2020 No. 1647

Exiting The European Union
Environmental Protection

The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020

Made

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 8C of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20181.

In accordance with paragraphs 1(1) and 8F(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of this instrument has been laid before Parliament and approved by resolution of each House of Parliament.

PART 1Introduction

Citation, commencement and extent1

1

These Regulations may be cited as the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020.

2

This Part, and Part 5, come into force immediately before IP completion day.

3

Parts 2, 3 and 4, and Schedules 1 and 2, come into force on IP completion day.

4

Parts 2 and 3, and Schedules 1 and 2, extend to England and Wales and Scotland.

5

Part 4 extends to Northern Ireland.

PART 2Retention of legislative functions: restriction of hazardous substances in electrical and electronic equipment

Interpretation2

In this Part and in Schedule 1—

  • “the 2012 Regulations” means the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 20122;

  • “EEE” has the meaning given in regulation 4 of the 2012 Regulations, and a reference to a numbered category of EEE is a reference to the category of EEE so numbered in Schedule 1 to the 2012 Regulations;

  • “exemption” means an exemption, for a specified application of a specified material or component of EEE, from the restriction in regulation 3(1) of the 2012 Regulations on the use of certain hazardous substances in EEE;

  • “expiry date”, in relation to an exemption in Table 1 in Schedule A2 to the 2012 Regulations3, means the date specified in the sixth column of that table as the date on which, subject to regulation 5(8), the exemption expires;

  • “GB REACH” means Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)4;

  • “homogeneous material” has the meaning given in regulation 3(3) of the 2012 Regulations;

  • “restricted substance” means a substance listed in Schedule A1 to the 2012 Regulations5;

  • “the list of restricted substances” means the list of substances set out in Schedule A1 to the 2012 Regulations;

  • “waste” means any substance or object which the holder discards or intends or is required to discard.

Power to amend list of restricted substances and maximum concentration values3

1

The Secretary of State may, by regulations, make provision for or in connection with—

a

amending the list of restricted substances;

b

prescribing maximum concentration values by weight of restricted substances in homogeneous materials which may be contained in EEE placed on the market.

2

Regulations under paragraph (1) may only be made—

a

for the purpose of contributing to achievement of the objective of the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE, and taking account of the precautionary principle; and

b

following a review of the list of substances.

3

When carrying out a review of the list of substances or making regulations under paragraph (1), the Secretary of State must—

a

take into account other relevant legislation relating to chemicals, including among other things Annexes 14 and 17 to GB REACH, and use publicly available knowledge obtained from the application of such legislation;

b

take into account whether a substance, including substances of very small size or with a very small internal or surface structure, or a group of similar substances—

i

could have a negative impact during EEE waste management operations, including on the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE;

ii

could give rise, given its uses, to uncontrolled or diffuse release into the environment of the substance, or could give rise to hazardous residues, or transformation or degradation of products through the preparation for reuse, recycling or other treatment of materials from waste EEE under current operational conditions;

iii

could lead to unacceptable exposure of workers involved in the waste EEE collection or treatment processes;

iv

could be replaced by substitutes or alternative technologies which have less negative impacts.

Power to prescribe detailed rules for complying with maximum concentration values4

The Secretary of State may, by regulations, make provision for or in connection with prescribing detailed rules for complying with maximum concentration values.

Power to grant, extend or revoke exemptions5

1

The Secretary of State may, by regulations, amend Schedule A2 to the 2012 Regulations to make provision for or in connection with granting, renewing or revoking an exemption.

2

Regulations under paragraph (1) may only be made if they are for the purposes of—

a

adapting Schedule A2 to take into account scientific or technical progress; and

b

contributing to achievement of the objective of the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.

3

The Secretary of State must, when making regulations under paragraph (1)—

a

when determining whether to grant or renew an exemption, take into account the availability of substitute materials or components and the socioeconomic impact of substitution;

b

when determining the duration of an exemption, take into account any potential adverse impacts on innovation;

c

where relevant, take into account the overall environmental, social and economic impacts of an exemption over the whole duration of the exemption.

4

The regulations may not make any provision which the Secretary of State considers would weaken the environmental or health protection afforded by GB REACH.

5

The regulations may not grant or renew an exemption unless the Secretary of State considers that—

a

the elimination or substitution of the material or component, via design changes or use of materials or components which do not include any restricted substances, is scientifically or technically impracticable;

b

the reliability of substitute materials or components is not ensured; or

c

the total negative environmental, health and consumer safety impacts caused by substitution of another material or component is likely to outweigh the total environmental, health and consumer safety benefits of the substitution.

6

Subject to paragraph (9), regulations which grant or renew an exemption must specify its expiry date.

7

The expiry date must be not more than—

a

5 years from the date on which the exemption or renewal comes into force, for an exemption relating to EEE in category 1 to 7, 10 or 11;

b

7 years from the date on which the exemption or renewal comes into force, for an exemption relating to EEE in category 8 or 9.

8

The expiry date for an exemption is subject to—

a

any regulations which may be made by the Secretary of State to revoke the exemption from an earlier date, or to renew the exemption; and

b

the exemption continuing into force after its expiry date under regulation 6(4) or 7(4), or the expiry date not applying by virtue of regulation 10(3), where the circumstances specified in those paragraphs apply.

9

Regulations need not specify an expiry date for an exemption if the exemption is for spare parts for EEE manufactured before a date specified in the regulations.

