarding recall destructions assigned by competent authorities. |
| 第 4 條 |
Article 4 |
| 本辦法所定之回收銷毀處理作業，由直轄市、縣（市）主管機關監督執行。 |
Local competent authorities of municipal or county (city) governments shall supervise and execute the recall and destruction operations set forth in these Regulations. |
| 直轄市、縣（市）主管機關應查核責任廠商實施回收能力及監督執行回收措施，其作業包括下列事項： |
Local competent authorities of municipal or county (city) governments shall inspect the recall capability of the Responsible Manufacturer and supervise their performance of recall measures, operations of which include: |
| 一、稽查違規物品，依法處理，並通知責任廠商進行回收。 |
1.inspect the violating products that do not conform to the laws, and notify the Responsible Manufacturer to conduct a recall; |
| 二、審核責任廠商所提出回收計畫之回收等級及回收層面，並核定其回收計畫。 |
2.examine the class and level of the recall in recall projects presented by the Responsible Manufacturer for final approval; |
| 三、監督回收計畫內容不完善之責任廠商限期改善。 |
3.supervise incomplete recall projects presented by the Responsible Manufacturer which should be amended within a limited time; |
| 四、依據案件之急迫程度，指示廠商通報回收狀況之頻率，並追蹤責任廠商之回收進度。 |
4.give instruction on the frequency of reporting the recall condition of manufacture according to urgency of the cases and track recall progress of the Responsible Manufacturer; |
| 五、定期進行查核，確認廠商回收計畫執行之達成度。 |
5.regularly process inspections to confirm achievement of performance on manufacturers’ recall projects; |
| 六、監督責任廠商完成回收計畫。 |
6.supervise the Responsible Manufacturer to accomplish recall project; |
| 七、查核責任廠商之回收報告。 |
7.inspect recall report of the Responsible Manufacturer; |
| 八、對責任廠商進行後續輔導。 |
8.process subsequent guidance for the Responsible Manufacturer; |
| 九、回收物品為應銷毀者，監督責任廠商限期完成銷毀行動。 |
9.supervise the Responsible Manufacturer and set a time limit for complete destruction of the recalled products that should be destroyed; |
| 十、相關回收案例資料之建檔及必要之新聞發布。 |
10.data of relevant recall cases shall be filed and offered as a necessary press release; |
| 十一、其他經中央主管機關指定事項。 |
11.other items, as specified by the central competent authority. |
| 應回收之物品跨越不同縣市或對衛生安全有重大影響者，中央主管機關得指示直轄市、縣（市）主管機關為一定之處理，必要時得統一指揮。 |
In the event that any recalled products is cross-county (city) or has a significant influence on sanitation and safety, the central competent authority shall instruct local competent authorities of municipal or county (city) governments to act accordingly, or direct unified command if necessary. |
| 第 5 條 |
Article 5 |
| 物品因違反食品衛生或其他相關法令規定，責任廠商應自行實施物品回收，不為自行回收者，主管機關應限期命其回收。 |
In case any products violates the regulations pursuant to the Act Governing Food Sanitation or relevant laws, the Responsible Manufacturer shall settle products recall by oneself; if failure to self-recall, the competent authorities shall order the Responsible Manufacturer to recall within a limited time. |
| 第 6 條 |
Article 6 |
| 物品如有下列情形之一者，應予沒入銷毀： |
If any of the following conditions exist, products shall be confiscated for destruction: |
| 一、違反本法第五十二條第一項第三款規定，經通知限期改善，屆期未改善者。 |
1.those violating Paragraph 1-3 of Article 52 of the Act that fails to duly improve within the given time limit after notice; |
| 二、依本法第五十二條規定應予沒入銷毀者。 |
2.those that shall be confiscated for destruction according to the provisions of Article 52 of the Act. |
| 第 7 條 |
Article 7 |
| 責任廠商應建立適當之編組，負責回收與銷毀時機評估、計畫研擬、執行監控及完成後彙總報告。 |
Responsible Manufacturers shall build up a proper organization into groups to be responsible for recall and destruction timing assessment, project planning, monitoring and filing summary reports after completion. |
| 前項編組應置召集人一人，於物品回收原因發生時，召集相關部門為之。 |
