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食品安全衛生管理 Act Governing Food Safety and Sanitation
第 一 章 總則 Chapter I General Principles
第 1 條 Article 1
為管理食品衛生安全及品質,維護國民健康,特制定本法。 This Act is enacted to govern the food sanitation, safety and quality, and protect the health of citizens.
第 2 條 Article 2
本法所稱主管機關:在中央為衛生福利主管機關;在直轄市為直轄市政府;在縣(市)為縣(市)政府。 For purposes of this Act, the term "competent authority" shall mean the competent health and welfare authority at the central government level, the municipal governments at the municipal level, and the county/city governments at the county/city level.
第 2-1 條 Article 2-1
為加強全國食品安全事務之協調、監督、推動及查緝,行政院應設食品安全會報,由行政院院長擔任召集人,召集相關部會首長、專家學者及民間團體代表共同組成,職司跨部會協調食品安全風險評估及管理措施,建立食品安全衛生之預警及稽核制度,至少每三個月開會一次,必要時得召開臨時會議。召集人應指定一名政務委員或部會首長擔任食品安全會報執行長,並由中央主管機關負責幕僚事務。 To enhance the coordination, monitoring, promotion, and inspection of national food safety affairs, the Executive Yuan shall establish the Food Safety Board. The Premier of the Executive Yuan shall serve as the convener with the participation of the heads of other relevant ministries and commissions, experts, scholars, and representatives of non-governmental organizations to take charge of inter-agency coordination for the food safety risk assessment and management measures as well as establish the alert and auditing system of food safety and sanitation. The Food Safety Board shall meet once at least every three months. When necessary, a temporary meeting may be convened. The convener shall appoint a Minister without Portfolio or a head of ministries and commissions to act as the Chief Executive of the Food Safety Board and the central competent authority shall be in charge of staff affairs.
各直轄市、縣(市)政府應設食品安全會報,由各該直轄市、縣(市)政府首長擔任召集人,職司跨局處協調食品安全衛生管理措施,至少每三個月舉行會議一次。 Each municipal/county/city government shall establish the Food Safety Board; the head of the municipality/county/city shall serve as the convener to take charge of inter-departmental coordination for the food safety management measures. A meeting shall be convened once at least every three months.
第一項食品安全會報決議之事項,各相關部會應落實執行,行政院應每季追蹤管考對外公告,並納入每年向立法院提出之施政方針及施政報告。 Decisions made by the Food Safety Board in Paragraph 1 shall be carried out and implemented in compliance by relevant ministries and commissions. Each quarter the Executive Yuan shall announce the supervision results included in its administrative policies report to the Legislative Yuan every year.
第一項之食品安全會報之組成、任務、議事程序及其他應遵行事項,由行政院定之。 The regulations governing the formation, tasks, parliamentary procedures and other matters to be complied with for such Food Safety Board in Paragraph 1 shall be prescribed by the Executive Yuan.
第 3 條 Article 3
本法用詞,定義如下: For purposes of this Act, the following terms shall have the meaning set forth below:
一、食品:指供人飲食或咀嚼之產品及其原料。 1. The term “foods” shall mean goods provided to people for eating, drinking, or chewing, and the raw materials of such goods.
二、特殊營養食品:指嬰兒與較大嬰兒配方食品、特定疾病配方食品及其他經中央主管機關許可得供特殊營養需求者使用之配方食品。 2. The term “special dietary foods” shall mean infant and follow-up formula, formula for certain disease or other formula approved by the central competent authority to be consumed by people with special nutrient requirement.
三、食品添加物:指為食品著色、調味、防腐、漂白、乳化、增加香味、安定品質、促進發酵、增加稠度、強化營養、防止氧化或其他必要目的,加入、接觸於食品之單方或複方物質。複方食品添加物使用之添加物僅限由中央主管機關准用之食品添加物組成,前述准用之單方食品添加物皆應有中央主管機關之准用許可字號。 3. The term "food additives" shall mean a single substance or combination of substances that are added to or brought into contact with foods for the purpose of coloring, seasoning, preserving, bleaching, emulsifying, flavoring, stabilizing quality, enhancing fermentation, increasing viscosity, enriching nutritional value, preventing oxidation or other necessary purpose. Contents of the food additive combinations shall be limited to food additives approved by the central competent authority. The single food additive shall be granted an approval number by the central competent authority.
四、食品器具:指與食品或食品添加物直接接觸之器械、工具或器皿。 4. The term "food utensils" shall mean instruments, tools, or containers that come into direct contact with foods or food additives.
五、食品容器或包裝:指與食品或食品添加物直接接觸之容器或包裹物。 5. The terms "food containers or packaging" shall mean containers and packaging materials that come into direct contact with foods and food additives.
六、食品用洗潔劑:指用於消毒或洗滌食品、食品器具、食品容器或包裝之物質。 6. The term "food cleansers" shall mean substances used to disinfect or clean foods, food utensils, food containers and food packaging.
七、食品業者:指從事食品或食品添加物之製造、加工、調配、包裝、運送、貯存、販賣、輸入、輸出或從事食品器具、食品容器或包裝、食品用洗潔劑之製造、加工、輸入、輸出或販賣之業者。 7. The term "food businesses" shall mean those businesses that engage in the manufacture, processing, preparation, packaging, transportation, storage, sale, import or export of foods, or engage in the manufacture, processing, import, export or sale of food utensils, food containers or packaging, or food cleansers.
八、標示:指於食品、食品添加物、食品用洗潔劑、食品器具、食品容器或包裝上,記載品名或為說明之文字、圖畫、記號或附加之說明書。 8. The term "labels" shall mean wording, pictures, symbols or additional instruction sheet affixed to foods, food additives, food cleansers, food utensils, food containers or food packaging to indicate the product name or to give explanation.
九、營養標示:指於食品容器或包裝上,記載食品之營養成分、含量及營養宣稱。 9. The term “nutrition label” shall mean the nutrients, contents or nutrient claims of the food affixed to food containers or packaging.
十、查驗:指查核及檢驗。 10. The term “inspection” shall mean examination and testing.
十一、基因改造:指使用基因工程或分子生物技術,將遺傳物質轉移或轉殖入活細胞或生物體,產生基因重組現象,使表現具外源基因特性或使自身特定基因無法表現之相關技術。但不包括傳統育種、同科物種之細胞及原生質體融合、雜交、誘變、體外受精、體細胞變異及染色體倍增等技術。 11. The term “genetic modification” shall mean the transferring of genetic materials or implant of live cells or organisms via genetic engineering, molecular biotechnology, or other related technologies to produce genetic recombination, exogenous genetic characteristics, or to suppress certain genes of the recipient. However, this does not include traditional breeding methods or techniques such as the merging, hybridization, mutation, in-vitro fertilization, somaclonal variation, and chromosome doubling of plants of the same species and protoplasts.
十二、加工助劑:指在食品或食品原料之製造加工過程中,為達特定加工目的而使用,非作為食品原料或食品容器具之物質。該物質於最終產品中不產生功能,食品以其成品形式包裝之前應從食品中除去,其可能存在非有意,且無法避免之殘留。 12. The term “processing aid” shall mean any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. Any residues of processing aids shall be removed before the food reaches its finished form and remaining in the food after processing should not perform a function in the final product.
第 二 章 食品安全風險管理 Chapter II Risk Management for Food Safety
第 4 條 Article 4
主管機關採行之食品安全衛生管理措施應以風險評估為基礎,符合滿足國民享有之健康、安全食品以及知的權利、科學證據原則、事先預防原則、資訊透明原則,建構風險評估以及諮議體系。 The actions taken by the competent authority in the governing of food safety and sanitation shall base on risk assessment and shall align with satisfying the citizens’right to have healthy and safe food and the right to know, as well as the principles of scientific evidence, precaution, and information transparency. The competent authority shall establish a risk assessment and advisory system.
前項風險評估,中央主管機關應召集食品安全、毒理與風險評估等專家學者及民間團體組成食品風險評估諮議會為之。其成員單一性別不得少於三分之一。 For the risk assessment mentioned in the preceding paragraph, the central competent authority shall assemble experts and scholars specialized in food safety, toxicology, risk assessment, and etc., as well as non-governmental organizations, to form a food risk assessment advisory committee. Each gender shall not be less than one-third of the total number of the committee members.
第一項諮議體系應就食品衛生安全與營養、基因改造食品、食品廣告標示、食品檢驗方法等成立諮議會,召集食品安全、營養學、醫學、毒理、風險管理、農業、法律、人文社會領域相關具有專精學者組成之。其成員單一性別不得少於三分之一。 The advisory system in Paragraph 1 shall refer to a council advisory committee comprising of experts and scholars specializing in food safety, nutrition, medicine, toxicology, risk management, agriculture, law, and humanities and social science to facilitate regulation of food sanitation and safety, nutrition, genetically modified foods, food advertising and labeling, and food testing methods. Each gender shall not be less than one-third of the total number of the committee members.
諮議會委員議事之迴避,準用行政程序法第三十二條之規定;諮議會之組成、議事、程序與範圍及其他應遵行事項之辦法,由中央主管機關定之。 The members of the committee shall abide by the recusal regulation of Article 32 of the Administrative Procedure Act. The regulations governing the formation, proceedings, procedures, scope and other matters to be complied with for such council advisory committee shall be prescribed by the central competent authority.
中央主管機關對重大或突發性食品衛生安全事件,必要時得依預警原則、風險評估或流行病學調查結果,公告對特定產品或特定地區之產品採取下列管理措施: Whenever necessary, the central competent authority may take the following actions on specified products and products from specified areas on the basis of the precautionary principle, the risk assessment or the epidemiological survey result when a significant or an unexpected food safety incident occurs:
一、限制或停止輸入查驗、製造及加工之方式或條件。 1.to suspend import, manufacturing and processing of the specified products or products from specified areas, or to conduct control measures and requirements to restrict the import, manufacturing and processing of the specified products or products from specified areas.
二、下架、封存、限期回收、限期改製、沒入銷毀。 2.to withdraw from the market, seal the products, recall within a prescribed time period, recondition within a prescribed time period, confiscate and destroy.
第 5 條 Article 5
各級主管機關依科學實證,建立食品衛生安全監測體系,於監測發現有危害食品衛生安全之虞之事件發生時,應主動查驗,並發布預警或採行必要管制措施。 The competent authority at all levels shall establish a food sanitation and safety monitoring system based on scientific evidence. Upon discovery of incidents that may be harmful to food sanitation and safety during monitoring, an active inspection shall be conducted and an alert shall be issued or other necessary measures shall be implemented.
前項主動查驗、發布預警或採行必要管制措施,包含主管機關應抽樣檢驗、追查原料來源、產品流向、公布檢驗結果及揭露資訊,並令食品業者自主檢驗。 The issuance of the active inspection and alert or implementation of necessary measures referred to in the preceding paragraph which will be done by the competent authority shall include conducting sampling and testing, investigating the source of raw material and the flow of the product, publishing testing results, disclosing other relevant information and ordering food businesses to perform testing on their own.
第 6 條 Article 6
各級主管機關應設立通報系統,劃分食品引起或感染症中毒,由衛生福利部食品藥物管理署或衛生福利部疾病管制署主管之,蒐集並受理疑似食品中毒事件之通報。 The competent authority at all levels shall establish a reporting system, distinguishing poisoning caused by either food or infections, to be under the jurisdiction of either the Food and Drug Administration, Ministry of Health and Welfare or Centers for Disease Control, Ministry of Health and Welfare, and to collect and handle the reporting of suspicious food poisoning incidents.
