Regarding QInstruments activities with respect to the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS), please be advised of the following:
Executive Summary Each manufacturer of laboratory instruments and medical devices bear a heavy responsibility for its products. These have to comply with legal requirements and EU regulations. The new RoHS Directive 2011/65/EU (RoHS II) became effective on 3 January 2013. RoHS 2 deals with the same hazardous substances and the same maximum concentration limits as Directive 2002/95/EC (RoHS 1). Therefore, all products meeting the substance restrictions of RoHS 1 remain compliant to the substance restrictions of RoHS 2. The scope of RoHS 2 expanded to phase in the previously excluded categories of medical devices and monitoring & control instruments, as well as certain cables. In addition, RoHS 2, for finished EEE (EEE = Electrical and Electronic Equipment), requires the use of the CE mark to demonstrate compliance with the Directive. The commentary below provides more detail related to QInstruments approach to ensure compliance to RoHS 2. To reduce the environmental impact of waste electrical and electronic equipment (WEEE), the European Parliament and the Council of the European Union have implemented Directive 2002/96/EC. The directive mandates that producers of the electrical and electronic equipment provide their customers information about proper disposal.
Awareness and Focus QInstruments is fully aware of RoHS 2, which entered into force on 21 July 2011 and requires Member States to transpose the provisions into their respective national laws by 2 January 2013. QInstruments has continued to monitor the developing implementation guidelines and national transpositions.
Substance Restrictions RoHS 2 deals with the same six hazardous substances and the same maximum concentration limits as RoHS 1: lead (0.1%), mercury (0.1%), cadmium (0.01%), hexavalent chromium (0.1%), polybrominated biphenyls [PBB] (0.1%), polybrominated diphenyl ethers [PBDE] (0.1%). Therefore, all products meeting the substance restrictions of RoHS 1 remain compliant to the substance restrictions of RoHS 2.
Expansion of Scope RoHS 2 expands the scope of products covered by phasing in EEE categories 8 (medical devices) and 9 (monitoring and control instruments) which were previously excluded under RoHS 1. Most QInstruments component products that are used in equipment falling into these categories are already compliant and we expect no issues in providing compliant versions of any remaining products well before the respective phase in dates.
CE Marking In contrast to RoHS 1, RoHS 2 is a CE marking Directive, and requires, for finished EEE, the use of the CE mark on the product to show compliance. The responsibility for affixing the CE mark resides with the manufacturer. For finished EEE where QInstruments is the legal manufacturer, QInstruments will affix the CE mark. For finished EEE that QInstruments produces for OEMs, the CE mark can, similar to other customer specifications, be affixed by QInstruments on the customers behalf without QInstruments assuming the OEMs’ (manufacturers’) responsibility (see section on technical documentation).
Please be advised that CE marking for RoHS 2 only applies to finished EEE in scope of RoHS 2.
Declaration of Conformity (DoC) and Technical Documentation In addition to placing the CE mark on all finished EEE in scope of RoHS 2, all CE marked EEE will require a Declaration of Conformity (DoC) and associated technical documentation. The responsibility for this DoC and documentation resides with the manufacturer. For finished EEE where QInstruments is the legal manufacturer, QInstruments will provide the DoC and prepare technical documentation per Harmonised European Standard EN50581. For finished EEE that QInstruments produces for OEMs, it is only the OEM that can fulfil the obligations to provide the required documentation under its own name.
WEEE Registration Number DE 50498740 We have registered with the Electrical and Electronic Equipment Waste Register (EAR) for articles in accordance with §6 Abs.2 ElektroG. Reporting and notification obligations pursuant to Section 18 of the Electrical and Electronic Equipment Act / Section 2 of the Act on the Implementation of the Waste Framework Directive: https://www.take-e-way.com/services/weee-elektrog/reporting-and-information-obligations/
Disposal of Electronic Equipment The various national implementations of the Directive suggest regulations governing the proper disposal of equipment will vary. For electrical devices, which were delivered before the 08/13/2005, the last user is responsible for proper disposal. A return of devices which were delivered after 8/13/2005 with consumer brands Q.Instruments and BioShake to municipal collection points is no longer permitted. With the disposal of the equipment which was delivered after 8/13/2005 QInstruments have engaged the certified waste disposal firm "Municipal Service Jena" (operating through the city of Jena/Germany). The WEEE symbol and description apply to all QInstruments electrical and electronic products placed on the European Market after August 13, 2005. Do not dispose of this product as unsorted municipal waste. Follow local municipal waste ordinances for proper disposal provisions to reduce the environmental impact of waste electrical and electronic equipment (WEEE). European Union customers: Call our QInstruments Customer Service office for complimentary equipment pick-up and recycling.
Beginning August 13, 2005, QInstruments affixed the wheeled bin symbol with a bar to appropriate products. The bar indicates that the product was placed on the market after August 13, 2005.
LUCID Register Number DE5774190439468-V for packaging recycling We have licensed our packaging at Interseroh's dual system absolutely legally compliant and in accordance with the specifications of the Central Agency Packaging Register. https://www.lizenzero.de/en/
Conclusion QInstruments will continue to closely monitor legislative and guidance developments and update this letter as appropriate.