iLenSys Compliance Manager White Paper
20 Feb 2024

The materials are essential for critical performance of electronic products. Disposal of some of these materials,

Abstract:
The materials are essential for critical performance of electronic products. Disposal of some of these materials, however, poses a serious threat to the environment after end of- life of the product. The European Union and other developed countries have already enacted legislative measures as Restriction of Hazardous Substances (RoHS) Directive to restrict the use of certain substances in the manufacturing of the electronic products. India has also notified similar legislation on 12th May 2011 to address this serious issue. Indian electronic manufactures are however facing serious challenges due to this legislative restriction.

Industry needs testing and certification of admissible level of hazardous substances in the product for necessary compliance. The testing facilities available with few private laboratories are not adequate. Department of electronics and Information Technology, Government of India, has therefore created a state-of-art laboratory with modern analytical instruments to address the growing demand of the industry. This article provides an overview of the RoHS and other related legislative measures present in the world and in India. An attempt is also made to study the preparedness of the industry and the immediate impact on the business of electronic sector.

 

Introduction:
RoHS is the acronym for Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of specific hazardous materials found in electrical and electronic products.

 

4 Phthalates from July 22, 2019

Hazardous substances which are present in certain EEE. These substances may pose risks to human health and the environment. Therefore, it is imperative that legislative action is taken globally–in most cases, action has been taken–to restrict the use of hazardous substances in EEE to effectively manage them and minimize their risks. This Regulatory Alert provides an overview of the EU RoHS Regulation and its implications, which supplements this Regulatory Alert, compares, and takes a deeper look into the key RoHS Regulations in various countries/regions.

Uses of RoHS Substances:
When RoHS goes into effect, manufacturers of electronic equipment for the EU marketplace must be compliant. The regulations do not recognize or grant any leeway to foreign manufacturers or suppliers.

One of the surveys show that the usage of lead, cadmium and mercury has considerably reduced in the EU, because of RoHS.

 

 

 

 

How to comply with RoHS requirements?
RoHS could be a product level compliance supported the EU Union's Directive 2011/65/EU & 2015/863, the Restriction of the employment of sure risky Substances in Electrical and Electronic equipment (RoHS). Products compliant with this directive don't exceed the allowable amounts of the subsequent restricted materials: lead, mercury, cadmium, hexavalent metallic element, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), with some restricted exemptions.

This directive applies to makers, approved representatives, importers, and distributors of product together with massive social unit appliances (refrigerators, etc.), little social unit appliances (vacuum cleaners, etc.), computing & communications instrumentation, client physical science, lighting, power tools, toys and equipment (videogames, electrical trains, etc.) and automatic dispensers (vending machines, ATM machines, etc.)

 

 

How will RoHS affect my company?


Substances


Main use

  Lead

Lead in plating finishes and solder- X-ray, Ultrasound, MRI; PVC stabilizer in medical tubing, ECG lead sets, cables and patient monitoring cables; Anaesthesia equipment.

  Cadmium

Cadmium pigments in ECG patient cables; Flexible copper cadmium wire in Ultrasound equipment; All diagnostic X-ray systems.

  Mercury

Very high capacitance and loss measurement bridges High frequency RF switches and relays in monitoring and control instruments; reference electrodes.

 Hexavalent             Chromium

Alkali dispensers for in-situ production of photocathodes; image intensifier tubes and assemblies; All X-ray systems.

  PBB

Flame retardant

  PBDE

Flame retardant

  DEHP

DEHPs are used to soften PVC and vinyl insulation on electrical wires and in medical tubing.

  BBP

These are used to soften PVC and vinyl insulation on electrical wires.

  DBP

DBPs are part of the dinaphthalene family used to soften PVC and vinyl insulation on electrical wires.

  DIBP

Added to give flexibility to die attach material in integrated circuit packages.


