Electronic Equipment (Amendment) Regulations, 2022

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,794, 25 ta’ Frar, 2022 B 519

L.N. 93 of 2022

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment) Regulations, 2022

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 (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, 2022, 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)

These regulations transpose

(a) Commission Delegated Directive (EU) 2021/1978 of

11 August 2021 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 the use of bis(2-ethylhexyl) phthalate (DEHP),

butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and

diisobutyl phthalate (DIBP) in spare parts recovered from and

used for the repair or refurbishment of medical devices;

(b) Commission Delegated Directive (EU) 2021/1979 of

11 August 2021 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 the use of bis(2-ethylhexyl) phthalate (DEHP) in

plastic components in magnetic resonance imaging (MRI)

detector coils; and

(c) Commission Delegated Directive (EU) 2021/1980 of

11 August 2021 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 the use of bis(2-ethylhexyl) phthalate (DEHP) in

ion-selective electrodes for analysing human body fluids and/or

dialysate fluids.

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

on 21 July 2021.

In Schedule IV to the principal regulations, immediately

after item 44 thereof, there shall be added the following three new

items

"45. Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective

electrodes applied in point of care analysis of ionic substances present

in human body fluids and/or in dialysate fluids. Expires on 21 July

2028.

46. Bis(2-ethylhexyl) phthalate (DEHP) in plastic components

in MRI detector coils. Expires on 1 January 2024.

47. Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate

(BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in

spare parts recovered from and used for the repair or refurbishment of

medical devices, including in vitro diagnostic medical devices, and

their accessories, provided that the reuse takes place in auditable

closed-loop business-to-business return systems and that each reuse of

parts is notified to the customer. Expires on 21 July 2028.".

Immediately after the item "Commission Delegated

Directive (EU) 2021/884 of 8 March 2021 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

the validity period of an exemption for the use of mercury in electric

rotating connectors used in intravascular ultrasound imaging

systems********." in Schedule VIII to the principal regulations, there

shall be added the following new items

"-

Commission Delegated Directive (EU) 2021/1978 of 11

August 2021 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 the use of

bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP),

dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts

recovered from and used for the repair or refurbishment of medical

devices*********.

-

Commission Delegated Directive (EU) 2021/1979 of 11

August 2021 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 the use of

bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic

resonance imaging (MRI) detector coils*********.

-

Commission Delegated Directive (EU) 2021/1980 of 11

August 2021 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 the use of

bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for

analysing human body fluids and/or dialysate fluids*********.

********* Applicable as from 21 st July, 2021.".

€0.18