10

The Secretary of State must make regulations to revoke an exemption if the Secretary of State considers that—

a

the exemption weakens the environmental or health protection afforded by GB REACH; or

b

the relevant condition in paragraph (5) is no longer fulfilled in relation to the exemption.

Applications for granting, renewing or revoking an exemption6

1

Subject to paragraph (5), a person specified in paragraph 1 of Schedule 1 may make an application to the Secretary of State for the granting, renewal or revocation of an exemption.

2

An application—

a

must be made in such form and manner as the Secretary of State may specify;

b

must include the information set out in paragraph 2 of Schedule 1; and

c

if the application is for the renewal of an exemption, must be made no later than 18 months before the exemption expires.

3

Where the Secretary of State receives an application in accordance with paragraphs (1) and (2), the Secretary of State must—

a

within one month, provide to the applicant—

i

an acknowledgement of receipt of the application; and

ii

an estimate of the time within which the Secretary of State will determine the application and, if applicable, the time within which the Secretary of State will make regulations to implement the determination;

b

publish a summary of the application;

c

consider, in particular, the matters referred to in paragraphs (2) to (5) of regulation 5;

d

consult such persons as the Secretary of State considers appropriate about the application; and

e

publish a summary of the responses to the consultation.

4

If an application is made under paragraph (1) for the renewal of an exemption in Table 1 of Schedule A2 to the 2012 Regulation, the expiry date for the exemption does not apply, and instead—

a

the exemption continues in force until the Secretary of State determines the application; and

b

thereafter regulation 7(3) or (4) applies.

5

No application may be made for the renewal of an exemption if—

a

the expiry date of the exemption is before 1st July 2022; or

b

regulation 10(2) applies.

Determinations7

1

When the Secretary of State determines whether to grant, renew or revoke an exemption, the Secretary of State must publish a summary of the determination and, if applicable, the date on which the exemption is to cease to apply.

2

If the determination is to grant or renew an exemption, or to revoke an exemption before its expiry date, the Secretary of State must make regulations under regulation 5 to give effect to the determination.

3

If the Secretary of State decides to renew an exemption, the exemption remains in force until the Secretary of State makes regulations to give effect to the determination.

4

If the Secretary of State decides—

a

not to renew an exemption; or

b

to revoke an exemption before its expiry date,

the exemption remains in force until such date as the Secretary of State determines, which must be not less than 12 months and not more than 18 months after the date on which the determination is made.

Consultation8

1

Before making any regulations under this Part, the Secretary of State must consult such persons as the Secretary of State considers appropriate.

2

The Secretary of State must publish a summary of the responses to a consultation under paragraph (1).

3

A consultation on regulations under regulation 3(1) must contain at least the following information—

a

precise and clear wording of any proposed restriction, or amendment of a restriction;

b

references and scientific evidence for the restriction, or amendment of a restriction;

c

information on the use of the substance, or the group of similar substances, in EEE;

d

information on detrimental effects and exposure, in particular during waste EEE management operations;

e

information on possible substitutes and other alternatives, and on their availability and reliability;

f

justification for the proposed provision being the most appropriate measure;

g

a socioeconomic assessment of the effect of the proposed provision.

4

Paragraph (1) does not apply—

a

to regulations under regulation 3(1) which are implementing a review of the list of restricted substances, if the Secretary of State has already consulted as part of that review, provided that such consultation satisfies the requirements in paragraph (3);

b

to regulations under regulation 5 if—

i

the Secretary of State has already consulted in accordance with regulation 6(3)(d) or 10(9) before deciding to make the regulations; or

ii

regulation 9(3)(b) or 10(8)(b) applies.

Transitional provision: new exemptions9

1

Paragraph (3) applies where—

a

the Secretary of State proposes, either on an application under regulation 6 or on the Secretary of State’s own initiative, to make regulations under regulation 5(1) granting an exemption (“the proposed exemption”); and

b

the conditions in paragraph (2) are satisfied in relation to the proposed exemption.

2

The conditions are that—

a

before IP completion day, an application has been made to the European Commission for an exemption to be granted under Article 5 of Directive 2011/65/EC;

b

on or after IP completion day, the European Commission publishes a decision to grant that exemption (“the EU exemption”); and

c

the proposed exemption has substantially the same effect as the EU exemption.

3

Where this paragraph applies—

a

the Secretary of State may treat the requirements in paragraphs (2) to (5) of regulation 5 as satisfied, without considering or determining any of those matters; and

b

the Secretary of State is not required to consult before determining the application (if any) or making the regulations.

Transitional provision: renewal of exemptions10

1

In this regulation—

a

a “relevant exemption” means an exemption in Table 1 in Schedule A2 to the 2012 Regulations (“the table”) in respect of which either—

i

in the entry in the table, in the column headed “expiry date or status”, it states “transitional case”6; or

ii

paragraph (i) does not apply but, before IP completion day, an application has been made to the European Commission for renewal of the corresponding EU exemption;

b

“the corresponding EU exemption”, in relation to an exemption in the table, means the exemption in Annex 3 or 4 to Directive 2011/65/EC with the number specified in the fourth column of the entry in the table for that exemption.

2

No application may be made to the Secretary of State for the renewal of a relevant exemption.

3

If an expiry date is specified in the entry in the table for a relevant exemption, that expiry date does not apply.

4

A relevant exemption remains in force until the Secretary of State makes a determination under paragraph (5) or (6), and thereafter regulation 7(3) or (4) applies.

5

The Secretary of State must determine whether or not to renew a relevant exemption if the European Commission has published a decision whether to renew the corresponding EU exemption.

