食品安全評估與食品衛生管理 黃顯宗

聯合國FAO Assuring Food Safety and Quality: Guidelines for Strengthening National Food Control Systems

國家食品安全系統的元件 Food Law and Regulations Food Control Management Inspection Services Laboratory Services: Food Monitoring and Epidemiological Data Information, Education, Communication and Training

STRENGTHENING NATIONAL FOOD CONTROL SYSTEMS Principles of Food Control: Issues for Consideration Developing a National Food Control Strategy Strengthening Organizational Structures for National Food Control Systems Funding National Food Control Systems

Principles of Food Control: Issues for Consideration Integrated farm-to-table concept Risk Analysis Transparency Regulatory Impact Assessment

Principles of Food Control: Issues for Consideration關鍵原則 Maximizing risk reduction by applying the principle of prevention as fully as possible throughout the food chain; Addressing the farm-to-table continuum（時間線）; Establishing emergency procedures for dealing with particular hazards (e.g. recall of products); Developing science-based food control strategies;

Principles of Food Control: Issues for Consideration關鍵原則 Establishing priorities based on risk analysis and efficacy in risk management; Establishing holistic（整體性）, integrated initiatives which target risks and impact on economic well-being; and Recognizing that food control is a widely shared responsibility that requires positive interaction between all stakeholders（利害關係人）.

Risk Analysis Risk assessment Risk management Risk communication

Risk communication the interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions

Regulatory Impact Assessment consideration must be given to the costs of compliance (resources, personnel, and financial implications) to the food industry, as these costs are ultimately passed onto consumers. The important questions are: Do the benefits of regulation justify the costs? What is the most efficient management option?

Regulatory Impact Assessment Export inspection systems designed to assure the safety and quality of exported foods, will protect international markets, generate business and secure returns. Animal and plant health measures improve agricultural productivity. In contrast, food safety is an essential public health goal and may impose costs on producers, yet investments in food safety may not be immediately rewarded in the market place.

Regulatory Impact Assessment Two approaches to determine cost/benefit of regulatory measures in food safety: Theoretical models can be developed to estimate willingness to pay (WTP) for reduced risk of morbidity and mortality; and Cost of illness (COI) covering lifetime medical costs and lost productivity. Both approaches require considerable data for interpretation

Regulatory Impact Assessment COI estimates are perhaps easier for policy makers to understand and have been widely used to justify measures for food control, even though they do not measure the full value of risk reduction. Not surprisingly, it is easier to perform a RIA for an export inspection intervention, than for regulatory policy which achieves a public health outcome.

Developing a National Food Control Strategy Collection of Information Development of Strategy

Collection of Information The profile should permit a review of health and socioeconomic issues impacting on foodborne hazards, consumers concerns, and the growth of industry and trade, as well as identification of the functions of all sectors which are directly and indirectly involved in ensuring food safety and quality and consumer protection. The collection of epidemiological data on foodborne illness is an indispensable component of a country profile and should be done whenever possible.

Development of Strategy The strategy will be influenced by the country's stage of development, the size of its economy, and the level of sophistication of its food industry.

Development of Strategy The final strategy should include: A national strategy for food control with defined objectives, a plan of action for its implementation, and milestones; Development of appropriate food legislation, or revision of the existing legislation to achieve the objectives defined by the national strategy; Development or revision of food regulations, standards and codes of practice as well as harmonizing these with international requirements; A programme for strengthening food surveillance and control systems;

Development of Strategy Promotion of systems for improving food safety and quality along the food chain i.e. introduction of HACCP-based food control programmes; Development and organization of training programmes for food handlers and processors, food inspectors, and analysts; Enhanced inputs into research, foodborne disease surveillance, and data collection, as well as creating increased scientific capacity within the system; and Promotion of consumer education and other community outreach initiatives.

