RESTRICTION OF USE OF HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC EQUIPMENT REGULATIONS

SUBSIDIARY LEGISLATION 427.57

RESTRICTION OF USE OF HAZARDOUS

SUBSTANCES IN ELECTRICAL AND

ELECTRONIC EQUIPMENT REGULATIONS

1st January, 2013

LEGAL NOTICE 84 of 2013, amended by Legal Notices 118 of 2014, 39,

347 of 2015, 391 of 2016 and 196 of 2018, 119 of 2019 and 185, 361 of

2020, 388 of 2021, 93 and 239 of 2022, 68 and 195 of 2023, 77, 198 and

297 of 2024.

The title of these regulations is the Restriction of Use of

Hazardous Substances in Electrical and Electronic Equipment

Regulations.

(1) These regulations implement the requirements of

Directive 2011/65/EU of the European Parliament and of the

Council of 8th June 2011 on the Restriction of the Use of certain

Hazardous Substances i n Electrical E quipment (recast), as

amended by Directives 2012/51/EU and 2011/65/EU of the

European Parliament and of the Council of 10 October 2012

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 applications containing

cadmium and an exemption for applications containing lead.

(1A) These regulations also implement the European Union

legislation listed in Schedule VIII.

(2) These regulations lay down rules on the restriction of the

use of hazardous substances in electrical and electronic equipment

with a view to contributing to the protection of human health and

the environment, including the environmentally sound recovery

and disposal of waste electrical and electronic equipment and shall

apply to electrical and electronic equipment falling within the

categories set out in Schedule I.

(3)

Deleted by Legal Notice 119 of 2019.

(4) These regulations shall apply without prejudice to the

requirements of European Union legislation on safety and health,

and on chemicals, in particular Regulation (EC) No 1907/2006, as

well as the requirements of specific European Union waste

management legislation.

(5)

These regulations shall not apply to

(a) equipment which is necessary for the protection of the

essential interests of the security of Member States,

including arms, munitions and war material intended

for specifically military purposes;

(b) equipment designed to be sent into space;

(c) equipment which is specifically designed, and is to be

installed, as part of another type of equipment that is

excluded or does not fall within the scope of these

regulations, which can fulfil its function only if it is

part of that equipment, and which can be replaced only

by the same specifically designed equipment;

(d) large-scale stationary industrial tools;

(e) large-scale fixed installations;

(f)

means of transport for persons or goods, excluding

electric two-wheel vehicles which are not type-

approved;

(g) non-road

mobile

machinery

made

available

exclusively for professional use;

(h) active implantable medical devices;

(i)

photovoltaic panels intended to be used in a system

that is designed, assembled and installed by

professionals for permanent use at a defined location

to produce energy from solar light for public,

commercial, industrial and residential applications;

(j)

equipment specifically designed solely for the

purposes of research and development only made

available on a business-to-business basis;

(k) pipe organs.

Deleted by Legal Notice 119 of 2019.

In these regulations, unless the context otherwise requires

"authorised representative" means any natural or legal person

established within the European Union who has received a written

mandate from a manufacturer to act on his behalf in relation to

specified tasks;

"availability of a substitute" means the ability of a substitute to

be manufactured and delivered within a reasonable period of time

as com pared wi th th e ti m e r equ ired for m an ufa cturin g and

delivering the substances listed in Schedule II;

"active implantable medical device" means any active

implantable medical device within the meaning of regulation 3 of

the Active Implantable Medical Devices Regulations;

"cables" means all cables with a rated voltage of less than 250

volts that serve as a connection or an extension to connect

electrical and electronic equipment to the electrical outlet or to

connect two or more electrical and electronic equipment to each

other;

"CE marking" means a marking by which the manufacturer

indicates that the product is in conformity with the applicable

requirements set out in European Union harmonisation legislation

providing for its affixing;

"competent authority" means Malta Competition and Consumer

Affairs Authority established by the Malta Competition and

Consumer Affairs Authority Act;

"conformity assessment" means the process demonstrating

whether the requirements of these regulations relating to an

electrical and electronic equipment, are met;

"dependent", within the context of the definition "electrical and

electronic equipment" means the need of electric currents or

electromagnetic fields to fulfil at least one intended function;

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes

electrical and electronic equipment available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"electrical and electronic equipment" means equipment which is

dependent on electric currents or electromagnetic fields in order to

work properly and equipment for the generation, transfer and

measurement of such currents and fields and designed for use with

a voltage rating not exceeding 1000 volts for alternating current

and 1500 volts for direct current;

"harmonised standard" means a standard adopted by one of the

European standardisation bodies listed in Annex I to Directive 98/

34/ EC of the European Parliament and of the Council of 22 June

1998 laying down a procedure for the provision of information in

the field of technical standards and regulations and of rules on

Information Society services on the basis of a request made by the

Commission in accordance with Article 6 of Directive 98/34/EC;

"homogeneous material" means one material of uniform

composition throughout or a material, consisting of a combination

of materials, that cannot be disjointed or separated into different

materials by mechanical actions such as unscrewing, cutting,

crushing, grinding and abrasive processes;

"importer" means any natural or legal person established within

the European Union, who places an electrical and electronic

equipment from a third country on the European Union market;

"in vitro diagnostic medical device’ means an in vitro diagnostic

medical device within the meaning of regulation 3 of the In Vitro

Diagnostic Medical Devices Regulations;

"industrial monitoring and control instruments" means

monitoring and control instruments designed for exclusively

industrial or professional use;

"large-scale fixed installation" means a large-scale combination

of several types of apparatus and, where applicable, other devices,

which are assembled and installed by professionals, intended to be

used permanently in a pre-defined and dedicated location, and de-

installed by professionals;

"large-scale stationary industrial tools" means a large-scale

assembly of machines, equipment, and, or components, functioning

together for a specific application, permanently installed and de-

installed by professionals at a given place, and used and

maintained by professionals in an industrial manufacturing facility

or research and development facility;

"making available on the market" means any supply of electrical

and electronic equipment for distribution, consumption or use on

the European Union market in the course of a commercial activity,

whether in return for payment or free of charge;

"manufacturer" means any natural or legal person who

manufactures electrical and electronic equipment or who has

electrical and electronic equipment designed or manufactured and

markets it under his name or trademark;

"market surveillance" means the activities carried out and

measures taken by the Division to ensure that electrical and

electronic equipment complies with the requirements set out in

these regulations and does not endanger health, safety or other

issues of public interest protection;

"medical device" means a medical device within the meaning of

regulation 3 of the Medical Devices Regulations and includes

electrical and electronic equipment;

"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;

"placing on the market" means making available an electrical

and electronic equipment on the European Union market for the

first time;

"recall" means any measure aimed at achieving the return of a

product that has already been made available to the end user;

"reliability of a substitute" means the probability that an

electrical and electronic equipment using a substitute will perform

a required function without failure under stated conditions for a

stated period of time;

"spare part" means a separate part of an electrical and electronic

equipment that can replace a part of an electrical and electronic

equipment. The electrical and electronic equipment cannot function

as intended without that part of the electrical and electronic

equipment. The functionality of electrical and electronic equipment

is restored or is upgraded when the part is replaced by a spare part;

" Te c h n i c a l R e g u l a t i o n s D i v i s i o n " m e a n s t h e Te c h n i c a l

Regulations Division established by article 19 of the Malta

Competition and Consumer Affairs Authority Act, hereinafter

referred to as "competent authority";

"technical specification" means a document that prescribes

technical requirements to be fulfilled by a product, process or

service;

"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;

"withdrawal" means any measure aimed at preventing a product

in the supply chain from being made available on the market.