6

Where, in relation to a relevant exemption, the European Commission has not published a decision whether to renew the corresponding EU exemption, the Secretary of State may, at any time, determine on the Secretary of State’s own initiative whether to renew the relevant exemption.

7

When making a determination under paragraph (5) or (6), the Secretary of State must take into account—

a

any publicly available information about the application for renewal of the corresponding EU exemption; and

b

if the European Commission has published its decision on that application, that decision.

8

Where the Secretary of State proposes to make a determination under paragraph (5) which has substantially the same effect as the European Commission’s decision in relation to the corresponding EU exemption—

a

the Secretary of State may treat the requirements in paragraphs (2) to (5) of regulation 5 as satisfied, without considering or determining any of those matters; and

b

the Secretary of State is not required to consult before making the determination, or (if the determination is to renew the exemption) before making any regulations to give effect to the determination.

9

Except where paragraph (8) applies, before making a determination under paragraph (5) or (6) the Secretary of State must consult such persons as the Secretary of State considers appropriate.

Regulations: general11

1

Regulations by the Secretary of State under this Part are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

2

Regulations under this Part may—

a

include consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

b

make different provision for different purposes.

PART 3Amendment of subordinate legislation: Great Britain

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 201212

1

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 are amended as follows.

2

In regulation 2—

a

in the definition of “the Directive”, for “Commission Delegated Directive (EU) 2019/178” substitute “Commission Delegated Directive (EU) 2019/1846”7, and read in accordance with regulation 2B”;

b

for the definition of “importer”, substitute—

  • “importer” means a person who is established in—

    1. a

      the United Kingdom, who places on the market EEE from a country outside of the United Kingdom; or

    2. b

      Northern Ireland, who places on the market EEE that has been supplied to that person for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

c

in the definitions of “make available on the market” and “place on the market”, for “on the EU market” substitute “on the market of Great Britain”;

3

In regulation 3—

a

in paragraph (1), for “Annex II to the Directive, as amended from time to time” substitute “Schedule A1”;

b

in paragraph (2), for “that Annex, as so amended” substitute “Schedule A1”;

c

in paragraph (4), for “Annex III and IV to the Directive, as amended from time to time” substitute “Schedule A2”.

4

In regulation 14, in paragraph (5), omit “in the United Kingdom”.

5

In regulation 16, for paragraph (2) substitute—

2

The UK marking must be affixed to—

a

the EEE;

b

a data plate affixed to the EEE; or

c

where paragraph (2A) applies—

i

a label affixed to the EEE; or

ii

a document accompanying the EEE.

2A

This paragraph applies to EEE that is placed on the market within a period of 24 months beginning with IP completion day.

6

In regulation 24, for paragraph (2) substitute—

2

Paragraph (1) does not apply where—

a

either—

i

it is not possible to set out the information referred to in paragraph (1) on the EEE; or

ii

the importer has imported the EEE from the EU and places it on the market within the period of 24 months beginning with IP completion day; and

b

before placing the EEE on the market, the importer sets out the information referred to in paragraph (1) on the packaging of the EEE or in a document accompanying the EEE.

7

After regulation 34A8, insert—

Expiry of regulation 34A34B

1

Subject to paragraphs (2) and (3), regulation 34A ceases to have effect at the end of the period of 12 months beginning with IP completion day.

2

Notwithstanding the expiry of regulation 34A—

a

any EEE which was placed on the market pursuant to regulation 34A may continue to be made available on the market on or after the expiry of regulation 34A;

b

any obligation to which a person was subject in respect of EEE placed on the market pursuant to regulation 34A continues to have effect after the expiry of regulation 34A, in respect of that EEE.

3

Regulation 34A continues to apply to EEE that—

a

was available on the market in the EU prior to IP completion day; and

b

is placed on the market on or after IP completion day.

4

Where EEE is placed on the market pursuant to paragraph (3), regulation 24(1) does not apply where—

a

the importer has imported the EEE from the EU; and

b

before placing the product on the market, the importer sets out the information referred to in regulation 24(1) in a document accompanying the EEE.

Qualifying Northern Ireland goods34C

1

Where paragraph (2) applies, EEE is to be treated as being in conformity with these Regulations.

2

This paragraph applies where—

a

the goods which are EEE—

i

are in conformity with these Regulations as they apply in Northern Ireland; and

ii

are qualifying Northern Ireland goods; and

b

an importer has complied with the obligations set out in paragraph (3).

3

The obligations referred to in paragraph (2)(b) are that, before placing the EEE on the market, the importer—

a

complies with regulation 21; and

b

ensures that the manufacturer has done all of the following in relation to the EEE, in accordance with these Regulations as they apply in Northern Ireland—

i

carried out the conformity assessment procedure in accordance with regulation 12(1);

ii

drawn up the technical documentation; and

iii

affixed the CE marking.

4

For the purposes of this regulation—

a

“in conformity with these Regulations” means, in relation to EEE, that—

i

the EEE is not prohibited by regulation 3 from being placed on the market; and

ii

each person who has obligations under this Part in respect of the EEE has complied, or is complying, with those obligations;

b

“CE marking” and “technical documentation” have the meanings given in regulation 2 of these Regulations as they apply in Northern Ireland;

c

“qualifying Northern Ireland goods” has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

8

Before Schedule 1, insert Schedules A1 and A2 as set out in Schedule 2 to these Regulations.

The Packaging (Essential Requirements) Regulations 201513

1

The Packaging (Essential Requirements) Regulations 20159 are amended as follows.

