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VIJAY KUMAR
FEB-2024
Page 2
Session 1
• Why RoHS?
• Overview of EU- ROHS
- EU-ROHS basics
• EU-ROHS directives
- Directive 2011/65/EU (RoHS-Recast or RoHS
- Directive 2015/863 (RoHS 3)
• Compliance importance
• Restricted substances
• Challenges in Supply chain management
Restriction of Certain Hazardous Substances (RoHS)
Directive reference : 2002/95/EC
Member states shall ensure that from 1st July 2006, new
EEE put on the EU market does not contain 6 restricted
substances
1. Lead (Pb)
2. Cadmium ( Cd)
3. Mercury(Hg)
4. Hexavalent Chromium ( Cr+6)
5. Polybrominated Biphenyles ( PBB)
6. Polybrominated Diphenyle Ether ( PBDE)
Some examples…
Where these substances are used ??
•Lead is used in almost all the
solder joints in PCB
Cadmium is used in cable protective casing or
covering as anti corrosive agent
•Mercury is used in thermostats,
sensors & various forms of
energy saving lamps
5
•Hexavalent chromium is used in metal
coatings for corrosion protection and
wear resistance
•PBB & PBDE are fire retardant
materials and added to PCB,
connectors, Plastics etc.
Where these substances are used ??
Some examples…
• For the purpose of RoHS regulations, a maximum
concentration value of up to 0.1% by weight in
homogeneous materials for Lead, Mercury, Hexavalent Cr,
PBB, PBDE and up to 0.01% by weight in homogeneous
materials for Cadmium will be permitted in the manufacture
of EEE ( DTI, UK )
Are there any limits for the substances ?
• Lead (Pb): < 1000 ppm
• Mercury (Hg): < 1000 ppm
• Cadmium (Cd): < 100 ppm
• Hexavalent Chromium: (Cr VI) < 1000 ppm
• Polybrominated Biphenyls (PBB): < 1000 ppm
• Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
• Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
• Benzyl butyl phthalate (BBP): < 1000 ppm
• Dibutyl phthalate (DBP): < 1000 ppm
• Diisobutyl phthalate (DIBP): < 1000 ppm
• All homogeneous components within the product need
to conform to the maximum concentration limits by July
1 2006
Where to look for these substances ?
• Materials that can not be disjoined into different materials.
• Mechanically disjoined means, material that can be separated by mechanical
actions such as unscrewing, cutting, crushing, grinding & abrasive process
• Understood as uniform composition throughout – like plastic, ceramics, metals,
alloys, etc.
 Producer
Who is responsible ?
• Produces are required to keep appropriate records for a period up to 4 years
after the use.
 Who is a producer ?
Any person / company who irrespective of selling technique used,
• Manufactures & sells Electrical and Electronics Engineering Goods under
his own brand
• Resells under their own brand, equipment produced by other suppliers
• Imports or exports electrical & electronic equipment on a professional basis
into member states.
How it is enforced ?
• Test purchases are made in the market
• Tested for restricted substances
• Compliance documents can be requested
• Issue non-compliance notice / ask for actions taken
What is the major impact on business ?
• EOL – end of life for parts, products have seen a steady
upward trend in recent past & is expected to grow at faster
rate.
• Restriction from selling Products in EU
• Penalty and Confiscation of products
Page 10
1. Large household appliances - refrigerators, washers, stoves, air
conditioners
2. Small household appliances - Vacuum cleaners, hair dryers, coffee makers,
irons
3. IT and Telecommunications equipment - computers, printers, copiers,
phones
4. Consumer equipment - TVs, DVD players, stereos, video cameras
5. Lighting equipment - Lamps, lighting fixtures, light bulbs
6. Electrical and electronic tools (with the exception of largescale
stationary industrial tools) - drills, saws, nail guns, sprayers, lathes, trimmers,
blowers
7. Toys, leisure and sports equipment - videogames, electric trains, treadmills
8. Medical devices – x-Ray Machines, Ultrasound Machines, Lab Equipment
9. Monitoring and control instruments – CCTV, Camera
10. Automatic dispensers - vending machines, ATM machines
11. All other electrical equipment not covered by any of these
categories
Product Categories Required to Comply with
RoHS and RoHS2
EU RoHS Directives
• Regulation: RoHS Directive 2002/95/EC
• Effective: 1 July 2006 for ITE and consumer products
• Scope: EEE placed on the market must comply with material restrictions for; Lead, Mercury, Cadmium,
Hexavalent chromium (Cr6+), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE)
• Non-compliance impact: products cannot be imported and placed on the market or made available to the market
in the EU. Enforcement is by market surveillance.
