EU Market Access Compliance Guide: CE, REACH, RoHS, GPSR Explained

For Chinese cross-border sellers entering the European market, CE marking, REACH, RoHS, and the new GPSR regulation form four mandatory compliance pillars. Missing any one can result in customs seizure, marketplace delisting, or fines. This article provides a comprehensive overview.

1. CE Marking — EU Market Passport

CE (Conformité Européenne) is a mandatory conformity mark for products sold in the EU/EEA. It indicates the product meets EU health, safety, and environmental requirements. Key points:

• Who needs it: Electronics, machinery, toys, medical devices, PPE, construction products, and 20+ other categories
• How to obtain: Self-declaration (low-risk) or Notified Body assessment (high-risk)
• Documentation: Technical file + EU Declaration of Conformity
• Penalties: Product withdrawal, fines up to product value, criminal liability

2. REACH — Chemical Substance Regulation

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulates chemical substances in products. Key obligations:

• Registration: Substances >1 ton/year must be registered with ECHA
• SVHC (Substances of Very High Concern): Products containing >0.1% SVHC must notify ECHA and inform customers
• Restrictions (Annex XVII): Banned or restricted substances list — lead, cadmium, phthalates, etc.
• Chinese sellers’ impact: Non-EU manufacturers must appoint an Only Representative (OR) in the EU

3. RoHS — Hazardous Substance Restriction

RoHS (Restriction of Hazardous Substances) limits 10 substances in electrical and electronic equipment: lead, mercury, cadmium, hexavalent chromium, PBBs, PBDEs, and 4 phthalates (DEHP, BBP, DBP, DIBP). Maximum concentration: 0.1% (0.01% for cadmium). CE marking references RoHS compliance — no RoHS = no CE for electronics.

4. GPSR — General Product Safety Regulation (NEW)

Effective December 13, 2024, GPSR replaces the old GPSD. Key changes:

• Authorized Representative mandatory: Non-EU sellers must designate an EU-based authorized representative
• Product traceability: Batch/serial number, manufacturer name + address on product or packaging
• Online marketplace liability: Platforms (Amazon, eBay, etc.) share responsibility
• Risk assessment: Required technical documentation for all consumer products

5. Compliance Roadmap for Chinese Sellers

1. Determine which regulations apply to your product category
2. CE: prepare technical file + DoC; engage Notified Body if needed
3. REACH: check SVHC list; appoint EU Only Representative
4. RoHS: test for 10 restricted substances; ensure supply chain compliance
5. GPSR: designate EU authorized representative; label products properly

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