Regulations and directives
Two European Directives aimed at protecting the environment have been enacted to reduce waste electrical and electronic equipment from entering landfills or being incinerated at end of life, through enhanced product life cycle management and improvements in environmental controls at end of life.
Similar regulations are being enacted by numerous national authorities - notably China, Korea, Japan, California (USA) and Norway - with minor amendments.
Waste Electronic & Electrical Equipment (WEEE) Directive 2002/96/EC
Aimed at reduction of electrical and electronic waste through increased reuse and refurbishment and improvements in materials recovery and recycling at end of product life. All electronic equipment placed on the EU market after 13 August 2005 must bear the crossed-out "wheelie" bin symbol of EN 50419:2005, indicating need for separate collection, if the product contains substances suitable for recycling. Components, sub-assemblies and consumables forming part of the equipment at the time of discarding are covered under WEEE. Design and production of electrical and electronic equipment must facilitate dismantling and recovery, in particular reuse and recycling.
Recast of WEEE - Directive 2012/19/EC (WEEE2)
On 4 July 2012 the Official Journal of the European Union published the 'Recast' WEEE Directive (WEEE2) and Member States have until the 14 February 2014 to transpose the Directive into national law. WEEE2 specifically includes medical devices, introduces a host of requirements and penalpties for non-compliance, and establishes for the first time minimum recovery/ recycling targets, as below:
Minimum Targets set for Medical Devices (Cat. 8) :
refer to Annex V of Directive2012/19/EU
Annex VII specifies selective treatment for batteries, PCBs, cables, capacitors, plastics containing flame retardants, etc.
|Restrictions on use of Hazardous Substances (RoHS) Directive 2002/95/EC
Effective 1 July 2006, all electronic and electrical equipment placed on the EU market cannot contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE) in concentrations exceeding established limits or intentionally added. Maximum concentration in each "homogenous" material (which cannot be mechanically disjointed) are 0.01 % (100 ppm) for Cadmium and 0.1 % (1,000 ppm) for the remaining hazardous substances. The intent of this Directive is to ensure that all new electronic items are designed and manufactured using safer alternate materials, so that these hazardous substances are no longer in use.
Recast of RoHS - Directive 2011/65/EC (RoHS2)
On 1 July 2011 the Official Journal of the European Union published the 'Recast' RoHS Directive (RoHS2), with a number of substantial changes.
Medical devices placed on the EU market with effect from 22 July 2014 are covered under RoHS2. Conformity with CE marking and Declaration of Conformity, Authorized Representative obligations, and other administrative measures have been adopted, with the ability under Annex II to periodically include additional Hazardous Substances. coherent with other legislation related to chemicals, in particular REACH Regulation (EC 1907/2006).