• Regulation: ‘RoHS II’ Directive 2011/65/EU
• Effective: 22 July 2017 for ISM products, 22 July 2016 for Medical Device/IVD products
• Now a CE marking directive. It requires the CE marking on product and a DoC that has a
supporting technical file per EN 50581 standard.
• Excluded - Spare parts & products solely used for maintenance / repair of non-compliant
products placed on the EU market before the effective date
• Regulation: ‘RoHS II Amendment’ 2015/863 to Directive 2011/65/EU
• Effective: 22 July 2021 for IVD(Regent and Blood testing)-MD(Instruments and apparatus) and ISM (Category 8 &
9).
• Scope: EEE placed on the market must comply with new material restrictions for Phthalates; DEHP, BBP, DBP,
and DIBP
• Regulation: Amendment 2017/2102/EU to Directive 2011/65/EU
• Effective: 12 June 2019
• Scope: Clarifies wording related to spare parts and refurbished EEE.
11
‘RoHS II Amendment’ 2015/863 to Directive
2011/65/EU
Page 12
Why were the phthalates added?
RoHS is related to the safety of the recycling workers
and their environment
- Not related to consumer safety
• Low molecular weight phthalates
- Category 1b Reproductive Toxins
- Found to be in the blood stream of recycling workers, in the air/dust in the
facilities, and in the environment surrounding the facility justified restrictions
Page 13
What is wrong with these phthalates?
‘RoHS II Amendment’ 2015/863 to Directive
2011/65/EU
These substances are
- Endocrine disruptors
- (recent classification from the REACH process)
• Their metabolites are estrogenic endocrine disruptors
- DEHP is not dangerous
- Its metabolites (ie. MEHP)
Where are phthalates used?
Rigid plastics
- example - PVC
• Phthalates create flexibility
- by getting in between the vinyl chloride strand and forcing them apart
- leading to weaker forces of attraction
- creating fluidity (flexibility)
2/22/2017 Page 14
High Risk Materials with Phthalates
Principal high risk materials
- Flexible PVC
- Neoprene
- Nitrile rubber
- SBR rubber
- Adhesives
- ‘Toughened’ or rubberized ABS
Concentrations
- 1,000 to 300,000 ppm
Typical high risk components
- wires and cables
- strain relief
- o-rings, gaskets
- sealed radial bearings
- motor belts
- stickers (PVC)
- soft rubber components
- synthetic leather
- soft covers
China → Electrical and electronic products Restriction of Hazardous Substances Management Measures, - Effective: 2016.07.01,
• EEE manufactured after this date must have EFUP label and date of manufacture on the product and material composition matrix with product documentation [per
SJ/T 11364-2014 standard]
• T&M Instruments not included in catalog
Japan → Law for the Promotion of Utilization of Recyclable Resources and JIS C 0950, - Effective 2006.07.01
• ISM products are out of scope, only home appliances and personal computers are in scope (Mark required)
Korea → Act for Resource Recycling of Electrical and Electronic Equipment and Vehicles, - Effective 2008.07.01
• ISM products are out of scope, only home appliances and personal computers are in scope
Singapore → Environmental Protection and Management Act , - Effective 2017.07.01
• ISM products are out of scope, only home appliances and personal computers are in scope
Taiwan → BSMI certification against Taiwanese standard CNS 15663, - Effective 2017.07.01
• ISM product are out of scope, only Automatic data processing equipment, Printers, Notebooks, PCs, Servers, and Monitors are in scope, and requires inspection
mark and material composition matrix. ITE accessories sold with ISM products are in scope
India → E-Waste (Management and Handling) Rules, 2016” under Chapter V - Reduction in the use of hazardous substances in the manufacture of EEE
and their components or consumables or parts or spares, - Effective 2016.10.01
• ISM products are out of scope, only applies to ITE and consumer EEE. ITE accessories sold with ISM products are in scope
California → California's Electronic Waste Recycling Act of 2003 (EWRA), - Effective 2007.01.01
• ISM products are out of scope - Prohibits the sale of covered electronic devices that are prohibited from being sold under the EU RoHS directive
EAEU → Eurasian Economic Commission EEC Decision 113, 2016 – similar to EU, Medical device and measuring instruments are out of scope
UAE → Effective 1 January 2020 for Group A (cat 8,9), Scope, registration, certification process unclear, testing, registration & mark See GCC
regulation
Ukraine → Effective 1 January 2018 (RoHS6) & July 22, 2021 (RoHS10). Requires DoC in accordance with Annex V and Ukrsepro mark.
