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Restriction of hazardous substances - an overview
1. Amit Ghai
June - 2018
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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2. Session 1
• 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
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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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
Article 4.1 of RoHS directive states the following 6 substances
1. Lead (Pb)
2. Cadmium ( Cd)
3. Mercury(Hg)
4. Hexavalent Chromium ( Cr6)
5. Polybrominated Biphenyles ( PBB)
6. Polybrominated Diphenyle Ether ( PBDE)
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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4. • Lead is used in almost all solder joint & lead finish.
• Cadmium is used in cable protective casing or covering as
anti corrosive agent for protecting connectors & fixing in salt
spray conditions.
• Mercury is used in thermostats, sensors & various forms of
energy saving lamps
• 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.
• RoHS directive does not apply to spare parts for the repair
or reuse of EEE put on the market before 1st Jul 2006
Some examples…
Where these substances are used ??
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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5. • 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
• Disobutyl phthalate (DIBP): < 1000 ppm
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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Added in 2015
Directive
6. • All homogeneous components within the product need
to conform to the maximum concentration limits by July
1 2006
Where to look for these substances ?
What is homogeneous material ?
• 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.
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead 6
7. 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.
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead 7
8. 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 productsPrepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead 8
9. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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10. 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.
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11. ‘RoHS II Amendment’ 2015/863 to Directive
2011/65/EU
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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12. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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)
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13. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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14. 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
Korea → Act for Resource Recycling of Electrical and Electronic Equipment and Vehicles, - Effective 2008.07.01
Singapore → Environmental Protection and Management Act , - Effective 2017.07.01
Taiwan → BSMI certification against Taiwanese standard CNS 15663, - Effective 2017.07.01
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
California → California's Electronic Waste Recycling Act of 2003 (EWRA), - Effective 2007.01.01
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
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15. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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?
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16. Session 2
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
• 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
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17. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
• 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
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18. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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 is an
essential starting point for the development of a complete health and safety
program.
• 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.
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19. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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20. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
MSDS Examples
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21. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
ROHS CERTIFICATE OF CONFORMITY
(CoC)
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22. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
Datasheet
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24. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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25. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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Risks in RoHS Data collection(Continued)
26. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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Risks in RoHS Data collection(Continued)
27. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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 can help identify shared components and enable OEMs to evaluate whether or not
the part needs to be split off.
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.
• Track RoHS compliance bottom-up. Track the compliance status of the complete end-
product by
rolling up the compliance status of the individual components that make up the product.
• Track progress and risk as functions of part criticality. Product designs typically contain a
number of critical parts, either due to design parameters or sourcing restrictions. By classifying
components based on criticality, OEMs can generate an overview of compliance status for
each
class.
Enable reporting on an “as-built” configuration basis. OEMs have a limited time window in
which to submit the technical documentation to substantiate a compliance claim. The
compliance data needs to be related to the actual shipped product, not the current build.27
28. EU-RoHS 2 Exemptions and Exclusions
Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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.
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29. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
China RoHS Introduction
• China RoHS (Restriction of Hazardous Substances), officially known
as Administrative Measure on the Control of Pollution Caused by
Electronic Information Products[1] 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.
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30. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
China RoHS
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31. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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32. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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.
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33. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
China RoHS Table
This Table needs to be inserted in every product.
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34. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
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
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35. Prepared by : Amit Ghai – PMP®, LEAN Facilitator, Quality Lead
Q&A
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