Standards Comparison

    CE Marking

    Mandatory
    1985

    EU marking for product conformity to health/safety rules

    VS

    FSSC 22000

    Voluntary
    2023

    GFSI-benchmarked certification scheme for food safety management.

    Quick Verdict

    CE Marking declares EU product safety conformity for free market access, while FSSC 22000 certifies food safety systems via audits. Manufacturers use CE for legal EU sales; food firms adopt FSSC for GFSI trust and supply chain approval.

    Product Safety

    CE Marking

    CE Marking (Conformité Européenne)

    Cost
    €€€
    Complexity
    High
    Implementation Time
    6-12 months

    Key Features

    • Manufacturer's self-declaration of conformity to essential requirements
    • Enables free movement across EEA single market
    • Risk-proportionate conformity assessment modules A-H
    • OJEU-published harmonised standards presume conformity
    • Mandatory technical file retention for 10 years
    Food Safety

    FSSC 22000

    Food Safety System Certification 22000

    Cost
    €€€€
    Complexity
    High
    Implementation Time
    6-12 months

    Key Features

    • GFSI-benchmarked FSMS certification scheme
    • Integrates ISO 22000 with sector PRPs
    • Mandatory food defense and fraud mitigation
    • Additional requirements for allergens and culture
    • Rigorous audit duration and reporting rules

    Detailed Analysis

    A comprehensive look at the specific requirements, scope, and impact of each standard.

    CE Marking Details

    What It Is

    CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation like Low Voltage Directive and Machinery Directive. It signifies the manufacturer's declaration that products meet essential health, safety, and environmental requirements. The approach is risk-based, using conformity assessment modules (A-H) scaled to product hazards.

    Key Components

    • Identification of applicable directives/regulations and essential requirements.
    • Harmonised standards from OJEU for presumption of conformity.
    • Technical documentation, EU Declaration of Conformity (DoC), and CE mark affixing.
    • Self-assessment or Notified Body involvement; post-market surveillance under Regulation (EU) 2019/1020.

    Why Organizations Use It

    Mandated for EEA market access, it enables free circulation, reduces trade barriers, and ensures compliance to avoid fines/recalls. Benefits include risk mitigation, stakeholder trust, and competitive edge via proven safety.

    Implementation Overview

    Map legislation, perform risk assessment, compile technical file, issue DoC, affix mark. Applies to manufacturers/importers across industries; self-certification for low-risk, audits for high-risk. Retain files 10+ years.

    FSSC 22000 Details

    What It Is

    FSSC 22000 (Food Safety System Certification 22000) is a GFSI-benchmarked certification scheme for Food Safety Management Systems (FSMS). It applies across food chain categories like manufacturing, packaging, and logistics. The scheme uses a risk-based management system approach integrating ISO 22000:2018 with sector PRPs and additional requirements.

    Key Components

    • **Three pillarsISO 22000:2018 (clauses 4-10), sector-specific PRPs (e.g., ISO/TS 22002-1 for manufacturing), FSSC Additional Requirements (e.g., food defense, fraud, allergens).
    • Over 100 requirements across governance, operations, and verification.
    • Built on PDCA cycle and HACCP principles.
    • Third-party certification by licensed bodies per ISO 22003-1:2022.

    Why Organizations Use It

    • Meets retailer and export demands via GFSI recognition.
    • Reduces recalls, enhances supply chain trust.
    • Manages risks like fraud, defense, and allergens.
    • Builds reputation with 40,000+ certified sites globally.

    Implementation Overview

    • Phased: gap analysis, FSMS design, training, audits.
    • 6-12 months typical for small sites.
    • Applies to food chain organizations worldwide.
    • Requires initial, surveillance, recertification audits.

    Key Differences

    Scope

    CE Marking
    EU product health/safety conformity
    FSSC 22000
    Food chain safety management systems

    Industry

    CE Marking
    Manufacturing (electronics, machinery, toys)
    FSSC 22000
    Food processing, packaging, catering

    Nature

    CE Marking
    Mandatory self-declaration for EU market
    FSSC 22000
    Voluntary GFSI-benchmarked certification

    Testing

    CE Marking
    Self or notified body assessment modules
    FSSC 22000
    ISO audits with PRP/HACCP verification

    Penalties

    CE Marking
    Market withdrawal, fines by authorities
    FSSC 22000
    Loss of certification, no legal penalties

    Frequently Asked Questions

    Common questions about CE Marking and FSSC 22000

    CE Marking FAQ

    FSSC 22000 FAQ

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