Study to assess requests for 29
renewal requests concerning one
specific EEE category and two (-2-)
new exemption requests under the
Directive 2011/65/EU
Under the Framework Contract No ENV.B.3/FRA/2019/0017:
Assistance to the Commission on technical, socio-economic andcost-benefit assessments related to the implementation andfurther development of EU waste legislation

Final Report

May 2024

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU
Prepared by Fraunhofer-Institute for Reliability and Microintegration (IZM), the United Nations Institutefor Training and Research (UNITAR), and BIO Innovation Services (Bio IS)
Dr. Otmar Deubzer, Fraunhofer IZM and UNITAR
Chris Eckstein, Fraunhofer IZM
Alexandra Morozow, Fraunhofer IZM
Christian Clemm, UNITARElena D’Angelo, UNITARElena Fernandez, UNITAR
Vittoria Luda, UNITAR
Shailendra Mudgal, Bio IS
30 May 2024

United Nations Institute for Training and Research (UNITAR) Bonn Office
UN Campus, Platz der Vereinten Nationen 1, 53113 Bonn, Germany
E-Mail: otmar.deubzer@unitar.org
Web: https://unitar.org/about/offices-training-centres-around-world/bonn
Fraunhofer IZM
Gustav-Meyer-Allee 25
13355 Berlin, Germany
Tel: +49 30 46403 157
E-Mail: otmar.deubzer@izm.fraunhofer.de
Web: www.fraunhofer.de
BIO Innovation Service
7 rue Oberkampf
75011 Paris (France)
Tel: +33 662 767 565
Fax: +33 95 72 12 598
Email: contact@biois.eu

Acknowledgements
We would like to express our gratitude towards stakeholders who contributed information concerning therequests for exemptions handled during this project.
Disclaimer
Bio Innovation Services, Fraunhofer IZM and UNITAR have taken due care in the preparation of this report toensure that all facts and analysis presented are as accurate as possible within the scope of the project.
However, no guarantee is provided in respect of the information presented, and Bio Innovation Services,
Fraunhofer IZM and UNITAR are not responsible for decisions or actions taken based on the content of thisreport.

EUROPEAN COMMISSION
Directorate-General for Environment
Directorate B — Circular Economy
Unit [B3 — Waste to Resources
Contact: Hendrik Engelkamp
E-mail: ENV-ROHS@ec.europa.eu
European Commission
B-1040 Brussels

3Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

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4Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Table of Contents
SUMMARY – ENGLISH ........................................................................................... 26
1.1.

Background and objectives .......................................................................... 26

1.2.

Key findings – Overview of the evaluation results ........................................... 27

NOTE DE SYNTHÈSE : FRANÇAIS ........................................................................... 34
2.1.

Contexte et objectifs ................................................................................... 34

2.2.

Principales conclusions - Aperçu des résultats de l'évaluation ........................... 35

INTRODUCTION ................................................................................................... 42
3.1.

Project scope ............................................................................................. 42

3.2.

Overview: Links between the RoHS Directive and the REACH Regulation ........... 45

SPECIFIC REACH-RELATED INFORMATION FOR SUBSTANCES OF RELEVANCE FOR
THE EXEMPTION REQUESTS OF THIS REVIEW ......................................................... 48
4.1.

Cadmium ................................................................................................... 48

4.2.

Lead

4.3.

Mercury ................................................................................................... 54

4.4.

DEHP

................................................................................................... 51................................................................................................... 55

EXEMPTION 6(A)-SERIES OF ANNEX III: LEAD AS ALLOYING ELEMENT IN STEEL ........ 57
Declaration ......................................................................................................... 57
Acronyms ........................................................................................................... 57
5.1.

Background and technical information ........................................................... 58

5.1.1.
5.1.2.
5.1.3.
5.1.4.
5.1.5.
5.2.

Justification of the requested exemption ........................................................ 63

5.2.1.
5.2.2.
5.2.3.
5.3.

REACH compliance – Relation to the REACH Regulation ............. 66
Substitution and elimination of the restricted substance ................... 67
Environmental, health, safety and socioeconomic impacts ............... 68
Contributions to the stakeholder consultation ................................... 69
Summary and conclusions ................................................................. 70

Recommendation ........................................................................................ 71

5.4.1.
5.5.

Substitution and elimination of the restricted substance ................... 64
Environmental, health, safety and socioeconomic impacts ............... 65
Roadmap towards substitution or elimination of the restricted
substance ........................................................................................... 66

Critical review ............................................................................................ 66

5.3.1.
5.3.2.
5.3.3.
5.3.4.
5.3.5.
5.4.

History of the exemption ................................................................... 59
Focus of the review of this renewal request ...................................... 59
Summary of the requested exemption ............................................... 60
Technical description of the exemption and use of the restricted
substance ........................................................................................... 61
Amount(s) of restricted substance(s) used under the exemption ...... 63

Applicants’ feedback on the recommendation .................................. 72

References ................................................................................................. 73

EXEMPTION 6(B)-SERIES OF ANNEX III: LEAD IN ALUMINIUM ALLOYS ....................... 75

5

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU
Declaration .......................................................................................................... 75
Acronyms............................................................................................................ 75
6.1.

Background and technical information ........................................................... 76

6.1.1.
6.1.2.
6.1.3.
6.1.4.
6.1.5.
6.2.

Justification of the requested exemption ........................................................ 81

6.2.1.
6.2.2.
6.2.3.
6.3.

History of the exemption ................................................................... 77
Focus of the review of this renewal request ...................................... 78
Summary of the requested exemption ............................................... 79
Technical description of the exemption and use of the restricted
substance ........................................................................................... 80
Amount(s) of restricted substance(s) used under the exemption ...... 80
Substitution and elimination of the restricted substance ................... 81
Environmental, health, safety and socio-economic impacts ............. 82
Roadmap towards substitution or elimination of the restricted
substance ........................................................................................... 83

Critical review ............................................................................................ 86

6.3.1.
6.3.2.
6.3.3.
6.3.4.
6.3.5.

REACH compliance – Relation to the REACH Regulation ............. 86
Substitution and elimination of the restricted substance ................... 86
Environmental, health, safety and socio-economic impacts ............. 92
Stakeholder contributions .................................................................. 92
Summary and conclusions ................................................................. 93

6.4.

Recommendation ........................................................................................ 95

6.5.

References ................................................................................................. 97

EXEMPTION 7(A) OF ANNEX III: LEAD IN HIGH MELTING TEMPERATURE TYPESOLDERS .......................................................................................................... 100
Declaration ....................................................................................................... 100
Acronyms ......................................................................................................... 100
7.1.

Background and technical information ......................................................... 101

7.1.1.
7.1.2.
7.1.3.
7.1.4.
7.1.5.
7.2.

Justification of the requested exemption ...................................................... 111

7.2.1.
7.2.2.
7.2.3.
7.2.4.
7.3.

History of the exemption ................................................................. 102
Focus of the review of this renewal request .................................... 104
Summary of the requested exemption ............................................. 104
Technical description of the exemption and use of the restricted
substance ......................................................................................... 105
Amount(s) of restricted substance(s) used under the exemption .... 110
Substitution and elimination of the restricted substance ................. 111
Environmental, health and safety impacts ....................................... 112
Socioeconomic impacts ................................................................... 112
Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 113

Critical review .......................................................................................... 115

7.3.1.
7.3.2.

REACH compliance – Relation to the REACH Regulation ........... 115
Substitution and elimination of the restricted substance ................. 116

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

7.3.3.
7.3.4.

Environmental, health, safety and socio-economic impacts ........... 122
Summary and conclusions ............................................................... 122

7.4.

Recommendation ...................................................................................... 124

7.5.

References ............................................................................................... 125

EXEMPTION 7(C)(I) OF ANNEX III: LEAD IN GLASS AND CERAMIC ........................... 128
Declaration ....................................................................................................... 128
Acronyms and Definitions.................................................................................... 128
8.1.

Background and technical information ......................................................... 129

8.1.1.
8.1.2.
8.1.3.
8.1.4.
8.1.5.
8.2.

Justification of the requested exemption ...................................................... 140

8.2.1.
8.2.2.
8.2.3.
8.2.4.
8.3.

History of the exemption ................................................................. 130
Focus of the review of this renewal request .................................... 131
Summary of the requested exemption ............................................. 132
Technical description of the exemption and use of the restricted
substance ......................................................................................... 134
Annual amount(s) of restricted substance(s) used under the
exemption ........................................................................................ 140
Substitution and Elimination of the restricted substance ................ 140
Environmental, health and safety impacts ....................................... 143
Socioeconomic impacts ................................................................... 144
Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 145

Critical review .......................................................................................... 149

8.3.1.
8.3.2.
8.3.3.
8.3.4.
8.3.5.

REACH compliance – Relation to the REACH Regulation ........... 149
Substitution and elimination of the restricted substance ................. 150
Environmental, health, and safety impacts ...................................... 158
Socioeconomic impacts ................................................................... 159
Summary and conclusions ............................................................... 159

8.4.

Recommendation ...................................................................................... 161

8.5.

References ............................................................................................... 163

EXEMPTION 8(B)-SERIES OF ANNEX III: CADMIUM IN ELECTRICAL CONTACTS ......... 166
Declaration ....................................................................................................... 166
Acronyms and Definitions.................................................................................... 167
9.1.

Background and technical information ......................................................... 167

9.1.1.
9.1.2.
9.1.3.
9.1.4.
9.1.5.
9.2.

History of the exemption ................................................................. 167
Focus of the review of this renewal request .................................... 169
Summary of the renewal request ..................................................... 170
Technical description of the exemption and use of the restricted
substance ......................................................................................... 171
Amount(s) of restricted substance(s) used under the exemption .... 171

Justification of the requested exemption ...................................................... 171

9.2.1.
9.2.2.

Substitution and Elimination of the restricted substance ................ 171
Environmental, health, safety and socioeconomic impacts ............. 173

7

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

9.2.3.
9.3.

Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 174

Critical review .......................................................................................... 176

9.3.1.
9.3.2.
9.3.3.
9.3.4.

REACH compliance – Relation to the REACH Regulation ........... 176
Substitution and elimination of the restricted substance ................. 176
Environmental, health, safety and socioeconomic impacts ............. 178
Summary and conclusions ............................................................... 179

9.4.

Recommendation ...................................................................................... 180

9.5.

References ............................................................................................... 182

EXEMPTION 13(A) OF ANNEX III: PB IN WHITE GLASSES USED FOR OPTICALAPPLICATIONS .................................................................................................. 184
Declaration ....................................................................................................... 184
Acronyms and Definitions.................................................................................... 184
10.1. Background and technical information ......................................................... 184

10.1.1. History of the exemption ................................................................. 185
10.1.2. Focus of the review of this renewal request .................................... 187
10.1.3. Summary of the requested exemption and stakeholder
contributions .................................................................................... 188
10.1.4. Technical description of the exemption and use of the restricted
substance ......................................................................................... 188
10.1.5. Amount(s) of restricted substance(s) used under the exemption .... 190
10.2. Justification of the requested exemption ...................................................... 191

10.2.1. Substitution and Elimination of the restricted substance ................ 191
10.2.2. Environmental, health, safety, and socioeconomic impacts ............ 191
10.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 192
10.3. Critical review .......................................................................................... 193

10.3.1. REACH compliance – Relation to the REACH Regulation ........... 193
10.3.2. Substitution and elimination of the restricted substances ............... 193
10.3.3. Adoption of the recommendation from the previous evaluation
report......................................................................................... 194
10.3.4. Environmental, health, safety, and socioeconomic impacts ............ 195
10.3.5. Summary and conclusions ............................................................... 195
10.4. Recommendation ...................................................................................... 196

Feedback on recommendation ....................................................................... 197
10.5. References ............................................................................................... 198
EXEMPTION 13(B) OF ANNEX III: CD AND PB IN FILTER GLASSES AND
REFLECTANCE STANDARDS ................................................................................. 199
Declaration ....................................................................................................... 199
Acronyms and Definitions.................................................................................... 199
11.1. Background and technical information ......................................................... 200

11.1.1. History of the exemption ................................................................. 200
11.1.2. Focus of the review of this renewal request .................................... 202

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

11.1.3. Summary of the requested exemption and stakeholder
contributions .................................................................................... 203
11.1.4. Technical description of the exemption and use of the restricted
substance ......................................................................................... 203
11.1.5. Amount(s) of restricted substance(s) used under the exemption .... 205
11.2. Justification of the requested exemption ...................................................... 205

11.2.1. Substitution and Elimination of the restricted substance ................ 205
11.2.2. Environmental, health, safety, and socioeconomic impacts ............ 207
11.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 207
11.3. Critical review .......................................................................................... 208

11.3.1. REACH compliance – Relation to the REACH Regulation ........... 208
11.3.2. Substitution and elimination of the restricted substances ............... 209
11.3.3. Adoption of the recommendation from the previous evaluation
report......................................................................................... 209
11.3.4. Environmental, health, safety, and socioeconomic impacts ............ 211
11.3.5. Summary and conclusions ............................................................... 212
11.4. Recommendation ...................................................................................... 212

Feedback on recommendation ....................................................................... 214
11.5. References ............................................................................................... 214
EXEMPTION 15-SERIES OF ANNEX III: LEAD IN SOLDERS OF FLIP CHIP PACKAGES....................................................................................................................... 216
Declaration ....................................................................................................... 216
Acronyms and Definitions.................................................................................... 217
12.1. Background and technical information ......................................................... 217

12.1.1.
12.1.2.
12.1.3.
12.1.4.

History of the exemption ................................................................. 217
Focus of the review of this renewal request .................................... 218
Summary of the renewal request by (TMC 2023a) ......................... 219
Technical description of the exemption and use of the restricted
substance ......................................................................................... 220
12.1.5. Amount(s) of restricted substance(s) used under the exemption .... 220
12.2. Justification of the requested exemption ...................................................... 220

12.2.1.
12.2.2.
12.2.3.
12.2.4.

Substitution and Elimination of the restricted substance ................ 221
Environmental, health, and safety impacts ...................................... 221
Socioeconomic impacts ................................................................... 222
Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 222

12.3. Critical review .......................................................................................... 224

12.3.1.
12.3.2.
12.3.3.
12.3.4.

REACH compliance – Relation to the REACH Regulation ........... 224
Substitution and elimination of the restricted substance ................. 225
Environmental, health, safety and socioeconomic impacts ............. 228
Summary and conclusions ............................................................... 229

9Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU
12.4. Recommendation ...................................................................................... 230
12.5. References ............................................................................................... 231
EXEMPTION 18(B) OF ANNEX III: LEAD IN FLUORESCENT POWDER OF DISCHARGELAMPS .............................................................................................................. 233
Declaration ....................................................................................................... 233
Acronyms ......................................................................................................... 233
13.1. Background and technical information ......................................................... 234

13.1.1.
13.1.2.
13.1.3.
13.1.4.

History of the exemption ................................................................. 234
Focus of the review ......................................................................... 235
Summary of the requested exemption ............................................. 236
Technical description of the exemption and use of the restricted
substance ......................................................................................... 236
13.1.5. Amount(s) of restricted substance(s) used under the exemption .... 238
13.2. Justification of the requested exemption ...................................................... 238

13.2.1.
13.2.2.
13.2.3.
13.2.4.

Substitution and Elimination of the restricted substance ................ 238
Environmental, health, safety and socioeconomic impacts ............. 239
Stakeholder contributions ................................................................ 241
Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 241

13.3. Critical review .......................................................................................... 241

13.3.1.
13.3.2.
13.3.3.
13.3.4.
13.3.5.

REACH compliance – Relation to the REACH Regulation ........... 241
Substitution and elimination of the restricted substance ................. 242
Environmental, health, safety and socioeconomic impacts ............. 243
Categorisation of suntanning equipment ......................................... 243
Summary and conclusions ............................................................... 244

13.4. Recommendation ...................................................................................... 244
13.5. References ............................................................................................... 245
EXEMPTION 34 OF ANNEX III: LEAD IN TRIMMER POTENTIOMETERS ....................... 247
Declaration ....................................................................................................... 247
Acronyms ......................................................................................................... 247
14.1. Background and technical information ......................................................... 248

14.1.1.
14.1.2.
14.1.3.
14.1.4.

History of the exemption ................................................................. 248
Focus of the review of this renewal request .................................... 249
Summary of the requested exemption ............................................. 249
Technical description of the exemption and use of the restricted
substance ......................................................................................... 250
14.1.5. Amount(s) of restricted substance(s) used under the exemption .... 252
14.2. Justification of the requested exemption ...................................................... 254

14.2.1. Substitution and Elimination of the restricted substance ................ 254
14.2.2. Environmental, health, safety and socioeconomic impacts ............. 254
14.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 255

10Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

14.2.4. Stakeholder contributions ................................................................ 256
14.3. Critical review .......................................................................................... 256

14.3.1.
14.3.2.
14.3.3.
14.3.4.

REACH compliance – Relation to the REACH Regulation ........... 256
Substitution and elimination of the restricted substance ................. 257
Environmental, health, safety and socioeconomic impacts ............. 259
Summary and conclusions ............................................................... 259

14.4. Recommendation ...................................................................................... 260
14.5. References ............................................................................................... 260
EXEMPTION 42 OF ANNEX III: LEAD IN BEARINGS AND BUSHES ............................. 262
Declaration ....................................................................................................... 262
Acronyms ......................................................................................................... 262
15.1. Background and technical information ......................................................... 263

15.1.1. History of the exemption ................................................................. 263
15.1.2. Summary of the requested exemption ............................................. 263
15.1.3. Technical description of the exemption and use of the restricted
substance ......................................................................................... 265
15.1.4. Amount(s) of restricted substance(s) used under the exemption .... 272
15.2. Justification of the requested exemption ...................................................... 273

15.2.1. Substitution and Elimination of the restricted substance ................ 273
15.2.2. Environmental, health, safety and socioeconomic impacts ............. 277
15.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 277
15.2.4. Stakeholder contributions ................................................................ 278
15.3. Critical review .......................................................................................... 279

15.3.1.
15.3.2.
15.3.3.
15.3.4.
15.3.5.

REACH compliance – Relation to the REACH Regulation ........... 279
Substitution and elimination of the restricted substance ................. 279
Wording of the exemption ............................................................... 280
Environmental, health, safety and socioeconomic impacts ............. 282
Summary and conclusions ............................................................... 283

15.4. Recommendation ...................................................................................... 283
15.5. References ............................................................................................... 284
EXEMPTION 44 OF ANNEX III: LEAD IN SOLDER IN ENGINES .................................. 286
Declaration ....................................................................................................... 286
Acronyms and Definitions.................................................................................... 286
16.1. Background and technical information ......................................................... 287

16.1.1. History of the exemption ................................................................. 287
16.1.2. Summary of the requested exemption and stakeholder
contributions .................................................................................... 287
16.1.3. Technical description of the exemption and use of the restricted
substance ......................................................................................... 289
16.1.4. Amount(s) of restricted substance(s) used under the exemption .... 297
16.2. Justification of the requested exemption ...................................................... 298

11Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

16.2.1. Substitution and Elimination of the restricted substance ................ 298
16.2.2. Environmental, health, safety, and socioeconomic impacts ............ 301
16.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 302
16.3. Critical review .......................................................................................... 304

16.3.1.
16.3.2.
16.3.3.
16.3.4.
16.3.5.

REACH compliance – Relation to the REACH Regulation ........... 304
Scope clarification ........................................................................... 305
Substitution and elimination of the restricted substance ................. 307
Environmental, health, safety, and socioeconomic impacts ............ 310
Summary and conclusions ............................................................... 310

16.4. Recommendation ...................................................................................... 311

Feedback on recommendations ..................................................................... 312
16.5. References ............................................................................................... 312
REQUESTED NEW EXEMPTION 2022-1 OF ANNEX III: OPTICAL CALOMELCOMPONENTS ................................................................................................... 314
Declaration ....................................................................................................... 314
Acronyms ......................................................................................................... 314
Definitions ........................................................................................................ 315
17.1. Background and technical information ......................................................... 317

17.1.1. History of the exemption ................................................................. 317
17.1.2. Summary of the requested exemption ............................................. 317
17.1.3. Technical description of the exemption and use of the restricted
substance ......................................................................................... 318
17.1.4. Amount(s) of restricted substance(s) used under the exemption .... 324
17.2. Justification of the requested exemption ...................................................... 324

17.2.1. Substitution and Elimination of the restricted substance ................ 324
17.2.2. Environmental, health, safety and socioeconomic impacts ............. 325
17.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 326
17.3. Critical review .......................................................................................... 326

17.3.1.
17.3.2.
17.3.3.
17.3.4.
17.3.5.
17.3.6.
17.3.7.
17.3.8.
17.3.9.

REACH compliance – Relation to the REACH Regulation ........... 326
Compliance with the Mercury Regulation ...................................... 327
Timing of the exemption request..................................................... 327
BBT as only applicant and producer ............................................... 328
Scope clarification ........................................................................... 328
Substitution and elimination of the restricted substance ................. 332
Wording of the exemption ............................................................... 336
Environmental, health, safety and socio-economic impacts .......... 338
Summary and conclusions ............................................................... 339

17.4. Recommendation ...................................................................................... 339
17.5. References ............................................................................................... 340
EXEMPTION 1(A) OF ANNEX IV: PB AND CD IN ION SELECTIVE ELECTRODES ........... 342

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU
Declaration ....................................................................................................... 342
Acronyms and Definitions.................................................................................... 342
18.1. Background and technical information ......................................................... 343

18.1.1.
18.1.2.
18.1.3.
18.1.4.

History of the exemption ................................................................. 343
Focus of the review of this renewal request .................................... 345
Summary of the requested exemption ............................................. 346
Technical description of the exemption and use of the restricted
substance ......................................................................................... 346
18.1.5. Amount(s) of restricted substance(s) used under the exemption .... 350
18.2. Justification of the requested exemption ...................................................... 350

18.2.1. Substitution and elimination of the restricted substance ................. 350
18.2.2. Environmental, health, safety, and socioeconomic impacts ............ 354
18.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 354
18.3. Critical review .......................................................................................... 355

18.3.1. REACH compliance – Relation to the REACH Regulation ........... 355
18.3.2. Adoption of the recommendation from the previous evaluation
report......................................................................................... 356
18.3.3. Substitution and elimination of the restricted substances ............... 358
18.3.4. Environmental, health, safety, and socioeconomic impacts ............ 365
18.3.5. Summary and conclusions ............................................................... 365
18.4. Recommendation ...................................................................................... 366

Feedback on recommendation ....................................................................... 368
18.5. References ............................................................................................... 368
EXEMPTION 1(B) OF ANNEX IV: PB IN ELECTROCHEMICAL OXYGEN SENSORS .......... 369
Declaration ....................................................................................................... 369
Acronyms and Definitions.................................................................................... 369
19.1. Background and technical information ......................................................... 370

19.1.1.
19.1.2.
19.1.3.
19.1.4.

History of the exemption ................................................................. 371
Focus of the review of this renewal request .................................... 372
Summary of the requested exemption ............................................. 373
Technical description of the exemption and use of the restricted
substance ......................................................................................... 375
19.1.5. Amount(s) of restricted substance(s) used under the exemption .... 386
19.2. Justification of the requested exemption ...................................................... 386

19.2.1. Substitution and Elimination of the restricted substance ................ 386
19.2.2. Environmental, health, safety and socioeconomic impacts ............. 399
19.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 401
19.3. Critical review .......................................................................................... 408

19.3.1. REACH compliance – Relation to the REACH Regulation ........... 408

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

19.3.2. Adoption of the recommendation from the previous evaluation
report......................................................................................... 408
19.3.3. Scope clarification ........................................................................... 412
19.3.4. Substitution and elimination of the restricted substances ............... 419
19.3.5. Environmental, health, safety, and socio-economic impacts .......... 427
19.3.6. Summary and conclusions ............................................................... 427
19.4. Recommendation ...................................................................................... 430

Feedback on recommendations ..................................................................... 431
19.5. References ............................................................................................... 432
EXEMPTION 1(C) OF ANNEX IV: PB, CD AND HG IN INFRARED DETECTORS .............. 435
Declaration ....................................................................................................... 435
Acronyms ......................................................................................................... 435
20.1. Background and technical information ......................................................... 436

20.1.1.
20.1.2.
20.1.3.
20.1.4.

History of the exemption ................................................................. 436
Focus of the review ......................................................................... 437
Summary of the requested exemption ............................................. 438
Technical description of the exemption and use of the restricted
substance ......................................................................................... 439
20.1.5. Amount(s) of restricted substance(s) used under the exemption .... 439
20.2. Justification of the requested exemption ...................................................... 439

20.2.1. Substitution and Elimination of the restricted substance ................ 439
20.2.2. Environmental, health, safety and socioeconomic impacts ............. 439
20.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 439
20.2.4. Stakeholder contributions ................................................................ 441
20.3. Critical review .......................................................................................... 441

20.3.1. REACH compliance – Relation to the REACH Regulation ........... 441
20.3.2. Substitution and elimination of the restricted substance ................. 444
20.3.3. Summary and conclusions ............................................................... 444
20.4. Recommendation ...................................................................................... 445
20.5. References ............................................................................................... 446
EXEMPTION 4 OF ANNEX IV: LEAD IN GLASS FRITS OF X-RAY TUBES, ETC. .............. 447
Declaration ....................................................................................................... 447
Acronyms ......................................................................................................... 447
21.1. Background and technical information ......................................................... 448

21.1.1.
21.1.2.
21.1.3.
21.1.4.

History of the exemption ................................................................. 448
Focus of the review ......................................................................... 448
Summary of the requested exemption ............................................. 448
Technical description of the exemption and use of the restricted
substance ......................................................................................... 449
21.1.5. Amount(s) of restricted substance(s) used under the exemption .... 450
21.2. Justification of the requested exemption ...................................................... 450

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

21.2.1. Substitution and Elimination of the restricted substance ................ 450
21.2.2. Environmental, health, safety and socioeconomic impacts ............. 450
21.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 451
21.3. Critical review .......................................................................................... 451

21.3.1.
21.3.2.
21.3.3.
21.3.4.
21.3.5.
21.3.6.
21.3.7.

REACH compliance – Relation to the REACH Regulation ........... 451
Relevance of the exemption for reuse of EEE ................................ 452
Scope of the renewal request ........................................................... 453
Substitution and elimination of the restricted substance ................. 453
Wording of the exemption ............................................................... 457
Environmental, health, safety and socioeconomic impacts ............. 458
Summary and conclusions ............................................................... 458

21.4. Recommendation ...................................................................................... 459
21.5. References ............................................................................................... 460
EXEMPTION 9 OF ANNEX IV: CD IN HELIUM-CADMIUM LASERS ............................... 463
Declaration ....................................................................................................... 463
Acronyms ......................................................................................................... 463
Definitions ........................................................................................................ 464
22.1. Background and technical information ......................................................... 464

22.1.1. History of the exemption ................................................................. 464
22.1.2. Summary of the requested exemption ............................................. 464
22.1.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 465
22.1.4. Technical description of the exemption and use of the restricted
substance ......................................................................................... 465
22.1.5. Amount(s) of restricted substance(s) used under the exemption .... 468
22.2. Justification of the requested exemption ...................................................... 468

22.2.1. Substitution and Elimination of the restricted substance ................ 468
22.2.2. Environmental, health, safety and socioeconomic impacts ............. 469
22.3. Critical review .......................................................................................... 470

22.3.1.
22.3.2.
22.3.3.
22.3.4.

REACH compliance – Relation to the REACH Regulation ........... 470
Substitution and elimination of the restricted substance ................. 470
Environmental, health, safety and socio-economic impacts ........... 475
Summary and conclusions ............................................................... 475

22.4. Recommendation ...................................................................................... 476
22.5. References ............................................................................................... 477
EXEMPTION10 OF ANNEX IV: PB AND CD IN ATOMIC ABSORPTION SPECTROSCOPYLAMPS .............................................................................................................. 478
Declaration ....................................................................................................... 478
Acronyms ......................................................................................................... 478
23.1. Background and technical information ......................................................... 479

23.1.1. History of the exemption ................................................................. 480

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23.1.2. Summary of the requested exemption ............................................. 480
23.1.3. Technical description of the exemption and use of the restricted
substance ......................................................................................... 481
23.1.4. Amount(s) of restricted substance(s) used under the exemption .... 489
23.2. Justification of the requested exemption ...................................................... 489

23.2.1. Substitution and Elimination of the restricted substance ................ 489
23.2.2. Environmental, health, safety and socioeconomic impacts ............. 494
23.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 494
23.2.4. Stakeholder contributions ................................................................ 496
23.3. Critical review .......................................................................................... 496

23.3.1.
23.3.2.
23.3.3.
23.3.4.

REACH compliance – Relation to the REACH Regulation ........... 496
Substitution and elimination of the restricted substance ................. 496
Environmental, health, safety and socioeconomic impacts ............. 504
Summary and conclusions ............................................................... 505

23.4. Recommendation ...................................................................................... 506
23.5. References ............................................................................................... 507
EXEMPTION 46 OF ANNEX IV: DEHP IN MRI DETECTOR COILS ................................ 510
Declaration ....................................................................................................... 510
Acronyms ......................................................................................................... 510
Definitions ........................................................................................................ 511
24.1. Background and technical information ......................................................... 511

24.1.1. History of the exemption ................................................................. 511
24.1.2. Summary of the requested exemption ............................................. 511
24.1.3. Technical description of the exemption and use of the restricted
substance ......................................................................................... 512
24.1.4. Amount(s) of restricted substance(s) used under the exemption .... 513
24.2. Justification of the requested exemption ...................................................... 514

24.2.1. Substitution and Elimination of the restricted substance ................ 514
24.2.2. Environmental, health, safety and socioeconomic impacts ............. 514
24.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 515
24.3. Critical review .......................................................................................... 516

24.3.1.
24.3.2.
24.3.3.
24.3.4.

REACH compliance – Relation to the REACH Regulation ........... 516
Substitution and elimination of the restricted substance ................. 516
Environmental, health, safety and socio-economic impacts ........... 517
Summary and conclusions ............................................................... 518

24.4. Recommendation ...................................................................................... 518
24.5. References ............................................................................................... 519
REQUESTED NEW EXEMPTION 2022-2 OF ANNEX IV: CD IN HERSCH CELL OXYGENSENSORS.......................................................................................................... 520
Declaration ....................................................................................................... 520

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Acronyms and Definitions.................................................................................... 520
25.1. Background and technical information ......................................................... 520

25.1.1. History of the exemption ................................................................. 521
25.1.2. Summary of the requested exemption ............................................. 522
25.1.3. Technical description of the exemption and use of the restricted
substance ......................................................................................... 522
25.1.4. Amount(s) of restricted substance(s) used under the exemption .... 524
25.2. Justification of the requested exemption ...................................................... 524

25.2.1. Substitution and Elimination of the restricted substance ................ 524
25.2.2. Environmental, health, safety and socioeconomic impacts ............. 527
25.2.3. Roadmap towards substitution or elimination of the restricted
substance ......................................................................................... 528
25.3. Critical review .......................................................................................... 528

25.3.1.
25.3.2.
25.3.3.
25.3.4.

REACH compliance – Relation to the REACH Regulation ........... 528
Substitution and elimination of the restricted substances ............... 529
Environmental, health, safety, and socio-economic impacts .......... 532
Summary and conclusions ............................................................... 532

25.4. Recommendation ...................................................................................... 533

Feedback on recommendations ..................................................................... 533
25.5. References ............................................................................................... 534

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

List of Figures

Figure 3-1: Relation of REACH categories and lists to other chemical substances .......... 46
Figure 6-1: Roll out of compliant equipment ..................................................................... 84
Figure 8-1: Amended timeline for compliance ................................................................ 153
Figure 13-1: Examples of indoor tanning equipment....................................................... 237
Figure 14-1: Examples of trimmer potentiometers .......................................................... 250
Figure 15-1: Tri-metal bearing ......................................................................................... 269
Figure 15-2: Parts of a typical internal combustion engine with bearings and bushes shownin pink and green ...................................................................................................... 270
Figure 15-3: Calculation of amount of lead in bearings used in engines in scope of thisexemption request .................................................................................................... 272
Figure 15-4: Copper bearing chip resistance testing (1) .................................................. 274
Figure 15-5: Copper bearing chip resistance testing (2) .................................................. 275
Figure 15-6: Comparative testing of leaded bearing to lead-free alternative ................... 276
Figure 15-7: Example of structure of a multilayer bearing. ............................................. 280
Figure 15-8: Specifications of overlay coating according to ISO 4383 (2012) ............... 281
Figure 15-9: Specifications of layer below overlay coating compositions according to ISO
4383:201(E) .............................................................................................................. 282
Figure 16-1: Example ECU CAD diagram and its location on the engine block ............ 291
Figure 16-2: Example ECU and its location in service .................................................... 291
Figure 17-1: Calomel based optical polarisers mounted in protective housings.............. 319
Figure 17-2: Birefringence ............................................................................................... 320
Figure 17-3: Different types of polarization prisms made from mercurous chloride
crystalline material ................................................................................................... 320
Figure 17-4: Comparison of optical transmission spectra of calomel vs. other materials withlogarithmic scale ...................................................................................................... 321
Figure 17-5: Schematic description of AOTF functionality ............................................ 322
Figure 17-6: Custom made calomel optical components ................................................. 323

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Figure 17-7: Quantum Random Number Generator ........................................................ 324
Figure 17-8: Birefringence values for mercurous halides and calcite .............................. 325
Figure 18-1: Technical illustration of the thick film paste as part of the sensor .............. 347
Figure 18-2: Exemplary image of replaceable blood gas system cartridge ..................... 348
Figure 18-3: Exemplary schematic showing the printing layers wherein the paste is used on
the substrate layer ..................................................................................................... 348
Figure 18-4: Exemplary image showing a blood gas system ........................................... 349
Figure 19-1: Schematic of a capillary sensor ................................................................... 377
Figure 19-2: Temperature dependence of capillary oxygen sensors ................................ 379
Figure 19-3: Capillary sensor pressure response.............................................................. 379
Figure 19-4: Schematic of test sampling of a Hersch cell ................................................ 380
Figure 19-5: Examples of Honeywell lead-anode oxygen sensors .................................. 382
Figure 19-6: Effects of temperature changes on lead-free partial pressure galvanic sensors(top) and leaded capillary sensors (middle) tested from – 30 to +50oC ................... 388
Figure 19-7: Response of partial pressure galvanic lead-free sensors (top) and lead capillary
sensors (middle) to a pressure step of 25 kPa at 60s in air....................................... 389
Figure 19-8: Comparison of an Alphasense O2A2 sensor and galvanic lead-free partialpressure sensors ........................................................................................................ 389
Figure 19-9: Warm up times of amperometric lead-free oxygen sensor outlining start uptime after battery disconnection ............................................................................... 392
Figure 19-10: Dependence of oxygen sensors on temperature – above three-electrodepump-cell electrochemical sensor, below capillary lead anode galvanic sensor ..... 394
Figure 19-11: Comparing direct vs. indirect measurement .............................................. 397
Figure 21-1: Life cycle of cat. 9 IMCI ............................................................................. 452
Figure 22-1: Schematic diagram of the HeCd laser ......................................................... 466
Figure 23-1: Outline of an AAS ....................................................................................... 481
Figure 23-2: Outline of a HCL with cathode made of restricted substance ..................... 482
Figure 23-3: Outline of an EDL with the restricted substance contained within the partlabelled as “Lamp” ................................................................................................... 483

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Figure 23-4: Bandwidths of lamp emission spectrum and sample absorbance spectra ... 484
Figure 23-5: Outline of an ICP-OES ................................................................................ 491
Figure 23-6: Comparison of footprints of AAS and potential alternatives ...................... 493
Figure 23-7: AAS for operation with HCL and EDL lamps ............................................ 501
Figure 23-8: Selected standards using AAS and the respective light source ................... 504
Figure 24-1: MRI shoulder coil with cable connects containing DEHP .......................... 512
Figure 24-2: Effect of cable strain relief on movement of cable at connection to equipment.................................................................................................................................. 513

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

List of Tables

Table 1-1: Overview of exemption requests, recommendations and expiry dates............. 28
Tableau 2-1 : Aperçu des demandes d'exemption, des recommandations et des dates
d'expiration. ................................................................................................................ 36
Table 3-1: Overview of exemptions to be reviewed .......................................................... 42
Table 5-1: Current wording of the exemption 6(a)-series .................................................. 57
Table 5-2: Requested renewals of exemption III-6(a) ....................................................... 58
Table 5-3: Stakeholder contributions ................................................................................. 58
Table 5-4: Renewal of the current exemption 6(a) and 6(a)(i) .......................................... 59
Table 6-1: Current wording of the exemption 6(b)-series.................................................. 75
Table 6-2: Exemption renewals requested by TMC........................................................... 76
Table 6-3: Exemption renewals requested by EUROMOT ............................................... 76
Table 6-4: Stakeholders’ contributions .............................................................................. 77
Table 6-5: Renewal of current exemption 6(b) series recommended by (Baron et al. 2022a).................................................................................................................................... 78
Table 7-1: Current wording of the exemption .................................................................. 100
Table 7-2: Requested renewals of exemption III-7(a) ..................................................... 101
Table 7-3: Stakeholder contributions ............................................................................... 101
Table 7-4: Renewal of exemption III-7(a) recommended by (Baron et al. 2022) ........... 103
Table 7-5: Examples of components and cat. 9 IMCI relying on exemption 7(a) ........... 109
Table 8-1: Current wording of the exemption .................................................................. 128
Table 8-2: Requested renewals of exemption III-7(c)(I) ................................................. 129
Table 8-3: Contributions to the stakeholder consultation ................................................ 129
Table 8-4: Renewal of current exemption 7(c)(I) recommended by (Baron et al. 2022) 131
Table 8-5: Uses of exemption III-7(c)(I) in components and EEE of EUROMOT members.................................................................................................................................. 135
Table 8-6: Proposed modification of exemption sub-clause 7(c)(V)(4) recommended by(Baron et al. 2022) .................................................................................................... 155

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Table 9-1: Current wording of the exemption 8(b)-series................................................ 166
Table 9-2: Wording and scope of the requested exemption ............................................. 167
Table 9-3: Potential renewal of exemption III-8(b) as exemption III-8(b)(II) ................. 168
Table 10-1: Current wording of the exemption ................................................................ 185
Table 10-2: Wording and scope of the requested exemption ........................................... 185
Table 10-3: Wording option 1 recommended by (Deubzer et al. 2022) .......................... 186
Table 10-4: Wording option 2 recommended by (Deubzer et al. 2022) .......................... 187
Table 10-5: Option 3 recommended by (Deubzer et al. 2022)......................................... 187
Table 10-6: List of relevant product groupings and equipment types.............................. 190
Table 11-1: Current wording of the exemption ................................................................ 199
Table 11-2: Wording and scope of the requested exemption ........................................... 200
Table 11-3: Currently valid wording of exemption 13(b)-series ..................................... 201
Table 11-4: Recommended renewal of exemption 13(b)-series by (Deubzer et al. 2022).................................................................................................................................. 201
Table 11-5: List of relevant product groupings and equipment types.............................. 204
Table 11-6: Renewal of exemption 13(b)-series, adapted from (Deubzer et al. 2022) .... 210
Table 12-1: Current wording of the exemption 15-series ................................................ 216
Table 12-2: Wording and scope of the requested exemption renewal ............................. 217
Table 12-3: Potential renewal of exemption III-15(a) ..................................................... 218
Table 13-1: Current wording of the exemption ................................................................ 233
Table 13-2: Requested exemption renewal ...................................................................... 234
Table 13-3: Renewal of current exemption 18(b) recommended by (Baron et al. 2022) 235
Table 14-1: Current wording of the exemption ................................................................ 247
Table 14-2: Requested exemption renewal ...................................................................... 248
Table 14-3: Renewal of the current exemption 34 recommended by (Baron et al. 2022)249
Table 14-4: Full material disclosure for the most common cermet trim pot family used 253

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Table 15-1: Current wording of the exemption ................................................................ 262
Table 15-2: Requested exemption renewal ...................................................................... 263
Table 15-3 Examples of lead overlay compositions ........................................................ 269
Table 15-4: Qualification requirements ........................................................................... 278
Table 16-1: Current wording of the exemption ................................................................ 286
Table 16-2: Wording and scope of the requested exemption ........................................... 287
Table 16-3: Operational environment of applications covered by this exemption comparedto passenger vehicles ................................................................................................ 294
Table 16-4: Types of qualification activity required and timescales for lead solder
substitution ............................................................................................................... 303
Table 17-1: Wording and scope of the requested exemption ........................................... 317
Table 17-2: Spectral ranges of the IR spectrum ............................................................... 319
Table 17-3: Classification and categorisation of calomel element uses ........................... 330
Table 17-4: Parameters of acousto-optic materials .......................................................... 334
Table 17-5: Parameters of birefringent crystals ............................................................... 335
Table 17-6: Wording of the exemption elaborated with the applicant ............................. 336
Table 18-1: Current wording of the exemption ................................................................ 342
Table 18-2: Wording and scope of the requested exemption ........................................... 343
Table 18-3: Wording option A recommended by (Deubzer et al. 2022) ......................... 344
Table 18-4: Wording option B recommended by (Deubzer et al. 2022) .......................... 345
Table 18-5: Timeframe for the assessment of two potential replacement pastes ............. 355
Table 18-6: Renewal of exemption 1(a) reflecting wording option A, adapted from(Deubzer et al. 2022). ............................................................................................... 356
Table 18-7: Renewal of exemption 1(a) reflecting wording option B, adapted from (Deubzer
et al. 2022) ................................................................................................................ 357
Table 18-8: Constituents of thick film paste after firing .................................................. 358
Table 18-9: Cost comparison for handheld and hybrid point of care systems ................. 364

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Table 19-1: Current wording of the exemption ................................................................ 369
Table 19-2: Wording and scope of the requested renewal of exemption IV-1(b)............ 370
Table 19-3: Exemption wording and scope recommended by (Deubzer et al. 2022) ...... 372
Table 19-4: Comparison of lead-containing and lead-free partial pressure galvanic oxygen
sensors ...................................................................................................................... 387
Table 19-5: Comparison of lead-free and lead based sensor response when exposed to 8 –15 % CO2 .................................................................................................................. 393
Table 19-6: Recovery time of lead-free sensors to a ~20.91 reading for O2, in comparison
lead based sensors always returned to this value within 3 minutes. ........................ 393
Table 19-7: Comparing sensitivity of oxygen sensing devices ........................................ 396
Table 19-8: Status of lead-anode and alternative sensor types ........................................ 399
Table 19-9: Prototype Hersch oxygen sensor testing ....................................................... 402
Table 19-10: Development of lead-free galvanic capillary oxygen gas sensor ............... 404
Table 19-11: Development of lead-free amperometric oxygen gas sensor ...................... 405
Table 19-12: Qualification requirements and timeframe ................................................. 405
Table 19-13: Lead-free oxygen sensor development for safety applications ................... 407
Table 19-14: Lead-free ATEX approved analyser development timescale ..................... 407
Table 19-15: Lead-free analyser development timescale ................................................. 407
Table 19-16: Lead-free analyser development timescale 0 – 2 ppm................................ 408
Table 19-17: Renewal of exemption 1(b), adapted from (Deubzer et al. 2022) .............. 409
Table 19-18: Overview on relevant specifications of the sensor technologies in scope of the
exemption renewal requests ..................................................................................... 413
Table 19-19: Comparison of capillary and partial pressure sensors ................................ 417
Table 19-20: Specifications of lead-free galvanic oxygen sensors from Maxell ............. 424
Table 20-1: Current wording of the exemption ................................................................ 435
Table 20-2: Requested exemption renewal ...................................................................... 436
Table 20-3: Renewal of current exemption IV-1(c) recommended by (Deubzer et al. 2022).................................................................................................................................. 437

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Table 21-1: Current wording of the exemption ................................................................ 447
Table 21-2: Requested exemption renewal ...................................................................... 448
Table 22-1:Current wording of the exemption ................................................................. 463
Table 22-2: Wording and scope of the requested exemption ........................................... 464
Table 22-3: Penetration depth of Si samples with light of different wavelengths ........... 467
Table 22-4: Comparison of analytical methods for detecting ultraviolet spectrum ......... 469
Table 22-5: Optical penetration depth in silicon at characteristic micro-Raman wavelengths.................................................................................................................................. 473
Table 23-1: Current wording of the exemption ................................................................ 478
Table 23-2: Requested exemption renewal ...................................................................... 480
Table 23-3: Standards adopting AAS for detection of lead, cadmium and/or mercury ... 487
Table 24-1:Current wording of the exemption ................................................................. 510
Table 24-2: Wording and scope of the requested exemption ........................................... 511
Table 24-3: Stages for establishment of possible substitute and respective timeframe needed
for completion of such stages ................................................................................... 515
Table 25-1: Previously valid wording and scope of the exemption ................................. 521
Table 25-2: Wording and scope of the requested exemption ........................................... 521

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Summary – English
Under Framework Contract no. ENV.B.3/FRA/2019/0017, a consortium coordinated by Bio
Innovation Service was requested by DG Environment of the European Commission toprovide technical and scientific support for the evaluation of the renewal request of 29
exemptions to Annex III of Directive 2011/65/EU. The work has been undertaken by the
Bio Innovation Service, UNITAR and Fraunhofer Institute IZM, and has been peerreviewed by experts from the three organisations.

1.1.

Background and objectives

Directive 2011/65/EU (hereafter “the Directive”) on the restriction of the use of certain
hazardous substances in electrical and electronic equipment provides “that EEE 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 Annex
II” (i.e. lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls,
polybrominated diphenyl ethers and starting July 2019 bis (2-ethylhexyl) phthalate, butyl
benzyl phthalate, dibutyl phthalate and diisobutyl phthalate). Article 5(1)(a) provides abasis for excluding certain applications from these provisions through the inclusion ofmaterials and components of EEE for specific applications in the lists in Annexes III and
IV. This article further specifies the criteria on which such exemptions can be justified: incases where the environmental and health protection afforded by Regulation
1907/2006/EC (REACH) is not weakened, exemptions can be justified in cases where atleast one of the following criteria is fulfilled:o“Their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;o

The reliability of substitutes is not ensured; andoThe total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.”

Furthermore, the availability of substitutes; the socio-economic impacts of substitution; any
potential adverse impacts on innovation and life cycle thinking information can also be
considered to determine the duration of exemptions.
Article 5(2) of the RoHS Directive stipulates that exemptions listed in Annexes III and
Annex IV shall have an expiration date. Where a specific date is not specified, this article
lists provisions to clarify the validity. Article 5(3) requires stakeholders to submit
applications for granting, renewing or revoking exemptions to the European Commission.
Such applications provide the basis for the Commission to initiate evaluations of the
exemptions listed in the annexes (or evaluations of requests for new exemptions).

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

1.2.

Key findings – Overview of the evaluation results

The exemption requests covered in this project and the applicants concerned, as well as
the final recommendation and proposed expiry dates are presented in Table 1-1 below.
The reader is referred to the corresponding section of this report for details on theevaluation result. For better readability of the table, the following acronyms are used:Cat.
I)

category, referring to categories of EEE in the scope of the RoHS Directive (Annex

MCI

monitoring and control instrument

MD

medical device

IMCI

industrial monitoring and control instrument

Incl.

includingIVD

in-vitro diagnostic medical device

Notes:•The terms “cat. 8” and “cat. 9” address all EEE under these categories, respectively.
For example, “cat. 8” includes IVD as well as other MD.

•

The consultants recommended the COM to allow sufficient time for preparation andtimely submission of renewal requests between the official publication of the COM’s
decision as to granting exemptions or their renewal and the expiry date of the
exemptions. Recommended expiry dates in 2024, 2025 and early/mid 2026 may
therefore, actually be shifted at the COM’s discretion.

•

The below summary only includes the recommended exemption wordings and scopes
for cat. 8, cat. 9 and 11. Recommendations for renewals of these exemptions fromrecent reviews in 2021 and 2022 by Ramboll/Oeko-Institut and BIO IS/Fraunhofer
IZM/UNITAR for other categories of EEE remain valid.

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Directive 2011/65/EU

Table 1-1: Overview of exemption requests, recommendations and expiry dates#

III6(a)III6(b)Current exemption requested forrenewal (or request for new
exemption)

Lead as an alloying element in steel formachining purposes and in galvanised
steel containing up to 0,35 % lead byweightLead as an alloying element inaluminium containing up to 0,4 % leadby weight

Applicantsandrecommend
ation

Recommended wording incl. numbering

Scope and expiry date6(a)(I)

Renew with current wording:Lead as an alloying element in steel for machining
purposes containing up to 0,35 % lead by weight

Expires on 21 July 2024 forcat. 9 and 11

6(a)(II)

Renew with wording recommended in previous
review:
Lead in batch hot dip galvanised steel components
containing up to 0,2 % lead by weight

Expires on 21 July 2026 forcategories 9 IMCI and 11

6(b)(I)

Renew with current wording:Lead as an alloying element in aluminium containing
up to 0,4 % lead by weight, provided it stems fromlead-bearing aluminium scrap recycling

Expires on 21 July 2026 forcat. 9 IMCI and 11

6(b)(II)

Renew with current wording:Lead as an alloying element in aluminium formachining purposes with a lead content up to 0,4 %by weight

Expires on 21 July 2026 forcat. 9 IMCI and 11

EUROMOT,TMC

EUROMOT,
TMC

III7(a)Lead in high melting temperature typesolders (i.e. lead-based alloys
containing 85 % by weight or more
lead)

EUROMOT,
TMC

7(a)

Renew

Expires on 21 July 2026 forcat. 9 IMCI and 11

III7(c)(I)Electrical and electronic components
containing lead in a glass or ceramicother than dielectric ceramic in
capacitors, e.g. piezoelectronic devices,or in a glass or ceramic matrix
compoundEUROMOT,
TMC,
Werfen7(c)(I)

Renew

Expires on 21 July 2026 forcat. 9 IMCI and 11

III8(b)Cadmium and its compounds inelectrical contacts

TMC

8(b)(II)

Renew with wording recommended in previous
review:

Expires on 31 December
2025 for cat. 9 IMCI

28

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU
Cadmium and its compounds in electrical contacts
used in- circuit breakers- thermal sensing controls- thermal motor protectors (excluding hermetic thermal
motor protectors)- AC switches- DC switches
III13(a)Lead in white glasses used for opticalapplications

TMC

13(a)
13(b)(I)13(b)(II)

III13(b)Cadmium and lead in filter glasses andglasses used for reflectance standards

TMC

13(b)(IV)

13(b)(V)

Renew with current wording (+ options, cf.
recommendation section)

Expires on 21 July 2028 forcat. 9 IMCI

Renew with current wording:Lead in ion coloured optical filter glass types
Renew with current wording:Cadmium in striking optical filter glass types;
excluding applications falling under point 39 of Annex
III
Renew with wording recommended in previous
review:
Cadmium in glazes used for reflectance standards
Renew with wording recommended in previous
review:
Lead compound coatings in infrared interference
filters used in infrared gas analysis and mid-farinfrared spectroscopy

Expires on 21 July 2028 forcat. 9 IMCI

Renewal not recommended due to lack ofevidence required by Art. 5(1)(a).

Expires on 21 July 2024 forcat. 9 IMCI

III-15

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

TMC

III18(b)Lead as activator in the fluorescentpowder (1 % lead by weight or less) ofdischarge lamps when used as suntanning lamps containing phosphorssuch as BSP (BaSi2O5:Pb)

LightingEuro
pe

18(b)

Renew with current wording.

Expires on 21 July 2026* forcat. 11.

III-34

Lead in cermet-based trimmer
potentiometer elements

TMC

34

Renew with current wording.

Expires on 21 July 2024* forcat. 9 IMCI

15

29

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU

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

Renew with modified wording:
Up to 95 % of lead in overlay coatings and/or up to 33% of lead in linings of 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;- with engine total displacement ≥ 15 litres;orIII-42or
EUROMOT

42(a)- with engine total displacement < 15litres and the engine is designed tooperate in applications where the time
between signal to start and full load isrequired to be less than 10 seconds;
or regular maintenance is typically
performed in a harsh and dirty outdoor
environment, suchas mining,
construction,
andagriculture
applications;III-44

Lead in solder of engine control units of
combustion engines within the scope ofRegulation (EU) 2016/1628 of theEuropean Parliament and of theCouncil(1), installed in equipment used
at fixed positions while in operation,
which is designed for professionals, butalso used by non-professional users;

Expires on 21 July 2029 forcat. 11- with engine total displacement < 15 litres and theengine is designed to operate in applications where
the time between signal to start and full load isrequired to be less than 10 seconds; or regular
maintenance is typically performed in a harsh anddirty outdoor environment, such as mining,
construction, and agriculture applications;

EUROMOT

44

Renew with current wording.

Expires on 21 January 2027
for cat. 11

1 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).

30

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU
Grant with below wording:
Mercury in optical materials made of mercurous
chloride monocrystal (calomel) for use in applications
requiring a polarizing material or in acousto-optic
applications, if at least one of the below properties isrequired:a)A crystal material is required for the specificapplication, and its transmission must include[1] atleast one wavelength in the spectrum from more than
8 µm up to 17 µm.

III-X

New exemption:
Optical components made of mercurous
chloride monocrystal (calomel)

BBTXb) Indices of refraction of no > 1,89 and ne > 2,44 at
10,6 µm wavelength, and no > 2,11 and ne > 3,18 at
0,38 μm wavelength, as well as a birefringence of morethan +0,5 at any part of the wavelength spectrum from
0,38 µm to 17 µm.

Expires on (date of official
publication + 5 years) for cat.
3 and 9 IMCIc) Extinction ratio of more than 1:20 000 in the infrared
wavelength spectrum between 3 µm and 17 µm.
d) Velocity of elastic wave propagation of less than
400 m/se) Value for acousto-optical figure of merit M2 = 640
x 10-15 s3/kg at 632,8 nm wavelengthf) Damage threshold of more than 5 x 105 W/cm2 at
1.064 nmIV1(a)

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

COCIR

1(a)(I)

Renew with below wording:Lead and cadmium in thick film pastes in ion selective
electrodes used for blood gas systems.

Expires on 31 August 2026
for cat. 8 IVD

31

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU

IV1(b)

Lead anodes in electrochemical oxygen
sensors.

Alphasense,
AmetekMocon,
Draeger,
Honeywell,1(b)(I)

Renew with below wording:Lead anodes in electrochemical sensors that measureoxygen concentrations of inhaled and/or exhaled air
for patients and that are intended to be used asconsumables in medical devices put on the market
before 26 May 2024.

Expires on 21 July 2025 forcat. 8 MD other than IVD

1(b)II)

Renew with wording recommended in previous
review:
Lead in galvanic oxygen sensors in instruments thatare designed for the measurement of dissolved
oxygen in concentrations below 30 ppb.

Expires on 21 July 2025 forcat. 91(b)(III)

Renew with modification of wording
recommended in previous review:
Lead anodes in galvanic capillary oxygen sensors in
instruments that are designed for the measurement ofoxygen in gases.

1(b)(IV)

1(b)(V)1(b)(VI)

IV1(c)

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

Bruker,PPTF

1(c)(I)

Renew with wording recommended in previous
review:
Lead anodes in Hersch cells for oxygen sensors
where sensitivity below 100 ppm is required.
Renew with wording recommended in previous
review:
Cadmium anodes in Hersch cells for oxygen sensors
where sensitivity below 100 ppm is required.
Renew with wording recommended in previous
review:
Lead anodes in permeable membrane oxygen
sensors in instruments that are designed for themeasurement of oxygen in gases.
Renew with wording recommended in previous
review:
Cadmium and mercury in mercury cadmium telluride(MCT) of infrared light detectors

Applies to cat. 9 IMCI and
expires on- 21 January 2027 forgeneral applications- 21 July 2028 for ATEXrated products
Expires on 21 July 2028 forcat. 9 IMCI
Expires [7 years after official
publication of the COM’s
decision] for cat. 9 IMCI

Expires on 31 December
2025 for cat. 9 IMCI

Expires on 21 July 2028 forcat. 8 and 932

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU

IV-4

Lead in glass frit of X-ray tubes andimage intensifiers and lead in glass fritbinder for assembly of gas lasers andfor vacuum tubes that convert
electromagnetic radiation into electrons.

4(a)Renew with below wording:Lead in glass frit binders for assembly of HeNe gas
lasers used in heterodyne interferometry calibrationand heterodyne interferometry positioning
applications.

TMC

Expires on 21 July 2026 forcat. 9 IMCI

IV-9

Cadmium in helium-cadmium lasers

JBCE

9

Renewal not recommended due to lack of
substantiated evidence required by Art. 5(1)(a).

Expires on 21 July 2024 forcat. 9 IMCI

IV-10

Lead and cadmium in atomic absorption
spectroscopy lamps

PerkinElmer,
Agilent
Technologies, JBCE,
Analytik
Jena,
Heraeus10(a)Renew with current wording until 24 February
2027, thereafter with below wording:Lead, cadmium, and mercury in electrodelessdischarge lamps for atomic absorption spectroscopy

Applies to cat. IMCI from 25
February 2027 on;
Expires on 21 July 2031

IV-46

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

COCIR

46

Renew with current wording.

Expires on 31 December
2026

IV-X

New exemption:
Cadmium in Hersch cells for oxygen
sensors used in industrial monitoring
and control instruments, where
sensitivity below 100 ppm is required

AMETEK
MOCON

1(b)(V)

Grant with below wording:Cadmium anodes in Hersch cells for oxygen sensors
where sensitivity below 100 ppm is required

Expires on [7 years after
official publication of COM
decision]

Note: Like in the RoHS legal text, commas are used as a decimal separator for exemption formulations appearing in this table, in contrast to the decimal point used throughout the rest of
the report as a separator.

33

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Note De Synthèse : Français
Au titre du contrat-cadre n°. ENV.B.3/FRA/2019/0017, un consortium coordonné par Bio
Innovation Service a été sollicité par la DG Environnement de la Commission Européenne
pour fournir un soutien technique et scientifique pour l'évaluation de la demande derenouvellement de 29 exemptions à l'annexe III de la directive 2011/65/UE. Le travail a été
entrepris par le Bio Innovation Service, UNITAR et le Fraunhofer Institute IZM, et a été
revu par des experts des trois organisations.

2.1.

Contexte et objectifs

La Directive 2011/65/UE (ci-après « la Directive ») relative à la limitation de l'utilisation decertaines substances dangereuses dans les équipements électriques et électroniquesprévoit « que les EEE mis sur le marché, y compris les câbles et les pièces détachéesdestinées à leur réparation, à leur réemploi, à la mise à jour de leurs fonctionnalités ou au
renforcement de leur capacité, ne contiennent aucune des substances énumérées à
l’annexe II » (à savoir le plomb, le mercure, le cadmium, le chrome hexavalent, les
polybromobiphényles, les polybromodiphényléthers et, à partir de juillet 2019, le phtalate
de bis(2-éthylhexyle), le phtalate de butylbenzyle, le phtalate de dibutyle et le phtalate dediisobutyle). L'article 5(1)(a), fournit une base pour exclure certaines applications de ces
dispositions par l'inclusion de matériaux et de composants d'EEE destinés à desapplications spécifiques dans les listes des annexes III et IV. Cet article précise en outre
les critères sur lesquels ces exemptions peuvent être justifiées : dans les cas où laprotection de l'environnement et de la santé assurée par le règlement 1907/2006/CE(REACH) n'est pas affaiblie, les exemptions peuvent être justifiées dans les cas où au
moins un des critères suivants est rempli :o« leur élimination ou leur remplacement sur la base de modifications de laconception, ou par des matériaux et composants ne nécessitant aucun desmatériaux ou substances énumérés à l’annexe II, est scientifiquement ou
techniquement impraticable,ola fiabilité des produits de substitution n’est pas garantie,oil est probable que l’ensemble des incidences négatives sur l’environnement, surla santé et sur la sécurité du consommateur liées à la substitution l’emportent sur
l’ensemble des bénéfices qui en découlent pour l’environnement, la santé et lasécurité du consommateur. »En outre, la disponibilité des substituts, les impacts socio-économiques de la substitution,
tout impact négatif potentiel sur l'innovation et les informations sur le cycle de vie peuventégalement être pris en compte pour déterminer la durée des exemptions.
L'article 5(2), de la Directive RoHS stipule que les exemptions énumérées à l'annexe III età l'annexe IV ont une date d'expiration. Lorsqu'aucune date spécifique n'est spécifiée, cetarticle énumère les dispositions permettant d’en clarifier la validité. L'article 5(3), exige queles parties prenantes soumettent à la Commission européenne des demandes d'octroi, derenouvellement ou de révocation des exemptions. Ces demandes servent de base à la34

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Commission pour lancer les évaluations des exemptions énumérées dans les annexes (oules évaluations des demandes de nouvelles exemptions).

2.2.

Principales conclusions - Aperçu des résultats del'évaluation

La demande d'exemption couverte par ce projet et le demandeur concerné, ainsi que larecommandation finale et la date d'expiration proposée sont présentés dans le Tableau 21 ci-dessous. Plus de détail sur le résultat de l'évaluation est présenté dans le chapitre
correspondant à chaque évaluation. Pour une meilleure lisibilité du tableau, les acronymes
suivants sont utilisés :cat.
catégorie de produit électriques et électronique tel que c’est défini dans l’annex I
de la directive RoHSCOM Commission européenne
MCI

instrument de contrôle et de surveillanceMDdispositifs médicaux

IMCI

instrument de contrôle et de surveillance industrielIncl.

inclusIVD

appareil médical de diagnostic in vitro

NB :

•

Les termes « cat. 8 » et « cat. 9 » appliquent à tous les EEE sous ces catégories. Par
exemple, « cat. 8 » inclut l'IVD ainsi que d'autres MD.

•

Les consultants suggèrent à la COM de prévoir un délai suffisant pour la préparation
et la soumission dans les délais des demandes de renouvellement entre la publication
officielle de la décision de la COM relative à l’accord des dérogations ou à leurrenouvellement et la date d’expiration des dérogations. Les dates d’expiration
recommandées en 2024, 2025 et début/mi-2026 peuvent donc effectivement êtredécalées à la discrétion de la COM.

•
Le résumé ci-dessous présent uniquement les formulations et les champs
d'exemption recommandées pour le cat. 8, cat. 9 et cat.11. Les recommandations derenouvellement de ces exemptions issues des récents examens effectués en 2021 et 2022
par Ramboll/Oeko-Institut et BIO IS/Fraunhofer IZM/UNITAR pour d'autres catégories
d'EEE restent valables.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU

Tableau 2-1 : Aperçu des demandes d'exemption, des recommandations et des dates d'expiration.
Ex.
no

Formulation actuelle de l’exemption(ou la nouvelle demanded’exemption)

Candidats

Recommandation

6(a)(I)
III6(a)Le plomb comme élément d'alliagedans l'acier destiné à l'usinage et dansl'acier galvanisé contenant jusqu'à 0,35
% de plomb en poids

EUROMOT,
TMC
6(a)(II)6(b)(I)
III6(b)Le plomb comme élément d'alliagedans l'aluminium contenant jusqu'à 0,4% de plomb en poids

EUROMOT,
TMC
6(b)(II)

Renouveler avec la formulation actuelle :Le plomb comme élément d'alliage dans l'acierdestiné à l'usinage contenant jusqu'à 0,35 % deplomb en poids
Renouveler avec la formulation recommandéedans l’évaluation précédente :Le plomb dans les composants en acier galvanisé à
chaud en lots contenant jusqu'à 0,2 % de plomb en
poids
Renouveler avec la formulation actuelle :Le plomb comme élément d'alliage dans l'aluminium
contenant jusqu'à 0,4 % de plomb en poids, àcondition qu'il provienne du recyclage de déchetsd'aluminium contenant du plomb
Renouveler avec la formulation actuelle :Le plomb comme élément d'alliage dans l'aluminium
destiné à l'usinage avec une teneur en plomb allant
jusqu'à 0,4 % en poids

Date d’expiration et champ
d’application

Expire le 21 juillet 2024 pourcat. 9 et 11

Expire le 21 juillet 2026 pourcat. 9 IMCI et 11

Expire le 21 juillet 2026 pourcat. 9 IMCI et 11

Expire le 21 juillet 2026 pourcat. 9 IMCI et 11

III7(a)Le plomb dans les soudures à hautetempérature de fusion (c'est-à-dire lesalliages à base de plomb contenant
85 % en poids ou plus de plomb)

EUROMOT,
TMC

7(a)Renouveler.

Expire le 21 juillet 2026 pourcat. 9 IMCI et 11

III7(c)(I)

Composants électriques etélectroniques contenant du plomb dans
un verre ou une céramique autre que lacéramique diélectrique dans lescondensateurs, par ex. dispositifs
piézoélectroniques, ou dans uncomposé à matrice de verre ou decéramique

EUROMOT,
TMC,
Werfen7(c)(I)

Renouveler.

Expire le 21 juillet 2026 pourcat. 9 IMCI et 1136

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU
Renouveler avec la formulation recommandéedans l’évaluation précédente :Le cadmium et ses composés dans les contactsélectriques pour- disjoncteurs,
III8(b)

Le cadmium et ses composés dans lescontacts électriques

TMC

8(b)(II)- contrôles de captage thermique,- dispositifs thermiques de protection des moteurs(sauf protecteurs thermiques des moteurs type
hermétique)- Interrupteurs CA

Expire le 31 décembre 2025
pour cat. 9 IMCI

- interrupteurs CC
III13(a)Le plomb dans les verres blancs utiliséspour les applications optiques

TMC

13(a)
13(b)(I)13(b)(II)

III13(b)Le cadmium et le plomb dans les verres
filtrants et les verres utilisés pour lesnormes de réflectanceTMC

13(b)(IV)

13(b)(V)

III-15

Le plomb dans les soudures pourréaliser une connexion électrique viable
entre la puce semi-conductrice et lesupport dans les boîtiers de puces
retournées de circuits intégrés

TMC

15

Renouveler avec la formulation actuelle (+options, cf. le sous chapitre recommandation)

Expire le 21 juillet 2028 pourcat. 9 IMCI

Renouveler avec la formulation actuelle : Le plomb
dans les verres à filtres optiques colorés
Renouveler avec la formulation actuelle : Le
cadmium dans les types de verres à filtres optiquesfrappants ; à l'exclusion des demandes relevant dupoint 39 de l'annexe III
Renouveler avec la formulation recommandéedans l’évaluation précédente :Le cadmium dans les émaux utilisés pour les normesde réflectance
Renouveler avec la formulation recommandéedans l’évaluation précédente :Revêtements composés de plomb dans les filtresinterférentiels infrarouges utilisés dans l'analyse desgaz infrarouges et la spectroscopie infrarouge moyen
et lointain

Expire le 21 juillet 2028 pourcat. 9 IMCI

Renouvellement non recommandé en raison dumanque de preuves requises par l'art. 5(1)(a).

Expire le 21 juillet 2024 pourcat. 9 IMCI

37

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU

III18(b)III-34

Le plomb comme activateur dans lapoudre fluorescente (1 % de plomb enpoids ou moins) des lampes à décharge
lorsqu'elles sont utilisées commelampes de bronzage contenant desluminophores tels que le BSP(BaSi2O5:Pb)
Le plomb dans les éléments depotentiomètre trimmer à base decermetLightingEuro
pe

18(b)

Renouveler avec la formulation actuelle.

Expire le 21 juillet 2026*
pour cat. 11.

TMC

34

Renouveler avec la formulation actuelle.

Expire le 21 juillet 2024*
pour cat. 9 IMCILe plomb dans les roulements et lesbagues des moteurs à combustion
interne alimentés au diesel ou au
carburant gazeux utilisés dans leséquipements à usage professionnel nonroutier :Renouveler avec une formulation modifiée :Jusqu'à 95 % de plomb dans les revêtements derecouvrement et/ou jusqu'à 33 % de plomb dans lesgarnitures de roulements et de coussinets de moteurs
à combustion interne fonctionnant au diesel ou àcarburant gazeux, utilisés dans des équipements nonroutier à usage professionnel :- avec cylindrée totale du moteur ≥ 15
litres;- avec cylindrée totale du moteur ≥ 15 litres;orIII-42ou
EUROMOT

42(a)- avec une cylindrée totale du moteur <15 litres et le moteur est conçu pourfonctionner dans des applications où letemps entre le signal de démarrage et lapleine charge doit être inférieur à 10
secondes ; ou un entretien régulier estgénéralement
effectuédans
unenvironnement extérieur difficile et sale,comme dans les applications minières,de construction et agricoles ;III-44

Le plomb dans la soudure des unités decommande des moteurs à combustion
relevant du champ d'application durèglement (UE) 2016/1628 duExpire le 21 juillet 2029 pourcat. 11- avec une cylindrée totale du moteur < 15 litres et lemoteur est conçu pour fonctionner dans desapplications où le temps entre le signal de démarrageet la pleine charge doit être inférieur à 10 secondes ;ou un entretien régulier est généralement effectué
dans un environnement extérieur difficile et sale,comme dans les applications minières, de construction
et agricoles.

EUROMOT

44

Renouveler avec la formulation actuelle.

Expire le 21 janvier 2027
pour cat. 11

38

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU
Parlement européen et du Conseil(2),installées dans des équipements
utilisés à des positions fixes enfonctionnement, destinés aux
professionnels, mais également utilisé
par des utilisateurs non professionnels ;Accorder avec la formulation ci-dessous :Le mercure dans les matériaux optiques constitués demonocristal de chlorure mercureux (calomel) à utiliser
dans les applications nécessitant un matériau
polarisant ou dans les applications acousto-optiques,si au moins une des propriétés ci-dessous est
requise :a) Un matériau cristallin est requis pour l'application
spécifique, et sa transmission doit inclure[1] deslongueurs d'onde dans le spectre allant de plus de 8
µm à 17 µm.
III-X

Nouvelle exemption:
Composants optiques en monocristal
de chlorure mercureux (calomel)

BBTXb) Indices of réfraction de no > 1,89 et ne > 2,44 à une
longueur d’onde de 10,6 µm et no > 2,11 et ne > 3,18 à
une longueur d’onde de 0,38 μm ainsi qu’unebiréfringence supérieure à +0,5 à n’importe quellepartie du spectre de longueur d’onde de 0,38 µm à
17 µm.

Expire le (date officiel depublication + 5 ans) pour cat.
3 et 9 IMCIc) Taux d'extinction supérieur à 1:20 000 dans lespectre des longueurs d'onde infrarouges comprises
entre 3 µm et 17 µm.
d) Vitesse de propagation des ondes élastiques
inférieure à 400 m/s

2 èglement (UE) 2016/1628 du Parlement européen et du Conseil du 14 septembre 2016 relatif aux exigences concernant les limites d'émission pour les gaz polluantset les particules polluantes et la réception par type pour les moteurs à combustion interne destinés aux engins mobiles non routiers, modifiant les règlements (UE)n° 1024/2012 et (UE) n° 167/2013 et modifiant et abrogeant la directive 97/68/CE (JO L 252, 16.9.2016, p. 53).

39

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EUe) Valeur du facteur de mérite acousto-optique M2 =640 x 10-15 s3/kg à une longueur d'onde de 632,8 nm
Seuil de dommage supérieur à 5 x 105 W/cm2 à 1.064
nm
IV1(a)

IV1(b)

Le plomb et le cadmium dans lesélectrodes sélectives d’ions, y compris
le verre des électrodes de mesure dupH

Les anodes en plomb dans les capteursélectrochimiques d’oxygène

COCIR

Alphasense,
AmetekMocon,
Draeger,
Honeywell,1(a)(I)

Renouveler avec la formulation ci-dessous :Le plomb et le cadmium dans les pâtes à film épais
des électrodes sélectives d'ions utilisées pour lessystèmes de gaz du sang.

Expire le 31 août 2026 pourcat. 8 IVD

1(b)(I)

Renouveler avec la formulation ci-dessous :Les anodes en plomb dans les capteursélectrochimiques mesurant la concentration del’oxygène de l’air inspiré et/ou expiré par les patients,
et qui sont des consommables dans des dispositifs
médicaux mis sur le marché avant le 26 mai 2024.

Expire le 21 juillet 2025 pourcat. 8 MD autres que l’IVD

1(b)II)

Renouveler avec la formulation recommandéedans l’évaluation précédente :Le plomb dans les capteurs d'oxygène galvaniques
dans les instruments conçus pour mesurer l'oxygène
dissous dans des concentrations inférieures à 30 ppb.

Expire le 21 juillet 2025 pourcat. 91(b)(III)

Renouveler avec la formulation recommandéedans l’évaluation précédente :Anodes en plomb dans les capteurs d'oxygène
capillaires galvaniques dans les instruments conçus
pour la mesure de l'oxygène dans les gaz.

1(b)(IV)

1(b)(V)

Renouveler avec la formulation recommandéedans l’évaluation précédente :Anodes en plomb dans les cellules Hersch pourcapteurs d'oxygène où une sensibilité inférieure à 100
ppm est requise.
Renouveler avec la formulation recommandéedans l’évaluation précédente :Anodes en cadmium dans les cellules Hersch pourcapteurs d'oxygène où une sensibilité inférieure à 100
ppm est requise.

Applique à la cat. 9 IMCI et
expires- le 21 janvier 2027 pour desapplications générales- 21 juillet 2028 pour desproduits certifiés ATEX
Expire le 21 juillet 2028 pourcat. 9 IMCI

Expire [7 ans après lapublication officielle dedécision de la COM] pourcat. 9 IMCI

40

Study to assess requests for 29 renewal requests concerning one specific EEE category and two (-2-) new exemption requests under the
Directive 2011/65/EU

1(b)(VI)

IV1(c)

Le plomb, le cadmium et le mercuredans les détecteurs à infrarouges

IV-4

Le plomb dans la fritte de verre destubes à rayons X et les intensificateurs
d'images et le plomb dans liant de fritte
de verre au plomb pour l'assemblage
de lasers à gaz et de tubes à vide qui
convertissent le rayonnementélectromagnétique en électrons.

TMC

IV-9

Le cadmium dans les lasers héliumcadmium

JBCE

Le plomb et le cadmium dans leslampes de spectroscopie d'absorption
atomique

IV-10

IV-46

IV-X

Bis(2-ethylhexyl) phtalate (DEHP) dansles composants en plastique desbobines de détection IRM
Nouvelle exemption :Le cadmium dans les cellules Hersch
pour les capteurs d'oxygène utilisés
dans les instruments de surveillance etde contrôle industriels, où une
sensibilité inférieure à 100 ppm est
requiseBruker,PPTF

1(c)(I)

Renouveler avec la formulation recommandéedans l’évaluation précédente :Anodes en plomb dans les capteurs d'oxygène à
membrane perméable dans les instruments conçus
pour la mesure de l'oxygène dans les gaz.
Renouveler avec la formulation recommandéedans l’évaluation précédente :Le cadmium et le mercure dans le tellurure demercure et de cadmium (MCT) des détecteurs delumière infrarouge

Expire le 31 décembre 2025
pour cat. 9 IMCI

Expire le 21 juillet 2028 pourcat. 8 et 94(a)Renouveler avec la formulation ci-dessous :Le plomb dans les liants de fritte de verre pourl'assemblage de lasers à gaz HeNe utilisés dans lesapplications d'étalonnage d'interférométrie
hétérodyne et de positionnement d'interférométrie
hétérodyne.

Expire le 21 juillet 2026 pourcat. 9 IMCI

9

Renouvellement non recommandé en raison dumanque de preuves motivées requises par l'art.
5(1)(a).

Expire le 21 juillet 2024 pourcat. 9 IMCIPerkinElmer,
Agilent
Technologies, JBCE,
Analytik
Jena,
Heraeus10(a)Renouveler avec la formulation actuelle jusq’au
24 février 2027, ensuite la formulation ci-dessous
Le plomb, le cadmium et le mercure dans les lampes
à décharge sans électrode pour la spectroscopied'absorption atomique.

Applique à la cat. IMCI à
partir du 25 février 2027 ;Expire le 21 juillet 2031

COCIR

46

Renouveler avec la formulation actuelle.

Expire le 31 décembre 2026

1(b)(V)

Accorder avec la formulation ci-dessous :Anodes en cadmium dans les cellules Hersch pourcapteurs d'oxygène où une sensibilité inférieure à 100
ppm est requise.

Expire le [7 ans après lapublication officielle dedécision de la COM]

AMETEK
MOCON

41

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Introduction
The consortium for the Framework Contract Assistance to the Commission ontechnological, socio-economic and cost benefit assessments related to the implementationand further development of EU waste legislation (ENV.B.3/FRA/2019/0017) coordinated by
Bio Innovation Service (BioIS) was mandated by the European Commission with the “Study
to assess requests for a renewal of eleven exemptions of Annex III of Directive 2011/65/EU”
performed under the study request No 090202/2023/900216/ENV.B.3.

3.1.

Project scope

The Commission needs clear technical and scientific evidence and an assessment of theserequests for granting, renewing or revoking exemptions in the light of the criteria listed in
the Directive, notably the provisions cited above, taking into consideration the differing
validity periods and expiry dates for the various product categories 1-11 of Annex I of the
RoHS Directive. During the evaluation, a public online stakeholder consultation was alsoorganised.
This study will provide the Commission required technical and scientific support for theevaluation of the requests for renewal and amendment of the exemptions displayed in the
below table. The number of exemptions in the table less than 29 since the exemptions wereregrouped for the review.
Abbreviations used in the below table:
Cat.
IMCI
IVD

Category
Industrial monitoring and control instruments
In vitro diagnostic medical devices

Table 3-1: Overview of exemptions to be reviewed
Exemp. Requested Exemption wording
entry
for cat.

Current expiry dates
for categories
relevant for therequest

III-20221

Requested for 7 years

9, 11

Request for new exemption:
Optical components made of mercurous chloride
monocrystal (Calomel)

IV-2022- 9
2

Request for new exemption:

III-6(a)Lead as an alloying element in steel for machining
purposes and in galvanised steel containing up to 21 July 2024 for cat. 9
IMCI and for cat. 11
0,35 % lead by weight

9 IMCI, 11

Requested for 7 years

Cadmium in Hersch cells for oxygen sensors used inindustrial monitoring and control instruments, where
sensitivity below 100 ppm is required

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Exemp. Requested Exemption wording
entry
for cat.

Current expiry dates
for categories
relevant for therequestIII-6(b)9 IMCI, 11

Lead as an alloying element in aluminium containing up
21 July 2024 for cat. 9
to 0,4 % lead by weight
IMCI and 11

III-6b(I)11

Lead as an alloying element in aluminium containing up Currently not applicable toto 0,4 % lead by weight, provided it stems from lead- cat. 11
bearing aluminium scrap recycling

III-6b(II)11

Lead as an alloying element in aluminium for machining Currently not applicable topurposes with a lead content up to 0,4 % by weightcat. 11

III-7(a)9 IMCI, 11

Lead in high melting temperature type solders (i.e. lead21 July 2024 for cat. 9
based alloys containing 85 % by weight or more lead)
IMCI and 11

III-7(c)(I) 8 IVD,
IMCI, 11

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

21 July 2023 for cat. 8
IVD
21 July 2024 for cat. 9
IMCI and 11

III-8(b)9 IMCI

Cadmium and its compounds in electrical contacts

III-13(a)9 IMCI

Lead in white glasses used for optical applications

III-13(b)9 IMCI

Cadmium and lead in filter glasses and glasses used for 21 July 2024 for cat. 9
reflectance standards

III-15

9 IMCI

Lead in solders to complete a viable electricalconnection between semiconductor die and carrier 21 July 2024 for cat. 9
within integrated circuit flip chip packages

III 18b

11

Lead as activator in the fluorescent powder (1 % lead byweight or less) of discharge lamps when used as sun 21 July 2024 for cat. 11.
tanning lamps containing phosphors such as BSP(BaSi2O5:Pb)

III 34

9 IMCI

Lead in cermet-based trimmer potentiometer elements

III 42

11

Lead in bearings and bushes of diesel or gaseous fuel- 21 July 2024 for cat. 11
powered internal combustion engines applied in nonroad professional use equipment:
displacement≥15

21 July 2024 for cat. 9
IMCI and 11
21 July 2024 for cat. 9

litres;

-

with
or

-

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

enginetotal

21 July 2024 for cat. 9
IMCI

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Exemp. Requested Exemption wording
entry
for cat.

Current expiry dates
for categories
relevant for therequest

III 44

11

Lead in the solder of sensors, actuators, and engine 21 July 2024 for cat. 11
control units of combustion engines within the scope ofRegulation (EU) 2016/1628, installed in equipment used
at fixed positions while in operation, which is designed
for professionals, but also used by non-professional
users

IV 1a

8 IVD

Lead and cadmium in ion-selective electrodes, including 21 July 2023 for cat. 8 IVD
glass of pH electrodes

IV 1b

9 IMCI

Lead anodes in electrochemical oxygen sensors

21 July 2024 for cat. 9
IMCI

IV 1c

9 IMCI

Lead, cadmium and mercury in infra-red light detectors

21 July 2024 for cat. 9
IMCI

IV 4

9 IMCI

Lead in glass frit of X-ray tubes and image intensifiers 21 July 2024 for cat. 9
and lead in glass frit binder for assembly of gas lasers IMCIand for vacuum tubes that convert electromagnetic
radiation into electrons

IV 9

9 IMCI

Cadmium in helium-cadmium lasers

IV 10

9 IMCI

Lead and cadmium in atomic absorption spectroscopy 21 July 2024 for cat. 9
lamps
IMCI

IV 46

8

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

21 July 2024 for cat. 9
IMCI

21 July 2024 for cat. 8other than IVD

44Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

3.2.

Overview: Links between the RoHS Directive and the
REACH Regulation

Article 5 of the RoHS 2 Directive 2011/65/EU on “Adaptation of the Annexes to scientificand technical progress” provides for that:“Inclusion of materials and components of EEE for specific applications in the lists
in Annexes III and IV, provided that such inclusion does not weaken theenvironmental and health protection afforded by Regulation (EC) No 1907/2006”.
Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH) regulates the manufacturing, use or placing on themarket of chemical substances on the Union market. REACH, for its part, addresses
hazardous substances through processes of authorisation (substances of very highconcern) and restriction (substances of any concern):▪

Substances that may have serious and often irreversible effects on human health andthe environment can be added to the candidate list to be identified as Substances ofVery High Concern (SVHCs). Following the identification as SVHC, a substance may
be included in Annex XIV of the REACH Regulation (Authorisation list): “List of
Substances Subject to Authorisation”. If an SVHC is placed on the Authorisation list,
companies (manufacturers and importers) that wish to continue using it or continue
placing it on the market must apply for an authorisation for a specified use. Article 22of the REACH Regulation states that:“Authorisations for the placing on the market and use should be granted by theCommission only if the risks arising from their use are adequately controlled, where
this is possible, or the use can be justified for socio-economic reasons and no suitable
alternatives are available, which are economically and technically viable.”▪ If a Member State or the European Chemicals Agency (ECHA), upon request of theCommission, considers that the manufacture, placing on the market or use of a
substance on its own, in a mixture or in an article poses a risk to human health or theenvironment that it is not adequately controlled, it shall prepare a restriction dossier.
ECHA also has the initiative to prepare a restriction dossier for any substance in theauthorisation list if the use of that substance in articles poses a risk to human healthand the environment that is not adequately controlled. The provisions of the restriction
may be made subject to total or partial bans or conditions for restrictions based on anassessment of the risks and the assessment of the socio-economic elements.
The approach adopted in this report is that once a substance has been included in the
Annexes related to the authorisation or restriction of substances and articles under the
REACH Regulation, the environmental and health protection afforded by REACH may be
weakened in cases where an exemption would be granted for these uses under theprovisions of RoHS.
Substances for which an authorisation or restriction process is underway may be discussed
in some cases in relation to a specific exemption to check possible overlaps in the scope of45

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

such processes and of requested RoHS exemptions and to identify the need for possiblealignments of these two legislations.3
When evaluating the exemption requests, with regard to REACH compliance, we havechecked whether the substance / or its substitutes are:▪

on the list of substances of very high concern (SVHCs- the Candidate List);▪ in the recommendations of substances for Annex XIV (recommended to be added to
the Authorisation List);▪ listed in REACH Annex XIV itself (the Authorisation List); or▪ listed in REACH Annex XVII (the List of Restrictions).
As ECHA is “the driving force among regulatory authorities in implementing the EU's
chemicals legislation”, the ECHA website has been used as the reference point for the
aforementioned lists, as well as for the register of the amendments to the REACH legal text.
The figure below shows the relationship between the two processes under REACH as wellas the process on harmonized classification and labelling under the CLP regulation(Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging). Substances
included in the red areas may only be used when certain specifications and or conditions
are fulfilled.
Figure 3-1: Relation of REACH categories and lists to other chemical substances

Before reaching the "Registry of Intentions" as shown in the figure above, there are
additional activities and processes in order to identify substances of potential concern

3 In 2014, the European Commission has prepared a Common Understanding Paper regarding the REACH

and RoHS relationship in 2014 with a view to achieving coherence in relation to risk management measures,
adopted under REACH and under RoHS:
REACH AND DIRECTIVE 2011/65/EU (RoHS) A Common Understanding; Ref. Ares(2014)2334574 14/07/2014 at http://ec.europa.eu/DocsRoom/documents/5804/attachments/1/translations

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

conducted by the ECHA together with the Member States and different ECHA Expert
Groups.4 If a Member State evaluates a certain substance to clarify whether its use posesa risk to human health or the environment, the substance is subject to a Substance
Evaluation. The objective is to request further information from the registrants of thesubstance to verify the suspected concern. Those selected substances are listed by ECHA
in the community rolling action plan (CoRAP).5 If the Substance Evaluation concludes thatthe risks are not sufficiently under control with the measures already in place and if a Risk
Management Option (RMO) analysis does not conclude that there are appropriate
instruments by other legislation / actions, the substance will be notified in the Registry of
Intentions.
The following bullet points explain in detail the above-mentioned lists and where they canbe accessed:
▪

▪

▪

▪

Member States Competent Authorities (MSCAs) / ECHA, on request by theCommission, may prepare Annex XV dossiers for identification of SVHCs, Annex XV
dossiers for proposing a harmonised Classification and Labelling, or Annex XV
dossiers proposing restrictions. The aim of the public Registry of Intentions is to inform
interested parties of the substances for which the authorities intend to submit Annex
XV dossiers and, therefore, to facilitate timely preparation of the interested parties forcommenting later in the process. It is also important to avoid duplication of work andencourage co-operation between Member States when preparing dossiers. Note that
the Registry of Intentions is divided into three separate sections: listing new intentions;
intentions still subject to the decision-making process; and withdrawn intentions. The
registry of intentions is available at the ECHA website at:https://echa.europa.eu/registry-of-intentions;
The identification of a substance as a Substance of Very High Concern and its
inclusion in the Candidate List is the first step in the authorisation procedure. The
Candidate List is available at the ECHA website at https://echa.europa.eu/candidatelist-table;
The last step of the procedure, prior to the inclusion of a substance into Annex XIV(the Authorisation list), involves ECHA issuing a Recommendation of substances forAnnex XIV. The previous ECHA recommendations for inclusion in the Authorisation
List are available at the ECHA website at https://echa.europa.eu/previousrecommendations;
Once a decision is made, substances may be added to the Authorisation List available
under Annex XIV of the REACH Regulation. The use of substances appearing on thislist is prohibited unless an Authorisation for use in a specific application has been
approved. The Annex can be found in the consolidated version of the REACH legal
text;

4 For an overview in these activities and processes see the ECHA webpage at:https://echa.europa.eu/substances-of-potential-concern
5 Updates and general information can be found under: https://echa.europa.eu/information-on-

chemicals/evaluation/community-rolling-action-plan/corap-list-of-substances. The list can be found on thefollowing page: https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-actionplan/corap-table47

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU▪

In parallel, if a decision is made concerning the restriction on the use of a substance ina specific article or concerning the restriction of its provision on the European market,
then a restriction is formulated to address the specific terms, and this shall be added
to Annex XVII of the REACH Regulation. The Annex can be found in the consolidated
version of the REACH legal text; andThe ECHA web page was used to reference Annexes XIV and XVII:•

Annex XIV: https://echa.europa.eu/authorisation-list•

Annex XVII: https://echa.europa.eu/substances-restricted-under-reach

Relevant annexes and processes related to the REACH Regulation have been crosschecked to clarify:
In what cases granting an exemption could “weaken the environmental and healthprotection afforded by Regulation (EC) No 1907/2006” (Article 5(1)(a) of the RoHS
Directive).
▪ Where processes related to the REACH Regulation should be followed to understandwhere such cases may become relevant in the future.
In this respect, restrictions and authorisations as well as processes that may lead to theirinitiation, have been reviewed, in respect of where RoHS Annex II substances are
mentioned (i.e. cadmium, lead, mercury, hexavalent chromium, polybrominated biphenyls(PBB) and polybrominated diphenyl ethers (PBDE) as well as bis (2-ethylhexyl) phthalate(DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DiBP).6▪

Specific REACH-related information for substancesof relevance for the exemption requests of this review
The exemption requests to be reviewed included the following substances:•

Cadmium (Cd)•

Lead (Pb)•

Mercury (Hg)

•

DEHP

4.1.

Cadmium

Annex XIV
Cadmium and several of its compounds are classified as substances of very high concern
but so far are not adopted to Annex XIV as substances that require authorisation for use.

6 The four phthalates, DEHP, BBP, DBP and DIBP have been added to the Annex according to Commission

Delegated Directive (EU) 2015/863 of 31 March 2015.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Annex XVII
Cadmium is mentioned in a few of the listed restrictions.
Entry 23
This entry refers to cadmium and its compounds. Under this entry, several restrictions are
mentioned for cadmium and the compounds. The restrictions for cadmium and its
compounds with potential relevance for EEE are listed in the following paragraphs7:
1. They shall not be used in mixtures and articles produced from the following
synthetic organic polymers (hereafter referred to as plastic material) unless they
contain cadmium for safety reasons:•polymers or copolymers of vinyl chloride (PVC) [3904 10] [3904 21]•

polyurethane (PUR) [3909 50]•

low-density polyethylene (LDPE), with the exception of low-density
polyethylene used for the production of coloured masterbatch [3901 10]•

cellulose acetate (CA) [3912 11]•

cellulose acetate butyrate (CAB) [3912 11]•

epoxy resins [3907 30]•

melamine-formaldehyde (MF) resins [3909 20]•

urea-formaldehyde (UF) resins [3909 10]•

unsaturated polyesters (UP) [3907 91]•

polyethylene terephthalate (PET) [3907 60]•

polybutylene terephthalate (PBT)•

transparent/general-purpose polystyrene [3903 11]•

acrylonitrile methylmethacrylate (AMMA)•

cross-linked polyethylene (VPE)•

high-impact polystyrene•

polypropylene (PP) [3902 10]

Mixtures and articles produced from plastic material as listed above shall not be
placed on the market if the concentration of cadmium (expressed as Cd metal) is
equal to or greater than 0.01 % by weight of the plastic material.
In the exemptions that were reviewed in pack 27, cadmium or any of its compounds are notused in any of the above materials. The above restriction is thus not applicable.
2. Cadmium and its compounds shall not be used or placed on the market in certain
paints with specific coces in concentrations of more than 0.01 % (mass), or 0.1 %7 Missing numberings refer to uses of cadmium in mixtures and arcticles whose relevance for EEE can be
excluded.

49

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(mass) if they colour contains more than 10 % (weight) of zinc, unless they
contain cadmium for safety reasons.
In the exemptions that were reviewed in pack 27, cadmium or any of its compounds are notused in paints. The above restriction is thus not applicable.
3. Cadmium and its compounds shall not be used for cadmium plating8 metallic
articles or components of articles used ina. equipment and machinery in the following sectors/applications:•

Food production•

Cooling and freezing,•

Printing and book-binding

b. Equipment and machinery for the production of :•Household goods•

Furniture•

Sanitary ware•

Central heating and air conditioning plant•

Paper and board•

Textiles and clothing•

Industrial handling equipment and machinery

In any case, whatever their use or intended final purpose, the placing on themarket of cadmium-plated articles or components of such articles used in the
sectors/applications listed in points (a) and (b) above and of articles
manufactured in the sectors listed in point (b) above is prohibited.
In the exemptions that were reviewed in pack 27, cadmium is not used in metallic cadmium
platings. In the exemption 8(b) series, cadmium is applied as silver cadmium-oxide andhence as an alloy, not in metallic form as cadmium. The above stipulation is thus notapplicable. Any other uses of cadmium in exemptions reviewed in pack 27 cannot be related
to the plating of elemental cadmium on metallic surfaces.
Overall, the above stipulations do not apply to the use of cadmium in any of the exemptionsof pack 27.
4. Cadmium and its compounds shall not be used in brazing fillers in concentrationsof 0.01 % (mass) or higher unless used for safety reasons. For the purpose ofthis paragraph brazing shall mean a joining technique using alloys andundertaken at temperatures above 450 °C.
None of the exemptions reviewed in pack 27 includes uses of cadmium or its compounds
in brazing fillers.

8 ‘Cadmium plating’ means any deposit or coating of metallic cadmium on a metallic surface.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

5. Cadmium and its compounds shall not be used or placed on the market if theconcentration is equal to or greater than 0.01 % by weight of the metal parts ofjewellery and imitation jewellery articles, e.g. in wristwatches and wrist-wear.
While the exemptions reviewed in pack 27 do not imply the use of cadmium or its
compounds in jewellery or imitation jewellery, cadmium could, in principle, be used inelectrical contacts of wristwatches according to the wording of exemption III-8(b). The
applicability of the exemption is, however, limited to use in EEE of cat. 8, 9 and 11, like thescope of exemption 8(b)(II) recommended by (Deubzer et al. 2022c) as renewal of
exemption 8(b). Further on, the switches in the scope of exemption 8(b)(II) can bereasonably excluded from occurring in wristwatches.
Entry 23 is not applicable to the exemptions in the scope of the pack 22 review.
Entries 28 and 30
These entries refer to substances which are•classified as carcinogen category 1A or 1B, and/or as reproductive toxicants in Part
3 of Annex VI to Regulation (EC) No 1272/2008 (CLP-Annex VI), and•listed in Appendices 1, 2, 5 or 6.

The placing on the market, or use of various substances as such, as constituents ofother substances, or in mixtures, for supply to the general public is restricted.
Lead and lead compounds are mentioned in the related appendices 2 and 5, as well as inpart 3 of CLP-Annex VI with the above-mentioned classifications. Entry 72 defines thethresholds for these substances as 1 mg/kg.
The use of cadmium or cadmium compounds in exemptions that were reviewed in pack 27
does not imply the supply of such substances in any of the above described forms to thegeneral public. Cadmium or its compounds are used in articles, i.e. in electrical andelectronic equipment.
Entry 72
Entry 72 lists substances which are classified as carcinogenic, mutagenic or toxic for
reproduction in entries 28, 29 and 30. It stipulates that the substances listed in column 1 of
the table in Appendix 12 shall not be used in textiles, clothing and footwear. The table lists
cadmium and its compounds as listed under entries 28, 29 and 30.
Like entries 28 and 30, this entry does not address the use of cadmium in the scope of anyof the requested new exemptions or exemption renewal requests.

4.2.

Lead

Annex XIV
Lead and several of its compounds, e.g. lead zirconium oxide and lead monoxide, aresubstances of very high concern.9 So far, lead has not been adopted to REACH Annex XIV

9 Cf. ECHA, https://echa.europa.eu/candidate-list-table51

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

as an element. The fact that substances are candidate substances therefore does not
weaken the environmental and health protection afforded by“ the REACH Regulation until
they are also adopted to Annex XIV.
Annex XIV lists lead compounds, the placing on the market and use of which would requireauthorisation in the European Economic Area:•

Entry 10: Lead chromate;•

Entry 11: Lead sulfochromate yellow;•

Entry 12: Lead chromate molybdate sulphate red;•

Entry 55: Tetraethyllead

Some of the above substances could in principle be of relevance for exemptions III-13(a)and III-13(b) (glasses for optical applications). Exemption 13(a) does not refer to coloured
glasses, and the applicants do not mention any relevance of substances on Annex XIV intheir renewal request. For 13(b) dealing with coloured glasses, the applicants confirmed theabsence of these substances in the products in the scope of these exemptions.
For other exemptions in the scope of this review, the above substances are not relevant.
Annex XVII
Annex XVII contains entries restricting the use of lead compounds:•

Entry 16 restricts the use of lead carbonates in paints;•

Entry 17 restricts the use of lead sulphates in paints;•

Entry 19 refers to arsenic compounds but includes a few lead compounds andrestricts their use as anti-fouling agent, for treatment of industrial water or for thepreservation of wood;

None of the above entries is applicable to the use of lead and its compounds in the scopeof the exemptions that were reviewed in pack 27.
Entry 23
Entry 23 restricts the use of lead in certain types of plastics (see respective paragraph for
cadmium in this chapter). This includes the cadmium compound cadmium copper lead zinc
sulfide.
This substance is not relevant for the exemptions to be reviewed in pack 27, and lead is not
used in plastics in the context of any of these exemptions. Entry 23 is, therefore notapplicable.
Entry 27
Entry 27 restricts the use nickel in “post assemblies” inserted into pierced parts of the humanbody and in articles intended to come into direct and prolonged contact with skin, such as,
among others, wristwatches. Lead nickel silicate is mentioned in entry 27.
This lead-containing substance is not relevant for the exemptions of pack 27.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Entries 28 and 30
For details of the entry conditions see the entry for 28 and 30 under cadmium.
Lead and lead compounds are mentioned in the related appendices 1, 2, and 5, as well as
in part 3 of CLP-Annex V with the above-mentioned classifications. Entry 72 defines thethresholds for these substances as 1 mg/kg.
The use of lead or lead compounds in exemptions to be reviewed in pack 27 do not imply
the supply of such substances in any of the above-described forms to the general public.
Lead or its compounds are used in articles, i.e. in electrical and electronic equipment.
Entry 63
Point 1 stipulates that lead and its compounds shall not be placed on the market or used in
any individual part of jewellery articles if the concentration of lead (expressed as metal) insuch a part is equal to or greater than 0.05 % by weight. Jewellery articles addressed in thiscontext include, among others, bracelets, piercing jewellery, and wristwatches. According
to point 4, this restriction of lead does, however, not apply to lead used in internal
components of watch timepieces that are inaccessible to consumers. 10
Point 7 restricts the use of lead in articles and accessible parts thereof that may, during
normal or reasonably foreseeable conditions of use, be placed in the mouth by children,which does, however, not apply to articles in the scope of Directive 2011/65/EU (RoHS
Directive).
The restriction of lead use in wristwatches (point 1 of entry 63) that qualify as EEE, even if
it is applicable, is not relevant for the exemptions at hand since the focus of the review istheir use in EEE of categories 8, 9 and 11 only while wristwatches are EEE of cat. 4(consumer equipment) or possibly cat. 3 (IT and telecommunication equipment).
Legally, point 7 is not relevant either because articles/EEE in the scope of the RoHS
Directive are excluded. Other restrictions of lead and its compounds in entry 63, like forexample, lead in gunshots, are not applicable to EEE and its components and materials.
Entry 72
Entry 72 lists substances which are classified as carcinogenic, mutagenic or toxic for
reproduction. It stipulates that the substances listed in column 1 of the table in Appendix 12
shall not be used in textiles, clothing and footwear. The table lists lead and its compounds
mentioned in entries 28, 29, 30 and Appendices 1-6.
The use of lead and its compounds in the exemptions to be reviewed is not related to
textiles, clothing and footwear. Entry 72 is, therefore, not relevant.
The use of lead within the scope of the requested exemption does not regard paints or
jewellery nor components that could be expected to be placed in the mouth by children
under normal or foreseeable use. Furthermore, this use of lead is not a supply of leadcompounds as a substance, mixture or constituent of other mixtures to the general public.
Lead is part of an article and as such, the above entries of Annex XVII of the REACH
Regulation would not apply.

10 Cf. Conditions of restriction for entry 63, https://echa.europa.eu/documents/10162/64e0e958-99c2-e75e-

4fa8-d2b71b18f0b4)

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No other entries with relevance for the use of lead in the requested exemption could be
identified in Annexes XIV and Annex XVII. Based on the current status of these annexes,
granting the requested exemption would not weaken the environmental and healthprotection afforded by the REACH Regulation. An exemption could therefore be granted if
the respective criteria of Art. 5(1)(a) apply.

4.3.

Mercury

Annex IX
There are no entries for mercury or its compounds.
Annex XVII
Annex XVII of the REACH Regulation contains several entries restricting the use of mercury
and of mercury compounds.
Entry 18
Entry 18 restricts placing on the market, or use, as substances or in mixtures mercury
compounds where the substance are intended for certain uses, e.g. in treatment of industrial
sewage or for the impregnation of heavy-duty industrial textiles and yarn.
Mercury in the applications in scope of the requested exemption is not used for any of theabove applications, and the restrictions are therefore not applicable.
Entry 18a
Entry 18a restricts the use of mercury in:•fever thermometers;•other measuring devices intended for sale to the general public (such as
manometers, barometers, sphygmomanometers, thermometers other than fever
thermometers);•

a number of specified measuring devices intended for industrial and professional
uses, in particular barometers, hygrometers, manometers, sphygmomanometers11,
strain gauges to be used with plethysmographs12, tensiometers, thermometers andother non-electrical thermometric applications, mercury pycnometers and mercury
metering devices for determination of the softening point.

In the exemptions that were reviewed in pack 27, mercury is neither used in fever
thermometers or other measuring devices for sale to the general public nor in the above
devices for industrial and professional uses.

11 Device used to measure blood pressure.
12 Device for measuring changes in volume within an organ.

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Entry 23
Entry 23 restricts the use of cadmium in certain types of plastics (see respective paragraphfor cadmium in this chapter). This includes the cadmium compound “cadmium mercury red”.
This substance is not relevant for the exemptions of pack 27.
Entry 30This entry refers to substances which are•classified as reproductive toxicants in Part 3 of Annex VI to Regulation (EC) No
1272/2008, and•listed in Appendices 5 or 6. The placing on the market, or use of various substances
as such, as constituents of other substances, or in mixtures, for supply to the generalpublic is restricted.

Mercury is mentioned in appendix 6, as well as in part 3 of CLP-Annex V with the abovementioned classifications.
The use of mercury or mercury compounds in exemptions to be reviewed do not imply the
supply of mercury or mercury compounds as substances or mixtures to the general public.
Cadmium or its compounds are used in articles, i.e. in electrical and electronic equipment.
Entry 62
Entry 62 lists several phenylmercury compounds13.
Phenylmercury compounds are not relevant for any of the exemptions in the scope of thisreview.

4.4.

DEHP

Annex XIV
DEHP has been included in the SVHC REACH candidate list for the reason of being toxic
for reproduction in 2008 and has been added to Annex XIV in 2012. In July 2017, DEHP
has been additionally recognized for endocrine disrupting properties. Thus, DEHP as
substance cannot be placed on the Union market or used after the 21 February 2015
(sunset date), unless an authorisation is granted.
The above stipulation is, in principle, relevant for the renewal of exemption IV-46(phthalate (DEHP) in plastic components in MRI detector coils). Since the PVC material forthe cable strain reliefs is supplied from outside the EU, Annex XIV is not relevant because
the stipulation does not apply to imported articles into the EU.

13 ECHA, https://echa.europa.eu/substances-restricted-under-

reach?p_p_id=disslists_WAR_disslistsportlet&p_p_lifecycle=1&p_p_state=normal&p_p_mode=
view&_disslists_WAR_disslistsportlet_javax.portlet.action=searchDissLists

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Annex XVIIDEHP is listed on Annex XVII.
Entry 30
Entry 30 (for details see above entry 30 for mercury) is relevant. DEHP is listed inAppendix 6, and in part 3 of CLP-Annex V due to its properties as reproductive toxicant.
DEHP shall not be placed on the market, or used, as substances, constituents of othersubstances, or in mixtures for supply to the general public.
The use of DEHP in exemption IV-46 does not imply the supply of such substances in anyof the above described forms to the general public. DEHP is used in articles, i.e. in electricaland electronic equipment.
Entry 51
Clauses 1 and 2 stipulate that DEHP shall not be used as substances or in mixtures,individually or in an combination with the other phthalates listed in entry 51 (equivalent tothose restricted under RoHS, status May 2024), in concentrations equal or greater than
0.1 % by weight of the plasticised material, in toys and childcare articles.
Toys and childcare articles containing DEHP in a concentration greater than 0.1 % by weightof the plasticized material shall not be placed on the market.
The exemptions at hand are not used in toys or childcare EEE so that the above stipulations
are not relevant.
Clause 3 stipulates that DEHP shall not be placed on the market after 7 July 2020 in articles,
individually or in any combination of the other phthalates that are also restricted under RoHS
(DBP, BBP, DiBP) in a concentration equal to or greater than 0,1 % by weight of theplasticised material in the article.
The restriction of clause 3 does, however, not apply to medical devices within the scope of
Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof, and it shall not apply toelectrical and electronic equipment within the scope of Directive 2011/65/EU (RoHS
Directive).
Thus, the restriction for lead and it compounds in clause 3 is not relevant for the exemptions
to be reviewed.
In the consultants’ understanding, the restrictions for substances under entry 30 of Annex
XVII do not apply. The supply of DEHP in plastic strain reliefs is in the consultants’ point ofview not a supply of DEHP as a substance, mixture or constituent of other mixtures to thegeneral public. DEHP is part of an article and as such, entry 30 of Annex XVII of the REACH
Regulation would not apply.
No other entries, relevant for the use of DEHP in the requested exemption could be
identified in Annex XIV and Annex XVII (status May 2020). Based on the current status of
Annexes XIV and XVII of the REACH Regulation, the requested exemption would not
weaken the environmental and health protection afforded by the REACH Regulation. An
exemption could, therefore be granted if other criteria of Art. 5(1)(a) apply.

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Exemption 6(a)-series of Annex III: Lead as alloying
element in steel
The below Table 5-1 shows the wording, scope and expiry dates of the exemption.
Table 5-1: Current wording of the exemption 6(a)-series
No.

Exemption

Scope and dates of applicability

6(a)Lead as an alloying
element in steel formachining purposes
and in galvanised steel
containing up to 0,35 %lead by weight

Applies to categories 8, 9 and 11 and expires on

6(a)(I)

Lead as an alloying
element in steel formachining purposescontaining up to 0,35 %lead by weight and inbatch hot dip galvanised
steel components
containing up to 0,2 %lead by weight-on 21 July 2021 other than category 8 in vitro
diagnostic medical devices and for category 9other than industrial monitoring and control
instruments.

-

on 21 July 2023 category 8 in vitro diagnostic
medical devices-

on 21 July 2024 for cat. 9 industrial monitoring
and control instruments and for cat. 11

Expires on 21 July 2021 for categories 1-7 and 10

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
RoHS
Restriction of Hazardous Substances in Electrical and Electronic
Equipment
SEA

socio-economic analysis

TMC

Test & Measurement Coalition

UP 6(a)Umbrella Project Working Group 6(a)57Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

WEEE

Waste from Electrical and Electronic Equipment

5.1.

Background and technical information

On 20 January 2023, (TMC 2023a) and (EUROMOT 2023a) requested the renewal of
exemption III-6(a), as displayed in the table below.
Table 5-2: Requested renewals of exemption III-6(a)Applicant

Exemption

Scope
and
applicability

dates

of

(TMC
2023a),[(TMC2023b)]

Lead as an alloying element in steel formachining purposes [and in galvanised
steel] containing up to 0,35 % lead byweightApplies to category 9 industrial
monitoring and control instruments
and expires on 21 July 2031(= 2024 + 7 years).

(EUROMOT
2023a)[(EUROMOT
2024b)]

Lead as an alloying element in steel formachining purposes [and in galvanised
steel] containing up to 0,35 % lead byweightApplies to category 11 and expireson 21 July 2029 (= 2024 + 5 years)

In their renewal request, (EUROMOT 2023a) and (TMC 2023a) apply for the renewal of
exemption III-6(a) without galvanised steel being incorporated into the wording. In theclarification questionnaire, (TMC 2023b) state that they request the renewal of exemption
6(a) with “galvanised steel” included in the wording. In a corrigendum to the clarificationquestionnaire, (EUROMOT 2024b, S. 49–65)clarify that their renewal request shall also
include galvanised steel.
(EPPA 2023) submitted a socioeconomic analysis (SEA) along with the TMC renewal
request. (NAM 2023) contributed a support letter to the renewal request of (EUROMOT
2023a), is included in the list below, along with the nine contributions that were received
during the consultation period for the exemption.
Table 5-3: Stakeholder contributions
Contributors

Contribution/request(EGMF 2024)(JCB 2023)
Letter of support for renewal request submitted by (EUROMOT 2023a)(EMA 2023)(Cummins 2023)(EUROPGEN
2023)(Volvo Penta
2023)

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Letter of support for renewal request submitted by (EUROMOT 2023a)(MTE 2023)

Letter of support for exemption renewal requests submitted by ‘Umbrella
Project’ in 2020 for “lead exemptions” including cat. 8 medical technology(UP 6 (a) 2023)

Objection against the split of exemptions recommended by (Baron et al.
2022) and request for extension of exemption III-6(a) for all categories of
EEE for the maximum validity period.

5.1.1.

History of the exemption

When Directive 2002/95/EC (RoHS 1) was published in 2003, exemption 6 exempted theuse of lead in steel. Following a review in 2009, exemption 6 was split into three exemptions
6a, 6b and 6c in order to cover lead in steel, aluminium and copper alloys with a separate
wording, respectively. Exemption 6(a) covered the use of lead as an alloying element insteel for machining purposes and the presence of lead in galvanised steel. The exemption
was transferred to Annex III of the current RoHS Directive 2011/65/EU, with its expiry dated
for 21 July 2016. Ex. 6(a) was reviewed in 2015/16 by (Gensch et al. 2016), resulting in thecurrently (status February 2024) still valid exemption displayed in Table 5-4. Exemptions
6(a) and 6(a)(I) were reviewed then by (Baron et al. 2022), resulting in the below
recommendation, including also the EEE of cat. 9 IMCI and cat. 11.
Table 5-4: Renewal of the current exemption 6(a) and 6(a)(i)

Source: (Baron et al. 2022)

5.1.2.

Focus of the review of this renewal request

The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status as of January 2024). The COM has

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requested the consultants to assess in this current review round whether there are any
substantial reasons in line with Art. 5(1)(a) against the adoption of the above
recommendation of (Baron et al. 2022) for EEE of categories 9 and 11.
A re-evaluation of the previous review by (Baron et al. 2022) is not intended. The
consultants rely on the critical review conducted by (Baron et al. 2022) and on the resulting
conclusions and recommendations unless the renewal request gives reasons to reassess
the state of science and technology.

5.1.3.

Summary of the requested exemption(TMC 2023a) explain that lead as an alloying element in steel containing up to 0.35% leadby weight is intrinsic for machining purposes in niche applications and as such, is used innumerous product groupings and equipment types of category 9 industrial monitoring andcontrol instruments (IMCI). Alternatives to lead for all type 6 exemptions are in development.
However, the manufacturers of Test & Measurement Instruments are not component
manufacturers and need to rely on component manufacturer supplies of parts for 75%+ of
the components in their instruments. As and when such alternative parts become available,
they will be designed into new equipment that is developed in a cycle of 7-10 years,
depending on the type of Category 9 equipment concerned. The applicants, therefore,
believe a technical solution will and possibly is already available, but it needs to be
implemented for the specific usage, tried by the downstream user (e.g., producer,
manufacturer) of the component, and then tested in the full individual piece of equipment.
(TMC 2023a) conclude that in consideration of the specific characteristics of Category 9
equipment and its long life span and development cycles, they apply for a renewal of the
exemption 6(a) for the maximum validity period to allow for this process to take place.
According to (EUROMOT 2023a),lead is used in steel alloys as a machining aid to allow
deep drilling and/or high-speed operations and to aid hot workability in a number of different
components in internal combustion engines, associated components and end-products.
(EUROMOT 2023a) explain that their products are commonly used in highly demanding
conditions, including exposure to contaminants, high vibration, and high mechanical loads
while being required to operate for extended periods and sometimes without the opportunity
for servicing of parts. Many of the applications are critical, such as back-up generators or
operate in highly dangerous environments such as mining and construction. As aconsequence of this, design changes to all components need to be rigorously formallyassessed, especially as alternative alloys are not always identical drop-in replacements tothe lead-based alloys.
Therefore, EUROMOT members always need to carry out research and testing to determine
whether each potentially suitable substitute is able to offer the required technicalperformance. If the properties of the alternative alloy are significantly different such thateither the engine design needs to change, or this could potentially affect reliability or
emissions, then it may be necessary to gain approval for the engines made with alternative
alloy parts as required by engine emissions legislation.
Alternative alloy compositions to include bismuth, increased sulphur (with and without
tellurium), tin (with low and high copper), phosphorus and calcium give inferior performance.
Bismuth especially has additional concerns regarding its environmental impact, which isworse than lead, and its availability.

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EUROMOT indicate that they are making initial progress on developing alternatives, but
additional time is required to undertake the necessary assessments and testing. Timescales
vary between manufacturers due to the number of affected parts and the technicalrequirements of those parts and range between 5 and 7 years.

5.1.4.

Technical description of the exemption and use of the restricted
substance

This section provides the basic knowledge that is required to follow the applicant’s
arguments. The technical background is described in more detail by (Baron et al. 2022) andby (TMC 2023a) and (EUROMOT 2023a).
TMC explain that industrial test and measurement instruments (category 9 – Industrial
under the RoHS Directive) are very different from low-mix, high-volume consumer products
which are frequently re-designed to follow consumer trends and are placed on the market
for a limited duration. Industrial test and measurement are high mix, low volume producers,
managing portfolios of thousands of highly complex instruments. Each instrument isintentionally designed for high reliability and serviceability to support long useful lifespans,
and are made available on the market for at least a decade. These instruments aredesigned: exclusively for professional and industrial use; to meet high performancerequirements in critical applications; and last up to 40 years. Redesign is not frequent andhappens every seven years on average (as compared to every 1.5 years or less for
consumer products). Once test and measurement instruments are placed on the market,
they are typically accompanied with a long-term customer support arrangement to maintainreliability and calibration.
Product portfolios are widely diversified, with TMC members each having typically 2,000 to
3,000 products currently on the market. These are highly complex, sophisticated electronic
instruments, each having many necessary options and accessories. Each instrument canhave a minimum of 2,000 and up to 40,000 parts; requiring a vast supply chain involving
tens of thousands of suppliers and hundreds of thousands of unique components.
The full list of product groupings and equipment types relevant to exemption 6(a) is provided
by (TMC 2023a). Examples of TMC products include:• Oscilloscopes, Analyzers & Meters including for instance Spectrum Analyzers(Signal Analyzers), Bit Error Ratio Testers, Noise Figure Analyzers and Noise
Sources, Materials Test Equipment, etc.
• Generators, Sources and Power: including for instance Signal Generators (Signal
Sources), Pulse Generator Products, HEV/EV/Grid Emulators and Test Systems,
Source Measure Units, Sourcemeter, Sensitive Meter/Source etc.
• Wireless: including for instance Wireless Network Emulators, Channel Emulation
Solutions, 5G OTA Chambers, Wireless Analyzers, IoT Regulatory Compliance
Solutions, etc.
• Modular Instruments: including for instance PXI Products, Data Acquisition – DAQ,USB Products, etc.
• Network Test, Security & Network Visability: including for instance Protocol andLoad Test, Network Test Hardware, 5G NR Base Station Test, Network Security,
Application and Threat Intelligence, Cloud Visibility, Industrial Communications
Hardware, etc.
• Application-Specific Test Systems and Components

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•
•
•
•
•

•

Photonic Test & Measurement Products
Laser Interferometers and Calibration Systems: including for instance Monolithic
Laser Combiners & Precision Optics, etc.
In-Circuit Test Systems
Used Equipment
Bioprocessing Equipment Automation: including for instance Large Chambers,
Mixers for Processing Drug Intermediaries
Laboratory Products: including for instance Autoclave Sterilizers, Biological Safety
Cabinets, Blood Culturing Devices, Electrophoresis, Refrigerators, Freezers, Water
Purification
Chemical Analysis: including for instance Handheld XRF Analyzers, Dosemetry
Personnel Contamination Monitors, etc.
Genetic Sciences: Gold Standard Products for COVID-19, PCR Testing Modules
etc.
Other: including for instance Test and Measurement Upgrades and Accessories,
Semiconductor Characterization System, Chromatography, Mass Spectrometry,
etc.

•(EUROMOT 2023a) application concerns internal combustion engines, associatedcomponents and end-products in which these are used, under category 11. EUROMOT
products are commonly used in highly demanding conditions including exposure tocontaminants, high vibration, and high mechanical loads, while being required to operate
for extended periods of time and sometimes without the opportunity for servicing of parts.
Many of the applications are critical, such as back-up generators or operate in highly
dangerous environments such as mining and construction.
Examples of steel parts used by EUROMOT’s members and reliant on this exemption
include:• Air compressors• Air intakes and exhausts• Alternator parts• Bolts, nuts, screws• Brackets, mechanical assemblies (e.g., flanges, blocks, rocker arms, tensioners)• Component housings and covers (e.g., oil or fuel filter, heater, flywheel)• Connectors, unions, and inserts• Gaskets (e.g., cylinder head)• Hose assembly components• Parts of fuel filters• Pumps and hydraulic components (e.g., valves, injectors, tubes, pipes, pistons,
springs, stems, stators, yokes, nipples, armatures)• Shaft, gears and shaft intake assemblies• Spacers and fixings (e.g., spacers, plugs, sleeves, bushes, locking pins)• Turbochargers.

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5.1.5.

Amount(s) of restricted substance(s) used under the exemption

Category 9 IMCI
According to the SEA of (EPPA 2023), TMC members stressed that up to 35 % leadamounts are used in their homogenous materials. The applicant mentions that category 9– Industrial equipment contributes a fraction of one percent of the total annual quantities of
RoHS substances. TMC indicates that the amount of substance entering the EU market
annually through application for which the exemption is requested is approximately 9.82 kg.
No information was provided on how this amount was calculated.

Category 11
According to (EUROMOT 2023a) in 2013, the import of steel products for machining
purposes amounted to approximately 73,000 tonnes. EUROMOT does not have more
recent figures specific to machining, however, EUROFER data on EU consumption levelsof steel indicates that this has risen by 8.9 % over the course of 2013 to 2022.
Assuming that the lead content in steel for machining purposes is between 0.2 and 0.35 %,this means that the lead annually entering the EU market through the import of free-cutting
steels can vary between 159 and 278 tonnes for all uses. These figures do not correspondsolely to steel intended for EEE (which it was not possible to estimate) and encompass steel
intended for other applications, such as automotive applications.
(EUROMOT 2023a) underline that they have data only regarding their members’ products
only. Based on members’ uses, the amount of lead from both free-machining andgalvanised steels is estimated to be 700 kg per annum. It should be noted that this estimate
is not for all of Category 11, which is unable to be calculated in part due to its less precise
scope compared to other RoHS Categories.

5.2.

Justification of the requested exemption

According to (TMC 2023a), industrial test and measurement instruments under category 9
are high mix, low volume producers, managing portfolios of thousands of highly complex
instruments, each of which is intentionally designed for high reliability for long useful
lifespans and available on the market for at least a decade. Lead as an alloying element insteel containing up to 0.35% lead by weight is intrinsic for machining purposes in nicheapplications and as such used in numerous product groupings and equipment types ofcategory 9 Industrial Test & Measurement instruments.
Such instruments are designed exclusively for professional and industrial use and last up
to 40 years. Redesign happens every seven years on average. According to (TMC 2023a),alternatives to lead for all type 6 exemptions are under development and are possibly
already available in some cases. But once such alternatives become available, they willneed to be implemented for the specific usage, tried by downstream users (e.g., producer,
manufacturer) of the component, and then tested in the full individual piece of equipment.
This process will require a cycle of 7-10 years depending on the type of category 9
equipment concerned. For these reasons, (TMC 2023a) applies for an extension of thecurrent exemption.

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As regards category 11, according to the application and information provided by(EUROMOT 2023a), lead is used in steel alloys as a machining aid to allow deep drilling
and/or high-speed operations to aid hot workability in a number of different components ininternal combustion engines, associated components and end-products. According to(EUROMOT 2023a), research on substitutes is ongoing but a number of technical issues
continue to be raised making the substitution not immediately be possible from a technicalperspective. The applicant therefore argues that additional time is required to undertake therequired assessments and testing. (EUROMOT 2023a) therefore requests an extension of
the current exemption.

5.2.1.

Substitution and elimination of the restricted substance(TMC 2023a) maintain that currently there are still no substitutes of lead as alloying element
in steel for machining purposes available and tested that could be used for at least somecurrent applications under this category. Nonetheless, the applicant states that alternatives
to lead for all type 6 exemptions are in development. (TMC 2023a) argue that an extensionof the existing exemption is required as such technical solutions will need to be implemented
for the specific usage, tried by the downstream user (e.g., producer, manufacturer) of thecomponent, and then tested in the full individual piece of equipment. According to theapplicant, the process required for re-designing of the test and measurement equipment
could take five to seven years.
For what concerns category 11, (EUROMOT 2023a) state that it is known that lead-freemachining alloys are marketed by alloy manufacturers and are being used. However, thesealloys are not always drop-in replacements to the lead-based alloys used in internal
combustion engines, associated components, and end-products in which these are used.
Therefore, it is always necessary for EUROMOT’s members to carry out research andtesting to determine whether each potentially viable substitute is suitable. Also, theymention that in case the properties of the alternative alloy are significantly different suchthat either the engine design needs to change, or this could potentially affect reliability or
emissions, which may require to gain approval for the engines made with alternative alloyparts according to the EU engine emissions legislation. The applicant states that tests on
non-leaded alternative grades (including bismuth, increased sulphur - with and without
tellurium, tin - with low and high copper, phosphorus and calcium) generally gave inferior
performance. (EUROMOT 2023a) indicate that bismuth is best able to substitute lead,
however, the hot workability of bismuth steels is reduced compared to leaded steels.
According to the applicant, this means that it is not possible for a steel roller to produce abar with the same machining properties and surface integrity as steel containing lead.
Therefore, the expected energy cost associated with bismuth is higher as well as potentiallyhigher error rates leading to increased waste.
They also make reference to a comparative study of the machinability of different free
cutting steels to realise their real behaviour and potential as alternatives to conventional
steels, whose results showed that the presence of lead extended the tool life at low andmedium cutting speeds between two and four times depending on the free-machining steel.
(EUROMOT 2023a) also mentions that satisfactory machining results were obtained using
CMnCr steel alloyed with 0.08 wt. % Bi however no comparison with leaded alloys wasprovided.
(EUROMOT 2023a) request a five-years extension as they argue that at least 5 years are
expected to be necessary as if the properties of the alternative alloy are significantly

64Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

different such that either the engine design needs to change, or this could potentially affectreliability or emissions, then it may be necessary to gain approval for the engines made withalternative alloy parts as required by the EU engine emissions legislation. (EUROMOT
2023b) affirms that the (Baron et al. 2022) proposal would be suitable for 6(a)(I) relating tomachining purposes if the extension is granted for 5 years. (EUROMOT 2024b) add thatthe same applies to 6(a)(II) relating to hot dip galvanised steel.

5.2.2.

Environmental, health, safety and socioeconomic impacts

According to (EPPA 2023), the environmental impact of industrial test and measurement
products is negligible. The participating companies have reported that changes in releases
to the environment of lead will be unlikely during equipment production or use phases of theconcerned products over the next seven years as a consequence of the revocation of the
RoHS exemption. During equipment production, any discarded material is properly
recycled. At component manufacturers, waste is controlled. Under normal conditions ofequipment use, the lead content associated with the application of Annex III, exemption 6(a)is encapsulated within the equipment enclosure and will neither be touched nor released tothe environment. As this equipment is sold B2B for professional/industrial use only,
equipment that finally reaches end-of-life will be appropriately processed by professional
recyclers who are obligated to have suitable controls to avoid any environmental releases
and are notified of the presence of the substance under the producers’ obligation to provide
a SCIP notification.
As a result of the participating companies’ relatively low consumption of parts, incomparison to the product Categories 1-7 and 10, renewing this exemption for Category 9
will have a minimal impact on the environment. (EPPA 2023) explain that Category 9
Industrial equipment’s contribution to the waste electrical and electronic equipment is very
limited (equivalent to 0.2% by weight of EU WEEE). Also, EPPA indicate that these test andmeasurement equipment enter typically the waste stream many decades after it is placedon the EU market. (EPPA 2023) explain that at this stage of the availability of alternatives,
there is no material gain for the environment in restricting the alternative compared to thehuge costs involved in gradual substitution of existing equipment.
According to (EUROMOT 2023a), bismuth raises concerns regarding its environmental
impact, which is regarded as being worse than lead. Also, concerns are linked to its
availability as this is a critical raw material existing in limited supply, mainly mined in China(approx. 80%) and imported in the EU. The applicant also suggests that expected energy
cost associated with bismuth is higher as well as potentially higher error rates leading toincreased waste. (EUROMOT 2023a) also recall that the previous Umbrella Project (UP)
exemption request pointed out a number of benefits of using lead in free-machining steel,including: the addition of lead into low carbon free cutting steels enhances machinability
and can increase the production rate of a component by up to 40% depending upon partand machining process design; and a potential reduction in energy usage of approximately
27% when machining parts using leaded versus non-leaded steel. As supporting evidence,(EUROMOT 2023a) cite the partial LCA previously provided by the Umbrella Project which
they still considered valid although it did not cover end of life aspects.
As regards environmental and health impacts, (EUROMOT 2023a) argue that lead-freemachining alloy alternatives also have larger negative impact on health compared to current
lead-based alloys.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(TMC 2023b) state that its members have difficulty in understanding how the rewording andrelisting and/or splits recommended by the consultants will lead to greater protection ofhuman health and the environment compared to the wording in its current form.
In their SEA, (EPPA 2023) mention that the total impact of a non-renewal is monetized in
the range of 2.1 billion EUR and 2.9 billion EUR (conservative estimates in net losses),consisting of economic impacts (EBIT loss) on test and measurement industrial typeproducts’ manufacturers; substitution costs for test and measurement industrial typeproducts’ manufacturers; and social impacts (i.e., unemployment in the EU-27).
Also, (TMC 2023b) emphasise the importance of retaining the initial wording and numbering
as published in the original RoHS annexes. They argue that amending the scope of the
exemption by changing the application or substance restriction value has a significant
administrative burden to industry and negatively impacts the compliance.
(EUROMOT 2023a) state that should the exemption not be renewed, engine and endproduct manufacturers would be forced to stop selling non-ROHS compliant products. They
believe that the non-renewal of the extension could affect many types of end-users: they
indicate that some industries, such as the ones in the construction sector, may not be able
to operate because of the non-renewal of the extension as some essential equipment may
not available. In case supply of emergency generators is affected, hospitals, for example,
could suffer power cuts which may affect the health of patients.
Both applicants argue that the non-renewal of the extension would ultimately lead to job
losses resulting from reduction in sales over the years.

5.2.3.

Roadmap towards substitution or elimination of the restricted
substance

As regards category 9 IMCI, (TMC 2023a) recognize that alternatives to lead for all 6(b)type exemptions are in development. As and when they become available, they will need
to be designed for the specific usage, tried by downstream user (e.g., producer,
manufacturer) of the component, and then tested in the full individual piece of equipment.
(TMC 2023b) claim that as a result the substitution process to take a minimum of 5 to 7
years.
As regards category 11, (EUROMOT 2023a) have indicated that they are making initialprogress on developing alternatives, but additional time is required to undertake therequired assessments and testing. These timescales vary between manufacturers due tothe number of affected parts and the technical requirements of those parts and ranges
between 5 and 7 years.

5.3.
5.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in66

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation.
The article details further criteria which need to be fulfilled to justify an exemption, however
the reference to the REACH Regulation is interpreted by the consultants as a thresholdcriterion: an exemption could not be granted should it weaken the protection afforded by
REACH. The first stage of the evaluation thus includes a review of possible incoherence ofthe requested exemption with the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of the exemption6(a)-series in EEE of cat. 9 IMCI and 11.
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

5.3.2.

Substitution and elimination of the restricted substance

Following the approach to assess whether the recommendation of (Baron et al. 2022) canbe adopted to cat. 9 IMCI and cat. 11 in the light of applicants’ arguments presented by(TMC 2023a) and (EUROMOT 2023a), it is worthwhile realizing the reasoning of (Baron etal. 2022) for their recommendation.
(Baron et al. 2022) concluded from the information made available during their review that
substitutes are still under development, or design adjustments are necessary and/or theavailability of substitutes is not sufficient to allow a quick transition of the whole EEE sector.
For this reasons, (Baron et al. 2022) state that revoking the exemption would not be
pragmatic as it would de facto require a transition in a very short time and is likely to resultin withdraw of product.
(Baron et al. 2022) thus propose a short-termed exemption, which in their view would allow
industry to gather information as to lead content and EEE components that need theexemption for leaded steel for machinability purposes based on supply chaincommunications. (Baron et al. 2022) conclude that in case the industry fails to provide
sufficient and relevant data in the next assessment, it would be recommended to withdraw
the exemption, possibly allowing a longer transition period that would be sufficient for
implementing a phase-out where it is possible, but also for identifying application areas
where this is not the case and for applying for new and specific exemptions.
Based on the information provided through the two applications, possible alternatives areeither still under development, or - when already available - they still require research,development and testing before they are ready to be used.
(TMC 2023a) explain that alternatives to lead for all 6(a) series exemptions are underdevelopment, but do not provide information on the actual status of development of suchalternatives.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EPPA 2023) mention they are not aware of specific alloys able to substitute all parts.
According to the applicant “A single assessment of the performance of the alternatives is
not possible because of the ubiquity of the alternative use. Each use must be considered inand of itself to validate if an alternative would work as well as or better than the component
made currently using the exemption.”
No additional information is offered as to concrete activities aimed at developing or testingsuch alternatives. The explanations and argumentation provided by the (TMC 2023a) are
generic, and do not detail any information for specific applications.
(TMC 2023b) argue that lead as an alloying element in steel containing up to 0.35% leadby weight is intrinsic for machining purposes in niche applications and as such used innumerous product groupings and equipment types of category 9.
(EUROMOT 2023a) point out that the main supposed alternatives to lead are bismuth,
increased sulphur (with and without tellurium), tin (with low and high copper), phosphorus
and calcium.
(EUROMOT 2023a) explain that such alternative alloy compositions when tested gave
inferior performance compared to lead. (EUROMOT 2023a) indicate bismuth as the bestalternative solution, referring to test and research carried out by the Umbrella Project (UP)(2022), which concluded “that leaded steels showed the best performance in tests at lower
cutting speeds, with high-speed steel tools and in deep hole drilling. Non-leaded alternative
grades generally gave inferior performance However, EUROMOT point out that the hot
workability of bismuth steels is reduced compared to leaded steels. They mention that the
expected energy cost associated with bismuth is higher as well as potentially higher error
rates leading to increased waste. (EUROMOT 2023a) refer also to other more recent
studies which shows that research on substitutes is ongoing.
(EUROMOT 2023a) concludes that it is known that lead-free machining alloys are marketedby alloy manufacturers and are being used. However, these alloys are not always drop-in
replacements to the lead-based alloys. Therefore, it is always necessary for EUROMOT’s
members to carry out research and testing to determine whether each potentially viable
substitute is suitable.
The applicants do not provide specific information regards the application of lead-free steels
for specific applications with specific requirements for potential lead-free steels. The
situation reflects the consideration by (Baron et al. 2022) that “it is not expected that a onefits-all solution will be found for lead in steel alloys used in machined parts but rather thatdifferent substitutes can be applied to different groups of applications which thus can beseparated from each other. A distinction between future substitute candidates and theirrange of application may become relevant in the future, and for this purpose industry should
investigate how certain applications could be grouped in terms of the different properties ofthe lead alloy required for machining or different properties required for the operation of theEEE component parts made of such alloys.”5.3.3.