Strengthening Organizational Structures for National Food Control Systems (a) Multiple Agency System (b) Single Agency System (c) Integrated System

SPECIFIC ISSUES OF DEVELOPING COUNTRIES Food Systems Food Processing Industry Street Foods Food Control Infrastructure and Resources Technical Assistance: Role of International Agencies

SPECIFIC ISSUES OF DEVELOPING COUNTRIES Food Systems 上游小供應商多，參與人手多，收穫和保存等問題

SPECIFIC ISSUES OF DEVELOPING COUNTRIES Food Processing Industry 大小不一 良莠不齊 政府不能得罪小業者，就業人口故

SPECIFIC ISSUES OF DEVELOPING COUNTRIES Street Foods 依賴街食 安全問題多

SPECIFIC ISSUES OF DEVELOPING COUNTRIES Food Control Infrastructure and Resources 資源不足 管理制度和人力問題

Technical Assistance: Role of International Agencies Establishing or strengthening national food control systems and infrastructure; Assistance in preparation of food law and regulations; Workshops on developing national strategies for food control; Assistance in establishing or improving food analysis capabilities; Assessing the implications of SPS（食品安全檢驗與動植物防疫檢疫措施協定）and TBT （Technical Barriers to Trade）Agreements;

Technical Assistance: Role of International Agencies Providing training in food inspection, analysis and food handling; Providing training of trainers in HACCP; Providing training in management of food control systems; and Assistance in strengthening National Codex Committees.

食品添加物管理

假的黑珍珠？！

粉圓含防腐劑

瓜子太白

添加物使用準則 能抑制 / 殺死微生物 能防止 / 減緩敗化 不傷害消費者健康 無刺激性 容易取得與準備 檢驗測試不困難 使用不昂貴

政府規定 食品添加物使用範圍及限量暨規格標準 Gras, Generally Recognized as safe http://mohwlaw.mohw.gov.tw/Chi/FLAW/FLAWQRY01-1.asp?fcode=A011 Gras, Generally Recognized as safe

食品添加物法規 衛生福利部受理食品及食品添加物查驗登記審查費證書費收費標準 (102.10.03) 行政院衛生署受理食品、食品添加物查驗、登記審查費收費標準 (78.07.01) 食品添加物使用範圍及限量暨規格標準 (102.09.12) 食品添加物查驗登記作業要點 (86.09.01) 食品業者製造調配加工販賣貯存食品或食品添加物之場所及設施衛生標準 (92.03.31)

添加物分類 防腐劑 ( Preservatives ) : 如 己二烯酸、去水醋酸、苯甲酸及其鈉鹽等。 殺菌劑 ( Bacteriocides ) :  如 次氯酸鈉、過氧化氫等。 抗氧化劑 ( Antioxidants ) :    如BHA、BHT、L-抗壞血酸等。 漂白劑 ( Bleaching Agents ) :  如 亞硫酸鈉、酸性亞硫酸鈉、低亞硫酸鈉等。 保色劑 ( Color fasting ( Developing ) Agents ) : 如亞硝硫酸鈉、硝酸鈉、亞硝酸鉀、硝酸鉀等。 膨脹劑 ( Leavening Agents ) : 如 酸氫鈉、酸胺、合成膨脹劑等。 品質改良用、釀造用及食品製造用劑 ( Quality Improvement Distillery and Food Stuff Processing AgentS) : 如 硫酸鈣、乳酸鈣、磷酸氫鈣等。 營養添加劑 ( Nutritional enriching agents ) : 如 維生素A、B1、B6、D2、E、L-蛋胺酸、碘化鉀等。

添加物分類 著色劑 ( Coloring Agents ( Food Colors) ) : 如 食用紅色6號、食用黃色4號、水溶性婀娜多等。 香料( Perfumery ) :  如 丁香醇、乙酸丁酯、香莢蘭醛、桂皮酸等。 調味劑 ( Flavoring Agents ) : 如 檸檬酸、L-麩酸鈉(味精)、甘草素、糖精、胺基乙酸等。 黏稠劑( 糊料 ) ( Pasting ( Binding ) Agents ) : 如 海藻酸鈉、CMC、乾酪素等。 結看劑 ( Coagulating Agents ) :  如 焦磷酸鈉、多磷酸鈉、磷酸氫二鈉等。 食品工業用化學藥品 ( Chemicals for food industry ) : 如 氫氧化鈉、鹽酸、酸鉀等。 溶劑 ( Dissolving Agents ) : 如 丙二醇、己烷等。 乳化劑 ( Emuulsifiers ) : 如 脂肪酸甘油酯、大豆磷脂質等。 其他 ( Others ) : 如 矽藻土、矽樹脂等。