 

RoHS Upcoming updates:
The European Commission has proposed adding two new substances to the restricted substance list: tetrabromobisphenol A (TBBPA) and medium-chain chlorinated paraffins (MCCPs). Adding TBBPA and MCCPs would increase the number of restricted substances under EU RoHS from 10 to 12.
 

• TBBPA is a flame retardant commonly used to reduce the flammability of plastics and synthetic resins in consumer products, including electrical and electronic equipment parts. It is being considered as an addition to the restricted substances list due to its potential to harm human health, as it is a known carcinogen.

• MCCPs are industrial chemicals often used as flame retardants or plasticizers in plastics, rubber, adhesives, paints, and more. They are also used in metal operations as lubricants or coolants. MCCPs are being considered as an addition to the restricted substances list because they are expected to be bio-accumulative and are considered toxic to the environment by some agencies.

Starting in Europe, RoHS-like regulations are now being developed worldwide. The scope, the listed hazardous substances, and their applicable exemptions differ from one market to another. This is the case of the Eurasian Economic Union (Russia RoHS), the United Arab Emirates (UAE RoHS), Turkey RoHS, California RoHS, and other states and countries. Unlike Europe RoHS, some countries like the United Arab Emirates RoHS request external audits.

 

    Country

      EU RoHS

 
   China RoHS

 


   Japan RoHS

 


  South Korea      RoHS

 

   India RoHS

 

  Legislation    Adopted

European Commission

 

MIIT

Law for Promotion of Effective Utilization of Resources in Japan (Japanese Recycling Law)

Act for Resource Recycling of Electrical and Electronic Equipment and Vehicles

E-Waste (Management) Rules, 2016

  Scope

EEE products

 

EEE products

 

EEE products

 

EEE products and Vehicles

 

EEE products

 

  Regulatory    Timeline

13 August 2004

 

1 July 2016

 

 In force: 1 April 2001
 

1 July 2021

1 October 2016

 

  Substance      Restrictions

10 Substances

6 Substances

6 Substances

6 Substances

6 Substances

Exemptions

Applicable

not applicable

applicable

 

applicable

 

applicable

 

  Concerned    Actors

Manufacturers, importers and exporters

 

Manufacturers, importers and exporters

 

Manufacturers, importers and exporters

 

Manufacturers, importers and exporters

 

Manufacturers, importers and exporters

 

  Risk

Up to $11.71 million USD.

 

No Penalties

 

500,000 Yen.

 

10 million Won and imprisonment up to 2 years.

Penalties for non-compliance include fines.

 

  Marking

CE Mark

China RoHS marks​

Japan marks​

No Marking

No Marking

 

     
      Country

         
          UAE


   Saudi Arabia

         
             UK


               EAEU

  Legislation      Name

Emirates Authority for
Standardization & Metrology (ESMA)

Saudi Standards, Metrology and Quality Organization (SASO)

UK Department

EAEU Technical Regulations (TR)

  Scope

EEE Products

EEE Products

EEE Products

EEE Products

  Regulatory      timeline

In force: 1 January 2018

In force: 9 July 2021

In force (Amendment): 12 June 2019

In force: 1 March 2018

 Substance   Restrictions

10

6

10

10

  Exemption

Applicable

Applicable

Applicable

Applicable

  Concerned      Actors

Manufacturers, importers and exporters

Manufacturers, importers and exporters

Manufacturers, importers and exporters

Manufacturers, importers and exporters

  Marking

Applicable

-

UK CA Marking

EAC marking

  Risk

AED 30,000 and/or imprisonment

Penalties for non-compliance include fines

Penalties for non-compliance include fines

Penalties for non-compliance are determined by individual countries.

 

Conclusion:
RoHS regulations play an important role in encouraging the elimination of 10 hazardous substances. Medical devices, medical equipment and EEE products need to comply with RoHS regulations.

References:
https://ec.europa.eu/environment/pdf/waste/weee/hazardous_substances_report.pdf

Author:
Pavani Muriki, Senior Compliance Engineer
iLenSys Technologies Pvt. Ltd.

 

 

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