FDA水产品HACCP 法规.ppt

1、食品论坛 ,FDA水产品HACCP 法规- 21 CFR 123, 1240,食品论坛 ,FDA水产品HACCP 法规,Subpart A Definitions 定义 Good Manufacturing Practices （GMP） Hazard Analysis including amphibians, mollusks, and roe.,食品论坛 ,FDA水产品HACCP法规,Definitions: Fishery Products 水产制品 - any human food product in which fish is the characterizing ingredi

2、ent.,食品论坛 ,FDA水产品HACCP法规,Good Manufacturing Practices (GMPs) Ties GMPs HACCP regulations,食品论坛 ,FDA水产品HACCP法规,Includes all seven principles of HACCP 七个原则或原理: Conducting a Hazard Analysis 危害分析 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

3、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 Procedures 验证程序,食品论坛 ,FDA水产品HACCP法规,Conducting a hazard analysis: Are there food safety hazards associated with my product that are reas

4、onably likely to occur? Are there preventative measures that I can apply to control these hazards?,Hazards are defined as physical, microbiological and/or chemical 物理、化学与生物危害,食品论坛 ,FDA水产品HACCP法规,Hazard must be one that is reasonably likely to occur 极可能发生的危害,食品论坛 ,FDA水产品HACCP法规,No one way to do a haz

5、ard analysis 进行危害分析的途径很多 Be certain to use the Guide 一定要使用指南,No hazards - No HACCP plan is necessary 没有（显著）危害，就不需要HACCP计划,食品论坛 ,FDA水产品HACCP法规,The HACCP Plan Each Location Each Product HACCP计划是针对于每一个加工地点、每一种产品,食品论坛 ,FDA水产品HACCP法规,HACCP计划必须包括 : The Food Safety Hazard 食品安全危害 The Critical Control Points

6、 of Each Hazard 每一个危害的关键控制点 The Critical Limits 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,食品论坛 ,FDA水产品HACCP法规,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 化学杀虫

7、剂 （农药） Drug Residues 药物（兽药）残留 Unapproved 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 与安全有关的腐败,食品论坛 ,FDA水产品HACCP法规,HACCP Plan - Critical Control Points and Critical Limits: Critical Control Points 关键控制点 - A point in processing where controls

8、 need to be in place Critical Limits 关键限值 - A limit expressed as a value (i.e. time or temperature) listed at a critical control point.,食品论坛 ,FDA水产品HACCP法规,Monitoring Procedures 监测程序: What Will Be Monitored 监测什么？ How Will Monitoring Be Done 怎样监测？ Frequency of Monitoring 监测频率、时间？ Who? 谁负责监测？ Where? 在

9、哪监测？,食品论坛 ,FDA水产品HACCP法规,Corrective Action - Predetermined 预先确定好的纠正措施: Corrective Action Plans 纠正措施计划,食品论坛 ,FDA水产品HACCP法规,Verification 验证 - Reassessment 重新评估: Verify Plans No Less Than Once A Year 验证HACCP计划每年至少一次,食品论坛 ,FDA水产品HACCP法规,Verification - List Changes 以下改变必须验证: Raw Materials or Sources of R

10、aw Materials 原料或原料来源 Product Formulation 产品配方 Processing Methods or Systems 加工方法或系统 Finished Product Distribution 成品的配发 Intended Use of the Finished Product by Consumers 消费者对成品预期用途,食品论坛 ,FDA水产品HACCP法规,Verification - Verifying Performance 验证的措施: Consumer Complaints 消费者投诉 Calibrating Instruments (i.e.

11、, thermometers) 校准仪器 Testing 检测 Reviewing Records 审核记录,食品论坛 ,FDA水产品HACCP法规,Verification - Reassess Hazard Analysis 重新评估危害分析: Reassess Hazard Analysis - Whenever There Is a Change 一旦有改变，就必须重新进行危害分析。,食品论坛 ,FDA水产品HACCP法规,Records - Types 文件记录的类型: HACCP Plan HACCP计划 Monitoring Records 监测记录 Corrective Act

12、ion Records 纠偏记录 Verification Measures 验证记录 Sanitation Records 卫生方面的记录 Importer Verification Records 进口商验证记录,食品论坛 ,FDA水产品HACCP法规,Records - Required Information 记录的信息: Name and Location of Processor or Importer 加工者或进口商的名称和地点 Date and Time of Activity Being Recorded 被记录活动的日期和时间 Signature or Initials o

