EU ROHS regulations

I. Regulatory Evolution and Versions

• Initial Version (2002/95/EC): Released in 2003, officially implemented on July 1, 2006, restricting six substances: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE).

• RoHS 2.0（2011/65/EU）: Revised in 2011, expanding the scope of control to ten categories of electrical and electronic equipment, requiring manufacturers to obtain CE certification and introducing market surveillance mechanisms.chinawto.mofcom.gov.cn。

• RoHS 3.0（2015/863/EU）: In 2015, four phthalates (DEHP, BBP, DBP, DIBP) were added, bringing the total controlled substances to 10, with full enforcement on July 22, 2019.。

II. Controlled Hazardous Substances and Limit Values

1. Heavy Metals：

• Lead (Pb) ≤ 0.1% (1000 ppm)

• Mercury (Hg) ≤ 0.1%

• Cadmium (Cd) ≤ 0.01% (100 ppm)

• Hexavalent Chromium (Cr⁶⁺) ≤ 0.1%

2. Flame Retardants：

• Polybrominated Biphenyls (PBB) ≤ 0.1%

• Polybrominated Diphenyl Ethers (PBDE) ≤ 0.1%

3. Phthalates：

• DEHP (Di(2-ethylhexyl) phthalate) ≤ 0.1%

• BBP (Butyl benzyl phthalate) ≤ 0.1%

• DBP (Dibutyl phthalate) ≤ 0.1%

• DIBP (Diisobutyl phthalate) ≤ 0.1%

III. Scope of Applicable Products

1. Large Household Appliances(e.g., refrigerators, washing machines)

2. Small Household Appliances(e.g., hair dryers, vacuum cleaners)

3. IT and Telecommunications Equipment(e.g., computers, mobile phones)

4. Consumer Electronics(e.g., televisions, audio equipment)

5. Lighting Equipment(e.g., LED lamps)

6. Electrical and Electronic Tools(e.g., electric drills)

7. Toys, Leisure and Sports Equipment

8. Medical Devices(e.g., CT scanners, electrocardiographs)

9. Industrial Monitoring and Control Equipment

10. Automatic Dispensers (Vending Machines)

IV. Exemption Clauses and Latest Revisions

1. Mercury Exemptions：

• Revised July 2023: Mercury is permitted in melt pressure sensors for capillary rheometers operating at temperatures above 300°C and pressures above 1000 bar, valid until the end of 2025.Shandong Provincial Department of Commerce。

2. Lead Exemptions：

• Lead as an alloying element in steel, aluminum, and copper alloys, with maximum concentrations of 0.35% (steel), 0.4% (aluminum), and 4% (copper), valid until December 31, 2026.fairtrade.sww.sh.gov.cn。

• Lead in high-melting-temperature solders (e.g., alloys with lead content > 85%), valid until December 31, 2027.fairtrade.sww.sh.gov.cn。

• January 2025 Draft:

V. Certification Process and Enforcement Requirements

1. Self-Declaration and CE Marking：
   Manufacturers must ensure product compliance with RoHS requirements. After passing third-party testing (e.g., XRF screening + chemical analysis confirmation), they must sign a Declaration of Conformity (DoC) and affix the CE mark.

2. Technical Documentation：
   Product design drawings, bills of materials (BOM), supplier compliance declarations, and other documentation must be retained for inspection by EU market surveillance authorities.

3. Testing Method Upgrades：
   From 2025, high-precision instruments such as ICP-MS (Inductively Coupled Plasma Mass Spectrometry) are recommended, with detection limits as low as 0.1 ppm, to meet more stringent compliance requirements.

VI. Differences from REACH Regulation

• ROHS：

• Scope: Targets only hazardous substances in electrical and electronic equipment, directly restricting substance content in finished products.

• Control Approach: Managed through limit values and exemption clauses, requiring self-declaration and CE certification.。

• REACH：

• Scope: Covers chemicals in all products (excluding food and pharmaceuticals), requiring enterprises to register, evaluate, and authorize Substances of Very High Concern (SVHC).

• Control Approach: Managed through full chemical lifecycle management, involving supply chain information communication and authorization licensing.。

VII. Latest Developments and Industry Impact

1. Supply Chain Traceability: The EU requires enterprises to provide complete supply chain hazardous substance data to ensure raw material compliance.

2. Alignment with Chinese Regulations: China RoHS 2.0 (GB/T 26572-2024) is synchronized with EU standards, with mandatory enforcement from September 2025, covering 11 product categories.

3. Technical Challenges: Testing for phthalates requires penetrating coatings or material surfaces; enterprises need to optimize processes to avoid migration exceedances.

VIII. Compliance Recommendations

1. Supply Chain Management: Prioritize suppliers with RoHS certification and require Material Safety Data Sheets (MSDS).

2. Testing Strategy: For complex products (e.g., medical devices), adopt tiered testing with emphasis on high-risk components (e.g., circuit boards, solders).

3. Exemption Tracking: Regularly review official EU announcements and promptly update exemption clause validity periods and scope of application.fairtrade.sww.sh.gov.cn。

Summary