醫療機構診治病人時發現有疑似食品中毒之情形,應於二十四小時內向當地主管機關報告。 Upon diagnosing a patient suspected of food poisoning, a medical institution shall report to the local competent authority within 24 hours.
第 三 章 食品業者衛生管理 Chapter III Sanitary Control of Food Businesses
第 7 條 Article 7
食品業者應實施自主管理,訂定食品安全監測計畫,確保食品衛生安全。 Food businesses shall implement self-management and enact food safety monitoring plan to ensure food sanitation and safety.
食品業者應將其產品原材料、半成品或成品,自行或送交其他檢驗機關(構)、法人或團體檢驗。 Food businesses shall test their raw materials, semi-products or end products on their own, or deliver them to other testing agency (institution), corporation, or organization for testing.
上市、上櫃及其他經中央主管機關公告類別及規模之食品業者,應設置實驗室,從事前項自主檢驗。 Food businesses that are Exchange-Listed, OTC-Listed or belonging to a category and scale designated by the central competent authority in a public announcement shall be equipped with laboratories to perform said self-testing.
第一項應訂定食品安全監測計畫之食品業者類別與規模,與第二項應辦理檢驗之食品業者類別與規模、最低檢驗週期,及其他相關事項,由中央主管機關公告。 The central competent authority shall prescribe in a public announcement on the category and scale of the food businesses that shall enact the food safety monitoring plan in Paragraph 1 and conduct testing in Paragraph 2, the minimum testing cycle, and other relevant matters in paragraph 2.
食品業者於發現產品有危害衛生安全之虞時,應即主動停止製造、加工、販賣及辦理回收,並通報直轄市、縣(市)主管機關。 Upon discovery that food products may be harmful to sanitation and safety, the food businesses shall immediately cease manufacturing, processing, sale and recall such products voluntarily and report to the municipal or county/city competent authority.
第 8 條 Article 8
食品業者之從業人員、作業場所、設施衛生管理及其品保制度,均應符合食品之良好衛生規範準則。 The personnel, operation sites, sanitation management of facilities and quality assurance system of food businesses shall meet the regulations on good hygiene practice for foods.
經中央主管機關公告類別及規模之食品業,應符合食品安全管制系統準則之規定。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall meet the regulations on food safety control system.
經中央主管機關公告類別及規模之食品業者,應向中央或直轄市、縣(市)主管機關申請登錄,始得營業。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement may commence its business operation only after applying for registration with the central competent authority, the municipal or county/city competent authority.
第一項食品之良好衛生規範準則、第二項食品安全管制系統準則,及前項食品業者申請登錄之條件、程序、應登錄之事項與申請變更、登錄之廢止、撤銷及其他應遵行事項之辦法,由中央主管機關定之。 The regulations on good hygiene practice for foods referred to in Paragraph 1, the regulations on food safety control system referred to in Paragraph 2 and the regulations governing the condition, procedure, and the matters to be registered for the application for registration and application for amendment, revocation or termination of registration and other matters to be complied with mentioned in the preceding paragraph shall be prescribed by the central competent authority.
經中央主管機關公告類別及規模之食品業者,應取得衛生安全管理系統之驗證。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall obtain the certification of sanitation and safety management systems.
前項驗證,應由中央主管機關認證之驗證機構辦理;有關申請、撤銷與廢止認證之條件或事由,執行驗證之收費、程序、方式及其他相關事項之管理辦法,由中央主管機關定之。 The certification in the preceding paragraph shall be performed by the institution accredited by the central competent authority. The regulations governing the condition or reason of the application, termination and revocation for accredition; the charge, procedure, method for performing such certification; and other relevant matters shall be prescribed by the central competent authority.
第 9 條 Article 9
食品業者應保存產品原材料、半成品及成品之來源相關文件。 Food businesses shall retain the related source documents of the raw materials, semi-products and end products.
經中央主管機關公告類別與規模之食品業者,應依其產業模式,建立產品原材料、半成品與成品供應來源及流向之追溯或追蹤系統。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall establish their own traceability system for tracing the source and tracking the flow of the raw materials, semi-products and end products according to their respective industry modes.
中央主管機關為管理食品安全衛生及品質,確保食品追溯或追蹤系統資料之正確性,應就前項之業者,依溯源之必要性,分階段公告使用電子發票。 To govern the food safety, sanitation and quality, and ensure the information accuracy of food traceability system, the central competent authority shall require the businesses in the preceding paragraph to use electronic uniform invoices in a phased public announcement, according to the necessity of tracing the source.
中央主管機關應建立第二項之追溯或追蹤系統,食品業者應以電子方式申報追溯或追蹤系統之資料,其電子申報方式及規格由中央主管機關定之。 The central competent authority shall establish the traceability system in Paragraph 2. Food businesses shall use electronic methods to declare the information of the traceability system. The electronic declaration method and specification shall be prescribed by the central competent authority.
第一項保存文件種類與期間及第二項追溯或追蹤系統之建立、應記錄之事項、查核及其他應遵行事項之辦法,由中央主管機關定之。 The types of documents to be retained and the period of retention mentioned in Paragraph 1 and the regulations governing the establishment, matters to be recorded, examination and other matters to be complied with for the traceability system mentioned in Paragraph 2 shall be prescribed by the central competent authority.
第 10 條 Article 10
食品業者之設廠登記,應由工業主管機關會同主管機關辦理。 Factory registration of food businesses shall be handled by the competent industrial authority in conjunction with the competent authority.
食品工廠之建築及設備,應符合設廠標準;其標準,由中央主管機關會同中央工業主管機關定之。 The construction and equipment of a food factory shall conform to the establishment standard, which shall be prescribed by the central competent authority in conjunction with the central competent industrial authority.
食品或食品添加物之工廠應單獨設立,不得於同一廠址及廠房同時從事非食品之製造、加工及調配。但經中央主管機關查核符合藥物優良製造準則之藥品製造業兼製食品者,不在此限。 The food or food additive factory shall be independently established and shall not engage in non-food manufacturing, processing, or preparation at the same address and the same factory. However, this regulation shall not apply to those factories manufacturing both drug and food products, were examined and confirmed to conform to the Pharmaceutical Good Manufacturing Practice Regulations by the central competent authority.
本法中華民國一百零三年十一月十八日修正條文施行前,前項之工廠未單獨設立者,由中央主管機關於修正條文施行後六個月內公告,並應於公告後一年內完成辦理。 For the factories mentioned in the preceding paragraph that were not independently established prior to the amendment of this Act on 18th November 2014, the central competent authority shall announce within six months after promulgation of this Act, and those factories shall complete independent establishment within one year after the announcement.
第 11 條 Article 11
經中央主管機關公告類別及規模之食品業者,應置衛生管理人員。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall have sanitation control personnel.
前項衛生管理人員之資格、訓練、職責及其他應遵行事項之辦法,由中央主管機關定之。 The regulations governing the qualification, training, duty and other matters to be complied with for the sanitation control personnel of the preceding paragraph shall be prescribed by the central competent authority.
第 12 條 Article 12
經中央主管機關公告類別及規模之食品業者,應置一定比率,並領有專門職業或技術證照之食品、營養、餐飲等專業人員,辦理食品衛生安全管理事項。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall have a certain percentage of professionals with vocational or technical certification in food, nutrition, catering etc. responsible for food sanitation and safety control.
前項應聘用專門職業或技術證照人員之設置、職責、業務之執行及管理辦法,由中央主管機關定之。 The regulations governing the placement, duty, execution of business, and management of professionals with vocational or technical certification mentioned in the preceding paragraph shall be prescribed by the central competent authority.
第 13 條 Article 13
經中央主管機關公告類別及規模之食品業者,應投保產品責任保險。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall take out product liability insurance.
前項產品責任保險之保險金額及契約內容,由中央主管機關定之。 The insured amount and contents of the insurance contract of the preceding paragraph shall be prescribed by the central competent authority.
第 14 條 Article 14
公共飲食場所衛生之管理辦法,由直轄市、縣(市)主管機關依中央主管機關訂定之各類衛生標準或法令定之。 The regulations governing the sanitation of public food and beverage sites shall be prescribed by the municipal or county/city competent authority based on the various sanitation standards or laws promulgated by the central competent authority.
第 四 章 食品衛生管理 Chapter IV Food Sanitation Control
第 15 條 Article 15
食品或食品添加物有下列情形之一者,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: Foods or food additives with any one of the following circumstances shall not be manufactured, processed, prepared, packaged, transported, stored, sold, imported, exported, presented as a gift or publicly displayed:
一、變質或腐敗。 1. those that have deteriorated or rotten;
二、未成熟而有害人體健康。 2. those that are unripe and thus harmful to human health;
三、有毒或含有害人體健康之物質或異物。 3. those that are toxic or contain substances or foreign materials that are harmful to human health;
四、染有病原性生物,或經流行病學調查認定屬造成食品中毒之病因。 4. those that are contaminated by pathogenic organisms, or have been established by epidemiological survey to be cause of food poisoning;
五、殘留農藥或動物用藥含量超過安全容許量。 5. those with pesticide or veterinary drugs residue exceeding the permissible tolerance;
六、受原子塵或放射能污染,其含量超過安全容許量。 6. those that have been contaminated by and contain nuclear fallout or radioactivity exceeding the permissible tolerance;
七、攙偽或假冒。 7. those that have been adulterated or counterfeited;
八、逾有效日期。 8. those that have passed their expiry date;
九、從未於國內供作飲食且未經證明為無害人體健康。 9. those that have never been provided for human consumption and proven to be harmless to human health;or
十、添加未經中央主管機關許可之添加物。 10. those that contain food additives that are not approved by the central competent authority.
前項第五款、第六款殘留農藥或動物用藥安全容許量及食品中原子塵或放射能污染安全容許量之標準,由中央主管機關會商相關機關定之。 The standards governing the permissible tolerance of pesticide or veterinary drugs residue, and the nuclear fallout or radioactivity mentioned in Subparagraphs 5 and 6 of the preceding paragraph shall be prescribed by the central competent authority through consultation with the relevant authorities.
第一項第三款有害人體健康之物質,包括雖非疫區而近十年內有發生牛海綿狀腦病或新型庫賈氏症病例之國家或地區牛隻之頭骨、腦、眼睛、脊髓、絞肉、內臟及其他相關產製品。 Substance that is harmful to human health mentioned in Subparagraph 3 of Paragraph 1 includes skulls, brains, eyes, spinal marrow, ground beef, viscera and other related products from non-epidemic areas and countries still having Bovine Spongiform Encephalopathy or New Variant of Creutzfeldt-Jakob Disease cases in past ten years.
國內外之肉品及其他相關產製品,除依中央主管機關根據國人膳食習慣為風險評估所訂定安全容許標準者外,不得檢出乙型受體素。 Beta-agonists shall not to be detected via tests in domestic and foreign meat products and other meat-related products, with the exception that the central competent authority may set a permissible tolerance of Beta-agonists after assessing risks in accordance to the citizens’ diet habits.