2

After regulation 6 insert—

Qualifying Northern Ireland Goods6A

1

Where paragraph (2) applies, packaging is to be treated as being in conformity with these Regulations.

2

This paragraph applies where—

a

the packaging—

i

is in conformity with these Regulations as they apply in Northern Ireland; and

ii

is a qualifying Northern Ireland good.

3

For the purposes of this regulation—

a

“in conformity with these Regulations” means, in relation to packaging, that—

i

the packaging is not prohibited by regulation 4 or 5 from being placed on the market; and

ii

the responsible person has complied, or is complying, with any obligations under this Part in respect of the packaging;

b

“qualifying Northern Ireland goods” has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

PART 4Amendment of subordinate legislation: Northern Ireland

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 201214

1

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 are amended as follows.

2

In regulation 2—

a

in the definition of “CE marking” after “RAMS” insert “as amended from time to time before or after IP completion day”;

b

in the definition of “the Directive” for “Commission Delegated Directive (EU) 2019/178” substitute “Commission Delegated Directive 2019/1846”;

c

in the definition of “importer”—

i

for “within the EU” substitute “in a relevant state”;

ii

for “EU market” substitute “relevant market”;

d

in the following definitions for “EU” substitute “relevant”—

i

“make available on the market”;

ii

“place on the market”;

e

after the definition of “recall notice” insert—

  • “relevant market” means the market comprised of the market in Northern Ireland and the markets of the EEA states;

  • “relevant state” means Northern Ireland or any EEA state;

3

In regulation 3, in paragraphs (1) and (4), at the end insert “before or after IP completion day”.

4

In regulation 14, omit paragraph (4).

5

In regulations 20(b), 26(2)(b) and 30(2)(b), for “member States” substitute “relevant states”.

6

In regulation 22(1), for “the EU” substitute “a relevant state”.

7

In regulation 29, in paragraph (1)(b), for “Member State” substitute “relevant state”.

8

In regulation 42—

a

omit paragraphs (1) and (2);

b

in paragraph (5), omit “(or in Scotland, the Lord Advocate)”.

9

In regulation 43(2), omit the words from “(in England” to “(in Scotland)”.

10

In regulation 46(2), omit “other”.

11

In Schedule 1, in paragraph 12, after “security of” insert “the United Kingdom or”.

The Packaging (Essential Requirements) Regulations 201515

1

The Packaging (Essential Requirements) Regulations 2015 are amended as follows.

2

In regulation 2(1)—

a

in the definition of “importer” for “the United Kingdom” substitute “Northern Ireland”;

b

in the definition of “responsible person”, in sub-paragraph (e), after “in” insert “Northern Ireland or”.

3

In regulation 3(5), for the words from “provisions” to the end, substitute “provisions of the Hazardous Waste Regulations (Northern Ireland) 200510”.

4

In regulations 4(1) and 5(1), after “on the” insert “Northern Ireland or”.

5

In regulation 7(1), omit sub-paragraph (a).

6

In regulation 9—

a

in paragraph (1)(a)—

i

omit paragraph (i);

ii

in paragraph (ii), omit “Scotland or”;

b

in paragraph (1)(b), omit “Scotland or”;

c

in paragraph (2)—

i

omit sub-paragraph (a);

ii

in sub-paragraph (b), omit “Scotland or”.

7

In regulation 10(2), omit the words from “(in England” to “(in Scotland)”.

8

In regulation 12(2), omit “other”.

9

In Schedule 2—

a

in paragraph 2(1)(b) and 2(2), after “established in” insert “Northern Ireland or”;

b

in paragraph 2(2), for “within” substitute “in Northern Ireland or”.

10

In Schedule 3, in paragraph 2(1), for “within” substitute “in Northern Ireland or”.

11

In Schedule 4—

a

in paragraph (1)—

i

in sub-paragraph (c), omit “in England and Wales, and Northern Ireland,”;

ii

omit sub-paragraph (d).

PART 5Amendment of EU Exit legislation

The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 201916

1

The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 201911 are amended as follows.

2

In regulation 18(2), omit sub-paragraphs (c), (e) and (f).

The Waste (Miscellaneous Amendments) (EU Exit) Regulations 201917

1

The Waste (Miscellaneous Amendments) (EU Exit) Regulations 201912 are amended as follows.

2

In regulation 14—

a

in paragraph (2), in paragraph 2(a) of the inserted Article A1—

i

for “Community” substitute “the Community”;

ii

for “United Kingdom” substitute “Great Britain”;

b

in paragraph (5)(b)(i)—

i

for “European” substitute “the European”;

ii

for “United Kingdom” substitute “Great Britain”.

3

In regulation 16—

a

in paragraph (4)(c)(ii)(aa)—

i

for “Community” substitute “the Community”;

ii

for “United Kingdom” substitute “Great Britain”;

b

in paragraph (6)(b)(ii), for “the United Kingdom” substitute “Great Britain”.

Rebecca PowParliamentary Under Secretary of StateDepartment for Environment, Food and Rural Affairs

SCHEDULE 1Restriction of hazardous substances: applications for an exemption

Regulation 6

1

An application for an exemption, the renewal of an exemption, or the revocation of an exemption may be submitted by a manufacturer, the authorised representative of a manufacturer, or any economic operator in the supply chain.