Environmental, health, safety and socioeconomic impacts(EPPA 2023) foresee severe socio-economic, health and safety consequences if the
exemption is not renewed for cat. 9 IMCI.

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As the consultants do not recommend revoking the exemption, or restricting its scope sothat cat. 9 IMCI would be excluded, these consequences will not arise unless the COM
decides otherwise.
(EUROMOT 2023a) reference the LCA submitted by the Umbrella Project during the reviewof the exemption by (Baron et al. 2022) pointing out that lead-containing machining alloys
have a higher environmental impact than lead-free machining alloys. (Baron et al. 2022),
however, rejected this LCA in the 2021/2022 review stating that higher values in the abovementioned LCA impact categories for bismuth compared to lead that hold for a few life-cycle
stages would not justify a renewal of the exemption in their view.
(EUROMOT 2023a) also foresee negative socio-economic, health and safety
consequences. In case of non renewal of this exemption, engine and end-productmanufacturers will be forced to stop selling products that do not comply with RoHS, withgeneral severe impacts that “could affect many types of end-users” which the applicant is
not in the position to detail “as is not known which products would be affected”. Also,(EUROMOT 2023a) lament that “manufacturers of affected products would also be
impacted with loss of jobs and “possibly some also by loss of competitiveness”. Also,(EUROMOT 2023a) states that should the exemption not be renewed, engine and endproduct manufacturers would be forced to stop selling non-ROHS compliant products.
EUROMOT did not provide quantitative impacts of possible socio-economic impact as theyargue that, at this stage, it is not known which products would be affected.

5.3.4.

Contributions to the stakeholder consultation

While the other stakeholder submitted letters in support of applicants’ renewal requests,(UP 6 (a) 2023) (Umbrella Project Working Group 6(a) additionally contributed specificarguments for the renewal of the exemption which are discussed below.
(UP 6 (a) 2023) indicate that the use/presence of lead in galvanised steel is not addressed
the renewal applications made by either EUROMOT or TMC. They strongly disagree that“no additional time is to be permitted for exemption 6(a)(II) so that it can expire in 2026 forcat. 11” and they understand that this was not the intention of these Pack 27 renewal
applications. (UP 6 (a) 2023) underline that the technical situation for lead in galvanizedsteel is largely unchanged from the situation reviewed by (Baron 2022a) and it would be theintention of the Umbrella Project to seek to further renew this Exemption 6(a)(II) dependent
on the timing of the Commission response to the current application. That application would
likely include all categories, including 9 and 11. In fact, Category 11 is the most relevant for
the exemption 6(a)(II).
The above comment refers to the renewal requests of EUROMOT et al. and TMC for
exemption 6(a) which did not include galvanised steel. Both applicants amended theirrenewal requests to include galvanised steel (cf. Table 5-4 Renewal of the current
exemption 6(a) and 6(a)(I) on page 59).
(UP 6 (a) 2023) propose that all EEE Categories and subcategories covered under Ex. 6(a)(all Cat. 8, Cat. 9 and Cat 11 EEE Categories and subcategories under scope of Ex. 6(a)would be merged into the current Ex. 6(a)-I in the future (which would then be valid for All
EEE Categories and subcategories 1 - 11), with the following proposed wording for All EEE

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Categories and subcategories 1 - 11: “Lead as an alloying element in steel for machining
purposes containing up to 0,35 % lead by weight and in batch hot dip galvanised steel
components containing up to 0,2 % lead by weight”. The validity of this exemption should
be extended for all categories of EEE for the maximum validity periods.
They consider that (Baron et al. 2022) proposal to split the exemption 6a into 6(a)-I and6(a)-II would generate administrative burden with no benefit for the environment and humanhealth. They underline that the reason for their proposal is mainly related to the substitution
issue on which UP are still working and need additional time to conduct and finalise
research.
UP is invited to submit the above proposal for the next review of the exemption 6(a)-series.
The consultants’ mandate for this review of the exemptions is focused to assess whether
the proposal of (Baron et al. 2022) can be adopted for cat. 9 IMCI and for cat. 11.
(UP 6 (a) 2023) indicate that they are aware of lead-free substitutes being used in EEE ofcat. 11 and in general. Not only for substitutes used in cat. 11, but used in general, they do
not have enough information so far for instance on 11SMn30-EM + C as a possible
alternative, so they cannot conclude if it can be used for all specific applications. Between
different other alternatives, they mention that bismuth has been able to substitute for leadunder certain conditions, although the reduced hot ductility and the increased cost of Bi
addition may make it uneconomic, particularly for large scale applications. (UP 6 (a) 2023)
also mention a study of 2005 that shows that calcium can also substitute in C45 steels foruse at higher cutting speeds. Steels containing tin generally did not show good
performance. The alternative grades generally showed equivalent fatigue performance tothe leaded grades. (UP 6 (a) 2023) also reference life cycle assessments which in their view
show that the use of lead is environmentally preferable compared to lead substitutes.
UP 6(a) submitted the above information already to the previous review of the exemption
where its was discussed by (Baron et al. 2022) who still recommended to renew the 6(a)series exemptions as displayed in Table 5-4 on page 59. The consultants therefore see theabove comments to be considered in that recommendation.

5.3.5.

Summary and conclusions

Article 5(1)(a) ROHS provides that an exemption can be justified if at least one of thefollowing criteria is fulfilled:•••

their elimination or substitution via design changes or materials and components which do
not require any of the materials or substances listed in Annex II is scientifically or technicallyimpracticable;
the reliability of substitutes is not ensured;
the total negative environmental, health and consumer safety impacts caused by substitution
are likely to outweigh the total environmental, health and consumer safety benefits thereof.

Following their mandate for this exemption, the consultants assessed whether the result of
the previous review of this exemption by can be adopted for cat. 9 industrial monitoring andcontrol instruments (IMCI) and cat. 11 in the light of the applications at hand. (TMC 2023a)
and (EUROMOT 2023a) request the renewal of exemption 6(a) for the maximum validity
periods of 7 and 5 years, respectively.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(TMC 2023b) argue that no lead-free alternatives are currently available, and once they will
be available, five to seven years will be required for their qualification to ensure their testing
and reliable functioning in cat. 9 IMCI.
(EUROMOT 2023a) claim that tests on non-leaded alternative grades of lead-free steels formachining purposes (including bismuth, and others) generally gave inferior performance,and hot workability of bismuth steels is reduced compared to leaded steels.
Both applicants’ arguments are general rather than providing application-specificinformation as to the status of lead-free steel alloys in different fields of applications in cat.
9 IMCI and cat. 11. In the evaluation by (Baron et al. 2022), the applicants presented
similarly general and unspecific arguments as to the scientific and technical statusconcerning the practicability of lead substitution or elimination. This situation caused (Baronet al. 2022) to recommend the renewal of the exemption only for a short period for all
categories of EEE in order to point out to the industry that the information has to be updated
and that support in phasing out the exemption is expected. The parallel review for all
categories would, in their view, avoid future co-existence of several sub-items with slightly
different scopes and align the expiry dates, and motivate producers of EEE to provide
information for the specification and possibly restriction of the exemption scope.
(Baron et al. 2022) recommended the expiry of exemption 6(a) and integrating cat. 9 IMCIand cat. 11 into the renewed exemptions 6(a)(I) and 6(a)(II). In the light of the above, theapplicants were asked whether they would agree to follow this recommendation.
(EUROMOT 2023b) agree with (Baron et al. 2022) proposal under the condition that the
expiration dates of both exemptions are extended for 5 years, as they state that
EUROMOT’s members need to carry out research and testing to determine whether eachpotentially viable substitute is suitable.
(TMC 2023b) do not agree with the proposal of (Baron et al. 2022) and insisted on the
renewal of the exemption in its current wording and numbering as published in the RoHS
annexes until 21 July 2031. (TMC 2023b) underline that amending the scope of the
exemption by changing the application or substance restriction value has a significant
administrative burden to industry and negatively impacts the compliance.
Overall, the consultants could not identify technical aspects suggesting that the approach
proposed by (Baron et al. 2022) could not be followed for cat. 9 IMCI and cat. 11. On thisground, it can be concluded that substitution and elimination of lead are currently stillscientifically and technically impracticable so that the renewal of the exemptions for cat.9
IMCI and cat.11 can be justified by Art. 5(1)(a).

5.4.

Recommendation

The consultants conclude from the available information that the approach proposed by(Baron et al. 2022) can be adopted for cat. 9 IMCI and cat. 11. If the COM decides to follow
the proposed approach, the consultants recommend the below wording and expiry dates.

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No.

Exemption

Scope and dates of applicability

6(a)Lead as an alloying element insteel for machining purposescontaining up to 0,35 % lead byweight and in galvanized steel
containing up to 0,35 % lead byweightApplies to categories 8, 9 and 11.

Lead as an alloying element insteel for machining purposescontaining up to 0,35 % lead byweightApplies to6(a)(I)

Expires on 21 July 2023 for category 8 in vitro
diagnostic medical devices.
Expires on 21 July 2024 for cat. 9 industrial
monitoring and control instruments and for cat. 11-

categories 1-7 and 10.

-

from [expiry date of exemption 6(a) + 1 day]on to categories 9 industrial monitoring andcontrol instruments, and to category 11

Expires on 21 July 2024 for categories 1 to 11.
6(a)(II)

Lead in batch hot dip galvanised
steel components containing up
to 0,2 % lead by weight

Applies to-categories 1-7 and 10.

-

from [expiry date of exemption 6(a) + 1 day]on to categories 9 industrial monitoring andcontrol instruments, and to category 11

Expires on 21 July 2026 for categories 1 to 11.

This transfer of cat. 9 IMCI and cat. 11 from exemption 6(a) formally can be understood asa rejection of the applicants’ renewal request for exemption 6(a) with the consequence thatthe exemption expires for cat. 9 IMCI and cat. 11. If the COM follows this interpretation, atransition period is to be granted according to Art. 5(6). The consultants recommend 12
months of transition to allow for administrative adaptations since no actual scope restriction
is linked to this shift.
The COM should leave sufficient time for the preparation and timely submission of renewal
requests between the official publication of their decision as to the renewal of the
exemptions and their expiry.
The adverse socioeconomic impacts assessed by EPPA will not arise until 2026 since theconsultants do not recommend revoking the exemption. TMC will, however, have to bear
the cost for preparing and processing a renewal request prior to 2031, which they requested
as expiry date in their current renewal request.

5.4.1.

Applicants’ feedback on the recommendation(TMC 2024) do not agree with the recommendation reiterating that they applied for the
renewal of exemption III-6(a) in its current wording for the maximum validity period of 7
years. (EUROMOT 2024b) underline that their preferred option for renewal would be theexpiry date in 2029.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been72

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evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

5.5.

References

Baron et al. (2022): Study to assess requests for a renewal of nine (-9-) exemptions 6(a), 6(a)-I,
6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I and 7 (c)-II of Annex III of Directive 2011/65/EU (Pack 22) –Final Report (Amended Version). RoHS Pack 22. In cooperation with Yifaat Baron, Carl-Otto
Gensch, Andreas Köhler, Ran Liu, Clara Löw, Katja Moch, Oeko-Institut e. V. Retrieved fromhttps://data.europa.eu/doi/10.2779/869784.
Cummins (2023): Request Extension of RoHS Annex III Exemptions. Stakeholder consultation 6
December. Retrieved from https://rohs.biois.eu/Cummins.pdf.
EGMF (2024): Extension Request of RoHS Annex III Exemptions - Pack 27. Stakeholder
consultation 24 January. Retrieved from https://rohs.biois.eu/egmf.pdf.
EMA (2023): Request Extension of RoHS Annex III Exemptions. Stakeholder consultation 7
December. Retrieved from https://rohs.biois.eu/EMA.pdf.
EPPA (2023): Socio-economic Analysis (SEA) of the impacts of non-renewal of Lead (Pb)exemption for test & measurement industrial type products (Category 9) Exemption 6(a) – Annex
III. Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_6(a)_2023_PUBLIC_VERSION.pdf.
EUROMOT (2023a): Exemption Request Form 20 January 2023. Retrieved fromhttps://rohs.biois.eu/RoHS_Exemption_Application_Form_6a_EUROMOT.pdf.
EUROMOT (2023b): Questionnaire 1 (Clarification) for Exemption I (a) and III-6(a)(I) (EUROMOT). Retrieved from https://rohs.biois.eu/Ex_III-6a_EUROMOT_Questionnaire1_Clarification.pdf.
EUROMOT (2024a): Comments on Recommendation exemption III-6(a) sent via e-mail by
Maitheya Riva, RINA, to Vittoria Luda 8 March 2024.
EUROMOT (2024b): Corrigendum to questionnaire 1 sent by sent via e-mail by Maitheya Riva,
RINA, to Otmar Deubzer. RoHS Pack 27 (RoHS 29).
EUROPGEN (2023): Request Extension of RoHS Annex III Exemptions: 6a, 6b-I, 6b-II & 7a.
Stakeholder consultation. 5 December. Retrieved from https://rohs.biois.eu/EUROPGEN.pdf.
Gensch et al. (2016): Assistance to the Commission on Technological, Socio-Economic and Cost Benefit Assessment Related to Exemptions from the Substance Restrictions in Electrical andElectronic Equipment - Study to assess renewal requests for 29 RoHS 2 Annex III exemptions.
RoHS 14. In cooperation with Carl-Otto Gensch, Yifaat Baron, Markus Blepp, Katja Moch, Susanne
Moritz, Oeko-Institut und Dr. Deubzer, Otmar, Fraunhofer Institut Zuverlässigkeit und
Mikrointegration IZM (Adaptation to Scientific and Technical Progress of Annexes III and IV of
Directive 2011/65/EU, RoHS XIV). Retrieved from https://circabc.europa.eu/sd/a/eda9d68b-6ac94fb9-8667-5e561d8c957e/RoHS-Pack_9_Final_Full_report_Lamps_Alloys_Solders_June2016.pdf.
JCB (2023): Request of Extension of RoHS Annex III Exemption. Stakeholder consultation. 11
December. Retrieved from https://rohs.biois.eu/JCB_support_EUROMOT.pdf.

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MTE (2023): MedTech Europe recommendation for the extension of RoHS lead exemptions for
medical technologies in the scope of category 8. Stakeholder consultation. 11 December.
Retrieved from https://rohs.biois.eu/MTE.pdf.
NAM (2023): Request Extension of RoHS Annex III Exemption 6(a)-I: Lead as an Alloying Elementin Steel for Machining Purposes Containing up to 0.35%. Support letter 20 January. Retrieved fromhttps://rohs.biois.eu/NAM%20%20Support%20Letter,%20EU%20RoHS%20Application%20to%20Extend%20Exemption%206(a)-I.pdf.
TMC (2023a): Exemption Request Form. Retrieved fromhttps://rohs.biois.eu/RoHS_Application_Form_6(a)_TMC.pdf.
TMC (2023b): Questionnaire 1 (Clarification) for Exemption III-6(a) and III-6(a)(I), (TMC). Retrieved
from https://rohs.biois.eu/TMC-Reply_Ex_III-6a_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024): Comments on Recommendation exemption III-6(a) sent via email 8 March 2024.
UP 6 (a) (2023): Consultation Questionnaire Exemptions 6(a) and 6(a)(I) of RoHS Annex III.
Stakeholder consultation. In cooperation with Umbrella Project Working Group 6 (a). Retrieved
from https://rohs.biois.eu/Umbrella_Project_WG_6a.pdf.
Volvo Penta (2023): Request of Extension of RoHS Annex III Exemptions 6a, 6b, 7a, 7c, 42, 44.
Stakeholder consultation 12 December. Retrieved from https://rohs.biois.eu/Volvo_Penta.pdf.

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Exemption 6(b)-series of Annex III: Lead inaluminium alloys
The below Table 6-1 shows the wording, scope and expiry dates of the exemption.
Table 6-1: Current wording of the exemption 6(b)-series
No.

Exemption

Scope and dates of applicability

III-6(b)Lead as an alloying element inaluminium containing up to 0,4 %lead by weight

Applies to categories 8, 9 and 11, and expires on- 21 July 2021 for cat. 8 other than in-vitro
diagnostic medical devices, and cat. 9 other thanindustrial 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

III6(b)-I

Lead as an alloying element inaluminium containing up to 0,4 %lead by weight, provided it stems
from lead-bearing aluminium scrap
recycling

Expires on 21 July 2021 for categories 1-7 and 10

III6(b)-II

Lead as an alloying element inaluminium for machining purposeswith a lead content up to 0,4 % byweightExpires on 18 May 2021 for categories 1-7 and 10

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

RoHS 1

Directive 2002/95/EC

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6.1.

Background and technical information

On 20 January 2023, (TMC 2023a) submitted a request for renewal of exemption III-6(b)for EEE of category 9 industrial monitoring and control instruments (IMCI) in its current
wording for the maximum validity period.
Table 6-2: Exemption renewals requested by TMC
No.

Requested exemption

Requested scope and dates
of applicability

III-6(b)Lead as an alloying element in aluminium
containing up to 0,4 % lead by weight

Applies to category 9 monitoring
and control instruments andexpires on 21 July 2031

On 20 January 2023, (EUROMOT 2023a) submitted a request for the renewal of exemption
III-6(b) and III-6(b)(I) for category 11. On the same day, (EUROMOT 2023b) submitted
another request for the renewal of exemptions III-6(b) and III-6(b)(II) for EEE category 11.
The below table reflects EUROMOT’s exemption requests.

Table 6-3: Exemption renewals requested by EUROMOT
No.

Requested exemption

Requested scope and dates
of applicability

III-6(b)Lead as an alloying element in aluminium
containing up to 0,4 % lead by weight, provided it
stems from lead-bearing aluminium scrap
recycling

Expires on 21 July 2029 (= 2024 +5 years) for cat. 11

III6(b)(I)

Lead as an alloying element in aluminium
containing up to 0,4 % lead by weight, provided it
stems from lead-bearing aluminium scrap
recycling

Applies to category 11 from 22
July 2024 on and expires on 21
July 2029 (= 2024 + 5 years)

III6(b)(II)

Lead as an alloying element in aluminium formachining purposes with a lead content up to
0,4 % by weight

Applies to cat. 11 from 22 July2024 on and expires on 21 July
2029 (= 2024 + 5 years)(EPPA 2023) submitted a socioeconomic impact assessment (SEA) along with theirrenewal request. (NAM 2023) submitted a letter of support along with the EUROMOT
renewal request. Their contribution was added to the below table which summarises thecontributions submitted during the consultation period.

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Table 6-4: Stakeholders’ contributions
Contributors

Contribution/request(Copreci S Coop
2023)
(NAM 2023)(JCB Power
System 2023)(Deutz AG 2023)(The Truck andEngineManufacturers
Association(EMA) 2023)(Volvo Penta 2023)(EuropeGen 2023)(Cummins 2023)(EGMF 2024)

Letter of support for renewal requests submitted by (EUROMOT 2023a)
and (EUROMOT 2023b)(APPLiA Italia
2023)(Afecor 2023)

6.1.1.

Express their support to the agreement of (EUROMOT 2023c) thatexemption 6(b)(IV) proposed as renewal of exemption 6(b)(II) (cf. Table
6-5) is applicable to cat. 11 provided it will remain valid until 2029. Bothstakeholders request this expiry date of exemption 6(b)(IV) to be applied
to EEE of categories 1 and 2 as well.

History of the exemption

The predecessor exemption of the current 6(b) series exemptions was already listed on the
Annex of (European Union 13.02.2003) when it was published in 2003:
Lead as an alloying element in steel containing up to 0.35 % lead by weight, aluminium
containing up to 0.4 % lead by weight and as a copper alloy containing up to 4 % lead byweight.
According to (Baron et al. 2022a), following an assessment in 2009, exemption 6 was split
into three exemptions 6a, 6b and 6c in order to cover the use of lead in steel, aluminiumand copper alloys with a separate wording respectively. Exemption 6(b) was reformulated
again after its last review by (Gensch et al. 2006), which resulted in the current architecture
and wordings of the exemption 6(b) series.
The exemption was reviewed by (Baron et al. 2022a) for all categories of EEE including cat.
9 industrial monitoring and control instruments (IMCI) even though the exemption would
have expired on 21 July 2024 only. (Baron et al. 2022a) recommended the architecture andwordings for the exemption 6(b) series as displayed in the below table.

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Table 6-5: Renewal of current exemption 6(b) series recommended by (Baron et al.
2022a)

Source: (Baron et al. 2022a)

6.1.2.

Focus of the review of this renewal request

The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation. The COM required to assess in this current review
round whether there are any substantial reasons in line with Art. 5(1)(a) against the adoptionof the above recommendation for EEE of categories 8, 9 and 11.
Unless the review shows that the applicants’ arguments justify a different approach, theconsultants would therefore prefer recommending the wordings of III-6(b)(III) and III6(b)(IV). The expiry dates may be adapted to the specific situation of cat. 9 IMCI and cat. 1178

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in the scope of the renewal requests where the expiry dates and the underlying approaches
proposed by the previous reviewers may not be applicable.

6.1.3.

Summary of the requested exemption

TMC (cat. 9 IMCI)In (TMC 2023a) it is reported that: Lead as an alloying element in aluminium containing up
to 0.4% lead by weight is intrinsic for machining purposes in niche applications. Aluminium
alloys (containing lead) are used to make a very wide range of categories 9 industrial EEE
products, parts, and product components. As further outlined in [TMC] submission,
alternatives to lead for all type 6 exemptions are in development. However, themanufacturers of Test & Measurement Instruments are not component manufacturers andneed to rely on component manufacturer supplies of parts for 75%+ of the components intheir instruments. As and when such alternative parts become available, they will be
designed into new equipment that is developed in a cycle of 7-10 years depending on thetype of Category 9 equipment concerned. The applicants therefore believe a technicalsolution will and possibly is already available, but it needs to be implemented for the specificusage, tried by the downstream user (e.g., producer, manufacturer) of the component, andthen tested in the full individual piece of equipment. Given the specific characteristics ofCategory 9 equipment and its long-life span and development cycles, the Test &Measurement Coalition applies for a renewal of the exemption 6(b) for the maximum validity
period to allow for this process to take place.
According to the socio-economic analysis conducted by TMC, the total impact of nonrenewal of this exemption is monetized in the range of 2 billion EUR and 2.8 billion EUR(conservative lower bound estimate).
EUROMOT (cat 11)
According to (EUROMOT 2023a): Lead is present as an impurity in aluminium up to 0.4%
by weight whose removal or dilution would have a significant negative environmental andhealth impact. Although there is the trend of reducing lead content in some alloy
specifications, some specifications still permit >0.3% lead which are utilised in EUROMOT
members parts. Parts with up to 0.4% lead are still used by EUROMOT members as they
produce special types of engines some of which are sold annually in only small numbers,
as few as one or two per year. Stocks of parts for these special types of engines may lastfor up to seven years before they are consumed, and new batches of parts are obtained.
Some of the parts currently in stock contain between 0.3% and 0.4% lead and so
manufacturers need this exemption to allow up to 0.4% lead until these parts are used infinished products that are placed on the market. Without the continuation of the exemption
these parts will become waste and have to be disposed of and replaced which has aconsiderable environmental impact.
In addition, (EUROMOT 2023b) provides the following summary of the requested
exemption: Lead is added to aluminium components used in internal combustion engines,
associated components and end-products in which these are used mostly to achieve
superior machinability by aiding chip fracturing and improved surface finish. Lead also aids
in anodisation and extrusion performance, electrical conductivity, corrosion resistance andother mechanical properties. Leads inclusion in aluminium allows the manufacture oflightweight, intricately shaped parts which is especially important for the many very small
and light weight parts used in engines. Although there are lead-free alternatives, they are

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not always identical drop-in replacements to the lead-based alloys. Therefore it is always
necessary for EUROMOT’s members to carry out research and testing to determine
whether each potentially suitable substitute offer the necessary technical performance.
Material testing and development activities take many years to complete and so far isincomplete. The time required by manufacturer varies from five to eight years.
Bismuth is commonly used as an alternative to lead, however it has significantly morenegative impact than lead. EUROMOT members also have machined parts which are kept
in stock, but not yet placed on the market which without the exemption will become waste
and have to be disposed of and replaced.

6.1.4.

Technical description of the exemption and use of the restricted
substance

The technical background is described in more detail by (Baron et al. 2022b)

6.1.5.

Amount(s) of restricted substance(s) used under the exemption

TMC (cat. 9 IMCI)
According to (TMC 2023b): the surveyed companies stressed that the content of substancein homogeneous material is highly variable. Based on literature review, contacts in electricalswitching devices typically contain less than 0.4% lead in the homogeneous material.
Overall, through application for which the exemption is requested (cat 9 IMCI),
approximately 1.80 kg of Pb enters the EEA market every year.
EUROMOT (cat. 11)
In (EUROMOT 2023a) and (EUROMOT 2023b), two EUROMOT members provided data
for III-6(b)-I and III-6(b)II, relevant to cat 11, as detailed below.
Manufacturer A: Figures for 6b (not differentiated for 6bI and 6bII).
Total of lead in aluminium parts containing >0.1% lead in one typical engine: 233 grams.
Based on the 20131 EUROMOT 68,000 engines are in scope of RoHS sold in the EU andEUROMOT stated in its 2017 lead in sensor request that this figure was unchanged. As
such there is 15.84 tonnes placed on the EU + UK market annually. The UK is 7.42% of the
EU sales quantity according to Power Systems Research with 2021 information. As such
this manufacturer estimates the amount of lead placed on the EU market annually is 14.67
tonnes from both 6bI and 6bII.
Manufacturer B: Provided information for genset engines in range 250 – 550kVA.
This manufacturer estimated that for 6(b)-I they place 60kg of lead annually on the market
combined EU and UK market. Based on their estimated market share of 30%, the amountof lead placed on the market by all manufactures would be 200kg.
250 – 550kVA range accounts for 6% of total gensets, therefore using EUROMOTs
estimates for EU (excluding the UK) market (also considering Power Systems Researchwith 2021 information that the UK accounts for 7.42% of EU sales). As such, based on thismanufacturers estimation the annual amount placed on the EU market for 6(b)-I is 3.08
tonnes.

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This manufacturer estimates for 6(b)-II they place 150 kg of lead annually on the EU and
UK market. Following the same methodology as outlined above, this would result in 500kg
of lead placed on the EU and UK market for genset engines in range 250 – 500kVA.
Therefore, the total amount of lead placed on the EU market for all manufacturers is 7.71
tonnes for exemption 6b-II.
As such the combined value for 6bI + 6bII total is 10.8 tonnes

6.2.

Justification of the requested exemption

6.2.1.

Substitution and elimination of the restricted substance

TMC (cat. 9 IMCI)
According to (TMC 2023a), alternative to lead for all types of 6(x) exemptions, including
6(b), are in development. While the applicant needs to rely on component manufacturer
supplies of parts for 75%+ of the components of their instruments, they believe it is likelythat component manufacturers will gradually make available workable alternatives to thelead containing parts currently on the market. And if such parts become available, they will
be designed into new equipment that is developed in a cycle of 7-10 years depending on
the type of Cat. 9 equipment involved.
The applicants therefore believe a technical solution will and possibly is already available,
but it needs to be implemented for the specific usage, tried by the downstream user (e.g.,
producer, manufacturer) of the component, and then tested in the full individual piece ofequipment. Given the specific characteristics of Category 9 equipment and its long-life spanand development cycles, the Test & Measurement Coalition applies for a renewal of the
exemption 6(b) for the maximum validity period to allow for this process to take place.
EUROMOT (cat. 11)
According to (EUROMOT 2023a), three options are considered as possible alterative
applications or alternatives for use of RoHS substances: 1) Lead removal from aluminium
alloy; 2) use of primary metal to dilute lead concentration; 3) achieving a lower lead content
in refined scrap metal.
Moreover, in (EUROMOT 2023b) it states that it is always necessary for EUROMOT’s
members to carry out research and testing to determine whether each potentially suitable
substitute is suitable […] Many lead-free substitute alloys contain tin, but alloys containing
tin often cannot be used in engines because tin is known to cause cracking in machinedparts when subjected to stress and high temperature, both of which can be common inengines. The most commonly used machining aid apart from tin is bismuth, although it isvery different from lead […] The LCA provided by the Umbrella project to support renewalof exemption 6(b) does show that bismuth has significantly more negative impacts then
lead.

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6.2.2.

Environmental, health, safety and socio-economic impacts

TMC (cat. 9 IMCI)(TMC 2023b) aims at demonstrating that the non-renewal of the exemption would havedisproportionate negative impacts on society when compared with the risk to human health,animal health or the environment.
The total monetized impact of non-renewal is estimated in the range of 2 billion EUR and2.8 billion EUR – the analysis includes confidential data with regard to detailed costs related
to test and measurement of industrial product type manufacturers; substitution costs; social
impact deriving from unemployment; also mentioning that this is a conservative estimate.
In terms of business and market impacts, a non-renewal would constraint most of thecompanies currently supplying RoHS-based test and measurement industrial products tocease production and business activities of all products that include lead.
EUROMOT (cat. 11)
Also (EUROMOT 2023b) elaborated on the possible impacts of the non-renewal of the
exemption. The use of substitutes, such as bismuth, as also assessed in the LCA provided
by the Umbrella project to support renewal of exemption 6(b), has significantly morenegative impacts than lead and EUROMOT requests that this is taken into account.
Another environmental issue that specifically affects EUROMOT’s members is that they
manufacture many special types of engines some of which are sold annually in only small
numbers, as few as one or two per year. However, the machined parts that are used tomake these are made in moderately large numbers either by the engine manufacturers orby their suppliers and then kept in stock until needed. Stocks of parts for these special typesof engines may last for up to seven years before they are consumed, and new batches ofparts are obtained. This exemption will be needed to allow those parts that have alreadybeen made to be used in finished products that are placed on the market, otherwise, they
will become waste and have to be disposed of and replaced.
Another argument is that: if this exemption is not renewed, engine and end-productmanufacturers will be forced to stop selling products that do not comply with RoHS. At thisstage, it is not known which products will be affected but this is likely to affect many typesof end-users. For example, construction and other industries may not be able to operate if
essential equipment is not available. If emergency generators are affected, this may affect,
for example, hospitals who use these when there are power cuts. Unavailability will either
pose a safety risk during essential surgical operations and will pose a risk to patient’s
survival or these operations and also other medical procedures (such as MRI examinations
and monitoring patients in intensive care) may not be possible if emergency generators are
not available.
(EUROMOT 2023a) also makes reference to environmental and health impact related tothe use of primary instead of secondary aluminium. If the secondary alloys cannot be used
due to lead restriction, then primary metal will be needed to dilute the lead content. But useof primary aluminium foresees 18 times more energy and its associated impacts on global
warming, hazardous substance emissions etc. Considering all lifecycle phases, reuse of
secondary aluminium will have the least impact on health and the environment.

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6.2.3.

Roadmap towards substitution or elimination of the restricted
substance

TMC (cat. 9 IMCI)(TMC 2023a) refer that the companies have indicated that there are currently no suitable
alternatives that meet the performance expectations of their customers. However, it isforeseeable that such alternatives will be made available in the coming years but theimplementation for the different uses will be very gradual and implementation is not likely tobe linear. Members of the Test & Measurement Coalition have pointed out that theyprincipally rely on their component suppliers to find alternatives since most of the
exemptions used in those components are not produced by the supplier but are bought offthe-shelf from their suppliers. As such, this part of the supply chain are slower and moreinconsistently able to adapt. Assuring full adaption in the supply chain and validating thealternatives in the final product application can and often does require up to 4 years.
If a new substance-free part is available from a supplier, this part must be qualified for use
by the Category 9 manufacturer by performing a variety of additional tasks. Due to thecomplexity and diversity of the applications, this must be done individually by each company
for each product group. This process diverts resources from other projects and increases
the cost to ensure continued availability of these products. This validation and testingprocess varies according to part complexity; which can be categorised as low, medium, andhigh:•

Low complexity parts are the off-the-shelf components or hardware parts that do nothave a substantial performance impact. Replacement can be done based on
supplier information, assuming a form/fit/function compliance, with standard
manufacturing, testing, and validation processes. Based on process timescales
reported by a TMC coalition company, the average time that it can take for theseparts to be replaced ranges from 3 to 6 months.

•

Medium complexity parts are more complex sub-assembly electronic parts, such as
small motors, which need additional validation for their performance. These parts
are often commercial assemblies that are generally available to the electronic
industry and are utilised by the TMC companies. Replacement of these assemblies,
like-for-like, requires testing and validation prior to integration into the manufacturing
process. The average time to find an alternative for medium complexity parts for
production is reported to range from 6 to 12 months.

•

High Complexity parts are the complex sub-assemblies or parts that have asignificant impact on performance of the company’s products or play a critical rolein overall safety of the products. These parts need to go through extensive validation
for performance and/or compliances for varying regulations before the appropriate
files can be updated and the proper competent authorities or regulatory bodies canbe notified prior to purchase of parts for validation. The average time that it would
take to find an alternative for high complexity parts for production is up to 1 year for
additional testing. Where the exemption directly impacts the performance of thatcomponent (e.g., a centrifuge rotor) the evaluation of the replacement could takefrom 3 to 5 years.

What makes substituting exemption 6(b) challenging is the ubiquity of the application of the
exemption. Below it is reported a graphic summarizing the substitution milestones:

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Figure 6-1: Roll out of compliant equipment

Source : (TMC 2023a)

According to (TMC 2023a), the conclusion on the suitability and availability of alternatives
is that whilst substitution is possible, it will require time. Time that is likely to exceed theredesign cycle of equipment which as of today are already being developed without use of
the exemption. There is therefore a continued need for a 7-year additional exemption for
Category 9 to allow the phasing out of the older equipment for newly designed ones which
are lead-free.
EUROMOT (cat. 11)
In their application for exemption III-6(b)(I), (EUROMOT 2023a) refers that once
manufacturers have identified parts that use alloys with 0.3% – 0.4% lead, they will need tocarry out the following work:
Determine whether the alloy currently used can be sourced with <0.3% lead andwhether this will affect essential performance requirements. This may be possibleby either sourcing the component from a different supplier, or by the current supplierselecting batches of scrap metal with lower lead content after chemical analysis. The
latter option may not always be possible as suppliers may not be willing to do this if
most of their production is for products excluded from the RoHS Directive.
If it is not possible to guarantee that the currently used alloy will always contain <0.3%
lead, if the alloy specification does not limit lead to this value or below. As all alloys
have slightly different performance and properties, assessment and testing of
prototypes will be required. The timescale will vary depending on how significant thechanges and the types of engine and the end-uses are. This will involve some or allof the following:oSelection of alloys based on published propertieso

Production of prototype parts and laboratory testing to determine
suitabilityoRe-tooling if required, selection and approval of new suppliers, etc.

oConstruction of engines using prototype parts and bench testing todetermine reliability

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If substitute alloys require significant changes, such as re-design,then approvals under the NRMM Emissions legislation will be
required. This will take as long as it takes for a new engine design.

The timescales for these stages vary between 18 months and eight years depending on thetype of component.

•

Timescales for above:oWithout NRMM Emissions Regulation re-approval up to seven yearsoWith approvals eight years. This may be longer as approvals will be
required globally as usually each design of engine is sold worldwide, not only in the EU.

o

As a minimum, to consume existing stocks of components, anadditional 7 years is required from the date when substitutes withverified reliability are available.

o

In addition, in its application for exemption 6(b)-II, EUROMOT refers
that the following will be required before lead-free substitute parts
can be used in end-equipment. This work is required before
modified engines can be sold in the EU and in the UK. It may also
be necessary for much lengthier trials to be carried out to comply
with emissions legislation. The current situation is that each
EUROMOT member may use up to several hundred of machined
aluminium parts. Research will be needed with each part to:

1. Confirm which parts are currently made using a lead-based alloy.
2. Identify one or more lead-free substitute alloys that have comparable
properties and performance and appear to meet any essential technicalrequirements. Any heat treatment requirements would also need to beinvestigated at this stage. These requirements will depend on thespecific applications of the component and where the end-products areused. Any one part is likely to be used in several end-products and be
used under a variety of environmental conditions.
3. Make prototype parts and assess for quality, dimensional accuracy,
surface finish, strength, corrosion resistance and any other property thatis essential for the parts made using this alloy. Specific heat treatments
may also need to be investigated to identify suitable processes.
4. Reliability testing. These are in-house tests carried out to ensure thatparts are suitable and meet manufacturer’s specifications.
5. If a change to the alloy is not trivial (e.g. if the properties are different
or a design change is needed), it is likely that manufacturers will need tobuild prototype engines using new parts and test these. This is because
they have found previously that laboratory testing does not always
identify long term field failure issues, which are identified only whentested in real engines.

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6. If necessary, testing of modified engines to comply with the NRMM
Emissions Regulations
7. Request re-approvals if necessary. Changing some components suchas throttle and control units will require re-certification as these are
essential components for granting of emissions certificates.
The time required for all of the above for each manufacturer will dependon how many lead-based alloy parts are identified, how successful is thework to identify suitable substitutes and if re-certification are needed.
The predicted timescales for these activities to be fully completed are
between 5-8 years, depending on the types of component eachmanufacturer uses and the changes and testing that are required foreach component.

6.3.
6.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of the exemption
6(b)-series in EEE of cat. 9 IMCI and 11.
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

6.3.2.

Substitution and elimination of the restricted substance

Both applicants apply for the renewal of exemption 6(b), and EUROMOT additionally for the
renewal of exemptions 6(b)(I) and 6(b)(II). Following their mandate, the consultants
assessed whether the recommendations for the renewal of exemptions 6(b), 6(b)(I) and6(b)(II) as exemptions 6(b)(III) and 6(b)(IV) recommended by (Baron et al. 2022a) (cf. Table
6-5 on page 78) can be adopted for cat. 9 IMCI and cat. 11 in the light of their renewal
requests.

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Renewal of exemption 6(b) and 6(b)(II) as exemption 6(b)(IV)14
TMC (cat. 9 IMCI)(TMC 2023c) do not agree to adopt the recommendation of (Baron et al. 2022a) to cat. 9
IMCI.
They stated that lead as an alloying element in aluminium containing up to 0.4% lead byweight is intrinsic for machining purposes in niche applications. Aluminium alloys(containing lead) are used to make a very wide range of category 9 IMCI, parts, andcomponents. In the context of adopting the recommended renewed exemption 6(b)(IV) forcat. 9 IMCI, TMC (2023c) stated that “[…] alternatives to lead for all type 6 exemptions are
in development [...] As and when such alternative parts become available, they will be
designed into new equipment that is developed in a cycle of 7-10 years depending on thetype of category 9 equipment concerned. The applicants therefore believe a technicalsolution will be forthcoming and is possibly already available in some cases, but it needs tobe implemented for the specific usage, tried by downstream user (e.g., producer,
manufacturer) of the component, and then tested in the full individual piece of equipment”.
However, (Baron et al. 2022a) refer in the context of exemption III-6(b)(IV) that “[…]substitutes are available on the market for which reliability is claimed by aluminium alloy
producers. It has also been demonstrated that most of these alloys were already available
on the market in 2016 when the last review of this exemption was finalised. This availability
is understood to have allowed substitution in most applications.
Moreover, the industry did not provide specific evidence to show that the suitability of leadfree Al alloys used for machining purposes differs between EEE in Cat. 8 in-vitro, Cat. 9
industrial and Cat. 11 and between other EEE. It is thus assumed that should the above
recommendation not be feasible for such categories that stakeholders will be able to submit
a request for the renewal of Ex. 6(b) for machining purposes in such cases relatively quickly,
providing detailed evidence as to why available substitutes are not applicable for specific
EEE”.
On this basis, TMC was asked to provide examples of specific cases where lead-freealuminium alloys are readily available but are not applicable for cat 9 IMCI. However, no
specific examples were provided. (TMC 2024) reiterated that the reliability of substitution
has not been ensured for all parts made of this material.
It can therefore be concluded that TMC does not know of any specific cases where
substitutes would not be available. The consultants also asked to further explain why,
considering that substitutes were already present on the market when the last review was
carried out in 2016, still seven to ten years are required to design alternatives into newequipment around eight years later, and why this process was not started earlier already.
(TMC 2024) mentioned that detailed examples are listed in their SEA, associated with thescale of the equipment portfolios, active life of equipment, and detailed breakdowns of thesteps required to assure the reliability of substitution in cat 9 IMCI.
By double checking (TMC 2023b), the consultants found out rather general descriptions,
mentioning that each TMC member typically has between 2-3,000 products available on the

14 The adoption of 6(b)(IV) for cat. 9 IMCI and cat. 11 implies that the wording would be adapted to allow the

integration of these two categories of EEE into the exemption scope.

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market – which are highly complex, sophisticated electronic instruments (e.g. signal
generators, power analysers, oscilloscopes, spectrum analysers etc.) and each instrument
can have up to 40,000 parts. However, we could not find technical specification on thereasons why the revising of the portfolio products have not started already – at least forsome of them. The lack of examples makes it difficult to assess the reasons why alternatives
have not been integrated yet, considering that substitutes were already present on themarket during the last review. The consultants can, however, follow that the redesign andpartially requalification of cat. 9 IMCI is required to ensure the reliability of the substitutes.
EUROMOT (cat. 11)(EUROMOT 2023c) agree that their cat. 11 EEE would be covered by exemption 6(b)(IV)
recommended by (Baron et al. 2022a) provided that the exemption remains valid until
31 July 2029 to have 5 more years for essential testing as outlined in their renewal request.
Regarding exemption renewal request for III-6(b)(II), recommended to be renewed as
6(b)(IV), (Baron et al. 2022a) understand[…] that there are lead-free alternatives on themarket that are reliable according to aluminium producers. […]. While the aluminium
manufacturing industry stated that they would be immediately able to supply any quantity
needed of lead-free alloys, some other stakeholders such as (Mondragón Componentes S.
Coop. 2021) mention that for “very long delivery dates, for example for alloy 2077 and […]for “Ø10.5mm aluminium coil” there is no lead-free alternative on the market.
As specified by (EUROMOT 2024), even though their members are developing their new
applications to be in compliance with lower threshold of lead in this exemption, legacy
applications still require validation to ensure that lower limits are suitable. EUROMOT’s
members cannot use parts made using different alloys until prototypes have been made,assessed, and tested to ensure that the properties and performance meet the specificrequirements. So while priority is given to develop new products, higher lead content is stillrequired according to EUROMOT for legacy applications.
As a technical constraint, (EUROMOT 2024) put forward that lead-free aluminium
containing tin or bismuth cannot be used in EUROMOT members’ products (engines). Tin
is known to cause cracking in machined parts when subjected to stress and hightemperature, both of which can be common in engines, and from the technical standpoint
bismuth offers very different properties to lead. .
This statement seems implausible as a technical argument against the use of lead-freealuminium alloys in EEE of cat. 11. The automotive industry as a user of engines agreed tothe expiry of the corresponding ELV exemption 2(c)(i) in the review by (Deubzer et al. 2021),
acknowledging that lead-free alloys are available that can be used.
(EUROMOT 2024) put forward that their applications might differ from the automotive
sector, as light duty vehicles are in scope of ELV while heavy-duty vehicles might be inscope of RoHS. If the automotive industry is able to use a lead-free alloy it is a good
indication that it may be suitable, but it could not be implemented without the relevant testing
being undertaken.
The applicant already conceded that exemption III-6(b)(IV) can be adopted for cat. 11 if
more time is granted for redesign, testing and qualification. From the above, it can beconcluded that substitution of lead is scientifically and technically practicable for cat. 9 IMCIand cat. 11. The limitation is only time-related, i.e. to ensure the reliability of the substitutes,

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a redesign of the equipment or parts thereof is required including testing and, at least insome cases, requalification.
(Baron et al. 2022a) recommended the expiry of exemption III-6(b)(IV) in 2024, based on
the fact that Al alloys suppliers have developed alternatives with performance comparable
to most uses of leaded-alloys. It is conceivable that manufacturers of EEE should also beable to phase-in such alternatives. Where this is not the case, given the expiry dates in the
short term, applications for renewal would have already started/been submitted.
With substitution of lead being scientifically and technically practicable in the consultants’point of view, the two renewal requests represent a case where the applicants claim thatthe phase-in of lead-free aluminium alloys is not feasible until the expiry of therecommended exemption 6(b)(IV) on 21 July 2024.
The arguments of TMC can be followed that EEE of cat. 9 IMCI can be complex devices
with long model lives, which is reflected in the maximum validity period for exemptions ofseven instead of only five years. Long model lives are also plausible for most cat. 11
equipment of EUROMOT members. Redesign and, where obligatory, recertification of theseproducts take time.
(EUROMOT 2024) demand that, since supply chains are to a large extent shared with
automotive (light duty vehicles in scope of ELV and heavy-duty vehicles excluded from both
ELV and RoHS), any exemption expiry dates imposed on industry’s use of lead in aluminium
alloys used in engines will be technically impractical if these are not the same dates as forthe corresponding ELV exemptions.
ELV exemption 2(c)(i) corresponding to the recommended renewed exemption 6(b)(IV)
expires on 31 December 2027. In the related review resulting in the current wording andexpiry date of exemption 2(c)(i), (Deubzer et al. 2021) found that the last lead-free alloys
which are relevant to avoid lead in aluminium completely have become available in 2019and 2020. Taking 2020 as reference point, an expiry of exemption 6(b)(IV) would result ina seven year period to implement lead-free alloys in cat. 9 IMCI and cat. 11, whichcorresponds to the seven to ten years of time TMC claim to be required for phase-in whenlead-free alloys are available. For cat. 11, the expiry date would be aligned with the ELV
exemption as requested by EUROMOT. The consultants therefore recommend adopting
the recommended exemption 6(b)(IV) with an expiry date for cat. 9 IMCI and cat. 11 notexceeding 31 December 2027.

Renewal of exemptions 6(b) and 6(b)(I) as exemption 6(b)(III)The adoption of the recommended exemption 6(b)(III) would result in a reduced leadcontent in casting aluminium alloys, down from 0.4 % to 0.3 % after 21 July 2024. The
review was therefore focused on whether this is feasible for cat. 9 IMCI and cat. 11
technically, and in the foreseen timeframe.
(EUROMOT 2023c) reject adopting the renewed exemption 6(b)(III) recommended by(Baron et al. 2022a), stating that exemption 6(b)(I) permitting lead up to 0.4% is stillrequired, rather than 6(b)(III) permitting 0.3%.

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EUROMOT (cat. 11)(EUROMOT 2023a) has been using casting alloys according to EN 1706 AC 46500, which
is normally used for high pressure diecasting as it can be used to make thin-walled
components with complex geometries. This alloy was specified by EU standard EN 1706
until its revision in 2020 with up to 0.35% lead for this alloy, but the concentration was
reduced to 0.29% by the 2020 revision.
The applicant was therefore requested to clarify how EUROMOT members comply with the
new standard stipulating a maximum of 0.29 % of lead, if it takes five years and more toqualify and test such parts until they can be used in their products.
(EUROMOT 2024a) confirm that parts made to EN 1706 before the standard was changed
in 2020 contain up to 0.35% lead. Changes to this standard has changed several othercasting alloys by lowering the maximum lead content. Components which (EUROMOT
2023c) used to manufacture for their devices prior to the change in the specification of thestandard, have been pre-bought to support long term manufacture and therefore are stockparts with the original lead concentration. Without an exemption these parts would justbecome waste as they would not be able to be used in equipment placed on the market in
the coming years.
With this regard, the consultants asked why EUROMOT pre-buy these parts on stock, for aperiod of time that makes it an obstacle against a change in aluminium content. The
consultants assume that pre-buys are made instead of redesigning parts to facilitate theuse of aluminium alloys with lower lead contents according to the new standard.
(EUROMOT 2024b) replied that their “[…] members are system manufactures and not alloy
manufacturers and as such rely on their supply chain to provide those components.
EUROMOT members have no control over the chemical composition of alloys and have torely on their suppliers to implement the changes. Alloy suppliers in some instances are tier
4 or 5 in the EUROMOT members products supply chain which makes control on thecomposition of the alloy even more challenging. Moreover, although suppliers might beaware of new restriction of concentration of lead in aluminium alloys and have acted
accordingly, the components with the reduced concentration of lead might not have reachedsystem manufacturers yet”.
The consultants asked whether EUROMOT could provide an estimate of how long
manufacturers need to terminate the stocks of aluminium parts still containing between
0.3 % and 0.4 % of lead. As a minimum, to consume existing stocks of components, anadditional 7 years is required from the date when substitutes with verified reliability areavailable, according to (EUROMOT 2024b).
If any changes to EUROMOT products are significant, such as having to use a totallydifferent type of alloy, the temper needs to be changed (as this can affect corrosion
resistance), the casting method or the shape or design of the part is changed, then morecomprehensive testing will be needed and it may be necessary to gain re-approvals for theengine under the EU Non-Road Mobile Machinery (NRMM) Emissions Regulation(Regulation (EU) 2016/1628).
The consultants wondered why a change in a material composition should require a reapproval under an emissions regulation. (EUROMOT 2024b) explained that the use ofaluminium alloys in EUROMOT applications is implemented in relative moving parts, andthe change in alloy composition would have different friction coefficient, which is directly
linked to emissions and therefore would require the above-mentioned approval under the90

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NRMM Emission Regulation. Also, where a change in the design of the system isimplemented, this would also trigger the requirement for requalification under the same
Regulation.
In addition, for the parts which require qualification to permit the reduction in lead content,
this needs to be scheduled into the testing of each manufacturer. Priority is given to new
products to be qualified and therefore this creates a longer timeframe for legacy products
to be transitioned to lower lead content. As the EUROMOT requirements are highly specificand demanding, and only a finite number of test rigs are available, and a limited number ofqualifications can be performed at a given time making the validating of systems timeextensive. The testing required for the qualification of EUROMOT applications can take up
to several years to accurately simulate the long operating timeframes. If an appropriate
timeframe is not granted, then the qualification activities to ensure that the reduced leadcontent is technically suitable would not be able to occur. As such, this would result in theunavailability of equipment for the EU market.
The consultants conclude that, like in the case of lead-free alloys for machining purposes,
redesign of devices is required to ensure the reliability of substitutes which requires time
beyond the expiry dates suggested by (Baron et al. 2022).
TMC (cat. 9 IMCI)The main technical reason put forward by (TMC 2023b), as for recommended ex 6(b)(IV),is that lead as an alloying element in aluminium containing up to 0.4% lead by weight isintrinsic for machining purposes in niche applications. Aluminium alloys (containing lead)
are used to make a very wide range of category 9 IMCI, parts, and components.
(TMC 2024a) also mention: “[…] while new product introductions have adopted lead-free or
lower lead concentration aluminium alloys as materials for the production of new parts, thisdoes not address all of the unique parts in TMC mature portfolio, which rely on the current
wording of exemption 6(b) for conformity with the RoHS Directive.
When asked why TMC did not participate in the previous review of the exemption III-6(b)series by (Baron et al. 2022), as result of which the reduction of the lead level down to 0.3 %was recommended, they made reference to their contribution to the previous consultation,
where they mentioned a detailed rationale why the renewal application for III-6(b) was
considered premature for cat 9 IMCI.15 The COM had, however, already rejected thisargument in the review of exemptions by (Deubzer et al. 2022) so that the exemptions werereviewed for all categories of EEE for which the renewal was requested.
Overall, the information provided by both applicants suggest that in the end, in line with thefindings of (Baron et al. 2022), substitution and elimination of lead in cast aluminium alloys
are scientifically and technically practicable in cat. 9 IMCI and EEE of cat. 11. The reliabilityof the substitutes needs, however, to be ensured, which is achieved with redesign and,
where required, the requalification of EEE. The renewal of the exemption would therefore
be in line with the requirements of Art. 5(1)(a). Since the redesign of cat. 9 IMCI and cat. 11
EEE can be assumed to enable both the use of lead-free machining alloys as well as theuse of aluminium alloys with 0.3 % of lead, the expiry dates of the renewed exemptions
should be aligned.

15 https://rohs.exemptions.oeko.info/exemption-consultations/2020-consultation-2/aiii-ex-6b/6b-i

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6.3.3.

Environmental, health, safety and socio-economic impacts(EUROMOT 2023a) and (EUROMOT 2023b) claim that exemption 6(b) is needed to avoid
that several parts in stock will become waste and will have to be disposed of and replaced.
(For further details, see paragraph 6.2.2) They also specified a period of 7 years to consume
all the stocks which, according to the consultant, could to some extent justify the need ofthe exemption renewal.
Another issue brought up by (EUROMOT 2023a) is that the most commonly used machining
aid apart from tin is bismuth […] The LCA provided by the Umbrella project to support
renewal of exemption 6(b) does show that bismuth has significantly more negative impacts
then lead.
However, it was already concluded by (Baron et al. 2022a) that the 3rd criterion of Article
5(1)(a) is not fulfilled and cannot follow the argumentation of the Umbrella Project that arenewal of the exemption is justified on the background of the higher environmental impactof bismuth compared to lead described in an LCA study on metal extraction. (EUROMOT2024) further on point out that bismuth is being listed as a critical raw material, of whichavailability is scarce and of higher impact to source from the environmental impact
standpoint.
Bismuth actually has been listed as critical raw material16 in 2020 already at the time of thereview of the exemption 6 series by (Baron et al. 2022a). The criteria to qualify a material
as “critical” are its economic importance and the supply risk, not the environmental impacts,
and bismuth is to a large degree mined together with lead. In the light of Art. 5(1)(a), thelisting of a material as a critical material does not justify recommending the exemption to be
granted unless the availability of this material would be severely reduced. In the consultants’
understanding of the current situation, this is not the case with bismuth and its
criticality/scarcity is at maximum, if at all, reflected in its price. The consideration of legal or
strategic conflicts with other EU policies are beyond the consultants’ mandate and will be
addressed by the COM if deemed appropriate in the decision whether the exemption is
granted.
TMC foresee substantial socio-economic impacts if exemption 6(b), including 6(b)(I), is notrenewed. The consultants cannot exclude that at least some of these impacts would actuallyarise if the COM does not renew the exemption.

6.3.4.

Stakeholder contributions

While the other stakeholder submitted letters in support of applicants’ renewal requests (cf.
Table 6-4), two of them specifically expressed their support to the agreement of (EUROMOT
2023c) that exemption 6(b)(IV) proposed as renewal of exemption 6(b)(II) (cf. Table 6-5) isapplicable to cat. 11 provided it will remain valid until 2029.

16 See https://single-market-economy.ec.europa.eu/sectors/raw-materials/areas-specific-interest/critical-raw-materials_e92

Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(Afecor 2023) and (APPLiA Italia 2023) request exemption 6(b)(IV) to remain valid until
2029 (for 5 more years beyond the recommended expiry in 2024), also for EEE of categories
1 and 2. They justify their request with delays due to unexpected global events (Covid,
Ukraine war etc.) so that they cannot substitute the aluminium alloys with 0.4 % by alloys
with 0.3 % lead until 31 December 2024.The above requests are beyond the consultants’mandate and thus out of scope of this current review. The consultants therefore did not
follow up on these requests but recommend the stakeholders to bring their above issues to
the COM’s attention.

6.3.5.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;•

the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts causedby substitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

(EUROMOT 2023b; TMC 2023a) applied for the renewal of exemption 6(b), and exemption
6(b)(I) and 6(b)(II) (EUROMOT only). (Baron et al. 2022) recommended the renewal of
exemption 6(b) that covers both cast aluminium alloys as well as alloys for machining
purposes, as exemptions 6(b)(III) (cast aluminium alloys) and 6(b)(IV) (aluminium alloys formachining) for cat. cat. 9 IMCI and cat. 11.
The consultants in 2022 proposed the same for current exemptions 6(b)(I) (cast aluminium
alloys) and 6(b)(II) (alloys for machining), i.e. their renewals as exemptions 6(b)(III) and6(b)(IV) (cf. Table 6-5). Following their mandate, the current consultants assessed in theirreview whether these recommendations can be adopted for cat. 9 IMCI and cat. 11.

Renewal of exemption 6(b) and 6(b)(II) as exemption 6(b)(IV)(EUROMOT 2023b; TMC 2023a) agree that EEE of cat. 11 would be covered by exemption
6(b)(IV) as recommended by (Baron et al. 2022), but 5 years until 2029 are still necessary
to undertake necessary development and testing. They raise doubts as to whether leadfree aluminium alloys can actually be used in engines and other components of theirmembers’ products. The applicant can, however, not substantiate this claim consideringthat the automotive industry agreed to the expiry of the corresponding ELV exemption 2(c)(i)on 31 December 2027, the more as they argue that they share part of their supply chain
with the automotive sector. For the same reason, they also mention aligning the expiry dateof the renewed exemption 6(b)(IV) with the expiry date 31 December 2027 of thecorresponding exemption 2(c)(i) in (Directive 2000/53/EC 21.10.2000).

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TMC explain that new product introductions have adopted lead-free aluminium alloys asmaterials for the production of new parts but that this does not address all of the uniqueparts in the TMC mature portfolio, which rely on the current wording of exemption 6(b). As
and when lead-free alternatives to lead-containing aluminium alloys become available, they
will be designed into new equipment that is developed in a cycle of 7-10 years dependingon the type of cat. 9 IMCI equipment concerned.
The consultants take from the submitted information for cat. 9 IMCI and for cat. 11 and inline with the findings of (Baron et al. 2022), that substitution of lead in machining aluminium
alloys is scientifically and technically practicable. The reliability of substitutes needs,
however, to be ensured via redesign and, at least in some cases, requalification. Lead-freealuminium alloys for machining purposes have been available since 2020 latest. Taking
2020 as reference point, EUROMOT members and cat. 9 IMCI producers had four years
time already to implement the use of lead-free alloys in their EEE. Seeing the technicalspecificities of cat. 9 IMCI and cat. 11, it can be followed that this process requires time toensure the reliability of the substitutes so that renewing the exemption for the use of lead inmachining alloys would be in line with Art. 5(1)(a).
As to the expiry date of the exemption for cat. 9 IMCI and cat. 11, the COM requires theconsideration of the expiry dates recommended by (Baron et al. 2022) in the previous
review, in this case the expiry of the recommended exemption 6(b)(III) on 21 July 2026
which is the only expiry date recommended while the other exemptions were recommended
for expiry.

Renewal of exemptions 6(b) and 6(b)(I) as exemption 6(b)(III)EUROMOT reject the adoption of the renewed exemption 6(b)(III) recommended by (Baronet al. 2022a) stating that exemption III-6(b)(I) permitting up to 0.4 % of lead in aluminium
cast alloys is still required for cat. 11 EEE, instead 0.3 % permitted in 6(b)(III).
EUROMOT reason with the revision of standard EN1706 AC 46500 in 2020 lowering thelead content in Al from 0.35 % to 0.29 %, which caused their members to pre-buy andmanufacture components prior to the change which would become waste without an
exemption renewal. They also argue that a change in the material composition of cat. 11
EEE would require a re-approval under the NRMM emission regulation, which would taketime and could result in the unavailability of equipment for the EU market. EUROMOT claim
seven additional years to be needed to consume the pre-bought parts – from the date whensubstitutes with verified reliability are available.
Like in the case of lead-alloys for machining, TMC explain that new product introductions
have adopted lower lead concentration aluminium alloys as materials for the production of
new parts. However, this does not address all of the unique parts in the TMC mature
portfolio, which rely on the current wording of exemption 6(b) for conformity with the(Directive 2011/65/EU 2011).
The information and arguments provided by both applicants suggest that in the end, in linewith the findings of (Baron et al. 2022), substitution and elimination of lead in cast aluminium
alloys are scientifically and technically practicable in cat. 9 IMCI and EEE of cat. 11. The
reliability of the substitutes needs, however, to be ensured, which is achieved with a94

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redesign and, where required, the requalification of EEE, which is plausible to require moretime for EEE of cat. 9 IMCI and cat. 11 than for other categories of EEE.
Like for the aluminium alloys for machining purposes, the consultants recommend 21 July2026 as expiry date.

6.4.

Recommendation

The information provided by the applicants suggests that for cat. 9 IMCI as well as for EEE
of cat. 11, substitution of lead in aluminium alloys is scientifically and technically practicable,
which is in line with the conclusions of (Baron et al. 2022). The reliability of substitutes
needs, however, to be ensured, which requires time for redesign, requalification and insome cases for recertification. A renewal of the exemptions would thus be justifiable byArt. 5(1)(a).
The consultants recommend adopting the recommendation of (Baron et al. 2022) which
implies the expiry of exemption 6(b) and the transfer of cat. 9 IMCI and cat. 11 to otherexemptions of the 6(b)-series. The exemption architecture recommended by (Baron et al.
2022) is recommended to be modified to allow the integration of cat. 9 IMCI and cat. 11
without complicating the complexity of the 6(b)-series exemptions.
No.

Recommended
Exemption

Recommended scope and dates of applicability

6(b)Lead as an alloying
element in aluminium
containing up to 0,4 %lead by weight

Applies to categories 8, 9 and 11.
Expires on- 21 July 2021 for cat. 8 other than in-vitro diagnostic
medical devices, and cat. 9 other than industrial
monitoring and control instruments

6(b)(I)

Lead as an alloying
element in aluminium
containing up to 0,4 %lead by weight,
provided it stems fromlead-bearingaluminium scrap
recycling-

21 July 2023 for category 8 in-vitro diagnostic medical
devices-[date of official publication of the COM decision +12 months] for categories 9 industrial monitoring
and control instruments, and 11

Applies to-categories 1 to 7 and 10-

from [date of official publication of the COM
decision + 12 months + 1 day] on to categories 9
industrial monitoring and control instruments, and11

Expires on-[date of official publication of COM decision + 12
months] for categories 1 to 7 and 10-

21 July 2026 for categories 9 industrial monitoring
and control instruments, and 11

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6(b)(II)

Lead as an alloying
element in aluminium
for machining
purposes with a leadcontent up to 0,4 % byweightApplies to-categories 1 to 7 and 10-

from [date of official publication of the COM
decision + 12 months+ 1 day] on to categories 9
industrial monitoring and control instruments, and11

Expires on

6(b)(III)

Lead as an alloying
element in aluminium
casting alloys
containing up to 0,3 %lead by weightprovided it stems fromlead-bearingaluminium scrap
recycling-

21 July 2026 for gas valves in category 1 large
household appliances, and for categories 9
industrial monitoring and control instruments, and11-[date of official publication of the COM decision + 18
months] for other uses of lead in category 1, and for
categories 2 to 7 and 10

Applies from [date of official publication of COM decision +12 months + 1 day] on to categories 1 to 8, 9 other thanindustrial monitoring and control instruments, and 10

Expires on 21 July 2026 for categories 1 to 8, category 9other than monitoring and control instruments, and 10

As to the expiry date of the exemption for cat. 9 IMCI and cat. 11, the COM requires theconsideration of the expiry dates recommended by (Baron et al. 2022) in the previous
review, in this case the expiry of the recommended exemption 6(b)(III) on 21 July 2026
which is the only expiry date recommended while the other exemptions were recommended
for expiry.
The COM should ensure to allow sufficient time for preparation and timely submission ofrenewal requests between the official publication of the decision concerning the renewal of
the above exemptions and their expiry dates.
The adverse socioeconomic impacts assessed by EPPA will not arise until 2026 since theconsultants do not recommend revoking the exemption. TMC will, however, have to bear
the cost for preparing and processing a renewal request prior to 2031, which they requested
as expiry date in their current renewal request.
Applicants’ feedback on the recommendations(EUROMOT 2024c) recognise that the alignment of the expiration dates for all categories
of EEE would be beneficial from an administrative viewpoint. They criticise the short validity
period and that the expiry date is not aligned with the corresponding exemption in Directive
2000/53/EC (ELV Directive) in December 2027.
(TMC 2024b) highlight that the RoHS legal text requires that decisions on granting
exemptions have to take into account the socioeconomic impact of substitution which they
deem to be disregarded with the alignment of the expiry date for all categories of EEE.

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Furthermore, this approach goes against the logic of having different validity periods. Thisapproach would not take the specificities of the cat. 9 into account.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

6.5.

References

Afecor (2023): Consultation Questionnaire Exemption 6(b) of RoHS Annex III. Retrieved fromhttps://rohs.biois.eu/Afecor.pdf.
APPLiA Italia (2023): Consultation Questionnaire Exemption 6(b) of RoHS Annex III. Retrieved
from https://rohs.biois.eu/APPLiA_Italia.pdf.
Baron et al. (2022): Study to assess requests for a renewal of nine (-9-) exemptions 6(a), 6(a)-I,
6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I and 7 (c)-II of Annex III of Directive 2011/65/EU (Pack 22) –Final Report (Amended Version). RoHS Pack 22. In cooperation with Yifaat Baron, Carl-Otto
Gensch, Andreas Köhler, Ran Liu, Clara Löw, Katja Moch, Oeko-Institut e. V. Retrieved fromhttps://data.europa.eu/doi/10.2779/869784.
Copreci S Coop (2023): Consultation Questionnaire Exemption 6(b) of RoHS Annex III. Retrieved
from https://rohs.biois.eu/Copreci.pdf.
Cummins (2023): Request extentions RoHS Annex 3 Exemption. Retrieved fromhttps://rohs.biois.eu/Cummins.pdf.
Deubzer et al. (2021): 11th adaptation to scientific and technical progress of exemptions 2(c)(i), 3
and 5(b) of Annex II to Directive 2000/53/EC (ELV). Final report. In cooperation with Dr. Deubzer,
Otmar, Fraunhofer IZM und UNITAR, UNITAR Christian Clemm und BioIS Shailendra Mugdal.
Retrieved from https://data.europa.eu/doi/10.2779/373311
Deubzer et al. (2022): Study to assess requests for renewal of 16 exemptions to Annex IV of
Directive 2011/65/EU. Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Final Report. In cooperation with Dr. Otmar Deubzer, Saskia
Huber, Marina Proske, Jana Rückschloss (Fraunhofer IZM), Dr. Otmar Deubzer, Christian Clemm(UNITAR) und Shailendra Mudgal (BIO IS) (RoHS 26 (Pack 21). Retrieved fromhttps://data.europa.eu/doi/10.2779/248998.
Deutz AG (2023): Request extension of RoHS Annex III Exemption 6a, 6b, 6c, 7a, 7c, 42, 44.
Retrieved from https://rohs.biois.eu/DEUTZ.pdf.
Directive 2000/53/EC (21.10.2000): Directive 2000/53/EC of the European Parliament and of theCouncil of 18 September 2000 on end-of life vehicles. ELV Directive, vom 11.06.2013.
Fundstelle: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32000L0053:EN:NOT.
Directive 2011/65/EU (2011): Directive 2011/65/EU of the European Parliament and of the Councilof 8 June 2011 on the restriction of the use of certain hazardous substances in electrical andelectronic equipment (recast). RoHS 2. European Union. Retrieved from http://eurlex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065.

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EGMF (2024): Request extension RoHS Annex III exemption - Pack 27. Retrieved fromhttps://rohs.biois.eu/egmf.pdf.
EPPA (2023): Socioeconomic analysis of the impacts of non-renewal of Lead (Pb) exemption fortest & measurement industrial type products (Category 9) Exemption 34 – Annex III. RoHS Pack
27. Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_34_2023_PUBLIC_VERSION.pdf.
EUROMOT (2023a): Request for renewal of exemption 6(b)-6(b)-I. RoHS Pack 27 (RoHS 29).
Retrieved fromhttps://rohs.biois.eu/RoHS%20Exemption%20Application%206b%20and%206(b)I%20EUROMOT.
pdf.
EUROMOT (2023b): Request for renewal of exemption 6(b)-6(b)-II. RoHS Pack 27 (RoHS 29).
EUROMOT (2023c): Answers to questionnaire 1 (clarification questionnaire), sent via email byEmily Tyrwitt Jones, RINA. RoHS Pack 27 (RoHS 29). Retrieved from https://rohs.biois.eu/Ex_III6b_EUROMOT_Questionnaire-1_Clarification.pdf.
EUROMOT (2024a): Corrigendum to questionnaire 1 sent by sent via e-mail by Maitheya Riva,
RINA, to Otmar Deubzer. RoHS Pack 27 (RoHS 29).
EUROMOT (2024b): Answers to questionnaire 2 sent via e-mail by Maitheya Riva, RINA, to Elena
D’Angelo, UNITAR. RoHS Pack 27 (RoHS 29).
EUROMOT (2024c): Feedback on revised recommendations, sent via e-mail by Emily Tyrwhitt
Jones (RINA) to Otmar Deubzer (UNITAR SCYCLE). RoHS Pack 27 (RoHS 29).
European Union (13.02.2003): Directive 2002/95/EC of the European Parliament and of theCouncil of 27 January 2003 on the restriction of the use of certain hazardous substances inelectrical and electronic equipment. RoHS 1. Fundstelle: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002L0095:EN:NOT, Last updated
04.12.2013.
EuropeGen (2023): Request extension of RoHS Annex III Exemption 61, 6bI, 6bII, 7a. Retrieved
from https://rohs.biois.eu/EUROPGEN.pdf.
JCB Power System (2023): Request extension of RoHS Annex III Exemption. Retrieved fromhttps://rohs.biois.eu/JCB_support_EUROMOT.pdf.
NAM (2023): Support letter - Request Extension of RoHS Annex III Exemption 6(b)-I (EUROMOT).
Retrieved from https://rohs.biois.eu/NAM_Support%20Letter_6(b)-I.pdf.
The Truck and Engine Manufacturers Association (EMA) (2023): Request extension of RoHS
Annex III Exemption. Retrieved from https://rohs.biois.eu/EMA.pdf.
TMC (2023a): Request for renewal of exemption III-6(b). RoHS Pack 27 (RoHS 29). Retrieved fromhttps://rohs.biois.eu/RoHS_Application_Form_15.pdf.
TMC (2023b): Answers to questionnaire 1 (clarification questionnaire). RoHS Pack 27 (RoHS 29).
Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_15_2023_PUBLIC_VERSION.pdf.
TMC (2024a): Answers to questionnaire 2 sent via e-mail byTobias Steinbrecher, EPPA, to Elena
D’Angelo, UNITAR. RoHS Pack 27 (RoHS 29).
TMC (2024b): Feedback on revised recommendations sent via e-mail by Tobias Steinbrecher,
EPPA, to Dr. Otmar Deubzer (RoHS 29).

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Volvo Penta (2023): Request extension of RoHS Annex III Exemption 6a, 6b, 6c, 7a, 7c, 42, 44.
Retrieved from https://rohs.biois.eu/Volvo_Penta.pdf.

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Exemption 7(a) of Annex III: Lead in high melting
temperature type solders
The below Table 7-1 shows the wording, scope and expiry dates of the exemption.
Table 7-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

III-7(a)Lead in high melting
temperature typesolders (i.e. lead-based
alloys containing 85 %by weight or more
lead)

Applies to categories 1 to 11 (except applications covered bypoint 24 of this Annex)
Expires on-

21 July 2021 for categories 1 to 7, 8 medical devices otherthan in vitro diagnostic medical devices, 9 monitoring andcontrol instruments other than industrial monitoring andcontrol instruments, and 10-

21 July 2023 for category 8 in vitro diagnostic medical
devices;-

21 July 2024 for category 9 industrial monitoring andcontrol instruments, and for category 11

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments (sub-group of category 9)

HMP(S)High melting point (solders), i.e. solder with 85 % of lead and more

LHMPS

Lead-containing high melting point solder, i.e. solder with 85 % of lead and
more

NRMM

Non-road mobile machinery

Pb

Lead [chem.]100Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

UP

7.1.

Umbrella Project

Background and technical information

The below Table 7-2 shows the requested exemption renewals that were submitted 18
months prior to the expiries of exemption III-7(a) for category (cat.) 9 industrial monitoring
and control instruments (IMCI) and for cat. 11. Requested wordings deviating from thecurrent wording are underlined.
Table 7-2: Requested renewals of exemption III-7(a)ApplicantsRequested Exemption

Requested Scope and dates ofapplicability(EUROMOTet al. 2023a)

Lead in high melting temperature typesolders (i.e. lead-based alloys
containing 85 % by weight or more oflead) used in engines, engine
components and ancillary components
and in end-products in which they areused

Applies to category 11

Lead in high melting temperature typesolders (i.e. lead-based alloys
containing 85 % by weight or more
lead)

Applies to category 9 industrial
monitoring and control instruments(TMC 2023a)

Expires on
21 July 2029 (= 2024 + 5 years) forcat. 11

Expires on 21 July 2031 (= 2024 + 7
years)The below Table 7-3 lists stakeholder contributions that were submitted with the renewal
requests or during the stakeholder consultation for exemption 7(a).
Table 7-3: Stakeholder contributions
Contributors

Contribution/request(DEUTZ 2023)(EGMF 2024)(EMA 2023)

Letter of support for renewal request submitted by (EUROMOT et al.
2023a)(EUROPGEN
2023)(JCB 2023)(Volvo Penta
2023)(KEMI 2023)

Support for new wording of exemption 7(a) to specify applications forwhich exemption can be used, for example as suggested by (Baron et al.
2022) to stop products with more than 85 % lead that should not benefit
from the exemption.

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MTE

Letter of support for exemption renewal requests submitted by ‘Umbrella
Project’ in 2020 for “lead exemptions” including cat. 8 medical technology(NAM 2023)

Letter of support for renewal request submitted by (EUROMOT et al.
2023a)(SRT 2023)

Structured scope recommended by (Baron et al. 2022) (cf. Table 7-4)
probably too narrow but no specific cases known.

(UP 7(a)2023)

Objection against subdivision of exemption scope recommended by(Baron et al. 2022) and concerns about consequences, e.g. that not leadapplications are not covered where elimination or substitution of lead arestill scientifically and technically unpracticable.

7.1.1.

History of the exemption

The exemption was listed with the current wording already on the Annex of (European
Union 13.02.2003) (RoHS 1) when it was officially published in 2003. In 2008/2009, theexemption was reviewed for the first time, by (Gensch et al. 2009). The reviewers foundthat the exemption was still required. However, they raised concerns that exemption
7(a) is material-specific, while most other RoHS exemptions are application-specific.
LHMPS can therefore be used in each application as long as it contains at least 85 %of lead, even if lead-free alternatives are available. The Commission (COM) renewed
the exemption, and it was reviewed again by (Gensch et al. 2016) who concluded thatelimination or substitution of lead are scientifically and technically not yet practicable.
The consultants undertook a first attempt to structure the scope towards applicationspecific uses of lead-containing high melting point solders which was placed on theannex of the review report as an interim step towards further elaboration andrefinement. The COM renewed the exemption as recommended by the consultants withthe same wording. The exemption was reviewed by (Baron et al. 2022), again with theresult that its renewal was recommended, however with a different, application-oriented
wording which is reflected in the below table.

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Table 7-4: Renewal of exemption III-7(a) recommended by (Baron et al. 2022)

Source: (Baron et al. 2022)

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7.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status March 2024). The applicants therefore
applied for the renewal of the current exemption III-7(a) for cat. 8, cat. 9 IMCI and cat. 11
which are earmarked for expiry on 21 July 2023 and 2024 respectively in the currently valid
exemption III-7(c)(I). The exemption thus became due for review.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal requests at hand whether and how far the recommendation of (Baronet al. 2022) can be adopted to EEE of categories 8, 9 IMCI and 11 in the light of theinformation provided by the applicants and stakeholders. A re-evaluation of the previous
review by (Baron et al. 2022) is not intended. The consultants will rely on the critical review
conducted by the previous consultants and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the status of science and technology.

7.1.3.

Summary of the requested exemption(EUROMOT et al. 2023a)
High temperature melting point (HMP) solders containing lead are used to electrically andphysically join two elements in internal combustion engines, associated components andend-products in which they are used. Lead provides essential characteristics such as highmelting point, strong heat conduction, high electrical conductivity, high ductility corrosion
resistance and high reliability. Components using HMP solder are subject to aggressive
environments, vibration and temperatures. Alternative technologies with similar ductility andstrength as lead alloys and that can survive a standard reflow process (or several) on PCB
with either leaded or unleaded solder are as yet unavailable for the intended uses
EUROMOT members require them for.
Due to the operational environment and an expected service for up to and beyond 20 years,
material testing and development activities necessarily take many years to complete toensure long term reliability. Conversion to lead-free processes cannot begin until
alternatives are developed and perfected by solder manufacturers. Testing then needs tobe undertaken by each engine manufacturer to ensure the testing reflects the demands oftheir application and the tolerances that are inherently in-built into each system. The
reliability of the system then needs to be proven to understand if the alternative is able tooffer the required technical characteristics. As such the qualification timeframe is estimatedto be 5 - 7 years (without NRMM Emissions Regulation re-approval) and 6 - 8 years (withNRMM Emissions Regulation approvals) from the date a promising alternative is identified.
EUROMOT recognises that there is the recommendation to limit the exemption scope to
sub-divided scope listing out specific uses. EUROMOT members, as end equipment
suppliers does not have the necessary technical information to be able to determine if all of
the HMP solder uses are listed. However, EUROMOT members are of the opinion that thisscope is too restrictive and will likely preclude to necessary technical use of HMP solders
in applications not listed. In the meantime it is essential that the original scope of the
exemption remain valid for EUROMOT members uses such that there is sufficient time toallow for these activities to be undertaken.

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Lead is a significant ingredient of the solder alloys used to electrically or physically join twoelements. High Melting Point (HMP) solders are used for a wide variety of applications.
Based on the application type, a lead amount of >85% is required to achieve the necessary
melting temperature and to obtain other material properties.
As further outlined in this submission, there is no single substitute available that would besuitable for all the applications identified and match the technical performance of lead.
Currently, substitutes for even the major uses have rarely been found. Evaluating
alternatives for each of the niche uses would take an enormous amount of time andresources, with little probability of success. The Test & Measurement Coalition therefore
applies for the renewal of exemption 7(a) for the maximum renewal period.
A thorough Socio-Economic Analysis was conducted in addition to the technicalassessment and attached to this submission, further illustrating the negative socioeconomic impacts a non-renewal of exemption 7(a) would have at this stage. Overall, theanalysis concludes that the total impact of non-renewal of this exemption is monetized in
the range of 2.9 billion EUR and 4.1 billion EUR (conservative lower bound estimate).

7.1.4.

Technical description of the exemption and use of the restricted
substance

The technical background of this exemption is described in detail in the previous review
reports of (Gensch et al. 2009, 2016) and (Baron et al. 2022). Specifically for their renewal
requests, the applicants provide the below information.

(EUROMOT et al. 2023a)
EUROMOT members manufacture engines used in a wide variety of end-applications
including heavy goods vehicles, excavators, emergency generators, compressors, pumps,
and tools (portable and stationary). The majority of these engines have end-uses that are
excluded from the scope of RoHS as they are forms of transport or non-road mobile
machinery as defined by the RoHS Directive. As a result, only a small proportion of engines
and their solders that are used by EUROMOT members need to comply with RoHS17.
EUROMOT’s members use commercially available electronic components but select thosethat are specified for use at higher temperatures where these are necessary. High melting
point solders are used in these components only if standard eutectic solders cannot be usedbecause of the temperatures that are experienced. Lead is used as the majority constituent
in High Melting Point (HMP) solder alloys to make electrical connections. Based on the typeof application, a lead level >85 % is necessary to achieve the required melting temperatureand other material properties.
The following is an illustrative list of uses of exemption 7a obtained from EUROMOT
members and from other sources of information:

17 These engines are not used in road vehicles in scope of the EU End of Life Vehicle (ELV) Directive; remark

adopted from EUROMOT et al. 2023a.

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Solders used to attach components, sensor, etc to wiring looms, etc.

•

Internal solder bonds in sensors that operate at high temperatures (>180⁰C in
exhausts)•

Solders used to lead wire for ignition coil, motor etc.

•

First and second level soldering inside components where these bonds must not
melt when components are solder reflow bonded to circuit boards•

Voltage transient suppressors•

Field effect transistors•

Switching ICs and many other types of integrated circuit including voltage regulatorsand current monitors, used as die attach (a wide range of die size may require HMP
solder especially if the components are used in engines•

Engine Control Units (ECUs) which can operate at temperatures of 150 ⁰C•

Bridge rectifiers•

Various types of diodes•

High power transistors•

Ball grid arrays (BGAs) with lead HMP solder balls•

Thermistors•

Fuses, solder used for hermetic sealing and for electrical connections•

High power resistors and other passive components such as relays, inductors,
potentiometers, sensors, transformers, oscillators, capacitors, etc. Note that moststandard passive components do not use HMP solder, but some of these that need
to be used in high temperature environments may require lead HMP solder to be
used, e.g. for internal bonding or as a hermetic seal.

•

MOSFET (Metal Oxide Semiconductor Field Effect Transistor), as die attach•

Crystal components for internal bonding and as hermetic sealing•

Internal solder bonds in components that use high temperature over-moulding (thisis for superior sealing from moisture and environmental pollutants)•

Sensors and actuators

These electronic components of the engines in scope of RoHS can experience severe
operating conditions of temperature, vibration and corrosion and must be reliable for at least
several decades, although service conditions and lifetime are end-product dependent.
(EUROMOT et al. 2023a) provide more information as to specific components applying
lead-containing high melting point solders (LHMPS), and on assessment of potential
substitutes versus LHMPS that highlight the superior properties of LHMPS. More details areavailable in the exemption renewal request of (EUROMOT et al. 2023a) and in former
review reports (cf. (Gensch et al. 2009, 2016; Baron et al. 2022).

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Cat. 9 IMCI are very different from low-mix, high-volume consumer products which arefrequently re-designed to follow consumer trends and are placed on the market for a limited
duration. Industrial test and measurement instruments are high mix, low volume producers,
managing portfolios of thousands of highly complex. Each instrument is intentionallydesigned for high reliability and serviceability to support long useful lifespans, and are madeavailable on the market for at least a decade. These instruments are designed: exclusively
for professional and industrial use; to meet high performance requirements in criticalapplications; and last up to 40 years. Redesign is not frequent and happens every sevenyears on average (as compared to every 1.5 years or less for consumer products). Once
test and measurement instruments are placed onto the market, they are typicallyaccompanied with a long-term customer support arrangement to maintain reliability andcalibration.
Product portfolios are widely diversified, with T&M Coalition members each having typically
2,000 to 3,000 products currently made available on the market. These are highly complex,
sophisticated electronic instruments such as signal generators, power analysers,
oscilloscopes, spectrum analysers, digital multi-meters, electron microscopes, chemicaland biological analysers, complex chromatography systems and their detectors, eachhaving many necessary options and accessories. The Annex of this SEA contains further
details concerning the product groupings and equipment types of the participatingcompanies. Each instrument can have between 2,000 and 40,000 parts; requiring a vast
supply chain involving tens of thousands of suppliers and hundreds of thousands ofcomponents.
Considering the EU added-value, test and measurement equipment is manufactured andsold in relatively small volumes (per instrument design) and placed on the global market.
There is an added value in community level action, which guarantees more coherent andconsistent rules across Europe. But with the expansion of RoHS-like requirements beyond
the EU, this creates a risk of discrepancies in RoHS-like national laws adopted in third
countries.
The professional test and measurement products provide the tools for engineers to develop
new solutions and businesses to bring them to market. These instruments are used in
Research, Quality Control and Testing laboratories (including field testing) in Universities,
Manufacturing and clinical facilities and by Governmental Agencies for conformanceverification and environmental testing. They are essential to the good functioning ofelectronic communications networks, heavy industrial processes such as steel
manufacturing, the testing of vehicles for compliance with emissions standards, and themonitoring of complex and critical systems. The nature of the tests and measurements
made by industrial equipment necessitates that the equipment itself is highly complex; withupwards of 40,000 components necessary to produce a single instrument. Even a relatively
simple hand-held instrument incorporates significantly more components than a typicalconsumer product.
Historically, between 25 % to 35 % of the components used in cat. 9 IMCI are custom
designed. The features of the T&M Coalition’s equipment necessitate the development andproduction of unique components that are not commercially made available on the open
market and are typically made by sole, boutique suppliers. These components have theirown development lifecycle and take years to bring into production. When these suppliers

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are unable to deliver compliant parts that meet current RoHS regulations, the product would
be stopped from being sold into the EU.
The below table lists some of the components and devices for which exemption III-7(a) isrelevant.

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Table 7-5: Examples of components and cat. 9 IMCI relying on exemption 7(a)Source: (TMC 2023a)

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(TMC 2023a) provide a more comprehensive list in their renewal request.
The use of lead in high melting temperature type solders provide superior properties andreliability compared to lead-free alternatives. Some of these properties and reasons forthese required characteristics include:•high melting point (>260°C) that is higher than standard eutectic solders. This
prevents melting during secondary installations and the deterioration of thefunctionality of electrical parts;•

thermal conductivity ensures the reliability of electronic components due to heatdissipation;•

ductility is essential to join materials that have different coefficients of thermal
expansion together in order to guarantee mechanical reliability;•

electrical conductivity is essential for electrical functionality;•

electrical resistivity;•

corrosion resistivity ensures reliability;•

resistance to thermal oxidation;•

appropriate oxidation nature prevents oxidation at the secondary mounting andguarantees reliability;•

wettability;•

manufacturability;•

reliability in a harsh environment.

Lead, as stated in the application of the RoHS Umbrella Industry from January 2020, is the
only known element which satisfies all these properties. It is the combination of physicaland chemical properties of the leaded alloys that is important. It is therefore not possible topick a single property as a criterion of distinction under RoHS.

7.1.5.

Amount(s) of restricted substance(s) used under the exemption(TMC 2023a) state that the quantity of lead utilized in their homogeneous materials cancontain between 85 % and 95 % of lead by weight. Based on TMC members’ data, they
indicate approximately 25.5 kg of lead entering the EU market annually through applications
for which the exemption is requested.
(EUROMOT et al. 2023a) that the amount of lead varies significantly between the various
types of cat. 11 equipment and that they are therefore unable to be quantify it.

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7.2.

Justification of the requested exemption

7.2.1.

Substitution and elimination of the restricted substance(EUROMOT et al. 2023a)
Since RoHS was first proposed, research has also been carried out to identify substitutes
for LHMP solders but with only limited success. The main candidates at present are:•

Alternative solders•

Conducting adhesives•

Metal Sintering•

Transient Liquid Phase Sintering (TLPS)•

Brazing or welding – due to the much higher temperature required (>400°C forbrazing and several thousand degrees for welding, these are not suitable for use inengines or for all of their components. One manufacturer has substituted lead solder
by welding in an application where the high temperature does not damage otherparts or materials and reliability was proven to be at least as good as the solder.

•

Other innovative bonding method(EUROMOT et al. 2023a) describe the drawbacks of these methods in their renewal
request. More details are available the previous review reports ( (Gensch et al. 2016; Baronet al. 2022) and in the exemption renewal request of (EUROMOT et al. 2023a).
(EUROMOT et al. 2023a) summarise that all of these potential substitutes have inferiorreliability and / or performance and so are unsuitable for use in EUROMOT members’
engine systems. EUROMOT’s members do not make electronic components and so rely on
the supply chain, which has the expertise, to carry out this research. Only when suitable
substitute components and bonding materials are developed and proven to be reliable will
EUROMOT’s members be able to test these in their engine systems which will require
additional time.
(TMC 2023a)
To TMC’s the best knowledge, there remains no single substitute available that would besuitable to all the applications identified. Currently, substitutes for even the major uses haverarely been found. Evaluating alternatives for each of the niche uses would take anenormous amount of time and resources, with little probability of success.
HMP solders are used for a wide variety of applications. There are potential substitutes forseveral applications; however, when the chemical and physical properties of substitutes arecompared with HMP solder bonds, it becomes clear why these substitutes are not broadly
suitable.
Alternatives must melt above the temperature for Pb-free solder reflow. Potential
alternatives, and the main reason why these are not suitable for substitution, are listed here:111

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Standard lead-free solders have a lower melting point than HMP lead solders but
are also used for reflow soldering of PCBs. These would melt during reflow andtherefore cause bond failure when used for sealing components and for making
bonds inside components or in modules.

•

Welding and brazing are alternative bonding methods but require much higher
temperatures. Brazing alloys typically melt at >400°C and welds are formed at>1,000°C. The silicon chip and the polymers used in electronic components will be
destroyed at these temperatures.

•

Crimp connections are often used in electrical equipment but suffer from amultitude of disadvantages. They cannot be used for sealing and their size precludes
them from use inside small electronic components. Their main limitation isunreliability; repeated temperature cycles and vibrations cause very small
movements between crimp and terminal that expose the underlying base metals thatre-oxidise after their natural air-formed oxide is disrupted. The increase in the oxideamount can increase contact resistance to a value where the equipment no longer
functions. The increased resistance in power circuits, for example, will cause heatingthat can ultimately lead to fires.

The following alternatives are also deemed unsuitable for substitution and replacement:•

Mixed alloy pastes that combine when melted to a new high temperature alloy.
These are new to the market. Manufacturability and reliability of the resultant hightemperature alloys has not been fully tested. These pastes could, in due time,achieve 70 % efficacy.

•Gold-tin braze requires a particularly high melting temperature that can damage thecomponents. This alternative has a limited 10 % efficacy.

•

Sintered silver is currently being tested but has not yet proven to be manufacturable
and reliable. This alternative has a limited efficacy at 30 %.

These alternatives are, for the reasons listed above, not suitable for substitution or
replacement. They do not fulfil the same functions and do not have the same unique
combinations of advantageous characteristics as lead.

7.2.2.

Environmental, health and safety impacts(EUROMOT et al. 2023a) state that some applications utilising this exemption are safety
relevant and may cause accidents in case of failure.
(TMC 2023a) claim that cat. 9 IMCI contribute only 0.2 % by weight to the Waste Electricaland Electronic Equipment stream. Consequently, the environmental impact of cat. 9 IMCI
is negligible. Nevertheless, test and measurement equipment does enter the waste stream,
typically many decades after it is placed on the EU market.

7.2.3.

Socioeconomic impacts(EUROMOT et al. 2023a) forecast that, if this exemption is not renewed, engine and endproduct manufacturers will be forced to stop selling products that do not comply with RoHS.
At this stage, it is not known which products would be affected, but could affect many types

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be able to operate if essential equipment is not available. If supply of emergency generators
is affected, this may affect, for example, hospitals who use these during power cuts. There
would be a risk to patients’ survival during operations or other medical procedures (such as
MRI examinations and monitoring patients in intensive care) may not be possible if
emergency generators are not available. Manufacturers of affected engines and their endproducts would also be negatively affected causing loss of competitiveness, potentiallyleading to loss of jobs.
(TMC 2023a) conclude from the main findings of the SEA prepared by (EPPA 2023) thatthe total impact of a non-renewal is monetized in the range of 2.9 billion EUR and 4.1 billion
EUR (conservative estimates in net losses; potential gains for suppliers of othercomponents have been already taken into account), consisting of: economic impacts (EBITloss) on test and measurement industrial type products’ manufacturers; substitution costs;
social impacts (i.e., unemployment in the EU-27). More details are available in the SEA
provided by (EPPA 2023).

7.2.4.

Roadmap towards substitution or elimination of the restricted
substance(EUROMOT et al. 2023a)(EUROMOT et al. 2023a) state that they and their suppliers have been monitoring researchso that, if an apparently suitable substitute is discovered, this could be evaluated and tested
for reliability in engines. Careful scrutiny will be needed by manufacturers of engines andtheir components to maintain the required high quality in the production process and highreliability of products to avoid failures of equipment with engines and this will continue to be
the case. Therefore, the adoption of any new technology will take many years.
If a promising lead-free bonding process is developed, then this must next be tested underrealistic engine conditions by EUROMOT’s members. The timescale will vary depending on
how significant the changes, the types of engine and their end-uses. This will involve someor all of the following:•

Production of prototype parts/ circuits and laboratory testing to determine suitability
and reliability. This would include accelerated environmental testing such as thermal
cycling, vibration, high humidity, corrosion tests, functional testing of circuits, etc.
However, if there are many components to assess, this could take longer due tolimitations in the availability of suitable trained engineers.

•

Construction of engines using the lead-free replacement HMP material and bench
testing to determine reliability. This is the only reliable way of assessing new bonding
methods.

•

Field trials in end-use equipment. This is important because it is not possible toreliably reproduce field conditions in laboratory testing environments.

•

If use of substitute bonding material requires significant changes, such as re-designof circuits or of the engine, then approvals under the NRMM Emissions legislation
will be required.

•

Installation and evaluation of new production processes able to use new materials.

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Timescales for above depending on the type of component, engine and the enduses:oWithout NRMM Emissions Regulation re-approval 5 - 7 yearsoWith NRMM Emissions Regulation approvals at least 6 - 8 years

In addition to the above timescale, as a minimum, to consume existing stocks ofcomponents, 7 years are required from confirmation that a substitute exists and is reliable.
(TMC 2023a)
As to their past compliance efforts, (TMC 2023a) report that some combinations of
substitutes will meet some criteria, but the significance of lead in HMP solders is its uniqueability to satisfy a unique combination of essential properties. It is therefore not possible topick a single property as a criterion of distinction under RoHS. Substitution is therefore notpossible due to the numerous properties required from substitutes. Alternative technologies
that match the ductility and strength of lead whilst retaining reliability during one or several
reflow processes (melting of solder), which would otherwise weaken the bond, are not yet
available.
The unavailability of alternatives for replacement and substitution asserted above echoes
the findings of the previous review of exemption 7(a) by (Baron et al. 2022). The information
made available accordingly suggests that the substitution and elimination of lead in highmelting temperature type solders is still technically and scientifically impracticable. The
granting of exemption 7(a) should therefore be justified by Art. 5(1).
As to their future compliance activities, (TMC 2023a) pointed out that that they principally
rely on their component suppliers to find alternatives to the use of restricted substances
since most of the components utilizing exemption 7(a) incorporated into cat. 9 IMCI are
COTS18 parts. Therefore, meeting with suppliers to understand their (potential) alternatives,
getting samples, measuring, and testing are part of the typical process to evaluate thesuitability of potential alternatives. The process would then be followed by the validation of
the potential suitable alternatives.
The companies reported that the validation period alone would take a minimum of 6 months
and up to a year after the delivery of suitable alternatives per product. It is significant to notethat this validation period would only apply if the component were a fit, form, and function
drop-in replacement. If any design changes to the exemption-free part of the product would
be required to accommodate for the alternative, a validation period would be required foreach redesigned product that used to utilize the component that relied on the exemption.
Moreover, the validation would lead to the organizations incurring additional expenses.
These include labour costs and costs arising from potential product resubmission
requirements for testing to various notified bodies to ensure that substitution does not create
any electrical and functional safety concerns.
If a new substance free part is available, this part must be qualified for use by performing avariety of tasks, as described above. Due to the complexity and diversity of the applications,this must be done individually by each company for each product group. This process would

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divert resources from other projects and increase the cost to ensure continued availabilityof these products. This validation and testing process varies according to part complexity
and impact upon the final product design; which can be categorised as low, medium, and
high:

•

Low complexity parts are the off-the-shelf components or hardware parts that do
not have a substantial performance impact. Replacement can be done based on
supplier information, assuming a form/fit/function compliance, with standard
manufacturing, testing, and validation processes. Based on process timescales
reported by a T&M coalition company, the average time that it can take for theseparts to be replaced ranges from 3 to 6 months.

•

Medium complexity parts are more complex sub-assembly electronic parts, suchas small motors, which need additional validation for their performance. These parts
are often commercial assemblies that are generally available to the electronic
industry, and are utilised by the Test & Measurement coalition companies.
Replacement of these assemblies, like-for-like, requires testing and validation prior
to being integrated into the manufacturing process. The average time to find analternative for medium complexity parts for production is reported to range from 6 to
12 months.

•

High Complexity parts are the complex sub-assemblies or parts that have asignificant impact on performance of the company’s products or play a critical rolein overall safety of the products. These parts need to go through extensive validation
for performance and/or compliances for varying regulations before the appropriate
files can be updated and the proper competent authorities or regulatory bodies canbe notified prior to purchase of parts for validation. The average time that it would
take to find an alternative for high complexity parts for production is up to 1 year for
additional testing. Where the exemption directly impacts the performance of thatcomponent (e.g., a centrifuge rotor) the evaluation of the replacement could takefrom 3 to 5 years.

7.3.
7.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of incoherence of the requested exemption with the
REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of exemption 7(a) in
EEE of cat. 9 IMCI and 11.

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Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

7.3.2.

Substitution and elimination of the restricted substance(EUROMOT et al. 2023a)
EEE of cat. 11 was not included in any of the renewal requests reviewed by (Baron et al.
2022). Nevertheless, (Baron et al. 2022) recommend the expiry of the renewed exemptions
7(a)(I to VII) for all categories on 21 July 2026. EUROMOT were asked whether therecommended exemptions 7(a)(I to VII) could be adopted for cat. 11.
(EUROMOT et al. 2023b) replied that the original scope of 7(a), rather than the proposed7(a)(I to VII) is required for internal combustion engines, associated components, and endproducts in which these are used. The proposed scope of the renewed exemption 7(a) is
too restrictive and will likely preclude to necessary technical use of high melting point
solders in applications not listed. EUROMOT members are not able to determine if all leadhigh melting point solders are captured by the proposed 7(a)(I to VII) as they use a wide
variety of electronic components utilising exemption 7(a), but electronics suppliers do notprovide information as to whether this is covered by 7(a)(I to VII). As such, it is essentialthat sufficient time is required where the 7(a) scope remains valid for EUROMOT members,
so the qualification of lead-free alternatives is able to be undertaken. Due to the impacts toreliability and the consideration that EUROMOT member products have a lifetime of up to
20 years, 5 - 7 years (without NRMM Emissions Regulation re-approval) and 6 - 8 years(with NRMM Emissions Regulation approvals) is required to undertake the relevant testing.
With the testing starting from the date a promising alternative is identified. Without thecontinued provision of 7(a) engine and end-product manufacturers will be forced to stop
selling products that do not comply with RoHS.
It is, on the one hand, plausible that users of electrical and electronic components do notknow in which exact application under exemption 7(a) lead is used. Producers and suppliersof these components do not provide additional information besides the fact that thecomponent contains lead as authorised by exemption 7(a). Producers of electrical andelectronic components provide information to their customers confirming the RoHScompliance of their products even though they are not legally obliged, since the RoHS
Directive does not apply to their products, but to the end-products. On the other hand,producers of EEE could include into their requested supplier declarations information as tothe specific use of LHMPS. Since such more detailed supplier declarations might cause
additional administrative expenses, suppliers may not be willing to provide such information,or they only do this for key customers that purchase large volumes of components.
Ultimately, EEE producers’ access to such information cannot necessarily be expected. As
a consequence, in the consultants’ view, producers of EEE should include the expertise ofcomponent manufacturers to be in the position to answer technical questions related toexemption 7(a). The Umbrella Project Technical Working Group 7(a) – which includes
manufacturers of electrical and electronic components – show with some examples that thecurrent wordings of the recommended exemptions 7(a)(I to VII) do not include all uses oflead in the scope of the current exemption 7(a) for which substitution or elimination of lead116

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are scientifically and technically still impracticable (cf. section “Stakeholder contribution of
the Umbrella Project” on page 119).
With view to the adoption of the recommended exemptions 7(a)(I to VII), and given therelevance of the current exemption 7(a) across almost all electrical and electronic
components, producers of cat. 11 EEE actually face the risk that uses of lead remain out of
scope for which its substitution or elimination are scientifically and technically not yet
practicable.
(EUROMOT et al. 2023a) want to avoid this risk by extending the scope of the exemption
in its wording by adding to the current wording of exemption 7(a) that the LHMPS can be“used in engines, engine components and ancillary components and in end-products” ofcat. 11 (cf. Table 7-2 on page 101). This addition neither fits the architecture of the current
exemption 7(a) if it shall remain applicable for other categories of EEE as well, nor theintention of the recommended exemptions 7(a)(I to VII), which attempt specifying andstructuring the exemption scope by specific technical application criteria instead of renewing
the exemption with the current material-specific exemption scope.
(TMC 2023a)(TMC 2023a) request the renewal of exemption 7(a) with the current wording for sevenyears. Cat. 9 IMCI was included in the review of exemption 7(a) by (Baron et al. 2022) since
its renewal was requested by applicants including the Umbrella Project at that time.
Upon request, (TMC 2023b) state that they do not agree to adopt the recommended
exemptions 7(a)(I to VII) to cat. 9 IMCI. Lead is a significant ingredient of the solder alloys
used to electrically or physically join two elements. High Melting Point (HMP) solders areused for a wide variety of applications. Based on the application type, a lead amount of>85% is required to achieve the necessary melting temperature and to obtain other material
properties. There is no single substitute available that would be suitable for all theapplications identified and match the technical performance of lead. Currently, substitutes
for even the major uses have rarely been found. Evaluating alternatives for each of theniche uses would take an enormous amount of time and resources, with little probability ofsuccess. The Test & Measurement Coalition therefore applies for the renewal of exemption
7(a) for the maximum renewal period.
As regards the proposed splitting of exemption III-7(a), (TMC 2023b) would like toemphasise the importance of retaining the initial wording and numbering as published in theoriginal RoHS annexes. Amending the scope of the exemption by changing the applicationor substance restriction value has a significant administrative burden to industry andnegatively impacts the compliance. This includes:•

The data management and ERP Solution re-engineering to segregate existing
supplier declarations from those of the new (re-worded) exemption takes time aswell as resources and is open to error.

•

Separating and managing suppliers’ declarations when schemas are in transition
adds huge complexity where the same exemption number exists with a different
description.

It needs to be kept in mind that industrial monitoring and control instrument manufacturers
have to manage suppliers’ declarations for hundreds of thousands of items. Additionally,
after reviewing the current state of the evolution of technology for the cat. 9 industrial

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measurement and control instruments, TMC members have difficulty in understanding how
the rewording and relisting and/or splits recommended by the consultants will lead to greater
protection of human health and the environment compared to the wording in its current form.
The recommended rewording/split would only lead to significant unnecessary burden forstakeholders without commensurate benefits.
As noted, the European Commission (COM) have not yet officially published their decision
as to the adoption of the above recommendations, and so the global electronics supply
chain is not able to provide any information regarding these revised exemption definition
proposals. Expiring exemption 7(a) in the proposed timeline of July 2024 would necessitate
a complete market withdrawal triggering the financial impacts as outlined in the SEA
prepared by (EPPA 2023).
(TMC 2023b) therefore do not agree with the consultants’ proposed wording and splitting
as outlined in the above table and reiterate the renewal request as outlined in renewal
application documents.
The applicants’ above-answer addresses non-technical aspects why the recommended
renewed exemptions cannot be adopted for cat. 9 IMCI, and they argue with the seemingly
imminent expiry of the exemption. In the consultants’ understanding, (Baron et al. 2022)
targeted structuring the scope but not excluding uses of lead for which its substitution andelimination is scientifically and technically not yet practicable. Additionally, (Baron et al.
2022) do not recommend the expiry of their recommended exemptions 7(a)(I to VI) in 2024,
but in 2026, including cat. 9 IMCI, and the COM can be assumed to leave sufficient time forrequesting renewals of the exemption. In the consultants’ view, TMC’s above arguments
are thus not relevant for the technical assessment.
Technically, the applicants' statement concerning the impracticability of lead substitution
and elimination is, however, in line with the findings of (Baron et al. 2022). Like producers
of cat. 11 EEE (see previous section), producers of cat. 9 IMCI face the risk that not all usesof LHMPS are covered for which elimination or substitution are scientifically or technicallynot yet practicable.
Stakeholder contribution of (KEMI 2023)
The stakeholder contributions and the core of the information they provided is listed in Table
7-3 on page 101. The information provided by (KEMI 2023), the Swedish Chemicals
Agency, is more detailed and could not be fully reflected in that table. (KEMI 2023) statethat they have many years of experience as a market surveillance authority to conduct
enforcement activities on the RoHS Directive and especially on exemption 7a.
(KEMI 2023) report their observations from these many years: „With the current wording of
exemption 7(a), we cannot stop products with more than 85 % lead from being placed on
the market even though it is obvious that there is no need for high melting temperature typesolders. The products that we have this problem with are typically cheap non-complex
products with a short lifespan. Only in 2023 we have analysed seven products that containmore than 85 % lead in solders and to our knowledge should not benefit from thisexemption.
We support a new wording of the exemption which specifies in what applications the
exemption can be used. With such a wording of the exemption, for example thesuggestion by the consultant, the enforcement authorities will be able to stop products

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with more than 85 % lead that should not benefit from the exemption, from being placedon the market. Another solution or addition to a specified exemption could be to requirethat the exemption is justified in the technical documentation if applied.“
The consultants requested KEMI to provide details on the seven cases in 2023 where they
considered the LHMPS to be misuses, but they could not make more information publicly
available for legal reasons.
Stakeholder contribution of the Umbrella Project(UP 7(a) 2023) (Umbrella Project Technical Working Group 7(a) highlight that several
applications might exist that are not covered by the consultants´ (i.e. (Baron et al. 2022)
recommended new wording for exemption 7 (d). (UP 7 (a) 2024a) provide the below
examples which they claim to be by no means exhaustive:
1) Zener diodes (which do not “block” voltages and do not always have steady state ortransient/impulse currents > 0,1 A) some with die edge sizes smaller than 0.3 mm;(related to 7(a)(I)
2) Transient voltage suppressors, some with die edge sizes smaller than
0.3 mm x 0.3 mm. Some are manufactured specifically for the protection of USB and
HDMI interfaces and are therefore below the 0,1A/10V thresholds proposed by Baronet al. (2022). (Related to 7(a)(I)
3) Integrated Circuits, such as voltage regulators and references and current monitors
4) Self-protected MOSFETs
5) Clip bonded diodes and other products with currents ≤ 1 A & ≤ 200 V
6) SMD and axial diodes and bridge rectifier < 1 A and < 200 V;
7) SMD and axial diodes < 0.3 mm;8) Products with life time expectation above 2000 h of product use
9) Products where operating conditions exceed 60 °C.
10) Some crystals parts use LHTMPS internally to solder the crystal element to the
package, this is not die attach.
The consultants derive from the above examples that the recommended exemptions 7(a)(Ito VII) seem not to cover all uses of lead that are in the scope of the current exemption 7(a)assuming that substitution and elimination of lead are scientifically and technically not yet
practicable for the above examples. Following their mandate for this review, the consultants
did not conduct a detailed assessment on this aspect. Given, on the one hand, the broaduse of exemption 7(a) in electrical and electronic components and the exemplary characterof the above list, and on the other hand the use of multiple such components in EEE of all
categories, it can be assumed that cat. 9 IMCI and 11 would be affected if the recommended
exemptions 7(a)(I to VII) do not cover all applications of lead.
(UP 7(a)2023) also would like to clarify that there is no agreement to any sub divisions of
the exemption wording and the exemption wording should stay as it is currently published.
They assume that any split will enact legislation, which will not be implementable and willcause increased administrative burden only. In view of the implementation of the

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harmonized standard 19 EN IEC 63000, (UP 7(a)2023) would like to emphasise that the splitof the exemption wording would lead to the situation that more evidence is required whether
the application of the solder is justified.
(UP 7(a)2023) have also identified that this approach will result in a single component
claiming multiple exemptions due to the possible use of lead-containing high melting
point solders in different roles within the component. The implications cannot be
assessed for the time being and it should be avoided that there is an interruption inavailability of electronics in the EU market and competitiveness is damaged. As there is an
end-of-life product stream for electrical and electronic products in place, they suggest
conducting representative material analysis every 5 years. (UP 7(a)2023) are confident thatthese procedures will testify that intentional lead uses are on very low levels andcontinuously decreasing.
In the case at hand, it is expectable that any change of the so far completely undefined
scope of exemption 7(a) will result in additional administrative and compliance burdens.
Producers of EEE check, however, compliance on the component level, not on the
exemption level, i.e. they ask for supplier declarations for specific components. Even if one
component uses different exemptions, there will be only one such declaration. Additional
effort will, however, occur in the supply chain to prepare such declarations.
As to the implications which the Umbrella Project (UP 7(a)2023) could not yet assess, thequestion arises why they have not yet assessed them in the last years since the publicationof the report prepared by (Baron et al. 2022). A first attempt to structure the 7(a) scope wasstarted during the review by (Gensch et al. 2016) already – against the opposition of
applicants and stakeholders - but was only added as an Annex to the report. There would
have been sufficient time and reason for the Umbrella Project to have had suchassessments performed for the review of (Baron et al. 2022), and for this current review.
The same holds true for the UP’s proposal to conduct representative material analyses ofwaste EEE. The UP could have had such an assessment conducted in the past years ifthey are confident that the result will testify the low levels of intentional lead use and its
continuous decrease.
It needs to be added in this context, however, that Art. 5(1)(a), as interpreted in the past
more than 15 years of exemption review practice, demands exemption scopes that are as
broad as necessary and as narrow as possible. Exemption reviews can thus not rely on
evidence that a wide and unstructured scope of an exemption is not abused, and that
producers of EEE invest time and efforts in further reducing the use of restricted substances
as alternative to define the scope accordingly.
Applicants in past reviews have followed the approach of a 1:1 substitution, i.e. they claimed
that the lead-containing high melting point solder (LHMPS) in the scope of exemption 7(a)must be replaceable in all its manifold uses by one lead-free solution. The applicants
otherwise considered substitution and elimination of lead to be scientifically and technicallyimpracticable. In past reviews, it was observed that applicants and stakeholders highlighted
the activities of the DA5 consortium20 investigating lead-free die-attach substitutes for more

19 Harmonized Standard to Demonstrate RoHS Compliance
20 DA = Die Attach; the „5“ stands for the number of semiconductor manufacturers that established theworking group.

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than 10 years. They claimed that once the DA5 identified a viable lead-free solution, it would
be adopted for all the other current uses of LHMPS. In the consultants’ view, it is not selfevident that this approach is viable. The DA5 research, inter alia, bonding techniques which
do not imply the use of solder, and it is not clear how, if successful for die attach, such asolution could be used in all other applications of LHMPS.
Gensch et al. (2016) had criticised this approach and demanded diversified, applicationspecific research and development efforts for the time of the next review of this exemption.
The Umbrella Project was therefore requested to provide evidence of their research anddevelopment efforts related to the above examples which they see not covered by therecommended exemptions 7(a)(I to VII).
(UP 7 (a) 2024a) report material suppliers to be working on alternatives for LHMPS toaddress the requirements of industry. High temperature adhesives and Transient Phase
Liquid Sinter materials are showing particular promise for the future, but there is nothing
now that meets all the technical requirements that LHMPS meets. Until the materials areavailable, development of the products to use them will remain restricted. Once materials
become available, there will obviously be a timescale for product qualification and approval
within application. Substitution still seems to be several years in the future. While industry
continues its efforts to phase out lead wherever possible, there are many applications where
this is not possible and therefore, they ask to grant the exemption as applied for and suggest
a follow up review not before five years.
As the requested evidence for their application-specific efforts to find lead-free solutions fortheir above 10 examples, (UP 7 (a) 2024a) submitted the DA5 customer presentation21
describing the efforts of this group to identify lead-free solutions for die attach, which canbe interpreted as confirming the observations of past reviews described above.
Overall, it seems that the exemptions 7(a)(1 to VII) recommended by (Baron et al. 2022) intheir current wording do not cover all applications of lead which have been practiced under
the current exemption 7(a). Granting the exemptions 7(a)(I to VII) with their wordings could
therefore exclude from the exemption scope uses of lead for which its elimination or
substitution are scientifically and technically not yet practicable.
UP criticise the approach of (Baron et al. 2022), but just request the perpetuation of thecurrent situation with the purely material-specific scope which, in the consultants’ view, does
neither promote application-specific research and development nor a clear demarcation ofareas where substitution and elimination of lead may already be feasible. UP Technical
Working Group 7(a) do not commit themselves to participate in a constructive dialogue andcooperation with all stakeholders to find a perhaps viable, if not perfect, solution. This isdifferent for exemption 7(c)(I) where the respective UP Working Group (UP 7(a)2024)
committed themselves to preparing a proposal for the next review as a base for further
discussions instead of insisting on their objections.
In the light of the feedback from applicants and stakeholders, the consultants neverthelessrecommend the same proceeding like for exemption 7(c)(I), i.e. renewing the current
exemption 7(a) and amend the current approach and wordings in the next review of the

21 Cf. Infineon,

https://www.infineon.com/dgdl/DA5+Customer+Presentation+23112023.pdf?fileId=5546d4616102d2670161
0905cfde0005

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exemption taking up critical points raised in this and the previous review. The objective
could be to arrive at a viable wording as a start for further refinements in later reviews. Better
solutions will be feasible with constructive participation from industry to pool the expertiseof all stakeholders.

7.3.3.

Environmental, health, safety and socio-economic impacts(EUROMOT et al. 2023a) are concerned about adverse safety and health impacts if theycannot produce emergency systems such as power generators for hospitals. The
consultants agree that such negative impacts could arise given the broad use of exemption
7(a) in all categories of EEE.
(TMC 2023a) claim that cat. 9 IMCI contribute only 0.2 % by weight to the Waste Electricaland Electronic Equipment stream. Consequently, the environmental impact of cat. 9 IMCI
is negligible.
The current RoHS Directive does not define any thresholds for use of restricted substancesor contributions to the overall waste generation for which Art. 5(1)(a) would justify granting
an exemption if these thresholds are not exceeded.
As to the socioeconomic impacts, the consultants cannot exclude that adverse impacts
described by TMC (cf. section 7.2.3 on page 112 and (EPPA 2023) arise if the renewal of
the exemption 7(a) is not granted for cat. 9 IMCI.
(TMC 2023b) point out that it needs to be kept in mind that industrial monitoring and control
instrument manufacturers have to manage suppliers’ declarations for hundreds ofthousands of items. TMC members have difficulty in understanding how the rewording andrelisting and/or splits recommended by the consultants (Baron et al. 2022) will lead togreater protection of human health and the environment compared to the wording in its
current form. The recommended rewording/split would only lead to significant unnecessary
burden for stakeholders without commensurate benefits.
In the consultants’ view, this administrative aspect is part of the compliance obligations of
all manufacturers of all categories of EEE. Even though it should be kept in mind thatchanges of exemption wordings and exemption scopes may cause temporary
administrative burdens for affected manufacturers, Articles 4 and 5(1)(a) require priority of
substitution and elimination of use of restricted substances, and well-defined exemption
scopes are a pre-condition for this. The attempt of (Baron et al. 2022) to structure theexemption scope is motivated by this priority. It is at the discretion of the COM to decide
whether specific cases would justify different priorities, e.g. administrative or other socioeconomic impacts.

7.3.4.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria22 is fulfilled:

22 Differently from Art. 5(1)(a) in the RoHS Directive, the criteria are numbered so that they can be addressedin the below text.

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1. their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;
2. the reliability of substitutes is not ensured;
3. the total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.
EUROMOT (cat. 11) and TMC (cat. 9 IMCI) applied for the renewal of exemption III-7(a) forthe maximum validity period claiming that substitution or elimination of lead is scientificallyand technically not yet practicable for the applications of lead in the scope of this exemption.
These statements are in line with the conclusions of (Baron et al. 2022). Cat. 9 IMCI was
included in the recent review of exemption 7(a) by (Baron et al. 2022), while cat. 11 wasnot. Exemption 7(a) is, however, of central importance for electrical and electronic
components that are used in all categories of EEE so that the impracticability of lead
substitution or elimination in lead-containing high melting point solders (LHPMS) can beconsidered to apply to all categories.
The applicants objected adopting the recommended exemptions 7(a)(I to VII) as renewal of
exemption 7(a) to cat. 9 IMCI and cat. 11. EUROMOT see the risk that not all uses of
LHMPS may be covered by these exemptions, and (UP 7(a)2024) (Umbrella ProjectTechnical Working Group 7(a) contribute examples which they consider not to be covered.
Granting these exemptions as proposed would thus actually result in a high risk that usesof LHMPS are not covered where elimination or substitution of lead are scientifically andtechnically not yet practicable. (UP 7(a)2023; UP 7 (a) 2024a) also object structuring the
exemption scope as proposed by (Baron et al. 2022) stating that, besides not all applicationsof LHMPS being covered, this structure would result in too many sub-clauses and would
not be practicable. Differently from the Umbrella Project Working Group 7(c)(I) ( (UP
7(a)2024) in the context of the renewal of exemption 7(c)(I), there is, however, neither any
commitment to provide a concept for a better approach nor for a constructive cooperation
to arrive at a better solution.
Considering the overall situation, the consultants recommend renewing exemption 7(a) andaspire an amendment of the approach and the wordings of the exemptions recommendedby (Baron et al. 2022), taking into account the critical points raised by stakeholders. This
could be more successful than the previous recommendation from 2022 if industry supports
these efforts so that all the expertise required for a solid approach and wording would beaccessible. Possibly, ideas can be adopted from the concept which the UP Technical
Working Group 7(c)(I) provided, if this concept turns out to be a good approach. In case theindustry will, like in previous reviews of exemption 7(a), not cooperate to move the currently
purely material-specific exemption 7(a) towards an application-specific one, a viableapproach and wording may still be achievable. KEMI do not only support structuring thescope of exemption 7(a) but also propose that “Another solution or addition to a specified
exemption could be to require that the exemption is justified in the technical documentation
if applied”. This approach may be complemented with the requirement to declare thespecific uses of LHMPS in components. The viability of this proposal could be evaluated in
the next review.

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7.4.

Recommendation

Substitution and elimination of lead in lead-containing high melting point solder (LHMPS)
are scientifically and technically not yet practicable in EEE of cat. 9 IMCI and cat. 11.
Renewing exemption 7(a) would therefore be in line with the requirements of Art. 5(1)(a).
The information provided by the applicants and stakeholders suggests that therecommended renewal of exemption 7(a) as exemptions 7(a)(I to VII) as proposed by(Baron et al. 2022) would not yet cover all uses of lead in cat.9 IMCI and cat.11 for which
its substitution or elimination are scientifically and technically not yet practicable.
The consultants therefore recommend renewing exemption 7(a) with its current wording forcat. 9 and cat. 11 but with the expiry dates proposed by (Baron et al. 2022). This would
enable an early review of the exemption for cat. 9 IMCI and cat. 11 with the other categories
of EEE which should enable a defined scope for all categories of EEE.
Adding to this, both applicants highlight that they depend on their suppliers to provide themwith RoHS-compliant materials and components but do not have such suppliers in theirconsortia that requested the renewal of the exemption. A joint next review of the exemption
with other consortia representing material and component manufacturers as well istherefore considered to be a precondition to further develop the exemption from the current
purely material- to a more application-specific scope.
No.

Exemption

Scope and dates of applicability

III7(a)Lead in high melting
temperature type solders(i.e. lead-based alloys
containing 85 % by weight ormore lead)

Applies to categories 9 IMCI and 11 (except applications
covered by point 24 of this Annex)
Expires on 21 July 2026 for category 9 industrial
monitoring and control instruments, and for category 11

The consultants further recommend that the COM ensures sufficient time between theofficial publication of the decision and the expiry date of the exemption to allow for the
preparation and timely submission of renewal requests.
This offers a chance that all relevant stakeholder groups can be involved to either elaboratea different approach. There is, however, currently no commitment from UP or otherstakeholders to support or cooperate in this effort, differently from exemption 7(c)(I), where
the respective Umbrella Project Working Group 7(c)(I) committed itself to provide a concept.
Possibly, the approach and concept, if expedient to structure the scope, could give guidance
for an approach for exemption 7(a) as well. Alternatively, as a fallback option, the current
proposal of (Baron et al. 2022) could be amended despite the Umbrella Project’s (Working
Group 7(a) reservations, taking into account stakeholder inputs of this review related to yet
uncovered applications.23 To ensure that all applications of lead in the scope of the renewed
exemption 7(a) are covered, a salvatory clause could be added that would cover all
applications that are not yet specifically defined in the scope. This approach would require
producers to specifically declare the use of lead in the specific applications at least. For theapplications of lead under the salvatory clause, the practicability of the approach proposed

23 Cf. section “Stakeholder contribution of the Umbrella Project”.

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by KEMI could be assessed to require that the exemption is justified in the technicaldocumentation if applied, and to declare the specific uses of LHMPS.
Applicants’ and stakeholders’ feedback on the recommendation(EUROMOT et al. 2024) support the exemption wording and recognise that the alignmentof the expiration dates for all categories of EEE would be beneficial from an
administrative viewpoint. EUROMOT members criticise, however, that this alignment
does not fully consider the technical evidence submitted which outlines the need for the
maximum validity period of the exemption.
(TMC 2024) support the wording of the exemption but contest the expiry on 21 July 2026
since they submitted a full application dossier requesting the renewal of exemption 7(a) forcat. 9 IMCI in its current wording for a maximum validity period of 7 years.
(UP 7(a) 2024c) regret that they can’t offer an exemption wording proposal for the moment.
To agree on such a proposal more time is needed for discussion and alignment within the
Umbrella Project working group 7(a).
(SRT 2024) state that renewing exemption 7(a) with its current wording for cat. 9 and cat.
11 but with the 2026 expiry date proposed by Baron et al. seems feasible keeping in mind
that a new request is possible.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

7.5.

References

Baron et al. (2022): Study to assess requests for a renewal of nine (-9-) exemptions 6(a), 6(a)-I,
6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I and 7 (c)-II of Annex III of Directive 2011/65/EU (Pack 22) –Final Report (Amended Version). RoHS Pack 22. In cooperation with Yifaat Baron, Carl-Otto
Gensch, Andreas Köhler, Ran Liu, Clara Löw, Katja Moch, Oeko-Institut e. V. Retrieved fromhttps://data.europa.eu/doi/10.2779/869784.
DEUTZ (2023): Contribution to the stakeholder consultation: Letter of support for renewal of
exemption III-7(a). Retrieved from https://rohs.biois.eu/DEUTZ.pdf.
EGMF (2024): Contribution to the stakeholder consultation: Letter of support for renewal of
exemption III-7(a). In cooperation with European Garden Machinery Industry Federation. Retrieved
from https://rohs.biois.eu/egmf.pdf.
EMA (2023): Contribution to the stakeholder consultation: Letter of support for EUROMOT renewal
request of exemption 7(a) for cat. 11. In cooperation with Truck & Engine Manufacturers
Association. Retrieved from https://rohs.biois.eu/EMA.pdf.
EPPA (2023): SOCIO-ECONOMIC ANALYSIS Of the impacts of non-renewal of Lead (Pb)exemption for test & measurement industrial type products (Category 9) Exemption 7(a) – Annex
III. Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_7(a)_2023_PUBLIC_VERSION.pdf.
EUROMOT et al. (2023a): Request for renewal of exemption III-7(a) for cat. 11. Retrieved fromhttps://rohs.biois.eu/RoHS_Exemption_Application_Form_%207a_EUROMOT.pdf.

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EUROMOT et al. (2023b): Answers to questionnaire 1 (clarification questionnaire) exemption 7(a).
In cooperation with Test and Measurement Coalition (TMC). Retrieved fromhttps://rohs.biois.eu/Ex_III-7a_EUROMOT_Questionnaire-1_Clarification.pdf.
EUROMOT et al. (2024): Feedback on recommendation exemption III-7(a) sent via e-mail by Emily
Tyrwhitt Jones to Dr. Otmar Deubzer.
European Union (13.02.2003): Directive 2002/95/EC of the European Parliament and of theCouncil of 27 January 2003 on the restriction of the use of certain hazardous substances inelectrical and electronic equipment. RoHS 1. Fundstelle: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002L0095:EN:NOT, Last updated
04.12.2013.
EUROPGEN (2023): Contribution to the stakeholder consultation: Letter of support for EUROMOT
renewal request for exemption 7(a). In cooperation with European generating set industry.
Retrieved from https://rohs.biois.eu/EUROPGEN.pdf.
Gensch et al. (2009): Adaptation to scientific and technical progress under Directive 2002/95/EC.
Final Report. Document „final_reportl_rohs1_en.pdf“. In cooperation with Carl-Otto Gensch,
Stéphanie Zangl, Rita Groß, Anna Weber, Öko-Institut e. V. und Otmar Deubzer, Fraunhofer IZM.
Öko-Institut e.V. and Fraunhofer IZM. Freiburg (Adaptation to Scientific and Technical Progressunder Directive 2002/95/EC; RoHS Exemption Reviews). Retrieved fromhttp://ec.europa.eu/environment/waste/weee/pdf/final_reportl_rohs1_en.pdf.
Gensch et al. (2016): Assistance to the Commission on Technological, Socio-Economic and Cost Benefit Assessment Related to Exemptions from the Substance Restrictions in Electrical andElectronic Equipment - Study to assess renewal requests for 29 RoHS 2 Annex III exemptions.
RoHS 14. In cooperation with Carl-Otto Gensch, Yifaat Baron, Markus Blepp, Katja Moch, Susanne
Moritz, Oeko-Institut und Dr. Deubzer, Otmar, Fraunhofer Institut Zuverlässigkeit und
Mikrointegration IZM (Adaptation to Scientific and Technical Progress of Annexes III and IV of
Directive 2011/65/EU, RoHS XIV). Retrieved from https://circabc.europa.eu/sd/a/eda9d68b-6ac94fb9-8667-5e561d8c957e/RoHS-Pack_9_Final_Full_report_Lamps_Alloys_Solders_June2016.pdf.
JCB (2023): Contribution to the stakeholder consultation: Letter of support for EUROMOT
exemption renewal request. In cooperation with JCB Power Systems Limited. Retrieved fromhttps://rohs.biois.eu/JCB_support_EUROMOT.pdf.
KEMI (2023): Contribution to the stakeholder consultation: Letter of support for new wording of
exemption 7(a). In cooperation with Swedish Chemicals Agency. Retrieved fromhttps://rohs.biois.eu/KemI.pdf.
NAM (2023): Support letter for renewal of exemption 7(a). In cooperation with National Associationof Manufacturers.
SRT (2023): Answers to consultation questionnaire for exemption 7(a). SRThttp://rohs.biois.eu/
SRT.pdfAnswers to consultation questionnaire for exemption 7(a)11 December 2023SRT11
December 2023http://rohs.biois.eu/SRT.pdf. Retrieved fromhttp://rohs.biois.eu/SRT.pdf.
SRT (2023a): Contribution to the stakeholder consultation (accessory information). Retrieved fromhttps://rohs.biois.eu/SRT_7(c)(I).pdf;https://rohs.biois.eu/SRT_hvc.pdf;https://rohs.biois.eu/SRT_hv
c_Japan_FineChem.pdf.
SRT (2024): Feedback on recommendation for exemption 7(a) sent via e-mail by Dr. Stephan
Prucker, SRT-Restech, to Dr. Otmar Deubzer. SRTFeedback on recommendation for exemption

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7(a) sent via e-mail by Dr. Stephan Prucker, SRT-Restech, to Dr. Otmar Deubzer10 April
2024SRT10 April 2024.
TMC (2023a): Request for renewal of exemption III-7(a) for cat. 9 IMCI. In cooperation with Test
and Measurement Coalition (TMC). Retrieved fromhttps://rohs.biois.eu/RoHS_Application_Form_7(a)_TMC.pdf.
TMC (2023b): Answers to questionnaire 1 (clarification) for exemption III-7(a). In cooperation with
Test and Measurement Coalition (TMC). Retrieved from https://rohs.biois.eu/Ex_III7a_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024): Feedback on recommendation exemption 7(a) sent via e-mail by Tobias Steinbrecher,
EPPA, to Dr. Otmar Deubzer.
UP 7(c) (I) (2023): Consultation questionnaire exemption 7(c)(I). Answers of the Umbrella ProjectWorking Group 7(c)(I) to the consultation questionnaire. In cooperation with Members of Umbrella
Project Technical Working Group 7(c) (I). Retrieved fromhttps://rohs.biois.eu/Umbrella_Project_TWG_7(c)-I.pdf.
UP 7(c) (I) (2024): Addendum to questionnaire 1 for exemption 7(c)(I) sent via e-mail by Walter
Huck to Dr. Otmar Deubzer. In cooperation with Members of Umbrella Project Technical Working
Group 7(c) (I).
UP 7 (a) (2024a): Answers to questionnaire 1 for exemption III-7(a) sent via e-mail by Thomas
Behrens, Infineon, to Dr. Otmar Deubzer. In cooperation with Umbrella Project Technical Working
Group 7 (a).
UP 7 (a) (2024b): Feedback on recommendation exemption III-7(a) sent via e-mail by Thomas
Behrens, Infineon, to Dr. Otmar Deubzer. In cooperation with Umbrella Project Technical Working
Group 7 (a).
Volvo Penta (2023): Contribution to the stakeholder consultation: Letter of support for EUROMOT
request for renewal of exemption III-7(a). Retrieved from https://rohs.biois.eu/Volvo_Penta.pdf.

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Exemption 7(c)(I) of Annex III: Lead in glass andceramic
The below Table 8-1 shows the wording, scope and expiry dates of the exemption.
Table 8-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

III7(c)(I)Electrical andelectronic components
containing lead in a
glass or ceramic otherthan dielectric ceramic
in capacitors, e.g.
piezoelectronic
devices, or in a glassor ceramic matrix
compoundApplies to categories 1 to 11 (except applications covered
under point 34) and expires on-

21 July 2021 for categories 1-7 and 10, and for category 8other than in vitro diagnostic medical devices and cat. 9other than industrial monitoring and control instruments-

21 July 2023 for category 8 in vitro diagnostic medical
devices;-

21 July 2024 for category 9 industrial monitoring andcontrol instruments, and for category 11

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and DefinitionsΩ

Ohm, unit of electrical resistanceCat.

