Article 6 of 2002/95/EC RoHS (Restriction of Hazardous Substances) Directive requires the European Commission (EC) to carry out a review of the directive within four years of its adoption. The main issues include:
o The possibility of including categories 8 (medical devices) and 9 (monitoring and control instruments) of the WEEE (Waste Electrical and Electronic Equipment) Directive within the scope of RoHS
o The possibility of restricting more substances that are hazardous, are used in significant quantities and where there are suitable substitutes
o All of the existing exemptions to be reviewed and may be either modified, be more restrictive or removed completely
o Other aspects such as where definitions and scope are unclear, as well as the subject of enforcement
ERA Technology, based in Surrey
o There would be a need for many more exemptions
o There
was a danger of stifling innovation if it was done wrong (e.g.
inhibiting the development of novel sensors using restricted
substances, the use of which far outweighs the small amounts used)
o These
are relatively slow moving industries in terms of design cycles. If a
restriction was brought in too early it could force products off the
market early, damaging industry and affecting users such as hospitals,
patients etc.
o The
rapid introduction of a restriction would put an enormous strain on a
finite resource (the design team) in industries where there are many
diverse designs sold in relatively low volume.
o ERA advised that it would be feasible to bring most products within scope from 2012 except for
§ In vitro diagnostics (IVD) where 2016 was proposed
§ Industrial test and measurement instruments in 2016-2018
§ Active implanted devices such as pacemakers where 2020 was recommended or indefinitely excluded if reliability cannot be assured
The
ERA study provided an input to the RoHS review which, at the time of
writing, is still on-going. Any change in scope with regard to
categories 8 and 9 will only happen with a revision of the directive
itself. The EC intends to table a new RoHS draft by around November
2008. It is unlikely that categories 8 and 9 will be brought within
scope, if that is what they decide to do, until 2012 at the earliest.
It
is possible even then that they may exclude part or all of these
categories due to health and safety fears or the fact that categories 8
and 9 represent only 1%, or thereabouts, of all electrical equipment
put on the market, and that most Producers are going compliant anyway.
To that extent RoHS has pretty much done its job already.
Either
way, both categories would remain within the WEEE Directive and would
need to be efficiently, and safely recycled at end of life.
Typical products that would fall with categories 8 and 9:
Category
8: Radiotherapy equipment, cardiology, pulmonary ventilators, nuclear
medicine, laboratory equipment for in-vitro diagnosis, analysers,
freezers, fertilisation tests and other appliances for detecting,
preventing, monitoring, treating, alleviating illness, injury or
disability.
Category
9: Smoke detectors, heating regulators, thermostats, measuring,
weighing or adjusting appliances for household or as laboratory
equipment and other monitoring and control instruments used in
industrial installations such as in control panels.
Obviously such equipment would need to be totally reliable and these two categories were originally excluded because of concerns over the use of lead-free solders. Today there is more confidence in the solder and it is felt that this can no longer be a reason for medical devices and monitoring and control instruments to remain outside the scope of the RoHS directive.
Thanks to Chris Robertson at ERA www.era.co.uk/rfa
Directive Decoder
Gary Nevison, Head of Legislation at 
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