EFTA → Switzerland, Norway, Lichtenstein, and Iceland have adopted EU directive by national law
RoHS - Rest of the World
15
Page 16
Challenges in Supply Chain due
to RoHS
• End of life of non-compliant parts
• Different soldering techniques for RoHS vs Non ROHS parts
• Small suppliers don’t have RoHS Testing facilities
• Mixed inventory of Compliant and non-compliant parts during manufacturing, storage,
transit and FG
• Identify supplied parts from their Bill of Materials (BOM)
• Send requests for declarations to their suppliers
• Managing all the data associated with compliance activities
• need
• To track sub-suppliers and their suppliers
• Industry is still not ready of RoHS 2015 Directives.
• The data is not reliable at all
• The ‘ask’ is not clear
• RoHS 3? RoHS 10? RoHS / phthalates?
Session 2
17
• Way to collect RoHS Data
• Material Safety Data sheet for declaration of material
• Risk identification & management
• EU-RoHS 2 Exemptions
• Overview of China-ROHS 2
• Scope of China -ROHS & Restrictions
• China ROHS Marking
• China RoHS 2 v/s EU- RoHS 2
• China & EU RoHS Declaration
• MSDS - Material Safety Data Sheets (MSDSs)
• Full Material Declaration
• Certificate of compliance(CoC)
• Manufacturer Website
• Datasheet
• Survey Forms
• 3rd Party Tools
Way to collect RoHS Data
Material Safety Data Sheets (MSDSs): General
• A Material Safety Data Sheet (MSDS) is a document that contains
information on the potential hazards (health, fire, reactivity and
environmental) and how to work safely with the chemical product.
• It also contains information on the use, storage, handling and emergency
procedures all related to the hazards of the material.
• The MSDS contains much more information about the material than the label.
• MSDSs are prepared by the supplier or manufacturer of the material.
• It is intended to tell what the hazards of the product are, how to use the
product safely, what to expect if the recommendations are not followed, what
to do if accidents occur, how to recognize symptoms of overexposure, and
what to do if such incidents occur.
What information is on the MSDS?
Here are nine (9) categories of information that must be present on an MSDS
in Canada. These categories are specified in the Controlled Products
Regulations and include:
1.Product Information: product identifier (name), manufacturer and suppliers
names, addresses, and emergency phone numbers
2.Hazardous Ingredients
3.Physical Data
4.Fire or Explosion Hazard Data
5.Reactivity Data: information on the chemical instability of a product and the
substances it may react with
6.Toxicological Properties: health effects
7.Preventive Measures
8.First Aid Measures
9.Preparation Information: who is responsible for preparation and date of
preparation of MSDS
MSDS Examples
ROHS CERTIFICATE OF CONFORMITY
(CoC)
2/22/2017 Product Regulatory Affairs Page 23
Datasheet
Risks in RoHS Data collection
There are the seven most common Risk that can strongly impact the
success or failure of transition to RoHS compliance:
1. “Passing the Buck” to Suppliers
• Don’t rely on suppliers solely. “Certificates of Compliance” that will
confirm their products’ compliance with the RoHS Directive.
• In the event of an inadvertent error on the part of the supplier, the
OEM will still be held accountable
2. Exempt vs. Non-exempt Products
• Exemption is perhaps the most misunderstood and misperceived
issue regarding the RoHS Directive.
• While some manufacturers may be able to benefit from an
exemption, RoHS will still impact their businesses, which is why
they must have a solid RoHS strategy.
3. Resource Allocation
• Lack of resources for dedicated RoHS Compliance Efforts.
• Lack of Knowledge on RoHS Directives
4. Component Compatibility, Identification and Availability
• Highest volume of activity resulting from RoHS will be in the area of
component change management
• Companies Need to ensure that Form Fit Function(performance) of the
product don’t fall while conversion
• Traceability of compliant products inventory through Date code or part
number
5. Supplier Due Diligence
• The RoHS Directive requires that companies exercise due diligence by
validating that their supply chain partners are shipping RoHS-compliant
products.
• Certificate of compliance are informational only, and do not pass
responsibility from the “Producer” (i.e. the OEM) to the supplier.
6. Delayed Action
• Waiting for authorities to notify compliance issues
• Not being proactive to the latest RoHS Directives
• Wait until deadlines
Risks in RoHS Data collection
7. Data Management and Reporting
• RoHS regulations clearly make the OEM responsible and liable for meeting RoHS
requirements.
• The OEM must demonstrate compliance by submitting appropriate technical
documentation to the EU law-enforcement bodies.
• In order to do so, proper data management will be critical.
• A centralized repository of RoHS Documents is recommended
Risks in RoHS Data collection
Mitigation of Risks in RoHS Data
collection
Track RoHS requirements top-down. After identifying and separating transition
products from non-transition products, traverse the BOM tree and tag the parts
that have RoHS requirements (i.e. those that are exempt and those wherein
the requirements do not apply). “Where-used” analysis of parts.
