Royal Decree 219/2013 of 22 March on restrictions on the use of certain dangerous substances in electrical and electronic equipment incorporated into the Spanish legal order Directive 2011 /65/EU of the The European Parliament and the Council of 8 June 2011 on restrictions on the use of certain hazardous substances in electrical and electronic equipment. Annex II to this royal decree on restricted substances referred to in Article 6.1 and maximum values for the permissible concentrations by weight in homogeneous materials and Annex IV, referring to applications exempted from the restriction of the the use of prohibited substances specific to medical devices and the surveillance and control instruments incorporated, respectively, Annexes II and IV to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011.

In use of the power contained in Articles 5 and 6 of Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011, the European Commission has, by means of delegated acts, amended Annexes II and IV to adapt them to technical progress and contribute to the protection of human health and the environment. The amendments to these Annexes are set out in four Commission Delegated Directives: Commission Delegated Directive (EU) 2015 /863/EU of 31 March 2015 amending Annex II to Directive 2011 /65/EU of the European Parliament and of the Council European and Council of 8 June 2011 on the list of restricted substances; Commission Delegated Directive (EU) 2016 /585/EU of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to the Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on an exemption for lead, cadmium, hexavalent chromium and polybromodiphenyl ethers (PBDE) of spare parts recovered from medical devices or electronic microscopes and used for the repair and refurbishment of such products; the Delegated Directive (EU) Commission Implementing Regulation (EU) No 1028/EU of 19 April 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on an exemption for lead in welding of electrical connections with temperature sensors on certain devices; and the Directive Commission Delegated Regulation (EU) No 1029/EU of 19 April 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on an exemption for the cadmium anodes used in Hersch cells for oxygen sensors used in industrial monitoring and control instruments.

It is therefore appropriate to amend Annexes II and IV to Royal Decree 219/2013 of 22 March to incorporate the four delegated directives into our legal order. The fourth paragraph of Royal Decree 219/2013, second paragraph, of 22 March, empowers the Ministers for Agriculture, Food and the Environment, Industry, Energy and Tourism, and Health, Social Services and Equality to introduce In the Annexes, any amendments of a technical nature are necessary in order to maintain the Annexes adapted to the technical innovations which are produced and in particular the provisions of Community legislation.

Since all the delegated directives which are the subject of incorporation by this order are in accordance with technical innovations, in the terms provided for in the fourth subparagraph of Article 22 (2) of Royal Decree 219/2013, 22 March, the appropriate instrument for its incorporation into our order is the ministerial order

In the elaboration of this order, the hearing procedure provided for in Article 26.6 of Law 50/1997 of 27 November, of the Government, has been followed, the autonomous communities and the cities with status of the autonomy of Ceuta and Melilla, as well as the representative entities of the sectors concerned and the project has been submitted to the process of public participation in the field of the environment provided for in Article 16 in connection with the article 18.1.h) of Law 27/2006 of 18 July on the rights of access to information, of public participation and access to justice in the field of the environment (incorporates Directives 2003 /4/EC and 2003 /35/EC). The mandatory report of the Environmental Advisory Council pursuant to Article 19.2.a) of Law 27/2006, dated July 18, has also been sought.

Under the proposal of the Minister for Agriculture and Fisheries, Food and the Environment, the Minister for Economic Affairs, Industry and Competitiveness, and the Minister for Health, Social Services and Equality, according to the Council State, I have:

Single item. Amendment of Royal Decree 219/2013 of 22 March on restrictions on the use of certain hazardous substances in electrical and electronic equipment.

Royal Decree 219/2013 of 22 March on restrictions on the use of certain hazardous substances in electrical and electronic equipment is amended as follows:

One. Annex II is worded as follows:

" ANNEX II

Restricted substances referred to in Article 6.1 and maximum permissible concentration values by weight in homogeneous materials

Lead (0.1%).

Mercury (0.1%).

Cadmium (0.01%).

Hexavalent Chromium (0.1%).

Polybromobiphenyls (PBB) (0.1%).

Polybromodiphenylethers (PBDE) (0.1%).

Bis (2-ethylexyl) phthalate (DEHP) (0.1%).

Benzyl and butyl phthalate (BBP) (0.1%).

Dibutyl Phthalate (DBP) (0.1%).

Diisobutyl Phthalate (DIBP) (0.1%).

The restriction of DEHP, BBP, DBP and DIBP will be applied to medical devices, including in vitro, and to surveillance and control instruments, including industrial surveillance and control instruments, from 22 March onwards. July 2021.

The restriction of DEHP, BBP, DBP and DIBP will not apply to cables or spare parts intended for repair, reuse, update of functions or the improvement of the capacity of EEE introduced in the the market before 22 July 2019, or to medical devices, including in vitro, or to surveillance and control instruments, including industrial surveillance and control instruments, which have been placed on the market before 22 July from 2021.

The restriction of DEHP, BBP, DBP and DIBP shall not apply to toys which are already subject to the restriction of those substances via entry 51 of Annex XVII to Regulation (EC) No 1907/2006 of 18 December 2006, on the registration, assessment, authorisation and restriction of chemicals (REACH), establishing the European Chemicals Agency, amending Directive 1999 /45/EC and repealing the Directive Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as the Directive Council Directive 76 /769/EEC and Commission Directives 91 /155/EEC, 93 /67/EEC, 93 /105/EC and 2000 /21/EC. '

Two. Annex IV is worded as follows:

" ANNEX IV

Applications exempted from the restriction of Article 6.1, specific to sanitary products and surveillance and control instruments

Teams that use or detect ionising radiation:

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

2. Lead bearings in X-ray tubes.

3. Lead in electromagnetic radiation amplification devices: microchannel plate and capillary plate.

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

5. Lead in shielding for ionising radiation.

6. Lead in X-ray test objects.

7. X-ray diffraction crystals of lead stearate.

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

Sensors, detectors and electrodes:

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

1b. Lead anodes in electrochemical oxygen sensors.

1c. Lead, cadmium and mercury in infrared detectors.

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

Other.

9. Cadmium in helium and cadmium lasers.

10. Lead and cadmium in atomic absorption spectroscopy lamps.

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

12. Lead and cadmium in metallic bonds that allow the creation of superconducting magnetic circuits in IRM, SQUID, NMR (nuclear magnetic resonance) or FTMS (Fourier transform mass spectrometry) detectors. Expires June 30, 2021.

13. Lead in counterweights.

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

15. Lead in welds to attach to ultrasonic transducers.

16. Mercury in very high precision capacitors and loss measuring bridges and in high frequency RF switches and repeaters in surveillance and control instruments that do not exceed 20 mg of mercury per switch or repeater.

17. Lead in welds of emergency portable defibrillators.

18. Lead in welds of high-performance infrared imaging modules to detect a range between 8 and 14 μm.

19. Lead in liquid crystal on silicon screens (LcoS).

20. Cadmium in X-ray measurement filters.

21. Cadmium in the phosphorus coatings of X-ray imaging intensifiers until 31 December 2019 and in spare parts for X-ray systems marketed in the EU before 1 January 2020.

22. Lead acetate used as a marker in stereotactic head frames for CT and MRI and in systems for positioning gammaterapia and particle therapy equipment. Expires June 30, 2021.

23. Lead as an alloying element in the bearings and contact surfaces of the sanitary products exposed to ionising radiation. Expires June 30, 2021.

24. Lead in vacuum-proof watertight connections between aluminum and steel in X-ray image intensifiers. Expires on December 31, 2019.

25. Lead in surface coatings of pin connector systems that require non-magnetic connectors and are used for an extended period of time at a temperature of less than -20 ° C under normal operating conditions and storage. Expires June 30, 2021.

26. Lead in the following applications, which are used for an extended period of time at a temperature of less than -20 ° C under normal operating and storage conditions:

a) Solds used in printed circuits;

(b) terminations of electrical and electronic component terminations and printed circuit boards;

c) welds for wire and cable connection;

d) welds for connection of transducers and sensors.

Lead in welding of electrical connections with temperature sensors on devices designed to be used periodically at temperatures below -150 ° C.

expires June 30, 2021.

27. Lead in:

a) Solds,

(b) terminations of electrical and electronic component terminations and printed circuit boards,

c) electrical cable connections, screens, and closed connectors used in:

1. Magnetic fields located in a sphere of 1 m radius around the magnet of the magnet of medical imaging equipment by magnetic resonance, including patient monitors designed for use within that sphere, or

2. magnetic fields not more than 1 m away from the external surfaces of the cyclotronic magnets and of the magnets for the transport of the beams and the control of the steering thereof, used in particle therapy.

expires June 30, 2020.

28. Lead in solders for the assembly of digital detectors of cadmium telluride and cadmium-zinc telluride in printed circuits. It expires on December 31, 2017.

29. Lead in alloys, as a superconductor or thermal conductor, used in cold heads of chryorrefrigerators and/or in cold-cooled cold probes and/or in cryorrefrigerated equipotential connection systems, in medical devices (category 8) and/or in industrial surveillance and control instruments. Expires June 30, 2021.

30. Hexavalent chromium in alkaline dispensers used to create photocathodes in X-ray imaging intensifiers until 31 December 2019 and in replacement parts of X-ray systems marketed in the EU before 1 January 2019. 2020.

31. Lead, cadmium, hexavalent chromium and polybromodiphenyl ethers (PBDE) in spare parts recovered from medical devices, including in vitro diagnostic or electronic microscopes and their accessories, and used for repair or reconditioning of such products, provided that the reuse is framed in closed circuit intercompany recovery systems and that each reuse of such parts is notified to the consumer.

expires on:

a) July 21, 2021 for medical devices other than in vitro diagnostics;

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

c) July 21, 2024 for electron microscopic and its accessories.