13、f Person Making Record 记录人员的签名 Product Identity and Code (when appropriate) 产品名称和代码,食品论坛 ,FDA水产品HACCP法规,Records - Retention 记录保留的时间: Refrigerated Products - 1 Year 冷藏产品 一年 Frozen Products - 2 Years 冷冻产品 二年,食品论坛 ,FDA水产品HACCP法规,Records - Access: FDA Has Access to HACCP Records and Plans and may copy t

14、hem (for domestic processors) FDA Has Access to Importer Records FDA有权检查有关记录，并进行复印。,食品论坛 ,FDA水产品HACCP法规,Plan Contents (复习)HHACCP计划的内容包括： Hazards 危害 Critical Control Points 关键控制点 Critical Limits 关键限值 Corrective Actions 纠正措施 Records 记录 Verification 验证,食品论坛 ,FDA水产品HACCP法规,Training - Options 培训方面的要求: Tr

15、aining in HACCP 参加相当的培训 On-The Job Experience 有一定工作经验 “The Seafood HACCP Alliance” 美国水产品HACCP联盟,食品论坛 ,FDA水产品HACCP法规,Training - Choices: One Trained Employee 工作人员参加培训 Trained Consultant 请培训过的专家顾问,食品论坛 ,FDA水产品HACCP法规,Training - Individual Shall 下列工作必须要有一定资格的人员来进行: Develop or Amend the HACCP Plan 制订或修改

16、HACCP计划 Reassess and/or Modify the HACCP Plan 重新评估、修改HACCP计划 Reassess and Modify the Hazard Analysis 重新评估和修改危害分析 Review All Records 审核所有的记录,食品论坛 ,FDA水产品HACCP法规,Sanitation - Prerequisit HACCP的前提条件 :Prerequisite to HACCP Monitoring 监测 Records 记录 Corrections 纠偏,食品论坛 ,FDA水产品HACCP法规,Sanitation - 8 Areas

17、:SSOP至少包括8个方面 Safety of Water That Comes in Contact With Food, Food Contact Surfaces, or Used to Make Ice Condition of Food Contact Surfaces Prevention of Cross Contamination Exclusion of Pests Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities Protection From Contaminants Proper Lab

18、eling, Storage and Use of Toxic Compounds Control of Employee Health Conditions,食品论坛 ,FDA水产品HACCP法规,Sanitation - Monitoring Frequency: Monitoring Frequencies 监测频率 Corrective Measures 纠正措施 Records 记录,Records are required even if no HACCP plan is required 即使没有HACCP计划，仍然要求SSOP记录,食品论坛 ,FDA水产品HACCP法规,San

19、itation - Handled Separately:,Sanitation controls can be included in the HACCP plan. 卫生控制可包含再HACCP计划中。,Sanitation controls can be handled outside of the HACCP plan. 卫生控制可不包含在HACCP计划里。,食品论坛 ,IMPORTER REQUIREMENTS 对进口商的要求,食品论坛 ,Coverage General Provisions 一般条款： All Processors 对所有加工者 Special Requiremen

20、ts for Importers 对进口商 Special Provisions 特殊条款： Smoked Fish Raw Molluscan Shellfish,食品论坛 ,Definitions 定义 Importer 进口商 - means either the U.S. owner or consignee at the time of entry into the United States, or the U.W. agent or representative of the foreign owner or consignee at the time of entry in t

21、he United States, who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation,食品论坛 ,Imports 21 CFR Part 123.12 Importer Verification 进口商验证 Import From Countries With An MOU 从与FDA签署相应MOU的国家进口 Or或 Implement Verific

22、ation Procedures 实施进口商验证程序 -（可由有资格的第三方实施）,食品论坛 ,Written Verification Procedures 书面的验证程序 Product Specifications to ensure that the product is not injurious to health and not processed under insanitary conditions 产品说明书 Affirmative Step 确认步骤,食品论坛 ,HACCP REGULATION OVERVIEW IMPORTER REQUIREMENTS,Affirma

23、tive Step Requirement - Choose at least one: 任选其一 On-site visits by the importer 进口商现场检查 Obtaining the processors HACCP and sanitation records 得到加工者的HACCP计划和卫生方面的记录 Obtaining the processors HACCP plan and guarantee 得到加工者的HACCP计划和保证书 End-product testing and guarantee 最终产品检测和保证书 Obtaining a continuing

24、 or lot-by-lot certification 得到连续的或逐批的证书 （官方或第三方） Other verification methods其他验证方法,食品论坛 ,Aquaculture Processing 养殖过程中的药物使用 Hazards associated with use of medications in feed or by direct administration,Office of Seafood,食品论坛 ,Aquaculture Processing Drugs used for: 药物用于 Treating and preventing diseas

