Electronic Equipment (Amendment) Regulations, 2019

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,208, 6 ta’ Ġunju, 2019 B 839

Taqsima B

L.N. 119 of 2019

PRODUCT SAFETY ACT

(CAP. 427)

Restriction of Use of Hazardous Substances in Electrical and

Electronic Equipment (Amendment) Regulations, 2019

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

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

Government, 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 Title and

of Hazardous Substances in Electrical and Electronic Equipment commencement.

(Amendment) Regulations, 2019, 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) Regulations 3(b) to 3(e), 5 and 6 shall apply from the 12th

June 2019; regulations 7(a) to 7(e), 7(m) and 7(p) shall apply from the

1st July 2019; regulation 7(r) shall apply from the 22nd July 2019 and

regulations 7(f) to 7(h), 7(j) to 7(l), 7(n), 7(o) and 7(q) shall apply

from the 1st March 2020.

(1) The scope of these regulations is to implement Scope and

Directive (EU) 2017/2102 of the European Parliament and of the applicability.

Council of 15 November 2017 and Commission Delegated Directives

(EU) 2018/736 of 27 February 2018, 2018/737 of 27 February 2018,

2018/738 of 27 February 2018, 2018/739 of 1 March 2018, 2018/740

of 1 March 2018, 2018/741 of 1 March 2018, 2018/742 of 1 March

2018, 2019/169 of 16 November 2018, 2019/170 of 16 November

2018, 2019/171 of 16 November 2018, 2019/172 of 16 November

2018, 2019/173 of 16 November 2018, 2019/174 of 16 November

2018, 2019/175 of 16 November 2018, 2019/176 of 16 November

2018, 2019/177 of 16 November 2018 and 2019/178 of 16 November

2018. (2) These regulations shall apply to equipment falling within

the scope of the principal regulations.

Regulation 2 of the principal regulations shall be amended Amends

regulation 2 of

as follows

the principal

regulations.

(a)

sub-regulation (1A) shall be substituted by the

following

"(1A) These regulations also implement the European

Union legislation listed in Schedule VIII.";

(b) in sub-regulation (2) thereof, the words ", subject to

sub-regulation (3)," shall be deleted;

(c)

sub-regulation (3) thereof, shall be deleted;

(d) sub-regulations (4) and (5) thereof, shall be

renumbered as sub-regulations (3) and (4) respectively;

(e) in paragraph (j) of sub-regulation (4) thereof, as

renumbered, the word "basis." shall be substituted by the word

"basis;" and immediately thereafter there shall be added the

following new paragraph

"(k) pipe organs.".

Regulation 2A of the principal regulations shall be deleted.

In regulation 3 of the principal regulations, the definition

"non-road mobile machinery made available exclusively for

professional use" shall be substituted by the following

" "non-road mobile machinery made available exclusively

for professional use" means machinery, with an on-board power

source or with a traction drive powered by an external power

source, the operation of which requires either mobility or

continuous or semi-continuous movement between a succession

of fixed working locations while working, and which is made

available exclusively for professional use;".

Regulation 4 of the principal regulations shall be amended

as follows

(a) sub-regulation (3) thereof shall be substituted by the

following

"(3) Sub-regulation (1) shall apply to medical

devices and monitoring and control instruments which are

placed on the market from 22 July 2014, to in vitro

diagnostic medical devices which are placed on the market

from 22 July 2016, to industrial monitoring and control

instruments which are placed on the market from 22 July

2017, and to all other electrical and electronic equipment

that was outside the scope of Directive 2002/95/EC and

which is placed on the market from 22 July 2019.";

(b)

in sub-regulation (4) thereof

(i)

in paragraph (a)

(aa) sub-paragraph

(vi)

shall

be

renumbered as sub-paragraph (vii);

(bb) immediately after sub-paragraph

(v), there shall be added the following new sub-

paragraph

"(vi) all other electrical and

electronic equipment that was outside the

scope of Directive 2002/95/EC and which

is placed on the market before 22 July

2019;";