32. Lead in welds in the printed circuit of detectors and data acquisition units for positron emission tomographers integrated in magnetic resonance imaging equipment. Expires December 31, 2019.

33. Lead in welds on printed circuits, with assembled electronic components, used in mobile medical devices of Classes IIa and IIb of Council Directive 93 /42/EEC of 14 June 1993 on medical devices, other than portable emergency defibrillators. It expires on 30 June 2016 for products of Class IIa and 31 December 2020 for products of Class IIb.

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

35. Mercury in cold cathode fluorescent lamps, at the rate of 5 mg per lamp maximum, for liquid crystal displays used in the industrial surveillance and control instruments introduced on the market before 22 July 2017. Expires on July 21, 2024.

36. Lead used in connector systems of pins other than those of the type C-press which comply with the standards and which are intended for industrial monitoring and control instruments. It expires on December 31, 2020. It may be used after that date in spare parts for industrial surveillance and control instruments placed on the market before 1 January 2021.

37. Lead in platinised platinum electrodes used for conductivity measurements, provided that at least one of the following conditions is met:

a) wide range measurements with a range of conductivity covering more than 1 order of magnitude (e.g. between 0.1 mS/m and 5 mS/m) in laboratory applications of unknown concentrations,

(b) measurement of solutions that require an accuracy of ± 1% of the sample range and a high corrosion resistance of the electrode, for any of the following:

1. º Solutions with an acidity < pH 1,

2. solutions with an alkalinity > pH 13,

3. Corrosive solutions containing halogen gas,

c) conductivity measurements above 100 mS/m to be carried out with portable instruments.

expires December 31, 2018.

38. Lead in welds in an interface of large area stacked dielectric elements with more than 500 connections per interface used in X-ray detectors of computed tomography and radiography systems. It expires on December 31, 2019. After that date, it may be used in spare parts for computed tomography and X-ray systems placed on the market before 1 January 2020.

39. Lead in microchannel plates (MCPs) used in equipment when at least one of the following properties is present:

a) A compact size of the electron or ion detector, if the sensor space is limited to a maximum of 3 mm/MCP (detector thickness + space for the installation of the MCP), a maximum of 6 mm in total, and is scientific and technically impossible an alternative design that offers more space for the detector,

b) a two-dimensional spatial resolution to detect electrons or ions, with application of at least one of the following conditions:

1. º A response time less than 25 ns,

2. a sample detection area greater than 149 mm²,

3. a multiplication factor greater than 1.3 × 10³,

c) a response time less than five ns to detect electrons or ions,

d) a sample detection area greater than 314 mm² to detect electrons or ions,

e) a multiplication factor greater than 4.0 × 107.

The exemption expires at the following dates:

1. July 21, 2021 for sanitary products and surveillance and control instruments,

2. July 21, 2023 for in vitro diagnostic medical devices,

3. July 21, 2024 for industrial surveillance and control instruments.

40. Lead in dielectric ceramic of capacitors with a nominal voltage of less than 125 V ac or 250 V dc for industrial monitoring and control instruments. It expires on December 31, 2020. It may be used after that date in spare parts for industrial surveillance and control instruments introduced on the market before 1 January 2021.

41. Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as a base material in the amperimetric, potentiometric and conductive electrochemical sensors used in in vitro diagnostic medical devices for blood and other blood tests and body fluids. Expires December 31, 2018.

42. Mercury in rotating electrical connectors used in systems for obtaining intravascular ultrasound imaging capable of high frequency operating modes (> 50 MHz). Expires on June 30, 2019.

43. Cadmium anodes used in Hersch cells for oxygen sensors used in industrial surveillance and control instruments, when a sensitivity of less than 10 ppm is required.

expires July 15, 2023. "

Final Disposition first. Incorporation of European Union Law.

The following European Commission Delegated Directives are incorporated into Spanish law by this order:

(a) Commission Delegated Directive 2015 /863/EU of 31 March 2015 amending Annex II to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on the list of substances restricted.

(b) Commission Delegated Directive 2016 /585/EU of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on the concerning an exemption for lead, cadmium, hexavalent chromium and polybromodiphenyl ethers (PBDE) from spare parts recovered from medical devices or electronic microscopes and used for the repair and refurbishment of such products products.

(c) Commission Delegated Directive 2016 /1028/EU of 19 April 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on the concerning an exemption for lead in welding of electrical connections with temperature sensors on certain devices.

(d) Commission Delegated Directive 2016 /1029/EU of 19 April 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011 /65/EU of the European Parliament and of the Council of 8 June 2011 on the concerning an exemption for cadmium anodes used in Hersch cells for oxygen sensors used in industrial monitoring and control instruments.

Final Disposition second. Entry into effect.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, April 7, 2017. -Government Vice President and Minister of the Presidency and for Territorial Administrations, Soraya Saenz de Santamaria Anton.