Standards Comparison

    CE Marking

    Mandatory
    1985

    EU marking indicating product conformity to harmonised legislation

    VS

    APPI

    Mandatory
    2003

    Japan's regulation for personal information protection

    Quick Verdict

    CE Marking declares product conformity to EU safety rules for EEA market access, while APPI mandates privacy protections for Japanese personal data. Companies adopt CE for free EU trade; APPI to avoid PPC fines and build consumer trust.

    Product Safety

    CE Marking

    CE Marking (Conformité Européenne)

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

    Key Features

    • Manufacturer's legally binding conformity declaration
    • OJEU harmonised standards presumption of conformity
    • Risk-based modules A-H for assessment
    • Enables free circulation across EEA markets
    • Technical file retention for 10+ years
    Data Privacy

    APPI

    Act on the Protection of Personal Information

    Cost
    €€€€
    Complexity
    High
    Implementation Time
    12-18 months

    Key Features

    • Extraterritorial scope for foreign businesses targeting Japan
    • Pseudonymously processed information enables analytics flexibility
    • Explicit consent required for sensitive data transfers
    • Data subject rights with 30-day response timelines
    • PPC enforcement with ¥100M fines and audits

    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 the New Legislative Framework (NLF). It signifies the manufacturer's declaration that products meet essential health, safety, and environmental requirements. The risk-based approach scales assessment from self-declaration to notified body involvement via modules A-H.

    Key Components

    • Essential requirements from directives (e.g., LVD 2014/35/EU, Machinery Directive).
    • Harmonised standards in OJEU for presumption of conformity.
    • Technical documentation, EU Declaration of Conformity (DoC), and CE affixation.
    • Post-market surveillance under Regulation (EU) 2019/1020. Self-assessment or third-party certification model applies.

    Why Organizations Use It

    Mandated for EEA market access, it enables free circulation, reduces trade barriers, and ensures compliance liability. Benefits include risk mitigation, stakeholder trust, competitive edge in tenders, and alignment with sustainability goals.

    Implementation Overview

    Involves legislation mapping, risk assessment, testing, documentation compilation, DoC issuance, and marking. Applies to manufacturers across industries; suitable for SMEs to globals. Requires audits for notified body routes; timelines vary by risk (6-12 months typical).

    APPI Details

    What It Is

    The Act on the Protection of Personal Information (APPI) is Japan's cornerstone regulation governing personal data handling, enacted in 2003 with major amendments in 2022-2024. It defines personal information broadly, including pseudonymous data, and employs a risk-based approach balancing privacy safeguards with data utility in a digital economy, applying extraterritorially to foreign businesses targeting Japanese residents.

    Key Components

    • Pillars: explicit consent, purpose limitation, security controls, data subject rights (access, correction, deletion)
    • Heightened rules for sensitive information (e.g., medical, racial data)
    • Pseudonymously processed information for analytics flexibility
    • Overseen by PPC; fines up to ¥100 million; no fixed controls, compliance via guidelines

    Why Organizations Use It

    APPI ensures legal compliance amid PPC enforcement, mitigates breach risks, and builds trust—78% of consumers prefer compliant brands. It drives efficiency (15-25% cost savings), enables cross-border transfers via SCCs, and provides competitive edges like P Mark certification for contracts.

    Implementation Overview

    Phased 12-24 month framework: gap analysis, policy design, technical deployment (encryption, DSR portals), training, monitoring. Applies to all organizations handling Japanese data; DPOs mandatory for large firms; PPC audits required, P Mark voluntary.

    Key Differences

    Scope

    CE Marking
    Product safety, health, conformity to EU harmonised rules
    APPI
    Personal data protection, privacy handling

    Industry

    CE Marking
    Manufacturers of regulated products (machinery, electronics), EEA-focused
    APPI
    All businesses handling Japanese residents' data, Japan-focused

    Nature

    CE Marking
    Mandatory self-declaration for covered products, EU legislation
    APPI
    Mandatory data protection law, enforced by PPC

    Testing

    CE Marking
    Conformity assessment modules, notified body for high-risk
    APPI
    Security measures, risk assessments, no formal certification

    Penalties

    CE Marking
    Market withdrawal, fines by national authorities
    APPI
    ¥100M fines, PPC orders, criminal penalties

    Frequently Asked Questions

    Common questions about CE Marking and APPI

    CE Marking FAQ

    APPI FAQ

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