review of directive 2002/95/ec (rohs) categories 8 and 9...
TRANSCRIPT
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
1© Copyright ERA Technology Ltd 200601372 367444, www.era.co.uk/rfa.htm
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Pb
Review of Directive 2002/95/EC (RoHS) –possible inclusion of Categories 8 and 9
Dr. Paul Goodman+44 (0)1372 367221 [email protected]
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Agenda
• Morning – ERA presentations– Part 1 - Main issues affecting Category 8 and 9 products– Part 2 - Applications of six RoHS substances and
exemption requests– Part 3 – Conclusions and options
• Afternoon - Input from Stakeholders
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Objectives of the study
• Review Directive 2002/95/EC– Determine whether it is possible to include categories 8
and 9 in the scope of RoHS
• Provide data for European Commission to carry out impact assessment
• Consult with all stakeholders– This workshop is part of this objective
• Investigate technical issues including the need for exemptions
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Part 1
Main issues affecting Category 8 and 9 products
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Category 8 and 9 products
• Characteristics of products– Quantities put on EU market, variety, product life,
complexity, etc.
• Main issues– Scope– Issues currently affecting category 8 and 9 manufacturers – Reliability, health, safety and the environment
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Category 8 & 9 equipment - Characteristics
• Different to products in other WEEE categories, e.g.:-
– Some are safety critical– Individual model sales can be very small (as low as 2 p.a.)– High proportion of SMEs– Significant EU market share– Larger variety of products – many more types of products– Greater cost of compliance as proportion of turnover– Longer life cycles– Legislative and other formal requirements
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Category 8 - Examples
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Category 9- Examples
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Characteristics of products 1 - Safety critical products
• Unexpected failure of category 8 and 9 products can affect health, safety and environment, e.g.
– Smoke detectors – early warnings of fires– Radiotherapy – wrong dose or interruption of treatment can
harm patients– Defibrillators – Death likely if not functioning– Aircraft instrument calibration – must be accurate– Pollutant analysers – environmental impact
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Characteristics of products 2 - Numbers produced
• Category 8 and 9 consumer-type products made in large numbers
– Smoke detectors, thermostats, heating regulators, retail weighing, medical self-test (e.g. blood pressure), heart pacemakers (10’s thousands – 100’s thousands)
• Industrial and professional products made in much smaller numbers
– Industrial test instruments (some <5 p.a.), – CT scanners, immunoassay instruments (~500 p.a.)
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Characteristics of products 3 - SMEs, EU market leader
• High proportion of SMEs – many have very large variety of models, all sold in very
small numbers (<5 each per year not unusual)– will find modification of products very difficult
• EU is a market leader in category 8 and 9 but not in most other WEEE categories
– EU exports exceed imports of Category 8 and 9 products– Potential negative impact on EU industry
• Non-EU competitors in non-EU markets
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Characteristics of products 4 - Product diversity
• Product diversity – can be large for all types of producers– Where cost of change is greater than future profit, product will be
withdrawn from EU market– But: some potentially profitable products could not be modified
because of the limited number of engineers so would be withdrawn from EU market
• Estimates from manufacturers vary (industrial-type products) :
– If Categories 8 and 9 in scope 2012 - would stop production of from 10 to 50% of products
– If date is 2018, number 5% or less• Assumes exemptions accepted
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Characteristics of products 5 - Life cycles
• Life cycle– Design cycle may take up to 7 years (concept to launch)– Used for 20+ years– Many individual models available for 8 – 20 years– So by 2012, only ~ 50% of products on EU market will
have been launched since 2006• Therefore 50% would need to be changed
– this may be uneconomic– also not possible due to limitations to numbers of trained
