FDA水产品HACCP法规(3)

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1、FDA水产品水产品HACCP 法规法规(fgu)- 21 CFR 123, 1240第一页，共七十七页。FDA水产品水产品HACCP 法规法规(fgu) Subpart A Definitions 定义 Good Manufacturing Practices GMP Hazard Analysis & Hazard Analysis Critical Control Point plan HACCP方案 Corrective Actions纠正措施 Verification 验证(ynzhng) Records 记录 Training 培训 Sanitation 卫生 SSOP Requir

2、ements of Imported Products 对进口产品的要求第二页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) Subpart B - Smoked Fish 烟熏鱼第三页，共七十七页。FDA水产品水产品HACCP 法规法规(fgu) Subpart C - Raw Molluscan Shellfish 生的软体贝类第四页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) HACCP 只适用于 : 食品(shpn)平安的危害第五页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) Subpart A 适用(shyng)于所有加工者第六页，共七十

3、七页。FDA水产品水产品HACCP法规法规(fgu) 不受法规制约的设施: Fishing Vessels 捕捞船 Transportation Vehicles 运输工具 Retail Establishments, Including Restaurants 包括(boku)餐馆在内的零售设施 第七页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) Definitions: Processing 加工(ji gng) - Handling, storing, preparing, heading, eviscerating, shucking, freezing, changi

4、ng form, manufacturing, preserving, packing, labeling, dockside unloading, or holding. 第八页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)Definitions: Fish 水产(shuchn) - all forms of aquatic animal life intended for human consumption; including amphibians, mollusks, and roe. 第九页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)Definition

5、s: Fishery Products 水产(shuchn)制品 - any human food product in which fish is the characterizing ingredient. 第十页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) Good Manufacturing Practices (GMPs)Ties GMPs HACCP regulations第十一页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)Includes all seven principles of HACCP 七个原如此或原理:Conducting a Haz

6、ard Analysis 危害(wihi)分析Identifying Critical Control Points (CCP) 确定关键控制点Establishing Critical Limits 建立关键限值Monitoring Each CCP 监测每个CCP点Establishing Corrective Actions to be Taken When a Critical Limit Deviation Occurs 纠正措施Establishing a Record-Keeping System 记录保持系统Establishing Verification Procedure

7、s 验证程序 第十二页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)Conducting a hazard analysis: Are there food safety hazards associated with my product that are reasonably likely to occur? Are there preventative measures that I can apply to control these hazards? Hazards are defined as physical, microbiological and/or chem

8、ical 物理物理(wl)、化学与生物危害、化学与生物危害第十三页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) Hazard must be one that is reasonably likely to occur 极可能发生(fshng)的危害第十四页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) No one way to do a hazard analysis 进展危害(wihi)分析的途径很多 Be certain to use the Guide 一定要使用?指南? No hazards - No HACCP plan is necessary 没

9、有显著没有显著(xinzh)危害，就不需要危害，就不需要HACCP方案方案第十五页，共七十七页。FDA水产品水产品HACCP法规法规(fgu) The HACCP Plan Each Location Each Product HACCP方案(fng n)是针对于每一个加工地点、每一种产品第十六页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)HACCP方案必须包括 :The Food Safety Hazard 食品平安危害The Critical Control Points of Each Hazard 每一个危害的关键(gunjin)控制点The Critical Limi

10、ts 关键限值The Monitoring Procedures 监测程序The Required Records 要求的记录A Corrective Action 纠正措施The Verification Procedures 验证程序 第十七页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)HACCP Plan - Hazards to be considered 要考虑到的危害:Natural Toxins 天然毒素Microbiological 微生物Chemical Pesticides 化学(huxu)杀虫剂 农药Drug Residues 药物兽药残留Unapprov

11、ed Uses of Food and Color Additives 未经批准使用的食品添加剂和色素Physical Hazards 物理的危害Decomposition Related to Safety 与平安有关的腐败 第十八页，共七十七页。FDA水产品水产品HACCP法规法规(fgu)HACCP Plan - Critical Control Points and Critical Limits: Critical Control Points 关键(gunjin)控制点 - A point in processing where controls need to be in pla