Category, referring to the categories of EEE specified in Annex II of the current
RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments (sub-group of category 9)

IVD

In vitro diagnostic medical devices (sub-group of category 8)

UP

Umbrella Project128

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8.1.

Background and technical information

The below Table 8-2 shows the requested exemption renewals that were submitted 18
months prior to the expiries of exemption III-7(c)(I) for category (cat.) 8 in vitro diagnostic
medical devices (IVD) in January 2022, and in January 2023 for cat. 9 industrial monitoring
and control instruments (IMCI) and for cat. 11. Requested wordings deviating from thecurrent wording are underlined.
Table 8-2: Requested renewals of exemption III-7(c)(I)
ApplicantsRequested Exemption

Requested Scope and dates ofapplicability(EUROMOTet al. 2023a)

Electrical and electronic components
containing lead in a glass or ceramicother than dielectric ceramic in
capacitors, e.g. piezo-electronic
devices, or in a glass or ceramic matrix
compound used in engines, engine
components and ancillary components
and in end-products

Applies to category 11.

(TMC 2023a)

Electrical and electronic components
containing lead in a glass or ceramicother than dielectric ceramic in
capacitors, e.g. piezo-electronic
devices, or in a glass or ceramic matrix
compoundApplies to cat. 9 industrial monitoring
and control instruments

Electrical and electronic components
containing lead in a glass or ceramicother than dielectric ceramic in
capacitors, e.g., piezoelectronic
devices, or in a glass or ceramic matrix
compound, which are used in in vitro
diagnostic medical devices for the
analysis of whole blood

Applies to category 8 in vitro diagnostic
medical devices (IVD)(Werfen
2023)

Expires on 21 July 2029 (= 2024 + 5
years) for cat. 11

Expires on 21 July 2031 (= 2024 + 7
years) for cat. 9 industrial monitoring
and control instruments

Expires on 21 July 2028 (= 2023 + 5
years)The stakeholders listed in the below Table 8-3 contributed to the stakeholder consultationfor exemption 7(c)(I).
Table 8-3: Contributions to the stakeholder consultation
Contributors

Contribution/request(DEUTZ 2023)(JCB 2023)

Letter of support for EUROMOT request(Volvo Penta
2023)

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Letter of support for exemption renewal requests submitted by ‘Umbrella
Project’ in 2020 for exemption 7(c)(I) including cat. 8 medical technology(Pari Pharma
2023)

Inclusion of "vibrating membrane nebulizers in active medical devices forinhalation therapy” in addition to IVD for the analysis of blood (cf.
application of (Werfen 2023) in Table 7-2)

(SRT 2023b)

Resistivity limits of 7(c)(V)(4) recommended by (Baron et al. 2022) (cf.
Table 7-4) too narrow(UP 7(c) (I) 2023)

Renewed exemptions 7(c)(IV to VI) recommended by (Baron et al. 2022)
do not cover all uses of lead for all cat. of EEE

8.1.1.

History of the exemption

When (European Union 13.02.2003) (RoHS 1) was published in 2003, the use of lead inglass and ceramics was covered by two different exemptions with a different wording:
Exemption 5 allowed the use of lead in glass:•“Lead in glass of cathode ray tubes, electronic components and fluorescent tubes”

Exemption 7d covered the use of lead in ceramics of electronic components:•“Lead in electronic ceramic parts (e.g. piezoelectronic devices)”

In 2007, the Commission received an application for exemption of “Lead in cermet-based
trimmer potentiometer elements“. The applicant requested this exemption claiming thatexemptions 5 and 7(d) did not cover the use of lead in these cermet-based trimmer
potentiometers. The applicants said that this resistive layer in the cermet-based trimmer
potentiometer is a homogeneous material, as it can be mechanically separated from theceramic base. This homogeneous material, the thick-film layer containing the lead, is in
itself neither a glass nor a ceramic material. The exemption request was reviewed (Gensch
et al. 2007) and the Commission granted the exemption as exemption 34 in the annex of
RoHS 1.
Exemption 11 of Annex II in Directive 2000/53/EC (ELV Directive), the equivalent to thecurrent exemption 7c(I) of RoHS Annex III, was reviewed in 2007/2008 by (Lohse et al.
2008). The stakeholders decided that the wording in the ELV Directive covers applications
like lead in cermet-based trimmer potentiometers. To avoid uncertainty whether and how
far similar uses of lead, like in the cermet-based trimmer potentiometers, are exempted, it
was decided in the review of RoHS exemption 7d in 2008/2009 by (Gensch et al. 2009) toadopt the wording of the ELV exemption with slight modifications for RoHS exemption 7d
and merge it with exemption 5 to form the current exemption III-7c-I.
Exemption 7c-I was transferred from the annex of RoHS 1 into annex III of RoHS 2 withoutchanges. The wording of the exemption remained unchanged after the next review by(Gensch et al. 2016). The last review of the exemption was performed by (Baron et al.
2022), resulting in the proposal to renew exemption 7(c)(I) as exemptions 7(c)(V) and7(c)(VI) as shown in the below table.

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Table 8-4: Renewal of current exemption 7(c)(I) recommended by (Baron et al. 2022)

Source: (Baron et al. 2022)**Exemption III-34

8.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status March 2024). The applicants therefore
applied for the renewal of the current exemption III-7(c)(I) for cat. 8, cat. 9 IMCI and cat. 11
which are earmarked for expiry on 21 July 2023 and 2024 respectively in the currently valid
exemption III-7(c)(I). The exemption thus became due for review.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal requests at hand whether and how far the recommendation of (Baronet al. 2022) can be adopted to EEE of categories 8, 9 IMCI and 11 in the light of the131Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

information provided by the applicants and stakeholders. A re-evaluation of the previous
review by (Baron et al. 2022) is not intended. The consultants will rely on the critical review
conducted by the previous consultants and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the status of science and technology.

8.1.3.

Summary of the requested exemption(EUROMOT et al. 2023a)
Lead in glass and ceramic materials are widely used in all types of Electrical and Electronic
Equipment, including in EUROMOT member applications. Lead is used for its uniqueproperties including high precision sensors, hermetic sealing properties and material
stability in a wide range of conditions.
EUROMOT applications have to withstand temperature cycling in the range of -40°C to+150°C, harsh environmental conditions with high humidity and exhaustion fumes in
addition to mechanical strain due to the high vibrations. Those operation conditions require
the high reliability that is characteristic of the of leaded glass and ceramic materials such as
low-melting point, excellent wettability with different materials, weather and corrosion
resistance, low susceptibility to dielectric breakdown under high electric loads and highmechanical strength and crack resistance. Those properties make leaded glasses andceramics components reliable over a life cycle of over 10 years.
Industry has investigated the substitution of lead in glass, ceramic and matrix compounds
for the last 20 years with the aim of the developing reliable technical solutions on anindustrial scale. Despite this extensive research, substitution technology has not been foundup to the present day for many critical applications and there are no prospects of finding
substitutes with comparable characteristics of performances and reliability in the near
future. Once a viable alternative has been developed, EUROMOT members will need toundertake systems level testing, reliability assessments and approvals for some component
changes.
EUROMOT recognises that there is the recommendation to change the current wording of
the exemption and sub-divide the scope listing into specific uses. EUROMOT members, as
end equipment suppliers does not have the necessary technical information to be able todetermine if all of the uses of lead in a glass or ceramic are listed. However, EUROMOT
members have engaged extensively with their supply chain and, although information is
scarce it has been made apparent that lead-free alternatives for EUROMOT applications
are not available from the manufacturers and therefore a timeline for assessing thetransition to a lead-free alternative is difficult to predict. Moreover, EUROMOT members areof the opinion that the proposed scope is too restrictive and will likely prevent the use oflead in a glass or ceramic in applications that are not listed and this would prevent engines
and the corresponding end-products from being sold in the EU. In the meantime, it isessential that the original scope of the exemption remain valid for EUROMOT members
uses such that there is sufficient time to allow for these activities to be undertaken.

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Exemption 7(c)-I is the most frequently used exemption in T&M electronic products; mostelectronic products contain this exemption because of the broad range of applications.
There is no single substitute available that would be suitable to all the applications identified.
TMC therefore apply for a renewal of exemption 7(c)-I for the maximum validity period.
A thorough Socio-Economic Analysis was conducted in addition to the technicalassessment and attached to this submission, further illustrating the negative socioeconomic impacts a non-renewal of exemption 7(c)-I would have at this stage. Overall, theanalysis concludes that the total impact of non-renewal of this exemption is monetized in
the range of 3.1 billion EUR and 4.3 billion EUR (conservative lower bound estimate).
(Werfen 2023)(Werfen 2023) manufacture equipment which analyses critical care analytes in whole blood,used in hospitals and laboratories in all world markets. Werfen manufacture the suite of
GEM Premier diagnostic medical analysers for the entire EU Market. These instruments areused to measure the blood of patients and provide clinicians with accurate measurementsof specific analytes vital to medical diagnosis and patient treatment. The reported analytes
include, among others, pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate andhaematocrit.
Based on the GEM Premier 5000 Werfen is currently in the process of developing an
instrument incorporating a piezoceramic material. The RoHS-regulated substance, Lead, isa constituent material in the Piezoceramic material of the disposable cartridge to be usedwith the GEM Premier 5000 MARS analyser. The Piezoceramic material is a vital
component in the cartridges of the GEM Premier 5000 MARS used for measuring andreporting concentrations of critical care analytes in blood (pO2, pCO2, pH, Na+, K+, Ca++,
Cl-, glucose, lactate and haematocrit). Lead is part of the Piezoceramic material of thepiezoelectric transducer used to create acoustic power in a microfluidic detection flowchamber to separate plasma from whole blood patient samples by acoustofluidic
separation. The purity and viability of the separated blood constituents is critical for
diagnostic accuracy and for the therapeutic efficacy as well.
Any change in the Piezoceramic material can directly impact analytical performance
characteristics and thereby impede the intended function of the GEM Premier 5000 MARS
analyser. For the GEM Premier 5000 MARS analyser to provide patient blood data with
uncompromised reliability and accuracy, continued use of Lead in the Piezoceramicmaterial of the GEM Premier 5000 MARS analyser is required while the search continues
for alternative substances.
The core obligation for their product in terms of meeting current EU requirements fordiagnostic medical analysers is limiting the use of alternative lead-free PZT material.
Currently there is no lead-free material on the market meeting our product requirementswith equivalent performance. Despite the achieved improvement in piezoelectric properties,
there are problems in the synthesis, processing and poling of the sintered ceramics.
For the reasons outlined above the substitution of Lead in the Piezoceramic material cannot
be completed before the date of applicability of the restriction on use of Lead according to
the RoHS Directive.

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8.1.4.

Technical description of the exemption and use of the restricted
substance

The technical background of this exemption is described in detail in the previous review
reports of (Gensch et al. 2009, 2016) and (Baron et al. 2022). Specifically for their renewal
requests, the applicants provide the below information.
(EUROMOT et al. 2023a)
EUROMOT members manufacture engines used in a wide variety of end-applications
including heavy goods vehicles, excavators, emergency generators, compressors, pumps,
and tools (portable and stationary. Only a small proportion of engines and their glass or
ceramic materials that are used by EUROMOT members need to comply with RoHS.
Lead is used in a wide variety of Electric and Electronic Components that are incorporated
into Electrical and Electronic Equipment (EEE). EUROMOT members use similar
components to the wider electrical industry sector which is described in the Umbrella Project
in its exemption 7(c)-I renewal request and its answers to clarification questions24.
In addition to the general use of 7(c)-I components, there are also engine-specificcomponents such as sensors and actuators which rely upon 7(c)-I. The following is an
illustrative list of uses of components and their end uses utilising exemption 7(c)-I obtained
from EUROMOT members and other sources of information.

24 4 https://rohs.exemptions.oeko.info/exemption-consultations/2020-consultation-2/aiii-ex-7c-i; source asreferenced by EUROMOT et al. 2023a.

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Table 8-5: Uses of exemption III-7(c)(I) in components and EEE of EUROMOT
members

Source: (EUROMOT et al. 2023a)

Piezoelectric materials are used due to their accuracy and sensitivity, in components suchas actuators, resistors and IC‘s. In addition, lead containing piezoelectric materials have ahigh Curie temperature (Tc) and depolarisation stability of material properties underchanging temperature conditions. This is particularly important due to the operating
temperatures of engines in which components can reach +150°C or higher in some
applications. Piezoelectric materials are used in general applications, such as actuators forhigh precision positioning of tools with an accuracy in the order of micrometres (μm).
Another indicative use is as heat-sensitive sensors whose resistance increases withtemperature, and can be used in almost all areas where a digital temperature measurement
is required, for example in motor protection.
Lead is also used in sealing and bonding glass, in applications such as a glaze overlay onchip components, to prevent corrosion of internal parts. Leaded glass is also used as an

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hermetically sealing material for diodes, IC’s and other components. The glass ischaracterised by particular resistance to high humidity environments and operating/storage
temperatures varying between -55°C to +175°C. Moreover, it provides mechanicalprotection of components surfaces, electrical insulation, including dielectric breakdown
resistance.
EUROMOT’s members use many 100s and probably 1000s of components that rely on thisexemption. The manufacturer of each component specifies the function and characteristics
of each component and everyone will be different. EUROMOT members needs thesecomponents such that their engines operate correctly and meet emissions limits requiredby EU legislation. If there are significant changes in a component’s characteristics (forexample, if an IC is replaced by one with a different design), it may not be possible to supply
these engines in the EU until re-design, testing and recertification are completed, which willtake many years. In addition for EUROMOT’s members, the components need to operate
under harsh environmental conditions and all components must operate as specified formany decades.
EUROMOT recognises that from the Umbrella project there is the proposal to limit theexemption scope to sub-divided scope listing out specific uses. EUROMOT members, as
end equipment suppliers, have not been able to obtain the necessary technical informationfrom suppliers to be able to determine if all of the lead in a glass or ceramic uses are listed.
However, EUROMOT members are of the opinion that this scope would be too restrictive
and will likely exclude some essential technical use of lead in a glass or ceramic inapplications that are not listed. Engagement with EUROMOT members supply chain is ongoing to identify if any specific uses are not included. In the meantime, it is essential thatthe original scope of this exemption remain valid such that there is sufficient time to allow
for these activities to be undertaken.

(TMC 2023a)
Cat. 9 IMCI are very different from low-mix, high-volume consumer products which arefrequently re-designed to follow consumer trends and are placed on the market for a limited
duration. Industrial test and measurement instruments are high mix, low volume producers,
managing portfolios of thousands of highly complex. Each instrument is intentionallydesigned for high reliability and serviceability to support long useful lifespans, and are madeavailable on the market for at least a decade. These instruments are designed: exclusively
for professional and industrial use; to meet high performance requirements in criticalapplications; and last up to 40 years. Redesign is not frequent and happens every sevenyears on average (as compared to every 1.5 years or less for consumer products). Once
test and measurement instruments are placed onto the market, they are typicallyaccompanied with a long-term customer support arrangement to maintain reliability andcalibration.
Product portfolios are widely diversified, with T&M Coalition members each having typically
2,000 to 3,000 products currently made available on the market. These are highly complex,
sophisticated electronic instruments such as signal generators, power analysers,
oscilloscopes, spectrum analysers, digital multi-meters, electron microscopes, chemicaland biological analysers, complex chromatography systems and their detectors, eachhaving many necessary options and accessories. The Annex of this SEA contains further
details concerning the product groupings and equipment types of the participating136

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companies. Each instrument can have between 2,000 and 40,000 parts; requiring a vast
supply chain involving tens of thousands of suppliers and hundreds of thousands of items.
Considering the EU added-value, test and measurement equipment is manufactured andsold in relatively small volumes (per instrument design) and placed on the global market.
There is an added value in community level action, which guarantees more coherent andconsistent rules across Europe. But with the expansion of RoHS-like requirements beyond
the EU, this creates a risk of discrepancies in RoHS-like national laws adopted in third
countries.
The professional test and measurement products provide the tools for engineers to develop
new solutions and businesses to bring them to market. These instruments are used in
Research, Quality Control and Testing laboratories (including field testing) in Universities,
Manufacturing and clinical facilities and by Governmental Agencies for conformanceverification and environmental testing. They are essential to the good functioning ofelectronic communications networks, heavy industrial processes such as steel
manufacturing, the testing of vehicles for compliance with emissions standards, and themonitoring of complex and critical systems. The nature of the tests and measurements
made by industrial equipment necessitates that the equipment itself is highly complex; withupwards of 40,000 components necessary to produce a single instrument. Even a relatively
simple hand-held instrument incorporates significantly more components that a typicalconsumer product.
Historically, between 25 - 35% of the components used in cat. 9 IMCI are custom designed.
The features of the T&M Coalition’s equipment necessitate the development and productionof unique components that are not commercially made available on the open market andare typically made by sole, boutique suppliers. These components have their own
development lifecycle and take years to bring into production. When these suppliers areunable to deliver compliant parts that meet current RoHS regulations, the product would be
stopped from being sold into the EU.
Exemption 7(c)-I is the most frequently used exemption in cat. 9 IMCI. Most electronic
products contain this exemption because of the broad range of applications. These include,
but are not limited to, the following:•Resistor networks•

Diodes•

DC-DC converters•

Microwave and mm Wave frequency custom components•

Thermistors•

Thyristors•

Relays•Crystal oscillators•

Bandpass filters•

Amplifiers•

Couplers

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High frequency RF filters(TMC 2023a) provide a more comprehensive list of the relevant product groupings andequipment types relevant to exemption 7(c)-I in their renewal request.
(Werfen 2023)
The technical background is described in the applicant’s summary.
As to the particular function of lead, the applicant says that the metal is a constituent of the
Piezoceramic material used in the disposable cartridge in the form of Lead zirconate titanate(PZT) used as piezoelectric transducer due to superior performance referring to high Qvalue and more. As noted the piezoelectric transducer used to create acoustic power in a
microfluidic detection flow chamber to separate plasma from whole blood patient samples
by acoustofluidic separation.
Acoustofluidic separation is based on the interaction of acoustic waves with fluids andinclusions within the fluids. One convenient way to generate acoustic waves is to use
transducers made of piezoelectric materials. Piezoelectric materials can generate electricalpolarization under an applied mechanical stress or, vice versa, mechanical deformationarise from electrical polarization.
There are various types of piezoelectric transducers based on their material properties,
configurations, and actuation modes. Some materials like quartz show natural piezoelectric
properties due to its crystal structure yielding a net electrical dipole, while others like leadzirconate titanate can be made piezoelectric by applying an external electric polarization.
Depending on the material and orientation, the vibration mode can be different. The mostcommon vibration modes used in piezoelectric transducers are thickness expansion mode.
When an alternating current (AC) signal is applied to the planer electrodes of a transducer,
piezoelectric materials vibrate at the frequency of the AC signal. In both the thickness
expansion and thickness shear modes, the whole body of the piezoelectric material
vibrates, producing waves that are usually referred as “bulk acoustic waves” (BAW).
Based on the combined action of ultrasound waves and the flow of carrier fluids,
acoustofluidics has emerged as a useful tool for manipulation of biofluids and biologicalsuspensions in microfluidic devices. These devices exploit standing acoustic pressure
waves that through the purely mechanical parameters, such as compressibility, density andsize, induce fluid- and particle-specific forces leading to acoustophoresis this phenomenon
is the basis of the development of gentle and robust methods for concentrating, trapping,washing, aligning and separating cells [2]. To be used for manipulation purposes, theacoustic pressure wave inside the microchannel must exhibit well defined pressure nodes
and intense pressure fields, that effectively attract or repel particles.
For these reasons, acoustofluidic devices operate at acoustic resonance frequencies.
Because the speed of sound in water is around 1500 m/s, and the typical characteristic
dimensions of acoustofluidic microchannels range in 200 − 500 μm, it is seen thatultrasound frequencies of about 1.5 − 2.5 MHz are ideally suited for creating effect.
The effectiveness of the device in focusing microparticles is quantified by two mechanicalindicators: the average direction of the pressure gradient and the amount of acoustic energy
localized in the microchannel. Further, we derive the relations between the Lagrangian, theHamiltonian and three electrical indicators: the resonance Q-value, the impedance and theelectric power (Bruus et al.). The acoustic standing wave formed by the channel walls

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continuously translated blood cells from their original medium to clean plasma solution with
virtually no mixing of the fluids.
As mentioned above, any change in the Piezoceramic material can directly impact analytical
performance characteristics of this system. This is critical because the quality management
system, which ensures high quality and accurate blood measurements in the GEM Premier
5000 MARS system, is designed around the analytical performance of the Piezoceramicmaterial containing Lead.
The following advantages of the GEM Premier 5000 MARS as compared to other existing
technologies on the market today are directly related to the material and require extensive
validation for an alternative substance:
The GEM Premier 5000 MARS analyser utilizes the renowned Intelligent Quality
Management (iQM™) System which automatically detects, corrects, and documents all
errors, and confirms resolution ensuring patient safety and the highest quality of test results.
iQM continuously monitors on-board Process Control Solutions (PCS), reducing the time toerror detection to minutes instead of the hours required by traditional manual or AutomatedQuality Control (AQC) that normally are run every 8 hours, as regulated by CLIA in the
United States and by applicable national legislation in EU Member States.
iQM eliminates manual intervention to correct sensor errors, such as removal of blood clots
from the system, thereby significantly reducing time needed for the testing process andenhancing ease of use. The reduced testing time will, in critical situations, significantly
improve patient safety by producing rapid and correct results that reduce the need for userinterpretation of results or repeat testing.
iQM results in a longer usable lifetime of the disposable cartridge, compared to otheranalysers based on AQC technology. The iQM system conducts quality control as anintegrated part of the testing process, whereas AQC counts quality control samples as
separate tests thus reducing available number of patient blood samples during cartridge
life.
The GEM Premier 5000 MARS analyser offers a single, disposable measurement cartridge
which can be stored up to 6 months at room temperature. Other competing technologies
utilize multiple cartridges to perform the same functions, some of which require refrigerated
storage. This place an additional burden on the customer of stocking multiple consumablecartridges and providing refrigerated storage at point-of-care testing locations, where space
is often limited.
Transducers produced for the GEM Premier 5000 MARS analyser are tested at the factory
to ensure highest levels of quality to the customer. The combination of the iQM System,
single measurement cartridge design, and rigorous testing procedure for the transducer
ensures that the GEM Premier 5000 MARS analyser provides the best possible results inall relevant use scenarios. This combination curtails the need for users to perform
correctional analytical actions, enabling Healthcare staff to better focus on critical patientcare tasks. These advantages are directly linked to the performance of the transducers acritical component of the measurement system.

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8.1.5.

Annual amount(s) of restricted substance(s) used under the
exemption(EUROMOT et al. 2023a) use up to 93 % by weight of lead in the homogeneous material.
As to the total amount of lead used they provide data based on estimates of two
manufacturers. Manufacturer A estimated that the total quantity of lead in parts using
exemption 7(c)(I) is 11.5 kg, based on their estimated use and market share. Manufacturer
B estimated 1.5 kg based on their estimated use and market share. As such the quantity oflead used in engines in scope of RoHS for exemption 7(c)(I) is expected to be between 1.5
kg and 11.5 kg per year in the EU (excluding the UK). It should be noted that this is notreflective of all Category 11 uses which is not able to be calculated by EUROMOT.
Given the limitations of the applicants’ above estimates, the actual amount of lead used incat. 11 under exemption 7(c)(I) can be assumed to be higher.
(TMC 2023a) state that their members emphasized that the quantity of lead utilized in their
homogeneous materials varies based on the application. Therefore, companies indicatedthat the homogeneous materials can contain between 3 % and 93 % lead by weight. As tothe total amount of lead placed on the EU market under exemption 7(c)(I), they indicate
8.2 kg based on their members’ data.
Since not all producers of cat. 9 IMCI are members of TMC, the actual amount of lead canbe assumed to be higher.
(Werfen 2023) estimate the respective amount of lead used only in their products with 0.1 kg
to 5 kg per year.

8.2.
8.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substance(EUROMOT et al. 2023a)
EUROMOT’s members do not make electronic components and rely on their supply chain,
which has the necessary expertise, to carry out research into lead-free alternatives. As
such, the following is a summary of published literature on research on possible lead-freecomponents. Additional work by EUROMOT’s members‘ suppliers may have been carriedout but as this is confidential it has not been divulged to EUROMOT’s members. Only whensuitable substitute components and bonding materials are developed and proven to bereliable by these suppliers will EUROMOT’s members be able to start the systems level
qualification and recertification activities which will require additional time.
Since RoHS was first proposed, a huge effort has been made to develop alternative leadfree glass and ceramic materials but with only limited success. The main candidates atpresent are:
1. Lead-free piezoelectric ceramics,
2. Lead-free PTC thermistors,
3. Low melting point glasses,
4. Lead-free glass alternatives.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EUROMOT et al. 2023a) describe the drawbacks of these materials in their renewal
request. Since the information is from public sources and not specific for the applications of
EUROMOT’s members, and is at least in parts discussed in the previous review reports,
they are not listed here in more detail.
(TMC 2023a)
To TMC’s the best knowledge, there remains no single substitute available that would besuitable to all the applications identified. Currently, substitutes for even the major uses haverarely been found. Evaluating alternatives for each of the niche uses would take anenormous amount of time and resources, with little probability of success.
The overall lack of a suitable alternative for lead as used in exemption 7(c)-I has also beenechoed in the application submissions of other businesses relying on this particular RoHS
exemption. Industry as a whole has been involved in finding substitutes for lead in glass,ceramic, or glass or ceramic matrix compounds for more than two decades.25 Despite these
tremendous efforts, a substitute for lead that is broadly applicable to the numerous
applications has not been found.
For instance, low melting point (LMP) glass solders have been attempted with multiple
substances with no success: They either melt at too high of a temperature (120-160 °C
higher); do not perform functionally (do not wet, do not seal); or are more toxic than Pb(such as beryllium oxide BeO, uranium dioxide UO2) – or a combination of these.
Additionally, lead-free resistor element materials have poorer reliability than Pb-containing
materials due to low moisture resistance during load heating and low mechanical strength
during overload heating. Resistance values are not stable, changing gradually over time orsometimes with sharp changes. For the accuracy and long life required by cat. 9 IMCI,
substitutes with these technical inadequacies are not acceptable.
(Werfen 2023)(Werfen 2023) have been working to replace Lead in the Piezoceramic material in close
cooperation with commercial suppliers of Piezoceramic materials, academic institutions andprivate consultants to identify alternatives for Lead. This work is not yet complete, andWerfen is submitting this application for an exemption to allow additional time to complete
this work while at the same time assuring uninterrupted supply to the EU healthcare sectorof equipment critical to providing optimum care of critically ill patients.
A key finding of the work completed until now was that replacement of Lead in the
Piezoceramic material resulted in deterioration in analytical performance of the GEM
Premier analyser. We therefore conclude that presence of Lead in the Piezoceramicmaterial is aiding performance, and published product claims were based on this optimum
performance.

25 A comprehensive overview of industry’s efforts in this regard is outlined in the exemption renewal dossier of

the Umbrella Project, which is downloadable from the Commission’s webpage. Available at:https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/implementation-rohs-directive_en 11;
source as referenced by TMC 2023a.

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At present, the evaluation continues for an alternative, RoHS compliant material which will
restore functions to their original level of performance, consistent with product claims, EN
ISO 13485:2012 (EN ISO 13485:2016 Medical Devices – Quality Management Systems –Requirements for Regulatory Purposes), EU Directive 98/79/EC on in vitro diagnostic
medical devices, and the European In Vitro Diagnostic Regulation IVDR 2017/746 which iscurrently in progress. In vitro diagnostic medical devices mandate that a manufacturer must
demonstrate its ability to provide medical devices and related services that consistently
meet customer and applicable regulatory requirements. The legal obligation for the
manufacturer to meet applicable requirements of the current EU requirements includes
performance in terms of analytical sensitivity, analytical specificity, accuracy, repeatability,
reproducibility, and limits of detection stated by the manufacturer. The Manufacturer needs
to document compliance with the above requirements of the EU by updating the TechnicalFile as appropriate.
Due to the aforementioned issues, the investigated alternatives are not technicallypracticable or viable alternatives at this time, as they affect the accuracy and reproducibilityof test results carried out with the alternatives, thereby preventing the analyser fromperforming its intended function within established product claims. There is no lead-freeferroelectric ceramics product on the market yet with high piezoelectric properties needed
for their application. Despite the achieved improvement in piezoelectric properties, there
are problems in the synthesis, processing and poling of the sintered ceramics. Lead freepiezo ceramics are available on the market today, ( i.e., by one of the market leaders andkey suppliers, PI Ceramics, but they, suffer from their low Q-value (a Q-value26 of >>1 isneeded for the application used in the MARS product).
Although the search for practical and viable alternatives is on-going, Werfen must continue
to manufacture the current cartridge using Lead until a new, non-Lead material is
successfully identified, with performance equivalent to currently manufactured product.
Based on their evaluations (Werfen 2023) conclude that this application for an exemption
falls within all three categories as established in Article 5(1)(a) with respect to the possibility
to substitute the use of Lead in the Piezoceramic material:
1. Their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable,
2. The reliability of the substances investigated for substitution is not ensured.
3. The total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.
Continued use of Lead in the Piezoceramic material of the GEM Premier cartridge isrequired while the search evaluation of substances continues for an alternative material withperformance characteristics equivalent to the currently manufactured product. The
alternative must not interfere with measurement of any analyte on the system over the

26 A parameter indicating the efficiency in vibrating, and inversely its damping or internal losses. For power

applications, the higher the Q-value, the better the device. The Qm value is approximately the number oftimes the device oscillates at no-load condition after excitation ceases. Source: ATCP Physical Engineering,https://www.atcp-ndt.com/en/support/faq_trz/413-what-is-the-mechanical-quality-factor-qm-and-what-is-itfor.html (modified)142

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claimed product shelf-life (up to 6 months at room temperature) and use-life (up to 31 daysin the analyser).
Stakeholder contributions
Exemption clause 7(c)(V)(4) recommended by (Baron et al. 2022) (cf. Table 7-4 on page103) sets resistivity limits between 1 Ohm/square and 1 Megaohm/square to qualify for theuse of lead in “resistance materials”.
(SRT 2023a, 2023b) state that lead-free pastes with resistivities of 100 MΩ/square andmore are not available on the market, and that their availability is not foreseeable. They also
state that they successfully produced several lead-free resistors from pastes withresistivities of 1 Ω/square, 10 kΩ/square and 10 MΩ/square. They still need, however, totest their life time, and whether they are trimmable. “Trimming” is a process to define theexact resistance of the resistor produced from the resistivity paste.
(Pari Pharma 2023) manufacture medical devices for the treatment of a broad range of
respiratory diseases. Their "eFlow" devices are used in several clinical studies and are partof commercial drug- and device-combination products. Therefore, they are also part of
medicinal product approvals and many patients profit from using their devices.
Their eFlow Technology is based on vibrating membrane technology. They are using a
piezo element made of PZT to operate the membrane which falls under the RoHS
exemption III-7c(I) (Pari Pharma 2023) and their suppliers have been working on
substituting PZT for several years. However, due to the high performance and safety
requirements of their devices, they have not yet succeeded in replacing the material. PZT
is essential for their application and we will not be able to replace the material by July 21,2026. They therefore request that the scope under III-7(c)(VI) be expanded to include theuse of “Category 8 vibrating membrane nebulizers in active medical devices for inhalation
therapy” in addition to the scope expansion "IVD for the analysis of blood" proposed by(Werfen 2023).

8.2.2.

Environmental, health and safety impacts(EUROMOT et al. 2023a) reference the Life Cycle Assessment (LCA) of lead-freepiezoelectrics submitted by the Umbrella Project to the last review of exemption 7(c)(I) by(Baron et al. 2022) where the lead-free alternatives assessed have a greater total negativeenvironmental impact.
(TMC 2023a) claim that cat. 9 IMCI contribute only 0.2 % by weight to the Waste Electricaland Electronic Equipment stream. Consequently, the environmental impact of cat. 9 IMCI
is negligible. Nevertheless, test and measurement equipment does enter the waste stream,
typically many decades after it is placed on the EU market.
(Werfen 2023) had a life cycle assessment (LCA) prepared by Intertek and criticallyreviewed by Intertek. They interpret the results as showing that lead has lower
environmental impacts (in terms of the measures produced by LCA) in certain categories
than the two alternatives.

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8.2.3.

Socioeconomic impacts

According to (EUROMOT et al. 2023a), if this exemption is not renewed and include all of
the applications in engines made by EUROMOT’s members, engine and end-productmanufacturers will be forced to stop selling products that do not comply with RoHS. At thisstage, it is not known which products would be affected for the following reason. (Baron etal. 2022) have recommended the renewal of 7cI but with a limited scope. The proposed
scope will include many of the components used by EUROMOT’s members, but may notinclude all of them for the reasons explained above in section 4 (B). Therefore, this could
affect many types of end-users in the EU. For example, construction and other industries
may not be able to operate if essential equipment is not available. If supply of emergency
generators is affected, this may affect, for example, hospitals who use these during power
cuts. There would be a risk to patient’s survival during operations or other medical
procedures (such as MRI examinations and monitoring patients in intensive care) may not
be possible if emergency generators are not available. Manufacturers of affected engines
and their end-products would also be negatively affected causing loss of competitiveness,potentially leading to loss of jobs. Due to the uncertainty over which products would be
affected, it is not possible for (EUROMOT et al. 2023a) to determine quantitative impacts.
(TMC 2023b) ask to keep in mind that cat. 9 IMCI manufacturers have to manage suppliers’
declarations for hundreds of thousands of items. Additionally, after reviewing the current
state of the evolution of technology for the cat. 9 industrial measurement and control
instruments, TMC members have difficulty in understanding how the rewording and relisting
and/or splits recommended by the consultants will lead to greater protection of humanhealth and the environment compared to the wording in its current form. The recommended
rewording/split would only lead to significant unnecessary burden for stakeholders without
commensurate benefits.
(EPPA 2023) further elaborate that there are currently no suitable lead-free alternatives thatmeet RoHS exemption criteria on the EU market for cat. 9 IMCI and that re-designing of thecat. 9 IMCI equipment could take five to seven years per product line. Hence, losing theability to apply Annex III, exemption 7(c)-I when considering RoHS conformity for the
associated test and measurement industrial products would entail the development of afairly large number of new alternative compliant materials as well as the increased costs
connected to the redesign, retesting, requalification, and replacement of the assembly
process.
Overall, (EPPA 2023) monetize in their SEA the total impact of a non-renewal of exemption
7(c)(I) in the range of 3.1 billion EUR and 4.3 billion EUR (conservative estimates in net
losses; potential gains for suppliers of other components have been already taken into
account), consisting of: economic impacts (EBIT loss) on test and measurement industrial
type products’ manufacturers; substitution costs and social impacts (i.e., unemployment in
the EU-27).
(Werfen 2023) request that this application for an extension of the current exemption beapproved because otherwise the supply of vital analytical instruments that support hospitals
and laboratories across the entire EU will be jeopardized with a clear negative impact on
the EU Health Care Sector. Meanwhile, they have a project plan and are diligently
evaluating new piezoceramic materials compliant to RoHS.

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8.2.4.

Roadmap towards substitution or elimination of the restricted
substance(EUROMOT et al. 2023a)
As to their past compliance efforts, (EUROMOT et al. 2023a) state that manufacturers oflead in glass and ceramic in electronic components have been carrying out research on
substitutes for lead in glass and ceramic for over 20 years. When promising lead-freealternative becomes available, EUROMOT members will have to test them in systems they
are used in and for some components the systems as a part of the engine to ensure thatthey offer the necessary technical performance and will be no less reliable. Due to theoperational environment and an expected service for up to and beyond 20 years, material
testing and development activities necessarily take many years to complete to ensure longterm reliability.
After laboratory tests of materials / components, extensive “on-engine” and field testing
must be executed to evaluate the reliability and durability of the substitute material/parts.
This testing needs to be undertaken by each engine manufacturer to ensure the testingreflects the demands of their application and the tolerances that are inherently in-built into
each system. The reliability of the system then needs to be proven with an estimated500,000+ cumulative hours of testing to understand if the alternative is equal to that ofcurrent leaded materials.
It should also be mentioned that the EEE industry and automotive industry have an
extensive overlap in their supply chains. For example, many components are used in both
EUROMOT’s members engines that are in scope of RoHS as well as by the automotive
industry. EUROMOT would recommend that the EU maintain consistent wording between
this exemption and ELV exemption 10 where feasible.
When manufacturers are qualifying changes to specific components the following are someof the tests which engine manufacturers must undertake. The following tests are notintended to be an exhaustive list, as different manufacturers have different testing
requirements, but rather indicate the number and variety of tests which have to beundertaken.
Sensors:•

Vibration testing•

Vibration resonant sweep: a shaker test used to detect if any resonances in thecomponent may adversely affect the device•

Humidity testing•

Water intrusion testing•

Thermal Shock: extreme temperature swings are used to stress the assembly•Salt fog testing•Electromagnetic compatibility testing•

Connector housing testing, such as durability testing, chemical stress fracture etc.

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Combined Environment: sensors are subjected to a combination of temperature andvibration to evaluate the component assembly for the expected life of the item,
testing functionality such as pressure, differential pressure, temperature, positions,
speed of sensor results and performance.

•

Engine system testing to ensure that, as a system, the component is suitable for theapplication and has the necessary performance

In addition to these there are also sensor specific testing which is required for certain
sensors such as gravel bombardment testing or exhaust system mounted sensors, flow
velocity testing for sensors in high flow locations, or chemical compatibility if there areexternal material changes.
Actuators:
In addition to many of the tests required for sensors, actuators also commonly have toundergo the following additional tests:•

Circuit analysis- examined at maximum temperature voltage and duty cycle
combinations and shown to be in the devices specified operational envelope•

Immersion testing•Electrostatic discharge (ESD) exposure robustness testing•

Temperature cycling durability•

Electrical field immunity testing-radiated immunity and high voltage spike•

Software testing to ensure compatibility and no errors•

Lifetime mechanical wear

Each of these tests would need to be undertaken for each sensor or actuator used, withtesting times varying from around 15 hours per test to around two months per test. Testing
timeframes for each of these tests cannot be further accelerated as some attributes are
non-linear, such as long-term reliability or durability.
Timescale once substitute components become available to EUROMOT members
If a promising lead-free alternative is developed, then this must next be tested under realistic
engine conditions by EUROMOT’s members. The timescale will vary depending on how
significant the changes, the types of engine and their end-uses. For example, if thecomponent’s electrical and functional properties are apparently identical, then minimal
testing is necessary. However, substitute materials often given different characteristics somore extensive testing is needed. Sometimes substitution results in component suppliers
withdrawing their products from the market and replacement by a different component (thisis common with ICs) in which case EUROMOT’s members may need to redesign circuits
and this could affect engine emissions and so recertification will be required.
This will involve some or all of the following:•

Production of prototype parts/ circuits and laboratory testing to determine suitability
and reliability. This would include accelerated environmental testing such as thermal
cycling, vibration, high humidity, corrosion tests, functional testing of circuits, etc.
However, if there are many components to assess, this could take longer due tolimitations in the availability of suitable trained engineers.

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Construction of engines using the lead-free replacement components and bench
testing to determine reliability. This is the only reliable way of assessing new bonding
methods.

•

Field trials in end-use equipment. This is important because it is not possible toreliably reproduce field conditions in laboratory testing environments. This isrealistically essential to assess long term reliability.

•

If use of substitute bonding materials or new components requires significant
changes, such as re-design of circuits or of the engine, then approvals under the
Non-Road Mobile Machinery (NRMM) Emissions legislation will be required.

The timescales for these stages vary between five and up to eight years depending on thetype of component substitution, type of engine and its end-uses. For example, assuming
the exemption is used in a large number of parts (200-300 assemblies in the case of
EUROMOT applications), it could take more than five years to integrate an available
alternative. If those alternatives were not „drop-in replacements“ the estimated time would
be much longer to produce emission certificates and safety approvals.
Timescales for above:•

Without NRMM Emissions Regulation re-approval 5 - 7 years after lead-freesubstitutes become available•

With NRMM Emissions Regulation approvals at least 6 - 8 years after lead-freesubstitutes become available

In addition to the above timescale, as a minimum, to consume existing stocks ofcomponents, 7 years is required from confirmation that a substitute exists and is reliable.
(TMC 2023a)
As to their past compliance efforts, (TMC 2023a) contacted their component suppliers toinquire if, since the submission of the renewal request in 2020 by other stakeholders (e.g.,the Umbrella Project), new technological developments have occurred that would allow thesubstitution of lead as used in RoHS exemption 7(c)-I. It was reported back that noalternative substance with the same required characteristics of lead for the respective
components is known to the manufactures of those components.
As to their future compliance activities, (TMC 2023a) point out that that they principally relyon their component suppliers to find alternatives to the use of restricted substances sincemost of the components utilizing exemption 7(c)-I incorporated into cat. 9 IMCI are COTS27
parts (and so forth, potentially many levels down). Implementation of change necessitatedby regulatory pressures typically starts with raw material manufacturers and the cat. 9 IMCI
manufacturers who have the largest economic stake. Intermediate manufacturers are
geographically and jurisdictionally diverse and are often SMEs. As such, this part of the
supply chain is slower and more inconsistently able to adapt. Assuring full adaption in the
supply chain and validating the alternatives in the final product application can and often
does require up to 4 years. The general process involves communicating with the supply
chain, evaluating samples, conducting design impact studies, reconfiguring the instrument

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and its software where necessary and testing in manufacture and validating the final
assembly.
The companies reported that the validation period alone would take a minimum of 6 months
and up to a year after the delivery of suitable alternatives per product. It is significant to notethat this validation period would only apply if the component were a fit, form, and function
drop-in replacement. If any design changes to the exemption-free part of the product would
be required to accommodate for the alternative, a validation period would be required foreach redesigned product that used to utilize the component that relied on the exemption.
Moreover, the validation would lead to the organizations incurring additional expenses.
These include labour costs and costs arising from potential product resubmission
requirements for testing to various notified bodies to ensure that substitution does not create
any electrical and functional safety concerns.
If a new substance free part is available, this part must be qualified for use by performing avariety of tasks, as described above. Due to the complexity and diversity of the applications,this must be done individually by each company for each product group. This process would
divert resources from other projects and increase the cost to ensure continued availabilityof these products. This validation and testing process varies according to part complexity
and impact upon the final product design; which can be categorised as low, medium, and
high:

•

Low complexity parts are the off-the-shelf components or hardware parts that do
not have a substantial performance impact. Replacement can be done based on
supplier information, assuming a form/fit/function compliance, with standard
manufacturing, testing, and validation processes. Based on process timescales
reported by a T&M coalition company, the average time that it can take for theseparts to be replaced ranges from 3 to 6 months.

•

Medium complexity parts are more complex sub-assembly electronic parts, suchas small motors, which need additional validation for their performance. These parts
are often commercial assemblies that are generally available to the electronic
industry, and are utilised by the Test & Measurement coalition companies.
Replacement of these assemblies, like-for-like, requires testing and validation prior
to being integrated into the manufacturing process. The average time to find analternative for medium complexity parts for production is reported to range from 6 to
12 months.

•

High Complexity parts are the complex sub-assemblies or parts that have asignificant impact on performance of the company’s products or play a critical rolein overall safety of the products. These parts need to go through extensive validation
for performance and/or compliances for varying regulations before the appropriate
files can be updated and the proper competent authorities or regulatory bodies canbe notified prior to purchase of parts for validation. The average time that it would
take to find an alternative for high complexity parts for production is up to 1 year for
additional testing. Where the exemption directly impacts the performance of thatcomponent (e.g., a centrifuge rotor) the evaluation of the replacement could takefrom 3 to 5 years.

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Actions to develop alternative substances are currently in progress. Project phases aredefined in the Design Control Procedure (QMDD-20001-00) for Design Control projects.

•

Project Proposal•

Design Input (Phase 1)•

Design Output (Phase 2)•

Design Verification (Phase 3)•

Design Transfer (Phase 4)•

Design Validation (Phase 5)•

Product Launch (Phase 6)

Currently, Project MARS is still a Design Control project within Phase III – Verification. See
the project schedule below. The development cycle covers the Design Input and Design
Output phases. Product Launch will be beginning after FDA and IVDR submission whenapproval is attained.

8.3.

Critical review(Baron et al. 2022) conclude in their review of exemption 7(c)(I) that the exemption isjustified as available substitutes are either not suitable and cannot be fabricated into leadfree components that could be used in the same applications, or such components provide
an inferior reliability leading to malfunctions that would not be acceptable in the respective
EEE. The current exemption wording is not confined to specific applications. The existenceof many different applications results in the assessment focusing on how these relate toeach other and to the properties that lead enables in the applications of the various
materials. An application specific assessment would allow a stronger focus on each of theapplications and its specific obstacles to substitution. Specifying the exemption to aconfined set of application would allow a more detailed assessment in the future and shallalso add certainty to market surveillance in considering in which cases the exemption isapplied properly.
(Baron et al. 2022) had circulated a proposal for exemption specification to stakeholders
and after integrating their views, two more detailed exemption wordings were formulated.
As the duration of the assessment did not allow a final check of this formulation withindustry, it is not completely certain that the specific thresholds may not exclude certain
articles where lead is not avoidable.
As a result of their above considerations, (Baron et al. 2022) elaborate two options for the
renewal of the exemption and recommend the option displayed in Table 8-4 on page 131
for the renewal of exemption 7(c)(I) as exemptions 7(c)(V) and 7(c)(VI).

8.3.1.

REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in

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Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of exemption 7(c)(I)in EEE of cat. 9 IMCI and 11.
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

8.3.2.

Substitution and elimination of the restricted substance(Baron et al. 2022) conclude as a result of their review that substitution and elimination oflead are scientifically and technically not yet practicable and hence recommend renewing
the exemption, however, with the attempt to structure the scope. The recommended
structure is not intended to restrict the scope compared to the current exemption 7(c)(I)since (Baron et al. 2022) did not identify applications of lead in the scope of the exemption
for which substitution or elimination of lead would be scientifically and technicallypracticable.
All applicants mention that exemption 7(c)(I) is used in manifold electrical and electronic
components in their categories of EEE, i.e. categories cat. 8 IVD, cat. 9 IMCI and cat. 11.
The scientific and technical practicability of lead substitution or elimination therefore mostly
depends on the availability of lead-free alternatives on component level rather than on the
EEE categories in which these components are used, even though there may becomponents that are only used in specific categories of EEE.
The conclusion of (Baron et al. 2022) as to the impracticability of lead substitution andelimination in the context of exemption 7(c)(I) is therefore applicable to all categories of
EEE, including cat. 8 and 9 that were part of the review of (Baron et al. 2022). The reviewof the requested exemption renewals in this current round was therefore focused on thepotential adoption of the recommended exemptions 7(c)(V) and 7(c)(VI), in particular withview to the applicability of the structured exemption scope.
EUROMOTEEE of cat. 11 was not included in any of the renewal requests reviewed by (Baron et al.
2022). Nevertheless, (Baron et al. 2022) recommend the expiry of the recommended
exemptions 7(c)(V) and 7(c)(VI) for all categories on 21 July 2026.
EUROMOT were asked whether the renewed exemptions 7(c)(V) and 7(c)(VI)
recommended by (Baron et al. 2022) could be adopted for cat. 11.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EUROMOT et al. 2023b) state to require the current scope of 7(c-I), rather than the
proposed 7(c-V) and 7(c-VI) for internal combustion engines, associated components, andend-products in which these are used. The proposed scopes of 7(c-V) and 7(c-VI) are too
restrictive and will likely preclude to necessary technical use of components containing leadin glass or ceramic in applications not listed. EUROMOT members are not able to determine
if all lead in glass or ceramic in applications are captured by the proposed 7(c-V) and 7(cVI) and to differentiate them, as they use a wide variety of electronic components utilising
exemption 7(c-I), but electronics suppliers do not provide information as to whether this iscovered by the proposed 7(c-V) or 7(c-VI). As such, it is essential that sufficient time isprovided where the 7(c-I) scope remains valid for EUROMOT members, to engage with
their supply chain to identify which exemption would be applying to their uses. Without thecontinued provision of 7(c-I) engine and end-product manufacturers will be forced to stop
selling products that do not comply with RoHS. At this stage, it is not known which
EUROMOT products would be affected, but could affect many types of end-users in the EU.
It is plausible that users of electrical components do not know in which exact application
under exemption 7(c)(I) lead is actually used as long as producers and suppliers of thesecomponents do not provide additional information besides the fact that the component
contains lead as authorised by exemption 7(c)(I). Producers of electrical and electronic
components are, however, not obliged to specify the exact use of lead. Such information
thus actually may not be readily available at the level of EEE producers. Applicants like
producers of EEE and their associations are, however, expected to substantiate theirrenewal requests with the technical evidence that substitution or elimination of lead are stillscientifically and technically unpracticable to justify granting an exemption in line with Art.
5(1)(a). This implies that they either include component producers in their supply chain into
the consortium requesting the renewal, or they access the supply chain to be able to provide
adequate technical expertise.
With view to the adoption of the recommended exemptions 7(c)(V) and 7(c)(VI) in theircurrent wordings, the absence of the respective expertise actually bears the risk for
producers of cat. 11 EEE that uses of lead remain out of scope for which its substitution or
elimination are scientifically and technically not yet practicable. (EUROMOT et al. 2023a)
want to avoid this risk by extending the scope of the exemption in its wording by adding to
the current wording of exemption 7(c)(I) that these components can be “used in engines,
engine components and ancillary components and in end-products” of cat. 11 (cf. Table 8-2
on page 129).
This addition neither fits the architecture of the current exemption 7(c)(I) if it shall remain
applicable for other categories of EEE as well, nor the intention of the recommended
exemptions 7(c)(V) and 7(c)(VI) which attempt specifying and structuring the exemption
scope by specific technical application criteria instead of renewing the exemption with thecurrent material specific exemption scope.
TMC
Cat. 9 IMCI was included in the review of exemption 7(c)(I) of (Baron et al. 2022) since its
renewal was requested by applicants including the Umbrella Project at that time.
(TMC 2023b) do not agree to adopt the recommended renewed exemption 7(c)(V) and7(c)(VI) for cat. 9 IMCI because exemption 7(c)-I is the most frequently used exemption in
test and measurement electronic products; most electronic products contain this exemption

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because of the broad range of applications. As further outlined in TMC’s submission there
is no single substitute available that would be suitable to all the applications identified. The
Test & Measurement Coalition therefore applies for a renewal of exemption 7(c)-I for the
maximum validity period, as it considers the criteria of RoHS art. 5(1)(a) are met.
This answer does not explain why the recommended renewed exemptions cannot be
adopted for cat. 9 IMCI since the recommended renewals target structuring the scope but
not to exclude uses of lead for which its substitution and elimination is scientifically andtechnically not yet practicable. TMC do not provide technical justifications.
TMC are in the same situation as EUROMOT, i.e. they do not know the specific applicationsof lead that are applied in electrical and electronic components used in cat. 9 IMCI. Adopting
the recommended renewed exemption 7(c)(V) and 7(c)(VI) in their current wordings bears
the risk for producers of cat. 9 IMCI that uses of lead remain out of scope for which its
substitution or elimination are scientifically and technically not yet practicable. However, likein the case of EUROMOT, producers of EEE and their associations requesting the renewalof exemptions are obliged to organise adequate technical expertise so that they can
substantiate their renewal requests.
Werfen(Werfen 2024) confirm that exemption III-7(c)(VI)(1) for PZT in category 8 IVD for diagnostic
medical devices for the analysis of whole blood would cover Werfen’s exemption renewal
application completely.
(Werfen 2022) had originally requested the exemption for 5 years only. (Werfen 2023)
amended the original request extending the requested validity period to 7 years.
(Werfen 2024) explain that at the time of filing the original exemption application in January2022, 5 years were deemed sufficient time for implementation, based on initial benchtop
data from external consultants. Since then, internal feasibility activities have progressed
toward developing an alternative lead-free material:•

Additional benchtop studies expanding the scope and sample sizes compared tostudies conducted by consultants•

Integration into the full GEM system to evaluate complete functionality•

Assessing impacts on the constraints of the established GEM system

After initial testing, currently available lead-free alternatives have not proven to have theperformance that is required to move forward with implementation. The result is that 5
additional years from our proposed exemption extension in the January 2022 application
are required for internal development, to the full 7-year maximum validity (also referred to2026 + 2 or 2028). Testing thus far has shown that the available lead-free alternatives are
not a viable solution to implement as all options are accompanied by substantial impact tothe existing architecture of the system.
Optimization to achieve equivalent performance would require multiple rounds of highvolume testing in conjunction with modifying the manufacturing process. The goal of
additional development is to implement a solution that does not compromise safety,
effectiveness, and reliability of the current device utilizing PZT. It is for this reason theapplication is being updated to request the maximum validity renewal of 7 years. The

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additional timeline for compliance includes both the internal development required as wellas the external regulatory processes with IVDR.
The timeline requested allows for internal timeline completion and factors in time for any
external process completion that may follow making any changes to the product once it ison-market. Below table shows the project timeline for compliance with the RoHS directive.
Figure 8-1: Amended timeline for compliance

Source: (Werfen 2024)

The above plan shows that substitution should be achieved until end of 2029.
Stakeholder contribution PARI Pharma(Pari Pharma 2023) request that the scope under III-7(c)(VI) be expanded to include theuse of “Category 8 vibrating membrane nebulizers in active medical devices for inhalation
therapy” in addition to the scope expansion "IVD for the analysis of blood" proposed by(Werfen 2023). The stakeholder uses a piezo element made of PZT to operate themembrane.
Like in the case of the applicant Werfen, the renewed exemption 7(c)(VI) recommended by(Baron et al. 2022) covers the above use of lead. Lead-zirconium-titanate (PZT) ceramics
are explicitly mentioned in sub-clause 7(c)(VI)(1).
Stakeholder contribution SRT(SRT 2023a, 2023b) criticise the resistivity limits of sub-clause 7(c)(V)(4) (cf. Table 8-4 onpage 131) and demand their expansion. They announced that they successfully produced
several lead-free resistors from pastes with resistivities of 1 Ω/square, 10 kΩ/square and
10 MΩ/square. They still need, however, to test their life time, and whether they aretrimmable (cf. section “Stakeholder contributions” on page 143).
Asked why sub-clause 7(c)(V)(4) is still required for lower resistivities in the light of theirabove information, (SRT 2024b) report about the results of their tests with these lead-freeresistivity pastes. The lead-free pastes from 1 MOhm/square upwards are not usable for
their trimming processes (Nd:YAG laser-trimming). They cannot achieve the tolerance
which their customers are ordering. To their knowledge the pastes below 1 MOhm/square
are different to the pastes at 1 MOhm/square and above regarding the chemistry. The
material is conducting phase changes there and is different. This and the higher resistanceregion is – to their knowledge – are the reasons for failing the trimming process. The printing
process itself is fairly good, but does not have the quality to have most of the parts within+-1% accuracy (more like +-10 %).

153Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(SRT 2024b) need more time of testing to find a workaround for the trimming problem, andfor environmental testing, especially for durability at different climatic conditions. They
adhere mostly to a standard test catalogue (MIL-STD202 or/and IEC60068-2) or a mixtureof it, also depending on the customers. Some tests are done within a few days (e.g.
resistance to soldering heat or short time overload), but some tests take half a year or more
(load life test 1000 h or 8000 h, high temperature exposure 1000 h or 8000 h, high humidity
test 1000 h or more). These tests have to be done for different case sizes (at least 6 different
SMD sizes) and resistance values (e.g. every decade) which means that a huge amount ofwork. They neither have the equipment nor the manpower to do all these tests; they haveto engage a company whose is specialised in such tests.
As to the lower end of the resistivity range, (SRT 2024b) produce resistance values below
1 Ohm down to 0.1 Ohm for which they use pastes below 1 Ohm/square that are not leadfree. Using a conducting paste is probably too low in resistance value. To the best
knowledge of (SRT 2024b), there is no supplier of a lead-free paste below 1 Ohm/square,for example 0.5 Ohm/square or 0.3 Ohm/square.
SRT undertake efforts to find lead-free solutions and the provided information suggests that
lead-free pastes are available for some resistivity ranges but they need to be qualified toensure their reliability.
(Baron et al. 2022) justify the applied resistivity limits stating that lead is used in Resistor
Networks, Power Resistors, Chip Resistors/Arrays, Fuel cards, PTCs, Sensors, and Diodes
to name some examples. For these examples the ink resistivity range may be from1 Ohms/square to 1 Mega Ohms/square but again is just an example of other resistive
products outside of the cermet-based trimming potentiometers that need to be included in
the definition of resistance material. Adding the parameter specification of the resistivity
could allow confining this entry to some degree, though it is not clear whether this range issuitable or not.
The consultants conclude from the above reasoning that the resistivity limits in exemption
clause III-7(c)(V)(4) are based on example values for which lead-free solutions were notavailable. Examples for very low and very high resistivity pastes may not have been
available at that time and were thus excluded from the exemption scope. The available
examples of (Baron et al. 2022) and SRT suggest that the substitution or elimination of leadis scientifically and technically impracticable in resistivity pastes and inks independently
from the resistivity values.
The consultants therefore recommend removing the resistivity ranges in the wording of thissub-clause.
(SRT 2023b, 2024a) further state that they use a wrap-around material which is not leadfree, and where no alternative material is available. This wrap-around of their resistors
establishes the electrical path from the lower side of the resistor to the upper side where
the resistive layer is printed. It is very resistant to leaching (with a high content of platinum)
which is important for soldering, and it is also used as contact material. This application is
not covered by the recommended renewed exemption 7(c)(V) either.
(SRT 2023a) mention a lead-free glazing paste which they can use. (SRT 2024b) specify
that they have started to use this lead-free passivation in first projects for only a small
number (<10) of batches and therefore have only limited production experience with thislead-free paste. Some problems are still to overcome, for example, this paste seems to be
more prone to air bubbles at printing. Completely missing are long term production data and154

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climate/environmental data e.g. humidity, high temperature, and so on. This will take one to
one and a half year.
The above potential substitute for lead can be taken into account in the next review of
exemption 7(c)(I) to specify and/or narrow the exemption scope.
In the light of the information provided, the consultants conclude that adopting exemption
sub-clause 7(c)(V)(4) as recommended by (Baron et al. 2022) may exclude uses of lead forwhich substitution or elimination is scientifically and technically still impracticable. The
consultants propose adapting the wording as illustrated in the below wording to include
these uses of lead.
Table 8-6: Proposed modification of exemption sub-clause 7(c)(V)(4) recommendedby (Baron et al. 2022)
No.

Exemption

Scope
and
applicability

dates

7(c)(V)Electrical and electronic components containing
lead in a glass or glass matrix compound that
fulfils the following functions:Applies to cat. 1 to 11ofExpires on 21 July 2026…
4) Used as resistance materials such as ink or
paste…
6) Used as contact, passivation and wrap-aroundcontact material (pastes, inks) for resistors

Stakeholder contribution of the Umbrella Project
Coverage of applications requiring the use of lead
(UP 7(c) (I) 2023) state that the applications listed in 7(c)(V) and 7(c)(VI) were provided in
the exemption request issued by the UP in 2020 and reviewed by (Baron et al. 2022) as
illustrative non-exhaustive examples. They wanted to explain why lead is essential toachieve the required properties and performance of the material. By no means it covers all
applications and relevant components within the scope of 7(c)(I).
Upon request, (UP 7(c) (I) 2024a) provide more examples for applications which in theirview are not covered:•In 7(c)(V)(4), ink denotes only one technology, there are others like thin film, or foils
employed. The clause currently refers to a thick film paste technology in the rangeof 1 to 10 MΩ/square, which could be used to make i.e. 1 Ω to 10 MΩ lead-freeresistors with certain specifications, in this case with a temperature coefficient (TCR)of 100 ppm/K, but not for a TCR of 50 ppm/K where this paste could not be used,
but maybe a leaded paste was required. This means that the resistivity value R isnot sufficient to define a lead-free and lead-bearing resistor, respectively.

•

In 7(c)(V)(1), the proposed wording limits the scope to glass beads for high voltage
diodes and to specific materials. This would not cover uses like155

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electrical passivation layers of semiconductor chips and wafers•

glass as part of the package (i.e. pressure contact glass sleeve packages) ofelectronic discrete components•

7(c)(VI(1) excludes•

lead containing piezoelectric ceramics that are not PZT•lead containing pyroelectric ceramics•

lead containing ferroelectric ceramics

The stakeholder contribution of (SRT 2023a, 2023b) is in line with the above statement forthe case of resistivity materials (see above section) and confirm the above statement.
The consultants derive from the above examples that the recommended exemptions 7(c)(V)and 7(c)(VI) actually may not cover all uses of lead that are in the scope of the current
exemption 7(c)(I) for which substitution and elimination of lead is scientifically andtechnically not yet practicable based on the conclusions of (Baron et al. 2022).
Impracticability of the splitting approach(UP 7(c) (I) 2023) also criticise that splitting the exemption as proposed is not a feasible
solution and would create more work for the EU as applications that are not covered by the
proposed split/wording would force requests for additional exemptions to be raised. They
believe that it is almost unrealistic to provide an exhaustive list that identifies the application
categories in which lead is essential. Even if the applications could be categorized and split
scientifically and technically correct, the number of different scopes is unpredictable, withsome in industry predicting that the number will exceed 100. A technical assessment ofsuch a large number of applications and related renewal requests would not be feasible andwould cause extreme administrative burden without measurable benefit to the environment.
Considering the above, industry would like to reiterate that the recommended wording of
exemptions 7(c)(V) and 7(c)(VI) is not fully developed to cover both the European market
and the global supply chain. The adoption of this wording would prevent an unpredictable
range of electrical and electronic equipment essential to society, such as medical
equipment, from being placed on the European market, contrary to the intent of Article 5(1)of the RoHS Directive.
(UP 7(c) (I) 2023) state that the criteria for applications indicated in 7(c)-V and 7(c)-VI are
an arbitrary mixture of materials, process parameters and products, which cannot be related
to actual electrical and electronic components as well as the equipment using them in termsof physical properties, electrical properties, and applications, and their proper classificationand information.
UP claim that they provided the examples which (Baron et al. 2022) listed under therecommended renewed exemptions 7(c)(V) and 7(c)(VI). This raises questions as to theabove statement of (UP 7(c) (I) 2023) in the context that they submitted these materials,
process parameters and products as examples for the use of lead in the scope of exemption
7(c)(I).
(UP 7(c) (I) 2024a) refer their statement to the fact that the approach used to develop thewording is inapplicable. The proposal is constructed in a way to list criteria for applications,156

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specific materials and parameters, where lead is indispensable. To cover all uses of lead,
where alternatives are not available would create a nearly endless “positive” list. In addition,
this approach is in contradiction to the current construction of 7(c), where 7(c)(I) is used asa joker to cover non-identified and special applications, where 7(c)(II) and the following parts
identify applications, where alternatives are available and certain materials and applications
can become restricted. Thus, we strongly recommend continuing that applicable approachand to identify future candidates for restrictions.
Another fact is, according to (UP 7(c) (I) 2024a), that criteria are defined, which are notaccessible in the supply chain, thus prevent verification of RoHS compliance:•7(c)(V)(3) defines a process parameter window for a specific glass used for bonding
purposes. Such information normally is company proprietary and not disclosed tocustomers of the components manufactured with such materials. RoHS compliancecannot be verified in such a situation.

•7(c)(V)(4) defines a resistivity range of a material. Like in the above case, suchinformation is not available to the customers of the component and RoHS
compliance cannot be verified.

The consultants understand from the above explications that process parameters like inexemption 7(c)(V)(3) applied to manufacture a certain component cannot be verified fromthis component. An indirect verification would be feasible if this component could only be
manufactured with one specific process which still requires lead. The latter seems not to be
applicable to the case at hand, and if it was applicable, the component itself could be used
to define the scope of the exemption.
The same seems to apply to 7(c)(V)(4), where resistors with the same resistance (indicatedin Ω (Ohm) can be produced from materials with different resistivity/sheet resistance(Ohm/square) depending on the resistor size, area covered by the resistivity material on theresistor, thickness of the resistivity material, trimming of the resistor, etc. While theresistance of a resistor can be measured on the product, the resistivity of the material thatwas used to produce this resistor cannot be verified from the product. Additionally, as theconsultants understand from the information provided by (UP 7(c) (I) 2024a), the interplayof the various parameters is proprietary knowledge of producers. To summarize, theexemption wording for the above cases should be based on component properties – typeof component and/or its performance parameters - that can be verified rather thanproperties of materials and process parameters that were used to produce the component.
Alternative approach proposed by (UP 7(c) (I) 2024a)
As an alternative to the above approach of (Baron et al. 2022), (UP 7(c) (I) 2024a) propose
continuing the current approach in 7(c) to identify and list such applications where lead-freealternatives or advanced technologies can become available to replace the current leadcontaining materials, as is visible in the current exemptions 7(c)-III and 7(c)-IV, which
already have expired.
Even though the consultants understand that the approach of (Baron et al. 2022) may
adverse implications, the above suggested strategy seems to be the perpetuation of thecurrent situation. The attempt to structure the scope of the renewed exemption 7(c)(I) in
exemptions 7(c)(V) and 7(c)(VI) is an attempt to change this situation.
(UP 7(c) (I) 2024b), following up on their above proposal, are fully aware of industry's
obligation to provide a substantial proposal and a feasible way to realize that in practice.

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The Umbrella Project technical Working group 7(c)-I fully understand the legislatorsconcerns that the wide and undifferentiated scope of 7(c)-I would allow the use of lead,even where it is not essential anymore. However, knowledge of solid-state physics,
chemistry, material science, and electrical and electronic component technology isnecessary. Additionally, the ability to convert these constraints into a legally sound and also
for non-scientists understandable text is essential for the formulation of a new and moredifferentiated wording of the exemption.
(UP 7(c) (I) 2024b) therefore started activities to develop a concept for a new wording
clarifying that lead is allowed only in applications in electrical and electronic components
where it is essential to fulfil the needed requirements. This proposal would fall into several
classifications, if necessary, and would identify alternative technologies to replace leadcontaining materials. It is planned to provide these recommendations in conjunction withthe exemption renewal request, which is due to be issued in January 2025 assuming an
expiry date of current 7(c)-I on 31 July 2026. This initiative continues the efforts undertaken
by component industry and material suppliers to make electrical and electronic components
lead-free, and part of these efforts was included in their previous renewal requests(submitted in 2015 and 2020). As soon as they identify alternatives which fulfil therequirements of Article 5(1) of the RoHS Directive, they feel committed to identify andclassify scopes for which lead phase-out would be possible during renewal requests (andpropose expiry of exemptions for those scopes on a planned basis).
In the reviews of exemption 7(c)(I) by (Gensch et al. 2016) and (Baron et al. 2022),
applicants and stakeholders objected all attempts to specify the scope of exemption 7(c)(I),
which hampered progress and affected the success of such efforts. In this respect, theabove commitment can offer a chance to access the expertise of industry as to the actual
applications of lead in 7(c)(I), and to arrive at a concise and well applicable wording for astructured scope of exemption 7(c)(I) rather than in the past where consultants had to work
against industry.
Weighting the risk that the scope structure proposed by (Baron et al. 2022) currently does
not cover all still required uses of lead, versus the risk that the above UP proposal will notbring progress either, the renewal of exemption 7(c)(I) with the current wording until 21 July2026 may be acceptable and the most practicable solution. (Baron et al. 2022) recommend
this expiry date for their recommended exemptions 7(c)(V and VI). If the COM renews thecurrent exemption 7(c)(I) until 21 July 2026 – or a later date to ensure sufficient time
between the COM’s official decisio and the deadline for submission of renewal requests –applicants like UP could present their alternative approach to structure the scope. Should
this turn out to be inexpedient, the consultants reviewing the exemption next time could, forexample, still try to amend the current approach of (Baron et al. 2022) based on the insights
obtained from the stakeholder feedbacks of this review as how to better formulate suchconditions.

8.3.3.

Environmental, health, and safety impacts(Werfen 2023) had an LCA prepared which they interpret as showing that lead has lower
environmental impacts (in terms of the measures produced by LCA) in certain categories
than the two alternatives. Further details of the LCA were provided as confidential
information. The LCA can therefore not be considered in the consultants’ recommendation
for the applicant’s exemption renewal request. Recommendations as to granting – or notgranting – requested exemptions can only be based on publicly available information.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EUROMOT et al. 2023a) reference the Life Cycle Assessment (LCA) of lead-freepiezoelectrics submitted by the Umbrella Project to the last review of exemption 7(c)(I) by(Baron et al. 2022) where the lead-free alternatives assessed have a greater total negativeenvironmental impact.
(Baron et al. 2022) did not review this LCA as base for their recommendations stating theirunderstanding that the applicant’s main arguments for the renewal of exemption 7(c)(I) werebased on the scientific and technical impracticability of lead substitution or elimination.
The consultants’ mandate for this review is to assess whether the recommendations of(Baron et al. 2022) can be adopted to cat. 8 IVD, cat. 9 IMCI and cat. 11 in the light of therenewal requests at hand, not to re-evaluate the recommendations of (Baron et al. 2022).
The consultants therefore followed that same approach like (Baron et al. 2022) and focused
their review on the applicants’ arguments concerning the scientific and technicalpracticability of lead substitution or elimination.

8.3.4.

Socioeconomic impacts

If the exemption is not renewed, the consultants cannot exclude that negative socioeconomic impacts elaborated by the applicants (cf. section 8.2.3 on page 144) may actuallyarise.
(TMC 2023b) point out that it needs to be kept in mind that industrial monitoring and control
instrument manufacturers have to manage suppliers’ declarations for hundreds ofthousands of items. TMC members have difficulty in understanding how the rewording andrelisting and/or splits recommended by the consultants (Baron et al. 2022) will lead togreater protection of human health and the environment compared to the wording in its
current form. The recommended rewording/split would only lead to significant unnecessary
burden for stakeholders without commensurate benefits.
In the consultants’ view, this administrative aspect is part of the compliance obligations of
all manufacturers of all categories of EEE. Even though it should be kept in mind thatchanges of exemption wordings and exemption scopes may cause administrative burdens
for affected manufacturers, articles 4 and 5(1)(a) require priority of substitution andelimination of use of restricted substances, and well-defined exemption scopes are a precondition for this. The attempt of (Baron et al. 2022) to structure the exemption scope ismotivated by this priority. It is at the discretion of the COM to decide whether specific cases
would justify different priorities, e.g. administrative or other socio-economic impacts.

8.3.5.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria28 is fulfilled:

28 Differently from Art. 5(1)(a) in the RoHS Directive, the criteria are numbered so that they can be addressedin the below text.

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4. their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;
5. the reliability of substitutes is not ensured;
6. the total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.
EUROMOT (cat. 11), TMC (cat. 9 IMCI) and Werfen (cat. 8 IVD) applied for the renewal of
exemption III-7(c)(I) – in case of EUROMOT and Werfen with a modified wording - for the
maximum validity period claiming that substitution or elimination of lead is scientifically andtechnically not yet practicable for the applications of lead in the scope of this exemption.
These statements are in line with the conclusions of (Baron et al. 2022) so that granting therequested exemptions would be covered by Art. 5(1)(a) but the modifications of the
exemption wording for a renewed exemption 7(c)(I) as proposed by EUROMOT and Werfen
are not practicable.
As to the adoption of the exemptions 7(c)(V) and 7(c)(VI) recommended by (Baron et al.
2022), two stakeholders (SRT and Pari Pharma) request adding or changing sub-clauses
to the these renewed exemptions to ensure that they cover their specific uses of lead in thescope of the current exemption 7(c)(I). While Pari Pharma’s lead application is included into
the scope of 7(c)(VI), the use case of SRT seems to be excluded so that the respective
exemption sub-clause would have to be amended accordingly.
The Umbrella Project (UP) contributed their perspective on the approach of (Baron et al.
2022) stating that the recommended exemptions 7(c)(V) and 7(c)(VI) by far do not cover alluses of lead in the scope of the current 7(c)(I) for which substitution and elimination are
scientifically and technically not yet practicable. They provide examples to substantiate theirstatement, and the case of SRT is a further hint that not all still required lead applications
may be covered. UP point out that, in order to cover the manifold uses of lead under
exemption 7(c)(I), a long list with up to 100 sub-clauses may have to be defined for the
renewed exemptions 7(c)(V and VI).
UP also put forward that at least part of the wordings of the various sub-clauses in therecommended exemptions 7(c)(V) and 7(c)(VI) are not practicable as they refer to processparameters or specific material properties that cannot be verified from the component/EEE.
Examples for verifiable component properties are exemptions 7(c)(II and III) and 7(c)(IV)
where voltage thresholds or specific uses of a lead-containing material in a component
demarcate the exemption scope in a way that can be verified on the component.
The above stakeholder requests and information suggest that the recommended
exemptions 7(c)(V and VI) in their current wordings are neither complete nor fully applicableand implementable, and should therefore not be adopted to the requested exemption
renewals for cat. 9 IMCI and cat. 11. Even though the changes requested for cat. 8 IVD
would be covered, it can be assumed that this would not be the case for all other uses oflead in cat. 8 and in all other categories of EEE since the current exemption 7(c)(I) is of
relevance across all categories of EEE in manifold applications.
Nevertheless, the attempt of (Baron et al. 2022) should be considered as an important andvaluable incentive for industry to take initiative and use their expertise to elaborate a better
approach. The Umbrella Project declared their commitment to develop a concept for a new160

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wording would imply several classifications, if necessary, and identify alternativetechnologies to replace lead containing materials until January 2025.
Considering all information submitted by applicants and stakeholders, the consultants
recommend renewing exemption 7(c)(I) taking over the expiry date 21 July 2026 set by(Baron et al. 2022) for cat 8 IVD, cat. 9 IMCI and cat. 11, as well as for all other categories
of EEE. Applicants like the Umbrella Project can then submit their new concept, and, should
this be inexpedient, the consultants reviewing the exemption renewal requests could try
amending the current proposal of (Baron et al. 2022) based on the insights obtained fromthe information submitted to this review.

8.4.

Recommendation

The information provided suggests, in line with the conclusions of (Baron et al. 2022), thatelimination or substitution of lead in the applications in scope of the current exemption 7(c)(I)is scientifically and technically not yet fully practicable. Art. 5(1)(a) thus would justify
renewing the exemptions for cat. 8 IVD and for cat. 9 IMCI as proposed as a result of theprevious review by (Baron et al. 2022) already, as well as for cat. 11, which was not includedin that previous review but also relies on exemption 7(c)(I).
The information provided by the applicants and stakeholders also suggests, however, thatthe recommended renewal of exemption 7(c)(I) with a split and structures exemption scope
as proposed by (Baron et al. 2022) does not yet cover all uses of lead for which its
substitution or elimination are scientifically and technically are currently in and the coming
years not practicable. Furthermore, some of the proposed wordings seem not yet to be
applicable to precisely and verifiably describe the scope of the renewed exemptions.
Following up on the recommendation of (Baron et al. 2022) to structure the scope of thecurrent exemption 7(c)(I), the Umbrella Project announced to elaborate an alternative
proposal to structure the scope of exemption 7(c)(I) and committed themselves to submit
their approach to the next review of exemption 7(c)(I) in 2026.
Overall, in the light of the information made available and the above commitment of theUmbrella Project, the consultants recommend renewing exemption 7(c)(I) for cat. 8 IVD,
cat. 9 IMCI and cat. 11. (Baron et al. 2022) recommend 21 July 2026 as expiry date of therenewed exemptions for all categories of EEE. This expiry of the renewed exemption 7(c)(I)should be adopted to enable the review of the exemption for cat. 9 IMCI and cat. 11 together
with all other categories of EEE to arrive at a more application-specific scope of thisexemption for all EEE covered by the RoHS Directive.
Adding to this, both applicants highlight that they depend on their suppliers to provide themwith RoHS-compliant materials and components but do not have such suppliers in theirconsortia that requested the renewal of the exemption. A joint next review of the exemption
with other consortia representing material and component manufacturers as well istherefore considered to be a precondition to further develop the exemption from the current
purely material- to a more application-specific the announced contribution of the Umbrella
Project found to be inexpedient in the next review after 2026, the reviewers may consider
amending the approach of the Umbrella Project.

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Alternatively, as a fall-back option, the current proposal of (Baron et al. 2022) could be
amended taking into account the stakeholder inputs of this review.29.To ensure that all
applications of lead in the scope of the renewed exemption 7(c)(I) are covered, a salvatory
clause could be added that covers all uses of LHMPS that are not yet defined in the scope.
This approach would require producers to specifically declare the use of lead in the specificapplications at least. For the applications of lead under the salvatory clause, thepracticability of the approach proposed by (KEMI 2023) for exemption 7(a) could beassessed to require that the exemption is justified in the technical documentation if applied,
and to declare the specific uses of lead.
The below table shows the recommended renewed exemption.
No.

Exemption

Scope
and
applicability

III-7(c)(I)Electrical and electronic components
containing lead in a glass or ceramic otherthan dielectric ceramic in capacitors, e.g.
piezoelectronic devices, or in a glass or
ceramic matrix compound

Applies to categories 8 in vitro
diagnostic medical devices, category
9 industrial monitoring and control
instruments, and category 11.

This exemption does not include the usesof lead in the scope of the following
exemptions:-

32 and 34 of Annex III-

1(a), 4 and 39 of Annex IV

dates

of

Expires on 21 July 2026 forcategories 8 in vitro diagnostic
medical devices, category 9
industrial monitoring and control
instruments, and for category 11.

Exemptions III-32 and III_34, as well as IV-1(a), IV-4 and IV-39 should be excluded30 fromthe scope of the renewed exemption III-7(c)(I) to avoid scope overlaps.
The consultants further recommend that the COM ensures sufficient time between theofficial publication of the COM’s decision and the expiry date of the exemption to allow for
the preparation and timely submission of renewal requests 18 months prior to the expiry of
the exemption.
Applicants’ and stakeholders’ feedback on the recommendation(EUROMOT et al. 2024) support the recommended wording and recognised that the aligned
expiration dates for all categories would be beneficial from an administrative viewpoint.
EUROMOT members reiterate the need for at least 5 years to qualify alternatives.
(TMC 2024) agree with the recommended wording but contest the expiry date in the light of
the information provided in their application dossier where a 7 years renewal was requested.

29 Cf. sections “Stakeholder contribution SRT” and “Stakeholder contribution of the Umbrella Project”.
30 The COM should take into account potential changes in the exemption numbering due to pending renewalsof some of these exemptions.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(Werfen 2024) criticise the 2026 expiry date as inadequate in the light of lacking
commercially available piezo replacements.
(SRT 2024c) support the exemption wording and the 2026 expiry date for all categories of
EEE as the best way for SRT provided the possibility to start a new request.
(UP 7(c)(I) 2024b) agree to the above recommendation but criticise the early expiry datewith respect to the time remaining for submitting renewal requests.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

8.5.

References

Baron et al. (2022): Study to assess requests for a renewal of nine (-9-) exemptions 6(a), 6(a)-I,
6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I and 7 (c)-II of Annex III of Directive 2011/65/EU (Pack 22) –Final Report (Amended Version). Under the Framework Contract: Assistance to the Commission
on technical, socio-economic and cost-benefit assessments related to the implementation andfurther development of EU waste legislation. In cooperation with Yifaat Baron, Carl-Otto Gensch,Andreas Köhler, Ran Liu, Clara Löw, Katja Moch, Oeko-Institut e. V. (Pack 22). Retrieved fromhttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/RoHS_Pack22_final_report_amended_February_2022.pdf.
DEUTZ (2023): Contribution to the stakeholder consultation: Letter of support for renewal of
exemption 7(c)(I) for cat. 11. Retrieved from https://rohs.biois.eu/DEUTZ.pdf.
Directive 2002/95/EC: Directive 2002/95/EC of the European Parliament and of the Council of 27
January 2003 on the restriction of the use of certain hazardous substances in electrical andelectronic equipment. RoHS 1. Directive 2002/95/EC.
EPPA (2023): SOCIO-ECONOMIC ANALYSIS Of the impacts of non-renewal of Lead (Pb)exemption 7(c)(I) for test & measurement industrial type products (Category 9) Exemption 7(c)-I –Annex III. In cooperation with Test and Measurement Coalition (TMC). Retrieved fromhttps://rohs.biois.eu/TMC_SEA_Exemption_7(c)-I_2023_PUBLIC_VERSION.pdf.
EUROMOT et al. (2023a): Request for renewal of exemption III-7(c)(I) for cat. 11. Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form%207(c)-I-EUROMOT_Final.pdf.
EUROMOT et al. (2023b): Answers to questionnaire 1 (clarification) for exemption 7(c)(I).
Retrieved from https://rohs.biois.eu/Ex_III-7(c)(I)_EUROMOT_Questionnaire-1_Clarification.pdf.
EUROMOT et al. (2024): Feedback on recommendation exemption 7(c)(I) sent via e-mail by Emily
Tyrwhitt Jones to Dr. Otmar Deubzer.
Gensch e al. (2009): Adaptation to scientific and technical progress under Directive 2002/95/EC.
Final Report. Document „final_reportl_rohs1_en.pdf“. In cooperation with Carl-Otto Gensch,
Stéphanie Zangl, Rita Groß, Anna Weber, Öko-Institut e. V. und Otmar Deubzer, Fraunhofer IZM.
Öko-Institut e.V. and Fraunhofer IZM. Freiburg (Adaptation to Scientific and Technical Progressunder Directive 2002/95/EC; RoHS Exemption Reviews). Retrieved fromhttp://ec.europa.eu/environment/waste/weee/pdf/final_reportl_rohs1_en.pdf.

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Gensch et al. (2007): Adaptation to scientific and technical progress under Directive 2002/95/EC.
Final report. In cooperation with Carl-Otto Gensch, Stéphanie Zangl (Oeko-Institut e.V.), Otmar
Deubzer (Fraunhofer IZM). Öko-Institut e.V. (Freiburg). Freiburg (Adaptation to Scientific andTechnical Progress under Directive 2002/95/EC; RoHS Exemption Reviews). Retrieved fromhttp://ec.europa.eu/environment/waste/weee/pdf/rohs.pdf.
Gensch et al. (2016): Assistance to the Commission on Technological, Socio-Economic and Cost Benefit Assessment Related to Exemptions from the Substance Restrictions in Electrical andElectronic Equipment - Study to assess renewal requests for 29 RoHS 2 Annex III exemptions.
RoHS 14. In cooperation with Carl-Otto Gensch, Yifaat Baron, Markus Blepp, Katja Moch, Susanne
Moritz, Oeko-Institut und Dr. Deubzer, Otmar, Fraunhofer Institut Zuverlässigkeit und
Mikrointegration IZM (Adaptation to Scientific and Technical Progress of Annexes III and IV of
Directive 2011/65/EU, RoHS XIV). Retrieved from https://circabc.europa.eu/sd/a/eda9d68b-6ac94fb9-8667-5e561d8c957e/RoHS-Pack_9_Final_Full_report_Lamps_Alloys_Solders_June2016.pdf.
JCB (2023): Contribution to the stakeholder consultation: Letter of support for EUROMOT
exemption renewal request. In cooperation with JCB Power Systems Limited. Retrieved fromhttps://rohs.biois.eu/JCB_support_EUROMOT.pdf.
KEMI (2023): Contribution to the stakeholder consultation: Letter of support for new wording of
exemption 7(a). In cooperation with Swedish Chemicals Agency. Retrieved fromhttps://rohs.biois.eu/KemI.pdf.
Lohse et al. (2008): Adaptation to Scientific and Technical Progress of Annex II Directive
2000/53/EC. Final Report - Amended Final. In cooperation with Joachim Lohse, Carl-Otto Gensch,
Rita Groß, Stéphanie Zangl, [Öko-Institut e.V.] und Dr. Deubzer, Otmar [Fraunhofer IZM]. ÖkoInstitut e. V., Fraunhofer IZM. Freiburg (Adaptation to Scientific and Technical Progress of Annex II
Directive 2000/53/EC, ELV I). Retrieved from https://circabc.europa.eu/sd/a/f5d79a51-2e5a-47eb85d3-7b491ae6a4b3/Final_report_ELV_2008_Annex_II_revision.pdf.
MTE (2023): Contribution to stakeholder consultation: MedTech recommendation of the exentsiono fRoHS lead exempitns for medical technologies in the scope of cat. 8. Support ofr the exemption
renewal requests submitted by the “Umbrella Project” in 2020 for the abovementioned exemptions
including for the cat. 8 medical technology uses. In cooperation with MedTech Europe.
Pari Pharma (2023): Request for add-on to renewed exemption 7(c)(I) sent via e-mail by Martin
Gallien, PARI Pharma, to Dr. Otmar Deubzer.
SRT (2023a): E-Mail communication Dr. Stephan Prucker, SRT Resistor Technology GmbH, with
the COM.
SRT (2023b): Contribution to the stakeholder consultation (consultation questionnaire andaccessory information). Retrieved fromhttps://rohs.biois.eu/SRT_7(c)(I).pdf;https://rohs.biois.eu/SRT_hvc.pdf;https://rohs.biois.eu/SRT_hv
c_Japan_FineChem.pdf.
SRT (2024a): Answers to questionnaire 1, sent via e-mail by Dr. Stephan Prucker, SRT Resistor
Technology GmbH, to Dr. Otmar Deubzer.
SRT (2024b): Feedback on recommendation for exemption 7(c)(I), sent via e-mail by Dr. Stephan
Prucker, SRT Resistor Technology GmbH, to Dr. Otmar Deubzer.
TMC (2023a): Request for renewal of exemption III-7(c)(I) for cat. 9 IMCI. In cooperation with Test
and Measurement Coalition (TMC). Retrieved fromhttps://rohs.biois.eu/RoHS_Application_Form_7(c)-I_TMC.pdf.

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TMC (2023b): Answers to questionnaire 1 (clarification) for exemption 7(c)(I). In cooperation with
Test and Measurement Coalition (TMC). Retrieved from https://rohs.biois.eu/Ex_III7(c)(I)_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024): Feedback on recommendation for exemption 7(c)(I) sent via e-mail by Tobias
Steinbrecher, EPPA, to Dr. Otmar Deubzer.
UP 7(c) (I) (2023): Consultation questionnaire exemption 7(c)(I). Answers of the Umbrella ProjectWorking Group 7(c)(I) to the consultation questionnaire. In cooperation with Members of Umbrella
Project Technical Working Group 7(c) (I). Retrieved fromhttps://rohs.biois.eu/Umbrella_Project_TWG_7(c)-I.pdf.
UP 7(c) (I) (2024a): Answers to questionnaire 1 of exemption 7(c)(I) sent via e-mail by Walter Huck
to Dr. Otmar Deubzer. In cooperation with Members of Umbrella Project Technical Working Group7(c) (I).
UP 7(c) (I) (2024b): Addendum to questionnaire 1 for exemption 7(c)(I) sent via e-mail by Walter
Huck to Dr. Otmar Deubzer. In cooperation with Members of Umbrella Project Technical Working
Group 7(c) (I).
UP 7(c) (I) (2024c): Feedback on recommendation for exemption 7(c)(I) sent via e-mail by Walter
Huck, SQE Consult, to Dr. Otmar Deubzer. In cooperation with Members of Umbrella ProjectTechnical Working Group 7(c) (I).
Volvo Penta (2023): Contribution to the stakeholder consultation: Letter of support for EUROMOT
exemption renewal request. Retrieved from https://rohs.biois.eu/Volvo_Penta.pdf.
Werfen (2022): Original request for renewal of exemption III-7(c)(I) for cat. 8 IVD. Amendment ofrequest submitted on 15 September 2023.
Werfen (2023): Request for renewal of exemption III-7(c)(I) for cat. 8 IVD (amended). Amendmentof original request submitted on 20 January 2023. Retrieved fromhttps://rohs.biois.eu/Instrumentation_Laboratory_RoHSFormV_NON_confidential_20220120_Mars_GEM5000_update20230915.pdf.
Werfen (2024): Feedback on recommendation for exemption III-7(c)(I) sent via e-mail by Torben
Norlem, Intertek, to Dr. Otmar Deubzer.

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Exemption 8(b)-series of Annex III: Cadmium inelectrical contacts
The below Table 9-1 shows the wording, scope and expiry dates of the exemption.
Table 9-1: Current wording of the exemption 8(b)-series
No.

Current exemption wording

Current scope and dates ofapplicability

III8(b)Cadmium and its compounds in electricalcontacts

Applies to categories 8, 9 and 11.

III8(b)(I)

Cadmium and its compounds in electricalcontacts used in:-circuit breakers,-

thermal sensing controls,-

thermal motor protectors (excluding
hermetic thermal motor protectors)-

AC switches rated at:-

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

12 A and more at 125 V AC and more-

DC switches rated at 20 A and more at 18
V DC and more, and-switches for use at voltage supply
frequency ≥ 200 Hz

Expires on-

21 July 2021 for categories 8 otherthan in vitro diagnostic medical
devices and for cat. 9 other thanindustrial monitoring and control
instruments;-

21 July 2023 for category 8 in vitro
diagnostic medical devices;-

21 July 2024 for category 9
industrial monitoring and control
instruments, and for category 11.

Applies to categories 1 to 7 and 10.
Expires on 21 July 2021 for categories
1 to 7 and 10.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

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Acronyms and Definitions
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments

Cadmium-free

Not containing cadmium in the applications covered by the scope of the
exemption to be reviewed

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive

TMC

Test & Measurement Coalition

9.1.

Background and technical information

On 20 January 2023, (TMC 2023a) requested the renewal of exemption III-8(b) for cat. 9
industrial monitoring and control instruments (IMCI) for the maximum validity period of 7
years as displayed in the below table.
Table 9-2: Wording and scope of the requested exemption
No.

Requested exemption

Requested scope and dates
of applicability

III8(b)Cadmium and its compounds in electrical contacts

Applies to category 9 industrial
monitoring
andcontrol
instruments.
Expires on 21 July 2031 (2024 + 7)
for cat. 9 industrial monitoring andcontrol instruments.

9.1.1.

History of the exemption

The use of cadmium in electrical contacts was already exempted under exemption no. 8 in
the Annex of Directive 2002/95/EC (RoHS 1) when RoHS 1 entered into force in 2003:

8. Cadmium plating except for applications banned under Directive
91/338/EEC amending Directive 76/769/EEC relating to restrictions on themarketing and use of certain dangerous substances and preparations.
With the Commission Decision 2005/747/EC in October 2005, the exemption wording waschanged to:167

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8. Cadmium and its compounds in electrical contacts and cadmium plating
except for applications banned under Directive 91/338/EEC amending
Directive 76/769/EEC relating to restrictions on the marketing and use ofcertain dangerous substances and preparations.
The exemption was first reviewed by (Gensch et al. 2006), later again by (Gensch et al. 2009)
and thus gradually transferred into the below status with a split into exemption 8a and 8b:8(a) Cadmium and its compounds in one shot pellet type thermal cut-offs
Expires on 1 January 2012 and after that date may be used in spare parts for
EEE placed on the market before 1 January 20128(b) Cadmium and its compounds in electrical contacts”(Gensch et al. 2009) recommended the expiry date 31 July 2014 for exemption 8(b), which
was the maximum duration (i.e., 4 years) under RoHS Directive 2002/95/EC (RoHS 1).
Cadmium-free contact materials were available for applications under exemption 8(b), but
industry required time to adapt and test their use to their applications to make sure thecadmium-free contacts suffice in terms of safety and other requirements. The COM adopted
the exemption with a validity period of four years.
The exemptions in the Annex of RoHS 1 including exemptions 8(a) and 8(b) weretransferred into the recast RoHS Directive 2011/65/EU (RoHS 2). During that process, theexpiry dates of all exemptions with maximum validity of four years were systematicallyextended to five years starting from July 2011 on. This gave industry a total of seven years
since 2009 to substitute or eliminate cadmium in contacts.
(Sensata et al. 2015 )nevertheless requested the renewal of exemption 8(b) for another five
years in 2015. The review by (Gensch et al. 2016) resulted in the split into two exemptions
8(b) and 8(b)(I) with the current wordings and scopes. (Sensata et al. 2020) submitted
another request on 16 January 2020 for another renewal of the exemption so that the two
exemptions had become due for review again. (Deubzer et al. 2022) recommended torenew exemption 8(b) as exemption 8(b)(II) for cat. 8 and for cat. 9. IMCI:
Table 9-3: Potential renewal of exemption III-8(b) as exemption III-8(b)(II)No.

Exemption

Scope and dates of applicability

8(b)Cadmium and its compounds in electricalcontacts

Applies to categories 8, 9 and 11
Expires on-[date of official publication of the
COM decision in the Official Journal+ 12 months] for cat. 11-[date of official publication of the
COM decision in the Official Journal+ 18 months] for category 8 medical
devices including in-vitro diagnostic
medical devices, and category 9
monitoring and control instruments
including industrial monitoring andcontrol instruments

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8(b)(II)

Cadmium and its compounds in electricalcontacts used in:-circuit breakers-

thermal sensing controls-

thermal motor protectors (excluding
hermetic thermal motor protectors)-

AC switches-

DC switches

Applies to categories 8 and 9 from [dateof the official publication of the COM
decision in the Official Journal + 18
months + 1 day] on.
Expires on-

31 December 2023 for circuit
breakers in rotating parts ofcomputer tomography (CT) medical
devices (category 8 medical devices
other than in-vitro diagnostic
medical devices)-

31 December 2025 for portable
emergency defibrillators (cat. 8
medical devices other than in-vitro
diagnostic medical devices) with a
Declaration of Conformity (DOC)
issued for the first time before 1
January 2015-31 December 2025 for other cat. 8
medical devices including in-vitro
diagnostic medical devices, and for
category 9 monitoring and control
instruments including industrial
monitoring
andcontrol
instruments.

Source: (Deubzer et al. 2022)

9.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status March 2024). The applicant therefore
applied for the renewal of the current exemption 8(b) for cat. 9 IMCI since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE. The exemption thus becamedue for review even though the recommendation for the renewal of exemption 8(b) and8(b)(I) of (Deubzer et al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Deubzer
et al. 2022) can be adopted to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Deubzer et al. 2022) is not intended. The consultants will rely on thecritical review conducted by the previous consultants and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

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9.1.3.

Summary of the renewal request(TMC 2023a) summarise their renewal request explaining that under Exemption 8(b)cadmium and its compounds, such as silver cadmium oxide (AgCdO), are used for electricalisolation purposes in electrical contacts. The need for creating an open contact (vs solidstate switching) is typical for electrical isolation purposes, where the safety standards
require a minimum electrical clearance between contacts if it is being relied upon for safety
isolation. A common example includes supplemental circuit breakers on equipment for
configuration or servicing, where relying on the power cord as the disconnect device is notpractical.31
The function of Cd and AgCdO as well as the chemical and physical advantageous
properties of Cd/AgCdO in the components used for cat. 9 IMCI include:•

Resistance to arcing•

Resistance to corrosion / pitting / material transfer•

Resistance to oxidation in order to keep the electrical contacts clean and free of
insulating oxides. This enhances the life-span of connectors, especially those thatare high frequency.

•

Resistance against contact welding•

High electrical conductivity•

High thermal conductivity, which helps the effective dissipation of heat•High melting point, which is required to avoid accidental overheating as aconsequence of the fusion of contact points.

Since the RoHS directive was adopted, electric contact and switch manufacturers haveresearched potential alternative materials. The substitution or elimination of cadmium andits compounds is, in principle, scientifically and technically practicable for some applications.
Each substitute that has been evaluated had differing properties and therefore, to the best
knowledge of the Test & Measurement Coalition, no single “drop-in” replacement exists for
cadmium and its compounds for all applications.
Pursuant to Article 5 of the RoHS Directive a continuation of exemption 8(b) should thus be
granted on the basis that alternatives are not suitable for substitution or replacement
for all applications. These applications include circuit breakers, thermal sensing controls,
and high power / high frequency switches. This echoes the stance of the Oeko-Institut
Report published in 2016.
A thorough Socio-Economic Analysis was conducted in addition to the technicalassessment and attached to this submission, further illustrating the negative socioeconomic impacts a non-renewal of exemption 8(b) would have. Overall, the analysis
concludes that the total impact of a non-renewal of this exemption is monetized in therange of 1.6 billion EUR and 2.3 billion EUR (conservative lower bound estimate).

31 See EN 61010-1:2017 clause 6.11 for disconnect requirements for Category 9, industrial equipment.

Additionally, the circuit breaker itself needs to comply with IEC 60947-2; source as referenced by TMC
2023a.

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9.1.4.

Technical description of the exemption and use of the restricted
substance(TMC 2023a) describe the advantages of Cd and AgCdO which have been used in electricalcontacts due to its below properties:•

Resistance to arcing•

Resistance to corrosion / pitting / material transfer•

Resistance to oxidation in order to keep the electrical contacts clean and free of
insulating oxides. This enhances the life-span of connectors, especially those thatare high frequency.

•

Resistance against contact welding•

High electrical conductivity•

High thermal conductivity, which helps the effective dissipation of heat•High melting point, which is required to avoid accidental overheating as aconsequence of the fusion of contact points.

The technical background of cadmium uses and requirements for electrical contacts was
described in more details in the review reports of (Gensch et al. 2016) and (Gensch et al.
2009), and in Deubzer et al. (2022).
(TMC 2023b) claim that currently available alternatives are not suitable for substitution or
replacement in T&M instruments’ critical components and their applications.

9.1.5.

Amount(s) of restricted substance(s) used under the exemption(TMC 2023a; EPPA 2023) estimate between 5 kg and 6 kg of Cd to be placed on the EU
market contained in applications in the scope of the requested exemption, based on thereplies provided by the TMC members.
Since not all producers of cat. 9 IMCI are members of TMC, the actual amount of cadmium
could be higher.

9.2.
9.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substance(TMC 2023a) claim that currently available alternatives are not suitable for substitution or
replacement in cat. 9 IMCI critical components and their applications. These applications
include circuit breakers, thermal sensing controls, and high power / high frequency
switches. Cd and AgCdO exhibit certain unique physical and technical characteristics. The
advantageous properties of AgCdO especially in relation to the impact of repeated arcs fromhigh current DC loads is further outlined in a dissertation by Frederic Pons from the Georgia

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Institute of Technology.32 The study investigates said impacts switched from a resistive load
for a uniform and repeatable arc format and analysed the results on the contact faces usinga scanning electron microscope to compare the response of AgCdO coated contact to arcs
to AgSnO2. When the arc occurs, it causes the silver to melt but due to the close melting
point temperature of the silver and CdO, there are CdO clusters finely distributed in thelayer. This effectively restores the contact material skin reducing the impact of repeatedarcs and yielding a consistent contact resistance. The AgSnO2 did not yield as good a result
as predicted by the dissimilar decomposition temperature of the alternate oxide to silver.
(TMC 2023a) put forward scientific research, as well as testing by several manufacturers,
that has shown that alternative substances are more prone to electrical arc erosion and tackwelding.33 This will result in more product failures that are anticipated to impact productsafety. Each substitute that has been evaluated had differing properties and therefore no
single “drop-in” replacement exists for all applications that rely on cadmium and its
compounds.
Therefore, (TMC 2023a) argue, based on the current state of the art, AgCdO still represents
a stable solution to the repeated arc model which is inherent to an inductive switching loador other high voltage switching that currently continues to require the 8(b) and 8(b)-I
exemption. The alternatives, thus far, will yield a poorer contact surface which will ultimately
lead to premature component failure and potential unreliable results leading up to totalcomponent failure. (EPPA 2023) claim that there are currently no suitable cadmium-freealternatives that meet RoHS exemption criteria on the EU market for cat. 9 IMCI and thatthe re-designing of the cat. 9 IMCI could take four to six years per product line. Hence,losing the ability to apply Annex III, exemption 8(b) when considering RoHS conformity forthe associated test and measurement industrial products would entail the development ofa fairly large number of new alternative compliant materials as well as the increased costs
connected to the redesign, retesting, requalification and replacement of the assembly
process.
(TMC 2023a) are of the opinion that the renewal of exemption 8(b) should be granted on
the basis that currently available alternatives are not suitable for substitution or replacementin cat. 9 IMCI critical components and their applications like circuit breakers, thermal
sensing controls, and high power / high frequency switches. More time is required to adapt
designs, find contact materials, and for qualifying cadmium-free solutions in the supply
chain and in the products of EEE manufacturers. This is required since the cadmium-freecontact materials are not “drop-in” replacements. This echoes the stance of the OekoInstitut Report of (Gensch et al. 2016) published in 2016. No further technologicaldevelopments have, to the best knowledge of the participating companies, occurred sincethen. Thus, the unavailability of alternatives for all applications that use cadmium-based
electrical contacts warrants the renewal of this exemption. More time is required to adapt

32 F.Pons, “Electrical contact material arc erosion: experiments and modelling towards the design of an

AgCdO substitute”, PhD Thesis, May 210, Georgia Institute of Technology,
https://smartech.gatech.edu/bitstream/handle/1853/33816/pons_frederic_201005_phd.pdf; source asreferenced by TMC 2023a.
33 Building a Better Cadmium Replacement. Available at: https://connectorsupplier.com/a-mil-plating-cadmium-061912/; source as referenced by TMC 2023a.

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designs, find contact materials, and for qualifying cadmium-free solutions in the supply
chain and in the products of EEE manufacturers.

9.2.2. Environmental, health, safety and socioeconomic impacts(EPPA 2023) prepared a socio-economic analyses (SEA) for TMC showing the impacts
which a non-renewal of the exemption for cat. 9 IMCI would cause. (EPPA 2023) declarethat the SEA was prepared in line with the official ECHA guidance on the preparation of theSocio-Economic Analysis. The SEA is based on information and data gathered from theindustrial and professional test and measurement equipment manufacturers. A survey has
been conducted by providing a detailed questionnaire to gather information and data fromactors likely to be affected by a non-renewal of the RoHS exemption in the EU. TMC
member manufacturers of cat. 9 IMCI participated in the survey. The market share coveredby this survey represents approximately 70 % of the EEA market so that (EPPA 2023)
consider the survey as highly representative so that it can serve as a basis for defining the
anticipated socio-economic impacts resulting from the non-renewal of the RoHS exemption.
(EPPA 2023) inform that participating TMC member companies report no releases to theenvironment of cadmium can be anticipated during neither equipment production nor use
phases of the concerned products over the next seven years as a consequence of therevocation of the RoHS exemption. During equipment production, the cadmium is not
exposed because it is internal to the component. At component manufacturers level,
exposure and waste and exposure to cadmium is considered controlled through good
occupational health and safety management practices.
Under normal conditions of equipment use, the cadmium content associated with theapplication of the exemption is encapsulated within the equipment enclosure and will neither
be touched nor released to the environment. As this equipment is sold B2B for
professional/industrial use only, equipment that finally reaches end-of-life will beappropriately processed by professional recyclers who are obligated to have suitable
controls to avoid any environmental releases and are notified of the presence of thesubstance under the producers’ obligation to provide a SCIP notification.
The TMC member companies have only indicated a minor risk for substances to be released
to the environment during the manufacture of the components. These are not produced by
TMC members. Thus, data are not available, however the estimate is expected to bebounded by the total use of the substance (i.e., release to the environment is expected tobe less than the mass of substance incorporated into the components).
(EPPA 2023) are of the opinion that due to the participating TMC member companies’
relatively low consumption of parts, in comparison to the product Categories 1-7 and 10,
renewing this exemption for Category 9 will have a minimal impact on the environment.
Category 9 Industrial producers are only responsible for 0.2 % of annual WEEE production.
cat. 9 IMCI contribute to the Waste Electrical and Electronic Equipment stream only around
0.2 % by weight of EU WEEE, with industrial WEEE being collected through B2B systems.
Consequently, the environmental impact of cat. 9 IMCI is negligible.
(EPPA 2023) expect “[ ] no, or at least minimal, expected additional waste before the endof the regular lifetime (non-compliant stock) reported by the companies. Finished goods
inventory is typically minimal as T&M equipment manufacturers’ production is based on
short-term demand, or even per order. Any non-compliant materials will be consumed

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through sale into markets where there isn’t a similar restriction“. TMC member
manufacturers of cat. 9 IMCI emphasise, however, that the exemption is utilized in part toimprove reliability and longevity of components. A reduced product lifetime would be
expected leading to an increase in electronic waste and virgin material use in thereplacement in apparent conflict to the concepts proposed under the proposed Eco-design
for Sustainable Product Regulation. Moreover, in the case of a discontinuation of exemption
15 for category 9 products, factories using products with older designs may need to re-tool
their test process, adding to electronic waste from the replaced equipment.
The majority of the components that utilize this exemption, that constitute Category 9
industrial usage, are common to all product categories. The component manufacturers
therefore rely on volume use of the other categories to justify their continued production.
Renewing this exemption only for Category 9 for the full 7 years will not extend the
production life of these higher volume components beyond the exemption renewal period
assigned to Categories 1-7 and 10. It will, however, enable the Test & Measurement
coalition members to buy sufficient (relatively small) quantities to update the design andcontinue to use the relevant components for an extended period. As a result, a renewal ofthis exemption will a minimal environmental impact and has a positive socio-economic
impact by enabling the continued production of Category 9 products critical to the healthand welfare of the EU (and global) society whilst the multi-year redesign process is
executed.
Overall, (EPPA 2023) monetise the total impact of a non-renewal of this exemption in therange of 1.6 billion EUR and 2.3 billion EUR (conservative estimates in net losses; potential
gains for suppliers of other components have been already taken into account. (EPPA 2023)
calculated the total socioeconomic impacts by summarising business impacts on
manufacturers, impacts on the wider economy and social impacts caused byunemployment.
Further details are available in the report prepared by (EPPA 2023).

9.2.3.

Roadmap towards substitution or elimination of the restricted
substance

As to actions taken in the past to achieve RoHS compliance, (TMC 2023a) repeat theirstatements with which they justify their request in section 9.2.1 on page 171. They do notprovide any information concerning such activities in the past.
As to future efforts, (TMC 2023a) add that each substitute that has been evaluated had
differing properties and therefore, to the best knowledge of TMC, no single “drop-in”
replacement exists for cadmium and its compounds for all applications. The renewal of
exemption 8(b) should thus be granted on the basis that alternatives are not suitable for
substitution or replacement for all applications. These applications include circuit breakers,
thermal sensing controls, and high power / high frequency switches. This echoes the stanceof the review of the exemption 8(b) series by (Gensch et al. 2016).
According to (TMC 2023a), this lack of a “drop-in” alternative enhances the difficulty of
replacing or substituting cadmium in several applications especially (i.e., circuit breakers,
thermal sensing controls, and high power / high frequency switches).
Members of the Test & Measurement Coalition have pointed out that they principally relyon their suppliers to find alternatives since most of the exemptions used in their products

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are not produced by the suppliers but bought off-the-shelf from their suppliers (and so forth,potentially many levels down). Therefore, meeting with suppliers to understand their(potential) alternatives, getting samples, measuring, and testing are part of the typical
process to evaluate the suitability of potential alternatives. The process would then befollowed by the validation of the potential suitable alternatives.
The companies reported that the validation period alone would take a minimum of 6 months
and up to a year after the delivery of suitable alternatives per product. It is significant to notethat this validation period would only apply if the component were a fit, form, and function
drop-in replacement. If any design changes to the exemption-free part of the product would
be required to accommodate for the alternative, an additional validation period would be
required for each redesigned product that used to utilize the component that relied on the
exemption. Moreover, the validation would lead to the organizations incurring additional
expenses. These include labour costs and costs arising from potential product resubmission
requirements for testing to various notified bodies to ensure that substitution does not create
any electrical and functional safety concerns.
If a new cadmium free part is available, this part must be qualified for use by performing avariety of tasks, as described above. Due to the complexity and diversity of the applications,this must be done individually by each company for each product group. This process would
divert resources from other projects and increase the cost to ensure continued availabilityof these products. This validation and testing process varies according to part complexity;
which can be categorised as low, medium, and high:•Low complexity parts are the off-the-shelf components or hardware parts that do
not have a substantial performance impact. Replacement can be done based on
supplier information, assuming a form/fit/function compliance, with standard
manufacturing, testing, and validation processes. Based on process timescales
reported by a T&M coalition company, the average time that it can take for theseparts to be replaced ranges from 3 to 6 months.

•

Medium complexity parts are more complex sub-assembly electronic parts, suchas small motors which need additional validation for their performance. These parts
are often commercial assemblies that are generally available to the electronic
industry, and are utilised by the Test & Measurement coalition companies.
Replacement of these assemblies, like-for-like, requires testing and validation prior
to being integrated into the manufacturing process. The average time to find analternative for medium complexity parts for production is reported to range from 6 to
12 months.

•

High complexity parts are complex sub-assembly parts and have a significant
impact on the performance of the companies’ products. These also have a criticalrole in the overall safety of the products. These parts need to go through extensive
validation for performance and/or compliances, according to varying regulations,
before the appropriate files can be updated and the proper competent authorities orregulatory bodies can be notified prior to the purchase of parts for validation. The
average time that it would take to find an alternative for high complexity parts for
production is up to 1 year of additional testing. Where the exemption directly impacts
the performance of that component (e.g., a centrifuge rotor) the evaluation of thereplacement could take 3 to 5 years.

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9.3.
9.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several restrictions of cadmium and its compounds are listed on Annex XVII (cf. section 4.1
on page 48). None of those, however, is applicable to the use of cadmium in therecommended exemption 8(b)(II) for cat. 9 IMCI.
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

9.3.2.

Substitution and elimination of the restricted substance(TMC 2023a) highlight the advantages of Cd in contacts and point out the concerns against
its substitution that have been raised – and acknowledged as justification for the renewal of
the respective exemptions - against the substitution of Cd in electrical contacts in the past
decade of exemption reviews prior to 2021. TMC sources, however, are from 2010 and2012 respectively (cf. section 9.2.1 on page 171). These referenced sources describe thechallenges that or had to be overcome for the reliable substitution or elimination of cadmiumin electrical contacts but they do not reflect the current scientific and technical practicabilityof substitution or elimination of cadmium.
Furthermore, (TMC 2023a) identified in their renewal request the technical status assessedby (Gensch et al. 2016) as the point in time where “No further technological developments
have, to the best knowledge of the participating companies, occurred since then.”This statement suggests that TMC members do not follow the technical developments on
the market and that they are thus not aware of the technical status of cadmium replacement. The statement is factually incorrect. Deubzer et al. (2022) assessed in
2021/2022 that exemptions 8(b) and 8(b)(I) can expire latest on 31 December 2025,
including cat. 8 and cat. 9 IMCI. Differently from TMC, the consultants at that time concludedin agreement with the applicants – representatives of the Umbrella Project - that substitution
or elimination of cadmium is scientifically and technically practicable for all applications inthe scope of exemptions 8(b) and 8(b)(I). This statement included EEE of cat. 8 and cat. 9
IMCI for which the renewal had been requested as well at that time. Sensata and Marquardt,
the members of the Umbrella Project who managed the renewal request, announced thatthe conversion to cadmium-free contacts will have been achieved by 31 December 2025
latest in cooperation with their customers. (Sensata et al. 2022) stated in (Deubzer et al.

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2022) that “[…] all thermal controls, motor protectors and circuit breakers with Cadmium
free electrical contacts can be completely approved internally, by agencies and customers
during the fourth quarter of 2022. Additional time till the end of 2023 is needed to cover any
unforeseen issues and for cleaning the supply pipeline.” For the switches, (Sensata et al.
2022) announced that the exemption clause for switches used at voltage supply frequency≥ 200 Hz is no longer required so that its renewal has become obsolete. Marquardt – aproducer of switches - will have substituted cadmium in all electrical contacts until end of2025.
TMC’s claim is thus incorrect that cadmium-free alternatives are not available and/or notsuitable for cat. 9 IMCI, and that this applies in particular to circuit breakers, thermal sensing
controls, and high power / high frequency switches.
(TMC 2023b) also put forward that more time is required to adapt designs, find contact
materials, and for qualifying cadmium-free solutions in the supply chain and in the productsof EEE manufacturers. This is required since the cadmium-free contact materials are not“drop-in” replacements. If producers of protective and other switches stop the production of
cadmium-containing electrical contacts, (TMC 2023b) want to perform life (last) time buys
of components to complete projected production and support needs to avoid re-design andrequalification for equipment. Furthermore, in highly specialized applications where
cadmium contacts cannot be substituted, niche manufacturers can provide the requiredparts where the criticality of the part can bear the cost of such a premium part. This
represents a small fraction of the already limited amount of CdO used for cat 9 IMCI (< 600 g
year), but will enable the continued manufacturing of highly specialized equipment (likeElectron Microscopes).
The principal fact that cadmium-free solutions are not drop-in replacement actually was thecore reason why the exemption 8(b) series was renewed several time in the past years, andit can be followed that this requires redesigns of EEE and requalification and possiblyrecertification of devices using such contacts. (Deubzer et al. 2022) understood during thereview of exemption 8(b) and 8(b)(I) at that time that cadmium-free electrical contacts areapproved internally, by agencies and customers, i.e. producers like Marquardt and Sensata
developed their cadmium-free products in cooperation with their customers to ensure thereliability of the substitutes. This means that this time for the application-specific adaptationand qualification of the cadmium-free contacts is already included in the timeline ending on
31 December 2025. It should also be noted that producers of cat. 9 IMCI were members of
the consortium (Umbrella Project) that had submitted the renewal request for the exemption
8(b) series which was reviewed by (Deubzer et al. 2022). Further, TMC’s claim to be allowed
last-time buys to avoid redesign and requalification of equipment is not in line with Art.
5(1)(b) which expects producers to undertake efforts including the redesign of EEE toachieve RoHS compliance.
TMC contributed to the stakeholder consultation of the 2021/2022 review by (Deubzer et al.
2022) expressing their disagreement that cat. 9 IMCI, even though expiring in 2024 only,
was nevertheless included into the review of the 8(b) series exemptions upon the requestof other applicants, including the Umbrella Project whose members include producers ofcat. 9 IMCI as well. The COM rejected TMC’s objections stating that exemption requests
will be processed as requested, i.e. including cat. 9 IMCI (cf. (Deubzer et al. 2022).
In the light of the information provided by the applicant, the consultants do not see reasons
why the recommendation of (Deubzer et al. 2022) for category 9 IMCI should not be
maintained. TMC appear to be unaware of the current status and practicability of cadmium

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substitution in electrical contacts, and they neither present any specific past nor future
efforts to achieve RoHS compliance without exemptions 8(b) or 8(b)(I). Other manufacturersof cat. 9 IMCI seem to be able to comply with the timeline of the proposed renewed
exemptions displayed in Table 9-3 on page 168. Furthermore, the applicant missed theopportunity to bring in the views of their members during the stakeholder consultation of theprevious review by (Deubzer et al. 2022).
(TMC 2023a) request the renewal of exemption 8(b) with a broad, unspecific scope which(Deubzer et al. 2022) propose to renew for cat. 9 IMCI as exemption 8(b)(II) with anapplication-oriented scope. TMC was therefore asked to provide examples of applications
which the scope of the recommended renewed exemption 8(b)(II) would not cover.
(EPPA 2023) highlight that the need for creating an open contact (vs solid state switching)is typically for electrical isolation purposes, where the safety standards require a minimum
electrical clearance between contacts if it is being relied upon for safety isolation. Cadmiumfree solutions available do not cover all the electrical contacts that cat 9 utilizes to isolate
circuits from high voltage circuits, inductive load switching and control relays. We therefore
recommend that the original verbiage of electrical contacts remain in place for this renewal.
The applicant thus wishes exemption 8(b) to be maintained for cat. 9 IMCI, without,
however, providing any specific reasoning, for example as to which electrical contacts would
not be covered by the narrower exemption 8(b)(II). The consultants rate the above
explanation as technically insufficient as argument for not adopting the recommendation of(Deubzer et al. 2022) to include cat. 9 IMCI into the scope of the renewed exemption 8(b)(II).

9.3.3.

Environmental, health, safety and socioeconomic impacts

TMC state that cat. 9 IMCI contribute to the Waste Electrical and Electronic Equipment(WEEE) stream only around 0.2 % by weight of EU WEEE so that the environmental impact
of cat. 9 IMCI is negligible. They also state that there is no exposure of humans and theenvironment to cadmium contained in electrical contacts during manufacturing and use ofcat. 9 IMCI.
The current RoHS Directive does not define any thresholds for use of restricted substancesor contributions to the overall waste generation for which Art. 5(1)(a) would justify granting
an exemption if these thresholds are not exceeded. Exemptions are to be granted in linewith Art. 5(1)(a) if – next to “REACH-compliance” - any of its three sub-clauses (cf. section
9.3.4 on page 179) is fulfilled. TMC address environmental, health and safety impacts but
do not claim that the third sub-clause of Art. 5(1)(a) would be applicable, which would
require a more detailed and life-cycle-oriented assessment.
(EPPA 2023) claim that there are currently no suitable cadmium-free alternatives that meet
RoHS exemption criteria on the EU market for cat. 9 IMCI and that the re-designing of thecat. 9 IMCI could take four to six years per product line. Hence, losing the ability to apply
Annex III, exemption 8(b) when considering RoHS conformity for the associated test andmeasurement industrial products would entail the development of a fairly large number of
new alternative compliant materials as well as the increased costs connected to theredesign, retesting, requalification and replacement of the assembly process.
Timely start of compliance efforts are part of producers’ compliance obligations. The above
situation applies to all producers of EEE which is in the scope of the RoHS Directive.
Exemptions cannot be granted to avoid such compliance efforts.

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EPPA monetise the total impact of a non-renewal of this exemption in the range of 1.6 billion
EUR and 2.3 billion EUR, which they summarise from business impacts on cat. 9 IMCI
manufacturers, impacts on the wider economy and socioeconomic impacts cause by
unemployment. The individual contributions of each of these types of impacts are marked
as confidential and are not publicly available. Even though not explicitly stated, the data for
the SEA seem to have been collected from TMC member companies which, according to(EPPA 2023), cover 70 % of the EEA market. In this context, it needs to be kept in mind
that the other 30 % of cat. 9 IMCI producers serving the EEA market, from which at least
some were involved in the previous review of the exemption 8(b) series, did not object the
expiry of the exemption like recommended by (Deubzer et al. 2022).
The consultants base their recommendation on the result of the technical assessment in
the light of the three sub-clauses of Art. 5(1)(a). If the exemption will not be granted on thisground, the consultants cannot exclude that adverse impacts described by TMC/EPPA (cf.
section 9.2.2 on page 173) arise. The consultants consider beyond their mandate any
judgement as to which degree of socioeconomic impact would justify granting an exemption
on socioeconomic grounds in the case that none of the three sub-clauses of Art. 5(1)(a) isfulfilled. 34

9.3.4.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria35 is fulfilled:
1. their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;
2. the reliability of substitutes is not ensured;
3. the total negative environmental, health and consumer safety impacts
caused by substitution are likely to outweigh the total environmental, health andconsumer safety benefits thereof.
TMC request the renewal of exemption 8(b) for 7 years claiming that cadmium-freesubstitutes are not available for cat. 9 IMCI, not suitable for cat. 9 IMCI, or do not cover all
applications of cadmium in contacts of cat. 9 IMCI.
The applicant’s justification for the renewal of the exemption is based on the scientific andtechnological status reflected in the review report of (Gensch et al. 2016) which was updatedby (Deubzer et al. 2022) during the previous review of the exemption 8(b) series. They
recommended that exemption 8(b) should be renewed for cat. 9 IMCI as exemption 8(b)(II)34 Art. 5(1)(a) stipulates that any of the three sub-class must be fulfilled, and that decisions on the inclusion ofmaterials and components of EEE in the lists in Annexes III and IV shall take into account thesocioeconomic impact of substitution.

35 Differently from Art. 5(1)(a) in the RoHS Directive, the criteria are numbered so that they can be addressedin the below text.

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which can expire on 31 December 2025 as by then substitution of cadmium is scientificallyand technically practicable. The expiry date was understood as including time to ensure thereliability of substitutes.
The information provided by the applicant is outdated, general, and not consistent. The
actual reason for the renewal request implied in some of TMC’s arguments seems to bethat TMC members want to avoid redesign of their products, or 7 more years of time to do
this redesign. This raises the question why other producers of cat. 9 IMCI, e.g. those that
contributed to the previous review by (Deubzer et al. 2022) seem to be able to comply withthe 2025 expiry. Further, TMC missed the opportunity to contribute to the stakeholder
contribution at that time. It should also be taken into account that not all producers of cat. 9
IMCI are members of TMC, and none of these supported TMC’s renewal request. (Deubzer
et al. 2022) state that “The 2025 expiry date for other cat. 8 EEE and cat. 9 EEE also reflects
the time from which on the reliability of cadmium-free switches can be ensured.”
The applicant raised objections against the approach in this current review of exemption
8(b) to adopt the recommendation of (Deubzer et al. 2022), i.e. the renewal of exemption
8(b) as 8(b)(II) for cat. 9 IMCI. The consultants rate these objections as technicallyunspecific and thus insufficient.
Overall, the consultants conclude that substitution of cadmium in electrical contacts has
become scientifically and technically practicable, and that the reliability of substitutes canbe ensured also for cat. 9 IMCI, until 31 December 2025, cf. Table 9-3 on page 168. Taking
account of remaining uncertainties concerning the exemption expiry in 2025, (Deubzer et
al. 2022) state: “Should cases arise where the reliability proves to still be compromised in
specific application cases, the 2025 expiry date would still allow timely renewal requests.”
Such applications would have had to be submitted 18 months prior to the recommended
exemption expiry on 30 June 2022 and 30 June 2024 latest. The consultants recommendthat the COM sets an expiry date beyond 31 December 2025 that allows sufficient time after
the official publication of the COM’s decision for preparing and submitting such specificrenewal requests.

9.4.

Recommendation

The consultants recommend adopting the recommendation of (Deubzer et al. 2022) for cat.
9 IMCI including the proposed expiry date for cat. 9 IMCI as shown in the below table.
Substitution of cadmium is scientifically and technically practicable, and the reliability of
substitutes can be ensured by timely redesigns of EEE including cat. 9 IMCI.
The applicant’s justification for the requested 7 year renewal of exemption 8(b) is based on
the scientific and technical status of cadmium substitution assessed by (Gensch et al. 2016)
and thus outdated, and the applicant’s justification for the exemption renewal is unspecificand not consistent.
The consultants therefore recommend adopting the exemption proposed by (Deubzer et al.
2022), i.e. renewing exemption 8(b) as exemption 8(b)(II) as shown in the below table.
No.

Exemption

Scope and dates of applicability

8(b)Cadmium and its compounds in electricalcontacts

Applies to categories 8, 9 and 11.

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Expires on

8(b)(II)

Cadmium and its compounds in electricalcontacts used in:-circuit breakers-

thermal sensing controls-

thermal motor protectors (excluding
hermetic thermal motor protectors)-

AC switches-

DC switches-[date of official publication of the
COM decision in the Official Journal+ 12 months] for cat. 11-[date of official publication of the
COM decision in the Official Journal+ 18 months] for category 8 medical
devices including in-vitro diagnostic
medical devices, and category 9
monitoring and control instruments
including industrial monitoring andcontrol instruments

Applies to categories 8 and 9 from [dateof the official publication of the COM
decision in the Official Journal + 18
months + 1 day] on.
Expires on-

31 December 2023 for circuit
breakers in rotating parts ofcomputer tomography (CT) medical
devices (category 8 medical devices
others than in-vitro diagnostic
medical devices)-

31 December 2025 for portable
emergency defibrillators (cat. 8
medical devices others than in-vitro
diagnostic medical devices) with a
Declaration of Conformity (DOC)
issued for the first time before 1
January 2015-31 December 2025 for other cat. 8
medical devices including in-vitro
diagnostic medical devices, and for
category 9 monitoring andcontrol instruments including
industrial monitoring and control
instruments.

The COM may consider, as recommended by (Deubzer et al. 2022), setting the expiry date
for cat. 9 IMCI leaving sufficient time for the preparation and timely submission of renewal
requests for potentially remaining specific cases where the reliability of substitutes could
not yet be ensured. Applicants should then submit specific renewal requests including
detailed descriptions of compliance efforts, when they were started for which type of EEE,
and why the substitution or elimination of cadmium remained scientifically and technicallyimpracticable despite these efforts. Support of the renewal request from suppliers of
cadmium-containing/cadmium-free contacts would add plausibility to the renewal request.

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Applicant’s feedback on the recommendation(TMC 2024) consider, with reference to the information they had provided, that the criteria
laid down in Article 5 of the RoHS Directive are fulfilled and reiterate their request to renew
the exemption III-8(b) for cat. 9 IMCI for the maximum validity period of 7 years.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

9.5.

References

Deubzer et al. (2022): Study to assess requests for renewal of 12 exemptions to Annex III of
Directive 2011/65/EU Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Final Report. Pack 23. In cooperation with Dr. Otmar
Deubzer (Fraunhofer IZM and UNITAR], Jana Rückschloss (Fraunhofer IZM) und Christian Clemm(UNITAR). Hg. v. Publication Office of the European Union. European Commission (RoHS 28,
Pack 23). Retrieved from https://data.europa.eu/doi/10.2779/507661.
EPPA (2023): Socioeconomic analysis of the impacts of non-renewal of Lead (Pb) exemption fortest & measurement industrial type products (Category 9) Exemption 34 – Annex III. RoHS Pack
27. Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_34_2023_PUBLIC_VERSION.pdf.
Gensch et al. (2006): Adaptation to scientific and Technical progress under Directive 2002/95/EC.
Final Report - final version. RoHS 1. In cooperation with Carl-Otto Gensch, Stéphanie Zangl, Martin
Möller, Joachim Lohse (Oeko-Institut) und Jutta Müller, Karsten Schischke, Otmar Deubzer(Fraunhofer IZM). Freiburg (Adaptation to Scientific and Technical Progress under Directive
2002/95/EC; RoHS Exemption Reviews, RoHS 1). Retrieved fromhttp://ec.europa.eu/environment/waste/weee/pdf/rohs_report.pdf.
Gensch et al. (2009): Adaptation to scientific and technical progress under Directive 2002/95/EC.
Final Report. Document „final_reportl_rohs1_en.pdf“. In cooperation with Carl-Otto Gensch,
Stéphanie Zangl, Rita Groß, Anna Weber, Öko-Institut e. V. und Otmar Deubzer, Fraunhofer IZM.
Öko-Institut e.V. and Fraunhofer IZM. Freiburg (Adaptation to Scientific and Technical Progressunder Directive 2002/95/EC; RoHS Exemption Reviews). Retrieved fromhttp://ec.europa.eu/environment/waste/weee/pdf/final_reportl_rohs1_en.pdf.
Gensch et al. (2016): Assistance to the Commission on Technological, Socio-Economic and Cost Benefit Assessment Related to Exemptions from the Substance Restrictions in Electrical andElectronic Equipment - Study to assess renewal requests for 29 RoHS 2 Annex III exemptions.
RoHS 14. In cooperation with Carl-Otto Gensch, Yifaat Baron, Markus Blepp, Katja Moch, Susanne
Moritz, Oeko-Institut und Dr. Deubzer, Otmar, Fraunhofer Institut Zuverlässigkeit und
Mikrointegration IZM (Adaptation to Scientific and Technical Progress of Annexes III and IV of
Directive 2011/65/EU, RoHS XIV). Retrieved from https://circabc.europa.eu/sd/a/eda9d68b-6ac94fb9-8667-5e561d8c957e/RoHS-Pack_9_Final_Full_report_Lamps_Alloys_Solders_June2016.pdf.
Sensata (2015): Request for renewal of exemption III-8(b). In cooperation with Sensata
Technologies. Retrieved fromhttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_9/Exemption_8_b_/8b_Final_RoHS_Exemption_Renewal_Dossier_2015_01_16.pdf.

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Sensata et al. (2020): Application for renewal of exemptions III-8(b) and III-8(b)-I for EEE of cat. 110. In cooperation with Albert van der Kuij, Sensata, NEMA Mark Kohorst und RoHS Umbrella
Industry Project. Retrieved from https://rohs.biois.eu/8(b)_8(b)I_Exemption%20Request_31Jan2020_final.pdf.
Sensata et al. (2022): Answers to questionnaire 3 received from Albert van der Kuij, Sensata via email by Dr. Otmar Deubzer, Fraunhofer IZM.
TMC (2023a): Request for renewal of exemption III-8(b). RoHS Pack 27 (RoHS 29). Retrieved fromhttps://rohs.biois.eu/RoHS_Application_Form_15.pdf.
TMC (2023b): Answers to questionnaire 1 (clarification questionnaire). RoHS Pack 27 (RoHS 29).
Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_15_2023_PUBLIC_VERSION.pdf.
TMC (2024): Feedback on recommendation, sent via e-mail by Tobias Steinbrecher, EPPA, to Dr.
Otmar Deubzer. RoHS Pack 27 (RoHS 29).

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Exemption 13(a) of Annex III: Pb in white glasses
used for optical applications

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and Definitions
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments

IVD

In vitro diagnostic medical devices

MTE

MedTech EuropePblead [chem.]

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive

TMC

Test & Measurement Coalition

10.1.

Background and technical information

The below Table 10-1 shows the wording, scope and expiry dates of the exemption.

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Table 10-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

III-13(a)Lead in white glasses used for
optical applications

Applies to all categories; expires on:-

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 andsubcategories.

On 20 January 2023, (TMC 2023a) requested the renewal of the exemption as displayed inTable 10-2 for EEE of category (cat.) 9 industrial monitoring and control instruments (IMCI).
Table 10-2: Wording and scope of the requested exemption
No.

Requested Exemption

Requested scope and dates of applicability

III-13(a)Lead in white glasses used for
optical applications

Applies to category 9 industrial monitoring andcontrol instruments and expires on 21 July 2031.

TMC submitted a socio-economic analysis (SEA) of the impacts of the non-renewal of thisexemption performed by (EPPA 2023). One contribution to the stakeholder consultation
was submitted by (MTE 2023).

