(a) 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;

(b) equipment designed to be sent into space;

(c) 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;

(d) large-scale stationary industrial tools;

(e) large-scale fixed installations;

(f) means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;

(g) non-road mobile machinery made available exclusively for professional use;

(h) active implantable medical devices;

(i) 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;

(j) equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.

(1) ‘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;

(2) 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;

(3) ‘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;

(4) ‘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;

(5) ‘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;

(6) ‘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;

(7) ‘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;

(8) ‘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;

(9) ‘importer’ means any natural or legal person established within the Union, who places an EEE from a third country on the Union market;

(10) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(11) ‘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;

(12) ‘placing on the market’ means making available an EEE on the Union market for the first time;

(13) ‘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;

(14) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service;

(15) ‘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;

(16) ‘conformity assessment’ means the process demonstrating whether the requirements of this Directive relating to an EEE, are met;

(17) ‘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;

(18) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(19) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(20) ‘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;

(21) ‘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;

(22) ‘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;

(23) ‘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 );

(24) ‘industrial monitoring and control instruments’ means monitoring and control instruments designed for exclusively industrial or professional use;

(25) ‘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;

(26) ‘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;

(27) ‘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;

(28) ‘non-road mobile machinery made available exclusively for professional use’ means machinery, with an on-board 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 is made available exclusively for professional use.

(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.

(a) 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:

— 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,

— the reliability of substitutes is not ensured,

— 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.

(b) 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.

(a) acknowledge receipt of an application in writing within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(b) inform the Member States of the application without delay and make the application and any supplementary information supplied by the applicant available to them;

(c) make a summary of the application available to the public;

(d) evaluate the application and its justification.

(a) could have a negative impact during EEE waste management operations, including on the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE;

(b) could give rise, given its uses, to uncontrolled or diffuse release into the environment of the substance, or could give rise to hazardous residues, or transformation or degradation products through the preparation for reuse, recycling or other treatment of materials from waste EEE under current operational conditions;

(c) could lead to unacceptable exposure of workers involved in the waste EEE collection or treatment processes;

(d) could be replaced by substitutes or alternative technologies which have less negative impacts.

(a) precise and clear wording of the proposed restriction;

(b) references and scientific evidence for the restriction;

(c) information on the use of the substance or the group of similar substances in EEE;

(d) information on detrimental effects and exposure in particular during waste EEE management operations;

(e) information on possible substitutes and other alternatives, their availability and reliability;

(f) justification for considering a Union-wide restriction as the most appropriate measure;

(g) socioeconomic assessment.

(a) when placing EEE on the market, manufacturers ensure that it has been designed and manufactured in accordance with the requirements set out in Article 4;

(b) manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out;

(c) where compliance of EEE with the applicable requirements has been demonstrated by the procedure referred to in point (b), manufacturers draw up an EU declaration of conformity and affix the CE marking on the finished product. Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up;

(d) manufacturers keep the technical documentation and the EU declaration of conformity for 10 years after the EEE has been placed on the market;

(e) manufacturers ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account;

(f) manufacturers keep a register of non-conforming EEE and product recalls, and keep distributors informed thereof;

(g) manufacturers ensure that their EEE bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the EEE does not allow it, that the required information is provided on the packaging or in a document accompanying the EEE;

(h) manufacturers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE. The address must indicate a single point at which the manufacturer can be contacted. Where other applicable Union legislation contains provisions for the affixing of the manufacturer’s name and address which are at least as stringent, those provisions shall apply;

(i) manufacturers who consider or have reason to believe that EEE which they have placed on the market is not in conformity with this Directive immediately take the necessary corrective measures to bring that EEE into conformity, to withdraw it or recall it, if appropriate, and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;

(j) manufacturers, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the EEE with this Directive, in a language which can be easily understood by that authority, and that they cooperate with that authority, at its request, on any action taken to ensure compliance with this Directive of EEE which they have placed on the market.

(a) manufacturers have the possibility to appoint an authorised representative by written mandate. The obligations laid down in point (a) of Article 7 and the drawing up of technical documentation shall not form part of the authorised representative’s mandate;

(b) an authorised representative performs the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

— keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 10 years following the placing on the market of the EEE,

— further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EEE with this Directive,

— cooperate with the competent national authorities, at their request, on any action taken to ensure compliance with this Directive of EEE covered by their mandate.