engineers where re-design needed– Category 8 & 9 products tend to use more older-type
components than EEE in other categories. Many not available as RoHS versions so re-design required (unless “LTB” exemption)
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Characteristics of products 6 - Legislation
• Legislation and approvals– Significant changes to medical products will require re-
licensing in EU and rest of world• Up to 1 year in EU for medical devices
– May not be required if only change is to solder type and lead-free solder is known to be reliable
• Re-licensing can be expensive and take many years (especially in Asia)
• Potential impact on competitiveness of EU based producers in other markets – where non-EU competitors do not change
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Characteristics of products 6- continued
• Products must also comply with:– Medical Device Directives– Customer approvals and requirements– Many other EU Directives; EMC, ATEX, etc.– Legislation outside EU
• Legislation and approvals– Many category 8 & 9 products will require re-testing– Inclusion of Cat 8 & 9 in scope of RoHS will not affect new
products but will affect any existing ones that have to be modified• BUT – RoHS-type legislation is being introduced
worldwide– China, South Korea, Japan, US States, etc. – Tends to follow EU so Category 8 and 9 likely to be within scope
if included in EU
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Scope issues - Category 8
• Medical devices defined by three Medical Device Directives
– 90/385/EEC AIMD– 93/42/EEC MDD– 98/79/EC IVD
• A few products would be excluded by this definition (e.g. veterinary)
– WEEE Directive excludes “infected products and implanted products”
• These exclusions not necessarily required for RoHS
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Scope issues- Category 9
• Scope is very unclear• Manufacturers receive different interpretations from
WEEE registration bodies• These variations unacceptable for Article 95 RoHS
directives• Many control instruments used as part of “large-scale
stationary industrial tools”• Most confusion over “fixed installations”
– Unclear where boundary between in-scope and out-of-scope occurs
• Laboratory equipment status often unclear– Many products do not “monitor or control”
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Issues currently affecting category 8 and 9 manufacturers
• RoHS is already affecting category 8 and 9 manufacturers
– Many components changed or withdrawn– PCB sub-contractors changing to “lead-free”
• Manufacturers already planning for eventual inclusion– A small minority will have converted all of their products to
comply with RoHS by end 2007– Many are developing all “new” models as RoHS compliant,
where possible (but not changing existing models) but some admit there is an un-quantified risk to reliability
– Others carrying out research but will not change products until all risks have been eliminated
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Issues currently affecting category 8 and 9 manufacturers - continued
• Conflicting customer requirements– Military, aerospace customers will not accept lead-free– Some products sold to both military and commercial
markets (world-wide)• Usually uneconomic to supply two versions
• Suppliers– Some specialist components used mainly by military and
will not be changed to RoHS compliant– Commercial products using such military components will
not comply with RoHS
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Reliability
• Categories 8 and 9 originally excluded from RoHS directive due to concerns over reliability of substitute materials – especially lead-free solder
– Defect in medical devices can result in death or serious injury,e.g.
• Wrong X-ray dose• Radiotherapy machine not functioning when treatment due• Failure of most products dangerous
– Defect in category 9 products can cause death, serious injury oraffect environment e.g.
• Carbon monoxide detector malfunction• Faulty thermostat – too high temperature, global warming impact• Inaccurate or non-functioning pollution sensor or emissions analyser
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Reliability issues - Lead-free solders
• Four main types investigated– Manufacturing defects– Thermal fatigue– Tin whiskers– Vibration
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Reliability - Manufacturing
• Lead-free soldered products are more difficult to make
– Many production defects are more likely with lead-free solders due to higher temperature, etc. e.g.