(ii) paragraph (b) thereof, shall be substituted by

the following

"(b) the following reused spare parts, provided

that reuse takes place in auditable closed-loop

business-to-business return systems, and that the

reuse of spare parts is notified to the consumer

(i) recovered from electrical and

electronic equipment placed on the market

before 1 July 2006 and used in electrical and

electronic equipment placed on the market

before 1 July 2016;

(ii) recovered from medical devices or

monitoring and control instruments placed on

the market before 22 July 2014 and used in

electrical and electronic equipment placed on

the market before 22 July 2024;

(iii) recovered from in vitro diagnostic

medical devices placed on the market before 22

July 2016 and used in electrical and electronic

equipment placed on the market before 22 July

2026;

(iv) recovered

from

industrial

monitoring and control instruments placed on

the market before 22 July 2017 and used in

electrical and electronic equipment placed on

the market before 22 July 2027;

(v) recovered from all other electrical

and electronic equipment that was outside the

scope of Directive 2002/95/EC and which is

placed on the market before 22 July 2019, and

used in electrical and electronic equipment

placed on the market before 22 July 2029.".

Schedule III to the principal regulations shall be amended

Amends

Schedule III to

as follows

the principal

regulations.

(a)

item 6(a) shall be substituted by the following

" 6(a)

Lead as an alloying element in

Expires on

steel for machining purposes

— 21 July 2021 for categories 8 and 9

and in galvanised steel

other than in vitro diagnostic medical

devices and industrial monitoring and

containing up to 0,35% lead

by weight

control instruments;

— 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.

6(a)-I

Lead as an alloying element in

Expires on 21 July 2021 for categories 1-7

and 10. ";

steel for machining purposes

containing up to 0,35% lead

by weight and in batch hot dip

galvanised steel components

containing up to 0,2% lead by

weight

(b)

item 6(b) shall be substituted by the following

" 6(b)

Lead as an alloying element

Expires on

in aluminium containing up

— 21 July 2021 for categories 8 and 9

to 0,4% lead by weight

other than in vitro diagnostic medical

devices and industrial monitoring and

control instruments,

— 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.

6(b)-I

Lead as an alloying element

Expires on 21 July 2021 for categories 1-7

in aluminium containing up

and 10.

to 0,4% lead by weight,

provided it stems from lead-

bearing aluminium scrap

recycling

6(b)-II

Lead as an alloying element

Expires on 18 May 2021 for categories 1-7

and 10. ";

in aluminium for machining

purposes with a lead content

up to 0,4% by weight

(c)

item 6(c) shall be substituted by the following

" 6(c)

Copper alloy containing up

Expires on

to 4% lead by weight

— 21 July 2021 for categories 1-7 and 10,

— 21 July 2021 for categories 8 and 9 other

than in vitro diagnostic medical devices

and industrial monitoring and control

instruments,

— 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. ";

(d)

item 7(a) shall be substituted by the following

" 7(a)

Applies to categories 1-7 and 10 (except

Lead

in

high

melting

temperature type solders (i.e.

applications covered by item 24 of this

Annex) and expires on 21 July 2021.

lead-based alloys containing

85% by weight or more lead)

For categories 8 and 9 other than in vitro

diagnostic medical devices and industrial

monitoring and control instruments

expires on 21 July 2021.

For category 8 in vitro diagnostic medical

devices expires on 21 July 2023.

For category 9 industrial monitoring and

control instruments, and for category 11

expires on 21 July 2024. ";

(e)

item 7(c)-I shall be substituted by the following

" 7(c)-I

Electrical and electronic

Applies to categories 1-7 and 10 (except

components containing lead

applications covered under item 34) and

in a glass or ceramic other

expires on 21 July 2021.

than dielectric ceramic in

For categories 8 and 9 other than in vitro

capacitors,

e.g.

piezo-

diagnostic medical devices and industrial

electronic devices, or in a

monitoring and control instruments

glass or ceramic matrix

expires on 21 July 2021.

compound

For category 8 in vitro diagnostic medical

devices expires on 21 July 2023.

For category 9 industrial monitoring and

control instruments, and for category 11

expires on 21 July 2024. ";

(f)

item 7(c)-II shall be substituted by the following

" 7(c)-II Lead in dielectric ceramic Does not apply to applications covered by

in capacitors for a rated

point 7(c)-I and 7(c)-IV of this Annex.

voltage of 125 V AC or

Expires on

250 V DC or higher

— 21 July 2021 for categories 1-7 and 10;

— 21 July 2021 for categories 8 and 9

other than in vitro diagnostic medical

devices and industrial monitoring and

control instruments;

— 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. ";

(g)

item 7(c)-IV shall be substituted by the following

" 7(c)-IV Lead

Expires on

in PZT based

dielectric

ceramic

— 21 July 2021 for categories 1-7 and 10;

— 21 July 2021 for categories 8 and 9

materials for capacitors

which

are

part

of

other than in vitro diagnostic medical

integrated circuits or

devices and industrial monitoring and

discrete semiconductors

control instruments;

— 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. ";

(h)

item 8(b) shall be substituted by the following

" 8(b)

Cadmium and its compounds

Applies to categories 8, 9 and 11 and

in electrical contacts

expires on

— 21 July 2021 for categories 8 and 9

other than in vitro diagnostic medical

devices and industrial monitoring and

control instruments;

— 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.

Applies to categories 1 to 7 and 10 and

8(b)-I

Cadmium and its compounds

expires on 21 July 2021. ";

in electrical contacts used in

— circuit breakers,

— thermal sensing controls,

— thermal motor protectors

(excluding

hermetic

thermal

motor

protectors),

— AC switches rated at

- 6 A and more at 250 V

AC and more, or

- 12 A and more at 125 V

AC and more,

— DC switches rated at 20

A and more at 18 V DC

and more, and

— switches for use at

voltage supply frequency

≥ 200 Hz.

(i)

item 13(b) shall be substituted by the following

" 13(b)

Applies to categories 8, 9 and 11; expires

Cadmium and lead in filter

glasses and glasses used

on

for 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

Applies to categories 1 to 7 and 10;

optical filter glass types;

expires on 21 July 2021 for categories 1

excluding

applications

to 7 and 10.

falling under point 39 of

this Annex

13(b)-(III)

Cadmium and lead in

Applies to categories 1 to 7 and 10;

glazes used for reflectance

expires on 21 July 2021 for categories 1

to 7 and 10. ";

standards

(j)

item 15 shall be substituted by the following

" 15

Lead in solders to

Applies to categories 8, 9 and 11 and

complete

a

viable

expires on

— 21 July 2021 for categories 8 and 9

electrical

connection

between

semiconductor

other than in vitro diagnostic medical

die and carrier within

devices and industrial monitoring

integrated circuit flip chip

and control instruments;

packages

— 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.

15(a)

Lead in solders to

Applies to categories 1 to 7 and 10 and

expires on 21 July 2021. ";

complete a viable

electrical connection

between the semi-

conductor die and carrier

within integrated circuit

flip chip packages where

at least one of the

following criteria applies

— a semi conductor

technology node of

90nm or larger;

— a single die of

300mm 2 or larger in

any semi conductor

technology node;

— stacked die packages

with die of 300mm 2 or

larger,

or

silicon

interposers of 300mm 2

or larger.

(k)

item 18(b) shall be substituted by the following

" 18(b)

Lead as activator in the

Expires on

fluorescent powder (1%

— 21 July 2021 for categories 1-7 and

lead by weight or less) of

10;

discharge lamps when used

— 21 July 2021 for categories 8 and 9

as sun tanning lamps

other than in vitro diagnostic

containing phosphors such

medical devices and industrial

as BSP (BaSi 2 O 5 :Pb)

monitoring and control instruments;

— 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.

18(b)-I

Lead as activator in the

Applies to categories 5 and 8, excluding

fluorescent powder (1%

applications covered by entry 34 of

lead by weight or less) of

Annex IV, and expires on 21 July

2021. ";

discharge lamps containing

phosphors such as BSP

(BaSi 2 O 5 :Pb) when used

in medical phototherapy

equipment

(l)

item 21 shall be substituted by the following

" 21

Lead and cadmium in printing

Applies to categories 8, 9 and 11 and

inks for the application of

expires on

enamels on glasses, such as

— 21 July 2021 for categories 8 and 9

borosilicate and soda lime

other than in vitro diagnostic

glasses

medical devices and industrial

monitoring and control instruments;

— 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(a)

Cadmium when used in colour

Applies to categories 1 to 7 and 10

printed glass to provide

except applications covered by entry

filtering functions, used as a

21(b) or entry 39 and expires on 21 July

component

in

lighting

2021. applications

installed

in

displays and control panels of

EEE

21(b)

Cadmium in printing inks for

Applies to categories 1 to 7 and 10

the application of enamels on

except applications covered by entry

glasses, such as borosilicate

21(a) or entry 39 and expires on 21 July

and soda lime glasses

2021. 21(c)

Lead in printing inks for the

Applies to categories 1 to 7 and 10 and

expires on 21 July 2021. ";

application of enamels on

other than borosilicate glasses

(m) item 24 shall be substituted by the following

" 24

Expires on

Lead in solders for the

soldering to machined through

— 21 July 2021 for categories 1-7 and

hole discoidal and planar array

10,

ceramic multilayer capacitors

— 21 July 2021 for categories 8 and 9

other than in vitro diagnostic

medical devices and industrial

monitoring and control instruments,

— 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. ";

(n)

item 29 shall be substituted by the following

" 29

Lead bound in crystal glass

Expires on

— 21 July 2021 for categories 1-7 and 10;

as defined in First Schedule

(Categories 1, 2, 3 and 4) of

— 21 July 2021 for categories 8 and 9

other than in vitro diagnostic medical

the Crystal Glass Order

(S.L. 427.04)

devices and industrial monitoring and

control instruments;

— 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. ";

(o)

item 32 shall be substituted by the following

" 32

Lead oxide in seal frit used

Expires on

for

making

window

— 21 July 2021 for categories 1-7 and 10;

assemblies for Argon and

— 21 July 2021 for categories 8 and 9

Krypton laser tubes

other than in vitro diagnostic medical

devices and industrial monitoring and

control instruments;

— 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. ";

(p)

item 34 shall be substituted by the following

" 34

Lead

in

cermet-based

Applies to all categories; expires on

trimmer

potentiometer

— 21 July 2021 for categories 1-7 and 10,

elements

— 21 July 2021 for categories 8 and 9

other than in vitro diagnostic medical

devices and industrial monitoring and

control instruments,

— 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. ";

(q)

item 37 shall be substituted by the following

" 37

Lead in the plating layer of

Expires on

— 21 July 2021 for categories 1-7 and

high voltage diodes on the

basis of a zinc borate glass

10;

body

— 21 July 2021 for categories 8 and 9

other than in vitro diagnostic medical

devices and industrial monitoring and

control instruments;

— 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. ";

(r)

item 42 shall be added

Applies to category 11, excluding

Lead in bearings and bushes

applications covered by entry 6(c) of this

of diesel or gaseous fuel

Annex.

powered internal combustion

Expires on 21 July 2024. ".

engines applied in non-road

professional use equipment

— with

engine

total

displacement ≥ 15 litres;

or

— with

engine

total

displacement < 15 litres

and the engine is

designed to operate in

applications where the

time between signal to

start and full load is

required to be less than

10 seconds; or regular

maintenance is typically

performed in a harsh and

dirty

outdoor

environment, such as

mining, construction, and

agriculture applications.

