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 is currently used in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used on the one hand in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere; and on the other hand in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.
(3) There are currently no scientifically and technically practicable and sufficiently reliable substitutes available for the abovementioned applications of lead. Manufacturers need additional time to find reliable and safe lead-free solutions.
(4) Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE:
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
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.
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 18 October 2013.
For the Commission
The President
José Manuel Barroso
In Annex IV to Directive 2011/65/EU the following point 27 is added:
Lead in
solders,
termination coatings of electrical and electronic components and printed circuit boards,
connections of electrical wires, shields and enclosed connectors,
which are used in
magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or
magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.
Expires on 30 June 2020.’