Standards Comparison

    RoHS

    Mandatory
    2011

    EU regulation restricting hazardous substances in EEE

    VS

    EU AI Act

    Mandatory
    2024

    EU regulation for risk-based AI governance

    Quick Verdict

    RoHS restricts hazardous substances in EEE for EU market access, while EU AI Act regulates high-risk AI systems with conformity assessments. Companies adopt RoHS for safe recyclability and AI Act for ethical, safe AI deployment and compliance.

    Hazardous Substances

    RoHS

    Directive 2011/65/EU (RoHS 2)

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

    Key Features

    • Restricts 10 hazardous substances at 0.1% in homogeneous materials
    • Open scope covers all EEE unless explicitly excluded
    • Time-limited exemptions for impracticable substitutions
    • Requires technical file and EU Declaration of Conformity
    • Dynamic updates through delegated acts and reviews
    Artificial Intelligence

    EU AI Act

    Regulation (EU) 2024/1689 Artificial Intelligence Act

    Cost
    €€€
    Complexity
    Medium
    Implementation Time
    18-24 months

    Key Features

    • Risk-based four-tier AI classification framework
    • Prohibitions on unacceptable AI practices (Art. 5)
    • High-risk conformity assessments and CE marking
    • GPAI model transparency and systemic risk duties
    • Post-market monitoring and tiered fines

    Detailed Analysis

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

    RoHS Details

    What It Is

    RoHS (Directive 2011/65/EU, or RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE). It protects health and environment by limiting risks in waste management, using an open-scope approach for all EEE unless excluded, with homogeneous material concentration thresholds as the core methodology.

    Key Components

    • Ten restricted substances: Pb, Hg, Cd, Cr(VI), PBB, PBDE, DEHP, BBP, DBP, DIBP
    • Thresholds: 0.1% w/w (Cd at 0.01%)
    • Time-limited exemptions (Annexes III/IV)
    • Compliance model: technical documentation, EU Declaration of Conformity (DoC), CE marking

    Why Organizations Use It

    • Mandatory for EU/EEA market access, avoiding fines/recalls
    • Improves recyclability, supply chain integrity, ESG reporting
    • Manages risks from decentralized enforcement
    • Builds stakeholder trust, competitive edge in global markets

    Implementation Overview

    Risk-based: product scoping, BoM analysis, supplier declarations, tiered testing (IEC 62321), technical files. Targets EEE manufacturers/importers; 6-18 months initial, ongoing for exemptions/updates. Applies globally via equivalents like China RoHS 2.

    EU AI Act Details

    What It Is

    Regulation (EU) 2024/1689, the EU Artificial Intelligence Act, is a comprehensive horizontal regulation establishing a risk-based framework for AI systems. It prohibits unacceptable-risk practices, regulates high-risk systems via lifecycle controls, mandates transparency for limited-risk AI, and minimally regulates others.

    Key Components

    • **Four risk tiersunacceptable (banned), high-risk (conformity assessment, risk management), limited (transparency), minimal (voluntary).
    • Core obligations: risk management (Art. 9), data governance (Art. 10), documentation (Arts. 11-13), human oversight (Art. 14), cybersecurity (Art. 15).
    • GPAI models (Chapter V) with systemic risk duties; CE marking, EU database registration; tiered fines up to 7% global turnover.

    Why Organizations Use It

    Mandatory for EU market access; mitigates legal risks, fines; enhances trust, competitiveness in sectors like employment, healthcare; integrates with GDPR, product safety laws.

    Implementation Overview

    Phased rollout (6-36 months); inventory/classify AI, build QMS, conformity assessments, post-market monitoring. Applies EU-wide to providers/deployers; cross-industry, high complexity for high-risk AI.

    Key Differences

    Scope

    RoHS
    Hazardous substances in EEE materials
    EU AI Act
    Risk-based AI systems and practices

    Industry

    RoHS
    EEE manufacturers, EU/EEA market
    EU AI Act
    AI providers/deployers, EU-wide sectors

    Nature

    RoHS
    Mandatory EU directive, decentralized enforcement
    EU AI Act
    Mandatory EU regulation, hybrid oversight

    Testing

    RoHS
    XRF screening, IEC 62321 lab tests
    EU AI Act
    Conformity assessment, notified bodies

    Penalties

    RoHS
    Member State fines, recalls, decentralized
    EU AI Act
    Up to 7% global turnover fines

    Frequently Asked Questions

    Common questions about RoHS and EU AI Act

    RoHS FAQ

    EU AI Act FAQ

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