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現行有效國際標準update 最後更新:Codex Alimentarius 2003 / FSMA 2011

HACCP

危害分析與關鍵控制點 食品法典食品安全體系

apartment發布組織:食品法典委員會 (FAO/WHO)

標準簡介

HACCP 是由 食品法典委員會 (FAO/WHO) 發布的現行有效標準,常用於食品飲料、製造業等產業,並適用於全球等市場。

本頁整理了 HACCP 的官方文件、目前狀態以及常見相關認證或評估機構,便於快速理解要求與落地路徑。

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Seven Principles

A systematic framework based on seven principles: hazard analysis, CCP identification, critical limits, monitoring, corrective actions, verification, and record-keeping — applied from raw materials to finished products.

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Legally Mandated

Unlike many food safety standards, HACCP is legally required in the US for seafood, juice, and meat/poultry processors. The EU also mandates HACCP-based procedures under Regulation (EC) No 852/2004.

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Preventive Approach

Focuses on preventing food safety hazards rather than detecting them in finished products — addressing biological, chemical, and physical hazards at critical control points in the production process.

list_alt The Seven HACCP Principles

  • Principle 1: Conduct a hazard analysis
  • Principle 2: Determine critical control points (CCPs)
  • Principle 3: Establish critical limits for each CCP
  • Principle 4: Establish monitoring procedures
  • Principle 5: Establish corrective actions
  • Principle 6: Establish verification procedures
  • Principle 7: Establish record-keeping and documentation

Who Needs to Comply?

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Food manufacturers, processors, and handlers — including seafood, meat, poultry, and juice processors (legally mandatory in the US), as well as any food business seeking to systematically manage food safety risks. Required by regulation in the US, EU, and many other jurisdictions.

Key Requirements

1

Hazard Analysis

Identify and evaluate all potential biological, chemical, and physical hazards associated with each step of the food production process — from raw material receipt through processing, storage, and distribution.

2

Critical Control Points

Determine the points, steps, or procedures in the process where control can be applied to prevent, eliminate, or reduce food safety hazards to acceptable levels. Use decision trees to systematically identify CCPs.

3

Critical Limits & Monitoring

Establish scientifically-based critical limits (e.g., temperature, time, pH) for each CCP. Implement monitoring procedures with defined frequency and responsibility to ensure critical limits are consistently met.

4

Corrective Actions & Verification

Define specific corrective actions when monitoring indicates a CCP deviation. Establish verification activities including CCP validation, record review, and periodic reassessment of the HACCP plan.

5

Documentation & Records

Maintain comprehensive records including the HACCP plan, hazard analysis, CCP monitoring logs, corrective action records, and verification activities. Records must be available for regulatory inspection.

Penalties & Enforcement

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As HACCP is legally mandated for certain food categories, non-compliance can result in FDA warning letters, injunctions, product seizures, and facility shutdowns. Criminal penalties for food safety violations can include fines and imprisonment. In the EU, failure to implement HACCP-based procedures can result in enforcement action by national food safety authorities.

官方文件

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實施時間線

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1960s
HACCP concept developed by Pillsbury for NASA space food safety
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1993年
Codex Alimentarius Commission adopts HACCP guidelines
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1997年
FDA mandates HACCP for seafood processing under 21 CFR Part 123
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1998年
USDA mandates HACCP for meat and poultry processing plants
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2001年
FDA mandates HACCP for juice processing and packaging
update
2011年
FSMA signed into law, building on HACCP with Hazard Analysis and Risk-Based Preventive Controls (HARPC)

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