January 9, 2014 – RoHS 2 exemptions for Annex IV

The EU has updated the substance exemptions in RoHS 2 Annex IV with 14 new exemptions and a modification of exemption 12. The Annex IV exemptions are applicable to Category 8 and 9 products. The new exemptions are:

21. 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.

22. 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.

23. Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. Expires on 30 June 2021.

24. Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers. Expires on 31 December 2019.

25. 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.

26. Lead in
– 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.

27. Lead in
— solders,
— termination coatings of electrical and electronic components and printed circuit boards,
— connections of electrical wires, shields and enclosed connectors,
which are used in
(a) 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
(b) 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.’

28. Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards. Expires on 31 December 2017.

29. 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.

30. 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.

31. 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.

32. 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.

33. 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.
Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. Expires on 22 July 2021.

34. Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. Expires on 22 July 2021.

The modified wording for exemption 12 is:
12. 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.

December 16, 2013: Seven substances added to the EU REACH SVHC Candidate List.

The 7 substances are Cadmium sulphide, C.I. Direct Red 28, C.I. Direct Black 38, Dihexyl phthalate, Imidazolidine-2-thione (2-imidazoline-2-thiol), Lead di(acetate), and Trixylyl phosphate. Manufacturers, importers and distributors have communication obligations if any of these substances are in their products in Europe contain one of these substances above the reporting threshold.

October 22, 2013: Four substances for addition to RoHS.

A public consultation was launched on the draft technical dossiers of four substances that have been assessed for addition to  the RoHS Directive.  The four substances include the flame retardant HBCDD and the three phthalates  DEHP, BBP and DBP.  All four substances are already listed on the REACH SVHC Candidate List; however, the restriction of these substances in homogeneous materials will impose a significant challenge on the EEE industry. 

July 5, 2013: Six EU Countries publish new guidance on 0.1% SVHC threshold.

The countries France, Belgium, Denmark, Germany, Sweden and Norway have published a guidance document  “Guidance for Suppliers of Articles”   that explains SVHC communication responsibilities based on the “Once an article, always an article” principle.  These countries have previously disagreed with the ECHA guidance that allows the 0.1% threshold to be applied based on the weight of the imported article.  The guidance document advocates a reporting threshold for SVHCs that is based on when substances/mixtures containing an SVHC are first made into an article.  According to the guidance, the information on SVHC content must be provided to downstream manufacturers and users even if the the first article (usually a part) is assembled into a larger article.   This principle will have a significant impact on the restricted substance control systems for many EEE manufacturers and distributors.

January 31, 2013: IEC 62474 substance list is updated

IEC 62474 Declarable Substance List (DSL) was updated with additional regulated substances that may be found in electrical and electronic equipment (EEE).  Most of the substances that were added are REACH Candidate List SVHCs.  The International Standard  IEC 62474 DSL replaces the JIG-101 substance list that was commonly used by industry since 2006. The IEC 62474 database is available at:  http://std.iec.ch/iec62474