何謂安全性？ 相對安全性，沒有絕對安全 急性毒性：單劑量，短期病變 亞急性毒性：重複劑量，一星期至約200天 慢性毒性：重複劑量，長期追蹤 年輕人開車與老成人士開車 急性毒性：單劑量，短期病變 亞急性毒性：重複劑量，一星期至約200天 慢性毒性：重複劑量，長期追蹤

WHO/FAO評估依據 依據世界衛生組WHO織與糧農組織FAO在1958年發表的「使用化學物質為食品添加物時之安全性確認法」實施的毒性試驗(動物試驗)所得的毒性資料做為評估安全性的基本依據。主要的項目包括有： 基本試驗資料 每日攝取量的預估 代謝、吸收、排泄、分布、蓄積 對生物體機能的影響 毒性試驗資料 急性毒性 亞急性毒性 慢性毒性 (包括致癌性 ) 對次世代的影響 突變原性 畸胎性(催奇性)

急性毒性 甚麼是LD50？ LD， Lethal Dosage 致死劑量 LD50，半數動物致死之劑量 當LD50為 5g /Kg 時，一般認為無毒害

毒性試驗 急性毒性， LD50 每公斤5克無害 化學品 LD50 (g) NaCl 鹽 8-10 Vitamin B1 維生素B1 3.0 Lactic acid  乳酸 3.9 Acetic acid  醋酸 0.3 NaBenzoate  甲苯酸鹽防腐劑 2.0 BHT  抗氧化劑 1.39 BHA  抗氧化劑 4.13 Boric acid  硼酸 0.2-0.3 KCN   氰化鉀 0.004 急性毒性， LD50 每公斤5克無害

添加物安全用量評估 動無實驗評估無害劑量 安全用量多為無害用量之1/100 使用不只一種動物，常用者齧齒類（鼠類）、猿猴類、狗等 安全用量多為無害用量之1/100 WHO考慮人與動物的差別(10)，人與人的差別(10)，有些亦做1/250

絕對安全 零檢出？

Risk-Benefit Assessment 美國糖精(saccharin)的例子

食品衛生管理制度

食品衛生管理法 64公佈，72年修訂 不是食品管理法 第一章 總則 第一章 總則 第二章 食品衛生管理 只名不合衛生的狀況，如染有病原 菌，屠體，檢驗不及格等 添加物，器具，容器，包裝， 洗潔劑管理等 第三章 食品標示及廣告 第四章 食品衛生管理 場地環境，衛生人員

第五章 檢查及取締 省(市)，縣(市)主管檢驗方法依國家標準 第六章 罰則 1. 沒入 回收 2. 停止製造、販售、輸入等 3. 公告商號、地址、負責人 4. 3年以下有期徒刑、拘役、併科三千以上， 四萬以下罰金 5. 吊銷營業或設廠許可 第七章 附則

相關法令標準 CNS食品標準與檢驗方法標準 實品衛生標準 工場建築及設備標準 添加物使用標準 環境管理法規 健康食品管理法 基因改造食品管理

行政機構 中央級 衛生署：食品衛生處，藥檢局（合為TFDA），疾病管理局 衛生福利部 農委會 財政部：海關 經濟部：國貿局，工業局，標準檢驗局 　　　　智慧財產局（CNS）

行政機構 省與直轄市 衛生處(局)、建設廳(局)、農林廳、農業局 財產廳(局)、糧食局、警務處 縣市 衛生局、建設局

食品衛生的缺失 行政問題 衛生標準問題 國際關係問題 國民教育問題 法令問題 基層人力不足，訓練不足 經費不足 業者的不注意，不配合 延伸閱讀：http://microbiology.scu.edu.tw/wong/courses/foodmic/ppt/13food%20hygiene.ppt