國內外如發生因食用安全容許殘留乙型受體素肉品導致中毒案例時,應立即停止含乙型受體素之肉品進口;國內經確認有因食用致中毒之個案,政府應負照護責任,並協助向廠商請求損害賠償。 In the event of food poisoning caused by consumption of meat products containing Beta-agonists of a permissible tolerance, the importation of meat products containing Beta-agonists shall be suspended immediately. If said domestic food poisoning case is confirmed, the government shall take responsibility to health care for such victims and assist them in seeking compensation from the attributable entities.
第 15-1 條 Article 15-1
中央主管機關對於可供食品使用之原料,得限制其製造、加工、調配之方式或條件、食用部位、使用量、可製成之產品型態或其他事項。 The central competent authority may restrict the methods or conditions of manufacture, processing and preparation, edible parts, usage quantity, product form or other matters of the raw materials provided for food use.
前項應限制之原料品項及其限制事項,由中央主管機關公告之。 The central competent authority shall prescribe in a public announcement on the items and restrictions for the raw materials that shall be restricted in the preceding paragraph.
第 16 條 Article 16
食品器具、食品容器或包裝、食品用洗潔劑有下列情形之一,不得製造、販賣、輸入、輸出或使用: Food utensils, food containers or packaging, food cleansers under any of the following circumstances shall not be manufactured, sold, imported, exported or used:
一、有毒者。 1. those that are toxic;
二、易生不良化學作用者。 2. those that tend to cause unfavorable chemical reactions;
三、足以危害健康者。 3. those that are otherwise harmful to health; or
四、其他經風險評估有危害健康之虞者。 4. those that may be harmful to health through the risk assessment results.
第 17 條 Article 17
販賣之食品、食品用洗潔劑及其器具、容器或包裝,應符合衛生安全及品質之標準;其標準由中央主管機關定之。 Foods, food cleansers, food utensils, food containers or packaging being sold shall conform to sanitation, safety and quality standards which are prescribed by the central competent authority.
第 18 條 Article 18
食品添加物之品名、規格及其使用範圍、限量標準,由中央主管機關定之。 The product names, specification, use and limitation of food additives shall conform to the standards prescribed by the central competent authority.
前項標準之訂定,必須以可以達到預期效果之最小量為限制,且依據國人膳食習慣為風險評估,同時必須遵守規格標準之規定。 The standards mentioned in the preceding paragraph shall be restricted to the minimum required for anticipated effect and shall be based on risk assessment of the citizen’s diet habits while conforming to the provisions of specification standards.
第 18-1 條 Article 18-1
食品業者使用加工助劑於食品或食品原料之製造,應符合安全衛生及品質之標準;其標準由中央主管機關定之。 The processing aids which are used in the processing of food or its raw materials by food businesses shall conform to safety, sanitation and quality standards which are prescribed by the central competent authority.
加工助劑之使用,不得有危害人體健康之虞之情形。 The use of processing aids shall not include any circumstances that may be harmful to human health.
第 19 條 Article 19
第十五條第二項及前二條規定之標準未訂定前,中央主管機關為突發事件緊急應變之需,於無法取得充分之實驗資料時,得訂定其暫行標準。 Before the standards stipulated by Paragraph 2 of Article 15 and the preceding two Articles have been promulgated, the central competent authority may prescribe a provisional standard for responding to unexpected emergency and where sufficient experimental data cannot be obtained.
第 20 條 Article 20
屠宰場內畜禽屠宰及分切之衛生查核,由農業主管機關依相關法規之規定辦理。 Hygienic examination of the slaughtering and cutting of livestock and poultry at the slaughterhouses shall be conducted by the competent agricultural authority in accordance with relevant laws and regulations.
運送過程之屠體、內臟及其分切物於交付食品業者後之衛生查核,由衛生主管機關為之。 Hygienic examination of the carcasses, viscera and meat cuts in transport shall be made by the competent health authority after delivery to the food businesses.
食品業者所持有之屠體、內臟及其分切物之製造、加工、調配、包裝、運送、貯存、販賣、輸入或輸出之衛生管理,由各級主管機關依本法之規定辦理。 The sanitation of the manufacture, processing, preparation, packaging, transportation, storage, sale, import or export of carcasses, viscera and meat cuts which are in the possession of food businesses shall be subject to the governance of the competent authority at all levels in accordance with this Act.
第二項衛生查核之規範,由中央主管機關會同中央農業主管機關定之。 The direction of the hygienic examination of Paragraph 2 shall be prescribed by the central competent authority in conjunction with the central competent agricultural authority.
第 21 條 Article 21
經中央主管機關公告之食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑,其製造、加工、調配、改裝、輸入或輸出,非經中央主管機關查驗登記並發給許可文件,不得為之;其登記事項有變更者,應事先向中央主管機關申請審查核准。 None of the foods, food additives, food cleansers, food utensils, food containers or packaging and food cleansers which are designated by the central competent authority in a public announcement shall be manufactured, processed, prepared, repacked, imported or exported without filing product registration with and procuring a permit document from the central competent authority. Any change in the registered matters shall be subject to the prior approval of the central competent authority.
食品所含之基因改造食品原料非經中央主管機關健康風險評估審查,並查驗登記發給許可文件,不得供作食品原料。 None of the genetically modified food raw materials shall be used as the food raw materials without being reviewed by the central competent authority in the health risk assessment, filing product registration with and procuring a permit document.
經中央主管機關查驗登記並發給許可文件之基因改造食品原料,其輸入業者應依第九條第五項所定辦法,建立基因改造食品原料供應來源及流向之追溯或追蹤系統。 Importers of genetically modified food raw materials, that have filed product registration with and procured a permit document from the central competent authority, shall establish a traceability system for tracing the source and tracking the flow of the genetically modified food raw materials in accordance to Paragraph 5 of Article 9.
第一項及第二項許可文件,其有效期間為一年至五年,由中央主管機關核定之;期滿仍需繼續製造、加工、調配、改裝、輸入或輸出者,應於期滿前三個月內,申請中央主管機關核准展延。但每次展延,不得超過五年。 The permits mentioned in the preceding paragraphs 1 and 2 shall be valid for a term of one year to five years subject to the decisions by the central competent authority. Application for extension shall be filed within three months prior to the expiration of the term with the central competent authority if continued manufacture, processing, preparation, repacking, importation or exportation is desired after the expiration. The term of each extension shall not exceed five years.
第一項及第二項許可之廢止、許可文件之發給、換發、補發、展延、移轉、註銷及登記事項變更等管理事項之辦法,由中央主管機關定之。 The regulations governing the revocation of the permits mentioned in Paragraphs 1 and 2, and issuance, replacement, re-issuance, extension, transfer, de-registration, and change in the registered matters of the permit document, etc. shall be prescribed by the central competent authority.
第一項及第二項之查驗登記,得委託其他機構辦理;其委託辦法,由中央主管機關定之。 The product registration under Paragraphs 1 and 2 may be commissioned to another institution in accordance with regulations which are prescribed by the central competent authority.
本法中華民國一百零三年一月二十八日修正前,第二項未辦理查驗登記之基因改造食品原料,應於公布後二年內完成辦理。 For the unregistered genetically modified food raw materials mentioned in Paragraph 2 prior to the amendment of this Act on 28th January 2014, shall complete review and registration within two years after promulgation of this Act.
第 五 章 食品標示及廣告管理 Chapter V Food Labeling and Advertisement
第 22 條 Article 22
食品及食品原料之容器或外包裝,應以中文及通用符號,明顯標示下列事項: The container or external packaging of food and food raw materials shall conspicuously indicate in Chinese and common symbols the following matters:
一、品名。 1. product name;
二、內容物名稱;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。 2. name of the ingredients; those that contain two or more ingredients shall indicate the respective ingredients in descending order of proportion;
三、淨重、容量或數量。 3. net weight, volume or quantity;
四、食品添加物名稱;混合二種以上食品添加物,以功能性命名者,應分別標明添加物名稱。 4. name of food additives; in the case of a mixture of two or more food additives which are named according to its function shall indicate the name of each additive separately;
五、製造廠商或國內負責廠商名稱、電話號碼及地址。國內通過農產品生產驗證者,應標示可追溯之來源;有中央農業主管機關公告之生產系統者,應標示生產系統。 5. name, telephone number and address of the manufacturer or that of the responsible domestic company. The tracing sources of the domestic certified agricultural products; and the production systems prescribed by the central agricultural competent authority in a public announcement;
六、原產地(國)。 6. country of origin;
七、有效日期。 7. expiry date;
八、營養標示。 8. nutrition label;
九、含基因改造食品原料。 9. genetically modified food raw materials;
十、其他經中央主管機關公告之事項。 10. other matters designated by the central competent authority in a public announcement.
前項第二款內容物之主成分應標明所佔百分比,其應標示之產品、主成分項目、標示內容、方式及各該產品實施日期,由中央主管機關另定之。 Labeling of the ingredients mentioned in Subparagraph 2 of the preceding paragraph, shall indicate the percentage of the main ingredient. The labeling of food items, main ingredient, labeling content, labeling method, and the implementation date of each product shall be prescribed by the central competent authority.
第一項第八款及第九款標示之應遵行事項,由中央主管機關公告之。 The compliance matters of the labels mentioned in Subparagraphs 8 and 9 of paragraph 1 shall be prescribed by the central competent authority in a public announcement.
第一項第五款僅標示國內負責廠商名稱者,應將製造廠商、受託製造廠商或輸入廠商之名稱、電話號碼及地址通報轄區主管機關;主管機關應開放其他主管機關共同查閱。 For the food only labels the name of the responsible domestic company prescribed in Subparagraph 5 of Paragraph 1, its name, telephone number, address of the manufacturers, and those businesses that are entrusted to manufacture or importers shall be reported to the local competent authority. The competent authority shall open those information to other competent authority for reviewing.
第 23 條 Article 23
食品因容器或外包裝面積、材質或其他之特殊因素,依前條規定標示顯有困難者,中央主管機關得公告免一部之標示,或以其他方式標示。 In the event that labeling pursuant to the preceding paragraphs prove to be difficult due to the dimension, material or other special circumstances of the food container or external packaging, the central competent authority may exempt part of the labeling or allow labeling with other methods through public announcement.
第 24 條 Article 24
食品添加物及其原料之容器或外包裝,應以中文及通用符號,明顯標示下列事項: The container or external packaging of food additives and their raw materials shall conspicuously indicate in Chinese and common symbols the following matters:
一、品名。 1.product name;
二、「食品添加物」或「食品添加物原料」字樣。 2.printed words “Food Additive”or “Food Additive Raw Material”;
三、食品添加物名稱;其為二種以上混合物時,應分別標明。其標示應以第十八條第一項所定之品名或依中央主管機關公告之通用名稱為之。 3.name of food additives or, in the case of a mixture of two or more ingredients, each of the ingredients shall be indicated separately. The labeling of the name of food additives shall be handled in accordance with the food additive items prescribed in Paragraph 1 of Article 18 or the names commonly known prescribed by the central competent agency in a public announcement;
四、淨重、容量或數量。 4.net weight, volume or quantity;
五、製造廠商或國內負責廠商名稱、電話號碼及地址。 5.name, telephone number and address of the manufacturer or that of the responsible domestic company;
六、有效日期。 6.expiry date;
七、使用範圍、用量標準及使用限制。 7.scope of use, maximum allowance and limitation of use of food additives;
八、原產地(國)。 8.country of origin;
九、含基因改造食品添加物之原料。 9.genetically modified food raw materials;
十、其他經中央主管機關公告之事項。 10.other matters designated by the central competent authority in a public announcement.
