Commission Delegated Directive 2014/1/EU
of 18 October 2013
amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation
(Text with EEA relevance)
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 equipment1, and in particular Article 5(1)(a) thereof,
Whereas:
Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.
The only reliable dry lubricant material with a long life that does not decompose when exposed to ionising radiation has been found to be alloys that contain particles of lead.
The current use of lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation cannot be eliminated, nor is a feasible substitute available.
Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE: