Order Pra/329/2017, Of 7 April, By Which Modify Annexes Ii And Iv Of The Real Decree 219/2013, Of 22 March, On Restrictions On The Use Of Certain Hazardous Substances In Electrical And Electronic Equipment.

Original Language Title: Orden PRA/329/2017, de 7 de abril, por la que se modifican los anexos II y IV del Real Decreto 219/2013, de 22 de marzo, sobre restricciones a la utilización de determinadas sustancias peligrosas en aparatos eléctricos y electrónicos.

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The Royal Decree 219/2013, 22 March, on restrictions on the use of certain hazardous substances in electrical and electronic equipment, incorporated into the Spanish legal system directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, restrictions on the use of certain hazardous substances in electrical and electronic equipment. Annex II of this Royal Decree, on restricted substances referred to in article 6.1 and maximum values of the tolerable concentration of weight in homogeneous materials, and annex IV, referring to applications that are exempt from the restriction of the use of specific banned substances for medical devices and monitoring and control instruments incorporated, respectively, annexes II and IV of the directive 2011/65/EU of the European Parliament and of the Council , June 8, 2011.

In the option contained in articles 5 and 6 of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, the European Commission has modified, by means of delegated acts, annexes II and IV to adapt them to technical progress and to contribute to the protection of human health and the environment. Amendments of these annexes are collected in four delegates Commission directives: the directive delegate (EU) 863-2015-EU Commission of 31 March 2015 by amending Annex II of Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, on the list of restricted substances; the directive delegate (EU) 2016/585/EEC of the Commission of 12 February 2016, amending, to adapt to technical progress, the annex IV of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, in relation to an exemption for lead, cadmium, hexavalent chromium and polybrominated diphenyl ethers (PBDE) spare recovered from medical devices or electronic microscopes and parts used for the repair and overhaul of such products; the Executive Directive (EU) 2016/1028/EU Commission, of 19 April 2016, which modify, to adapt to technical progress, the annex IV of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, in relation to an exemption for lead in solders for electrical connections with temperature sensors in certain devices; the Executive Directive (EU) 2016/1029/EU Commission, of 19 April 2016, which modify, to adapt to technical progress, the annex IV of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, in relation to an exemption for cadmium anodes used in cells Hersch for oxygen sensors used in industrial monitoring and control instruments.

It should therefore modify annexes II and IV of the Real Decree 219/2013, March 22, to incorporate into our legal system the four mentioned proxy directives. Final disposition fourth, second paragraph, of Royal Decree 219/2013, 22 March, faculty to the Ministers of agriculture, food and environment, industry, energy and tourism, and health, social services and equality into annexes modifications of a technical nature were accurate to keep the annexes adapted to technical innovations occurring and particularly to the provisions in Community legislation.

Since all delegates directives which are the subject of incorporation by this order respond to technical innovations, in the terms provided for in the fourth final provision, paragraph second, the Royal Decree 219/2013, 22 March, the instrument suitable for incorporation into our system is the ministerial order in the preparation of this order, has been followed the hearing process provided for in article 26.6 of the Law 50/1997 (, November 27, the Government has been consulted to the autonomous communities and cities with statute of autonomy of Ceuta and Melilla, as well as representative of the sectors concerned entities and the project has been subject to the procedure of public participation in environmental matters laid down in article 16 in connection with article 18.1. h) of law 27/2006 18 July, which regulates the rights of access to information, public participation and access to justice in environmental matters (incorporates directives 2003/4/EC and 2003/35/EC). In addition, it has obtained the mandatory report of the Council Adviser of environment under article 19.2. to) of law 27/2006, of July 18.

By virtue, on the proposal of the Minister of agriculture and fisheries, food and environment, the Minister of economy, industry and competitiveness, and the Minister of health, social services and equal, according to the Council of State, I have: single article. Modification of the Real Decree 219/2013, of 22 March, on restrictions on the use of certain hazardous substances in electrical and electronic equipment.

The Royal Decree 219/2013, 22 March, on restrictions on the use of certain hazardous substances in electrical and electronic equipment, is to be re-worded as follows: one. Annex II is worded as follows: "annex II restricted substances referred to in article 6.1 and maximum concentration values tolerated by weight in homogeneous materials lead (0.1%).

Mercury (0.1%).

Cadmium (0.01%).

Hexavalent chromium (0.1%).

Polybrominated biphenyls (PBB) (0.1%).

Polybrominated diphenyl ethers (PBDE) (0.1%).

Phthalate bis(2-etilexilo) (DEHP) (0.1%).

Phthalate (BBP) (0.1%) butyl and benzyl.

Phthalate dibutyl phthalate (DBP) (0.1%).

Phthalate diisobutyl (DIBP) (0.1%).

DEHP, BBP, DBP and DIBP restriction shall apply to medical devices, including the in vitro, and the instruments of surveillance and control, including the industrial instruments of surveillance and control, from July 22, 2021.