One convener should be set for the aforementioned organization that convenes the relevant department when reasons to recall products occur. |
| 第 8 條 |
Article 8 |
| 責任廠商應依回收物品對民眾健康可能造成之危害程度，依下列三個等級，自行訂定回收級別，辦理回收，但主管機關得變更級別： |
Responsible Manufacturers shall divide recall by themselves into the following three classes subject to the degree of harm the recalled articles cause to public health; however, the competent authorities may alter the classes: |
| 一、第一級：指物品對民眾可能造成死亡或健康之重大危害，或主管機關命其應回收者。 |
1.class 1: The products may cause death or serious harm to public health, or the competent authorities order the recall; |
| 二、第二級：指物品對民眾可能造成健康之危害者。 |
2.class 2: The products may cause harm to public health; |
| 三、第三級：指物品對民眾雖然不致造成健康危害，但其品質不符合規定者。 |
3.class 3: The products may not cause harm to public health, but quality is not in conformity with the regulations. |
| 責任廠商執行物品回收作業之前，應檢具其回收計畫向直轄市、縣（市）主管機關報備。 |
The Responsible Manufacturer shall submit a recalled project to report to the competent authorities of municipal or county (city) governments. |
| 第 9 條 |
Article 9 |
| 物品回收深度分為三個層面： |
Products recall is divided into the following three levels depending on the extent sales channels concerned: |
| 一、消費者層面：回收深度達到個別消費者之層面。 |
1.consumers: to the extent of individual consumers; |
| 二、零售商層面：回收深度達到販售場所之層面。 |
2.retailers: to the extent of sales premises; |
| 三、批發商層面：回收深度達到進口商、批發商等非直接售予消費者之層面。 |
3.wholesalers: to the extent of importer and wholesaler premises etc. where the products is not directly sold to consumers. |
| 第 10 條 |
Article 10 |
| 各級回收情形，如有下列情形之一者，應發布新聞稿公告周知： |
Any one of the following conditions subject to recall classes shall provide a press release for wide publicity: |
| 一、遇第一級回收之情況。 |
1.class 1 occurs; |
| 二、遇第二級及第三級回收之情況，並經直轄市、縣（市）主管機關評估，該物品確有危害民眾健康之虞，且回收深度達消費者層面。 |
2.classes 2 or 3 occur and the products actually caused harm to public health reaching the level of consumers after being evaluated by the competent authorities of municipal or county (city) governments. |
| 第 11 條 |
Article 11 |
| 責任廠商應於物品回收之過程中，定期向直轄市、縣（市）主管機關提出回收進度報告，其內容應包括下列資料： |
Responsible Manufacturers shall regularly report the recall progress in the procedure of recalling products to the competent authorities of municipal or county (city) governments, including the following data: |
| 一、通知下游廠商家數或人數、日期及方式。 |
1.number of downstream manufacturers or individuals being notified, date and methods; |
| 二、回應廠商家數及其持有該物品之數量。 |
2.number of responded manufacturers and total quantity of holding products; |
| 三、未回應廠商家數或人數。 |
3.number of people of non-responding manufacturers or individuals; |
| 四、已回收物品數量。 |
4.recalled products quantity; |
| 五、回收物品保管地點，及負責保管之人員。 |
5.storage location and responsible person for recalled products; |
| 六、查核次數及結果。 |
6.numbers and results of inspection; |
| 七、預計完成之期限。 |
7.deadline of completion as scheduled; |
| 八、其他經主管機關指定應報告事項。 |
8.other matters to report as appointed by the competent authorities. |
| 第 12 條 |
Article 12 |
| 責任廠商於完成物品回收後，應將其處理過程及結果函報直轄市、縣（市）主管機關核備，必要時陳報中央主管機關。 |
After completion of the recall, Responsible Manufacturers shall report in writing the procedure and results to the competent authorities of municipal or county (city) governments, or the central competent authority if necessary. |
| 第 13 條 |
Article 13 |
| 責任廠商之銷毀行動須經直轄市、縣（市）主管機關核可後，始得為之。 |
Any destruction action of the Responsible Manufacturer shall be subject to approval of the competent authorities of municipal or county (city) governments. |
| 第 14 條 |
Article 14 |
| 責任廠商應詳載並保存有關物品回收與銷毀之完整書面資料，以供查核。 |
The Responsible Manufacturer shall record and keep written details of complete data for the relevant products recall and destruction for inspection. |