(1) The competent authority shall ensure that electrical and

electronic equipment placed on the market, including cables and

spare parts for its repair, its reuse, updating of its functionalities or

upgrading of its capacity, does not contain the substances listed in

Schedule II.

(2) For the purposes of these regulations, the maximum

concentration value by weight in homogeneous materials as

specified in Schedule II shall be tolerated.

(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.

(4)

Sub-regulation (1) shall not apply to

(a) cables or spare parts for the repair, the reuse, the

updating of functionalities or upgrading of capacity of

the following

(i)

electrical and electronic equipment placed on the

market before 1 July 2006;

(ii)

medical devices placed on the market before 22

July 2014;

(iii)

in vitro diagnostic medical devices placed on the

market before 22 July 2016;

(iv)

monitoring and control instruments placed on

the market before 22 July 2014;

(v)

industrial monitoring and control instruments

placed on the market before 22 July 2017;

(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;

(vii)

electrical and electronic equipment which

benefited from an exemption and which was

placed on the market before that exemption

expired as far as that specific exemption is

concerned;

(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; and

(c) to the applications listed in Schedules III and IV.

(1) The competent 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.

The competent

authority

shall

ensure

that

all

manufacturers

(a) ensure, when placing electrical and electronic

equipment on the market, that the equipment has been

designed and manufactured in accordance with the

requirements set out in regulation 4;

(b) draw up the required technical documentation and

carry out the internal production control procedure in

line with module A of Annex II to Decision No 768/

2008/EC or have it carried out;

(c) draw up, where compliance of electrical and electronic

equipment with the applicable requirements has been

demonstrated by the procedure referred to in paragraph

(b), an EU declaration of conformity and affix the CE

marking on the finished product. Where other

applicable European Union legislation requires the

application of a conformity assessment procedure

which is at least as stringent, compliance with the

requirements of paragraph (b) may be demonstrated

within the context of that procedure. A single technical

documentation may be drawn up;

(d) keep the technical documentation and the EU

declaration of conformity for ten years after the

electrical and electronic equipment has been placed on

the market;

(e) furthermore ensure that procedures are in place for

series production to remain in conformity. Changes in

product design or characteristics and changes in the

harmonised standards or in technical specifications by

reference to which conformity of electrical and

electronic equipment is declared shall be adequately

taken into account;

(f)

keep a register of non-conforming electrical and

electronic equipment and product recalls, and keep

distributors informed thereof;

(g) furthermore ensure that their electrical and electronic

equipment bears a type, batch or serial number or

other element allowing its identification, or, where the

size or nature of the electrical and electronic

equipment does not allow it, that the required

information is provided on the packaging or in a

document accompanying the electrical and electronic

equipment;

(h) indicate their name, registered trade name or

registered trade mark and the address at which they

can be contacted on the electrical and electronic

equipment or, where that is not possible, on its

packaging or in a document accompanying the

electrical and electronic equipment. The address must

indicate a single point at which the manufacturer can

be contacted. Where other applicable European Union

legislation contains provisions for the affixing of the

manufacturer’s name and address which are at least as

stringent, those provisions shall apply;

(i)

who consider or have reason to believe that electrical

and electronic equipment which they have placed on

RESTRICTION OF USE OF HAZARDOUS SUBSTANCES

IN ELECTRICAL AND ELECTRONIC EQUIPMENT

the market is not in conformity with these regulations,

immediately take the necessary corrective measures to

bring that electrical and electronic equipment into

conformity, to withdraw it or recall it, if appropriate,

and immediately inform the Division, giving details, in

particular, of the non-compliance and of any corrective

measures taken;

(j)

provide, further to a reasoned request from the

Division, all the information and documentation

necessary to demonstrate the conformity, with these

regulations, of the electrical and electronic equipment

in either Maltese or English, and that they cooperate

with the Division at its request, on any action taken to

ensure compliance with these regulations of electrical

and electronic equipment which they have placed on

the market.

The competent authority shall ensure that

(a) manufacturers have the possibility to appoint an

authorised representative by written mandate. The

obligations laid down in regulation 5(a) and the

drawing up of technical documentation shall not form

part of the authorised representative’s mandate;

(b) authorised representatives perform the tasks specified

in the mandate received from the manufacturer and the

mandate shall specify, that authorised representatives

(i)

keep, at the disposal of the Division for ten years

following the placing on the market of the

electrical and electronic equipment, all EU

declarations of conformity and technical

documentation;

(ii) provide, further to a reasoned request from the

Division, all the information and documentation

necessary to demonstrate conformity with these

regulations;

(iii) cooperate, at the request of the Division, on any

action taken to ensure compliance with these

regulations of all electrical and electronic

equipment covered by their mandate.

The competent authority shall ensure that all importers

(a) place only electrical and electronic equipment which

complies with these regulations on the European

Union market;

(b) ensure, before placing an electrical and electronic

equipment on the market, that the appropriate

conformity assessment procedure has been carried out

by the manufacturer, and that they further ensure that

the manufacturer has drawn up the technical

documentation, that the electrical and electronic

equipment bears the CE marking and is accompanied

by the required documents, and that the manufacturer

has complied with the requirements set out in

regulation 5(f) and (g);

(c) do not place any equipment on the market until the

equipment has been brought in conformity with these

regulations in the case where the importers consider or

have reason to believe that the electrical and electronic

equipment is not in conformity with regulation 4 and

they shall inform the manufacturer and the Division to

that effect;

(d) indicate their name, registered trade name or

registered trade mark and the address where they can

be contacted, on the electrical and electronic

equipment or, where this is not possible, on its

packaging or in a document accompanying the

electrical and electronic equipment. Where other

applicable European Union legislation contains

provisions regarding the affixing of the importer’s

name and address which they deem to be less

stringent, those provisions shall apply;

(e) keep, in order to ensure compliance with these

regulations, a register of non-compliant electrical and

electronic equipment and electrical and electronic

equipment recalls, and keep distributors informed

thereof;

(f)

who consider or have reason to believe that any

electrical and electronic equipment which they have

placed on the market is not in conformity with these

regulations, immediately take the corrective measures

necessary to bring that equipment in conformity with

these regulations, to withdraw it or recall it, as

appropriate, and immediately inform the Division,

giving details, in particular, of the non-compliance and

of any corrective measures taken;

(g) keep, at the disposal of the Division for ten years

following the placing on the market of the electrical

and electronic equipment, a copy of the EU declaration

of conformity and furthermore they must ensure that

any technical documentation will be made available

upon request;

(h) provide, further to a reasoned request from the

Division, all the information and documentation

necessary to demonstrate the conformity with these

regulations of the electrical and electronic equipment

in either Maltese or English, and that they cooperate

with the Division at its request, on any action taken to

ensure compliance with these regulations of electrical

and electronic equipment which they have placed on

the market.

The competent authority shall ensure that distributors

(a) act, when making available on the market any

electrical and electronic equipment, with due care in

relation to the requirements applicable in particular by

verifying that the electrical and electronic equipment

bears the CE marking, that it is accompanied by the

required documents in either Maltese or English, and

that the manufacturer and the importer have complied

with the requirements set out in regulation 5(g) and (h)

and in regulation 7(d);

(b) do not make available on the market any equipment,

until the equipment has been brought in conformity

with regulation 4 in the case where the distributors

consider or have reason to believe that the electrical

and electronic equipment is not in conformity with

regulation 4 and they shall inform the manufacturer

and the Division to that effect;

(c) who consider or have reason to believe that electrical

and electronic equipment which they have made

available on the market is not in conformity with these

regulations, make sure that the corrective measures

necessary to bring that equipment in conformity with

these regulations, to withdraw it or recall it, if

appropriate, and immediately inform the Division,

giving details, in particular, of the non-compliance and

of any corrective measures taken;

(d) provide, further to a reasoned request from the

Division, all the information and documentation

necessary to demonstrate the conformity, with these

regulations, of the electrical and electronic equipment,

and that they cooperate with the Division at its

request, on any action taken to ensure compliance with

these regulations of electrical and electronic

equipment which they have made available on the

market.

Importers or distributors shall be considered as

manufacturers for the purposes of these regulations and shall

furthermore be subject to the provisions of regulation 5 in the case

where either of them has placed on the market electrical and

electronic equipment under their names or trademarks or modified

any electrical and electronic equipment which has already been

placed on the market in such a way that compliance with the

applicable requirements may be affected.

On request, all economic operators shall identify the

following to the Division for ten years following the placing on the

market of the electrical and electronic equipment

(a) any economic operator who has supplied them with

electrical and electronic equipment;

(b) any economic operator to whom they have supplied

electrical and electronic equipment.

(1) The EU declaration of conformity shall particularly

specify that the requirements specified in regulation 4 have been

observed and shall be made in the form and manner as provided in

Schedule VI, either in Maltese or English.

(2) Where other applicable European Union legislation

requires the application of a conformity assessment procedure

which is less stringent, compliance with the requirements of

regulation 4(1) may be demonstrated within the context of that

procedure. A single technical documentation may be drawn up.

(3) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance with

these regulations of any electrical and electronic equipment.

(1) CE markings shall be subject to the general principles

set out in Article 30 of Regulation (EC) No 765/2008 and shall be

(a) affixed visibly, legibly and indelibly to the finished

electrical and electronic equipment or to its data plate.

Where this is not possible or not warranted on account

of the nature of the electrical and electronic

equipment, it shall be affixed to the packaging and to

the accompanying documents;

(b) duly affixed before the electrical and electronic

equipment is placed on the market.

(2) The Division shall build upon existing mechanisms to

ensure the correct application of the regime governing the CE

marking and take appropriate action in the event of improper use of

the CE marking.

(1) In the absence of evidence to the contrary, the Division

shall presume electrical and electronic equipment bearing the CE

marking to comply with these regulations .

(2) Materials, components and electrical and electronic

equipment on which tests and measurements demonstrating

compliance with the requirements of regulation 4 have been

performed, or which have been assessed, in accordance with

harmonised standards, the references of which have been published

in the Official Journal of the European Union, shall be presumed to

comply with the requirements of these regulations.

(1) Where it is considered that a harmonised standard does

not entirely satisfy the requirements which it covers and which are

set out in regulation 4, the Division shall bring the matter before

the Committee, set up pursuant to Article 5 of Directive 98/34/EC,

giving its arguments, and requesting the Committee to deliver its

opinion without delay, after consulting the relevant European

standardisation bodies.

(2) In the light of the Committee’s opinion, the Division shall

decide to publish, not to publish, to publish with restriction, to

maintain, to maintain with restriction or to withdraw the references

to the harmonised standard concerned.

(3) On the basis of the Committee’s opinion, the Commission

may inform the relevant European standardisation body and, if

necessary, request the revision of the harmonised standards

concerned.

The Division shall carry out market surveillances in

accordance with Articles 15 to 29 of Regulation (EC) No 765/2008.

Any person who contravenes the provisions of these

regulations shall be guilty of an offence and shall, on conviction,

be liable to the penalties established by the Product Safety Act.

Schedule I

Categories of Electrical and Electronic Equipment covered by these regulations

1. Large household appliances

2. Small household appliances

3. IT and telecommunications equipment

4. Consumer equipment

5. Lighting equipment

6. Electrical and electronic tools

7. Toys, leisure and sports equipment

8. Medical devices

9. Monitoring and control instruments including industrial monitoring and control

instruments

10. Automatic dispensers

11. Other Electrical and Electronic Equipment not covered by any of the categories

above.

Schedule II

Amended by

Restricted substances referred to in regulation 4(1) L.N. 347 of 2015.

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.

Schedule III

Amended by

L.N. 118 of 2014;

L.N. 39 of 2015;

L.N. 196 of 2018;

L.N. 119 of 2019;

L.N. 185 of 2020;

L.N. 361 of 2020;

L.N. 388 of 2021.;

L.N. 239 of 2022;

L.N. 195 of 2023;

L.N. 198 of 2024;

L.N. 297 of 2024.

Applications exempted from the restriction in regulation 4(1)

Exemption

Scope and dates of applicability

Mercury

in

single

capped

(compact) fluorescent lamps not exceeding

(per burner)

1(a)

For general lighting purposes < 30 Expires on 24 February 2023

W: 2.5 mg

1(b)

For general lighting purposes ≥ 30 Expires on 24 February 2023

W and < 50 W: 3.5 mg

1(c)

For general lighting purposes ≥ 50 Expires on 24 February 2023

W and < 150 W: 5 mg

1(d)

For general lighting purposes ≥ Expires on 24 February 2023

150 W: 15 mg

1(e)

For general lighting purposes with Expires on 24 February 2023

circular or square structural shape and tube

diameter ≤ 17 mm: 5 mg

1(f)-I

For lamps designed to emit Expires on 24 February 2027

mainly light in the ultraviolet spectrum: 5

mg

1(f)-II For special purposes: 5 mg

Expires on 24 February 2025

1(g)

For general lighting purposes < 30 Expires on 24 August 2023

W with a lifetime equal or above 20,000 h

3.5 mg

2(a)

Mercury in double-capped linear

fluorescent lamps for general lighting

purposes not exceeding (per lamp)

2(a)(1) Tri-band phosphor with normal Expires on 24 February 2023

lifetime and a tube diameter < 9 mm (e.g.

T2): 4 mg

2(a)(2) Tri-band phosphor with normal Expires on 24 August 2023

lifetime and a tube diameter ≥ 9 mm and ≤

17 mm (e.g. T5): 3 mg

2(a)(3) Tri-band phosphor with normal Expires on 24 August 2023

lifetime and a tube diameter > 17 mm and ≤

28 mm (e.g. T8): 3.5 mg

2(a)(4) Tri-band phosphor with normal Expires on 24 February 2023

lifetime and a tube diameter > 28 mm (e.g.

T12): 3.5 mg

2(a)(5)

Tri-band phosphor with long Expires on 24 February 2023

lifetime (≥ 25,000 h): 5 mg.

2(b)

Mercury in other fluorescent

lamps not exceeding (per lamp)

2(b)(1)

Linear halophosphate lamps Expires on 13 April 2012

with tube > 28 mm (e.g. T10 and

T12): 10 mg

2(b)(2)

Non-linear halophosphate lamps Expires on 13 April 2016

(all diameters): 15 mg

2(b)(3)

Non-linear tri-band phosphor Expires on 24 February 2023; 10 mg may be

lamps with tube diameter > 17 mm (e.g. used per lamp from 25 February 2023 until 24

T9): 15 mg

February 2025

2(b)(4)-I Lamps for other general lighting Expires on 24 February 2025

and special purposes (e.g. induction

lamps): 15 mg

2(b)(4)-II Lamps emitting mainly light in Expires on 24 February 2027

the ultraviolet spectrum: 15 mg

2(b)(4)-III Emergency lamps: 15 mg

Expires on 24 February 2027

Mercury

in

cold

cathode

fluorescent lamps and external electrode

fluorescent lamps (CCFL and EEFL) for

special purposes used in EEE placed on the

market before 24 February 2022 not

exceeding (per lamp)

3(a)

Short length (≤ 500 mm): 3.5 mg Expires on 24 February 2025

3(b)

Medium length (> 500 mm and ≤ Expires on 24 February 2025

1,500 mm): 5 mg

3(c)

Long length (> 1,500 mm): 13 mg Expires on 24 February 2025

4(a)

Mercury in other low pressure Expires on 24 February 2023

discharge lamps (per lamp): 15 mg

4(a)-I

Mercury in low pressure non- Expires on 24 February 2027

phosphor coated discharge lamps, where

the application requires the main range of

the lamp-spectral output to be in the

ultraviolet spectrum: up to 15 mg mercury

may be used per lamp

4(b)

Mercury in High Pressure Sodium Expires on 24 February 2027

(vapour) lamps for general lighting

purposes not exceeding (per burner) in

lamps with improved colour rendering

index Ra > 80: P ≤ 105 W: 16 mg may be

used per burner

4(b)-I

Mercury in High Pressure Expires on 24 February 2023

Sodium (vapour) lamps for general lighting

purposes not exceeding (per burner) in

lamps with improved colour rendering

index Ra > 60: P ≤ 155 W: 30 mg may be

used per burner

4(b)-II

Mercury in High Pressure Expires on 24 February 2023

Sodium (vapour) lamps for general lighting

purposes not exceeding (per burner) in

lamps with improved colour rendering

index Ra > 60: 155 W < P ≤ 405 W: 40 mg

may be used per burner

4(b)-III Mercury in High Pressure Sodium Expires on 24 February 2023

(vapour) lamps for general lighting

purposes not exceeding (per burner) in

lamps with improved colour rendering

index Ra > 60: P > 405 W: 40 mg may be

used per burner

4(c)

Mercury in other High Pressure

Sodium (vapour) lamps for general lighting

purposes not exceeding (per burner)

4(c)-I P ≤ 155 W: 20 mg

Expires on 24 February 2027

4(c)-II 155 W < P ≤ 405 W: 25 mg

Expires on 24 February 2027

4(c)-III P > 405 W: 25 mg

Expires on 24 February 2027

4(d)

Mercury in High Pressure Expires on 13 April 2015

Mercury (vapour) lamps

(HPMV)

4(e)

Mercury in metal halide lamps Expires on 24 February 2027"; and

(MH)

4(f)-I

Mercury in other discharge lamps Expires on 24 February 2025

for special purposes not specifically

mentioned in this Annex

4(f)-II Mercury in high pressure mercury Expires on 24 February 2027

vapour lamps used in projectors where an

output ≥2000 lumen ANSI is required

4(f)-III Mercury in high pressure sodium Expires on 24 February 2027

vapour lamps used for horticulture lighting

4(f)-IV Mercury in lamps emitting light in Expires on 24 February 2027

the ultraviolet spectrum

4(g)

Mercury

in

hand

crafted Expires on 31 December 2018

luminous discharge tubes used

for signs, decorative or

architectural and specialist

lighting and light-artwork,

where the mercury content shall

be limited as follows: (a) 20 mg

per electrode pair + 0,3 mg per

tube length in cm, but not more

than 80 mg, for outdoor

applications and indoor

applications exposed to

temperatures below 20 °C; (b)

15 mg per electrode pair + 0,24

mg per tube length in cm, but

no t mo re t han 80 mg, f or all

other indoor applications

5(a)

Lead in glass of cathode ray

tubes

5(b)

Lead in glass of fluorescent

tubes not exceeding 0,2% by

weight

Lead as an alloying element in Expires on

steel for machining purposes and

in galvanised steel containing up to — 21 July 2021 for categories 8 and 9 other

than in vitro diagnostic medical devices and

0,35% lead by weight

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.

Lead as an alloying element in Expires on 21 July 2021 for categories 1-7 and

steel for machining purposes

containing up to 0,35% lead by 10.

weight and in batch hot dip

gal vanised steel components

containing up to 0,2% lead by

weight

Lead as an alloying element in Expires on

aluminium containing up to 0,4%

— 21 July 2021 for categories 8 and 9 other

lead by weight

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.

Lead as an alloying element in Expires on 21 July 2021 for categories 1-7 and

aluminium containing up to

0,4% lead by weight, provided it 10.

stems from lead-bearing

aluminium scrap recycling

Lead as an alloying element in Expires on 18 May 2021 for categories 1-7 and

aluminium for machining

purposes with a lead content up 10.

to 0,4% by weight

Copper alloy containing up to 4% Expires on

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.

Lead in high melting temperature Applies to categories 1-7 and 10 (except

type solders (i.e. lead-based alloys

containing 85% by weight or more applications covered by item 24 of this Annex)

and expires on 21 July 2021.

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.

Lead in solders for servers,

storage and storage array

systems, network infrastructure

equipment for switching,

signalling, transmission, and

network management for

telecommunications

Electrical

and

electronic

Applies to categories 1-7 and 10 (except

components containing lead in a

applications covered under item 34) and expires

glass or ceramic other than

on 21 July 2021.

dielectric ceramic in capacitors,

e.g. piezo-electronic devices, or in

For categories 8 and 9 other than in vitro

a glass or ceramic matrix

diagnostic medical devices and industrial

compound

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.

Lead in dielectric ceramic in Does not apply to applications covered by point

capacitors for a rated voltage of

125 V AC or 250 V DC or higher 7(c)-I and 7(c)-IV of this Annex.

Expires on

— 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.

Lead in dielectric ceramic in Expires on 1 January 2013 and after that date

capacitors for a rated voltage of may be used in spare parts for Electrical and

less than 125 V AC or 250 V DC Electronic Equipment placed on the market

before 1 January 2013

Lead in PZT based dielectric Expires on

ceramic materials for capacitors

w h i c h a r e p a r t o f i n t e g r a t e d — 21 July 2021 for categories 1-7 and 10;

circuits or discrete semiconductors — 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.

Cadmium and its compounds in Expires on 1 January 2012 and after that date

one shot pellet type thermal cut- may be used in spare parts for Electrical and

offs

Electronic Equipment placed on the market

before 1 January 2012

Cadmium and its compounds in Applies to categories 8, 9 and 11 and expires on

electrical contacts

— 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.

Cadmium and its compounds in

Applies to categories 1 to 7 and 10 and expires on

electrical contacts used in

21 July 2021.

— 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,

- 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.

Hexavalent chromium as an anti-

Applies to categories 8, 9 and 11 and expires on

corrosion agent of the carbon steel cooling

— 21 July 2021 for categories 8 and 9 other than

system in absorption refrigerators up to

in vitro diagnostic medical devices and

0,75% by weight in the cooling solution

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.

hexavalent Applies to categories 1-7 and 10 and expires on 5

Up

to

0,75%

March 2021.

chromium by weight, used as an anti-

corrosion agent in the cooling solution of

carbon steel cooling systems of absorption

refrigerators (including minibars) designed

to operate fully or partly with electrical

heater, having an average utilised power

input <75W at constant running conditions

hexavalent Applies to categories 1-7 and 10 and expires on 21

9(a)-II Up

to

0,75%

July 2021.

chromium by weight, used as an anti-

corrosion agent in the cooling solution of

carbon steel cooling systems of absorption

refrigerators

designed to operate fully or partly

with electrical heater, having an

average utilised power input

≥75W at constant running

conditions,

designed to fully operate with non-

electrical heater.

9(a)-III Up to 0.7% hexavalent chromium Applies to category 1 and expires on 31 December

2026. by weight, used as an anticorrosion agent in

the working fluid of the carbon steel sealed

circuit of gas absorption heat pumps for

space and water heating

Lead in bearing shells and bushes Applies to categories 8, 9 and 11; expires on

for refrigerant-containing —

21 July 2023 for category 8 in vitro

compressors for heating,

diagnostic medical devices,

ventilation, air conditioning and

—

July 2024 for category 9 industrial

refrigeration

monitoring and control instruments and

applications

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 2019.

bushes for refrigerant-

containing hermetic scroll

compressors with a stated

electrical power input equal or

below 9 kW for heating,

ventilation, air conditioning and

refrigeration

applications

Lead used in C-press compliant May be used in spare parts for Electrical and

pin connector systems

Electronic Equipment placed on the market

before 24 September 2010

Lead used in other than C-press Expires on 1 January 2013 and after that date

compliant pin connector systems may be used in spare parts for Electrical and

Electronic Equipment placed on the market

before 1 January 2013

Lead as a coating material for May be used in spare parts for Electrical and

the thermal conduction module Electronic Equipment placed on the market

C-ring

before 24 September 2010

Lead in white glasses used for Applies to all categories; expires on

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

Cadmium and lead in filter glasses Applies to categories 8, 9 and 11; expires on

and glasses used for reflectance

— 21 July 2023 for category 8 in vitro

standards

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 optical filter Applies to categories 1 to 7 and 10; expires on 21

glass types

July 2021 for categories 1 to 7 and 10.

13(b)-(II) Cadmium in striking optical filter Applies to categories 1 to 7 and 10; expires on 21

glass types; excluding applications July 2021 for categories 1 to 7 and 10.

falling under point 39 of this

Annex

13(b)-(III) Cadmium and lead in glazes used Applies to categories 1 to 7 and 10; expires on 21

for reflectance standards

July 2021 for categories 1 to 7 and 10.

Lead in solders consisting of Expired on 1 January 2011 and after that date

more than two elements for the may be used in spare parts for Electrical and

connection between the pins and Electronic Equipment placed on the market

the package of microprocessors before 1 January 2011

with a lead content of more than

80% and less than 85% by

weight

Lead in solders to complete a Applies to categories 8, 9 and 11 and expires on

viable electrical connection

between semiconductor die and — 21 July 2021 for categories 8 and 9 other

than in vitro diagnostic medical devices and

carrier within integrated circuit flip

chip packages

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.

15(a)

Lead

in

solders

to Applies to categories 1 to 7 and 10 and expires on

complete a viable electrical connection

b e t w e e n t h e s e m i - c o n d u c t o r d i e a n d 21 July 2021.

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.

Lead in linear incandescent Expires on 1 September 2013

lamps with silicate coated tubes

Lead halide as radiant agent in

high intensity discharge (HID)

lamps used for professional

reprography applications

18(a)

Lead as activator in the Expired on 1 January 2011

fluorescent powder (1% lead by

w e i g h t o r l e s s ) o f d i s c h a rg e

lamps when used as speciality

lamps for diazoprinting

reprography, lithography, insect

traps, photochemical and curing

processes containing phosphors

such as SMS ((Sr,Ba) 2 MgSi 2

O 7 :Pb)

18(b)

Lead as activator in the fluorescent Expires on

powder (1% lead by weight or

less) of discharge lamps when used — 21 July 2021 for categories 1-7 and 10;

as sun tanning lamps containing — 21 July 2021 for categories 8 and 9 other

phosphors such as BSP

than in vitro diagnostic medical devices and

(BaSi 2 O 5 :Pb)

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.

18(b)-I Lead as activator in the Applies to categories 5 and 8, excluding

fluorescent powder (1% lead by weight or

l e s s ) o f d i s c h a r g e l a m p s c o n t a i n i n g applications covered by entry 34 of Annex IV,

phosphors such as BSP (BaSi 2 O 5 :Pb) when and expires on 21 July 2021.

used in medical phototherapy equipment

Lead with PbBiSn-Hg and Expires on 1 June 2011

PbInSn-Hg

in

specific

compositions as main amalgam

and with PbSn-Hg as auxiliary

amalgam in very compact

energy saving lamps (ESL)

Lead oxide in glass used for Expires on 1 June 2011

bonding front and rear substrates

of flat fluorescent lamps used

for Liquid Crystal Displays

(LCDs)

Lead and cadmium in printing inks Applies to categories 8, 9 and 11 and expires on

for the application of enamels on

glasses, such as borosilicate and — 21 July 2021 for categories 8 and 9 other

than in vitro diagnostic medical devices and

soda lime glasses

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 except

printed glass to provide filtering functions,

u s e d a s a c o m p o n e n t i n l i g h t i n g applications covered by entry 21(b) or entry 39

a p p l i c a t i o n s i n s t a l l e d i n d i s p l a y s a n d and expires on 21 July 2021.

control panels of EEE

Cadmium in printing inks for the Applies to categories 1 to 7 and 10 except

application of enamels on glasses,

such as borosilicate and soda lime applications covered by entry 21(a) or entry 39

and expires on 21 July 2021.

glasses

Lead in printing inks for the Applies to categories 1 to 7 and 10 and expires on

application of enamels on other

21 July 2021.

than borosilicate glasses

Lead in finishes of fine pitch May be used in spare parts for Electrical and

c o m p o n e n t s o t h e r t h a n Electronic Equipment placed on the market

connectors with a pitch of 0,65 before 24 September 2010

mm and less

Lead in solders for the soldering to Expires on

machined through hole discoidal

a n d p l a n a r a r r a y c e r a m i c — 21 July 2021 for categories 1-7 and 10,

— 21 July 2021 for categories 8 and 9 other

multilayer capacitors

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.

Lead

oxide

in

surface

conduction electron emitter

displays (SED) used in

structural elements, notably in

the seal frit and frit ring

Lead oxide in the glass envelope Expires on 1 June 2011

of black light blue lamps

Lead alloys as solder for Expired on 24 September 2010

transducers used in high-

powered (designated to operate

for several ho urs at acou stic

power levels of 125 dB SPL and

above) loudspeakers

Lead bound in crystal glass as Expires on

defined in First Schedule

(Categories 1, 2, 3 and 4) of the — 21 July 2021 for categories 1-7 and 10;

Crystal Glass Order (S.L. 427.04) — 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.

Cadmium alloys as electrical/

mechanical solder joints to

electrical conductors located

directly on the voice coil in

transducers used in high-

powered loudspeakers with

sound pressure levels of 100 dB

(A) and more

Lead in soldering materials in

mercury free flat fluorescent

lamps (which, e.g. are used for

liquid crystal displays, design or

industrial lighting)

Lead oxide in seal frit used for Expires on

making window assemblies for

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

Argon and Krypton laser tubes

— 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.

Lead in solders for the soldering

of thin copper wires of 100 µm

diameter and less in power

transformers

Lead in cermet-based trimmer Applies to all categories; expires on

potentiometer elements

— 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.

Mercury used as a cathode Expired on 1 July 2010

sputtering inhibitor in DC

plasma displays with a content

up to 30 mg per display

Lead in the plating layer of high Expires on

voltage diodes on the basis of a

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

zinc borate glass 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.

Cadmium and cadmium oxide in

thick film pastes used on

aluminium bonded beryllium

oxide

Cadmium selenide in downshifting Expires for all categories on 21 November 2025

cadmium-based semiconductor

nanocrystal quantum dots for use

in display lighting applications (<

0,2 μg Cd per mm 2 of display

screen area)

Cadmium in downshifting Expires for all categories on 31 December 2027.

semiconductor nanocrystal quantum dots

directly deposited on LED semiconductor

chips for use in display and projection

applications (< 5μg Cd per mm 2 of LED

chip surface) with a maximum amount per

device of 1mg

Cadmium in photoresistors for Expires on 31 December 2013

analogue optocouplers applied

in professional audio equipment

Lead in solders and termination Applies to all categories and expires on

finishes of electrical and electronic

components and finishes of printed — 31 March 2022 for categories 1 to 7, 10 and

circuit boards used in ignition

11;

modules and other electrical and

electronic engine control systems,

which for technical reasons must — 21 July 2021 for categories 8 and 9 other than

be mounted directly on or in the

in vitro diagnostic medical devices and

crankcase or cylinder of hand-held

industrial monitoring and control instruments;

combustion engines (classes SH:1,

SH:2, SH:3 of Directive 97/68/EC

of the European Parliament and of — 21 July 2023 for category 8 in vitro diagnostic

the Council (*))

medical devices;

— 21 July 2024 for category 9 industrial

monitoring and control instruments

Lead in bearings and bushes of Applies to category 11, excluding applications

diesel or gaseous fuel powered

i n t e r n a l c o m b u s t i o n e n g i n e s covered by entry 6(c) of this Annex.

applied in non-road professional Expires on 21 July 2024.

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.

Bis(2-ethylhexyl) phthalate in

Applies to category 11 and expires on 21 July

rubber components in engine systems,

2024. designed for use in equipment that is not

intended solely for consumer use and

provided that no plasticised material comes

into contact with human mucous membranes

or into prolonged contact with human skin

and the concentration value of bis(2-

ethylhexyl) phthalate does not exceed

(a) 30% by weight of the rubber for

(i) gasket coatings;

(ii) solid-rubber gaskets; or

(iii) rubber components included

in assemblies of at least three

components using electrical,

mechanical or hydraulic

energy to do work, and

attached to the engine.

(b) 10% by weight of the rubber for

rubber-containing components not

referred to in point (a).

For the purposes of this entry, "prolonged

contact with human skin" means continuous

contact of more than 10 minutes duration or

intermittent contact over a period of 30

minutes, per day

Lead in solder of sensors,

Applies to category 11 and expires on 21 July

actuators, and engine control units of

2024. combustion engines within the scope of

Regulation (EU) 2016/1628 of the European

Parliament and of the Council***, installed

in equipment used at fixed positions while in

operation

which

is

designed

for

professionals, but also used by non-

professional users

Lead diazide, lead styphnate, lead Applies to category 11 and expires on 20 April

dipicramate, orange lead (lead tetroxide), 2026.

lead dioxide in electric and electronic

initiators

of

explosives

for

civil

(professional) use and barium chromate in

long time pyrotechnic delay charges of

electric initiators of explosives for civil

(professional) use

Cadmium and lead in plastic Applies to category 11 and expires on 28 May

profiles containing mixtures produced from 2028.

polyvinyl chloride waste (hereinafter

referred to as "recovered rigid PVC"), used

for electrical and electronic windows and

doors, where the concentration in the

recovered rigid PVC material does not

exceed 0,1 % cadmium by weight and 1,5 %

lead by weight.

From 28 May 2026, rigid PVC

recovered from electrical and electronic

windows and doors shall only be used for the

production of new articles under the

categories specified in entry 63, points 18(a)

to (d) of Annex XVII to Regulation (EC) No

1907/2006.

Suppliers of PVC articles

containing recovered rigid PVC with a

concentration of lead equal to or greater than

0,1 % by weight of the PVC material shall

ensure, before placing those articles on the

market, that they are visibly, legibly and

indelibly marked with the statement

"Contains ≥ 0,1 % lead". Where the marking

cannot be provided on the article due to the

nature of the article, it shall be on the

packaging of the article.

Suppliers of PVC articles

containing recovered rigid PVC shall submit

to national enforcement authorities upon

request

documentary

evidence

to

substantiate the claims on the recovered

origin of the PVC in those articles.

Certificates issued by schemes to provide

proof of traceability and recycled content,

such as those developed according to EN

15343:2007 or equivalent recognised

standards, may be used to substantiate such

claims for PVC articles produced in the

European Union. Claims made on the

recovered origin of the PVC in imported

articles shall be accompanied by a certificate

that provides equivalent proof of traceability

and recycled content, issued by an

independent third party.

Directive 97/68/EC of the European Parliament and of the Council of 16 December

1997 on the approximation of the laws of the Member States relating to measures

against the emission of gaseous and particulate pollutants from internal combustion

engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).

Applicable as from 21st November, 2018.

Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14

September 2016 on requirements relating to gaseous and particulate pollutant

emission limits and type-approval for internal combustion engines for non-road

mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013,

and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53)

Schedule IV

Amended by

L.N. 118 of 2014;

L.N. 39 of 2015;

L.N. 347 of 2015;

L.N. 391 of 2016;

L.N. 119 of 2019;

L.N. 361 of 2020;

L.N. 388 of 2021;

L.N. 93 of 2022;

L.N. 68 of 2023;

L.N. 77 of 2024.

Applications exempted from the restriction in regulation 4(1) specific to

medical devices and monitoring and control instruments

Equipment utilising or detecting ionising radiation

1. Lead, cadmium and mercury in detectors for ionising radiation.

2. Lead bearings in X-ray tubes.

3. Lead in electromagnetic radiation amplification devices: micro-channel plate and

capillary plate.

4. Lead in glass frit of X-ray tubes and image intensifiers and lead in glass frit binder

for assembly of gas lasers and for vacuum tubes that convert electromagnetic

radiation into electrons.

5. Lead in shielding for ionising radiation.

6. Lead in X-ray test objects.

7. Lead stearate X-ray diffraction crystals.

8. Radioactive cadmium isotope

source for portable X-ray fluorescence

spectrometers.

Sensors, detectors and electrodes

Lead and cadmium in ion selective electrodes including glass of pH electrodes.

Lead anodes in electrochemical oxygen sensors.

Lead, cadmium and mercury in infra-red light detectors.

Mercury in reference electrodes: low chloride mercury chloride, mercury sulphate

and mercury oxide.

Others

9. Cadmium in helium-cadmium lasers.

10. Lead and cadmium in atomic absorption spectroscopy lamps.

11. Lead in alloys as a superconductor and thermal conductor in MRI.

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.

13. Lead in counterweights.

14. Lead in single crystal piezoelectric materials for ultrasonic transducers.

15. Lead in solders for bonding to ultrasonic transducers.

16. Mercury in very high accuracy capacitance and loss measurement bridges and in

high frequency RF switches and relays in monitoring and control instruments not

exceeding 20 mg of mercury per switch or relay.

Lead in solders in portable emergency defibrillators.

Lead in solders of high performance infrared imaging modules to detect in the

range 8-14 µm.

Lead in Liquid crystal on silicon (LCoS) displays.

Cadmium in X-ray measurement filters.

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 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.

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 1m radius around the isocentre of the

magnet in medical magnetic resonance imaging equipment, including

patient monitors designed to be used within this sphere;

(b) magnetic fields within 1m distance from the external surfaces of cyclotron

magnets, magnets for beam transport and beam direction control applied

for particle therapy;

(c) MRI non-integrated coils, for which the Declaration of Conformity of this

model is issued for the first time before 23 September 2022; or

(d) MRI devices including integrated coils, which are used in magnetic fields

within the sphere of 1m radius around the isocentre of the magnet in

medical magnetic resonance imaging equipment, for which the

Declaration of Conformity is issued for the first time before 30th June

2024. Expires on 30 June 2027.

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, 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 vitro diagnostic medical devices and expires on 21

July 2024 for the use in electron microscopes and their accessories.

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.

Mercury in cold cathode fluorescent lamps 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. - Expires on 21 July 2024.

Lead used in other than C-press compliant pin connector systems for industrial

monitoring and control instruments. Expires on 31 December 2020. May be used after that

date in spare parts for industrial monitoring and control instruments placed on the market

before 1 January 2021.

Lead in platinized platinum electrodes used for conductivity measurements where

at least one of the following conditions applies

(a) wide-range measurements with a conductivity range covering more than 1

order of magnitude (e.g. range between 0,1mS/m and 5mS/m) in laboratory

applications for unknown concentrations;

(b) measurements of solutions where an accuracy of +/– 1% of the sample range

and where high corrosion resistance of the electrode are required for any of

the following

(i)

solutions with an acidity <pH 1;

(ii)

solutions with an alkalinity >pH 13;

(iii)

corrosive solutions containing halogen gas;

(c) measurements of conductivities above 100mS/m that must be performed with

portable instruments.

Expires on 31 December 2025.

Lead in solder in one interface of large area stacked die elements with more than

500 interconnects per interface which are used in X-ray detectors of computed tomography

and X-ray systems. Expires on 31 December 2019. May be used after that date in spare

parts for CT and X-ray systems placed on the market before 1 January 2020.

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;

a sample detection area larger than 149mm 2 ;

(ii)

a multiplication factor larger than 1,3 × 10 3 ;

(iii)

(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;

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

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.

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. Expires on 31 December

2020. May be used after that date in spare parts for industrial monitoring and control

instruments placed on the market before 1 January 2021.

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 March 2022.

41a. Lead as a thermal stabilizer 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 creatinine and blood urea

nitrogen in whole blood. Applies to category 8 and expires on 31 December 2023.

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 2026.

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.

Cadmium in radiation tolerant video camera tubes designed for cameras with a

centre resolution greater than 450 TV lines which are used in environments with ionising

radiation exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy. Applies to

category 9. Expires on 31 March 2027.

Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of

care analysis of ionic substances present in human body fluids and/or in dialysate fluids.

Expires on 21 July 2028.

Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils.

Expires on 1 January 2024.

Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl

phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used

for the repair or refurbishment of medical devices, including in vitro diagnostic medical

devices, 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 2028.

Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor

cables and wires and lead in electrical connections to these wires. Expires on 30 June

2027.

Mercury in melt pressure transducers for capillary rheometers at temperatures

over 300°C and pressures over 1,000 bar. Applies to category 9 and expires on 31

December 2025.

Schedule V

Applications for granting, renewing and revoking exemptions as referred to

in Article 5 of Directive 2011/65/EU

Applications for exemptions, renewal of exemptions or, mutatis mutandis, for revoking

an exemption may be submitted by a manufacturer, the authorised representative of a

manufacturer, or any economic operator in the supply chain and shall include at least the

following

(a) the name, address and contact details of the applicant;

(b) information on the material or component and the specific uses of the

substance in the material and component for which an exemption, or its

revocation, is requested and its particular characteristics;

(c) verifiable and referenced justification for an exemption, or its revocation, in

line with the conditions established in Article 5;

(d) an analysis of possible alternative substances, materials or designs on a life-

cycle basis, including, when available, information about independent

research, peer-review studies and development activities by the applicant and

an analysis of the availability of such alternatives;

(e) information on the possible preparation for reuse or recycling of materials

from waste Electrical and Electronic Equipment, and on the provisions

relating to the appropriate treatment of waste according to Schedule 2 of the

Waste Management (Electrical and Electronic Equipment) Regulations, 2007

(S.L. 504.75).

(f)

other relevant information;

(g) the proposed actions to develop, request the development and, or to apply

possible alternatives including a timetable for such actions by the applicant;

(h) where appropriate, an indication of the information which should be regarded

as proprietary accompanied by verifiable justification;

(i)

when applying for an exemption, proposal for a precise and clear wording for

the exemption;

(j)

a summary of the application.

Schedule VI

EU Declaration of Conformity

1. No ................ (unique identification of the Electrical and Electronic Equipment)

2. Name and address of the manufacturer or his authorised representative

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer (or installer)

4. Object of the declaration (identification of Electrical and Electronic Equipment

allowing traceability. It may include a photograph, where appropriate)

5. The object of the declaration described above is in conformity with Directive

2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the

restriction of the use of certain hazardous substances in electrical and electronic

equipment

6. Where applicable, references to the relevant harmonised standards used or

references to the technical specifications in relation to which conformity is

declared

7. Additional information

Signed for and on behalf of

(place and date of issue)

(name, function) (signature)

Schedule VII

Added by

L.N. 118 of 2014.

