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EU
May Expand Scope of RoHS
Review of RoHS: Categories 8 & 9
Directive 2002/95/EC - RoHS
Directive 2002/96/EC - WEEE
Article 6 of
the RoHS directive requires a review (by February 2005) to
consider new scientific evidence, especially whether
category 8 and 9 equipment should be included within the scope
of RoHS. The required review was
prepared by ERA Technology, which issued its final report "Review of Directive 2002/95/EC (RoHS) Categories 8
and 9" in September 2006.
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Categories 8 and 9
refer to the categories of waste electrical and electronic equipment
listed in Annex 1A to Directive 2002/96/EC (WEEE); examples
are provided in Annex 1B: |
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Category 8: medical devices such as radiotherapy equipment, cardiology, dialysis, pulmonary
ventilators, nuclear medicine, laboratory equipment for
in-vitro; other appliances for detecting, preventing,
monitoring, treating or alleviating illness, injury or
disability; but specifically excludes all implanted and infected
products |
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Category 9: monitoring & control
instruments such as smoke detectors, heating
regulators, thermostats; measuring, weighing or adjusting
appliances for household or laboratory equipment; other
monitoring and control instruments used in industrial
installations (e.g. in control panels) |
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FINDINGS: CATEGORY 8 & 9 EQUIPMENT |
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Only about 1% of all
electrical equipment sold in the EU, approximately 60,000 tonnes
yearly. |
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Require extensive reliability testing,
validation or clinical trials performed by a limited
number of trained engineers (18 months or more for complex
products)
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Must comply with large number of directives and obtain approval
from Notified Bodies (1 year or more) |
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Made
in small numbers and produced for long
periods of time without design changes (7 to 10
years);
compliance
is only feasible when new models are introduced |
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If
compliance is required for existing product line, costs double
for reliability testing and approval with only a reduced number
of future sales possible; products likely to be withdrawn from
market |
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Most manufacturers (categories 8 & 9) have assumed eventual
inclusion in RoHS and are working towards this;
components from suppliers
are increasingly available only as RoHS compliant |
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Innovation cost: inclusion
in scope of RoHS
could prevent development of life-saving technology
because
research on restricted substances is unlikely (exemption request
takes 9 months or longer and use of exemption is only temporary) |
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FINDINGS: RELIABILITY OF RoHS SUBSTITUTES |
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Manufacturing defects
with lead-free solders: risk is well-understood and should be
avoidable. |
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Thermal fatigue
in lead-free solders: accelerated test data for equipment used
for more than 10 years in hostile conditions should be available
within the next five years. |
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Tin Whiskers
in lead-free solders: risk is low if minimization strategies
that have been developed are followed; components increasingly
are available only as lead-free |
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Vibration and effect of g-forces
on lead-free solders: less reliable at high g-forces in the
direction perpendicular to printed circuit boards |
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Corrosion
with lead-free solders: occurs on gold-coated boards and
components used in the most severe environments; unforeseen
behavior shows that sufficient time for research is always
needed. |
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Passivation coatings
with
hexavalent chromium: substitutes can be used except in the most
severe environments |
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RECOMMENDED RoHS
AMENDMENTS |
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Include
category 8 & 9 equipment
in scope from 2012, with the following exceptions: |
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Include
in-vitro
diagnostics
from 2016 (very complex instruments, large number of tests to be
validated for accuracy) |
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Include
industrial test and measurement equipment
from 2016, or possibly 2018 (large range of technically complex
products sold in small numbers, many are safety critical)
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Exclude
active implanted medical devices
permanently or delay inclusion until 2020 (failure could be
fatal, only small amounts involved) |
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Provide temporary exemption for lead
solder,
until approximately 2012 (review in 2012 allows time for test
data on reliability) |
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Provide
permanent exemption for
lead, mercury and cadmium in sensors,
detectors and electrodes used in category 8 & 9 equipment |
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Provide
clearer definition of
category 9 equipment
because current inconsistency between Member States is
unacceptable;
decide whether it includes all laboratory equipment or just
monitors & controls |
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Provide clearer definition of category 8 equipment
by referencing the medical device directives |
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Provide clearer definition of spare
parts such as the one used in the electromangnetic
capatibility directive; extend exclusion for spare parts to
include equipment brought under the scope of RoHS after July 1,
2006 |
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Clarify
that
put on the market
means put on the market anywhere in the EU |
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Clarify
exclusion of
military & national security equipment
with
text
from WEEE Article 2(3) |
Study of the RoHS directive
In addition, Arcadis/Ecolas
prepared a "Study of the RoHS
Directive" as part of the larger
EC legislative simplification exercise.
The draft final report was issued in December 2007, with the public comment period ending January
31, 2008. Per the study, arguments for continuing to exclude category 8 & 9 equipment from
the scope of RoHS include:
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There are
no substantiated studies that prove the
long-term reliability
of lead-free solder. Reliability
is a key requirement of category 8 and 9 products which have
a long product life (up to 30 years), high market value and
a lot of customization. |
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Retrofitting existing products for RoHS compliance would
double their lifetime costs. Category 9
products are redesigned only every 5 to 15 years (7 years is
the average). |
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Without a
reasonable transition period, many older products will be
obsoleted prematurely, resulting in huge costs for companies
and unnecessary environmental waste. |
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Compliance
costs for category 8 and 9 products are estimated to be 10%
of annual revenues. Cost per unit will increase considerably
because of the limited number of units sold. |
This summary is
intended to give you an easy-to-understand overview and does not
constitute legal advice. The actual standard in the original language
should be reviewed and used for all business, legal, and product
compliance purposes.
If you would like assistance in
preparing your company for the expected changes to RoHS, please
email
or call at 972-679-8996.
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