| 第 15 條 |
Article 15 |
| 本辦法自發布日施行。 |
These Regulations shall be implemented as of its being promulgated. |
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| 食品及其相關產品追溯追蹤系統管理辦法 |
Regulations Governing Traceability of Foods and Relevant Products |
| 第 1 條 |
Article 1 |
| 本辦法依食品安全衛生管理法（以下簡稱本法）第九條第五項規定訂定之。 |
This regulation is prescribed in accordance with the provision of Paragraph 5 of Article 9 of the Act Governing Food Safety and Sanitation (hereinafter referred to as “this Act”). |
| 第 2 條 |
Article 2 |
| 本辦法所稱食品及相關產品，指本法第三條第一項第一款至第六款之食品、特殊營養食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑。 |
“Foods and relevant products” referred to in this regulation shall mean foods, special dietary foods, food additives, food utensils, food containers or packaging, and food cleansers prescribed under Subparagraphs 1 to 6, Paragraphs 1, Article 3 of this Act. |
| 第 3 條 |
Article 3 |
| 本辦法所稱之追溯追蹤系統，指食品業者於食品及其相關產品供應過程之各個環節，經由標記得以追溯產品供應來源或追蹤產品流向，建立其資訊及管理之措施。 |
“Traceability” referred to in this regulation shall mean food businesses established the information and management to trace the source and track the flow of foods and relevant products at all stage of supply chain. |
| 第 4 條 |
Article 4 |
| 食品業者從事食品及其相關產品製造、加工、調配業務時建立之追溯追蹤系統，至少應包含下列各管理項目： |
Food businesses that engage in the manufacture, processing, preparation of the foods and relevant products shall establish traceability system including at least the following management items: |
| 一、原材料來源資訊： |
1. Raw material source information: |
| （一）原材料供應商之名稱、食品業者登錄字號、地址、聯絡人及聯絡電話。 |
(1) name, food business registration number, address, contact person and contact telephone number of raw material supplier; |
| （二）原材料名稱。 |
(2) raw material name; |
| （三）淨重、容量、數量或度量。 |
(3) net weight, volume, quantity or measurement; |
| （四）批號。 |
(4) lot/batch number; |
| （五）有效日期、製造日期或其他可辨識該原材料來源之日期或資訊。 |
(5) expiry date, manufacture date or other recognizable date or information about the source of the raw material; |
| （六）收貨日期。 |
(6) receiving date; and |
| （七）原料原產地（國）資訊。 |
(7) country of origin of raw material. |
| 二、產品資訊： |
2. Product information: |
| （一）產品製造廠商。 |
(1)product manufacturer; |
| （二）產品國內負責廠商之名稱、食品業者登錄字號、地址、聯絡人及聯絡電話。 |
(2)name, food business registration number, address, contact person and contact phone number of the product responsible domestic company; |
| （三）產品名稱。 |
(3) product name; |
| （四）主副原料。 |
(4) main and minor raw materials; |
| （五）食品添加物。 |
(5) food additives; |
| （六）包裝容器。 |
(6) packaging containers; |
| （七）儲運條件。 |
(7) storage conditions; |
| （八）淨重、容量、數量或度量。 |
(8) net weight, volume, quantity or measurement; and |
| （九）有效日期及製造日期。 |
(9) expiry date and manufacture date. |
| 三、標記識別：包含產品原材料、半成品及成品上任何可供辨識之獨特記號、批號、文字、圖像等。 |
3. Identification: including any unique mark, lot/batch number, text or picture that is identifiable on raw materials, semi- products or end products. |
| 四、產品流向資訊： |
4. Product flow information |
| （一）產品運送之物流業者其名稱、食品業者登錄字號、地址、聯絡人及聯絡電話。 |
(1)name, food business registration number, address, contact person and contact telephone number of the product transporting distributor; |
| （二）非屬自然人之直接產品買受者之名稱、地址、聯絡人及聯絡電話；其為食品業者，並應包含食品業者登錄字號。 |
(2) name, address, contact person and contact telephone number of the product recipient besides natural person; in the case of that is food business, the food business registration number shall be included; |
| （三）產品名稱。 |
(3) product name; |
| （四）淨重、容量、數量或度量。 |
(4) net weight, volume, quantity or measurement; |
| （五）批號。 |
(5) lot/batch number; |
| （六）有效日期或製造日期。 |
(6) expiry date or manufacture date; |
| （七）交貨日期。 |
(7) delivery date; and |
