# Commission Delegated Directive 2014/3/EUShow full title

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)         

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U.K.

# 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,

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)Lead acetate is an ideal substance for use as marker within head-frames used for positioning for radiotherapy and gamma-ray                              tumour extractions procedures.

(3)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.

(4)Directive 2011/65/EU should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

# Article 1U.K.

Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

# Article 2U.K.

1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive                        by the last day of the sixth month after entry into force at the latest. They shall forthwith communicate to the Commission                        the text of those provisions.                  

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference                     on the occasion of their official publication. Member States shall determine how such reference is to be made.                  

2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the                        field covered by this Directive.                  

# Article 3U.K.

This Directive shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

# Article 4U.K.

This Directive is addressed to the Member States.

Done at Brussels, 18 October 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

In Annex IV to Directive 2011/65/EU the following point 22 is added:

Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam                                 and particle therapy equipment. Expires on 30 June 2021.’                           

1

OJ L 174, 1.7.2011, p. 88.