10.1.1. History of the exemption
Exemption 13 was added to the Annex of RoHS 1 in October 2005 as “Lead and cadmiumin optical and filter glass.” Exemption 13(a) with the current wording “Lead in white glasses
used for optical applications” was published in the Official Journal of the European Union
on 25. September 2010 36.
Exemption 13(a) was reviewed by (Gensch et al. 2016a), concluding that the eliminationand substitution of lead in white optical glasses was at the time not practical for the fullrange of applications, stating that a large part of the potential for substitution had alreadybeen realised and that the development of further alternatives and their implementation was
likely more challenging and more time-consuming. (Gensch et al. 2016a) discussed thepossibility to exclude consumer products from the scope of the exemption in order to narrow
the scope to equipment used by professionals, which tends to be associated with higher
requirements, however, the applicants at the time, SPECTARIS et al., explained that evenconsumer equipment required the exemption, such as for sophisticated photographic
lenses, binoculars or digital projectors. Differentiating between consumer and professionalgrade equipment was also said to be not feasible, as many products may be used byprofessionals and consumers alike. (Gensch et al. 2016a) also discussed the specification

36 Publication in the Official Journal of the European Union: https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=celex%3A32010D0571

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of a refractive index threshold to narrow the scope to only include such types of glasses inscope of the exemption that cannot be manufactured without the addition of lead. However,adjustment of the scope to include only a specified part of the refractive index range fromthe Abbe diagram was also found to be impractical. Performance thresholds for different
properties of glass could also not be set due to the complexity of interdependent variables(refractive index, dispersion, temperature dependent dispersion, transmission of different
light wave lengths, birefringence, etc.).
Gensch et al. (2016a) recommended the exemption to be renewed for all categories at thetime. The European Commission renewed the exemption accordingly and published in thedecision in the Official Journal37 on 16 June 2017.
The last review of exemption 13(a) was conducted by (Deubzer et al. 2022). At the time,
the applicants, SPECTARIS et al., requested a renewal of the exemption using the samewording until 21 July 2028 for cat. 8 in vitro diagnostic medical devices (IVD) and cat. 9
IMCI, and until 21 July 2026 for all other categories and subcategories. (Deubzer et al.
2022) concluded that substitution of lead-containing glasses with lead-free glasses or
optical polymers had already taken place in applications where it was technically feasible.
In recent years, no ground-breaking new developments have been achieved regarding thedevelopment of new substitutes.
The term ‘white glass’ was found to denote ‘transparent glass’ and is not a precise technicalterm. Therefore, the consultants proposed another wording option to delineate glasses in
optical applications covered by this exemption from the glasses covered by exemption 13(b)series, in which the latter are explicitly excluded from the scope of exemption 13(a). The
applicants agreed to this wording option in principle, but stated to prefer the current wording,as a change in wording would create administrative burden in the relevant value chains.
Due to a lack of evidence that the exemption was required in all RoHS Annex I EEE
categories, (Deubzer et al. 2022) considered it justified to either exclude the affectedcategories from the exemption scope or to include them with a reduced validity period, togive the applicants more time to gather evidence regarding the types of equipment in which
the leaded glass is used in practice before a possible next evaluation of the exemption.
(Deubzer et al. 2022) recommended two exemption wording options reproduced below.
Table 10-3: Wording option 1 recommended by (Deubzer et al. 2022)
No.

Exemption

Scope and dates of applicability

13(a)Lead in white glasses used
for optical applications

Applies to categories 1-11 and expires on:-

21 July 2025 for categories 1, 2, 5, and 10;-

21 July 2026 for categories 3, 4, 6, 7, 8, 9, and 11;-

21 July 2028 for category 8 in vitro diagnostic
medical devices and category 9 industrial
monitoring and control instruments.

37 Publication in the Official Journal of the European Union: https://eur-lex.europa.eu/legal-

content/EN/TXT/HTML/?uri=CELEX:32017L1011&from=EN186

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Table 10-4: Wording option 2 recommended by (Deubzer et al. 2022)
No.

Exemption

Scope and dates of applicability

13(a)Lead in glasses used for
optical applications excluding
applications falling underpoints 13(b), 13(b)(I),13(b)(II), 13(b)(IV) of thisAnnex

Applies to categories 1-11 and expires on:-

21 July 2025 for categories 1, 2, 5, and 10;-

21 July 2026 for categories 3, 4, 6, 7, 8 medical
devices others than in-vitro diagnostic medical
devices, 9 monitoring and control instruments
others than industrial monitoring and control
instruments, and 11;-

21 July 2028 for category 8 in vitro diagnostic
medical devices and category 9 industrial
monitoring and control instruments.

A third option was proposed to the COM that relies on either of the above wording options,but removes categories 1, 2, 5, and 10 from the scope, due to a lack of evidence that theexemption was required in EEE covered by those categories.
Table 10-5: Option 3 recommended by (Deubzer et al. 2022)
No.

Exemption

Scope and dates of applicability

13(a)Lead in […]*

Applies to categories 3, 4, 6, 7, 8, 9, and 11 and expireson:* following sentence
depending on wording
options 1 or 2 above-

21 July 2026 for categories 3, 4, 6, 7, 8, 9, and 11;-

21 July 2028 for category 8 in vitro diagnostic
medical devices and category 9 industrial
monitoring and control instruments.

At the time of the current evaluation of exemption 13(a), the COM have not yet officiallypublished their decision as to the adoption of the above recommendation. The COM wish
the consultants to assess in this current review round whether there are any substantial
reasons in line with Art. 5(1)(a) against the adoption of the above recommendation for EEE
of categories 8, 9 and 11.

10.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). (TMC 2023a) therefore
applied for the renewal of the current exemption 13(a) for cat. 9 IMCI since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE. The exemption thus becamedue for review even though the recommendation for the renewal of exemption 13(a) of(Deubzer et al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Deubzer
et al. 2022) can be adopted to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Deubzer et al. 2022) is not intended. The consultants will rely on thecritical review conducted by (Deubzer et al. 2022) and on the resulting conclusions and187

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recommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

10.1.3. Summary of the requested exemption and stakeholder contributions
Summary of the requested exemption“Exemption 13(a) is an exemption to allow the addition of lead into glass for specific opticalcomponents. These optical components (glass lenses, filters, and fibres) are highly
specialised, individually specified components that perform a key part of the functionality of
the instruments in which they reside. Their use within the heart of the measurement system
is such that replacement of these components, even if an equivalent fit, form, and function
part is available must undergo rigorous and extensive testing and validation.
The addition of lead (typically as PbO) into glass introduces unique properties. As lead is aheavy element, it increases the density of the glass, thereby increasing its refractive index.
The typical refractive index of lead glass is ~1.6, compared to 1.46 of typical (soda) glass.
In addition to increased refractive index, the addition of lead increases the transmission oflight through glass, particularly in the UV spectrum.
As further outlined in this submission, the Test & Measurement Coalition has no knowledge
suggesting that there is a substitute available that would be suitable for lead-glass in highaccuracy measurement instruments. At this point, eliminating the use of leaded-glass is notpossible without the reduction of performance of critical instrumentation. The Test &Measurement Coalition therefore applies for a renewal of the exemption 13(a) for the
maximum validity period.
A thorough Socio-Economic Analysis was conducted in addition to the technicalassessment and attached to this submission, further illustrating the negative socioeconomic impacts a non-renewal of exemption 13(a) would have. Overall, the analysis
concludes that the total impact of non-renewal of this exemption is monetized in the rangeof 1.2 billion EUR and 1.6 billion EUR (conservative lower bound estimate).” (TMC 2023a)
Summary of the stakeholder contribution
MedTech Europe (MTE 2023), the European trade association representing the medical
technology sector express their support for the renewal of this exemption specifically undercategory 8 medical equipment including in vitro diagnostic medical devices for the maximum
validity period.
As this renewal request only pertains to category 9 IMCI, the statements in support of arenewal for category 8 are not reproduced here.

10.1.4. Technical description of the exemption and use of the restricted
substance
A technical description of this exemption was provided by (Deubzer et al. 2022), which theconsultants consider to cover the essential information provided by (TMC 2023a). The

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following information was provided by (TMC 2023a) to indicate for which equipment fallingunder cat. 9 IMCI the exemption is needed.
The addition of lead (typically as PbO) into glass introduces unique properties. As lead is aheavy element, it increases the density of the glass, thereby increasing its refractive index.
The typical refractive index of lead glass is ~1.6, compared to 1.46 of typical (soda) glass.
In addition to increased refractive index, the addition of lead increases the transmission oflight through glass, particularly in the UV spectrum.
Industrial test and measurement instruments (cat. 9 IMCI) are very different from low mix,
high-volume consumer products which are frequently re-designed to follow consumer
trends and are placed on the market for a limited duration. Industrial test and measurement
are high mix, low volume producers, managing portfolios of thousands of highly complex
instruments. Each instrument is intentionally designed for high reliability and serviceability
to support long useful lifespans, and are made available on the market for at least a decade.
These instruments are designed: exclusively for professional and industrial use; to meethigh performance requirements in critical applications; and last up to 40 years. Redesign is
not frequent and happens every seven years on average (as compared to every 1.5 years
or less for consumer products). Once test and measurement instruments are placed onto
the market, they are typically accompanied with a long-term customer support arrangement
to maintain reliability and calibration.
Product portfolios are widely diversified, with TMC members each having typically 2,000 to
3,000 products currently made available on the market. These are highly complex,
sophisticated electronic instruments such as signal generators, power analysers,
oscilloscopes, spectrum analysers, digital multi-meters, electron microscopes, chemicaland biological analysers, complex chromatography systems and their detectors, eachhaving necessary options and accessories. Each instrument can have a minimum of 2,000
and up to 40,000 parts; requiring a vast supply chain involving tens of thousands of suppliers
and hundreds of thousands of unique components.
Considering the EU added-value, test and measurement equipment is manufactured andsold in relatively small volumes (per instrument design) and placed on the global market.
The professional test and measurement products provide the tools for engineers to develop
new solutions and businesses to bring them to market. These instruments are used in
Research, Quality Control and Testing laboratories (including field testing) in Universities,
Manufacturing and clinical facilities and by Governmental Agencies for conformanceverification and environmental testing. They are essential to the good functioning ofelectronic communications networks, heavy industrial processes such as steel
manufacturing, the testing of vehicles for compliance with emissions standards, and themonitoring of complex and critical systems of all types. The nature of the tests andmeasurements made by industrial equipment necessitates that the equipment itself is highly
complex; with upwards of 40,000 components necessary to produce a single instrument.
Even a relatively simple hand-held instrument incorporates significantly more componentsthat a typical consumer product.
(TMC 2023a) provided a comprehensive list of the relevant product groupings andequipment types relevant to exemption 13(a), reproduced in the below table.

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Table 10-6: List of relevant product groupings and equipment types
Product grouping

Equipment types

Generators, Sources and Power

Waveform and Function Generators

Application-Specific Test Systems andComponents
Photonic Test & Measurement Products
Laser Interferometers and Calibration
Systems

Monolithic Laser Combiners & Precision
OpticsUsed Equipment
Liquid Chromatography
Gas Chromatography
Cell Analysis
Laboratory Products and Industrial
Monitoring Capital Equipment

Autoclave; Sterilizers; Baths andCirculators; Biological Safety Cabinets;
Blood Culturing Devices; Centrifuges;
Chillers; Electrophoresis; Environmental
Chambers; Freeze Dryers; Furnaces; Heat
Controllers/Exchangers; Ovens;
Refrigerators; Freezers; Mixers; Water
Purification; Electron Microscopes;
Spectroscopy Equipment

Source: (TMC 2023a)(EPPA 2023) further specified that the optical components in the scope of exemption 13(a)are glass lenses, filters, and fibres that are highly specialised, individually specified
components that perform a key part of the functionality of the instrument in which they
reside. Optical systems and fibre optics are used in a wide variety of test and measurement
instrumentation over large application areas. Some of the instrumentation using leaded
glass optics and fibre optics include cell imaging systems, multimode UV/visible plate
readers, and chromatography systems.

10.1.5. Amount(s) of restricted substance(s) used under the exemption(TMC 2023a) indicate the quantity of lead utilized in the TMC's homogeneous materials
varies based on the application. Therefore, the homogeneous materials can containbetween 37% and 65% lead by weight. (TMC 2023a) estimate the amount of lead entering
the EU market annually through applications for which this exemption is requested to beapproximately 0.9 kg.

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10.2.

Justification of the requested exemption

10.2.1. Substitution and Elimination of the restricted substance(TMC 2023a) state that, to the best of their knowledge, there is no substitute available thatwould be suitable for lead-glass in high accuracy measurement instruments. There aremany available alternative glasses that do not contain lead, and low-grade consumer optics
are now commonly manufactured from plastics. The alternatives do not match the opticalproperties of lead-glass, and even throughout the visible spectrum many of thesealternatives have a decrease in transmission leading to losses in the signal. As
spectroscopy and imaging plays a greater role in the scientific industries from chemistry to
drug discovery and environmental monitoring, it is essential that the industries are able touse the most sensitive and accurate instrumentation.
(TMC 2023a) further state that since the introduction of RoHS 1, and the restriction of theuse of lead, there has been a dramatic improvement in the availability of lead-free glass,and where appropriate these glasses are used. This investment in new glass types
continues, and as lead-free glasses approach the performance characteristics of leaded
glass then the use of lead glass will naturally diminish. TMC anticipate that, with continued
technical advances, the use of lead glass may reduce to negligible levels within the next
two decades. However, at this point, eliminating the use of leaded-glass is not possible
without the reduction of performance of critical instrumentation.

10.2.2. Environmental, health, safety, and socioeconomic impacts(EPPA 2023) performed a socio-economic analysis (SEA) at the request of TMC, in view ofproviding regulators with strong evidence-based findings on the expected social andeconomic impacts that are expected to occur should the use of lead (Pb) be impacted by
the non-renewal of the RoHS exemption.
In line with the existing official guidance from ECHA on the preparation of the SocioEconomic Analysis, the SEA therefore gathers technical and economic information todescribe ex-ante in both qualitative and (if feasible) quantitative terms the (orders ofmagnitude of) socio-economic impacts TMC as well as the relevant EEA supply chain andsociety are expected to face from the non-renewal of the lead (Pb) exemption in whiteglasses used for optical applications, which would otherwise expire on 21 July 2024.
The main findings from the SEA conclude that, the total impact of a non-renewal ismonetized in the range of 1.2 billion EUR and 1.6 billion EUR (conservative estimates in net
losses; potential gains for suppliers of other components have been already taken into
account), consisting of: economic impacts (EBIT loss); substitution costs and social impacts(i.e., unemployment in the EU-27) for test and measurement industrial type products’
manufacturers.

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10.2.3. Roadmap towards substitution or elimination of the restricted
substance(TMC 2023a) explain that research has already been carried out for all applications and in
the cases where lead-free alternatives have been found, they are being used. In virtually all
applications of optical glass, a combination of three or more properties contribute to thetechnical performance of lead-based optical white glasses; it is therefore not possible topick a single property as a criterion of distinction under RoHS. The renewal of exemption
13(a) should accordingly be granted on the ground that there are no alternatives available
for the use of lead in white glasses used for optical applications.
(TMC 2023a) elaborate that further research, by the optical glass manufacturers, into
alternative designs is uncertain and may never be successful due to the demanding
combinations of essential characteristics obtained when using lead in white glass. It istherefore not possible for the test and measurement equipment manufacturers, who use theoptical glass to predict how much time this type of R&D will take or whether substitutes canbe found for all of the diverse applications. It is very probable that it will never be possible
to replace leaded glass in all applications. Lead-based glass manufacturers constantly
review the published literature on new glass formulations but, in recent years, no new glass
types have been discovered that could replace lead-based optical glass. Unless a new
formulation is discovered, it is difficult to see what other steps can be taken by glass
manufacturers to replace lead. Equipment manufactures also regularly review their design
to assess whether lead-free glass can be used but, for the reasons discussed above, thishas not been possible. This echoes the findings by (Deubzer et al. 2022).38
Independent of these findings, the Test & Measurement Coalition has contacted theircomponent suppliers to inquire if since the submission of the renewal request by otherstakeholders (e.g., Spectaris) new technological developments have occurred that would
allow the substitution of cadmium and lead as used in RoHS exemption 13(a). It wasreported back that no alternative substance with the same required characteristics of leadand cadmium for the respective components is known to the manufactures of thosecomponents.
(TMC 2023a) claim that should new lead-free optical parts become available, theparticipating companies would need to perform a variety of tasks in order to qualify a newpart from suppliers. This would divert resources from other projects. It would also increase
the cost to ensure the continued availability of the device due to the additional resources
required by optics manufactures and by the TMC members. The validation and testingprocesses would vary according to part complexity and impact upon the final product design
which can be categorized as either be of a medium or high complexity:−

Medium complexity optical parts are when a like-for-like replacement can besubstituted and when the part performs a relatively simple optical function. Despite
these characteristics, the change in the optical parameters will require testing and

38 Consultants’ comment: Indeed, the applicant during the previous review of this exemption, SPECTARIS etal., a German industrial association for optics, photonics, analysis, and medical technology, made these same
claims and the consultants at the time confirmed to not have identified any evidence that would contradict thisposition.

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performance validation. The average time to switch a medium complexity part for
production is reported to range from 6 to 12 months.
−

10.3.

High complexity parts are optical components that perform a complex function or
are part of an optical subassembly. These parts will be critical to the performanceand accuracy of the device and will require extensive characterisation as the firststep of the replacement process. The output of the characterisation will likely impact
other parts of the instrument (for example, the analysis/interpretation software).
Once fully characterised, these high complexity optical parts will require testing andvalidation for their performance and functionality in the instrument. Depending on
the application, updated documentation of the device may require notification to theappropriate competent authorities or regulatory bodies. The average time that it
would take to perform a high complexity component change for production is
between 2 and 5 years.

Critical review

10.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of exemption 13(a).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

10.3.2. Substitution and elimination of the restricted substances
TMC argue the justification of the exemption first and foremost on the basis that asubstitution or elimination of lead in the applications in scope of this renewal request aretechnically impracticable. The previous review of this exemption by (Deubzer et al. 2022)
concluded that lead had largely been substituted and eliminated where this was technicallyfeasible, such as consumer products, and remains to be used only in applications in which
substitution and elimination is not yet technically feasible, as eliminating the use of leadedglass is not possible without the reduction of performance of critical instrumentation. A
comprehensive list of affected equipment was provided by TMC and is reproduced in
section 10.1.4 (page 188 ff.).

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TMC claim that instrument manufacturers largely depend on the supply chain for thedevelopment of substitution options, such as speciality glass makers. TMC state to haveinquired with SPECTARIS, representing the latter, but no breakthroughs in the developmentof substitutes for lead in glasses could be reported.
The consultants conclude the technical arguments that justify the exemption that werediscussed during the previous review remain valid for equipment for cat. 9 IMCI. It iscurrently not yet practicable to phase out lead from all applications, therefore consultantsconsider the request for the maximum validity period justified in principle. However,following the mandate to assess whether the recommendations of (Deubzer et al. 2022)
can be adopted to cat. 9 IMCI in line with Art. 5(1)(a), the consultants consider therecommended validity period until 21 July 2028 can be maintained.
The consultants note that the list of applications provided by TMC is identical between
exemptions 13(a) and 13(b). In case of a future renewal request for these exemptions, theconsultants consider it necessary for the applicants to differentiate the types of equipment
for each exemption.

10.3.3. Adoption of the recommendation from the previous evaluation report
Exemption III-13(a) was reviewed by (Deubzer et al. 2022) who recommended a renewal,
providing two wording options to the European Commission (COM): Wording option 1 andwording option 2, reproduced in section 10.1.1 “History of the exemption” in Table 10-3 andin Table 10-4, respectively. During the review of the current exemption renewal request, theapplicants were informed that if this review shows that the applicants’ arguments justify therenewal of the exemption, the consultants would recommend the wordings, scopes andexpiry dates given in Table 10-3 (reflecting option 1) and Table 10-4 (reflecting option 2).
When requested to comment on and explain any obstacles to the adoption of the above
proposal for the requested exemption for category 9 IMCI, (TMC 2023b) responded thatthey apply for renewal of exemption III-13(a) in its current wording and for the maximum
validity period, i.e., 7 years.
(TMC 2023b) emphasize the importance of retaining the initial wording and numbering as
published in the original RoHS annexes. Amending the scope of the exemption by changing
the application or substance restriction value has a significant administrative burden toindustry and negatively impacts the compliance.
Further, (TMC 2023b) highlight that industrial monitoring and control instrument
manufacturers have to manage suppliers’ declarations for hundreds of thousands of items.
Additionally, after reviewing the current state of the evolution of technology for the cat. 9
industrial measurement and control instruments, TMC members have difficulty inunderstanding how the rewording and relisting and/or splits recommended by the
consultants will lead to greater protection of human health and the environment comparedto the wording in its current form. The recommended rewording/split would only lead tosignificant unnecessary burden for stakeholders without commensurate benefits.
Therefore, (TMC 2023b) state to favour and apply for the wording of option 1 with anextension of the applicability dates for category 9 industrial test and measurement
instruments until 21 July 2031.

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Regarding wording option 2, (TMC 2024a) further highlighted that the exclusion of 13(b)(I),13(b)(II), 13(b)(IV) does not make sense, given that they are not relevant for equipment of
category 9. The consultants note that this is only partially correct, as exemptions 13(b)(I),13(b)(II), 13(b)(IV) and the newly added 13(b)(V) were recommended to apply to category 9
by (Deubzer et al. 2022). In fact, only the recommended exemption 13(b)(III) was
recommended to expire for categories 1 to 7 and 10, as it is superseded by exemption
13(b)(IV), if the COM follows the recommendations made by (Deubzer et al. 2022).

10.3.4. Environmental, health, safety, and socioeconomic impacts
The publicly available version for the SEA does not report data on the individual indicators,
being economic impacts (losses in earnings before interest and taxes), substitution costs,
and social impacts, which are, however, provided in a confidential version of the SEA.
(EPPA 2023) describe that the SEA is based on information collected from surveying TMC
member companies, which represent more than 70 % of the entire European Economic
Area test and measurement equipment market.
The consultants cannot exclude that at least some of these impacts would actually arise if
the COM does not renew the exemption. The consultants do, however, not recommend
revoking the exemption, or restricting its scope so that cat. 9 IMCI would be excluded fromthe scope of the future exemption so, that no adverse environmental or socioeconomic
impacts can be expected to arise.
TMC stated that the equipment falling into cat. 9 IMCI placed on the EU market per anno
only contains 0.9 kg of lead. This is in stark contrast to the 275 tonnes per anno that were
estimated by SPECTARIS et al. during the previous review of this exemption, albeit thelatter being an estimate for all RoHS categories. The SEA provided by TMC included astatement on this as follows: As a result of the participating companies’ relatively low
consumption of parts, in comparison to the product Categories 1-7 and 10, renewing thisexemption for Category 9 will have a minimal impact on the environment. As previously
indicated, Category 9 Industrial producers are only responsible for 0.2% of annual WEEE
production.
The consultants consider that in case of a future renewal request for this exemption, theapplicants should provide an approximation of the amount of lead that is used in equipment
differentiated by RoHS equipment category to highlight the relevance of this exemption for
the individual categories.

10.3.5. Summary and conclusions
TMC request the 7-year renewal of exemption III-13(a) with its current wording for cat. 9
industrial monitoring and control instruments (IMCI) until 21 July 2031. Following theirmandate for this exemption, the consultants assessed whether the result of the previous
review of this exemption by (Deubzer et al. 2022) - which included cat. 9 IMCI - can be
adopted for cat. 9 IMCI in the light of the applicant at hand.
The consultants conclude the technical arguments that justify the exemption that werediscussed during the previous review remain valid for equipment for cat. 9 IMCI.

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In the last review, (Deubzer et al. 2022) recommended to renew the exemption using thesame wording as the previous exemption (option 1), or, based on the applicants’ request at
the time, using an adjusted wording that omits the term ‘white’ glass (option 2). The
applicants of this current review round agreed to the adoption of the renewal of thisexemption recommended by (Deubzer et al. 2022), but emphasize that they favour andapply for wording option 1, preserving the currently valid wording, as changes to wording
and numeration of existing exemptions leads to high administrative burdens through the
supply chain. The applicants also emphasized that the renewal is requested for the
maximum validity period of 7 years.

10.4.

Recommendation

The consultants recommend maintaining the exemption renewal proposed by (Deubzer et
al. 2022), which includes cat. 9 IMCI.
If the COM decides to follow the approach of (Deubzer et al. 2022), the below wording is
recommended for the renewed exemption III-13(a):No.

Exemption

Scope and dates of applicability

13(a)Lead in white glasses used
for optical applications

Applies to categories 1-11 and expires on:-

21 July 2028 for category 8 in vitro diagnostic
medical devices and category 9 industrial
monitoring and control instruments;-

21 July 2026 for all other categories.

(Deubzer et al. 2022) recommended a shorter expiry date for equipment falling into
categories 1, 2, 5, and 10 until 21 July 2025. However, applicants would not be able to apply
for a renewal of this exemption 18 months before its expiry, given that the COM’s decisionon the adoption of this recommendation cannot be published 18 months before this date.
The consultants therefore recommend granting the renewal for all other categories, besides
cat. 8 IVD and cat. 9 IMCI for at least 24 months after the publication of the COM’s decision.
If the COM wish to remove the ambiguity of the term ‘white’ glasses from the exemption
wording, despite both the current and previous applicants stating this would cause
additional administrative burdens throughout the supply chains, the below wording is
recommended for the renewed exemption III-13(a):No.

Exemption

Scope and dates of applicability

13(a)Lead in glasses used for
optical applications excluding
applications falling underpoints 13(b), 13(b)(I),13(b)(II), 13(b)(IV) of thisAnnex

Applies to categories 1-11 and expires on:-

21 July 2028 for category 8 in vitro diagnostic
medical devices and category 9 industrial
monitoring and control instruments;-

21 July 2026 for all other categories.

It should be noted that this wording is interlinked with exemption 13(b) series, for which the
COM also has not yet published their decision on the adoption of the recommendations of
the previous review, and which has also been reviewed as part of this current pack of

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exemption reviews. It should further be noted that (TMC 2024a) explicitly disagree with the
adoption of this exemption wording.
If the COM wish to not renew the exemption for those categories for which the previous
applicant could not provide evidence that the exemption was in fact required, while
maintaining that it is required, the below wording and scope are recommended for the
renewal of exemption III-13(a):No.

Exemption

Scope and dates of applicability

13(a)Lead in […]*

Applies to categories 3, 4, 6, 7, 8, 9, and 11 and expireson:* following sentence
depending on wording
options 1 or 2 above-

21 July 2026 for categories 3, 4, 6, 7, 8, 9, and 11;-

21 July 2028 for category 8 in vitro diagnostic
medical devices and category 9 industrial
monitoring and control instruments.

-

If the COM wish to align the validity periods for different EEE categories to enable a joint
review, if it was requested again in the future, an aligned renewal of all categories for which
the exemption is to be renewed is recommended until 21 July 2028.
The adverse socioeconomic impacts assessed by EPPA will not arise until 2028 since theconsultants do not recommend revoking the exemption, but TMC will have to bear the costfor preparing and processing a renewal request prior to 2031, which they requested as
expiry date in their current renewal request.
Lastly, the consultants consider that in case of a future renewal request for this exemption,
the applicants should provide an approximation of the amount of lead that is used inequipment differentiated by RoHS equipment category to highlight the relevance of thisexemption for the individual categories.
Applicants’ feedback on recommendation(TMC 2023b) stated to favour and apply for the wording of option 1 with an extension of theapplicability dates for category 9 IMCI until 21 July 2031. They criticise that therecommendation favors a stronger consideration of the expiry dates recommended by
Deubzer et al. in the previous review to enable the review of the exemption for all categories
of EEE. This approach counters the RoHS Directive’s logic of having different productcategories with different validity periods and neglects the specificities of cat. 9 IMCI. The
recommendation increases business uncertainty and enhances the likelihood of negativesocio-economic impact across the EU as a consequence of potential pre-mature market
withdrawal.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

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10.5.

References

Deubzer et al. (2022): Study to assess requests for renewal of 12 exemptions to Annex III of
Directive 2011/65/EU Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Final Report. Pack 23. In cooperation with von Dr. Otmar
Deubzer (Fraunhofer IZM and UNITAR], Jana Rückschloss (Fraunhofer IZM) und Christian Clemm(UNITAR). Hg. v. Publication Office of the European Union. European Commission (RoHS 28,
Pack 23). Retrieved from https://data.europa.eu/doi/10.2779/507661.
EPPA (2023): Socio-economic analysis. Of the impacts of non-renewal of Cadmium (Cd) and Lead
(Pb) exemption for test & measurement industrial type products (Category 9) Exemption 13(b) –Annex III. EPPA (RoHS 29). Retrieved fromhttps://rohs.biois.eu/TMC_SEA_Exemption_13(b)_2023_PUBLIC_VERSION.pdf.
Gensch et al. (2016a): Study to assess four renewal requests for RoHS 2 Annex III exemptions no.
7(b), no. 9(b), no. 13(a) and no. 13(b).(RoHS Directive). Report for the European Commission DG
Environment under Framework Contract No ENV.C.2/FRA/2011/0020 Assistance to theCommission on Technological Socio-Economic and Cost-Benefit Assessment Related to
Exemptions from the Substance restrictions in Electrical and Electronic Equipment. RoHS 12 (Pack7). In cooperation with von Carl-Otto Gensch, Yifaat Baron, Moch, Katja, Öko-Institut und Dr.
Deubzer, Otmar, Fraunhofer IZM. Retrieved fromhttps://circabc.europa.eu/faces/jsp/extension/wai/navigation/container.jsp.
MTE (2023): Answers to stakeholder questionnaire. RoHS Pack 27. MTE (RoHS 29). Retrieved
from https://rohs.biois.eu/MTE.pdf.
TMC (2023a): Request for renewal of exemption III-13(a). RoHS Pack 27 (RoHS 29). Retrieved
from https://rohs.biois.eu/RoHS_Application_Form_15.pdf.
TMC (2023b): Answers to questionnaire 1 (clarification questionnaire), sent by Tobias
Steinbrecher, Eppa, to Christian Clemm. RoHS Pack 27. TMC (RoHS 29). Retrieved fromhttps://rohs.biois.eu/TMC_reply_Ex_III-13a_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024a): Answers to questionnaire 2, sent by Tobias Steinbrecher, Eppa, to Christian Clemm.
RoHS Pack 27. TMC (RoHS 29).
TMC (2024b): Comments on recommendation, sent by Tobias Steinbrecher, Eppa, to ChristianClemm. RoHS Pack 27. TMC (RoHS 29).

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Exemption 13(b) of Annex III: Cd and Pb in filter
glasses and reflectance standards
The below Table 11-1 shows the wording, scope and expiry dates of the exemption.
Table 11-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

III-13(b)Cadmium and lead in filter
glasses and glasses used forreflectance standards

Applies to categories 8, 9 and 11; expires on:-

21 July 2023 for category 8 in vitro
diagnostic medical devices;-

21 July 2024 for category 9 industrial
monitoring and control instruments and for
category 11;-

21 July 2021 for other subcategories ofcategories 8 and 9.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and Definitions
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

Cd

cadmium [chem.]

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments

MTE

MedTech EuropePblead [chem.]

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

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RoHS

Directive 2011/65/EU, current RoHS Directive

TMC

Test & Measurement Coalition

11.1.

Background and technical information

On 20 January 2023, (TMC 2023a) requested the renewal of the exemption as displayed inTable 11-2 for EEE of category (cat.) 9 industrial monitoring and control instruments (IMCI).

Table 11-2: Wording and scope of the requested exemption
No.

Requested wording

Requested
scope
applicability

and

dates

of

III-13(b)Cadmium and lead used in filter
glasses and glasses used forreflectance standards

Applies to category 9 industrial monitoring andcontrol instruments and expires on 21 July2031.

TMC submitted a socio-economic analysis (SEA) of the impacts of non-renewal of thisexemption performed by (EPPA 2023). One contribution to the stakeholder consultation
was submitted by (MTE 2023).

11.1.1. History of the exemption
According to (Deubzer et al. 2022), exemption 13 was added to the Annex of RoHS 1 in
October 2005 as “Lead and cadmium in optical and filter glass.” Exemption 13(b) with thewording “Cadmium and lead in filter glasses and glasses used for reflectance standards”
was published in the Official Journal of the European Union on 25. September 2010 39.
Exemption 13(b) was reviewed by (Gensch et al. 2016a), who recommended splitting the
exemption into a series of more specific exemptions, resulting in the current four exemptions
under number 13 series, in which Exemption 13(b) has maintained its wording and only
includes categories 8, 9, and 11 in its scope, while all other categories are in scope of themore specific exemptions 13(b)(I), (II), and (III).

39 Publication in the Official Journal of the European Union: https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=celex%3A32010D0571

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Table 11-3: Currently valid wording of exemption 13(b)-series
No.

Exemption

Scope and dates of applicability

13(b)Cadmium and Lead used in filter
glasses and glasses used forreflectance standards

Applies to categories 8, 9 and 11; expires on:

13(b)(I)

Lead in ion coloured optical filter
glass types

13(b)(II)Cadmium in striking optical filter
glass types; excluding
applications falling under point 39of this Annex

13(b)(III)Cadmium and lead in glazes used
for reflectance standards-

21 July 2023 for category 8 in vitro
diagnostic medical devices;-

21 July 2024 for category 9 industrial
monitoring and control instruments and for
category 11;-

21 July 2021 for other subcategories ofcategories 8 and 9.

Applies to categories 1 to 7 and 10; expires on
21 July 2021 for categories 1 to 7 and 10.

The last review of exemption 13(b) was conducted by (Deubzer et al. 2022), who concluded
that substitution and elimination of lead and/or cadmium in the filter glasses and reflectancestandards are scientifically and technically impracticable where their unique properties areneeded in a range of applications. A renewal of the exemption 13(b)-series wasrecommended as displayed in the following table:

Table 11-4: Recommended renewal of exemption 13(b)-series by (Deubzer et al. 2022)
No.

Exemption

Scope and dates of applicability

13(b)Cadmium and lead used in filter
glasses and glasses used forreflectance standards

Applies to categories 8, 9 and 11.
Expires on [date of publication in Official
Journal + 12 months] for-category 8 medical devices including invitro diagnostic medical devices;-

category 9 monitoring and control
instruments including industrial monitoring
and control instruments;-

category 11.

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13(b)(I)

Lead in ion coloured optical filter
glass types

13(b)(II)Cadmium in striking optical filter
glass types; excluding
applications falling under point 39of this Annex

Applies to categories 1 to 7 and 10 and from[date of publication in Official Journal + 12
months + 1 day] to categories 8, 9 and 11.
Expires on-

21 July 2025 for categories 1, 4;-

21 July 2026 for categories 2, 3, 5, 6, 7, 10
and 11;-21 July 2028 for category 8 medical
devices including in-vitro diagnostic
medical devices and category 9 monitoring
and control instruments including industrial
monitoring and control instruments.

13(b)(III)Cadmium and lead in glazes
used for reflectance standards

Expires on [date of publication in Official Journal+ 12 months] for categories 1 to 7 and 10.

13(b)(IV)

Cadmium in glazes used forreflectance standards

Applies to cat. 8 and 9 from [date of publicationin Official Journal + 12 months+ 1 day] on.
Expires on 21 July 2028 for category 8 medical
devices including in-vitro diagnostic medical
devices and category 9 monitoring and control
instruments including industrial monitoring andcontrol instruments.

13(b)(V)

Lead compound coatings ininfrared interference filters used
in infrared gas analysis and midfar-infrared spectroscopy

Applies to category 9 industrial monitoring andcontrol instruments from [date of publication in
Official Journal + 12 months + 1 day] on.
Expires on 21 July 2028 for category 9 industrial
monitoring and control instruments.

EEE of categories 8, 9 and 11, currently in the scope of exemption 13(b), wererecommended to be integrated into the scopes of exemptions 13(b)(I), 13(b)(II), and13(b)(III) so far only covering EEE of cat. 1-7 and 10. Formally, this is equivalent tonarrowing the exemption scopes for these categories of EEE which is considered a partial
revocation of the exemption. For this reason, a transition period of 12 months wasrecommended. Exemption 13(b)(III) was updated to reflect that lead was no longer requiredin glazes used for reflectance standards, leading to the recommendation of exemption
13(b)(IV). A new exemption 13(b)(V) was recommended to reflect that infrared interference
filters require the exemption but are only covered by exemption 13(b) which shall expire.

11.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). (TMC 2023a) therefore
applied for the renewal of the current exemption 13(b) for cat. 9 IMCI since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE. The exemption thus became

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due for review even though the recommendation for the renewal of exemption 13(a) of(Deubzer et al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Deubzer
et al. 2022) can be adopted to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Deubzer et al. 2022) is not intended. The consultants will rely on thecritical review conducted by (Deubzer et al. 2022) and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

11.1.3. Summary of the requested exemption and stakeholder contributions
Summary of the requested exemption“Exemption 13(b) is an exemption to allow the addition of cadmium (Cd) and lead (Pb) into
glass specifically for the creation of filters and reflectance standards. Category 9 products
use glass filters within the optical design for highly specialist applications. These opticalsystems are part of sensitive measuring apparatus used throughout a wide variety of
applications and industries, where highly sensitive accurate measurements are needed.
As further outlined in this submission, to the best of knowledge of the Test & Measurement
Coalition no alternatives have been developed for the applications described in thisexemption renewal request and other applications that require cadmium and lead filter
glasses. The Test & Measurement Coalition therefore applies for a renewal of the
exemption 13(b) for the maximum validity period.
A thorough Socio-Economic Analysis was conducted in addition to the technicalassessment and attached to this submission, further illustrating the negative socioeconomic impacts a non-renewal of exemption 13(b) would have at this stage. Overall, theanalysis concludes that the total impact of non-renewal of this exemption is monetized in
the range of 1 billion EUR and 1.5 billion EUR (conservative lower bound estimate).” (TMC
2023a)
Summary of the stakeholder contribution
MedTech Europe (MTE 2023), the European trade association representing the medical
technology sector express their support for the renewal of this exemption specifically undercategory 8 medical equipment including in vitro diagnostic medical devices for the maximum
validity period.
As this renewal request only pertains to category 9 IMCI, the statements in support of arenewal for category 8 are not reproduced here.

11.1.4. Technical description of the exemption and use of the restricted
substance
A technical description of this exemption was provided by (Deubzer et al. 2022), which theconsultants consider to cover the essential information provided by (TMC 2023a). The
following information was provided by (TMC 2023a) to indicate for which equipment fallingunder cat. 9 IMCI the exemption is needed.

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Industrial test and measurement instruments (category 9 – Industrial under the RoHS
Directive) are very different from low mix, high-volume consumer products which arefrequently re-designed to follow consumer trends and are placed on the market for a limited
duration. Industrial test and measurement are high mix, low volume producers, managing
portfolios of thousands of highly complex instruments. Each instrument is intentionallydesigned for high reliability and serviceability to support long useful lifespans, and are madeavailable on the market for at least a decade. These instruments are designed: exclusively
for professional and industrial use; to meet high performance requirements in criticalapplications; and last up to 40 years. Redesign is not frequent and happens every sevenyears on average (as compared to every 1.5 years or less for consumer products). Once
test and measurement instruments are placed onto the market, they are typicallyaccompanied with a long-term customer support arrangement to maintain reliability andcalibration.
Product portfolios are widely diversified, with T&M Coalition members each having typically
2,000 to 3,000 products currently made available on the market. These are highly complex,
sophisticated electronic instruments such as signal generators, power analysers,
oscilloscopes, spectrum analysers, digital multi-meters, electron microscopes, chemicaland biological analysers, complex chromatography systems and their detectors, eachhaving many necessary options and accessories. Each instrument can have a minimum of
2,000 and up to 40,000 parts; requiring a vast supply chain involving tens of thousands ofsuppliers and hundreds of thousands of unique components.
The professional test and measurement products provide the tools for engineers to develop
new solutions and businesses to bring them to market. These instruments are used in
Research, Quality Control and Testing laboratories (including field testing) in Universities,
Manufacturing, and clinical facilities and by Governmental Agencies for conformanceverification and environmental testing. They are essential to the good functioning ofelectronic communications networks, heavy industrial processes such as steel
manufacturing, the testing of vehicles for compliance with emissions standards, and themonitoring of complex and critical systems. The nature of the tests and measurements
made by industrial equipment necessitates that the equipment performing those tests areitself is highly complex; with upwards of 40,000 components necessary to produce a single
instrument. Even a relatively simple hand-held instrument incorporates significantly morecomponents that a typical consumer product.
(TMC 2023a) provided a comprehensive list of the relevant product groupings andequipment types relevant to exemption 13(b), reproduced in the table below.

Table 11-5: List of relevant product groupings and equipment types
Product Grouping

Equipment Types

Generators, Sources and Power

Waveform and Function Generators

Application-Specific Test Systems andComponents
Photonic Test & Measurement Products
Laser Interferometers and Calibration
Systems

Monolithic Laser Combiners & Precision
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Used Equipment
Liquid Chromatography
Gas Chromatography
Cell Analysis
Laboratory Products and Industrial
Monitoring Capital Equipment

Autoclave Sterilizers; Baths andCirculators; Biological Safety Cabinets;
Blood Culturing Devices; Centrifuges;
Chillers; Electrophoresis; Environmental
Chambers; Freeze Dryers; Furnaces; Heat
Controllers/Exchangers; Ovens;
Refrigerators; Freezers; Mixers; Water
Purification

Material and Structural Analysis

Electron Microscopes; Spectroscopy
Equipment

Source: (TMC 2023a)

11.1.5. Amount(s) of restricted substance(s) used under the exemption(TMC 2023a) indicate that cadmium-based filter glass typically contains approximately 0.4%
cadmium by weight and lead-based filter glass contains between 13% and 28% of lead byweight. Overall, through application for which the exemption is requested, approximately
0.08 kg of Cd and 0.58 kg of Pb enter the EU market annually.

11.2.

Justification of the requested exemption

11.2.1. Substitution and Elimination of the restricted substance(TMC 2023a) state that since the introduction of RoHS 1, and the restriction of the use oflead and cadmium, there has been a dramatic improvement in the development of leadand cadmium-free glass. These glasses are used where appropriate. Glass with lead andcadmium is only used where their optical properties are required, and where no suitable
alternative is available. The TMC members anticipate that the use of these glasses willcontinue to reduce, however, the participating companies do not foresee a removal of theneed of Pb and Cd containing glass from the specialist industrial applications. Eliminating
the use of lead and cadmium-glass for optical applications is not possible without theremoval of some instrumentation from the EU market, and a reduction of the performanceof instrumentation.
According to (TMC 2023a), there are three main alternative types of optical filters that areused for some applications identified by Spectaris. These alternatives, however, cannot
replace cadmium-based optical filter glass where the essential characteristics of cadmium
filters are required. These alternatives are: alternative additives in glass; coatings on glass;and coloured “plastic fibres.”205

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Alternative additives to the glass. Various other elements are added to cadmium tomake a material that contains microparticles of cadmium as mixed sulphide,
selenide, and telluride. The cut-off wavelength is controlled by the ratio of theseelements and by their heat treatment conditions. The exact form of the cadmium
compound is unclear but can be seen as very small particles in a colourless matrix.
To obtain the same optical properties, alternative inorganic compounds would beneeded that are thermally stable at the melting temperature of the types of glass
used and gives the same optical spectrum with sharp wavelength cut-offs. Researchhas been conducted for decades to search for alternatives to cadmium, but with nosuccess.

−

Thin film coatings on transparent substrates. Interference filters (or, equivalently,
dichroic filters) are widely used for certain applications but their properties are very
different to glass filters based on cadmium compounds. Their main characteristic isthat they absorb light within a specific but rather narrow wavelength range with sharp
cutoffs at both ends of this wavelength range. Spectra of light that has passed
through this type of filter are quite different to spectra obtained with cadmium glass
filters. Interference filters also depend on the viewing angle and can give “ghost
images.” These filters may also transmit light in unwanted side-bands at lower
intensities. The light spectrum transmitted through a cadmium-based optical filter
will always be the same, whereas spectra of light transmitted through dichroic filters
varies according to the angle of incidence−

Transparent plastics with organic pigments. These are used as optical filters andhave advantages and disadvantages; these disadvantages, however, make them
unsuitable for many applications. The addition of organic dyes and organic pigments
to molten glass is impossible as all are thermally unstable at glass melting
temperatures. Only heat stable inorganic compounds such as cadmium
chalcogenides can be used. Achieving optical clarity is not possible for all
combinations of coloured compounds and polymers. Most polymers are available
only as opaque materials and most pigments will not dissolve so give opaquedispersions. The main disadvantages of coloured transparent plastics are: plastics
are easily scratched; they are affected by humidity as all plastics absorb water fromhumid air; they are affected by high temperatures (distort, degrade, change colour);organic pigments fade when exposed to ultraviolet light and polymers are also
affected causing changes in colour (brittle fracture may also occur when exposed toultraviolet light); image quality tends to be poor as the surfaces of plastic filters areeasily warped, so are not optically flat; some polymer filters with organic pigments
have relatively poor maximum transmission percentages at wavelengths of light thatshould pass through the filter; and some polymer filters transmit light at wavelengths
where light needs to be blocked.

For lead, (TMC 2023a) explain that only one type of filter glass is currently produced that
contains lead and it is used because of its unique combination of properties. The interaction
between the coloured metal ions and lead atoms in a glass matrix is what gives the required
performance of lead-based applications. Research has not identified an alternative material
with the same combination of essential properties. Glass filter manufacturers haveevaluated many other combinations of ions in lead-free glass, but none give the required
properties.

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11.2.2. Environmental, health, safety, and socioeconomic impacts(EPPA 2023) performed a socio-economic analysis (SEA) at the request of TMC, in view ofproviding regulators with strong evidence-based findings on the expected social andeconomic impacts that are expected to occur should the use of cadmium and lead be
impacted by the non-renewal of the RoHS exemption.
In line with the existing official guidance from ECHA on the preparation of the SocioEconomic Analysis, the SEA therefore gathers technical and economic information todescribe ex-ante in both qualitative and (if feasible) quantitative terms the (orders ofmagnitude of) socio-economic impacts TMC as well as the relevant EEA supply chain andsociety are expected to face from the non-renewal of the cadmium and lead exemption in
filter glasses and glasses used for reflectance standards, which would otherwise expire on
21 July 2024.
The main findings from the SEA conclude that the total impact of a non-renewal ismonetized in the range of 1 billion EUR to 1.5 billion EUR (conservative estimates in net
losses; potential gains for suppliers of other components have been already taken into
account), consisting of: economic impacts (EBIT loss); substitution costs and social impacts(i.e., unemployment in the EU-27) for test and measurement industrial type products’
manufacturers.

11.2.3. Roadmap towards substitution or elimination of the restricted
substance(TMC 2023a) explain that most of the alternatives to cadmium and lead in filter glasses do
not exhibit the required sharp wavelength “cut-offs.” Interference filters can sometimes beused as they do have sharp “cut-offs” but the wavelength at which this occurs depends onthe viewing angle and so these filters are unsuitable for many applications. Most of theapparent alternatives are, in addition, detrimentally affected by harsh environmental
conditions such as moisture, heat, and UV light which makes them unsuitable for many
applications.
Further, according to (TMC 2023a), research has been carried out for decades andalternatives to lead and cadmium have already been used where these are suitable. So far,alternatives have not been developed for the applications described in this exemption
renewal request and other applications that require cadmium and lead filter glass. It is also
not possible to envisage alternative designs of equipment that would provide the samefunction and performance without these filters; research timelines can accordingly not be
estimated. No substitutes are therefore likely to be developed in the foreseeable future andby extension in the validity period required for this exemption.
Independent of these findings, the Test & Measurement Coalition has contacted theircomponent suppliers to inquire if since the submission of the renewal request by otherstakeholders (e.g., Spectaris) new technological developments have occurred that would
allow the substitution of cadmium and lead as used in RoHS exemption 13(b). It wasreported back that no alternative substance with the same required characteristics of leadand cadmium for the respective components is known to the manufacturers of thosecomponents.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(TMC 2023a) describe that if a new substance-free part became available, this part must
be qualified for use by performing a variety of tasks. Due to the complexity and diversity of
the applications, this must be done individually by each company for each product group.
This validation and testing process varies according to part complexity and impact upon the
final product design.

•Medium complexity optical parts are where a like-for-like replacement can besubstituted, and the part performs a relatively simple optical function. Despite this,the change in the optical parameters will require testing and performance validation.
The average time to switch a medium complexity part for production is reported torange from 6 to 12 months.

•

High complexity parts are optical components that perform a complex function, or
are part of an optical subassembly. These parts will be critical to the performanceand accuracy of the device and will require extensive characterisation, as the firststep of the replacement process. The output of the characterisation will likely impact
other parts of the instrument (for example, the analysis/interpretation software).
Once fully characterised, these high complexity optical parts will then require testingand validation performing their function in the instrument. Depending on theapplication, updated documentation of the device may require notification to theappropriate competent authorities or regulatory bodies. The average time that it
would take to perform a for high complexity component change for production is
between 2 and 5 years.

11.3.

Critical review

11.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. The applicants,
SPECTARIS et al., explained in the previous review of this exemption by (Deubzer et al.
2022) that Pb compounds contained in batches for filter glass are present as a complex
multi-element mixed oxide in the new substance glass (CAS 65997-17-3) after the melting
process, so there is not necessarily an exact stoichiometric chemical formula. SPECTARIS
and JBCE, another applicant, confirmed, however, that the lead compounds listed on
REACH Annex XIV are not contained in glasses relevant for this exemption.
Additionally, Annex XVII contains several restrictions for lead and its compounds (cf. section
4.2 on page 51). Additionally, restrictions of cadmium and its compounds are listed on

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Annex XVII (cf. section 4.1 on page 48). None of those entries, however, are applicable tothe use of cadmium in the recommended exemption 13(b).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

11.3.2. Substitution and elimination of the restricted substances
TMC argue the justification of the exemption first and foremost on the basis that asubstitution or elimination of cadmium and lead in the applications in scope of this renewal
request are technically impracticable. The previous review of this exemption by (Deubzer
et al. 2022) concluded that lead had largely been substituted and eliminated where this wastechnically feasible and remains to be used only in applications in which substitution andelimination is not yet technically feasible.
TMC claim that instrument manufacturers largely depend on the supply chain for thedevelopment of substitution options, i.e. speciality glass and component makers. TMC state
to have inquired with SPECTARIS and others, representing the latter, but no breakthroughsin the development of substitutes for lead in glasses could be reported.
The consultants conclude the technical arguments that justify the exemption that werediscussed during the previous review remain valid for equipment for cat. 9 IMCI. As it iscurrently not feasible to phase out lead from all applications, the consultants consider therequest for the maximum validity period justified in principle. However, the consultantsconsider it would also be justified to rely on the validity periods recommended on the basisof the previous exemption review.
The consultants note that the list of applications provided by TMC is identical between
exemptions 13(a) and 13(b). In case of a future renewal request for these exemptions, theconsultants consider it necessary for the applicants to differentiate the types of equipment
for each exemption.

11.3.3. Adoption of the recommendation from the previous evaluation report
Exemption III-13(b) was reviewed by (Deubzer et al. 2022) who recommended a renewal,
as reproduced in section 11.1.1 in Table 11-4. During the review of the current exemption
renewal request, the applicants were informed that if this review hows that the applicants’arguments justify the renewal of the exemption, the consultants would recommend thewordings, scopes and expiry dates given in Table 18-6, adapted from the recommendationsby (Deubzer et al. 2022).

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Table 11-6: Renewal of exemption 13(b)-series, adapted from (Deubzer et al. 2022)
No.

Exemption

Scope and dates of applicability

13(b)Cadmium and lead used in filter
glasses and glasses used forreflectance standards

Applies to categories 8, 9 and 11.

13(b)(I)

Lead in ion coloured optical filter
glass types

13(b)(II)Cadmium in striking optical filter
glass types; excluding
applications falling under point 39of this Annex

Expires on [date of publication in Official
Journal + 12 months] for-category 8 medical devices including invitro diagnostic medical devices;-

category 9 monitoring and control
instruments including industrial monitoring
and control instruments;-

category 11.

Applies to categories 1 to 7 and 10 and from[date of publication in Official Journal + 12
months + 1 day] to categories 8, 9 and 11.
Expires on-

21 July 2025 for categories 1, 4;-

21 July 2026 for categories 2, 3, 5, 6, 7, 10
and 11;-21 July 2028 for category 8 medical
devices including in-vitro diagnostic
medical devices;-

21 July 2028 for category 9 monitoring andcontrol instruments other than industrial
monitoring and control instruments;-

21 July [2028 + X] for category 9 industrial
monitoring and control instruments.

13(b)(III)Cadmium and lead in glazes
used for reflectance standards

Expires on [date of publication in Official Journal+ 12 months] for categories 1 to 7 and 10.

13(b)(IV)

Cadmium in glazes used forreflectance standards

Applies to cat. 8 and 9 from [date of publicationin Official Journal + 12 months+ 1 day] on.
Expires on

13(b)(V)

Lead compound coatings ininfrared interference filters used-

21 July 2028 for category 8 medical
devices including in-vitro diagnostic
medical devices;-

21 July 2028 for category 9 monitoring andcontrol instruments other than industrial
monitoring and control instruments;-

21 July [2028 + X] for category 9 industrial
monitoring and control instruments.

Applies to category 9 industrial monitoring andcontrol instruments from [date of publication in
Official Journal + 12 months + 1 day] on.

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in infrared gas analysis and midfar-infrared spectroscopy

Expires on 21 July [2028 + X] for category 9
industrial monitoring and control instruments.

X can be a maximum of 3 years
When requested to comment on and explain any obstacles to the adoption of the above
proposal for the requested exemption for category 9 IMCI, (TMC 2023a) responded thatthey apply for renewal of exemption III-13(b) in its current wording and for the maximum
validity period, i.e., 7 years.
(TMC 2023a) emphasize the importance of retaining the initial wording and numbering as
published in the original RoHS annexes. Amending the scope of the exemption by changing
the application or substance restriction value has a significant administrative burden toindustry and negatively impacts the compliance.
Further, (TMC 2023a) highlight that industrial monitoring and control instrument
manufacturers have to manage suppliers’ declarations for hundreds of thousands of items.
Additionally, after reviewing the current state of the evolution of technology for the cat. 9
industrial measurement and control instruments, TMC members have difficulty inunderstanding how the rewording and relisting and/or splits recommended by the
consultants will lead to greater protection of human health and the environment comparedto the wording in its current form. The recommended rewording/split would only lead tosignificant unnecessary burden for stakeholders without commensurate benefits.
Therefore, (TMC 2023a) did not agree with the consultants’ proposed renewal as outlined
above.
The consultants note that TMC did not described any technical barriers to the adoption of
the recommendations made following the previous review of this exemption but base theirarguments on administrative burdens that would arise.

11.3.4. Environmental, health, safety, and socioeconomic impacts
While the publicly available version of the SEA does not report data on all individual
indicators, being economic impacts (losses in earnings before interest and taxes),
substitution costs, and social impacts, TMC also submitted a confidential version that
includes more specific data. (EPPA 2023) describe that SEA is based on informationcollected from surveying TMC member companies, which represent more than 70 % of theentire European Economic Area test and measurement equipment market.
In the consultants’ view, the described impacts seem plausible and in case the exemption
is not renewed, it cannot be excluded that the impacts occur as described. The consultantsdo, however, not recommend revoking the exemption, or restricting its scope so that cat. 9
IMCI would be excluded from the scope of the future exemption so, that no adverse
environmental or socioeconomic impacts can be expected to arise.
The consultants note that the amounts of Cd and Pb that have been stated by TMC to enter
the EU market annually through equipment being placed on the market appear very low. In
case of a future review of this exemption, applicants should be expected to provide moredetailed information on the basis of their estimates.

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11.3.5. Summary and conclusions
TMC request the 7-year renewal of exemption III-13(b) with its current wording for cat. 9
industrial monitoring and control instruments (IMCI) until 21 July 2031. Following theirmandate for this exemption, the consultants assessed whether the result of the previous
review of this exemption by (Deubzer et al. 2022) - which included cat. 9 IMCI - can be
adopted for cat. 9 IMCI in the light of the applicant at hand.
The applicants did not agree to the adoption of the renewal of this exemption recommendedby (Deubzer et al. 2022) on the basis that they do not see how the rewording and relisting
and/or splits recommended by the consultants will lead to greater protection of humanhealth and the environment compared to the wording in its current form. Further, theyemphasize that the rewording and splitting will lead to additional administrative burden
throughout the supply chain.
The consultants note that the splitting of exemption 13(b) into 13(b) series is already inforce, and that the previous review by (Deubzer et al. 2022) established that the integrationof the remaining categories covered by exemption 13(b) into the more specific 13(b) series
exemptions was feasible. TMC did not provide any arguments based on technicalimpracticability of the transition of equipment under category 9 IMCI from exemption 13(b)to 13(b) series. Therefore, although the consultants acknowledge that additional
administrative burdens associated with a managing conformity declarations of a potentiallylong list of affected equipment throughout the supply chains, as stated by TMC, may indeed
occur, it seems feasible to maintain the recommendations made by (Deubzer et al. 2022).
In line with the consultants’ mandate, this also applies to the validity periods recommendedby (Deubzer et al. 2022).
When requested to comment on this proposal, (TMC 2023b) did not agree, reiterating thatthey request the renewal of 13(b) with its currently valid wording and scope.

11.4.

Recommendation

The consultants recommend maintaining the exemption renewal proposed by (Deubzer et
al. 2022), which includes cat. 9 IMCI. However, it becomes necessary to adapt the validity
periods, as (Deubzer et al. 2022) proposed a shorter period until 21 July 2025 for categories
1 and 4, for which the previous applicants did not produce evidence that the exemption was
in fact required. As a publication of the COM’s decision will not be available at least 18
months before that date, therefore making it impossible for stakeholders to apply for arenewal of the exemption for these categories, the consultants recommend aligning thevalidity period with those recommended for categories other than 8, 9, and 11.
If the COM decides to follow the approach of (Deubzer et al. 2022), the below wording is
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No.

Exemption

Scope and dates of applicability

13(b)Cadmium and lead used in filter
glasses and glasses used forreflectance standards

Applies to categories 8, 9 and 11.

13(b)(I)

Lead in ion coloured optical filter
glass types

13(b)(II)Cadmium in striking optical filter
glass types; excluding
applications falling under point 39of this Annex

Expires on [date of publication in Official
Journal + 12 months] for-category 8 medical devices including invitro diagnostic medical devices;-

category 9 monitoring and control
instruments including industrial monitoring
and control instruments;-

category 11.

Applies to categories 1 to 7 and 10 and from[date of publication in Official Journal + 12
months + 1 day] to categories 8, 9 and 11.
Expires on-

21 July 2026 for categories 1 to 7, 10, and
11;-

21 July 2028 for category 8 medical
devices including in-vitro diagnostic
medical devices and category 9 monitoring
and control instruments including industrial
monitoring and control instruments;

13(b)(III)Cadmium and lead in glazes
used for reflectance standards

Expires on [date of publication in Official Journal+ 12 months] for categories 1 to 7 and 10.

13(b)(IV)

Cadmium in glazes used forreflectance standards

Applies to cat. 8 and 9 from [date of publicationin Official Journal + 12 months+ 1 day] on.
Expires on-

13(b)(V)

Lead compound coatings ininfrared interference filters used
in infrared gas analysis and midfar-infrared spectroscopy

21 July 2028 for category 8 medical
devices including in-vitro diagnostic
medical devices and category 9 monitoring
and control instruments including industrial
monitoring and control instruments;

Applies to category 9 industrial monitoring andcontrol instruments from [date of publication in
Official Journal + 12 months + 1 day] on.
Expires on 21 July 2028 for category 9 industrial
monitoring and control instruments.

If the COM wish to align the validity periods for different EEE categories to enable a joint
review in case a renewal was requested again in the future, an aligned renewal of all
categories for which the exemption is renewed is recommended until 21 July 2028. This
could be applied uniformly to the recommended exemptions 13(b)(I), 13(b)(II), 13(b)(IV),and 13(b)(V), for all covered EEE categories.

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The adverse socioeconomic impacts assessed by EPPA will not arise until 2028 since theconsultants do not recommend revoking the exemption but TMC will have to bear the costfor preparing and processing a renewal request prior to 2031, which they requested as
expiry date in their current renewal request.
Applicants’ feedback on the recommendation(TMC 2024 a/b) stated to favour and apply for the wording of option 1 with an extension of
the applicability dates for category 9 IMCI until 21 July 2031. They criticise that therecommendation favors a stronger consideration of the expiry dates recommended by
Deubzer et al. in the previous review to enable the review of the exemption for all categories
of EEE. This approach counters the RoHS Directive’s logic of having different productcategories with different validity periods and neglects the specificities of cat. 9 IMCI. The
recommendation increases business uncertainty and enhances the likelihood of negativesocio-economic impact across the EU as a consequence of potential pre-mature market
withdrawal.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

11.5.

References

Deubzer et al. (2022): Study to assess requests for renewal of 12 exemptions to Annex III of
Directive 2011/65/EU Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Final Report. Pack 23. In cooperation with von Dr. Otmar
Deubzer (Fraunhofer IZM and UNITAR], Jana Rückschloss (Fraunhofer IZM) und Christian Clemm(UNITAR). Hg. v. Publication Office of the European Union. European Commission (RoHS 28,
Pack 23). Retrieved from https://data.europa.eu/doi/10.2779/507661.
EPPA (2023): Socio-economic analysis. Of the impacts of non-renewal of Cadmium (Cd) and Lead
(Pb) exemption for test & measurement industrial type products (Category 9) Exemption 13(b) –Annex III. EPPA (RoHS 29). Retrieved fromhttps://rohs.biois.eu/TMC_SEA_Exemption_13(b)_2023_PUBLIC_VERSION.pdf.
Gensch et al. (2016a): Study to assess four renewal requests for RoHS 2 Annex III exemptions no.
7(b), no. 9(b), no. 13(a) and no. 13(b).(RoHS Directive). Report for the European Commission DG
Environment under Framework Contract No ENV.C.2/FRA/2011/0020 Assistance to theCommission on Technological Socio-Economic and Cost-Benefit Assessment Related to
Exemptions from the Substance restrictions in Electrical and Electronic Equipment. RoHS 12 (Pack7). In cooperation with von Carl-Otto Gensch, Yifaat Baron, Moch, Katja, Öko-Institut und Dr.
Deubzer, Otmar, Fraunhofer IZM. Retrieved fromhttps://circabc.europa.eu/faces/jsp/extension/wai/navigation/container.jsp.
MTE (2023): Answers to stakeholder questionnaire. RoHS Pack 27. MTE (RoHS 29). Retrieved
from https://rohs.biois.eu/MTE.pdf.
TMC (2023a): Request for renewal of exemption III-13(b). RoHS Pack 27 (RoHS 29). Retrieved
from https://rohs.biois.eu/RoHS_Application_Form_15.pdf.

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TMC (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Tobias Steinbrecher,
Eppa, to Christian Clemm. RoHS Pack 27. TMC (RoHS 29). Retrieved fromhttps://rohs.biois.eu/TMC_reply_Ex_III-13b_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024a): Answers to questionnaire 2 sent by Tobias Steinbrecher, Eppa, to Christian Clemm.
RoHS Pack 27. TMC (RoHS 29).
TMC (2024b): Comments on recommendation sent by Tobias Steinbrecher, Eppa, to ChristianClemm. RoHS Pack 27. TMC (RoHS 29).

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Exemption 15-series of Annex III: Lead in solders offlip chip packages
The below Table 12-1 shows the wording, scope and expiry dates of the exemption.
Table 12-1: Current wording of the exemption 15-series
No.

Current exemption wording

Current scope and dates ofapplicability

III-15

Lead in solders to complete a viable electricalconnection between semiconductor die andcarrier within integrated circuit flip chip packages

Applies to categories 8, 9 and 11.

III15(a)Lead in solders to complete a viable electricalconnection between the semiconductor die andcarrier within integrated circuit flip chip packages
where at least one of the following criteria
applies:-a semiconductor technology node of 90 nm orlarger;-a single die of 300 mm² or larger in any
semiconductor technology node;-stacked die packages with die of 300 mm² orlarger, or silicon interposers of 300 mm² orlarger.

Expires on-

21 July 2021 for category 8other than in vitro diagnostic
medical devices and category 9
industrial monitoring and control
instruments;-

21 July 2023 for category 8 invitro
diagnostic
medicaldevices;-

21 July 2024 for category 9
industrial monitoring and control
instruments, and for category
11

Applies to categories 1 to 7 and
10.
Expires on 21 July 2021 forcategories 1 to 7 and 10.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

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Acronyms and Definitions
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

FCP

Flip chip package

IMCI

Industrial monitoring and control instruments

Lead-free

Not containing lead in the applications covered by the scope of the
exemption to be reviewed

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive

TMC

Test & Measurement Coalition

12.1.

Background and technical information

On 20 January 2023, (TMC 2023a) submitted a request for the renewal of exemption III-15
with its current wording for the maximum validity period of 7 years as shown in the below
table.
Table 12-2: Wording and scope of the requested exemption renewal
No.

Requested exemption

Requested scope and dates
of applicability

III-15

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

Applies to category 9 industrial
monitoring and control instruments
and expires on 21 July 2031
(2024 +7 years)

12.1.1.

History of the exemption

The exemption was added to the Annex of RoHS 1 in 2005 after a review of the related
exemption request by (Goodman 2004) with an expiry date in 2010. (Zangl et al. 2010)
reviewed the exemption in 2008/2009 under RoHS 1. The consultants recommended toextend the exemption’s validity until 2014, the maximum allowed validity period for
exemptions under RoHS 1. Exemption 15 was transferred to Annex I of RoHS 2, and the
maximum validity period was thereby extended to July 2016. Upon a request for renewal,(Gensch et al. 2016) reviewed the exemption under RoHS 2 resulting in the split of the
exemption into exemption 15, which maintained the previous status of the exemption for217

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EEE of cat. 8 and cat. 9, and introduced exemption 15(a) with a restricted scope for theother categories of EEE in the scope of RoHS.
The exemption was reviewed again in 2021/2022 by (Deubzer et al. 2022). Applicants had
requested the renewal of exemption 15 for a specific application, and of exemption 15(a)for EEE of categories 1 to 11. (Deubzer et al. 2022) recommend not to renew theexemptions because the applicants failed to demonstrate that the exemption was stillrequired so that recommending the exemption to be granted would have infringed Art.
5(1)(a) in the consultants’ understanding.
In case that the COM decide to still grant the renewal of exemption 15(a), (Deubzer et al.
2022) recommended the expiry of exemption 15 and the integration of cat. 8, 9 and 11 into
the scope of the renewed exemption 15(a).
Table 12-3: Potential renewal of exemption III-15(a)No.

Exemption

Scope
and
applicability

15

Lead in solders to complete a viable electricalconnection between semiconductor die andcarrier within integrated circuit flip chip packages

Applies to categories 8, 9 and 11.

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

Applies15(a)-a semiconductor technology node of
90 nm or larger;-a single die of 300 mm2 or larger in any
semiconductor technology node;-stacked die packages with die of
300 mm2or larger, or silicon interposers of
300 mm2 or larger.

dates

of

Expires on [date of publication in
Official Journal + 12 months] forcategories 8, 9 and 11-

to categories 1-7 and 10-

from [date of publication in
Official Journal + 12 months+ 1 day] on, to cat. 8, 9 and11Expires on [DATE] for categories 1
to 11.

Source: (Deubzer et al. 2022)

12.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status March 2024). The applicant therefore
applied for the renewal of the current exemption 15 for cat. 9 IMCI since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE. The exemption thus becamedue for review even though the recommendation for the renewal of exemptions 15 and 15(a)of (Deubzer et al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Deubzer
et al. 2022) can be adopted to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Deubzer et al. 2022) is not intended. The consultants will rely on the

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critical review conducted by the previous consultants and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

12.1.3.

Summary of the renewal request by (TMC 2023a)

Exemption Annex III, 15 permits lead in solders to complete a viable electrical connection
between semiconductor die and carrier within integrated circuit flip-chip packages and iscurrently in force for Industrial Monitoring and Control equipment. Alternatives have entered
the market in recent designs, a change to 15(a) restricting Pb-containing solder by die andnode size has occurred, and some older components have been updated with thesechanges. However, there are still a significant number of suppliers that have notinvestigated or implemented these changes.
Given the intrinsic physical and technical characteristics of lead, solders containing Pb
exhibits certain advantages that lead-free solders lack, including:•

Solders containing lead are more ductile and softer than Pb-free alternatives andcan therefore better absorb stresses originating from mismatch in the coefficient ofthermal expansion between semiconductor die and carrier. Subsequently, they areless prone to develop solder cracks.

•

The die attach reflow temperature is reduced given the lower melting temperatureof eutectic tin-lead solders. Consequently, the internal package stress during flipchip die attach is reduced. Package failures, including package material interface
delamination (the glue under the chip delaminates from the package substrate) arehence prevented.

•

An additional failure mechanism for packages with flip-chip die is electro-migration.
This mechanism causes solder joint failure when high current density (amps per
square millimetre) causes atoms to migrate from one side of the joint to the other,
depleting metal at the connection. Exemption 15(a) has been defined to address
this; however, many suppliers have not yet investigated or implemented the effectof this change.

The T&M Coalition acknowledges that there are suitable alternatives available to substitutelead in solders for new components into newly designed instruments. Indeed, industry has
demonstrated a strong commitment to developing lead-free flip-chip devices as newtechnologies become available.
However, while exemption 15 will be designed out over time as new lead-free components
become available, a continuation of exemption 15 for category 9 industrial test andmeasurement instruments is still warranted as these lead-free components cannot be used
for existing T&M products. Additionally, given the long lifetime of T&M instruments as wellas the greater inventory of older parts used for the repair of products currently placed on
the market, a discontinuation of exemption 15 for category 9 products would counter the
logic of an increased circular economy and create avoidable EEE waste.
A thorough Socio-Economic Analysis was conducted in addition to the technicalassessment and attached to this submission, further illustration the negative socioeconomic impacts a non-renewal of exemption 15 would have. Overall, the analysis

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concludes that the total impact of a non-renewal of this exemption is monetized in the rangeof 309 million EUR and 442 million EUR (conservative lower bound estimate).

12.1.4.

Technical description of the exemption and use of the restricted
substance

A technical description of this exemption was provided by (Deubzer et al. 2022) and(Gensch et al. 2016). The information and facts provided by the applicant were addressedin these previous reviews.

12.1.5.

Amount(s) of restricted substance(s) used under the exemption(TMC 2023a) estimate around 1.3 kg of lead to be placed annually on the EU market inapplications in the scope of the exemption. This figure is based on information provided by
the TMC members. Since not all cat. 9 IMCI producers are members of TMC, the actual
amount of lead could be higher.

12.2.

Justification of the requested exemption(TMC 2023a) reference their thorough socioeconomic analyses performed by (EPPA 2023)
in view of providing regulators with evidence-based findings on the expected social andeconomic impacts that are expected to occur should the use of lead (Pb) be impacted by
the non-renewal of the RoHS exemption.
In line with the existing official guidance from ECHA on the preparation of the SocioEconomic Analysis, the SEA therefore gathers technical and economic information todescribe ex-ante in both qualitative and (if feasible) quantitative terms the (orders ofmagnitude of) socio-economic impacts TMC ell as the relevant EEA supply chain andsociety are expected to face from the non-renewal of the lead (Pb) exemption in solders tocomplete a viable electrical connection between semiconductor die and carrier within
integrated circuit flip chip packages, which would otherwise expire on 21 July 2024.
(EPPA 2023) inform that many suppliers have implemented lead-free alternatives on the
EU market for test & measurement industrial type products, or have changed the applied
exemption to 15(a) with restrictions on die and node size. In the sector of the participatingcompanies, there are still some niche and specialty suppliers with components claiming
exemption 15 and not exemption 15(a). The components either meet the uniquerequirements of the sector, such as more demanding precision, performance, or reliability
or are older parts that are still used in the product designs of the TMC members from 5 to
20 years ago. The sector of the participating companies has long-lived product designs thatare still in demand by their customers. The re-designing of the test & measurement
equipment could take four to six years per product line. Hence, losing the ability to apply
Annex III, exemption 15, when considering RoHS conformity for the associated test andmeasurement industrial products would entail the development of a fairly large number of
new alternative, compliant materials, as well as the increased costs connected to theredesign, retesting, requalification, and replacement of the assembly process.

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12.2.1.

Substitution and Elimination of the restricted substance

The status of substitution and elimination of lead in the applications in scope of thisexemption was discussed by (Deubzer et al. 2022).

12.2.2. Environmental, health, and safety impacts(EPPA 2023) inform that participating TMC member companies report no releases to theenvironment of lead can be anticipated during neither equipment production nor use phasesof the concerned products over the next seven years as a consequence of the revocationof the RoHS exemption. During equipment production, the lead is not exposed because it
is internal to the component. At component manufacturers level, exposure and waste andexposure to lead is considered controlled through good occupational health and safety
management practices.
Under normal conditions of equipment use, the lead content associated with the applicationof the exemption is encapsulated within the equipment enclosure and will neither betouched nor released to the environment. As this equipment is sold B2B for
professional/industrial use only, equipment that finally reaches end-of-life will beappropriately processed by professional recyclers who are obligated to have suitable
controls to avoid any environmental releases and are notified of the presence of thesubstance under the producers’ obligation to provide a SCIP notification.
The TMC member companies have only indicated a minor risk for substances to be released
to the environment during the manufacture of the components. These are not produced by
TMC members. Thus, data are not available, however the estimate is expected to bebounded by the total use of the substance (i.e., release to the environment is expected tobe less than the mass of substance incorporated into the components).
(EPPA 2023) are of the opinion that due to the participating TMC member companies’
relatively low consumption of parts, in comparison to the product Categories 1-7 and 10,
renewing this exemption for Category 9 will have a minimal impact on the environment.
Category 9 Industrial producers are only responsible for 0.2 % of annual WEEE production.
cat. 9 IMCI contribute to the Waste Electrical and Electronic Equipment stream only around
0.2 % by weight of EU WEEE, with industrial WEEE being collected through B2B systems.
Consequently, the environmental impact of cat. 9 IMCI is negligible.
(EPPA 2023) expect “[ ] no, or at least minimal, expected additional waste before the endof the regular lifetime (non-compliant stock) reported by the companies. Finished goods
inventory is typically minimal as T&M equipment manufacturers’ production is based on
short-term demand, or even per order. Any non-compliant materials will be consumed
through sale into markets where there isn’t a similar restriction“. TMC member
manufacturers of cat. 9 IMCI emphasise, however, that the exemption is utilized in part toimprove reliability and longevity of components. A reduced product lifetime would be
expected leading to an increase in electronic waste and virgin material use in thereplacement in apparent conflict to the concepts proposed under the proposed Eco-design
for Sustainable Product Regulation. Moreover, in the case of a discontinuation of exemption
15 for category 9 products, factories using products with older designs may need to re-tool
their test process, adding to electronic waste from the replaced equipment.

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The majority of the components that utilize this exemption, which constitute Category 9
industrial usage, are common to all product categories. The component manufacturers
therefore rely on volume use of the other categories to justify their continued production.
Renewing this exemption only for Category 9 for the full 7 years will not extend the
production life of these higher volume components beyond the exemption renewal period
assigned to Categories 1-7 and 10. It will, however, enable the Test & Measurement
coalition members to buy sufficient (relatively small) quantities to update the design andcontinue to use the relevant components for an extended period. As a result, a renewal ofthis exemption will a minimal environmental impact and has a positive socio-economic
impact by enabling the continued production of Category 9 products critical to the healthand welfare of the EU (and global) society whilst the multi-year redesign process is
executed.

12.2.3.

Socioeconomic impacts(EPPA 2023) prepared a socio-economic analyses (SEA) for TMC showing the impacts
which a non-renewal of the exemption for cat. 9 IMCI would cause. (EPPA 2023) declarethat the SEA was prepared in line with the official ECHA guidance on the preparation of theSocio-Economic Analysis. The SEA is based on information and data gathered from theindustrial and professional test and measurement equipment manufacturers. A survey has
been conducted by providing a detailed questionnaire to gather information and data fromactors likely to be affected by a non-renewal of the RoHS exemption in the EU. TMC
member manufacturers of cat. 9 IMCI participated in the survey. The market sharecovered by this survey represents approximately 70 % of the EEA market so that (EPPA2023) consider the survey as highly representative so that it can serve as a basis for defining
the anticipated socio-economic impacts resulting from the non-renewal of the RoHS
exemption.
Overall, the total impact of a non-renewal of this exemption is monetized in the range of 309
million EUR and 442 million EUR (conservative estimates in net losses; potential gains for
suppliers of other components have been already taken into account). (EPPA 2023)
calculated the above total economic impacts by summarising business impacts on
manufacturers, impacts on the wider economy and social impacts caused byunemployment.
Further details are available in the report prepared by (EPPA 2023).

12.2.4.

Roadmap towards substitution or elimination of the restricted
substance

As to their actions taken to develop further potential lead-free alternatives, (TMC 2023a)
acknowledge that there are suitable alternatives available to substitute lead in solders for
new components into newly designed instruments. Indeed, industry has demonstrated astrong commitment to developing lead-free flip-chip devices as new technologies become
available.
However, while exemption 15 will be designed out over time as new lead-free components
become available, a continuation of exemption 15 for category 9 industrial test andmeasurement instruments is still warranted as these lead-free components cannot be used
for existing T&M products. Additionally, given the long lifetime of T&M instruments as well222

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as the greater inventory of older parts used for the repair of products currently placed on
the market, a discontinuation of exemption 15 for category 9 products would counter the
logic of an increased circular economy and create avoidable EEE waste.
As to their roadmap to achieve RoHS compliance without exemption 15, (TMC 2023a)
understand that new products can be designed to use lead-free components that utilize therestricted scope of exemption 15(a), the challenges of substitution are substantial for thevast majority of their portfolio that are in production but may have been designed while only
exemption 15 was available.
Components which benefit from exemption 15 typically do not have form-fit-function dropin replacements that are either lead-free or can benefit from exemption 15(a). Older productdesigns utilizing exemption 15 components would therefore need to be redesigned to match
new component parameters, including a revised layout for PCB. Such changes require
product-by-product projects to manage the change, including verification of each productagainst published performance specifications.
For products that will be newly designed, members of the Test & Measurement Coalition
have pointed out that they mainly rely on their suppliers to find alternatives since most of
the exemptions used in their products are not produced on-site by the company but bought
off-the-shelf from suppliers. Therefore, meeting with suppliers to understand their (potential)
alternatives, getting samples, measuring, and testing is the typical process to evaluate thesuitability of potential alternatives which can take up to 4 years, as reported by thecompanies. The process would then be followed by the validation of the potential suitable
alternatives accompanied by testing done by the manufacturers of the finished T&M
equipment, with the validation of the functionality and performance being their responsibility
as well. However, the companies noted the impacts deriving from their suppliers as,
depending on the complexity, there can be little to significant time and resources needed tovalidate alternatives.
The companies reported that the validation period alone would take a minimum of 6 months
and up to a year after the delivery of suitable alternatives per product. It is significant to notethat this validation period would only apply if the component were a fit, form, and function
drop-in replacement. If any design changes to the exemption-free part of the product would
be required to accommodate for the alternative, an additional validation period would be
required for each redesigned product that used to utilize the component that relied on the
exemption. Moreover, the validation would lead to the organizations incurring additional
expenses. These include labour costs and costs arising from potential product resubmission
requirements for testing to various notified bodies to ensure that substitution does not create
any electrical and functional safety concerns.
Contrary to the statement of the Commission’s external consultant BIOIS, made in the
recent exemption assessment report (pack 23, i.e., (Deubzer et al. 2022), the Test and
Measurement sector did not start incorporating lead-free components (much less in leadfree flip chip) in 2007. In fact, customers of T&M equipment demand continued sales of
products designed before this sector’s compliance date of 2017; this allows their
manufacturing test processes to have consistent equipment and software. Re-design ofthese older products with new-technology components is not feasible or practical becauseof the number of products and relatively low volume and thus lower payback.
If a new substance free part is available, this part must be qualified for use by performing avariety of tasks, as described above. Due to the complexity and diversity of the applications,223

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this must be done individually by each company for each product group. This process would
divert resources from other projects and increase the cost to ensure continued availabilityof these products. This validation and testing process varies according to part complexity;
which can be categorised as low, medium, and high:•Low complexity parts are the off-the-shelf components or hardware parts that do
not have a substantial performance impact. Replacement can be done based on
supplier information, assuming a form/fit/function compliance, with standard
manufacturing, testing, and validation processes. Based on process timescales
reported by a T&M coalition company, the average time that it can take for theseparts to be replaced ranges from 3 to 6 months.

•

Medium complexity parts are more complex sub-assembly electronic parts, suchas small motors which need additional validation for their performance. These parts
are often commercial assemblies that are generally available to the electronic
industry, and are utilised by the Test & Measurement coalition companies.
Replacement of these assemblies, like-for-like, requires testing and validation prior
to being integrated into the manufacturing process. The average time to find analternative for medium complexity parts for production is reported to range from 6 to
12 months.

•

High complexity parts are complex sub-assembly parts and have a significant
impact on the performance of the companies’ products. These also have a criticalrole in the overall safety of the products. These parts need to go through extensive
validation for performance and/or compliances, according to varying regulations,
before the appropriate files can be updated and the proper competent authorities orregulatory bodies can be notified prior to the purchase of parts for validation. The
average time that it would take to find an alternative for high complexity parts for
production is up to 1 year of additional testing. Where the exemption directly impacts
the performance of that component (e.g., a centrifuge rotor) the evaluation of thereplacement could take 3 to 5 years.

12.3.
12.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of the exemption 15series in EEE of cat. 9 IMCI.

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Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

12.3.2.

Substitution and elimination of the restricted substanceTransfer of cat. 9 IMCI from the scope of exemption 15 to exemption 15(a).
In the last review of exemptions 15 and 15(a) conducted by (Deubzer et al. 2022), theapplicants had proposed transferring cat. 8, 9 and 11 from exemption 15 into the scope of
exemption 15(a). TMC were asked whether they agree that the current wording of
exemption 15(a) covers the applications of lead in flip chip packages (FCPs) for use in cat.
9 IMCI.
(TMC 2023c) did not agree and explain that exemption III-15 permits lead in solders tocomplete a viable electrical connection between semiconductor die and carrier within
integrated circuit flip-chip packages and is currently in force for cat. 9 IMCI. Alternatives
have entered the market in recent designs and a change to 15(a) restricting Pb-containing
solder by die and node size has occurred. However, there are still a significant number ofsuppliers that have not investigated or implemented these changes.
Considering that exemption 15(a) was introduced in 2016, it is remarkable that suppliers
should not even be informed about these changes. Technically, the applicants’ answer is
implausible. The current wording of exemption 15(a) represents the technical status of leadfree FCPs at the time of the last review conducted by (Gensch et al. 2016), predating thereview by (Deubzer et al. 2022). The current wording was proposed by the applicants in2015 including manufacturers of such FCPs. To the consultants’ best knowledge fromprevious reviews, FCPs with nodes of less than 90 nm were from the time of introduction
designed to be assembled with lead-free solders, i.e. they cannot be assembled with leadcontaining solders. It can be assumed that the same applies to the other types of FCPs in
the scope of the two other sub-clauses of exemption 15(a).
The applicant did not provide any information that would have given reasons to disprove
the above statement. TMC was requested to provide examples of lead-containing FCPs
which their members use, and which would not be covered by exemption 15(a).
(TMC 2024) answered that the submitted SEA document provides a detailed description of
the TMC products, whereas the product portfolios are widely diversified, with TMC members
each having typically 2,000 to 3,000 products currently made available on the EEA market.
These are highly complex, sophisticated electronic instruments, which can have between
2,000 and 40,000 parts and therefore rely on a vast supply chain involving tens of
thousands of suppliers and hundreds of thousands of items. The Annex of the SEA
document contains further details concerning the product groups and equipment types that
benefit from the current exemption III-15. Please also note that the product groups
mentioned in the annex of the SEA document exemplify the types of products concerned,
but do not represent an exhaustive list of each and every category 9 industrial productcurrently benefiting from exemption III-15.
Given the complexity of category 9 industrial test and measurement instruments and thevast supply chain as well as the short deadline to respond to this follow-up question (1225Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU

week), it is impossible for TMC members to confirm with the necessary due diligence andcertainty that the proposed continuation of only exemption III-15(a)40 covers all applications
currently benefiting from exemption III-15.
As regards the obsolete parts where TMC members consume last-time-buy inventory forthe remaining life of the product - the typical active life of TMC products is 10 years (i.e.
being placed on the market) - it is impossible to reach out to the supplier and get a
confirmation, as the supplier would not provide this information for obsolete parts.
Without this information from the supply chain, it is not possible to definitively state thedefinition for exemption III-15(a) covers all applicable uses in the components used to
produce test and measurement equipment benefitting from Exemption III-15 today.
In addition, TMC would like to highlight again that members acknowledge that there aresuitable alternatives available to substitute lead in solders for new components in newly
designed instruments. However, while exemption III-15 will be designed out over time as
new lead-free components become available, a continuation of exemption 15 for category
9 industrial test and measurement instruments is still warranted as these lead-freecomponents cannot be used for existing T&M products. Given the typical active lifetimeof 10 years of T&M instruments as well as the greater inventory of older parts used for the
repair of products currently placed on the market, a discontinuation of exemption III-15 forcategory 9 products would counter the logic of an increased circular economy and create
avoidable EEE waste.
As detailed in the SEA, the total monetized impact of a non-renewal is estimated in therange of 309 million EUR and 442 million EUR.
Lastly, we would like to highlight again that after reviewing the current state of the evolutionof technology for the cat. 9 industrial measurement and control instruments, TMC members
have difficulty in understanding how the narrowing down of the scope of exemption III-15
as suggested by the consultants will lead to greater protection of human health and theenvironment compared to the wording in its current form. This holds especially true when
considering that cat. 9 industrial test and measurement instrument contribute to only afraction of 1% of the total annual quantities of RoHS restricted substance (please refer tothe SEA document for details). The recommended scope reduction would only lead tosignificant unnecessary burden for stakeholders without commensurate environmental
and/or human health benefits.
In conclusion, TMC maintains that a renewal of exemption III-15 in its current wording iswarranted according to article 5 of the RoHS Directive.
The above reply repeats non-technical statements that have been expressed in the renewal
request and in the SEA. The applicants do not answer the technical question nor can theanswer be found in the SEA of (EPPA 2023). They cannot provide a single example of a
FCP used by TMC members that would not be covered by exemption 15(a).

40 TMC: In a previous questionnaire sent to TMC members by the consultants, it was suggested that only

exemption III-15(a) would be recommended to continue beyond the initial expiry date of 21 July 2021 by an“x” number of years, whereas x could range between 0 – 7 years. Although this information is not mentioned
in this document, it is assumed that the consultants refer to the possibility of extending exemption III-15(a)by a maximum of 7 years as opposed to also continuing exemption III-15 in its current wording beyond theexpiry date of 21 July 2024 for cat. 9 IMCI.

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The consultants therefore conclude that the applicant has no technical arguments against
the inclusion of cat. 9 IMCI into the scope of exemption 15(a).
Open questions from the previous review by (Deubzer et al. 2022)
The below core questions remained open in the previous review of exemptions 15 and 15(a)so that (Deubzer et al. 2022) recommended the expiry of exemption 15 and exemption
15(a). The applicant was therefore requested to answer these open questions:•First clause of exemption 15(a)Flip chip packages (FCPs) with technology nodes larger than 90 nm are still placedon the EEA market in new EEE. These older FCP models cannot be redesigned toenable the use of lead-free solders but smaller node lead-free FCPs have been
available since 2007. Cat. 9 IMCI will have been in the scope of the RoHS Directive
2011/65/EU since 2011, i.e. for 13 years, when exemption 15 will expire in 2024.
Please explain why FCPs with technology nodes larger than 90 nm are still requiredin cat. 9 IMCI for another 7 years until 2031 in the presence of lead-free alternatives
since 2007, and 20 years after cat. 9 IMCI were adopted to the scope of the RoHS
Directive.

•

Second clause of exemption 15(a)The applicants claim that the use of lead is scientifically and technicallyimpracticable for FCPs with dies of 300 mm2 or more, independently from thetechnology nodes. The review process revealed that larger die size FCPs (single
dies and stacked) with smaller technology nodes can be produced with lead-freesolders. The applicants did not provide information as to which die size (> 300 mm²)
and technology nodes FCPs can be produced with lead-free solders.

•Third clause of exemption 15(a)The review of exemption 15/15(a) by (Gensch et al. 2016) showed that using
plastic/organic interposers instead of silicon interposers enables lead-free solderingof stacked die FCPs with interposers of 300 mm² and more. In the last review by
Deubzer et al. (2022), applicants stated that the usability of plastics instead of siliconinterposers has its limits and, among others, depends on the number of connections
between adjacent dies in the FCP. The applicants failed, however, to explain theconditions and limitations for the use of organic interposers, or why these conditions
are not adequate to restrict the exemption scope. The actual scientific and technicalpracticability of lead-free soldering in FCPs with large (≥ 300 mm²) interposers
remained unclear.

•

Please explain the conditions – or sets of conditions – that require the use of siliconinterposers for interposer sizes ≥ 300 mm² instead of organic interposers. Pleasealso take into account whether and how far the chiplet technology and/or the use ofsilicon bridges instead of silicon interposers enable the use of lead-free solders insuch FCPs.

When asked to provide insights into these open questions, (TMC 2024) repeat earlier
statements about suitable substitutes that can be used in newly designed instruments, andthat they will design out over time exemption 15 as new lead-free components become
available. Additionally, given the long lifetime of T&M instruments as well as the greater
inventory of older parts used for the repair of products currently placed on the market, a227

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discontinuation of exemption 15 for category 9 products would counter the logic of anincreased circular economy and create avoidable EEE waste.
(TMC 2024) state to have further outlined in the submission documents that components
which benefit from exemption 15 typically do not have form-fit-function drop-in replacementsthat are either lead-free or can benefit from exemption 15(a). Older product designs utilizing
exemption 15 components would therefore need to be redesigned to match new component
parameters, including a revised layout for PCB. Such changes require product-by-productprojects to manage the change, including verification of each product against publishedperformance specifications.
Taking additionally into account the socio-economic consequences of a nonrenewal of
exemption III-15, which is monetised in the range of 309 million and 442 million EUR , TMC
considers that a renewal of exemption III-15 is warranted in accordance with RoHS art.
5(1)(a).
The above reply repeats non-technical statements that have been expressed in the renewal
request and in the SEA. Neither does it answer the technical questions nor can the answer
be found in the SEA of (EPPA 2023). Adding to this, TMC still speak about using lead-free
FCPs once they become available, ignoring that (Gensch et al. 2016) and (Deubzer et al.
2022) found such alternatives to have been available since 2007, for more than 15 years
already, at least for the FCPs in the scope of the first sub-clause of exemption 15(a). TMC
do not provide any technical argument as to why the exemption has still been used in new
cat. 9 IMCI placed on the European Economic Area market, and why this exemption should
be renewed for another 7 years to allow the continued use of such FCPs.
The consultants conclude that the question why FCPs covered by that sub-clause are stillused in cat. 9 IMCI as well as the status of lead-free soldering in FCPs addressed in
subclauses 2) and 3) of exemption 15(a) remain unclear like in the previous review by(Deubzer et al. 2022)

12.3.3.

Environmental, health, safety and socioeconomic impacts

TMC state that cat. 9 IMCI contribute to the Waste Electrical and Electronic Equipment(WEEE) stream only around 0.2 % by weight of EU WEEE so that the environmental impact
of cat. 9 IMCI is negligible. They also state that there is no exposure of humans and theenvironment to lead contained in FCPs during manufacturing and use of cat. 9 IMCI.
The current RoHS Directive does not define any thresholds for use of restricted substancesor contributions to the overall waste generation for which Art. 5(1)(a) would justify granting
an exemption if these thresholds are not exceeded. Exemptions are to be granted in linewith Art. 5(1)(a) if – next to “REACH-compliance” - any of its three sub-clauses (cf. section
12.3.4 on page 229) is fulfilled.
TMC address environmental, health and safety impacts but do not claim that the third subclause of Art. 5(1)(a) would be applicable, which would require a more detailed and lifecycle-oriented assessment. For example, potential impacts on workers by exposure in thewaste treatment and at the end of life of devices in general would have to be considered,as well as impacts arising in the mining and refining of lead.
(EPPA 2023) quantify the economic impacts of a non-renewal of the exemption with 309
million EUR to 442 million EUR, which they summarise from business impacts on cat. 9228

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IMCI manufacturers, impacts on the wider economy and socioeconomic impacts cause by
unemployment. The individual contributions of each of these types of impacts are marked
as confidential and are not publicly available. Even though not explicitly stated, the data for
the SEA seem to have been collected from TMC member companies which, according to(EPPA 2023), cover 70 % of the EEA market.
The consultants base their recommendation on the result of the technical assessment in
the light of the three sub-clauses of Art. 5(1)(a). If the exemption will not be granted on thisground, the consultants cannot exclude that adverse impacts described by TMC/EPPA (cf.
section 12.2.2 on page 221) arise. The consultants consider beyond their mandate any
judgement as to which degree of socioeconomic impact would justify granting an exemption
on socioeconomic grounds in the case that none of the three sub-clauses of Art. 5(1)(a) isfulfilled. 41

12.3.4.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria42 is fulfilled:11) their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;
12) the reliability of substitutes is not ensured;
13) the total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.
(TMC 2023a) request the 7 year renewal of exemption 15 claiming that this exemption isrequired to allow the continued placing on the market of cat. 9 IMCI. In the previous review
of exemptions 15 and 15(a), (Deubzer et al. 2022) recommended not to renew these
exemptions. The applicants failed to provide evidence as to how far substitution or
elimination of lead are scientifically and technically practicable in applications within thescope of the current exemption III-15(a).
TMC could not provide this information either but put forward their complex supply chain on
which they rely to obtain such information, and which their suppliers do not have available.
In the consultants’ understanding, applicants are responsible to organise the expertise
required to substantiate exemption renewal requests with the required expertise, and to beable to answer technical questions adequately. The critical review shows that TMC could
not answer technical questions adequately. RoHS compliance and the related efforts are
the responsibility of EEE producers, not of the supply chain.
(Deubzer et al. 2022) presented a fallback option for the case that the COM decide to renew
the exemption (cf. Table 12-3 on page 218) which implies the renewal of exemption III-15

41 Art. 5(1)(a) stipulates that any of the three sub-class must be fulfilled, and that decisions on the inclusion ofmaterials and components of EEE in the lists in Annexes III and IV shall take into account thesocioeconomic impact of substitution.
42 Differently from Art. 5(1)(a) in the RoHS Directive, the criteria are numbered so that they can be addressedin the below text.

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as the currently still valid exemption III-15(a) for cat. 9 IMCI. TMC reject adopting thisapproach insisting on the 7 year renewal of exemption 15 as requested and claiming thatexemption 15(a) would not cover all applications of lead in the scope of exemption 15(a).
Upon request, TMC could, however, not provide any specific example of lead-containing
FCPs used in cat. 9 IMCI which exemption 15(a) would not cover. Technically, TMC’s claim
is not plausible either because FCPs that are not in scope of the current exemption 15(a) in
the consultants understanding were designed to be assembled with lead-free solders.
In the light of the above situation, the consultants recommend adopting the recommendationof (Deubzer et al. 2022) and not to renew exemption III-15 for cat. 9 IMCI.
The consultants cannot exclude that adverse socioeconomic impacts described by theapplicant (cf. section 12.2.3 on page 222) arise at least to some degree if the exemption is
not renewed for cat. 9 IMCI.

12.4.

Recommendation

In the light of the information made available by the applicant, the consultants propose
adopting the recommendation of (Deubzer et al. 2022) in the previous review of exemptions
15 and 15(a), which was not to renew the exemptions. The applicants did not answer
technical questions, including those that had remained open in the previous review, andwhich resulted in the above recommendation not to renew the exemption. In the consultants’
understanding, recommending the exemption to be granted would infringe Art. 5(1)(a) in theabsence of clear evidence to which degree the substitution of lead in FCPs is stillscientifically and technically impracticable.
The consultants cannot exclude that adverse socioeconomic impacts described by theapplicant may arise if the exemption is not renewed for cat. 9 IMCI. The consultants consider
beyond their mandate any judgement as to which degree of socioeconomic impact would
justify granting an exemption on socioeconomic grounds if none of the three sub-clauses ofArt. 5(1)(a) is fulfilled.
If the COM decides to renew the exemption, the consultants recommend adopting thewording and scopes proposed by (Deubzer et al. 2022) for this case:
No.

Exemption

Scope
and
applicability

15

Lead in solders to complete a viable electricalconnection between semiconductor die andcarrier within integrated circuit flip chip packages

Applies to categories 8, 9 and 11.

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

Applies to category 9 industrial
monitoring and control instrumentsfrom [date of expiry of exemption
15 + 1 day] on

15(a)

-

dates

of

Expires on 21 July 2024 [ifapplicable: date of publication in
Official Journal] + 12 or 18 months
for categories 8, 9 and 11

a semiconductor technology node of 90 nm orlarger;230

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a single die of 300 mm2 or larger in any semiconductor technology node;-stacked die packages with die of 300 mm2orlarger, or silicon interposers of 300 mm2 orlarger.

Expires on [DATE] for category 9
industrial monitoring and control
instruments

The COM may consider a short-term expiry date for the above renewed exemption 15(a)defined by the time required to prepare and timely submit renewal requests.
Applicant’s feedback on the recommendation(TMC 2024a) do not agree to the recommendation refering to the statements in theirapplication documents and pointing out that Article 5(1)(a) of the RoHS Directive requiresthat decisions on granting exemptions need to consider the socioeconomic impact of
substitution.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a) and the mandate
commissioned by the COM for the review of this exemption.

12.5.

References

Deubzer et al. (2022): Study to assess requests for renewal of 12 exemptions to Annex III of
Directive 2011/65/EU Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Final Report. Pack 23. In cooperation with Dr. Otmar
Deubzer (Fraunhofer IZM and UNITAR], Jana Rückschloss (Fraunhofer IZM) und Christian Clemm(UNITAR). Hg. v. Publication Office of the European Union. European Commission (RoHS 28,
Pack 23). Retrieved from https://data.europa.eu/doi/10.2779/507661.
EPPA (2023): Socio economic analysis of the impacts of non renewal of the Lead (Pb) exemption
for the test & measurement industrial type products category 9, Exemption 15 Annex I II ’, T&M
Coalition, January 2023, Report for T&M Coalition. RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/TMC_SEA_Exemption_15_2023_PUBLIC_VERSION.pdf.
Gensch et al. (2016): Assistance to the Commission on Technological, Socio-Economic and Cost Benefit Assessment Related to Exemptions from the Substance Restrictions in Electrical andElectronic Equipment - Study to assess renewal requests for 29 RoHS 2 Annex III exemptions.
RoHS 14. In cooperation with Carl-Otto Gensch, Yifaat Baron, Markus Blepp, Katja Moch, Susanne
Moritz, Oeko-Institut und Dr. Deubzer, Otmar, Fraunhofer Institut Zuverlässigkeit und
Mikrointegration IZM (Adaptation to Scientific and Technical Progress of Annexes III and IV of
Directive 2011/65/EU, RoHS XIV). Retrieved from https://circabc.europa.eu/sd/a/eda9d68b-6ac94fb9-8667-5e561d8c957e/RoHS-Pack_9_Final_Full_report_Lamps_Alloys_Solders_June2016.pdf.
Goodman, Paul (2004): Technical adaptation under Directive 2002/95/EC (RoHS) - Investigation ofexemptions. Final Report. ERA Report 2004-0603. In cooperation with Philip Strudwick, Robert
Skipper. Retrieved fromhttp://ec.europa.eu/environment/waste/weee/pdf/era_technology_study_12_2004.pdf, Last updated
05.12.2013.

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TMC (2023a): Request for renewal of exemption III-15 series. RoHS Pack 27 (RoHS 29). Retrieved
from https://rohs.biois.eu/RoHS_Application_Form_15.pdf.
TMC (2023c): Answers to questionnaire 1 (clarification questionnaire). RoHS Pack 27 (RoHS 29).
Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_15_2023_PUBLIC_VERSION.pdf.
TMC (2024): Answers to questionnaire 2 sent by Tobias Steinbrecher, EPPA, to Dr. Otmar
Deubzer. RoHS Pack 27 (RoHS 29).
TMC (2024a): Feedback on the recommendation for renewal of exemption III-15 sent by Tobias
Steinbrecher, EPPA, to Dr. Otmar Deubzer. RoHS Pack 27 (RoHS 29).
Zangl et al. (2010): Adaptation to scientific and technical progress of Annex II to Directive
Adaptation Directive2000/53/EC (ELV) and of the Annex to Directive 2002/95/EC (RoHS). Finalreport - revised version. Final Report. In cooperation with Stéphanie Zangl, Markus Blepp, CarlOtto Gensch, Ran Liu, Katja Moch [Öko-Institut e.V.] und Otmar Deubzer, Deubzer, Otmar[Fraunhofer IZM]. Öko-Institut e. V. und Fraunhofer IZM. Freiburg (Adaptation to scientific andtechnical progress of Directive 2000/53/EC and 2002/96/EC; ELV and RoHS exemption review,
RoHS IV, ELV II). Retrieved fromhttp://elv.exemptions.oeko.info/fileadmin/user_upload/Consultation_2014_1/Ex_3_2010_Review_Fi
nal_report_ELV_RoHS_28_07_2010.pdf; or https://circabc.europa.eu/sd/d/a4bca0a9-b6de-401dbeff-6d15bf423915/Corr_Final%20report_ELV_RoHS_28_07_2010.pdf.

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Exemption 18(b) of Annex III: Lead in fluorescentpowder of discharge lamps
The below Table 13-1 shows the wording, scope and expiry dates of the exemption.
Table 13-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

III18(b)Lead as activator in the
fluorescent powder (1 %lead by weight or less) ofdischarge lamps whenused as sun tanninglamps containing
phosphors such as BSP(BaSi2O5:Pb)

Applies to categories 1 to 11.
Expires on-

21 July 2021 for categories 1-7 and 10.

-

21 July 2021 for category 8 other than in vitro
diagnostic medical devices and category 9 otherthan 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.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
BSP

Barium silicate phosphor doped with lead, also known as BaSi2O5:Pb

Cat.

Category, referring to the categories of EEE specified in Annex I of thecurrent RoHS Directive

Ce doped

Cerium-doped

COM

European Commission

CFL

Compact Fluorescent Lamp

EEEElectrical and electronic equipment

HID

High-intensity discharge lamp

Hg

Mercury

IMCI

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Lead-free

Not containing lead in the applications in scope of the exemption to bereviewed

LED

Light-emitting diode

OLED

Organic light-emitting diode

SEA

Socioeconomic analysis

UV

Ultraviolet

UVA

Ultraviolet A

UVB

Ultraviolet B

WPE

Wall Plug Efficiencies

YPO

Yttrium orthophosphate

13.1.

Background and technical information

On 13 January 2023, (LightingEurope 2023a), an industry consortium (Umbrella Project),applied for renewal of the exemption III-18(b) for the maximum validity period of 5 years forcat. 11. Exemption III-18(b) expires on 21 July 2024 for cat. 9 IMCI, and for cat. 11.
Table 13-2: Requested exemption renewal
No.

Requested exemption

Requested scope and dates
of applicability

III18(b)Lead as activator in the fluorescent powder (1 %lead by weight or less) of discharge lamps whenused as sun tanning lamps containing phosphorssuch as BSP (BaSi2O5:Pb)

Applies to category 11 andexpires on 21 July 2029 (= 2024 +5 years)

The European Sunlight Association (ESA 2022) and NARVA Lichtquellen GmbH & Co
(NARVA 2022) support LightingEurope’s request. No contributions were received during
the public consultation.

13.1.1.

History of the exemption

The exemption was reviewed by (Baron et al. 2022). LightingEurope (LE) with the supportof the European Sunlight Association (ESA) and based on additional information provided
by Mallinckrodt Pharmaceuticals c/o Therakos, Inc. submitted a request for the renewal of
the following three exemptions:•Annex III, 18(b): “Lead as activator in the fluorescent powder (1 % lead by weight orless) of discharge lamps when used as sun tanning lamps containing phosphorssuch as BSP.”

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Annex III, 18(b)-I: “Lead as activator in the fluorescent powder (1 % lead by weightor less) of discharge lamps containing phosphors such as BSP when used in
medical phototherapy equipment.”•

Annex IV, 34: “Lead as an activator in the fluorescent powder of discharge lamps
when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb)
phosphors.”

According to (Baron et al. 2022), in this renewal application, the applicants requested thatthe three applications should be combined into a single exemption. The aim was to avoid
ambiguity or repetition in the renewal application. (Baron et al. 2022) identified a preference
for merging the medical applications covered by Annex III 18(b)-I and Annex IV Ex. 34 on
the one hand and keeping Annex III 18(b) separate on the other. It was the applicant’s
intention that the scope of the exemptions should not be changed. In 2020 the renewal was
requested for EEE categories 5, 8 and 9 with a maximum possible validity period.
Following the renewal requests submitted in January 2020, (Baron et al. 2022) reviewed
the exemption and recommended its renewal as listed in Table 13-3. (Baron et al. 2022) did
not review the exemption for cat. 11 as it was not requested by the applicant.
Table 13-3: Renewal of current exemption 18(b) recommended by (Baron et al. 2022)

Source: (Baron et al. 2022).

13.1.2. Focus of the review
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). On 13 January 2023,(LightingEurope 2023a) applied for the renewal of the current exemption 18(b) for cat. 11
since it will expire on 21 July 2024.

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In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Baron etal. 2022) can be adopted to cat. 11 in line with Art. 5(1)(a). A re-evaluation of the previous
review by (Baron et al. 2022) is not intended. The consultants will rely on the critical review
conducted by (Baron et al. 2022) and on the resulting conclusions and recommendation
unless the renewal request or stakeholder contributions give reasons to reassess the stateof science and technology.

13.1.3.

Summary of the requested exemption

According to (LightingEurope 2023a) exemption 18(b) covers indoor sun tanning discharge
lamps containing lead as an activator in the fluorescent powder. These lamps are producedin T12, T8 and T5 diameters and CFL (compact fluorescent lamp) configurations. The
phosphors contained in these lamps are manufactured from the same components but canvary in spectral discharge across the UVA and UVB spectrum by the specified proportional
phosphor mix. The lamps, and equipment they are installed in, are governed by EU
regulations concerning the allowable output of ultraviolet radiation permitted within adetermined exposure time. The EU regulates tanning equipment and the installed lamps
which are marked by a specific “X, Y” code system for the erythemally-weighed UV radiationin accordance with EN standard 61228 Ed.2 (2008-01). The lamps are installed in various
commercial and residential indoor tanning equipment. This can be in the form of a suntanning bed or booth or a tabletop appliance for facial tanning. The abovementioned EN
standard forms the basis of lamp marking and is mandatory. It clearly limits room for
substitution by lead-free phosphors.
(LightingEurope 2023a) state that in the past months, since (Baron et al. 2022) have beenin contact with LightingEurope to request clarifications and further input, no new
developments have taken place. In addition, during the past 2 years, the suntanningindustry was heavily impacted by Covid-19 restrictions, with salons being some of the firstestablishments to be closed down.

13.1.4.

Technical description of the exemption and use of the restricted
substance

Discharge lamps for the purpose of (sun) tanning and for medical purposes (photo-therapy
and extracorporeal photopheresis (ECP) contain BaSi2O5:Pb (BSP) as a phosphor(activator) to produce UV radiation of dedicated wave lengths. An (inorganic) phosphor is a
doped (here Pb) pigment that emits electromagnetic radiation – in this case UV (290nm400nm) – after being stimulated – also through UV radiation (254 nm). The lead is required
to activate the barium silicate phosphor to be able to fluoresce in the designatedwavelength. Pb-doped barium silicate phosphor is used in over 95 % of the indoor lowpressure mercury vapour fluorescent lamps43 (Baron et al. 2022).
According to (LightingEurope 2023a) this exemption covers indoor sun tanning discharge
lamps containing lead as activator in the fluorescent powder. The lamps produce UVA and43 Low-pressure mercury vapor fluorescent lamps and neon lights based on cold cathode fluorescent lamp (CCFL), e.g. foradvertisement, are different types of fluorescent lamps and should not be confused. (Baron et al. 2022)

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UVB in predetermined dosages and ratios for the purpose of producing artificial sunlight.
The lamps are installed in tanning equipment which are calibrated for the use of specificlamp types and they are marked in accordance with EU regulations for tanning lamps andequipment. Brochures and data about these lamps can be seen in several websites, e.g.:•

Lighttech http://www.light-sources.com/tanning/tanning-lamp-products•

Cosmedico: https://www.cosmedico.de/en/products/•

iSOLde: https://www.isoldelicht.de/en/isolde-tanning-lamps/

The lamps and equipment are governed by EU regulations concerning the allowable output
of ultraviolet radiation permitted within a determined exposure time. The EU regulatestanning equipment and the installed lamps which are marked by a specific “X, Y” code
system. For example, see, IEC 606335-2-27 and EN standard 61228 Ed.2 (2008-01). The
lamps are installed in various commercial and residential indoor tanning equipment which
can be in the form of a tanning bed or booth or a tabletop appliance for facial tanning.
The typical lifetime of these lamps ranges from 600 to 1000 hours with a session or usage
time that ranges approximately from 5-30 minutes.
These lamps are not used for the production of visible light so general lighting efficacy
standards do not apply. UV output efficacy (UVA radiation out vs electrical power in) is
typically between 15 % and 25 %, but the real measure is with what power the desired effectis reached. This is governed by the equipment, lamp type, lamp power, UV output measured
by standardized means, user skin type and other such factors.
Indoor sun tanning lamps are light sources that produce ultraviolet light in the regions of the
UVA and UVB spectrum. Their intent is to produce artificial sunlight to replicate sunlight
exposure for the human body (similar to that as produced by the sun) yet applied in
calculated doses per European regulations. It is estimated that over 90 % of indoor tanninglamps produced and used throughout Europe are manufactured with BSP (BaSi2O5 :Pb)
phosphors containing 1 % or less lead as an activator. There is no feasible alternative forthis phosphor that will yield the same or similar results and has undergone the extensive
European and US regulatory testing associated with the application of the tanning lamps
using these phosphors. Almost 100 % of the tanning lamps using these phosphors areproduced in the EU. Below (Figure 13-1) are three examples of typical indoor suntanningequipment. Left and centre photos are tanning beds and right photo is a tanning booth.
Figure 13-1: Examples of indoor tanning equipment

Source: (LightingEurope 2023a)

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(LightingEurope 2023a) state that the market demand for tanning lamps will remain stablein the coming years.
Further details as to the technical background of lead as activator in the fluorescent powder(1 % lead by weight or less) of discharge lamps when used as sun tanning lamps containing
phosphors such as BSP are described in (Baron et al. 2022).

13.1.5.

Amount(s) of restricted substance(s) used under the exemption

According to (LightingEurope 2023a) the phosphor coating represents the homogenous
material used in the fluorescent lamps with respect to this exemption. The lead content of
the BSP phosphor is less than 1 % of the total phosphor weight and there is no publisheddata available for the quantity of tanning lamps entering the EU.
However, based on market estimations of (LightingEurope 2023a) the lead content oftanning lamps is limited to 180.5 kg of lead total per year entering the EU44. This amount isapproximately 10 % less in the BSP phosphor and taking into account the decrease inavailable market, compared to the amount in the 2015 exemption renewal request.

13.2.

Justification of the requested exemption

13.2.1.

Substitution and Elimination of the restricted substance(LightingEurope 2023a) state that in the use of lead according to exemption III-18(b) there
is no substitution for lead available and that no new developments have taken place since
the last contact with (Baron et al. 2022). Therefore, please refer to the descriptions of (Baronet al. 2022) for more details regarding substitution and elimination.
In summary, (LightingEurope 2023a) state that the only potential alternative material,
Ce doped YPO phosphor, does not fulfil all the necessary criteria.
In their renewal request (LightingEurope 2023a) also make clear that in principle, othertechnologies can be evaluated for eliminating fluorescent technology for tanning. For
example, LED, OLED, HID, and incandescent or halogen technology. However, for any newtechnology the replacement market (replacing lamps in existing fixtures) and the market for
new equipment using the new technology need to be addressed. The criteria to determine
whether a new technology can replace existing fluorescent technology using BSP (and Hg)
in existing equipment are:•Lamp specification must be the same with regard to UVA and UVB output andspectral power distribution•

Safety•Compatibility (Electrical and mechanical specification)•

Reliability

44 This estimated lead quantity now excludes the UK market. LightingEurope 2023a.

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Tanning result•

Compliance with CE regulations (X/Y coding system for tanning lamps according to
EN 60335-2-27)•

No (negative) side effects•

Effective treatment results for phototherapy patients (e.g. clearance rates forpsoriasis, effective chemotherapy, etc.)•

Economic feasibility (cost of replacement technology)

For new equipment similar criteria apply as above.

13.2.2.

Environmental, health, safety and socioeconomic impacts

Environmental impacts
According to (LightingEurope 2023a) information on the environmental impacts of lead
usage in the scope of this exemption is not available as no alternate phosphor types areavailable that will yield the same result nor have undergone the regulatory testing of the EU
or US. There are no statistical data available specific to the Life Cycle Analysis of thetanning and medical lamps represented in this exemption request, however due to therelatively low market quantities for special lighting, the total environmental impact is
expected to be limited. Research conducted about fluorescent lamps for general lighting
applications does not specifically equate to these specialty lamps as they are not designed
to produce visible light. Efficacies, expressing the amount of visible light in Lumen per Watt,
are normally related to e.g. fluorescent lamps for general lighting, and do not apply totanning lamps. Cradle to grave estimates for the production of the components and thefinished lamps in this exemption request are similar to those of general lighting fluorescentlamps.
(LightingEurope 2023a) refer to the fact however that the use of lead as an activator of thephosphor in these lamps allows the transmission of the specific wavelengths of light to be
emitted in such a fashion to be the most effective form for its purpose, which is notachievable with other phosphor types or other technologies. Therefore, efficacies of any
alternate product types would not be an adequate comparison.
The potential substitution or replacement to other wavelengths or ultraviolet dosages would
require revalidation of all existing installed equipment in the EU market or could result in theelimination of such equipment, causing great hardship to the small business owners oftanning salons throughout the EU. These current lamp types have been tested, studied andregulated in the EU and changes to these products would require a duplication of the clinicaltesting which has been compiled over years of study and regulation. It is further noted thatthe overall lead content of such lamps, as in general lighting, has been reduced in the past
five years to the less than 0.1 % lead content, to allow for recycled glass in the glass
envelope of the lamp.
Additionally, the sun tanning lamps are collected and sent without dismantling for recycling.
(LightingEurope 2023a) state that sun tanning lamps are in the scope of EU Directives
2002/96/EC - WEEE and 2012/19/EU - WEEE Recast. Take back systems are in place inall EU Member States: end users and most commercial customers can bring back the lamps

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free of charge. Sun tanning lamps are collected separately from general household waste
and separately from other WEEE waste. A dedicated recycling process exists for lamps.
European lamp manufacturing companies have founded Collection & Recycling
Organizations in the EU Member-States, represented by EucoLight, with the objective toorganize the collection and recycling of gas discharge lamps. The goal is to comply withpresent and probable future EU legislation and meet or exceed national targets.
According to (LightingEurope 2023a), the following channels have been established in therespective member states providing countrywide coverage:•

Direct collection from large end users and professional installers: Containers havebeen made available, ad hoc or permanently, and will be collected upon notificationby the end user that the container is full.

•Collection through distribution: Wholesalers and Retailers place collection means attheir premises respectively in their shops. Collection is done upon notification.

•

Collection through municipalities: Where the infrastructure allows collection, meansare placed at municipality depots.

Socio-economic impacts(LightingEurope 2023a) state that is expected that even if UVA LEDs become available withfeasible specifications, tanning equipment may become much more expensive. It will
therefore become an economically unattractive solution and this can have a significant
impact on the application.
The possibility of lead-free technology for these lamps is not feasible for replacement lamps
in existing equipment due to the scientific and clinical evaluations that would need to be
carried out on every type of tanning equipment in the field. This would place an economic
burden on small business owners, such as tanning salons and dermatologists, and in theworst case could lead to the closure of many businesses.
It is conceivable that new equipment could be converted to non-lead phosphors. However,
over 90 % - and it is estimated that it could be as high as 99 % - of the tanning phosphors
are lead activated. There are no alternative non-lead activated phosphors available todaythat provide the same or equivalent spectral radiation.
If the exemption is not renewed, the indoor tanning industry in Europe will cease to exist as
there are no reliable substitutes. LightingEurope members estimate that almost 100 % of
these lamps used in Europe are manufactured in Europe by fluorescent lamp companies.
It is estimated that•

almost 100 % of the indoor tanning equipment sold in Europe is manufactured inEurope.

•almost 100 % of the tanning lamps sold as aftermarket lamps are sold by
manufacturers or distributors located in Europe.

•

over 90 % of the tanning lamps used in the US are manufactured in Europe.

•

over 75 % of the tanning equipment sold in the United States is made in Europe.

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13.2.3.

Stakeholder contributions

During the public consultation phase no contributions were received. Like alreadymentioned, the European Sunlight Association (ESA 2022) and NARVA LichtquellenGmbH & Co (NARVA 2022) support LightingEurope’s request and their letter of support
were provided together with the renewal request.
The European Sunlight Association, acting on behalf of the European indoor tanningindustry, are endorsing LightingEurope's application to renew exemption III-18(b) for cat.
11. (ESA 2022) highlight the importance of this exemption, noting that despite previous
efforts to find technological alternatives, there have been no significant developments
providing comparable substitutes. They emphasize that the lamps containing lead are
integral components of tanning equipment and that there are currently no suitablereplacements available or expected in the near future.
(ESA 2022) point out that any potential alternative would not only require changes in lamp
technology but also adjustments in control gear, such as power supplies, which could havesignificant economic implications for both manufacturers and small, independent businessowners operating tanning salons. They highlight the substantial contribution of the indoor
tanning industry to the economy, including a turnover of approximately 2.1 billion Eurosannually, and stress the potential socio-economic impacts if the exemptions were notrenewed.

13.2.4.

Roadmap towards substitution or elimination of the restricted
substance(LightingEurope 2023a) state that given the market size and in combination with strict
regulations, efforts to substitute BSP containing lamps are extremely limited (to nonexistent). No plans are made to replace Pb with Ce as earlier tests were unsuccessful andno new insights have been created.
Regarding LEDs, other UVA applications are available in LEDs but tanning development
has been limited. At this moment it is not possible to predict if and when UVA LED based
equipment will become feasible, however the tests and approval process would take a very
long period. Therefore, (LightingEurope 2023a) request a renewal for the maximum validity
period.
In their letter of support (NARVA 2022) discuss different possible lead-free alternatives: CEdoped YPO, high-pressure lamps and LEDs. However, they summarize that none of thesetechnologies can substitute or eliminate the UV lamps with lead-containing BSP phosphor.

13.3.
13.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria

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which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds (cf. section 4.2 on page 51). Noneof these entries are, however, relevant for the use of lead in the scope of exemption III18(b).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

13.3.2.

Substitution and elimination of the restricted substance

Following the approach to assess whether the recommendation of (Baron et al. 2022) canbe adopted to cat. 11 in the scope of the exemption renewal request, it is worthwhile
realising also the reasons for their recommendation.
(LightingEurope 2023a) tested the substitution of lead in barium silicate phosphor withcerium (Ce) doped yttrium phosphate phosphor (YPO). The results indicate that it is not
feasible due to high UVA and UVB output variance. Limited phosphor options hinder finding
alternatives, and switching to other phosphors may emit harmful radiation. LED technology,
though available, isn't optimal for required wavelengths. (Baron et al. 2022) concluded that
Ce-doped YPO isn't feasible, LED approaches are inadequate, and lead reduction is notchemically possible. Renewal applications should detail progress, but the current one lacks
substantial updates.
In (LightingEurope 2023a) state that it is estimated that over 90 % of indoor tanning lamps
produced and used throughout Europe are manufactured with BSP (BaSi2O5 :Pb)
phosphors containing 1 % or less lead as an activator.
The consultants therefore wanted to understand why the remaining 10 % of the lamps
mentioned do not contain BSP phosphors.
(LightingEurope 2023b) state that there is no suntanning equipment that does not containa lead activated phosphor lamp, as its specific UVB spectrum is needed to initiate thepigmentation process by melanin synthesis. There is one very specific type of suntanningequipment on the market, which is supplied in extremely small quantities, that in order toboost the pigmentation effect, has added pure UVA lamps besides the lead activatedphosphor lamps. This is a pure UVA lamp with 368 nm wavelength emission peak whose
phosphor does not contain a lead activator.
The above aligns with the information provided for the last review of the exemption by(Baron et al. 2022). For tanning applications, no test results are available yet regarding theeffectiveness in reaching the desired effect in a comparative study between equipmentusing fluorescent lamps and equipment using LEDs. For most of the applications tests are
not done yet as no LEDs were available. Hence data on the effectiveness is not available.
(Baron et al. 2022) concluded that substitution or elimination of lead is scientifically and242

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technically not practicable in the applications in the scope of the exemption and therefore
recommended the renewal of exemption 18(b) for categories 5, 8 other than in vitro
diagnostic medical devices and 9 other than industrial monitoring and control instruments.
In the light of the submitted renewal requests and additional information, the consultants
see no reasons to diverge from the above recommendation of (Baron et al. 2022) andthe below approach.
(Baron et al. 2022) envisage to review the exemptions 18(b) and 18(b)-II in parallel in the
future. In case a substitute was found for one of both uses of lead, it is highly probable that
this substitute could be implemented in both applications. Thus, (Baron et al. 2022)
recommend to align all named categories in terms of the validity period. Also, this will
be more pragmatic for market surveillance and will with time lower the administrative burdenof stakeholders and the European Commission with regards to renewed exemption
requests for the coexisting exemptions.

13.3.3.

Environmental, health, safety and socioeconomic impacts

The applicant submitted information as to environment, health and safety impacts which isreflected in section 13.2.2 on page 239. According to (Baron et al. 2022) information on
environmental, health, and safety impacts is limited due to technically infeasible substitutes.

13.3.4.

Categorisation of suntanning equipment

According to (LightingEurope 2023a) suntanning lamps are used in suntanning equipment.
It is, however, not completely clear how to classify suntanning equipment and consequently
LightingEurope see that the classification can differ. According to (LightingEurope 2023b)
manufacturers are not sure whether to exclusively focus on the suntanning lamps andassign them to category 5 (lighting equipment) or whether the focus should be on theequipment itself (e.g., sunbeds) which includes lighting functionalities. Due to this uncertain
situation, the application for category 11 (other EEE) was made for reasons of legal
certainty, to ensure that certain suntanning equipment types do not end up being
unintentionally excluded. (LightingEurope 2023a) regards the decision of the European
Commission to avoid the separation in categories in the decisions for the exemptions 1-4
of Annex III from February 2022 as very helpful. (LightingEurope 2023a) state that aseparation of this exemption in different categories is not helpful as a clear and legallycertain classification is not available. The named application is specifically "sun tanning",and LightingEurope do not have information that there are possibilities of uses in products
falling in other categories.
Overall, the argumentation appears reasonable given the complexities and uncertainties
involved in classifying suntanning equipment within the regulatory framework. By seeking
legal certainty and referencing relevant decisions, LightingEurope present a plausible
rationale for their approach. As the categorisation of EEE is in the responsibility of the
producers, the consultants follow the applicant’s reasoning.

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13.3.5.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;•

the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts causedby substitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

(LightingEurope 2023a) request a 5-year renewal of exemption III-18(b) with its current
wording for cat. 11 until 21 July 2029. The consultants recommend adopting the result of
the previous review of this exemption by (Baron et al. 2022) - which included cat. 5, 8 and
9 - for cat. 11. Following the recommendation of (Baron et al. 2022)the renewal of the
exemption for category 11 until 2026 can be justified by Art. 5(1)(a). (LightingEurope 2023b)
rejected the alignment of the expiry dates for cat.11. They argued that applying in thistimeframe (18 months before the exemption expires in 2026) would not allow time for new
developments in the industry to be reported in the exemption application.
The consultants agree that an expiry in 2026 would actually conflict with the 18 months
period prior expiry of the exemption for renewal requests. Therefore the consultants
recommend an alignment following the approach proposed by (Baron et al. 2022) but toextend the exemption until 21 July 2026 for all categories of EEE in scope of the exemption
to allow sufficient time for renewal applications.

13.4.

Recommendation

The consultants conclude that the recommendation of (Baron et al. 2022) can be adopted
for cat. 11. The substitution and elimination of lead in the scope of exemption III-18(b) are
scientifically and technically still impracticable so that, in line with (Baron et al. 2022),
granting the exemption would be in line with Art. 5(1)(a).
As to the validity period, (Baron et al. 2022) recommend a parallel future review of
exemptions 18(b) and the new item 18(b)(II) since a substitute found for one of both usesof lead is highly probable to be a substitute for both applications. Aligning validity periods isbeneficial for efficiency and reduced administrative burden on stakeholders and theEuropean Commission regarding exemption requests.

The consultants recommend the below wording and scope for the renewed exemption.

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No.

Exemption

Scope and dates of applicability

III18(b)Lead as activator in the fluorescentpowder (1 % lead by weight or less)of discharge lamps when used as suntanning lamps containing phosphorssuch as BSP (BaSi2O5:Pb)

Applies to categories 1 to 11
Expires on-

21 July 2021 for categories 1 to 4, 6, 7, 8
medical devices other than in vitro
diagnostic medical devices, 9 monitoring
and control instruments other thanindustrial
monitoring
andcontrol
instruments, and 10.

-

21 July 2023 for category 8 in vitro
diagnostic medical devices-

21 July 2024 for industrial monitoring andcontrol instruments-

21 July 2026 for categories 5, 8 other thanin vitro diagnostic medical devices, 9
other than industrial monitoring andcontrol instruments, and cat. 11.

It is recommended that the COM allows sufficient time to remain between the official
publication of the COM decision and the expiry date so that renewal requests can besubmitted no later than 18 months prior to the exemption expiry.
Applicants’ feedback on the recommendations(LightingEurope 2024) have no further comments regarding the above recommendation.

13.5.

References

Baron et al. (2022): RoHS Pack 24. Study to assess requests for renewal of seven (-7-)
exemptions 18(b), 18(b)-I, 24, 29, 32 and 34 of Annex III and exemption 34 of Annex IV of Directive
2011/65/EU (Pack 24) – Final Report. In cooperation with Yifaat Baron, Carl-Otto Gensch, Andreas
Köhler, Ran Liu, Clara Loew, Katja Moch, Öko-Institut. Retrieved fromhttps://data.europa.eu/doi/10.2779/123658.
ESA (2022): ESA - Support Letter, EU RoHS Application to Extend Exemption III-18(b). RoHS
Pack 27. Retrieved fromhttps://rohs.biois.eu/ESA%20Letter_RoHS%20Exemption%2018(b)%20cat%2011_6.12.2022.pdf,
Last updated 26.02.2024.
EUROMOT (2024): Answers to recommendation sent via e-mail by Maitheya Riva, RINA, toAlexandra Morozov, Fraunhofer IZM. RoHS Pack 27 (RoHS 29).
LightingEurope (2023a): Request for renewal of exemption III-18(b). RoHS Pack 27. Retrieved
from https://rohs.biois.eu/LE_RoHS_Exemptions_18b_Cat.11_20230112_FINAL.pdf, Last updated
26.02.2024.
LightingEurope (2023b): Answers to questionnaire 1 (clarification questionnaire) sent via e-mail by
Sophia Ehmke, Lighting Europe, to Alexandra Morozov, Fraunhofer IZM. RoHS Pack 27. Retrieved

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from https://rohs.biois.eu/Ex_III-18b_LE_Questionnaire-1_Clarification.pdf, Last updated
26.02.2024.
LightingEurope (2024): Answers to recommendation sent via e-mail by Sophia Emke,
LightingEurope, to Alexandra Morozov, Fraunhofer IZM. RoHS Pack 27 (RoHS 29).
NARVA (2022): NARVA - Support Letter, EU RoHS Application to Extend Exemption III-18(b).
RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/NARVA_Supportletter%20RoHS%20exemption%2018b%20Cat.%2011_4.1.20
23.pdf, Last updated 26.02.2024.

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Exemption 34 of Annex III: Lead in trimmer
potentiometers
The below Table 14-1 shows the wording, scope and expiry dates of the exemption.
Table 14-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

III-34

Lead in cermet-based
trimmer potentiometer
elements

Applies to categories 1 to 11.
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 andcontrol instruments,-

21 July 2023 for category 8 in vitro diagnostic medical
devices,-

21 July 2024 for category 9 industrial monitoring andcontrol instruments, and for category 11.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Cat.

Category, referring to the categories of EEE specified in Annex I of
the current RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instrument

Lead-free

Not containing lead in the applications in scope of the exemption to
be reviewed

SEA

Socioeconomic analysis

TP

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14.1.

Background and technical information

On 20 January 2023, (TMC) requested the renewal of the above exemption for cat. 9
industrial monitoring and control instruments (IMCI) with the wording, scope and validity
period shown in the below table.
Table 14-2: Requested exemption renewal
No.

Requested exemption

Requested scope and dates
of applicability

III-34

Lead in cermet-based trimmer potentiometer
elements

Applies to category 9 industrial
monitoring and control
instruments.
Expires on 21 July 2031 (= 2024
+7 years) for category 9 industrial
monitoring and control
instruments.

(EPPA 2023) submitted a socioeconomic analysis (SEA) along with their renewal request.
(MTE 2023) contributed to the stakeholder consultation stating their support for the
exemption renewal requests submitted by the ‘Umbrella Project’ in 2020 (Pack 24 review)for the exemption, including for category 8 medical technology uses.

14.1.1.

History of the exemption

The exemption was reviewed once in 2007. The applicant requested this exemption
claiming that exemptions 5 and 7 listed in the annex of directive 2002/95/EC (RoHS 1), as
they were formulated in 2006/2007, did not cover the use of lead in these cermet-based
trimmer potentiometers:•

No. 5: Lead in glass of cathode ray tubes, electronic components and fluorescenttubes;•

No. 7: Lead in electronic ceramic parts (e.g. piezoelectronic devices).