(a) importers place only EEE that complies with this Directive on the Union market;

(b) importers, before placing an EEE on the market, ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer, and that they further ensure that the manufacturer has drawn up the technical documentation, that the EEE bears the CE marking and is accompanied by the required documents, ►C1  and that the manufacturer has complied with the requirements set out in points (g) and (h) of Article 7; ◄

(c) where an importer considers or has reason to believe that an EEE is not in conformity with Article 4, that importer does not place the EEE on the market until it has been brought into conformity, and that that importer informs the manufacturer and the market surveillance authorities to that effect;

(d) importers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE. Where other applicable Union legislation contains provisions for the affixing of the importer’s name and address which are at least as stringent, those provisions shall apply;

(e) importers, in order to ensure compliance with this Directive, keep a register of non-compliant EEE and EEE recalls, and keep distributors informed thereof;

(f) importers who consider or have reason to believe that an EEE which they have placed on the market is not in conformity with this Directive immediately take the corrective measures necessary to bring that EEE into conformity, to withdraw it or recall it, as appropriate, and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;

(g) importers keep, for 10 years following the placing on the market of the EEE, a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request;

(h) importers, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EEE with this Directive in a language which can be easily understood by that authority, and that they cooperate with that authority, at its request, on any action taken to ensure compliance with this Directive of EEE which they have placed on the market.

(a) when making an EEE available on the market, distributors act with due care in relation to the requirements applicable in particular by verifying that the EEE bears the CE marking, that it is accompanied by the required documents in a language which can be easily understood by consumers and other end-users in the Member State in which the EEE is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in points (g) and (h) of Article 7 and in point (d) of Article 9;

(b) where a distributor considers or has reason to believe that an EEE is not in conformity with Article 4, that distributor does not make the EEE available on the market until it has been brought into conformity, and that that distributor informs the manufacturer or the importer as well as the market surveillance authorities to that effect;

(c) distributors who consider or have reason to believe that an EEE which they have made available on the market is not in conformity with this Directive make sure that the corrective measures necessary to bring that EEE into conformity, to withdraw it or recall it, as appropriate, are taken and that they immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;

(d) distributors, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of EEE with this Directive, and that they cooperate with that authority, at its request, on any action taken to ensure the compliance with this Directive of the EEE which they have made available on the market.

(a) any economic operator who has supplied them with an EEE;

(b) any economic operator to whom they have supplied an EEE.

1. Large household appliances.

2. Small household appliances.

3. IT and telecommunications equipment.

4. Consumer equipment.

5. Lighting equipment.

6. Electrical and electronic tools.

7. Toys, leisure and sports equipment.

8. Medical devices.

9. Monitoring and control instruments including industrial monitoring and control instruments.

10. Automatic dispensers.

11. Other EEE not covered by any of the categories above.

Lead (0,1 %)

Mercury (0,1 %)

Cadmium (0,01 %)

Hexavalent chromium (0,1 %)

Polybrominated biphenyls (PBB) (0,1 %)

Polybrominated diphenyl ethers (PBDE) (0,1 %)

1. Lead, cadmium and mercury in detectors for ionising radiation.

2. Lead bearings in X-ray tubes.

3. Lead in electromagnetic radiation amplification devices: micro-channel plate and capillary plate.

4. Lead in glass frit of X-ray tubes and image intensifiers and lead in glass frit binder for assembly of gas lasers and for vacuum tubes that convert electromagnetic radiation into electrons.

5. Lead in shielding for ionising radiation.

6. Lead in X-ray test objects.

7. Lead stearate X-ray diffraction crystals.

8. Radioactive cadmium isotope source for portable X-ray fluorescence spectrometers.

1a. Lead and cadmium in ion selective electrodes including glass of pH electrodes.

1b. Lead anodes in electrochemical oxygen sensors.

1c. Lead, cadmium and mercury in infra-red light detectors.

1d. Mercury in reference electrodes: low chloride mercury chloride, mercury sulphate and mercury oxide.