• Via cracks• Delamination of PCBs• Damage to components• Poor soldering
– Most defects are well understood and can be resolved if manufacturer understands issues and has sufficient time and resources
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Reliability - Thermal fatigue
• Caused by cyclic temperature changes leading to cracks - can take 5 – 10 years or longer
– Decades of field data for tin/lead solder– Currently very little useful lead-free field data
• Accelerated testing used for research– Indicates that lead-free better than tin/lead at low
stress but inferior at high stress
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Reliability – Thermal fatigue
• Lead and lead-free solders are clearly different so it is not known with certainty if accelerated test predictions will be reliable
• Prediction models are being developed
Cycles to fail
Low strain High Strain
SnPb
Pb-free
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Reliability – Thermal fatigue
• Should be able to predict field life of lead-free products by 2010
– Millions of lead-free computers, etc. will have been in use for ~5 years by 2010 - useful data to confirm predictions
Accelerated test (3 months)
Field life ~20 years
Time to fail
Test data available
Field data not yet
available
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Reliability – Tin whiskers
• A lot of research carried out – caused by stress in tin plating• Understanding improving
– Guidelines for minimising risk published by iNEMI– “Whisker resistant” tin coatings available– Most components changing from tin/lead coatings to tin coatings and
category 8 and 9 producers are forced to use these• Long term behaviour not known (these products are new)• Mistakes in plating process cannot be
detected quickly– Tin plating carried out by sub-contractors
– often not possible to determine if process carried out correctly
• Evidence that risk increased in – corrosive atmospheres -– industrial environments
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Reliability - Vibration
• Can cause cracks in solder joints• Research has been reviewed
– At low g force, lead-free and tin/lead similar– At high g-force in direction perpendicular to PCB, lead-free
is clearly inferior and will fail sooner– Most products do not experience high G-forces
• Implications for portable defibrillators which experience high G
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Reliability - Conclusions
• Thermal fatigue– Most researchers believe lead-free solders will “probably” be
safe to use but no certainty without field data– Review concludes that reliability will be better understood by
2010 so that life predictions should be possible
• Tin whiskers– Much better understanding now, mitigation strategies should be
effective– “Whisker resistant” coatings are new – no long term experience– No accurate quick test – cannot detect mistakes in coating
process
• Vibration – risk only at high G perpendicular to PCB
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Other issues - Innovation
• Innovations in categories 1 – 7 and 10 usually do not improve health, safety or the environment
• Innovations in category 8 and 9 products usually intended to improve health, safety or the environment, e.g.
– Innovation in medical products• improves diagnosis – clearer X-ray images• reduces risk to patients – lower X-ray doses
– Innovation in category 9 could reduce risk to environment by earlier detection of pollutants
• Why is this important?– Researchers will avoid RoHS substances due to lengthy exemption
review process and so could potentially miss important discoveries –impossible to predict where future discoveries will occur
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Other issues - Impact on users
• Healthcare– All healthcare providers have limited budgets– Increase in prices of medical equipment likely especially if
Category 8 brought within scope of RoHS early– Result would be less new equipment – this would have a
negative impact on healthcare
• EU Industry– Early inclusion in scope of Category 9 would result in many
products being withdrawn from EU market– This would have a negative impact on EU industry only as these
products could be sold elsewhere
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Any questions?
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Part 2
Applications of six RoHS substances and exemption requests
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Applications of six RoHS substances & exemption requests
• Quantities of equipment• Quantities of RoHS substances
– Lead– Cadmium– Mercury– Hexavalent chromium– PBB and PBDE flame retardants
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Estimated quantities of equipment
0.24 – 0.71 %0.25 – 0.54 %Quantity as percent of all 10 WEEE categories
~ 20,000 – 60,000 tonnes
21,000 – 46,000 tonnes
Quantity sold in EU per year
Category 9Category 8Estimates
Total for categories 8 and 9 = 0.5 – 1.25% of all WEEECurrent estimate for all WEEE in EU is 8.5 million tonnes based on EU estimate of 6 million tonnes in 1998 increasing by 4% p.a.