食品添加物之原料,不受前項第三款、第七款及第九款之限制。前項第三款食品添加物之香料成分及第九款標示之應遵行事項,由中央主管機關公告之。 The labeling of food additive raw materials are not regulated to be handled in accordance with Subparagraph 3, 7, and 9 in the preceding paragraph. The compliance matters of labels on the flavoring agents of food additives mentioned in Subparagraph 3 and in Subparagraph 9 of the preceding paragraph shall be prescribed by the central competent authority in a public announcement.
第一項第五款僅標示國內負責廠商名稱者,應將製造廠商、受託製造廠商或輸入廠商之名稱、電話號碼及地址通報轄區主管機關;主管機關應開放其他主管機關共同查閱。 For the food only labels the name of the responsible domestic company prescribed in Subparagraph 5 of Paragraph 1, its name, telephone number, address of the manufacturers, and those businesses that are entrusted to manufacture or importers shall be reported to the local competent authority. The competent authority shall open those information to other competent authority for reviewing.
第 25 條 Article 25
中央主管機關得對直接供應飲食之場所,就其供應之特定食品,要求以中文標示原產地及其他應標示事項;對特定散裝食品販賣者,得就其販賣之地點、方式予以限制,或要求以中文標示品名、原產地(國)、含基因改造食品原料、製造日期或有效日期及其他應標示事項。國內通過農產品生產驗證者,應標示可追溯之來源;有中央農業主管機關公告之生產系統者,應標示生產系統。 The central competent authority may require food labeling showing country of origin and other matters ought to be labeled in Chinese on specific food products supplied at food vending locations. For specific bulk food vendors, the central competent authority may prescribe restrictions on the vending location and methods, or may require food labeling showing product name, country of origin, genetically modified food raw materials, manufacturing date, expiry dates and other matters ought to be labeled in Chinese. The domestic certified agricultural products shall label the tracing sources, and the production systems if there are production systems prescribed by the central agricultural competent authority in a public announcement.
前項特定食品品項、應標示事項、方法及範圍;與特定散裝食品品項、限制方式及應標示事項,由中央主管機關公告之。 The central competent authority shall prescribe in a public announcement on the items, labeling, methods and scope for specific food products; also the items, restrictions and labeling for specific bulk foods in the preceding paragraph.
第一項應標示可追溯之來源或生產系統規定,自中華民國一百零四年一月二十日修正公布後六個月施行。 The provision concerning the labeling of tracing sources or production systems specified in Paragraph 1 amended on 20th January 2015 shall be implemented six months after promulgation of this Act.
第 26 條 Article 26
經中央主管機關公告之食品器具、食品容器或包裝,應以中文及通用符號,明顯標示下列事項: Food utensils, food containers or packaging designated by the central competent authority in a public announcement shall conspicuously indicate in Chinese and common symbols the following matters:
一、品名。 1. product name;
二、材質名稱及耐熱溫度;其為二種以上材質組成者,應分別標明。 2. name of materials and thermal resistance temperature or, in the case of a mixture of two or more materials, each of the materials shall be indicated separately;
三、淨重、容量或數量。 3. net weight, volume or quantity;
四、國內負責廠商之名稱、電話號碼及地址。 4. name, telephone number and address of the responsible domestic company;
五、原產地(國)。 5. country of origin;
六、製造日期;其有時效性者,並應加註有效日期或有效期間。 6. manufacturing date, and the expiry date or the term of validity if the product has a limited duration of stroage;
七、使用注意事項或微波等其他警語。 7. precautions for use or microwavable and other warnings;
八、其他經中央主管機關公告之事項。 8. other matters designated by the central competent authority in a public announcement.
第 27 條 Article 27
食品用洗潔劑之容器或外包裝,應以中文及通用符號,明顯標示下列事項: The container or external packaging of food cleansers shall conspicuously indicate in Chinese and common symbols the following matters:
一、品名。 1. product name;
二、主要成分之化學名稱;其為二種以上成分組成者,應分別標明。 2. chemical names of main ingredients or, in the case of a mixture of two or more ingredients, each of the ingredients shall be indicated separately;
三、淨重或容量。 3. net weight or volume;
四、國內負責廠商名稱、電話號碼及地址。 4. name, telephone number and address of the responsible domestic company;
五、原產地(國)。 5. country of origin;
六、製造日期;其有時效性者,並應加註有效日期或有效期間。 6. manufacturing date, and the expiry date or the term of validity if the product has a limited duration of stroage;
七、適用對象或用途。 7. applicable targets or purpose;
八、使用方法及使用注意事項或警語。 8. method of use, precautions for use or warnings;
九、其他經中央主管機關公告之事項。 9. other matters designated by the central competent authority in a public announcement.
第 28 條 Article 28
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,其標示、宣傳或廣告,不得有不實、誇張或易生誤解之情形。 The labeling, promotion or advertisement of foods, food additives, food cleansers and food utensils, food containers or packaging designated by the central competent authority in a public announcement shall not be false, exaggerated or misleading.
食品不得為醫療效能之標示、宣傳或廣告。 Foods shall not be so labeled, promoted or advertised as having medical efficacy.
中央主管機關對於特殊營養食品、易導致慢性病或不適合兒童及特殊需求者長期食用之食品,得限制其促銷或廣告;其食品之項目、促銷或廣告之限制與停止刊播及其他應遵行事項之辦法,由中央主管機關定之。 The central competent authority may prescribe restrictions on the sales, promotion or advertising for special dietary foods or foods which easily lead to chronic diseases or are unsuitable for long term consumption for children and persons with special needs. The regulations governing the food items, restrictions on the sales promotion or advertising, prohibition of publishing and broadcasting and other matters to be complied with shall be prescribed by the central competent authority.
第一項不實、誇張或易生誤解與第二項醫療效能之認定基準、宣傳或廣告之內容、方式及其他應遵行事項之準則,由中央主管機關定之。 The regulations governing the determining standards of the false, exaggerated or misleading labeling, promotion or advertisement referred to in Paragraph 1 and medical efficacy referred to in Paragraph 2, contents, methods of the promotion or advertisement and other matters to be complied with shall be prescribed by the central competent authority.
第 29 條 Article 29
接受委託刊播之傳播業者,應自廣告之日起六個月,保存委託刊播廣告者之姓名或名稱、國民身分證統一編號、公司、商號、法人或團體之設立登記文件號碼、住居所或事務所、營業所及電話等資料,且於主管機關要求提供時,不得規避、妨礙或拒絕。 Media businesses being commissioned by a principal to publish or broadcast an advertisement shall maintain the particulars of its principal, such as its name or trade name, national ID Card number, establishment registration document number of company, business, corporation or organization, domicile or residence, representative office or business offices and telephone number, etc., for six months from the date of such advertisement, and shall not evade, impede or refuse any request by the competent authority for such particulars.
第 六 章 食品輸入管理 Chapter VI Food Import Control
第 30 條 Article 30
輸入經中央主管機關公告之食品、基因改造食品原料、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑時,應依海關專屬貨品分類號列,向中央主管機關申請查驗並申報其產品有關資訊。 Application for inspection with the central competent authority and declaration of the relevant information of the product are required and shall be in accordance with the customs commodity code and classification when importing foods, genetically modified food raw materials, food additives, food utensils, food containers or packaging and food cleansers designated by the central competent authority in a public announcement.
執行前項規定,查驗績效優良之業者,中央主管機關得採取優惠之措施。 The central competent authority may impose preferential measures to the food businesses with excellent performances in the import inspections referred to in the preceding paragraph.
輸入第一項產品非供販賣,且其金額、數量符合中央主管機關公告或經中央主管機關專案核准者,得免申請查驗。 The importation of products under Paragraph 1 that are not intended for sale and whose value and quantity are consistent with the public announcement of the central competent authority, or are approved by the central competent authority, may be exempt from applying for inspection.
第 31 條 Article 31
前條產品輸入之查驗及申報,中央主管機關得委任、委託相關機關(構)、法人或團體辦理。 The central competent authority may authorize or commission relevant agency (institution), corporation or organization to conduct inspection and declaration of imported products of the preceding paragraph.
第 32 條 Article 32
主管機關為追查或預防食品衛生安全事件,必要時得要求食品業者、非食品業者或其代理人提供輸入產品之相關紀錄、文件及電子檔案或資料庫,食品業者、非食品業者或其代理人不得規避、妨礙或拒絕。 In order to investigate and prevent food sanitation and safety incidents, the competent authority may require food businesses, non-food businesses or their representative to provide relevant records, documents and electronic files or databases of the imported products when necessary. In this case, the food businesses, the non-food businesses, or their representatives shall not evade, impede or refuse such requests.
食品業者應就前項輸入產品、基因改造食品原料之相關紀錄、文件及電子檔案或資料庫保存五年。 The food businesses shall retain the related records, documents, electronic files, or database of imported products and genetically modified food raw materials mentioned in the preceding paragraph for five years.
前項應保存之資料、方式及範圍,由中央主管機關公告之。 The central competent authority shall prescribe in a public announcement on the information to be retained, method and scope of retention in the preceding paragraph.
第 33 條 Article 33
輸入產品因性質或其查驗時間等條件特殊者,食品業者得向查驗機關申請具結先行放行,並於特定地點存放。查驗機關審查後認定應繳納保證金者,得命其繳納保證金後,准予具結先行放行。 Food businesses of imported products with special conditions due to their nature or inspection timeframe may apply for prior release of the imported goods and store them at a specific location. In the event where a deposit is deemed to be required after review by the inspection authority, the imported products may be granted prior release with provision of affidavit after payment of said deposit.
前項具結先行放行之產品,其存放地點得由食品業者或其代理人指定;產品未取得輸入許可前,不得移動、啟用或販賣。 The storage location of the products granted prior release in accordance with the preceding paragraph may be designated by the food businesses or their representative. The products shall not be moved, used or sold before obtaining the import permit.
第三十條、第三十一條及本條第一項有關產品輸入之查驗、申報或查驗、申報之委託、優良廠商輸入查驗與申報之優惠措施、輸入產品具結先行放行之條件、應繳納保證金之審查基準、保證金之收取標準及其他應遵行事項之辦法,由中央主管機關定之。 The regulations governing the inspection, declaration, commission of the inspection and declaration, preferential measures of import inspections and declarations for businesses with excellent performances, conditions of application to prior release, the criteria for which applications for prior release shall pay the deposit, standard of amount for deposit as referred to Articles 30, 31 and Paragraph 1 of this Article, and other matters to be complied with, shall be prescribed by the central competent authority.
第 34 條 Article 34
中央主管機關遇有重大食品衛生安全事件發生,或輸入產品經查驗不合格之情況嚴重時,得就相關業者、產地或產品,停止其查驗申請。 In the event of significant food sanitation and safety incidents or in case of serious failure to comply upon inspection of imported products, the central competent authority may suspend the application for inspection of the relevant businesses, place of origin or product.
第 35 條 Article 35
中央主管機關對於管控安全風險程度較高之食品,得於其輸入前,實施系統性查核。 For the management and control of foods with a higher degree of safety risk, the central competent authority may perform systematic inspections before the importation thereof.
