391/2016 Sb.
GOVERNMENT REGULATION
of 16 December 2002. November 2016,
amending Government Decree No. 481/2012 Coll. on restriction of the use
certain hazardous substances in electrical and electronic equipment
Government orders under section 22 of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
Act No. 71/2000 Coll., Act No. 204/2002 Coll. and Act No. 34/2007 Coll.
(hereinafter referred to as the "Act") for the implementation of paragraph 2 (a). (d)), section 12 and 13 of the Act:
Article. (I)
Government Regulation No. 481/2012 Coll., on the restriction of the use of certain
hazardous substances in electrical and electronic equipment, is amended
as follows:
1. footnotes 1 and 2 shall be added:
"1) directive of the European Parliament and of the Council 2002/95/EU of 8 March. June
2011 the restriction of the use of certain dangerous substances in electrical and
electronic equipment.
The Commission delegated directive no 2012/50/EU of 10. October
2012, which for the purposes of adapting to technical progress the annex to
(III) directive of the European Parliament and of the Council 2002/95/EC, as regards the
the exception to the use of lead.
The Commission delegated directive 2012/51/EU of 10. October 2012,
amending, for the purposes of adapting to technical progress Annex III to
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for the use of cadmium.
The Commission delegated directive 2014/1/EC of 18 June 2003. October 2013,
amending, for the purposes of adapting to technical progress Annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for the use of lead as an alloying element in bearings and friction surfaces
medical equipment subjected to ionizing radiation.
The Commission delegated directive 2014/2/EC of 18 June 2003. October 2013,
amending, for the purposes of adapting to technical progress Annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for cadmium in luminoforových coatings for x-ray image amplifiers
photography by 31 December. December 2019 and spare parts for x-ray systems
listed on the EU market before 1. January 2020.
The Commission delegated directive 2014/3/EC of 18 June 2003. October 2013,
amending, for the purposes of adapting to technical progress Annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for marker of lead acetate used to stereotaktických frames for
the fixation of the head used in the Computerised tomography (CT), and magnetic
resonance imaging (MRI) and localization systems for gamaterapii and
equipment for nuclear medicine.
The Commission delegated directive 2014/4/EC of 18 June 2003. October 2013,
amending, for the purposes of adapting to technical progress Annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for the use of lead in enabling the vacuum tight joints in aluminium and steel
x-ray image amplifiers.
The Commission delegated directive 2014/5/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead in solders on the cover of printed circuit boards, in the covering layer
the earbuds, electrical and electronic components and boards
printed circuit boards, in solders for joining wires and cables, solders
connecting sensors and sensors, which under normal and storage
conditions permanently use at temperatures lower than-20 ° c.
The Commission delegated directive 2014/6/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead in surface coatings systems pin connectors
requiring non-magnetic connectors, which are, under normal and
storage conditions, continuous use at temperatures lower than-20
° C.
The Commission delegated directive 2014/7/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead in solders in the upholstery layer the earbuds of electrical and
electronic components and printed circuit boards, electrical connections
wires, connectors, shielding and connectors used and protected)
the magnetic field within a radius of 1 m from the isocentra of the magnet, which is part of the
equipment for magnetic resonance imaging for medical purposes,
including patient monitors are designed to be under this heading
used, or (b)) in the magnetic field within a radius of 1 m from the external surface of the
Cyclotron magnets and magnets used in nuclear medicine to
transmission and routing of beam.
The Commission delegated directive 2014/8/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead in solders are used for mounting digital detectors of
teluridu cadmium and zinc from cadmium-teluridu on the PCB.
The Commission delegated directive 2014/9/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead and cadmium in metal glue superconducting materials in
devices, magnetic resonance imaging (MRI), detectors for superconductive
quantum interference devices (SQUID), nuclear magnetic
resonance (NMR) or weight of a biomolecule with Fourier
transform (FTMS).
The Commission delegated directive 2014/10/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead as a superconductor and thermal conductor in alloys used in
freezing cryogenic cooler heads and/or refrigerated kryogenně
refrigeration probes and/or kryogenně cooled systems
ekvipotenciálního bonding in medical devices (category
8) and/or industrial equipment for monitoring and control.
The Commission delegated directive 2014/11/EC of 18 June 2003. October 2013,
amending, for the purposes of adapting to technical progress Annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for hexavalent chromium in alkaline distributors used to produce
fotokatod for x-ray image amplifiers imagery to 31. December
2019 and in spare parts for x-ray systems placed on the market in the EU
1. January 2020.
The Commission delegated directive 2014/12/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead in solders on printed circuit boards and control units
data acquisition units for Positron Emission Tomography (PET), which
are incorporated into equipment for magnetic resonance imaging (MRI).
The Commission delegated directive 2014/13/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead in solders on printed circuit boards used, inserted into the
other mobile medical devices class IIa and IIb according to
Directive 93/42/EEC than portable emergency defibrillators.
The Commission delegated directive 2014/14/EU of 18. October 2013,
that is because of adaptation to technical progress, annex III
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for mercury in quantities of 3.5 mg per bulb in the jednopaticových
compact fluorescent lamps for general lighting purposes 30 W life < 20
000 h or higher.
Directive, the Commission delegated the 2014/15/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead, cadmium and hexavalent chromium used again
spare parts obtained from the medical devices referred to in
the market before the 22. July 2014 and used in category 8 equipment
placed on the market before 22. July 2021, provided that the re-
the use takes place in the framework of the controllable closed system
take-back between businesses and the consumer is about reusing
parts shall be informed.
The Commission delegated directive 2014/16/EC of 18 June 2003. October 2013,
that is because of the adaptation to technical progress, the annex IV
Directive of the European Parliament and of the Council 2002/95/EC, as regards the derogation
for lead as activator in the fluorescent powder discharge if
used as radiators in tanning salons containing BSP
(BaSi2O5: Pb).
The Commission delegated directive 2014/69/EU of 13 July. March
2014, amending, for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead in dielectric ceramic capacitors at parts
rated voltage of less than 125 V AC or 250 VDC
for industrial monitoring and control instruments.
The Commission delegated directive 2014/70/EU of 13 July. March
2014, which for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead in mikrokanálových.
The Commission delegated directive 2014/71/EU of 13 July. March
2014, which for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead in solder in one interface, large-size elements of the
stacked chips.
The Commission delegated directive 2014/72/EU of 13 July. March
2014, which for the purposes of adapting to technical progress the annex to
(III) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead in solders and coatings of electrical outlets and
electronic components and PCB surface treatment
used ignition modules and other electrical and
electronic engine control systems.
The Commission delegated directive 2014/73/EU of 13 July. March
2014, which for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
the exception to the platinized Platinum electrodes of lead in used
to measure conductivity.
The Commission delegated directive 2014/74/EU of 13 July. March
2014, amending, for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
the exception to the lead used in flexible connector systems, other
than compliant pins type C-press for industrial monitoring and
control instruments.
The Commission delegated directive 2014/75/EU of 13 July. March
2014, amending, for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exception for mercury in fluorescent lamps, cold cathode fluorescent lamp (CCFL) backlighting
based on liquid crystal displays, in quantities not exceeding 5 mg per
fluorescent lamp, used in industrial monitoring and control
equipment placed on the market before 22. July 2017.
The Commission delegated directive 2014/76/EU of 13 July. March
2014, amending, for the purposes of adapting to technical progress the annex to
(III) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exception for mercury-emitting tubes in hand-crafted manufactured (HLDT)
used for marking, decorative or architectural and special
lighting and light artwork.
The Commission delegated Directive 2015/573/EC of 30 March 2004. January
2015, which for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead in polyvinyl chloride sensors diagnostic
in vitro medical devices.
The Commission delegated Directive 2015/574/EC of 30 March 2004. January
2015, which for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
the exception to the use of mercury in intravascular ultrasound systems
the image capture.
The Commission delegated Directive 2015/863/EC of 31 May 1995. March
2015, amending Annex II to the directive of the European Parliament and of the Council
2011/65/EC, as regards the list of restricted substances.
The Commission delegated directive 2016/585/EU of 12. February
2016, amending, for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead, cadmium, hexavalent chromium and polybrominated
diphenyl ethers (PBDE) contained in spare parts obtained from
medical devices or electron microscopes and used to
their repair or renovation.
The Commission delegated directive 2016/1028/EC of 19 June 2000. April
2016, amending, for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exemption for lead in solders for electrical connection of temperature sensors
in certain devices.
The Commission delegated directive 2016/1029/EC of 19 June 2000. April
2016, amending, for the purposes of adapting to technical progress the annex to
(IV) directive of the European Parliament and of the Council 2002/95/EC, as regards the
an exception for cadmium anodes in Herschových articles for some
oxygen probes used in industrial monitoring and
control devices.
2) Government Regulation No. 55/2015 Coll. on technical requirements on the active
implantable medical devices ".
2. In paragraph 4, at the end of paragraph 4, the following sentence "the restriction of substances, BBP, DEHP
DBP and DIBP applies to medical devices ^ 4), including the
in vitro diagnostic medical devices ^ 5) and on monitoring
and control devices including industrial monitoring and control
equipment placed on the market from 22. July 2021. ".
Footnotes 4 and 5 are added:
"4) Government Regulation No. 54/2015 Coll. on technical requirements for
medical devices.
5) of Decree-Law No 56/2015 Coll. on technical requirements for
in vitro diagnostic medical devices ".
3. In section 4, paragraph 4. 6 is the text "and again" is replaced by the text "2006
again ".
4. In paragraph 4, at the end of paragraphs 4, 7 and 8, including
footnote # 7 are added:
"(7) the restriction of substances, BBP DEHP, DBP and DIBP does not apply to cables or
spare parts for repair, reuse, modernize the functions or
increase the capacity for
and electrical and electronic equipment put on the market) before 22. July 2019,
(b)) ^ 4) medical devices, including diagnostic medical
in vitro ^ 5), placed on the market before 22. July 2021, and
(c) monitoring and control instruments) including industrial
monitoring and control instruments placed on the market before 22.
July 2021.
(8) the restriction of substances, DEHP, BBP and DBP does not apply to toys which are
already subject to restrictions the following substances through a record 51 in annex
XVII to the directly applicable European Union legislation in the field of registration,
evaluation, authorisation and restriction of chemicals) ^ 7.
7) European Parliament and Council Regulation (EC) No 1907/2006 of 18 May.
December 2006 concerning the registration, evaluation, authorisation and restriction of
chemicals, establishing a European Chemicals Agency,
amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93,
Commission Regulation (EC) No 1488/94, Council Directive 77/796/EEC and directives
Of the Commission 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, as
version. ".
5. In section 8 paragraph 1. 1 letters e) and (f)):
"e) to ensure that it was given a type, batch, serial number or
any other element allowing their identification, or, in cases where
the size or nature of the Eee does not allow, ensure that
the requested information was provided on the packaging or in a document accompanying the
electrical and electronic equipment,
(f)) said the Eee, or if this is not possible, on its packaging or in
a document accompanying the Eee your name or names, and
last name, business name, business name or the trade mark, if it can be
under it to uniquely identify and address a single point,
on which you can contact him. ".
6. Appendix 1:
' Annex 1 to the regulation of the Government No. 481/2012 Sb.
Restricted substances and the maximum values of the mass concentration of tolerated in
homogeneous materials
Lead (0.1%)
Mercury (0.1%)
Cadmium (0.01%)
Hexavalent chromium (0.1%)
Polybrominated biphenyls (PBBs) (0.1%)
Polybrominated diphenyl ethers (PBDE) (0.1%)
Bis (2-ethylhexyl) phthalate (DEHP) (0.1%)
Butylbenzylphthalate (BBP) (0.1%)
Dibutylftalát (DBP) (0.1%)
Diisobutylftalát (DIBP) (0.1%) ".
7. Appendix 2 is added:
"Annex 2 to the regulation of the Government No. 481/2012 Sb.
List of applications of lead, mercury and hexavalent chromium, which can be used
under the specified conditions
------------------------------------------------------------ -------------------------------------------------
The number of the use of the term and scope of application
------------------------------------------------------------ -------------------------------------------------
1 mercury in compact fluorescent lamps, whose jednopaticových
not exceeding (on one burner):
1 a) for general lighting purposes < 30 W: 5 mg expires december 31, 2011; after the 31 december 2011 3.5 mg may be used on one burner, until 31 december 2012; after 31 december 2012 2.5 mg may be used on one burner 1 b) for general lighting purposes > = 30 W and < 50 W: 5 mg expires december 31, 2011; after the 31 december 2011 3.5 mg may be used on one burner 1 c) for general lighting purposes > = 50 W and < 150 W: 5 mg 1 d) for general lighting purposes > = 150 W: 15 mg
1 (e)) For circular or square shape Force without restrictions until 31 December 2006. December 2011; after 31 December 2006.
with a tube diameter
lifetime and a tube diameter > = 9 mm and 2011 3 mg may be used on one lamp
17 mm and 3.5 mg may be used on one lamp
28 mm 2012 3.5 mg may be used on one lamp
(for example, T12): 5 mg
2 a) 5) For three-band fluorescent lamps with phosphors with validity until 31 December 2004. December 2011; after 31 December 2006. December
longer service life (> = 25 000 h): 8 mg of 2011 may be used 5 mg per lamp
2 (b)) mercury in other fluorescent lamps, the content of which does not exceed the
(one bulb):
2 (b)) 1) for linear fluorescent lamps with phosphor halofosfátovými expires 13. April 2012
with a tube diameter > 28 mm (for example, T10 and T12):
10 mg
2 (b)), 2) For non-linear fluorescent lamps with phosphor halofosfátovými expires 13. April 2016
(all diameters): 15 mg
2 (b)) 3) For non-linear fluorescent lamps with phosphor halofosfátovými Force without restrictions until 31 December 2006. December 2011; after 31 December 2006.
with a tube diameter > 17 mm (for example, T9) December 2011 can be used 15 mg per
fluorescent tube
2 (b)) 4) For light sources for general lighting and other Force without restrictions until 31 December 2006. December 2011; after 31 December 2006.
special purposes (such as induction lamps) December 2011 can be used 15 mg per one
luminaire
------------------------------------------------------------ -------------------------------------------------
3 mercury in fluorescent lamps, cold cathode fluorescent lamp (CCFL) and
with an external electrode fluorescent lamps (EEFL) for special
the purpose, the content of which does not exceed (for one fluorescent lamp):
3 a) for short (500 mm and 1 500 mm) Force without restrictions until 31 December 2006. December 2011; after 31 December 2006.
December 2011 can be used 13 mg per
fluorescent tube
------------------------------------------------------------ -------------------------------------------------
4 a) low-pressure mercury in other lamps, of which the validity of the content without restrictions until 31 December 2006. December 2011; after 31 December 2006.
does not exceed (one lamp): December 2011 can be used 15 mg per
discharge lamp
4 (b)) mercury in high pressure sodium lamps with
improved color Ra > 60 for General
the lighting, the content of which does not exceed (for one
burner):
4 (b))-I P
for example, piezoelectric devices, or in
glass or ceramic connective mixture
7 (c))-II lead in dielectric ceramic parts
capacitors for the nominal AC voltage in the 125
or DC voltage 250 V or higher
7 (c))-III lead in dielectric ceramic parts of the Force to 1. by 1 January 2013 and after this date may be
capacitors for the nominal AC voltage is less used in the works of electrical equipment that has been
than 125 V or 250 V DC voltage listed on the market before 1. January 2013
7 (c))-IV lead in dielectric ceramic materials to Force into the 21st century. July 2016
the basis of PZT solid solutions (lead, zirconium oxide and
Titanium) for capacitors that are part of
integrated circuit or discrete semiconductors
------------------------------------------------------------ -------------------------------------------------
8) cadmium and its compounds in the Security Force to 1. January 2012 and after that date may be
thermal fuses used in the works of electrical equipment that has been
placed on the market before 1. January 2012
8 b) cadmium and its compounds in electrical contacts
------------------------------------------------------------ -------------------------------------------------
9 hexavalent chromium as anti-corrosion agent in
carbon steel cooling systems in absorption
refrigerators to 0.75% in cooling
liquid
9 (b)) lead in lead-bearing shells and bushes
containing the cooling substance in air compressors
in systems of heating, ventilation, air conditioning and
cooling
------------------------------------------------------------ -------------------------------------------------
11 a) lead used in flexible connector systems can be used in parts, electrical equipment, which
compliant pins type C-press was put on the market before 24. September 23rd, 2010
11 (b)) lead used in flexible connector systems Force to 1. by 1 January 2013 and after this date may be
non-compliant type C-press pins used in the works of electrical equipment that has been
placed on the market before 1. January 2013
------------------------------------------------------------ -------------------------------------------------
12 lead used as the surface material for module can be used in parts, electrical equipment, which
type C-ring for the conduction of heat was put on the market before 24. September 23rd, 2010
------------------------------------------------------------ -------------------------------------------------
13 a) lead in glass for optical purposes
13 b) cadmium and lead in filter glass and glass
used for etalons reflectivity
------------------------------------------------------------ -------------------------------------------------
14 lead in solders containing more than two elements for the Force to 1. January 2011 and after that date may be
the connection between the pins and the microprocessors of the content used in the works of electrical equipment that has been
lead of more than 80% and less than 85% placed on the market before 1. January 2011
by weight
------------------------------------------------------------ -------------------------------------------------
lead in solders for 15 build a stable
the electrical connection between semiconductor material
and carrier in sets of integrated circuits
using the "Flip Chip" technology
------------------------------------------------------------ -------------------------------------------------
16 Lead in linear incandescent lamps with tubes coated with Force to 1. September 2013
with silicate
------------------------------------------------------------ -------------------------------------------------
17 Halides of lead as a source of radiation in the lamps
high intensity discharge (HID) used
in professional reprographic applications
------------------------------------------------------------ -------------------------------------------------
18 a) Lead as activator in the fluorescent powder Force to 1. January 2011
(not more than 1% lead by weight) lamps, if they are
used as a special light sources
in the diazografické of reprography, lithography, lapačích
insects, photochemical and konzervovacích procedures
and containing phosphors such as SMS
((Sr, Ba) 2 MgSi2O7: Pb)
18 (b)) Lead as activator in the fluorescent powder
(not more than 1% lead by weight) lamps, if they are
used as radiators in containing
phosphors such as BSP (BaSi2O5: Pb)
------------------------------------------------------------ -------------------------------------------------
19 Lead containing PbBiSn-Hg and PbInSn-Hg in specific Force to 1. June 2011
as main amalgam and with PbSn-Hg as a side
amalgam in very compact energy-saving
lamps
------------------------------------------------------------ -------------------------------------------------
20 lead oxide in glass used for bonding front Force to 1. June 2011
and rear substrates of flat fluorescent lamps used
Displays based on liquid crystal display (LCD)
------------------------------------------------------------ -------------------------------------------------
21 lead and cadmium in printing inks for the application
enamel on glass, such as borosilicate glass or
soda-lime glass
------------------------------------------------------------ -------------------------------------------------
23 lead in finishes of fine pitch components may be used in parts, electrical equipment, which
other than connectors with a pitch of 0.65 mm or smaller has been put on the market before 24. September 23rd, 2010
------------------------------------------------------------ -------------------------------------------------
24 lead in solders for the soldering of summer bags through the opening in the
diskoidních and vícevrstvově organized
ceramic capacitors
------------------------------------------------------------ -------------------------------------------------
25 lead oxide surface displays leadership
electron emitter (SED) used in particular in the
building components, in particular, the seal frit and
frit ring
------------------------------------------------------------ -------------------------------------------------
26 lead oxide in the glass envelope of UVB fluorescent lamps with black Force to 1. June 2011
glass
------------------------------------------------------------ -------------------------------------------------
27 lead as solder for transducers used in force until 24. September 2010
high-powered (designated for
several operate at sound
the performance of 125 dB SPL and above)
------------------------------------------------------------ -------------------------------------------------
29 lead bound in Crystal glass as defined in annex I (categories
1, 2, 3 and 4) of Council Directive 69/493/EEC
------------------------------------------------------------ -------------------------------------------------
30 Cadmium alloys as electrical/mechanical solder
connections of electrical conductors located directly on the
the voice coil in transducers used in the
high-powered with surface
the sound pressure of 100 dB (A) and higher
------------------------------------------------------------ -------------------------------------------------
31 lead in soldering materials in flat fluorescent lamps
Mercury (which are used for example in the
based on liquid crystal displays, in design
or industrial lighting)
------------------------------------------------------------ -------------------------------------------------
32 lead oxide in seal frit used in production
window assemblies for argon and krypton
laser tube
------------------------------------------------------------ -------------------------------------------------
33 lead in solders for the soldering of thin copper wires
with a diameter equal to or less than 100 µm in
power transformers
------------------------------------------------------------ -------------------------------------------------
34 lead in the debugging elements potentiometers
from kovovo-ceramic materials
------------------------------------------------------------ -------------------------------------------------
36 mercury used as an inhibitor of cathode sputtering Force to 1. July 2010
in DC plasma screens with content
to 30 mg on the screen
------------------------------------------------------------ -------------------------------------------------
37 Lead in the plating layer high-voltage diodes
with the sleeve of glass based on zinc Borate
------------------------------------------------------------ -------------------------------------------------
38 cadmium and cadmium oxide in thick pastes
the layer used to carbon berylnatý associated
with aluminium
------------------------------------------------------------ -------------------------------------------------
39 Cadmium in light diodes (LED) II-VI entry into force 1. July 2014
the color of the LEDs (10 µ g Cd < per mm 2 area
emitting light) for use in systems
Semiconductor lighting and visualization
------------------------------------------------------------ -------------------------------------------------
40 fotoresistorech for cadmium in analog optical Force until 31 December 2006. December 2013
interface modules used in professional audio
device
------------------------------------------------------------ -------------------------------------------------
41 lead in solders and coatings leads to 31 Apply. December 2018
electrical and electronic components and
in the surface treatment of printed circuits boards
used ignition modules and other
electrical and electronic control systems
the engines, which for technical reasons must be
mounted directly on or in the crankcase, or
the cylinder manually held by internal combustion engines (class SH:
1, SH: 2, SH: 3 according to the directive of the European Parliament
97/68/EC of 16 December 2002. December 1997
on the approximation of the laws of the Member States
relating to measures against the emission of gaseous
pollutants and particulate pollutants from
internal combustion engines for non-road mobile
the machine)
------------------------------------------------------------ -------------------------------------------------
".
8. Appendix 3:
' Annex No. 3 to Decree-Law No 481/2010 Sb.
A list of the use of certain hazardous substances in medical
devices and monitoring and control instruments
Devices that use or detect ionizing radiation
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 optical amplifiers
and lead in glass frit Binder for folding gas lasers and vacuum
tubes that convert electromagnetic radiation into electrons.
5. lead in shielding for ionising radiation.
6. lead in x-ray test test subjects.
7. lead Stearate x-ray diffraction of crystals.
8. The source of the radioactive isotopes of cadmium for portable x-ray
fluorescence spectrometers.
Sensors, detectors and electrodes
1a. Lead and cadmium in ion selective electrodes including glass pH
the electrodes.
1B. The lead anodes in electrochemical oxygen sensors.
1 c lead, cadmium and mercury in detectors for infrared radiation.
1 d mercury in reference electrodes: mercurous chloride with low content of
chloride, mercuric sulfate mercuric oxide and.
Other
9. cadmium in helium-cadmium lasers.
10. Lead and cadmium in atomic absorption spectral lamps.
11. lead alloys as a superconductor and thermal conductor in instruments
magnetic resonance imaging.
12. lead and cadmium in metal glue superconducting materials in
devices, magnetic resonance imaging (MRI), detectors for superconductive
quantum interference devices (SQUID), nuclear magnetic
resonance (NMR) or weight of a biomolecule with Fourier
transform (FTMS). Valid to 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 transducer.
16. Mercury in high precision stages for capacitive and loss measurement
in the high-frequency RF switches and relays in monitoring and
control devices, not more than 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 the bandwidth of 8-14 µm.
19. lead in the screens of liquid crystal on Silicon (LCoS) layer.
20 cadmium in x-ray measurement filters.
21. cadmium in luminoforových coatings for x-ray image amplifiers
slides to 31. December 2019 and spare parts for x-ray systems
listed on the EU market before 1. January 2020.
22. Markér of lead acetate used to stereotaktických frames for
the fixation of the head used in the Computerised tomography (CT), and magnetic
resonance imaging (MRI) and localization systems for gamaterapii and
equipment for nuclear medicine. Valid to 30. June 2021.
23. lead as an alloying element in bearings and friction surfaces
medical equipment subjected to ionizing radiation. Valid to 30.
June 2021.
24. lead to allow vacuum-tight connections of aluminium and steel in x-ray
amplifiers of the image. Valid until 31 December 2006. December 2019.
25. lead in surface coatings systems pin connectors
requiring non-magnetic connectors, which are, under normal and
storage conditions, continuous use at temperatures lower than-20
° C. Valid to 30. June 2021.
26. lead in the following programs, which under normal operating
and storage conditions permanently used at a temperature lower than-20 ° c:
and in solders on the covers) printed circuit boards,
(b)) in the upholstery layer the earbuds, electrical and electronic components and
covers of printed circuit boards,
c) solders connecting wires and cables,
d) solders joining sensors and sensors. Lead in solders for
the electrical connection of temperature sensors in devices intended for
regular use at temperatures below-150 ° c.
Valid to 30. June 2021.
27. lead
-solders,
-in the upholstery layer the earbuds, electrical and electronic components and
covers of printed circuit boards,
-in the joints of electrical wires, connectors, shielded and protected
the connectors used
and) in the magnetic field within a radius of 1 m isocentra around the magnet, which is
equipment for magnetic resonance imaging
medical purposes, including patient monitors are designed to be
in this circuit are used or
(b)) in the magnetic field within a radius of 1 m from the external surface of the cyclotron
magnets and magnets used in nuclear medicine to transfer and
beam routing.
Valid to 30. June 2020.
28. Lead in solders are used for mounting digital detectors of
teluridu cadmium and zinc from cadmium-teluridu on the PCB.
Valid until 31 December 2006. December 2017.
29. lead as a superconductor and thermal conductor in alloys used in
freezing cryogenic cooler heads and/or refrigerated kryogenně
refrigeration probes and/or kryogenně cooled systems
ekvipotenciálního bonding, in medical devices
(category 8) and/or industrial equipment for monitoring and
control. Valid to 30. June 2021.
30. Hexavalent chromium in alkaline distributors used to produce
fotokatod for x-ray image amplifiers imagery to 31. December
2019 and in spare parts for x-ray systems placed on the market in the EU
1. January 2020.
31. Lead, cadmium and hexavalent chromium used again
spare parts obtained from the medical devices referred to in
the market before the 22. July 2014 and used in category 8 equipment
placed on the market before 22. July 2021, provided that the re-
the use takes place in the framework of the controllable closed system
take-back between businesses and the consumer is about reusing
parts shall be informed. Valid until 21. July 2021.
32. Lead in solders on printed circuit boards and control units
data acquisition units for Positron Emission Tomography (PET), which
are incorporated into equipment for magnetic resonance imaging (MRI). Valid to
on December 31, 2019.
33. Lead in solders on the printed circuit boards used, inserted into the
other mobile medical devices class IIa and IIb according to
Directive 93/42/EEC than portable emergency defibrillators. For
class applies to 30 Ha. June 2016 and for class IIb to 31. December 2020.
34. lead is used as activator in the fluorescent powder
lamps are used as radiators in containing
BSP (BaSi2O5: Pb). Applies to 22. July 2021.
35. mercury in fluorescent lamps, cold cathode fluorescent lamp for backlight display
liquid crystal display, in quantities not exceeding 5 mg per lamp,
used in industrial monitoring and control instruments
placed on the market before 22. July 2017. Valid until 21. July 2024.
