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Global Certification Technical Update

September 2019

September 2019 Updates

Europe

Europe (EC) – RoHS 2 Changes

Effective July 22, 2019

 

The European Union (EU) tightens regulations governing the use of hazardous materials in all electrical and electronic equipment. The regulation applies to all electrical and electronic equipment categories except medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments. These products have a two-year extension until July 22, 2021 to meet RoHS compliance.

 

A Certificates of Compliance from suppliers must include coverage of four new EU RoHS substances. The new substances and their maximum concentration values tolerated by weight in homogeneous materials are:

 

  • Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
  • Butyl benzyl phthalate (BBP) (0,1 %)
  • Dibutyl phthalate (DBP) (0,1 %)
  • Diisobutyl phthalate (DIBP) (0,1 %)

 

Homogenous materials that contain more than 0.1 weight percent of the named substance (Cd 0.01 weight percent) cannot be used in electrical equipment which come under the 11 categories of equipment under EU RoHS-2.

 

All businesses that sell applicable electronic products, sub-assemblies or components directly to EU countries, or sell to resellers, distributors or integrators must comply with RoHS requirements if they utilize any of the restricted materials.

 

There were 10 different categories for which the RoHS Directive was applicable. As of July 22, 2019, category 11 was added.

 

Category 11 includes “other EEE not covered by any of the categories above”, such as 2-wheeled vehicles, electronic nicotine delivery systems (ENDS) such as e-cigarettes, cannabis vaporizers, and vape pens. Electrical cables that are less than 250V of working voltage are also added. This scope of application is open to all equipment that meets the definitions of “Electrical and Electronic Equipment” of EU RoHS-2.

 

The complete list of eleven categories:

  1. Large household appliances
  2. Small household appliances
  3. IT and telecommunications equipment
  4. Consumer equipment
  5. Lighting equipment
  6. Electrical and electronic tools
  7. Toys, leisure, and sport equipment
  8. Medical devices
  9. Monitoring and control instruments including industrial monitoring and control instruments
  10. Automatic dispensers
  11. Other EEE not covered by any of the categories above

 

Europe (EC) – Expand The Scope of Lead Restrictions under The EU’s Regulation No 1907/2006 (REACH Regulation)

 

Proposed date of adoption: 3rd quarter of 2019

 

The European Commission (EC) proposed to amend a portion of Annex XVII of the regulation dealing with lead restrictions. The proposed change would “prohibit the use of lead and lead compounds in articles produced from polymers or copolymers of vinyl chloride as well as their placing on the market of articles produced from PVC if the concentration of lead (expressed as metal) is equal to or greater than 0.1% by weight of the PVC material.”

 

Europe – ETSI EN Standards

 

The final drafts have been produced by ETSI Technical Committee Electromagnetic Compatibility and Radio Spectrum Matters (ERM), and are now submitted for the vote phase of the ETSI Standards EN Approval Procedure.

 

  • Final draft ETSI EN 303 446-2 V1.2.1 (2019-07) – Electromagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 2: Requirements for equipment intended to be used in industrial locations
  • Final draft ETSI EN 303 446-1 V1.2.1 (2019-07) – Electromagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 1: Requirements for equipment intended to be used in residential, commercial and light industry locations
  • Final draft ETSI EN 301 908-18 V13.1.0 (2019-07) – IMT cellular networks; Harmonized Standard for access to radio spectrum; Part 18: E-UTRA, UTRA and GSM/EDGE Multi-Standard Radio (MSR) Base Station (BS)
  • Final draft ETSI EN 301 908-14 V13.1.0 (2019-07) – IMT cellular networks; Harmonized Standard for access to radio spectrum; Part 14: Evolved Universal Terrestrial Radio Access (E-UTRA)Base Stations (BS)
  • Final draft ETSI EN 301 908-3 V13.1.0 (2019-07) – IMT cellular networks; Harmonized Standard for access to radio spectrum; Part 3: CDMA Direct Spread (UTRA FDD) Base Stations (BS)
  • ETSI EN 300 328 V2.2.2 (2019-07) – Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonized Standard for access to radio spectrum
  • ETSI TR 103 088 V2.1.1 (2019-07) – Electromagnetic compatibility and Radio spectrum Matters (ERM); Using the EN 301 489 series of EMC standards
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