Capture any relevant compliance data. For each purchased part, review the
Approved Manufacturer List (AML) and find compatible and RoHS-compliant
substitutes.
Change part numbers for modified AMLs. To clearly communicate the RoHS
transitions for parts to your suppliers, determine when and where to use part
number changes.
Enable reporting on an “as-built” configuration basis. The compliance data
needs to be related to the actual shipped product, not the current build.
EU-RoHS 2 Exemptions and Exclusions
Exemptions
RoHS II exempts certain applications from the substance restrictions. The
exemptions are temporary and reviewed at least every four years. The current list
of exemptions is contained in Annex III.
Exclusions
Permanent exclusions from RoHS include the following: military equipment,
space equipment, equipment designed to be part of another piece of equipment
falling outside the scope of RoHS, large scale industry tools, large scale fixed
installations, means of transport for persons or goods, non-road mobile
machinery, active implantable medical devices, photovoltaic panels, equipment
for research and development only available business to business.
China RoHS Introduction
• China RoHS (Restriction of Hazardous Substances), officially known
as Administrative Measure on the Control of Pollution Caused by
Electronic Information Products is a Chinese government regulation to
control certain materials, including lead.
• China RoHS does not allow any technology exemptions unlike EU RoHS 2
Directive.
• It restricts same 6 substances like EU RoHS but have different labeling
guidelines
• All the products those contains hazardous substances needs a EFUP Logo
• Environment Friendly Use Period (EFUP) is the period of time before any of
the RoHS substances are likely to leak out, causing possible harm to health
and the environment.
China RoHS
China RoHS First Batch
•Refrigerators
•Air conditioners
•Washing machines
•Electric water heaters
•Printers
•Copiers
•Fax machines
•TVs
•Monitors
•Micro-computers
•Handheld phones for mobile
communication
•Telephone sets
China RoHS Exemptions
• China RoHS Exemptions are same as of EU RoHS except numbering
ie. 6(c) Pb in copper allows is 7.3 in China RoHS
• It is different in terms of no technological exemptions is permitted like
EU RoHS
• The exemptions include all the exemptions of Annex III of EU RoHS 2,
39(a) in amending directive (EU) 2017/1975
• It is different from EU RoHS 2 in that the exemption list of China RoHS
2 is grouped based on the six hazardous substances, and most of them
do not have expiration dates.
China RoHS Table
This Table needs to be inserted in every product.
Conclusion
• RoHS is an EU Directive that is being adapted by the countries round the world
• All Electrical and Electronics components are in scope
• There are 10 substances we need to identify, measure and declare in PPM
• Producer of the product have responsibility to declare RoHS Compliance of
product
• Penalties, product impound and Legal action may be taken by the EU in case a
product is found to be non-compliant
Introduction to REACH
REACH is the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18
December 2006 concerning the Registration, Evaluation, Authorization and Restriction of
Chemicals. It came into force on 1 June 2007.
• It applies to substances manufactured or imported into the EU in quantities of 1
tonne per year or more
• in a preparation or in an article manufactured, imported, placed on the market or
used:
 Preparation: A mixture or solution composed of two or more substances. e.g.
ink, detergents. Substances in preparations shall be registered separately.
 Article: An object which during production is given a special shape, surface or
design, which determines its function to a greater degree than its chemical
composition. e.g. car, clothes, toys.
The Key Provisions
•Registration: Substances manufactured/imported over 1ton per year need to be
registered with the European Chemical Agency (ECHA) by EU manufacturers and
importers; non-EU companies have to rely on EU based REACH Only
Representative to submit registrations on their behalf;
•Evaluation: Registration dossiers submitted will be examined by ECHA in terms of
completeness and data requirements. ECHA will also assess a substance of
concern for its environment/public health impact;
•Authorization: Listed Substances of Very High Concern(SVHC)in Annex XIV
will not be allowed to be used, placed on the market or imported into the EU after a
date to be set unless the company is granted an authorization;
•Restriction: Annex XVII of the REACH Regulation contains the list of all restricted
substances, specifying which uses are restricted or even banned;
•Communication in the supply chain: Information about the safe use of
chemicals (risk management measures) need to be communicated up and down
the supply chain in the format of Safety Data Sheets or Chemical Safety Report.
Substances of very high concentration
Under REACH, substances that are one of the following can be regarded as
substance of very high concern(SVHC):
 carcinogenic, mutagenic or toxic to reproduction (CMRs);
 persistent, bio-accumulative and toxic (PBTs); https://echa.europa.eu/pbt
 very persistent and bio-accumulative (vPvBs);
 seriously and / or irreversibly damaging the environment or human health, as
substances damaging the hormone system;
REACH and its impacts
 The impact of REACH is not only on the chemical industry.
 Industries such as electronics, toys, textiles and tyres, etc, are all affected by
REACH.
