CE Marking
EU marking indicating product conformity to harmonised rules
RoHS
EU regulation restricting hazardous substances in EEE.
Quick Verdict
CE Marking declares broad EU product safety conformity via self-assessment or notified bodies, enabling EEA market access. RoHS specifically restricts 10 hazardous substances in EEE materials. Companies adopt both for legal EU sales, risk mitigation, and supply chain trust.
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer's legally binding conformity declaration
- Enables free circulation across EEA market
- Risk-proportionate conformity assessment modules A-H
- OJEU harmonised standards presumption of conformity
- 10-year technical file retention obligation
RoHS
Directive 2011/65/EU (RoHS 2)
Key Features
- Restricts 10 substances at 0.1% in homogeneous materials
- Open scope: all EEE unless explicitly excluded
- Time-limited exemptions via delegated directives
- Requires technical file and EU Declaration of Conformity
- Tiered testing per IEC 62321 standards
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 New Legislative Framework directives. It signifies the manufacturer's declaration that products meet essential health, safety, and environmental requirements. Scope covers categories such as electrical equipment, machinery, and medical devices. Key approach is risk-proportionate, using conformity assessment modules (A-H) and OJEU-published harmonised standards for presumption of conformity.
Key Components
- Essential requirements translation into design and testing.
- Conformity modules from self-assessment (Module A) to full quality assurance (Module H).
- Technical documentation, EU Declaration of Conformity (DoC), and CE affixation rules.
- Built on New Approach principles; no fixed control count, legislation-specific. Compliance model: manufacturer-led self-declaration or Notified Body verification.
Why Organizations Use It
Mandated for EEA market access; enables free movement without national barriers. Reduces trade friction, builds stakeholder trust, mitigates liability. Strategic benefits include procurement advantages and fair competition. Addresses post-market surveillance under Reg (EU) 2019/1020.
Implementation Overview
Map applicable directives, conduct risk assessments, compile technical files, issue DoC. Applies to manufacturers/importers across industries/geographies targeting EEA. Self-assessment for low-risk; Notified Body audits for high-risk. Retain files 10 years; ongoing surveillance required. (178 words)
RoHS Details
What It Is
RoHS (Directive 2011/65/EU, recast as RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE) to protect health and environment during waste management. It applies an open-scope approach to all EEE unless excluded, using homogeneous material thresholds (0.1% w/w for most, 0.01% for Cd).
Key Components
- Restricts 10 substances (Pb, Hg, Cd, Cr(VI), PBB, PBDE, DEHP, BBP, DBP, DIBP).
- Annex III/IV exemptions (time-limited, application-specific).
- Technical documentation per EN IEC 63000 and EU Declaration of Conformity (DoC).
- **Tiered verificationsupplier declarations + IEC 62321 testing (XRF screening, ICP-MS/GC-MS confirmation).
Why Organizations Use It
- Mandatory for EU market access; prevents fines, recalls.
- Enhances supply chain governance, recyclability, ESG reporting.
- Reduces e-waste risks, ensures level playing field.
Implementation Overview
- **Risk-basedscope analysis, BoM mapping, supplier controls, testing strategy.
- Applies to manufacturers/importers of EEE; 10-year documentation retention.
- Phased: governance, gap analysis, design controls, audits (3-18 months typical).
Key Differences
| Aspect | CE Marking | RoHS |
|---|---|---|
| Scope | Health, safety, environmental requirements across multiple directives | Hazardous substances restriction in EEE homogeneous materials |
| Industry | Broad product categories (machinery, toys, medical, electronics) | Electrical and electronic equipment (EEE) categories 1-11 |
| Nature | Manufacturer self-declaration of conformity, mandatory for scope | Mandatory substance limits with exemptions, CE-integrated |
| Testing | Conformity modules A-H, self or notified body assessment | Tiered XRF screening + IEC 62321 lab confirmation |
| Penalties | Market withdrawal, fines by Member States | Product bans, fines up to turnover percentage |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CE Marking and RoHS
CE Marking FAQ
RoHS FAQ
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