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Quantities of RoHS substances - Estimates
Not known
data incomplete
~ 9 kg
data incomplete
120 tonnes
Category 9
<10 tonnesNot knownPBB & PBDE
0.3 – 0.8 tonnesdata incompleteHexavalent
chromium
~ 20 kg~ 12 kgMercury
2.24 tonnes1.8 tonnesCadmium
1180 tonnes1060 tonnesLead
Categories 8 & 9 totalCategory 8RoHS
substance
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Quantities of RoHS substances- Summary
• Very limited data for category 9 as many manufacturers are unclear which products are within scope
• More than half of lead used is in radiation shielding• Most of cadmium is in detectors• Mercury use has very significantly declined in recent
years due to US legislation• Flame retardants
– PBB and PBDE not intentionally used so no data from manufacturers
– Penta and Octa-BDE already restricted– Deca-BDE is exempt from RoHS
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Lead – main uses (examples)
Zinc, calciumStabiliser PVC
Steel, brassBalance suspended equipment (radiotherapy, CT)Counterweights
Lower lead content or Bi/Sn additions
Machining additives at > exempt concentrations (e.g. 5% Pb in aluminium)
Alloys
Yes - lead-free alloysElectrical connectionsSolder
Apparent substitutesReason for useApplication
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Cadmium- main uses (examples)
Apparent substitutesReason for useApplication
Alternative soldersVarious but none identified by manufacturersSpecial solders
Cadmium-free products available, some with lead
Conducting tracks on ceramicsThick-film materials
Organic and inorganic materialsRed/orange yellow pigmentsSulphide/selenides
Alternative copper alloysFlexible, fracture resistantCuCd wire
Zn, CaStabiliserPVC
Outside scope of RoHSBattery – main use of cadmium in EEE
Nickel cadmium batteries
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Mercury – main uses (examples)
Apparent substitutesReason for useApplication
Various organic pigmentsRed/pink paintsPigments
Already phased out by redesign
Was used in consumer productsLevel sensors
Silver chlorideReference electrodeCalomel electrodes
Usually goldLong life, zero bounceRelays, thermostats, switches, sensors
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Hexavalent chromium- main uses (examples)
Apparent substitutesReason for useApplication
Substitutes are availableCorrosion resistancePrimers
Bismuth vanadate, etc.Bright yellow colourPigments
Proprietary substitutes being developedProduction of photo-cathodesAlkali
dispensers
Trivalent chromium and others
Protection from corrosion, maintain electrical conductivity
Passivation coatings
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Main uses (excluding batteries)
~99%Passivation coatingsHexavalent chromium
25%Infrared detectors *Mercury
58%X-ray detectors *Cadmium
58%Shielding *Lead
Percent of estimated totalMain useRoHS substance
* Exemptions appear to be justified
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Exemptions requested
• 12 of the current published exemptions would be utilised
• ~ 40 requests for new exemptions– ~ 8 for various sensors, detectors and electrodes– ~ 13 requests related to ionising radiation equipment (2
not required after 2012)
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Exemptions
• Accept where no substitute available based on criteria of Article 5.1b of RoHS
• Increased cost is not directly a criterion of 5.1b but has to be considered because:
– Increased price of products could affect healthcare (results in purchase of less new products)
– May result in essential products being withdrawn from EU market as this could affect consumer safety
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Lead – exemptions requested (examples- not a complete list)
Lead-free glass with same TCE has lower electrical resistance
pH electrodes, X-ray tubes, etc.