| （八）回收、銷貨退回與不良產品之名稱、總重量或總容量、原因及其處理措施；回收、銷貨退回產品之返貨者，其名稱及地址。 |
(8)name, total weight or total capacity, reason and follow-up measure of recall products, sales returned products and inferior products ; name and address of product-returning businesses. |
| 五、庫存原材料及產品之名稱、總重量或總容量。 |
5. Name, total weight or total capacity of inventory materials and products. |
| 六、報廢（含逾有效日期）原材料與產品之名稱、總重量或總容量、處理措施及發生原因。 |
6. Name, total weight or total capacity, follow-up measure and the cause of materials and products that discard (including passed their expiry date). |
| 七、其他具有效串聯產品來源及流向之必要性追溯追蹤管理資訊或紀錄。 |
7. Other necessary information or record for internal traceability system management with effective connection for tracing the source and tracking the flow. |
| 前項第一款第一目、第二款第二目及第四款第一目、第二目之食品業者登錄字號，指該業者屬中央主管機關公告應申請登錄始得營業者，應留存該業者之食品業者登錄字號之資訊。 |
The information of food business registration number mentioned in the Item 1 of Subparagraph 1, Item 2 of Subparagraph 2, and Item 1 and 2 of Subparagraph 4 of the preceding paragraph, shall mean that the food business registration number information for those food businesses designated by the central competent authority in a public announcement shall be retained. |
| 第一項第一款第七目之原料原產地（國）資訊，其原料屬中央主管機關公告應標示原料原產地者，須留存原料原產地（國）資訊。 |
The information of country of origin of raw material mentioned in the Item 7 of Subparagraph 1 of the Paragraph 1 shall mean that the country of origin information for those raw materials required to be labeled designated by the central competent authority in a public announcement shall be retained. |
| 第一項第二款第一目製造廠商與第二目國內負責廠商，若為相同者可擇一記錄。 |
If the manufacturer and the responsible domestic company in the Item 6 and 7 of Subparagraph 2 of the Paragraph 1 are the same, either of them may be chosen to be recorded. |
| 第一項第四款第八目及第五款自中華民國一百零八年一月一日施行。 |
Item 8 of Subparagraph 4 of Paragraph 1 and Subparagraph 5 shall be implemented on 1 January 2019. |
| 第 5 條 |
Article 5 |
| 食品業者從事食品及其相關產品輸入業務時建立之追溯追蹤系統，至少應包含下列各管理項目： |
Food businesses that engage in the import of the foods and relevant products shall establish traceability system including at least the following management items s: |
| 一、產品資訊： |
1. Product Information: |
| （一）產品中、英（外）文名稱。 |
(1) Chinese and English (foreign) product name; |
| （二）主副原料。 |
(2) main and minor raw materials; |
| （三）食品添加物。 |
(3) food additives; |
| （四）包裝容器。 |
(4) packaging containers; |
| （五）儲運條件。 |
(5) storage conditions; |
| （六）報驗義務人名稱之統一編號、食品業者登錄字號。 |
(6) employer identification number and food business registration number; |
| （七）國外出口廠商及製造（屠宰或產品國外負責）廠商之名稱或代號、地址、聯絡人及聯絡電話。 |
(7) name or factory code,address, contact person and contact phone number of the exporter and manufacturer (slaughter or responsible company of the export country) ; |
| （八）淨重、容量、數量或度量。 |
(8) net weight, volume, quantity or measurement; |
| （九）批號。 |
(9) lot/batch number; |
| （十）有效日期、製造日期或其他可辨識該產品來源之日期或資訊。 |
(10) expiry date, manufacture date or other recognizable date or information about the source of the product; |
| （十一）海關放行日期。 |
(11) date of customs release; |
| （十二）輸入食品查驗機關核發之食品及相關產品輸入查驗申請書號碼。 |
(12) application number for import food and relevant products inspection; and |
| （十三）原料原產地（國）資訊。 |
(13)country of origin of raw material. |
| 二、標記識別：包含產品上任何可供辨識之獨特記號、批號、文字、圖像等。 |
2. Identification: including any unique mark, lot/batch number, text or picture that is identifiable on products |
| 三、產品流向資訊： |
3. Product flow information: |
| （一）產品運送之物流業者其名稱、食品業者登錄字號、地址、聯絡人及聯絡電話。 |
(1) name, food business registration number, address, contact person and contact telephone number of the product transporting distributor; |