DEHP, BBP, DBP and DIBP restriction does not apply to cables or spare parts for repair, reuse, updating the functions or the improvement of the capacity of EEE introduced on the market before July 22, 2019, or to medical devices, including the in-vitro, or to surveillance and control instruments including industrial monitoring and control instruments, introduced on the market before July 22, 2021.


DEHP, BBP, DBP and DIBP restriction does not apply to toys which are already subject to the restriction of such substances through the 51 entry in annex XVII of Regulation (EC) No. 1907 / 2006 of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) and substances «, whereby establishing a European Agency of chemicals, amending Directive 1999/45/EC and repealing Regulation (EEC) No. 793/93 and Council Regulation (EC) No. 1488/94 the Commission as well as 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 free from the restriction of article 6.1, specific to medical devices and monitoring and control instruments machines that use or detect ionizing radiation: 1. lead, cadmium and mercury in detectors of ionizing radiation. "

2. lead in x-ray tube bearing.

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

4 lead frit of x-ray tubes glass and lead in Binder of frit glass for Assembly of gas lasers and vacuum tubes that convert electromagnetic radiation into electrons and image intensifiers.

5. lead in shielding for ionising radiation.

6. lead in x-ray test objects.

7 lead stearate x-ray diffraction crystals.

8. source of radioactive isotope of cadmium for portable x-ray fluorescence espectometros.

Sensors, detectors and electrodes: 1st. lead and cadmium in included ion selective electrodes glass pH electrodes.

1B. anodes in electrochemical oxygen sensor lead.

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

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

Others.

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 metal links that allow the creation of magnetic circuits superconducting detectors of IRM, SQUID, NMR (nuclear magnetic resonance) or FTMS (mass spectrometry with Fourier transform). Expires June 30, 2021.

13 lead in counterweights.

14. lead in piezoelectric single crystals for ultrasonic transducers materials.

15. lead in solders to attach to ultrasonic transducers.

16 mercury in very high precision capacitors and loss measurement bridges and switches and repeaters high frequency RF in surveillance 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 image modules to detect a range of between 8 and 14 μm.

19 lead in liquid crystal on Silicon (LcoS) displays.

20 cadmium in x-ray measurement filters.

21 cadmium in phosphorus of x-ray image intensifiers liners until December 31, 2019 and the spare parts for x-ray systems marketed in the EU by 1 January 2020.

22 lead acetate used as a marker in marcos Stereotactic head for CT and MRI and positioning of equipment gammaterapia and particle therapy systems. Expires June 30, 2021.

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

24 lead in watertight connections to test vacuum between the aluminum and steel on x-ray image intensifiers expires December 31, 2019.

25. lead in the surface coatings of systems of connectors pins that require non-magnetic connectors and are used for an extended period of time at a temperature below - 20 ° C in normal operation and storage. Expires June 30, 2021.

26 lead in the following applications, which are used for an extended period of time at a temperature below - 20 ° C in normal operation and storage conditions: at) welds used in printed circuit boards;

(b) coatings of electrical and electronic components and printed circuit board terminations;

(c) soldering for the connection of wires and cables;

(d) soldering for the connection of sensors and transducers.

Lead in solders for electrical connections with temperature sensors in devices designed to be used periodically to temperatures below - 150 ° C.

Expires June 30, 2021.

27 lead in: a) welding, b) coatings of terminations of electrical and electronic components and printed circuit boards, c) electrical cables, screens and closed connectors used in connections: 1. magnetic fields in an area of 1 m radius around the isocenter of magnet of medical magnetic resonance imaging equipments, including patient monitors designed for use within this area , or 2. magnetic fields than to 1 m from the external surfaces of magnets ciclotronicos and magnets for the transportation of the beams and the control of the direction of these used in particle therapy.

Expires June 30, 2020.

28. lead in solders of Assembly of digital detectors of cadmium telluride and Telluride cadmio-zinc in printed circuit boards. Expires December 31, 2017.

29. lead alloys, such as superconductor and thermal conductor, used in the cool heads of criorrefrigeradores and/or probes cold criorrefrigeradas or equipotential bonding systems criorrefrigerados, in sanitary products (category 8) and/or industrial monitoring and control instruments. Expires June 30, 2021.

30. hexavalent chromium in alkaline dispensers used to create photocathodes in the x-ray image intensifiers until December 31, 2019 and spare parts marketed in the EU by 1 January 2020 x-ray systems.


31 lead, cadmium, hexavalent chromium and polybrominated diphenyl ethers (PBDE) in spare parts recovered from products health, including in vitro diagnostic or electron microscopes and their accessories, and used for the repair or reconditioning of such products, always reuse is framed in recovery interempresas of CCTV systems and each reuse of such parts is notified to the consumer.

Expires the: to) 21 July 2021 for different the in vitro diagnostic medical devices;

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

c) 21 July 2024 for the microscopic electronic and accessories.