Glass
Properties destroyed at temperature used for lead-free soldering
Ultrasound imagingUltrasound transducers solders
Exempt as ceramic but single crystal is more sensitive, no alternative
Ultrasound imagingUltrasonic transducers
No substitutes for many applicationsMeasurement of oxygen concentration
Oxygen sensors
No alternative at 4°KSuperconducting bonds at 4°K in magnetic field
Superconductor alloys (also Cd)
Tungsten very difficult to fabricate and recycle. Also supply limited (environment)
Protection of patients and workers
Radiation shielding
Main reasonReason for useApplication
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Cadmium - Exemptions requested (examples)
Main reasonsReason for useApplication
No alternativeCadmium analysisHollow cathode lamps
No alternativeCadmium analysisIon selective electrodes
Substitutes not available except to patent holders
detector in CT scanners
Cadmium tungstate
Allows 10 x less X-rays, gives better resolution
X-ray detectorsCadmium telluride
No alternatives for certain applications
Infrared sensorsMercury cadmium telluride
Current exemption, Ag/SnO2has shorter life than AgCd/O
Resistant to arcingElectric contacts (AgCdO)
Current exemptionCorrosion protectionPlating
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Mercury - Exemptions requested (examples)
Already exempt, no substitutes
Backlights, mercury analysis, medical applications
Lamps
Main reasonsReason for useApplication
Under reviewVery small sizeMEMS micro-switch
No substitutesAnalysis, researchReference electrodes (several types but not calomel)
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Hexavalent chromium- Exemptions requested (examples)
Apparent substitutesReason for useApplication
Substitutes are new and untested
Production of photo-cathodesAlkali dispensers
Substitutes are new and untested
Protection from corrosion, maintain electrical conductivity
Passivation coatings
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Other exemption options- Life-time-buy components
• More common with category 8 and 9 than other categories
• Frequently products cannot be made to comply with RoHS because 1 component is not available as RoHS compliant version
• Too costly to redesign so product would be withdrawn• Life-time-buy exemption would allow inclusion in scope
earlier and resolve issue with small number of military specification components
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Other exemption options- Lead in solders
• Long term reliability is “probably” OK but there can be no certainty without >5 years field data
• Suitable field data is not available yet but will be by 2010 – 2012
• Lead in solders in servers, storage, storage arrays and telecommunications network infrastructure equipment exemption will be reviewed in 2010 (after 4 years). Lead in solders in Category 8 and 9 equipment could be linked to this review
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Exemption requests- Sensors, detectors, electrodes
• Sensors, detectors, electrodes– All used in category 8 and 9 only– Contain Pb, Cd or Hg– Exemption requests for most are justified on a technical basis
• X-ray detectors (various types)• Infra-red detectors (several types)• Oxygen sensors (lead)• Reference electrodes (several types)• pH electrode glass (glass)
• Option: grouping these into one exemption reduces total number of new exemptions and allows limited innovation in this area
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Exemption request - Examples
No lead-free substituteClear lead glass protects workers but enables patient to be seen
Restricted supply, expensivePlentiful supply, low price
Becomes radioactive from high energy radiation (e.g. radiotherapy) – lasts up to 6 years
Does not become radioactive from high energy radiation (safe after <day)
Very difficult to recycleEasy to recycle at end of life
Very hard, difficult to make into complex shapes, melts 3422°C
Ductile, easy to make into complex shapes, melts 327°C
Substitute - TungstenLead
•Lead in shielding for ionising radiation–Requested by many manufacturers–Included in early draft of RoHS directive–Main substitutes based on tungsten
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Exemption request – Chromate passivation
• Main use for hexavalent chromium• Used to prevent corrosion and for electrical conductivity
(EMC directive and electrical performance)• Substitutes are available:
– Suitable for some applications– Most category 8 & 9 manufacturers not yet tested these– Substitutes may not be suitable in most severe environments (but
these are “LSIT” and so excluded from WEEE)– Thin transparent chromate passivation – no Cr(VI) detectable –
research continuing– No published research on EMC performance of substitutes
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Any questions?
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Part 3
Conclusions and Options
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Conclusions and options
• Conclusions– Is it possible to include categories 8 and 9 in scope of
RoHS?– What would be the impact on industry, users, healthcare
and environment?– When would be a reasonable date for inclusion in scope?– Which exemptions will be required?
• Options for amending RoHS• Next steps
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Is it possible to include categories 8 and 9 within the scope of RoHS?
