Electronic Equipment (Amendment No. 2) Regulations, 2015

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,489, 27 ta’ Ottubru, 2015

L.N. 347 of 2015

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment No. 2) Regulations, 2015

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 No. 2) Regulations, 2015, 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) 2015/573

of 30 January 2015 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 polyvinyl chloride sensors in in-vitro

diagnostic medical devices;

(b)

Commission Delegated Directive (EU) 2015/574 of

30 January 2015 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 mercury in intravascular ultrasound imaging

systems; and

(c)

Commission Delegated Directive (EU) 2015/863 of

31 March 2015 amending Annex II to Directive 2011/65/EU of

the European Parliament and of the Council as regards the list of

restricted substances.

(2) These regulations shall apply to equipment falling under

the scope of the principal regulations.

(3) Regulation 3 shall apply as from the 22nd July 2019.

Schedule II to the principal regulations shall be substituted

by the following

"Schedule II

Restricted substances referred to in regulation 4(1) and maximum

concentration values tolerated by weight in homogeneous materials

Lead (0,1 %)

Mercury (0,1 %)

Cadmium (0,01 %)

Hexavalent chromium (0,1 %)

Polybrominated biphenyls (PBB) (0,1 %)

Polybrominated diphenyl ethers (PBDE) (0,1 %)

Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)

Butyl benzyl phthalate (BBP) (0,1 %)

Dibutyl phthalate (DBP) (0,1 %)

Diisobutyl phthalate (DIBP) (0,1 %)

The restriction of DEHP, BBP, DBP and DIBP shall apply to

medical devices, including in vitro medical devices, and

monitoring and control instruments, including industrial

monitoring and control instruments, from 22 July 2021.

The restriction of DEHP, BBP, DBP and DIBP shall not apply to

cables or spare parts for the repair, the reuse, the updating of

functionalities or upgrading of capacity of EEE placed on the

market before 22 July 2019, and of medical devices, including

in vitro medical devices, and monitoring and control

instruments, including industrial monitoring and control

instruments, placed on the market before 22 July 2021.

The restriction of DEHP, BBP and DBP shall not apply to toys

which are already subject to the restriction of DEHP, BBP and

DBP through entry 51 of Annex XVII to Regulation (EC) No

1907/2006.".

The following points shall be added to the list in Schedule

IV of the principal regulations

"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 December

2018.

42. Mercury in electric rotating connectors used in

intravascular ultrasound imaging systems capable of high

operating frequency (> 50 MHz) modes of operation. Expires on

30 June 2019.".

€0.18