2

An application must include—

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 renewal or revocation, is requested and its particular characteristics;

c

verifiable and referenced justification for an exemption, or its renewal or revocation, in line with the conditions in regulation 5;

d

an analysis of possible alternative substances, materials or designs, 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 EEE, and on the appropriate treatment of waste;

f

any other information held by or known to the applicant that is relevant to the application;

g

the proposed actions to develop, request the development or 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, a proposal for clear and precise wording for the exemption;

j

a summary of the application.

3

In paragraph 1, “authorised representative”, “economic operator” and “manufacturer” have the meanings given in regulation 2 of the 2012 Regulations.

SCHEDULE 2Schedules A1 and A2 to the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

Regulation 12

SCHEDULE A1Restricted substances referred to in regulation 3 and maximum concentration values tolerated by weight in homogeneous materials

Regulation 3

  • Lead (0.1%)

  • Mercury (0.1%)

  • Cadmium (0.1%)

  • Hexavalent chromium (0.1%)

  • Polybrominated biphenyls (PBB) (0.1%)

  • Polybrominated diphenyl ethers (PBDE) (0.1%)

  • Bis (2-ethylexyl) 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 does not apply to—

    1. a

      medical devices, including in vitro medical devices;

    2. b

      monitoring and control instruments, including industrial monitoring and control instruments;

    3. c

      cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22nd July 2019.

  • The restriction of DEHP, BBP and DBP does not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex 17 to Regulation (EC) No 1907/200613.

SCHEDULE A2Applications exempted from the restriction in regulation 3(1)

Regulation 3

The tables of exempted applications1

In this Schedule—

a

Table 1 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in EEE, other than exemptions for applications for spare parts for EEE;

b

Table 2 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in spare parts for EEE.

Interpretation of the tables

2

The following provisions apply for the purposes of interpreting Tables 1 and 2.

3

In Table 1, in the column headed “corresponding EU exemption”, a reference to a numbered Annex, followed by another number, is a reference to the exemption with that number in that Annex to Directive 2011/65/EU.

4

In Tables 1 and 2, in the column headed “categories of EEE to which exemption applies”, the entries indicate the categories of EEE to which an exemption applies, as follows—

a

a number from 1 to 11, which is not followed by any letters, means the category of EEE with that number in Part 1 of Schedule 1;

b

“8iv” and “8x” are sub-categories of category 8 (medical devices) with the following meanings—

i

8iv means in vitro diagnostic medical devices;

ii

8x means medical devices, other than in vitro diagnostic medical devices;

c

“9ind” and “9x” are sub-categories of category 9 (monitoring and control instruments) with the following meanings—

i

9ind means industrial monitoring and control instruments;

ii

9x means monitoring and control instruments, other than for industrial use.

5

In Table 1, in the column headed “expiry date or status”—

a

a date, in relation to an exemption and a category of EEE, is the expiry date of the exemption for that category of EEE, that is, the date on which the exemption expires subject to regulation 5(8) of the 2020 Regulations;

b

“transitional case”, in relation to an exemption and a category of EEE, means that the exemption for that category of EEE is a transitional case for the purposes of regulation 10 of the 2020 Regulations.

6

For the purposes of entries 1 to 9 in Table 1 (entries related to lighting) a lamp is for “general lighting purposes” if it is designed for the purpose of illuminating a room or space in order to provide or improve visibility, and it is for “special purposes” if it is designed for any other purpose.

7

In paragraph 5, “the 2020 Regulations” means the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020.

Table 1Table of exempted applications

No.

Application

Maximum quantity exempted (if any)

Corresponding EU exemption

Categories of EEE to which exemption applies

Expiry date or status

1

Mercury in single capped (compact) fluorescent lamps:

1.1

For general lighting purposes < 30 W

2.5 mg per burner

Annex 3, 1(a)

all categories

transitional case

1.2

For general lighting purposes ≥ 30 W and < 50 W

3.5 mg per burner

Annex 3, 1(b)

all categories

transitional case

1.3

For general lighting purposes ≥ 50 W and < 150 W

5 mg per burner

Annex 3, 1(c)

all categories

transitional case

1.4

For general lighting purposes ≥ 150 W

15 mg per burner

Annex 3, 1(d)

all categories

transitional case

1.5

For general lighting purposes with circular or square structural shape and tube diameter ≤ 17 mm

7 mg per burner

Annex 3, 1(e)

all categories

transitional case

1.6

For special purposes

5 mg per burner

Annex 3, 1(f)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

1.7

For general lighting purposes < 30 W with a lifetime equal or above 20,000 h

3.5 mg per burner

Annex 3, 1(g)

all categories

transitional case

2

Mercury in double-capped linear fluorescent lamps for general lighting purposes:

2.1

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter < 9 mm (e.g. T2)

4 mg per lamp

Annex 3, 2(a)(1)

all categories

transitional case

2.2

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5)

3 mg per lamp

Annex 3, 2(a)(2)

all categories

transitional case

2.3

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 17 mm and ≤ 28 mm (e.g. T8)

3.5 mg per lamp

Annex 3, 2(a)(3)

all categories

transitional case

2.4

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 28 mm (e.g. T12)

3.5 mg per lamp

Annex 3, 2(a)(4)

all categories

transitional case

2.5

Tri-band phosphor with long lifetime (≥ 25,000 h)

5 mg per lamp

Annex 3, 2(a)(5)

all categories

transitional case

3

Mercury in other fluorescent lamps:

3.1

Non-linear tri-band phosphor lamps with tube diameter > 17 mm (e.g. T9).

15 mg per lamp

Annex 3, 2(b)(3)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

3.2

Lamps for other general lighting and special purposes (e.g. induction lamps).

