Electronic Equipment (Amendment) Regulations, 2024

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 21,214, 28 ta’ Marzu, 2024 B 451

L.N. 77 of 2024

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment) Regulations, 2024

IN EXERCISE of the powers conferred by articles 38 and 39 of

the Product Safety Act, the Minister responsible for consumer affairs,

on the advice of the Director General (Technical Regulations), has

made the following regulations:-

(1) The title of these regulations is the Restriction of Use Citation, scope,

of Hazardous Substances in Electrical and Electronic Equipment and

commencement.

(Amendment) Regulations, 2024, and these regulations shall be read

and construed as one with the Restriction of Use of Hazardous S.L. 427.57.

Substances in Electrical and Electronic Equipment Regulations,

hereinafter referred to as the "principal regulations".

(2) The scope of these regulations is to transpose Commission

Delegated Directive (EU) 2023/1437 of 4 May 2023 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 mercury in melt pressure transducers for

capillary rheometers under certain conditions and Commission

Delegated Directive (EU) 2023/1526 of 16 May 2023 amending

Directive 2011/65/EU of the European Parliament and of the Council

as regards an exemption for lead as a thermal stabilizer in polyvinyl

chloride used as base material in sensors used in in vitro diagnostic

medical devices

(3) These regulations shall be deemed to have come into force

on the 1 st of February 2024.

Schedule IV to the principal regulations shall be amended Amends

Schedule IV to

as follows

the principal

regulations.

(a) immediately after item 41 thereof, there shall be

added the following new item

"41a. Lead as a thermal stabilizer 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 creatinine and blood urea nitrogen in whole

blood. Applies to category 8 and expires on 31 December

2023."; and

(b) immediately after item 48 thereof, there shall be

added the following new item

"49. Mercury in melt pressure transducers for

capillary rheometers at temperatures over 300°C and

pressures over 1,000 bar. Applies to category 9 and expires

on 31 December 2025.".

Schedule VIII to the principal regulations shall be amended

as follows

(a) immediately after the item "Commission Delegated

Directive (EU) 2023/171 of 28 October 2022 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 hexavalent chromium as

anticorrosion

agent

in

gas

absorption

heat

pumps***********.", there shall be added the following new

items

"-

Commission Delegated Directive (EU) 2023/

1437 of 4 May 2023 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 mercury in melt

pressure transducers for capillary rheometers under certain

conditions************.

-

Commission Delegated Directive (EU) 2023/

1526 of 16 May 2023 amending Directive 2011/65/EU of

the European Parliament and of the Council as regards an

exemption for lead as a thermal stabilizer in polyvinyl

chloride used as base material in sensors used in in vitro

diagnostic medical devices************."; and

(b)

immediately after the footnote "*********** Applicable as

from 1 st September 2023. ", there shall be added the following new

footnote

"************ Applicable as from 1 st February 2024."

€0.09