The RoHS2 Directive restricts the use of lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr6+), polybrominated biphenyls (PBB), and polybrominated diphenyl ether (PBDE) in the manufacturing of certain electrical and electronic equipment sold in the European Union. The new RoHS Directive, also known as RoHS 2, introduces new CE marking and declaration of conformity requirements.
REACH is an EU regulation that places the responsibility to provide safety data and manage hazards associated with their products on manufacturers, importers and distributors of substances.
SIRONA develops and produces a complete spectrum of dental equipment for dental offices, clinics, dental labs and the dental trade. This includes CAD/CAM systems for computer-supported ceramic restorations (CEREC), digital imaging systems for intraoral and panorama x-rays, as well as volume tomography (3D), treatments units, instruments, and hygiene systems. Sirona has a staff of more than 3,000 employees in 25 locations throughout the world and markets its products in more than 135 countries.
"As a global market and technology leader in the dental industry, SIRONA must comply with RoHS2 requirements by the 2014 deadline. During extensive preliminary discussions, Intertek identified that additional regulations to RoHS2 and REACH may be applicable and should be included in an overall chemical management strategy. The decisive factor for accepting Intertek's bid for implementation of the RoHS2 and REACH-SVHC requirements project was that Intertek provides a complete service portfolio supporting all of Sirona's product lines," stated Wilhelm Pfleger, Director Health, Environment & Regulatory, Germany. "Intertek experts will act as advisors to the SIRONA Group on an ongoing basis. To ensure SIRONA's high quality standards Intertek will also implement a random sampling program with expert, independent testing performed within the Intertek network of testing laboratories."
Additional information on Intertek services in the area of chemicals and pharmaceuticals can be found at www.intertek.com/RoHS and www.intertek.com/REACH.