前項實施系統性查核之產品範圍、程序及其他相關事項之辦法,由中央主管機關定之。 The regulations governing the scope of products, procedures and other relevant matters for the systematic inspections referred to in the preceding paragraph shall be prescribed by the central competent authority.
中央主管機關基於源頭管理需要或因個別食品衛生安全事件,得派員至境外,查核該輸入食品之衛生安全管理等事項。 According to the needs for source control or due to a specific food sanitation and safety incident, the central competent authority may send personnel abroad to conduct on-site inspection of the sanitation and safety management of the imported foods.
食品業者輸入食品添加物,其屬複方者,應檢附原產國之製造廠商或負責廠商出具之產品成分報告及輸出國之官方衛生證明,供各級主管機關查核。但屬香料者,不在此限。 When food businesses import food additive combinations, they shall attach product ingredients report issued by the manufacturer or responsible manufacturer of the origin country and official sanitary certificate issued by the export country for the examination of the competent authority at all levels. However, this regulation shall not apply to flavoring agents.
第 36 條 Article 36
境外食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑對民眾之身體或健康有造成危害之虞,經中央主管機關公告者,旅客攜帶入境時,應檢附出產國衛生主管機關開具之衛生證明文件申報之;對民眾之身體或健康有嚴重危害者,中央主管機關並得公告禁止旅客攜帶入境。 When carrying into the territories any offshore foods, food additives, food utensils, food containers or packaging and food cleansers that have been designated by the central competent authority in a public announcement and which may be harmful to the body or health of the people, the passenger shall declare the goods with the sanitation certificate issued by the health competent authority of the country of origin; if the item is seriously harmful to the body or health of the people, the central competent authority may prohibit the entry of such item in a public announcement.
違反前項規定之產品,不問屬於何人所有,沒入銷毀之。 Products violating the preceding paragraph, irrespective of who the owner is, shall be confiscated and destroyed.
第 七 章 食品檢驗 Chapter VII Food Testing
第 37 條 Article 37
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之檢驗,由各級主管機關或委任、委託經認可之相關機關(構)、法人或團體辦理。 The testing for foods, food additives, food utensils, food containers or packaging and food cleansers shall be performed by the competent authority at all levels or the authorized and appointed relevant agency (institution), corporation or organization with approval.
中央主管機關得就前項受委任、委託之相關機關(構)、法人或團體,辦理認證;必要時,其認證工作,得委任、委託相關機關(構)、法人或團體辦理。 The central competent authority may issue accreditation for the authorized and appointed relevant agency (institution), corporation or organization mentioned in the preceding paragraph. When necessary, the accreditation process may be commissioned to the authorized and appointed relevant agency (institution), corporation or organization.
前二項有關檢驗之委託、檢驗機關(構)、法人或團體認證之條件與程序、委託辦理認證工作之程序及其他相關事項之管理辦法,由中央主管機關定之。 The regulations governing the commission for testing, the accreditation conditions and procedures of the agency (institution), corporation or organization, the commission process of the accreditation and other relevant matters mentioned in the two preceding paragraphs shall be prescribed by the central competent authority.
第 38 條 Article 38
各級主管機關執行食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑之檢驗,其檢驗方法,經食品檢驗方法諮議會諮議,由中央主管機關定之;未定檢驗方法者,得依國際間認可之方法為之。 The method of test for foods, food additives, food utensils, food containers or packaging and food cleansers to be used by the competent authority at all levels shall be consulted with and advised by the Council Advisory Committee of Food Testing Methods and then be prescribed by the central competent authority; In the absence of any prescribed method, an internationally recognized method may be used.
第 39 條 Article 39
食品業者對於檢驗結果有異議時,得自收受通知之日起十五日內,向原抽驗之機關(構)申請複驗;受理機關(構)應於三日內進行複驗。但檢體無適當方法可資保存者,得不受理之。 Where food businesses object to the testing results, it may apply for a retesting from the original sampling agency (institution) within fifteen (15) days upon the receipt of the relevant notification. The agency (institution) receiving the application shall perform the retesting within three (3) days. However, specimen that is without appropriate methods of preservation may be rejected.
第 40 條 Article 40
發布食品衛生檢驗資訊時,應同時公布檢驗方法、檢驗單位及結果判讀依據。 When publishing testing information on food sanitation, the method of test, testing unit and the evidence used in interpreting the results shall be concurrently disclosed.
第 八 章 食品查核及管制 Chapter VIII Food Examination and Control
第 41 條 Article 41
直轄市、縣(市)主管機關為確保食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑符合本法規定,得執行下列措施,業者應配合,不得規避、妨礙或拒絕: The municipal or county/city competent authority may take the following actions to ensure that foods, food additives, food utensils, food containers or packaging and food cleansers are in compliance with the provisions of this Act, and businesses shall cooperate with the competent authority and shall not evade, impede or refuse:
一、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。 1. entering the place of manufacturing, processing, preparation, packaging, transportation, storage and sales, performing on-site examination and conducting sampling and testing;
二、為前款查核或抽樣檢驗時,得要求前款場所之食品業者提供原料或產品之來源及數量、作業、品保、販賣對象、金額、其他佐證資料、證明或紀錄,並得查閱、扣留或複製之。 2. when conducting the examination or sampling and testing referred to in the preceding paragraph, it may be required for the food businesses of the place referred to in the preceding paragraph to provide the source and amount of raw materials or products, processing, quality assurance, sales counterpart, sales amount, other supporting information, evidence or records, and such may be reviewed, detained and copied;
三、查核或檢驗結果證實為不符合本法規定之食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑,應予封存。 3. foods, food additives, food utensils, food containers or packaging and food cleansers found to be not in compliance with the provisions of this Act according to the examination and testing results shall be sealed;
四、對於有違反第八條第一項、第十五條第一項、第四項、第十六條、中央主管機關依第十七條、第十八條或第十九條所定標準之虞者,得命食品業者暫停作業及停止販賣,並封存該產品。 4. those with possible violations of Paragraph 1 of Artcle 8, Paragraphs 1 and 4 of Article 15, and Article 16, or standards prescribed by the central competent authority pursuant to Articles 17, 18 or 19, the food businesses may be ordered to suspend operations or cease such sales, and the products shall be sealed;
五、接獲通報疑似食品中毒案件時,對於各該食品業者,得命其限期改善或派送相關食品從業人員至各級主管機關認可之機關(構),接受至少四小時之食品中毒防治衛生講習;調查期間,並得命其暫停作業、停止販賣及進行消毒,並封存該產品。 5. upon receipt of reports of food poisoning accidents, the relevant food businesses may be ordered to make correction within a prescribed time period or send the relevant food personnel to participate in at least four hours of food poisoning prevention seminar at agencies (institutions) certified by the competent authority at all levels. During the investigation, it may be ordered to suspend operations, cease sales or undertake disinfection and seal such products.
中央主管機關於必要時,亦得為前項規定之措施。 Where necessary, the central competent authority may also execute the measures described in the preceding paragraph.
第 42 條 Article 42
前條查核、檢驗與管制措施及其他應遵行事項之辦法,由中央主管機關定之。 The regulations governing the examination, testing and control measures and other matters to be complied with referred to in the preceding article shall be prescribed by the central competent authority.
第 42-1 條 Article 42-1
為維護食品安全衛生,有效遏止廠商之違法行為,警察機關應派員協助主管機關。 In order to safeguard food safety and sanitation and effectively stem illicit behaviour of businesses, the police agency shall dispatch its personnel to assist the competent agency.
第 43 條 Article 43
主管機關對於檢舉查獲違反本法規定之食品、食品添加物、食品器具、食品容器或包裝、食品用洗潔劑、標示、宣傳、廣告或食品業者,除應對檢舉人身分資料嚴守秘密外,並得酌予獎勵。公務員如有洩密情事,應依法追究刑事及行政責任。 The competent authority shall keep strictly confidential the particulars of, and may grant reward to, anyone informing against foods, food additives, food utensils, food containers or packaging, food cleansers, labels, promotional materials, advertisements or food businesses that are found to have violated the provisions of this Act. If civil services disclose the confidential information, they will be punished with criminal and administrative responsibilities.
前項主管機關受理檢舉案件之管轄、處理期間、保密、檢舉人獎勵及其他應遵行事項之辦法,由中央主管機關定之。 The regulations governing the jurisdiction of the complaints received by the competent authority, processing time period, confidentiality, reward to informant and other matters to be complied with mentioned in the preceding paragraph shall be prescribed by the central competent authority.
第一項檢舉人身分資料之保密,於訴訟程序,亦同。 Confidentiality of identity of informants in Paragraph 1 shall be subject to the same requirements by throughout litigation procedures.
第 九 章 罰則 Chapter IX Penal Provisions
第 44 條 Article 44
有下列行為之一者,處新臺幣六萬元以上二億元以下罰鍰;情節重大者,並得命其歇業、停業一定期間、廢止其公司、商業、工廠之全部或部分登記事項,或食品業者之登錄;經廢止登錄者,一年內不得再申請重新登錄: Anyone committing any of the following shall be fined between NT$60,000 and NT$200,000,000. In severe circumstances, the enterprise may be ordered to terminate business, suspend business for a certain period of time, revoke all or part of the items listed in the company registration, business registration or factory registration, or registration of the food businesses. If registration of the food businesses is revoked, re-application for new registration within one (1) year shall be prohibited:
一、違反第八條第一項或第二項規定,經命其限期改正,屆期不改正。 1. violating Paragraph 1 or 2 of Article 8, and failing to correct the violation within the time limit prescribed;
二、違反第十五條第一項、第四項或第十六條規定。 2. violating Paragraph 1 or 4 of Article 15 or Article 16;
三、經主管機關依第五十二條第二項規定,命其回收、銷毀而不遵行。 3. incompliance with order by the competent authority to recover or destruct in accordance to Paragraph 2 of Article 52;
四、違反中央主管機關依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。 4. violating the public announcement by the central competent authority to ban the manufacture, sale, import or export in accordance to Paragraph 1 of Article 54.
前項罰鍰之裁罰標準,由中央主管機關定之。 The penalty standards of the fine mentioned in the preceding paragraph shall be prescribed by the central competent authority.
第 45 條 Article 45
違反第二十八條第一項或中央主管機關依第二十八條第三項所定辦法者,處新臺幣四萬元以上四百萬元以下罰鍰;違反同條第二項規定者,處新臺幣六十萬元以上五百萬元以下罰鍰;再次違反者,並得命其歇業、停業一定期間、廢止其公司、商業、工廠之全部或部分登記事項,或食品業者之登錄;經廢止登錄者,一年內不得再申請重新登錄。 Those with violations of Paragraph 1 of Article 28 or the regulations prescribed by the central competent authority pursuant to Paragraph 3 of Article 28 shall be fined between NT$40,000 and NT$4,000,000; violation of Paragraph 2 of such article shall be fined between NT$600,000 and NT$5,000,000. Where the offense is repeated the enterprise may be ordered to terminate business, suspend business for a certain period of time, revoke all or part of the items listed in the company registration, business registration or factory registration, or registration of the food businesses. If registration of the food businesses is revoked, re-application for new registration within one (1) year shall be prohibited.
違反前項廣告規定之食品業者,應按次處罰至其停止刊播為止。 Food businesses in violation of the preceding food advertisement provisions shall be consecutively fined by such authority for each violation until the publication or broadcast is ceased.
