Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – … · 2016. 3. 30. · Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting - Brussels -

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

A company

Pb

Review of Directive 2002/95/EC (RoHS) –possible inclusion of Categories 8 and 9

Dr. Paul Goodman+44 (0)1372 367221 [email protected]

A company©ERA Technology Ltd 20062www.era.co.uk/rfa.htm

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


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

A company

Pb

Part 1

Main issues affecting Category 8 and 9 products


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


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


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April 2006



Category 8 - Examples


Category 9- Examples


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


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.)


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


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


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April 2006



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)


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


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


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


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”


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


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April 2006



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


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


Reliability issues - Lead-free solders

• Four main types investigated– Manufacturing defects– Thermal fatigue– Tin whiskers– Vibration


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


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


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


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April 2006



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


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


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


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


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


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


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April 2006



Any questions?

A company

Pb

Part 2

Applications of six RoHS substances and exemption requests


Applications of six RoHS substances & exemption requests

• Quantities of equipment• Quantities of RoHS substances

– Lead– Cadmium– Mercury– Hexavalent chromium– PBB and PBDE flame retardants


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.


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


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


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April 2006



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


Cadmium- main uses (examples)


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


Mercury – main uses (examples)


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


Hexavalent chromium- main uses (examples)


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


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


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)


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April 2006



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


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


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


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)


Hexavalent chromium- Exemptions requested (examples)


Substitutes are new and untested

Production of photo-cathodesAlkali dispensers

Substitutes are new and untested

Protection from corrosion, maintain electrical conductivity

Passivation coatings


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


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April 2006



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


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


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


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


Any questions?

A company

Pb

Part 3

Conclusions and Options


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April 2006



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


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


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


Opportunity to amend RoHS Directive to address other issues

• Clarification of scope (especially category 9)• Spare parts exclusion• Definitions of terms


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


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


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April 2006



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


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


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


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


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


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!


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April 2006



Any questions?


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

Documents

Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – … · 2016. 3. 30. · Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Stakeholder Meeting - Brussels -