15 mg per lamp

Annex 3, 2(b)(4)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

4

Mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFL and EEFL) for special purposes:

4.1

Short length (≤ 500 mm)

3.5 mg per lamp

Annex 3, 3(a)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

4.2

Medium length (> 500 mm and ≤ 1500 mm)

5 mg per lamp

Annex 3, 3(b)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

4.3

Long length (> 1500 mm)

13 mg per lamp

Annex 3, 3(c)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

5

Mercury in other low pressure discharge lamps.

15 mg per lamp

Annex 3, 4(a)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

6

Mercury in High Pressure Sodium (vapour) lamps for general lighting purposes in lamps with improved colour rendering index Ra > 60:

6.1

P ≤ 155 W

30 mg per burner

Annex 3, 4(b)-I

all categories

transitional case

6.2

155 W < P ≤ 405 W

40 mg per burner

Annex 3, 4(b)-II

all categories

transitional case

6.3

P > 405 W

40 mg per burner

Annex 3, 4(b)-III

all categories

transitional case

7

Mercury in other High Pressure Sodium (vapour) lamps for general lighting purposes:

7.1

P ≤ 155 W

25 mg per burner

Annex 3, 4(c)-I

all categories

transitional case

7.2

155 W < P ≤ 405 W

30 mg per burner

Annex 3, 4(c)-II

all categories

transitional case

7.3

P > 405 W

40 mg per burner

Annex 3, 4(c)-III

all categories

transitional case

8

Mercury in metal halide lamps.

Annex 3, 4(e)

1–7, 10

transitional case

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

9

Mercury in other discharge lamps for special purposes not specifically mentioned in another entry in this Table.

Annex 3, 4(f)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

10

Lead in glass of cathode ray tubes.

Annex 3, 5(a)

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

11

Lead in glass of fluorescent tubes.

0.2% lead by weight

Annex 3, 5(b)

1–7, 10

transitional case

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

12

Lead as an alloying element in steel for machining purposes and in galvanised steel.

0.35% lead by weight

Annex 3, 6(a)

8, 9

transitional case

11

21st July 2024

13

Lead as an alloying element in steel for machining purposes.

0.35% lead by weight

Annex 3, 6(a)-I

1-7, 10

transitional case

14

Lead as an alloying element in batch hot dip galvanised steel components.

0.2% lead by weight

Annex 3, 6(a)-I

1-7, 10

transitional case

15

Lead as an alloying element in aluminium.

0.4% lead by weight

Annex 3, 6(b)

8, 9

transitional case

11

21st July 2024

16

Lead as an alloying element in aluminium, provided it stems from lead-bearing aluminium scrap recycling.

0.4% lead by weight

Annex 3, 6(b)-I

1-7, 10

transitional case

17

Lead as an alloying element in aluminium for machining purposes.

0.4% lead by weight

Annex 3, 6(b)-II

1-7, 10

transitional case

18

Copper alloy containing lead.

4% lead by weight

Annex 3, 6(c)

1-10

transitional case

11

21st July 2024

19

Lead in high melting temperature type solders, i.e. lead-based alloys containing 85% by weight or more lead.

This entry does not apply to applications covered by entry 42.

Annex 3, 7(a)

1-10

transitional case

11

21st July 2024

20

Lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission, and network management for telecommunications.

Annex 3, 7(b)

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

21

Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound.

This entry does not apply to applications covered by entry 49.

Annex 3, 7(c)-I

1-10

transitional case

11

21st July 2024

22

Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher.

This entry does not apply to applications covered by entry 21 or 23.

Annex 3, 7(c)-II

1 – 10

transitional case

11

21st July 2024

23

Lead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors.

Annex 3, 7(c)-IV

1-7, 8x, 9x, 10

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

24

Cadmium and its compounds in electrical contacts.

Annex 3, 8(b)

8, 9

transitional case

11

21st July 2024

25

Cadmium and its compounds in electrical contacts used in:

— circuit breakers,

— thermal sensing controls,

— thermal motor protectors (excluding hermetic thermal motor protectors),

— AC switches rated at:

  1. a

    6 A and more at 250 V AC and more, or

  2. b

    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.

Annex 3, 8(b)-I

1-7, 10

transitional case

26

Hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75 % by weight in the cooling solution.

Annex 3, 9

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

27

Lead in bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications.

Annex 3, 9(b)

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

28

Lead in white glasses used for optical applications.

Annex 3, 13(a)

all categories

transitional case

29

Cadmium and lead in filter glasses and glasses used for reflectance standards.

Annex 3, 13(b)

8, 9, 11

transitional case

30

Lead in ion coloured optical filter glass types.

Annex 3, 13(b)-(I)

1-7, 10

transitional case

31

Cadmium in striking optical filter glass types.

Annex 3, 13(b)-(II)

1-7, 10

transitional case

32

Cadmium and lead in glazes used for reflectance standards.

Annex 3, 13(b)-(III)

1-7, 10

transitional case

33

Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages.

Annex 3, 15

8, 9

transitional case

11

21st July 2024

34

Lead in solders to complete a viable electrical connection between the semiconductor die and carrier within integrated circuit flip chip packages where at least one of the following criteria applies:

— a semiconductor technology node of 90 nm or larger;

— a single die of 300 mm² or larger in any semi-conductor technology node;

— stacked die packages with die of 300 mm² or larger, or silicon interposers of 300mm2 or larger.

Annex 3, 15(a)

1–7, 10

transitional case

35

Lead halide as radiant agent in high intensity discharge (HID) lamps used for professional reprography applications.