違反第二十八條有關廣告規定之一,情節重大者,除依前二項規定處分外,主管機關並應命其不得販賣、供應或陳列;且應自裁處書送達之日起三十日內,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。 Severe violation of any of the advertisement provisions under Article 28 shall not only be punished by the preceding two provisions, the competent authority shall order to halt all sale, supply or display; and shall publish or broadcast a specific number of corrective advertising in the same size and time period as the original within thirty (30) days of receiving the sanction order, which shall express regret and convey the message for elimination of error.
違反前項規定,繼續販賣、供應、陳列或未刊播更正廣告者,處新臺幣十二萬元以上六十萬元以下罰鍰。 Violation of the preceding provisions by continuing to sell, supply, display or failure to publish or broadcast corrective advertising shall be fined between NT$120,000 to NT$600,000.
第 46 條 Article 46
傳播業者違反第二十九條規定者,處新臺幣六萬元以上三十萬元以下罰鍰,並得按次處罰。 Media businesses in violation of Article 29 shall be fined between NT$60,000 to NT$300,000, and may be consecutively fined.
直轄市、縣(市)主管機關為前條第一項處罰時,應通知傳播業者及其直轄市、縣(市)主管機關或目的事業主管機關。傳播業者自收到該通知之次日起,應即停止刊播。 When the competent authority at the municipal level or county/city level impose fines in accordance with Paragraph 1 of the preceding article, the media businesses, and the relevant competent authority at the municipal or county/city level or industry competent authority shall be notified. The media businesses shall cease the broadcast or publication of the advertisement concerned from the day following its receipt of the above notification.
傳播業者未依前項規定停止刊播違反第二十八條第一項或第二項規定,或違反中央主管機關依第二十八條第三項所為廣告之限制或所定辦法中有關停止廣告之規定者,處新臺幣十二萬元以上六十萬元以下罰鍰,並應按次處罰至其停止刊播為止。 Media businesses continuing to publish or broadcast following the notification referred to in the preceding paragraph, in violation of Paragraphs 1 and 2 of Article 28 or any limit on advertisements or relevant regulations relating to the permanent suspension of advertisements prescribed by the central competent authority pursuant to Paragraph 3 of Article 28, shall be fined between NT$120,000 and NT$600,000 and shall be consecutively fined by such authority for each violation until the publication or broadcast is ceased.
傳播業者經依第二項規定通知後,仍未停止刊播者,直轄市、縣(市)主管機關除依前項規定處罰外,並通知傳播業者之直轄市、縣(市)主管機關或其目的事業主管機關依相關法規規定處理。 When media businesses fail to cease publication or broadcasting following receipt of notification referred to in Paragraph 2, in addition to imposing fines in accordance with the preceding paragraph, the competent authority at the municipal level or county/city level shall also notify the competent authority of the media businesses at the municipal level or county/city level or its industry competent authority to address these issues.
第 46-1 條 Article 46-1
散播有關食品安全之謠言或不實訊息,足生損害於公眾或他人者,處三年以下有期徒刑、拘役或新臺幣一百萬元以下罰金。 A person who disseminates a rumor or incorrect information concerning food safety and thus causes damage to the public or others shall be punished with imprisonment for not more than three years, detention, or a fine of not more than NT$1,000,000.
第 47 條 Article 47
有下列行為之一者,處新臺幣三萬元以上三百萬元以下罰鍰;情節重大者,並得命其歇業、停業一定期間、廢止其公司、商業、工廠之全部或部分登記事項,或食品業者之登錄;經廢止登錄者,一年內不得再申請重新登錄: Anyone committing any of the following shall be fined between NT$30,000 and NT$3,000,000. In severe circumstances, the enterprise may be ordered to terminate business, suspend business for a certain period of time, revoke all or part of the items listed in the company registration, business registration or factory registration, or registration of the food businesses. If registration of the food businesses is revoked, re-application for new registration shall not be permitted within one year:
一、違反中央主管機關依第四條所為公告。 1. violating the public announcement prescribed by the central competent authority pursuant to Article 4;
二、違反第七條第五項規定。 2. violating Paragraph 5 of Article 7;
三、食品業者依第八條第三項、第九條第二項或第四項規定所登錄、建立或申報之資料不實,或依第九條第三項開立之電子發票不實致影響食品追溯或追蹤之查核。 3. in the event that the registered, established or declared information pursuant to Paragraph 3 of Article 8 and Paragraph 2 or 4 of Article 9 is false, or the incorrect electronic uniform invoices issued pursuant to Paragraph 2 of Article 9 to affect the examination of food tracing or tracking;
四、違反第十一條第一項或第十二條第一項規定。 4. violating Paragraph 1 of Article 11 or Paragraph 1 of Article 12;
五、違反中央主管機關依第十三條所為投保產品責任保險之規定。 5. violating the provisions concerning product liability insurance prescribed by the central competent authority pursuant to Article 13;
六、違反直轄市或縣(市)主管機關依第十四條所定管理辦法中有關公共飲食場所安全衛生之規定。 6. violating the regulations concerning the safety and sanitation of public food and beverage sites prescribed by the municipal or county/city competent authority pursuant to Article 14;
七、違反中央主管機關依第十八條之一第一項所定標準之規定,經命其限期改正,屆期不改正。 7. violating the standards prescribed by the central competent authority pursuant to Paragraph 1 of Article 18-1, and failing to correct the violation within the time limit prescribed;
八、違反第二十一條第一項及第二項、第二十二條第一項或依第二項及第三項公告之事項、第二十四條第一項或依第二項公告之事項、第二十六條或第二十七條規定。 8. violating Paragraphs 1 and 2 of Article 21, Paragraph 1 or public announcement made pursuant to Paragraphs 2 and 3 of Article 22, Paragraph 1 or public announcement made pursuant to Paragraph 2 of Article 24, Article 26 or Article 27;
九、除第四十八條第九款規定者外,違反中央主管機關依第十八條所定標準中有關食品添加物規格及其使用範圍、限量之規定。 9. other than the provisions specified in Paragraph 9 of Article 48, violating the provisions concerning the specification, use and limitation of food additives prescribed by the central competent authority pursuant to the standard prescribed in Article 18;
十、違反中央主管機關依第二十五條第二項所為之公告。 10. violating the public announcement prescribed by the central competent authority pursuant to Paragraph 2 of Article 25;
十一、規避、妨礙或拒絕本法所規定之查核、檢驗、查扣或封存。 11. evading, impeding or refusing an examination, testing, seizure or seal stipulated in this Act;
十二、對依本法規定應提供之資料,拒不提供或提供資料不實。 12. refusing to provide or providing false information for the information which are required to be submitted in accordance with the provisions specified in this Act;
十三、經依本法規定命暫停作業或停止販賣而不遵行。 13. failing to observe a suspension on operation or cease of sales in accordance with the provisions specified in this Act;
十四、違反第三十條第一項規定,未辦理輸入產品資訊申報,或申報之資訊不實。 14. violating Paragraph 1 of Article 30 which fails to declare the information of imported goods or the information declared is false; or
十五、違反第五十三條規定。 15. violating Article 53.
第 48 條 Article 48
有下列行為之一者,經命限期改正,屆期不改正者,處新臺幣三萬元以上三百萬元以下罰鍰;情節重大者,並得命其歇業、停業一定期間、廢止其公司、商業、工廠之全部或部分登記事項,或食品業者之登錄;經廢止登錄者,一年內不得再申請重新登錄: Anyone committing any of the following and failing to correct the violation within the time limit prescribed shall be fined between NT$30,000 and NT$3,000,000. In severe circumstances, the enterprise may be ordered to terminate business, suspend business for a certain period of time, revoke all or part of the items listed in the company registration, business registration or factory registration, or the registration of the food businesses. If registration of the food businesses is revoked, re-application for new registration shall not be permitted within one year:
一、違反第七條第一項規定未訂定食品安全監測計畫、第二項或第三項規定未設置實驗室。 1.violating Paragraph 1 of Article 7 for failing to enact food safety monitoring plan, or Paragraph 2 or Paragraph 3 for failing to be equipped with the laboratory;
二、違反第八條第三項規定,未辦理登錄,或違反第八條第五項規定,未取得驗證。 2.violating Paragraph 3 of Article 8, failing to file registration; or violating Paragraph 5 of Article 8, failing to obtain certification;
三、違反第九條第一項規定,未保存文件或保存未達規定期限。 3.violating Paragraph 1 of Article 9, failing to retain document or attain the required period of retention ;
四、違反第九條第二項規定,未建立追溯或追蹤系統。 4.violating Paragraph 2 of Article 9, failing to establish tracing or tracking system;
五、違反第九條第三項規定,未開立電子發票致無法為食品之追溯或追蹤。 5.violating Paragraph 3 of Article 9, failing to issue electronic uniform invoices for the purpose of food tracing or tracking;
六、違反第九條第四項規定,未以電子方式申報或未依中央主管機關所定之方式及規格申報。 6.violating Paragraph 4 of Article 9, failing to declare in the electronic method or to declare according to the method and specification prescribed by the central competent authority;
七、違反第十條第三項規定。 7.violating Paragraph 3 of Article 10;
八、違反中央主管機關依第十七條或第十九條所定標準之規定。 8.violating any of the standards prescribed by the central competent authority in accordance with Article 17 or Article 19;
九、食品業者販賣之產品違反中央主管機關依第十八條所定食品添加物規格及其使用範圍、限量之規定。 9.the products sold by the food businesses violating the specification, use and limitation of food additives prescribed by the central competent authority pursuant to the standard prescribed in Article 18;
十、違反第二十二條第四項或第二十四條第三項規定,未通報轄區主管機關。 10.violating Paragraph 4 of Article 22 or Paragraph 3 of Article 24, failing to report to the competent authority; or
十一、違反第三十五條第四項規定,未出具產品成分報告及輸出國之官方衛生證明。 11.violating Paragraph 4 of Article 35, failing to attach product ingredients report and official sanitation certificate issued by the export country.
十二、違反中央主管機關依第十五條之一第二項公告之限制事項。 12.violating the restrictions prescribed by the central competent authority in a public announcement pursuant to Paragraph 2 of Article 15-1.
第 48-1 條 Article 48-1
有下列情形之一者,由中央主管機關處新臺幣三萬元以上三百萬元以下罰鍰;情節重大者,並得暫停、終止或廢止其委託或認證;經終止委託或廢止認證者,一年內不得再接受委託或重新申請認證: Anyone committing any of the following shall be fined between NT$30,000 and NT$3,000,000 by the central competent authority. In severe circumstances, the enterprise may be ordered to suspend, terminate or revoke its commission or accreditation. Enterprise which commission has been terminated or accreditation has been revoked, shall not be re-commissioned and shall not re-apply for accreditation within one year:
一、依本法受託辦理食品業者衛生安全管理驗證,違反依第八條第六項所定之管理規定。 1.enterprise which is commissioned in accordance with this Act for conducting the certification of sanitation and safety control of food businesses, violates provisions made pursuant to Paragraph 6 of Article 8;
二、依本法認證之檢驗機構、法人或團體,違反依第三十七條第三項所定之認證管理規定。 2.institution, corporation or organization which is accredited in accordance with this Act for testing, violates provisions concerning accreditation made pursuant to Paragraph 3 of Article 37; or
三、依本法受託辦理檢驗機關(構)、法人或團體認證,違反依第三十七條第三項所定之委託認證管理規定。 3.enterprise which is commissioned in accordance with this Act for conducting the accreditation of institution, corporation or organization for testing, violates provisions concerning accreditation commission made pursuant to Paragraph 3 of Article 37.