 For example, chemical companies need to do REACH registration and
prepare SDS.
 Manufacturers and importers of toys shall ensure that the concentrations of
REACH restricted substances and SVHC in their products do not exceed
certain threshold limits.
Q&A

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RoHS stands for Restriction of Hazardous Substances, which is also known as the Directive 2002/95/EC

  • 2. Page 2 Session 1 • Why RoHS? • Overview of EU- ROHS - EU-ROHS basics • EU-ROHS directives - Directive 2011/65/EU (RoHS-Recast or RoHS - Directive 2015/863 (RoHS 3) • Compliance importance • Restricted substances • Challenges in Supply chain management
  • 3. Restriction of Certain Hazardous Substances (RoHS) Directive reference : 2002/95/EC Member states shall ensure that from 1st July 2006, new EEE put on the EU market does not contain 6 restricted substances 1. Lead (Pb) 2. Cadmium ( Cd) 3. Mercury(Hg) 4. Hexavalent Chromium ( Cr+6) 5. Polybrominated Biphenyles ( PBB) 6. Polybrominated Diphenyle Ether ( PBDE)
  • 4. Some examples… Where these substances are used ?? •Lead is used in almost all the solder joints in PCB Cadmium is used in cable protective casing or covering as anti corrosive agent •Mercury is used in thermostats, sensors & various forms of energy saving lamps
  • 5. 5 •Hexavalent chromium is used in metal coatings for corrosion protection and wear resistance •PBB & PBDE are fire retardant materials and added to PCB, connectors, Plastics etc. Where these substances are used ?? Some examples…
  • 6. • For the purpose of RoHS regulations, a maximum concentration value of up to 0.1% by weight in homogeneous materials for Lead, Mercury, Hexavalent Cr, PBB, PBDE and up to 0.01% by weight in homogeneous materials for Cadmium will be permitted in the manufacture of EEE ( DTI, UK ) Are there any limits for the substances ? • Lead (Pb): < 1000 ppm • Mercury (Hg): < 1000 ppm • Cadmium (Cd): < 100 ppm • Hexavalent Chromium: (Cr VI) < 1000 ppm • Polybrominated Biphenyls (PBB): < 1000 ppm • Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm • Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm • Benzyl butyl phthalate (BBP): < 1000 ppm • Dibutyl phthalate (DBP): < 1000 ppm • Diisobutyl phthalate (DIBP): < 1000 ppm
  • 7. • All homogeneous components within the product need to conform to the maximum concentration limits by July 1 2006 Where to look for these substances ? • Materials that can not be disjoined into different materials. • Mechanically disjoined means, material that can be separated by mechanical actions such as unscrewing, cutting, crushing, grinding & abrasive process • Understood as uniform composition throughout – like plastic, ceramics, metals, alloys, etc.
  • 8.  Producer Who is responsible ? • Produces are required to keep appropriate records for a period up to 4 years after the use.  Who is a producer ? Any person / company who irrespective of selling technique used, • Manufactures & sells Electrical and Electronics Engineering Goods under his own brand • Resells under their own brand, equipment produced by other suppliers • Imports or exports electrical & electronic equipment on a professional basis into member states.
  • 9. How it is enforced ? • Test purchases are made in the market • Tested for restricted substances • Compliance documents can be requested • Issue non-compliance notice / ask for actions taken What is the major impact on business ? • EOL – end of life for parts, products have seen a steady upward trend in recent past & is expected to grow at faster rate. • Restriction from selling Products in EU • Penalty and Confiscation of products
  • 10. Page 10 1. Large household appliances - refrigerators, washers, stoves, air conditioners 2. Small household appliances - Vacuum cleaners, hair dryers, coffee makers, irons 3. IT and Telecommunications equipment - computers, printers, copiers, phones 4. Consumer equipment - TVs, DVD players, stereos, video cameras 5. Lighting equipment - Lamps, lighting fixtures, light bulbs 6. Electrical and electronic tools (with the exception of largescale stationary industrial tools) - drills, saws, nail guns, sprayers, lathes, trimmers, blowers 7. Toys, leisure and sports equipment - videogames, electric trains, treadmills 8. Medical devices – x-Ray Machines, Ultrasound Machines, Lab Equipment 9. Monitoring and control instruments – CCTV, Camera 10. Automatic dispensers - vending machines, ATM machines 11. All other electrical equipment not covered by any of these categories Product Categories Required to Comply with RoHS and RoHS2
