Commission Delegated Directive 2014/3/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 acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.
Lead acetate is an ideal substance for use as marker within head-frames used for positioning for radiotherapy and gamma-ray tumour extractions procedures.
It is scientifically and technically impracticable to substitute or eliminate lead in the respective application and it appears that a practicable substitute will not become available in the near future.
Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE: