Fourteen new exemptions were issued on January 9, 2014 for Category 8 and 9 products and are added to Annex IV:
- Cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020. (DIRECTIVE 2014/2/EU)
- Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment. Expires on 30 June 2021. (DIRECTIVE 2014/3/EU)
- Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. Expires on 30 June 2021. (DIRECTIVE 2014/1/EU)
- Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers. Expires on 31 December 2019. (DIRECTIVE 2014/4/EU)
- Lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions. Expires on 30 June 2021. (DIRECTIVE 2014/6/EU)
- solders on printed circuit boards,
- termination coatings of electrical and electronic components and coatings of printed circuit boards,
- solders for connecting wires and cables,
- solders connecting transducers and sensors, that are used durably at a temperature below – 20 °C under normal operating and storage conditions.
Expires on 30 June 2021. (DIRECTIVE 2014/5/EU)
- Lead in
- termination coatings of electrical and electronic components and printed circuit boards,
- connections of electrical wires, shields and enclosed connectors,
which are used in
- magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or
- magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.
Expires on 30 June 2020. (DIRECTIVE 2014/7/EU)
- Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards. Expires on 31 December 2017. (DIRECTIVE 2014/8/EU)
- Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments. Expires on 30 June 2021. (DIRECTIVE 2014/10/EU)
- Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020. (DIRECTIVE 2014/11/EU)
- Lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer. Expires on 21 July 2021. (DIRECTIVE 2014/15/EU)
- Lead in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment. Expires on 31 December 2019. (DIRECTIVE 2014/12/EU)
- Lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb. (DIRECTIVE 2014/13/EU)
- Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi 2 O 5 :Pb) phosphors. Expires on 22 July 2021. (DIRECTIVE 2014/16/EU)
In addition, Exemption 12 in Annex IV was updated on January 9, 2014 to read:
Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors. Expires on 30 June 2021. (DIRECTIVE 2014/9/EU)
Finally, in Annex III, new exemption 1(g) was issued on January 9, 2014 for Mercury in single capped (compact) fluorescent lamps not exceeding (per burner):
For general lighting purposes < 30 W with a lifetime equal or above 20 000 h: 3,5 mg; Expires on 31 December 2017 (DIRECTIVE 2014/14/EU)
Until we see a consolidated version of the RoHS Directive sometime in the future, you can view all these Directives in the Official Journal of the European Union.
Category 11 Consultation
A curious aspect of the new RoHS Directive is how it addresses "everything else" not defined in Categories 1 through 10. This newly introduced "open scope", identified as Category 11 to be "Other EEE not covered by any of the categories above," along with the "broader interpretation of EEE as a result of a new definition of the dependency on electricity," never went through an impact assessment prior to being added to the Directive.
Another aspect that is particularly controversial is the wording of Article 2(2). This states that any product which was outside the scope of the RoHS 1 Directive (2002/95/EC) but would not comply with the current Directive (2011/65/EU) would be allowed to be made available on the market until July 22, 2019, but not afterward. According to the Consultation Guidance:
As a consequence of the current wording, non-compliant products that have been placed on the market (made available for the first time) between January 2013 and July 2019, are not allowed any secondary market operations after 22 July 2019. This affects all products newly in scope, including non-compliant medical devices and monitoring and control instruments (EEE categories 8 and 9) placed on the market before their specific Article 4(3) compliance dates (22 July 2014/2016/2017).
Effectively this means there can be no market in the EU for used medical equipment, test/monitor/control equipment, and anything that would be considered Category 11 EEE, placed on the market from January 2013 thru July 21, 2019, after July 22, 2019.
Other aspects of the Directive, including scope exclusions and treatment of spares, are also covered by this consultation, which is now open for stakeholder review and comment.
Visit the Consultation Page for more information, as well as the Questionnaire. Responses are due by March 10, 2014.
Analysis of a Possible Ban of Several New Substances under RoHS 2
The scope of the new consultation, which will begin in February, is twofold:
- Prepare a substance assessment of Diisobutylphthalate (DIBP), and
- Provide input concerning quantitative usage data for the previously-identified 21 priority substances in EEE
DIBP, according to the consultants’ project overview, is often used to replace DEHP. Given industry’s tendency to replace "like with like," we occasionally end up with "regrettable substitutions": replacement substances that themselves are, toxicologically, no better – and sometimes worse or entirely unknown – than the substance being restricted, so the replacement also runs the risk of becoming restricted. This appears to be an attempt to address that possibility.
Regarding the 21 priority substances, back in 2008, if you will recall, The Oko Institut published its controversial "Study on Hazardous Substances in Electrical and Electronic Equipment, not Regulated by the RoHS Directive." They will be looking for use information on the substances in this consultation, which is expected to begin this month.
Reminder: Annex III Exemption Expiration
As I mentioned in my previous TTI MarketEYE contribution, exemptions in Annex III that do not otherwise state an expiration date are expiring in July 2016 for products in RoHS Categories 1 through 7 and 10. Applications for justifying an extension of those exemptions are due in January 2015. Several industry trade associations in the U.S. and Europe are working with their members on identifying exemptions that they cannot find appropriate replacement technologies for, presumably with an eye toward developing Annex V-compliant applications. Component manufacturers that have not yet done so should immediately start to assess their products for which exemptions are being use, which can be safely substituted (not regrettably – see above) or designed out, and which must be kept and therefore justified.