The manufacturer said that this resistive layer in the cermet-based trimmer potentiometeris a homogeneous material, as it can be mechanically separated from the ceramic base.
This homogeneous material, the thick film layer containing the lead, is neither a glass nor aceramic material and thus would not be covered by the above exemptions. As aconsequence, exemption 34 was adopted to the annex of RoHS 1 with its current wording:“Lead in cermet-based trimmer potentiometer elements”
Exemption 34 was transferred to Annex III of RoHS 2 with an expiry date in July 2016.
To avoid confusion about the scopes of exemptions 5 and 7, and to make sure these
exemptions actually cover those uses of lead where it cannot be substituted or eliminated,the consultants aspired to improve exemptions 5 and 7, and to align them with the
exemption wording of parallel exemptions within the ELV Directive as far as possible.
Exemption 11 of annex II in directive 2000/53/EC (ELV Directive), the equivalent toexemption 7(c)-I of RoHS Annex III, was reviewed in 2007/2008. The stakeholders decided

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that the wording in the ELV Directive covers applications like lead in cermet-based trimmer
potentiometers.
In the subsequent review of RoHS exemption 7c in 2008/2009, it was therefore decided toadopt the wording of ELV exemption 11 with slight adaptations resulting in the current
wording of RoHS exemption 7(c)(I). This wording integrated the scopes of exemptions 5
and 7, and in principle the use of lead in trimmer potentiometers in the scope of exemption
34. Nevertheless, the exemption was decided to be maintained after the review of
exemption 34 by (Gensch et al. 2016) to avoid confusion in industry as to whether the useof lead in trimmer potentiometers would still be allowed. To avoid overlaps, the scope of
exemption 34 was excluded from the scope of exemption 7(c)(I).
Following renewal requests submitted in January 2020, (Baron et al. 2022) reviewed theexemption. The renewal requests included cat. 9 IMCI, which was hence included as wellinto the renewal of exemption 34 proposed by (Baron et al. 2022).
Table 14-3: Renewal of the current exemption 34 recommended by (Baron et al. 2022)

Source: (Baron et al. 2022)

14.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). (TMC 2023a) therefore
applied for the renewal of the current exemption 34 for cat. 9 IMCI since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE. The exemption thus becamedue for review even though the recommendation for the renewal of exemption 34 of (Baronet al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Baron etal. 2022) can be adopted to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Baron et al. 2022) is not intended. The consultants will rely on the criticalreview conducted by (Baron et al. 2022) and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

14.1.3.

Summary of the requested exemption(TMC 2023a) explain that the cermet potentiometer is typically used to calibrate a specificmeasurement or control parameter so that the final product can meet that exacting
measurement resolution or output control parameter that the application requires. Thick film
is a resistive and conductive film greater than 0.0001 inches thick resulting from firing apaste or ink that has been deposited on a ceramic substrate. The lead oxide (PbO) within249

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the glass substrate with the resistive ink allows the thick film to be fired at lower
temperatures. This makes the resultant cermet to have the thermal characteristics andresistive value stability of the ceramic material and enable the electric resistance of thematerial to remain stable under changing temperatures.
Of the alternates investigated, most were eliminated either because they were also toxic or
had a melting point too high for current substrate materials and the manufacturing
processes employed. Only Sodium Bismuth Titanate has the potential to be used but would
require further investigation. Bismuth Oxide is another alternate though the toxicity needs
to be assessed to see if it would be a regrettable substitution. However, in both cases TMC
currently have not identified any alternates cermet resistor that employ these materials andare commercially available. A thorough Socio-Economic Analysis was conducted in addition
to the technical assessment and attached to this submission, further illustrating the negativesocio-economic impacts a non-renewal of exemption 34 would have at this stage. Overall,
the analysis concludes that the total impact of non-renewal of this exemption is monetizedin the range of 0.3 billion EUR and 1 billion EUR (public range; conservative lower boundestimate).

14.1.4.

Technical description of the exemption and use of the restricted
substance(EPPA 2023) explain that a cermet potentiometer is typically used to calibrate a specificmeasurement or control parameter so that the final product can meet that exacting
measurement resolution or output control parameter that the application requires.
Figure 14-1: Examples of trimmer potentiometers

Source: (EPPA 2023)

Whenever there is a critical measurement that can vary from production unit to production
unit (because of component tolerances) then precise calibration adjustment is required toeach product during the manufacturing process. Once calibrated in the factory, that setting
must remain stable during storage, transport and use for the installed life of the product,
only checked during annual calibration or the preventative maintenance program for the
product in question. For further technical details see (Baron et al. 2022) and (EPPA 2023).
(TMC 2023a) highlight that cat. 9 IMCI are very different from low mix, high-volume
consumer products which are frequently re-designed to follow consumer trends and areplaced on the market for a limited duration. Cat. 9 IMCI are high mix, low volume products
and their producers portfolios of thousands of highly complex instruments. Each instrument
is designed for high reliability and serviceability to support long useful lifespans and aremade available on the market for at least a decade. These instruments are designed:•

exclusively for professional and industrial use;•

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to last up to 40 years.

Redesign is not frequent and happens every seven years on average as compared to every
1.5 years or less for consumer products. Once cat. 9 IMCI are placed onto the market, they
are typically accompanied with a long-term customer support arrangement to maintainreliability and calibration.
Product portfolios are widely diversified, with TMC members each having typically 2,000 to
3,000 products currently made available on the market. These are highly complex,
sophisticated electronic instruments, each having many necessary options andaccessories. Each instrument can have a minimum of 2,000 and up to 40,000 parts;
requiring a vast supply chain involving tens of thousands of suppliers and hundreds ofthousands of items.
According to (EPPA 2023), the physical function of lead in the components that are utilisedby cat. 9 IMCI are like those outlined in the previous exemption renewal request that wasreviewed by (Baron et al. 2022). Cermet potentiometers (CPT) that contain lead have thefollowing characteristics:•

Long lifetime, typically up to 50,000 rotation cycles (they are usually rated at 25,000
cycles)•Low temperature coefficient (TC), which is a measurement of the resistancechange relative to ambient temperature change and is expressed as parts per
million (PPM) per degree centigrade change, or as a percentage. The TC for atypical Cermet potentiometer is 150 ppm/°C which is lower than other types ofpotentiometer•

High level of heat dissipation•

Wide operating temperature range, -55 °C to +125 °C•

Higher wattage rating, e.g. 3 watts•

Low reactance at high maximum frequency•

Good resolution (resolution is the smallest possible change in resistance ratio)•

Low electrical noise when resistance is adjusted•

Small size enabling use in high density microelectronic circuits•

Preliminary tests with lead-free inks seem to show that a lubricant shall benecessary•

Even with a lubricant, the same performance will not be reached with all ohmic
values(EPPA 2023) indicate the below example types of cat. 9 IMCI that use CPTs:•

Relative Humidity sensors•

Power supplies•

Dosimetry Readers•

Temperature controller modules•

Sample Prep Liquid Chromatography

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Liquid Chromatography / Mass Spectrometry•

CO2 Incubators•

Environmental Chambers•

Minimum Inhibitory Concentration (MIC) Lab test automation•

Spectroscopy Equipment•

Electron Microscopes

14.1.5.

Amount(s) of restricted substance(s) used under the exemption

Based on the full material disclosures displayed in Table 14-4, (EPPA 2023) conclude thattrimmer potentiometers contain lead specifically as PbO within the glass matrix of the
conductor (the potentiometer sweep arm) and the resistor itself which represent only 0.14 %of the mass of the potentiometer.

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Table 14-4: Full material disclosure for the most common cermet trim pot family used

Source: (EPPA 2023)

According to (EPPA 2023), out of a total mass of 1.2 g per cermet potentiometer, the PbO
totals 0.7 mg. The types of products using the exemption are typically cap expenditurepurchases and represent less than 3,000 products sold into the EU:

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(0.377 mg + 0.324 mg + 0.0259 mg) * 3,000 ≈ 0.73 mg * 3,000 ≈ 2.2 g(EPPA 2023) conclude that the total PbO import is less than 10 g per year for Cat 9 IMCI.
The main lead-containing substance is actually the ruthenium-containing one, followed by
the lead-oxide. The lead content in both these substances is thus less than 2.2 g. According
to (TMC 2023a), the above figures are based on their members’ feedbacks. The actual
figures may thus actually be higher.
Based on the information provided, it is plausible to assume that maximum 10 g of lead areplaced on the EU market every year under the exemption 34 with cat. 9 IMCI.

14.2.
14.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substance(EPPA 2023) state that only Sodium Bismuth Titanate has the potential to be used but would
require further investigation. Bismuth Oxide is another alternate though the toxicity needs
to be assessed to see if it would be a regrettable substitution. However, in both cases they
currently have not identified any alternate cermet resistors that employ these materials andare commercially available. According to (TMC 2023a), the qualification of potential leadfree trimmer potentiometers would require five to seven years to ensure their reliability inthe cat. 9 IMCI. More details about substitution and elimination efforts are provided by(TMC; EPPA 2023).

14.2.2.

Environmental, health, safety and socioeconomic impacts(EPPA 2023) identify in their SEA the main potential negative consequences that the EU
society at large would face in the framework of the potential restriction of non-renewal of
Annex III, exemption 34, lead in cermet-based trimmer potentiometer elements. The results
are based on a survey focused on the EU test and measurement equipment industry, withmarket share coverage of approximately 70 % of the EU market. It therefore provided
sufficiently reliable data for a representative extrapolation of the EU market.
In the opinion of (EPPA 2023), overall, the results of the SEA demonstrate the safe use oflead in cermet-based trimmer potentiometer elements and can reasonably justify therenewal of this exemption, on the grounds that a broad restriction would havedisproportionate negative impacts on society when compared with the risk to human health,animal health or the environment.
(EPPA 2023) monetise the total impact of a non-renewal of this exemption in the range of
0.3 billion EUR and 1 billion EUR (conservative estimates in net losses, potential gains for
suppliers of other components have been already taken into account), consisting of
economic impacts (EBIT loss) on test and measurement industrial type products’
manufacturers, substitution costs for test and measurement industrial type products’
manufacturers, and social impacts (i.e., unemployment in the EU-27). In terms of businessand market impacts, a non-renewal would constraint most of the companies currently
supplying RoHS-based test and measurement industrial products to cease production andbusiness activities of all products that include lead.

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14.2.3.

Roadmap towards substitution or elimination of the restricted
substance

Following (TMC 2023a), their members have pointed out that they principally rely on theircomponent suppliers to find alternatives since most of the exemptions used in their products
are not produced on-site by the company but bought off-the-shelf from suppliers. Therefore,
meeting with suppliers to understand their (potential) alternatives, getting samples,
measuring, and testing is the typical process to evaluate the suitability of potential
alternatives which can take up to 4 years, as reported by the companies. The process would
then be followed by the validation of the potential suitable alternatives accompanied by
testing done by the manufacturers by the finished cat. 9 IMCI with the validation of thefunctionality and performance being their responsibility as well. However, the companies
noted the impacts deriving from their suppliers as, depending on the complexity, there canbe little to significant time and resources needed to validate alternatives.
The companies reported that the validation period alone would take a minimum of 6 months
and up to a year after the delivery of suitable alternatives per product. It is significant to notethat this validation period would only apply if the component were a fit, form, and function
drop-in replacement. If any design changes to the exemption-free part of the product would
be required to accommodate for the alternative, a validation period would be required foreach redesigned product that used to utilize the component that relied on the exemption.
Moreover, the validation would lead to the organizations incurring additional expenses.
These include labour costs and costs arising from potential product resubmission
requirements for testing to various notified bodies to ensure that substitution does not create
any electrical and functional safety concerns.
If a new substance free part is available, this part must be qualified for use by performing avariety of tasks, as described above. Due to the complexity and diversity of the applications,this must be done individually by each company for each product group. This process would
divert resources from other projects and increase the cost to ensure continued availabilityof these products. This validation and testing process varies according to part complexity
and impact upon the final product design; which can be categorised as low, medium, and
high:

•

Low complexity parts are the off-the-shelf components or hardware parts that do
not have a substantial performance impact. Replacement can be done based on
supplier information, assuming a form/fit/function compliance, with standard
manufacturing, testing, and validation processes. Based on process timescales
reported by a T&M coalition company, the average time that it can take for theseparts to be replaced ranges from 3 to 6 months.

•

Medium complexity parts are more complex sub-assembly electronic parts, suchas small motors, which need additional validation for their performance. These
parts are often commercial assemblies that are generally available to the electronic
industry, and are utilised by the Test & Measurement coalition companies.
Replacement of these assemblies, like-for-like, requires testing and validation prior
to being integrated into the manufacturing process. The average time to find analternative for medium complexity parts for production is reported to range from 6
to 12 months.

•

High Complexity parts are the complex sub-assemblies or parts that have asignificant impact on performance of the company’s products or play a critical role255

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in overall safety of the products. These parts need to go through extensive
validation for performance and/or compliances for varying regulations before theappropriate files can be updated and the proper competent authorities or regulatory
bodies can be notified prior to purchase of parts for validation. The average timethat it would take to find an alternative for high complexity parts for production is
up to 1 year for additional testing. Where the exemption directly impacts theperformance of that component (e.g., a centrifuge rotor) the evaluation of thereplacement could take from 3 to 5 years.
Taking everything into consideration, (TMC 2023a) claim the substitution process to take aminimum of 5 to 7 years.

14.2.4.

Stakeholder contributions(MTE 2023) contributed the “MedTech Europe recommendation for the extension of RoHS
lead exemptions for medical technologies in the scope of category 8” and “[…] would like toreiterate its support for the exemption renewal requests submitted by the ‘Umbrella Project’in 20204 for the abovementioned exemptions, including for the category 8 medical
technology uses.”(MTE 2023) submitted the same contribution to support several other renewal requests. It
is of generic nature, and the arguments focus on cat. 8, for which the renewal of exemption
34 was not requested and which is therefore not addressed in this review.

14.3.
14.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds. None of these entries are,however, relevant for the use of lead in the scope of exemption III-34 in EEE of cat. 9 IMCI
(cf. section 4.2 on page 51).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

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14.3.2.

Substitution and elimination of the restricted substance

Following the approach to assess whether the recommendation of (Baron et al. 2022) canbe adopted to cat. 9 IMCI in the light of TMC’s exemption renewal request, it is worthwhile
realizing also the reasons for their recommendation.
(Baron et al. 2022) recommend to renew the exemption since “[…] it appears that nosuitable substitutes for lead-based cermet materials are available to date that meet all of
the performance characteristics of lead-based thick-film materials for resistive cermets. Thisfinding supports the first criterion: it is still scientifically or technically impractical to replacelead in cermet materials that are used in frequent operated variable resistors. However, as
it is not likely that most trimmer potentiometers will be operated frequently enough to affecttheir reliability during their service life, the consultant concludes that the second criterion“reliability” applies only for a subset of trimmer potentiometers, notably those that aredesigned for frequent use. The exemption is only needed for lead-based resistive materials
in cermet-based potentiometers, in particular for application purposes that involve frequent
operation cycles. […] The technical specification of lead-containing cermet-based trimmers[…], in particular the wide operating temperature range (-55 °C to +125 °C) […] as well as
the higher wattage rating allows the use of leaded trimmers for EEE applications that
operate at high temperatures or have strong heat generation due to their wattage. However,for most trimmer applications, it is unlikely that high wattage and high temperature stability
would be required. […] The consultant understands that a specification of the use conditions
or for the type of equipment could be a way forward to narrow down the scope of the
exemption in the future. […] (Baron et al. 2022) further argue that not all trimmer
potentiometers may require service lives of up to 50 000 revolutions. Lead-free substitutes
for cermet-based trimmers could at least be used for some applications e.g. that are
intended for infrequent operation and installation in low-power EEE. This possibility tonarrow down the scope of the exemption should be followed up by e.g. supply chain surveys
by the industry.“
As to the validity period of the renewed exemption 34, (Baron et al. 2022) conclude that“[…] the exemption should be renewed only for a short period in order to point out to theindustry that the information has to be updated and that active support in phasing out theexemption is expected. As for the categories, it was already noted that category 9 industrial
monitoring and control instruments, and for category 11, Ex. 34 is anyway valid until 21 July
2024. The short duration for the renewal until 21 July 2024 allows to set one common expiry
date. The earlier expiry date for category 8 in vitro diagnostic medical devices, where Ex.
34 expires 21 July 2023, is also recommended to be aligned with the other EEE categories.
This common expiry date is recommended together with a request from industry to prepare
technical information for a future review should the exemption renewal be necessary. This
includes the provision of technical details as to the different applications addressed under
this exemption and specify possibilities to narrow down the scope of the exemption. “
The consultants asked the applicant whether they agree to the adoption of therecommendation (cf. Table 14-3 on page 249) of (Baron et al. 2022), which only deviatesfrom the current exemption 34 in its 2024 expiry date for all categories of EEE. (JBCE et al.
2023) reiterated “[…] that all submitted renewal applications, including the renewal
application for RoHS exemption III-34, request the renewal of the exemption […] with thesubsequent maximum renewal period of 7 years. […] The only available alternative to theThick-Film (Cermet) potentiometer was a Polymer Thick-Film (PTF) device. A PTF device
could approach the electrical characteristics required (though inferior) but the environmental

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characteristics were significantly different – humidity tolerance was an order of magnitude
worse off (± 10 %). This would render a PTF device unusable in a significant portion of cat.
9 Industrial products with examples provided within the renewal submission. […] At thistime, no such alternative film technology exists and are commercially available unless theconsultants are aware of a technology that did not come up in our worldwide search. […]When a lead-free substitution becomes available, the substitution process would take aminimum of 5-7 years […]. Hence, the full 7-year extension is requested, with the
expectation of a further renewal request after that to accommodate that substitution process
if a suitable alternative were to become available during the next renewal period. To renew
with any other time period would make no practical sense at this time.
TMC base their opposition on the lack of lead-free alternatives and, if such alternatives wereavailable, the time required for their qualification to enable their reliable use in cat. 9 EEE.
(Baron et al. 2022) in principle share this view as to the availability of lead-free alternatives,
however, only for frequently used potentiometers installed in high power EEE. For others,
they see opportunities for substitution to narrow down the exemption scope if thecorresponding technical details are collected along the supply chain and provided in theapplications for the next renewal of exemption 34 which they therefore recommend to expire
on 21 July 2024 already for all categories. (EPPA 2023) explain that some trimmer
potentiometers are used to once calibrate an IMCI in the factory, after which the calibrationis checked during annual calibration. These trimmer potentiometers could thus becandidates for which (Baron et al. 2022) see opportunities for substitution or elimination oflead.
To facilitate the approach of (Baron et al. 2022), exemption 34 should therefore be renewed
as proposed by (Baron et al. 2022), i.e. renewal with its current wording for all categories of
EEE, and expiry45 on 21 July 2024 for all categories of EEE including cat. 8 and 9 with all
their subcategories. Since this does not imply any changes in the exemption scopecompared to the currently valid exemption 34, nor is its final expiry intended. The applicant’s
arguments as to the non-availability of lead-free trimmer potentiometers are obsolete fromthe technical point of view. Further on, the renewal request46 of the Umbrella Project from15 January 2020 for the renewal of exemption 34 (review by (Baron et al. 2022) included
cat. 9 IMCI as well. TMC could have contributed to the related stakeholder consultation atthat time to bring in their members’ perspective.
The COM had made clear in earlier reviews that exemption requests require category
specific evidence in line with Art. 5(1)(a) and in case of absence there is no justification to
grant deviating exemptions for specific categories.
Also worthwhile to note is that not all manufacturers of cat. 9 IMCI are members of TMC.
Further on, the TMC request did not find specific support of other cat. 9 IMCI manufacturers
during the stakeholder consultation for this current review where they could have expressed
objections against the adoption of the recommendation of (Baron et al. 2022).

45 This implies the assumption that the COM would leave sufficient time between the official publication of thedecision as to the renewal of the exemption in the Official Journal to allow renewal request to be submitted
no later than 18 months prior to the expiry of the renewed exemption.
46 Cf.

https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_24/Exemptions/34/34_Exemption_Re
quest__15012020_final.pdf

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14.3.3.

Environmental, health, safety and socioeconomic impacts(EPPA 2023) describe severe socioeconomic, health and safety consequences if exemption
34 is not renewed for cat. 9 IMCI. The consultants cannot exclude that the revocation of the
exemption could have adverse socioeconomic impacts. The consultants do, however, notrecommend revocating the exemption, or restricting its scope so that cat. 9 IMCI would be
excluded from the scope of the future exemption so that no adverse environmental or
socioeconomic impacts can be expected to arise.

14.3.4.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;•

the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts causedby substitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

TMC request the 7 year renewal of exemption III-34 with its current wording for cat. 9 IMCI
until 21 July 2031. Following their mandate for this exemption, the consultants assessed
whether the result of the previous review of this exemption by (Baron et al. 2022) - which
included cat. 9 IMCI - can be adopted for cat. 9 IMCI in the light of the applicant at hand.
The applicant objects the adoption of the renewal of this exemption recommended47 by(Baron et al. 2022) with its current wording but an expiry on 21 July 2024 for all categories
of EEE. They argue that no lead-free alternatives are available, and once they are available,
five to seven years are required for their qualification to ensure their reliable functioning in
cat. 9 IMCI.
(Baron et al. 2022) see possibilities to narrow the scope of the exemption in a next review
for all categories of EEE including cat. 9 IMCI and therefore recommend the 2024 expiry toverify and reflect this potential in a restricted exemption scope. The current review
confirmed this potential for cat. 9 IMCI. The consultants therefore recommend adopting the
exemption proposed by (Baron et al. 2022) to support the approach targeting the restrictionof the exemption scope in 2024 for all categories of EEE. No additional evidence for cat.9
IMCI was provided that would require to deviate from the wording recommended in 2022,
which also included cat. 9 IMCI.
The COM should grant sufficient time beyond the official publication of the COM decision
as to the renewal of exemption 34 and the expiry date of the exemption to allow time for the
preparation and timely submission of renewal requests less than 18 months prior to the
expiry of the exemption.

47 Cf. Table 14-3 on page 6259

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Stakeholders applying for the renewal of exemption III-34 should take account of theintentions expressed by (Baron et al. 2022) whether and how far the exemption could be
restricted to devices in which the trimmer potentiometers are seldomly used and low
voltages are applied.

14.4.

Recommendation

The consultants recommend maintaining the exemption renewal proposed by (Baron et al.
2022) which includes cat. 9 IMCI. (Baron et al. 2022) identified a potential to narrow thescope of the exemption and recommend the renewal of the current exemption III-34 withthe same wording and scope until 21 July 2024 for all categories of EEE including cat. 9
IMCI.
The aligned exemption expiry shall enable a harmonized renewal of exemption 34 for all
categories of EEE with a new scope that verifies the potential for a restriction of the scope
identified by (Baron et al. 2022). (Baron et al. 2022) want the industry to collect information
for the next renewal request as to the use of lead-free cermet-based trimmer potentiometersin less demanding applications, i.e. those where they are used less frequently in particularin EEE with lower power.
If the COM decides to follow the approach of (Baron et al. 2022), the below wording is
recommended for the renewed exemption III-34:
No.

Exemption

Scope and dates of applicability

III-34

Lead in cermet-based
trimmer potentiometer
elements

Applies to categories 1 to 11.
Expires on 21 July 2024 for categories 1 to 11.

The consultants recommend that the COM ensures sufficient time between the officalpublication of the decision and the expiry date to allow timely submissions of renewal
requests 18 months prior to the exemption expiry.
Applicant’s feedback on the recommendation(TMC 2024) do not agree to the recommended expiry date stating that the information
provided has not been fully considered and none of their arguments have been taken into
account in the consultants’ recommendation in line with Art. 5(1)(a).
The consultants are confident that they considered all relevant arguments made available
by the applicants and stakeholders during the review and that the arguments have been
evaluated in line with the mandate commissioned by the COM for the review of thisexemption.

14.5.

References

Baron et al. (2022): RoHS Pack 24. Study to assess requests for renewal of seven (-7-)
exemptions 18(b), 18(b)-I, 24, 29, 32 and 34 of Annex III and exemption 34 of Annex IV of Directive
2011/65/EU (Pack 24) – Final Report. In cooperation with Yifaat Baron, Carl-Otto Gensch, Andreas

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Köhler, Ran Liu, Clara Loew, Katja Moch, Öko-Institut. Retrieved fromhttps://data.europa.eu/doi/10.2779/123658.
EPPA (2023): Socioeconomic analysis of the impacts of non-renewal of Lead (Pb) exemption fortest & measurement industrial type products (Category 9) Exemption 34 – Annex III. RoHS Pack
27. Retrieved from https://rohs.biois.eu/TMC_SEA_Exemption_34_2023_PUBLIC_VERSION.pdf.
Gensch et al. (2016): Assistance to the Commission on Technological, Socio-Economic and Cost Benefit Assessment Related to Exemptions from the Substance Restrictions in Electrical andElectronic Equipment - Study to assess renewal requests for 29 RoHS 2 Annex III exemptions.
RoHS 14. In cooperation with Carl-Otto Gensch, Yifaat Baron, Markus Blepp, Katja Moch, Susanne
Moritz, Oeko-Institut und Dr. Deubzer, Otmar, Fraunhofer Institut Zuverlässigkeit und
Mikrointegration IZM (Adaptation to Scientific and Technical Progress of Annexes III and IV of
Directive 2011/65/EU, RoHS XIV). Retrieved from https://circabc.europa.eu/sd/a/eda9d68b-6ac94fb9-8667-5e561d8c957e/RoHS-Pack_9_Final_Full_report_Lamps_Alloys_Solders_June2016.pdf.
MTE (2023): MedTech Europe recommendation for the extension of RoHS lead exemptions for
medical technologies in the scope of category 8. Support for the exemption renewal requests
submitted by the ‘Umbrella Project’ in 2020 for the abovementioned exemptions, including forcategory 8 medical technology uses. Retrieved from https://rohs.biois.eu/MTE.pdf.
TMC (2023a): Request for renewal of exemption IV-34. RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/RoHS_Application_Form_34.pdf.
TMC (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Tobias Steinbrecher,
EPPA, to Dr. Otmar Deubzer via e-mail. RoHS Pack 27. Retrieved from https://rohs.biois.eu/Ex_III34_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024): Feedback on the recommendation, sent by Tobias Steinbrecher, EPPA, to Dr. Otmar
Deubzer via e-mail. RoHS Pack 27.

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Exemption 42 of Annex III: Lead in bearings andbushesThe below Table 15-1 shows the wording, scope and expiry dates of the exemption.
Table 15-1: Current wording of the exemption
No.

Exemption

Scope and dates ofapplicability

III-42

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

Applies to category 11.

-

Expires on 21 July2024.

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

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Cat.

Category, referring to the categories of EEE specified in Annex I of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

EU

European Union

EUROMOT

European Association of Internal Combustion Engine Manufacturers

IMCI

Industrial monitoring and control instrument262

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Lead-free

Not containing lead in the applications in scope of the exemption to bereviewed

Pb

Lead

PFAS

Perfluoroalkyl and Polyfluoroalkyl Substances

SEA

Socioeconomic analysis

15.1.

Background and technical information

On 20 January 2023, (EUROMOT 2023a) requested the renewal of the exemption III-42 forcat. 11 with the wording, scope and validity period shown in the below table.
Table 15-2: Requested exemption renewal
No.

Requested exemption

III-42

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;•with engine total displacement < 15 litres
and the engine is designed to operate inapplications where the time between
signal to start and full load is required tobe less than 10 seconds; or regular
maintenance is typically performed in aharsh and dirty outdoor environment, suchas mining, construction, and agriculture
applications

Requested scope and dates
of applicability
Applies to category 11.
Expires on 21 July 2029 (2024 + 5
years).

or

The request is supported by the (National Association of Manufacturers 2023).

15.1.1.

History of the exemption(Gensch et al. 2016) reviewed the exemption request of EUROMOT and recommended to
grant the exemption in its current wording for 5 years with the validity starting in 2019 andexpiry on 21 July 2024. The European Commission (COM) followed the recommendation.
After a renewal request of (EUROMOT 2023a), the exemption has become due for review.

15.1.2.

Summary of the requested exemption

According to (EUROMOT 2023a) lead as an overlay coatings and alloying element is used
in a number of bushings and bearings in specific non-road professional use engines. The
engines which require the use of lead are ones which have:263

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engine total displacement ≥ 15 litres to compensate for slight misalignments that
often occur in extreme high load operations,•engine total displacement < 15 litres and requires a quick (<10sec) signal to start toachieve good reliability as lead acts as the initial lubricant, or•

requires maintenance in harsh and dirty environments where contaminants can be
introduced to the system.

Lead provides seizure resistance, resistance to damage, conformability, embeddability,
fatigue strength, flexibility, chemical resistance, impact of manufacturing tolerances andtolerance to cold temperature and limited lubrication during start-up.
The development and qualification of lead-free alternatives is underway by bearing andengine manufacturers, however additional time is required to test and qualify potential
alternatives. The testing of bushings and bearings can be characterised by the following
key steps, each of which brings increased confidence that a solution can be deployed as a
viable alternative:
1. Laboratory tests of bearings to determine if they meet required performance criteria
2. Engine trials with new bearings
3. Field trials with finished equipment containing engines that have new bearings thatare being tested.
However, it is essential that all steps are undertaken as failures have been identified in thelast stage of testing. There is no internationally accepted standard test regime to test
bushings and bearings, so each company has developed their own methodology with themost difficult to achieve performance parameters usually being tested first.
Lead-free alternatives, relying upon alternative alloy compositions or polymer overlays(which for some rely upon Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
substances) are starting to show initial signs of suitable performance when tested bybearing manufacturers. The activities undertaken by bearing manufacturers are starting to
identify potential alternatives which looks to offer similar key technical characteristics.
However, other bearing manufacturers are still in the processes of developing bearings
which can offer the same performance as lead-based bearings.
Engine manufacturers in both their current engine designs and new designs are testing
potential lead-free alternatives, with the types of testing they undertake being reflective of
their own in-service applications. Currently, all testing undertaken by engine manufacturers
identifies the lead-free alternative which they tested having significant loss of technicalperformance in at least one critical parameter. As such, none yet have been determined to
be a viable alternative.
Two different engine manufacturers have trialled using lead-free bearings, as testing
indicated lead-free alternative in these specific applications, they might have suitableperformance. In both cases, however, engine failure was observed. This underlines theimportance of testing.
Given current lead-free alternatives still cannot offer the same performance as leadcontaining bushings and bearings, this exemption is therefore requested on the basis of theinferior reliability of lead-free substitutes.

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15.1.3.

Technical description of the exemption and use of the restricted
substance(EUROMOT 2023a) points out that the exemption III-42 for cat. 11 is relevant for bearingsand bushes in internal combustion engines designed for professional use, with either:14) a large engine size (≥15L),
15) highly demanding applications (where signal to start and full load is <10 sec), and/or
16) or is exposed to harsh and dirty environment during maintenance.
17) Examples of applications of each of these criteria are as follows:18) Emergency generators, fire pumps and uninterruptable power system (UPS)
installations
19) Drills, compressors, rock crushers, irrigation pumps, fire pumps, mine trucks, tub
grinders, excavator, screeners, wheel loader, skid steer loader and generators
installed temporarily on site. Such applications are used in a number of different
industries including mining, agriculture, and construction.
Consumer equipment with small engine sizes do not have the same technological andreliability demands, so are not proposed to be included in the scope of this exemption.
Due to the scope of the RoHS Directive, "forms of transport", "professional non-road mobile
machinery" and “stationary industrial tools or fixed installations” are excluded from thescope of the Directive. As discussed in the previous exemption request, this significantly
impacts the types of internal combustion engines which are in scope of the Directive’s
requirements. The key differentiator for many of these applications is whether they aredesigned to be stationary when in use.
It is worthwhile noting the possible overlap of this exemption with exemption 6c of Annex III
of the Directive, for lead in copper alloys, as bearings and bushings produced from copper
alloys with up to 4% lead are also used in professional use non-road equipment engines. It
is understood that all such applications are to be covered by exemption 6c as long as thisexemption is renewed.
Highly demanding applications
Applications which require the 10 second signal-to-start have many key features whichmake it a highly demanding application:•

Applications, such as emergency back-up power, will sit for extended periods of time
without being exercised and only started for planned maintenance or an actual
power outage. During the latter one of these, power is required to be restored within
10 seconds.

•

The signal to start requirement is in all weather conditions and can be in situations
where ambient temperature is below -4oC, which causes oil to be more viscous andso will move much slower than at higher temperatures and may not reachreciprocating components for minutes, compared to seconds in less harshconditions.

It is during this period, where it is only the lubricity of lead in the bearings that enables theengine to move without seizing and with minimal wear to internal components. To enable
the quicker flow of oil at lower temperatures, engines are designed with a filtration bypass

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system to avoid the added restriction of the oil filters and enable faster flow to thereciprocating components. This of course allows for particles of any size to be circulated
throughout the engine that can cause damage, until such time as the oil is warmed to theappropriate temperature and the filtration loop is again enabled.

•

For engines designed for fast start-up applications, lead is necessary to achieve
good reliability.

Harsh and Dirty:
The terminology of harsh and dirty, is once again requested to be included in the scope ofthe exemption. The inclusion of terminology is important given that many applications
require engines to be located in ‘harsh and dirty’ environments for significant lengths of time,for example in quarries or construction sites, where providing a sufficiently clean
environment such that particles will not be introduced to the engine, especially during
maintenance, is impossible. Debris may be introduced during service and maintenanceprocedures or from the environment that the engine operates in.
It is recognised that whenever a term is included in an exemption, to allow for the consistent
determination across Member States and companies, it is always preferred that suchterminology is accompanied by a quantitative definition. Efforts have been expended in theintervening timeframe since exemption 42 was granted to try to better define the terms,
however a consolidated quantitative wording was unable to be defined due to the complex
and interplaying factors of what is deemed as acceptable.
There are multiple permissible values of determining ‘dirty’ which depend on multiple
interdependent factors including particle size and distribution, number of particles, particle
hardness and engine specific parameters. There are manufacturers’ cleanliness standards,
which define a permissible particle load for differing types of components, as well as a
maximum permissible particle size are outlined. However, these standards vary between
companies, both in terms of what are defined as critical parameters and quantitative values
listed, with indicative examples listed below:•

Company A: ‘clean’ is defined as parts which are exposed to particles of <850μm
debris particle size only.

•

Company B: Maximum particle size allowed is 80-100μm based upon clearances
and tolerances. The maximum size may be less for abrasive particles, which can
key on to bearing surfaces.

•

Company C: Maximum permissible particle size for a metallic crankshaft is 120μm
for mineral particles and 600μm for metallic particles, with a maximum of 1 mineralparticle per 1000cm2 surface in the 80 to 120μm range and 10 metallic particles per
100cm2 surface in the 400 to 600μm range.

•

Company D: Maximum particle size 500μm.

The disparity in the values listed by each company reflect the different engine specificparameters (e.g., design, intended use, etc.) which affect the impact of particles including
clearances, tolerances, and wear. It is important to note that these standards relate to‘components ready for shipment’, rather than parts which are operating in engines in suchan environment. As such it is not possible to extrapolate the values listed in these standards
to produce a permissible level for whole engines in the field a due to the large numbers ofvariables that affect engine reliability.

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Indications can be seen in some of the companies’ standards that critical parameterssometimes require tighter control, however in an operational environment these increase in
their complexity, as well as introducing other critical parameters. As an example, the typeof particle has a large impact on the bearing or bushing’s ability to withstand its introduction,with the hardness and abrasiveness of particles playing a critical role. Dry sand particles
compared to moist clay particles have very different impacts on acceptability and listing all
potential contaminants in equipment utilising the exemption that are expected to experiencewould be impossible. Another consideration is the number of particles per cubic meter of
air, which to date only one company standard has been identified that gives a permissible
number of particles, with most EUROMOT members stating that this is not a measured
parameter in real environments.
An indicative estimate provided by a EUROMOT member is no more than 2 grams ofparticulates ingested through an air intake system, but this is not a transferable parameteras this will also depend on other variables such as engine size and the fact that
contamination may also be introduced through handling during maintenance and service,i.e., that it cannot always be attributed to the quality of air in which equipment is operated
or serviced.
Harsh can be described in a qualitative way, such as a description provided by an engine
manufacturer below, but a quantitative description for particle, size, number, and hardness
is impossible to bound in a straightforward way as they are interdependent.
‘A harsh environment is one where dirt and debris particles, that contain abrasive particles,
are present and will / may accumulate on machinery (powered by reciprocating engines) or
engines, tools used to service engines and technicians / mechanics clothing or person, and/ or environment where the dirt, debris and contaminants, including abrasive particles, areairborne in the environment such that contaminates will be present in the proximity of theengine at times of service or maintenance.
In these environments the dirt and debris, including abrasive particles, can enter the engine
at times or moments of service or maintenance when internal passages or surfaces of theengine are exposed to the environment.’
For example, a few small very hard particles may be similarly damaging as a larger numberof larger, softer particles. Hence, it has not been possible for the industry to defineboundaries for all three variables under all real field conditions.
According to (EUROMOT 2023a) the lead has the function as a coating or alloying element
to produce a tribological interface for bushings and bearings, to provide the required
performance and reliability which include seizure resistance, resistance to damage,conformability, embeddability, fatigue strength, flexibility, chemical resistance, impact ofmanufacturing tolerances and tolerance to cold temperature and limited lubrication during
start-up.
Various lead alloys are used as bearings or as layers of bearing surfaces. Lead bushingsand bearings, including the following which is provided as a non-exhaustive list48:

48 Note that there are sometimes differences in naming convention of certain bushings and bearings

depending on the company in question and location, where possible alternative naming has been indicated.

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Main bearings,•

Con rod (crankshaft) bearings,•

Piston pin bushings,•

Camshaft bushings,•

Cam follower roller pins,•

Thrust (camshaft and crankshaft) bearings,•

Gear box (gear train) bearings and bushings,•

Turbocharger bearings and bushings,•

Idler gear bearing and bushings (gear box bearing),•

Oil pump bearing and bushings, and•Valve train (rocker arm) bearing and bushings.

(EUROMOT 2023a) state that lead is used in bushings and bearings, which are mechanicalelements providing movement relative to another element with minimum power loss.
Bushings are technically identical to a bearing except that they are a single independent
one-part device whereas bearings are mostly made of two or more materials orcomponents.
Lead is used as a thin coating (up to 90% lead) to provide a tribological interface between
two moving parts which helps to prevent seizure and it can absorb debris which mightotherwise cause engine failure. Lead is also used as an alloying element (up to 20% lead),often as a layer below the thin lead-rich coating, which provides conformability to help the
bearing to compensate for slight misalignments that often occur following service or extreme
high load operations. Lead would typically comprise between 1 and 3% of a complete
leaded bearing (based on total part weight). Lead from all these components would typicallycomprise less than 0.025% of a complete engine.
There are multiple types of bearings and bushes, as outlined by Section 4 to 6, which comein a variety of shapes, designs, and sizes, all of which are required to have a combinationof important properties to provide the required performance and reliability for the intended
conditions of use and lifetime. The specific requirements for each specific property depend
on multiple variables including engine capacity, conditions of use, conditions during rebuild
and servicing, rotation velocity, loading, etc.
Bearings may be constructed in three layers as shown in Figure 15-1, with the steel backproviding rigidity, the bearing alloy generally consisting, typically of copper or aluminium
plus lead alloys and the thin overlayer that provides anti-friction properties through a highlead content (even when oil lubricant is absent). A bond or dam layer may be deposited
between the overlay and the bearing alloy to prevent migration of metals from one layer intoanother.

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Figure 15-1: Tri-metal bearing

Source: (EUROMOT 2023a)

Lead overlay compositions vary depending on the application and bearing in question, withindicative examples provided in Table 15-3. The lining material can then either be a copperor aluminium alloy, with lead contained up to 25% of the alloy depending on the alloy used.
Table 15-3 Examples of lead overlay compositions
Lead (Pb),
%
90
88
88
87
85
82
80
78
75.5

Tin (Sn), %
10
10
10
10
9
18
14
12.5

Copper(Cu), %
2
3
5
2
8
2

Indium (In),
%
10
9
10

Alumina(Al2O3), %2-

Source: (EUROMOT 2023a)

Engine bearings are designed to operate in a hydrodynamic lubrication regime with alubricant film layer between two moving surfaces, but during starting and stopping, speed
and load changes, these two surfaces may not be fully separated by a lubricant film. As
such bearings may operate in boundary and mixed lubrication regimes, meaning that thebearing may need to operate with insufficient oil and so require the lead to also provide
lubrication. Under these conditions, the contacting material surfaces as well as the engine
oils containing additives play an important role in determining the friction and wear.
Lubricant starvation can easily lead to metal to-metal contact, without a suitable surface
on the bearing this can cause high wear of the bearing surfaces due to severe ploughing,
and wear debris can initiate seizure failure.
Each engine contains many different designs of bearings, an indicative example engine isshown in Figure 15-2.

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Figure 15-2: Parts of a typical internal combustion engine with bearings and bushes
shown in pink and green

Source: (EUROMOT 2023a)

Engines also contain bushings that are made from one leaded alloy and are usually in the
shape of hollow cylinders. These can be made of copper alloys that contain lead where thelead acts as a dry lubricant. Some contain <4% lead and so would be in scope of exemption
III-6c but at some need to contain >4% lead to provide sufficient dry lubricity.
According to (EUROMOT 2023a) the particular characteristics and functions of the lead in
the scope of this exemption request that require its use are the following.
Bearings and bushes are required to have many important properties to provide the required
performance and reliability for the intended conditions of use and lifetime, which aredescribed below. Usually, a combination of essential properties is required by each bearingor bushing. The specific requirements for each specific bearing or busing depends on one
or more of many variables including engine capacity, conditions of use, conditions during
rebuild and servicing, rotation velocity, loading, etc. but can be generally described as a
combination of the following.
Seizure resistance is the ability of the bearing material to resist physical joining (metal tometal bonding), which is important as it provides a measure of the bearings ability to survive
momentary contact with the counter surface when there is not enough oil film to fully
separate the two surfaces. This in combination with resistance to damage is an importantcharacteristic of bearings covered by the exemption. Seizure usually occurs due to the heatgenerated, and resultant high temperature, by high friction forces that occur when
lubrication fails. All bearings experience some metal-to-metal contact, however undercertain circumstances seizure resistance is especially important. One such example is when
the bearing experiences cold start and/or oil starvation which are often experienced inapplications where the time between signal to start and full load is required to be less than
10 seconds as the lubrication oil drains away. Another factor where high seizure resistanceis especially important is when high roughness of the bearing or shaft surfaces is causedby dirt particles being introduced to bushings and bearings. Without the ability to resist

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seizure, the heat generated at the surface of the bearings can cause the metal surfaces tomelt and then seize, resulting in catastrophic failure of the engine.
Conformability is the ability of the bearing material to accommodate misalignments in thegeometry of the bearing, without which bearings can experience excessive wear and highspecific loading. Misalignment is most notable after when the engine is new or after a rebuildand conformability is essential to compensate for this. This is critical at start-up of all engines
in scope of the exemption request, as the metal surfaces are likely to have little or no
lubrication. For larger sized engines, small variations in the dimensions of bushings andbearings are more common, which can result in misalignment of parts. Lead’s soft
properties provides the desired conformability, allowing the bearing to conform to thevariation when there is metal to metal contact, allowing the engine to function correctly,
which is especially important during the wear in period of a new or reconditioned engine.
Poor conformability of the bearing material can result in excessive wear, premature failureof the bearing and catastrophic failure of the engine.
Embeddability is the ability of the bearing material to entrap and trap within the surface
layer small foreign particles, such as dirt, engine wear debris, dust, and other abrasive
residuals, allowing the continued function of the part. Poor embeddability of a bearing
material causes accelerated wear and allows particles to produce scratches on the bearing
surfaces, which significantly reduces the lifetime of the engine, and may also lead to seizure.
Lead has low affinity for iron that allows it to accept debris in a way that minimises shaft
damage and manages energy dissipation in the system to avoid the debris accelerating
progressive damage.
Although embeddability is an important characteristic of any bearing, as soot and debris are
inherent to the operation of all internal combustion engines, the applications and end-uses
in scope of this exemption require regular maintenance activities performed in a harsh anddirty outdoor environment and also to operate in such an environment so that these engines
need to be able to function with much more dirt that those engines that can be maintainedin clean workshops. This characteristic cannot be overstated in its importance. In suchenvironments the ability to limit dirt ingress is often impossible as there is often significant
amount of fine dust within the environment which is therefore expected to enter the engine.
In addition to environmental considerations, embeddability is still an important factor during
the running-in of an engine as metal shards or ‘chips’ can be introduced as part of thenormal manufacturing processes.
Fatigue strength is the maximum value of cycling stress that the bearing can withstandafter an infinite number of cycles. Cycling stresses applied to the bearings are the result of
the combustion and inertia forces developed in the internal combustion engines.
In addition to the key performance behaviours outlined above, the following are also
important:•

Flexibility of the coatings.

•

Chemical resistance to resist chemical attack of oxidized and impure lubricant.

•Tolerance to cold temperature and limited lubrication during start-up.

•

Low yield strength.

•

Thermal conductivity.

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Load Capacity. A measure of the maximum hydrodynamic pressure which a material
can be expected to endure. Important for some types of engines, as high loads cancause misalignment which lead based bearings can more easily accommodate.

•

Ability to withstand some manufacturing tolerances.

15.1.4.

Amount(s) of restricted substance(s) used under the exemption(EUROMOT 2023a) state that the lead content is between 20 and 90%, depending on
application, with higher values attributable to overlay coatings and the lower values as analloying element.
According to (EUROMOT 2023a) the amount of lead used for products in scope of the RoHS
Directive varies depending upon bearing and engine design, as well as the engine
displacement (larger engines would typically utilise more lead due to larger componentsize).
The previous exemption renewal request (EUROMOT 2015) outlined a methodology forcalculating the lead placed on the market from this exemption, which has been utilised inthis calculation. Much of the previous information which underpins the calculation has beenutilised, with the annual genset sales in the EU recalculated based on information from
Association of Equipment Manufacturers (AEM) in terms of percentage change of sales.
The assumption that non-genset applications add 25% of numbers sold has been used andthe data following data taken from the renewal as it is deemed to still be relevant:•Average engine mass•

Average lead content from bearings•

Percentage of units in scope of RoHS for each power band

The calculation in Figure 15-3 indicates that 1.73 tonnes of lead is placed on the EU market
due to bearings of new engines that are in scope of this exemption renewal request. It
should be noted that professional engines can have new bearings which are installed during
the service life of the engine, but this calculation does not account for any spares use.
Figure 15-3: Calculation of amount of lead in bearings used in engines in scope of
this exemption request

Source: (EUROMOT 2023a)

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15.2.

Justification of the requested exemption

15.2.1.

Substitution and Elimination of the restricted substance(EUROMOT 2023a, 2023b) claim that since they submitted the original exemption request(EUROMOT 2015) for lead in bearings, manufacturers of bearings and of engines havecarried out research into lead-free substitutes, however so far without success.
To identify if lead-free bearings can be considered as an alternative, they have to undergo
multiple stages of testing, involving both bearing and engine suppliers to replicate theenvironments they will likely see during their operations. Testing involves at least threestages:1. Laboratory tests of bearings to determine if they meet required performance criteria
2. Engine trials with new bearings
3. Field trials with finished equipment containing engines that have new bearings thatare being tested.
As explained in EUROMOT’s original exemption request (EUROMOT 2015), bearings thatappear to meet performance requirements often fail when used in engines, especially during
field trials.
For less challenging environments, such as in road vehicles (e.g., private cars), lead-freebearings are able to be used, however the on-going testing undertaken for applications
covered by this exemption request indicate that lead-free alternative are not suitable at thistime due to decreased reliability and inferior performance.
EUROMOT (EUROMOT 2023a, 2023b) outline the activities that have been undertaken to
identify alternatives, however, to date no alternative has been identified with either therequired technical performance to support products covered by this exemption request, or
their long-term reliability was found to be very poor with many premature failures. Testing
is being undertaken on a continual basis with other lead-free alternatives when they become
available. More time is needed for these to be developed and the necessary testingundertaken with the aim that they give reliable performance comparable to current
materials. Furthermore, It is important to note that some of the polymer alternatives rely
upon Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) substances which could be
impacted by the upcoming REACH restriction The detailed descriptions of the tests
undertaken can be found in (EUROMOT 2023a, 2023b).
According to (EUROMOT 2023b) multiple alternatives have been investigated by
EUROMOT members since the last exemption application as possible alternatives for leadin bearings. The following materials have been investigated:•

Copper alloy,•

SnAl bearing,•

Lead free brome bearing (with and without Bi addition),•

Lead free multi-layer materials,•

Multi-layer materials with additional coatings,

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Polymer coated bearings consisting of PFAS materials, (currently under evaluation
for Restriction under REACH).

•

Aluminium bushes(EUROMOT 2023a, 2023b) provide examples of the tests carried out by two manufacturers
which are representative for a significant proportion of the bearing market. The following
overlay materials were further tested by these two bearing manufacturers since the last
exemption request in 2015:•

Lead (PbSn10In14 + Al2O3)•

Lead-free 1 (Sn)•

Lead-free 2 (PAI; Al (10-15) PTFE (5-7) Silane 5)•

Lead-free 3 (PAI 45%; MoS2 55%)•

Lead-free 4 (PAI; MoS2 44%; graphite 23%)•

Lead-free 4 (Bi)The testing included chip contamination tests (see Figure 15-4, Figure 15-5), where theability to resist seizure is tested via the introduction of chips of different sizes, dynamic
seizure tests and stress testing. The chip contamination testing showed that lead-containing
bearings outperformed most lead-free alternatives. It was only in late 2021 that one potential
alternative (LF sintered bronze | LF Galv.) was identified as showing comparable
performance to lead-containing alternatives. It is important to note that although comparable
attributes are starting to be identified, this has only been as a result of significant
development by bearing manufacturers, which needs to be taken forward by engine
manufacturers for testing.
Figure 15-4: Copper bearing chip resistance testing (1)Source: (EUROMOT 2023a)
LF: Lead-free
LD: leaded
PVD: PVD Sputter coating (Part 2)

Galv.: Galvanized coating274

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Figure 15-5: Copper bearing chip resistance testing (2)Source: (EUROMOT 2023a)
LF: Lead-free
LD: leaded
POL: Polymer spray coat (Part 2)

Galv:. Galvanized coating

In addition to the contamination test, (EUROMOT 2023a) state that this bearing
manufacturer carried out dynamic seizure testing, stress testing, cap shift testing andbearing debris testing. (EUROMOT 2023a) conclude that currently no tested alternative
offers the same performance as the lead bearing.
The second manufacturer mentioned in (EUROMOT 2023a) conducted a bearing debris
testing with the following materials:
1) Pb base overlay/Copper base alloy
2) Pb base overlay/Aluminium base alloy
3) Pb free overlay/Copper base PB free alloy
4) PVD (sputter)/Copper base alloy
5) Polymer overlay/Aluminium base alloy
According to (EUROMOT 2023a) the material 2 (Pb-based) was considered by the
manufacturer to be the best performer due to the value and consistency of the average
number to failure. Material 5 (Pb-free) gave results superior to both 1 and 3. However, thevariability in the results of material 5 is greater, which was considered unacceptable, andMaterial 1 (Pb based) and Material 3 (Pb free) had similar performance. As Material 3 hasan equivalent debris tolerance to one of the conventional Pb-based materials (Material 1),
it is at a stage where engine manufacturers could test it in their applications to determine
its suitability.

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Furthermore, (EUROMOT 2023a) describes test undertaken by an engine manufacturer. In
those tests 2 lead-free bearings were tested. The conclusion reached by this manufacturer
was that this was due to the hardness and higher resistance to conformance in the bearing
contact area (a bearing with lead is more relenting) of the lead-free bearing. Once leadbearings were used no further failures were observed due to this issue. This issue isespecially important to stationary engines, such as power generators, due to their sensitivity
during the dry start phase and if lead-free bearings had to be used it should be expectedthat there would be a significant increase in the failure rate in such applications.
Another manufacturer is currently comparing the most promising lead-free alternative
bearing to the current lead bearing, as outlined in Figure 15-6. This compares seven
performance parameters necessary for their applications for leaded bearings and the mostpromising lead-free substitute tested by this manufacturer to date.
Figure 15-6: Comparative testing of leaded bearing to lead-free alternative

Source: (EUROMOT 2023a)

It can be seen that although the lead-free alternative shows higher performance for someof the tested characteristics, namely cavitation resistance and corrosion resistance, leaded
bearings still outperform the tested alternative on the other attributes (wear resistance,
embeddability/conformability, seizure resistance and debris robustness). Given theoperational environment of the products in scope of this exemption, decreased performanceof any of these attributes poses a real risk to causing engine failure. Work to understandthe extent to which failures would be experienced on this manufacturer’s engines due to thedecreased performance is being undertaken, along with investigating if the bearings can be
developed further to reduce the decrease in performance.
The tests from two other engine manufacturers are described in (EUROMOT 2023a). Du toengine failure the performance of the lead-free alloys was also insufficient in these tests.
The detailed descriptions of the tests carried out, as well as the conclusions can be foundin (EUROMOT 2023a, 2023b). Furthermore, the logistical challenges associated with276

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conducting maintenance in remote or inaccessible locations, such as mines or disaster sites
were also addressed. (EUROMOT 2023b) underlined the critical need for on-site
maintenance to ensure the continued operation of essential equipment, emphasizing theimpracticality of transporting heavy machinery to workshops, which would not be a harshand dirty environment for servicing.

15.2.2.

Environmental, health, safety and socioeconomic impacts

According to (EUROMOT 2023a), in the commercial internal combustion engine sector
there is effectively a closed-loop system for the recycling of mixed metal components
generated during the remanufacturing process and at end of life. End-of-life bearings havea positive metal value, whereas landfilling has a cost, so almost 100% of bearings arecollected and recycled, although not always by the original engine manufacturer. Closed
loops are in effect industry-wide, as it is not possible for bearing or engine manufacturers
to guarantee the take-back of their own bearings for recycling, but the metals are recovered
through traditional metal recycling processes that take place within the EU and are reused,although not necessarily in bearings. Therefore, there is no closed loop as defined in Article
4.5 of RoHS.

15.2.3.

Roadmap towards substitution or elimination of the restricted
substance

EUROMOT (EUROMOT 2023a, 2023b) claims that due to the operational environment andan expected service for up to and beyond 20 years, material testing and development
activities necessarily take many years to complete to ensure long term reliability.
(EUROMOT 2023a) outlines the activities that have been undertaken to identify
alternatives, however, as explained above, to date no alternative has been identified witheither the required technical performance to support products covered by this exemption
request, or their long-term reliability was found to be very poor with many premature failures.
Testing is being undertaken on a continual basis with other lead-free alternatives when they
become available. More time is needed for these to be developed and the necessary testingundertaken with the aim that they give reliable performance comparable to current
materials.
After laboratory tests, extensive “on-engine” and field testing must be executed to evaluate
the reliability and durability of the substitute material. This testing needs to be undertaken
by each engine manufacturer to ensure the testing reflects the demands of their applicationand the tolerances that are inherently in-built into each system. The reliability of the systemthen needs to be proven with an estimated 500,000+ cumulative hours of testing tounderstand if the alternative is equal to that of current leaded bearings / bushings.
Even then, as evidenced by failures where lead-free alternatives have been incorporated
into current manufacturing, real world conditions are impossible to fully replicate withtesting.
(EUROMOT 2023a) provided the qualification requirements which can be seen in Table
15-4. It provides an estimation on the expected timeframes for the development of analternative, it is important to note that the following are based on the concept that each test

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will ‘pass’ first time. If any further development is required to resolve technical issues thetimeframes outlined would be much longer.
Table 15-4: Qualification requirements

Source: (EUROMOT 2023a)

Internal combustion engines are required to comply with emission legislation. As changing
a bearing material may affect emissions and so compliance must be confirmed before a
new design can be placed on the market. The EU, USA, Canada, China, Japan, and manyother countries all have their own specific emissions legislation, with for global approvals
this also needs to be considered. This will require between 1-3 years depending on theengine manufacturer, which for the majority of engine manufacturers will be in addition to
the above timescale.

15.2.4.

Stakeholder contributions

The request is supported by the National Association of Manufacturers (National
Association of Manufacturers 2023). During the public consultation five contributions(DEUTZ 2023; EGMF 2023; EMA 2023; JCB 2023; Volvo Penta 2023) were received.
Those consisted entirely of letters of support expressing general support for all requests by
EUROMOT during the Pack 27 reviews. None of the above-mentioned stakeholders has
provided any technical arguments, and the questions in the consultation questionnaire havenot been answered.

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15.3.
15.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds. None of these entries are,however, relevant for the use of lead in the scope of exemption III-42 (cf. section 4.2 on
page 51 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

15.3.2.

Substitution and elimination of the restricted substance

Generally, lead-free overlay coatings and alloying elements are used in bearings andbushes. (EUROMOT 2023a, 2023b) state that these cannot be used for the applications
within the scope of exemption III-42 because lead-free alternatives do not have theproperties required in a harsh and dirty environment.
The operation, maintenance and repair of cat. 11 EEE in harsh and dirty environments asa core obstacle to the substitution of lead was already discussed in the previous review ofthe exemption by (Gensch et al. 2016). The applicants plausibly describe that maintenanceand repair of the EEE in the scope of the exemption is impracticable since they are operated
in remote or inaccessible locations, such as mines or disaster sites.
Since the last exemption request in 2015, (EUROMOT 2023a, 2023b) can demonstratesignificant efforts to explore alternative materials and evaluate their suitability for different
applications. EUROMOT members tested many lead-free bearings from various
manufacturers in engines covered by this exemption request. The results consistently
demonstrate unacceptable performance and reliability (cf. section 15.2.1).
Overall, the provided information suggests that substitution and elimination of lead isscientifically and technically still impracticable.

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15.3.3.

Wording of the exemption

The consultants investigated whether the exemption scope can be narrowed or at least be
specified and proposed the following amendment of the wording: “Lead as an overlay
coating and alloying element in bearings and bushes […]”.
(EUROMOT 2023b) suggest to keep the current wording, as the suggested change aims ataccommodating instances in which the two applications are used separately. (EUROMOT
2023b) state that the wording may create misunderstanding on the substances covered by
the exemption as lead is used as an alloying element as well and not in its pure form. Achange of the wording to “Lead as an overlay coating and alloying element” might bemisunderstood as applicable only to the use of 100% lead concentration in overlay coatings.
The consultants thereupon proposed a new wording: “Lead (up to 90 %) in overlay coatingsof tribological interfaces and lead (up to 20 %) in layers below the overlay coatingcompensating misalignments in bearings and bushes […]”.
However, (EUROMOT 2024a) raised two concerning aspects with the suggested new
wording:•

The enforceability of the new wording,•

The concentrations identified to be used in bearings and bushing liners and overlay
coatings.

(EUROMOT 2024a) state that implementation of the proposed exemption would create
confusion as there is no standard test to assess misalignment and it would be overlooking
other technical parameters that are of equal importance for safe operation and reliability.
Lead-containing coatings and layers are not used solely to compensate for misalignments
but it is fundamental to ensure seizure resistance, resistance to damage, conformability,
embeddability, fatigue strength, flexibility, chemical resistance, impact of manufacturing
tolerances and tolerance to cold temperature and limited lubrication during start-up.
Moreover, the definition of a tribological interface is of difficult understanding as it is notuniquely defined by a standard or a regulation, this characteristic can only be assessed bydestructive testing techniques that would require the sectioning of a bearing to assess
compliance. This would introduce challenges to the implementation of the Directive as thetribological interface cannot be tested in a non-destructive way by Member States assessing
conformity.
Figure 15-7: Example of structure of a multilayer bearing.

Source: (EUROMOT 2024a)

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Considering the example of bearing structure highlighted in Figure 15-7, the following layers
are identifiable:•

Steelback, the thickest layer without lead.

•

Lining, composed of a lead containing alloy (up to 33 % Pb).

•

Overlay coating, which is a galvanised layer on the lining that can contains lead up
to 95 %.

Further investigation on the concentration of lead in overlay coatings have highlighted thatspecification generally allow Pb up to ~95% as per ISO 4383 (2012). Below Figure 15-8 of
ISO 4383 shows various specifications for overlay coatings.
Figure 15-8: Specifications of overlay coating according to ISO 4383 (2012)

Source: (EUROMOT 2024a)

The lining material can either be a copper or aluminium alloy, with lead contained up to
33 % depending on the alloy used. Moreover, lead-containing alloying materials generally
allow Pb up to 33% as per ISO 4383. Below Figure 15-9 shows various lead based copper
alloy specifications for bearings.

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Figure 15-9: Specifications of layer below overlay coating compositions according to
ISO 4383:201(E)Source: (EUROMOT 2024a)

In light of the considerations discussed in the previous point, (EUROMOT 2024a) suggested
the following wording: “Lead in overlay coating up to 95% and/or lead in lining up to 33% ofbearings and bushes […]”
Based on the proposal of (EUROMOT 2024a), the consultants developed the following
adjusted wording: ”Up to 95 % of lead in overlay coatings and/or up to 33 % of lead in liningsof bearings and bushes […]”.

15.3.4.

Environmental, health, safety and socioeconomic impacts

Although the consequences of not extending the exemption are not explicitly mentioned in(EUROMOT 2023a, 2023b, 2024a), the consultants understand that this would have asignificant impact on the applications mentioned. This is evident from the test results forlead-free alternatives described in section 15.2.1. For example, emergency generators, firepumps and uninterruptable power system installations could no longer be placed on themarket due to performance and reliability concerns. For this reason, the consultants
conclude that the revocation of the exemption could have adverse socioeconomic impacts.
According to (EUROMOT 2023a) all bushings and bearings are subsequently recycled.
Additionally, professional engines at end of life are recycled as steel scrap and lead isrecovered in the EU by steel recycling processes. The number of engines and quantity oflead are not recorded consistently in the EU, so a calculation on quantities is difficult,especially as the engines reaching their end of life currently are over 30 years old. In astable market, the quantity of lead used in new engines will be similar to the amountreaching the end of life. The amount of lead in end-of-life bearings and bushings that arerecycled is the amount used in new engines minus lead lost due to wear.
The amount of lead lost due to wear is expected to be very low, but unable to be calculated.
However, it is important to note that any lead lost due to wear would be collected in theengine oil system and therefore not released into the environment.

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It is worthwhile noting that bearings are not intended to be replaced during the lifetime ofthe engine, and as such only an extremely small number of bearings are used as spareparts.

15.3.5.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;•

the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

(EUROMOT 2023a) request a 5-year renewal of exemption III-42 with its current wording
for cat. 11 until 21 July 2029. (EUROMOT 2023a, 2023b) argue that no lead-freealternatives are available, and once they are available, minimum five years are required fortheir qualification to ensure their reliable functioning in cat. 11.
The main obstacle for the substitution of lead in the applications in the scope of
exemption 42 is the requirement of servicing, maintenance and repair in the field, i.e. in theharsh and dirty environments in which the machines are operated, instead of performing
these operations in workshops. The research and development efforts of (EUROMOT
2023a, 2023b, 2024a) since the last review by (Gensch et al. 2016) did not yet yield viablelead-free solutions.
The consultants conclude from the provided evidence that substitution or elimination of lead
are scientifically and technically still impracticable so that granting an exemption could bejustified based on the criteria outlined in Article 5(1)(a).
In cooperation with the applicant, the use of lead in the bearings and bushes was specified
and integrated into the exemption scope.

15.4.

Recommendation

The consultants recommend renewing the exemption. Substitution or elimination of lead are
scientifically and technically not yet practicable so that granting the exemption would be inline with the requirements of Art. 5(1)(a). Since the practicability of substitution or elimination
is not foreseeable within the next five years, the applicant’s request for a five-year renewal
could be followed.

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If the COM decides to renew the exemption, the below wording is recommended:
No.

Exemption

Scope
and
applicability

III42(a)Up to 95 % of lead in overlay coatings and/or
up to 33 % of lead in linings of bearings andbushes of diesel or gaseous fuel-poweredinternal combustion engines applied in nonroad professional use equipment:

Applies to category 11 from [dateof publication of COM decision +12 months + 1 day] on-with engine total displacement ≥ 15
litres;-with engine total displacement < 15litres and the engine is designed tooperate in applications where thetime between signal to start and fullload is required to be less than 10
seconds; or regular maintenance istypically performed in a harsh anddirty outdoor environment, such as
mining, construction, and agriculture
applications

dates

of

Expires on 21 July 2029.

orApplicants’ feedback on the recommendations(EUROMOT 2024b) state that they agree with the recommendations for the above
exemption and have no additional comments to provide.

15.5.

References

DEUTZ (2023): Consultation response by DEUTZ AG for the exemption request III-42. RoHS
Pack27. Retrieved from https://rohs.biois.eu/DEUTZ.pdf, Last updated 26.02.2024.
EGMF (2023): Consultation response by European Garden Machinery Industry Federation for the
exemption request III-42. RoHS Pack27. Retrieved from https://rohs.biois.eu/EMA.pdf, Last
updated 26.02.2024.
EMA (2023): Consultation response by Truck and Engine Manufacturers Association for the
exemption request III-42. RoHS Pack27. Retrieved from https://rohs.biois.eu/EMA.pdf, Last
updated 26.02.2024.
EUROMOT (2015): Request for renewal of exemption III-42. RoHS Pack 11. Retrieved fromhttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_11/Request_20161/RoHS_Lead_Bearings_Exemption_Request_Form_EUROMOT_2015-07-27.pdf, Last updated
26.02.2024.
EUROMOT (2023a): Request for renewal of exemption III-42. RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form-ex42-EUROMOT-LeadBearings.pdf, Last updated
26.02.2024.

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EUROMOT (2023b): Answers to questionnaire 1 (clarification questionnaire) sent via e-mail by
Maitheya Riva, RINA, to Alexandra Morozov. RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/Ex_III-42_EUROMOT_Questionnaire-1_Clarification_Answer.pdf, Last
updated 26.02.2024.
EUROMOT (2024a): Answers to questionnaire 2 sent via e-mail by Maitheya Riva, RINA, toAlexandra Morozov, Fraunhofer IZM, Last updated 26.02.2024.
EUROMOT (2024b): Answers to recommendation sent via e-mail by Maitheya Riva, RINA, toAlexandra Morozov, Fraunhofer IZM. RoHS Pack 27 (RoHS 29).
Gensch, Carl-Otto; Baron, Yifaat; Deubzer, Otmar (2016): Study to assess 2 RoHS new exemption
requests: #1 for lead in bearings and bushes of professional-use non-road equipment engines; #2
for lead in solders used to construct and connect to Peltier thermal cyclers used for in-vitro
diagnostic analysers that use polymerase chain reaction (Pack 11) – Final. Under the Framework
Contract: Assistance to the Commission on technical, socio-economic and cost-benefit
assessments related to the implementation and further development of EU waste legislation, Last
updated 26.02.2024.
JCB (2023): Consultation response by JCB Power Systems LTD for the exemption request III-42.
RoHS Pack27. Retrieved from https://rohs.biois.eu/JCB_support_EUROMOT.pdf, Last updated
26.02.2024.
National Association of Manufacturers (2023): NAM - Support Letter, EU RoHS Application toExtend Exemption III-42, Last updated 26.02.2024.
Volvo Penta (2023): Consultation response by Volvo Penta for the exemption request III-42. RoHS
Pack27. Retrieved from https://rohs.biois.eu/Volvo_Penta.pdf, Last updated 26.02.2024.

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Exemption 44 of Annex III: Lead in solder in engines
The below Table 16-1 shows the wording, scope and expiry dates of the exemption.
Table 16-1: Current wording of the exemption
No.

Exemption

Scope
and
applicability

dates

III-44

Lead in solder of sensors, actuators, and engine
control units of combustion engines within the scope ofRegulation (EU) 2016/1628 of the European
Parliament and of the Council (49), installed inequipment used at fixed positions while in operation
which is designed for professionals, but also used by
non-professional users

Applies to category 11 andexpires on 21 July 2024.

ofDeclaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and Definitions
BGA

Ball grid array (a specific surface-mount chip package used for integrated
circuits)

Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

ECM

Engine control module (synonymous to ECU)

ECU

Engine control unit (synonymous to ECM)

EEEElectrical and electronic equipment

ELV

End-of-life vehicles (Directive 2000/53/EC)

49 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).

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OEM

Original equipment manufacturer

PCB

Printed circuit board

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive

16.1.

Background and technical information

On 20 January 2022, (EUROMOT 2023a) requested the renewal of the exemption
displayed in Table 16-2 for EEE of category (cat.) 11.
Table 16-2: Wording and scope of the requested exemption
No.

Requested Exemption

Requested scope anddates of applicability

III-44

Lead in solder of engine control units of combustion
engines, installed in equipment used at fixed positions
while in operation which is designed for professionals,
but also used by non-professional users

Applies to category 11;
expires on 21 January 2027

Stakeholder contributions were submitted by (JCB 2023), (DEUTZ 2023), (Volvo Penta2023), (EMA 2023), (Cummins 2023) and (EGMF 2023).

16.1.1. History of the exemption
Exemption III-44 was first requested by EUROMOT in June 2017 and was evaluated by(Gensch et al. 2019) resulting in the current wording of the exemption displayed in Table
16-1.
(EUROMOT 2023a) applied for the renewal of the current exemption 13(a) for cat. 11 since
it was earmarked for expiry on 21 July 2024 for this subcategory of cat. 9 EEE.

16.1.2. Summary of the requested exemption and stakeholder contributions
Summary of the requested exemption (applicants)“Lead is used in solder to make electrical connections to components in engine control units(ECUs). Work has been undertaken since the last exemption renewal to qualify lead-freesolder in sensor and actuators, which were previously in scope of the exemption. However,more time is necessary to undertake the qualification of lead-free solder in ECUs.
ECUs are generally mounted on the engine block and as such experience a harsh
operational environment which includes severe vibration and temperature fluctuations from
-40⁰C to 105⁰C or greater for prolonged periods of time. Lead containing solder is known toprovide resistance to failures due to thermal cycling, vibration and shock, does not form

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whiskers which could cause short circuits, while still having a low but sharp melting pointsuch that it can be applied to PCB’s without damaging any components.
Manufacturers designing new ECUs, are designed with lead-free solder. However legacy
ECUs requires testing and usually also circuit redesign and component substitutions toensure that the ECUs will be reliable for many decades in demanding environments.
EUROMOT members produce equipment designed to voluntary consensus safety
standards and subject to third party certifications, customer requirements, and regulatory
testing obligations. Changes to the solder can affect function, performance, or safety andas such must undergo extensive testing to ensure it meets internal quality benchmarks,
design specifications, and regulatory requirements.
The type of ECU, engine and end-use equipment determines the types of tests that are
required, with each manufacturer requiring their own testing regime. Testing is underway
by EUROMOT members, but additional time is required for these to be completed.”(EUROMOT 2023a)
Summary of the stakeholder contributions
JCB is a British multinational manufacturer of equipment for construction, agriculture, waste
handling, and demolition. JCB design and manufacture internal combustion engines thatare used in a variety of applications and are an active member of EUROMOT. JCB support
the exemption request and urge the extension for a full five years. This continued exemption
is critical to support European businesses that form an essential arm of the supply chain,
and European distributors and consumers, by allowing the necessary time to extend thereliability and sustainability of their products. (JCB 2023)
DEUTZ AG is a publicly traded company and one of the world's leading manufacturers ofinnovative drive systems. Its core competencies are the development, production,
distribution, and servicing of drive solutions in the power range up to 620 kW for off-highway
applications. Their current portfolio extends from diesel, gas, and hydrogen engines tohybrid and all-electric drives. DEUTZ drives are used in a wide range of applications
including construction equipment, agricultural machinery, material handling equipment suchas forklift trucks and lifting platforms, commercial vehicles, rail vehicles, and boats used for
private and commercial purposes. DEUTZ supports the exemption renewal request of
EUROMOT and states that it is critical for European manufacturers and to support
businesses and consumers and to continue to improve the reliability and sustainability of
their products. (DEUTZ 2023)
Volvo Group manufactures trucks, buses, construction equipment, and power solutions forindustrial and marine applications. Volvo Penta is the part of Volvo Group that manufactures
engines and drivelines for off highway applications and power generation, as well as
propulsion solutions, drivelines, user interfaces and support for marine applications. Volvo
Penta supports the application for a renewal of the exemption for a full five years. The
continued exemption is critical to European manufacturers and to support businesses andconsumers and to continue to improve the reliability and sustainability of their products.
(Volvo Penta 2023)
EMA, the Truck and Engine Manufacturers Association, represents worldwide
manufacturers of internal combustion engines and on-highway medium and heavy-duty
vehicles. EMA member companies design and manufacture internal combustion enginesthat are used in a wide variety of applications, including trucks and buses, farm, construction

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and industrial equipment, marine vessels, locomotives, lawn, garden and utility equipment,
and electric generators and other stationary applications. EMA support the application forrenewal of this exemption for a full five years. The continued exemption is critical toEuropean manufacturers and to support businesses and consumers and to continue toimprove the reliability and sustainability of their products. (EMA 2023)
Cummins designs, manufactures, distributes and services diesel and natural gas engines
and powertrain-related component products, including filtration, aftertreatment,turbochargers, fuel systems, controls systems, air handling systems, transmissions, electric
power generation systems, batteries, and electrified power systems. They continue to makeinvestments in critical future technologies and products to meet future emission
requirements around the world and improve fuel economy performance of diesel and natural
gas-powered engines and related components as well as development activities aroundfully electric, hybrid and hydrogen power solutions and hydrogen production. Cummins
support the application for renewal of this exemption for a full five years. The continued
exemption is critical to European manufacturers and to support businesses and consumers
and to continue to improve the reliability and sustainability of their products. (Cummins
2023)
EGMF, the European Garden Machinery Industry Federation, is the largest representativeof the outdoor power equipment industry in Europe since 1977. EGMF support EUROMOT’s
application for the renewal of this exemption. Ensuring the continuation of these exemptions
is crucial for European manufacturers as it would support businesses and consumers andimprove the reliability and sustainability of their products.

16.1.3. Technical description of the exemption and use of the restricted
substance
Types of EEE for which the exemption renewal request is relevant
According to (EUROMOT 2023a), the scope of this exemption is electrical control
components of NRMM engine systems that are not excluded from the scope of the RoHS
Directive. Due to the scope of the RoHS Directive, "forms of transport", "professional nonroad mobile machinery" and “stationary industrial tools or fixed installations” are excluded
from the scope of the Directive. EUROMOT explain that this significantly impacts the typesof internal combustion engines which are in scope of the Directive’s requirements. The key
differentiator for many of these applications is whether they are designed to be stationary
when in use.
(EUROMOT 2023a) provide the following, non-comprehensive examples NRMM, addingthat some are clearly not in scope of RoHS:•

Construction, agricultural and forestry equipment such as bulldozers, truck-typeloaders, diesel engine powered compressors, hydraulic excavators, mobile welders,fork-lift trucks, cranes, aerial lifts, drilling machines, screeners, conveyors, utility
tractors, turf-care equipment, rock crushers, wheel loaders, crawler tractors, crawler
loaders, road maintenance equipment, and•Fluid pumps (including pumps such as irrigation pumps, fire pumps),•

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Generator sets (including emergency generators, and uninterruptable power system(UPS) installations)(EUROMOT 2023a) note that some engines utilizing this exemption are also in scope of the‘NRMM Emissions Directive’, i.e. Regulation 2016/1628/EC, which defines ‘non-road mobile
machinery different from the RoHS Directive [cf. section 16.1.1on page 287, theconsultants]: “‘non-road mobile machinery’ means any mobile machine, transportableequipment or vehicle with or without bodywork or wheels, not intended for the transport ofpassengers or goods on roads, and includes machinery installed on the chassis of vehicles
intended for the transport of passengers or goods on roads’”.50(EUROMOT 2023a) explain that due to the different definitions, although ‘professional
NRMM’ is excluded from the scope of RoHS, the NRMM Emissions Directive definition of
non-road mobile machinery does not include in its definition the differentiation of
professional or consumer equipment.
(EUROMOT 2023a) clarify that their exemption renewal request does not refer to engines
intended solely for consumer use. However, this equipment is also used in engines
designed for types of equipment that are excluded from the scope of the RoHS Directive.
Function of lead in this exemption
Regarding the function of lead in this particular application, (EUROMOT 2023a) state thatlead is a constituent of solder alloy used to make electrical connections to components in
Engine Control Units (ECUs). (EUROMOT 2023a) indicate that lead is used in tin/lead alloy
and tin/lead/silver alloy for solder used in ECUs.
Material or component in which lead is used
(EUROMOT 2023a) explain that exemption 44 of Annex III of the RoHS Directive originally
included lead in solders used for sensors, actuators and ECUs. However, as was indicatedin EUROMOT’s original exemption request, manufacturers have been able to substitutelead in solders used for sensors and actuators but its use in ECUs is still necessary as
substation has not yet been possible for all designs.
(EUROMOT 2023a) further state that solders are used in the electrical circuitry of engine
control units (ECU) which monitor and control a number of actuators and sensors that are
integral to the engine system to ensure the optimal performance of the engine.
(EUROMOT 2023a) provided two figures to illustrate ECUs and their location on the engine
block, reproduced in Figure 16-1 and Figure 16-2.

50 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

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Figure 16-1: Example ECU CAD diagram and its location on the engine block

Source: (EUROMOT 2023a)

Figure 16-2: Example ECU and its location in service

Source: (EUROMOT 2023a)

Comparing the applications in scope of this exemption renewal request, (EUROMOT
2023a) state that manufacturers of engines in scope of this exemption and their supply
chains share many similarities with the automotive and aerospace industries. These
manufacturers’ sectors sell complex products comprised of thousands of parts andcomponents, sourced from supply chains which overlap with the automotive and aerospaceindustries. However, applications served by this exemption are characterised by longer

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lifecycles, higher costs, larger number of parts, higher variability and lower volume of
products, and end-use applications which operate in harsh and dangerous environments
demanding extreme reliability.
Regarding the functions of ECUs, (EUROMOT 2023a) explain that they monitor values,
such as voltage or current, from numerous sensors within the engine bay, interprets thedata using multidimensional performance maps, and adjusts the engine’s actuators tocontrol the engine’s performance. The ECU ensures that sufficient fuel and air is used by
the engine to ensure that it provides sufficient power for the application, without providing
too much power and stressing the engine unnecessarily. It also ensures that the mixture offuel to air is correct such that the combustion minimises emissions and fuel consumption,
while still providing sufficient power.
As such, ECUs control parameters such as:−Air-fuel ratio based on the readings of sensors such as the oxygen sensors, thethrottle position sensor, air flow sensor and engine coolant temperature sensor todetermine if additional fuel should be added to the cylinders−

Idle speed based on readings of the crankshaft position sensor to determine
revolutions per minute (RPM) and therefore controlling the idle speed by the ECU
controlling throttle stop or an idle air bypass control stepper motor.

−

Variable valve timing by controlling the time in the engine cycle at which the valves
open, with valves usually being opened sooner at higher speeds to increase the flowof air into the cylinder, increasing power and fuel economy.

Further, according to (EUROMOT 2023a), ECU’s monitor many inputs which include:−

Camshaft position sensor−

Knock sensor−

Vehicle speed sensor−

Crank shaft sensor−

Throttle position sensor−

Coolant temperature sensor−

Exhaust gas recirculation sensor−

Manifold absolute pressure sensor−

Heated oxygen sensor−

Mass air flow sensor

Regarding the production and design of ECUs, (EUROMOT 2023a) explain that they cancontain one or more printed circuit boards as part of their design and are manufactured bothby engine manufactures in-house as well as by specific suppliers in the supply chain ofengine manufacturers. Vehicle manufacturers dictate the systems’ technical tailoring. The
systems’ technical tailoring differs not only from one manufacture to the other, but also fromone model to the other of the same manufacturer. There is no industry standard to qualify
lead free solder in these types of applications, but rather each vehicle manufacturer has

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their own sequence and testing regime which is informed by the technical needs resulting
from individual model design and operating environment. There are also certain end use
applications, such as generators which require application specific testing such as testing
to certain municipal codes or other regulatory requirements which can add additional
requirements.
Further, according to (EUROMOT 2023a), manufacturers of equipment that contain engines
determine where ECUs are located, but frequently the most appropriate location is attachedto the engine block. The rationale for mounting the ECUs directly on engine blocks include:−

Good electrical earth connections are essential and guaranteed when the ECU ismounted on the engine block. Without earthing, the signals that are sent fromsensors and to actuators may cause damage to components or the ECU will
malfunction.

−

Avoidance of electromagnetic interference that would be detrimental to the operationof the sensitive control circuits within the ECU.

−

The vibration profile and impacts are already well understood for the engine.
Attaching ECUs to engines means that these will experience the same wellunderstood levels of vibration and range of frequencies and so can be designed andtested to be reliable under these conditions.

Discussing the challenges arising from the operational environment, (EUROMOT 2023a)
state that ECUs are generally designed with vibration damping elements wherever possible
to limit the vibration and shock experienced by the ECU. However, heat shielding is notpossible as the ECM [engine control module, used synonymous with ECU in this document]is subjected to heat from the engine and surrounding heat sources such as the exhaustsystem. Any heat shielding would be ineffective since temperatures of the component andsurrounding environment would reach equilibrium.
(EUROMOT 2023a) claim that the only other way of reducing the challenges of theoperational environment is to consider remote mounting of the ECU (e.g., away of theengine block). For some applications this is not possible as the engine block is the only
location which is capable for mounting the ECU. For others, the challenges in designing awiring harness with additional cable length to reach more distant locations may introduce
challenges with electromagnetic interference capability and other electrically ormechanically related failure modes. It is important to note that the wiring harness diameter
ranges typically between 2.5 to 6 cm, which due to its physical size is not very flexible andhas around one hundred separate wires connecting the ECM to the engine and sensors.
Therefore, any additional length of the harness takes up additional space in the endproduct’s engine compartment, such as a genset enclosure space, which cannot always be
accommodated due to the design of the equipment. There will also be additional weight that
can also increase fuel consumption if the engine is also used to move the equipment.
When the ECM is mounted on the engine, variation in harness installation is minimised
since the ECM mounts in only one place. If remote mounting is considered, then the harness
would 10 have to accommodate multiple installation configurations, assuming that theOriginal Equipment Manufacturer (OEM) can mount the ECM in a suitable location. For
ECU manufacturers which are not in-house to end equipment suppliers there is limited
influence which could be exerted on OEM installation procedures and location. As such,
this can introduce factors such as the risk of improper installation, potential damage to the
ECM and harness during shipment.

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EUROMOT 2023a) provide a table that outlines the types of conditions experienced byapplications covered by this exemption, compared to passenger road vehicles in scope of
the End-of-Life (ELV) Directive, reproduced in Table 16-3.
Table 16-3: Operational environment of applications covered by this exemption
compared to passenger vehicles
Parameter

Environment experienced bydevices covered under thisexemption

Environment experienced bypassenger vehicles

Vibration as
Root Square
Mean (RSM)
valuesEngines are designed withwithstand up to 12g

There are no clear vibration levelpassenger vehicles are qualified
to, as research is focused on thecontinual reduction of vibration.
However, the value is expected tobe less than 12g and thetimeframes under which theengine operates under these
conditions is expected to beorders of magnitude less.51

Temperature of
ECU

95-105⁰C or greater (At 12 g
RMS)

It is expected that similar
temperatures are experienced,
but the timeframes which theengine operated under these
conditions is expected to beorders of magnitude less.51

Fuel

Diesel, natural gas, or petrol.
Some diesel engines are also
dosed with diesel exhaust fluid
to reduce exhausts NOx
emissions.

Petrol or diesel.

Duty Cycle52

Based on testing requirements
for NRMM: 30 - 70%

On average EU passenger
vehicles only travel 11,300 km
per year53, with some estimates
stating cars are only used on
average 4% of the time.54

Proportion oftime at full load

Up to 100% (commonly
required for generators) which

When the car is in use it isestimated that only an extremely

51 Based on 2021 Eurostat data the EU average distance travelled per person per day is 8.2km, given thatmost urban roads have a speed limit of 50km/h this results in an average travel time of less than 10 minutes
per day: File:Average distance per person per day (kilometres) v3.png - Statistics Explained (europa.eu)
52 Fraction of one period in which a signal or system is active
53 EU Sectoral Profile – Transport 2020 transport-eu.pdf (odyssee-mure.eu)
54 Based on UK usage General facts and figures about roads and road use (racfoundation.org)

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has a large impact on
operating temperature andvibration level.

small proportion is at full load andis estimated to be <5%.55

ATEX
compliance56

Can be required depending on
application.

Not required.

Environment

Used within harsh and dirty
environments. Can be
exposed to corrosive
chemicals when used infactories, oil refineries etc, orin areas with high humidity or
exposed to saltwater spray.
Large temperature cycles areoften experienced.

Exposed to water and saltwater
spray and limited amounts ofdust. However, ECUs tend to be
only indirectly exposed to theseso are only exposed tocondensation and moderatetemperature fluctuations.

Source: (EUROMOT 2023a)

Characteristics and functions of lead that require its use
According to (EUROMOT 2023a), the electrical connections in the ECU are made using
lead-containing solder to connect electronic components to the printed circuit board (PCB).
Solder is also used to connect the ECU to wiring looms to ensure that measurements areaccurate, and the often small signals are accurately transmitted to engine control units. The
solder must maintain a low electrical resistance for the lifetime of the engine, and they must
survive the hostile environmental conditions that will be experienced:−

Resistance to failures due to thermal cycling, vibration, and shock all of which aredefining features of applications supported by this exemption request- details
provided below.

−

Resistance to chemicals, high humidity, and corrosion due to salt laden
atmospheres- details provided below.

−

Able to withstand high temperatures for prolonged periods. Engines in scope of
RoHS are used at fixed locations and so do not experience the air flow that moving
vehicles experience. EUROMOT members estimate that the ECU could easily
experience temperatures of 150⁰C or greater for continual periods of many months
for some applications.

−Must not form long whiskers that could cause short circuits−

Low meting point- such that the solder is able to be applied without causing damage
to the PCB laminate or the components, but high enough not to melt or deform at
the operating temperature of the ECU.

55 Based on emissions testing schemes, such as those outline in Figure 12, where the car is at its maximum

velocity Road load determination of passenger cars - TNO-060-DTM-2012-02014.pdf(transportenvironment.org)
56 Equipment and protective systems intended for use in potentially explosive atmospheres Directive (ATEX)

94/9/EC.

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Sharp melting point- in order for the solder to be molten for as minimal a time as
possible to reduce the formation of intermetallic phases which occur during thisprocess and can introduce brittleness or unreliability to solder joints.

−

High thermal conductivity in order to conduct heat away from powered components(EUROMOT 2023a) provide more details on some of these aspects as follows:−

Thermal Cycling: Engines experience very large temperature fluctuations, withengines being used in temperatures as low as -40oC in the northern parts of Sweden
or Finland and the temperatures of components including the ECU adjacent to theengine experiencing temperatures of up to 150oC. This wide temperature range can
impose large stresses on solder bonds within the ECU. Components that get hot on
the PCB, such as a system basis chip with lots of voltage regulators, often suffer
with solder joint failure due to the thermal fatigue causing expansion and contraction.

−

Vibration and Shock: Engines will vibrate for very long periods, and this can cause
high frequency fatigue to solder bonds due to the repeated strain imposed. This isdue to the fact that when the ECU is connected to a vibration load, the PCB
assembly undergoes large bending and deformation, and large alternating stresses
and strains are generated on the solder joints. The mechanical alternating stressbetween PCB board and solder joint will make the solder joint undergo cyclic tension
and pressure, which may cause the generation, expansion, and extension of cracks.
In addition, cracks may occur between semiconductor chips and solder joints. In
addition to the vibration experienced during operation, although equipment withengines in scope of RoHS is used at fixed locations, it is moved between locations.
This can be over very rough terrain such as in quarries and building sites and thiscan cause sudden shocks which impose very high g-forces on solder bonds (similar
to dropping equipment onto a hard surface).

−

Chemical Resistance: Equipment with engines is used in a wide variety of
installations including chemical factories, oil refineries and marine environments
where they are exposed to corrosive chemicals, high humidity, and hightemperature, etc. These hostile conditions can accelerate corrosion of components
and circuitry. The corrosion of lead-free solders, due to the inclusion of elements
such as zinc, copper, silver and bismuth have higher corrosion susceptibility incorrosive environments9. The paper does highlight that some multielement solders,such as some tin-silver-copper combinations can offer higher chemical resistancethan lead based solders in limited situations. However, under higher corrosion
conditions (exposure to higher concentration to (NaCl) and higher temperatures the
corrosion susceptibility increased. Considering the environments EUROMOT
members product operate in, any potential susceptibility to corrosion could havesevere consequences on the operability of their products.

−

Tin Whiskers: Another potential failure mode is with exposed solderable coatings.
This can occur because the solder wetting of component terminals and the pads on
PCBs by lead-free solders is inferior to that of leaded solders so that areas of theterminals and the pads can remain uncoated by solder. When these terminals andpads are electroplated with tin metal (a common solderability preservative) and are
exposed to corrosive or high humidity environments, they can be susceptible to theformation of tin whiskers that can cause short circuits. Tin whiskers are mainly an
issue when low voltages are generated by a sensor which is connected to the ECU

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because a short circuit caused by a whisker will alter the output voltage so that thesensor transmits the wrong signal. Mitigation measures against whiskers are known
and are used, but until these are implemented and thoroughly tested in realistic
environmental conditions, the reliability will not be known. The areas that are notwetted by solder can also suffer from corrosion in corrosive atmospheres that canoccur in factories, and this causes an open circuit failure.
(EUROMOT 2023a) add that the long-term reliability of equipment with engines relies on
the reliability of all of the individual components and solder bonds. Only one of the solder
bonds needs to fail to cause the engine to stop functioning correctly.

16.1.4. Amount(s) of restricted substance(s) used under the exemption(EUROMOT 2023a) indicate the lead content in the solder alloy used to make electricalconnections to components in ECUs to be 30 – 40 % by weight. Through application forwhich the exemption is requested, an estimated 1.66 kg of lead is placed on the EU market
annually.
Providing more detail on their estimate, (EUROMOT 2023a) explain that the amount of leadin an ECU depends on the size and complexity of the ECU. Based on information fromEUROMOT members, the amount of lead varies from 2.485 to 13.88 mg per unit, dependingon the ECU and the application. In the previous exemption renewal request, an estimated
68,000 units were placed on the EU market annually which were in scope of RoHS, basedon information provided by The Association of Equipment Manufacturers (AEM) which
outlines the published worldwide market data representative of all power generationequipment regardless of manufacturer. Across the product category codes which are
determined to be included in the scope of RoHS, there has been an average increase insales of 76 % based on the growth between 2017 and 2021. As such, EUROMOT estimatesthat 119,680 units are placed on the EU market annually. Based on a worst-case estimatethat 13.88 mg of lead is used for all ECUs, this results in 1.66 kg of lead being placed on
the EU market.
The consultants note a sizable difference in the estimated amount of lead described above
compared to amount estimated in the initial application for this exemption by (EUROMOT2017), in which it was estimated that ECUs contained an average of 35 g of lead in solder,leading to an estimate of more than 2 tonnes of lead contained in the ECUs.
Requested to clarify this difference, (EUROMOT 2023b) state that the basis for the previous
calculation has not been able to be identified, but considers that the following factors may
have contributed to the difference:−

It could be that the previous evaluation took into consideration the entirety of theweight of the solder point, rather than the actual content of lead (40%)−

The change in technologies and the push towards miniaturization of electronic
components to achieve lighter and more versatile assemblies

While the consultants do not consider the above two factors sufficient to explain for thedifference between the amounts of lead estimated in the initial exemption and the current
renewal request, the new estimate of lead in solder per ECU (14 mg) appears moreplausible compared to the original estimate (35 g).

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16.2.

Justification of the requested exemption

16.2.1. Substitution and Elimination of the restricted substance
Substitution(EUROMOT 2023a) argue that while lead-free solder is already used in the electronics
industry and in type approved vehicles in scope of the ELV Directive, the environments
which are experienced in these applications are not equivalent to those applications utilising
this exemption as shown above in Table 16-3 (on page 294). Equipment using thisexemption operates in some of the most demanding and severe environments over a
product life cycle measured in decades, therefore specific testing replicating in-service
conditions is essential.
Tin, silver, copper (SAC) solder alloys were first developed for consumer electronics but
were found to have inferior thermal fatigue performance compared to tin/lead in automotiveengine compartment conditions57. Research showed that adding one more element to SAC
either gave an alloy with too high a melting temperature (so damaged components) or too
low a maximum operating temperature for engine compartment applications.
Lead-free solder processes in general need around 25 to 30 Kelvin higher soldering
temperatures than eutectic tin-lead, as most lead-free solders have higher melting points.
The elevated soldering temperatures impose additional thermal stress on components onelectronic circuit boards. Components therefore must be qualified for the elevatedtemperatures required for lead-free soldering processes. The higher soldering temperaturescause higher thermal stresses on the components, which may cause minor damages likemicro-cracks or delamination of composite or interconnected materials.
The operational conditions of engines in scope of this exemption experience large thermal
cycles with vibration (up to 12g) for prolonged periods of time, which is known to cause
cracking in SAC alloys58, a phenomenon termed high cycle fatigue.
Often research into lead free solders has given contradictory results in terms of its viability
as an alternative. This variability was investigated by JGPP59 which showed thatsusceptibility to failure depends on:−

The solder alloy composition,−

G-force of the application: with lower g-forces having lower failure rates,

57 See figure 3 of “Lead-free for High-reliability, High-temperature Applications”, H. Steen and B. Toleno,

whitepaper-lf-high-reliability-high-temperature-applications.pdf (henkel-dam.com)
58 High-Frequency Vibration Tests of Sn-Pb and Lead-Free Solder Joints, D Di Maio and C Hunt, NPL report

MAT 2, August 2007, MAT2.pdf (npl.co.uk)
59 T. Woodrow, JCAA/JG-PP Lead-free solder project: Vibration and Thermal Shock Tests”, April 2006 JTR

Executive Summary Draft July 30 2007.pdf (hlinstruments.com)

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Position on circuit board (as this affects the g-force),−

Type of component: with ball grid array (BGA) being the most susceptible.

Applications utilising this exemption often have a number of BGA’s and experience highvibration requirements, and as a result, qualifying a lead-free alternative solder has provento be very challenging. Automotive and solder alloy manufacturers collaborated to develop
a novel six-component alloy containing tin, silver, copper, nickel, bismuth, and antimony(called InnoLot) that was deemed superior to the standard SAC alloys60 for automotive
applications. InnoLot has been used in some applications since 2008, but again the specificoperational environment of engines utilising this exemption needs to be considered. Studies
have been undertaken assessing InnoLot performance, with one study determining that
InnoLot was slightly superior to SnPb at 30 MPa under low cycle fatigue conditions but
inferior to SnPb at about 34 MPa and higher stress levels under high cycle fatigue61. Studies
such as this highlight the need for testing reflective of the operational environment of theequipment, to ensure that lead-free alternatives are viable. It is important to note that testing
to predict service lifetimes is unable to be accurately estimated from accelerated testing as
the acceleration factors for tin/lead and lead-free solders are different. As such, testing new
solders on ECUs to the operational environment is still on-going.
EUROMOT members produce equipment designed to voluntary consensus safety
standards and subject to third party certifications, customer requirements, and regulatory
testing obligations. Changes to materials and formulations which affect fit, function,
performance, or safety must undergo extensive testing to ensure new designs meet internal
quality benchmarks, design specifications, and regulatory requirements.
Over the intervening time period since EUROMOT originally requested the exemption thatwas granted as 44 of Annex III, engine manufacturers have undertaken considerable efforts
to qualify lead-free solder in sensors and actuators, and now all that remains to beundertaken is the final stages of qualification of lead-free solder in all ECUs. Whenmanufacturers design new ECUs, these are designed with the use of lead-free solders.
However, simply replacing lead solder with lead-free solder in existing designs is usually
impossible and risks early failures and so any change in materials requires extensive testing
and usually also circuit redesign and component substitutions to ensure that the ECUs will
be reliable for many decades in demanding environments. One challenge is that tin-lead
BGAs are usually older designs often without lead-free equivalents and so new circuitdesigns are needed to accommodate alternative types of BGAs.
Other bonding methods(EUROMOT 2023a) acknowledge that soldering is not the only bonding method and others
pose potential alternative solutions in some scenarios. The following provides a briefsummary of their suitability for use in ECUs:−

Welding and brazing: Welding requires temperatures >1000⁰C and brazing 450500⁰C both of which would degrade or destroy the PCB and many types ofcomponents on the PCB

60 ALPHA® Innolot Solder Preforms | MacDermid Alpha
61 Barry08EngD.pdf (bham.ac.uk) Figures 4.46 and 4.50

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Plug and socket connectors/crimp connectors: This is not suitable for surface mountcomponent and through-hole components on PCBs. Connectors can also sufferfrom fretting failure when exposed to cyclic temperature changes or to vibration.

−

Conductive adhesives: The contact resistance can increase over time due to theoxidation of the terminal surfaces. Many conductive adhesives also contain silver,which when exposed to hydrogen sulphide, which is common in many of theindustrial environments where engine systems are use, forms insulating sulphides.
There are also concerns over the long-term reliability of conductive adhesives,
especially in high vibration environments, which can cause the delamination of theadhesive bonds.

(EUROMOT 2023a) conclude that as such, lead-free solder is continued to be thought ofas the most viable alternative to lead containing solder, with additional time required tocomplete the qualification necessary to use it.
Reliability of substitutes
According to (EUROMOT 2023a), when manufacturers have qualified lead-free solder, thefollowing are some of the tests which engine manufacturers must undertake. The following
list includes the type of testing undertaken to qualify lead-free solder for sensors andactuators which no longer require the exemption, to outline the amount of testingundertaken to date. The following tests are not intended to be an exhaustive list, as different
manufacturers have different testing requirements, but rather indicate the number andvariety of tests which have to be undertaken.
Besides a longer list of tests to which sensors and actuators need to be subjected,(EUROMOT 2023a) state that the following tests outline some of the requirements for
ECUs:−

Vibration Resonance Frequency±−

Component stress analysis±−

Thermal Analysis± including low and high temperatures operation and life tests,
thermal shock± (500 cycles minimum) and temperature to failure−

Humidity and salt atmosphere testing±−High pressure wash and chemical resistance testing± to ensure its durability−

Signal integrity- testing parameters such as signal overshoot, undershoot, rise andfall times, monotonic signal edges, jitter, droop, ringing, ground bounce, cross talk,reflection, power, and ground noise−

Combined Environment±: Same test as sensors but may use different vibration
profile depending on the application of the ECU−Electromagnetic compatibility testing such as conducted emissions and immunity
testing, and radiated immunity testing−Electrostatic Discharge Testing−

Tolerance to misconnections through the testing of parameters such as shortcircuits, power interruptions, over voltage

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EUROMOT 2023a) remark that the tests identified by this symbol “±” potentially require
duplication to evaluate the specific environments that each type of ECU operates within.
Lead-free soldered ECUs are expected to achieve a comparable lifetime and reliability as
the lead-soldered ones, in order to be considered sufficiently reliable. Otherwise, the engine
products’ lifetime either becomes shorter or the ECUs must be repaired and exchanged, if
this is at all possible, leading to greater waste and timeframes where the affected endproduct is no longer available. Given the essential sectors some of these engines serve,such as emergency generators in hospitals, this can have wider society implications.
Lead-free ECUs are currently available on the market62 but it is important to note that ECU
qualification can only be undertaken as part of a single point application, considering asingle system architecture or operational environment expected of the engine. Therefore,
any qualification undertaken by one manufacture is not transferable to other models, types
or operational environment served. This is due to the fact that the above listed testing needs
to qualify the ECU to the expected operational environment of the engine and therefore
even though lead-free applications have been available on the market for some
applications, not all manufacturers can use them.

16.2.2. Environmental, health, safety, and socioeconomic impacts(EUROMOT 2023a) point out that if this exemption is not renewed for ECUs, many types of
end-products will not be available in the EU. These may affect institutions that needemergency generators such as hospitals, it could also affect construction, mining, etc.
Employment by engine and end-product manufacturers would also be affected if products
cannot be placed on the EU market. Due to uncertainties over the scope of the RoHS
NRMM exemption and extreme difficulty with costing the impacts from equipment
unavailability, it is not possible to quantify socio-economic impacts. (EUROMOT 2023a)
further highlight that some applications utilising this exemption are safety relevant and may
cause accidents in case of failure. (EUROMOT 2024a) added that due to the varied andessential functions such equipment support to other sectors the unavailability of thosedevices could cause a much larger effect to downstream users in terms of availability of
products and services. (EUROMOT 2023a) do not claim that environmental impacts orhealth impacts would occur if this exemption were not renewed beyond the above
statements.

62 Electronic Control Units: Diesel Engine ECU - Transtron and Control Unit : Hitachi Astemo Americas, Inc.

(hitachi-automotive.us)301

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16.2.3. Roadmap towards substitution or elimination of the restricted
substance(EUROMOT 2023a) claim that engine manufacturers and their supply chain have been
undertaking a considerable effort to qualify lead-free solder in sensor and actuators, andefforts are continuing to qualify lead-free solder in ECUs.
(EUROMOT 2023a) note that depending on the manufacturer, different tests have been
undertaken to date and for some tests different testing profiles have been used dependingon the manufacturer. The differences in testing are as a consequence of the different
operational conditions each engine is expected to experience in its operational life. The
prioritisation of the tests is mostly based on a combination of key parameter testing andsimpler tests being undertaken first. This allows for the confidence in the lead-free solution
to be built as quickly as possible, and any critical technical differences identified as early as
possible.
The following tests are provided as a small sample of the tests which engine manufacturers
have undertaken to date to test lead-free solder in ECU’s, with test results submitted in theconfidential submission:−

Critical temperature profile−

High and low temperature operating life−

Thermal shock testing−

Combined environment testing (vibration testing at high and low temperatures)−

Humidity testing

According to (EUROMOT 2023a), the tests completed to date indicate the use of lead-freesolder is promising, with additional time required for the full testing requirements to beundertaken.
(EUROMOT 2023a) remark that the global shortage of semi-conductors has had an impact
on qualification timeframes for some manufacturers.
(EUROMOT 2023a) claim that the timescale for the re-design and validation of engine
control units is a little uncertain as only some ECUs are designed in-house by engine
manufactures. For other suppliers of ECUs, there is little or no incentive to develop leadfree versions specifically for the industrial equipment sector. This is due to the comparatively
small market size of products covered by this exemption compared to the same types of
ECUs used for heavy goods vehicles where there is no lead restriction. As such, thefollowing timeline is mostly based on in-house redesign, and additional time would be
required if other manufacturers are not able to undertake the same level of requalification
activities in the same timescale.
(EUROMOT 2023a) provide the following table, stating that the timeframes are also madeon the basis that all qualification stages are successful first time and manufacturers do not
encounter dead ends during their assessments.

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Table 16-4: Types of qualification activity required and timescales for lead solder
substitution
Typical activities

Timeline

Procure prototype materials

Up to 6 months is expected due to supply
chain shortages of some components

Testing of alternative of materials / 2-5 years depending on complexity the
ECU. Testing includes vibration andcomponents in laboratory testing
reliability testing which take at least 6months for each test
Durability test in engine

1500 operating hours for each productField test in machine

Between 3 months to three years (Forapplications where long-term functionality
is critical)

Supplier approval (if required)

Minimum 1 monthGlobal approvals

1-2 years

Source: (EUROMOT 2023a)

According to (EUROMOT 2023a), the above table outlines the main steps manufacturers
need to undertake, but as it can be seen there is significant variation in the timeframes foreach stage depending on the types of ECU, engine and end-use equipment which
determines the types of tests that are required in each stage. This varies between
manufacturers (as their product portfolios are very different to each other), as well as thenumber of tests required at each stage. The number of tests therefore vary between
manufacturers. Also, as the operational environment for different models of ECU/engine
made by a single manufacturer are often very different, this often necessitates different
testing regimes.
EUROMOT’s members have already started the testing listed above in the table andcurrently estimate that a further five years from the date of this application is required toundertake the remaining testing to qualify lead-free solder in all ECU types.
(EUROMOT 2023a) describe three factors from the above table in more detail in thefollowing.
Supply Chain Issues
The recent global shortage of electronics63 limits has had a significant impact on global
industries but is especially impacting the automotive sector. As such, this impacts the
manufactures’ ability to build prototype controllers for testing without impacting current
production demand.
Field testing

63 European Central Bank, 2021 bulletin The semiconductor shortage and its implication for euro area trade,

production and prices (europa.eu)

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Testing must also be conducted on actual diesel (or gas) engines to identify failure modes
which can only be identified with loads and environmental conditions that are consistent
with the entire reciprocating engine assembly working as a complete engine system and at
locations where the engines are intended to be used (e.g., on farms, in quarries, etc.). Dueto the complexity of the environment the equipment operate in EUROMOT members havefound that this step is essential in qualification activities and has identified failures ofpotential alternatives only at this stage for other qualification activities64.
Global Approvals
Some equipment in scope of this exemption, made by some manufactures, is also in scopeof the NRMM Emissions Directive which sets requirements relating to gaseous andparticulate pollutant emission limits, relating to carbon monoxide, hydrocarbons, nitrogenoxides (NOx) and particulates. There are also reliability requirements. These engines alsoneed to gain type-approval by Member State competent authorities to certify that they meetthe essential technical requirements of the legislation. As ECUs have the ability to control
engine emissions, any change in design or supplier may require lengthy emissions testing
and recertification, which takes as long as the testing needed for type approval of a newengine design.
Equipment manufacturers make their products available in more than just EU jurisdictions
and normally undertake all global approvals before incorporating a change such as this dueto the use of a single manufacturing line for all jurisdictions. Other jurisdictions impose
additional obligations such as the US Environmental Protection Agency (EPA) requiring
manufacturers to keep a list of parts which have impact to the emissions systems ofengines65. It is the manufacturers responsibility to identify which components have thepotential to impact emissions but given the functionality of the ECU this would be included
on all engine manufactures affected parts list. Engine manufactures for any identified
components must have documentation to demonstrate that any changes made to thecomponents had no negative effect on emissions. A change from leaded to lead free solder
would have a significant change to the architecture of the electronics and would trigger thefull complement of transparency testing which can include re-certification of the engine
overall in some markets. These emission certification test cells are in extremely highdemand due to the length of the testing required. Validation testing for lead-free solder for
current production engines means that these facilities may not be available for new productdevelopment which offer improvements such as increased fuel efficiency among otheraspects.

16.3.

Critical review

16.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in

64 This has been found to occur when testing substitute engine bearings
6565 eCFR :: 40 CFR Part 1068 -- General Compliance Provisions for Highway, Stationary, and Nonroad

Programs

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Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds. None of these entries are,however, relevant for the use of lead in the scope of exemption III-44 (cf. section 4.2 on
page 51 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

16.3.2. Scope clarification
Types of equipment that require the exemption(EUROMOT 2023a) provided an indicative list of examples of NRMM, adding that some areclearly not in scope of RoHS (cf. section 16.1.3 on page 289). In the consultants’ view, amore relevant and comprehensive list of applications is needed to better understand theapplications’ requirements. When asked, (EUROMOT 2024a) stated that EUROMOT
members produce combustion engines which are used in vast range of different end use
applications, so it is not possible to provide an exhaustive list of products, some indicative
end uses that require the use of exemption 44 are:−Air compressors,−

Liquid and Gas Fluid pumps (including pumps such as irrigation pumps, fire pumps),−

Trailer mounted equipment,−

Generator sets (GENSETs) including emergency generators, uninterruptable powersystem (UPS) installations, and Battery Energy Storage System (BESS),−

Non-professional non-road mobile machinery (NRMM) applications such as
construction, agricultural and forestry equipment such as bulldozers, mobile
welders, truck-type loaders, diesel engine powered compressors, hydraulicexcavators, mobile welders, fork-lift trucks, cranes, aerial lifts, drilling machines,
screeners, conveyors, utility tractors, turf-care equipment, rock crushers, wheel
loaders, crawler tractors, crawler loaders, road maintenance equipment

The consultants inquired whether the ‘product category codes’ mentioned by the applicants
could be shared for a more comprehensive list of applications. (EUROMOT 2024c) did
share the list but explained that it was only used in conjunction with trying to estimate thechange in market size since the last renewal application, therefore influencing the amountof lead being placed on the market from this exemption. The most appropriate categories
of products were selected as part of this review; however, it can be seen from the associateddescriptions that this will not aid in the concise but through explanation of the products within305

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the scope of this exemption. The consultants agree and the list is not reproduced in thisreport.
Reference to the NRMM Emissions Regulation in the exemption wording
The wording requested by (EUROMOT 2023a) omits the reference to Regulation (EU)2016/1628 (hereafter: the NRMM Emissions Regulation)66, which is part of the currently
valid wording. Assessing EUROMOT’s initial application for this exemption conducted by(Gensch et al. 2019), the consultants note that the reasoning for including the reference inthe currently valid wording was based on one of the applicants’ arguments at the time: Allequipment for which the exemption was requested was understood to be in scope of the
NRMM Emissions Regulation. At the time, EUROMOT explained that this Regulation has
mandatory emission and durability requirements and requires extensive engine testing
before equipment is allowed on the market. Therefore, switching to RoHS-compliant
components requires long testing and verification periods. In the consultants’ view,
removing the reference to the Regulation from the wording of exemption III-44 could
therefore mean broadening its scope. Whereas the currently valid wording restricts the typeof equipment in its scope to those that are also in scope of the NRMM Emissions Regulation,
which co-determines their testing and verification procedures, the new requested wording
would potentially also include equipment that is outside the scope of the NRMM Emissions
Regulation.
When asked for their rationale to omit the reference to the NRMM Emissions Regulation in
their requested wording, (EUROMOT 2023b) clarified that the Regulation refers to internal
combustion engines for non-road mobile machinery. This category of machinery is alreadyexcluded from the scope of the Directive and therefore it is deemed that the direct reference
to the Regulation can create misunderstanding in the interpretation of the exemption. The
removal of the explicit reference to Regulation 2016/1628 would not change the equipmentin scope of exemption 44 but aid in the clarity of understanding of the types of products inscope of the exemption.
(EUROMOT 2024a) reiterated that the change in the wording of exemption 44 would notchange the equipment in scope of the exemption but provide clarification to theinterpretation of the scope of the exemption. Moreover, due to the criticality of EUROMOT’s
applications, they are already subjected to the same challenging requirements of durability
and reliability and require extensive engine testing before equipment is allowed on themarket, as required by the NRMM Regulation.
On request, (EUROMOT 2024b) confirmed that all applications highlighted by EUROMOT
members requiring the use of Exemption 44 are, in fact, in scope of both RoHS Directive
and the NRMM Regulation, stating that “all of EUROMOT’s equipment that contains ECUs
is also in scope of the NRMM Regulation 2016/1628”.
Despite the definiteness of the last cited statement that all of EUROMOT’s equipment that
contains ECUs is also in scope of the NRMM Emissions Regulation, the consultantsconsider removing the reference from the exemption wording carries the risk of broadening

66 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

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its scope. Adopting a conservative approach may be preferable, which implies maintaining
the current wording of the exemption.

16.3.3. Substitution and elimination of the restricted substanceEngine manufacturers have successfully phased out the use of lead in solders used insensors and actuators associated with internal combustion engines, and now the only
remaining application for leaded solder in the scope of this exemption are ECUs.
The applicants make the following arguments for why a renewal is needed:•

Lead-free solders are available, but additional time is required to qualify those forthe use of ECUs in scope of this exemption•

Lead-free ECUs are already available on the market, but as qualification needs tobe undertaken for individual applications, and results from one model cannot
necessarily be transferred to others, more time is needed to complete the final
stages of qualification•

Other bonding methods are available but not suitable, so lead-free solders arethought to be the most viable alternative to leaded solders

The applicants provided information describing the issues of lead-free solders in demanding
environments as they occur for engine control units, particularly those mounted on engine
blocks. When asked whether the exemption wording could be adapted to reflect the latter,(EUROMOT 2024c) explained that this would be unsuitable. While the majority of ECUs aremounted on the engine block, some of the multiple ECUs needed in a single system are notmounted on the engine block. At least some of these are mounted in close proximity to theengine, so they are also subjected to the described conditions of high temperature,vibration, and exposure to electromagnetic interference. For example, ECUs can be foundin the after-treatment system, where the working temperature and vibration loading (fromthe engine and operational environment such as an excavator) is high. Moreover, the aftertreatment ECU is also used for very harsh operating conditions such as vibration andcorrosion.
In the consultants’ view, the line of reasoning is plausible, so restricting the scope of the
exemption explicitly to only those ECUs that are mounted on an engine may not be
sufficiently broad to cover other ECUs that may be subject to similarly harsh conditions.
The consultants contacted two suppliers of ECUs to inquire for which applications andenvironmental conditions lead-free ECUs (if any) had been qualified, but no information thatwould be useful for this review was received.
(EUROMOT 2023a) stated that lead-free ECUs are currently available on the market. When
asked when lead-free ECUs first became available, (EUROMOT 2024a) reiterated that
although lead-free ECUs are available, they are not a feasible solution for all applications.
Each company needs to undertake their own testing as there is no industry standard test toqualify alternatives, with the testing of each manufacturer specific to the end use theirequipment will serve. As such, although EUROMOT companies have been investigating
lead-free alternatives, in some instances from prior to 2011 this has only allowed for leadfree solders for some applications to be introduced in new designs from 2017. However,there are still highly complex legacy equipment that still require the lead-ECUs as there isno drop in substitute available.

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When asked why redesign of legacy equipment had not yet been completed although it has
been clear since at least 2011 that they would be in scope of RoHS category 11,(EUROMOT 2024a) reiterated that retrofitting of legacy ECM’s with lead-free alternatives
would require substantial redesign, and further system level testing to ensure continued
compliance to exhaust emissions would need to be performed and products needs to berecertified for exhaust emissions and other non-emissions requirements. For this reason,
although lead-free ECM are a known technology and can be used in certain applications
the challenge is not with testing but rather in the retrofitting of legacy parts.
When asked to confirm whether only legacy parts or also newly designed ECUs contained
leaded solder, (EUROMOT 2024b) responded that development of new and updated
products have been reducing and removing the use of lead-containing ECUs wherever
possible. Lead-containing ECUs are not being developed into wholly new designs, however,the definition of legacy design as it is not underpinned by a formal definition is notconsistently or clearly understood as an industry sector. As such making a statement that
only legacy devices use ECU’s is challenging. For example, there are products whichcontain some newly designed sub-systems, but also utilising legacy designs of other subsystems - the determination of if this is a legacy product or not is challenging.
When asked for which reasons legacy ECUs have not been re-designed to be lead-free,
while new designs of lead-free ECUs have been on the market from 2017, (EUROMOT
2024b) state that they are not aware of any additional technical challenges in the design oflegacy lead-free ECUs. Rather, the challenge relates to the systems level assessment
which need to be undertaken to allow their implementation into legacy devices. For new
products, these tests are intrinsically built into the initial qualification of the product, whereas
for devices which this phase has already passed requires additional time.
(EUROMOT 2024b) further specify the challenges that have been identified in the
progressions towards the implementation of lead-free alternatives:•

A system often relies on multiple ECU’s with completely different architectures andcommunication protocols. Even if a lead-free alternative is implemented for one of the
ECU’s this might create communication issues with the rest of the system. Due to thecomplexity of the system only a few components can be designed out or
fundamentally changed at a given time which significantly delay the implementationof changes.

•

As EUROMOT manufacturers have a large number of products, more than 50
products within a single company with several different models for each product type.
Each product needs not only the redesign of the ECU module but also the correlated
sensors and wiring harnesses. Moreover, this requires re-calibration and certification
which is a time demanding task. Due to the extensive requirements in terms of testingand system qualification, this is a demanding time effort as only few designs can be
implemented and tested for qualification at the same time. The complex and highly
specific nature of the testing rigs is such that only a limited number of tests can becompleted in parallel. Additionally, to correctly simulate operating conditions, long
testing times are required for the qualification of those parts. Due to the long operating
lives of the equipment the time required for validation can be several years to correctly
evaluate safety and reliability during the lifetime of the product. Moreover, priority isgiven for the development and qualification of new lead-free designs

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Study to assess requests for 29 renewal requests concerning one specific EEE category and two(-2-) new exemption requests under the Directive 2011/65/EU(EUROMOT 2024a) further describe that EUROMOT manufacturers’ applications share aconsistent share of their supply chain with the automotive industry. Although automotive
applications are not in scope of RoHS while EUROMOT applications are, automotive
application are leading the market trend in the manufacturers. Therefore, in many cases theparts supplied are shared by the two industries, where Exemption 8(a) of the End of Life
Vehicle Directive 2000/53/EC (ELV) mirrors the scope of exemption 44 in RoHS and
therefore still permits parts with lead. A possible divergence between the scope of the
exemption in the two Directives might result in EUROMOT members not being able to relyon their supplier chain.
The consultants note that exemption 8(a) of the ELV Directive covers “Vehicles typeapproved before 1 January 2016 and spare parts for these vehicles”. During the last review
of exemption 8(a) by (Zangl et al. 2010), the stakeholders had stated that it takes about five
to seven years to undergo a type approval for the whole car fleet of a vehicle manufacturer.
When interpreting the upper limit of this timeline strictly, the consultants assume thatvehicles in scope of the ELV Directive should no longer rely on this exemption since 1
January 2023. However, first, the timeline was an approximation (‘about five to sevenyears’), and secondly, the applications making use of exemption III-44 is different fromapplications (vehicles) in scope of the ELV Directive.
EUROMOT stated in their renewal request document that one challenge is that tin-lead ball
grid array (BGA) microchips are usually older designs often without lead-free equivalents
and so new circuit designs are needed to accommodate alternative types of BGAs. When
asked to specify whether BGAs were the only component that hindered the transition to fully
lead-free ECUs, (EUROMOT 2024c) confirmed that at present, only BGA microprocessors
rely on exemption 44. An ECU incorporates a substantial BGA microprocessor. In cases
where the ECU utilizes a lead-free BGA microprocessor, it has been determined that there
is no direct pin-to-pin upgrade version available that is also lead-free. If a transition to alead-free BGA is attempted, it will necessitate modifications to the BGA microprocessor's
dimensions and potentially affect certain interface definitions. Consequently, this will entail
more extensive changes to the overall printed circuit board (PCB) design due to the limited
space on the ECU PCB, which is already populated with electronic components. Even minor
adjustments might necessitate a complete redesign to maintain the original form factor, revalidation of electromagnetic compatibility / interference compliance and vibration
resistance, as well as verification of essential functions.
When asked whether exemption 15 of Annex III would cover the BGAs in scope of
EUROMOT’s exemption request, (EUROMOT 2024d) stated that the scope of exemption
15 and 44 is different and there are instances where BGA’s under exemption 44 would not
be covered by exemption 15. It is also worthwhile noting that exemption 44 has a much
more bound scope and is focused on the system application of the component and therefore
has greater relevance to only EUROMOT applications. It is also worthwhile considering thatthat exemption 15 of Annex III has currently not been recommended for renewal. Due to thetimeframe that exemption 15 would allow and the criticality of the application a transition to
the use exemption 15 would not be feasible for ECU applications. The consultants note thatindeed exemption 15 has not been recommended for a renewal after its most recent review
conducted by (Deubzer et al. 2022). In the light of the applicants’ above statement it should,
however, be considered to exclude the scope of exemption 44 from the scope of exemption
III-15.
The applicants were asked whether a more specific wording of the exemption would coverapplications in scope of their renewal request, in case it was found that a renewal of the309

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exemption was justified: “Lead in BGAs used in engine control units of combustion engines
installed in equipment used at fixed positions while in operation, which is designed for
professionals, but also used by non-professional users”. However, (EUROMOT 2024d)
stated to disagree with the change in wording as the solder material used on the BGA isdictating the material used on the remaining components on the same board. The soldering
process consists of the soldering paste being spread across the board according to a
specific geometry designed priorly. This stage is developed simultaneously for the entiretyof the components placed on the board that are therefore reflowed at the same temperature.
For this reason, the limiting component of the board will dictate the characteristics of theentire board including temperature of reflow and consequently material used for thesoldering process. In ECUs, as it has been stated in the exemption renewal submission thelimiting component is the BGA, which requires lead solder, which will limit the rest of theboard to the same solder material due to compatibility. Although EUROMOT members are
not an electronic component manufacturer they are aware that different solder materials on
the same board have been attempted. However, due to the different specific temperaturesof reflow of the solder materials, specifically that lead-free solder requires higher
temperature, this resulted in damage of the BGA connections. Therefore, it is recommended
that the original wording is maintained, with particular consideration to the already narrow
scope of the exemption and the fact that only legacy applications are still reliant on thisexemption. The consultants agree with the explanation provided by the applicants inprinciple.
Overall, from the information that was provided, the consultants derive that scientifically andtechnically, substitution or elimination of lead in solder in ECUs is practicable, but thereliability of the lead-free solutions has to be ensured via a redesign/new design of the ECUs
to accommodate the specific properties of lead-free solders.
Lead-free ECUs have been available on the market, and new designs do not necessarily
require lead in solder. Rather, it appears that some older designs of ECUs have not beenredesigned or replaced by new models for new models of engines to work with lead-freecomponents, as they rely on older designs of e.g. BGA microchips. The consultants assume
that this might be a problem of model policy and cost rather than technical feasibility.

16.3.4. Environmental, health, safety, and socioeconomic impacts
The potential impacts described by EUROMOT remain vague overall. The consultants findit plausible that some equipment may no longer be available on the EU market in case theexemption renewal was not granted. However, given that progress has been made using
lead-free ECUs and that the phase-out of lead-containing ECUs is foreseen to be complete
until January 2027, it appears reasonable to assume that only a small number of equipment
would be affected, thereby limiting the scope of potential negative impacts.

16.3.5. Summary and conclusions
EUROMOT request the renewal of exemption III-44 with the wording “Lead in solder ofengine control units of combustion engines, installed in equipment used at fixed positions
while in operation which is designed for professionals, but also used by non-professional
users” for equipment of category 11 until January 2027.

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Since the original exemption request, leaded solders have been phased out from sensors
and actuators. For engine control units, EUROMOT claim to be in the final stages ofqualifying lead-free solders. They also acknowledge that lead-free ECUs are alreadyavailable in the market but have not yet been qualified for all applications due to the required
individual testing to ensure reliability. Accordingly, EUROMOT applied for a renewal of thisexemption with an adjusted wording that reflects that sensors and actuators no longer
require the exemption to complete the qualification.
In the consultants’ view, it is plausible that ECUs are subject to particularly harshenvironmental conditions because they are mounted on and in the vicinity of engine blocks.
EUROMOT point out that retrofitting of legacy ECUs with lead-free alternatives would
require considerable redesign and testing efforts. The only remaining components thatnecessitate the leaded solder are certain microchip ball grid array (BGA) packages.
The consultants conclude from these statements that substitution of lead is scientificallyand technically practicable but require the redesign/new design and subsequent testing andqualification of the lead-free ECUs to ensure their reliability.
Exemption 8(a) under the ELV Directive covers the same applications for vehicles in its
scope. The exemption covers vehicles type approved before 1 January 2016. During thelast review of that exemption, a full ‘renewal’ of an OEM’s vehicle fleet was approximatedto take five to seven years, meaning vehicles may not rely on this exemption any longer
beyond January 2023. However, this timeline may not be directly transferable to theequipment in scope of this exemption request. The consultants consider it plausible that thecompletion of the phasing out of lead-containing ECUs for equipment in scope of exemption
III-44 may take some more time.
The exemption wording requested by the applicants omits a reference to Regulation (EU)2016/1628 (NRMM Emissions Regulation), arguing that it would remove ambiguity in thewording while not changing the scope in practice. However, in the consultants’ opinion, thischange in the wording carries the risk of broadening the scope of the exemption andtherefore consider it preferable to maintain the currently valid.

16.4.

Recommendation

The consultants recommend renewing the exemption until 21 January 2027, as this will givethe industry sufficient time to complete remaining redesign, testing and qualification tasks
for lead-free parts to ensure their reliability. Thus, the reliability of lead-free substitutes forthis specific application is not yet ensured. The consultants consider that a further renewal
after this date will not be justifiable, and the exemption can expire thereafter.
If the COM decides to follow this approach, the below wording is recommended for the
renewal of exemption III-44:
No.

Exemption

Scope andapplicability

dates

III-44

Lead in solder of engine control units of combustion
engines within the scope of Regulation (EU) 2016/1628 ofApplies to category 11.

ofExpires on 21 January
2027.

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the European Parliament and of the Council (67), installedin equipment used at fixed positions while in operation,
which is designed for professionals, but also used by nonprofessional users.

Applicants’ feedback on recommendations(EUROMOT 2024e) stated to have no further comments on the recommendation.

16.5.

References

Cummins (2023): Answers to the stakeholder consultation. RoHS Pack 27. Cummins (RoHS 29).
Retrieved from https://rohs.biois.eu/Cummins.pdf.
Deubzer et al. (2022): Study to assess requests for renewal of 12 exemptions to Annex III of
Directive 2011/65/EU Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Final Report. Pack 23. In cooperation with von Dr. Otmar
Deubzer (Fraunhofer IZM and UNITAR], Jana Rückschloss (Fraunhofer IZM) und Christian Clemm(UNITAR). Hg. v. Publication Office of the European Union. European Commission (RoHS 28,
Pack 23). Retrieved from https://data.europa.eu/doi/10.2779/507661.
DEUTZ (2023): Answers to the stakeholder consultation. RoHS Pack 27. DEUTZ (RoHS 29).
Retrieved from https://rohs.biois.eu/DEUTZ.pdf.
EGMF (2023): Answers to the stakeholder consultation. RoHS Pack 27. EGMF (RoHS 29).
Retrieved from https://rohs.biois.eu/egmf.pdf.
EMA (2023): Answers to the stakeholder consultation. RoHS Pack 27. EMA (RoHS 29). Retrieved
from https://rohs.biois.eu/EMA.pdf.
EUROMOT (2017): RoHS Annex V Request 2017-7 for a new exemption. RoHS Pack 14.
EUROMOT. Retrieved from https://rohs.biois.eu/RoHS_V_Application_FormAIII_Ex44_EUROMOT.pdf.
EUROMOT (2023a): RoHS Annex V Request for renewal of exemption III-44. RoHS Pack 27.
EUROMOT (RoHS 29). Retrieved from https://rohs.biois.eu/RoHS_V_Application_FormAIII_Ex44_EUROMOT.pdf.
EUROMOT (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Maitheya
Riva, RINA, to Christian Clemm via e-mail. RoHS Pack 27. EUROMOT (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Ex_III-44_EUROMOT_Questionnaire-1_Clarification_final.pdf.
EUROMOT (2024a): Answers to questionnaire 2 sent by Maitheya Riva, RINA, to Christian Clemm
via e-mail. RoHS Pack 27. EUROMOT (RoHS 29).

67 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).

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EUROMOT (2024b): Answers to questionnaire 3 sent by Maitheya Riva, RINA, to Christian Clemm
via e-mail. RoHS Pack 27. EUROMOT (RoHS 29).
EUROMOT (2024c): Answers to questionnaire 4 sent by Maitheya Riva, RINA, to Christian Clemm
via e-mail. RoHS Pack 27. EUROMOT (RoHS 29).
EUROMOT (2024d): Answers to questionnaire 5 sent by Maitheya Riva, RINA, to Christian Clemm
via e-mail. RoHS Pack 27. EUROMOT (RoHS 29).
EUROMOT (2024e): Comments on recommendation exemption III-44 sent by Maitheya Riva,
RINA, to Christian Clemm via e-mail. RoHS Pack 27. EUROMOT (RoHS 29).
Gensch et al. (2019): Study to assess eight (8) exemption requests inAnnexes III and IV to
Directive 2011/65/EU: “Renewal of exemptions III.41, IV.37, IV.41, and requests for new
exemptions for lead andDEHP in certain NRMM engines applications, lead in solder andhexavalent chromium to be used in massspectrometers, lead in certain thermal cutoff fusesand
lead in solders of certain applications used to identify radiation”(Pack 14) – Final-amended. Under
the Framework Contract: Assistance to the Commission on technical, socio-economic and costbenefit assessments related to the implementation and further development of EU waste
legislation. RoHS 19. In cooperation with von Carl-Otto Gensch, Baron, Yifaat, Öko-Institut e. V.
und Dr. Deubzer, Otmar, Fraunhofer IZM. Retrieved from https://circabc.europa.eu/sd/a/cb3dbaf51953-41c6-9071-2b7e75a8bed0/RoHS_Pack-14_final_report_amended_20190305.pdf.
JCB (2023): Answers to the stakeholder consultation. RoHS Pack 27. JCB (RoHS 29). Retrieved
from https://rohs.biois.eu/JCB_support_EUROMOT.pdf.
Volvo Penta (2023): Answers to the stakeholder consultation. RoHS Pack 27. Volvo Penta (RoHS
29). Retrieved from https://rohs.biois.eu/Volvo_Penta.pdf.
Zangl et al. (2010): Adaptation to scientific and technical progress of Annex II to Directive
Adaptation Directive2000/53/EC (ELV) and of the Annex to Directive 2002/95/EC (RoHS). Finalreport - revised version. Final Report. In cooperation with von Stéphanie Zangl, Markus Blepp,
Carl-Otto Gensch, Ran Liu, Katja Moch [Öko-Institut e.V.] und Otmar Deubzer, Deubzer, Otmar[Fraunhofer IZM]. Öko-Institut e. V. und Fraunhofer IZM. Freiburg (Adaptation to scientific andtechnical progress of Directive 2000/53/EC and 2002/96/EC; ELV and RoHS exemption review,
RoHS IV, ELV II). Retrieved fromhttp://elv.exemptions.oeko.info/fileadmin/user_upload/Consultation_2014_1/Ex_3_2010_Review_Fi
nal_report_ELV_RoHS_28_07_2010.pdf; or https://circabc.europa.eu/sd/d/a4bca0a9-b6de-401dbeff-6d15bf423915/Corr_Final%20report_ELV_RoHS_28_07_2010.pdf.

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Requested new Exemption 2022-1 of Annex III:
optical calomel components
Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
AO

Acousto-optic

AOD

Acousto-optic deflector

AOM

Acousto-optic modulator

AOTF

Acousto-optic tuneable filters

BBT

BBT Materials Processing

Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

CAGR

Cumulative average growth rate

COM

European Commission

EEE

Electrical and electronic equipment

IMCIs

Industrial monitoring and control instruments

LWIR

Long wavelength infrared

MWIR

Medium wavelength infrared

NDF

Neutral density filter

QKD

Quantum key distributor

QRNG

Quantum random number generator

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive, RoHS 2

SWIR

Short wavelength infrared314

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TIR

Thermal infrared

Definitions
Damage threshold

Highest quantity of laser radiation incident upon the opticalcomponent for which the extrapolated probability of damage iszero. Source: ISO 21254

Elastic wave propagation

Transmission of mechanical disturbances, or waves (sound),through a material that returns to its original shape after the
disturbance passes. These waves are characterised by the
propagation of stress and strain within the material. (BBT
2023b)

Extinction ratio

In context of polarisation optics in simplified terms indicates
how effectively the part of an electromagnetic radiation in a
specific direction can be blocked. A higher extinction ratio
indicates a more effective polariser. (BBT 2023b)

Source: https://byjus.com/physics/polarization-of-light/ in (BBT 2023b)

Figure of merit

A critical parameter for acousto-optic components to assess
their performance and suitability for various applications. In thecontext of this exemption request, the figure of merit is thediffraction efficiency, i.e. how effectively the acousto-optic
device scatters or modulates the incident light. It is often
expressed as the ratio of the optical power in the diffracted or
modulated beam to the incident optical power. A higher
diffraction efficiency indicates a more efficient acousto-optic
device. (BBT 2023b)

Index of refraction

Change in the speed of light when entering a material
compared to the speed of light in a vacuum, also “opticaldensity”. In anisotropic crystals, birefringence will occur
because light of different polarizations has varying refractive
indices (ordinary (o) and extraordinary (e) within the crystal andcauses the light rays to behave differently as they pass throughthe material. n0 expresses the index of refraction of an ordinary
beam while ne indicates the refraction of an extraordinary
beam. (BBT 2023b)

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Source: https://www.chegg.com/homework-help/questions-and-answers/part-2-mineralogy-crystalunpolarized-light-1--ordinaryray-extraordinary-ray-figure-2-lig-q53324072, referenced in (BBT 2023b)

Mercury-free

Not containing mercury in the applications covered by thescope of the exemption to be reviewed.

Neutral density filter

Filter used at the output of the laser to achieve the desired
power level needed to observe quantum effects. (BBT 2023c)

Optical resistanceIn the context of this exemption request, the resistance andstability of optical parameters under the influence of energy
emitted from high-power lasers. This parameter is not exactly
defined but is closest in meaning to laser load resistance. (BBT
2023b)

Transmissivity

Measure of how much of incident light passes through amaterial, typically expressed as a percentage. It quantifies theability of a material to transmit light without absorbing or
scattering it. Transmissivity takes into account all the light thatis both transmitted and refracted, and it can be affected byfactors such as the material's thickness and the angle ofincidence. (BBT 2023b)

Transparency

Qualitative term describing how well a material allows light topass through it and how easily objects can be seen through thematerial. Transparent materials are those that allow light topass through with minimal absorption or scattering, and they
typically have high transmissivity. Transparency is often used
to describe materials that are clear, like glass or certain plastics,
and they allow for good visibility through them.
Transparency depends on the wavelength of light. Materials aretransparent only in a limited range of wavelengths of light, which
is one of the fundamental optical properties of a given material.
(BBT 2023b)

Infrared spectrum

Electromagnetic waves in the range of around 0.7 µm to 30 µm(for details see Table 17-1: Wording and scope of the requested
exemption Table 17-1 on page 317).

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17.1.

Background and technical information

On 19 January 2022, (BBT 2022) requested the new exemption displayed in Table 17-1 for
EEE of category (cat.) 9 industrial monitoring and control instruments (IMCIs), and for cat.
11.
Table 17-1: Wording and scope of the requested exemption
No.

Requested
Exemption

Requested scope and dates of applicability

Annex
III

Optical components
made of mercurous
chloride monocrystal(calomel)

Applies to categories 9 industrial monitoring and control
instruments and to category 11
Expires on-

21 July68 [date of official publication + 7 years] forcategory 9 industrial monitoring and control instruments-

21 July 2027 (= 2022 + 5 years) for category 11

17.1.1. History of the exemption
The exemption is requested as a new exemption and therefore has never been reviewed
before.

17.1.2. Summary of the requested exemption“Products made of mercurous chloride monocrystals (solid state, stable crystal) represents
a unique, synthetically prepared optical components with extraordinary properties,
especially in the infra-red part of the electromagnetic spectrum. Nowadays, there are noother materials that can offer such a strong birefringence (Δn = 0.6) and simultaneously
broadband transparency reaching from visible (0.38 μm) up to mid-thermal IR region (17μm).
These extraordinary properties will find application mainly in ground sector applications
such as polarization optics and, spectroscopy, acousto-optics, microscopy, etc., as well as
in the space environment sector, too. Calomel is only crystal transparent in MWIR andbirefringent too, what makes him a great candidate for a polarization optics with manytechnical advantages over the wire-grid systems used today. Even if the optical products
made of mercurous chloride monocrystals are not directly electronic devices, many of the
final calomel based components are used as a subcomponent for the electronic devices.
Calomel windows, prisms, cubes, plates and other forms of products are usually mounted
into the protective housing for its particular use and then distributed to the final customers

68 Even though the exemption was submitted on 19 January 2022, the expiry data was assimilated to the

expiry of most other exemptions on Annex III.

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reaching from private companies and corporates, up to technology institutes, universities
and scientific centres producing or using corresponding electronic devices.
Even though calomel is mercurous based compound, handling represents no health risk69
since the mercury molecules are firmly bonded in the crystal lattice. The material is insoluble
in water and no harmful substances can be absorbed through the skin or mucous
membranes.” (BBT 2022)

17.1.3. Technical description of the exemption and use of the restricted
substance
According to (BBT 2022), in addition to chlorine, mercury (Hg) is one of two essential atoms
forming the Hg2Cl2 molecule (mercurous chloride) monocrystal. The crystal lattice, formedby the long linear chains of the Cl-Hg-Hg-Cl molecules, is responsible for unique physicalproperties. This crystalline form of the mercurous chloride is a synthetically prepared
monocrystal. The calomel (solid form) based optical components are used in polarization
optics, acousto-optical components and general optical components like prisms, windows,
cubes and other standard optics used in laser and photonics industry. All electrical orelectronic devices equipped with calomel are used by professionals in research anddevelopment photonics institutes, universities and private companies dealing mainly with
the infrared part of the electromagnetic spectrum, worldwide.
The calomel (solid form) based optical components are used in polarization optics,
acousto-optical components and general optical components like prisms, windows,
cubes and other standard optics used in laser and photonics industry.
All electrical or electronic devices equipped with calomel are used by professionals in
research and development photonics institutes, universities and private companies dealing
mainly with the infrared part of the electromagnetic spectrum, worldwide.
Polarisation Optics(BBT 2022) claim that calomel IR polarisation components are unique devices showing an
exceptionally high extinction ratio (ER)70 in comparison with the market competitors
targeting the MWIR/LWIR71 spectral band. Table 17-2 below illustrates a subdivision of theinfrared spectrum.

69 Inter-Academic committee ČSAV. Symposium on mercury (I) halides. I. Liblice: Institute of Solid State

Physics ČSAV, Praha, 1976; source as referenced by BBT 2022.
70 C.f. section “Definitions” on page 21
71 SWIR/MWIR/LWIR/TIR stands for specific wavelength ranges; Short Wavelength Infrared (SWIR), Medium

Wavelength Infrared (MWIR), Long Wavelength Infrared (LWIR) and Thermal Infrared (TIR)318

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Table 17-2: Spectral ranges of the IR spectrum
IR spectrum

Spectral range

Near IR spectrum (NIRS)

0.78 µm to 3 µm

Medium wavelength IR spectrum (MIRS)

3 µm to 8 µm

Long wavelength IR spectrum (LIRS)

8 µm to 15 µm

Far infrared

15 µm to 1,000 µm

Thermal(TIR)

infrared

Sources:Zeiss(https://www.zeiss.de/spectroscopy/loesungen-und-anwendungen/measuringprinciple/nahinfrarot-spektroskopie.html#die-wissenschaft) et al., in (Deubzer et al. 2021);
Land/AMETAK(https://www.ametekland.com/pressreleases/blog/2021/june/thermalinfraredrangeblog)

The below figure shows examples of optical polarisers.
Figure 17-1: Calomel based optical polarisers mounted in protective housings

Source: (BBT 2022)

The current optical market of MWIR/LWIR polarizers is covered only by wire-grid orholographic types of polarizers. These types provide only low, or limited ER values anddamage threshold which limit the final application performance of the products. The
combination of calomel’s two unique material properties: a high value of birefringence(no=1.973, ne=2,656 @ 589 nm) and a wide transparency range makes it a great candidate
for infrared polarizers.
(BBT 2023a) explain „birefringence: In an optically anisotropic medium (in this case, acrystal), the speed of light depends on the direction of propagation and polarisation. As aresult, the incoming unpolarized light beam splits into two polarised beams (ordinary (Oray) and extraordinary (E-ray) whose polarizations are perpendicular to each other. Thesebeams propagate through the crystal at different speeds and as a result propagate indifferent directions. This phenomenon is called birefringence. Figure 17-2 illustrates thesituation.

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Figure 17-2: Birefringence

Source: Go Photonics, https://www.gophotonics.com/community/what-is-birefringence, referenced by (BBT
2023c)In terms of material, (BBT 2022) distinguish two main types of optical polarizers: polymer
film polarizers or grid polarizers, and crystal (prism) polarizers.
Figure 17-3: Different types of polarization prisms made from mercurous chloride
crystalline material

Source: (BBT 2022)

The film/grid polarizers are the order of magnitude cheaper (especially applies to film
polarizers) compared to crystal polarizers but film/grid polarizers exhibit lower extinction
ratios (ER, 102 -103) and due to the higher absorption (50-90 %) in the IR spectrum, they
are not good for high power laser applications.
The crystal polarizers (calomel based prism) exhibit high ER (up to 104 – 105), transparency(95-98%) and high optical resistance. (BBT 2022)
A typical and traditional representative material of crystal polarizers is a Calcite. Calcite(CaCO3) is a naturally occurring birefringent crystal with excellent polarization properties
including very high extinction ratio and transmission efficiency. Unfortunately, Calcite
material exhibits only limited transmission performance in a wavelength bands from 320 nm

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to 2.300 nm. Figure 17-4 proves that mercury halides (including calomel) cover much wider
a spectral region than other optical materials. (BBT 2022)
Figure 17-4: Comparison of optical transmission spectra of calomel vs. othermaterials with logarithmic scale

Source: (BBT 2022)

Acousto optical filters
According to (BBT 2022), calomel is suitable for the construction of acousto-optical (AO)
devices such as AO tuneable filters (AOTFs), AO deflectors (AODs), and modulators(AOMs). (BBT 2023b) define these as three different types of acousto-optic devices thatuse acoustic waves to control and modify the passage of light through optical materials.
(BBT 2023b) describe AOTFs as optical devices that can selectively transmit - or block certain wavelengths of light based on specific acoustic wave frequencies that propagate
through an optical material, e.g. calomel. Figure 17-5 illustrates their components andfunctionality.

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Figure 17-5: Schematic description of AOTF functionality

Source: Brimrose, https://www.brimrose.com/fiber-coupled-ao, source as referenced by (BBT 2023c)

According to (BBT 2023b), AOTFs cause diffraction of incident light whereby the angle ofdiffraction is directly related to the wavelength being filtered. AOTFs are often used inspectroscopy and spectral analysis to quickly change the sensing wavelength.
AODs uses the same physical principle as AOTFs but are used for light beam direction
control and fast scanning in a variety of applications, including sound-guided lasers, laser
scanning systems, laser-based printing, and laser material processing. (BBT 2023b)
AOMs are used to modulate the intensity or phase of a laser beam by varying the intensityof the acoustic wave. Its purpose is to modulate light. In other words, by controlling theintensity of the acoustic wave, the intensity or phase of the diffracted light can be controlled.
This is particularly useful in laser communication, optical signal processing and generally
wherever amplitude modulation or phase shift is needed. (BBT 2022)(BBT 2023b) put forward that calomel’s figure of merit is comparable with tellurium dioxide(TeO2) and more than one order better than lead molybdenate PbMoO4. Moreover, thetransparency of calomel (0.38 to 17 μm) enables the use of AO units in a broad spectral
range (compared with TeO2 which is limited only up to 5 μm) covering an additional part of
the thermal IR region where no other materials can be applied. No other tuneable acoustooptical filter for the TIR region is currently available on the market which demonstrates thesignificant market advantage for this material. (BBT 2022)
Other optical elements
Optical elements as filters, beam-splitters, prisms, and windows offer a variety of nonpolarizing optical elements for operating light sources from the SWIR to TIR spectral
regions. (BBT 2022)

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Figure 17-6: Custom made calomel optical components

Source: (BBT 2022)

Custom made optical components may be supplied in different shapes, angles andconfigurations, and may be used for a wide range of applications, such as OPD (optical
path difference), spectroscopy or sample substrates. It may be also used in IR opticalsystems, where other IR transparent materials are struggling with low damage threshold ortransparency. (BBT 2022)
In the last year and a half since their application, (BBT 2023a) started developments of,among others, quantum mechanical devices like quantum random number generators(QRNGs) which use calomel optical elements. QRNGs work on a completely different
principle, the principle of quantum mechanics. Briefly and simplified it starts with a sourcethat generates single photons (Laser in the picture below). The single photon is sent to abeam splitter (PBS), made of calomel, as well as the polarizing optics used, which can let it
pass through or reflect it, each with a 50 % chance. Before the photon hits the beam splitter,it exists in two possible states at once (= Quantum Superposition). After the beam splitter,the photon goes through a device that measures its polarization state (SPD). The result of
the polarization measurement is used to create a random '0' or '1' bit. Several additional
steps may be performed afterwards to ensure that the numbers generated are truly random
and secure.

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Figure 17-7: Quantum Random Number Generator

Source: (BBT 2022)

PBS

Polarising beam splitter

SPD

Single photon detector

NDF

Neutral density filter(BBT 2023a) believe that the three technologies “polarisation optics”, “acousto-optics” and“optical elements” are general enough to cover all the systems considered so far.

17.1.4. Amount(s) of restricted substance(s) used under the exemption(BBT 2022) indicate the mercury content in the calomel compound to be 85 % (given by thestandard atomic weight). The mass content depends on the size of the optical components
produced, usually between 5-30 g, giving 4.25-25.5 g of mercury.
Considering the size of the optical market dealing with the infra-red polarization optics, (BBT2022) expect annual production of around 100 pieces of polarization components with agrowth rate around 10 % per year plus eventually another 50-100 pieces for custom
designed products. (BBT 2022) are specifically engaged in the production of small opticalpieces (approximately 0.5 – 4 cm3 with a weight about 5 - 20 g per one piece), which meansthat the final output doesn't go beyond 3.5 kg per year.

17.2.

Justification of the requested exemption

17.2.1. Substitution and Elimination of the restricted substance(BBT 2022) highlight the extraordinary characteristics of calomel:•

Broadband spectral range from the visible spectrum to TIR (0.38 µm to 17 μm).

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High value of birefringence (for example four times higher than Calcite, which is
nowadays commonly used because of the lack of materials as good as calomel).

•

Very high indices of refraction (no = 1.973, ne = 2.656).

•

Extremely low velocity of elastic wave propagation (347 m/s).

•

Extremely high values for acousto-optical figures of merit.

In the second half of the last century, (BBT 2022) began a research trying to find some
optically proper replacement for the commonly used calcite (CaCO3) crystal in optics.
Calcite exhibits birefringence almost as good as calomel, but its transparency, damage
threshold and other parameters essential for optical and photonic use are insufficient.
discovered the crystalline form of mercurous halides and its astonishing optical properties,some of them enormously outnumbering those of calcite or other known materials withbirefringence values almost as good as calomel. Next to the broad spectral range of calomel(c.f. Figure 17-4 on page 321), (BBT 2022) illustrate its high birefringence compared tocalcite in Figure 17-8.
Figure 17-8: Birefringence values for mercurous halides and calcite

Source: (BBT 2022)

There is no other optical material combining such optical properties as mercurous chloride.
(BBT 2022) therefore consider looking for substitutes as ineffective.

17.2.2. Environmental, health, safety and socioeconomic impacts(BBT 2022) point out that calomel monocrystal is a highly durable and stable compound,with almost endless lifetime cycle. When handling properly, there is zero risk of material
decomposition and/or degradation. Naturally occurring crystals of calomel are present innature for thousands of years without any change. The only possible way of the productdegradation is a mechanical damage by user, or accidental deposition to ultraviolet or Xray radiation. Their products are designed to be used by photonics specialist or industry
engineers for simple application, however, when use is no more possible because of theabove mentioned cases, calomel parts should be dismantled and sent for proper treatment
back to the manufacturer. Other parts of electronic devices (that are using calomel) should
be recycled accordingly.
As to socioeconomic impacts that might arise if the exemption is not granted, (BBT 2022)
are afraid that progress of scientific research would be reduced in some sectors due to325

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absence of suitable materials for IR polarization, acousto-optics, laser and/or microscopy
devices which would affect exploration.

17.2.3. Roadmap towards substitution or elimination of the restricted
substance
The applicant does not present a roadmap to substitute or eliminate the use of mercury inapplications in the scope of the requested exemption.

17.3.

Critical review

17.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Annex XVII of the REACH Regulation contains several entries restricting the use of mercury
and of mercury compounds. Entry 18 restricts72 placing on the market, or use, as
substances or in mixtures mercury compounds where the substance are intended for certain
uses, e.g. in treatment of industrial sewage or for the impregnation of heavy-duty industrial
textiles and yarn.
Mercury in the applications in scope of the requested exemption is not used for any of theabove applications, and the restrictions are therefore not applicable.
Entry 18a73 restricts the use of mercury:•in fever thermometers;•

in other measuring devices intended for sale to the general public (such as
manometers, barometers, sphygmomanometers, thermometers other than fever
thermometers);•

in a number of specified measuring devices intended for industrial and professional
uses, in particular barometers, hygrometers, manometers, sphygmomanometers74,

72 ECHA, https://echa.europa.eu/documents/10162/5a7222b0-9d3a-4a90-9e55-258149e92b1a
73 ECHA, https://echa.europa.eu/documents/10162/dbcaaec7-bd5b-4a7d-b164-23fa97950a86
74 Device used to measure blood pressure.

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strain gauges to be used with plethysmographs75, tensiometers, thermometers andother non-electrical thermometric applications, mercury pycnometers and mercury
metering devices for determination of the softening point.
To the consultants’ best knowledge, the applications in scope of the requested exemption
do not include the use of mercury in any of the above products/articles so that the above
restrictions do not apply.
Entry 62 lists several phenylmercury compounds76, which are, however, not related either
the use of mercury in the applications in the scope of the requested exemption.
No other relevant entries in regard to the use of mercury could be identified in Annex XIV
and Annex XVII. Based on the current status of these Annexes, the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if other criteria of Art. 5(1)(a) apply.

17.3.2. Compliance with the Mercury Regulation
Mercury is also restricted in certain applications through the Mercury Regulation 2017/852
implementing the international Minamata Convention on Mercury of 2013. The Mercury
Regulation refers to the RoHS Directive in Article 8(1) on “New mercury-added products
and new manufacturing processes” and stipulates that “Economic operators shall not
manufacture or place on the market mercury-added products that were not being
manufactured prior to 1 January 2018 (‘new mercury-added products’) unless authorised to
do so by means of a decision taken pursuant to paragraph 6 of this Article or allowed to doso under Directive 2011/65/EU of the European Parliament and of the Council”.
If the COM grants the requested exemption the use of mercury would be allowed underDirective 2011/65/EU so that the above restriction would not be applicable. The coherencewith the Mercury Regulation should therefore be established if the exemption is granted.

17.3.3. Timing of the exemption request(BBT 2023a) launched their first standardised calomel products (Glan Foucault andWollaston polarizers) in 2019, with some tailor-made products having been delivered even
earlier. This situation raises the question why the applicant requests the exemption now,
several years after mercury-containing optical elements had begun to be placed on themarket. No exemption of RoHS Annexes III or IV have covered the use of mercury in opticalcomponents.
(BBT 2023a) explain that those components were mainly used for research anddevelopment (R&D), and for scientific activities, not for commercial purposes. However,
over time, the company transformed from a research institute to an SME and therefore
focused on commercialisation. At that time, the company realised that RoHS is necessary
to facilitate its penetration of the world market (not only the EEA market, but also the Asian

75 Device for measuring changes in volume within an organ.
76 ECHA, https://echa.europa.eu/substances-restricted-under-

reach?p_p_id=disslists_WAR_disslistsportlet&p_p_lifecycle=1&p_p_state=normal&p_p_mode=
view&_disslists_WAR_disslistsportlet_javax.portlet.action=searchDissLists

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and American markets were being considered). (BBT 2023a) claim that this exemption will
significantly increase their competitiveness in the market. The parameters of this opticalmaterial significantly exceed those of the components used so far.
The applicant refers to Art. 2(4)(j) which excludes from the scope of RoHS equipment
specifically designed solely for the purposes of research and development only madeavailable on a business-to-business basis. Assuming that Art. 2(4)(j) is applicable, theapplicant’s explanation is plausible that entering other markets in the European Economic
Area (EEA) brings the applicant’s calomel products into the scope of the RoHS Directive,
which explains why the applicant had not requested the exemption prior to 2019 already.

17.3.4. BBT as only applicant and producer
BBT are the only applicant requesting this exemption. They were therefore requested to
explain why no other producers or stakeholders request or at least support the exemption
request. (BBT 2023b) claim that they (BBT) are the only manufacturer and supplier ofcalomel single crystals and calomel-based optical components in the world.
An investigation on the internet showed that two companies77 offer devices with calomelcomponents of the sort described by the applicant, which seems to contradict the applicants’
above statement.
Upon request, (BBT 2023c) state that BBT produce the calomel devices for Knight Optical,
a producer and distributor of scientific optical components. (BBT 2023c) further explain that
the French Fastlite Group owns approximately one third of BBT due to a capital investment
in BBT around 2010, due to the outstanding acousto-optic parameters of the calomel cuts.
Thus, it is still the case that BBT is the only manufacturer of the elements mentioned.
This situation explains why no other producers of calomel optics applied for this exemption
or supported the applicant’s exemption request. Still, BBT’s exemption request has not been
supported by producers of EEE who want to use the applicant's calomel optical components
in their EEE.
(BBT 2024a) explain this situation pointing out that their various technologies are in different
stages of development. Users/producers have expressed their interest. However, they haveidentified the lack of legislative approval such as RoHS as a problematic point. For thedevelopment of an FTIR spectrometer in collaboration with the Italian company NIREOS(nireos.com), it was considered necessary to have a RoHS exemption before launching acommercial campaign and obtaining a sufficient competitive advantage.

17.3.5. Scope clarification(BBT 2022) request the new exemption for cat. 9 IMCI, and for cat. 11. To ensure a correct
scope of the exemption, the categorisation of BBT’s equipment was discussed with the

77 C. f. Fastlite, https://fastlite.com/categorie/mid-ir-lwir-optics/, and Knight Optical, www.knightoptical.com

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applicant. It was clarified with BBT which of their products are actually used as components
for other EEE, and which ones are EEE for themselves that are used by end users. For theirproducts, (BBT 2024a) could not think of any cat. 11 EEE which would either be an EEE for
itself or be used as a component in cat. 11 EEE, and they agreed that the exemption is not
required for this category.

(BBT 2023b) specify their products as follows:•

Polarizers and prisms for polarizing optics are usually sold as components that mustthen be integrated into the EEE. A manufacturer will build e.g. a polarising IR
camera.

•FT spectrometers and interferometers are end products.

•

AO components can be used both as end products namely for research anddevelopment purposes, and as components of other EEE.

•In QRNG or QKD (Quantum key distribution), the calomel-based components,
specifically the beam splitter and a type of polarizer, are used as components while
the devices themselves are the end product.

(BBT 2023c) were asked to fill out the below table to clarify which categories of EEE may
be of relevance besides cat. 9 IMCI.

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2011/65/EU

Calomel EEE78
Calomeltechnology

Acoustooptical (AO)
components& devices

Polarisation
optics &deviceComponent
or EEE
AO
tuneablefilters (TF)
AOTF
AO
modulators(M)
AOM

Calomel components

Calomel EEE and components

EEE category otherthan cat. 9 IMCIEEE in which
component is used
if different from
EEE of cat. 9 IMCI

Cat. of EEE in which
component is used if
different from cat. 9

Product example for calomel EEE, or EEE which contain calomelcomponents

-

-

-

Hyperspectral camera

3

AOTF

-

Optical spectral analyser (OSA)-

A confocal microscope--

Laboratory & lasers

AOM

3

AOM

-

Optical communication lasers

AOD

3

AOD

-

Laser printer, Laser scanner, Laser material processing

Polarisers

-

-

-

IR Camera

Polarisers

-

-

-

Astronomical telescope

Polarisers
Depolarizers
BeamSplitter
Beam
Splitter
Savart plate

-

QKD

3

QKD

-

-

-

Microscope, Spectrometer

-

-

-

-

QRNG

3

QRNG

-

-

-

IR camera, ultra-high sensitive detectors

Wave plate

-

-

-

Laboratory optical setup

Specific cut
Specificcuts79---Hyperspectral FT interferometer

-

-

?

?*

Microscope, Spectrometer,

Table 17-3: Classification and categorisation of calomel element uses
Source: (BBT 2023c)

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According to (BBT 2024a), Savart plates are usually manufactured in either calcite or quartz from two equal thickness plates of birefringent
material cemented together, each with their optic axes at 45° to the surface normal and rotated through 90°with respect to each other. Light
entering the first plate is split into its two constituent polarization states, the ordinary and extra-ordinary polarized rays. The ordinary ray propagates
undisturbed, but the extra-ordinary ray is displaced parallel to one edge. On entering the second crystal, the ordinary ray in the first crystal
becomes the extra-ordinary ray in the second crystal and is displaced in a direction perpendicular to the first beam displacement. Each polarization
component effectively passes through its own shearing interferometer and produces a set of straight line fringes. Savart plates made of calomel
can measure 4 times weaker polarized signals than calcite ones and in addition it works in IR region where calcite does not work anymore.

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In most cases where the calomel optical elements are used as components, the applicant
refrained from categorising the EEE in which they are used. The product examples in thetable show that most of these EEEs could be cat. 9 IMCI, or possibly cat. 8 medical devices.
According to the above table, cat. 3 is of relevance for the calomel elements as well.
(BBT 2024a) agree that the scope of the exemption should only include categories 3, 8 and
9 IMCI whereas cat. 11 is not applicable.

17.3.6. Substitution and elimination of the restricted substance
The applicant highlights the unique individual properties and their combination in calomel
optics which differentiate it from other materials that could potentially be used as well:•

Broadband spectral range from the visible spectrum to TIR (0.38 µm to 17 μm).

•

High value of birefringence (for example four times higher than Calcite, which is
nowadays commonly used because of the lack of materials as good as calomel.

•

Exceptionally high extinction ratio in the MWIR/LWIR spectral band•

High transparency (95-98 %) and high optical resistance•

Very high indices of refraction (no = 1.973, ne = 2.656).

•

Extremely low velocity of elastic wave propagation (347 m/s).

•

Extremely high values for acousto-optical figures of merit.

BBT substantiate this claim with examples, e.g. with calcite exhibiting birefringence almost
as good as calomel, but inferior transparency, damage threshold, etc.. For acousto-optic
applications, the figure of merit of TeO2 is comparable to calomel but is limited in its
application by its narrower spectral range so that only calomel-based tuneable acoustooptical filters are currently available for the TIR region.
It is, however, questionable whether and how far these properties and/or the combinations
thereof are required in all uses. Figure 17-4 on page 321 shows that mercury-free polarizers
operate in the wavelength spectrum up to around 5 μm, like the above-mentioned TeO2
(BBT 2022) state that calomel’s figure of merit is comparable with TeO2 in acousto-optic
applications, and possibly also in other uses where the extended spectral range of calomel
is not relevant.
(BBT 2023a) agree that in theoretical terms it could be possible, but the advantage ofcalomel is not only that it covers a wavelength > 5 μm but that it covers a wavelength > 5 μm
plus(!) the visible (VIS) and short-wave infrared (SWIR) spectrum (cf. Figure 17-4 on page321). E.g., each molecule has specific vibrational bands that are characteristic of its
structure and chemical bonds, across the entire VIS (visible) and TIR (thermal infrared)
bands.
(BBT 2024b) explain vibrational bands as the effect when a molecule absorbs IR radiation
which it causes chemical bonds in the molecule to vibrate (resonates) it leads to absorption
bands that are specific for the molecule and can be used for its detection. According to (BBT
2023a), usingthe example of an AOTF (acousto-optic tuneable filter), this device makes
possible the electrical tuning of specific wavelengths. Should the device be placed on asatellite for the purpose of remote sensing of the earth, the greatest added value is the

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ability to compare over as many wavelengths as possible. The proposed limitation would
restrict the use to almost 30 %. In addition, we would have to place additional equipment
there for other wavelengths, which inevitably increases the weight and power consumption,
both of which are undesirable. Similar examples may be found for spectrometers.
Space applications are excluded from the scope of the RoHS Directive. The applicant wastherefore requested to substantiate the demand for the broad spectral range of calomel
optics with example EEE that are in the scope of the RoHS Directive.
(BBT 2023c) explain that such remote sensing imaging devices can be applied on platforms
for terrestrial applications like drones, automobiles, or also handheld applications e.g. in thecase of civil security, power engineering or the civil engineering industry. For further
advantages of EEE using calomel, (BBT 2024a) exemplarily point out the case of a
hyperspectral infrared camera with calomel polarization optics which can not only operate
in the thermal infrared region like other conventional cameras, but additionally is capable ofapplying a polarization effect in this spectral region and exhibits an unprecedentedly higher
degree of polarization than other systems. The user can benefit not only from conventional
non-polarized infrared data, and in addition has information about the polarization of thedetected signal, which significantly increases the information value of the acquired data.
Specific advantage could be seen by availability of a detection of absorption lines from VIS
up to LWIR.
As an example for the specific differences which the calomel optics can make, (BBT 2024a)
state that the four times higher degree of polarization [efficiency] of calomel compared tocalcite polarizers generates signals or images that are four times more contrasting. In
practice, this means that weakly polarized signals that are not detected by calcite polarizers
can still be detected. In addition, calcite is transparent only in a very limited spectral regionof 0.3 - 2.3 µm. Additionally and of relevance for polarization and acousto-optical uses,
calomel, unlike calcite and other mercury-free materials, has an unrivalled resistance tohigh power lasers. (BBT 2024a) thus deem the role of calomel to be unique and without
substitution.
The consultants understand that the broad spectral area which calomel optical elements
can cover increases the operational range of EEE in which these elements are used.
The applicant was also asked whether there are any products that did not exist prior to theintroduction of calomel optical elements, i.e. that these products cannot be built without thecalomel optical elements.
(BBT 2024a) name compact Fourier transform infrared spectrometers and high-efficiency
polarization optics for thermal infrared polarizers such as Glan-Foucault, Glan-Taylor,
Wollaston, Glan-Thompson polarizers, half- and quarter-wave plates, Savart plates, etc.
The above products are, however, products that can be produced from other birefringent
materials like magnesium fluoride, quartz, rutile, and yttrium orthovanadate.80 The
applicant’s statement as to the products that cannot be manufactured without calomel
optical elements thus only refers to the performance of these products. The existence of the80

See for example Thorlabs, https://www.thorlabs.com/navigation.cfm?guide_id=2458

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mentioned types of products (Glan-Foucault, Wollaston polarisers etc.) per se does notdepend on the availability of calomel optical elements.
The birefringent materials identified on the internet - magnesium fluoride, quartz, rutile, andyttrium orthovanadate – were not mentioned in BBT’s exemption request. The applicant
was therefore requested to explain the performance of these materials compared tocalomel. (BBT 2024b) submitted the below tables.
Table 17-4: Parameters of acousto-optic materials

Source: (BBT 2024b)(BBT 2024b) explain that the materials with the highest values of acousto-optic figure of
merit are Hg2Cl2, TeO2 and KRS-5. KRS-5 is transparent for an even broader wavelength
spectrum than Hg2Cl2 but has a tendency to cold-flow so that the shape of these optics maychange over time, and it is a toxic material. Lead molybdate actually exhibits the highest
acousto-optic figure of merit but cannot be used as a substitute for calomel due to its leadcontent.
Table 17-4 and the applicants’ explanations show that calomel is not the only material
exhibiting good acousto-optic properties.

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Table 17-5: Parameters of birefringent crystals

Source: (BBT 2024b)(BBT 2024b) explain that calomel exhibits the highest birefringence, the widest range ofspectral transmittance, high damage threshold and extinction ratio. The positive value ofthe birefringence is convenient when investigating ordinary beams which are less sensitive
to material inhomogeneities. Another advantage of calomel is it´s high resistance todamage. When using a laser, calomel did not show any damage under the given conditions.
The table shows that calomel exceeds the performance of the other materials in theparameters listed. The extinction ratios are, however, not comparable since they are related
to specific wavelength spectra.
Overall, calomel shows better performances in many of the parameters than otherbirefringent and acousto-optic materials even though mercury-free alternatives outperform
calomel in some individual properties. A specific quality of calomel is the combination ofthese good performance parameters which other materials cannot offer. It is, however, tobe noted that mercury-free birefringent and acousto-optic materials are available.
Since, in the absence of the requested exemption, calomel so far could not be applied in
EEE that falls into the scope of the RoHS Directive due to the missing exemption, thesemercury-free materials were the only birefringent and acousto-optic materials which themarket could offer. Recommending the exemption to be granted can therefore be justified

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with Art. 5(1)(a) for those cases where the performance of mercury-free materials is not
sufficient so that the specific properties and combination thereof which calomel can offer
are actually required. In this field, substitution and elimination of mercury is scientifically andtechnically still impracticable. The wording and scope of the respective potential exemption
must safeguard this condition.

17.3.7. Wording of the exemption
The consultants proposed a wording based on the applicant’s proposal and additionally 12
specific performance parameters to describe the conditions where the performance of
mercury-free materials is not sufficient so that the use of calomel can be justified.
(BBT 2024c) stated that some of these parameters are interdependent and suggested the
below ones that are independent from each other:
Optical components made of mercurous chloride monocrystal (calomel) where atleast one of the below conditions applies:a) The wavelengths to be detected, tuned, manipulated or used otherwise
include the spectrum 3 - 17 µmb) Value of birefringence of more than +0,50c) Indices of refraction of no > 1,89 and ne > 2,44 at λ = 10,6 µm, and no> 2,11 and ne > 3,18 at λ = 0,38 μmd) Extinction ratio of more than 1 : 20 000 in the infrared wavelength spectrum
between 3 - 17 µm.
e) Velocity of elastic wave propagation less than 400 m/sf) Value for acousto-optical figure of merit of M2 = 640 x 10-15 s3/kg at λ =632.8 nm or higherg) Damage threshold more than 5 x 105 W/cm2 at λ = 1 064 nmh) Transmissivity of more than 60 % in the spectral range of 0,38 µm to 17
μm
This wording was discussed with (BBT 2024d, 2024e) via questionnaires and in a web
conference to clarify last wording details until (BBT 2024e) agreed to the below wording:
Table 17-6: Wording of the exemption elaborated with the applicant
No.

Exemption

III-X

Mercury in optical materials made of mercurous chloride monocrystal (calomel) for use inapplications requiring a polarising material or in acousto-optic applications, if at least oneof the below properties is required:a) A crystal material is required for the specific application, and its transmission must
include at least one wavelength in the spectrum from more than 8 µm up to 17 µm.
b) Indices of refraction of no > 1,89 and ne > 2,44 at 10,6 µm wavelength, and no > 2,11
and ne > 3,18 at 0,38 μm wavelength, as well as a birefringence of more than +0,5 at
any part of the wavelength spectrum from 0,38 µm to 17 µm.
c) Extinction ratio of more than 1:20 000 in the infrared wavelength spectrum between
3 µm and 17 µm.

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EUd) Velocity of elastic wave propagation of less than 400 m/se) Value for acousto-optical figure of merit M2 = 640 x 10-15 s3/kg at 632,8 nm wavelengthf) Damage threshold of more than 5 x 105 W/cm2 at 1.064 nm

The number of sub-clauses was reduced by merging the sub-clauses addressing thebirefringence (sub-clause b)) and refraction (sub-clause c)) of the first proposal, and thetransmissivity clause was skipped since this property does not sufficiently differentiate
calomel from mercury-free alternatives.
The formulation of sub-clause a) takes account of the fact that calomel on the one handoffers a broad transmission for wavelengths between 0.38 µm and 17 µm which, however,is outperformed by the transmission range of zinc selenide (ZnSe) and KRS-5 on the upper
end of the wavelength spectrum. On the other hand, calcium fluoride (CaF2) has atransmission up to 8 µm and should thus demarcate the field where mercury-freealternatives are available for the wavelength spectrum of 8 µm and less. To exclude the useof calomel from this field, the lower wavelength limit for the use of calomel was set at 8 µm.
Still, however, the wavelength spectrum of calomel in the range of more than 8 µm up to
17 µm overlaps with the transmission ranges of ZnSe and KRS-5 which both also cover the
spectral range from 8 µm to17 µm. This would allow the use of calomel for wavelengths of
8 µm and more for which mercury-free alternatives are available. The wording therefore
needed to be refined to exclude these potential abuses of calomel.
ZnSe has a broad transmission range but low birefringence and thus low polarisation
efficiency, and it is not an acousto-optic material. Adding the condition that calomel can only
be used “in applications requiring a polarising material or in acousto-optic applications”
excludes the use of calomel in cases where only the transmission spectrum above 8 µm is
required, for which ZnSe can be applied.
KRS-5 is not a crystal material. Introducing the additional condition into sub-clause a) in
Table 17-6 that the specific application of the optical material requires the use of a crystal
material excludes the use of calomel where the non-crystal mercury-free KRS-5 would be
sufficient. The consultants noted that KRS-5 is toxic due to its content of thallium and thatits use may therefore be of limited benefit compared to calomel. There is, however, no
information available as to whether the use of KRS-5 instead of calomel is likely to outweighthe total negative environmental, health and consumer safety impacts, and as a matter offact the use of KRS-5 as acousto-optic material is not legally restricted. Further on, in
principle, other non-crystal materials may be made available on the market in the coming
years that can be used as RoHS-compliant substitutes.
If a crystal polarizing or acousto-optic material is required, the formulation of sub-clause a)in Table 17-6 allows the use of calomel for wavelengths of 8 µm and less, as long as
wavelengths of more than 8 µm and up to 17 µm are part of the required transmission
spectrum. This avoids the case that a specific EEE conceived to operate at less than 8 µm
and up to 17 µm must contain two different birefringent or acousto-optical materials:•

One material for the spectrum from 3 µm to 8 µm (mercury-free);•A second material for the wavelengths of more than 8 µm up to 17 µm (calomel).

Since calomel can cover the entire spectrum from 3 µm to 17 µm, it can still be used incases like the above one whereas the formulation of the sub-clause a) excludes its use if
the specific application does not require the spectrum above 8 µm.
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The other sub-clauses in the consultants understanding are also designed in a way thatthey facilitate the use of calomel where its specific properties are required and exclude its
use where mercury-free alternatives provide sufficient performance.
The applicant was asked whether the exemption could be further restricted by requiring atleast two of the exemption sub-clauses to be applicable instead of only one without
excluding calomel from applications where its properties are required.
(BBT 2024d) stated that they would rather avoid meeting two sub-clauses. At the moment,
we cannot think of any application where the physical parameters are not met, but it is more
up to the end users.
The consultants think that, taking account of the fact that calomel is introduced into newmarket segments, it is acceptable to maintain the currently agreed wording. The applicant
should, however, collect the necessary information to enable an informed decision on thefurther restriction of the exemption in case its renewal is requested later.

17.3.8. Environmental, health, safety and socio-economic impacts
The applicant describes in section 17.2.2 on page 325 environmental, health and safety
impacts as well as socioeconomic impacts if the exemption is not granted. (BBT 2024b)
point out that KRS-5 as a material competing with calomel in its transmission and acoustooptic figure of merit, contains thallium that is very toxic by ingestion with cumulative effects,
harmful in contact with skin, toxic to aquatic organisms, and may cause long term adverse
effects in the aquatic environment. In calomel, the mercury is bound by a strong covalentbond, which means it can not be released from the molecule easily.
(BBT 2023c) describe the largest terrestrial markets for remote sensing as an example ofmarkets to which they would not have access if the exemption is not granted. The
commercial figures describe the total market.

•

IR Cameras - Size USD 8.55 Billion (2022) and “cumulative average growth rate”(CAGR) of 7 % (2022 - 2023)
Possible ground applications for “calomel case” in: energy, civil engineering and in
the automotive industry•

Acousto-optics - size USD 469 million (2022), CAGR (2022-2023) 6.3 %Possible ground applications for “calomel case” in: medical, communications,
measurement and detection•

Spectrometry - size USD 111 billion (2021), CAGR 6.2 % (2022-2031)
Applications: testing and scanning of drugs, raw materials detection•

Lasers - size 1.7 billion (2022), CAGR 4.5 % (2023-2030)
Applications: communication, processing, measurement and detection.

If the exemption is not granted, the applicant sees disadvantages for research anddevelopment in the European Economic Area. The consultants cannot exclude thatthe
potential related to the superior performance of calomel optical elements would actually not
be accessible in this case so that such disadvantages may arise.

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17.3.9. Summary and conclusions
Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;•

the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts causedby substitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

(BBT 2022) request an exemption for the use of calomel in optical elements. The available
information suggests that BBT are the only producer of this material. BBT and theircustomers have been using calomel in applications outside the scope of the RoHS Directivein the past years and now see market potential for this material within the scope for which
the exemption is required.
The applicant could not present substantial efforts to substitute or eliminate the use of
mercury which is, however, reasonable in the consultants’ understanding in the light of theup to now out-of-scope use of calomel.
Technically, calomel exhibits advantageous properties that are in few cases outperformed
in individual parameters by mercury-free alternatives. Overall, and in particular in its
combination of these properties, calomel is a material that enables higher performances in
EEE of categories 3, 8 and 9 IMCI.
The consultants therefore conclude from the accessible information that calomel opticalelements provide specific individual properties and combinations thereof which mercuryfree alternatives cannot provide. Where these properties are required, substitution andelimination of mercury in calomel are scientifically and technically not yet
practicable, and the use of mercury in the applications at hand does not weaken theenvironmental and health protection afforded by the REACH Regulation. The exemption
can therefore be recommended to be granted in line with Art. 5(1)(a).
Mercury-free alternatives have been used in the past in the type of applications where
calomel can be used as well, and these mercury-free materials should be continued to be
used where their performance is sufficient. The consultants elaborated with the applicant awording that restricts the use of calomel to applications where its specific properties are
actually required (cf. section 17.3.7 on page 336) in EEE of categories 3, 8 and 9 IMCI.

17.4.

Recommendation

The consultants recommend granting the exemption for use in categories 3, 8 and 9 IMCI.
Calomel enables higher performances of acousto-optic devices and devices that apply
polarising materials, for which substitution or elimination of mercury in calomel, or of calomel
itself, is scientifically and technically not yet practicable.
To avoid the use of calomel where the performance of mercury-free materials is sufficient,
the consultants propose the below wording.

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No.

Exemption

Scope and dates ofapplicability

III-X

Mercury in optical materials made of mercurous chloride

Applies to categories
3, 8 and 9 industrial
monitoring and control
instruments.

monocrystal (calomel) for use in applications requiring apolarizing material or in acousto-optic applications, if at least
one of the below properties is required:a) A crystal material is required for the specific application,and its transmission must include 81 at least one
wavelength in the spectrum from more than 8 µm up to
17 µm.
b) Indices of refraction of no > 1,89 and ne > 2,44 at 10,6 µm
wavelength, and no > 2,11 and ne > 3,18 at 0,38 μm
wavelength, as well as a birefringence of more than +0,5 at
any part of the wavelength spectrum from 0,38 µm to 17 µm.

Expires on (date of
official publication + 5
years) for cat. 3, 8 and
9 industrial monitoring
and control
instruments.

c) Extinction ratio of more than 1:20 000 in the infrared
wavelength spectrum between 3 µm and 17 µm.
d) Velocity of elastic wave propagation of less than 400 m/se) Value for acousto-optical figure of merit M2 = 640 x 10-15
s3/kg at 632,8 nm wavelengthf) Damage threshold of more than 5 x 105 W/cm2 at 1.064 nm

Since mercury-free alternatives are not foreseeable to become available within the next five
years, it is recommended to grant the exemption for the maximum validity period of five
years.
BBT are expected to collect information for a potential future renewal request as to whether
the exemption scope could be further narrowed by requiring two of the above sub-clauses
to be applicable as a pre-condition for the use of calomel. Further on, the applicant shouldhave undertaken efforts to substitute or eliminate the use of mercury and present a roadmap
for further such activities in a future renewal request, and stakeholders are invited tocontribute information concerning potential substitutes and alternative technologies to avoid
the use of mercury in future stakeholder consultations.
Applicants’ feedback on the recommendation(BBT 2024e) agree to the above recommendation.

17.5.

References

BBT (2022): RoHS Annex V Request for a new exemption for mercury in optical calomelcomponents. RoHS Pack 27. BBT – Materials Processing (RoHS 29).

81 This implies that calomel can be used for wavelenghts of 8 µm and less if at least one wavelenght in the

spectrum of more than 8 µm up to 17 µm is required as well for the foreseen function/use of the EEE in which
the calomel element is used.

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BBT (2023a): Answers to questionnaire 1 (clarification questionnaire) sent via e-mail by Ondrej
Ballada, BBT, to Dr. Otmar Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
Retrieved from https://rohs.biois.eu/Ex-III-2022-1_NEW_BBT_Questionnaire-1_Clarification_.pdf.
BBT (2023b): Answers to questionnaire 2 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
BBT (2023c): Answers to questionnaire 3 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
BBT (2024a): Answers to questionnaire 4 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
BBT (2024b): Answers to questionnaire 5 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
BBT (2024c): Answers to questionnaire 6 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
BBT (2024d): Answers to questionnaire 7 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
BBT (2024e): Answers to questionnaire 8 sent via e-mail by Ondrej Ballada, BBT, to Dr. Otmar
Deubzer. RoHS Pack 27. BBT – Materials Processing (RoHS 29).
Deubzer et al. (2021): 11th adaptation to scientific and technical progress of exemptions 2(c)(i), 3
and 5(b) of Annex II to Directive 2000/53/EC (ELV). Final report. In cooperation with Dr. Deubzer,
Otmar, Fraunhofer IZM und UNITAR, UNITAR Christian Clemm und BioIS Shailendra Mugdal.
Retrieved from https://data.europa.eu/doi/10.2779/373311

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Exemption 1(a) of Annex IV: Pb and Cd in ion
selective electrodes
The below Table 18-1 shows the wording, scope and expiry dates of the exemption.
Table 18-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

IV-1(a)Lead and cadmium in ion
selective electrodes including
glass of pH electrodes

Applies to categories 8 and 9 and expires on-

21 July 2021 for category 8 other than invitro diagnostic medical devices (IVD) andfor category 9 other than industrial
monitoring and control instruments (IMCI);-

21 July 2023 for category 8 in vitro diagnostic
medical devices;-

21 July 2024 for category 9 industrial
monitoring and control instruments.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and Definitions
BGS

Blood gas system

Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments

IVD

In-vitro diagnostic medical devices

POC

point of care

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment342

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

RoHS

Directive 2011/65/EU, current RoHS Directive

18.1.

Background and technical information

On 19 January 2022, (COCIR 2022) requested the renewal of the exemption as displayed
Table 18-2 for EEE of category (cat.) 8 in-vitro diagnostic medical devices.
Table 18-2: Wording and scope of the requested exemption
No.

Requested Exemption

Requested scope and dates ofapplicability

IV-1(a)Lead and cadmium in thick film pastes in ion
selective electrodes used for blood gas
systems.

Applies to category 8 in-vitro
diagnostic medical devices andexpires on 31 August 2026

No contributions to the stakeholder consultation were made.

18.1.1. History of the exemption
Exemption 1(a) of Annex IV was not part of RoHS Directive 2002/95/EC (2003) (RoHS 1).
It was first evaluated by (Goodman 2006) and subsequently listed on Annex IV of RoHS
Directive 2011/65/EU (2011) (RoHS 2) when this was officially published in 2011.
Exemption 1(a) was first reviewed by (Deubzer et al. 2022). At the time, JBCE requested arenewal of the exemption for the use of lead in glass electrodes of three specific geometricforms (types) in EEE of cat. 9 monitoring and control instruments including industrial
monitoring and control instruments (IMCI). (Deubzer et al. 2022) concluded that lead-freeglass electrodes could not yet substitute leaded glass electrodes in all applications. Thiswas based mainly on performance differences between lead-containing electrodes and theirlead-free alternatives with respect to repeatability of measurements, tap water response
time, and the ability to measure extreme ends of the pH spectrum. At the time, no application
was received for a renewal of the exemption for cadmium. However, after the submissionof the draft report, the consultants received information that cadmium was in fact containedin some ion selective electrodes that detect cadmium ions. Further, no application wasreceived to renew the exemption for cat. 8 in vitro diagnostic medical devices at that time.
(Deubzer et al. 2022) recommended two exemption wording options, option A and option
B. Option B takes into account that the renewal request was submitted by JBCE aroundthree years earlier than the minimum 18 months prior to exemption expiry so that theevaluation of the exemption with relevance to cat. 9 IMCI also took place several years prior
to the exemption expiry date. Therefore, in option B, the exemption for cadmium wasrecommended to be renewed for a limited period of time so that stakeholders not aware of
the early review of this exemption had time to transition or apply for renewal. Both wording
options are reproduced below, with option A displayed in Table 18-3 and option B in Table
18-4.
Although the applicants at the time had requested a renewal for the maximum validity
period, i.e. 7 years, the consultants recommended a shorter period, as JBCE could not
produce unambiguous evidence that the reliability of available lead-free alternatives was infact not ensured. (Deubzer et al. 2022) stated that a renewal of the exemption for a time343

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frame below the maximum validity period would be sufficient to allow JBCE and otherstakeholders to comprehensively test available lead-free electrodes against leaded
electrodes and gather information on applications where repeatability, tap water responsetime and extreme ends of the pH spectrum are of relevance.
Table 18-3: Wording option A recommended by (Deubzer et al. 2022)

Source: (Deubzer et al. 2022)

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Table 18-4: Wording option B recommended by (Deubzer et al. 2022)

Source: (Deubzer et al. 2022)

At the time of the current evaluation of exemption IV-1(a), the COM have not yet officiallypublished their decision as to the adoption of the above recommendation. The COM wish
the consultants to assess in this current review round whether there are any substantial
reasons in line with Art. 5(1)(a) against the adoption of the above recommendation for EEE
of categories 8, 9 and 11.

18.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). (COCIR 2022) therefore
applied for the renewal of the current exemption 1(a) for cat. 8 IVD since it was earmarked
for expiry on 21 July 2023 for this subcategory of cat. 8 EEE. The exemption thus becamedue for review even though the recommendation for the renewal of exemption 1(a) of(Deubzer et al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Deubzer
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et al. 2022) can be adopted to cat. 8 IVD in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Deubzer et al. 2022) is not intended. The consultants will rely on thecritical review conducted by (Deubzer et al. 2022) and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

18.1.3. Summary of the requested exemption“Blood gas analysis systems use ion selective electrodes in their sensors, to detect bloodgases such as pO2 and pCO2 and biomarkers in patients blood. Blood gas systems areused to accurately diagnose various conditions such as asthma, chronic obstructive
pulmonary disease (COPD), kidney failure, uncontrolled diabetes and severe infections, aswell as treat patients in respiratory and/or metabolic distress.
Lead and cadmium are constituents of thick film screen printable paste used in the sensors.
These constituents are used to promote reaction bonding and for ensuring strong adhesionof the paste base metal (typically gold or palladium) to the ceramic substrate material on
firing. A planar sensor array can contain up to 10 sensors, with performance integral to thereliability, sensitivity and quick response time of the system. With the sensors themselves
reliant on the integrity of the connections formed by the thick film paste. For goodconnections to be made the paste is required to have a precise viscosity to allow for the
printing of fine features and low resistivity (≤ 4.5mΩ @ 10µm) which is determined by thepercent solids, the ability to form a dense film with minimal defects and good adhesion to
the substrate.
Testing is still ongoing for alternative RoHS compliant thick film pastes, with a focus onalternatives developed by the same manufacturer to minimise the changes to the technicalcharacteristics of the paste, and thus reduce the timeframes for qualification. Alternativetechnologies which avoid the use of thick film pastes are possible but would require
additional time to qualify alternatives due to more major product design and production
process changes. In addition to these changes, the many decades of experience andreliability data gathered while using thick film pastes would also have to be overcome,resulting in considerably longer timeframes for qualification.” (COCIR 2022)

18.1.4. Technical description of the exemption and use of the restricted
substance
Types of EEE for which the exemption renewal request is relevant
According to (COCIR 2022), the scope of this exemption is sensors for blood analysis
systems, using ion selective electrodes for the detection of blood gases such as pO 2 andpCO2 and biomarkers. These point of care blood gas systems are categorized as in-vitro
diagnostic medical devices within RoHS Annex I EEE category 8.
(COCIR 2022) describe that lead and cadmium are constituents of thick film screen
printable paste (also referred to as ‘ink’), used in the fabrication of planar sensors used in346

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

point of care blood gas systems. The lead and cadmium within the paste is cited82 aspromoting reaction bonding and ensuring strong adhesion of the paste base metal (typicallygold or palladium) to the ceramic sensor substrate material on firing.
Material and/or component in which lead and cadmium are used
(COCIR 2022) describe that lead and cadmium are used as constituents of thick film screen
printable pastes, also known as inks. ‘Thick film’ technology, uses conductive, resistive andinsulating pastes containing glass frit (a glass powder which acts as a filler which is typicallyused for producing the thick film pastes, (COCIR 2023), deposited in patterns defined byscreen printing and fused at high temperature onto a ceramic substrate. Compared withsolder pastes, the particle sizes are much smaller, and the suspensions therefore morestable. The printable paste is designed to give an appropriate viscosity for the screenprinting process.
The paste is applied (screen printed) onto a substrate in the fabrication of potentiometricand amperometric planar ion selective sensors. Potentiometric sensors measure thepotential difference between two electrodes under the conditions of no current flow. The
measured potential is then used to determine the analytical quantity of interest based on
the Nernst equation. Amperometric sensors measure the current response to detect theconcentration of an analyte at a fixed potential. The applied potential drives the electrontransfer reaction of the analytes, and the measured current indicates the analyte
concentration.
According to (COCIR 2022), the pastes are used for providing the electrical contact within
the sensors, and between the sensors and the blood gas system. They are critical for the
reliable transduction of the measured sensor response into an electrical signal that is further
converted by the blood gas system and associated algorithms into analysis results. A
technical illustration was provided by (COCIR 2023), reproduced in Figure 18-1.
Figure 18-1: Technical illustration of the thick film paste as part of the sensor

Source: (COCIR 2023)

The sensors are assembled into linear arrays which are incorporated into replaceable
measurement cartridges used in point of care blood gas systems.

82 Rapson, W.S. The bonding of gold and gold alloys to non-metallic materials. Gold Bull 12, 108–114 (1979).

https://doi.org/10.1007/BF03215110

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Figure 18-2: Exemplary image of replaceable blood gas system cartridge

Source: (COCIR 2022)(COCIR 2022) describe that the method for measuring a sample involves flow of theaqueous fluid or patient blood sample (analyte) over the planar sensor and a standard
reference electrode, the sensor and reference form an electrochemical cell. The resulting
electrical signal from the electrochemical cell is converted by the system into a meaningful
reading of the analyte. An example of the usage of the paste is shown in Figure 18-3. The
pastes are used on the contact pads as well as the ‘Via Fills’ that connect the planar sensors
to make electrical contact with the blood gas system.
Figure 18-3: Exemplary schematic showing the printing layers wherein the paste isused on the substrate layer

Source: (COCIR 2022)

The sensors are arranged in a linear array of up to 10 different sensors in some blood gas
systems, with each sensor designed to detect different analytes. These sensors form a
critical part of blood gas systems. The blood gas system measures pH, pCO2, pO2, sodium,
potassium, chloride, ionized calcium, glucose, lactate, total haemoglobin, haemoglobin
fractions, neonatal bilirubin, and several calculated parameters. A typical example of sucha product is shown in Figure 18-4.

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Figure 18-4: Exemplary image showing a blood gas system

Blood gas systems are known to help in accurate diagnosis of various conditions such asasthma, chronic obstructive pulmonary disease (COPD), kidney failure, uncontrolled
diabetes and severe infections, as well as treat patients in respiratory and/or metabolic
distress. Further details of their application can be found in this referenced document
Clinical Utility of Blood Gas83. The use of such devices has increased considerably in the
recent past and they have become an integral part of intensive care units (ICUs) andemergency medical services.
(COCIR 2022) claim that blood gas systems have been essential in supporting COVID-19
response efforts, where blood gas systems play a critical role in managing infected patientsand monitoring their respiratory distress. Arterial blood gas testing is also performed when
patients require critical pulmonary assessment, managing sepsis and kidney function
evaluation. These tests provide the clinician with a health assessment of the patient andhelp direct treatment options.
Arterial blood gas testing is not a routine blood test. The tests are performed on patients
who are critically ill in the intensive care units, operating rooms and emergency rooms. In
these locations, time is critical for the clinician to provide the best treatment based uponthese tests. Analysis results are available in approximately 60 seconds. Faster diagnosis
helps prescribe accurate therapy at an early stage of disorder, which helps avoid
complications. The performance of the sensors is integral to the reliability, sensitivity andresponse time of the system, the sensors themselves are reliant on the integrity of theconnections formed by the thick film paste. A significant advantage of this type of sensing
technology is that only a small sample of blood is required (typically 100µL), this isadvantageous especially when assessing infants or patients from whom obtaining a larger
sample due to their condition would be difficult.
Characteristics of lead and cadmium for which they are required

83 Siemens: Clinical Utility of Blood Gas. bg_clinical_utility_poster_fnl4-00278011_1800000000278011.pdf(scrvt.com)

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According to (COCIR 2022), in order to be able to manufacture the sensors, the paste has
to be suitable for application by screen printing. Screen printing is attributed to be a
reproducible and efficient method for large scale production of planar sensors84.
The key attribute of the paste to ensure printability is the viscosity, this is required to be in
the range 190 - 350 Kcps [kilo centipoise]. This not only determines the flow of the paste
but also the ability to print features to the required resolution (typically >75 µm lines andspaces), which is critical to minimising the size of the sensors.
The paste must also provide consistent physical and chemical properties after firing (theprocess of heating the paste to temperatures of >800⁰C, often multiple times to facilitate
bonding to the substrate).The key attribute required from the paste after firing is resistivity,
this is required to be ≤ 4.5mΩ @ 10 µm fired film thickness, which is determined by thepercent solids, the ability to form a dense film with minimal defects (pin holes) and goodadhesion to the substrate. Defects or pin holes in the fired paste act as air gaps increasing
the overall resistivity. These attributes also ensure the integrity and reliability of theconnections made by the paste.
The lead and cadmium within the paste is cited82 as promoting reaction bonding andensuring strong adhesion of the paste base metal (typically gold or palladium) to the ceramic
sensor substrate material on firing.
(COCIR 2022) highlight that manufacturers have built up many decades of experience, withsome utilising the principles of this technology for over 45 years and as such have refined
both the hardware and software of the system to maximise the analytical capability.

18.1.5. Amount(s) of restricted substance(s) used under the exemption(COCIR 2022) indicate the cadmium content in the thick film paste to be up to a maximumof 1.5 % by weight and lead compounds (frits) up to a maximum of 3.5 %. Throughapplication for which the exemption is requested, an estimated 82 g of cadmium and 191 gof lead are placed on the EU market annually. These numbers are based on calculations
including confidential market information.

18.2.

Justification of the requested exemption

18.2.1. Substitution and elimination of the restricted substance
Replacement thick film pastes (substitution)(COCIR 2022) state that lead and cadmium have been used in thick film pastes for many
decades and have known to have been used successfully for the manufacturing of sensors
for blood gas systems for the past 20+ years, citing William Rapson (1979)82. However, theyalso highlight that several manufacturers of thick film paste exist, including Du Pont 85,

84 Tymecki L, Glab S, Koncki R. Miniaturized, Planar Ion-selective Electrodes Fabricated by Means of Thick-film Technology. Sensors (Basel). 2006 Apr 7;6(4):390–6. PMCID: PMC3872359.
85 https://www.dupont.com/mobility-materials/thick-film-materials.html

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Koartan86, Ferro87, and Heraeus88, all of which have been developing lead- and cadmiumfree alternatives, the exact formulation of each paste however is proprietary to the paste
manufacturer.
According to (COCIR 2022), there are a number of variables inherent to each of the thickfilm pastes based on the following, which influence the technical characteristics:•

The constituents themselves, including rheology modifiers;•

The ratios of constituents;•

The constituent particle size and shape etc.

(COCIR 2022) explain that these variables impact the firing temperature, viscosity, shear
rate and printability of the paste, including the ability to print and resolve sufficiently finefeatures. They also impact the performance of the paste after it has been fired to form a
conductor, in terms of resistivity, bond strength, and reliability. Consequently, to optimise
the chances of success in transitioning to a new paste for a particular application, it isprudent for manufacturers to minimise the number of variables by first testing alternatives
with the same paste manufacturer. This helps to minimise these differences, but also utilises
the close technical relationship which usually is already in place to minimise the qualification
timeframes.
(COCIR 2022) describe that one thick film paste manufacturer launched a lead- andcadmium-free paste in late 201889 which was intended to be the replacement for pastes
containing lead and cadmium. As well as changing the constituent formulation, changes
have also been made to the particle size and shape of the constituents, with the intent of
improving performance. (COCIR 2022) describe that initial trials of this particular paste, bya manufacturer of blood gas systems and the sensors therein, were started in early 2019,with a batch of 6 wafers manufactured. Of this batch, 2 wafers failed due to print voids andthe production associate which produced the samples noted it was difficult to work with. The
sensors are required to pass a 100% conductivity test, which only 66% of the samples
passed, compared to the typical passing rate of the current paste >95%. As such, theinvestigations into this potential alternative were halted to try to investigate a more
promising alternative.
A second alternative paste was investigated which printed well and showed no continuity
issues. However, the sample was only able to achieve an average use life of 21 days, withsome samples failing at as early as 12 days, rather than the warranty use life of 30 days
which is currently offered for one system. (COCIR 2022) explain that the signal producedby the sensor (recovery) was also identified as being different to that of the current paste.
Testing showed that the potential alternative had a mean recovery less than that of thecurrent paste of 37 mg/dL, which was confirmed when a second lot was tested. Thisdifference in sensor signal was investigated by repeating the fabrication and creating a

86 https://koartan.com/thick-film-pastes/conductor-pastes/gold-pastes
87 https://www.ferro.com/
88 https://www.heraeus.com/en/group/home/home.html
89 https://www.heraeus.com/en/het/company_het/press_and_news_het/2018_het/09_imaps.html

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second batch (lot 2) of the sensors, and installing the sensors in other cartridges but keeping
the same reagents as the first test; all of which showed the same difference in sensor
results.
(COCIR 2022) provide more testing details for all of the above in a confidential submissionthat cannot be reproduced in this report.
(COCIR 2022) conclude that given all of these issues and with the advent of the COVID
pandemic, which impacted resource availability (due to a combination of a 31% rise inproduct demand and lockdown restrictions between 2019 and 2021), trials at this stage
were halted until late 2021. However, trials are still on-going for the currently selected
alternative with feasibility, conductivity testing completed and use life testing for 5 out of 13
of the analyte sensors, across multiple models of blood gas systems. However, additionaltime is still required to undertake all of the required testing.
Potential Alternative Technologies (elimination)(COCIR 2022) state that there are no currently qualified alternatives that provide a technicalsolution. They claim that it has been established90 that thick films based on nano-scaled
powders offer better sensing properties than thin films deposited through methods such as
sputtering, chemical vapor deposition, or laser ablating. As detecting analyte to very small
quantities is one of the defining technical characteristics of blood gas systems thesetechnologies are unsuitable for this application.
According to (COCIR 2022), photolithography is used on silicone wafers in the integrated
circuits industry. However, such technology requires extremely clean operating conditions
which are not currently in place. Although there have been some academic papers exploring
photolithography and its use on ceramics, the work has been limited thus far and has notdemonstrated this technology is suitable for the ceramic wafers used in blood gas systems.
(COCIR 2022) further explain that microprinting and inkjet printing was deemed as an
unsuitable alternative methodology as the resulting process was thought to be too
inconsistent. The inconsistency arises from the head space within the print heads, which
would cause different pressures to be applied to the print as the volumes of ink in the print
head changes. It is conceivable that the optimisation of such parameters to overcome this,and other design characteristics such as the redesign of the printer head, may be possible
given sufficient time. However, more crucially the areas of the printed ink are quite large,
with the smallest droplets deposited by this method being about 100 μm across 90 which is
not suitable for sensors in blood gas systems.
According to (COCIR 2022), these are the main manufacturers of blood gas systems:•

Radiometer: https://www.radiometer.co.uk/•

Siemens: https://www.siemens-healthineers.com/blood-gas/blood-gas-systems•

Nova: https://www.novabiomedical.com/•

Medica: https://www.medicacorp.com/products/blood-gas-analyzers/

90 Tomchenko, Alexey. (2006). Printed Chemical Sensors: from Screen-Printing to Microprinting. In book: as“Thick-Film Semiconductor Chemical Sensors” in Encyclopedia of Sensors (pp.279-290).

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Synergy Medical Systems: http://www.synergymedsys.com/Blood-GasAnalyser.html•

Eshweiler: https://www.eschweiler-kiel.de/en/eschweiler-automatic-analysingsystems/•

Sensa Core: https://www.sensacore.com/product/blood-gas-analyzer-abgem•

Roche: https://diagnostics.roche.com/global/en/products/product-category/bloodgas.html(COCIR 2022) state that of these, it is known that some manufacturers do not use planarsensors, instead they are likely to use macro sensors. However, even if manufacturers
relying upon planar sensors were to switch technology to macro sensors, the development
cycle of a new gas system is typically ten years so a suitable time period to allow for thisdevelopment to occur would need to be permitted.
Reliability of possible substitutes(COCIR 2022) point out that both manufacturability and finished product performance need
to be established in assessing the suitability of alternatives. According to (COCIR 2022),
in the first instance, the following properties determine the manufacturability or suitability forscreen printing and achieving the desired pattern resolution, adding that the precise values
can impact the printing mesh required, the print speed and achievable thickness andresolution:•

Viscosity: 190 - 350 Kcps %•Solids: 84.5 – 88 ±2%

The following are sought after the firing step(s) has been completed, firing is typically at apeak of between 850 and 950⁰C, the precise firing cycle, overall duration and dwell time atpeak temperature will need to be assessed for alternative pastes under consideration:•

Resistivity: ≤ 4.5 mΩ @ 10 µm fired film thickness

These features impact the performance and reliability of the sensors themselves which inturn impacts the performance and reliability of the blood gas system.
(COCIR 2022) further explain that in some blood gas systems, the sensors are arranged ina linear array of up to 10 different sensors each for detecting different analytes, it has beenshown that changes made to one sensor in these arrays can impact the performance ofother sensors, so changes to the paste used in the construction of each sensor need to beassessed sequentially rather than making changes to all of the sensors.
It is known that a manufacturer will carry out 100 % electrical conductivity testing on
sensors, scrapping any non-conforming product. Sample performance testing of sensors(between 0.27 and 1.7 % of sensors), to verify performance in measuring analytes is also
carried out, all sample sensors are scrapped after testing. The slope of the signal producedby the sensor over time when exposed to a known analyte and any drift of this signal are
the key parameters assessed to ensure suitable performance is achieved from each batch.

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18.2.2. Environmental, health, safety, and socioeconomic impacts(COCIR 2022) only stated that without this exemption, certain blood gas systems would not
be able to be sold in the EU. (COCIR 2024a) added that without this exemption, using
alternatives to blood gas systems could lead to delays in patient results and treatment.

18.2.3. Roadmap towards substitution or elimination of the restricted
substance
Actions taken to develop further possible alternatives(COCIR 2022) explain that a newly developed RoHS and REACH compliant paste, from aknown paste manufacturer is being evaluated. Initial trials of a RoHS compliant paste, by amanufacturer of blood gas system and the sensors therein, were started in 2019. Howeverwith the advent of the COVID pandemic, which impacted resource availability (due to a
combination of a 31% rise in product demand between 2019 and 2021 and lockdown
restrictions), trials were halted until late 2021.
(COCIR 2022) highlight a number of factors that can influence the quality of the final productwhen undertaking changes to thick film processing, including:•

Screen type, mesh size, filament diameter, frame size, wet print thickness.

•

Requirement for an emulsion layer to ensure that the stencil can seal onto thesubstrate whilst holding the mesh filaments clear of the substrate at the edge of thestencil apertures. This ensures that pastes can flow underneath the wires to theedge of the apertures therefore producing clean print edges.

•

Tension of screen and squeegee design and pressure, all of which influence theability to deposit the correct amount of paste on the surface of the substrate.

•

Screen-substrate gap needs to be tailored to ensure smudging doesn’t occur when
it is too small, but also not too large to allow distortion of the print.

(COCIR 2022) explain that after printing, the substrates must be fired, according to thethermal profile specified by the paste manufacturer and assembled into its final form. Dueto the critical nature of the end product, such factors needed to be considered and trialled
during the manufacturing feasibility testing. Currently there are 13 affected sensors, on
multiple model types, which require testing. Testing has been completed for 5 out of 13 of
the analyte sensors. The remaining testing is on-going.
Other alternative paste manufacturers are also being considered alongside the primaryalternative paste of interest, however for the reasons discussed earlier this is less likely toyield the required results.
Necessary stages and timeframe for establishing possible substitutes
According to (COCIR 2022), the steps for a change from an existing paste to a newly
developed RoHS compliant paste involves the following steps. In total the whole process
requires an additional 4 1/2 years to complete. This timeframe allows for the assessment of
up to two potential replacement pastes from two different paste manufacturers. Each of thesteps noted below have to be performed sequentially and following strict internal change
control procedures.

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Table 18-5: Timeframe for the assessment of two potential replacement pastes
DetailEst.
duration

Step

Description

1

Feasibility
Determining the equivalency of the paste in 18 months(completed for 5 out terms of manufacturability, to include thick remaining
film printing and subsequent process steps,of 13 sensors)
conductivity, and performance testing for
up to 13 different sensors.

2

Use - Life Testing Manufacture of lots and testing of sensors 14 months(completed for 5 out against
a known control
sensor. remaining
Measurement of spiked blood samples withof 13 sensors)different levels of analyte for a period of up
to 30 days depending on the system. This
test needs to be undertaken on multiple lotsof sensors, inks, and systems. Testing
timeframes are limited by capacity and test
cycles.

3

Shelf-life testing

Storage of the sensors and then 8 months
conductivity and performance testing
repeated to verify there has been no
degradation in function.

4

Verification

Repeat of conductivity and performance 8 months
testing for up to 13 different sensors toverify there has been no degradation infunction.

5

Implementation

Transfer of the new paste from R&D into 6 months
mainstream manufacturing.

Source: (COCIR 2022)

18.3.

Critical review

18.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.

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Several restrictions of cadmium and its compounds are listed on Annex XVII (cf. section 4.1
on page 48). None of those, however, is applicable to the use of cadmium and cadmium
compounds in the scope of exemption IV-1(a).
Further on, uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex
XVII contains several restrictions for lead and its compounds. None of those entries are,however, relevant for the use of lead in the scope of exemption IV-1(a) (cf. section 4.2 on
page 51 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

18.3.2. Adoption of the recommendation from the previous evaluation report
Exemption IV-1(a) was reviewed by (Deubzer et al. 2022) who recommended a renewal,
proposing two wording options to the European Commission (COM): Wording option A andwording option B, reproduced in section 18.1.1 “History of the exemption” in Table 18-3 andin Table 18-4, respectively.
During the review of the current exemption renewal request, the applicants were informedthat if this review shows that the applicants’ arguments justify the renewal of the exemption,
the consultants would recommend the wordings, scopes and expiry dates given in Table
18-6 (reflecting option A) and Table 18-7 (reflecting option B), adapted from therecommendations by (Deubzer et al. 2022).
Table 18-6: Renewal of exemption 1(a) reflecting wording option A, adapted from(Deubzer et al. 2022).
No.

Exemption

Scope and dates ofapplicability

IV-1(a)Lead and cadmium in ion selective electrodes
including glass of pH electrodes.

Expires on 21 July 2023

IV1(a)(I)

Lead in the stem glass of pH glass electrodes andion selective electrodes equipped with a pH glass
electrode with complex shape as following:

Applies to cat. 8 in vitro
diagnostic medical devices
starting 22 July 2023 and cat. 9
monitoring and control
instruments including industrial
monitoring and control
instruments.

- Micro type pH glass electrode
Composite electrode that has a spherical or tubeshaped pH responsive glass membrane with adiameter of 4.0 mm or less and a referenceelectrode with a liquid junction at a position
vertically within 6.5 mm from the tip;

Expires on-

21 July [2023 + X*] for cat.
8 in vitro diagnostic medical
devices-

21 July 2025 for cat. 9
monitoring
andcontrol
instruments
including- Flat type pH glass electrodepH glass electrode with a flat pH response
membrane at the tip of a glass tube with adiameter of 6.0 mm or more;- Needle type pH glass electrode356

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

Composite electrode that has a conical pH
response membrane with a tip angle of 40° or lessand with a diameter of 10 mm or more.”industrial monitoring
control instruments

and*X can be a maximum of 7 years
Table 18-7: Renewal of exemption 1(a) reflecting wording option B, adapted from(Deubzer et al. 2022)
No.

Exemption

Scope and dates ofapplicability

IV-1(a)Lead and cadmium in ion selective electrodes
including glass of pH electrodes.

Expires on 21 July 2023

IV-1(a)(I)

Cadmium in ion selective electrodes including
glass of pH electrodes.

Applies to cat. 8 in vitro
diagnostic medical devices
starting 22 July 2023 and cat. 9
monitoring and control
instruments including industrial
monitoring and control
instruments.
Expires on

IV-1(a)(II)

Lead in the stem glass of pH glass electrodes
and ion selective electrodes equipped with a pH
glass electrode with complex shape as following:- Micro type pH glass electrode
Composite electrode that has a spherical or
tube-shaped pH responsive glass membranewith a diameter of 4.0 mm or less and areference electrode with a liquid junction at a
position vertically within 6.5 mm from the tip;-

21 July [2023 + X*] for cat.
8 in vitro diagnostic
medical devices-

21 July 2024 for cat. 9
industrial monitoring andcontrol instruments

Applies to cat. 8 in vitro
diagnostic medical devices
starting 22 July 2023 and cat. 9
monitoring and control
instruments including industrial
monitoring and control
instruments.
Expires on-

21 July [2023 + X*] for cat.
8 in vitro diagnostic
medical devices-

21 July 2025 for cat. 9
monitoring and control
instruments including
industrial monitoring andcontrol instruments.

- Flat type pH glass electrodepH glass electrode with a flat pH response
membrane at the tip of a glass tube with adiameter of 6.0 mm or more;- Needle type pH glass electrode
Composite electrode that has a conical pH
response membrane with a tip angle of 40 ° orless and with a diameter of 10 mm or more.”*X can be a maximum of 7 years
When requested to comment on and explain any obstacles to the adoption of the above
proposal for the requested exemption for category 8 in vitro diagnostic medical devices,357

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(COCIR 2023) responded that the proposal would not cover all of the uses highlighted intheir exemption renewal request and therefore they could not agree its adoption.
Regarding their use of cadmium, (COCIR 2023) stated that from Table 18-7 (option B),
exemption IV-1(a)-(I) would be suitable for the use of cadmium if X equated 7 years. The
consultants note that exemption IV-1(a)(I) was recommended by (Deubzer et al. 2022) toprovide a transition period for manufacturers of cadmium-containing electrodes to transition
to cadmium-free alternatives in the absence of applications for a renewal of exemption IV1(a) for cadmium. At the time, the applicants had only requested the renewal of exemption
IV-1(a) for lead, but not for cadmium, in equipment in scope of RoHS Annex I cat. 9 IMCI.
Regarding the use of lead, (COCIR 2023) state that the recommended exemption 1(a)-(II)only permits the use of lead in stem glass of specific geometry types, which are notapplicable to blood gas systems. The consultants agree that the thick film paste and its use
in planar sensors in sensors in blood gas systems (BGS) for which the renewal of thisexemption is requested would not be covered by the recommendations made by (Deubzer
et al. 2022).
In this review of exemption IV-1(a), the consultants therefore focus on establishing whether
substitution and elimination of lead and cadmium are scientifically and technicallypracticable in the applications and equipment in scope of COCIR’s renewal request.

18.3.3. Substitution and elimination of the restricted substances
Substitution
When asked to clarify the functions of lead and cadmium in the thick film paste, (COCIR2023) responded that both substances contribute to the required viscosity and resistivity bylowering the melting temperature of the glass frit. With lower viscosity during the firing step,
the ink readily moves to the interface between the inks and the substrate. The lower
viscosity also helps the ink migrate into substrate pores to fill them. This forms a strong
mechanical bond between the metallic inks and the substrate.
When asked to clarify the typical composition of thick film paste in scope of this exemption
renewal request, (COCIR 2024a) provided the information reproduced in Table 18-8,
showing the constituents of thick film paste that remain after firing.
Table 18-8: Constituents of thick film paste after firing
Constituent% weight

FunctionGold

Up to 90

Provides electrical chemical connectivity forthe microsensor

Cadmium

Up to 1.5

Aid in the avoidance of defects and pin holes

Lead compounds (frits)

Up to 3.5

Aid in the avoidance of defects and pin holes

Source: (COCIR 2024a)

When asked whether both lead and cadmium were required to achieve the desired
attributes of the pastes, (COCIR 2024a) declared that pastes with either only lead or only
cadmium had not been tested, as efforts have been focused on fully RoHS compliant
solutions only. This approach appears sensible to the consultants.

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When asked about the composition of pastes that have been tested to achieve RoHScompliance, (COCIR 2024a) stated that they are predominantly gold-based inks to ensure
the electrochemical transduction bonding properties, however, the complete composition of
the alternative ink is proprietary information (trade secret). COCIR did state, however, thatone supplier had specified that their RoHS-compliant gold ink, which is currently underevaluation, uses a formulation that contains doped borosilicates along with the gold topromote the adhesion, with the dopant being an oxide material. These new substances
promote adhesion based on a mixed bond mechanism, specifically, both a mechanical andchemical bond.
In the renewal request, the applicants described testing two RoHS-compliant pastes, which
resulted in defects, while currently testing is ongoing with a third variant with promising
results. When asked why testing had only been done on so few RoHS-compliant variants
despite the fact that RoHS-compliant pastes have been described in patents91, literature92,
and press releases93 over several decades, (COCIR 2024a) stated that in order to maximise
the likelihood of success of identifying an alternative, and within the shortest time possible,
manufacturers tend to try to minimise any changes to the design, as any variation of theestablished system designs can have significant impact to sensor performance. To
minimise the impact of function and manufacturing process, vendors whose products havebeen previously established at the time of design were prioritised for testing. Another factor
is that new suppliers need to be audited and qualified, which is typically done before costand time-consuming testing commences, to ensure a supplier is willing to meet all
requirements.
When asked whether the testing of RoHS-compliant pastes had been conducted incorrespondence with their respective suppliers to maximize the chances for ideal outcomes,(COCIR 2024a) confirmed that supplier recommended parameters, such as thetemperatures used for curing/drying, have been utilised in the manufacturing processes
trailed. They reiterate that this resulted in printability issues with a high rate of print voids
which resulted in an approximate 30% failure rate for continuity testing.
The applicants’ line of arguments that the substitution of lead requires more time fordevelopment and testing appears plausible to the consultants overall. While the consultants
understand the chosen approach is reasonable from the manufacturers’ perspective, someuncertainty remains regarding the comprehensiveness of the extent of the testing that has
been conducted.

91 E.g. this patent for a lead-free thick film paste composition from 1993https://patents.google.com/patent/EP0711255B1/en
92 E.g. Mussler, B., Schwanke, D. (2009). Validation of alternative RoHS compliant au pastes for the DuPont

LTCC 951 system. Journal of Microelectronics and Electronic Packaging 6(1). DOI:10.4071/1551-48976.1.20
93 E.g. EPP Europe. (2004). Lead-free paste for ceramic modules. https://epp-europe-

news.com/technology/applications/lead-free-paste-for-ceramic-modules/359

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Elimination(COCIR 2022) discuss the following alternative technologies in the context of elimination:
Thin films, photolithography, microprinting, and macro sensors, each of which are discussed
below.
Thin film technology(COCIR 2022) stated that stated that thin film technology is unsuitable as detecting analyte
to very small quantities is one of the defining technical characteristics of blood gas systems.
When asked to explain the technical reasons for this, (COCIR 2024a) stated that detecting
specific molecules in complex environments like blood remains challenging, citing two
scientific publications94 & 95, adding that the sensor's sensitivity needs refinement to handle
the intricate mix of substances present in real-world samples. This is important as thescalability of the processes is not always ensured from proposing theoretical results, butrather needs to be tested to ensure that the necessary precision and reliability required by
the process is ensured. Further, COCIR stated that it is worthwhile noting that the generaltrend which we are aware of are either for systems which rely upon thick film pastes to moveto lead and cadmium free alternatives only, rather than there being a new technology which
would replace the need for such paste.
When asked to provide more detail explaining why thin film technology is not suitable forthe detection of analytes in small quantities, (COCIR 2024a) explained that thin films are
essentially ultra-thin layers with a large surface area compared to their volume. This makes
them ideal for micro and nanoscale sensor development. (COCIR 2024b) added that whenselecting at the design stage the most suitable manufacturing process, considerations isgiven to many aspects, including the application requirements, functionality, andmechanical constraints. While thin film technology offers unique advantages, such as
enabling miniaturization, thick film is better suited for planar sensors. The fundamental
challenge in using thin films is the 1 nm to 1 µm order of magnitude, whereas the range ofthickness of planar sensors used for this application are in the tens to hundreds of μm
thickness range. The long-term reliability of devices using thin-film technology would alsoneed to be tested, as exposure to blood repeatedly over the course of a month poses aharsh environment. These technical challenges would need to be fully explored andresolved to be able to implement thin film technology in devices of this type, will requiresignificant evaluation, development and validation activities followed by regulatory
approvals. To the best of our knowledge no device manufacturer is exploring thin film
technology as a potential alternative due to the level of development needed, rather efforts
are focused on lead and cadmium free thick film pastes.
(COCIR 2024a) further added that the general trend which they are aware of is either forsystems which rely upon thick film pastes to move to lead and cadmium free alternatives
only, rather than there being a new technology which would replace the need for such paste.
In the consultants’ view, the argument that an alternative technology that is a potential
candidate to eliminate the use of restricted substances is not explored due to the level ofdevelopment needed is generally not acceptable per se in the context of this review.

94 Schmaljohann, Frank & Hagedorn, Daniel & Löffler, Frank. (2021). Challenges of sensor development

based on thin film technology. 10.1016/b978-0-444-63237-1.00003-6
95 Tvarozek et. al (1998). Thin films in biosensors. https://doi.org/10.1016/S0042-207X(98)00050-5

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However, it is understandable that the manufacturers prefer to maintain their existing
technology and aim to achieve full RoHS-compliance by developing thick film pastes freeof restricted substance, especially considering that the applicants seem to be close toachieving this goal, given that the renewal is only requested until August 2026.
Photolithography(COCIR 2022) stated that photolithography has not been demonstrated for ceramic wafers.
The limitations of photolithography include micro size variance and the need for absolutely
flat substrates/surfaces and the need for a cleanroom environment (free from air
particulates or chemical containments) for manufacturing. This makes photolithography not
viable as an alternative manufacturing process, as cleanroom environments are not inplace. When asked about “thick-film semiconductor chemical sensors” as discussed in
Tomchenko (2006) 90 as potential alternative to thick film technology based sensors,(COCIR 2024a) stated that although offering immense value for detecting various
chemicals, these face limitations that make them unsuitable for most biosensing
applications due to following reasons:−

Biocompatibility concerns: The materials used in thick-film semiconductor chemicalsensors, such as metal oxides or polymers, may not be compatible with biologicalenvironments. They can potentially denature proteins or generate side products(sensor interferants) or interact with biomolecules in undesired ways, affecting thesensor's performance.

−

Stability and regeneration challenges: Semiconductor chemical sensors can besusceptible to changes in temperature, humidity, and other environmental factors.
Additionally, regeneration of the sensing surface after exposure to biologicalsamples can be difficult, making them less reusable and potentially affecting theirlonger-term performance. On the other hand, screen printed thick film biologicalsensor, despite harsh biological environments, are able to maintain their stability
and accuracy, and perform reliably for up to a month with repeated use.

The consultants understand that photolithography may not be immediately applicable toceramic wafers, as the technology requires extremely flat surfaces for which, typically,
semiconductor materials such as silicon dioxide are processed using a number of chemical
and mechanical processes. The consultants could not identify demonstrated applicability ofsemiconductor chemical sensors to biological samples in a limited screening of scientific
literature.
Macro sensors(COCIR 2022) stated that it is known that among the main manufacturers of blood gas
systems, some do not use planar sensors, but instead they likely use macro sensors. When
asked, (COCIR 2023) confirmed that macro sensors are used to measure the same
analytes that are measured by the planar sensors that require the requested exemption.
The applicants also confirmed that macro sensors do not require the addition of lead andcadmium to function, unlike micro sensors. When further asked about technical advantagesof planar sensors over macro sensors for the application in blood gas systems, (COCIR2023) explained that a macro sensor in this context is a sensor that is used in large,
centralized laboratory systems that need to process a high volume of samples quickly andefficiently. Individual macro sensors that use ion-selective sensor technology can be
independently replaced. Ion-selective sensor technology is used for detection of analytes
such as sodium, potassium etc. Macro sensors also require regular maintenance by361

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

qualified lab personnel. (COCIR 2024a) further specified that the term ‘macro sensors’ inthis application refers to sensors in non-cartridge-based systems.
In comparison, planar sensors are typically cartridge-based sensor arrays. These analysers
use planar sensor-arrays instead of individual macro sensors, which make them
maintenance-free and easily replaceable. Cartridge based system are smaller and easierto transport rather than macro-sensor-based systems, making them suitable for both pointof-care and central laboratory settings. While the principle of detection between two
systems [macro sensor-based BGS and planar sensor-based BGS, the consultants] areion-selective sensor technology principles, the intrinsic design differences do not allow forinter-compatibility of the sensors.
According to (COCIR 2023) the biggest technical advantage of planar over macro sensors
is the ability to integrate sensors and reagents into a single consumable cartridge. This
makes it possible to develop smaller footprint cartridge-based detection systems. In addition
to the smaller footprint, planar detection systems may also offer lower manufacturing costs
and reduced overall cost of system ownership due to reduced maintenance.
When asked whether portability is in fact a requirement for BGS in the context of their use
in practice, (COCIR 2024a) confirmed that they are used in a number applications providing
critical point of care. Examples given include neonatal intensive care unit (NICU),
emergency rooms (ER), and operating theatres. They add that using alternatives to Bloodgas systems could lead to delays in patient results and treatment.
Other potential alternatives
The consultants inquired about other bonding technologies that could, potentially, beemployed to eliminate thick film paste from the planar sensors, such as soldering andultrasonic bonding. (COCIR 2024a) stated that the planar sensor array systems leverage
screen printing for creating the conductive patterns on ceramic substrates. Alternative
methods such as soldering and ultrasonic soldering are unsuitable due to the potential forcavitation issues. This phenomenon, triggered by the acoustic energy from the soldering
tools, relies on bubbles in the molten solder breaking apart and violently disrupting oxide
layers on both the solder and the metal being joined. While cavitation excels at cleaningcertain metals, it falls short when dealing with ceramics and glass. Their inherent oxide
composition renders them immune to such forceful disruptions, making them incompatible
with cavitation-based soldering techniques.
Other manufacturers of BGS
When asked to describe and name market-available alternative BGS suitable for point ofcare (POC) settings that do not rely on planar sensors, and whether these require RoHSrelevant substances to operate, (COCIR 2024b) stated that it is not possible to provide alist of companies. For the renewal application, the majority of the information has been
provided by one main manufacturer. Requested to compare market-available alternatives
in POC settings to the BGS in scope of this exemption renewal request (featuring planarsensors), (COCIR 2024b) reiterated on the technical differences and disadvantages of
instruments using macro sensors.
The consultants invited five manufacturers of blood gas systems to comment on whether
BGS in their portfolio required RoHS-relevant substances to function and whether they
could cover all the same applications (use cases, e.g. laboratory settings, point of caresettings) as the applicants’ BGS. Some of them engaged in correspondence initially, only

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one of them provided the requested information. This supplier of BGS stated that theirinstruments so use a conductive paste that contains lead in the glass frit.
Requested to comment on a specific example, the Abbott i-STAT 1 analyzer96, a handheld
BGS, and its potential to cover the same applications as BGS in scope of their exemption
renewal request, (COCIR 2024b) responded that the Abbott I-STAT system is a handheld
single use cartridge-based system and is used in a wide variety of settings including POC.
However, the product is single use only. For example, the Abbott I-STAT requires bi-yearlysoftware updates, has non-integrated quality control, and is unable to report certain
parameters (e.g., ionized magnesium, CO-oximetry, bilirubin). There are also someinstances where the analytical measuring interval is not as expansive as other devices.
According to (COCIR 2024b), another important feature of the cartridge-based devices
referenced in the exemption request is the use of a single cartridge to concurrently test
multiple analytes including blood gases, electrolytes, metabolites. The same sample is used
across the different types of analytes tested, so concurrent results of various analytes inquestion can be obtained. The iSTAT system has the capability to test a broad range ofanalytes, however, it requires the use of multiple cartridge types, each of which is a tailoredsubset menu and does not necessarily consist of the entire menu that some of the othercartridge-based devices for providing concurrent results using a single sample. The
throughput also provided by multiuse cartridge-based systems in high turnaround hospital
locations such as ERs wherein there are consecutive samples run within very short intervals
provides high efficiency and continuity for hospital workflows.
(COCIR 2024b) further outline that there would also be an impact to the provision ofhealthcare services as this exemption supports devices which are multi-use, with eachsystem supporting many thousands of tests and care provision for patients each year. If
only single use devices are permitted, not only would this have significant impact on theamount of waste generated, but also on the ability to undertake the number of tests required
to support patient care.
Replacing multiuse cartridge-based system with a handheld POCT blood gas device
presents a cost burden to healthcare providers with respect to high volume testing. Referto the excerpt table below with devices described by this exemption being hybrid analyses
and ones such as the Abbott I-STAT a handheld analyser.
(COCIR 2024b) included this excerpt table comparing annual costs for handheld and hybrid
POCT systems, which is reproduced in Table 18-9. The consultants note that economic
analysis is not part of their mandate, so the information is not taken into account to derivea recommendation.

96 Website of Abbott on the i-STAT 1: https://www.globalpointofcare.abbott/us/en/product-details/apoc/i-stat-system-us.html (accessed on 13 January 2024)

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Table 18-9: Cost comparison for handheld and hybrid point of care systems

Source: (COCIR 2024b)

The applicant was also requested to comment on the polyvinyl chloride (PVC)-based
cartridge-based sensor systems described in the context of exemption IV-41 / 41a 97.
(COCIR 2024a) stated that exemption IV-41 relates to lead as a thermal stabiliser in PVC,
lead in this exemption is used in a thick film paste which doesn’t involve PVC. As such
although the end applications may seem similar, the technical rationale for the use of lead(and cadmium) is very different.
When asked to describe any technical advantages of, (COCIR 2024b) replied that the only
way to outline technical differences between applications which previously used ex.41 andthe ones under this exemption renewal would be to undertake a direct comparison of
specific products. The products previously utilizing ex.41 are unknown to the manufacturers
involved in this exemption renewal request as they do not use this application. As such it
can only be stated that in general most products on the market offer unique technicalfunctionality to differentiate them from other products.
Exemption IV-41 expired on 31 March 2022, and exemption IV-41a on 31 December 2023.
The applicant of the last review of exemption 41 was requested to provide information onwhether their cartridge-based sensor systems no longer rely on any RoHS exemptions,

97 Study by Gensch et al. (2019), available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/RoHS_Pack14_final_report_amended_20190305.pdf

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however, no response was received. Consequently, there is remaining uncertainty as towhether alternative instruments that do not require RoHS-regulated substances areavailable or not. From the information made available, it is the consultants’ opinion that the
BGS that use the lead-containing planar sensors in scope of this exemption renewal request
can likely be replaced by other technologies, such as those featuring macro sensors instationary settings and devices like the i-STAT 1 in POC settings. However, the BGS infocus on this review do appear to have some technical advantages over other available
technologies, including the capacity to measure a larger number of analytes in parallel,potentially leading to faster results.

18.3.4. Environmental, health, safety, and socioeconomic impacts
The applicants did not provide public information on such impacts, besides stating that using
alternative to blood gas systems in scope of their renewal request could lead to delays inpatient results and treatment. More detailed information was provided in a confidential
submission, which cannot be reproduced here, nor be accounted for to form an opinion
regarding the requested renewal of this exemption.

18.3.5. Summary and conclusions
COCIR request the renewal of exemption IV-1(a) with the wording “lead and cadmium inthick film pastes in ion selective electrodes used for blood gas systems” for cat. 8 IVD until
August 2026. Following their mandate for this exemption, the consultants assessed whether
the result of the previous review of this exemption by (Deubzer et al. 2022) can be adopted
for cat. 8 IVD with reference to the application at hand.
The thick film paste used in planar sensors of blood gas systems would not be covered by
the exemption wording that was recommended by (Deubzer et al. 2022) after the last review
of exemption IV-1(a). The recommended wording, labelled exemption 1(a)(I), would only
cover lead in glass electrodes of three specific geometric shapes, as was requested by theapplicant at the time. However, the sensor technology in scope of the current exemption
renewal request is entirely different. It relies on planar sensors that are manufactured on
ceramic substrates in a screen-printing process. Planar sensors are small and are laid out
in arrays within cartridges that are swappable in the BGS instruments and that measure anumber of analytes in parallel using only a single, relatively small amount of blood sample.
The technology employs thick film paste to establish an electrical connection between thesensing elements and the substrate, as well as to instrument analysing the data. Both leadand cadmium are added to the thick film paste to lower its viscosity. Viscosity determines
the flow of the paste as well as the ability to print features to the required resolution, whichis critical to minimising the size of the sensors.
The applicants’ line of arguments for the renewal of the exemption covering their applicationis that although lead- and cadmium-free thick film pastes have been available, testing has
shown that their reliability is not ensured, resulting in defects and reduced lifetime of thesensors. Other variants of Pb- and Cd-free thick film pastes have become available more
recently and testing has been described to result in promising results. The applicants365

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therefore request a renewal not for the maximum validity period but until August 2026 tocomplete the qualification of the RoHS-compliant paste.
Alternative manufacturing and sensor technologies for BGS that do not require RoHSrelevant substances have been discussed. The applicant provided arguments todemonstrate that the alternative production processes are not suitable to produce the planarsensors in scope of this request. Regarding alternative BGS that do not rely on planarsensors, in the consultants’ view, the applicants have not unambiguously demonstrated thatthe BGS in scope of their renewal request cannot be replaced with lead-free systems. Morespecifically, during the review process it has not become entirely clear whether the size
reduction of instruments enabled by planar sensor-based sensor cartridges is a requirementin practice or whether they can be replaced by larger instruments (e.g., those featuring
macro sensors) in laboratory settings and handheld systems in point of care settings. The
applicants however have stated that their instruments can measure a higher number ofanalytes in parallel than some handheld systems, leading to potentially faster results.
Despite this remaining uncertainty, the consultants conclude that the use of lead andcadmium in the sensor technology in scope of this renewal request may not yet be entirely
avoidable, as the reliability of substitutes is not ensured. The applicants have requested arenewal of the exemption until August 2026. The consultants consider this timeframe
appropriate to conclude testing and qualification of alternatives that do not rely on RoHSrelevant substances until full RoHS compliance is achieved.
The consultants reflected on the possibility that the use of lead in this application may becovered by exemption 7(c)-I 98 of RoHS Annex III, however, came to the conclusion that it
would be more appropriate to include both cadmium and lead in the wording of exemption
IV-1(a), with a relatively short validity period until August 2026 as requested, to make it clearthat both lead and cadmium are no longer needed in this application after that date.

18.4.

Recommendation

The consultants recommend renewing the exemption. Substitution or elimination of leadand cadmium are scientifically and technically not yet practicable so that granting the
exemption would be in line with the requirements of Art. 5(1)(a).
The consultants conclude the requested validity period until August 2026 seems sufficient
to complete the testing of lead-free alternatives. The consultants therefore recommend
renewing the exemption as requested with the wording and scope specified in the below
table as IV-1(a)(I).

98 Wording of ex. 7(c)-I: “Electrical and electronic components containing lead in a glass or ceramic other thandielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound”

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No.

Exemption

Scope
and
applicability

IV-1(a)Lead and cadmium in ion selective electrodes
including glass of pH electrodes.

Expires on 21 July 2023

IV-1(a)(I)

Lead and cadmium in thick film pastes in ion
selective electrodes used for blood gas systems.

Applies to category 8 in vitro
diagnostic medical devices andexpires on-

IV-1(a)(II)

dates

of

31 August 2026

Lead in the stem glass of pH glass electrodes andion selective electrodes equipped with a pH glass
electrode with complex shape as follows:

Applies to category 9 including
industrial monitoring and control
instruments and expires on--

Micro type pH glass electrode21 July 2025

Composite electrode that has a spherical shapeor tube-shaped pH responsive glass membranewith a diameter of 4.0 mm or less and a referenceelectrode with a liquid junction at a position
vertically within 6.5 mm from the tip;-

Flat type pH glass electrodepH glass electrode with a flat pH response
membrane at the tip of a glass tube with adiameter of 6.0 mm or more;-

Needle type pH glass electrode

Composite electrode that has a conical pH
response membrane with a tip angle of 40⁰ or lessand with a diameter of 10 mm or more.

The consultants reflected on the possibility that the use of lead in this application may becovered by exemption 7(c)-I of RoHS Annex III, however, came to the conclusion that it
would be more appropriate to include both cadmium and lead in the wording of exemption
IV-1(a), with a relatively short validity period until August 2026 as requested, to make it clearthat both lead and cadmium are no longer needed in this application after that date. To
prevent overlapping scopes between this new exemption at hand and exemption 7(c)(I), thescope of this exemption should be excluded from the scope of the renewed exemption III7(c)(I).
The currently valid wording of exemption IV-1(a) was recommended for expiry by (Deubzer
et al. 2022) by 21 July 2023. This exemption would in principle cover the applicant’s
requested exemption, but the recommendation for its expiry in 2023 should be upheld sothat it can be superseded by the more specific exemptions IV-1(a)(I) and IV-1(a)(II).
Regarding the wording option B recommended by (Deubzer et al. 2022), which included atransition period for cadmium in ion selective electrodes including glass of pH electrodes toallow suppliers of such electrodes to transition to cadmium-free alternatives or to apply fora renewal, it does not seem to be needed as no such application was received.
Exemption IV-1(a)(II), also recommended by (Deubzer et al. 2022), may be upheld,
however, the consultants further recommend that the COM ensures sufficient time between
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the official publication of the COM’s decision and the expiry date of the exemption to allow
for the preparation and timely submission of renewal requests 18 months prior to the expiryof the exemption.
Applicants’ feedback on the recommendation(COCIR 2024c) confirmed to agree with the recommendation.

18.5.

References

COCIR (2022): RoHS Annex V Request for renewal of exemption IV-1a. RoHS Pack 27. COCIR(RoHS 29). Retrieved from https://rohs.biois.eu/COCIR-Renewal_Form_1a_IVD_AnnexIVFINAL.pdf.
COCIR (2023): Answers to questionnaire 1 (clarification questionnaire) sent by Emily Tyrwhitt
Jones, RINA, to Christian Clemm via e-mail. RoHS Pack 27. COCIR (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Ex_IV-1a_COCIR_Questionnaire-1_Clarification-AnswersFinal.pdf.
COCIR (2024a): Answers to questionnaire 2 sent by Emily Tyrwhitt Jones, RINA, to ChristianClemm via e-mail. RoHS Pack 27. COCIR (RoHS 29).
COCIR (2024b): Answers to questionnaire 3 sent by Emily Tyrwhitt Jones, RINA, to ChristianClemm via e-mail. RoHS Pack 27. COCIR (RoHS 29).
COCIR (2024c): Comments on recommendation exemption IV-1(b) sent by Emily Tyrwhitt Jones,
RINA, to Christian Clemm via e-mail. RoHS Pack 27. COCIR (RoHS 29).
Deubzer et al. (2022): Study to assess requests for renewal of 16 exemptions to Annex IV of
Directive 2011/65/EU. Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Amended Final Report. In cooperation with von Dr. Deubzer,
Otmar, Fraunhofer IZM und UNITAR, Saskia Huber, Jana Rückschloss, Fraunhofer IZM, UNITAR
Christian Clemm und Bio I. S. Shailendra Mudgal. Hg. v. Publications Office of the European
Union. European Commission (RoHS 26, Pack 21). Retrieved fromhttps://op.europa.eu/en/publication-detail/-/publication/f46d5d27-2d8d-11ed-975d-01aa75ed71a1,
Last updated 26.02.2024.
Goodman (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9. Final Report July
2006, amended 19 Sep 2006. ERA Report 2006-0383. In cooperation with von Paul Goodman,
ERA Technology Ltd. ERA Technology Ltd. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf.

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Exemption 1(b) of Annex IV: Pb in electrochemical
oxygen sensors
The below table shows the wording, scope and expiry dates of the exemption.
Table 19-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

IV-1(b)Lead anodes in electrochemical
oxygen sensors.

Applies to categories 8 and 9 and expires on-

21 July 2021 for category 8 other than invitro diagnostic medical devices (IVD) andfor category 9 other than industrial
monitoring and control instruments (IMCI);-

21 July 2023 for category 8 in vitro diagnostic
medical devices;-

21 July 2024 for category 9 industrial
monitoring and control instruments.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and Definitions
ATEX

ATmosphère EXplosible (English: explosive atmospheres), referring to
the ATEX Directive 2014/34/EU: Equipment and Protective Systems
intended for use in potentially Explosive Atmospheres

Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments

IVD

In-vitro diagnostic medical devices

MOCON

AMETEK MOCONNISTNational Institute of Standards and Technology

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ppb

Parts per billion

ppm

Parts per million

ppt

Parts per trillion

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive

19.1.

Background and technical information

Four stakeholders requested the renewal of exemption IV-1(b) for EEE of RoHS Annex I
category 9 industrial monitoring and control instrument (IMCI) as displayed in Table 19-2.
Table 19-2: Wording and scope of the requested renewal of exemption IV-1(b)Applicants andapplication dateRequested
Exemption

Requested
scope
applicability

and

dates

(Alphasense 2023a),
20 January 2023

Lead anodes incapillary oxygen
sensors

Applies to cat. 9 IMCI and expires onof- 21 January 2027 for general applications;- 21 July 2028 for ATEX rated products.

(MOCON 2022),
9 December 2022

Lead anodes inelectrochemical
Hersch cells foroxygen sensors formeasurement of
permeation

Expires on 21 January 2028 for cat. 9 IMCI.

(Dräger 2023a),
20 January 2023

Lead anodes inelectrochemical
oxygen sensors

Applies to cat. 9 IMCI and expires on:- 31 December 2025 for new instruments thatuse electrochemical oxygen sensors;- 21 July 2031 for oxygen sensors that arespare parts for instruments placed on themarket before 1 January 2026.

(Honeywell 2023a),
19 January 2023

Lead anodes inelectrochemical
oxygen sensors

Expires on 21 July 2031 for cat. 9 IMCI.

Alphasense’s exemption request is stated to be supported by The Council of Gas Detection
and Environmental Monitoring (CoGDEM), TROLEX, AFRISO, ANALOX, fatair, GAS
DATA, GDS Technologies, GEMLOG controls, GfG, KANE, AMETEK MOCON, QED,
Sensotran, and SEWERIN.
(CoGDEM 2023), a Trade Association representing the majority of oxygen sensor
manufacturers and gas detector manufacturers, including City Technology, Alphasense,
Scientific, Draeger, New Cosmos and Figaro, contributed a statement on the exemption for370

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leaded oxygen sensors for industrial gas safety. (Trolex 2023), a member of CoGDEM, also
contributed a supporting letter.
(COCIR 2023) made a contribution to the stakeholder consultation.

19.1.1. History of the exemption
Exemption 1(b) of Annex IV was not part of RoHS Directive 2002/95/EC (2003) (RoHS 1).
It was first evaluated by (Goodman 2006) and subsequently listed on Annex IV of RoHS
Directive 2011/65/EU (2011) (RoHS 2) when this was officially published in 2011.
Exemption 1(b) was first reviewed by (Deubzer et al. 2022). At the time, COCIR requesteda renewal of the exemption for RoHS Annex I EEE of category (cat.) 8 medical devices
other than in-vitro diagnostic medical devices (IVD) and JBCE requested a renewal forcat. 9 monitoring and control instruments including industrial monitoring and control
instruments (IMCI). Both applicants requested a renewal without changes to the exemption
wording.
(Deubzer et al. 2022) drew conclusions separately for both fields of application:−

In the medical sector (cat. 8), lead-free galvanic oxygen sensors have become
viable alternatives to sensors with lead anode and have made progress inpenetrating the market of medical devices that use such sensors. As substitution isstill an ongoing process, the consultants can follow the applicant’s request to renew
the exemption until the year 2025 in order to allow the transition to proceed, while
no existing, in-use medical equipment need to be retired prematurely due to an
abrupt lack of replacement sensors as consumables.

−

The use of oxygen sensors in monitoring and control instruments (cat. 9) is a morediverse field with a wider range of requirements compared to medical applications.
The two general types of oxygen measurements with monitoring and control
instruments are the measurement of dissolved oxygen in liquids and themeasurement of oxygen in gases. For dissolved oxygen measurements, leadanodes are still needed to measure concentrations below 30 ppb (parts per billion).
For gaseous oxygen measurements, lead anodes are still needed to achieve a
response time below 3 seconds.

(Deubzer et al. 2022) recommended to split the exemption to reflect the scientific andtechnical progress in both separate fields as displayed in Table 19-3.

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Table 19-3: Exemption wording and scope recommended by (Deubzer et al. 2022)

Source: (Deubzer et al. 2022)

At the time of the current review of exemption IV-1(b), the COM have not yet officiallypublished their decision as to the adoption of the above recommendation. The COM wish
the consultants to assess in this current review round whether there are any substantial
reasons in line with Art. 5(1)(a) against the adoption of the above recommendation for EEE
of categories 8, 9 and 11.

19.1.2. Focus of the review of this renewal request
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). The applicants therefore
applied for the renewal of the current exemption 1(b) for cat. 9 IMCI since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE. The exemption thus becamedue for review even though the recommendation for the renewal of exemption 1(b) of(Deubzer et al. 2022) included cat. 9 IMCI.
In the light of this situation, the COM tasked the consultants to assess in their review of the
exemption renewal request at hand whether and how far the recommendation of (Deubzer
et al. 2022) can be adopted to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of theprevious review by (Deubzer et al. 2022) is not intended. The consultants will rely on thecritical review conducted by (Deubzer et al. 2022) and on the resulting conclusions andrecommendation unless the renewal request or stakeholder contributions give reasons toreassess the state of science and technology.

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19.1.3. Summary of the requested exemption
The exemption request summaries provided by the four applicants are reproduced below.
Alphasense wrote: “Lead is used as the anode in capillary oxygen sensors which are used
to measure oxygen gas in the range of 0-30% in fixed installations, personal monitoring
devices and permeation measurements, such that an alarm is triggered if the oxygen levels
are above or below a set threshold. Capillary sensors have minimal response to pressure,temperature and humidity, while having a short warm-up time and are self-powered. Other
sensors, such as amperometric type sensors can be lead-free but are not able to offer thesetechnical characteristics and are susceptible to high carbon monoxide (CO) and carbon
dioxide (CO2) concentrations and cannot be used in the absence of oxygen. Alphasense
and other sensor manufacturers have carried out research into substitute metals and none
are drop-in replacements as outlined above. More research is needed develop alternative
sensors that offer suitable technical performance, after which the design and validation ofanalyser instruments including performance certification can be undertaken. Depending on
the end use in question the level of redesign and testing will vary, with an estimatedtimeframe of at least 4 years for general applications and at least another 18-months
subsequent to this for ATEX rated products.”
MOCON wrote: “Lead is used as the anode of a Hersch cell, electrochemical sensor which
is used to measure the absolute oxygen permeation in industrial monitoring and control
devices. Specifically, Hersch cells are used in the production of pharmaceutical products,
medical applications such as wound dressings, assessment of the integrity of foodpackaging and solar panel lifespan calculations and improvements. Hersch cells can detect
oxygen in the range of 200 ppt (parts per trillion) to 70 ppm (parts per million) and is anabsolute method of measurement (Coulometric) which removes the need to calibrate thesensor (which would be impossible to undertake at the extremely low levels of detection it
undertakes). Alternative lead-free technologies do not offer the same level of detection
range as they require calibration and rely on membranes which limit the sensitivity of thesensor. Alternative lead-free anodes are currently being trialled with some anode/electrolyte combinations showing initial indications that suitable performance may beachievable. Additional testing of critical performance, followed by reliability andproductionisation testing needs to be undertaken to determine if a lead-free solution canoffer the required technical performance. As such, although an alternative lead-free solution
is being actively sought, it is not yet known if any potential alternative is a viable technicalsolution and additional time is required to determine this.”Dräger wrote: “This exemption is necessary to allow the use of electrochemical oxygen
sensors to measure oxygen concentration in industrial applications. This primarily includes
applications in inerting processes, i.e., when organic vapours or gases occur simultaneouslywith the oxygen in atmospheres for monitoring the lower explosion limit of industrial
processes. Lead-containing organic capsules are intrinsically safe here, as they cannot act
as a source of ignition, like potential lead-free sensors with electrodes made of platinum
black. The latter generate their working potential via a potentiostat circuit and not via anatural potential gradient between the lead and the gold of the working electrode, as is thecase with galvanic oxygen sensors. A shift of the reference potential due to penetratinggases from the sensor environment leads here to a failure of the sensor.”
Honeywell wrote: “Honeywell is submitting this exemption renewal request for lead inoxygen sensors because the recent Pack 21 review did not consider the types of sensor
and end-uses that are described here. Oxygen concentrations in gases can be measured
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using a variety of methods but each has advantages and disadvantages. For some enduses, such as small portable gas monitors and instruments that can operate in ATEX
environments, only instruments with galvanic sensors are suitable and usually only leadanode sensors can be used. One of the advantages of lead anode sensors are that they do
not consume electricity so small battery powered portable instruments can be used forwhole working shifts. Also, the electrical characteristics of lead anode sensors are different
to all other types of oxygen sensors, so alternative types cannot be used as drop-in
replacements in existing instrument designs. Research has been carried out with potential
substitute anode materials, but all have been found to have disadvantages, the main one
being that lead is the only suitable anode metal that does not self-corrode or passivate
under any conditions inside the sensor. Research into substitute sensor/instrument options
is being carried out by Honeywell, but due to the need for approvals for many of the enduses, this will take many years to complete.”
Summary of the submitted supporting information
The supporting statement submitted by (CoGDEM 2023) highlights the advantages leaded
galvanic oxygen sensors have over both alternative anode materials (Zn, Bi, W, etc.) andpotentiostatic (3-electrode) sensors: they have significantly lower and very stable zero(baseline) currents, are simple to implement and importantly for the gas safety industry,
have decades of field use where they have proven to be reliable and have saved lives; theirsimpler construction in comparison to potentiostatic sensors has been a main reason forthis reliability. Regarding substitution and elimination of lead, CoGDEM state that the market
is making progress towards viable lead-free alternatives to lead based oxygen sensors forindustrial applications but without further detailed technical analysis it is likely thatbusinesses are going to suffer and market acceptance/usability of detectors is going to becompromised if the exemption is lifted as planned in 2025. A further seven-year exemption
is requested to ensure continuing best safe practice in the gas safety industry.
As an active Council of Gas Detection and Environmental Monitoring (COGDEM) member,(Trolex 2023) supports the proposal to extend the permissible use of capillary lead oxygen
sensors for the next 4 years or more. Where explosive atmosphere (ATEX) applications areconcerned, Trolex would also recommend that a further increase on the extension isconsidered due to the importance of the proven detection capabilities of capillary lead
oxygen sensors, with yet no suitable alternative, and the lengthy time implications on
modifying, recertifying and performance testing new equipment.
Summary of contributions to the stakeholder consultation(COCIR 2023), the European Association of the radiological, radiotherapy and Healthcare
IT Industry noted that the proposed wording for 1(b)(I) does not seem to match the findingsof the original assessment for category 8. COCIR suggest that the exemption wording is
supposed to cover sensors that are used as consumables or sold as consumables for
medical devices that are already installed or will be installed before 2024. COCIR note thatthe recommended exemption wording, however, seems to suggest that it only applies tosensors that were consumables provided with the equipment when it was placed on themarket but not to additional spare sensors that will be used as consumables afterwards.
To avoid confusion of wrong interpretations COCIR therefore suggest the following change
to the recommended exemption wording:374

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Recommended wording for ex. IV-1(b)(I): Lead anodes in electrochemical sensors
that measure oxygen concentrations of inhaled and/or exhaled air for patients andthat are consumables in medical devices put on the market before 26 May 2024.

−

COCIR’s recommended wording: Lead anodes in electrochemical sensors thatmeasure oxygen concentrations of inhaled and/or exhaled air for patients and thatare intended to be used as consumables in medical devices put on the market before
26 May 2024.

19.1.4. Technical description of the exemption and use of the restricted
substance
Types of EEE for which the exemption renewal request is relevant(Alphasense 2023a) request the renewal for capillary sensors in industrial monitoring andcontrol devices for the electrochemical measurement of oxygen concentrations in whichlead metal is used as anode material. The sensors are used within gas detection devices
as a consumable part, with devices typically having a lifetime of about 8-10 years, with somedevices having a lifetime of decades. The sensors are also used as spare parts for
instruments already placed on the market as on average the sensor needs to be replaced
every two years. (Alphasense 2023a) indicate the following applications for capillary oxygen
sensors:-

Portable instruments that are either mains or battery powered for monitoring healthand safety-

Fixed installations for monitoring health and safety-

Automotive exhaust monitoring (portable and fixed instruments)-

Boiler flue monitoring (portable and fixed instruments)-

Biogas monitoring in anaerobic digestion plants (portable and fixed instruments)-

Permeation measurements of packaging of food and pharmaceutical packing (fixed
instruments)(MOCON 2022) request the renewal of this exemption for Hersch oxygen sensors formeasurement of permeation in industrial monitoring and control devices used for theabsolute oxygen permeation measurement of film, membranes, and packaging. MOCON
supply a number of different devices using Hersch cells to undertake permeability testing,with different models offering different technical characteristics, such as package testingunder environmental conditions, film testing in standard ranges and conditions, highsensitivity film testing and high throughput film testing, with between 1 to 4 test cartridges
containing Hersch cells per device. To the best of our knowledge MOCON is currently the
only supplier of lead based Hersch sensors for the global market. Further, (MOCON 2022)
note that Hersch cells support a number of industries requiring high-sensitivity oxygen
measurement, the following are indicative examples:−

Manufacture of certain pharmaceutical products which are sensitive to extremely
low levels of oxygen

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Integrity of food packaging design- for example testing the permeation throughpackaging barrier material to ensure it is below 0.001 cc/m2 ∙day (0.36 ppb v/v) withan upper range of 200 cc/m2 ∙day (72 ppm v/v).

−

Quantifying oxygen breathability for medical wound dressings to help minimise
infections−

Lifespan of solar panels, which require a high oxygen barrier to ensure component
integrity and in order to prolong the lifetime of the panels. Long-lasting Solar Panels
are necessary to generate “green” energy; which results in benefits for theenvironment.

(Dräger 2023a) request the renewal of this exemption for sensors for measuring oxygen inindustrial processes, such as inerting or in helium atmospheres. The concentration ofoxygen in air needs to be monitored to ensure that they are no highly flammable or evenspontaneously combustible atmosphere conditions. Oxygen concentrations need to beaccurately monitored if an atmosphere highly flammable gases or vapors, such ashydrocarbons, alcohols or hydrogen. (Dräger 2024a) specified their sensors are used tomonitor contaminated ambient atmospheres in the sense of personal occupational safety
or explosion protection in atmospheres with flammable organic vapors. (Dräger 2024a) also
state that they have not used lead-containing oxygen sensors in portable gas detectors for
decades, indicating they are rather operated in stationary gas measuring transmitters.
Dräger also describe medical applications of their oxygen sensors, but as this exemption
request only pertains to industrial monitoring and control instruments of category 9, thesedescriptions are omitted here.
(Honeywell 2023a) request the renewal of this exemption for oxygen gas concentration
analysers in industrial monitoring and control devices. (Honeywell 2023b) added that theuse of such devices are in both fixed and mobile applications, and end-uses include:−

Water treatment works, paper mills, farming−

Food packaging−

Refining, bio-gas monitoring, boiler flue/emissions analysis−

Ships and military applications such as in submarines and for inspection of fuelstorage tanks−

Semiconductor and photocell manufacture−

For working in confined spaces, such as tunnels, sewers, tanks, etc.

−

Building and construction sites, such as in tunnels and trenches, in mines−

Commercial buildings, medical and laboratories, such as boiler rooms, cryogenic
zones such as liquid nitrogen storage.

−

SCUBA diving gas analysis

Function of the RoHS-regulated substance used
Capillary oxygen sensors

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(Alphasense 2023a) describe that capillary sensor are electrochemical sensors with twoelectrodes; a lead anode and an inert cathode which are immersed in an alkaline electrolyte.
The anode and cathode reactions are:
Cathode: O2 + H2O + 4e- → OHAnode: 2Pb + 4OH- → 2PbO+ 2H2O +4eThe electrochemical reaction generates an electrical current which flows through the cellwhich is proportional to the amount of oxygen entering the sensor in accordance with
Faraday’s Law. The current is measured by a load resistor which is between the cathodeand anode which measures the resulting voltage drop.
(Alphasense 2023a) describe that capillary sensors measure oxygen in the range of 0-30%
in fixed installations and personal monitoring devices, such that an alarm is triggered if theoxygen levels are above or below a set threshold. (Alphasense 2023a) explain that unlike
other sensor designs which use a membrane which the oxygen must permeate through,capillary oxygen barrier uses a small hole (<200 µm in diameter) such that it can be detectedby the electrodes. The electrolyte used in capillary sensors is potassium acetate, and leadanode in a wool form. Capillary sensors are also used in permeation measurements operate
under the same principle as the capillary sensors described above, with the capillary holelarger in diameter to allow the measurement to levels of oxygen such as 20 ppb. The larger
hole size allows for a larger amount of signal to be gathered and therefore a lower level ofdetection is possible. The only other design difference from the other capillary sensor types
is a metal housing to limit oxygen permeation through the housing.
Figure 19-1: Schematic of a capillary sensor

Source: (Alphasense 2023a)

According to (Alphasense 2023a), there are several properties that are important to capillary
sensors:-

Able to measure oxygen within the range of 0-30%-

Sensor output of 100µA in ambient conditions which limits the transient sensor
response when undergoing pressure changes during which time the sensor cannot
be used in. For example, a sensor output of 20 µA would take that much longer tostabilise after pressure disturbances than a 100 µA output.

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Operating temperature range of -30 to +50oC-

Low output dependence with temperature-

Minimal response to pressure changes in the ranges of 80 – 120 kPa-

Operable time of over two years before lead fuel is exhausted (for the major sensor
types)-

A warmup time of <2 mins for portable instruments-

High surface area of the electrode to ensure a suitable sensor lifetime-

Self-powered systems, without the need for external power sources, allowing
detection to be undertaken within seconds and start up times of a few minutes-

Mechanical stability of the device such that it can be dropped and still function as
intended-Some applications, such as automotive, biogas and boiler flue exhaust monitoring,
there are additional requirements for carbon monoxide and carbon dioxide poison
resistance-Some applications are limited as to the sensor size the design can accommodate,for example portable devices such as personal monitoring devices would soon
become unwieldly if the senor was larger.

-

Some end uses are also operable within explosive atmospheres so need to becompliant to the requirements of the ATEX Directives(Alphasense 2023a) note that for capillary sensors used for oxygen transmission rate
through packaging or other barrier layers, for applications such food and pharmaceuticals,
it is essential that the sensor is able to measure to very low levels of detection (20 ppb) andable to operate at 0% oxygen concentrations.
On temperature dependence on capillary oxygen sensors, (Alphasense 2023a) provided afigure that is reproduced in Figure 19-2. The data demonstrate that although temperaturedependence has some effect on the device, the impact is limited as the rate of the gas
diffusion through the capillary is only weakly temperature dependent. This change is due tothe change is gas viscosity with temperature. However, the dependence is minimal and thedependence on temperature is highly repeatable. The diagram shows the temperaturedependence for capillary oxygen sensors against the output from the sensors as apercentage of the output at 20oC, showing high repeatability between sensors tested.
(Alphasense 2023a) emphasize that temperature dependence, including to especially cold
temperatures is important as industrial capillary oxygen sensors may be used in portablesafety oxygen monitors which operate outdoors or in fixed installations at industrial facilities
that may not be heated above the surrounding environments, such as mining operations oroil drilling riggs.

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Figure 19-2: Temperature dependence of capillary oxygen sensors

Source: (Alphasense 2023a)

On the pressure dependence of capillary oxygen sensors, (Alphasense 2023a) claim thatthe amount of oxygen available for the reduction at the cathode depends on the oxygen
concentration in the air, and not the oxygen partial pressure. As such the sensor output isnearly independent of ambient pressure. These types of devices are used in applications
where the steady state pressure undergoes substantial changes, for example an oxygen
monitor in a deep mine shaft taken to the surface. The capillary sensors have a temporarytransient pressure response which the oxygen monitors are designed to ignore. On thecontrary, designs which rely upon partial pressure by using membranes, have an output
which is always proportional to the partial pressure and therefore cannot be used in theseapplications. Figure 19-3 shows the capillary sensor response when subject to a 10 kPa
instantaneous positive pressure step.
Figure 19-3: Capillary sensor pressure response

Source: (Alphasense 2023a)(Honeywell 2023a) also request the renewal of this exemption for capillary cells, but referto the descriptions provided by Alphasense, reproduced above. (Honeywell 2023a) add that
one limitation of capillary sensors is that if the concentration of acidic gases such as SO2 or
CO2 concentrations in the gases being analysed are high, they can affect the accuracy ofmeasurements (it increases the oxygen signal by about 0.3% per 1% CO2). CO2 however379

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does not pass easily through the diffusion membrane and so membrane cells are much lessaffected by high CO2 (or SO2) concentrations.
Hersch cells(MOCON 2022) explain that Hersch cells are electrochemical sensors with two electrodes;
a lead anode and an inert cathode which are immersed in an alkaline electrolyte. The
reactions are the same as described by Alphasense for capillary oxygen sensors. (MOCON
2022) provided a schematic of a test sampling that is reproduced in Figure 19-4.
Figure 19-4: Schematic of test sampling of a Hersch cell

Source: (MOCON 2022)

According to (MOCON 2022), there are several properties that are important in Hersch cells:•

Must follow Faraday’s Law•

Oxygen efficiency measurement > 95%•

Flat discharge curve (accuracy) to enable the measurement of oxygen concentration
below 100 ppm, for example Hersch cells can detect oxygen in the range of 200ppt
to 70 ppm•

Absolute method of measurement (Coulometric) which removes the need tocalibrate the sensor which would be impossible to undertake at the extremely low
levels of detection it undertakes.

•

High Energy Density which results in a sensor with a sensor life of at least a year
for this oxygen permeation application at the varying ranges of detection.

•

Inherent method of maintaining electrolyte health over years allowing an average
sensor life of a year for most models, but for some this can be up to 4 years•

Temperature independent and able to operate in most sensor designs between 1040⁰C•

Sensor response (fast): < 8 minutes to 99 % full reading•

Compatible with nitrogen, hydrogen, water vapor

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No corrosion of the anode when in contact with the electrolyte or secondary chemical
reactions that negatively impact the lead reaction•

No chemical effects that cause excessive internal pressurisations of the sensor•

Size and format similar to current sensor•

Specific to Oxygen: Limited cross sensitivity to ensure that other reactions are notundertaken, and the sensor has high sensitivity•

Not affected by moisture, pressure changes or flow dependent.

(MOCON 2022)highlight that the sensitivity of Hersch cells is critical to the end users it
serves as 89% of permeation measurements are made below 70ppm, with 60% of
measurements below 2ppm and 10% below 20ppb. Further, coulometric measurement
allows for a calibration-free methodology which is critical as there are no calibration
standards available at the sensitivity range in which these devices operate. For example,
the lowest level of NIST [National Institute of Standards and Technology, the consultants]
calibration gas is 1 Mole% oxygen (10,000 ppm) and the best “Certified” gas is about 10
ppm (± 20%) which is still 10,000 times higher than where the application requires accurate
measurements.
Permeable membrane / partial pressure sensors(Dräger 2023a) describe permeable membrane oxygen sensors, in which oxygen ismeasured by small electrochemical sensors that contain lead anodes. These are connected
electrically to much larger analyser instruments that calculate and display the oxygen
concentration. The sensors are connected to the instrument using electrical cables. The
concentration of oxygen in air needs to be monitored to ensure that they are no highly
flammable or even spontaneously combustible atmosphere conditions. Oxygen
concentrations need to be accurately monitored if an atmosphere highly flammable gases
or vapors, such as hydrocarbons, alcohols or hydrogen. Lead (Pb) is used as the anode in
the oxygen (O2) sensor. During the operation of the sensor, oxygen from the gas being
analysed permeates through the membrane of the sensor and is electrochemically reduced
at the cathode of the sensor. The Pb anode of the sensor is oxidised to PbO / PbO 2. The
electrode reactions are the same as described by (Alphasense 2023a) for capillary oxygen
sensors. The electrochemical reaction generates an electrical current which flows throughthe cell (with an additional load resistor) which is proportional to the partial pressure of O 2
in the analysed gas. The voltage across the load resistor is proportional to the current andis measured to calculate the concentration of O2.
The output current of the electrochemical sensor is therefore dependent on the oxygen
concentration in the air that enters the sensor. The rate of access of airoxygen into thesensor is controlled by the design of the sensor, in particular by using diffusion barriers
which can be narrow capillaries or a porous layer. The sensor is designed so that the current
output is proportional to the oxygen concentration. The diffusion barrier is used to limit theamount of air that passes through the sensor so that only a small amount of oxygen reaches
the lead anode so that a proportionally small amount of lead is consumed, ensuring the
maximum lifetime of the product. With the increasing conversion of lead to lead oxide, thevoltage over the measurement resistor slowly decreases during use. To ensure the correct
calculation of the O2 concentration, the instrument and sensor is calibrated with air every
24 hours.

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When the voltage with air drops below 8.9 mV (under normal conditions) the instrument
detects that the sensor is consumed and informs the user to replace the sensor with a newone. Under normal conditions the sensor can be used for 1 to 2 years. Ambient temperature
also affects the current output of the sensor and so compensation circuits need to be
included either within the sensor or in the current measurement instrument. This isstraightforward with lead-based sensors, but is also a critical variable with other types of
sensor. Accurate O2-measurement in industrial processes provide explosions by enabling
the user to lower the O2 content of the atmosphere.
One of the main advantages of lead in electrochemical oxygen sensors is that it is notaffected by the majority of other gases used in industrial applications, such as inertising.
The few exceptions to this are acid gases and CO2 will react with the electrolyte (potassiumhydroxide or potassium acetate are usually used) and users are warned that this should be
minimised, but combustible gases have only a minimal effect on this type of sensor.
(Honeywell 2023a) also request the renewal of this exemption for membrane diffusion cells/ partial pressure oxygen cells, with similar descriptions as above. They provide illustrations
from datasheets for several Honeywell lead-anode oxygen sensors, reproduced in Figure19-5. On the left, they show the AO2 membrane cell, intended for the analysis of vehicle
exhausts, and on the right, they show the 7OX membrane cell, a compact type used foranalysis of oxygen in the 0 to 25 % range.
Figure 19-5: Examples of Honeywell lead-anode oxygen sensors(Honeywell 2023a) explain that Sensors are designed for specific oxygen concentration
ranges and use outside of these can damage them and severely shorten their lifetime. For
example, Honeywell sensors are designed for: 0 to 2ppm, for 0% to 25% and others for 0%
to 100%. Further, sensors are designed for specific end-uses such as SCUBA diving andvehicle exhaust analysers. Each design takes into account the environment in which they
will be used and the presence of other gases that will be present, CO2, CO, etc in vehicle
exhausts and diving gases can contain helium. These analyser instruments are certified byapproval bodies for these specific uses. For example, vehicle exhaust gas analysers must
be approved by New European Driving Cycle (NEDC) and the Bureau of Automotive
Inspection (BAR).
(Honeywell 2023a) list the following examples of locations where oxygen analysers areused, many of which are safety critical applications:−

Water treatment works

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Food packaging−

Refining−

Bio-gas monitoring−

Boiler flue/Emissions analysis−

In ships−

Military such as in submarines and for inspection of fuel storage tanks−

Paper mills−

Semiconductor and photocell manufacture−

For working in confined spaces, such as tunnels, sewers, tanks, etc.

−

Building and construction sites, such as in tunnels and trenches−

In mines−

Commercial buildings, medical and laboratories, such as boiler rooms, cryogenic
zones such as liquid nitrogen storage.

−

Farming−

SCUBA diving gas analysis(Honeywell 2023a) add that many of the sensor and analysers are designed to be used inindustrial areas where potentially explosive gases or liquids may occur such as in fuel tanks,
mines, etc., and so only ATEX approved equipment is permitted. The sensors are also usedboth in fixed positions as well as in some applications as mobile sensors. Sensors that areused for mobile applications need to be very small and lightweight as they are used in smallsize lightweight portable oxygen analysers that are worn by users. These analysers alert
users if oxygen levels in the air in which they are working drop to unsafe levels.
(Honeywell 2023a) point out that new analyser instruments are sold with oxygen sensors
already installed and many designs of instrument also analyse other gases. When the leadanode in an oxygen sensor is consumed in an analyser instrument, the analyser will nolonger function. The sensor therefore needs to be replaced by a new but identical oxygen
sensor as a replacement spare part. These replacements will need to be readily available
throughout the lifetime of the analysers which can be more than 10 years.
Characteristics and functions of the RoHS-regulated substanceAccording to (Alphasense 2023a), lead in electrochemical sensors is ideal as it does not
self-corrode in the absence of oxygen, so does not produce a current without oxygen
present. However, lead reacts rapidly when in contact with oxygen, giving a fast responsetime to the sensor with devices having a t90 value between 5 and 10 seconds. Capillarylead sensors are able to operate in the absence of oxygen for prolonged periods of time as
they do not require reference electrodes. The sensors based on lead do not require power
to operate, unlike other sensor types, which allows the sensor as a consumable part to havea relatively long lifetime, typically for 1 to 3 years which is important for sensors which are
in hard-to-reach areas where replacement opportunities are limited.