Schedule IV to the principal regulations shall be amended

as follows

(a) in item 31 thereof, the words " ’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.", shall be deleted;

(b)

item 39 thereof shall be substituted by the following

"39. Lead in micro-channel plates (MCPs) used in

equipment where at least one of the following properties is

present

(a) a compact size of the detector for electrons or

ions, where the space for the detector is limited to a

maximum of 3mm/MCP (detector thickness + space for

installation of the MCP), a maximum of 6mm in total, and

an alternative design yielding more space for the detector is

scientifically and technically impracticable;

(b) a two-dimensional spatial resolution for

detecting electrons or ions, where at least one of the

following applies

(i)

a response time shorter than 25ns;

(ii) a sample detection area larger than

149mm 2 ;

(iii) a multiplication factor larger than 1,3 ×

10 3 ;

(c) a response time shorter than 5ns for detecting

electrons or ions;

(d) a sample detection area larger than 314mm 2 for

detecting electrons or ions;

a multiplication factor larger than 4,0 × 10 7 .

(e)

The exemption expires on the following dates

(a) 21 July 2021 for medical devices and

monitoring and control instruments;

(b)

21 July 2023 for in vitro diagnostic medical

devices;

(c) 21 July 2024 for industrial monitoring and

control instruments.".

Immediately after Schedule VII to the principal regulations, Adds new

Schedule VIII to

there shall be added the following new Schedule

the principal

regulations.

"Schedule VIII

List of European Union legislation transposed by these regulations

[Regulation 2(1A)]

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Directive (EU) 2017/2102 of the European Parliament and of the

Council of 15 November 2017 amending Directive 2011/65/EU

on the restriction of the use of certain hazardous substances in

electrical and electronic equipment * .

Commission Delegated Directive (EU) 2018/736 of 27 February

2018 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 certain electrical and electronic components containing lead

in glass or ceramic ** .

Commission Delegated Directive (EU) 2018/737 of 27 February

2018 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 lead in solders for the soldering to machined through hole

discoidal and planar array ceramic multilayer capacitors ** .

Commission Delegated Directive (EU) 2018/738 of 27 February

2018 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 lead in cermet-based trimmer potentiometer elements ** .

Commission Delegated Directive (EU) 2018/739 of 1 March

2018 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 lead as an alloying element in steel ** .

Commission Delegated Directive (EU) 2018/740 of 1 March

2018 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 lead as an alloying element in aluminium ** .

Commission Delegated Directive (EU) 2018/741 of 1 March

2018 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 lead as an alloying element in copper ** .

Commission Delegated Directive (EU) 2018/742 of 1 March

2018 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 lead in high melting temperature solders ** .

Commission Delegated Directive (EU) 2019/169 of 16

November 2018 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 lead in dielectric ceramic in certain capacitors *** .

Commission Delegated Directive (EU) 2019/170 of 16

November 2018 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 lead in PZT based dielectric ceramic materials for

certain capacitors *** .

Commission Delegated Directive (EU) 2019/171 of 16

November 2018 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 and its compounds in electrical

contacts *** .

Commission Delegated Directive (EU) 2019/172 of 16

November 2018 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 lead in solders to complete a viable electrical

connection between semiconductor die and carrier within

integrated circuit flip chip packages *** .

Commission Delegated Directive (EU) 2019/173 of 16

November 2018 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 lead and cadmium in printing inks for the

application of enamels on glasses *** .

Commission Delegated Directive (EU) 2019/174 of 16

November 2018 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 lead bound in crystal glass as defined in Directive

69/493/EEC *** .

Commission Delegated Directive (EU) 2019/175 of 16

November 2018 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 lead oxide in seal frit used for making window

assemblies for certain laser tubes *** .

Commission Delegated Directive (EU) 2019/176 of 16

November 2018 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 lead in the plating layer of certain diodes *** .

Commission Delegated Directive (EU) 2019/177 of 16

November 2018 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 lead as activator in the fluorescent powder of

discharge lamps containing phosphors *** .

Commission Delegated Directive (EU) 2019/178 of 16

November 2018 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 lead in bearings and bushes applied in certain non-

road professional use equipment **** .

*

Applicable as from 12th June, 2019.

B

**

Applicable as from 1st July, 2019.

***

Applicable as from 1st March, 2020.

**** Applicable as from 22nd July, 2019. " .

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