Electronic Equipment (Amendment) Regulations, 2018

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,011, 19 ta’ Ġunju, 2018

L.N. 196 of 2018

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment) Regulations, 2018

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

Product Safety Act, the Minister for Ministry for Justice, Culture and

Local Government, on the advice of the Malta Competition and

Consumer Affairs Authority, has made the following regulations:-

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

of Hazardous Substances in Electrical and Electronic Equipment coming

force.

(Amendment) Regulations, 2018, 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) Regulation 4(a), (b), (c) shall apply as from 6th July 2018

and regulation 4(d) shall apply as from 21st November 2018.

Sub-regulation (IA), including paragraphs (a) to (f) of Amends

regulation 2 of

regulation 2 of the principal regulations shall be deleted.

the principal

regulations.

Regulation 2A of the principal regulations shall be Substitutes

regulation 2A of

substituted by the following

the principal

regulations.

"2A. These regulations implement the following European

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 4July

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 until31 December 2019 and in

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

before 1 January2020;

(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 digitalarray 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 22July 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

2O5:Pb) phosphors;

(r) Commission Delegated Directive 2014/69/EU

of 13 March 2014 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 dielectric ceramic in capacitors for a

rated voltage of less than 125 V AC or 250 V DC for

industrial monitoring and control instruments;

(s) Commission Delegated Directive 2014/70/EU

of 13 March 2014 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 micro-channel plates (MCPs);

(t) Commission Delegated Directive 2014/71/EU

of 13 March 2014 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 solder in one interface of large area

stacked die elements;

(u) Commission Delegated Directive 2014/72/EU

of 13 March 2014 amending, for the purposes of adapting

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

the European Parliament and of the Council as regards an

exemption for lead in solders and termination finishes of

electrical and electronic components and finishes of printed

circuit boards used in ignition modules and other electrical

and electronic engine control systems;

(v) Commission Delegated Directive 2014/73/EU

of 13 March 2014 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 platinised platinum electrodes used

for conductivity measurements;

(w) Commission Delegated Directive 2014/74/EU

of 13 March 2014 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 used in other than C-press compliant

pin connector systems for industrial monitoring and control

instruments;

(x) Commission Delegated Directive 2014/75/EU

of 13 March 2014 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 cold cathode fluorescent lamps

(CCFLs) for back-lighting liquid crystal displays, not

exceeding 5 mg per lamp, used in industrial monitoring and

control instruments placed on the market before 22 July

2017;

(y) Commission Delegated Directive 2014/76/EU

of 13 March 2014 amending, for the purposes of adapting

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

the European Parliament and of the Council as regards an

exemption for Mercury in hand crafted luminous discharge

tubes (HLDTs) used for signs, decorative or architectural

and specialist lighting and light-artwork;

(z) 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;

(aa) 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;

(bb) 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;

(cc) 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;

(dd) 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

(ee) 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;

(ff) Commission Delegated Directive (EU) 2017/

1009 of 13 March 2017 amending, for the purposes of

adapting to technical progress, Annex III to Directive 2011/

65/EU of the European Parliament and of the Council as

regards an exemption for cadmium and lead in filter glasses

and glasses used for reflectance standards;

(gg) Commission Delegated Directive (EU) 2017/

1010 of 13 March 2017 amending, for the purposes of

adapting to technical progress, Annex III to Directive 2011/

65/EU of the European Parliament and of the Council as

regards an exemption for lead in bearing shells and bushes

for certain refrigerant-containing compressors;

(hh) Commission Delegated Directive (EU) 2017/

1011 of 15 March 2017 amending, for the purposes of

adapting to technical progress, Annex III to Directive 2011/

65/EU of the European Parliament and of the Council as

regards an exemption for lead in white glasses used for

optical applications; and

(ii)

Commission Delegated Directive (EU) 2017/

1975 of 7 August 2017 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 cadmium in colour

converting light-emitting diodes (LEDs) for use in display

systems.".

Schedule III to the principal regulations shall be amended

as follows

(a) item 13(b) thereof shall be substituted by the

following

Cadmium and lead in filter

Applies to categories 8, 9 and 11; expires

glasses and glasses used for

on

reflectance standards

—

21 July 2023 for category 8 in

vitro

diagnostic

medical

devices;

—

21 July 2024 for category 9

industrial

monitoring

and

control instruments and for

category 11;

—

21 July 2021 for other

subcategories of categories 8

and 9

13(b)-(I) Lead in ion coloured

Applies to categories 1 to 7 and 10;

optical filter glass types

expires on 21 July 2021 for categories 1

to 7 and 10

13(b)-(II) Cadmium

in

striking

optical filter glass types;

excluding

applications

falling under point 39 of this

Annex

13(b)-(III)Cadmium and lead in

glazes used for reflectance

standards

";

(b) item 9(b) thereof shall be substituted by the

following

Lead in bearing shells and

Applies to categories 8, 9 and 11; expires

bushes for refrigerant-

on

containing compressors for

—

21 July 2023 for category 8 in

heating, ventilation, air

vitro

diagnostic

medical

conditioning

and

devices,

refrigeration

(HVACR)

—

21 July 2024 for category 9

applications

industrial

monitoring

and

control instruments and for

category 11,

—

21 July 2021 for other

subcategories of categories 8

and 9.

9(b)-(I) Lead in bearing shells and

Applies to category 1; expires on 21 July

bushes for refrigerant-

2019. containing hermetic scroll

compressors with a stated

electrical power input equal

or below 9 kW for heating,

ventilation, air conditioning

";

and refrigeration (HVACR)

applications

(c) item 13(a) thereof shall be substituted by the

following

Lead in white glasses used

Applies to all categories; expires on

for optical applications

—

21 July 2023 for category 8 in

vitro

diagnostic

medical

devices;

—

21 July 2024 for category 9

industrial

monitoring

and

control instruments and for

category 11;

—

21 July 2021 for all other

categories and subcategories";

and

(d)

item 39 thereof shall be substituted by the following

"39(a) Cadmium

selenide

in

Expires for all categories on 31 October

downshifting cadmium-based

2019. semiconductor

nanocrystal

".

quantum dots for use in

display lighting applications

(< 0,2 μg Cd per mm 2 of

display screen area)

€0.45