Directive 2011/65/EU of the European Parliament and of the CouncilShow full title

Article 4 Prevention

1. Member States shall ensure that EEE placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II.

2. For the purposes of this Directive, no more than the maximum concentration value by weight in homogeneous materials as specified in Annex II shall be tolerated. The Commission shall adopt, by means of delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22, detailed rules for complying with these maximum concentration values taking into account, inter alia, surface coatings.

3. Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diagnostic medical devices which are placed on the market from 22 July 2016 and to industrial monitoring and control instruments which are placed on the market from 22 July 2017.

4. Paragraph 1 shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following:

(a) EEE placed on the market before 1 July 2006;

(b) medical devices placed on the market before 22 July 2014;

(c) in vitro diagnostic medical devices placed on the market before 22 July 2016;

(d) monitoring and control instruments placed on the market before 22 July 2014;

(e) industrial monitoring and control instruments placed on the market before 22 July 2017;

(f) EEE which benefited from an exemption and which was placed on the market before that exemption expired as far as that specific exemption is concerned.

5. Paragraph 1 shall not apply to reused spare parts, recovered from EEE placed on the market before 1 July 2006 and used in equipment placed on the market before 1 July 2016, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer.

6. Paragraph 1 shall not apply to the applications listed in Annexes III and IV.