25、e 治疗和预防疾病 Controlling parasites 控制寄生虫 Controlling reproduction 控制繁殖 Controlling growth 控制生长 Tranquilizing 镇静,Office of Seafood,食品论坛 ,Aquaculture Processing Conditions for drug approval: Species for which the drug is approved 用药品种 Approved dosage 剂量 Approved route of transmission 用药途径 Approved freque

26、ncy of use 用药频率 Approved indications for use 症状,Office of Seafood,食品论坛 ,Aquaculture Processing Drugs approved by FDA: FDA批准的药物 Chorionic Gonadotropin Formalin solution Tricaine methanesulfonate Oxytetracycline Sulfamerazine Sulfadimethoxine/ormetoprim,Office of Seafood,食品论坛 ,Aquaculture Processing L

27、abels of approved drugs list the mandatory withdrawal times, where applicable. 停药期,Office of Seafood,食品论坛 ,Aquaculture Processing Tissue residue tolerances have been established for some drugs. 组织残留限量,Office of Seafood,食品论坛 ,Molluscan Shellfish,Shellfish Authority Government authority responsible fo

28、r enforcement of all regulatory requirements associated with shellfish,食品论坛 ,Molluscan Shellfish,Shellfish defined as: Oysters Clams Mussels Scallops,食品论坛 ,Molluscan Shellfish,Regulatory requirements of the Shellfish Authority include: Growing area classification Harvesting control Processing plant

29、and procedure control Product labeling Storage, handling and packing Shipment control,食品论坛 ,Molluscan Shellfish,Hazards Associated With Shellfish: Pathogen microorganisms Natural Toxins from the harvest water Chemical contaminants from the harvest water,食品论坛 ,Molluscan Shellfish,Import of Raw Mollus

30、can Shellfish Raw molluscan shellfish can only be imported into the United States from countries that have a current Memorandum of Understanding (MOU) with the United States Food and Drug Administration.,食品论坛 ,Molluscan Shellfish,Import of Molluscan Shellfish Current MOU countries include: Canada Ne

31、w Zealand Chile South Korea,食品论坛 ,Molluscan Shellfish,Control of Pathogenic Microorganisms in Shellfish from MOU Countries For countries that currently have a MOU with FDA, the control strategy for pathogenic microorganisms is implementation of NSSP requirements to control the growing, harvesting, p

32、rocessing, labeling, and shipping of molluscan shellfish.,食品论坛 ,Molluscan Shellfish,Control of Pathogenic Microorganisms in Shellfish from Non-MOU Countries For countries that DO NOT currently have a Memorandum of Understanding with FDA for importation of raw molluscan shellfish, the control strateg

33、y for pathogenic microorganisms will be adequate cooking.,食品论坛 ,Molluscan Shellfish,Control of Pathogenic Microorganisms in Shellfish from Non-MOU Countries Cooking or pasteurization process must reduce the target organism to a non-detectable level.,食品论坛 ,Molluscan Shellfish,Control of Pathogenic Mi

34、croorganisms Countries that do not currently have a Memorandum of Understanding with the United States for raw molluscan shellfish are NOT permitted to import raw shellfish into the United States.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Cooked molluscan shellfish is permitted to be impor

35、ted into the United States only if the processor has controlled the hazards associated with natural toxins from the harvest water.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Cooking will not eliminate or significantly reduce the level of natural toxins in shellfish meats.,食品论坛 ,Molluscan Sh

36、ellfish,Control of Natural Toxins 2 methods of Control Monitoring of shellfish meats from “key” locations in the growing areas OR Monitoring of shellfish meats on a lot-by-lot basis at the processing facility.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins If natural toxins are controlled by mo

37、nitoring shellfish at the growing area, the Control Authority must have authority to close the area from harvesting when unsafe levels are present in shellfish meats.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins There are four recognized shellfish poisoning syndromes resulting from natural to

38、xins produced by marine algae.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Paralytic Shellfish Poisoning (PSP) Neurotoxic Shellfish Poisoning (NSP) Diarrhetic Shellfish Poisoning (DSP) Amnesic Shellfish Poisoning (ASP),食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Action Levels in Meat

39、s Paralytic Shellfish Poisoning - 0.8 PPM (80ug/100g) saxitoxin equivalent.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Action Levels in Meats Neurotoxic Shellfish Poisoning - 0.8 PPM (20 mouse units/100g) brevetoxin-2 equivalent.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Action Levels in Meats Diarrhetic Shellfish Poisoning - 0.2 PPM okadaic acid plus 35-methyl okadaic acid.,食品论坛 ,Molluscan Shellfish,Control of Natural Toxins Action