  • 11. EU RoHS Directives • Regulation: RoHS Directive 2002/95/EC • Effective: 1 July 2006 for ITE and consumer products • Scope: EEE placed on the market must comply with material restrictions for; Lead, Mercury, Cadmium, Hexavalent chromium (Cr6+), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE) • Non-compliance impact: products cannot be imported and placed on the market or made available to the market in the EU. Enforcement is by market surveillance. • Regulation: ‘RoHS II’ Directive 2011/65/EU • Effective: 22 July 2017 for ISM products, 22 July 2016 for Medical Device/IVD products • Now a CE marking directive. It requires the CE marking on product and a DoC that has a supporting technical file per EN 50581 standard. • Excluded - Spare parts & products solely used for maintenance / repair of non-compliant products placed on the EU market before the effective date • Regulation: ‘RoHS II Amendment’ 2015/863 to Directive 2011/65/EU • Effective: 22 July 2021 for IVD(Regent and Blood testing)-MD(Instruments and apparatus) and ISM (Category 8 & 9). • Scope: EEE placed on the market must comply with new material restrictions for Phthalates; DEHP, BBP, DBP, and DIBP • Regulation: Amendment 2017/2102/EU to Directive 2011/65/EU • Effective: 12 June 2019 • Scope: Clarifies wording related to spare parts and refurbished EEE. 11
  • 12. ‘RoHS II Amendment’ 2015/863 to Directive 2011/65/EU Page 12 Why were the phthalates added? RoHS is related to the safety of the recycling workers and their environment - Not related to consumer safety • Low molecular weight phthalates - Category 1b Reproductive Toxins - Found to be in the blood stream of recycling workers, in the air/dust in the facilities, and in the environment surrounding the facility justified restrictions
  • 13. Page 13 What is wrong with these phthalates? ‘RoHS II Amendment’ 2015/863 to Directive 2011/65/EU These substances are - Endocrine disruptors - (recent classification from the REACH process) • Their metabolites are estrogenic endocrine disruptors - DEHP is not dangerous - Its metabolites (ie. MEHP) Where are phthalates used? Rigid plastics - example - PVC • Phthalates create flexibility - by getting in between the vinyl chloride strand and forcing them apart - leading to weaker forces of attraction - creating fluidity (flexibility)
  • 14. 2/22/2017 Page 14 High Risk Materials with Phthalates Principal high risk materials - Flexible PVC - Neoprene - Nitrile rubber - SBR rubber - Adhesives - ‘Toughened’ or rubberized ABS Concentrations - 1,000 to 300,000 ppm Typical high risk components - wires and cables - strain relief - o-rings, gaskets - sealed radial bearings - motor belts - stickers (PVC) - soft rubber components - synthetic leather - soft covers
  • 15. China → Electrical and electronic products Restriction of Hazardous Substances Management Measures, - Effective: 2016.07.01, • EEE manufactured after this date must have EFUP label and date of manufacture on the product and material composition matrix with product documentation [per SJ/T 11364-2014 standard] • T&M Instruments not included in catalog Japan → Law for the Promotion of Utilization of Recyclable Resources and JIS C 0950, - Effective 2006.07.01 • ISM products are out of scope, only home appliances and personal computers are in scope (Mark required) Korea → Act for Resource Recycling of Electrical and Electronic Equipment and Vehicles, - Effective 2008.07.01 • ISM products are out of scope, only home appliances and personal computers are in scope Singapore → Environmental Protection and Management Act , - Effective 2017.07.01 • ISM products are out of scope, only home appliances and personal computers are in scope Taiwan → BSMI certification against Taiwanese standard CNS 15663, - Effective 2017.07.01 • ISM product are out of scope, only Automatic data processing equipment, Printers, Notebooks, PCs, Servers, and Monitors are in scope, and requires inspection mark and material composition matrix. ITE accessories sold with ISM products are in scope India → E-Waste (Management and Handling) Rules, 2016” under Chapter V - Reduction in the use of hazardous substances in the manufacture of EEE and their components or consumables or parts or spares, - Effective 2016.10.01 • ISM products are out of scope, only applies to ITE and consumer EEE. ITE accessories sold with ISM products are in scope California → California's Electronic Waste Recycling Act of 2003 (EWRA), - Effective 2007.01.01 • ISM products are out of scope - Prohibits the sale of covered electronic devices that are prohibited from being sold under the EU RoHS directive EAEU → Eurasian Economic Commission EEC Decision 113, 2016 – similar to EU, Medical device and measuring instruments are out of scope UAE → Effective 1 January 2020 for Group A (cat 8,9), Scope, registration, certification process unclear, testing, registration & mark See GCC regulation Ukraine → Effective 1 January 2018 (RoHS6) & July 22, 2021 (RoHS10). Requires DoC in accordance with Annex V and Ukrsepro mark. EFTA → Switzerland, Norway, Lichtenstein, and Iceland have adopted EU directive by national law RoHS - Rest of the World 15
  • 16. Page 16 Challenges in Supply Chain due to RoHS • End of life of non-compliant parts • Different soldering techniques for RoHS vs Non ROHS parts • Small suppliers don’t have RoHS Testing facilities • Mixed inventory of Compliant and non-compliant parts during manufacturing, storage, transit and FG • Identify supplied parts from their Bill of Materials (BOM) • Send requests for declarations to their suppliers • Managing all the data associated with compliance activities • need • To track sub-suppliers and their suppliers • Industry is still not ready of RoHS 2015 Directives. • The data is not reliable at all • The ‘ask’ is not clear • RoHS 3? RoHS 10? RoHS / phthalates?
