The Commission of the European Union (EU) has published a revised version of its Directive on the use of lead, mercury, cadmium and other hazardous substances in electrical and electronic equipment, otherwise known as the RoHS Directive.
Published in early July 2011 in the Official Journal of the European Union, Directive 2011/65/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) broadens the scope of the original RoHS Directive to include medical devices, in-vitro diagnostic medical devices, and industrial monitoring and control equipment. In addition, certain types of electrical and electronic equipment that were not included in the original RoHS Directive are now covered. The complete list of product categories is listed in Annex 1 of the new Directive.
Directive 2011/65/EU entered into force on July 21, 2011, and replaces the original RoHS Directive, 2002/95/EC, on January 3, 2013. However, the new Directive provides staggered compliance deadlines for newly included equipment types, as follows:
- July 22, 2014—Medical devices
- July 22, 2016—In-vitro diagnostic medical devices
- July 22, 2017—Industrial monitoring and control equipment
- July 22, 2019—Electrical and electronic equipment formerly outside the scope of the Directive
In addition to its broader product scope, Directive 2011/65/EC includes modified CE marking and declaration of conformity requirements. Manufacturers, importers and distributors will need to ensure that the appropriate conformity assessment procedure, as defined in Annex II of Decision No. 768/2008/EC, has been used to evaluate the product before affixing the CE mark.
The list of restricted substances and their maximum concentrations is listed in Annex II of the new Directive, and remains unchanged from the original RoHS Directive. However, the list of restricted substances is subject to review by July 2, 2014.