第 49 條 Article 49
有第十五條第一項第三款、第七款、第十款或第十六條第一款行為者,處七年以下有期徒刑,得併科新臺幣八千萬元以下罰金。情節輕微者,處五年以下有期徒刑、拘役或科或併科新臺幣八百萬元以下罰金。 In the event that the acts described in Subparagraphs 3, 7 and 10 of Paragraph 1 of Article 15 or Paragraph 1 of Article 16 are committed, imprisonment of not more than seven years, and a fine of not more than NT$80,000,000 may be imposed. If the offense is light, imprisonment of not more than five years, detention and/or a fine of not more than NT$8,000,000 shall be imposed.
有第四十四條至前條行為,情節重大足以危害人體健康之虞者,處七年以下有期徒刑,得併科新臺幣八千萬元以下罰金;致危害人體健康者,處一年以上七年以下有期徒刑,得併科新臺幣一億元以下罰金。 In the event that the acts described from Article 44 to the preceding article are severe and may be sufficient to harmful to human health, imprisonment of not more than seven years, and a fine of not more than NT$80,000,000 may be imposed. For such acts are committed to the detriment of human health, imprisonment between one year to seven years and a fine of not more than NT$100,000,000 may be imposed.
犯前項之罪,因而致人於死者,處無期徒刑或七年以上有期徒刑,得併科新臺幣二億元以下罰金;致重傷者,處三年以上十年以下有期徒刑,得併科新臺幣一億五千萬元以下罰金。 In the event that the acts described in the preceding paragraph results in death, a life imprisonment or imprisonment of not less than seven years, and a fine of not more than NT$200,000,000 may be imposed. For such acts causing severe detriment of human body, imprisonment between three years and ten years, and a fine of not more than NT$150,000,000 may be imposed.
因過失犯第一項、第二項之罪者,處二年以下有期徒刑、拘役或科新臺幣六百萬元以下罰金。 Anyone committing any of the offenses described in Paragraphs 1 and 2 out of negligence shall be imprisoned for not more than two year, detained or fined NT$6,000,000.
法人之代表人、法人或自然人之代理人、受僱人或其他從業人員,因執行業務犯第一項至第三項之罪者,除處罰其行為人外,對該法人或自然人科以各該項十倍以下之罰金。 Where the representative of a legal entity or the agent, employees or other practitioners of a legal entity or natural person that commit the offenses from Paragraphs 1 to 3 during the performance of duties, not only shall the wrongdoer be punished but the legal entity or natural person shall also be fined not more than ten times of the fine stipulated in the respective preceding paragraphs.
科罰金時,應審酌刑法第五十八條規定。 When imposing a fine, the provision specified in Article 58 of the Criminal Code shall be considered.
第 49-1 條 Article 49-1
犯本法之罪,其犯罪所得與追徵之範圍及價額,認定顯有困難時,得以估算認定之;其估算辦法,由行政院定之。 The scope and value of the proceeds of crime in violating this Act may be based on an estimation if the valuation is deemed difficult. The regulation governing such estimation shall be established by the Executive Yuan.
第 49-2 條 Article 49-2
經中央主管機關公告類別及規模之食品業者,違反第十五條第一項、第四項或第十六條之規定;或有第四十四條至第四十八條之一之行為致危害人體健康者,其所得之財產或其他利益,應沒入或追繳之。 Food businesses belonging to a category and scale designated by the central competent authority in a public announcement violate the provisions specified in Paragraph 1 or 4 of Article 15 or Article 16, or perform the actions described from Article 44 to Article 48-1 causing detriment of human health, their acquired assets or property interests shall be forfeited or retrieved.
主管機關有相當理由認為受處分人為避免前項處分而移轉其財物或財產上利益於第三人者,得沒入或追繳該第三人受移轉之財物或財產上利益。如全部或一部不能沒入者,應追徵其價額或以其財產抵償之。 If there are considerable and sufficient reasons for the competent authority to believe that the penalized person transfers his/her assets or property interests to the third party for avoiding been punished pursuant to the preceding paragraph, the competent authority may forfeit or retrieve the transferred assets or property interests of the third party. If the above assets or property interests cannot be forfeited in whole or in part, the equivalent value thereof shall be indemnified either by demanding a payment from the offender or be offset by the property of the offender.
為保全前二項財物或財產上利益之沒入或追繳,其價額之追徵或財產之抵償,主管機關得依法扣留或向行政法院聲請假扣押或假處分,並免提供擔保。 To ensure the forfeit or retrieve of assets or property interests and a levy on payments or property compensation in the preceding two paragraphs, the competent authority may perform detainment pursuant to this Act or request the administrative court for provisional seizure or provisional disposition and is not required to provide guarantees.
主管機關依本條沒入或追繳違法所得財物、財產上利益、追徵價額或抵償財產之推估計價辦法,由行政院定之。 The regulations governing the valuation of illegally obtained assets, property interests, a levy on payments or property compensation which forfeited or retrieved by the competent authority pursuant to this Article shall be prescribed by the Executive Yuan.
第 50 條 Article 50
雇主不得因勞工向主管機關或司法機關揭露違反本法之行為、擔任訴訟程序之證人或拒絕參與違反本法之行為而予解僱、調職或其他不利之處分。 An employer may not discharge, transfer or otherwise take any adverse sanction against an employee who discloses an action which violates this Act to the competent authority or judicial authority, becomes witness of a litigation proceeding or refuses to participate in an action which violates this Act.
雇主或代表雇主行使管理權之人,為前項規定所為之解僱、降調或減薪者,無效。 Any dismissal, demotion or reduction of wage imposed by the employer or supervisory employees who exercise the managerial authority on behalf of the employer for reasons as prescribed in the preceding paragraph shall be null and void.
雇主以外之人曾參與違反本法之規定且應負刑事責任之行為,而向主管機關或司法機關揭露,因而破獲雇主違反本法之行為者,減輕或免除其刑。 For the person other than the employer who had participated in actions violating the provisions of this Act and under criminal responsibility but who discloses such action to the competent authority or judicial authority assisting the authority to uncover the violation of the employer, the penalty for such person shall be reduced or exempted.
第 51 條 Article 51
有下列情形之一者,主管機關得為處分如下: The competent authority may impose sanctions in the event of the following:
一、有第四十七條第十四款規定情形者,得暫停受理食品業者或其代理人依第三十條第一項規定所為之查驗申請;產品已放行者,得視違規之情形,命食品業者回收、銷毀或辦理退運。 1. at the occurrence of the circumstances described in Paragraph 14 of Article 47, the application for inspection in accordance with Paragraph 1 of Article 30 from the food businesses or their representatives may be suspended. For the products which are already released, the food businesses may recall, destroy or return such products depending on the violation thereof.
二、違反第三十條第三項規定,將免予輸入查驗之產品供販賣者,得停止其免查驗之申請一年。 2. in case of violation of Paragraph 3 of Article 30, for anyone who sells the products exempted from import inspection, application for inspection exemption may be suspended for one year.
三、違反第三十三條第二項規定,取得產品輸入許可前,擅自移動、啟用或販賣者,或具結保管之存放地點與實際不符者,沒收所收取之保證金,並於一年內暫停受理該食品業者具結保管之申請;擅自販賣者,並得處販賣價格一倍至二十倍之罰鍰。 3. in case of violation of Paragraph 2 of Article 33, for anyone who intentionally moves, uses or sells the products before receiving the import permit, or the confirmed storage location is inconsistent with the actual storage location. The competent authority may confiscate the deposit and temporarily suspend acceptance of an application for storage by the food businesses for one year. Anyone who sells the goods without authorization may be fined an amount that is between double and twenty times of the selling price of the goods.
第 52 條 Article 52
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,經依第四十一條規定查核或檢驗者,由當地直轄市、縣(市)主管機關依查核或檢驗結果,為下列之處分: The municipal or county/city competent authority shall impose the following punishment based on examination or testing results for foods, food additives, food utensils, food containers or packaging and food cleansers that have been examined or tested in accordance with Article 41:
一、有第十五條第一項、第四項或第十六條所列各款情形之一者,應予沒入銷毀。 1. those under any one of the circumstances listed in Paragraph 1 or 4 of Article 15 or Article 16 shall be confiscated and destroyed;
二、不符合中央主管機關依第十七條、第十八條所定標準,或違反第二十一條第一項及第二項規定者,其產品及以其為原料之產品,應予沒入銷毀。但實施消毒或採行適當安全措施後,仍可供食用、使用或不影響國人健康者,應通知限期消毒、改製或採行適當安全措施;屆期未遵行者,沒入銷毀之。 2. those not conforming to the standards prescribed by the central competent authority pursuant to Article 17 and Article 18, or those violating Paragraphs 1 and 2 of Article 21, the products or products containing such materials shall be confiscated and destroyed. However, if those can be edible or used or not affecting human health after disinfecting or appropriate safety measures are implemented, a notice shall be given for such disinfecting, reconditioning or measures to proceed within a prescribed time period; in case the notice is not complied with within the time limit, those goods shall be confiscated and destroyed;
三、標示違反第二十二條第一項或依第二項及第三項公告之事項、第二十四條第一項或依第二項公告之事項、第二十六條、第二十七條或第二十八條第一項規定者,應通知限期回收改正,改正前不得繼續販賣;屆期未遵行或違反第二十八條第二項規定者,沒入銷毀之。 3. in case the labels violate Paragraph 1 or public announcement made pursuant to Paragraphs 2 and 3 of Article 22, Paragraph 1 or public announcement made pursuant to Paragraph 2 of Article 24, Article 26, Article 27 or Paragraph 1 of Article 28, a notice shall be given for the goods to be recalled and correction made within a prescribed time period; the goods in question shall not be sold before the violation is corrected. In case the notice is not complied with within the prescribed time limit or Paragraph 2 of Article 28 is violated, those goods shall be confiscated and destroyed; and
四、依第四十一條第一項規定命暫停作業及停止販賣並封存之產品,如經查無前三款之情形者,應撤銷原處分,並予啟封。 4. the punishment with respect to goods which are subject to a suspension of operation as well as cease of sales, and are sealed pursuant to Paragraph 1 of Article 41 shall, in the absence of any of the situations described in the preceding three subparagraphs, be cancelled, and such goods shall be unsealed.
前項第一款至第三款應予沒入之產品,應先命製造、販賣或輸入者立即公告停止使用或食用,並予回收、銷毀。必要時,當地直轄市、縣(市)主管機關得代為回收、銷毀,並收取必要之費用。 The manufacturer, seller or importer of goods that are to be confiscated pursuant to Subparagraphs 1 to 3 of the preceding paragraph shall immediately announce the termination of use or consumption of such goods and recall and destroy those said goods. Where necessary, the municipal or county/city competent authority may act for such recall and destruction with necessary charges.
前項應回收、銷毀之產品,其回收、銷毀處理辦法,由中央主管機關定之。 Goods that shall be recalled and destroyed pursuant to the preceding paragraph shall be recalled and destroyed in accordance with regulations prescribed by the central competent authority.