32. lead in solders in printed circuits, detectors and units of data acquisition for the use of integrated imaging by magnetic resonance imaging positron emission. Expires December 31, 2019.

33. lead in soldering on printed circuit board, with mounted electronic components used in mobile medical devices of classes IIa and IIb of Directive 93/42/EEC of the Council of 14 June 1993 on health products other than the portable emergency defibrillators. Expires June 30, 2016 to products in class IIa and the 31 December 2020 for class IIb products.

34 used lead as activator in the fluorescent powder of discharge lamps used as lamps of extracorporeal photopheresis containing matches of the BSP (Basi2o5) type. Expires July 22, 2021.

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

36 lead used in systems other than those of type pin connectors C-press that conform to the standards for industrial monitoring and control instruments. Expires December 31, 2020. You can use after that date on spare parts for industrial instruments of surveillance and control marketed before 1 January 2021.

37 lead in platinizados Platinum electrodes used for the measurements of conductivity, provided that at least one of the following conditions is met: a) measurements of range with a range of conductivity that covers more than 1 order of magnitude (for example, between 0.1 mS/m and 5 mS/m) in laboratory applications of unknown concentrations, b) measurements of solutions that require an accuracy of ± 1% of the sample range and a high resistance to the (corrosion of the electrode, for any of the following: 1 solutions with acidity < pH 1, 2nd solutions with an alkalinity > pH 13, 3rd corrosive solutions containing halogen gas, c) measurements of conductivity above 100 mS/m, which must be carried out with portable instruments.

Expires December 31, 2018.

38. lead in solders on an interface of stacked dielectric elements of large area with more than 500 connections per interface used in x-ray computed tomography systems detectors and x-ray. Expires December 31, 2019. After that date, you can use on spare parts for computed tomography and x-ray systems, sold before January 1, 2020.

39 lead in plates of microchannels (MCP) used in computers when present at least one of the following properties: to) a compact size of the detector of electrons or ions, if the detector space is limited to a maximum of 3 mm/MCP (thickness of the sensor + space for the installation of the MCP), a maximum of 6 mm in total (, and scientific and technically impossible is an alternative design that offers more space for the detector, b) a spatial resolution two-dimensional to detect electrons or ions, with application of at least one of the following conditions: 1 less than 25 ns response time, 2nd a detection area of samples exceeding 149 mm2, 3rd greater than 1.3 × 103 multiplication factor (((, c) response time less than 5 ns to detect electrons or ions, d) a detection area samples more than 314 mm2 to detect electrons or ions, e) a superior to 4.0 × 107 multiplication factor.

The exemption expires on the following dates: 1 July 21, 2021 for sanitary products and instruments of surveillance and control, 2nd July 21, 2023 for in vitro diagnostic medical devices, 3rd July 21, 2024 for industrial monitoring and control instruments.

40. lead in ceramic dielectric capacitors with a rated voltage AC 125 V or 250 V DC for industrial monitoring and control instruments. Expires December 31, 2020. It can be used after that date in spare parts for industrial instruments introduced on the market before 1 January 2021 surveillance and control.

41. lead as a heat stabiliser in polyvinyl chloride (PVC) used as base materials in electrochemical sensors electrical, potentiometric and conductimetric used in in vitro diagnostic medical devices for analysis of other gases, blood and body fluids. Expires December 31, 2018.

42. mercury in Rotary electrical connectors used in systems of intravascular ultrasound imaging capable of operating modes of high frequency (> 50 MHz). Expires June 30, 2019.

43 cadmium anodes used in cells Hersch for oxygen sensors used in industrial monitoring and control instruments, when it requires a sensitivity below 10 ppm.

Expires July 15, 2023.»

First final provision. Incorporation of the law of the European Union.

By this order are incorporated into Spanish law the following European Commission delegates directives: to) policy delegate 863-2015-EU Commission of 31 March 2015, amending Annex II of Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, on the list of restricted substances.


b) directive delegate 2016/585/EEC of the Commission of 12 February 2016, amending, to adapt to technical progress, the annex IV of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, in relation to an exemption for lead, cadmium, hexavalent chromium and polybrominated diphenyl ethers (PBDE) spare recovered from medical devices or electronic microscopes and parts used for the repair and reconditioning of such products.

(c) associate directive 2016/1028/EU Commission, of 19 April 2016, which modify, to adapt to technical progress, the annex IV of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, in relation to an exemption for lead in solders for electrical connections with temperature sensors in certain devices.

(d) associate directive 2016/1029/EU Commission, of 19 April 2016, which modify, to adapt to technical progress, the annex IV of the directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, in relation to an exemption for cadmium anodes used in cells Hersch for oxygen sensors used in industrial monitoring and control instruments.

Second final provision. Entry into force.

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

Madrid, April 7, 2017.-the Vice-President of the Government and Minister of the Presidency and for territorial administrations, Soraya Sáenz de Santamaría Antón.

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