• Yes but!– Manufacturers need sufficient time– New exemptions will be required– Some uncertainty of reliability of lead-free solder that will not be
resolved until at least 2010
• Should also consider– Most manufacturers are voluntarily eliminating RoHS restricted
substances– Quantity of equipment and RoHS substances in categories 8 and
9 is small– Small environmental benefit for potentially a very significant
impact on manufacturers and users• 5% price increase would cost EU healthcare providers €2.7 Billion
based on industry estimate of €55 Billion annual expenditure
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Options for consideration
1. Do not include Categories 8 and 9 in scope of RoHS2. Include in scope from specified date with justified
exemptions and exclusions3. Include in scope at different dates for each sector with
justified exemptions and exclusions4. Include exemption for life-time-buy (earlier dates)5. Include temporary exemption for lead in solder6. Many specific exemptions or fewer but broader scope
exemptions (e.g. sensors, detectors, electrodes)7. Exclude specified products or components permanently
Note: Options 2 or 3 could be used in combination with some or all of Options 4 to 7
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Opportunity to amend RoHS Directive to address other issues
• Clarification of scope (especially category 9)• Spare parts exclusion• Definitions of terms
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Option 1 – Do not include in scope
• Disadvantages – Many manufacturers are already working towards compliance– Manufacturers who develop RoHS compliant products will be
unfairly penalised by free-riders• Advantages
– Quantities of EEE and reduction in RoHS substances relatively small
– Avoids need for lengthy discussions (within EU) and many new exemptions
– Manufacturers resources not diverted away from new product development
– Medical equipment prices would not increase – Compulsory eco-design may give greater environmental benefits
without risk to health, safety and environment• Already planned for medical industry
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Option 2 - Include in scope from specified date with justified exemptions
Most industrial products could be RoHS compliant without significant price increase. ~10% of products lost from EU market (most in category 9). Concern over AIMD product reliability
2016 - 2018
All products RoHS compliant with negligible price increase and all products available
2020
OK for consumer-type products but up to 50% of specialist industrial products could be lost from EU market, significant price increases in some sectors. >20 new exemptions needed
2012
Possible impactDate into force
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Option 3 - Include in scope at different dates for each sector with justified exemptions
2018Professional category 9
2012Consumer category 9
2012Other medical devices
2016IVD
2020AIMD
Date for inclusion in scope suggested by industrySector
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Option 4 - Include exemption for life-time-buy
• Advantage– Possible to include categories 8 and 9 in scope of RoHS up
to 2 years earlier– Would allow continued use of specialist military
components– Would not create additional waste as components are
already in manufacturers stocks • (they would otherwise be scrapped and resources would be
needed to make RoHS compliant replacements-an overall negative environmental impact)
• Disadvantages– Requires clear definition of scope and effective
enforcement
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Option 5 - Include temporary exemption for lead in solder
• Dates proposed by some sectors are on basis of lead solder being exempt until no possible risk (then 6 years to comply)
• Extensive research into lead-free solders– Results indicate that risk is low but -
• Cannot give 100% certain guarantee of long term reliability until field data is available
• Option – include temporary exemption linked to RoHS exemption 7b which will be reviewed in 2010 and so could terminate at same date when all reliability issues are resolved
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Option 6 - Many specific exemptions or fewer but broader scope exemptions
• >40 requested, many of these justified– >15 are justified but review of many incomplete– At least 7 will not be required beyond 2012
• Fewer but broader scope exemptions– One exemption for “lead, cadmium and mercury in
detectors, sensors and electrodes” combines many exemptions as one and allows future innovation in this limited area
– All detector, sensor and electrode exemption requests are being reviewed
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Option 7 - Exclude specified products or components permanently
• Due to safety concerns, e.g.– Portable defibrillators (risk of solder joint failure due to
vibration)– AIMD – Very high risk to patients from failure (also
excluded from WEEE)
• To minimise number of exemptions, e.g.– Equipment that uses or measures ionising radiation
• To allow innovation– Sensors, detectors and electrodes
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Next steps
• Review will consider opinions of EU Member States, NGOs, MEPs, industry and others
– Including this afternoon’s discussions
• Complete review of requested exemptions• Final report will include ERA’s recommendations
and information required by European Commission
– Will answer question – is it possible to include Categories 8 and 9 in scope of RoHS?
– Likely to be a complex answer!
Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting
- Brussels -
April 2006
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Feedback
• ERA welcomes further information and feedback from all stakeholders
• The deadline for feedback to ensure that it is considered in the final report of this study is 19 May 2006