Electronic Equipment (Amendment) Regulations, 2014

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,233, 8 ta’ April, 2014

L.N. 118 of 2014

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment) Regulations, 2014

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, 2014, 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".

These regulations implement the following European Implementation.

Union legislation

(a)

the requirements of Article 14(2)(e), Article 14(4),

Article 15(2) and Annex IX of Directive 2012/19/EU of the

European Parliament and of the Council of 4 July 2012 on waste

electrical and electronic equipment (WEEE) (recast);

(b)

Commission Delegated Directive 2014/1/EU of 18

October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead as an alloying element for bearings and wear

surfaces in medical equipment exposed to ionising radiation;

(c)

Commission Delegated Directive 2014/2/EU of 18

October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for cadmium in phosphor coatings in image

intensifiers for X-ray images until 31 December 2019 and in

spare parts for X-ray systems placed on the EU market before 1

January 2020;

(d)

Commission Delegated Directive 2014/3/EU of 18

October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead acetate marker for use in stereotactic head

frames for use with CT (Computed Tomography) and MRI and

in positioning systems for gamma beam and particle therapy

equipment;

(e)

Commission Delegated Directive 2014/4/EU of 18

October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead enabling vacuum tight connections between

aluminium and steel in X-ray image intensifiers;

(f)

Commission Delegated Directive 2014/5/EU of 18

October 2013 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 on printed circuit boards,

termination coatings of electrical and electronic components

and coatings of printed circuit boards, solders for connecting

wires and cables, solders connecting transducers and sensors

that are used durably at a temperature below -20°C under

normal operating and storage conditions;

(g)

Commission Delegated Directive 2014/6/EU of 18

October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead in the surface coatings of pin connector

systems requiring non-magnetic connectors which are used

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

and storage conditions;

(h)

Commission Delegated Directive 2014/7/EU of 18

October 2013 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, termination coatings of electrical

and electronic components and printed circuit boards,

connections of electrical wires, shields and enclosed connectors

which are used (a) in magnetic fields within the sphere of 1 m

radius around the isocentre of the magnet in medical magnetic

resonance imaging equipment, including patient monitors

designed to be used within this sphere, or (b) in magnetic fields

within 1 m distance from the external surfaces of cyclotron

magnets, magnets for beam transport and beam direction control

applied for particle therapy;

(i)

Commission Delegated Directive 2014/8/EU of 18

October 2013 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 for mounting cadmium telluride

and cadmium zinc telluride digital array detectors to printed

circuit boards;

(j)

Commission Delegated Directive 2014/9/EU of 18

October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead and cadmium in metallic bonds creating

superconducting magnetic circuits in MRI, SQUID, NMR

(Nuclear Magnetic Resonance) or FTMS (Fourier Transform

Mass Spectrometer) detectors;

(k)

Commission Delegated Directive 2014/10/EU of

18 October 2013 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 alloys, as a superconductor or thermal

conductor, used in cryo-cooler cold heads and/or in cryo-cooled

cold probes and/or in cryo-cooled equipotential bonding

systems, in medical devices (category 8) and/or in industrial

monitoring and control instruments;

(l)

Commission Delegated Directive 2014/11/EU of

18 October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for hexavalent chromium in alkali dispensers used to

create photocathodes in X-ray image intensifiers until 31

December 2019 and in spare parts for X-ray systems placed on

the EU market before 1 January 2020;

(m)

Commission Delegated Directive 2014/12/EU of

18 October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead in solders on printed circuit boards of

detectors and data acquisition units for Positron Emission

Tomographs which are integrated into Magnetic Resonance

Imaging equipment;

(n)

Commission Delegated Directive 2014/13/EU of

18 October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead in solders on populated printed circuit

boards used in Directive 93/42/EEC class IIa and IIb mobile

medical devices other than portable emergency defibrillators;

(o)

Commission Delegated Directive 2014/14/EU of

18 October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for 3,5 mg mercury per lamp in single capped

compact fluorescent lamps for general lighting purposes < 30 W

with a lifetime equal to or above 20 000 h;

(p)

Commission Delegated Directive 2014/15/EU of

18 October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead, cadmium and hexavalent chromium in

reused spare parts, recovered from medical devices placed on

the market before 22 July 2014 and used in category 8

equipment placed on the market before 22 July 2021, provided

that reuse takes place in auditable closed-loop business-to-

business return systems, and that the reuse of parts is notified to

the consumer;

(q)

Commission Delegated Directive 2014/16/EU of

18 October 2013 amending, for the purposes of adapting to

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

European Parliament and of the Council as regards an

exemption for lead as an activator in the fluorescent powder of

discharge lamps when used for extracorporeal photopheresis

lamps containing BSP (BaSi 2 O 5 :Pb) phosphors.

Regulation 3 of the principal regulations shall be amended

as follows

(a)

for the definition "Technical Regulations

Division", there shall be substituted the following

" "Technical Regulations Division" means the

Technical Regulations Division established by article 19 of

the Malta Competition and Consumer Affairs Authority

Act, hereinafter referred to as "competent authority";"; and

(b)

immediately after the new definition "Technical

Regulations Division", there shall be added the following new

definition

" "waste electrical and electronic equipment" or

"WEEE" means electrical and electronic equipment which

is waste as defined in regulation 4 of the Waste

Regulations, including all components, sub-assemblies and

consumables which are part of the product at the time of

discarding;".

Immediately after regulation 4 of the principal regulations, Adds new

regulation to the

there shall be added the following new regulation

principal

regulations.

" Competent

(1)

The competent authority

authority.

shall ensure that users of EEE in private

households are given the necessary

information about the meaning of the symbol

shown in Schedule VII.

(2) In order to enable the date upon

which the EEE was placed on the market to be

determined unequivocally, the competent

authority shall ensure that a mark on the EEE

specifies that the latter was placed on the

market after 13 August 2005. Preferably, the

European Standard EN 50419 shall be applied

for this purpose.

(3) With a view to minimising the

disposal of WEEE as unsorted municipal

waste and to facilitating its separate

collection, the competent authority shall

ensure that producers appropriately mark -

preferably in accordance with the European

standard EN 50419 - EEE placed on the

market with the symbol shown in Schedule

VII. In exceptional cases, where this is

necessary because of the size or the function

of the product, the symbol shall be printed on

the packaging, on the instructions for use and

on the warranty of the EEE.".

Immediately after item 1(f) in Schedule III of the principal Amendment of

Schedule III of

regulations, there shall be added the following new item

the principal

regulations.

" 1(g) For general lighting purposes < 30 Expires on

W with a lifetime equal or above 31 December

20 000 h: 3,5 mg

".

Schedule IV of the principal regulations shall be amended

as follows

(a)

item 12 thereof shall be substituted by the

following

"12. Lead and cadmium in metallic bonds creating

superconducting magnetic circuits in MRI, SQUID, NMR

(Nuclear Magnetic Resonance) or FTMS (Fourier

Transform Mass Spectrometer) detectors. Expires on 30

June 2021."; and

(b)

immediately after item 20 thereof, there shall be

added the following new items

"21. Cadmium in phosphor coatings in image

intensifiers for X-ray images until 31 December 2019 and

in spare parts for X-ray systems placed on the EU market

before 1 January 2020.

Lead acetate marker for use in stereotactic

head frames for use with CT and MRI and in positioning

systems for gamma beam and particle therapy equipment.

Expires on 30 June 2021.

Lead as an alloying element for bearings and

wear surfaces in medical equipment exposed to ionising

radiation. Expires on 30 June 2021.

Lead enabling vacuum tight connections

between aluminium and steel in X-ray image intensifiers.

Expires on 31 December 2019.

Lead in the surface coatings of pin connector

systems requiring nonmagnetic connectors which are used

durably at a temperature below -20°C under normal

operating and storage conditions. Expires on 30 June 2021.

Lead in

-

solders on printed circuit boards,

-

termination coatings of electrical and

electronic components and coatings of printed

circuit boards,

-

solders for connecting wires and cables,

-

solders

connecting

transducers

and

sensors,

that are used durably at a temperature below -20°C under

normal operating and storage conditions. Expires on 30

June 2021.

Lead in

-

solders,

-

termination coatings of electrical and

electronic components and printed circuit boards,

-

connections of electrical wires, shields

and enclosed connectors,

which are used in

(a) magnetic fields within the sphere of 1 m

radius around the isocentre of the magnet in

medical magnetic resonance imaging equipment,

including patient monitors designed to be used

within this sphere, or

(b) magnetic fields within 1 m distance

from the external surfaces of cyclotron magnets,

magnets for beam transport and beam direction

control applied for particle therapy. Expires on 30

June 2020.

Lead in solders for mounting cadmium

telluride and cadmium zinc telluride digital array detectors

to printed circuit boards. Expires on 31 December 2017.

Lead in alloys, as a superconductor or thermal

conductor, used in cryo-cooler cold heads and/or in cryo-

cooled cold probes and/or in cryo-cooled equipotential

bonding systems, in medical devices (category 8) and/or in

industrial monitoring and control instruments. Expires on

30 June 2021.

Hexavalent chromium in alkali dispensers

used to create photocathodes in X-ray image intensifiers

until 31 December 2019 and in spare parts for X-ray

systems placed on the EU market before 1 January 2020.

Lead, cadmium and hexavalent chromium in

reused spare parts, recovered from medical devices placed

on the market before 22 July 2014 and used in category 8

equipment placed on the market before 22 July 2021,

provided that reuse takes place in auditable closed-loop

business-to-business return systems, and that the reuse of

parts is notified to the consumer. Expires on 21 July 2021.

Lead in solders on printed circuit boards of

detectors and data acquisition units for Positron Emission

Tomographs which are integrated into Magnetic

Resonance Imaging equipment. Expires on 31 December

2019.

Lead in solders on populated printed circuit

boards used in Directive 93/42/EEC class IIa and IIb

mobile medical devices other than portable emergency

defibrillators. Expires on 30 June 2016 for class IIa and on

31 December 2020 for class IIb.’

Lead as an activator in the fluorescent powder

of discharge lamps when used for extracorporeal

photopheresis lamps containing BSP (BaSi 2 O 5 :Pb)

phosphors. Expires on 22 July 2021.".

7. Immediately after Schedule VI to the principal regulations,

there shall be added the following new schedule

"Schedule VII

The symbol indicating separate collection for EEE consists of

the crossed-out wheeled bin, as shown below. The symbol must be

printed visibly, legibly and indelibly.

".

€0.36