| （二）非屬自然人之直接產品買受者之名稱、地址、聯絡人及聯絡電話；其為食品業者，並應包含食品業者登錄字號。 |
(2) name, address, contact person and contact telephone number of the product recipient besides natural person; in the case of that is food business, the food business registration number shall be included; |
| （三）產品名稱。 |
(3) product name; |
| （四）淨重、容量、數量或度量。 |
(4) net weight, volume, quantity or measurement; |
| （五）批號。 |
(5) lot/batch number; |
| （六）有效日期、製造日期或其他可辨識該產品來源及流向之日期或資訊。 |
(6) expiry date or manufacture date or other recognizable date or information about the source of the raw materials; |
| （七）交貨日期。 |
(7) delivery date; and |
| （八）回收、銷貨退回與不良產品之名稱、總重量或總容量、原因及其處理措施；回收、銷貨退回產品之返貨者，其名稱及地址。 |
(8) name, total weight or total capacity, reason and follow-up measure of recall products, sales returned products and inferior products ; name and address of product-returning businesses. |
| 四、庫存產品之名稱、總重量或總容量。 |
4. Name, total weight or total capacity of inventory products. |
| 五、報廢（含逾有效日期）產品之名稱、總重量或總容量、處理措施及發生原因。 |
5. Name, total weight or total capacity, follow-up measure and the cause of materials and products that discard (including passed their expiry date). |
| 六、其他具有效串聯產品來源及流向之必要性追溯追蹤管理資訊或紀錄。 |
6. Other necessary information or record for internal traceability system management with effective connection for tracing the source and tracking the flow. |
| 前項第一款第六目及第三款第一目、第二目之食品業者登錄字號，指該業者屬中央主管機關公告應申請登錄始得營業者，應留存該業者之食品業者登錄字號之資訊。 |
The information of food business registration number mentioned in the Item 6 of Subparagraph 1, Item 1 and 2 of Subparagraph 3 of the preceding paragraph, shall mean that the food business registration number information for those food businesses designated by the central competent authority in a public announcement shall be retained. |
| 第一項第一款第十三目之原料原產地（國）資訊，其產品之原料屬中央主管機關公告應標示原料原產地者，須留存原料原產地（國）資訊。 |
The information of country of origin of raw material mentioned in the Item 13 of Subparagraph 1 of the Paragraph 1 shall mean that the country of origin information for those raw materials in food products required to be labeled designated by the central competent authority in a public announcement shall be retained. |
| 第一項第三款第八目及第四款自中華民國一百零八年一月一日施行。 |
Item 8 of Subparagraph 3 of Paragraph 1 and Subparagraph 4 shall be implemented on 1 January 2019. |
| 第 6 條 |
Article 6 |
| 食品業者從事食品及其相關產品販賣、輸出業務時建立之追溯追蹤系統，至少應包含下列各管理項目： |
Food businesses that engage in the sale and export of the foods and relevant products shall establish traceability system including at least the following management items: |
| 一、產品資訊： |
1. Product Information: |
| （一）產品供應商之名稱、食品業者登錄字號、地址、聯絡人及聯絡電話。 |
(1) name, food business registration number, address, contact person and contact telephone number of product supplier; |
| （二）產品名稱。 |
(2) product name; |
| （三）淨重、容量、數量或度量。 |
(3) net weight, volume, quantity or measurement; |
| （四）批號。 |
(4) lot/batch number; |
| （五）有效日期、製造日期或其他可辨識該產品來源之日期或資訊。 |
(5) expiry date or manufacture date or other recognizable date or information about the source of the raw material; |
| （六）收貨日期。 |
(6) receiving date; and |
| （七）原料原產地（國）資訊。 |
(7) country of origin of raw material. |
| 二、標記識別：產品上任何可供辨識之獨特記號、批號、文字、圖像等。 |
2. Identification: including any unique mark, lot/batch number, text or picture that is identifiable on products. |
| 三、產品流向資訊： |
3. Product flow information: |
| （一）產品運送之物流業者其名稱、食品業者登錄字號、地址、聯絡人及聯絡電話。 |
(1) name, food business registration number, address, contact person and contact telephone number of the product transporting distributor; |
| （二）非屬自然人之直接產品買受者之名稱、地址、聯絡人及聯絡電話；其為食品業者，並應包含食品業者登錄字號。 |