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(MOCON 2022) also note that lead does not self-corrode and reacts rapidly. Furthermore,they add that the solubility of lead metal in potassium hydroxide electrolyte is exceptionallylow, therefore does not migrate to the sensing electrode, precipitate, or block the sensing
electrode sights. This gives the Hersch cell extraordinarily long, stable sensitivity life, in theorder of at least a year and up to 4 years for some designs. The lead within the Hersch Cell
allows for the “Coulometric” analysis and follows Faraday’s Law at ppt levels. This removes
the need to calibrate at these extremely low levels, while providing a high degree ofsensitivity. Lead anodes in contact with the potassium hydroxide electrolyte do not create
any secondary reactions, as such it does not affect the primary reaction which converts theoxygen concentration to a specific current measurement. Gases such as hydrogen are notgenerated as part of the reaction when using lead, which would otherwise build up pressureand damage the sensor in the bypass state. Energy Density of the lead anode in conjunction
with the potassium hydroxide electrolyte are high which gives acceptable sensor life for thisoxygen permeation application at the varying ranges of detection.
(Dräger 2023a) highlight that the following characteristics are essential:•

Fast response. For example, < 15 seconds to respond to a change from air to 100 %oxygen•High sensitivity to small oxygen concentration changes•

High accuracy•

Long lifetime (at least 1 year, ideally 2 years)•

Measure oxygen concentration range of 0 % to 100 %•Must be usable and accurate in the presence of commonly used combustible gases
such as hydrogen or organic vapors•

Usable at 0 % to 99 % non-condensing humidity•

Accuracy should not be affected by typical CO2 concentrations in inertisingatmospheres(Honeywell 2023a) list the required characteristics for lead-anode electrochemical oxygen
sensors as follows:−

Capable of continuous analysis of oxygen in the concentration range 0% to 100%
oxygen−Lifetime of two years when used for recommended applications−

Must not passivate or self-corrode−

Capillary sensors are close to linear response for sensor’s output signal versus
oxygen concentration. Response is S = K loge 1/ (1-C) (S = output signal, C =concentration and K = constant). Partial pressure membrane sensors are inherently
linear • Sensor output must be stable throughout its lifetime−

A warmup time of <2 mins for portable and fixed instruments−

Can operate in the range -20°C to +45°C

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Effects of temperature and pressure of lead anode sensors are predictable so thatthese can be compensated for−

Sensor must give a sudden and large drop in output signal when the lead anodehas been consumed−

The sensor needs to be small, especially for portable air monitoring applications,typically less than 30mm wide and 25mm high. Honeywell’s 4-series sensors are
typically about 20 mm diameter, 17 mm high and weigh < 16 grams−

Power consumption of sensors for use in portable monitoring instruments needs tobe sufficiently low (ideally zero) so that the analyser can be powered by small
lightweight batteries, ideally rechargeable types, for at least one working shift of 8
– 10 hours.

−

Effects of other gases on output readings should be as follows: Methane (100%):
0%; Hydrocarbons (100%): 0%; Hydrogen 100%: <-2%; Carbon monoxide 20%: <0.5%; Carbon dioxide (1%): 0.3%−

Mechanical stability of the device such that it can be dropped and still function as
intendedAccording to (Honeywell 2023a), users will choose an oxygen analyser instrument on thebasis of the following characteristics:−

Accuracy within the range of concentrations required−

Resolution by the readout of the instrument−

Limited interference with other gases also experienced in the products operating
environment. This is mainly affected by the type of sensor chosen−

Size and weight. Important for portable analysers−

Short warm-up time after being switched off for 24 hours.

−

Response time is the time taken to give an accurate reading (usually 90 or 95% of
the actual concentration). In safety critical applications, this must be short.

−

Limited drift which is a measure of instrument stability over time. Drift can be causedby changes in the sensor or to the instrument’s electronics−

Operating time for battery powered instruments (this is maximised as lead sensors
do not consume power)−

Certification is required for several end-uses including diving, vehicle exhaustemissions analysis and ATEX environments−

If used as a personal monitor, it must be small and unobtrusive and not impair thewearer’s work function. They are usually worn continuously for the working shift of
8 hours or more so batteries must last much longer than this.

(Honeywell 2023a) claim that analysers with lead in electrochemical sensors are ideal as
the lead metal does not self-corrode in the absence of oxygen, so does not produce acurrent without oxygen being present. However, lead reacts rapidly when in contact withoxygen, giving a fast response time to the sensor. The sensors based on lead do not require385

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

power to operate, unlike other sensor types. The sensor is a consumable part of theanalyser with a relatively long lifetime, typically for 1 to 2 years. This is important for sensors
which are in hard-to-reach areas where replacement opportunities are limited.

19.1.5. Amount(s) of restricted substance(s) used under the exemption(Alphasense 2023a) provide the assumption that 10 g of lead is used per sensor, which
deemed as an average amount. Based on estimates from The Council of Gas Detection
and Environmental Monitoring (CoGDEM), with some assistance from its members,(Alphasense 2023a) indicate that an estimated 5 tonnes lead is placed on the EU market
per annum. This value is calculated for the O2A2 format which consists mostly of sensors
sold into the industrial safety and emissions monitoring markets but is not limited to capillary
sensors only.
(MOCON 2022) state that 4.075 kg of lead will enter the EU annually, based on confidential
information submitted for the review. They add that end-of-life Hersch cell sensors are
returned to the original manufacturer in the United States of America for recycling.
(Dräger 2023a) indicate that approximately 8 to 13.5 kg lead enter the EU market annually
through their applications. This is based on 9 to 0 grams of lead contained in each sensor
cell, with estimated sales in the EU for industrial applications to be about 1,000 to 1,500
sensors per year. They add that Dräger has established a take-back system for used
sensors and aims to receive up to 100% back from the market. The sensors are recycled
for materials recovery.
(Honeywell 2023a) refer to the same data from CoGDEM as does Alphasense. With regards
to end-of-life, they add that customer disposes of used sensors according to local waste
requirements and they are not returned to Honeywell.

19.2.

Justification of the requested exemption

19.2.1. Substitution and Elimination of the restricted substance
Substitution
According to (Alphasense 2023a), research has been carried out and published withalternative anode metals and with various acid and alkali electrolytes. Metals that have been
investigated include antimony, bismuth, copper, tin and its alloys, zinc and aluminium. Citing
Cobianu et al. (2021)99, the applicants explain that the more reactive metals such as tin,
zinc and aluminium are unsuitable as they are thermodynamically unstable in suitableelectrolytes. Electrolytes such as potassium hydroxide and other alkali solutions, acidic
solutions such as phosphoric acid and caesium carbonate solution (mildly alkali) have been
investigated.

99

C. Cobianu, B. Serban, V. Avramescu, B. Hobbs, K. Pratt and M. Willett, "Lead-free galvanic
oxygen sensors — A conceptual approach," CAS 2012 (International Semiconductor
Conference), Sinaia, Romania, 2012, pp. 161-164, doi: 10.1109/SMICND.2012.6400667.

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When a reactive metal anode is combined with an inert cathode, the two different materials
generate a galvanic couple which creates a small voltage with the electrode potential of theanode such that they self-corrode, generating a current and generate hydrogen. This
generated current between anode and cathode gives a false and incorrect oxygen
concentration.
Despite this, limited number of commercial galvanic lead-free oxygen sensors are available,
which unlike some other methods is suitable for portable and mobile analysis andmeasuring instruments. However, their technical performance is different than those
covered by this exemption, as outlined in Table 19-4.
Table 19-4: Comparison of lead-containing and lead-free partial pressure galvanic
oxygen sensors
SensorCurrent output

Operatingtemperature

Environmental dependence

Leadcontaining
capillary
sensor

100 µA in ambientconditions- 30° to + 50oC

Minimal temperaturedependence

ITG sensor100(using a barriersystem)Not listed

0° to 50oC

Pressure, temperature, andhumidity dependence101

HoneywellEnvitec102

7-13 µA in ambientconditions

0° to 50oC

Pressure, temperature, andhumidity dependence

Figaro103

10-15mV

5° to 40oC

Comparatively more
affected by pressure andtemperature than a capillarylead oxygen sensor

Source: (Alphasense 2023a)

Further, (Alphasense 2023a) explain that research with less reactive metals such as copper,
bismuth and antimony has also been reported, but no commercial products have beendeveloped. The reason why these metals are not used in commercial sensors could be thatthey can form thin oxide coatings (e.g. during storage before use) which may act as a barrier
to further oxidation and so hinder or prevent further electrochemical reaction. Lead may be
the optimal anode choice in electrochemical sensors because it does not self-corrode in theabsence of oxygen (such as aluminium and zinc) but it responds rapidly when in contact
with oxygen, unlike copper, which reacts and then rapidly passivates so stops working.

100 http://www.it-wismar.de/_documents/specs/I-01_spec.pdf
101 http://www.it-wismar.de/download.php?id=24
102 https://sps.honeywell.com/gb/en/products/advanced-sensing-technologies/healthcare-sensing/medical-gas-

sensors/ooa-envitec
103 https://www.figarosensor.com/product/docs/ke-lf_product%20information%28fusa%29_rev06.pdf

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Nobel metals such as gold and silver do not respond at all as they do not react with oxygenfrom air.
(Honeywell 2023a) add that the only metals in the periodic table that have standard
electrode potentials that are similar to lead are tin and germanium. Germanium is unsuitable
as it forms an inert oxide that will passivate the metal (germanium is also very uncommon).
Tin has a similar standard electrode potential for divalent ion formation, but the divalent tin
ion can be further oxidised to the tetravalent tin ion with a vastly different electrode potential
whereas, the divalent lead ion is stable and cannot easily be oxidised. Tin also selfcorrodes, generating hydrogen in acid and strongly alkali electrolytes, especially at higher
temperatures, so for substitution, the choice of electrolyte is important. Lead however does
not self-corrode or passivate at any pH value.
Response of partial pressure galvanic lead-free sensors and lead-containing capillary
senors from -30 to +50⁰C was tested by Alphasense, the results of which are shown in
Figure 19-6, relative to the output at 20⁰C. According to (Alphasense 2023a), this showsthat despite the thermistor, the output swings widely across the full range compared withlead oxygen. (Alphasense 2024a) add that the results show that lead-based capillary
sensors are not overly affected by termpature changes, but lead-free partial pressure
sensors are.
Figure 19-6: Effects of temperature changes on lead-free partial pressure galvanic
sensors (top) and leaded capillary sensors (middle) tested from – 30 to +50oC

Source: (Alphasense 2024a)

The response of partial pressure galvanic lead-free sensors and lead-containing capillary
sensors to a pressure step of 25 kPa was also tested by Alphasense, as shown in Figure19-7. According to (Alphasense 2024a), the results show that lead-based capillary sensors
quickly return to the original output where the lead-free partial pressure sensors do not.

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Figure 19-7: Response of partial pressure galvanic lead-free sensors (top) and leadcapillary sensors (middle) to a pressure step of 25 kPa at 60s in air

Source: (Alphasense 2024a)(Alphasense 2023a) claim that there is also a considerable size difference between theAlphasense detector and alternative designs, as show in Figure 19-8. It is estimated thatthe sensor on the left has around 2.5 x increase in volume.
Figure 19-8: Comparison of an Alphasense O2A2 sensor and galvanic lead-freepartial pressure sensors

Source: (Alphasense 2023a)(Alphasense 2023a) conclude that as can be seen from the technical differences in eachsensor, the current lead-free alternative does not offer the necessary technical performancerequired for the application sensors covered by this application serve and therefore cannot
be considered as viable alternatives.

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(MOCON 2022) address some of the same points that are addressed by Alphasense, sothey are not repeated here.
(Dräger 2023a) added that commercially available oxygen sensors that use tin anodes, as
substitute to lead anodes, in a caesium carbonate electrolyte104 are being sold in the EU by
the company ITG. However, they also state that the applicants of this renewal request haveevaluated these sensors for their specific applications and found that they do not meet their
specifications when used with existing designs of analysing instruments. (Dräger 2023a)
further explain that tests with a type of commercial lead-free electrochemical sensor havebeen carried out by one manufacturer. Concerning the output signal itself, results indicatethat sensors with alternative anode materials should eventually be suitable as areplacement for the lead anode sensors in redesigned instruments. However, test results
showed that these sensors have a completely different behaviour in the way that they
decrease voltage during operation. The voltage decreases very slowly and does not drop
below 8.9 mV even if the anode is complete consumed. In existing designs of oxygen
analyser, a consumed sensor with this behaviour would lead to wrong O2-values with nopossibility of detection by the device or the user that the output data was not correct.
(Honeywell 2023a) also discuss commercialized lead-free galvanic sensors, stating thatthese products are not drop-in replacements because they are larger size than the smaller
lead anode sensors and they also have different characteristics. Differences include:−

Temperature capability: No lead-free galvanic sensors are recommended for use
below 0°C (lead anode sensors are rated down to -20°C). Also, accuracy (static
temperature error) of lead-free galvanic sensors at temperatures below 10°C isreported to be only ±10%7 , which is inferior to lead anode sensors.

−

Pressure and temperature response: The temperature and pressure behaviour of
tin anode galvanic sensors is different to that of lead anode sensors, which prevents
their use as drop-in replacements.

−

Electrical behaviour: Testing by a member of COCIR found that the commercial tin
anode sensors do not behave electrically in the same way as lead anode sensors,
especially when the anode has been consumed as there is no sharp drop in output
when the sensor is no longer accurate. Without this sudden change, anodeconsumption is not detectable by the analyser instrument. This is a severe problem
in safety critical oxygen monitors that are used to warn workers of too low oxygen
concentrations if they do not provide an immediate alarm.

−

Response time: For lead-free cells with tin anodes, this varies depending on the typeof sensor and ranges from <5 seconds to 1 minute with many types being 25 to 40
seconds8 . Response times for lead anode sensors can be a short as 2 seconds.

−

Size: Currently there are no lead-free galvanic oxygen sensors that can replacesensors of 20mm diameter and 17mm height. A typical commercial medical leadfree oxygen sensor has dimensions 80 x 48mm7 whereas an industrial lead-free
sensor is 31.5mm wide and 40.5mm high (I-01 made by ITG). These are too large
for wearable oxygen monitors.

104 Material Safety Data Sheet of Lead-free gas sensors of ITG http://www.it-wismar.de/download.php?id=22

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Approvals: No lead-free galvanic sensors or their analyser instruments are available
that are approved for use in automotive emissions monitoring, for diving applications
or are ATEX approved. Instruments cannot be used in these applications without
having the appropriate certification and approvals.

−

Low oxygen concentrations: Analysers in the 0 – 2ppm O2 range with lead-freegalvanic sensors are not available.

(Honeywell 2023a) add that their own research has found that all lead-free anode galvanic
cell designs have technical issues that prevent them from being drop-in replacements forlead-anode galvanic cells. These issues include (details are given in the request form andare not reproduced here):−

Honeywell have determined that sensors with tin, antimony, bismuth and copper
would all have to be significantly larger than sensors with lead−

For alternative anode / cathode combinations, the cell voltage will be different tolead anode sensors and so these sensors cannot easily be used as drop-in
replacements.

−

Trials by Honeywell found that potassium acetate solutions (as electrolyte) that areused in lead anode cells gives inferior performance (such as passivation) as anelectrolyte for antimony, bismuth and copper−

As far as Honeywell know, all commercial lead-free two-electrode sensors havemembrane diffusion barriers, there are no commercial lead-free sensors withcapillaries−

Honeywell’s research with alternative anodes has found that at higher temperatures(above 20°C), self-corrosion becomes an issue so that a current is generated whenno oxygen is present. The effect of temperature on output is also different to that oflead anode cells.

−

Honeywell found that antimony, bismuth and copper will passivate when the sensor
is exposed to high concentrations of oxygen.

−

With zinc anodes, self-corrosion is an issue(Honeywell 2023a) conclude that despite these difficulties and limitations, substitution is an
option that warrants further research, but significant technical difficulties exist before twoelectrode lead-free anode sensors can be developed that are suitable for all end-use
applications. In practice, for some end-uses, 3- electrode pump cells can be used, but due
to their different characteristics, these cannot be drop-in replacements and are not suitable
for many end-uses.
Elimination(Alphasense 2023a) confirm that there are other sensor types other than partial pressure
galvanic sensors, however these do not offer the same combination of technicalcharacteristics, as discussed below.
Amperometric type sensors (3-electrode electrochemical sensors) measure current as aresult of the electrochemical reaction. The sensor operates on an oxygen pump principle
where oxygen is consumed at one electrode (the working electrode) and produced at
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another (the counter electrode) with a reference electrode. These can be used in a numberof different applications to great effect, but have the following disadvantages:-

Most sensors require power to be applied constantly. If power is lost the internal
cavity space will equilibrate with the oxygen content in the air. When power isrestored depending on the length of time without power, 15 mins to many hours is
required for the output to be stabilised. In comparison, galvanic sensors being selfpowered need only have the pins of the device connected to remain operable andso there is no wait when power is restored to display the correct output. Figure 19-9shows details of one amperometric sensor as an example.

-

Susceptible to high carbon monoxide (CO) and carbon dioxide (CO2)concentrations, which is important for automotive, biogas and boiler flue sectors.
The recovery time in CO2 conditions were longer when compared with capillary lead
oxygen sensors as outlined in Table 19-5 and Table 19-6. In addition to this there
was reduced sensitivity of amperometric sensors following exposure to CO above
10,000 ppm which can last several hours. Capillary lead oxygen sensors do not havethis susceptibility.

-

Require a reference electrode to operate to correctly maintain working electrodepolarisation and drive the oxygen pump. Due to this, amperometric sensors cannot
operate in an absence of oxygen for prolonged periods of time as the referenceelectrode requires oxygen to work. Galvanic sensors do not require referenceelectrodes so can operate in the absence of oxygen.

Figure 19-9: Warm up times of amperometric lead-free oxygen sensor outlining startup time after battery disconnection

Source: (Alphasense 2023a)

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Table 19-5: Comparison of lead-free and lead based sensor response when exposed
to 8 – 15 % CO2

Source: (Alphasense 2023a)

Table 19-6: Recovery time of lead-free sensors to a ~20.91 reading for O2, incomparison lead based sensors always returned to this value within 3 minutes.

Source: (Alphasense 2023a)(Honeywell 2023a) describe 3-electrode amperometric type electrochemical cells (pumpcells) in a similar manner, providing the following additional information:−

A disadvantage of this sensor when compared to the lead-anode two electrodesensor is that it requires more complex electronics to control the sensor andmeasure its output.

−

Changes in temperature and pressure cause different responses so they cannot be
used as a drop-in replacement in applications where accurate sensing of oxygen
content is required when these occur. The graphs in Figure 19-10 show that thetemperature dependence of electrochemical sensors is not identical to lead-anodecapillary and membrane sensors.

−

Oxygen gas is generated at the counter electrode. This must not reach the sensing
electrode as this would give false readings. This is a significant disadvantage in393

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

ATEX approved analysers as the evolved oxygen gas would usually be vented into
the analyser‘s housing and this could cause a potentially explosive gas mixture
when used in ATEX environments. Analyser instrument housings need to be vented
to prevent pressure build up from internally vented generated oxygen but venting
also allows flammable gases into the inside of the instrument’s housing.
−

It can be difficult or impossible to tailor the activity of the sensing electrode to avoid
cross sensitivity to contaminant gases that might also be present. This can beachieved with lead anode sensors but with three electrode oxygen pump sensors it
is difficult to find an anode material and bias voltage combination that gives sufficient
activity for rapid oxygen reduction that does not give unacceptable cross sensitivity.

Figure 19-10: Dependence of oxygen sensors on temperature – above three-electrodepump-cell electrochemical sensor, below capillary lead anode galvanic sensor

Source: (Honeywell 2023a)(Alphasense 2023a) explain that partial pressure sensors are a different type ofelectrochemical sensor (available in lead containing and lead-free containing versions)which but instead uses a membrane, such as Teflon, and inert electrodes in theirconstruction. The membrane is included in the design of the sensor as it increases the lifeof the sensor. The rate of gas diffusion through the membrane is linearly proportional to thepartial pressure of the oxygen on the two sides of the membrane, following Fick’s Law.
Since oxygen is reduced at the cathode, the partial pressure on the cathodic side of themembrane is virtually zero, giving a driving force which is linearly dependent on oxygen
partial pressure, so the rate of gas diffusion (and hence sensor output) is linearly dependent
on the oxygen partial pressure.
However, according to (Alphasense 2023a), all of these devices which rely on membranes
all have the following characteristics:394

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Any change in atmospheric pressure affects linearly the oxygen partial pressure, so
partial pressure sensors are linearly dependent on ambient pressure.

-

Since the gas must diffuse through a solid polymer membrane, the rate of diffusion
is dependent not only on the gas partial pressure but also on the diffusivity of themembrane. The diffusivity of polymer membranes has a high temperaturedependence, typically 2 to 3%/K; this is usually corrected by using a thermistor
sensor inside the body of the oxygen sensor to compensate for temperaturechanges. However, during thermal transients the membrane diffusivity andcompensating temperature sensor will not be in phase and significant thermaltransient errors can result.

-

Since diffusion through a polymer membrane is slower than through a capillary the
response time (as t90) of partial pressure sensors is typically105 20 to 40 seconds,
in comparison devices using this exemption have a t90 value between 5 and 10
seconds.

The consultants note that partial pressure sensors / permeable membrane sensors are inscope of the renewal requests submitted by (Dräger 2023a) and (Honeywell 2023a).
There are other types of oxygen sensors based on alternative technologies which are briefly
discussed by (Alphasense 2023a):-

Fluorescence- a fluorescent material is excited by a LED and quenched by oxygen
which passes through a permeable layer (membrane). The higher the oxygen
content the stronger the quenching and the less fluorescence is detected by the lightreceiving diode. At high oxygen levels the measurement accuracy decreases due tonoise and requires power to operate. See Table 19-7 for a more detailed review of
performance characteristics.

-

Tuneable diode laser absorption spectroscopy sensors (TDLAS)- a laser absorption
technique which is based on the reduction of the measured signal intensity of a laser
diode. Tuneable diode lasers have a sophisticated sub-micron structure and needfor precise temperature control to maintain the selected frequency. Due to its
reliance on absorption the technique is limited in terms of sensitivity due tobackground noise. See Table 19-7 for a more detailed review of performance
characteristics.

-

Zirconia sensors – These are solid state electrochemical sensors based on yttria
stabilised zirconia through which oxygen ions can diffuse when operated at hightemperature (400-600oC). As such they are used with gases at temperatures
between 350-700oC only. Require power to operate and due to interactions withother gases can have poor accuracy-

Paramagnetic - able to measure oxygen content between 1-100% due to theparamagnetic behaviour of oxygen. The measurement requires a suspended glass
dumbbell which rotates in a magnetic field according to the oxygen concentration of
the surrounding gas. As such the equipment is large and susceptible to effects from

105

Alphasense 2023a add that it is recognised that there are some devices on the market with a quicker
response time than 20 seconds, as a result of specific design features, however this is not true for all
designs and it an important technical offering of Alphasense sensors.

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the installation angle and therefore can only be used in fixed installations. Other
magnetic interference, either from other equipment, or paramagnetic gases such as
NOx can also affect the results.
Table 19-7: Comparing sensitivity of oxygen sensing devices

Source: (Alphasense 2023a)(MOCON 2022) highlight that in contrast to Hersch cells, membranes and capillaries areincluded in many sensors’ designs as they to keep the electrolyte from leaving the sensor
and thereby increase the life of the sensor. The principle difference is illustrated in Figure19-11. As a result, these types of sensors are only measuring a fraction (< 0.001%) of thetotal oxygen present. Inherently, this means they are far less sensitive to oxygen, and they
are not measuring all of the analyte. If a sensor does not collect and measure all the analyte,then it needs to be calibrated because the sensor is only measuring some unknown fractionof the total oxygen. Sensors with membrane or capillaries have to be flow and temperaturecompensated and are sensitive to pressure transients. These dependencies add to themeasurement uncertainty and effect reliability.
(MOCON 2022) detailed why it is highly unlikely that a reference gas to low enough oxygen
levels for the calibration of sensors is technically feasible and is why a calibration freemethod, i.e. Hersch cells, is essential.

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Figure 19-11: Comparing direct vs. indirect measurement

Source: (MOCON 2022)

According to (MOCON 2022), the following table aims to provide an analysis of somealternative oxygen sensors currently available on the market, and their sensitivity such thatthe difference in technical performance is easily identifiable.

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Source: (MOCON 2022)(Dräger 2023a) further discuss solid metal oxide semiconductor sensors, mass
spectroscopy, optical sensors, and luminescent oxygen sensors, as alternative sensor
technologies.
−

Solid metal oxide semiconductor sensors, also known as lambda probes. These areoften used in vehicles to measure the differences in oxygen concentrations in
supplied air and in exhaust gases by measurement of the current between
electrodes. They do not measure the actual oxygen concentration (only a difference)and these usually need to be heated to 300°C and so are unsuitable in medical
applications as they pose a safety risk due to the high temperature.

−

Mass spectrometers can analyse all substances in patients’ breath but the responsetime is too long taking many minutes to obtain a single concentration.

−

Optical sensors: There are many types of optical oxygen concentration analysis
methods, but most are either unsuitable or are designed for analysis of dissolved
oxygen only (e.g. in blood). Infrared absorption spectroscopy analysis can be used
to analyse many substances in industrial applications, but this technique does not
respond to oxygen gas and so is unsuitable. One technique uses substances thatchange colour when exposed to oxygen and the colour is measured electronically.
Response times can be slow and colour measurement is not very accurate and so
this method cannot be used for industrial oxygen analysers where fast response
times and high accuracy are essential. Another type of optical sensor uses anoxygen permeable polymer containing a luminescent compound. (Dräger 2023a)
describe a number of issues that make them less useful. Some are only useful for
dissolved oxygen measurements, some have slower response times.

Besides also discussing the above, (Honeywell 2023a) further discuss the following:−

Ultrasonic oxygen sensors measure the concentration of oxygen in a gas or liquidby measurement of the speed the ultrasonic sound waves through the gas or liquid.
These are suitable when the composition of the gas is known as every substance in398

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the gas will affect the speed of sound differently. They are therefore usually
unsuitable in industrial environments where the air composition is unpredictable.
−

Tuneable diode laser absorption spectroscopy sensors: These are a type of infrared
sensor in which the diode laser produces an infrared light beam that passes throughthe analysis gas to a photodiode that measures the infrared light received. By tuning
the laser to specific wavelengths, they can analyse a variety of gases including
oxygen. However, other gases also absorb infrared light at the absorption
wavelengths of oxygen gas and so these sensors cannot be used where thesegases might occur.

(Honeywell 2023a) summarize the status of lead-anode and alternative sensor types in atable reproduced below.
Table 19-8: Status of lead-anode and alternative sensor types

Source: (Honeywell 2023a)(Alphasense 2023a) point out that there are no lead-free drop-in replacements that can beused. Therefore, reliability issues are not relevant for this exemption renewal request. Thissentiment is mirrored by the other applicants as well.

19.2.2. Environmental, health, safety and socioeconomic impacts(Alphasense 2023a) point out that if oxygen sensors were no longer available there could
be serious harm to workers which use them both as portable devices and in fixedinstallations. Oxygen sensors provide key safety functionality to many different industries
and without them worker safety it impacted. If these industries choose to operate without
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the sensors there is the potential of death from asphyxiation from working in enclose
spaces, mines etc. If the industries are unable to operate without the sensors there could
be the loss of certain operations within the EU and consequentially the loss of jobs. A
quantitative estimate is not able to be provided due to the widespread and dispersive
impacts these would have.
(MOCON 2022) point out that there are several users of high-sensitivity Hersch oxygen
sensors requiring high sensitivity measurements. Applications affecting human health andthe environment include:•

The pharmaceutical industry uses Hersch cell sensors to ensure certain medications
are protected from oxygen. This is required to maintain strength, and therefore
public safety. The high instrument sensitivity is required to manufacture somemedicines which are extremely sensitive to even trace amounts oxygen.

•

Freshness and safety in food packaging design, which requires ppt sensitivity, is thelargest application of Hersch cell sensor technology. This affects consumer safety
and potentially human health.

•The solar panel industry relies on ppt oxygen sensors instruments to measure theirhigh oxygen barriers. Oxygen barriers are required to prolong the lifetime of thepanels. Long-lasting solar panels are necessary to generate “green” energy, which
results in benefits for the environment.

•

Similarly, the OLED [organic light-emitting diode, the consultants] industry requires
oxygen barriers to create OLED screens. Only very sensitive instruments using
Hersch cells are capable of measuring at the levels they require.

(MOCON 2022) further highlight that if this exemption were to expire before an accurate
and reliable alternative can be developed and commercialised, there would be a verysignificant risk to human health due to an ability to manufacture medicines at very low
oxygen concentrations and because food safety would be compromised. Somemanufacturing may not be possible without Hersch cells. It is not possible to quantify these
impacts.
(Dräger 2023a) only consider socio-economic impacts, stating that insufficient monitoringof oxygen in certain industrial applications may cause harmful condition for workers (e.g.
hydrogen production plants, hydrogen storage plants) thus this application has a direct
influence on occupational safety issues.
(Honeywell 2023a) state that if this exemption is not renewed, EU users of lead anodeoxygen sensors will not be able to obtain new instruments. This will negatively affect all of
the industries and end-users. Many would be forced to stop operations because not being
able to measure oxygen gas concentrations in their work environments would be too
dangerous. Some end-users may decide to risk operating without monitoring oxygen
concentrations, and this would pose a very severe risk to workers safety, such as when in
confined spaces, tunnels, mines, etc. Deaths from asphyxiation are potential outcomes.
Some EU manufacturers who produce analysers as well as end users of these analysers
may cease to operate in the EU with loss of employment. Honeywell is not able to provide
quantitative estimates of these impacts as they are dependent on many other industries.
(Honeywell 2023b) added that if the recommended exemption is not updated to cover leadanodes in electrochemical oxygen sensors for category 9 IMCI, this will lead to significant
social, economic and global impacts and the shutdown of manufacturing and processing

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sites for energy generation, mining (precious materials), water treatment, petrochemical,
chemical, semi-conductor and microchip fabrication.

19.2.3. Roadmap towards substitution or elimination of the restricted
substance
Actions that have been taken to develop further possible alternatives(Alphasense 2023a) reiterate that there are alternative oxygen sensors which do not relyon RoHS restricted substances, however these can only be used in specific uses. For
example, lead-free partial pressure galvanic oxygen sensors have pressure and humidity
dependence and amperometric type sensors require power, are susceptible to high carbon
monoxide (CO) and carbon dioxide (CO2) concentrations and cannot be used in theabsence of oxygen. Alphasense and other sensor manufacturers have carried out research
into substitute metals and none are drop-in replacements as outlined above.
(MOCON 2022) explain that the length of a Hersch sensor development is a considerable
undertaking due to the technical requirements the sensor has. For example, changing asingle component in the cadmium version of the Hersch cell took 3 years to undertake andfully qualify. Testing is underway to identify and qualify an alternative lead-free solution.
Testing to determine the corrosion and chemical compatibility has been undertaken,
identifying which potential alternatives are worthwhile taking forward for subsequent testing.
(MOCON 2022) provided a large table listing unnamed tested anode and electrolytematerials and observations made, which is not reproduced here, as well as more details ina confidential submission that cannot be reproduced here. Out of 32 listed material
combinations, 18 are observed to be unsuitable, while the remaining are either potential
alternatives for further testing or have a suitable performance for benchmarking. Further
tests were carried out and for the most promising combinations, prototype Hersch oxygen
sensors were constructed and installed in an AMETEK MOCON OX-TRAN Analysers totest efficiency, response, background and note other reactions. (MOCON 2022) conclude
that the results to date show that a number of the potential alternatives do not have thenecessary technical characteristics and as such only some combinations will be taken
forward for subsequent testing (Table 19-9).

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Table 19-9: Prototype Hersch oxygen sensor testing

Source: (MOCON 2022)(MOCON 2022) note that in the above table, none of the possible substitutes equals theefficiency of lead. Therefore, there is no certainty that a suitable substitute will be identified,
however, this work is continuing with the most promising materials. Subsequent to this,accelerated life testing is planned to be undertaken on the prototype sensors selected to betaken forward, measuring the oxygen transmission rate of the film to ensure there is no drop
off in efficiency. Testing for each sensor is a duration of 6 months. Two instruments areavailable for this testing so only two life tests can occur at one time during a 6-month period.
If sensors show suitable characteristics during the accelerated life testing, another key andusually defining characteristic is selectivity testing to ensure that potential alternative
sensors do not respond to carrier gases. After this, more testing is planned, including forsensitivity, linearity, backwards compatibility, and manufacturability, reliability, andproductionisation.
(Dräger 2023a) claim that research has been carried and published on a wide variety of
new lead-free oxygen sensors. Industrial device manufacturers evaluate any commercial
products that meet their specifications and appear to be suitable. Paramagnetic sensors
are now used in side-stream applications, but cannot be used where rapid and accurate
measurements are required such as in industrial applications. New lead-freeelectrochemical oxygen sensors are being evaluated and tests have shown that these
respond very differently and so are not drop-in replacements. As a result, analyser
instruments that are used with the sensors will have to be completely redesigned.
(Honeywell 2023a) reiterate that many alternative types of oxygen gas concentration
analyser have been developed and each type has specific uses. For most industrial
applications, lead anode cells still need to be used as there are no alternatives. For
example, of Honeywell’s competitors that sell lead-free galvanic sensors, there are none
suitable for ATEX, diving gas or vehicle exhaust gas emission applications and most types
that are available are lead anode sensors.

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Stages necessary for establishment of possible substitutes and timeframes needed
Alphasense
According to (Alphasense 2023a), more research is needed to firstly develop alternative
sensors that offer suitable technical performance, after which the design and validation ofanalyser instruments needs to occur. EU instrument manufacturers are varied, and we areunable to provide details for the full market, however all will need to be certified for theirperformance and depending on the end use in question the level of redesign and testing
will vary. For example, the testing of alternatives have to consider and evaluate the effects
of other gases which might occur during the products lifetime, for oxygen sensors up to 60
kinds of interference gases might occur, with different concentration levels depending on
the application. The effects of the gases and their relevant concentrations need to be fully
verified as they can influence the sensitivity and accuracy of the oxygen concentration
measurement. In addition to this many applications require instrumentation be ATEX
certified. The following tables provides an estimation on the expected timeframes for thedevelopment of an alternative, it is important to note that the following are based on theconcept that each test will ‘pass’ first time. If any further development is required to resolve
technical issues the timeframes outlined would be much longer.
Development of lead-free galvanic capillary oxygen sensor(Alphasense 2023a) state that currently no sensor of this type exists on the market, so it is
not certain if a technical alternative is possible. The initial phase of testing will determine if
an alternative is viable by testing parameters such as:-

The development of core chemistry (12-18 months)-

Sensor house development, including the tooling required for such sensors (6months)-Optimisation of the design, including aspects such as the review of differing wetting
layers and electrical contacting parts in the sensor (6 months)-

Performance and accelerated life testing (12 months)

Some of this testing can be undertaken in parallel so the overall timeframe is estimated to
be around 2 to 2.5 years. Field testing of sensors is critical as it involves testing theperformance in variable conditions with regard to temperature and pressure, mechanicalshock testing, vibration and drop testing. As well as ensuring the performance in thepresence of interfering gases. However, if all of these tests identify a suitable alternative
then the timeline outlined in Table 19-10 provides an estimated of how long this would take.

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Table 19-10: Development of lead-free galvanic capillary oxygen gas sensor

Source: (Alphasense 2023a)

According to to (Alphasense 2023a), performance testing to ISO 50104 and certification
mandates 23 tests, including stability testing, environmental testing, performance with othergases, etc. [for the full list see applicants’ exemption request form, the consultants]. Given
the wide range of tests required, the overall time to complete all of the tests will vary withthe availability of environmental chambers, gas supply facilities and personnel to undertake
the work, and has to be scheduled around other work using the same facilities. As suchthere is some uncertainty over the timeline estimated.
Development of lead-free amperometric oxygen sensor(Alphasense 2023a) highlight that some instrument manufacturers are migrating toamperometric lead-free oxygen sensors already (when the end use application allows forthis). Given the technical differences in amperometric sensors as described above for otherapplications additional time as outlined in Table 19-11 is required. (Alphasense 2023a) notethat there may be technical characteristics which will be intrinsically different with this using
an amperometric sensor compared to galvanic capillary sensors, which may offer
decreased technical performance not acceptable by certain customers.

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Table 19-11: Development of lead-free amperometric oxygen gas sensor

Source: (Alphasense 2023a)(Alphasense 2023a) conclude that as the majority of the capillary industrial market is
expected to change to amperometric sensors when the technical issues are resolved, theywould request the exemption be granted for another 4 years to allow for the necessary
testing and development to occur in general applications. For applications which are ATEX
rated, they would request that the exemption be granted for another 5.5 years.
MOCON(MOCON 2022) provided the following table provides an estimation on the expected
timeframes for the development of an alternative, it is important to note that the following
are based on the concept that each test will ‘pass’ first time. If any further development isrequired to resolve technical issues the timeframes outlined would be much longer.
Table 19-12: Qualification requirements and timeframe

Source: (MOCON 2022)(MOCON 2022) note that the above timelines are based on the assumption that suitable
technical performance is able to be achieved with one of the currently identified potential
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alternatives and further process refinements or alternatives are not required to beundertaken. Until stage 1 and 2 testing is completed it is not known if an alternative is able
to provide the necessary technical requirements as much of its viability depends onalternatives intrinsic chemical characteristics. As such there is some uncertainty in thetimeline of qualification, with current estimates based on the best information available atthe point of writing this request.
Reliability testing will include the following tests to ensure that the sensor is able to operate
at the stated technical requirement for its lifetime and no other factors influence its
operation:•

Shock and vibration testing to ensure that the sensor is not affected. Testing for thisis estimated to take 2-3 months,•

Pressure loading of the sensor. Testing for this is estimated to take 2-3 months,•

Impact of exposure to H2 and N2 over extended periods of time to ensure that it does
not affect the sensitivity of the sensor. The testing for this takes an estimated 3-6
months,•Temperature cycling to replicate shipping and in service use. Testing for this isestimated to take 3-4 months, and•Over-range recovery of the sensor to ensure the sensor is able to operate aseffectively in the extreme conditions of the sensor. Testing for this is estimated totake 2-3 months.

(MOCON 2022) emphasize that, as outlined above, although there are some initial signs
that a lead-free alternative might be possible at this time, it cannot be confidently stated thatan alternative material exists. It is only towards the end of the above outlined test periodthat this would be able to be stated.
Honeywell(Honeywell 2023a) state that For most end-uses, more research is needed to develop
alternative sensors that are suitable. It will also be necessary to design suitable analyser
instruments for the alternative sensors as these are unlikely to be drop-in replacements as
described above. Honeywell is developing alternative sensors and also replacement
analyser instruments. For most end-uses, validation testing and approvals are also required
before the new instruments can be sold in the EU or globally.
However, depending on the end use application in question it is expected that different
levels of redesign work will be required and hence different timeframes will needed. The
following timescales refer to instruments that currently use membrane cell sensors. In allcases below, the sensor development phase is uncertain. This would be up to 4 or 5 years
if a totally new sensor design is needed, but perhaps only about six months if an existing
Honeywell sensor such as a pump cell could be used. The actual timescale will not beknown until further development work and testing has been carried out although it is likelythat new sensors will be needed for at least some applications.
−

Oxygen gas concentration monitor for safety applications including portable
analysers. For portable applications, these must be small and lightweight and need
to be accurate and reliable with new batteries or after recharging during at least aworking shift. This is an issue with 3-electrode sensors as these have higher power

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consumption than the lead anode sensors. Likely steps and timescales are outlinedin Table 19-13.
Table 19-13: Lead-free oxygen sensor development for safety applications

Source: (Honeywell 2023a)−

ATEX approved analysers. The generation of oxygen inside the housing, which must
be vented is a serious limitation and currently, this is not technically possible. If a
suitable sensor is available, then the following would be required. Likely steps andtimescales are outlined in Table 19-14.

Table 19-14: Lead-free ATEX approved analyser development timescale

Source: (Honeywell 2023a)−

Vehicle exhaust analysis, SCUBA diving gases, Bio-ox and medical applications

Table 19-15: Lead-free analyser development timescale

Source: (Honeywell 2023a)−

More technically difficult applications such as 0 – 2ppm O2

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Table 19-16: Lead-free analyser development timescale 0 – 2 ppm

Source: (Honeywell 2023a)

19.3.

Critical review

19.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several uses of lead and lead compounds are listed in Annex XIV. Additionally, Annex XVII
contains several restrictions for lead and its compounds. None of those entries are,however, relevant for the use of lead in the scope of exemption IV-1(b) (cf. section 4.2 on
page 43 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

19.3.2. Adoption of the recommendation from the previous evaluation report
Exemption 1(b) was reviewed by (Deubzer et al. 2022) who recommended a renewal withthe wording and scope reproduced in section 19.1.1 “History of the exemption” in Table
19-3.
At the time of the current review of exemption IV-1(b), the COM have not yet officiallypublished their decision as to the adoption of the recommendations made by (Deubzer et
al. 2022). Therefore, the COM wish the consultants to assess in this current review whether
there are any substantial reasons in line with Art. 5(1)(a) against the adoption of the above
recommendation for EEE of categories 8, 9 and 11.
During the review of the current exemption renewal request, the applicants were informedthat if this review shows that the applicants’ arguments justify the renewal of the exemption,

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the consultants would recommend the wordings, scopes and expiry dates given in Table
19-17, adapted from the recommendations by (Deubzer et al. 2022).
Table 19-17: Renewal of exemption 1(b), adapted from (Deubzer et al. 2022)
No.

Exemption

Scope and dates of applicability

IV-1(b)Lead anodes in electrochemical oxygen
sensors.

Expires on 21 July 2021 for cat. 8
medical devices other than in vitro
diagnostic medical devices

IV-1(b)(I)

Lead anodes in electrochemical sensors
that measure oxygen concentrations of
inhaled and/or exhaled air for patients andthat are consumables in medical devices puton the market before 26 May 2024.

Expires on 21 July 2025 for cat. 8
medical devices other than in vitro
diagnostic medical devices

IV-1(b)(II)

Lead in galvanic oxygen sensors in
instruments that are

Expires on--

21 July 2025 for cat. 9
monitoring
andcontrol
instruments
other
than
industrial
monitoring
andcontrol instruments-

21 July [2025 + X*] for cat. 9
industrial
monitoring
andcontrol instruments(a) designed for the measurement of oxygenin gases with a response time < 3 s (t95)
and which are not handheld devices, and(b) designed for the measurement ofdissolved oxygen in concentrations below
30 ppb.

*X can be a maximum of 6 years
When requested to comment on and explain any obstacles to the adoption of the above
proposal for the requested exemption for category 9 IMCI, the applicants responded thatthey could not agree its adoption, based on the reasons summarized below.
−(Alphasense 2023b) stated that the criteria of a response time of less than 3 seconds
and having a sensitivity of 30 ppb are not applicable to capillary sensors. Rather,
capillary sensors are able to measure to 20 ppb and have other critical performance
characteristics which include the ability to operate at 0% oxygen, minimal responseto temperature and pressure and wide operating temperature range. (Alphasense2023b) also explain that technical differences between capillary sensors and thoseoutlined in the recommended exemption IV-1(b)(II) are that the former permit themeasurement of oxygen gas in fixed installations, personal monitoring devices andpermeation measurements, all of which are not captured by 1(b)(II).

−(MOCON 2023) stated that the criteria of a response time of less than 3 seconds
and having a sensitivity of 30 ppb are not applicable to Hersch sensors. Rather,
Hersch sensors are able to measure to 200 ppt. The sensor response takes lessthan 8 minutes to 99 % full reading. (MOCON 2023) also explain that technicaldifferences between Hersch cells and those outlined in the recommended
exemption IV-1(b)(II) are that Hersch cells permit ultra-low detection of the absolutemeasurement of oxygen gas in the range of 200ppt to 70 ppm, critical to the
production of pharmaceutical products, medical applications, assessment of theintegrity of food packaging and solar panel lifespan calculations and improvements.

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU−(Dräger 2023b) stated that the recommended exemption wording does not cover theuse of electrochemical sensors as consumables / spare parts in IMCI that will be puton the market before the expiry of the current exemption on 21st July 2024 or at theend of the requested exemption on 31st December 2025. (Dräger 2024a) added that
sensors have a response time of well over 3 seconds and that the exemption
wording would apply to their sensors if the restriction < 3 seconds response time
was waived from the wording.

−(Honeywell 2023b) stated that the criteria of a response time of less than 3 seconds
and having a sensitivity of 30 ppb are not applicable to galvanic IMCI sensors. The
criteria are limited and not representational of the requirements of industrial
monitoring and control instrumentation for safety, emissions, automotive, biogas,
diving gas analysis and environmental applications.

In the previous review of this exemption, the applicant JBCE had agreed to exclude sensors
with a reaction time > 3 seconds from the exemption scope for oxygen gas senors. The
applicants were asked to explain for which reasons their sensors require the exemption
even if their reaction time is higher than 3 seconds.
−(Alphasense 2024a) reiterated that lead is critical to achieving other required
technical performance characteristics, for example, sensors which have minimal
response to pressure, temperature and humidity, while having a short warm-up timeand are self-powered. This provides unique functionality, which is not able to beoffered without lead, and is critical to applications such as health and safety
monitoring devices and automotive exhaust gas monitoring. Generally, Alphasense
emphasize that the JBCE submission did not outline uses with relate to the industrial
safety market, which is the main market for Alphasense device types.

−(MOCON 2024a) also reiterated that lead is critical to achieving the other technicalperformance characteristics, such as absolute oxygen measurement (measurement
without the need for calibration) which allows the measurement down toconcentrations as low as 200 ppt. MOCON added that Hersch devices are not used
as handheld devices.

−(Honeywell 2024a) also stated that lead is critical to achieve the other technicalperformance characteristics. For example, it is self-powered and does not selfcorrode or passivate under any conditions inside the sensor. They elaborated thatthe response time for an electrochemical oxygen sensor is determined by a numberof factors, including the load resistor/electrical circuitry; the rate of diffusion ofoxygen through the diffusion barrier (capillary or solid membrane); the bulk flow
restriction of oxygen in capillary sensors; the diffusion rate of the oxygen throughthe electrode membrane and electrode structure; the electrolytic species (electrolytematerial and concentration); the three phase interface (O2, cathode catalyst andelectrolyte); and the the cathode and anode material, structure, composition andactivity. Due to these factors some sensor types cannot meet the 3 second response
time, but still provide unique technical functionality which requires the use of the
exemption. It is worthwhile noting that due to these fundamental characteristics
listed above, various sensor designs have had response times greater than 3 secs
since their conception in 1977.

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Further, the applicants during the previous review had agreed to exclude handheld devices
from the scope, stating that these do not require the use of lead anodes. The applicants
were asked to explain for which reasons handheld devices still require lead in their view.
−(Dräger 2024a) also state that they have not used lead-containing oxygen sensors
in portable gas detectors for decades and therefore agree that handheld devices do
not require lead. They specify that these would be used exclusively for the personal
protection of a worker. Ambient atmospheres consisting of saturated organic vapors
in which the oxygen content must be lowered to prevent ignition simply do not occur
in such cases. Once a portable measuring device has been in a harmful atmospherefor some time, it is taken out of this environment again by the worker and canregenerate in fresh air before being exposed to challenging atmospheres again.

−(Honeywell 2024a) reiterated that lead is critical in the functioning of capillary andmembrane diffusion cells used in applications such as portable air monitoring
applications; health and safety personal monitoring applications; exhaust monitoring
applications; diving and bio-gas measurement. The rationale for the use of leadbased sensors in handheld devices includes that power consumption of sensors foruse in portable monitoring instruments needs to be sufficiently low (ideally zero) sothat the analyser can be powered by small lightweight batteries, ideally rechargeabletypes, for at least one working shift of 8 – 10 hours. This allows the device to be asuitable size and weight. Mechanical stability and short warm-up time after being
switched off for 24 hours are also relevant factors. Environments where re-charging
is not practical requires lead-based sensors, such as marine applications. Lastly,
single gas use instrumentation with non-rechargeable batteries for continuous use
for 1-2 years require lead.

Given that Dräger had agreed that handheld devices did not require lead, Honeywell was
asked to respond to their statement: (Honeywell 2024b) responded not to agree to Dräger’s
above statement, as Honeywell does not regard those as the main reasons to use lead insensors in handheld devices. Honeywell assume that the alternative lead-free oxygen
sensor that Dräger are referring to is an oxygen pump. This type of sensor can be affectedby exposure to organic vapour and can take time to recover. The use case described by
Drager only applies to a minority of use cases and is therefore not the main reason for why
oxygen pump sensors are not widely used. According to (Honeywell 2024b), handheld
devices need to be low power and small. This can preclude the use of oxygen pumps (which
require power) and alternative lead-free anodes which are too large. Honeywell applications
have to be able to operate in an array of challenging applications including extreme climate
conditions, harsh environments, or remote locations (e.g., artic circle, sea, platform,
refinery, landfill, facility, emission efficiency monitoring) where they are not able to be
removed from the environment or location, due to access and/or lack of power.
Dräger were invited to comment on the above, and stated that they had been providing
lead-free oxygen-sensors for portable devices for several decades. Through purposefuldesign of the sensors and gas measurement devices, it is well possible to reduce the power
consumption to a degree that makes these sensors compatible with most of the abovedescribed requirements (rechargeable device for an 8-10 hour shift, warm-up time within
seconds). Concerning single gas units with run-times up to 2 years, Dräger Pac single gas
detection instruments with oxygen sensors are lead-free and last for approximately 10
months without need for recharging or battery replacement. Afterwards, the costumer needs
to replace the battery which we consider an acceptable inconvenience which does not justify
further use of lead-based sensors. This period of time is valid for typical applications of411

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personal air monitoring devices, where ambient air with an oxygen-content of 20.9 vol% ispresent for most of the time. (Dräger 2024b) further specified to use three-electrodeelectrochemical amperometric oxygen sensors operated by a potentiostat in their portablegas measuring devices, rather than partial pressure / permeable membrane sensors.
JBCE, the applicant during the previous review by (Deubzer et al. 2022) were also invited
to comment. (JBCE 2024a) provided the following statements:−

The applications for the oxygen sensors for which JBCE requested the renewal of
exemption IV-1(b) are gas measurements, and more specifically air pollution, factoryemissions, automotive emissions, dissolved oxygen in water, etc. JBCE has no
information on whether lead-free can or cannot be used in other applications. No
additional information regarding lead-free solutions for handheld devices wasprovided.

In the consultants’ view, it seems plausible that the applications for which JBCE requested
the renewal of exemption IV-1(b) overlap, but do not cover all applications for which thecurrent applicants request the exemption, such as industrial safety applications. It appears
plausible to the consultants that in different applications (use cases), different technicalspecifications are required to be fulfilled by the oxygen sensors, which may be different fromfast response time and may justify the use of lead in some cases. The same applies tohandheld devices, which, depending on their use case, may require certain specifications
that are different from use cases and specifications required by JBCE. Differences between
the viewpoints of Dräger and Honeywell are, at least in part, also likely due to differencesin end use applications.

19.3.3. Scope clarification
The applicants were requested to provide information on the sensor technologies and their
specifications in scope of the renewal requests, the results of which are reproduced in Table
19-18.
The consultants note that all sensor technologies in scope of the requests for renewal are
for the measurement of oxygen concentration in gases rather than for dissolved oxygen inliquids. This is in contrast to the previous review of this exemption by (Deubzer et al. 2022),
in which the applicant106, JBCE, described both fields of application and differing technicalrequirements, which caused the consultants to recommend the exemption wording listed inTable 19-17(page 409) referring to oxygen gas and dissolved oxygen sensors separately.
The consultants further note that the applicants request the exemption for three different
oxygen sensor technologies: capillary, membrane diffusion, and Hersch cells, which differ
in their technology, specifications, and applications (use cases).
Table 19-18 also shows that even for the same sensor technologies, applicants request
differring validity periods. This aspect is discussed further below in section 19.3.4.

106 COCIR were another applicant but only for cat. 8 medical devices which are not relevant for this review.

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Table 19-18: Overview on relevant specifications of the sensor technologies in scope of the exemption renewal requests
Sensor attributes

Alphasense (capillary)

Honeywell(capillary)

Honeywell(membrane diffusion)

Dräger(membrane diffusion)

MOCON(Hersch)Sensor technology

Capillary

CapillaryMembrane diffusion /partial pressure

Membrane diffusion /partial pressure

Hersch (Pb / Cd)

Oxygen gas /dissolved oxygen

Oxygen gas

Oxygen gas

Oxygen gas

Oxygen gas

Oxygen gas

Main technicaldifferentiator

Oxygen enters sensor
through a small hole,
not a membrane

Vented and non-vented
O2 measurement

Vented and non-vented
O2 measurement

The combination of thematerials gold and lead
results in an extremely
stable operating point that
can hardly be shifted byexternal influences. In
addition, there is anencapsulated design
without gas exchange
through a porous
membrane, which makes
the sensor very robust inchallenging technicalenvironments (e.g.
chemical industry,
aerospace, process
technology, etc.).

Absolute method of
measurement(Coulometric),
extremely low levels ofdetection

Applications /application
examples for cat. 9
IMCI

Fixed installations,personal monitoring
devices in mines,
automotive emissions
testing, anaerobic
digestion/ biogas,
permeation

Fixed installations andmobile; safety,
emissions, automotive,
biogas, diving gas
analysis, env.
applications

Fixed installations andmobile; automotive,
medical, biogas, diving
gas analysis, env.
applications

Inerting processes,monitoring lower explosion
limits of industrial
processes

Permeability
measurement of film,
membranes, packaging
in pharmaceutical,
medical, foodapplications…

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Sensor attributes

Alphasense (capillary)

Honeywell(capillary)

Honeywell(membrane diffusion)

Dräger(membrane diffusion)

MOCON(Hersch)measurements (to20 ppb) in applications
such as packaging offood andpharmaceuticalpacking.
ATEX relevancy

Yes

Many designs: Yes

Many designs: Yes

Yes

No

Response time t90< 15 sVarious:

Various:< 40 sec. with dust filter< 5 minTypical safety
applications require 1015s

Automotive: < 40 s
(T99.5)
Biogas: < 15 s
Diving: < 30 s & < 7 sInit. output voltage

N/A

Typical capillary safety
portable: 8-12 MV in air(100 ohms load resistor)

Typical membrane
partial pressure: 913mV in 210mbar O2

Up to -20 mV

N/A

Init. output
amperage

100 μA for standard
2 year sensor

Typical capillary safety
portable device: 0.08mA– 0.12mA in air

55 to 85 μA in 21% O2@ 20°C

I0 40 to 65 μA

N/AMeasurementrange

0 – 30%Volumetric oxygen: 030% or 0-1000 ppm

0 – 100%

0 - 100% Vol%

200 ppt – 70 ppm

Lower detection
limit

20 ppb (cap. O2
sensors forpermeation
measurements only)

Typically safety: 0.1-1%
O2.

Typically: 0.023-0.47%
O2.

5000 ppm

200 ppt

Operating temp.
range-30 to +50 ⁰C-20°C to +50°C-20°C to +50°C-20°C to +40°C

30 to 43 oC

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Sensor attributes

Alphasense (capillary)

Honeywell(capillary)

Honeywell(membrane diffusion)

Dräger(membrane diffusion)

MOCON(Hersch)Operating pressure
range

80 – 120 kPa

Typically: 900-1100 hPAor 800-1200 hPa
depending on specificsensor design

Typically: 500-2000 hPa

700 to 1300 hPa

530-1200 hPa

Sensor power
requirements

Self-powered

Self-powered

Self-powered

Self-powered

Self-powered

Lifetime

1-3 years, standard is
2 years

1-2 years

1-2 years

1-2 years

1-4 years

Unique advantages
over alternativetechnologies

Minimal response topressure, temperatureand humidity, while
having a short warmup time and are selfpowered.

Section 4C of Honeywellrequest. Pages 8-9.

Section 4C of Honeywellrequest. Pages 8-9.

The sensor is resistant topoisoning by organic
saturated vapor
atmospheres (alkanols,
esters, ketones) whenmonitoring ignitable airvapor mixtures.

Detection of trace
quantities; absolute
method ofmeasurement(Coulometric) whichremoves the need forsensor calibration

Promisingalternatives to lead(please highlight
those only thatjustify further
research)

There are no lead-freealternatives which
offer the same
technical performanceas the lead capillary
sensorSection 6 of Honeywellrequest. Pages 10-20.

Section 6 of Honeywellrequest. Pages 10-20.

Different combinationsof anode, cathode andelectrolyte material arebeing tested, withscreening testing
identifying
combinations to takeforward for further
testing. However, it
should be noted that so
far all possible
substitute offers thesame performance aslead and as such there

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Sensor attributes

Alphasense (capillary)

Honeywell(capillary)

Honeywell(membrane diffusion)

Dräger(membrane diffusion)

MOCON(Hersch)is no certainty that amaterial with suitable
technical performancecan be identified.

Promisingalternative sensor
technologies(please highlight
those only thatjustify further
research)

There are noalternativetechnologies which
offer the same
technical performanceas the lead capillary
sensorRenewal requested
until

January 2027 forgeneral applications;
July for 2028 for ATEX
rated products

July 2031

Section 6 of Honeywellrequest. Pages 10-20.

Technical solutions arebeing developed, but are
not yet fully developed andare not protected bypatents.

No alternativetechnologies exist withsuitable technicalperformance

July 2031

December 2025

January 2028

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From the provided information, among the three sensor technologies, Hersch cells seem
technically more distinct. In contrast to the other two technologies, Hersch cells are capableof measuring absolute oxygen and much lower concentrations. However, differences andsimilarities in the technical capabilities and use cases of capillary oxygen sensors andpermeable membrane (partial pressure) sensors were not immediately clear to theconsultants. Upon request, (Honeywell 2024b) provided some additional information,summarized in Table 19-19 below. They also stated that both techniques allow themonitoring of oxygen, however volumetric measurements at 0-30% allows for a simpler
design and faster responding sensor, i.e. capillary sensors, as opposed to a partial pressure(membrane diffusion) sensor. (Alphasense 2024b) confirmed that capillary lead oxygen
sensors are less reactive to temperature and pressure, and are smaller. Partial pressure
oxygen sensors are larger than the standard format capillary oxygen sensors.
Table 19-19: Comparison of capillary and partial pressure sensors
AspectCapillary oxygen sensors

Measurement 0 to 30 % and 0 to 2 ppm O2
range

Partial pressure oxygen sensors
0 to 100 % O2

Advantages

Faster; more robust for variableapplications
andconditions,
including temperature, pressure,humidity, dirt, dust, vapours,
chemical extremes) which could
cause damage to the solid-state
diffusion barrier; safety standard
4seriessize,
operation
temperature range -20 to 50°C,
no passivation or H2 evolution

Linear 0 to 100%, stabletemperature
onboardcompensation, tolerant to CO2,
operation temperature range -20 to
50°C, no passivation or H2
evolution

Use cases

Personal monitoring, confined
space entry (fire safety, sewage,
bilge tanks, tank inspection, foodstorage, manufacturing lines,
mining), area monitoring, remotesensing, food packaging, leakdetection. Emissions monitoring,boiler/burner domestic, burner
efficiency commercial, landfill,outgassing, refinery

Exhaustmeasurement
test
equipment: exhaust measurement.
Biogas, Industrial monitoring of gas
generation/manufacture of bottledgas, in applications eg: Selfcontained breathing apparatus

Limitations

Rapid temperature and pressure Output pressure sensitivity
transients. Slightly non-linear.
Intolerant to CO2. Resolution at
low O2.

Source: (Honeywell 2024b)(Honeywell 2024b) also noted that there are size considerations, stating that there is noalternative lead-free anode in the industrial safety standard size/format (4series 17 mm
high, 20.4 mm diameter) as a drop-in replacement for instrument manufacturers (OEM),due to the fundamental chemistry limitations. Additional time will be required for design,development, recertification, approval, and intrinsic safety.

EUR [number] ENStudy to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

Interlinkage with exemption request IV-2022-2
Besides this renewal requests for exemption IV-1(b), covering sensors using lead anodes
including Hersch cells, MOCON also requested a renewal for exemption IV-43, which
permitted the use of cadmium anodes in Hersch cells. However, as the latter renewal
request was submitted less than 18 months before the expiry date, it is considered as a
new exemption request in this report (IV-2022-2) rather than a renewal request.
The consultants noticed inconsistencies between statements made in both exemption
requests when the specifications of lead anodes in Hersch cells are discussed. For
instance, in the request form for IV-2022-2, the applicants stated that lead is unsuitable formeasurements in the parts per trillion (ppt) range, while (MOCON 2022) indicated lower
detection limits of 200 ppt in the request for renewal for IV-1(b). Similarly, in the request for
exemption IV-2022-2, the applicants had stated that lead does not provide the “Coulometric”(absolute) accuracy and characteristics of cadmium, while claiming the opposite in the
renewal request for IV-1(b). When requested to clarify, (MOCON 2024a) provided thefollowing explanation:“The change in the statements relates to the change in our understanding which has beendeveloping as testing for lead, and lead-free alternatives which has been ongoing. At the
point that the cadmium renewal application was submitted, testing for lead had not yet
started as investigations into RoHS compliant alternatives was on-going but not indicating
the possibility of finding a viable alternative. Investigations into RoHS compliant alternatives
was not halted, but lead was added to the scope of the work which was intended to provide
an interim solution. By the time IV-1(b) renewal was submitted the investigations into lead
were underway and reflect our change in understanding. It is important to note that whilesensitivity has been maintained with the transition from cadmium to lead, there has been a
reduction in manufacturability of the lead sensors (~20% reduction in sensors which meet
performance criteria). Due to these manufacturing issues there is an increase in scrap ofsuch sensors from this, and therefore an increase in the use of lead overall to meet thecustomer demand for sensors of this type.”
When asked whether both variants of Hersch cells, with lead and cadmium anodes, wereneeded on the market and for which reasons, (MOCON 2024a) explained the following:“The application for lead was submitted to ensure that Hersch cell devices, as MOCON is
the only manufacturer worldwide of such devices, were able to be placed on the market.
This is due to the consideration that the timeframe to renew the use for cadmium had
passed and we were informed that this would be treated as a new application not benefitingfrom continued validity while the application was reviewed. The transition to lead ensuresthat the critical functions that Hersch cells provide are still able to be provided, although
there are manufacturability concerns as outlined in our answer above.“
When asked how the substitution of cadmium with lead was achieved and how long theprocess took, (MOCON 2024a) stated:
The properties of lead are the most similar to the original design of cadmium, however leadhas distinct different technical parameters compared to cadmium. Importantly however itstill offers the necessary technical performance, especially when compared to solutions thatare free from RoHS-restricted substances. Work to develop a fully RoHS-compliant
alternative is still on-going but requires more time. The process to move from cadmium tolead is expected to take 24-36 months in total, with the development of the lead sensor stillon-going. It is important to note that due to the larger fundamental differences in properties

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of RoHS restricted substances, the timeframe to qualify these substances is expected to belonger, and it is still not clear if they will be able to offer all of the necessary technicalperformance characteristics.
When first investigating a cadmium replacement, as well as RoHS compliant alternatives,
an important item that must be considered is thermodynamic nobility. Thermodynamic
nobility of any metal is assessed in contrast to the standard hydrogen electrode (0V). Metals
with a higher equilibrium reaction potential are considered more noble thus being less likely
to corrode and poor anode candidates. Lead's thermodynamic nobility is quite similar to thatof Cadmium, with standard reduction potentials of (-0.58V) and (-0.81V), respectively. When
first investigating a cadmium replacement, as well as RoHS compliant alternatives, an
important item that must be considered is thermodynamic nobility. Thermodynamic nobilityof any metal is assessed in contrast to the standard hydrogen electrode (0V). Metals with ahigher equilibrium reaction potential are considered more noble thus being less likely tocorrode and poor anode candidates. Lead's thermodynamic nobility is quite similar to thatof Cadmium, with standard reduction potentials of (-0.58V) and (-0.81V), respectively.
(MOCON 2024a) summarize that throughout the investigation, alternatives free from RoHSrestricted substances have been investigated, but to ensure that the unique functionality of
Hersch cells could still be offered a shorter term solution in lead was implemented.

19.3.4. Substitution and elimination of the restricted substances
All applicants have described the challenges of substituting lead used in oxygen sensor
anodes with alternative metals. Honeywell was requested to elaborate on their testing
efforts using alternative anode materials, using tin as an example that is repeatedly
mentioned in the applicants’ renewal request forms, and which had been claimed to selfcorrode. (Honeywell 2024a) elaborated that no specific testing has been undertaken toexperimentally prove such an outcome, as the outcome is able to be predicted by basic
theoretical understanding of device types. Certain anode materials that are less active thanlead tend to passivate (form an insoluble oxide, so the sensor stops working), such as
bismuth and antimony. One approach used to reduce the activity of tin is to alloy it with lessactive materials. However, this does not completely solve the issue. Such sensors still
passivate before the whole anode is used up, because the more active material (tin) is
consumed first then the remainder is passive. Tin alloys and bismuth can be used in some
applications – for example medical sensors where there is a huge excess of anode (about
10x higher than is theoretically needed) and where the sensor current is very low. Thisapproach is not practical for portable safety sensors, where the whole of the anode needs
to be useable to achieve the necessary lifetime. In addition to this such applications which
use tin anodes require a load resistor to meet the voltage requirements, but has the
disadvantage that a lower sensor output current reduces resolution and accuracy, as wellas increasing noise. As such it is not a viable solution in the applications considered in the
renewal request.
In the following, substitution and elimination are discussed individually for each of the three
requested sensor technologies.

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Capillary oxygen sensors
Lead-free permeable membrane oxygen sensors are available on the market, however,according to the applicants, lead-free variants of capillary sensors are not.
Alphasense stated that the capillary industrial market is expected to change toamperometric sensors when technical issues are resolved, for which they estimate atimeframe until January 2027 for general applications and July 2028 for ATEX-rated
products. However, Honeywell requested a renewal of the exemption for capillary sensors
for the maximum validity period.
When requested to provide argumentation for requesting the maximum validity period,(Honeywell 2023b) stated to agree, in principle, with the validity period requested by
Alphasense at the sensor level. However, additional time will be required for instrument
development and certification as outlined in the Honeywell derogation. (Honeywell 2024b)
elaborated that Honeywell is a sensor manufacturer, as well as a Gas Instrumentation
manufacturer (OEM). Honeywell uses gas sensor products, and as such, need to take into
consideration both the timeframes needed to develop and validate a lead-free sensor(component), as well as the instrumentation (system) development, validation, andapprovals. For example, the Alphasense application outlines a timeline for sensor
development, however, it does not capture the need for instrument development. To thebest of our knowledge, Alphasense do not offer instrumentation. From Honeywell’s
perspective it is the instrument redesign, development, intrinsic safety, and approvals
through notified bodies (Atex, mining, EN, UKCA, AS/NZS, ANSI/ISA, BS EN) which will
require the majority of the time.
In the consultants’ view, the fact that Alphasense is capable of phasing out lead-based
capillary oxygen sensors through elimination until July 2028 makes it likely that the
manufacturers of instruments in which the sensors are used will also be adapted until thattime, otherwise there would be no market for Alphasense’s lead-free sensors. The
evaluation by instrument manufacturer’s is estimated to take 6 months or more, according
to Alphasense. This casts some doubt onto whether the industry is dependent on a renewalby the maximum validity period to achieve the development and qualification of lead-freecapillary oxygen sensors and their instruments, as requested by Honeywell. Potentially, a
renewal shorter than the requested maximum validity period may have to reflect this.
Hersch cells
The technical differentiator of Hersch cells is their capacity to measure extremely low levelsof oxygen concentrations, down to 200 ppt. (MOCON 2024b) confirmed that Hersch cells
are exclusively used for the measurement of permeation, as described in their renewal
request form. As MOCON are the only supplier of Hersch cells, they can determine withcertainty that the only lead-free Hersch cells are their own variant that uses cadmium
instead of lead.
MOCON have in the past made use of RoHS exemption IV-43 that covered Hersch cellswith cadmium anodes, however, as MOCON had not submitted a request on time for arenewal, exemption 43 is set to expire on 15 July 2023 107. To ensure the availability of

107 In parallel to this request for renewal of exemption IV-1(b), MOCON have submitted a parallel request to

exempt cadmium for Hersch cells, which is labelled exemption IV-2022-2 in this report.

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Hersch cells on the market despite the expiry of exemption IV-43, MOCON applied forrenewal of exemption IV-1(b) to allow them to place a Hersch cell variant using lead as
anode material on the EU market.
MOCON have described that only cadmium and lead meet the technical criteria to
manufacture Hersch cells. The applicant has plausibly outlined that other sensor
technologies are not capable of matching the technical specifications of Hersch cells.
(MOCON 2024a) explicitly confirmed that there are no other sensor technologies that
perform absolute measurements at similarly low oxygen concentration ranges, stating that
Hersch cells are a proprietary design and as such no other manufacturer of such devices,
irrespective of the anode material, can produce them.
When requested to provide more detail on the research and development of Hersch cells
that do not rely on substances restricted by the RoHS Directive, (MOCON 2024a) confirmed
to continue to research potential anode substitutes for both cadmium and lead based
Hersch sensors. However, due to the demanding technical requirements of a Hersch cell,
any change can have a detrimental impact on performance. For example, changing a single
component in the cadmium version of the Hersch cell took 3 years to undertake and fully
qualify. As a result, the development of a fully RoHS-compliant Hersch cell requires
meticulous and time-consuming attention to detail. Additional theoretical and experimental
work has been conducted to narrow down potential candidates. Based on theoretical cellpotentials, only seven metals exhibit characteristics that could work inside a Hersch
Coulometric Cell (Alkaline Electrolyte). Three of these have been the focus of ongoingexperimental investigations as they have the most similarities to lead and cadmium.
However, experiment results have still not led to a suitable substitute. Shifting to an acidic
electrolyte could open new options, which will be studied if no encouraging progress is madewith the current alkaline one. The move to an acidic electrolyte would trigger the need formore extensive testing and potentially design changes of the sensor. Overall this would
have the impact of creating an even longer timeline to qualify a RoHS-substance freealternative, and why this has not been trailed at this point.
(MOCON 2024a) conclude that it is still uncertain whether a RoHS compliant alternative
anode material will be able to offer the necessary technical performance they require of the
Hersch Cell. Even with the most recent developments in technology, there are no othertechnologies which can detect oxygen to the very low concentrations which Hersch cells
are able to detect.
When asked whether the renewal of exemption 1(b) was required in case their exemption
request covering cadmium in Hersch cells (IV-2022-2) was granted by the COM, (MOCON
2024b) denied this, stating that as long as there is an exemption permitting the use of
Hersch cells on a continuing basis, only one or the other exemption would need to be
granted to cover the necessary uses. However, it is essential that the lead based exemption
is not rejected until the cadmium based exemption is fully implemented, such that devices
are able to be continually sold in the EU.
MOCON described that both variants perform equally well, but that cadmium is consideredmore toxic than lead. Asked whether, against this background, it would not be preferable tomaintain lead-based Hersch cells while phasing out cadmium-based sensors, (MOCON
2024b) responded that it would be their preference that the exemption for cadmium be
granted over lead due to the reduction in manufacturability of the lead sensors (~20%
reduction in sensors which meet performance criteria). Due to these manufacturing issues
there is an increase in scrap of such sensors from this, and therefore an increase in the use

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of lead overall to meet the customer demand for sensors of this type. It is also worthwhile
noting that there is a difference between the amount of RoHS-restricted substance required
for a cadmium sensor and a lead sensor, so this should be considered when reviewing thepotential environmental impact. The cadmium Hersch sensor uses at least 24% lessmaterial by weight than the lead Hersch sensor.
Relating to their request for exemption IV-2022-2, when asked to explain for which reason
the requested wording includes a sensitivity threshold “below 100 ppm”, when the wordingof exemption IV-43 included a threshold of “below 10 ppm”, (MOCON 2024b) stated thatthe useable range of the Hersch cell sensor is between 200 ppt and 70 ppm. As such,
although both values are correct, it is most accurate to say that the sensor is able tomeasure to 100 ppm and below.
The consultants agree that setting at 100 ppm appears more suitable to cover Hersch
sensors that measure the given range, while 10 ppm might lead to some uncertainty. In
practice, if a potential exemption wording included the term “Hersch” cell or sensor as was
requested by the applicant, the scope of the exemption would not differ with either value.
When asked whether differing wording was required for both requested exemptions,(MOCON 2024b) stated that the differences in requested exemption wording is a reflectionof our thinking at the time in which the exemptions were submitted and not a reflection oftechnical differences. As such, either wording would cover MOCON applications.
In the consultants’ view, the information provided by the applicants plausibly demonstratethat only Hersch cells are capable of measuring the extremely low oxygen concentration
ranges, and that, thus far, only lead- and cadmium-based anodes are capable of achieving
this. Therefore, it seems reasonable to the consultants that the substitution and elimination
are technically and scientifically not yet practicable. Further, to ensure that Hersch cells
continue to be available on the market, it appears reasonable to renew exemption 1(b) tocover lead-based Hersch cells until a new exemption for cadmium-based Hersch cells canbe granted.
Permeable membrane / partial pressure oxygen sensors
Lead-free permeable membrane / partial pressure oxygen sensors have been available on
the market for several years, as had already been discussed in the previous review of
exemption 1(b) by (Deubzer et al. 2022). At the time of the previous review, remaining
uncertainty regarding the performance and reliability of lead-free alternatives had been
discussed.
For the current review, Dräger requested a renewal of this exemption for permeable
membrane oxygen sensors until the end of 2025, and the maximum validity period foroxygen sensors as spare parts. Honeywell requested a renewal for permeable membrane
oxygen sensors for the maximum validity period.
When requested to explain whether the membrane diffusion cells are identical in technology
to those in Dräger’s renewal request, (Honeywell 2024a) elaborated that they are in fact
identical technologies but, utilised across different applications, stating that it is important
to note that due to the difference in end applications, the testing requirements to qualify
alternatives in each application are likely to differ and hence explain the difference in theneed for different validity periods requested. (Honeywell 2024b) added that from the publicly
accessible information which Drager submitted, there is no breakdown of the timeline which422

Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU

they requested. As such it is assumed that they also do not have a need for instrument
redesign, development, intrinsic safety and approvals through notified bodies. However, thisis an assumption made on publicly available information and additional information should
be shared to confirm this.
When asked how the phasing out of lead-based partial pressure sensors will be achieved,(Dräger 2024b) explained that their strategy does not require redesigning analyser
instruments, but adapting an existing lead-free sensor to also be operated in an existingmeasuring head. The new sensors are still electrochemical amperometric gas sensors, butwith a three or four-electrode design and will be operated by a potentiostat in order to obtain
the required driving force to reduce oxygen. When asked about the applications of their
sensors, (Dräger 2024b) responded that while monitoring the lower explosion limit isprobably the most technically demanding, the sensors are also used in other inerting
applications, especially where light gases (such as hydrogen or helium) can also occur.
Oxygen displacement by these gases can only be reliably detected with a membranecovered oxygen sensor. The exemption sought by Dräger relates only to stationary
measuring heads in various industrial applications, generally to ensure occupational safety
for our customers' employees. (Dräger 2024b) also added that in their perception, any
future-oriented company should have been able to develop suitable alternatives to leadbased oxygen gas sensors within the last years.
Maxell, a supplier of lead-free permeable membrane oxygen sensors was invited tocomment on their view whether the exemption for lead was still needed for permeable
membrane oxygen sensors. (Maxell 2024) stated to have released a galvanic cell type leadfree oxygen sensor in 2019, based on a tin alloy anode and a weak acid electrolyte
consisting mainly of citric acid. These allowed the reaction to proceed without passivating
the tin, and achieved characteristics equivalent to those of leaded oxygen sensors. It has
been used in mass-produced equipment, switching from leaded oxygen sensors, and has
not caused any problems in the market. Differences in characteristics and appearance
between sensor manufacturers can be accommodated by the software and hardware of thedevice. In addition, Maxell's lead-free oxygen sensors are similar to leaded oxygen sensors
in both characteristics and end-of-life behavior, making the switch relatively easy in theiropinion. However, since no formal decision has been made after the report on RoHS Pack
21 by (Deubzer et al. 2022) was released, many customers are still trying to continue using
leaded oxygen sensors. On the other hand, Maxell have determined that their lead-freeoxygen sensors are technically ready to replace leaded oxygen sensors, which led them todecide to discontinue lead oxygen sensors in March 2025, after which Maxell will sell only
lead-free sensors.
Maxell referenced a press statement108, in which they announced to discontinue the sale oftheir KE series leaded galvanic cell-type oxygen sensors after 35 years, with last orders
accepted until September 2024, to switch to their successor, the KE-LF series lead-freegalvanic cell-type oxygen sensors. Examples for applications include combustion gas
monitoring and oxygen concentration measuring devices (oxygen monitors). Further
application examples mentioned on their website include health and safety, biotechnology,

108 Maxell press release “Discontinuation of KE series leaded galvanic cell-type oxygen sensors, available:

https://ssl4.eir-parts.net/doc/6810/ir_material22/209430/00.pdf (accessed 28 January 2024)

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medical devices and health equipment, food storage, and education. Some of the sensors’
specifications are reproduced in the Table 19-20.
Table 19-20: Specifications of lead-free galvanic oxygen sensors from Maxell109
Model

KE-25LF/KE25F3LF

Features

Standard productMeasurement
range
Initial output
voltage

KE-50LF

Fast responsetimeLong life0 ∼ 30 % O2
10∼15.5 mVOperatingtemperature
range

9∼15 mV

KE-25F3LFM
Measurable up
to 100 % O2
0 ∼ 100 % O2

4.5∼7.5 mV

5∼8 mV5 ∼ 40 ℃

Operatingpressure range
90% responsetime

KE-12F3LF

811~1216 hPa
Approx. 15 sec.

Power

Approx. 8 sec.

Approx. 60 sec.

Approx. 15 sec.

Self-powered

Lifetime

Approx. 5 years

Approx. 3 years

Approx. 10 years

Approx. 6 years

Source: Maxell109

Maxell were also invited to comment on specific arguments provided by the applicants tojustify the renewal of this exemption, to which (Maxell 2024) provided the following
information:−

Measurement of extremely low oxygen concentrations: Maxell’s lead-free oxygen
sensors cannot measure extremely low oxygen concentrations at the moment.

−

Measurement in the subzero temperature range: Maxell’s lead-free oxygen sensors
can measure even at -20°C because the electrolyte solution does not freeze. A
sensor that can be used at -30°C is currently under development.

−

Temperature- and pressure-dependence: According to (Maxell 2024), these are thefeatures of the capillary type. Maxell’s lead-free sensors, which are membrane type,can be used if instruments are adjusted accordingly while they are affected bytemperature and pressure.

109 Website of Maxell for lead-free oxygen sensors (O2 sensors), available:

https://biz.maxell.com/en/tokki/oxygen_sensors.html (accessed 28 January 2024)

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Lead-free sensors are affected by the presence of CO2: All of Maxell's lead-freeoxygen sensors use originally developed weak acidic electrolyte solution, so they
are unaffected by CO2 as disclosed in the KE-25 F3LFM news release110.

−

No lead-free sensors have been ATEX approved: According to (Maxell 2024), bothMaxell's lead-free and leaded oxygen sensors have the same sensor current. The
current flowing to the sensor at 1 atmosphere pressure (atm) in air is less than 15 μA
for standard models, so the sensor cannot be a source of ignition. Maxell believethat the explosion-proof design of the device itself is the critical issue, while whether
the sensor could be a source of ignition is not the reason for extending the
exemption.

In conclusion, (Maxell 2024) state that in their view, customers using oxygen sensors stilltend to continue using leaded oxygen sensors. (Maxell 2024) believe that, depending on
the outcome of the review, the shift to lead-free products in the industry can be accelerated.
The applicants were requested to provide arguments for why the exemption is needed whilelead-free permeable membrane oxygen sensors are available on the market.
(Honeywell 2024b) stated that the alternative lead-free anode options from Honeywell andother manufacturers are dimensionally larger compared to the current industrial safety
standard size/format (4series 17mm high, 20.4mm diameter) at 47.3mm/50mm high and
28mm/22.7mm diameter respectively. Currently there are no alternative lead-free anodeoptions available as a drop-in replacement for the instrument manufacturers (OEM), due tothe fundamental chemistry limitations. There is no backwards compatible sensor, form, fit
or function for the industry.
(Honeywell 2024b) further stated that technical characteristics that would require a leadbased sensor compared to the lead-free variant will be specific to the application andenvironmental conditions e.g., temperature, pressure, humidity, and other external
environmental factors. Such factors may limit usage in exhaust measurement test
equipment, biogas, and industrial monitoring of gas generation/manufacture of bottled gas
and in applications such as self-contained breathing apparatus.
Dräger had described that commercially available oxygen sensors using tin anodes in acaesium carbonate electrolyte are being sold in the EU, however that an evaluation of thesesensors found that they do not meet their specifications when used with existing designs ofanalysing instruments. When asked to elaborate on which specifications could not be met,
(Dräger 2024b) explained that the commercially available oxygen sensors that they had
tested so far did not meet the requirements of a typical application of a Dräger customer.
They either observed several sensor failures already at the very beginning of theirevaluation tests, indicating insufficient sensor quality, or the sensors did not meet therequired specifications in the first place and the suppliers were not willing or able to adapt
the sensor specifications to their needs. One example is a sensor that was developed forthe medical market in the same way as Dräger lead-containing oxygen sensors, but only
has a lower temperature limit of 0°C. As temperatures down to -20°C are also required and

110 Maxell press release on lead-free galvanic cell-type oxygen sensors suitable for medical use:

https://biz.maxell.com/en/tokki/20210413NR_LFo2sensors_en.pdf (accessed 1st March 2024)

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are also used by customers, this sensor is not suitable to be qualified as a 1:1 replacementfor our current sensor.
(Dräger 2024a) added that they have had lead-free oxygen sensors in their portfolio for over
30 years, which is significantly longer than the RoHS II directive requires the replacementof lead in oxygen sensors. Hundreds of thousands of sensors are now manufactured every
year using lead-free technology, compared to a few thousand sensors that still contain lead.
There are several reasons why this lead-containing type of sensor is being retained. Firstly,
this is due to the robustness and durability of Dräger gas measurement transmitters, which
are often used by their customers for decades and regularly require replacement sensors.
For reasons of sustainability in the use of valuable resources, they do not consider it
necessary to replace fully functional gas measuring transmitters prematurely. On the other
hand, it is also due to the extremely demanding measuring task that the sensors have tofulfil in practice. The transmitters that require this type of sensor operate under extremely
harsh conditions, which currently only the leaded version of Dräger’s oxygen sensor cansurvive in the long term. The development of a lead-free oxygen sensor for these harshconditions is accompanied by extreme challenges, as lead-free sensors, for example, haveto be much more open to their environment, as they generate O2 in their interior as so-called
oxygen pumps, which must be continuously dissipated. At the same time, however,interfering substances such as organic vapors must be prevented from penetrating thesensor and causing malfunctions.
(Dräger 2024a) stated to be confident that they will be able to achieve this with great effort
for the remaining applications of lead-containing sensors, but cannot explain this in moredetail at this point due to the lack of patent protection. The fact is that the vast majority ofindustrial applications are currently served by lead-free oxygen sensors and they still needsome time to achieve this for the remaining sensors.
In the consultants’ view, it can be concluded that lead-free permeable membrane sensors
are technically practicable, as has been demonstrated by market-available products.
Further, as was explained by Dräger, permeable membrane oxygen sensors can beeliminated by using alternative, lead-free technologies, such as amperometric sensors
featuring three or four electrodes, although not all technological challenges have yet been
overcome for a complete transition.
The applicants argue that available lead-free solutions are not drop-in replacements forexisting instruments, due to technical differences in form, fit, and function, requiring moretime for the redesign of instruments that use the oxygen sensors. Dräger reported to havefound a workable solution that can be fully implemented until the end of 2025. Honeywellstate to require the maximum validity period of 7 years to continue the process. The
consultants acknowledge that the applications for which Dräger and Honeywell manufacture
their sensors and instruments may be different, which may be a determinant of the differing
timelines.
(Dräger 2023a) requested a renewal of this exemption for new instruments that use
electrochemical oxygen sensors and for the maximum validity period for oxygen sensors
that are spare parts for instruments placed on the market until the end of 2025. (Dräger
2023b) confirmed that their intention is to continue servicing those instruments that were
designed to work with type of a sensor for which the exemption is requested beyond 2025
and that after the end of 2025, Dräger will no longer put onto the market lead containing
sensors.

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In the consultants’ view, RoHS Art. 4(4)(f) postulates that the substance restrictions
stipulated by RoHS Art. 4(1) do not apply to ‘spare parts’ for EEE which benefitted from an
exemption and which was placed on the market before that exemption expired. When asked
whether Dräger consider replacement oxygen sensors to be ‘spare parts‘ in the sense of
the definition under RoHS Art. 3(27), (Dräger 2023b) confirmed this to be the case, statingthat Electrochemical sensors used in our industrial monitoring and control instruments havea life span of maximum one year. After this period, the sensor must be replaced for thedevice to continue functioning as intended. In the absence of the replacement sensor, thedevice will be rendered non-functional.
Stakeholder contribution of COCIR
The consultants agree that the intention of the wording of for the recommended exemption
IV-1(b)(I) was to include both oxygen sensors sold as consumables as part equipment aswell as consumables sold as sensors to replace spent sensors. Therefore, introducing thechanged wording proposed by COCIR should increase the clarity of what is covered by the
exemption. The consultants do not consider any risk that the scope of the proposed
exemption is broadened by such a change.

19.3.5. Environmental, health, safety, and socio-economic impacts
Given that lead-free sensors seem to be able to cover many, but not all applications (usecases), it is conceivable that at least some of the impacts described by the applicants may
occur in case the exemption was not renewed as requested.

19.3.6. Summary and conclusions
Four applicants requested the renewal of this exemption, requesting different wording andvalidity periods, for industrial monitoring and control instruments of RoHS EEE category 9.
The applicants describe three distinct oxygen sensor technologies that require theexemption:−

capillary oxygen sensors (Alphasense and Honeywell),−

Hersch cell oxygen sensors (MOCON), and−permeable membrane / partial pressure oxygen sensors (Honeywell and Dräger).

These differ in their technology, technical specifications, and applications (use cases). All
sensors for which the renewal is requested measure oxygen in gases, rather than dissolved
oxygen in liquids.
During the last review of this exemption, (Deubzer et al. 2022) recommended to narrow theexemption wording to adapt to the scientific and technical progress. For sensors measuringoxygen in gases, the applicants at that time, JBCE, agreed to include two criteria in the
exemption wording to achieve this: Handheld instruments and sensors with a reaction time
above 3 seconds (t95) were found to not require lead and thus were excluded from thescope of the recommended wording. However, all applicants during the current review of
exemption IV-1(b) stated that these criteria do not apply to their technologies andapplications, and that lead is still needed in sensors and instruments that would be excluded

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if the two criteria were included in the exemption wording. Their sensors rely on different
technologies, have different specifications are applied in different use cases, which cannot
all be covered using lead-free alternatives.
Capillary oxygen sensors
Oxygen enters capillary oxygen sensors through a small hole that restricts the flow ofoxygen, by which the consumption of the anode is slowed and thereby the lifetime of thesensor is extended. In contrast to partial pressure / permeable membrane sensors, they aresmaller, measure only lower oxygen concentrations up to 30 % (rather than 100 % likepartial pressure sensors), and are used for different applications, including personalmonitoring.
No lead-free capillary oxygen sensors have been stated to be available on the market.
Alphasense requested a renewal until January 2027 for general applications and until July
2028 for ATEX-rated products. Honeywell requested a renewal for the maximum validity
period of 7 years, i.e. until 21 July 2031.
Alphasense explained to transition to lead-free amperometric sensors, which they also
stated is expected for the majority of the capillary industrial market, once the remaining
technical issues are solved. This transition would be possible within the requested validity
period of three and four years for specified uses. Honeywell refer to the fact that they needto account for adaptation of their instruments in addition to adaptation of the sensors, thus
requesting a longer validity period.
Both applicants did not agree that the recommendations made by (Deubzer et al. 2022)
after the last review of exemption 1(b) could be adopted for applications falling undercategory 9 IMCI. One difference to the applications for which the previous applicant, JBCE,
had requested the exemption, according to Alphasense, is that JBCE did not outline usesof their sensors in the industrial safety market, which is the main market for the Alphasense
sensors.
In the consultants’ opinion, as Alphasense have described that the majority of the capillary
oxygen sensor industry is expected to shift to lead-free amperometric sensors after
technical challenges have been solved, it may be possible to phase out lead-containing
capillary oxygen sensors sooner than the maximum validity period requested by Honeywell.
Although Honeywell has described amperometric sensors as having different form, fit, andfunction and so are not drop-in replacements for lead-based capillary oxygen sensors,
requiring the redesign of the relevant instruments, the consultants consider that the
maximum validity period may not be needed for all stakeholders in the industry. Honeywellargued that Alphasense only manufactures sensors, not oxygen sensor instruments,
however, the consultants consider that Alphasense would not be able to phase out theirlead-based sensors in favour of lead-free alternatives if their customers, being instrument
manufacturers and end users, were not ready for it. Therefore, it appears sensible to theconsultants to renew the exemption for capillary oxygen sensors not for the maximum
validity period until 2031, but until July 2028 as requested by Alphasense. Suppliers ofcapillary oxygen sensors who still require the exemption thereafter will need to specify atthat time for which reasons they have not yet been able to make the transition, while
competitors in the same market have.

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Hersch cells
Hersch cells using lead anodes are developed by MOCON as it became clear that theirrenewal request for exemption IV-43, covering Hersch cells using cadmium anodes, wassubmitted too late for a renewal and would be considered a request for a new exemption(exemption IV-2022-2). This means that exemption IV-43 expired on 15 July 2023,
effectively banning Hersch cells using cadmium anodes from the EU market.
MOCON also rejected the consultants’ proposal to adopt the recommendations made by(Deubzer et al. 2022) for their equipment in scope of cat.9 IMCI on the basis that Herschcells are capable of absolute measurements and measurements of extremely low oxygen
concentration ranges, which no alternative technology can achieve, but their response time
is not within 3 seconds.
MOCON have provided plausible arguments that lead and cadmium are the only materials
that are currently capable to achieve the technical specifications required of Hersch cells,
including extremely low detection limits. These cannot be matched by other oxygen sensor
technologies either. Therefore, in the consultants’ view, a renewal of the exemption for
Hersch cells appears to be justified.
MOCON requested a renewal of exemption IV-1(b) until January 2028 to cover lead-based
Hersch cells. In parallel, MOCON requested an exemption (IV-2022-2) to cover cadmiumbased Hersch cells for the maximum validity period of 7 years. Given the lack of substitution
and elimination opportunities at the current time, the consultants consider the timeframe
justified.
Permeable membrane / partial pressure oxygen sensors
Dräger requested a renewal of this exemption for permeable membrane oxygen sensors in
new instruments only until the end of 2025, after which they stated to be able to transition
fully to lead-free amperometric oxygen sensors. Honeywell requested the exemption for the
maximum validity period, citing different end uses (applications).
Neither applicant agreed to the adoption of the recommendations made by (Deubzer et al.
2022) for their equipment in scope of cat. 9 IMCI. Both applicants claim that their sensor
technology does not meet the criterion to have a response time below 3 seconds. While
Dräger highlight that handheld devices do not require lead, Honeywell highlight that
handheld devices for different end uses do. Under these circumstances, the consultantsnote remaining uncertainty regarding whether handheld devices require the exemption ornot. A focus on substituting or eliminating lead-anodes in all applications may be more
promising in this case.
Lead-free permeable membrane oxygen sensors have been available on the market for
years. Suppliers like Maxell have announced to fully phase out their lead-based oxygen
sensors in favour of a series of lead-free variants.
For these reasons, the consultants do not consider it necessary to renew the exemption for
permeable membrane oxygen sensors for the maximum validity period as was requested
by Honeywell. A shorter validity period would signal to the industry at large that the transition
to lead-free is becoming both increasingly feasible and urgent.
The consultants note that Dräger had requested the exemption renewal for oxygen sensors
in new instruments until the end of 2025, and for oxygen sensors as spare parts placed on
the market before 1 January 2026 for the maximum validity period, i.e. 7 years. However,429

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in the consultants’ view, RoHS Art. 4(4)(f) postulates that the substance restrictions
stipulated by RoHS Art. 4(1) do not apply to ‘spare parts’ for EEE which benefitted from an
exemption and which was placed on the market before that exemption expired. Therefore,
the consultants do not consider it necessary to reflect spare parts in the exemption wording.
Further conclusions
In the consultants’ opinion, one challenge during the review of this exemption has been to
identify which of the arguments provided by the applicants apply to which of the oxygen
sensor technologies in scope of the multiple renewal requests. Differentiating the technicalspecifications and application requirements for each technology should, in the consultants’view, make it more practical to specifically discuss the progress that has been maderegarding substitution and elimination of RoHS-restricted substances. Therefore, theconsultants consider it advisable to specify the exemption wording further to reflect thedifferent technologies in scope of exemption 1(b).
Whether handheld instruments featuring lead-free sensors can cover all relevant use cases
could not be fully clarified during this review. It is therefore seen as advisable that potential
future reviews of the exemption request additional evidence from applicants on this aspect.

19.4.

Recommendation

The consultants recommend the renewal of exemption IV-1(b), however, the wording andscope recommended by (Deubzer et al. 2022) was not found to be applicable to theequipment in scope of the cat. 9 IMCI for which the requested renewal is discussed in thisreview, and therefore requires adaptation. If the COM decides to follow the consultants’recommendations, it is proposed to further split exemption 1(b) with the numbering,
wording, scopes, and validity periods as displayed in the table below, to adapt it to technicaland scientific progress:
No.

Exemption

Scope and dates of applicability

IV-1(b)Lead anodes in electrochemical oxygen
sensors

Expires on

Lead anodes in electrochemical sensors
that measure oxygen concentrations of
inhaled and/or exhaled air for patientsand that are intended to be used asconsumables in medical devices put on
the market before 26 May 2024.

Applies to cat. 8 medical devices otherthan in vitro diagnostic medical devices.

Lead in galvanic oxygen sensors in
instruments that are designed for themeasurement of dissolved oxygen inconcentrations below 30 ppb.

Applies to cat. 9 including industrial
monitoring and control instruments.

IV-1(b)(I)

IV-1(b)(II)-

Expires on-

Lead anodes in galvanic capillary
oxygen sensors in instruments that aredesigned for the measurement ofoxygen in gases.

21 July 2025

Expires on-

IV-1(b)(III)21 July 2021

21 July 2025

Applies to cat. 9 industrial monitoring
and control instruments.
Expires on

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IV-1(b)(IV)

Lead anodes in galvanic Hersch cells foroxygen sensors where sensitivity below
100 ppm is required.

-

21 January
applications-

21 July
products

2027

2028

for

for

general

ATEX-rated

Applies to cat. 9 industrial monitoring
and control instruments.
Expires on-

21 January 2028

IV-1(b)(V)Cadmium anodes in galvanic Herschcells for oxygen sensors where sensitivity
below 100 ppm is required.

Applies to cat. 9 industrial monitoring
and control instruments and expires on[7 years after official publication of the
COM’s decision]

IV-1(b)(VI)

Lead anodes in galvanic permeable
membrane
oxygensensors
in
instruments that are designed for themeasurement of oxygen in gases.

Applies to cat. 9 including industrial
monitoring and control instruments.
Expires on-

31 December 2025

The recommendation by (Deubzer et al. 2022) to expire exemption 1(b) with the previous
wording “lead anodes in electrochemical oxygen sensors” can be upheld. The wording andscope of the recommended exemption 1(b)(I) can also be upheld. From the recommended
exemption 1(b)(II), only clause (b) on oxygen sensors in instruments designed to measure
dissolved oxygen can be upheld, while clause (a) on sensors in instruments that measureoxygen in gases is omitted. In its place, the newly recommended exemptions 1(b)(III)through 1(b)(VI) more specifically address individual oxygen sensor technologies and reflect
the status of technical and scientific practicability of substitution and elimination via differing
validity periods.
The consultants further recommend that the COM ensures sufficient time between theofficial publication of the COM’s decision and the expiry date of the exemption to allow for
the preparation and timely submission of renewal requests 18 months prior to the expiry of
the exemption.
The consultants note that the proposed exemption IV-1(b)(V) is equivalent in wording andscope to the exemption IV-X that is proposed as a result of the review of MOCON’s
exemption request IV-2022-2. The COM may decide to grant the exemption as a new
exemption or under exemption 1(b), should they decide to follow the consultants’recommendations.
Finally, with a view to possible future renewal requests for the above recommended
exemptions, it could be seen as preferable to align the expiry dates to reduce the required
effort for future reviews. Such an aligned expiry date could be 21 July 2028. This would notaffect the recommended expiry date of exemption 1(b) on 21 July 2021.
Applicants’ feedback on the recommendations(Alphasense 2024(c)), (Dräger 2024(c) and (MOCON 2024c) stated to agree with the above
recommendations. (Honeywell 2024c) agree to the proposed scope of the exemption 1(b)431Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

but maintain their request for the maximimum validity period for necessary sensor
developments and their system level qualifications.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a).

19.5.

References

Alphasense (2023a): RoHS Annex V Request for renewal of exemption IV-1b. RoHS Pack 27.
Alphasense (RoHS 29). Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form_1b_Alphasense_final.pdf.
Alphasense (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Richard
Dudeney, Alphasense AMETEK, to Christian Clemm via e-mail. RoHS Pack 27. Alphasense(RoHS 29). Retrieved from https://rohs.biois.eu/Ex_IV-1b_Alphasense_Questionnaire1_Clarification-AnswersFinal.pdf.
Alphasense (2024a): Answers to questionnaire 2 sent by Richard Dudeney, Alphasense AMETEK,
to Christian Clemm via e-mail. RoHS Pack 27. Alphasense (RoHS 29).
Alphasense (2024b): Answers to questionnaire 3 sent by Richard Dudeney, Alphasense AMETEK,
to Christian Clemm via e-mail. RoHS Pack 27. Alphasense (RoHS 29).
Alphasense (2024c): Comments on recommendation exemption IV-1(b) sent by Richard Dudeney,
Alphasense AMETEK, to Christian Clemm via e-mail. RoHS Pack 27. Alphasense (RoHS 29).
Alphasense (2024d): Comments on adapted recommendation exemption IV-1(b) sent by Richard
Dudeney, Alphasense AMETEK, to Christian Clemm via e-mail. RoHS Pack 27. Alphasense(RoHS 29).
COCIR (2023): Answers to stakeholder questionnaire sent by Emily Jones, RINA, to ChristianClemm via e-mail. RoHS Pack 27. COCIR (RoHS 29).
CoGDEM (2023): Statement from CoGDEM on Exemption of Leaded Oxygen Sensors for
Industrial Gas Safety. RoHS Pack 27. CoGDEM (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Supporting%20information.zip.
Deubzer et al. (2022): Study to assess requests for renewal of 16 exemptions to Annex IV of
Directive 2011/65/EU. Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Amended Final Report. In cooperation with Dr. Deubzer,
Otmar, Fraunhofer IZM und UNITAR, Saskia Huber, Jana Rückschloss, Fraunhofer IZM, UNITAR
Christian Clemm und Bio I. S. Shailendra Mudgal. Hg. v. Publications Office of the European
Union. European Commission (RoHS 26, Pack 21). Retrieved fromhttps://op.europa.eu/en/publication-detail/-/publication/f46d5d27-2d8d-11ed-975d-01aa75ed71a1.
Dräger (2023a): RoHS Annex V Request for renewal of exemption IV-1b. RoHS Pack 27. Dräger(RoHS 29). Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form_1b_oxygen_sensors_Draeger_Safety_Cat09.pdf.
Dräger (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Kondwani Chiwina,
Dräger, to Christian Clemm via e-mail. RoHS Pack 27. Dräger (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Ex_IV-1b_Drager_Questionnaire-1_Clarification_Answers_2023-10-13.pdf.

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Dräger (2024a): Answers to questionnaire 2 sent by Kondwani Chiwina, Dräger, to ChristianClemm via e-mail. RoHS Pack 27. Dräger (RoHS 29).
Dräger (2024b): Answers to questionnaire 3 sent by Kondwani Chiwina, Dräger, to ChristianClemm via e-mail. RoHS Pack 27. Dräger (RoHS 29).
Dräger (2024c): Comments on recommendation IV-1(b) sent by Tobias Marsen, Dräger, toChristian Clemm via e-mail. RoHS Pack 27. Dräger (RoHS 29).
Dräger (2024d): Comments on adapted recommendation IV-1(b) sent by Kondwani Chiwina,
Dräger, to Christian Clemm via e-mail. RoHS Pack 27. Dräger (RoHS 29).
Goodman (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9. Final Report July
2006, amended 19 Sep 2006. ERA Report 2006-0383. In cooperation with Paul Goodman, ERA
Technology Ltd. ERA Technology Ltd. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf.
Honeywell (2023a): RoHS Annex V Request for renewal of exemption IV-1b. RoHS Pack 27.
Honeywell (RoHS 29). Retrieved fromhttps://rohs.biois.eu/RoHS_exemption_1b_Application_Form_Honeywell_Final.pdf.
Honeywell (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Emily Jones,
RINA, to Christian Clemm via e-mail. RoHS Pack 27. Honeywell (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Ex_IV-1b_Honeywell_Questionnaire-1_Clarification_Answers%20Final.pdf.
Honeywell (2024a): Answers to questionnaire 2 sent by Emily Jones, RINA, to Christian Clemm via
e-mail. RoHS Pack 27. Honeywell (RoHS 29).
Honeywell (2024b): Answers to questionnaire 3 sent by Emily Jones, RINA, to Christian Clemm via
e-mail. RoHS Pack 27. Honeywell (RoHS 29).
Honeywell (2024c): Comments on recommendation exemption IV-1(b) sent by Emily Jones, RINA,
to Christian Clemm via e-mail. RoHS Pack 27. Honeywell (RoHS 29).
Honeywell (2024d): Comments on adapted recommendation exemption IV-1(b) sent by Emily
Jones, RINA, to Christian Clemm via e-mail. RoHS Pack 27. Honeywell (RoHS 29).
JBCE (2024a): Communication from Tetsusaburo Miura, JBCE, to Christian Clemm via e-mail.
RoHS Pack 27. JBCE (RoHS 29).
JBCE (2024b): Comments on adapted recommendation exemption IV-1(b) sent by Tetsusaburo
Miura, JBCE, to Christian Clemm via e-mail. RoHS Pack 27. JBCE (RoHS 29).
Maxell (2024): Communication from Hideaki Tsuji, Maxell, to Christian Clemm via e-mail. RoHS
Pack 27. Maxell (RoHS 29).
MOCON (2022): RoHS Annex V Request for renewal of exemption IV-1b. RoHS Pack 27. MOCON(RoHS 29). Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form_1b_Mocon_V1.6%20EU.pdf.
MOCON (2023): Answers to questionnaire 1 (clarification questionnaire) sent by Emily Jones,
RINA, to Christian Clemm via e-mail. RoHS Pack 27. MOCON (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Ex_IV-1b_MOCON_Questionnaire-1_Clarification_Answers_Final.pdf.
MOCON (2024a): Answers to questionnaire 2 sent by Emily Jones, RINA, to Christian Clemm via
e-mail. RoHS Pack 27. MOCON (RoHS 29).

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MOCON (2024b): Answers to questionnaire 3 sent by Emily Jones, RINA, to Christian Clemm via
e-mail. RoHS Pack 27. MOCON (RoHS 29).
MOCON (2024c): Comments on recommendation exemption IV-1(b) sent by Maitheya Riva, RINA,
to Christian Clemm via e-mail. RoHS Pack 27. MOCON (RoHS 29).
MOCON (2024d): Comments on adapted recommendation exemption IV-1(b) sent by Emily Jones,
RINA, to Christian Clemm via e-mail. RoHS Pack 27. MOCON (RoHS 29).
Trolex (2023): Lead Oxygen Sensor Exemption Application. RoHS Pack 27. Trolex (RoHS 29).
Retrieved from https://rohs.biois.eu/Supporting%20information.zip.

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Exemption 1(c) of Annex IV: Pb, Cd and Hg in
infrared detectors
The below Table 20-1 shows the wording, scope and expiry dates of the exemption.
Table 20-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

IV-1(c)Lead, cadmium andmercury in infra-red
light detectors.

Applies to categories 8 and 9.
Expires on-

21 July 2021 for category 8 other than in vitro diagnostic
medical devices and for category 9 other than industrial
monitoring and control instruments.

-

21 July 2023 for category 8 in vitro diagnostic medical
devices.

-

21 July 2024 for category 9 industrial monitoring andcontrol instruments.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Bruker

Bruker Optics GmbH&Co.KG

Cat.

Category, referring to the categories of EEE specified in Annex I of thecurrent RoHS Directive 2011/65/EU

Cd

CadmiumCOM

European Commission

EEE

Electrical and electronic equipment

EU

European Union

FTIR

Fourier transform infrared

Hg

Mercury

IMCI

Industrial monitoring and control instruments

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IVD

In-vitro diagnostic medical devices

LIRS

long-wavelength infrared spectrum (8μm to 14μm)

MCT

mercury cadmium telluride

MIRS

medium wavelength infrared spectrum (3μm to 8μm)

NIRS

near infrared spectrum (0.78μm to 3μm)

Pb

Lead

PPTF

Polish Technological Platform on Photonics

RoHS 1

Directive 2002/95/EC

RoHS 2, RoHS Directive 2011/65/EU
VLIRS

20.1.

very long wave IR spectrum (14μm to 30μm)

Background and technical information

Bruker Optics GmbH & Co. KG (Bruker 2023a) (on 17 January 2023) and the PolishTechnological Platform on Photonics (PPTF 2023, on 20 January 2023) requested therenewal of exemption IV-1(c) as displayed in the below table for EEE of category (cat.) 9
industrial monitoring and control instruments (IMCIs).
Table 20-2: Requested exemption renewal
No.

Requested exemption

Requested scope and dates
of applicability

IV1(c)

Lead, cadmium and mercury in infra-red lightdetectors

Applies to category 9 industrial
monitoring
andcontrol
instruments.
Expires on 21 July 2031
(2024 +7 years)(trinamiX 2023) contributed to the stakeholder consultation in support of the renewal of the
exemption for mercury-cadmium-telluride (MCT) sensors and for lead-sulphide and leadselenide sensors. (PPTF 2023) did not answer the clarification questionnaire even upon
repeated request to do so. Their renewal request was therefore not reviewed.

20.1.1.

History of the exemption

The COM followed the recommendation of (Goodman 2006) and listed exemption 1(c) on
Annex IV of RoHS Directive 2011/65/EU (2011) (RoHS 2) when it was officially publishedin 2011. Due to its expiry for EEE of cat. 8 other than in-vitro diagnostic medical devices(IVD) and cat. 9 other than industrial monitoring and control instruments (IMCI) on 21 July
2021, requests for the renewal of exemption 7(c)(I) were submitted, which included therenewal of the exemption for cat. 8 IVD and cat. 9 IMCI despite their expiry on 21 July

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2023/2024 respectively. (Deubzer et al. 2022) reviewed the exemption renewal requests
and recommended an amendment of the wording according to Table 20-3.
Table 20-3: Renewal of current exemption IV-1(c) recommended by (Deubzer et al.
2022)
No.

Exemption

Scope and dates of applicability

1(c)-I

Cadmium and mercury in mercury
cadmium telluride (MCT) of infrared
light detectors

Applies to categories 8 and 9

Lead in lead sulphide (PbS) and leadselenide (PbSe) of infrared lightdetectors

Applies to categories 8 and 9

Lead in PZT ceramics of infrared lightdetectors

Applies to categories 8 and 91(c)-II

1(c)-III

Expires on 21 July 2028 for category 8
medical devices including in-vitro diagnostic
medical devices, and for category 9
monitoring and control instruments incl.
industrial
monitoring
andcontrol
instruments.

Expires on 21 July 2028 for category 8
medical devices including in-vitro diagnostic
medical devices, and for category 9
monitoring and control instruments incl.
industrial
monitoring
andcontrol
instruments.

Expires on 21 July 2027 for category 8
medical devices including in-vitro diagnostic
medical devices, and for category 9
monitoring and control instruments incl.
industrial monitoring and control
instruments

Source: (Deubzer et al. 2022)

20.1.2. Focus of the review
The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). In January 2023, (Bruker
2023a) therefore applied for the renewal of the current exemption 1(c) for cat. 9 incl.
industrial monitoring and control instruments since it was earmarked for expiry on 21 July2024 for this subcategory of cat. 9 EEE. The exemption thus became due for review eventhough the recommendation for the renewal of exemption 1(c) of (Deubzer et al. 2022)
included cat. 9 IMCI.
The COM asked the consultants to assess in their review of the exemption renewal request
at hand whether and how far the recommendation of (Deubzer et al. 2022) can be adopted
to cat. 9 IMCI in line with Art. 5(1)(a). A re-evaluation of the previous review by (Deubzer et
al. 2022) is not intended. The consultants will rely on the critical review conducted by(Deubzer et al. 2022) and on the resulting conclusions and recommendation unless therenewal request or stakeholder contributions give reasons to reassess the state of scienceand technology.

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20.1.3.

Summary of the requested exemption

According to (Bruker 2023a) this exemption request relates to the substances mercury andcadmium which are integral material components of photon sensitive semiconductor
elements in light detectors (HgCdTe or, simplified, MCT detectors) designed for operationin the mid-infrared spectral range. Bruker Optics manufactures FTIR spectrometer systems
which use this detector type as an indispensable detecting component for mobile, advanced
and research applications in the field of mid-infrared spectroscopy.
In the mid-infrared spectral range (400cm-1 … 4000cm-1), and, particularly, in the so-called
fingerprint range (~ 1500cm-1 - 700cm-1), there is no suitable substitute available to replace
MCT detectors regarding the following combination of unique features:•

The sensitivity has its peak in the spectral range below 1500cm-1 and is at least of
the order 1010…1011 Jones (when cooled at liquid nitrogen temperature). In addition,
the sensitivity can be further spectrally fine-tuned by the relative material
composition of the detector element to be optimal for the corresponding
spectroscopic application.

•

The detector allows for high interferometer scanning velocities and can provide atime resolution with a rise time down to the nanosecond range.

Infrared spectroscopy with FTIR instruments is a widely used technique in many fields, e.g.,life and material science, chemistry, pharma, forensics. The extension of the existing
exemption, which Bruker Optics applies for in this form, would make possible to retain thehigh level of quality in this research fields within the EU for the upcoming years.
Furthermore, according to (PPTF 2023) infrared measurement technology has various
advantages over different techniques - it is highly sensitive, selective and very fast, allowing
for real-time measurement of various substances, gases and fluids. The most common
measurement technique is infrared spectroscopy. It covers a range of techniques, mostly
based on absorption spectroscopy. As with all spectroscopic techniques, it can be used to
identify and study chemicals.
Especially the MWIR (3-8μm) and LWIR (8-14μm) IR spectra are useful for analytical
purposes:•

Many gases have only in the MWiR significantly strong absorption features.

•

The fundamental absorptions of many gases are much stronger in the MWIR thanthe overtone bands in the SWIR (e.g., CO2 and CH4).

•

Separation of the absorption “fingerprints” of different molecules is easier in the
MWIR and LWIR.

The most sensitive IR devices are based on photon detectors – i.e. compound
semiconductors using II-VI, III-V and IV-VI compounds. The variable band gap Hg1-xCdxTe(also called in short HgCdTe or MCT) has been undeniably the champion among the large
variety of material systems, offering 2x up to 100x better detectivity levels in the MWIR andespecially LWIR spectrum.
There are possible substitutes used in less demanding measurement applications – III-V
compound semiconductor detectors. However, despite many years of development there
have not yet been any commercially available detectors matching MCT detectors in termsof detectivity.

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20.1.4.

Technical description of the exemption and use of the restricted
substance

Like in 2020 (cf. Deubzer et al. 2022), the renewal of the current exemption IV-1(c) isrequested. (Bruker 2023a; PPTF 2023; Deubzer et al. 2022) provide technical descriptionsof the exemption. They mention only applications and restricted substances that were in thescope of the last review of the exemption by (Deubzer et al. 2022), namely mercurycadmium-telluride (MCT) detectors for application in Fourier transform infrared (FTIR)
instruments.

20.1.5.

Amount(s) of restricted substance(s) used under the exemption

According to (PPTF 2023) mercury and cadmium are the basic components of mercury
cadmium telluride (HgCdTe), the variable band gap semiconductor used for infrared
photodetectors. The concentration of mercury in a typical infrared detector single element
chip is approximately 0.7 % of chip weight. The concentration of cadmium in a typicalinfrared detector single element chip is approximately 0.5 % of chip weight.
(PPTF 2023) state that there is no accurate data available to quantify the amount of mercury
and cadmium entering the EU market annually through the application in the scope of
exemption IV-1(c). It is estimated that the annual global production of MCT detectors forcommercial applications is approximately 20,000 units per year. The weight of a single pixel
detector chip is approximately 0.005g (5*10-3 g). Typical detector contains 0.0000314g(3.14*10-5 g) of mercury and 0.0000235g (2.35*10-5 g) of cadmium. Therefore, the total
global amount of mercury in MCT detectors per year is about 0.6g, and 0.5g of cadmium.
The calculation of the annual amount of Cd and Hg placed on the EU market provided by(Bruker 2023a) is confidential. They state that it is less than 0.1 g mercury per year and lessthan 1g of cadmium per year.

20.2.
20.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substanceA detailed justification for the renewal of exemption IV-1(c) after 2021 and the applicants’current justification is provided by (Bruker 2023a; PPTF 2023; Deubzer et al. 2022)

20.2.2.

Environmental, health, safety and socioeconomic impacts(Bruker 2023a; PPTF 2023; Deubzer et al. 2022) describe the environmental, health, safety
and socio-economic impacts.

20.2.3.

Roadmap towards substitution or elimination of the restricted
substance(Bruker 2023a) state that Bruker does not develop detectors but integrates these essential
components in its own spectrometer systems. Therefore, Bruker depends on what is439

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available on the market which is regularly observed. The standard mid-infrared detector is
the RoHS compatible DLaTGS pyroelectric detector. MCT detectors are only used for
dedicated applications where the performance of an MCT detector is needed.
Furthermore, (Bruker 2023a) elaborated the stages that are necessary for establishment ofpossible substitutes. Substitute detectors must match the current MCT detectors regarding
the following properties:•

They should offer an at least comparable performance within the same spectral
range which a MCT detector can cover. In particular, the low wavenumber range
including the so-called fingerprint below 1500 cm-1 is of essential importance ininfrared spectroscopy.

•

They should offer an at least comparable fast response for applications in time
resolved spectroscopy.

•

They should not be significantly more expensive.

From the point of view of (Bruker 2023a), which is the point of view of a customer of detector
manufacturers, it is difficult to assess the time frame needed for having such a substitutedetector in sufficient quantities commercially available. According to (Bruker 2023a), theindustry is working on replacement types, but they expect that it will take at least 5 more
years to realise a commercial replacement.
(PPTF 2023) state that the establishment of substitutes for the RoHS regulated substances
would require:•

Improved design of the InAs/InAsSb detector heterostructures taking into accountunavoidable limitations of the MBE and MOCVD epitaxial techniques•

Refinement of the growth procedures to reduce concentration of residual
uncontrolled dopants, SR centers and density of dislocations in the InAs/InAsSb SLbased detector heterostructures•

Growth and characterization of the heterostructures for several types ofphotodetectors.

•

Processing, packaging and characterization of the several types of photodetectors
for medical applications•

Iterative corrections of the design and growth procedures of detector
heterostructures.

•

Development of fast and sensitive devices with the use of plasmonic enhanced
absorption of IR radiation

The above mentioned stages require a lot of effort in development and refinement of
epitaxial growth techniques – where actual results are visible in nanoscale and are quitedifficult to be measured. (PPTF 2023) estimates that it would take another 5-7 years to
introduce new type of III-V detectors with detectivity and reliability levels of MCT.

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20.2.4.

Stakeholder contributions(trinamiX 2023) provided answers to the consultation questionnaire. (trinamiX 2023) agree
to the argumentation of (Bruker 2023a) that exemption IV-1(c)-I (cf. Table 20-3) would cover
their applications of cadmium and mercury in EEE of category 9 industrial monitoring andcontrol instruments provided that the exemption would remain valid for four years, i.e. until
2028 as recommended by (Deubzer et al. 2022). Furthermore (trinamiX 2023) agree thatthe specifications of many mercury-free, cadmium-free and lead-free IR detectors on themarket are still not competitive and that since the review of (Deubzer et al. 2022) nobreakthrough in Hg, Cd and Pb free IR detectors has happened. It is still unclear if materials
with comparable properties can be developed. (trinamiX 2023) also agreed with thestatements made by (Bruker 2023a) in their socioeconomic analysis related to cadmium
and mercury in Fourier-Transform Infrared Spectroscopy.

20.3.
20.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several restrictions of cadmium and its compounds are listed on Annex XVII (cf. section 4.1
on page 48). None of those, however, is applicable to the use of cadmium and cadmium
compounds in the scope of exemption 1(c).
Further on, uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex
XVII contains several restrictions for lead and its compounds. None of those entries are
relevant for the use of lead and lead compounds in the scope of exemption IV-1(c) (cf.
section 4.2 on page 51 for details).
Finally, Annex XVII contains several restrictions for the use of mercury and its compounds.
None of those entries are relevant for the use of mercury and mercury compounds in thescope of exemption IV-1(c) (cf. section 4.3 on page 54 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.
Cadmium
Cadmium and several of its compounds are substances of very high concern but so far are
not adopted to Annex XIV as substances that require authorisation for use.
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With regards to Annex XVII, cadmium is mentioned in a few of the listed restrictions.
Paragraph 1 of entry 23 of Annex XVII refers to cadmium and several of its compounds
including cadmium telluride. Under this entry, several restrictions are mentioned for
cadmium and the compounds, among others:
1.

A list of various polymers in which Cd may not be used unless required in colour
for safety reasons.

2.

Shall not be used for cadmium plating111 metallic articles or components of articles
used in equipment and machinery in certain branches and applications, e.g.
cooling and freezing, food production, etc.

3.

Shall not be used in brazing fillers unless used for safety reasons

4.

Shall not be used or placed on the market if the concentration is equal to or greaterthan 0.01 % by weight of the metal in metal beads and other metal components forjewellery making, or metal parts of jewellery and imitation jewellery articles andhair accessories, e.g. in wristwatches.

In the scope of the requested exemption, Cd is neither used in polymers or jewellery or for
plating, nor as brazing filler. The above stipulations are therefore not applicable to the useof cadmium in the requested exemption.
Due to their carcinogenicity, entry 28 of Annex XVII does not allow the placing on themarket, or use of various substances as such, as constituents of other substances, or in
mixtures. Various compounds are mentioned in this respect, including among others
cadmium sulphide and cadmium nitrate.
The use of cadmium in the scope of the requested exemption cannot be considered placing
on the market cadmium or cadmium compounds in the sense of the above since cadmium
is used in an article.
Entry 72 lists substances which are classified as carcinogenic, mutagenic or toxic for
reproduction. It stipulates that the substances listed in column 1 of the table in Appendix 12
shall not be used in textiles, clothing and footwear. The table lists cadmium and its
compounds as listed under entries 28, 29 and 30. Like entry 28, this entry does not address
the use of cadmium in the scope of the requested exemption.
To conclude, none of the entries currently listed under REACH would apply to the case athand. The use of Cd in the scope of the requested exemption cannot be considered to
weaken the protection afforded by REACH. The exemption can therefore be renewed if therelevant stipulations of Art. 5(1)(a) apply.
Mercury
Annex XVII of the REACH Regulation contains several entries restricting the use of mercury
and of mercury compounds. Entry 18 restricts112 placing on the market, or use, as
substances or in mixtures mercury compounds where the substance are intended for certain

111‘Cadmium plating’ means any deposit or coating of metallic cadmium on a metallic surface

112 ECHA, https://echa.europa.eu/documents/10162/5a7222b0-9d3a-4a90-9e55-258149e92b1a442

Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU

uses, e.g. in treatment of industrial sewage or for the impregnation of heavy-duty industrial
textiles and yarn.
Mercury in the applications in scope of the requested exemption is not used for any of theabove applications, and the restrictions are therefore not applicable.
Entry 18a restricts the use of mercury113:•

in fever thermometers;•

in other measuring devices intended for sale to the general public (such as
manometers, barometers, sphygmomanometers, thermometers other than fever
thermometers);•

in a number of specified measuring devices intended for industrial and professionaluses,
inparticularbarometers,
hygrometers,
manometers,
sphygmomanometers114, strain gauges to be used with plethysmographs115,
tensiometers, thermometers and other non-electrical thermometric applications,mercury pycnometers and mercury metering devices for determination of thesoftening point.

To the consultants’ best knowledge, the applications in scope of the requested exemption
do not include the use of mercury in any of the above products/articles so that the above
restrictions do not apply.
Entry 62 lists several phenylmercury compounds116, which are, however, not related either
the use of mercury in the applications in the scope of the requested exemption.
No other relevant entries in regard to the use of mercury could be identified in Annex XIV
and Annex XVII. Based on the current status of these Annexes, the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if other criteria of Art. 5(1)(a) apply.
Mercury is also restricted in certain applications through the Mercury Regulation 2017/852
implementing the international Minamata Convention on Mercury of 2013. The Mercury
Regulation refers to the RoHS Directive in Article 8(1) on “New mercury-added products
and new manufacturing processes” and stipulates that “Economic operators shall not
manufacture or place on the market mercury-added products that were not being
manufactured prior to 1 January 2018 (‘new mercury-added products’) unless authorised to
do so by means of a decision taken pursuant to paragraph 6 of this Article or allowed to doso under Directive 2011/65/EU of the European Parliament and of the Council”.
If the COM grants the renewal of the requested exemption the use of mercury would beallowed under Directive 2011/65/EU so that the above restriction would not be applicable.

113 ECHA, https://echa.europa.eu/documents/10162/dbcaaec7-bd5b-4a7d-b164-23fa97950a86
114

Device used to measure blood pressure.

115

Device for measuring changes in volume within an organ.

116 ECHA, https://echa.europa.eu/substances-restricted-under-

reach?p_p_id=disslists_WAR_disslistsportlet&p_p_lifecycle=1&p_p_state=normal&p_p_mode=
view&_disslists_WAR_disslistsportlet_javax.portlet.action=searchDissLists

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Additionally, exemption IV-1(c) was listed on RoHS Annex IV when it was published in 2011.
The mercury-added products in the scope of exemption IV-1(c) thus have been
manufactured and placed on the market before 1 January 2018. The coherence with the
Mercury Regulation is therefore established.
Based on the current status of the REACH annexes, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

20.3.2.

Substitution and elimination of the restricted substance(Deubzer et al. 2022) proposed the renewal of the exemption as displayed in Table 20-3 onpage 437 stating that substitution or elimination of cadmium, lead and mercury in theapplications in scope of the renewed exemption IV-1(c) are scientifically and technically not
yet practicable so that granting the recommended exemption would be justified by Art.
5(1)(a).
According to (Bruker 2023a; trinamiX 2023) no new materials for substitution or
technologies for elimination of the restricted substances were identified since the last review
of exemption IV-1(c) by (Deubzer et al. 2022).
These statements are in line with the findings of (Deubzer et al. 2022) for the use of
cadmium and mercury in mercury-cadmium-telluride (MCT) detectors, and for the use oflead in lead-selenide (PbSe) and lead-sulphide (PbS) detectors. Substitution or eliminationof these substances in these detectors were neither practicable at the time of the review
nor foreseeable for the time period until July 2028 for which the exemption wasrecommended to be granted. This was different for lead in PZT infrared detectors for which
the expiry was hence recommended for 21 July 2027.
The applications of the restricted substances in MCT are the same like in the previous
review by (Deubzer et al. 2022), and scientific progress towards substitution or eliminationof the restricted substances has neither happened nor did the previous reviewers expect it
to happen in the coming years. the consultants therefore asked the applicant to agree toadopt the recommendation of (Deubzer et al. 2022) illustrated in Table 20-3. (Bruker 2023b)
agreed provided that the exemption remains valid for four years (until 2028). (trinamiX 2023)
as well confirmed their agreement (cf. section 20.2.4 on page 441).
PPTF neither answered the clarification questionnaire despite of repeated request to do so
nor did they contribute to the stakeholder contribution. Their renewal request was therefore
not reviewed further.

20.3.3.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;

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the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts causedby substitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

The consultants could not find any technical evidence to deviate from the technicalconclusions in the last review and to recommend a different exemption for cat.9 IMCI. The
recommended expiry date of 21 July 2028 does not need to be adapted in view of theapplications received.
Bruker and trinamiX agree to the adoption of the recommendation of (Deubzer et al. 2022)
for the renewal of exemption IV-1(c). The consultants therefore conclude that the exemption
III-1(c) can be renewed as recommended by (Deubzer et al. 2022).

20.4.

Recommendation

The consultants recommend the renewal of the exemption like proposed by (Deubzer et al.
2022).
No.

Exemption

Scope and dates of applicability

1(c)-I

Cadmium and mercury in mercury
cadmium telluride (MCT) of infrared
light detectors

Applies to categories 8 and 9

Lead in lead sulphide (PbS) and leadselenide (PbSe) of infrared lightdetectors

Applies to categories 8 and 9

Lead in PZT ceramics of infrared lightdetectors

Applies to categories 8 and 91(c)-II

1(c)-III

Expires on 21 July 2028 for category 8
medical devices including in-vitro diagnostic
medical devices, and for category 9
monitoring and control instruments incl.
industrial
monitoring
andcontrol
instruments.

Expires on 21 July 2028 for category 8
medical devices including in-vitro diagnostic
medical devices, and for category 9
monitoring and control instruments incl.
industrial
monitoring
andcontrol
instruments.

Expires on 21 July 2027 for category 8
medical devices including in-vitro diagnostic
medical devices, and for category 9
monitoring and control instruments incl.
industrial monitoring and control
instruments

Applicants’ feedback on the recommendation(Bruker 2023a) (applicant) and (trinamiX 2023) (contributor to the stakeholder consultation)agreed to the above proposal.

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The second applicant did not react on questions during this review of exemption 1(c)(I).

20.5.

References

Bruker (2023a): Request for renewal of exemption IV-1(c). RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form-final.pdf, Last updated 26.02.2024.
Bruker (2023b): Answers to questionnaire 1 (clarification questionnaire) sent via e-mail by Michael
Jütte, Bruker, to Alexandra Morozov, Fraunhofer IZM. RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/Ex_IV_1c_Bruker_Questionnaire-1_Clarification.pdf, Last updated 26.02.2024.
Deubzer et al. (2022): Study to assess requests for renewal of 16 exemptions to Annex IV of
Directive 2011/65/EU. Under the Framework Contract: Assistance to the Commission on technical,
socio-economic and cost-benefit assessments related to the implementation and further
development of EU waste legislation. Amended Final Report. In cooperation with Dr. Deubzer,
Otmar, Fraunhofer IZM und UNITAR, Saskia Huber, Jana Rückschloss, Fraunhofer IZM, UNITAR
Christian Clemm und Bio I. S. Shailendra Mudgal. Hg. v. Publications Office of the European
Union. European Commission (RoHS 26, Pack 21). Retrieved fromhttps://op.europa.eu/en/publication-detail/-/publication/f46d5d27-2d8d-11ed-975d-01aa75ed71a1,
Last updated 26.02.2024.
Goodman, Paul (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 - Final Report(amended). ERA Report 2006-0383. In cooperation with Chris Robertson. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf, Last updated
26.02.2024.
PPTF (2023): Request for renewal of exemption IV-1(c). RoHS Pack 27. Retrieved fromhttps://rohs.biois.eu/RoHS_V_Application_Form%202022_final.pdf, Last updated 28.02.2024.
trinamiX (2023): Answers to consultation questionnaire by trinamiX. Retrieved fromhttps://rohs.biois.eu/trinamiX.pdf, Last updated 28.02.2024.

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Exemption 4 of Annex IV: Lead in glass frits of X-ray
tubes, etc.
The below Table 21-1 shows the wording, scope and expiry dates of the exemption.
Table 21-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

IV-4

Lead in glass frit of X-ray tubes andimage intensifiers and lead in glass
frit binder for assembly of gas lasers
and for vacuum tubes that convert
electromagnetic radiation into
electrons.

Applies to category 8 and 9.
Expires on-

21 July 2021 for category 8 medical devices
other than in vitro diagnostic medical
devices, and for cat. 9 monitoring and control
instruments other than industrial monitoring
and control instruments-

21 July 2023 for cat. 8 in vitro diagnostic
medical devices-

21 July 2024 for cat. 9 industrial monitoring
and control instruments

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Cat.

Category, referring to the categories of EEE specified in Annex I of thecurrent RoHS Directive

COM

European Commission

EEA

European Economic Area

EEEElectrical and electronic equipment

IMCI

Industrial monitoring and control instrument

Lead-free

Not containing lead in the applications in scope of the exemption to bereviewed

SEA

Socioeconomic analysis

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21.1.

Background and technical information

On 20 January 2023, (TMC 2023a) requested the renewal of the above exemption for
category (cat.) 9 industrial monitoring and control instruments (IMCI) with the wording,scope and validity period shown in the table below.
Table 21-2: Requested exemption renewal
No.

Requested exemption

Requested scope and dates
of applicability

IV-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 thatconvert electromagnetic radiation into electrons.

Applies to category 9 industrial
monitoring and control
instruments.
Expires on 21 July 2031 (= 2024
+7 years) for category 9 industrial
monitoring and control
instruments.

(EPPA 2023) submitted a socioeconomic analysis (SEA) along with the renewal request of(TMC 2023a).

21.1.1.

