Please note that the date you requested in the address for this web page is not an actual date upon which a change occurred to this item of legislation. You are being shown the legislation from , which is the first date before then upon which a change was made.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment(1), and in particular Article 5(1)(a) thereof,
Whereas:
(1) Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.
(2) Micro-channel plates (MCPs) are used for the detection and amplification of ions and electrons in medical devices and monitoring and control instruments. The substitution of lead in MCPs is scientifically and technically impracticable.
(3) The substitution of MCPs as components with alternative detectors is not viable under conditions where extreme miniaturisation, very short response times or very high signal multiplication factors are required. The use of lead in those cases where the performance and specific features of MCPs exceed alternative detectors should therefore be exempted from the prohibition. As currently no lead-free alternatives are in sight, pursuant to Article 5(2) of Directive 2011/65/EU, the validity period of the exemption should be 7 years from the relevant compliance dates for medical devices, monitoring and control instruments, in vitro medical devices and industrial monitoring and control instruments, as laid down in Article 4(3) of Directive 2011/65/EU. In view of the innovation cycles for all medical devices and monitoring and control instruments 7 years is a relatively short transition period which is unlikely to have adverse impacts on innovation.
(4) Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE: