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Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,475, 1 ta’ Settembru, 2020
Taqsima  B
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L.N. 361 of 2020
PRODUCT SAFETY ACT
(CAP. 427)
Restriction of Use of Hazardous Substances in Electrical and 
Electronic Equipment (Amendment No. 2) Regulations, 2020
IN EXERCISE of the powers conferred by articles 38 and 39 of
the Product Safety Act, the Minister for Tourism and Consumer
Protection, on the advice of the Director General (TechnicalRegulations), has made the following regulations:-
Title and 
commencement.
S.L. 427.57.1. (1) The title of these regulations is the Restriction of Use
of Hazardous Substances in Electr ical and Electronic Equipment
(Amendment No. 2) Regulations, 2020, and these regulations shal l be
read and construed as one with the Restriction of Use of Hazardous
Substances in Electrical and Electronic Equipment Regulations,hereinafter referred to as "the principal regulations". 
(2) Regulations 4(c) and 5 shall apply from 1st September
2020 and regulations 3, 4(a) and 4(b) shall apply from 1st April 2021.
Scope and 
applicability.2. (1) The scope of these regulations is to implement the
following European Union legislation:
(a) Commission Delegated Directive (EU) 2020/360 of
17 December 2019 amending, for the purposes of adapting to
scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an
exemption for lead in platinized platinum electrodes used for
certain conductivity measurements;
(b) Commission Delegated Directive (EU) 2020/361 of
17 December 2019 amending, for the purposes of adapting toscientific and techni cal progress, Annex III to Directive 2011/65/
EU of the European Parliament and of the Council as regards an
exemption for hexavalent chromium as an anti-corrosion agent
of the carbon steel cooling system in absorption refrigerators;
(c) Commission Delegated Directive (EU) 2020/364 of
17 December 2019 amending, for the purposes of adapting toscientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an
exemption for the use of cadmi um in certain radiation tolerant
video camera tubes;
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(d) Commission Delegated Directive (EU) 2020/365 of
17 December 2019 amending, for the purposes of adapting to
scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an
exemption for lead in solders and termination finishes used in
certain hand-held combustion engines; and 
(e) Commission Delegated Directive (EU) 2020/366 of
17 December 2019 amending, for the purposes of adapting toscientific and technical progress, Annex IV to Directive 2011/65/
EU of the European Parliament and of the Council as regards an
exemption for lead as a thermal stabiliser in polyvinyl chlorid e
used in certain in-vitro diagnostic medical devices for the
analysis of blood and other body fluids and body gases.
(2) These regulations shall apply to equipment falling within
the scope of the principal regulations.
Amends 
Schedule III to 
the principal regulations.3. Schedule III to the principal regulations shall be amended
as follows:
(a) item 9 thereof shall be substituted by the following:
"9 Hexavalent chromium as an
anti-corrosion agent of the
carbon steel cooling system in
absorption refrigerators up to0,75% by weight in the cooling
solutionApplies to categories 8, 9 and 11 and expires
on: 
— 21 July 2021 for categories 8 and 9 other
than in vitro diagnostic medical devices and
industrial monitoring and control
instruments, 
— 21 July 2023 for category 8 in vitro
diagnostic medical devices, 
— 21 July 2024 for category 9 industrial
monitoring and control instruments, and forcategory 11.
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9(a)-I Up to 0,75% hexavalent
chromium by weight, used as an
anti-corrosion agent in thecooling solution of carbon steel
cooling systems of absorption
refrigerators (includingminibars) designed to operatefully or partly with electrical
heater, having an average
utilised power input <75W atconstant running conditionsApplies to categories 1-7 and 10 and expires on
5 March 2021.
9(a)-
IIUp to 0,75% hexavalentchromium by weight, used as an
anti-corrosion agent in the
cooling solution of carbon steelcooling systems of absorptionrefrigerators:
— designed to operate
fully or partly with
electrical heater, havingan average utilisedpower input ≥75W atconstant runningconditions,
— designed to fully
operate with non-electrical heater.Applies to categories 1-7 and 10 and expires on
21 July 2021.
";
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(b) item 41 thereof shall be substituted by the following:
(*)  Directive 97/68/EC of the European Parliament and of the Counci l of 16
December 1997 on the approximation of the laws of the Member States
relating to measures against the emission of gaseous and particulate
pollutants from internal combustion engines to be installed in non-road
mobile machinery (OJ L 59, 27.2.1998, p. 1). ".
Amends 
Schedule IV to 
the principal regulations.4. Schedule IV to the principal regulations shall be amended
as follows:
(a) item 37 thereof shall be substituted by the following:
"37. Lead in platinized pla tinum electrodes used for
conductivity measurements where at least one of the
following cond itions applies:
(a) wide-range measurements with a
conductivity range covering more than 1 order of
magnitude (e.g. range between 0,1mS/m and 5mS/m)
in laboratory applications for unknownconcentrations;
(b) measurements of solutions where an
accuracy of +/– 1% of the sample range and wherehigh corrosion resistance of t he 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"
41 Lead in solders and termination
finishes of electrical and electronic
components and finishes of printedcircuit boards used in ignition
modules and other electrical and
electronic engine control systems,which for technical reasons must bemounted directly on or in the
crankcase or cylinder of hand-held
combustion engines (classes SH:1,SH:2, SH:3 of Directive 97/68/EC of
the European Parliament and of the
Council (*))Applies to all categories and expires on: 
— 31 March 2022 for categories 1 to 7, 10
and 11;
— 21 July 2021 for categories 8 and 9
other than in vitro diagnostic medical
devices and industrial monitoring and
control instruments; 
— 21 July 2023 for category 8 in vitro
diagnostic medical devices;
— 21 July 2024 for category 9 industrial
monitoring and control instruments.
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halogen gas;
(c) measurements of conductivities above
100mS/m that must be performed with portable
instruments.
Expires on 31 December 2025. ";
(b) item 41 thereof shall be substituted by the following:
"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.
Expires on 31 March 2022."; and
(c) immediately after item 43 thereof, there shall be
added the following new item:
"44. Cadmium in radiation tolerant video camera
tubes designed for cameras with  a centre resolution greater
than 450 TV lines which are used in environments with
ionising radiation exposure exceeding 100 Gy/hour and a
total dose in excess of 100kGy. Applies to category9. Expires on 31 March 2027. ".
Amends 
Schedule VIII to the principal 
regulations.5. The following items shall be appended to the list in
Schedule VIII to the principal regulations:
- Commission Delegated Directive (EU) 2020/360 of
17 December 2019 amending, for  the purposes of adapting to
scientific and technical progress,  Annex IV to Directive 2011/6 5/
EU of the European Parliament and of the Council as regards an
exemption for lead in platiniz ed platinum electrodes used for
certain conductivity measurements******.
- Commission Delegated Directive (EU) 2020/361 of
17 December 2019 amending, for the purposes of adapting to
scientific and techni cal progress, Annex III to Directive 2011/65/
EU of the European Parliament and of the Council as regards an
exemption for hexavalent chromium as an anti-corrosion agent
of the carbon steel cooling system in absorptionrefrigerators******.
- Commission Delegated Directive (EU) 2020/364 of
17 December 2019 amending, for the purposes of adapting toscientific and technical progress, Annex IV to Directive 2011/65/
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Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta
Mitbugħ fl-Istamperija tal-Gvern fuq karta FSC — Printed at the Government Printing Press on FSC certified paper
Prezz /Price
€0.27B 2290
EU of the European Parliament and of the Council as regards an
exemption for the use of cadmiu m in certain radiation tolerant
video camera tubes*****.
- Commission Delegated Directive (EU) 2020/365 of
17 December 2019 amending, for the purposes of adapting to
scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an
exemption for lead in solders and termination finishes used in
certain hand-held combustion engines******.
- Commission Delegated Directive (EU) 2020/366 of
17 December 2019 amending, for the purposes of adapting toscientific and technical progress, Annex IV to Directive 2011/65/
EU of the European Parliament and of the Council as regards an
exemption for lead as a thermal stabiliser in polyvinyl chlorid e
used in certain in-vitro diagnostic medical devices for the
analysis of blood and other body fluids and body gases******.
*****Applicable as from 1st September, 2020.
******Applicable as from 1st April, 2021.
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