(2) name, address, contact person and contact telephone number of the product recipient besides natural person; in the case of that is food business, the food business registration number shall be included; |
| （三）產品名稱。 |
(3) product name; |
| （四）淨重、容量、數量或度量。 |
(4) net weight, volume, quantity or measurement; |
| （五）批號。 |
(5) lot/batch number; |
| （六）有效日期、製造日期或其他可辨識該產品來源及流向之日期或資訊。 |
(6) expiry date or manufacture date or other recognizable date or information about the source of the raw material; |
| （七）交貨日期。 |
(7) delivery date; and |
| （八）回收、銷貨退回與不良產品之名稱、總重量或總容量、原因及其處理措施；回收、銷貨退回產品之返貨者，其名稱及地址。 |
(8) name, total weight or total capacity, reason and follow-up measure of recall products, sales returned products and inferior products ; name and address of product-returning businesses. |
| 四、庫存產品之名稱、總重量或總容量。 |
4. Name, total weight or total capacity of inventory products. |
| 五、報廢（含逾有效日期）產品之名稱、總重量或總容量、處理措施及發生原因。 |
5. Name, total weight or total capacity, follow-up measure and the cause of materials and products that discard (including passed their expiry date). |
| 六、其他具有效串聯產品來源及流向之必要性追溯追蹤管理資訊或紀錄。 |
6. Other necessary information or record for internal traceability system management with effective connection for tracing the source and tracking the flow. |
| 前項第一款第一目及第三款第一目、第二目之食品業者登錄字號，指該業者屬中央主管機關公告應申請登錄始得營業者，應留存該業者之食品業者登錄字號之資訊。 |
The information of food business registration number mentioned in the Item 1 of Subparagraph 1, Item 1 and 2 of Subparagraph 3 of the preceding paragraph, shall mean that the food business registration number information for those food businesses designated by the central competent authority in a public announcement shall be retained. |
| 第一項第一款第七目之原料原產地（國）資訊，其產品之原料屬中央主管機關公告應標示原料原產地者，須留存原料原產地（國）資訊。 |
The information of country of origin of raw material information mentioned in the Item 7 of Subparagraph 1 of the Paragraph 1 shall mean that the country of origin information for those raw materials in food products required to be labeled designated by the central competent authority in a public announcement shall be retained. |
| 第一項第三款第八目及第四款規定，自中華民國一百零八年一月一日施行。 |
Item 8 of Subparagraph 3 of Paragraph 1 and Subparagraph 4 shall be implemented on 1 January 2019. |
| 第 7 條 |
Article 7 |
| 食品業者從事食品及其相關產品包裝業務時，應符合第四條規定。其原料進行組合後未改變原包裝型態者，則應符合前條規定。 |
Food businesses that engage in the packaging of the foods and relevant products shall comply with the provisions of Article 4. If the original packaging has not been changed after combining the various raw materials, the provisions of the previous articles shall be complied with. |
| 第 8 條 |
Article 8 |
| 食品業者對第四條至第六條管理項目，應詳實記錄。 |
Food businesses shall record detailed information of management items referred to Articles 4 to 6. |
| 食品業者應以書面或電子文件，完整保存食品追溯追蹤憑證、文件等紀錄至少五年。 |
Food businesses shall retain records such as complete proof and shall also keep documents regarding food traceability in written or electronic form for at least 5 years. |
| 第 9 條 |
Article 9 |
| 直轄市、縣（市）主管機關為確認追溯追蹤系統紀錄，得進入食品業者作業場所查核及要求其提供相關證明文件，食品業者不得規避、妨礙或拒絕。 |
The municipal or county/city competent authority may enter the place of food businesses to perform on-site examination and ensure that food businesses are in compliance with the provisions of food traceability relevant documents, and businesses shall not evade, impede or refuse. |
| 第 10 條 |
Article 10 |
| 本辦法除另定施行日期者外，自發布日施行。 |
Unless otherwise specified, these regulation shall take effect as of the date of promulgation. |
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| 食品及相關產品標示宣傳廣告涉及不實誇張易生誤解或醫療效能認定準則 |
Regulations Governing Determination of the Label, Promotion and Advertisement of Foods and Food Products Identified as False, Exaggerated, Misleading or Having Medical Efficacy |