製造、加工、調配、包裝、運送、販賣、輸入、輸出第一項第一款或第二款產品之食品業者,由當地直轄市、縣(市)主管機關公布其商號、地址、負責人姓名、商品名稱及違法情節。 The municipal or county/city competent authority shall officially publish the company name, address, name of the responsible person, and product name of as well as the circumstances of the violations by, any food businesses manufacturing, processing, preparing, packaging, transporting, selling, importing or exporting goods under Subparagraph 1 or 2 of Paragraph 1.
輸入第一項產品經通關查驗不符合規定者,中央主管機關應管制其輸入,並得為第一項各款、第二項及前項之處分。 The central competent authority shall restrict the importation of goods under Paragraph 1 which are found to have failed to comply with provisions upon inspection at ports of entry, and may also impose the punishment under any of the subparagraphs of Paragraph 1 and under Paragraph 2 and the preceding Paragraph, with respect to such goods.
第 53 條 Article 53
直轄市、縣(市)主管機關經依前條第一項規定,命限期回收銷毀產品或為其他必要之處置後,食品業者應依所定期限將處理過程、結果及改善情形等資料,報直轄市、縣(市)主管機關備查。 After the products have been recalled and destroyed within a prescribed time period or taken with other necessary measures by the municipal or county/city competent authority pursuant to Paragraph 1 of the preceding article, the food businesses shall report the information in relation to the procedure, result, as well as the status of the above to the municipal or county/city competent authority for their review before the deadline.
第 54 條 Article 54
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,有第五十二條第一項第一款或第二款情事,除依第五十二條規定處理外,中央主管機關得公告禁止其製造、販賣、輸入或輸出。 In addition to being handled pursuant to Article 52, foods, food additives, food utensils, food containers or packaging and food cleansers which are found to be under any of the circumstances described in Subparagraph 1 or 2 of Paragraph 1 of Article 52 may be subject to a ban by the central competent authority on manufacture, sale, import or export through a public announcement.
前項公告禁止之產品為中央主管機關查驗登記並發給許可文件者,得一併廢止其許可。 Where a product that is subject to prohibition according to the preceding paragraph was registered and licensed by the central competent authority, the relevant license may be revoked.
第 55 條 Article 55
本法所定之處罰,除另有規定外,由直轄市、縣(市)主管機關為之,必要時得由中央主管機關為之。但有關公司、商業或工廠之全部或部分登記事項之廢止,由直轄市、縣(市)主管機關於勒令歇業處分確定後,移由工、商業主管機關或其目的事業主管機關為之。 Unless otherwise prescribed, the punishment prescribed in this Act shall be imposed by the municipal or county/city competent authority. The central competent authority may impose the punishment when necessary. However, upon the confirmation for the order of termination of business by the municipal or county/city competent authority, such order will be transferred to the industrial and business competent authority or other industry competent authority to revoke all or part of the items listed in the company registration, business registration or factory registration.
第 55-1 條 Article 55-1
依本法所為之行政罰,其行為數認定標準,由中央主管機關定之。 The determining standards of the number of administrative penalty made in violation of this Act shall be prescribed by the central competent authority.
第 56 條 Article 56
食品業者違反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,致生損害於消費者時,應負賠償責任。但食品業者證明損害非由於其製造、加工、調配、包裝、運送、貯存、販賣、輸入、輸出所致,或於防止損害之發生已盡相當之注意者,不在此限。 Should food businesses violate Subparagraph 3, 7, or 10 of Paragraph 1 of Article 15 or Paragraph 1 of Article 16 and result in harms to consumers, they shall bear the responsibilities for compensation. But if food businesses prove the harms are not caused by their manufacturing, processing, preparation, packing, shipment, storage, sales, import and export or have paid attention to preventing from the harms, they shall be exempted from the responsibilities.
消費者雖非財產上之損害,亦得請求賠償相當之金額,並得準用消費者保護法第四十七條至第五十五條之規定提出消費訴訟。 Consumers may claim a certain amount of monetary compensation, and may file for consumer litigation in accordance with the provisions specified from Article 47 to Article 55 of the Consumer Protection Law even without suffering property damage.
如消費者不易或不能證明其實際損害額時,得請求法院依侵害情節,以每人每一事件新臺幣五百元以上三十萬元以下計算。 In the event of difficulty for consumers to provide or inability to provide evidence to support the actual amount of damage, he/she may request the Court to determine the compensation in the amount between NT$500 and NT$300,000 for each case of damage per person based on the circumstances of such damage.
直轄市、縣(市)政府受理同一原因事件,致二十人以上消費者受有損害之申訴時,應協助消費者依消費者保護法第五十條之規定辦理。 The municipal or county (city) government shall assist consumers in accordance with Article 50 of Consumer Protection Law, when receiving complaints concerning the damage from 20 or more consumers for a certain result of the same incident.
受消費者保護團體委任代理消費者保護法第四十九條第一項訴訟之律師,就該訴訟得請求報酬,不適用消費者保護法第四十九條第二項後段規定。 Attorneys who represent the consumer protection organizations to litigate according to Paragraph 1 of Article 49 of the Consumer Protection Act shall request the litigation remuneration and shall not be applicable to the latter part of Paragraph 2 of Article 49 of the Consumer Protection Act.
第 56-1 條 Article 56-1
中央主管機關為保障食品安全事件消費者之權益,得設立食品安全保護基金,並得委託其他機關(構)、法人或團體辦理。 The central competent authority may establish a food safety protection fund for protecting the consumer's right in the event of food safety and the fund may be commissioned to the authorized and appointed other agency (institution), corporation or organization.
前項基金之來源如下: The sources of funds mentioned in the preceding paragraph are as follows:
一、違反本法罰鍰之部分提撥。 1. funds from the partial appropriation of administrative fines in violation of this Act;
二、依本法科處並繳納之罰金,及因違反本法規定沒收或追徵之現金或變賣所得。 2. criminal fines that are fined pursuant to this Act; and cash from confiscating or indemnifying or proceeds from the sale of the confiscated property due to the violation of this Act;
三、依本法或行政罰法規定沒入、追繳、追徵或抵償之不當利得部分提撥。 3. the partial appropriation of improper gains that are forfeited, retrieved, indemnified or offset pursuant to this Act or Administrative Penalty Act;
四、基金孳息收入。 4. accrued interest income generated by the fund;
五、捐贈收入。 5. revenues from donations;
六、循預算程序之撥款。 6. appropriations made by the government through budgetary process; or
七、其他有關收入。 7. other related revenues.
前項第一款及第三款來源,以其處分生效日在中華民國一百零二年六月二十一日以後者適用。 The sources of funds mentioned in the subparagraphs 1 and 3 of the preceding paragraph are applicable to the dispositions that become effective from the date after 21th June 2013.
第一項基金之用途如下: The fund mentioned in Paragraph 1 is used for the following purposes:
一、補助消費者保護團體因食品衛生安全事件依消費者保護法之規定,提起消費訴訟之律師報酬及訴訟相關費用。 1. to subsidize consumer protection groups the remuneration fees for the attorneys and the relevant fees for consumer litigation filed in accordance with the Consumer Protection Law and resulted from the food sanitation and safety incident;
二、補助經公告之特定食品衛生安全事件,有關人體健康風險評估費用。 2. to subsidize fees concerning human health risk assessment on specified food sanitation and safety incident which has been announced by a public notice;
三、補助勞工因檢舉雇主違反本法之行為,遭雇主解僱、調職或其他不利處分所提之回復原狀、給付工資及損害賠償訴訟之律師報酬及訴訟相關費用。 3. to subsidize employee the remuneration of attorneys and relevant litigation fees for restoring the original status, payment and damage compensation when an employee was fired, reassigned the jobs or otherwise took any adverse sanction by the employer due to disclosing the employers’ behavior which violates this Act;
四、補助依第四十三條第二項所定辦法之獎金。 4.to subsidize rewards governed by the regulations in Paragraph 2 of Article 43; or
五、補助其他有關促進食品安全之相關費用。 5.to subsidize other relevant fees concerning food safety promotion and consumer litigation.
中央主管機關應設置基金運用管理監督小組,由學者專家、消保團體、社會公正人士組成,監督補助業務。 The central competent authority shall establish a supervision panel for management and utilization of the fund which composed of experts and scholars, consumer protection organizations, and impartial citizens to supervise the subsidizing affairs.
第四項基金之補助對象、申請資格、審查程序、補助基準、補助之廢止、前項基金運用管理監督小組之組成、運作及其他應遵行事項之辦法,由中央主管機關定之。 The regulation governing the recipients of the subsidies, application qualifications, review procedures, subsidization standard, revocation of subsidies of the fund mentioned in Paragraph 4, the formation and operation of the supervision panel for management and utilization of the fund mentioned in the preceding paragraph and other matters to be complied with shall be prescribed by the central competent authority.
第 十 章 附則 Chapter X Supplementary Provisions
第 57 條 Article 57
本法關於食品器具或容器之規定,於兒童常直接放入口內之玩具,準用之。 The provisions of this Act regarding food utensils and food containers shall apply mutatis mutandis to toys that are often directly placed into the mouth of children.
第 58 條 Article 58
中央主管機關依本法受理食品業者申請審查、檢驗及核發許可證,應收取審查費、檢驗費及證書費;其費額,由中央主管機關定之。 The central competent authority shall charge a review fee, testing fee, and license fee with respect to applications by food businesses for review, testing and issuance of permits. The respective amount of such fees shall be prescribed by the central competent authority.
第 59 條 Article 59
本法施行細則,由中央主管機關定之。 The enforcement rules of this Act shall be prescribed by the central competent authority.
第 60 條 Article 60
本法除第三十條申報制度與第三十三條保證金收取規定及第二十二條第一項第五款、第二十六條、第二十七條,自公布後一年施行外,自公布日施行。 Other than the declaration procedure specified in Article 30 and the provision concerning the receipt of deposit specified in Article 33, and Subparagraph 5 of Paragraph 1 of Article 22, Article 26 and Article 27, which are to be implemented one year after promulgation, this Act shall be implemented as of its being promulgated.
第二十二條第一項第四款自中華民國一百零三年六月十九日施行。 Subparagraph 4 of Paragraph 1 of Article 22 shall be implemented on 19th June 2014.
本法一百零三年一月二十八日修正條文第二十一條第三項,自公布後一年施行。 Paragraph 3 of Article 21 amended on 28th January 2014 shall be implemented one year after promulgation of this Act.
本法一百零三年十一月十八日修正條文,除第二十二條第一項第五款應標示可追溯之來源或生產系統規定,自公布後六個月施行;第七條第三項食品業者應設置實驗室規定、第二十二條第四項、第二十四條第一項食品添加物之原料應標示事項規定、第二十四條第三項及第三十五條第四項規定,自公布後一年施行外,自公布日施行。 The articles of this Act amended on 18th November 2014 shall be implemented as of its being promulgated. Other than the provision concerning the labeling of tracing sources or production systems specified in Subparagraph 5 of Paragraph 1 of Article 22 shall be implemented six months after promulgation of this Act; the provision concerning food businesses equipped with laboratories specified in Paragraph 3 of Article 7, Paragraph 4 of Article 22, the labeling of raw materials of food additives specified in Paragraph 1 of Article 24, Paragraph 3 of Article 24 and Paragraph 4 of Article 35 shall be implemented one year after promulgation of this Act.
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