  • 17. Session 2 17 • Way to collect RoHS Data • Material Safety Data sheet for declaration of material • Risk identification & management • EU-RoHS 2 Exemptions • Overview of China-ROHS 2 • Scope of China -ROHS & Restrictions • China ROHS Marking • China RoHS 2 v/s EU- RoHS 2 • China & EU RoHS Declaration
  • 18. • MSDS - Material Safety Data Sheets (MSDSs) • Full Material Declaration • Certificate of compliance(CoC) • Manufacturer Website • Datasheet • Survey Forms • 3rd Party Tools Way to collect RoHS Data
  • 19. Material Safety Data Sheets (MSDSs): General • A Material Safety Data Sheet (MSDS) is a document that contains information on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product. • It also contains information on the use, storage, handling and emergency procedures all related to the hazards of the material. • The MSDS contains much more information about the material than the label. • MSDSs are prepared by the supplier or manufacturer of the material. • It is intended to tell what the hazards of the product are, how to use the product safely, what to expect if the recommendations are not followed, what to do if accidents occur, how to recognize symptoms of overexposure, and what to do if such incidents occur.
  • 20. What information is on the MSDS? Here are nine (9) categories of information that must be present on an MSDS in Canada. These categories are specified in the Controlled Products Regulations and include: 1.Product Information: product identifier (name), manufacturer and suppliers names, addresses, and emergency phone numbers 2.Hazardous Ingredients 3.Physical Data 4.Fire or Explosion Hazard Data 5.Reactivity Data: information on the chemical instability of a product and the substances it may react with 6.Toxicological Properties: health effects 7.Preventive Measures 8.First Aid Measures 9.Preparation Information: who is responsible for preparation and date of preparation of MSDS
  • 22. ROHS CERTIFICATE OF CONFORMITY (CoC)
  • 23. 2/22/2017 Product Regulatory Affairs Page 23 Datasheet
  • 24. Risks in RoHS Data collection There are the seven most common Risk that can strongly impact the success or failure of transition to RoHS compliance: 1. “Passing the Buck” to Suppliers • Don’t rely on suppliers solely. “Certificates of Compliance” that will confirm their products’ compliance with the RoHS Directive. • In the event of an inadvertent error on the part of the supplier, the OEM will still be held accountable 2. Exempt vs. Non-exempt Products • Exemption is perhaps the most misunderstood and misperceived issue regarding the RoHS Directive. • While some manufacturers may be able to benefit from an exemption, RoHS will still impact their businesses, which is why they must have a solid RoHS strategy. 3. Resource Allocation • Lack of resources for dedicated RoHS Compliance Efforts. • Lack of Knowledge on RoHS Directives
  • 25. 4. Component Compatibility, Identification and Availability • Highest volume of activity resulting from RoHS will be in the area of component change management • Companies Need to ensure that Form Fit Function(performance) of the product don’t fall while conversion • Traceability of compliant products inventory through Date code or part number 5. Supplier Due Diligence • The RoHS Directive requires that companies exercise due diligence by validating that their supply chain partners are shipping RoHS-compliant products. • Certificate of compliance are informational only, and do not pass responsibility from the “Producer” (i.e. the OEM) to the supplier. 6. Delayed Action • Waiting for authorities to notify compliance issues • Not being proactive to the latest RoHS Directives • Wait until deadlines Risks in RoHS Data collection
  • 26. 7. Data Management and Reporting • RoHS regulations clearly make the OEM responsible and liable for meeting RoHS requirements. • The OEM must demonstrate compliance by submitting appropriate technical documentation to the EU law-enforcement bodies. • In order to do so, proper data management will be critical. • A centralized repository of RoHS Documents is recommended Risks in RoHS Data collection
  • 27. Mitigation of Risks in RoHS Data collection Track RoHS requirements top-down. After identifying and separating transition products from non-transition products, traverse the BOM tree and tag the parts that have RoHS requirements (i.e. those that are exempt and those wherein the requirements do not apply). “Where-used” analysis of parts. Capture any relevant compliance data. For each purchased part, review the Approved Manufacturer List (AML) and find compatible and RoHS-compliant substitutes. Change part numbers for modified AMLs. To clearly communicate the RoHS transitions for parts to your suppliers, determine when and where to use part number changes. Enable reporting on an “as-built” configuration basis. The compliance data needs to be related to the actual shipped product, not the current build.
