This Directive lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.
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 (recast) (Text with EEA relevance)
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 (recast) (Text with EEA relevance)
Article 1 Subject matter
Article 2 Scope
1.
This Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.
3.
This Directive shall apply without prejudice to the requirements of Union legislation on safety and health, and on chemicals, in particular Regulation (EC) No 1907/2006, as well as the requirements of specific Union waste management legislation.
4.
This Directive does not apply to:
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equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes;
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equipment designed to be sent into space;
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equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment;
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large-scale stationary industrial tools;
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large-scale fixed installations;
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means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;
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non-road mobile machinery made available exclusively for professional use;
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active implantable medical devices;
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photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications;
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equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis;
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pipe organs.
Article 3 Definitions
For the purposes of this Directive, the following definitions shall apply:
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‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;
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for the purposes of point 1, ‘dependent ’ means, with regard to EEE, needing electric currents or electromagnetic fields to fulfil at least one intended function;
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‘large-scale stationary industrial tools’ means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;
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‘large-scale fixed installation’ means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;
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‘cables’ means all cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more EEE to each other;
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‘manufacturer’ means any natural or legal person who manufactures an EEE or who has an EEE designed or manufactured and markets it under his name or trademark;
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‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
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‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EEE available on the market;
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‘importer’ means any natural or legal person established within the Union, who places an EEE from a third country on the Union market;
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‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
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‘making available on the market’ means any supply of an EEE for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
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‘placing on the market’ means making available an EEE on the Union market for the first time;
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‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(1) on the basis of a request made by the Commission in accordance with Article 6 of Directive 98/34/EC;
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‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service;
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‘CE marking’ means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
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‘conformity assessment’ means the process demonstrating whether the requirements of this Directive relating to an EEE, are met;
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‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that EEE complies with the requirements set out in this Directive and does not endanger health, safety or other issues of public interest protection;
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‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;
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‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;
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‘homogeneous material’ means one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes;
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‘medical device’ means a medical device within the meaning of point (a) of Article 1(2) of Directive 93/42/EEC and which is also EEE;
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‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device within the meaning of point (b) of Article 1(2) of Directive 98/79/EC;
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‘active implantable medical device’ means any active implantable medical device within the meaning of point (c) of Article 1(2) of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(2);
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‘industrial monitoring and control instruments’ means monitoring and control instruments designed for exclusively industrial or professional use;
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‘availability of a substitute’ means the ability of a substitute to be manufactured and delivered within a reasonable period of time as compared with the time required for manufacturing and delivering the substances listed in Annex II;
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‘reliability of a substitute’ means the probability that an EEE using a substitute will perform a required function without failure under stated conditions for a stated period of time;
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‘spare part’ means a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a spare part;
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‘non-road mobile machinery made available exclusively for professional use’ means machinery, with an on-board power source or with a traction drive powered by an external power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working, and which is made available exclusively for professional use.
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, to industrial monitoring and control instruments which are placed on the market from 22 July 2017, and to all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market from 22 July 2019.
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:
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EEE placed on the market before 1 July 2006;
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medical devices placed on the market before 22 July 2014;
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in vitro diagnostic medical devices placed on the market before 22 July 2016;
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monitoring and control instruments placed on the market before 22 July 2014;
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industrial monitoring and control instruments placed on the market before 22 July 2017;
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all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market before 22 July 2019;
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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.
Provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of spare parts is notified to the consumer, paragraph 1 shall not apply to reused spare parts:
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recovered from EEE placed on the market before 1 July 2006 and used in EEE placed on the market before 1 July 2016;
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recovered from medical devices or monitoring and control instruments placed on the market before 22 July 2014 and used in EEE placed on the market before 22 July 2024;
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recovered from in vitro diagnostic medical devices placed on the market before 22 July 2016 and used in EEE placed on the market before 22 July 2026;
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recovered from industrial monitoring and control instruments placed on the market before 22 July 2017 and used in EEE placed on the market before 22 July 2027;
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recovered from all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market before 22 July 2019, and used in EEE placed on the market before 22 July 2029.
6.
Paragraph 1 shall not apply to the applications listed in Annexes III and IV.
Article 5 Adaptation of the Annexes to scientific and technical progress
1.
For the purposes of adapting Annexes III and IV to scientific and technical progress, and in order to achieve the objectives set out in Article 1, the Commission shall adopt by means of individual delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22, the following measures:
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inclusion of materials and components of EEE for specific applications in the lists in Annexes III and IV, provided that such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 and where any of the following conditions is fulfilled:
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their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable,
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the reliability of substitutes is not ensured,
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the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.
Decisions on the inclusion of materials and components of EEE in the lists in Annexes III and IV and on the duration of any exemptions shall take into account the availability of substitutes and the socioeconomic impact of substitution. Decisions on the duration of any exemptions shall take into account any potential adverse impacts on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant;
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deletion of materials and components of EEE from the lists in Annexes III and IV where the conditions set out in point (a) are no longer fulfilled.
2.
Measures adopted in accordance with point (a) of paragraph 1 shall, for categories 1 to 7, 10 and 11 of Annex I, have a validity period of up to 5 years and, for categories 8 and 9 of Annex I, a validity period of up to 7 years. The validity periods are to be decided on a case-by-case basis and may be renewed.
For the exemptions listed in Annex III as at 21 July 2011, unless a shorter period is specified, the maximum validity period, which may be renewed, shall be:
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for categories 1 to 7 and category 10 of Annex I, 5 years from 21 July 2011;
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for categories 8 and 9 of Annex I, 7 years from the relevant dates laid down in Article 4(3); and
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for category 11 of Annex I, 5 years from 22 July 2019.
For the exemptions listed in Annex IV as at 21 July 2011, the maximum validity period, which may be renewed, shall be 7 years from the relevant dates laid down in Article 4(3), unless a shorter period is specified.
3.
An application for granting, renewing or revoking an exemption shall be made to the Commission in accordance with Annex V.
4.
The Commission shall:
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acknowledge receipt of an application in writing within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application;
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inform the Member States of the application without delay and make the application and any supplementary information supplied by the applicant available to them;
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within 1 month of receipt of an application, provide to the applicant, the Member States and the European Parliament a timeline for the adoption of its decision on the application;
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make a summary of the application available to the public;
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evaluate the application and its justification.
5.
An application for renewal of an exemption shall be made no later than 18 months before the exemption expires.
The Commission shall decide on an application for renewal of an exemption no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines. The existing exemption shall remain valid until a decision on the renewal application is taken by the Commission.
6.
In the event that the application for renewal of an exemption is rejected or that an exemption is revoked, the exemption shall expire at the earliest 12 months, and at the latest 18 months, after the date of the decision.
7.
Before Annexes are amended, the Commission shall, inter alia, consult economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations and make the comments received publicly available.
8.
The Commission shall adopt a harmonised format for applications referred to in paragraph 3 of this Article as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19(2).