Electronic Equipment (Amendment) Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 19,685, 25 ta’ Novembru, 2016

L.N. 391 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment) Regulations, 2016

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, Minister for Social Dialogue, Consumer Affairs

and Civil Liberties, on the advice of the Malta Competition and

Consumer Affairs Authority, has made the following regulations:-

The title of these regulations is the Restriction of Use of Citation.

Hazardous Substances in Electrical and Electronic Equipment

(Amendment) Regulations, 2016, 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".

(1)

These regulations

implement

the

following Implementation.

European Union legislation

(a)

Commission Delegated Directive (EU) 2016/585 of

12 Feb 2016 amending, for the purposes of adapting to technical

progress, Annex IV to Directive 2011/65/EU of the European

Parliament and of the Council as regards an exemption for lead,

cadmium, hexavalent chromium, and polybrominated diphenyl

ethers (PBDE) in spare parts recovered from and used for the

repair or refurbishment of medical devices or electron

microscopes;

(b)

Commission Delegated Directive (EU) 2016/1028

of 19 April 2016 amending, for the purposes of adapting to

technical progress, Annex IV to Directive 2011/65/EU of the

European Parliament and of the Council as regards an

exemption for lead in solders of electrical connections to

temperature measurement sensors in certain devices; and

(c)

Commission Delegated Directive (EU) 2016/1029

of 19 April 2016 amending, for the purposes of adapting to

technical progress, Annex IV to Directive 2011/65/EU of the

European Parliament and of the Council as regards an

exemption for cadmium anodes in Hersch cells for certain

oxygen sensors used in industrial monitoring and control

instruments.

(2) These regulations shall apply to equipment falling under

the scope of the principal regulations.

(3) Regulation 3 shall apply as from the 6th November 2017.

Schedule IV to the principal regulations shall be amended

as follows

(a)

item 26 thereof shall be substituted by the following

"26. Lead in the following applications that are used

durably at a temperature below – 20 °C under normal operating

and storage conditions

(a)

solders on printed circuit boards;

(b) termination coatings of electrical and

electronic components and coatings of printed circuit

boards;

(c)

solders for connecting wires and cables;

(d) solders connecting transducers and sensors.

Lead in solders of electrical connections to temperature

measurement sensors in devices which are designed to be

used periodically at temperatures below – 150 °C. These

exemptions expire on 30 June 2021.";

(b)

item 31 thereof shall be substituted by the

following

"31. Lead, cadmium, hexavalent chromium, and

polybrominated diphenyl ethers (PBDE) in spare parts

recovered from and used for the repair or refurbishment of

medical devices, including in vitro diagnostic medical

devices, or electron microscopes 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 2021

for the use in medical devices other than in vitro diagnostic

medical device, expires on 21 July 2023 for the use in in

vitro diagnostic medical devices and expires on 21 July

2024 for the use in electron microscopes and their

accessories.’ Cadmium, hexavalent chromium, and

polybrominated diphenyl ethers (PBDE) in spare parts

recovered from and used for the repair or refurbishment of

medical devices, including in vitro diagnostic."; and

(c)

immediately after item 42 thereof there shall be

added the following new item

"43. Cadmium anodes in Hersch cells for oxygen

sensors used in industrial monitoring and control

instruments, where sensitivity below 10ppm is required.

Expires on 15 July 2023.".

€0.09