| 第 1 條 |
Article 1 |
| 本準則依食品安全衛生管理法（以下簡稱本法）第二十八條第四項規定訂定之。 |
The Regulations are prescribed in accordance with the provisions of Paragraph 4, Article 28 of the Act Governing Food Safety and Sanitation (hereinafter referred to as “the Act”). |
| 第 2 條 |
Article 2 |
| 本準則所稱食品及相關產品，指食品、食品添加物、食品用洗潔劑及經中央主管機關公告之食品器具、食品容器或包裝。 |
The “foods” and “food products” referred in the Regulations are defined as foods, food additives, food cleansers and food utensils, food containers or packaging designated by the central competent authority in the public announcement. |
| 第 3 條 |
Article 3 |
| 本法第二十八條第一項或第二項所定標示、宣傳或廣告涉及不實、誇張、易生誤解，或醫療效能之認定，應就其傳達予消費者之品名、文字敘述、圖案、符號、影像、聲音或其他訊息，依整體表現，綜合判斷之。 |
The determining standards of the false, exaggerated or misleading labeling, promotion or advertisement referred to in Paragraph 1, Article 28 and medical efficacy referred to in Paragraph 2 in the Act shall be comprehensively judged by the overall presentation of the name, description, image, symbol, visual, audio or other messages conveyed to consumers of the product. |
| 本條文有附件 第 4 條 |
Article 4 |
| 本法第二十八條第一項食品及相關產品之標示、宣傳或廣告，表述內容有下列情形之一者，認定為涉及不實、誇張或易生誤解： |
The labeling, promotion or advertisement of foods and food products referred to in Paragraph 1, Article 28 of the Act is identified as false, exaggerated or misleading if involving any of the following condition: |
| 一、與事實不符。 |
(i) The description does not conform to facts. |
| 二、無證據，或證據不足以佐證。 |
(ii) The description has no evidence or insufficient evidence to support it. |
| 三、涉及維持或改變人體器官、組織、生理或外觀之功能。 |
(iii) The description involves maintaining or altering the physiology, appearance or function of human organs and tissue. |
| 四、引用機關公文書字號或類似意義詞句。但依法令規定應標示之核准公文書字號，不在此限。 |
(iv) The content description refers to any number of official letters or any word or sentence with similar meanings; however, the use of approved official letter number complied with the laws and regulations are not subject to the limit. |
| 食品以「健康」字樣為品名之一部分者，認定該品名為易生誤解。但取得許可之健康食品，不在此限。 |
If the word "health" as part of the food product name, it is identified as misleading. However, this regulation shall not apply to food product issued with a health food permit. |
| 食品之標示、宣傳或廣告內容，得使用附件一所列通常可使用之詞句，或附件二所列營養素或特定成分之生理功能詞句；上開詞句，均不認定為涉及不實、誇張或易生誤解。 |
The phrases in Appendix 1 and the physiological functional description of the nutrients and specified components as in the Appendix 2 can be used for the labeling, promotion or advertisement of food products. The above descriptions are considered not false, exaggerated, or misleading. |
| 第 5 條 |
Article 5 |
| 本法第二十八條第二項食品之標示、宣傳或廣告，表述內容有下列情形之一者，認定為涉及醫療效能： |
The labeling , promotion or advertisement of the foods referred to in Paragraph 2, Article 28 in the Act shall be identified as having medical efficacy if involving any of the following statement: |
| 一、涉及預防、改善、減輕、診斷或治療疾病、疾病症候群或症狀。 |
(i) The description is related to prevention, improvement, mitigation, diagnosis or treatment of any diseases, syndromes or symptoms. |
| 二、涉及減輕或降低導致疾病有關之體內成分。 |
(ii) The description is related to alleviation or reduction of any substances in human body caused by diseases. |
| 三、涉及中藥材效能。 |
(iii) The description is related to the efficacy of raw materials in traditional Chinese medicine. |
| 第 6 條 |
Article 6 |
| 本準則自發布日施行。 |
The Regulations shall be implemented upon promulgation. |
| 本準則中華民國一百零九年八月四日修正發布之第四條，自一百十一年七月一日施行。 |
Articles 4 of these Regulations, amended and promulgated on 4 Auguest 2020, shall take force from 1 July 2022. |
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潮流時尚 (1)