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.

Schedule VIII

Added by

L.N. 119 of 2019;

List of European Union legislation transposed by these

Amended by

regulations [Regulation 2(1A)]

L.N.185 of 2020;

L.N. 361 of 2020;

L.N. 388 of 2021;

L.N. 93 of 2022;

L.N. 239 of 2022;

L.N. 68 of 2023;

L.N. 195 of 2023;

L.N. 77 of 2024;

L.N. 198 of 2024;

L.N. 297 of 2024.

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, as applicable

from 12th June 2019.

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, as applicable from 1st July 2019.

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, as applicable from 1st July 2019.

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, as applicable

from 1st July 2019.

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, as applicable from 1st July

2019. 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, as applicable from 1st

July 2019.

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, as applicable from 1st July

2019. 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, as applicable from 1st

July 2019.

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, as applicable from

1st March 2020.

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, as applicable from 1st March 2020.

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, as applicable

from 1st March 2020.

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, as

applicable from 1st March 2020.

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, as applicable from 1st March 2020.

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, as

applicable from 1st March 2020.

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, as applicable from 1st March 2020.

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, as applicable from 1st

March 2020.

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, as applicable from 1st March 2020.

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, as applicable from 22nd July 2019.

Commission Delegated Directive (EU) 2019/1845 of 8 August 2019 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 bis(2-ethylhexyl) phthalate (DEHP) in certain rubber components used in engine

systems.

Commission Delegated Directive (EU) 2019/1846 of 8 August 2019 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 used in certain combustion engines.

Commission Delegated Directive (EU) 2020/360 of 17 December 2019 amending,

for the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for lead in platinized platinum electrodes used for certain conductivity

measurements, as applicable from 1st April 2021.

Commission Delegated Directive (EU) 2020/361 of 17 December 2019 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 hexavalent chromium as an anti-corrosion agent of the carbon steel

cooling system in absorption refrigerators, as applicable from 1st April 2021.

Commission Delegated Directive (EU) 2020/364 of 17 December 2019 amending,

for the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of cadmium in certain radiation tolerant video camera tubes,

as applicable from 1st September 2020.

Commission Delegated Directive (EU) 2020/365 of 17 December 2019 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 and termination finishes used in certain hand-held

combustion engines, as applicable from 1st April 2021.

Commission Delegated Directive (EU) 2020/366 of 17 December 2019 amending,

for the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-

vitro diagnostic medical devices for the analysis of blood and other body fluids

and body gases, as applicable from 1st April 2021.

Commission Delegated Directive (EU) 2021/647 of 15 January 2021 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 the use of certain lead and hexavalent chromium compounds in

electric and electronic initiators of explosives for civil (professional) use, as

applicable from 1st November 2021.

Commission Delegated Directive (EU) 2021/884 of 8 March 2021 amending, for

the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards

the validity period of an exemption for the use of mercury in electric rotating

connectors used in intravascular ultrasound imaging systems, as applicable from

1st July 2022.

Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending,

for the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl

phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare

parts recovered from and used for the repair or refurbishment of medical devices,

as applicable from 21st July 2021.

Commission Delegated Directive (EU) 2021/1979 of 11 August 2021 amending,

for the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in plastic

components in magnetic resonance imaging (MRI) detector coils, as applicable

from 21st July 2021.

Commission Delegated Directive (EU) 2021/1980 of 11 August 2021 amending,

for the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion-selective

electrodes for analysing human body fluids and/or dialysate fluids, as applicable

from 21st July 2021.

Commission Delegated Directive (EU) 2022/274 of 13 December 2021 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 the use of mercury in cold cathode fluorescent lamps and external

electrode fluorescent lamps for special purposes, as applicable from 1st October

2022. Commission Delegated Directive (EU) 2022/275 of 13 December 2021 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 the use of mercury in other High Pressure Sodium (vapour) lamps

for general lighting purposes, as applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/276 of 13 December 2021 amending,

for the purpose of adapting to technical and scientific progress, Annex III to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of mercury in single capped (compact) fluorescent lamps for

general lighting purposes, as applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/277 of 13 December 2021 amending,

for the purpose of adapting to technical and scientific progress, Annex III to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of mercury in single capped (compact) fluorescent lamps for

general lighting purposes < 30 W with a lifetime equal to or above 20000 h, as

applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/278 of 13 December 2021 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 the use of mercury in metal halide lamps, as applicable from 1st

October 2022.

Commission Delegated Directive (EU) 2022/279 of 13 December 2021 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 the use of mercury in other discharge lamps for special purposes, as

applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/280 of 13 December 2021 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 the use of mercury in other low pressure discharge lamps, as

applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/281 of 13 December 2021 amending,

for the purpose of adapting to technical and scientific progress, Annex III to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of mercury in single capped (compact) fluorescent lamps for

special purposes, as applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/282 of 13 December 2021 amending,

for the purpose of adapting to technical and scientific progress, Annex III to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of mercury in non-linear tri-band phosphor lamps, as

applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/283 of 13 December 2021 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 the use of mercury in High Pressure Sodium (vapour) lamps with

improved colour rendering index for general lighting purposes, as applicable from

1st October 2022.

Commission Delegated Directive (EU) 2022/284 of 16 December 2021 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 the use of mercury in double-capped linear fluorescent lamps for

general lighting purposes, as applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/287 of 13 December 2021 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 mercury in fluorescent lamps for other general lighting and special

purposes, as applicable from 1st October 2022.

Commission Delegated Directive (EU) 2022/1631 of 12 May 2022 amending, for

the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of lead in bismuth strontium calcium copper oxide

superconductor cables and wires and lead in their electrical connections, as

applicable from 1st March 2023.

Commission Delegated Directive (EU) 2022/1632 of 12 May 2022 amending, for

the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for the use of lead in certain magnetic resonance imaging devices, as

applicable from 1st March 2023.

Commission Delegated Directive (EU) 2023/171 of 28 October 2022 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 hexavalent chromium as an anticorrosion agent in gas absorption

heat pumps, as applicable from 1st September 2023.

Commission Delegated Directive (EU) 2023/1437 of 4 May 2023 amending, for

the purposes of adapting to scientific and technical progress, Annex IV to

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for mercury in melt pressure transducers for capillary rheometers under

certain conditions, as applicable from 1st February 2024.

Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for lead as a thermal stabilizer in polyvinyl chloride used as base

material in sensors used in in vitro diagnostic medical devices, as applicable from

1st February 2024.

Commission Delegated Directive (EU) 2024/232 of 25 October 2023 amending

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for cadmium and lead in plastic profiles in electrical and electronic

windows and doors containing recovered rigid polyvinyl chloride, as applicable

from 1st August 2024.

Commission Delegated Directive (EU) 2024/1416 of 13 March 2024 amending

Directive 2011/65/EU of the European Parliament and of the Council as regards an

exemption for cadmium in downshifting quantum dots directly deposited on LED

semiconductor chips, as applicable from 1st January 2025.