36. Lead used in flexible connector systems other than
moulded studs (C)-press type for industrial monitoring and
control instruments. Valid until 31 December 2006. December 2020. After this date may only be
use in spare parts for industrial monitoring and control
apparatus placed on the market before 1. January 2021.
37. platinized Platinum electrodes of lead in used to
measurement of conductivity, where at least one of these conditions:
and) measurements in a wide range of values, and the range of values of conductivity
more than 1 order (for example, range from 0.1 mS/m up to 5 mS/m),
laboratory use for unknown concentrations,
b) measurement solutions where required accuracy of +/-1% range of samples and
high resistance against corrosion of the electrodes, in any of these
cases:
I) solutions with acidity < pH 1, ii) solutions with an alkalinity > pH 13,
III) corrosive solutions containing halogen gas,
(c) measurement of conductivity higher than) 100 mS/m, which is to be carried out
using portable devices.
Valid until 31 December 2006. December 2018.
38. lead in solder in one interface, large elements of the layered
chips with more than 500 links to one interface, which is used in
x-ray detectors for computed tomography and x-ray
systems. Valid until 31 December 2006. December 2019. After this date may only be used in
spare parts for the systems of computerized tomography and x-ray
systems placed on the market before 1. January 2020.
39. lead in mikrokanálových plates used in devices that are
they are characterized by at least one of the following:
and) compact size detector to electrons or ions, and space
for the detector is limited to a maximum of 3 mm/MCP (thickness
detector + space for installation of MCP)
a maximum of 6 mm, and an alternative structure for the detector
offered more space, it is scientifically and technically impracticable,
b) two-dimensional spatial resolution for the detection of electrons or ions,
If at least one of the following conditions:
I) response time is less than 25 ns,
II) sample detection area is greater than 149 mm2,
III) the multiplication factor is greater than 1.3 x 103,
(c)) a response time of less than 5 ns for the detection of electrons or ions;
d) detection area mm2 greater than 314 samples for the detection of electrons or
ions,
e) multiplication factor greater than 4.0 x 107.
Valid until:
and) 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 parts of condensate on the nominal
voltage less than 125 V AC or 250 VDC for
industrial monitoring and control instruments. Valid until 31 December 2006. December
20. After this date may only be used in spare parts for industrial
monitoring and control instruments placed on the market before 1. January 2021.
41. lead as a heat stabiliser in polyvinyl chloride (PVC) used
as a starting material in the potentiometric and amperometric,
conductivity of electrochemical sensors that are used in the
the case of the in vitro diagnostic medical devices for the analysis
blood and other body fluids and body. Valid until 31 December 2006. December
2018.
42. mercury in the means of turning electrical connectors used in systems
intravascular ultrasound image capturing capable
Working regimens with high operating frequencies (> 50 MHz). Valid to 30.
June 2019.
43. Cadmium anodes in Herschových articles for oxygen probes
used in industrial monitoring and control instruments
that sensitivity is required at a level of less than 10 parts per million. Applies
15. July 2023. ".
9. in annex No. 3 item 31 repealed.
10. In annex 3, the following new item item 30 31a:
"31a. Lead, cadmium, hexavalent chromium and polybrominated diphenyl ethers
(PBDE) contained in spare parts obtained from medical
resources, including in vitro diagnostic medical devices,
or electron microscopes and their accessories, and used to
their repair or renovation, on condition that the reuse of
takes place within the controllable closed system reverse
the subscription between businesses and the consumer is about each time you reuse parts
informed.
Valid until:
and) 21. July 2021, with respect to the use of other health
resources than are in vitro diagnostic medical devices;
(b)) 21. July 2023, if it concerns use in diagnostic medical
transport in vitro;
(c)) 21. July 2024, with respect to the use of the electron microscope and
their accessories. ".
Article II
The effectiveness of the
This Regulation shall enter into force on 31 March 2001. December 2016, with the exception of
the provisions of the
and) article. I, points 2, 4 and 6, which enter into force on 22 October 2005. July
2019, and
(b)) article. I, points 9 and 10, which shall take effect on the date 6. November 2017.
Prime Minister:
Mgr. Sobotka in r.
Minister of industry and trade:
Ing. Mládek, CSc., r.