Annex 3, 17

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

36

Lead as activator in the fluorescent powder of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used as sun tanning lamps.

1% lead by weight or less

Annex 3, 18(b)

1–7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

37

Lead as activator in the fluorescent powder of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipment.

This entry does not apply to applications covered by entry 88.

1% lead by weight or less

Annex 3, 18(b)-I

5, 8

transitional case

38

Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses.

Annex 3, 21

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

39

Cadmium when used in colour printed glass to provide filtering functions, used as a component in lighting applications installed in displays and control panels of EEE.

Annex 3, 21(a)

1–7, 10

21st July 2021

40

Cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses.

Annex 3, 21(b)

1–7, 10

21st July 2021

41

Lead in printing inks for the application of enamels on other than borosilicate glasses.

Annex 3, 21(c)

1–7, 10

21st July 2021

42

Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors.

Annex 3, 24

1–10

transitional case

11

21st July 2024

43

Lead oxide in surface conduction electron emitter displays (SED) used in structural elements, notably in the seal frit and frit ring.

Annex 3, 25

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

44

Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC(1).

Annex 3, 29

1–7, 10, 11

transitional case

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

45

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.

Annex 3, 30

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

46

Lead in soldering materials in mercury free flat fluorescent lamps (which e.g. are used for liquid crystal displays, design or industrial lighting).

Annex 3, 31

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

47

Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes.

Annex 3, 32

1–7, 8x, 9, 10

transitional case

8iv

21st July 2023

11

21st July 2024

48

Lead in solders for the soldering of thin copper wires of 100 μm diameter and less in power transformers.

Annex 3, 33

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

49

Lead in cermet-based trimmer potentiometer elements.

Annex 3, 34

1–10

transitional case

11

21st July 2024

50

Lead in the plating layer of high voltage diodes on the basis of a zinc borate glass body.

Annex 3, 37

1–7, 8x, 9x, 10

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

51

Cadmium and cadmium oxide in thick film pastes used on aluminium bonded beryllium oxide.

Annex 3, 38

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

52

Cadmium selenide in downshifting cadmium-based semiconductor nanocrystal quantum dots for use in display lighting applications (< 0.2 μg Cd per mm² of display screen area).

Annex 3, 39(a)

all categories

transitional case

53

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, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (category NRSh in Regulation (EU) 2016/1628 of the European Parliament and of the Council(2)).

Annex 3, 41

1–7, 10, 11

31st March 2022

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

54

Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment:

— with engine total displacement ≥ 15 litres; or

— with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications.

This entry does not apply to applications covered by entry 18.

Annex 3, 42

8x, 9x

transitional case

11

21st July 2024

55

Bis(2-ethylhexyl) phthalate in rubber components in engine systems, 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.

This entry applies where the concentration value of bis(2-ethylhexyl) phthalate does not exceed:

30 % by weight of the rubber for:

gasket coatings;

solid-rubber gaskets; or

rubber components included in assemblies of at least three components using electrical, mechanical or hydraulic energy to do work, and attached to the engine.

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.

Annex 3, 43

9ind

15th July 2023

11

21st July 2024

56

Lead in solder of sensors, actuators, and engine control units of 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.

Annex 3, 44

11

21st July 2024

57

Lead, cadmium and mercury in detectors for ionising radiation.

Annex 4, 1

8x, 9x, 9ind

transitional case

8iv

21st July 2023

58

Lead bearings in X-ray tubes.

Annex 4, 2

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

59

Lead in electromagnetic radiation amplification devices:

micro-channel plate and capillary plate.

Annex 4, 3

8, 9

transitional case

60

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.

Annex 4, 4

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

61

Lead in shielding for ionising radiation.

Annex 4, 5

8x, 9

transitional case

8iv

21st July 2023

62

Lead in X-ray test objects.

Annex 4, 6

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

63

Lead stearate X-ray diffraction crystals.

Annex 4, 7

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

64

Radioactive cadmium isotope source for portable X-ray fluorescence spectrometers.

Annex 4, 8

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

65

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

Annex 4, 1a

8x, 9

transitional case

8iv

21st July 2023

66

Lead anodes in electrochemical oxygen sensors.

Annex 4, 1b

8x, 9

transitional case

8iv

21st July 2023

67

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

Annex 4, 1c

8, 9

transitional case

68

Mercury in reference electrodes: low chloride mercury chloride, mercury sulphate and mercury oxide.

Annex 4, 1d

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

69

Cadmium in helium-cadmium lasers.

Annex 4, 9

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

70

Lead and cadmium in atomic absorption spectroscopy lamps.

Annex 4, 10

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

71

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

Annex 4, 11

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

72

Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors.

Annex 4, 12

8x, 9

transitional case

8iv

30th June 2021

73

Lead in counterweights.

Annex 4, 13

8x, 9x

transitional case

38iv

21st July 2023

9ind

21st July 2024

74

Lead in single crystal piezoelectric materials for ultrasonic transducers.

Annex 4, 14

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

75

Lead in solders for bonding to ultrasonic transducers.

Annex 4, 15

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

76

Mercury in very high accuracy capacitance and loss measurement bridges and in high frequency RF switches and relays in monitoring and control instruments.

20mg of mercury per switch or relay

Annex 4, 16

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

77

Lead in solders in portable emergency defibrillators.

Annex 4, 17

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

78

Lead in solders of high performance infrared imaging modules to detect in the range 8-14 μm.