9. Cadmium in helium-cadmium lasers.

10. Lead and cadmium in atomic absorption spectroscopy lamps.

11. Lead in alloys as a superconductor and thermal conductor in MRI.

12. Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors. Expires on 30 June 2021.

13. Lead in counterweights.

14. Lead in single crystal piezoelectric materials for ultrasonic transducers.

15. Lead in solders for bonding to ultrasonic transducers.

16. Mercury in very high accuracy capacitance and loss measurement bridges and in high frequency RF switches and relays in monitoring and control instruments not exceeding 20 mg of mercury per switch or relay.

17. Lead in solders in portable emergency defibrillators.

18. Lead in solders of high performance infrared imaging modules to detect in the range 8-14 μm.

19. Lead in Liquid crystal on silicon (LCoS) displays.

20. Cadmium in X-ray measurement filters.

21. Cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020.

22. 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.

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

24. Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers. Expires on 31 December 2019.

25. Lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions. Expires on 30 June 2021.

26. Lead in the following applications that are used durably at a temperature below – 20 °C under normal operating and storage conditions:

(a) solders on printed circuit boards;

(b) termination coatings of electrical and electronic components and coatings of printed circuit boards;

(c) solders for connecting wires and cables;

(d) solders connecting transducers and sensors.

27. Lead in

— solders,

— termination coatings of electrical and electronic components and printed circuit boards,

— connections of electrical wires, shields and enclosed connectors,

(a) 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

(b) 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.

28. Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards. Expires on 31 December 2017.

29. Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments. Expires on 30 June 2021.

30. Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020.

31. Lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, 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. Expires on 21 July 2021.

32. Lead in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment. Expires on 31 December 2019.

33. Lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb.

34. Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. Expires on 22 July 2021.

35. Mercury in cold cathode fluorescent lamps for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017

36. Lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments.

37. Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:

(a) wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0,1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations;

(b) measurements of solutions where an accuracy of +/– 1 % of the sample range and where high corrosion resistance of the electrode are required for any of the following:

(i) solutions with an acidity < pH 1;

(ii) solutions with an alkalinity > pH 13;

(iii) corrosive solutions containing halogen gas;

(c) measurements of conductivities above 100 mS/m that must be performed with portable instruments.

38. Lead in solder in one interface of large area stacked die elements with more than 500 interconnects per interface which are used in X-ray detectors of computed tomography and X-ray systems.

39. Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:

(a) a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable;

(b) a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies:

(i) a response time shorter than 25 ns;

(ii) a sample detection area larger than 149 mm2;

(iii) a multiplication factor larger than 1,3 × 103.

(c) a response time shorter than 5 ns for detecting electrons or ions;

(d) a sample detection area larger than 314 mm2 for detecting electrons or ions;

(e) a multiplication factor larger than 4,0 × 107.

(a) 21 July 2021 for medical devices and monitoring and control instruments;

(b) 21 July 2023 for in-vitro diagnostic medical devices;

(c) 21 July 2024 for industrial monitoring and control instruments.

40. Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments.

41. Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.

42. Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.

43. Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required.

(a) the name, address and contact details of the applicant;

(b) information on the material or component and the specific uses of the substance in the material and component for which an exemption, or its revocation, is requested and its particular characteristics;

(c) verifiable and referenced justification for an exemption, or its revocation, in line with the conditions established in Article 5;

(d) an analysis of possible alternative substances, materials or designs on a life-cycle basis, including, when available, information about independent research, peer-review studies and development activities by the applicant and an analysis of the availability of such alternatives;

(e) information on the possible preparation for reuse or recycling of materials from waste EEE, and on the provisions relating to the appropriate treatment of waste according to Annex II to Directive 2002/96/EC;

(f) other relevant information;

(g) the proposed actions to develop, request the development and/or to apply possible alternatives including a timetable for such actions by the applicant;

(h) where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;

(i) when applying for an exemption, proposal for a precise and clear wording for the exemption;

(j) a summary of the application.

1. No … (unique identification of the EEE):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4. Object of the declaration (identification of EEE allowing traceability. It may include a photograph, where appropriate):

5. The object of the declaration described above is in conformity with 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 ):

6. Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which conformity is declared:

7. Additional information: