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
Date: 2013-10-18
Institutions: European Commission
Subjects: alloy, ionising radiation, lead, market approval, medical device, technological change




L_2014004EN.01004501.xml










9.1.2014   


EN


Official Journal of the European Union


L 4/45








            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 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)


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.












(3)


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.












(4)


Directive 2011/65/EU should therefore be amended accordingly,





HAS ADOPTED THIS DIRECTIVE:



Article 1
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.


Article 2

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 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.


Article 4
This Directive is addressed to the Member States.




Done at Brussels, 18 October 2013.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 174, 1.7.2011, p. 88.




ANNEX
In Annex IV to Directive 2011/65/EU the following point 23 is added:






‘23.


Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. Expires on 30 June 2021.’