Annex 4, 18

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

79

Lead in liquid crystal on silicon (LCoS) displays.

Annex 4, 19

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

80

Cadmium in X-ray measurement filters.

Annex 4, 20

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

81

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.

Annex 4, 22

8, 9

30th June 2021

82

Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation.

Annex 4, 23

8, 9

30th June 2021

83

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.

Annex 4, 25

8, 9

30th June 2021

84

Lead in the following applications that are used durably at a temperature below –20 °C under normal operating and storage conditions:

  1. a

    solders on printed circuit boards;

  2. b

    termination coatings of electrical and electronic components and coatings of printed circuit boards;

  3. c

    solders for connecting wires and cables;

  4. 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.

Annex 4, 26

8x, 9

transitional case

8iv

30th June 2021

85

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:

  1. a

    magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or

  2. b

    magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.

Annex 4, 27

8, 9x

transitional case

86

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 or in industrial monitoring and control instruments.

Annex 4, 29

8x

transitional case

8iv, 9ind

30th June 2021

87

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.

Annex 4, 31a

8, 9x

transitional case

9ind

21st July 2024

88

Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors.

Annex 4, 34

8, 9

22nd July 2021

89

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.

Annex 4, 35

9ind

21st July 2024

90

Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:

  1. a

    wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0.1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations;

  2. 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:

    1. i

      solutions with an acidity < pH 1;

    2. ii

      solutions with an alkalinity > pH 13;

    3. iii

      corrosive solutions containing halogen gas;

  3. c

    measurements of conductivities above 100 mS/m that must be performed with portable instruments.

Annex 4, 37

8, 9

31st December 2025

91

Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:

  1. a

    a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable;

  2. b

    a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies:

    1. i

      a response time shorter than 25 ns;

    2. ii

      a sample detection area larger than 149 mm² ;

    3. iii

      a multiplication factor larger than 1.3 × 10³ .

  3. c

    a response time shorter than 5 ns for detecting electrons or ions;

  4. d

    a sample detection area larger than 314 mm² for detecting electrons or ions;

  5. e

    a multiplication factor larger than 4.0 × 107.

Annex 4, 39

8, 9

transitional case

92

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.

Annex 4, 41

8iv

31st March 2022

93

Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.

Annex 4, 42

8x, 9x

transitional case

94

Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required.

Annex 4, 43

9ind

15th July 2023

95

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.

Annex 4, 44

8x, 9

31st March 2027

(1)

OJ No L 326, 19.12.1969, p.36, as last amended by Council Directive 2006/96/EC (OJ No L 363, 20.12.2006, p.81).

(2)

EUR 2016/1628.

Table 2Table of exemptions for spare parts for EEE with no expiry date

No.

Application

Categories of EEE to which exemption applies

1

Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, where used in spare parts for EEE placed on the market before 1st January 2013.

all categories

2

Cadmium and its compounds in one shot pellet type thermal cut-offs, where used in spare parts for EEE placed on the market before 1st January 2012.

all categories

3

Lead used in C-press compliant pin connector systems, where used in spare parts for EEE placed on the market before 24th September 2010.

all categories

4

Lead used in other than C-press compliant pin connector systems, where used in spare parts for EEE placed on the market before 1st January 2013.

all categories

5

Lead as a coating material for the thermal conduction module C-ring, where used in spare parts for EEE placed on the market before 24th September 2010.

all categories

6

Lead in solders consisting of more than two elements for the connection between the pins and the package of microprocessors with a lead content of more than 80% and less than 85% by weight, where used in spare parts for EEE placed on the market before 1st January 2011.

all categories

7

Lead in finishes of fine pitch components other than connectors with a pitch of 0.65 mm and less, where used in spare parts for EEE placed on the market before 24th September 2010.

all categories

8

Cadmium in phosphor coatings in image intensifiers for X-ray images, in spare parts for X-ray systems placed on the market before 1st January 2020.

8, 9

9

Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers, where used in spare parts for X-ray systems placed on the market before 1st January 2020.

8, 9

10

Lead used in other than C-press compliant pin connector systems, where used in spare parts for industrial monitoring and control instruments placed on the market before 1st January 2021.

9ind

11

Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, where used in spare parts for industrial monitoring and control instruments placed on the market before 1st January 2021.

9ind

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(f)) arising from the withdrawal of the United Kingdom from the European Union. They are also made in exercise of the powers conferred by section 8C of that Act to implement, and deal with matters arising out of or related to, the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement (“the NI Protocol”).

Part 2 provides for legislative and administrative functions of the European Commission under Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) (“the RoHS Directive”) to be exercisable instead by the Secretary of State in relation to England and Wales and Scotland.

Part 3 amends the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (“the RoHS Regulations”) and the Packaging (Essential Requirements) Regulations 2015 (“the Packaging Regulations”) as they apply in England and Wales and Scotland, and Part 4 amends the RoHS Regulations and the Packaging Regulations as they apply in Northern Ireland.

In Part 3, regulation 12(8) inserts new Schedules, as set out in Schedule 2 to these Regulations, in the RoHS Regulations. Schedule A2 contains tables of exemptions from the restriction in regulation 3(1) of the RoHS Regulations, thereby setting out in the domestic law of England and Wales and Scotland exemptions corresponding to those in Annexes 3 and 4 of the RoHS Directive.

The rest of the amendments in Parts 3 and 4 are principally to take account of the NI Protocol.

Part 5 makes minor amendments to provisions of two other EU Exit Regulations, which amend the RoHS Regulations and two Commission Decisions relating to packaging.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.