  • 28. EU-RoHS 2 Exemptions and Exclusions Exemptions RoHS II exempts certain applications from the substance restrictions. The exemptions are temporary and reviewed at least every four years. The current list of exemptions is contained in Annex III. Exclusions Permanent exclusions from RoHS include the following: military equipment, space equipment, equipment designed to be part of another piece of equipment falling outside the scope of RoHS, large scale industry tools, large scale fixed installations, means of transport for persons or goods, non-road mobile machinery, active implantable medical devices, photovoltaic panels, equipment for research and development only available business to business.
  • 29. China RoHS Introduction • China RoHS (Restriction of Hazardous Substances), officially known as Administrative Measure on the Control of Pollution Caused by Electronic Information Products is a Chinese government regulation to control certain materials, including lead. • China RoHS does not allow any technology exemptions unlike EU RoHS 2 Directive. • It restricts same 6 substances like EU RoHS but have different labeling guidelines • All the products those contains hazardous substances needs a EFUP Logo • Environment Friendly Use Period (EFUP) is the period of time before any of the RoHS substances are likely to leak out, causing possible harm to health and the environment.
  • 31. China RoHS First Batch •Refrigerators •Air conditioners •Washing machines •Electric water heaters •Printers •Copiers •Fax machines •TVs •Monitors •Micro-computers •Handheld phones for mobile communication •Telephone sets
  • 32. China RoHS Exemptions • China RoHS Exemptions are same as of EU RoHS except numbering ie. 6(c) Pb in copper allows is 7.3 in China RoHS • It is different in terms of no technological exemptions is permitted like EU RoHS • The exemptions include all the exemptions of Annex III of EU RoHS 2, 39(a) in amending directive (EU) 2017/1975 • It is different from EU RoHS 2 in that the exemption list of China RoHS 2 is grouped based on the six hazardous substances, and most of them do not have expiration dates.
  • 33. China RoHS Table This Table needs to be inserted in every product.
  • 34. Conclusion • RoHS is an EU Directive that is being adapted by the countries round the world • All Electrical and Electronics components are in scope • There are 10 substances we need to identify, measure and declare in PPM • Producer of the product have responsibility to declare RoHS Compliance of product • Penalties, product impound and Legal action may be taken by the EU in case a product is found to be non-compliant
  • 35. Introduction to REACH REACH is the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals. It came into force on 1 June 2007. • It applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more • in a preparation or in an article manufactured, imported, placed on the market or used:  Preparation: A mixture or solution composed of two or more substances. e.g. ink, detergents. Substances in preparations shall be registered separately.  Article: An object which during production is given a special shape, surface or design, which determines its function to a greater degree than its chemical composition. e.g. car, clothes, toys.
  • 36. The Key Provisions •Registration: Substances manufactured/imported over 1ton per year need to be registered with the European Chemical Agency (ECHA) by EU manufacturers and importers; non-EU companies have to rely on EU based REACH Only Representative to submit registrations on their behalf; •Evaluation: Registration dossiers submitted will be examined by ECHA in terms of completeness and data requirements. ECHA will also assess a substance of concern for its environment/public health impact; •Authorization: Listed Substances of Very High Concern(SVHC)in Annex XIV will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization; •Restriction: Annex XVII of the REACH Regulation contains the list of all restricted substances, specifying which uses are restricted or even banned; •Communication in the supply chain: Information about the safe use of chemicals (risk management measures) need to be communicated up and down the supply chain in the format of Safety Data Sheets or Chemical Safety Report.
  • 37. Substances of very high concentration Under REACH, substances that are one of the following can be regarded as substance of very high concern(SVHC):  carcinogenic, mutagenic or toxic to reproduction (CMRs);  persistent, bio-accumulative and toxic (PBTs); https://echa.europa.eu/pbt  very persistent and bio-accumulative (vPvBs);  seriously and / or irreversibly damaging the environment or human health, as substances damaging the hormone system;
  • 38. REACH and its impacts  The impact of REACH is not only on the chemical industry.  Industries such as electronics, toys, textiles and tyres, etc, are all affected by REACH.  For example, chemical companies need to do REACH registration and prepare SDS.  Manufacturers and importers of toys shall ensure that the concentrations of REACH restricted substances and SVHC in their products do not exceed certain threshold limits.
  • 39. Q&A

Editor's Notes

  1. ISM Industrial, Scientific and Medical (ISM) equipment In vitro diagnostic products are those reagents,instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.