History of the exemption(Goodman 2006) recommended exempting the types of EEE covered by the current
exemption IV-4 if EEE of cat. 8 and cat. 9 were included in the scope of the RoHS Directive.
Consequently, the current exemption 4 was listed in Annex IV of (Directive 2011/65/EU
2011) (RoHS 2) when it was published and enacted in 2011. (TMC 2023a) requested therenewal of the exemption for category (cat.) 9 IMCI to avoid its expiry on 21 July 2024 sothat the exemption is due for review for the first time since its adoption to Annex IV.

21.1.2.

Focus of the review

The European Commission (COM) have not yet officially published their decision as to theadoption of the above recommendation (status January 2024). On January 2023, (TMC
2023a) applied for the renewal of the current exemption 4 for cat. 9 since it was earmarked
for expiry on 21 July 2024 for this subcategory of cat. 9 EEE.

21.1.3.

Summary of the requested exemption(TMC 2023a) explain that precision lasers with high spectral purity are manufactured witha borosilicate glass rod with glass frit containing lead oxide (PbO). PbO glass frit has a low
melting point and excellent wetting characteristics, which achieves a thermally matchedbond of the glass rod to other components in the manufacture of precision lasers without
damaging or distorting the glass. The materials and heat cycle for attaching glass to metalmust be precisely controlled to avoid stresses caused by thermal expansion differences.

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Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU(TMC 2023a) state that the unique characteristics of lead make the substance a necessary
part of the functioning of glass frit, which cannot be substituted with other substances. The
Test & Measurement Coalition therefore applies for a renewal of exemption 4 (IV) for the
maximum validity period.
A Socio-Economic Analysis (SEA) (EPPA 2023) was conducted in addition to the technicalassessment and attached to the exemption request submission. Overall, the analysis
concludes that the total impact of non-renewal of this exemption is monetized in the rangeof 15 million EUR and 40 million EUR (conservative lower bound estimate).

21.1.4.

Technical description of the exemption and use of the restricted
substance(TMC 2023a) explain that the exemption is relevant for the following EEE or components
within Cat.9:•

Laser Interferometers and Calibration Systems (Monolithic Laser Combiners &Precision Optics).

•

Application-Specific Test Systems and Components.

•

Used Equipment in the above categories.

According to (TMC 2023a), these instruments are used in research, for quality control andtesting laboratories (including field testing) in universities, manufacturing and clinicalfacilities and by governmental agencies for conformance verification and environmental
testing. They are employed to ensure the good functioning of electronic communications
networks, heavy industrial processes such as steel manufacturing, the testing of vehicles
for compliance with emissions standards, and the monitoring of complex and criticalsystems of all types.
They are also employed in the manufacturing of semiconductors, as lithography using
lasers create patterns down to the nanometre scale. Lasers are used for precision
measurement of the alignment of etched layers, critical to integrated circuit manufacturing.
The measurement uses interferometry, a technique that uses the interference of 2 lightbeams of very stable wavelength to make nanometre-scale measurements.
Precision lasers with high spectral purity are manufactured with a frit made of borosilicate
glass containing lead oxide (PbO) to connect this glass to the metal pieces of the assembly.
In highly precise, spectrally pure lasers, a heating element is attached to the glass rod toadjust the rod length to allow tuning; this attachment also uses a PbO-based glass frit. (TMC
2023a) state that PbO is used in glass frit in lasers due to its technical advantages,
including:•

Melting point below 490 °C, allowing usage with borosilicate glass which has amaximum processing temperature of 500 °C, and avoiding damage to the sensitive
optics.

•Good match for coefficient of thermal expansion, which reduces stresses andprevents cracking of the seal or the glass. Heating of the laser rid tunes the cavity

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length. Thermal expansion and contraction of the heating element/glass frit/glassrod must be closely matched to allow for this tuning and to prevent damage.
•Good wetting, allowing penetration into tighter spaces and effective sealing.

21.1.5.

Amount(s) of restricted substance(s) used under the exemption

According to (EPPA 2023), the content of substance in homogeneous material isapproximately 90 % of lead (Pb) by weight. The amount of Pb entering the EU market
annually through the application for which the exemption is requested would beapproximately 5.8 kg of Pb, based on the replies provided by the TMC members.
Since not all producers of cat. 9 IMCI are members of TMC, the actual amounts of leadplaced on the EU market under the exemption can be assumed to be higher.

21.2.
21.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substance(TMC 2023a) state that alternatives to lead (Pb) that have been suggested or tried arebarium oxide (BaO) with a melting point of 1923 °C, and strontium oxide, with a melting
point of 2531 °C. These alternatives require processing at conditions well above themaximum workable temperature for borosilicate glass and coefficients of expansion are too
different to be usable. Other alternatives, such as Bi-based frit, melt at 540 °C or higher,
and Bi-based frit flows poorly below 540 °C. PbO, on the other hand, melts at 880 °C andwhen used as a flux in the joining of glass to other materials, it can be processed below 500°C.
(TMC 2023a) conclude that there are currently no suitable lead-free alternatives that meet
RoHS exemption criteria on the EU market for cat. 9 IMCI and that re-designing cat. 9 IMCI
could take approximately four years if an alternative is found. The unique characteristics oflead make the substance a necessary part for the proper functioning of glass frit, whichcannot be substituted with other substances.

21.2.2. Environmental, health, safety and socioeconomic impacts(EPPA 2023) identify the main potential negative consequences that the EU society at large
would face in the framework of the potential restriction of non-renewal of Annex IV,
exemption 4. The results are based on a survey focused on the EU test and measurement
equipment industry, with market share coverage of approximately 70 % of the EU market.
It therefore provided sufficiently reliable data for a representative extrapolation of the EU
market.
(TMC 2023a) conclude that the total impact of a non-renewal is monetized in the range of
15 million EUR and 40 million EUR (conservative estimates in net losses; potential gains
for suppliers of other components have been already taken into account), consisting of:
economic impacts (EBIT loss) on test and measurement industrial type products’
manufacturers; substitution costs and social impacts (i.e., unemployment in the EU-27).

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From the environmental and health perspective, (EPPA 2023) state that under normal
conditions of equipment use, lead is encapsulated within the equipment enclosure. As thisequipment is sold for professional/industrial use only, when the equipment reaches the endof-life, it will be appropriately processed by professional recyclers who are obligated to havesuitable controls to avoid any environmental releases and are notified of the presence ofthe substance under the producers’ obligation to provide a SCIP notification.
From a socioeconomic perspective, (EPPA 2023) state that the revocation of the exemption
could lead to certain market distortions in the EU market. As the vast majority of sales into
the EEA relating to equipment utilizing lead in glass frit is sold to EEA producers ofsemiconductor lithography, if the exemption is not renewed it would have a direct impact ona critical tool in the production of silicon chips from within the EEA. (EPPA 2023) expose
the risk of customers of test and measurement equipment being forced to move operations
to other areas, outside the EEA, hampering the EU's position as a relatively important
exporter and trading partner. TMC manufacturers also declared that this would very likely
lead to unemployment within the companies.
(EPPA 2023) state that if the exemption is not renewed, there would be little economic
impact on frit suppliers as sales corresponding to this application are small and infrequent.
A substantial impact on chip producers is anticipated though, due to the non-availability ofsemiconductor lithography products (incorporating test equipment) exclusively needed forthis sector. It also states that the revocation would also have wider impacts on innovationin Europe and a direct negative impact on the research and innovation output within the
EEA, as a major use of the Category 9 products is for industrial research and development
processes, both within private companies and for state-sponsored research.

21.2.3.

Roadmap towards substitution or elimination of the restricted
substance(TMC 2023a) state that, to their best knowledge, there are no suitable lead-free alternatives
that meet the physical and technical performance criteria, and that fulfil RoHS exemption
criteria on the EU market for test & measurement industrial-type products. As stated before,
certain alternatives have been tested, but cannot be considered viable alternatives as their
melting points require processing above the maximum workable temperature forborosilicate glass.
(TMC 2023a) report that if an alternative is found re-designing of the test & measurement
equipment could take approximately four years.

21.3.
21.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however, the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not451

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be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.

21.3.2.

Relevance of the exemption for reuse of EEE(TMC 2023a) point out that the exemption is relevant for used equipment. (TMC 2023b)
added that due to the extended life and asset value of equipment, when customers nolonger need the equipment, it is frequently procured back from them within or outside theEU. The equipment is then refurbished and made available as used in the market. (EPPA2023) present the below life cycle of cat. 9 EEE. Figure 21-1 shows the lifecycle of thisequipment.
Figure 21-1: Life cycle of cat. 9 IMCI

Source: (EPPA 2023)

The above explanation is not fully correct. For EEE placed on the European Economic Area
(EEA) market, RoHS Art. 4(4) stipulates that substance restrictions do not apply to spareparts for the repair, reuse, updating of functionalities or upgrading of capacity of EEE which
benefited from an exemption and which was placed on the market before that exemption
expired as far as that specific exemption is concerned.
For the same EEE placed on the market outside the EEA, Art. 4(4) actually would apply
from the point in time on when the EEE is placed on the EEA market, for example as reused
equipment. The EEE would not be RoHS compliant if the exemption expired before placing
on the EEA market of this EEE as reused equipment.
If exemption IV-4 expires on 21 July 2024 without allowing time for its renewal, equipmentthat was placed on a market outside the EEA prior to the expiry of the exemption would beblocked from entering the EEA market as used equipment from 22 July 2024 on. Renewing
exemption IV-4 would prevent this situation.

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21.3.3.

Scope of the renewal request

The applicant was asked to describe the EEE covered in the exemption wording (X-ray
tubes, image intensifiers, gas lasers, and vacuum tubes) in more technical detail, as well as
the applications of such (parts of) equipment.
(TMC 2024a) stated that their members do not know specifics beyond their applications in
HeNe gas lasers which they claim to have explained in the exemption application and SEA.
As to the other types of EEE covered in the exemption wording (image intensifiers, X-ray
tubes, and vacuum tubes) (TMC 2024a) replied that such devices are not used or producedby their members, and therefore they cannot provide feedback.
(TMC 2023a) had applied for the renewal of the exemption in its current wording. The
consultants conclude from the applicant’s above statement that the exemption neverthelessis only required for gas lasers.
A potential to narrow the scope of the exemption has been identified, as it was concluded
from the renewal request that among the equipment named in the original wording, theexemption is only required for HeNe gas lasers. There is a further potential to narrow thescope, specifying the use of heterodyne interferometry and the applications of the HeNe
gas lasers.

21.3.4.

Substitution and elimination of the restricted substance

Substitution of lead by lead-free glasses(TMC 2023a) suggested alternatives to Pb in glass frit. These are barium oxide (BaO) witha melting point of 1923 °C, strontium oxide, with a melting point of 2531 °C, and Bi-based
frit, with a melting point of 540 °C which flows poorly below 540 °C. PbO, on the other hand,melts at 880 °C and when used as a flux in the joining of glass to other materials, it can beprocessed below 500 °C. When asked if other alternatives have been investigated and thestatus of the substitution efforts, (TMC 2024a) stated that producers continue to assess theavailability of new substances that may be potential substitutes for the use of lead in thisapplication. To date, there have been no usable alternatives found.
Argon and Krypton lasers use lead in seal frits of window assemblies in line with exemption
III-32, which was reviewed and recommended for renewal by (Baron et al. 2022c) until 21
July 2026. The reviewers concluded that substitution of lead in these glass frits wasscientifically and technically still impracticable. (TMC 2024a) confirmed that the use of leadin a frit seal described in their application is consistent with the justifications recommended
for the renewal of exemption III-32 where a gas-tight seal is required between glass andmetal materials of the laser tube. The exemption is, however, limited to Argon and/or
Krypton laser tubes and does not include Helium-Neon lasers.
The above information suggests that substitution of lead in the glass frits is actuallyscientifically and technically still impracticable.
The applicant was asked if the current exemption 7(c)(I) or one of the subclauses of therecommended renewed exemption 7(d)(V) cover the various uses of lead in the scope ofthe current exemption IV-4. (TMC 2023b) replied that given the likelihood of more frequentchanges to Annex III exemptions, particularly in the narrowing of scope and/or limited
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durations, it would not be appropriate to attempt to align with the AIII 7(c)-I or 7(c)-V asrecommended by (Baron et al. 2022a).
Since the COM decided to place this exemption on Annex IV specifically for use in cat. 8
and cat. 9, it would be consistent with this approach to maintain exemption IV-4 as aseparate exemption on Annex IV. The scope of a renewed exemption IV-4 should be
excluded from the scope of exemption III-7(c)(I) and its renewed versions to avoid scope
overlaps.
Exemption IV-4 could also be merged with exemption III-32 since both exemptions are
based on the vacuum tube technology that uses the leaded glass frits to seal the evacuatedtube. This would imply a transfer of exemption IV-4 from Annex IV to Annex III even though
the exemption, differently from exemption III-32, is only relevant for cat. 8 and cat. 9. Likein the above case related to the integration of exemption IV-4 into III-7(c) exemptions, itwould be consistent with the COM’s original approach to have two separated annexes
whereas the second is dedicated for specific EEE categories.
Elimination of lead by DPSS lasers
The applicant does not mention alternative technologies to eliminate the use of lead in theirapplication, and it was asked whether, for example, diode-pumped solid-state (DPSS)
lasers could replace those whose manufacturing requires lead. (TMC 2024a) replied thatalternative technologies, such as diode-pumped solid-state lasers, do not have thenecessary specifications to perform the aforementioned applications. For instance, thenecessary precision, power, and quality of the beam necessary for manufacturing
semiconductors are only achievable with temperature-stabilized gas lasers. According to(TMC 2024a), the main deficit of DPSS lasers has to do with the beam quality. The HeNe
gas laser light is extremely monochromatic with high “temporal coherence”, meaning as you
travel along the direction of propagation, the components of the electric field continue tooscillate like a sine-wave with a single wavelength, amplitude, and phase. The distanceover which the waveform remains similar to a sine-wave is called the coherence-length of
the beam and can be more than 100 m. Along with excellent coherence-length, the sine
wave is frequency stable.
(TMC 2024a) further stated that coherence length is the most difficult and expensive quality
to achieve with a diode laser. The most popular way of ensuring high coherence length andvery stable central wavelength is to apply external cavity designs (ECDL – external cavity
diode laser) by using Bragg gratings. This solution requires stable power and thermal
controls, safety controls due to high power, and has a limited lifespan compared to the HeNelaser tube. Consequently, even where the performance of DPSS of devices approaches
that of HeNe laser sources, their reliability is not ensured. When asked about the difference
in expected lifespan between HeNe lasers and DPSS lasers, (TMC 2024b) stated that HeNelaser heads produced by our members are warranted to meet all published specificationsfor 3 years of continuous operation (~26, 000 hours) with a typical lifespan over 5 years,
and a published MTBF value is >50,000 hours. By comparison, internet searching foundthe typical expected lifespan of a DPSS laser is approximately 20,000 hours. While this canbe extended to more than 100 K hours if operated well below maximum power, these figuresreflect typical use models of intermittent operation with anticipated duty cycles where theoutput is off.

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In the consultant's opinion, a shorter lifetime does not show that reliability is not ensured orthat a DPSS laser cannot be used for the requested applications. DPSS lasers can still
operate reliably for ~20, 000 hours, and a shorter lifetime would not per se be a reason to
grant the exemption unless sub-clause 3 of Art. 5(1)(a) would be applicable (cf. section
21.3.7 on page 458).
The consultants have found DPSS lasers on the internet with a coherence length greaterthan 100 m117, matching the coherence length of HeNe lasers. Furthermore, these lasers’
applications are, among others, interferometry, semiconductor inspection, wafer fabrication,and lithography. These DPSS lasers can thus be used for those applications for which TMC
claim that they do not have the specifications needed. Based on this, the applicant was
asked about the potential substitution of HeNe lasers by such DPSS lasers.
(TMC 2024b) replied that in the HeNe laser applications, knowing the exact position of thestage holding the semiconductor wafer down to the picometer regime is critical. Because of
the extensive history of HeNe lasers in industry, the install base of semiconductor tools has
optics coated specifically for 632 nm wavelength. There are no alternate 632 nm laser
sources that meet all of these requirements readily available in the market. The consultants
have not found a DPSS laser with a 632 nm wavelength in their research, and it was asked
why the 632 nm wavelength is required for the applications described.
(TMC 2024c) replied that system aspects have been optimised for the 632 nm wavelength
specific to HeNe laser sources, including optical properties of the interferometer optics, therequired optical materials and coatings, and the performance specifications ofphotoreceivers regarding bandwidth, dynamic range, and wavelength sensitivity. In the caseof using a different wavelength, it's crucial to assess whether the phase measurement
electronics hardware, firmware, and software can effectively accommodate the newwavelength “ruler.” Achieving a thorough understanding of the laser's required performance
demands extensive system-level study and experimentation. (TMC 2024d) stated thatshorter wavelengths, such as 394 nm in the ultraviolet range, are absorbed by the glass
which attenuates the beam and heats up the glass, leading to inaccuracies.
From these statements, it is understood that the laser's longer wavelength (632 nm) isrelevant for the functioning of the overall system. Nevertheless, 394 nm DPSS lasers areoffered on the market for the same tasks as the 632 nm gas lasers.
The critical characteristic for precision positioning in semiconductor manufacturing is thelasers’ accuracy. (TMC 2024b) stated that the approach taken to meet the needs of theseapplications is the heterodyne interferometry method, which allows high wavelengthstability, long coherence length, and a long lifetime. The heterodyne interferometry method
achieves the measurement accuracy and precision crucial for high-end tools, and otherposition measurement methods have yet to prove this capability. Heterodyne interferometry,in comparison to homodyne interferometry, uses phase measurement instead of signal
amplitude measurement which greatly improves signal-to-noise characteristics ofinterferometer systems. (TMC 2024d) further explained that heterodyne interferometry
requires two different frequencies with orthogonal polarizations, meaning that HeNe lasers
produce light of two different wavelengths at the same time. With the differences dependingon the characteristics desired; these frequencies are frequency-locked and in phase. The

117 Cf. Skylark, https://www.skylarklasers.com/product/349-nx

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stability in the difference of the frequencies is another key feature for stable measurement
capability, the heterodyne method uses a stabilized HeNe laser to achieve accuracy whichis also more configurable for multiple axes of measurements. DPSS lasers, regardless of
frequency, are single frequency beams (homodyne interferometry) and while locking thefrequency of two DPSS lasers is theoretically possible, it has not been demonstrated andis not commercially reproducible. Homodyne interferometry is less precise, known
homodyne systems have an accuracy of ~0.5 ppm (parts per million), while heterodyne
systems have an accuracy of ~0.5 ppb (parts per billion) – a difference of 1000x.
(TMC 2024b) shared the technical overview of a HeNe laser, where the vacuum wavelengthstability is stated as ±0.002 ppm typical (one hour) and ±0.02 ppm typical (lifetime)118. This
wavelength stability is unmatched by the DPSS laser with a coherence length greater than
100 m found by the consultants. The consultants asked if the performance criteria described
for the applications at 632 nm (wavelength stability) are identical for a laser with a different
wavelength, or if they vary with the wavelength. (TMC 2024c) replied that a comprehensive
analysis of the system's performance must encompass the characteristics and limitationsof the laser itself, the interferometer optics, and the electronics. This includes wavelength
sensitivity. When asked for the specific case of a 349 nm wavelength, (TMC 2024d) further
explained that while a 2x decrease in wavelength provides a 2x improvement in resolution
if all else is equal, the smaller wavelength is absorbed by the glass optics of theinterferometer, requiring higher power to compensate and resulting in heating of the glass
leading to poorer accuracy.
(TMC 2024d) state that DPSS lasers are much less expensive and widely available thangas lasers. These lasers are a good option for applications that tolerate homodyne-level
performance, but they have less wavelength accuracy (1 decimal place vs 5) and worse
spectral stability (0.2 picometers vs 0.06 picometers). They are also less easily configurable
for different axes.
In the consultant’s opinion, the information made accessible during the review suggests thatthe DPSS lasers with similar features and applications rely on homodyne interferometry.
Heterodyne interferometry as enabled by the HeNe lasers still seems to be needed toensure the accuracy required for precision positioning and calibration.
Elimination of lead by malleable metal seals(Baron et al. 2022c) mention in their review of exemption III-32 an alternative sealingmechanism based on malleable metals as a promising alternative technology to eliminate
the use of lead in glass seal frits. Coherent, a manufacturer of argon lasers, confirmed thatthe use of malleable metals will be investigated in the coming years. Coherent believe thistechnology to be fully qualified by 2025 so that the leaded glass frits can be replaced by amechanical metal seal by 2025. The solution would also be applicable for krypton lasers.
(Baron et al. 2022c) recommend assessing the status of the development of this alternativein the next review.

118 Optics and Laser Heads for Laser-Interferometer Positioning Systems | Keysight456

Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU(TMC 2024a) confirmed that the use of lead under exemption III-32 is consistent with thejustifications for the renewal of exemption IV-4 for HeNe-lasers where a gas-tight seal isrequired between glass and metal materials of the laser tube.
This statement raises the question of whether the lead-free malleable metal seal would not
be useable for HeNe-lasers as well.
(TMC 2024h) reply that they are unaware of any capability for “malleable metals” to be used
as a substitute for the lead frit seal in their HeNe laser application. The only similarity
between the Coherent Inc. application and the frit seal in the TMC application is both aregas lasers. It must be noted that there is no publicly accessible information regarding thepotential transition to using “malleable metals” as an alternative to a lead frit seal for the
Coherent Inc. application. (TMC 2024h) concluded that the application may be proprietaryand not commercially available to other producers. Even if such a solution were to becomecommercially available in the future, the reliability of substitution would still have to be
proven in the HeNe Laser applications. Consequently, they conclude that substitution or
elimination of lead in the frit seal of HeNe gas lasers remains scientifically and technicallyimpracticable, and so it is not possible to determine today the reliability of substitutes.
In the consultant's opinion, the above aspects should be clarified with view to the scientificand technical practicability of lead elimination in HeNe-lasers with the malleable metal
solution. The consultants therefore recommend a joint review of exemptions III-32 and IV4 which requires an alignment of the expiry dates.

21.3.5.

Wording of the exemption

A potential to narrow the scope of the exemption has been identified, as it can be concluded
from the exemption application and questionnaire responses that the need for HeNe lasers
has been justified only for semiconductor manufacturing.
The wording of the exemption was discussed with (TMC 2024e, 2024f, 2024g, 2024h). The
applicant does not agree with narrowing the scope to semiconductor manufacturing
because metrology applications are not exclusive to semiconductor manufacturing. The
proposed exemption statement would restrict the scope of the exemption including
metrology applications to semiconductor manufacturing. Semiconductor manufacturing waspresented as a well-understood example of heterodyne laser interferometry. The applicantspoint out that the criterion of “heterodyne interferometry” in the exemption wording would
prevent misuse of the exemption.
The consultants followed the applicants’ above argumentation and proposed a wording
based on the heterodyne interferometry technique but included the main application fields
that were mentioned in the renewal request and for which heterodyne interferometry seems
to be irreplaceable at the time being.
Lead in glass frit binders for assembly of HeNe gas lasers used in heterodyne
interferometry calibration and heterodyne interferometry positioning applications.
(TMC 2024i) do not agree with the recommended wording, as it limits the application of thefinished equipment (the HeNe laser) to specific applications (“used in heterodyne
interferometry calibration and heterodyne interferometry positioning applications.”). They
state that this could limit innovation on the future uses of HeNe Laser devices and request
to renew the current wording.

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The above statement confirms that the proposed wording covers all current uses of theselasers, the more since the applicant was requested to indicate any uses that would not becovered. As to the innovation, the applicant can request to exempt further uses of theselasers if there is evidence that substitution or elimination of lead are impracticable.
Exemptions are not intended to cover future uses of restricted substances.

21.3.6.

Environmental, health, safety and socioeconomic impacts(EPPA 2023) foresee severe socioeconomic, health and safety consequences if exemption
IV-4 is not renewed for cat. 9 IMCI. The consultants focused on technical practicability andreliability. If the exemption is withdrawn in the absence of viable lead-free alternatives, theconsultants cannot exclude that at least some of these negative impacts actually arise.

21.3.7.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria119 is fulfilled:
1. their elimination or substitution via design changes or materials andcomponents which do not require any of the materials or substances listed in
Annex II is scientifically or technically impracticable;
2. the reliability of substitutes is not ensured;
3. the total negative environmental, health and consumer safety impacts
caused by substitution are likely to outweigh the total environmental, healthand consumer safety benefits thereof.

TMC request a 7 year renewal of exemption IV-4 with its current wording for cat. 9 industrial
monitoring and control instruments (IMCI) until 21 July 2031. The applicant argues that nolead-free alternatives are available, and once they are available, approximately four years
are required for the re-design of the test & measurement industrial type products.
Even though the applicant had requested the renewal of the exemption in its current
wording, the review showed that only HeNe gas lasers are used or produced by TMC’smembers. TMC also point out that the exemption is relevant for the reuse in the EEA ofequipment originally placed outside the EEA. Recommending an exemption to allow this,contradicts the goal of substituting or eliminating hazardous substances.
Regarding lead elimination, DPSS lasers are a lead-free alternative to gas lasers, but they
face challenges with beam quality. Although DPSS lasers matching HeNe lasers incoherence length (greater than 100 m) exist, they lack the specific 632 nm wavelength
crucial for certain semiconductor applications. It is not the frequency itself that is critical but
the laser accuracy achieved with the heterodyne interferometry method used in HeNelasers, which allows a high wavelength stability, long coherence length, and a long lifetime.
DPSS lasers use homodyne interferometry which seems to have a lower accuracy than theheterodyne systems that achieve an accuracy of ~0.5 ppb. In conclusion, while DPSS lasers

119 Deviating from Art. 5(1)(a), the sub-clauses are numbered to allow addressing them specifically in the text.

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with similar features and applications exist, these lasers have less wavelength accuracy
and spectral stability than gas lasers. Heterodyne interferometry is needed to ensure theaccuracy of the laser for precision positioning and calibration in semiconductor
manufacturing.
Regarding lead substitution, TMC explored alternatives to lead in glass frit such as bariumoxide (BaO) and Bi-based frit, but deemed them unsuitable. Concerning exemptions thatallow use of lead in glass frits applied to seal tubes, exemption III-32 is similar to IV-4. TMC
confirm that the justifications for the use of lead for argon- and krypton lasers are relevant
for exemption IV-4 as well, In the last review of exemption III-32, a producer of argon-lasers
announced to have developed an alternative technology to eliminate the use of lead by2025. The consultants therefore recommend aligning the expiry of exemption IV-4 with theexpiry of exemption III-32 to clarify whether the identified lead-free solution for argon- andkrypton-lasers is applicable to HeNe-lasers as well. At the COM’s discretion, exemption IV4 could in principle be integrated into exemption III-32, or exemption 7(c)(I) as a specifc useof lead in glass.

21.4.

Recommendation

The consultants recommend renewing the exemption only for the glass frit binders for theassembly of HeNe-lasers where elimination or substitution of lead are scientifically andtechnically still impracticable. Granting an exemption for this use of lead would thus bejustifiable by Art. 5(1)(a).
The below wording is recommended for the renewed exemption IV-4, which reflects the
specific uses of these HeNe-lasers:
No.

Exemption

Scope and dates of applicability

IV-4(a)Lead in glass frit binders for
assembly of HeNe gas lasers
used in heterodyne
interferometry calibration andheterodyne interferometry
positioning applications.

Applies to category 9 monitoring and control
instruments from 22 July [2024 + 12 months]

Expires on 21 July 2026 for category 9 monitoring andcontrol instruments

A period of 12 months is recommended to allow a smooth administrative transition from thecurrent exemption IV-4 to the new exemption IV-4(a). Concerning the expiry of exemption
IV-4(a), the COM should allow sufficient time for preparation and timely submission ofrenewal requests between the official publication of their decision as to the renewal of the
exemption and its expiry.
As to the duration of the exemption, the consultants recommend aligning the expiry datewith exemption III-32 where lead-containing glass frits are used for gas lasers (argon andkrypton) as well to seal a tube. A producer of such lasers announced during the review ofthis exemption by (Baron et al. 2022b) to have a reliable lead-free solution – a mechanicalseal - available by 2025. (Baron et al. 2022b) recommend assessing the status ofdevelopment of this alternative in the next review, which raises the question of whether thissolution would also be applicable to HeNe lasers.

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TMC stated that the use of lead under exemption III-32 is consistent with their justifications
for the renewal of exemption IV-4 for HeNe-lasers. They said later that the only similarity of
the lasers in scope of these two exemptions is that both are gas lasers, and that the leadfree solution would probably be proprietary and not commercially available to otherproducers.
The consultants consider a joint review of exemptions III-32 and IV-4 as useful to clarify theabove questions. The adverse socioeconomic impacts assessed by EPPA will not arise until
2026 since the consultants do not recommend revoking the exemption but TMC will haveto bear the cost of preparing and processing a renewal request prior to 2031, which they
requested as expiry date in their current renewal request.
The COM may also consider merging above recommended exemption IV-4 with exemption
III-32 given the principal technical similarity of the exemptions (sealing of vacuum tubes witha lead-containing glass). Exemption IV-4 could, for example, be added to exemption III-32
as exemption III-32(a), or both exemptions could be numbered as a) and b) respectively
under exemption entry III-32.
For the next review of the exemption, the consultants would like to encourage theparticipation of DPSS laser manufacturers if they deem their DPSS laser technology
appropriate to eliminate the use of restricted substances in the lasers in the scope of
exemption IV-4. It is also recommended in a next step to define the exemption scope via
precision thresholds if scientifically and technically practicable, instead of the current
technology-based (heterodyne interferometry) scope definition.
Applicants’ feedback on the recommendation(TMC 2024i) do not agree to the recommended wording as it limits the application and thus
innovation on the future uses of HeNe Laser devices. They also disagree with the expiry
date aligned with exemption III-32 stating that the justification is technically inappropriate.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a).

21.5.

References

Baron et al. (2022a): Study to assess requests for a renewal of nine (-9-) exemptions 6(a), 6(a)-I,
6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I and 7 (c)-II of Annex III of Directive 2011/65/EU (Pack 22) –Final Report (Amended Version). Under the Framework Contract: Assistance to the Commission
on technical, socio-economic and cost-benefit assessments related to the implementation andfurther development of EU waste legislation. In cooperation with Yifaat Baron, Carl-Otto Gensch,Andreas Köhler, Ran Liu, Clara Löw, Katja Moch, Oeko-Institut e. V. (Pack 22). Retrieved fromhttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/RoHS_Pack22_final_report_amended_February_2022.pdf.
Baron et al. (2022b): RoHS Pack 24. Study to assess requests for renewal of seven (-7-)
exemptions 18(b), 18(b)-I, 24, 29, 32 and 34 of Annex III and exemption 34 of Annex IV of Directive
2011/65/EU (Pack 24) – Final Report. In cooperation with Yifaat Baron, Carl-Otto Gensch, Andreas
Köhler, Ran Liu, Clara Loew, Katja Moch, Öko-Institut. Retrieved fromhttps://data.europa.eu/doi/10.2779/123658.

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Baron et al. (2022c): Study to assess requests for renewal of seven (-7-) exemptions 18(b), 18(b)-I,
24, 29, 32 and 34 of Annex III and exemption 34 of Annex IV of Directive 2011/65/EU (Pack 24) Final Report. RoHS Pack 24. In cooperation with Yifaat Baron, Carl-Otto Gensch, Andreas Köhler,
Ran Liu, Clara Loew, Katja Moch, Öko-Institut. Retrieved fromhttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_24/RoHS_Pack24_final_16022022.pdf.
Directive 2011/65/EU (2011): Directive 2011/65/EU of the European Parliament and of the Councilof 8 June 2011 on the restriction of the use of certain hazardous substances in electrical andelectronic equipment (recast). RoHS 2. European Union. Retrieved from http://eurlex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065.
EPPA (2023): Socio economic analysis of the impacts of non renewal of Lead (Pb) exemption for
the test & measurement industrial type products category 9, Exemption 4 - Annex IV. Report for
TMC. In cooperation with Jonathan Blanckaert, Rudy Colacicco, Giacomo Miele, Meglena Mihova,
Tobias Steinbrecher, Karin Steiner, Julius Waller.
Goodman (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9. Final Report July
2006, amended 19 Sep 2006. ERA Report 2006-0383. In cooperation with Paul Goodman, ERA
Technology Ltd. ERA Technology Ltd. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf.
TMC (2023a): RoHS Annex V request for renewal of exemption IV-4. RoHS Pack 27. In
cooperation with Meglena Mihova.
TMC (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Tobias Steinbrecher,
EPPA, to Dr. Otmar Deubzer via e-mail. RoHS Pack 27. Retrieved from https://rohs.biois.eu/IV4_TMC_Questionnaire-1_Clarification.pdf.
TMC (2024a): Answers to questionnaire 2 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024b): Answers to questionnaire 3 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024c): Answers to questionnaire 4 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024d): Answers to questionnaire 5 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024e): Answers to questionnaire 6 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024f): Answers to questionnaire 7 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024g): Answers to questionnaire 8 sent by Tobias Steinbrecher, EPPA, to Elena Fernández
via e-mail. RoHS Pack 27.
TMC (2024h): Answers to questionnaire 9 sent via e-mail by Tobias Steinbrecher, EPPA, to Dr.
Otmar Deubzer. RoHS Pack 27.
TMC (2024i): Applicants’ feedback on the recommendation by Tobias Steinbrecher, EPPA, toElena Fernández via e-mail. RoHS Pack 27.

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Exemption 9 of Annex IV: Cd in helium-cadmium
lasersThe below Table 22-1 shows the wording, scope and expiry dates of the exemption.
Table 22-1:Current wording of the exemption
No.

Current exemption Current scope and dates of applicability
wording

IV-9

Cadmium in heliumcadmium lasers

Applies to categories 8 and 9.
Expires on-

21 July 2021 for category 8 other than in-vitro diagnostic
medical devices and for category 9 other than 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.

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

Cd

CadmiumCOM

European Commission

DPSS

Diode pumped solid state, used in the context with lasers (DPSS lasers)

EEE

Electrical and electronic equipment

He

Helium

IMCIs

Industrial monitoring and control instruments

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RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

SSM

Semiconductor stress measurement

UV

Ultraviolet, here referring to ultraviolet light (wavelength spectrum
between 100 nm and 400 nm)

Definitions
22.1.

Background and technical information

On 19 January 2022, (JBCE et al. 2023a) requested the 7 year renewal of this exemption
as displayed in Table 22-2 for EEE of category (cat.) 9 industrial monitoring and control
instruments (IMCIs).
Table 22-2: Wording and scope of the requested exemption
No.

Requested exemption

Requested scope
applicability

and

dates

of

IV-9

Cadmium in helium-cadmium lasers

Applies to category 9 monitoring and control
instruments.
Expires on 21 July 2031 (2024 + 7 years)

22.1.1. History of the exemption(Goodman 2006) found that helium-cadmium (HeCd) are the only light source producing
325 nm ultraviolet (UV) wavelengths in the required quality in particular for semiconductor
analyses. HeCd lasers were listed on Annex IV of (Directive 2011/65/EU 2011) (RoHS
Directive) when it was published in 2011.
(JBCE et al. 2023a) requested the renewal of the exemption to avoid its expiry on 21 July2024 for category (cat.) 9 industrial monitoring and control instruments (IMCI), so that theexemption is due for review the first time since its adoption to Annex IV.

22.1.2. Summary of the requested exemption(JBCE et al. 2023a) describe Raman Spectroscopy as a non-destructive chemical analysis
technique which provides detailed information about chemical structure, phase andpolymorphy, crystallinity and molecular interactions. It is based on the interaction of lightwith the chemical bonds within a material. Helium cadmium lasers enable wavelengths of
325 nm to be used in Raman spectroscopy measurements.
Diode Pump Solid State (DPSS) lasers, as an alternative to helium cadmium lasers, can beused in many applications. However, although DPSS lasers can be used for Raman
spectroscopy, at the moment 325 nm DPSS lasers for Raman spectroscopy are not464

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available commercially, due to a lack of stability and precision. Therefore, the extension of
the exemption is required for helium cadmium lasers to continue to be used in Raman
applications.

22.1.3. Roadmap towards substitution or elimination of the restricted
substance(JBCE et al. 2023a) say that, once the DPSS laser characteristics have been improved,
equipment manufacturers will conduct a detailed performance and stability evaluation. At
the same time, the system for procurement, manufacturing and service will be improved.
(JBCE et al. 2023a) reference (Goodman 2006) stating: "The new product development
time for many Category 8 and 9 products is over 4 years and can be 7 years or longer."(JBCE et al. 2023a) therefore estimate that it will take 4-7 years to develop the equipment
after the characteristics of the DPSS lasers are improved. They highlight that equipment
manufacturers sometimes change electronic circuits and mechanical designs in order toadopt lasers that eliminate the use of cadmium, and it is therefore not appropriate todescribe the equipment manufacturer's schedule in general.
(JBCE et al. 2023b) detail the steps to be taken:
1) Re-design of the instruments and reliability test; if successful,2) Evaluation of performance in service;3) Durability testing

22.1.4. Technical description of the exemption and use of the restricted
substance
According to (JBCE et al. 2023a), helium-cadmium lasers enable wavelengths of 325 nm
to be used in Raman spectroscopy measurements. Cadmium (Cd) and helium (He) gas are
enclosed in the laser tube. The cadmium is heated to convert it to its gas phase. Collisions
with He atoms which have been excited by electrical discharge then excite the Cd atoms
into the laser-emitting excited state. This generates lights of a specific wavelengths (325 nm
and 442 nm) in the laser tube, which is amplified by mirrors at both ends.

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Figure 22-1: Schematic diagram of the HeCd laser

Source: (JBCE et al. 2023a)(JBCE et al. 2023a) describe Raman Spectroscopy as a non-destructive chemical analysis
technique based on the interaction of light with the chemical bonds within a material. It
probes the chemical structure of a material and provides information about:•

Chemical structure and identity•

Phase and polymorphism•

Intrinsic stress/strain•

Contamination and impurity

Laser wavelengths used in Raman spectroscopy range from ultra-violet through visible tonear infra-red. Typical examples include (but are not limited to):•Ultra-violet: 244 nm, 266 nm, 325 nm•

Visible: 405 nm, 458 nm, 473 nm, 488 nm, 515 nm, 532 nm, 633 nm, 638 nm, 660
nm•

Near infra-red: 785 nm, 830 nm, 980 nm, 1064 nm

The choice of laser wavelength depends on the application. The HeCd laser is used as alaser source. It can stably emit a wavelength of 325 nm and provides the below benefits
according to (JBCE et al. 2023a):•

Increased sensitivity from UV excitation, since Raman scattering efficiency is
proportional to λ-4, where λ is the laser wavelength. Thus, Raman scattering at
325 nm is a factor of 14 times more efficient than for example at 633 nm.

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With certain samples, UV laser excitation can interact in ways not possible whenusing visible laser sources. For example, in semiconductor materials, thepenetration depth of UV light is typically in the order of a few nanometres, and thus
UV Raman can be used to selectively analyse a thin surface layer as it iscommonly found in silicon on insulator (SOI) materials. In another example, UV
excitation can give rise to specific resonance enhancement with biologicalmoieties, in particular protein, DNA and RNA structures. Specific analysis of thesematerials within tissue can be difficult using visible laser wavelengths.

•

Resonance Raman on carbon materials is well documented in scientific literature
at 325 nm and is frequently used for material characterisation. A small shift in
excitation even to 320 nm may invalidate the results.120•

Fluorescence suppression can often be assisted using UV lasers, by spectrally
separating the Raman and fluorescence signatures. With visible lasers it frequently
occurs that Raman and fluorescence are superimposed, and the incomparable
strength of the fluorescence is what can perturb or completely mask the Raman
spectrum. With UV excitation, the Raman spectrum lies close to the laser line,
whereas the fluorescence is often slightly removed to higher wavelengths. Thus,
they no longer overlap, and the fluorescence is no longer an issue.

(JBCE et al. 2023a) highlight that with certain samples, UV laser excitation can interact inways not possible when using visible laser sources. For example, in semiconductormaterials, the penetration depth of UV light is typically in the order of a few nanometres,
and thus UV Raman can be used to selectively analyse a thin, surface layer (as is commonly
found in silicon on insulator (SOI) materials). For example, the penetration depth is around
5 nm if a 320 nm laser is used. On the other hand, the penetration depth is around 450 nm
if a 500 nm laser is used like in the below table for a silicon sample.
Table 22-3: Penetration depth of Si samples with light of different wavelengths
Wavelength of light [nm]

250

320

500

800

1000

1200

Penetration depth

2.72 nm3.91 nm

450 nm

5.88 μm

78.1 μm

227 mmSource: (JBCE et al. 2023a)(JBCE et al. 2023a) report that helium-cadmium lasers are used for photoluminescence(PL) measurements, too. The application field is semiconductor materials for defectmeasurement and energy state analysis. In PL, light energy, or photons, stimulate theemission of a photon from any matter. It is a non-contact, non-destructive method of probing
materials. In essence, light is directed onto a sample, where it is absorbed and where a
process called photo-excitation can occur. The photo-excitation causes the material to jump
to a higher electronic state, where it will then release energy (photons) as it relaxes andreturns back to a lower energy level. The emission of light or luminescence through thisprocess is photoluminescence.

120 See for example Ferrari et.al (2004), Raman spectroscopy of amorphous, nanostructured, diamond–likecarbon, and nanodiamond, Volume 362, Issue 1824,
https://royalsocietypublishing.org/doi/10.1098/rsta.2004.1452; source as referenced by JBCE et al. 2023a.

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22.1.5. Amount(s) of restricted substance(s) used under the exemption
According to (JBCE et al. 2023a), helium-cadmium lasers use elemental cadmium, notcadmium compounds. They report approximately 800 g of cadmium being placed on themarket in “Europe” annually with helium-cadmium lasers.

22.2.

Justification of the requested exemption(JBCE et al. 2023a) state that without cadmium, it is not possible to achieve the specificwavelengths of 325 nm and 442 nm. Cd is the only substance that can achieve 325 nm
wavelength light.

22.2.1. Substitution and Elimination of the restricted substance
The applicant discusses the possibility to eliminate the use of lead by alternativetechnologies.
Diode Pump Solid State (DPSS) lasers with an oscillation wavelength band of 320 nm area potential technology that could eliminate the use of cadmium. (JBCE et al. 2023a) reportthat a HeCd laser manufacturer has also been developing a DPSS 320 nm band laser thatcomplies with the RoHS Directive. It is a laser that excites a fluoride-doped fibre with asemiconductor laser and converts red fundamental laser light into UV light with awavelength conversion element. The laser has an oscillation wavelength of 318 ± 1 nm andan output of 100 mW, which is similar to a HeCd laser. As such, it is considered analternative laser for many of the applications that use HeCd lasers. Currently, they areverifying whether DPSS lasers can actually be used in many applications, including Raman
spectroscopy. Today, the specifications of this laser types do not yet match what is requiredfor Raman spectroscopy. Various evaluations are conducted to improve the quality of thelaser, and they plan to place it on the market in the near future.
Raman spectroscopy requires a high stability of the wavelength value (better than
0.1 cm-1, which is 0.001 nm for 325 nm excitation, for measuring stress in semiconductors,
and a laser power of more than 20 mW). A Raman peak is typically 0.01 nm wide, and its
position is expected at the same precision level.
Recently, semiconductor lasers operating with a 320 nm wavelength have been released
by some laser manufactures. However, in these products the laser wavelength is generally
unstable because the resonator length is impacted by the temperature of both the laser
body and atmosphere. As a result, the wavelength value shifts by approximately 0.1 nm to
1 nm, which inevitably affects the Raman measurement, making it impossible for correct
spectral peak analysis. Semiconductor lasers are not yet suitable as an alternative.
Wavelength variations/instability also affect the Rayleigh filters, making it impossible toguarantee Raman spectra close to the laser line.
(JBCE et al. 2023a) also present the below table comparing the characteristics of a Raman
spectrometer for which the HeCd-laser is used with other type of analysers that operate
near UV wavelengths.

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Table 22-4: Comparison of analytical methods for detecting ultraviolet spectrum

Source: (JBCE et al. 2023a)

A fluorescence meter measures the fluorescence or light emitted by different fluorescing
objects. A fluorescence meter cannot be used for crystal analysis and stress analysis. A
spectrophotometer absorbs the lights of solutions and gases, and it measuresconcentrations, characteristics and molecule structures. A spectrophotometer cannot be
used to analyse solid materials.
Raman spectroscopy enables analysis of the physical properties of gases, liquids andsolids, and has many different applications beyond metal material structure analysis in theultraviolet, visible and infrared ranges.

22.2.2. Environmental, health, safety and socioeconomic impacts(JBCE et al. 2023a) claim that waste lasers are returned to a laser supplier outside the EU,
and are refurbished by the supplier. There are no cadmium emissions originating from HeCd
lasers in the EU.
During operation, cadmium flows out of a cadmium reservoir into the discharge tube. It thenmoves from the anode side to the cathode side, adheres to the discharge tube wall andsolidifies. When the cadmium in the cadmium pool has completely moved, the laser tube
reaches the end of its useful life. Laser manufacturers provide the service of replacing waste
laser tubes that have reached the end of their life. Manufacturers receive inquiries fromusers for replacing laser tubes. The waste laser is returned to the laser manufacturer's
factory outside the EU, and in less than a month, the old laser tube is replaced with a newlaser tube, adjusted, inspected and shipped back. Each laser tube is numbered andmanaged by recording the number, characteristics, etc. in the laser history document.

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22.3.

Critical review

22.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however, the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several restrictions of cadmium and its compounds are listed on Annex XVII (cf. section 4.1
on page 48). None of those, however, is applicable to the use of cadmium and cadmium
compounds in the scope of exemption IV-9.
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

22.3.2. Substitution and elimination of the restricted substance
Elimination of cadmium by DPSS lasers and exemption scope(JBCE et al. 2023a, 2024a, 2023b) concede that 320 nm DPSS lasers can eliminate theuse of cadmium in many UV Raman spectroscopy tasks. They report about a DPSS laserthat operates at 318 nm ± 1 nm with 100 mW output similar to HeCd lasers and which may
be placed on the market “in the near future”. The applicants claim that these lasers cannot
yet replace HeCd lasers in Raman spectroscopy at 325 nm due to their lacking wave lengthstability at more than 20 mW output power which is required for semiconductor stressmeasurement (SSM).
An investigation on the internet showed that 320 nm DPSS lasers are offered for Raman
spectroscopy.121 The consultants contacted a manufacturer of such DPSS lasers. The(DPSS laser manufacturer 2024) stated that their design for a DPSS Laser at 320 nm has
proven capable of delivering stable single-frequency emission at 20 mW output power overmore than 8,000 h, which is longer than the typical lifetime of a HeCd laser. The producthas been commercially available for at least two years. As to photoluminescence, theproducer stated that their 320 nm lasers which are used in Raman spectroscopy are also
often used for photo luminescence applications as the performance requirements are quite
similar. Therefore, although not specifically stated on their web page, they believe their 320
nm laser to meet all requirements for photoluminescence applications. When asked whether
these lasers can provide the wavelength stability for SSM - better than 0.1 cm-1 at laser

121 As an example see https://hubner-photonics.com/applications/lasers-for-raman-spectroscopy/)470

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power of more than 20 mW – the DPSS laser producer did not answer the question despitea second effort to obtain a reaction.
In the absence of contrary information, the consultants conclude from the above informationthat elimination of cadmium by DPSS lasers is scientifically and technically not yet
practicable for Raman spectrometers that are used in SSM.
(JBCE et al. 2023b, 2024b) indicate that, once appropriate lasers are available, seven years
or more would be required to develop and qualify Raman spectrometers operated with suchlasers. They state that this applies only to Raman spectrometers for SSM because they do
not know about other applications.
Scope of the renewed exemption
The applicant focused the discussion as to the elimination of cadmium by DPSS lasers to
SSM applications, and the applicants’ above statement suggests that the members of theapplying consortium require the exemption for use in SSM.
The consultants therefore proposed the below wording for the renewed exemption IV-9:“Cadmium in helium-cadmium lasers for stress measurement in semiconductors with325 nm wavelength and more than 20 mW laser output power”(JBCE et al. 2024b) replied that they request “Cadmium in helium-cadmium lasers” forcategory 9 IMCI. Stability is important in this application but "more than 20mW" is an
example and should not refer to the output in this proposed wording. Regarding the
wavelength, He-Cd lasers generate 325 nm and 442 nm waves at the same time so thatthe exemption wording should not refer to the wavelength.
Since the 325 nm and 442 nm wavelengths are inherent to HeCd lasers, i.e. they do not
generate different wavelengths, mentioning the wavelength in the exemption wording does
not contribute to define the scope.
The consultants wondered, however, why the applicants designated the 20 mW threshold
as a mere example while previously they consistently have pointed out the importance of
the wavelength stability of 325 nm at more than 20 mW output power. The applicant was
requested to detail the range of output power use for SSM.
(JBCE et al. 2024b) explain that the required laser power varies depending on theapplication and the device to which the laser is mounted. For example, the optics of a
Raman spectrometer reduce its laser intensity. Importantly during measurements, thesemust be properly adjusted so that the sample is not altered by laser irradiation. According
to (JBCE et al. 2024c), the output power of the lasers is adjusted to ensure that the sample
is not damaged when the laser is irradiated onto it. Measurements are sometimes made atless than 20 mW. They confirm that the same HeCd laser can produce each output power
required for SSM.
The above replies do not answer the question and they are not fully plausible. The
applicants point out that the output power depends on the application and the device anddo not give any clear indication as to the outpower power range used in SSM. The
consultants assume that the 20 mW output power which the applicants repeatedly stressas a threshold would also depend on the application, device and optics. In this case, theapplicants do not relativise this value. The information that had been provided so far
specified more than 10 mW output power used for surface measurements of inorganic
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samples. It is not clear whether this is related to SSM. Also mentioned is the output powerof 100 mW in the context with HeCd-lasers. The applicant was requested again to clarify
the situation for SSM with Raman spectroscopy.
(JBCE et al. 2024d) reply that sometimes measurements are made at 1 mW or less,sometimes at 100 mW, depending on the damage caused by the laser to the sample. (JBCEet al. 2024e) complement this information adding that the Raman intensity is generally
proportional to the power of the irradiated laser. Therefore, if the sample is not damaged by
the irradiation of the laser at high power, sufficient Raman signal can be obtained in a shorttime. If sufficient Raman signal can be obtained in a short time, a large number of locations
can be measured. This is useful for identifying where stresses are present on asemiconductor wafer.
The consultants asked the applicant why the damage levels of semiconductors inspectedin SSM with the lasers is so different. (JBCE et al. 2024e) replied that the semiconductor
samples include not only silicon but also compound semiconductors.
While the above explanation would have benefitted from some more detail, e.g. differencesin damage thresholds of different materials inspected in SSM, the consultants did not follow
up further since the applicant had been asked for a sound explanation twice already, andthe information provided already suggests that SSM with Raman spectrometers is
conducted at a range of output powers that may exceed 20 mW.
The consultants thereupon proposed the below wording:Cadmium in helium-cadmium lasers of Raman spectrometers for stress measurement insemiconductors.
(JBCE et al. 2024c) disagree proposing the current wording and that they had included
photoluminescence into their renewal request.
While the latter is correct, the applicants focused the discussion as to the elimination of
cadmium in HeCd lasers to SSM with Raman spectroscopy, and they concede that thereexpertise does not cover other applications of HeCd lasers. There is thus no evidence thatelimination or substitution of lead is scientifically and technically impracticable so that theabove wording reflects the technological status that was elaborated during the review.
Elimination of cadmium by lasers with different wavelengths
According to (JBCE et al. 2023a), the advantage of using 325 nm wavelength instead of
longer ones is the shallow penetration depth, e.g. around 3.9 nm in silicon compared toaround 450 nm and more for 500 nm and longer waves (cf. Table 22-3 on page 467). This
enables measurement of thin layers on semiconductors and stress measurement close to
the surface of semiconductors. Table 22-3 shows that a 500 nm laser would alreadypenetrate a silicon material 450 nm deep. It is thus clear that short wavelength lasers likethe HeCd lasers cannot be replaced by longer wavelength lasers. Lasers of various
wavelengths are used to measure stress levels in different layers or depths ofsemiconductors.
The applicants were requested to provide an independent source that describes the SSM
with Raman spectroscopy. They referenced the publications of (Liu 2003) and (Nazari et al.
2018) who explain the advantages of Raman spectroscopy with UV-light in the context of

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silicon semiconductors confirming the advantages of short wavelengths for semiconductor
inspections.
(Nazari et al. 2018) write that “Lasers operating in the near UV, and having sufficiently
narrow emission lines, are primarily argon (363.8, 351.1 nm), krypton (406.7, 350.7 nm),and helium-cadmium (325.0 nm). […] In the wavelength range above 350 nm, standardgrade optical materials are transparent. […] Generally, below 350 nm, specialized UV-grade
materials are needed for the optical components of micro-Raman instrumentation.”
The applicant list in Table 22-3 on page 467 only wavelengths of 250 nm, 320 nm and
500 nm. The above information shows that argon (Ar) and krypton (Kr) lasers fill the
wavelength gap between 320 nm and 500 nm in Table 22-3 provided by (JBCE et al.
2023a). (Nazari et al. 2018) illustrate the penetration depths of the various wavelengths insilicon in the below table.
Table 22-5: Optical penetration depth in silicon at characteristic micro-Raman
wavelengths

Source: (Nazari et al. 2018)

The applicants were asked the penetration depth of Ar- and Kr-lasers in the material which
is used as reference for the penetration depths listed for different wavelengths in Table 22-3
on page 467.
(JBCE et al. 2024d) reply that both argon and krypton lasers have several oscillation
wavelengths. The penetration length for silicon depends on the wavelength of lights. The
applicants reference Table 22-3 on page 467.
The applicants’ reply does not answer the question. Upon further request, (JBCE et al.
2024e) indicate about 10 nm penetration depth at the wavelength of 350 nm and 100 nm at
400 nm wavelength. These values do not quite coincide with the ones in the above Table
22-5 even though both reference materials are silicon. The applicants, however, also
indicate slightly different penetrations for 320 nm lasers (3.91 nm in Table 22-3, and around
5 nm in the text of their renewal request) so that there seems to be a certain range ofpenetration depths even if silicon is inspected in both cases.
In any case, some wavelengths emitted by HeCd and Ar-/Kr-lasers are close to the 325 nm
waves of HeCd lasers, i.e. 363.8 nm (Ar-lasers) and 350.7 nm (Kr-lasers), and thepenetration depths are similar. The applicant was therefore asked whether the small

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differences in penetration depths are significant, and if not, whether the use of cadmium inthe HeCd lasers could be eliminated by applying Ar-/Kr-lasers in SSM.
(JBCE et al. 2024d) point out that common wavelengths for argon lasers are 488 nm and
514 nm. Stable semiconductor lasers are available at these wavelengths, which has
reduced the demand for argon lasers. For this reason, the market of argon lasers, including
lasers with oscillation wavelengths around 325 nm, have recently been limited. As a result,the stable lasers in the UV region are He-Cd lasers.
The applicants did not answer the question. Ar-lasers have several emission wavelengths
according to (JBCE et al. 2024e) but (Nazari et al. 2018) explicitly mention the shorter
emission wavelengths of these lasers to be applied in near UV Raman inspection ofsemiconductors.
Following up on this with the applicant, (JBCE et al. 2024e) state that Ar lasers at thesewavelengths are difficult to procure as the manufacturers have withdrawn them from themarket. As for Kr lasers, they do not know of many cases there are where semiconductor
stresses have been measured by Raman.
In the report of (Baron et al. 2022) applicants stated in the context of the review exemption
III-32 (lead in glass-frits of Ar- and Kr-lasers) that “[…] these lasers are an integral
component in nearly all OEM semiconductor manufacturing processes for the inspection ofsilicon wafers.” “the demand for argon and krypton lasers has remained steady since 2019[….]. “[…] argon creates higher power for UV lasers with optics optimized for 364.1 nm
transmission.”” (Baron et al. 2022) conclude that “A discontinuation date for the use of suchlasers is currently not planned, indicating that this market shall probably remain stable orshall further decline gradually.” There are at least two manufacturers of such lasers.122
These statements contradict the applicants’ claim concerning the availability of such lasers
and that Ar-lasers commonly emit at 488 nm and more. The consultants understand fromthe above reply of (JBCE et al. 2024e) that Ar-lasers can in principle be used to eliminate
cadmium in HeCd-lasers. The applicant’s do not explicitly state this, but the consultants areof the opinion that the applicant had ample opportunity to explain in detail why and where
Ar-lasers – and possibly Kr-lasers – are technically inappropriate to replace HeCd-lasers in
SSM.
It should be noted in this context that Ar- and Kr-lasers use lead in seal frits of window
assemblies in line with exemption III-32. This exemption was reviewed and recommended
for renewal by (Baron et al. 2022) until 21 July 2026 since substitution and elimination oflead – e.g. via DPSS lasers - were found to be scientifically and technically impracticable.
(JBCE et al. 2024e) confirm that HeCd-lasers use such glass frits as well, however, under
the current exemption III-7(c)(I).
The use of Ar-lasers instead of HeCd-lasers would thus not increase the amount of leadused in glass frits for sealing of laser tubes but the use of cadmium would be eliminated.

122 Cf. https://www.coherent.com, https://www.lumentum.com/en474

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22.3.3. Environmental, health, safety and socio-economic impacts
JBCE exclude cadmium-emissions into the environment from their laser tubes due to a wellorganized manufacturer takeback of the spent tubes (cf. section 22.2.2 on page 469).
The consultants acknowledge the degree of protection which this systems offers. It needs,
however, to be noted that a well-established end-of-life stage per se would not justify
granting an exemption in line with Art. 5(1)(a).

22.3.4. Summary and conclusions
Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:
1. their elimination or substitution via design changes or materials andcomponents which do not require any of the materials or substances listed in
Annex II is scientifically or technically impracticable;
2. the reliability of substitutes is not ensured;
3. the total negative environmental, health and consumer safety impacts
caused by substitution are likely to outweigh the total environmental, healthand consumer safety benefits thereof.
(JBCE et al. 2023a) request the 7 years renewal of exemption IV-9 claiming that thesubstitution or elimination of cadmium in the HeCd lasers emitting the near-UV (ultraviolet)
wavelength of 325 nm is scientifically and technically still impracticable.
The discussion whether and how far DPSS-lasers can eliminate the use of cadmium
showed that the applying consortium was focused on the use of these lasers forsemiconductor stress measurement (SSM) with Raman spectroscopy. They claim that
DPSS-lasers are technically inappropriate for this task due to the still lacking quality of thelight beam. The consultants’ exchange with a manufacturer of such DPSS-lasers did notyield information to refute this claim.
During the review, the discussion evolved around the elimination of cadmium via argon (Ar)and krypton (Kr) lasers that emit wavelengths close to 325 nm and do not use restricted
substances to generate the emitted electromagnetic waves. Upon repeated requests toprovide a clear answer, the applicants stated that the market for Ar-lasers has become
limited, and that they do not know Kr-lasers to be used in Raman spectroscopy. The
consultants take from this explanation that at least the Ar-lasers can be used for SSM with
Raman spectroscopy after the applicants had not expressed technical objections.
The consultants found that Ar- and Kr-lasers are available and, according to information
provided by manufacturers of such systems in the report of (Baron et al. 2022), their market
has more or less been stable since 2019.
Overall, the consultants conclude that the applicants neither substantiated their claim as tothe impracticability of cadmium substitution or elimination in HeCd-lasers in general, nor in
the specific application of SSM.

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22.4.

Recommendation

The applicants claim that elimination of cadmium in HeCd lasers is scientifically andtechnically still impracticable. While this seems to be correct for the use of these lasers insemiconductor stress measurement with Raman spectrometers, the applicants could not
substantiate this claim for the elimination of cadmium by argon lasers.
In the consultants’ view, the renewal of the exemption would infringe Art. 5(1)(a) in theabsence of evidence that any of the criteria are met. It is therefore recommended not torenew the exemption.
If the COM decides to renew the exemption, the consultants recommend the below wording:
No.

Exemption

IV-9

CadmiumlasersScope and dates of applicability
inhelium-cadmium

Applies to categories 8 and 9.
Expires on

IV9(a)

Cadmiuminhelium-cadmium
lasers of Raman spectrometers forstressmeasurementinsemiconductors-

21 July 2021 for category 8 other than in-vitro
diagnostic medical devices and for category 9other than industrial monitoring and control
instruments.

-

21 July 2023 for category 8 in-vitro diagnostic
medical devices.

-

21 July [2024 + 12 or 18 months] forcategory 9 industrial monitoring andcontrol instruments.

Applies to category 9 industrial monitoring andcontrol instruments from [expiry date of exemption
IV-9 + 1 day] on.
Expires on XXX

In the case of a next review of this or other laser exemptions (exemptions III-32 and IV-4),
the consultants would like to encourage the participation of DPSS laser manufacturers
either in the stakeholder consultation, or with own revocation requests if they deem their
DPSS laser technology appropriate to eliminate the use of restricted substances in thelasers in the scope of the afore-mentioned lasers.
Applicants’ feedback on the recommendation(JBCE et al. 2024e) do not agree to the above recommendation argueing with insufficient
time allowed for the answers to the consultants’ questions.
The consultants are confident that there was sufficient opportunity for applicants to provide
and substantiate arguments for the renewal of justifiable applications in the scope of thecurrent exemption. All relevant arguments made available by applicants and stakeholders
during the review time available for this exemption were evaluated taking into account therequirements of Art. 5(1)(a).

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22.5.

References

Baron et al. (2022): Study to assess requests for renewal of seven (-7-) exemptions 18(b), 18(b)-I,
24, 29, 32 and 34 of Annex III and exemption 34 of Annex IV of Directive 2011/65/EU (Pack 24) Final Report. RoHS Pack 24. In cooperation with Yifaat Baron, Carl-Otto Gensch, Andreas Köhler,
Ran Liu, Clara Loew, Katja Moch, Öko-Institut. Retrieved fromhttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_24/RoHS_Pack24_final_16022022.pdf.
Directive 2011/65/EU (2011): Directive 2011/65/EU of the European Parliament and of the Councilof 8 June 2011 on the restriction of the use of certain hazardous substances in electrical andelectronic equipment (recast). RoHS 2. European Union. Retrieved from http://eurlex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065.
DPSS laser manufacturer (2024): Answers to questionnaire 1, sent via e-mail to Dr. Otmar
Deubzer. RoHS Pack 27 (RoHS 29).
Goodman (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9. Final Report July
2006, amended 19 Sep 2006. ERA Report 2006-0383. In cooperation with Paul Goodman, ERA
Technology Ltd. ERA Technology Ltd. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf.
JBCE et al. (2023a): Request for renewal of exemption IV-9. RoHS pack 27. Retrieved fromhttps://rohs.biois.eu/EU_RoHS_Annex%E2%85%A39_renewal%20application(JBCE)_19JAN2023.pdf.
JBCE et al. (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Tetsusaburo
Miura, JBCE, to Dr. Otmar Deubzer via e-mail. RoHS Pack 27. BBT – Materials Processing (RoHS
29). Retrieved from https://rohs.biois.eu/IV-9_JBCE_Questionnaire-1_Clarification_final.pdf.
JBCE et al. (2024a): Answers to questionnaire 2 sent via e-mail by Miura Tetsusaburo, JBCE, to
Dr. Otmar Deubzer. RoHS Pack 27 (RoHS 29).
JBCE et al. (2024b): Answers to questionnaire 3 sent via e-mail by Miura Tetsusaburo, JBCE, to
Dr. Otmar Deubzer. RoHS Pack 27 (RoHS 29).
JBCE et al. (2024c): Answers to questionnaire 4 sent via e-mail by Miura Tetsusaburo, JBCE, to
Dr. Otmar Deubzer. RoHS Pack 27 (RoHS 29).
JBCE et al. (2024d): Answers to questionnaire 5 sent via e-mail by Miura Tetsusaburo, JBCE, to
Dr. Otmar Deubzer. RoHS Pack 27 (RoHS 29).
JBCE et al. (2024e): Answers to questionnaire 6 sent via e-mail by Miura Tetsusaburo, JBCE, to
Dr. Otmar Deubzer. RoHS Pack 27.
JBCE et al. (2024f): Feedback on the recommendation for exemption IV-9, sent via e-mail by Miura
Tetsusaburo, JBCE, to Dr. Otmar Deubzer. RoHS Pack 27.
Liu (2003): Applications of UV-Raman Spectroscopy to Microelectronic Materials and Devices. In:
AIP Conf. Proc. 683 (1), S. 738–743. DOI: 10.1063/1.1622552.
Nazari et al. (2018): Near-ultraviolet Raman and micro-Raman analysis of electronic materials. In:
Appl. Phys. Rev. 5 (4), Artikel 041303. DOI: 10.1063/1.5054660.

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Exemption10 of Annex IV: Pb and Cd in atomic
absorption spectroscopy lamps
The below Table 23-1 shows the wording, scope and expiry dates of the exemption.
Table 23-1: Current wording of the exemption
No.

Exemption

Scope and dates of applicability

IV-10

Lead and cadmium inatomic absorption
spectroscopy lamps

Applies to categories 8 and 9.
Expires on-

21 July 2021 for category 8 other than in vitro diagnostic
medical devices and for category 9 other than industrial
monitoring and control instruments.

-

21 July 2023 for category 8 in vitro diagnostic medical
devices.

-

21 July 2024 for category 9 industrial monitoring andcontrol instruments

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
AAS

Atomic absorption spectroscopy

AFES

Atomic fluorescence emission spectroscopy

AJ

Analytik Jena

Cat.

Category, referring to the categories of EEE specified in Annex I of
the current RoHS Directive 2011/65/EU

Cd

CadmiumCOM

European Commission

CS-AASContinuum light source AAS

CS-AASContinuous spectrum AAS

CVG-AAS

Chemical vapour generation AAS

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CVG-AAS

Cold vapour generation AAS

EDLElectrodeless discharge lamp

EEA

European Economic Area (EU 27 + Iceland, Liechtenstein and
Norway)EEEElectrical and electronic equipment

EU

European Union

F-AAS

Flame AAS

GF-AAS

Graphite furnace AAS

HCLHollow cathode lamp

Hg

Mercury

HR-CS-AASHigh resolution
spectrometry

ICP-OES

Inductively coupled plasma optical emission spectroscopy

ICP-MS

Inductively coupled plasma mass spectroscopy

IMCI

Industrial monitoring and control instruments

LEDLight emitting diode

LS-AASLine source AAS, umbrella term for various types of AAS like CVGAAS, F-AAS, etc. that differ in the way of the sample preparation

Pb

Lead

PE

Perkin Elmer

RF

Radio frequency

RoHS

Directive 2011/65/EU

RoHS 1

Directive 2002/95/EC

UV

Ultraviolet

X-freeNot containing restricted substance X in the applications in scopeof the exemption to be reviewed, e.g. cadmium-free, or lead-free

23.1.

continuum

lightsourceatomicabsorption

Background and technical information

On 18 January 2023, Perkin Elmer, Agilent Technologies, JBCE, Analytik Jena, andHeraeus (PE et al. 2023a), requested the renewal of exemption IV-10 as displayed in Table

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23-2 for EEE of category (cat.) 9 industrial monitoring and control instruments (IMCI).
Underlined phrases indicate deviations from the current wording.
Table 23-2: Requested exemption renewal
No.

Requested exemption

Requested scope and dates
of applicability

IV-10

Lead, cadmium, and mercury in atomic absorption
spectroscopy lamps

Applies to category 9 industrial
monitoring
andcontrol
instruments.
Expires on 21 July 2031
(2024 +7 years).

23.1.1.

History of the exemption(Goodman 2006) stated that the exemption appeared to be justified if cat. 9 was included
into the scope of the RoHS Directive. The exemption would have had to include mercury as
well, which had, however, already been exempted for use in “other lamps” by exemption III4 of the Annex of (European Union 13.02.2003) (RoHS 1). When the recast directive
2011/65/EU (RoHS 2) was published with cat. 8 and 9 being included into the scope, theexemption was listed on Annex IV in its current wording and scope as exemption 10.
Following the exemption request of (PE et al. 2023a), the exemption is due for review for
the first time since its publication on Annex IV in 2011.

23.1.2.

Summary of the requested exemption(PE et al. 2023a) describe that Line Source Atomic Absorption Spectroscopy (LS-AAS)
systems use lamps which contain lead, cadmium, or mercury. The substance is used as areference material in the cathode of the Hollow Cathode Lamps (HCL) or in the bulb of theElectrodeless Discharge Lamp (EDL).
For detecting a substance, a reference material of the same substance is required, forexample to detect cadmium, a reference cathode of cadmium is required in the HCL or abulb containing cadmium in an EDL. The primary requirement of the lamp in a LS-AAS
system is to generate a narrow emission line of the substance which is being measured.
The narrow spectral line width optimises the conditions for absorbance by any atoms
matching the reference substance, in the sample under test. The transmitted light detectedenables the accurate calculation of absorbance and therefore the determination of theconcentration of the substance in the sample.
There are no alternatives for using the substance under analysis as the reference material
in HCL and EDL lamps. These are the only substances that produce the precise light
spectra required in LS-AAS, for determining the concentration of the same substance in test
samples. (PE et al. 2023a)
The exemption wording has been amended to cover mercury. To date AAS lamps
containing mercury (HCL and EDL) have been covered under exemption III-4(a)(I) –Mercury in other low pressure non-phosphor coated discharge lamps, where the application
requires the main range of the lamp-spectral output to be in the ultraviolet spectrum: up to480

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15 mg mercury may be used per lamp. Due to the wide application scope of the III-4(a)(I)
exemption and the use of mercury in AAS for the same technical rationale as outlined inthis application, it would be preferable to cover its use in AAS lamps under exemption IV10. No technically viable alternatives to the use of these substances, in lamps in line source
AAS systems, have been identified.
Analysis using LS-AAS has been an established methodology for over 50 years and isembedded in numerous European standards. The development of products to support
alternative methodologies and to qualify them for the wide range of established line source
AAS applications is anticipated to take more than seven years and have significant
implications on end users. Based on data from the Analytical Life Science & Diagnostic
Association (ALDA) an installed base of approximately 5,000 LS-AAS systems in Europe123
is estimated.”(PE et al. 2023a)

23.1.3.

Technical description of the exemption and use of the restricted
substance(PE et al. 2023a) state that line source atomic absorption spectroscopy (AAS) has been
established for over 50 years as an analysis technique used to determine the concentrationsof metals. It is widely used to analyse alloys, ceramics, plastics, and other materials.
Figure 23-1 illustrates the principle of AAS. The test solution (sample) is vaporized in aflame (F-AAS) or graphite furnace (GF-AAS), light produced by a lamp passes through thevaporized sample which absorbs a portion of the emitted spectrum, and the part of thespectrum that passes through the sample is detected.
Figure 23-1: Outline of an AAS

Source: (PE et al. 2023a)

Comparing the intensity of the emitted spectrum with the intensity of the detected spectrum
after passage through the sample allows concluding on the content of a specific substance,
e.g. Cd, Hg or Pb, in the sample.

123 ALDA data covers: Western Europe, the UK, Scandinavia, Eastern Europe (Belarus, Bulgaria, Czechia,

Hungary, Moldova, Poland, Romania, Russia, Slovakia and Ukraine), the Balkans (Cyprus, Greece andTurkey and the Baltics)

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Hollow Cathode and Electrodeless Discharge Lamps as light sources in AAS(PE et al. 2023a) explain that Line source Atomic Absorption Spectroscopy (AAS) systems
use lamps which contain lead, cadmium, or mercury, either hollow cathode lamps (HCLs)
or electrodeless discharge lamps (EDLs). To detect lead, cadmium or mercury with HCLs,
reference cathodes made of the same substances are used as reference materials in
Hollow Cathode Lamps (HCL, see Figure 23-2 below) or in the bulb of the ElectrodelessDischarge Lamp (EDL). For example cadmium is required to detect cadmium, a reference
cathode of cadmium is required in the HCL, or a bulb containing cadmium in an EDL.
Figure 23-2: Outline of a HCL with cathode made of restricted substanceSource: (PE et al. 2023a)(PE et al. 2023a) further elaborate:

When an electrical potential is applied between the anode and cathode, some of the fill gas
atoms (typically argon or neon, filling the inside of the lamp) are ionized. The positively
charged fill gas ions accelerate through the electrical field to collide with the negatively
charged cathode and dislodge individual metal atoms in a process called ‘‘sputtering’’.
Sputtered metal atoms are then excited to an emission state. The emitted light is at awavelength characteristic of the sputtered metal. For example, if the cathode is made fromlead the emitted spectra will be characteristic of lead. Light with a specific wavelengthcharacteristic is required for the next step in the AAS process.

EDLs contain a small quantity of cadmium, lead or mercury in the bulb as illustrated in
Figure 23-3.

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Figure 23-3: Outline of an EDL with the restricted substance contained within the partlabelled as “Lamp”

Source: (PE et al. 2023a)

Instead of electrical energy, an intense field of radio frequency (RF) radiation provides
ionization and excitation of the metal to produce a spectrum to be used in Line Source AAS.
Line Source Atomic Absorption Spectroscopy:(PE et al. 2023a) explain that the HCLs and EDLs described above are used to produce the‘line source, i.e. a narrow emission line of the element, which is being measured in AAS,
e.g. Cd, Hg or Pb. The primary wavelengths for the substances of concern are:•Lead 217.0 nm•

Cadmium 228.8 nm•

Mercury 253.7 nm

As a result of the low pressure and temperature in the HCL, the linewidth of the substancespecific emission is very narrow in the order of the linewidth of 10-3 to 10-4 nm. The
wavelength and the spectral linewidth of the element specific emission matches exactly or
is even narrower than the spectral absorption characteristic of the specific substance to be
detected in a sample.
Therefore, the spectral sensitivity is high, and the signal-to-noise ratio is low, allowing thecharacterisation of samples when only containing very low levels of the substance (parts
per quadrillion (ppq), for some applications). Figure 23-4 (top) shows the narrow bandwidthof the primary wavelength of light produced by the lamp. This is narrower that the absorption
bandwidth (middle) of the sample under analysis and narrower than the bandwidth of thedetector (monochromator).

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Figure 23-4: Bandwidths of lamp emission spectrum and sample absorbance spectra

Source: (PE et al. 2023a)

According to (PE et al. 2023a), only a small sample size is required (between μg and mg)
depending on the sample introduction methodology. Pb-HCLs have their principal
wavelength at 217.0 nm, Cd-HCLs at 228.8 nm and Hg-HCLs at 253.7 nm. Those
wavelengths cannot be addressed by spectral lines of other elements in a discharge lamp
as the emission wavelength is wholly dependent on the specific element. One strong line in
the spectrum is chosen (one where any other metals present will not interfere) and this lightpasses through the flame where any vaporised atoms of the test metal will absorb light of
the wavelength chosen. Figure 23-4 (bottom) shows the resulting spectrum after passage
through the sample. There is a logarithmic relationship between absorbance and the ratio
of incident intensity and transmitted intensity (transmittance) as given below.
Equation 23-1: Relationship between absorbance, and ratio of incident andtransmitted intensity (transmittance)A

Absorbance484

Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU

I0

Incident intensity

I

Transmitted intensity

T

TransmittanceSource: (PE et al. 2023a)

The light that has passed through the flame is measured using a monochromatic detector,
an optical device that selects and transmits a specified wavelength set at the required
wavelength. The detector produces an electrical signal that is proportional to the intensityof light. The intensity value is compared with the known intensity of that emitted from thelamp, from which the absorbance can be calculated. (PE et al. 2023a)
The Beer-Lambert Law (Beer’s Law, c.f. Equation 23-2), defines the linear relationshipbetween absorbance, concentration, the molar absorption coefficient, and the opticalcoefficient of a solution it is then possible to determine the concentration of the test
substance (lead / cadmium / mercury) in the test solution:
Equation 23-2: Beer-Lambert Law

Source: (PE et al. 2023a)(PE et al. 2023a) mention a number of different types of line source AAS, including:•

F-AAS – Flame AAS, as described above.

•

GF-AAS – Graphite Furnace AAS•

CVG-AAS – Chemical Vapour Generation AAS

They all use the line source lamps described above but different methods to introduce andatomise the sample.
End Use Applications(PE et al. 2023a) highlight the importance of detection and monitoring of toxic elements
such as lead, cadmium and mercury to prevent the exposure of humans and theenvironment to these toxic elements.
End use applications include:•

Environmental testing for contaminants or pollutants•

For example, the mining and metal processing industry can pollute the air in the formof dust, water in the form of ‘washings’ from ore processing, and the land in the formof waste heaps.

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Another example of a critical application would be the analysis of drinking water for
harmful contaminants.124•

Pharmaceuticals (manufactured pharmaceuticals), for example in the quality control
process to ensure a pharmaceutical product is free from heavy metals such as
cadmium, mercury & lead.125•

Food (contaminants)
Heavy metals like arsenic, cadmium, mercury, and lead can enter the food chain
through water, air, and soil. Although usually present at trace levels, the toxicity ofheavy metals, even at low levels, requires very sensitive analysis of metals in foods
to ensure safe levels that meet regulatory requirements.126•

Industrial (raw materials, finished goods)•

Clinical testing, for research purposes rather than diagnostic purposes, for example
for detecting lead levels in blood.127

Across the various application sectors, appropriate analytical methods are prescribed bystandards. Numerous standards require the use of AAS, explicitly by means of Hollow
Cathode Lamps (HCL). A non-exhaustive list of these standards is outlined in Table 23-3,
all of which mandate the use of AAS.

124 C.Radulescu.Determination of heavy metal levels in water and Therapeutic mud by atomic absorption

spectrometry. Romanian Journal of Physics 59(9-10):1057–1066,October2014; source as referenced by theapplicant
125 Nessa F, Khan SA, Abu Shawish KY. Lead, Cadmium and Nickel Contents of Some Medicinal Agents.

Indian J Pharm Sci. 2016 Jan-Feb;78(1):111-9. doi: 10.4103/0250-474X.180260. PMID: 27168689; PMCID:
PMC4852560; and Nancy S. Lewen, Martha M. Schenkenberger,Atomic Spectroscopy, Pharmaceutical
Applications, Pages 107-114, Encyclopedia of Spectroscopy and Spectrometry (Third Edition),ISBN
9780128032244; source as referenced by the applicant
126 Flame Atomic Absorption Spectrophotometry Analysis of Heavy Metals in Some Food Additives Available

in Baghdad Markets, Iraq. Indian Journal of Forensic Medicine and Toxicology, October 2020. Abdulwahid,
Dawood, Mohammed, Jamur; source as referenced by the applicant
127 Determination of lead in blood by graphite furnace atomic absorption spectrometry with Zeeman

background correction: Improving a well-established method to support a lower blood lead reference value forchildren – ScienceDirect; source as referenced by the applicant

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Table 23-3: Standards adopting AAS for detection of lead, cadmium and/or mercury

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Source: (PE et al. 2023a)

As a further area of regulation, (PE et al. 2023a) point out the European Pharmacopoeia(Ph.Eur. 10.0). The European Pharmacopoeia (Ph. Eur.) is a single reference work for thequality control of medicines. The official standards it contains provide a scientific basis for
quality control during the entire life cycle of a product.
These standards are legally binding – as laid down in the Council of Europe Convention on
the Elaboration of a European Pharmacopoeia and in EU and national pharmaceuticallegislation. Ph. Eur. quality standards become mandatory on the same date in all States
Parties to the convention.7•

In chapter Ph. Eur. 2.2.23 AAS and hollow cathode lamps are listed as a permitted
measurement technique. For the determination of lead in sugar the Pharmacopoeia
is regulated using AAS (Ph. Eur. chapter 2.4). Another example for the applicationof AAS in pharmaceutical industries is the determination of extractable cadmium inmaterials used for the manufacture of containers (Pharm.Eur. chapter 3.1).

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23.1.4.

Amount(s) of restricted substance(s) used under the exemption(PE et al. 2023a) provide the below information as to the use of the restricted substancesthat would be used under the exemption if it was granted:•

Lead: 99.140 kg•

Mercury: 0.010 kg•

Cadmium: 44.646 kg

According to (PE et al. 2023b), the above quantities are an estimate of the total expectedvolumes of the restricted substances being placed on the market under the renewed
exemption by all producers. The estimate is based on extrapolating sales and market sharedata made available by applicants.

23.2.
23.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substance(PE et al. 2023a) claim that there are no alternatives for using the substances under analysis
as the reference material in HCLs and EDLs. These are the only substances that produce
the precise light spectra (c.f. Figure 23-4 on page 484) required in line source AAS for
determining the concentration of the same substance in test samples. (PE et al. 2023a)
note that EDL utilises less of the restricted substance in comparison with HCL.
EDLs are an alternative light source for HCL. (PE et al. 2023a) note that EDLs utilise lessof the restricted substance in comparison with HCL. In the case of lead, the EDL contains
less than 1 mg of lead while an HCL contains 8-12 g of lead. So, although it would not
eliminate the use of lead, cadmium, or mercury in line source AAS lamps, a change to solely
EDL lamps would result in a reduction in the use of the restricted substances. In order for
EDL lamps to be used in place of HCL lamps in line source AAS systems, modifications tothe systems would be required, including but not limited to the addition of an EDL driver(High Frequency power source), mechanical, electrical, firmware & software interfaces.
According to (PE et al. 2023a), currently only one of the applicants has explored this option
and has a commercial solution. The development time for the other applicants would be
similar to the development of a new platform, i.e. around 10 years. This option would not
eliminate the use of the substances but would result in a 99 % reduction of the quantities ofrestricted substances involved.
While there seems to be no substitute for cadmium, lead and mercury in line source AAS,
(PE et al. 2023a) discuss alternative light sources, and inductively coupled plasma systems
as potential alternatives that might facilitate the elimination of these restricted substances.
Alternative light sources - LEDs
(PE et al. 2023a) explain that solid state light sources, like ultraviolet (UV)-LEDs do not
utilise any of the restricted substances and offer flexibility with peak wavelengths byadjusting the design and composition of the active region of the semiconductor. However,
UV-LED devices with peak wavelengths of < 250 nm are currently not commercially489

Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

available so that they cannot replace lead and cadmium which emit at 217.0 nm and
228.8 nm respectively. Even though mercury at a wavelength of 253.7 nm is detectable, a
UV-LED equipped system`s overall poor sensitivity does not render it a viable alternative to
HCL or EDL equipped systems.
UV-LEDs are adjustable in wavelength but have a typical spectral linewidth of around 10
nm. As a result, > 99.9 % of the light falls outside the absorption line of Cd, Pb or Hg in thesample but still arrives at the detector. This increases the background signal by a factor> 1000 and reduces the signal to noise-ratio correspondingly. Even if the peak wavelengthof UV-LEDs was the same, this is not a viable approach for detection of low levels of specifictrace elements in AAS. The perfect match of emission and absorption characteristic of thespectral line can only be achieved by using the substance to be detected in the sample as
the light emitting reference substance in the lamp.

Alternative light sources - Continuum light source(PE et al. 2023a) discuss continuum light sources (CSs), e.g. Xenon lamps, as analternative to HCLs and EDLs. A continuum light source emits radiation over a broad rangeof wavelengths. A continuum light source cannot be used in the existing platform for an
HCL/EDL based AAS. This is because the monochromators in these systems would provide
too large a spectral bandwidth resulting in poor sensitivity and specificity, non-linear
calibration curves and greater susceptibility to spectral interferences. In addition, theintensity of most CSs decreases dramatically below 280 nm to levels that are not detectable
by a line source monochromator. Consequently, the use of a CS for AAS requires re-designof the whole instrument.128(PE et al. 2023a) mention, however, one known example of a commercially available AAS
system using a continuum source (HR-CS AAS) launched in 2011 and manufactured byAnalytik Jena (AJ). This system provides simultaneous multi-element analysis. Whilst it canperform the analysis carried out by traditional HCL- and EDL-based AAS systems, it isconsidered overly complex in terms of hardware and software for applications where single
element analysis is required or where sequential multi-element analysis is not required.
(PE et al. 2023a) consider this to be reflected by the fact that Analytik Jena continue tomarket their traditional AAS systems. Having been launched in 2011 it is still relatively new
to market compared with line source AAS systems which have been around for over
50 years. Consequently, the adoption of this technology and qualification of testing on
different sample types/applications is still relatively low. There are no known standards
prescribing the use of this technology. In some applications, line source AAS is still
considered to be the optimal test method rather than CS-AAS. Steps that manufacturer’s
other than Analytik Jena would need to take in developing a new system platform based ona continuum source would result in a total time to market of around 10 years, and additionaltime would be required for the conversion/qualification of established test methods to thenew platform.

128 Welz et al. 2003 Source referenced by TMC

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Inductively Coupled Plasma (ICP) Systems(PE et al. 2023a) comment Inductively Coupled Plasma–Optical Emission Spectroscopy(ICP-OES)129 and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) as alternatives
to line source AAS.
(PE et al. 2023a) describe ICP-OES as being an optical emission spectrometry method, as
opposed to absorption like in AAS. Figure 23-5 shows an outline of an ICP-OES.
Figure 23-5: Outline of an ICP-OES

Source: (PE et al. 2023a)

One of the methods of sample introduction into an ICP-OES system and the analysis
method is that the sample to be analysed is dissolved in acid and water. Nitric acid is themost common acid used as most elements form water soluble nitrates. The water solution
is then pumped into the instrument nebulizer, which turns the sample into a spray that is
subsequently fed into the plasma. This plasma is most commonly composed of argon,
although nitrogen gas and mixed gas compositions may also be used. The plasma is
generated through the use of a high-power radio frequency signal or through microwave
irradiation, which causes the gas to ionize to form electrons and other charged species
within the plasma matrix. The plasma ionises the elements of interest in the sample. The
ionised elements recombine with free electrons available in the plasma source, emitting
specific spectral lines that are picked up by a detector. The detector converts the light signal
emitted from the elements into an electrical signal producing a response that is proportional
to the concentration of the element in the solution.
According to(PE et al. 2023a), the inductively coupled plasma mass spectrometry (ICPMS), like ICP-OES, operates with a fine aerosol of a sample that is introduced into a hot(6,000 – 10,000 K) argon plasma of sufficient energy to dry the aerosol and form analyte

129 Also referred to as Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) or Microwave

Plasma Atomic Emission Spectroscopy (MP-AES); information as provided by TMC.

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atoms, which are simultaneously ionized. The ions are then sorted and quantified based on
their mass-to-charge (m/z) ratio in the mass spectrometer.
(PE et al. 2023a) point out some disadvantages of ICP-OES and ICP-MS compared to AAS.
Complexity of use
AAS is much simpler to operate than ICP-OES or ICP-MS enabling its use by a lower skilled
operator. This is reflected in the training courses offered, the ICP-OES course being twice
the duration of that for AAS. Method development using ICP techniques can be a timeconsuming process, as it necessarily involves multiple steps:
4) Crude analysis to obtain a basic idea of the elements present in the sample;
5) Wavelength selection based on that initial knowledge;6) Optimisation of separation so that signals from the various wavelengths have limited
overlap;
7) Comparison with an internal standard to validate the method and system
performance;8) Analysis for spectral interferences and ways to eliminate those from the read-out
without eliminating target signals.
Due to the above the upfront time investment is greater for ICP-OES/MS than AAS, insituations where a fast turnaround for results is required, this is a limiting factor for ICPOES/MS. One example is the fast and immediate determination of oil in tankers before they
are unloaded. Pb and Cd are elements determined with ET-AAS before the ship isunloaded. With ET-AAS, the procedure can be run night or day without the need for ananalytical chemist.
Sensitivity and sample dilution
The ICP-OES technique is in most cases not sensitive enough (% to ppb) to reach thedetection limits of GF-AAS (ppm to ppt), especially for lead. So, this quantification technique
is no alternative to GF-AAS and ICP-MS (ppm to ppt) for many applications.
In applications where high salt concentrations are present GF-AAS is often technicallyfavoured as it requires minimal, or no dilution of the sample compared with ICP-MS which
requires dilution factors between 1:100 to 1:1000.
Isobaric Interferences
Isobaric interferences refer to different elements whose isotopes share a common mass,
which causes an issue in analysis techniques reliant on mass spectrometry such as ICPMS. Isobaric interferences occur in the quantification of cadmium by ICP-MS formolybdenum oxides, which leads to incorrect results if the molybdenum concentration isdominant. Tin is another element forming isobaric interferences regarding cadmium. As aresult, low cadmium concentrations in molybdenum or tin content in components or
chemicals, can yield poor results when using ICP-MS. Isobaric interferences do not arise
with AAS techniques.
Complexity of instrument architecture(PE et al. 2023a) point out that more infrastructure and consumables are required for an
ICP-OES/MS system than for an AAS system. An AAS system typically requires thefollowing consumable items and utilities: Compressed air source, ethylene, lamps,
reagents, standards and power. An ICP system requires argon gas (typically 25-20 L/min),492

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quartz torches, reagents and standards, pump tubing, power and cooling water. ET-AAS &CVG-AAS, require argon, but at a consumption rate of 20 times less than ICP. This means,
flame AAS can operate at remote sites (specifically for mining or chemical hygiene) where
it would be nearly impossible to run an ICP-OES/MS. ICP-OES/MS requires costly
instrumentation for plasma generation, sample aerosolising, and signal analysis. The
complexity of the instrument architecture results in a larger equipment footprint (as indicatedin the below table) and initial capital cost. (PE et al. 2023a) indicate that ICP-OES is typically
twice the cost of AAS and ICP-MS in the region of five times the cost of AAS. The ICP
systems also usually require an ultra-clean, thermostatically controlled environment.
There may be instances where this larger footprint prohibits the use of the larger systems
in some laboratory spaces. It is also possible that a laboratory would want to retain the AAS
for the detection of substances other than lead, mercury and cadmium.
Figure 23-6: Comparison of footprints of AAS and potential alternatives

Source: (PE et al. 2023a)

Adaptation of established methods(PE et al. 2023a) reference Table 23-3 on page 487 which demonstrates that the use of
AAS is embedded in a number of prescribed procedures. Many applications have methods
which have been developed and validated for years. Although these methods could be
adapted and converted into a method to enable the analysis using one of the other atomic
spectroscopy techniques such as ICP-OES or ICP-MS, this is not an easy or quick
undertaking. They illustrate this with an example from one of the applicants (“Applicant X“).
This Applicant X has recently worked with ASTM and an international collaboration task
group consisting of 12 independent laboratories around the world, to develop and validate
two new test methods for determination of elements in biodiesel and biodiesel blends byMicrowave Plasma Atomic Emission Spectrometry (MP-AES) and determination of metals
and other elements in residual fuel and crude oil by Microwave Plasma Atomic Emission
Spectrometry (MP-AES). The goal was to streamline this elemental analysis by allowing theuse of a single technique. Measuring the same elements previously required using multiple
ASTM methods and multiple techniques: Inductively Coupled Plasma Optical Emission
Spectroscopy (ICP-OES), Flame Atomic Absorption Spectrometry (Flame AAS), and X-ray
spectrometry.
Initially, this required Applicant X to develop a method for determination of the target
elements in biofuels, residual fuel and crude oil using a MP-AES method. This wascompleted and a draft standard test method was prepared in December 2014. It was thennecessary to “recruit” 12 laboratories who were either routinely completing this analysis
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already – or had the expertise to participate. Applicant X equipped these laboratories with
the MP-AES instrumentation, the analytical standards and other consumables required tocomplete the analysis and provided on-site training for each of the laboratories. The goal
was to generate data demonstrating the achieved performance, especially interlaboratory
reproducibility, for the ASTM committee. As part of this collaboration, the laboratories
involved in the study also compared the results for metals content in the biodiesel, residual
fuel and crude oil samples using the techniques of Inductively Coupled Plasma OpticalEmission Spectroscopy (ICP-OES), Inductively Coupled Plasma Mass Spectrometry (ICPMS), and Microwave Plasma Atomic Emission Spectroscopy (MP-AES).
The ASTM D8322-20 method for determination of metals and other elements in residual
fuel and crude oil using the Microwave Plasma Atomic Emission Spectrometry (MP-AES)
technique (ASTM D8322-20 Standard Test Method for Determination of Elements in
Residual Fuels and Crude Oils (V, Ni, Ca, Na, Al, Si, Zn, P, and S for residual fuel oil andFe, V, Ni, Ca, Na, K, and S for crude oils) by Microwave Plasma Atomic Emission
Spectroscopy (MP-AES) was finally released in July 2020.
The ASTM D8351-22 method for determination of trace elements (calcium (Ca),magnesium (Mg), phosphorus (P), potassium (K), and sodium (Na) in Biodiesel andBiodiesel Blends using the Microwave Plasma Atomic Emission Spectrometry (MP-AES)
technique (ASTM D8351-22 - Standard Test Method for Determination of Trace Elements
in Biodiesel and Biodiesel Blends by Microwave Plasma Atomic Emission Spectrometry(MP-AES) was finally released in May 2022.
The scope of this method development is similar to what would be expected for any of theEuropean (EU) methods using atomic absorption to either an ICP-OES or an ICP-MS
method. As noted in the above example where new ASTM methods were developed, theelapsed time was 6 – 8 years for EACH method.

23.2.2.

Environmental, health, safety and socioeconomic impacts(PE et al. 2023a) inform that complete AAS system including lamps are collected and sent
to treatment where the AAS lamps and reference cathode materials are recycled. They
assume that the lamps recycled will approximately equate to lamps purchased so that theannual volumes of restricted substances in the waste arising from the AAS devices is thesame as the masses of these materials that are used under the exemption on an annual
basis, c.f. section 23.1.3 on page 481.

23.2.3.

Roadmap towards substitution or elimination of the restricted
substance

Reduction of restricted substances
Conversion of existing HCL source systems to EDL sources(PE et al. 2023a) inform that changing from HCL to all EDL in line source AAS is an option.
The EDL utilises less material than HCL, for example for lead the EDL contains less than
1mg of lead compared with HCL, which contains 8-12 g lead. So, although it would not494

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eliminate the use of lead, cadmium, or mercury in AAS lamps, a change to solely EDL lamps
would result in a reduction in the use of these substances.
They further state that changing to ED lamps would require modifications to the existing
AAS platforms for some of the applicants, which is platform design / manufacturer specificand is anticipated to be similar to new product development timescales in the region of 10
years. This excludes the program required to replace or retrofit installed units. This solution
does not result in the elimination of the substances. They further estimate that the majority(> 95%) of the atomic absorption spectrometers that have already been installed and are in
operation incorporate HCLs.
Substitution or elimination of restricted substances
Change to Continuum Source AAS
Eliminating the use of restricted substances by means of continuum light source (CS) based
systems is currently possible for only one manufacturer with a commercial product available
on the market. For the others to take this approach would require just under a 10-year new
product development cycle for the technology.
The applicants provide as an example the steps and timeframes involved for the productdevelopment cycles for EDL- or CS-based AAS systems (PE et al. 2023a).
Pre-concept stage: requirements specification and technical feasibility ~12 months.
Concept stage: develop concept ideas and some proof of concepts to verify if they areachievable ~18 months.
Planning Stage: generate the baseline of schedule, cost, and quality, and define SRS(system requirements specs) ~12 months.
Development phase: generate detailed designs & drawings, build prototypes, and run
prototype verification (typically two prototype runs are required) ~48 months.
Validation & commercialisation stage: prepare materials and build pilot run instruments inthe manufacturing plant, run instrument validation tests, to make sure instruments accord
with URS12. This stage is also used to verify the design is ready for mass production andtrain service engineer ~24 months.
In total this is 114 months or around 10 years.
Change to ICP based System
All the applicants that manufacture line source AAS systems, also market ICP solutions.
Whilst this technology could perform the function of line source AAS, a blanket change tothis technology would require an extensive feasibility study involving end users andstandardisation bodies. Developing and qualifying new methodology for standardisation
would take up to a total duration of 10 years. This excludes the manufacture (typically 4-8
weeks), transit to (variable) and installation (typically 1-2 days) of ICP systems at end user
facilities.

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23.2.4.

Stakeholder contributions

The consultants reached out to different stakeholders130 producing similar analytical
instruments to inquire their perspective on the technological feasibilities of reducing or
substituting/replacing components or entire instrument systems including restricted
substances. Despite cooperatively providing information they could not provide substantial
evidence against restricting exemption IV-10 for cadmium, mercury and lead to EDL lamps.

23.3.
23.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however, the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several restrictions of cadmium and its compounds are listed on Annex XVII (cf. section 4.1
on page 48). None of those, however, is applicable to the use of cadmium and cadmium
compounds in the scope of exemption IV-10.
Further on, uses of lead and lead compounds are listed on Annex XIV. Additionally, Annex
XVII contains several restrictions for lead and its compounds. None of those entries are,however, relevant for the use of lead in the scope of exemption IV-10 (cf. section 4.2 on
page 51 for details).
Finally, Annex XVII contains several restrictions for the use of mercury and its compounds.
None of those entries are relevant for the use of mercury and mercury compounds in thescope of exemption IV-1(c) (cf. section 4.3 on page 54 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

23.3.2.

Substitution and elimination of the restricted substance

The applicants’ information indicates two principal options to avoid or at least to
considerably reduce the use of restricted substances. The CS-AAS manufactured by one
member of the applicants’ consortium may replace LS-AAS at least in some of its uses thus
eliminating the use of cadmium, lead and mercury in AAS. EDL as an alternative light source

130

Thermo Fisher Scientific GmbH and Lumex Analytics GmbH

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for HCLs require around 1 % of the volumes of the restricted substances used in HCLs. The
review will therefore focus on the potentials to eliminate or at least reduce the use of therestricted substances in AAS.
Alternative light sources for elimination of Cd, Hg and Pb
Solid state light sources(PE et al. 2023a) state that UV-LEDs are no alternative light source for LS-AAS with lead,
cadmium and mercury because they are not available for peak wavelengths below 250 nm.
The primary wave length of mercury is above 250 nm and thus within the spectral range of
UV-LEDs. However, (PE et al. 2023c) add that “Although UV-LEDs are available atwavelengths above 250 nm, their spectral line width of several 10 nm makes them notsuitable for line source AAS, as the sensitivity is far too low, even for very high Hgconcentrations.” In comparison LS-AAS have a linewidth of 10-3 to 10-4 nm (PE et al. 2023a).
With the evidence provided above and in section 23.2.1, the consultants conclude that due
to the lack of sensitivity for mercury and due to the lack of peak wavelengths below 250 nm,
UV-LEDs are no alternative to HCL/EDL for the elimination of mercury, lead and cadmiumin AAS.
Continuum light sources
Continuum light sources (CS), such as Xenon lamps, emit radiation over a broad range of
wavelengths and reach wavelengths below 200 nm without the need of restricted
substances. However, these light sources are not considered an alternative to existinglamps [as a direct replacement] because they cannot be retro fit on LS-AAS instruments
currently on the market due to drastically more complex monochromators (PE et al. 2023a).
(PE et al. 2024a) further explain that the spectral resolution required for continuum source
AAS is about 100 times higher than for a line source AAS. This is an extremely high opticalresolution which can only be achieved by gratings131 with an extremely high number ofgrooves per mm combined with a large focal length of about 1 m, or with a resolution in two
dimensions using 2 gratings or a grating/ prism combination. Both designs are more
complex, significantly more expensive and require much stricter control of theenvironmental conditions of the instruments compared with the monochromator of line
source AAS. In addition, the intensity of most CSs decreases dramatically below 280 nm tolevels that are not detectable by a line source monochromator.
A lamp substitution of LS-AAS systems with CS lamps would thus require a complete redesign of the system. While, overall, the above explanations also seem to exclude CS as a
RoHS-compliant alternative for HCL.

131 Diffraction gratings are optical components critical for a wide variety of applications including

spectrometers, other analytical instruments, telecommunications, and laser systems. Gratings contain amicroscopic and periodic groove structure - which splits incident light into multiple beam paths throughdiffraction, causing light of different wavelengths to propagate in different directions.
https://www.edmundoptics.com/knowledge-center/application-notes/optics/all-about-diffraction-gratings/

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(PE et al. 2023a) mention that one such re-designed system has been brought to market
by a member of the consortium Jena Analytik in the form of a high-resolution continuum
source AAS (HR-CS AAS) in 2011. According to (Welz et al. 2003) other HR-CS AAS had
been brought to market by the same company years earlier and when questioned (PE et al.
2024a) elaborated on the timeline of instruments brought to market by Jena Analytik:-

2005: “contrAA 300”, the first commercially available HR-CS AAS, flame-only-

2007: “contrAA 600”, the first HR-CS AAS for graphite furnaces-

2011: “contrAA 700”, the first HR-CS AAS that supports F-AAS and GF-AAS

These systems offered by Jena Analytik can perform analyses carried out by traditional
HCL- and EDL-based AAS systems.
This raises the question how the limitations of CSs described above could be overcome toenable their use in a system that can replace conventional AAS at least partially.
Jena Analytik have addressed the intensity loss below 280 nm by using a special design
xenon arc lamp that has been optimized to run in the so called “hot-spot” mode,characterized by an extremely small plasma spot close to the cathode surface. This isachieved using selected materials for the anode and cathode rods, maintaining a shortelectrode distance, using a higher xenon pressure inside the lamp and a specifictemperature regime. In addition to the lamp power supply of 300 W nominal (typically 20 V
and 15 A), an additional circuit is used to apply a short high-voltage pulse of about 30 kV toenable ignition (PE et al. 2024a).
Finally, the requirements of HR-CS-AAS on the spectrometer are extremely sophisticated.
The resolving power required is at least two orders of magnitude higher than in conventional
LS-AAS spectrometers, to ensure comparable sensitivity for each element and freedom
from spectral interferences due to wavelength overlaps. This requires a more expensive,
specially designed echelle spectrometer with either internal or external order separation (PEet al. 2023c).
Increasing successful academic method development for specific use cases demonstrates
the applicability and competitiveness of these CS-based AAS systems in many use cases
compared to traditional HCL/EDL-based AAS systems under controlled laboratory
experimental conditions (Welz 2005) (Ferreira et al. 2018) (Resano et al. 2013). From thesecontrolled laboratory-based efforts it is apparent that methodological development andstandardisation is still an ongoing process with currently no successful transfer or adoption
into industry-relevant HR-CS-AAS technical standards or norms, which can be regarded asa presently low industrial market adoption of the system.
HR-CS-AAS can, depending in use case, produce competitive results in single element
analysis compared to LS-AAS, however, it was developed as a multi element, simultaneousor sequential analysis system. These inherent instrumental features result in drasticallymore complex technological implementations as described above but also require higher
operational skill levels and control over the environmental conditions.
When questioned about the operational complexity (PE et al. 2024a) responded that thepresence of bands [results of matrix interference stemming from sample preparation]requires careful application of background correction. The continuous background can becorrected by the computer-aided signal processing of the instrument itself, which records
successive reference intensity spectra without any analyte absorption using a mechanicalshutter to block the radiation from the xenon lamp. The correction of the fine-structured

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background from the molecular absorption bands requires a reference spectra to be created
for the interfering species (without the analyte absorption). A least squares fitting algorithm
can then be applied through the instrument software to correct for this contribution. Thisrequires a higher level of training and experience to operate the system.
They further elaborate on the environmental conditions that the higher the optical resolutionof the monochromator, the more delicate is the system with respect to stable temperature
and atmospheric conditions. In the case of HR-CS AAS, for example the photon intensity of
the continuum lamp on the first collecting mirror is extremely high and much higher than in
LS-AAS. Fogging of this mirror by dust will result in a fast degradation of signal to noise,
specifically in the short wavelength range below 250 nm. This refers to a more controlledenvironment than that required for LS-AAS (PE et al. 2024a). LS-AAS is able to operate ina wider range of environments, including production areas, non-air-conditioned
environments and non-clean room conditions (BBT 2023a).
(PE et al. 2023c) exemplify critical non-clean room industrial work environments by referringto the principle of LS-AAS also being used in specialized measuring devices for various gas
measurements, e.g. flue gas analysis for cement plants, combustion power-plants, waste
incineration plants, etc. These devices are not known as AAS because they specialize intesting only one or a few selected elements (especially mercury) and are sometimes only
subsystems of more complex measuring systems that measure many other parameters.
They will, however, employ the same HCL/EDL lamp technology.
Based on the above the consultants conclude that despite being competitive in many
aspects, LS-AAS and HR-CS-AAS are not a direct instrumental replacement for one
another. End users must critically assess their use cases in terms of target analyte, sample
matrices, operational environment and choose a system most adequate to their individual
analytical circumstance. It is impossible to address every individual use case in the scopeof this critical review. Furthermore, when the capability to work in non-air-conditioned
environments is part of the definition of the technical requirements of thesystem/technology, then HR-CS-AAS does not offer a technological solution for a
substitution of HCL/EDL based AAS.
Inductive coupled plasma systems
ICP-OES and ICP-MS are elemental analysis methods based on emission and mass
spectrometry, in contrast to AAS as which is based on absorption spectroscopy. (PE et al.
2023a) regard ICP systems as alternatives to LS-AAS and elaborate in great detail on thesample introduction, analysis methods and operating principles, summarized in section
23.2.1above.
Depending on the use case ICP methods can replace HCL/EDL-based AAS. Indeed ICPOES is gaining popularity and more and more users are switching over, particularly comingfrom F-AAS (SPECTRO 2017). Some advantages of ICP methods are higher throughput ofsamples and multi-element analysis, with reduced sensitivity to matrix interference (ICPOES) and very low limits of detection (ICP-MS), to name but a few examples (Agilent 2024).
When asked for a direct comparison of the analytical capabilities of AAS and ICP systems(PE et al. 2023c) responded that Flame AAS (F-AAS) has detection limits for Cd, Pb, and
Hg in the µg/L (Pb, Cd) to mg/L (Hg) range and is comparable or worse in terms of detection
limits than conventional ICP-OES. GF-AAS has a better detection limit for Cd and Pb
compared to the ICP-OES technique. For lead, the difference between GF-AAS and ICPOES in standard operation is around a factor of 10 or more, for cadmium around 2 or more.

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The detection strength for GF-AAS can be further increased by using multiple injections of
the sample. This option is not available for F-AAS and ICP techniques. Hg has detection
limits in the medium µg/L range in the GF technique and shows therefore a lower
performance regarding the limit of detection than the ICP-OES technique. CV-AAS/AFES(CVG or cold vapor) offers detection limits for Hg in the ng/L to sub ng/L range. CV-AFS(cold vapor atomic fluorescence spectrometry) is one of the most powerful detection
techniques for Hg (CV-AES offers better detection limits than ICP-MS).
The ICP-MS technique offers detection limits in the low ng/L range for the elements Cd, Pb
as well as Hg and is more powerful than GF-AAS. This ICP technique, like the ICP-OES
instruments, has a high resource consumption [and sample volume!] compared to the AAS
technique. The high quantities of argon required, which is obtained through the energyintensive air liquefaction process, as well as high power consumption required for plasma
generation and cooling (ICP techniques in the several kilowatt range, AAS technique in theapprox. 1000 watt range).
In section 23.2.1 (PE et al. 2023a) detail some disadvantages of ICP systems and refer tothe complexity of use with the need to specially trained analytical chemists, high upfront
economical costs (up to five times the cost of AAS) and time investment in method
development. The complexity of the instrument architecture demands ultra-clean
thermostatically controlled environments, rendering these methods impracticable forsituations where a clean work environment cannot be guaranteed, e.g. cement industry or
mining sites.
The consultants take from the above explications that the choice of the optimum
instrumental setup in elemental analysis by end users highly depends on the specific task.
Similar to the discussion about continuum light sources above, there are particular use
cases where AAS systems are considered irreplaceable. In cases when a clean work
environment cannot be guaranteed, when analytes are contained in complex matrices withhigh total dissolved solids and when a low sample volume (microlitre range) where further
dilution would result in analyte falling below the limit of detection GF-AAS is currently
indispensable (TMC; PE et al. 2023; Agilent 2024). The consultants therefore do not see
the potential to replace LS-AAS systems as a whole with the aforementioned ICP
technology.
Reduction of the amounts of restricted substances by EDL light sources
Technological considerations(PE et al. 2023a) estimate that EDL-based AAS systems would not eliminate the use ofrestricted substances but would result in a 99 % reduction of the quantities compared to
HCL-based AAS systems, with lead content of Pb-HCL of 8 – 12 g and Pb-EDL of less than
1 mg. They further mention EDL to have about half the lifetime compared to HCL. When
asked about the average lifetimes of HCL (PE et al. 2023c) responded the following:o

HCL-Lead can be operated at 8mA for about 3.000 - 10.000 mAh, which
equates to around 375 – 1.250 h of operation.

o

HCL-Cadmium can be operated at 6mA for around 3.000 - 10.000 mAh,
which equates to around 500 - 1.666 h of operation.

o

HCL-Mercury can be operated at 5mA for around 3.000 - 10.000 mAh, which
equates to around 600 - 2.000 h of operation.

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When considering half the lifetime of EDL compared to HCL lamps, and the estimatedmasses of Pb-HCL and Pb-EDL provided, the reduction of lead would amount to up to
99.98 % of that of HCL lamps. Upon further inquiry they could, however, not provide further
non-confidential information about the exact contents of mercury and cadmium in EDLs (PEet al. 2023c).
The applicants bring forward several technological disadvantages and challenges of EDLbased AAS. (PE et al. 2023a) state that with EDL-based AAS systems there will be highheat generation during operation. Due to the atomization chambers in flame chambers orgraphite furnaces, significant heat generation is an intrinsic characteristic of AAS. So, theconsultants consider high heat generated by EDLs to be an insignificant additionalinconvenience to the end user. The instrument’s capability to handle these temperatures
has already been proven by manufacturers with machines already on the market.
Figure 23-7: AAS for operation with HCL and EDL lamps

Figure 23-7 is showing a commercially available spectrometer by PerkinElmer,Inc. showingthat both HCL and EDL can be accommodated within the same instrument.
(PE et al. 2023a) bring forward that 95% of AAS on market are HCL-based and explain thatin order for EDL lamps to be used in place of HCL lamps in line source AAS systems,
modification to the systems would be required, including but not limited to the addition of an
EDL driver (High Frequency power source), mechanical, electrical, firmware & softwareinterfaces. (PE et al. 2023b) point out the necessity for existing HCL-AAS owners tootherwise upgrade or modify their instruments and the difficulty to maintain CE compliancewhen retrofitting instruments with EDL power supplies. The consultants do not regard theabove arguments as evidence to substantiate the necessity to include HCL in exemption
IV-10. The estimated 95 % market share of HCL in LS-AAS systems refers to all HCL outof which the majority does not include restricted substances and which would remain
unaffected should the extension request for exemption IV-10 not be granted. In the
consultants’ understanding, Art. 4(4) would ensure that HCLs including restricted
substances could still be supplied to the market as spare parts for AAS systems that wereplaced on the market before the expiry of the current exemption, and therefore no upgrade
or modification to systems currently on the market would be required.

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Should the COM decide not to extend, or to restrict the exemption to EDL-based AAS, AAS
systems including HCLs not containing restricted substances could still be provided to themarket after the expiry. Since HCL are spare parts of LS-AAS systems, exchanging theselamps is relatively simple and HCL not including restricted substances can easily beswapped out for HCL including restricted substances. In order to avoid circumvention of a
restriction, HCL provided as spare parts would need to be made available to AAS systems
placed on the market prior to expiry of the exemption only, which may require additional
administrative control mechanisms (e.g. documentation with date of purchase of the LSAAS system).
(PE et al. 2024a) further add that EDL lamps are available on the market for fewer elements
compared to HCL lamps because EDL have not been developed for elements where an
improvement in lifetime or analytical quality could not be realized. Since EDL for Cd, Pd,
and Hg are available and AAS systems that can make use of both lamp types are alsoavailable, the consultants conclude that where EDLs are not available for certain elements
users can keep using HCLs without restricted substances.
Development of EDL-based AAS systems(PE et al. 2023a) state that currently only one of the applicants has explored this option[EDL-based AAS systems, Figure 23-7] and has a commercial solution. The development
time for the other applicants would be similar to the development of a new platform as
detailed in section 1.2.3 (around 10 years).
When questioned about the first commercial availability of EDL (PE et al. 2023b) stated thatthe first use or description of EDLs specially designed for AAS is from 1973. The consultants
further inquired why only one manufacturer made efforts to reduce amounts of restricted
substances (by means of EDL systems) since cat. 9 IMCI have been integrated into thescope of the RoHS Directive since 2011. According to (PE et al. 2023c) the manufacturer
in question held the patent for this technology. This patent has now expired so it is possible
for other manufacturers to exploit the technology. The consultants inquired the exact
expiration date and (PE et al. 2024a) responded that the patent had expired in 2002. Since
the patent had expired prior to 2011 the consultants do not consider the above argument
as evidence to substantiate an inability of the exploitation of EDL technologies since 2011.
In fact, at least one other company which is not part of the applicant consortium has madethese development efforts and is offering an AAS system that can be equipped with EDL
and HCL within the same instrument (Lumex Instruments Ltd.). Even though this company
does currently not offer EDL for Cd, Pb and Hg, this underlines the feasibility of HCL/EDLAAS hybrid systems beyond targeting solely restricted elements.
Nonetheless, (PE et al. 2023c) further add their main concern that, since EDL lamps still
use RoHS restricted substances, dedicating the resources and costs for the qualification ofsuch equipment would be misplaced and could be considered a regrettable substitution as
it would detract from the investigation into solutions which are free from RoHS restricted
substances.
Depending on the use case LS-AAS certainly has its analytical advantages, however, it isapparent to the consultants that multi-element analysis is increasingly gaining market sharein the field of elemental analysis. (PE et al. 2023a) stated that all applicants that
manufacture AAS systems also market ICP solutions. Furthermore (PE et al. 2023b)
provided a list of 12 manufacturers of AAS systems out of which 8 also offer ICP systems.
This is further supported by (SPECTRO 2017) who state that ICP-OES is gaining popularityand more and more users are switching over, particularly coming from F-AAS. Measuring502

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heavy metals simultaneously provides a drastic reduction in analysis time, therefore
instruments able to perform simultaneous multielement analysis, namely ICP-OES and ICPMS, are becoming more and more popular. New development in this field, such as ICPOES/MS with reduced argon consumption, contributes to decreasing instrument runningcosts (Pasinszki et al. 2023). Additionally, new technologies such as HR-CS-AAS are also
taking up market share.
Considering the above information, the consultants agree that EDL technologies could
become very much a niche application in the future and that further development of thesetechnologies might be considered a regrettable substitution since more and more market
share is drawn from LS-AAS systems. However, it is worth to note that if the number oftarget analytes is limited, AAS is expected to continue wide scale application in this field as
it is highly sensitive and instrumental costs are lower than those of ICP-OES and ICP-MS(Pasinszki et al. 2023).
EDL-based AAS system availability and standardization
The availability of commercial EDL-based solutions shows that the reduction of therestricted substances in LS-AAS lamps is not only scientifically and technically practicable
but that it could have been achieved in the available time until the expiry of exemption IV10. The consultants asked why exemption IV-10 should still be extended beyond 2024
without a restriction to the use of Cd, Hg and Pb in EDL lamps only.
(PE et al. 2023b) refer to the market share of the commercially available EDL-AAS
instrument provider and that currently, there is only one applicant that offers instrumentationthat can support or be used with the EDL lamps. While this is a major supplier, they do nothave a dominant share in the market. The consultants understand that the restriction of
HCL may include the risk of potential instrument supply shortages during a market transition
from HCL to EDL when the market abruptly has to be shouldered by a single provider.
However, it should be emphasized that the replacement of HCL with EDL would only benecessary for lamps including Hg, Cd and Pb in AAS systems new to the market. AAS
systems including HCL with other not restricted elements will remain unaffected.
Additionally, next to the instrument provider in the consortium, there is at least one moremanufacturer (Lumex Instruments) of such HCL/EDL-AAS hybrid system on the market,
which would only have to further develop EDL including restricted substances.
Given the 10 year development time of EDL-AAS put forward by (PE et al. 2023a),(section
23.2.3), the consultants believe that there was enough time since 2011, when 9 IMCI were
integrated into scope of the RoHS Directive, for all manufacturers in the AAS market sector
to develop new technologies reducing the use of restricted substances via the use of LSAAS systems using EDLs. This is further underlined by the fact that PerkinElmer, Inc., amember of the consortium and Lumex Instruments, Ltd., already have such HCL/EDL-AAS
hybrid systems on the market,
demonstrate that the use of AAS is embedded in a number of standards, many of whichhave been developed and validated for years. They illustrate the complexity of suchstandard method developments with an example highlighting the total duration of 6-8 years.
The consultants inquired about the lamp types used for the referenced AAS methods and(PE et al. 2024a) specified with selected examples in Figure 23-8 below.

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Figure 23-8: Selected standards using AAS and the respective light source

Source: (PE et al. 2024a)
The provided information about the standards using AAS and their respective lamp types
shows that the vast majority of presented standards already include the use of AAS with
EDL technology. In only one instance a standard specifically refers to the use of HCL andanother one generically refers to “light source for cadmium determination”, which would
include EDL. Therefore, the consultants conclude that if the scope of the exemption IV-10
were to be restricted to EDL, the vast majority of methodological standards would remain
unaffected. Where HCL are specifically addressed a re-issuance of the standard including
EDL should not be compared to the lengthy development of a completely new method, andtherefore the expected time frames to standard adaptation should be much shorter.

23.3.3.

Environmental, health, safety and socioeconomic impacts(PE et al. 2023a) estimate that the amount of restricted substances entering the market isabout the same as is being recycled under the current exemption. Restricting the exemption
IV-10 to EDL lamps would not result in significant reductions of restricted substances at first
due to the availability of HCL as spare parts for HCL-based AAS systems brought to market
prior to the renewal of the exemption. Significant reduction of restricted substances are
expected once the market has adapted to AAS with incorporated EDL technology for
restricted substances.
It is to be noted that the recycling of restricted substances per se cannot justify granting an
exemption in line with the stipulations of Art. 5(1)(a). The third clause of Art 5(1)(a) (cf.
section 23.3.4 on page 505) is not applicable either. EDL can be expected to be recycled
like HCL. Since EDLs contain less than 1 % of the restricted substances compared to HCL,
the total negative environmental, health and consumer safety impacts caused bysubstitution can be assumed not to be likely to outweigh the total environmental, health andconsumer safety benefits thereof.
(PE et al. 2023a) foresee the premature disposal of a large number of systems already on
the market as they could no longer source AAS lamps for these [restricted] substances. In
the absence of lead, cadmium and mercury line source lamps, line source AAS systems will
become obsolete in the EU for the analysis of these substances. The typical life of a line
source AAS is in excess of 10 years, so where the system is being used solely for the504

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detection of one or more of these substances (lead, mercury, or cadmium) the whole system
would become obsolete before end of life.
The consultants disagree. In the consultants’ understanding, to Art. 4(4) would ensure that
HCL lamps could still be supplied to the market as spare parts for AAS systems that wereplaced on the market before the expiry of the current exemption in case the COM decides
to restrict the exemption to ED lamps only. Such AAS systems operating with HCL could be
used until the end of their life. (PE et al. 2023c) confirm that they consider HCL as spareparts.

23.3.4.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria is fulfilled:•

their elimination or substitution via design changes or materials and components
which do not require any of the materials or substances listed in Annex II isscientifically or technically impracticable;•

the reliability of substitutes is not ensured;•

the total negative environmental, health and consumer safety impacts causedby substitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

(PE et al. 2023a) request a 7 year renewal of exemption IV-10 for cat. 9 industrial monitoring
and control instruments (IMCI) until 21 July 2031. They further request the uptake ofmercury in the exemption with an updated wording to compensate the potential revocationof exemption III-4(a)(I) which so far has been covering the use of mercury in the applicationsin the scope of exemption IV-10. The applicants argue that there are no alternatives to theuse of lead, cadmium and mercury in hollow cathode lamps (HCL) and electrodelessdischarge lamps (EDL) for the production of distinct spectral lines in line source atomic
absorption spectroscopy (LS-AAS) and that LS-AAS systems cannot be replaced by othersystems in every use case.
Alternative lamp technologies for LS-AAS (i.e. solid state and continuum light source lamps)
and entire analytical systems as a replacement of AAS as a whole (e.g. ICP-OES, ICP-MS)
are available to the market and could substitute or eliminate the use of restricted substances
in many use cases. However, depending on the combination of type and concentration of
the elements to be detected, sample matrix and the environmental conditions of operation,
the use of these alternatives can be scientifically or technically impracticable. Given thelarge number of sample conditions, environments in which the analytical tools are used,amount of total dissolved solids and total sample volume, and the interdependency of these,
it was not feasible to define conditions where alternative analytical tools can eliminate theuse of the restricted substances.
HCL and EDL contain, within their cathodes or bulbs, the element of interest to be detected
in a sample. Hence, HCL and EDL made to detect restricted substances contain restricted
substances. In comparison to HCL, the use of EDL does not eliminate but significantly
reduce the use of restricted substances. The vast majority of AAS systems solely rely on
HCL as their light source, whereas, as to the knowledge of the consultants, there are no505

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AAS systems that solely rely on EDL which are not highly niche applications utilizing a single
EDL to detect a single element. However, there are currently two manufacturers on themarket providing a commercial system utilizing a combination of HCL and EDL lamps.
These systems have proven to be reliable and scientifically and technically practicable,
even though only one manufacturer currently provides EDLs for the detection of Cd, Pb,
and Hg. The applicants estimate a total development time of about 10 years for othermanufacturers to develop and bring to the market such HCL/EDL-AAS hybrid systems. .
ICP-based multi-element analysis is increasingly gaining market share in the field of
elemental analysis and instruments are continuously improved on for cheaper cost ofoperation and new methodological adaptation to new use cases. New fields of applicationand method development for continuum light source AAS (HR-CS-AAS) is progressing andthese instruments also take up market share in the field of elemental analysis. Thesedevelopments put the economic feasibility for the development of EDL-based AAS systems
by other manufacturers in questions as it might be a regrettable substitution.
Based on the information provided the consultants conclude that there are still many
applications and specific use cases where there are no scientifically and technicallypracticable alternatives to eliminate the use of LS-AAS in the coming years.
They further do not see a potential for the substitution of Cd, Hg and Pb in LS-AAS. The
consultants see a potential to significantly reduce the use of restricted substances by
restricting the exemption to the use of EDL in AAS even though there may be repercussions
on the market and its supply and demand dynamics due the fact that there is currently only
one manufacturer of such a system.
Since HCL are spare parts of LS-AAS systems, exchanging these lamps is relatively simple
and HCL not including restricted substances can easily be swapped out for HCL including
restricted substances in LS-AAS systems that operate with HCL. This may pose challenges
to the market surveillance, but the problem should be diminished over the years since it isincreasingly implausible to supply HCL with cadmium, lead and mercury.

23.4.

Recommendation

Given the provided information by the applicants, the consultants do not see a potential forthe substitution of Pb, Hg and Cd in HCLs for LS-AAS.
Various alternative technologies that do not contain the restricted substances are available
and can replace or even outperform LS-AAS in several analytical tasks. It was, however,not possible to derive clear criteria to restrict the use of LS-AAS with HCLs to analyticaltasks where for the time being and for the coming years their use is indispensable. Thus,
while elimination of the restricted substances is scientifically and technically practicable insome cases, these cases cannot be transferred into a clear exemption wording. The
alternative technologies are, however, steadily gaining popularity with novel method andtechnological improvements so that the elimination of the restricted substances may
become feasible in an increasing number of analytical tasks and a future scope restriction
may become viable.
EDL are an alternative lamp technology for HCL in LS-AAS. They contain the restricted
substances as well but in much smaller quantities so that using EDL in LS-AAS systems
would largely reduce but not completely eliminate their use. The applicants point out that506

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such a shift from HCL to EDL implies the risk of a “regrettable substitution” due to further
development of the above-mentioned alternative technologies.
One producer, however, has been offering LS-AAS with EDLs for more than 10 years
already so that the effort related to the development and qualification of such an LS-AAS
system has already been performed. The consultants therefore recommend restricting the
exemption scope to EDL lamps after a transition period of around 3 years to allow time forthe adaptation of standards that stipulate the use of LS-AAS with HCLs.
No.

Exemption

Scope and dates of applicability

IV-10

Lead and cadmium in atomic
absorption spectroscopy lamps

Applies to categories 8 and 9.

IV-10(a)Lead, cadmium, and mercury inelectrodeless discharge lamps foratomic absorption spectroscopy

Expires on-

21 July 2021 for category 8 other than invitro diagnostic medical devices and for
category 9 other than industrial monitoring
and control instruments.

-

21 July 2023 for category 8 in vitro
diagnostic medical devices.

-

24 February 2027* for category 9
industrial monitoring and control
instruments

Applies to category 9 industrial monitoring
and control instruments from 25 February
2027 on.
Expires on 21 July 2031

*Aligned with expiry of exemption III-4(a)(I) to ensure the use of mercury in AAS remains
covered by an exemption during the transition time to exemption 10(a).
Applicant’s feedback on the recommendation
Most members of the consortium of (PE et al. 2024b) expressed strong concerns that therecommended renewed exemption does not allow sufficient time for system manufacturers
without an EDL system to develop one. This could result in losses of jobs and in a monopoly
position of one manufacturer in the EEA market. It is believed the risk to the EU testing
sector (including environmental testing) would outweigh the environmental benefit of apremature termination of this exemption. The majority of the consortim members would likea 7 years renewal of the exemption for HCL lamps.
The consultants are confident that they considered all relevant arguments made available
by applicants and stakeholders during the review, and that the arguments have been
evaluated taking into account the requirements of Art. 5(1)(a).

23.5.

References

Agilent (2024): Elemental Analysis using Graphite Furnace AAS, ICP-MS or ICP-OES. Retrieved
from https://www.agilent.com/en/product/atomic-spectroscopy/gfaas-vs-icp-ms-vs-icp-oes.

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European Union (13.02.2003): Directive 2002/95/EC of the European Parliament and of theCouncil of 27 January 2003 on the restriction of the use of certain hazardous substances inelectrical and electronic equipment. RoHS 1. Fundstelle: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002L0095:EN:NOT, Last updated
04.12.2013.
Ferreira, Sergio L.C.; Bezerra, Marcos A.; Santos, Adilson S.; dos Santos, Walter N.L.; Novaes,
Cleber G.; Oliveira, Olivia M.C. de et al. (2018): Atomic absorption spectrometry – A multi element
technique. In: TrAC Trends in Analytical Chemistry 100, S. 1–6. DOI: 10.1016/j.trac.2017.12.012.
Goodman (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9. Final Report July
2006, amended 19 Sep 2006. ERA Report 2006-0383. In cooperation with Paul Goodman, ERA
Technology Ltd. ERA Technology Ltd. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf.
Lumex Instruments Ltd.: MGA-1000. Zeeman Graphite Furnace Atomic Absorption Spectrometer.
Pasinszki, Tibor; Prasad, Shilvee S.; Krebsz, Melinda (2023): Quantitative determination of heavy
metal contaminants in edible soft tissue of clams, mussels, and oysters. In: Environmental
monitoring and assessment 195 (9), S. 1066. DOI: 10.1007/s10661-023-11686-9.
PE et al. (2023a): RoHS Annex V request for renewal of exemption IV-10. RoHS Pack 27. In
cooperation with Perkin Elmer, Agilent Technologies, JBCE, Analytik Jena, Heraeus Noblelight.
Retrieved from https://rohs.biois.eu/EU-RoHS_IV%2010_Application_Form-PE-V6%20%20final.pdf.
PE et al. (2023b): Answers to questionnaire 1 (clarification questionnaire) sent by Liz Kimber,
RINA, to Dr. Otmar Deubzer via e-maill. RoHS Pack 27. In cooperation with Perkin Elmer, Agilent
Technologies, JBCE, Analytik Jena, Heraeus Noblelight (RoHS 29). Retrieved fromhttps://rohs.biois.eu/Ex-III-2022-1_NEW_BBT_Questionnaire-1_Clarification_.pdf.
PE et al. (2023c): Answers to questionnaire 2 received from Liz Kimber, RINA, via e-mail by Dr.
Otmar Deubzer. RoHS Pack 27 (RoHS 29).
PE et al. (2024a): Answers to questionnaire 3 (clarification questionnaire) sent by Liz Kimber,
RINA, to Dr. Chris Eckstein. RoHS Pack 27. In cooperation with Perkin Elmer, Agilent
Technologies, JBCE, Analytik Jena, Heraeus Noblelight (RoHS 29).
PE et al. (2024b): Answers to questionnaire recommendation feedback sent by Emily Tyrwhitt
Jones, RINA, to Dr. Chris Eckstein. RoHS Pack 27. In cooperation with Perkin Elmer, Agilent
Technologies, JBCE, Analytik Jena, Heraeus Noblelight (RoHS 29).
Resano, M.; Flórez, M. R.; García-Ruiz, E. (2013): High-resolution continuum source atomic
absorption spectrometry for the simultaneous or sequential monitoring of multiple lines. A criticalreview of current possibilities. In: Spectrochimica Acta Part B: Atomic Spectroscopy 88, S. 85–97.
DOI: 10.1016/j.sab.2013.06.004.
SPECTRO (2017): Warum immer mehr Flammen-AAS-Nutzer zur ICP-OES wechseln.
Welz, Bernhard (2005): High-resolution continuum source AAS. The better way to do atomic
absorption spectrometry. Weinheim, Great Britain: Wiley-VCH.
Welz et al. (2003): High-resolution continuum-source atomic absorption spectrometry: what can we
expect? In cooperation with Welz, Becker-Ross, Florek,Heitmann,Vale. J. Braz. Chem. Soc. 14 (2).
Retrieved from https://doi.org/10.1590/S0103-50532003000200007.

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Exemption 46 of Annex IV: DEHP in MRI detector
coils
The below Table 24-1 shows the wording, scope and expiry dates of the exemption.
Table 24-1:Current wording of the exemption
No.

Current
exemption
wording

Current scope and dates of applicability

IV-46

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

Applies to categories 8 medical devices other than in vitro
diagnostic medical devices.
Expires on 1 January 2024 for category 8

Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms
COM

European Commission

DEHP

Bis(2-ethylhexyl) phthalate

DPSS

Diode pumped solid state, used in the context with lasers (DPSS lasers)

EEE

Electrical and electronic equipment

IVD

In vitro diagnostic medical devices

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU of the European Parliament and of the Council of 8June 2011 on the restriction of the use of certain hazardous substancesin electrical and electronic equipment; RoHS Directive, RoHS

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Definitions
24.1.

Background and technical information

In May 2022, (COCIR 2022) requested the renewal of this exemption as displayed in Table
24-2 for EEE of category (cat.) 8 medical devices other than in vitro diagnostic (IVD) medical
devices with the below wording and expiry date.
Table 24-2: Wording and scope of the requested exemption
No.

Requested exemption

Requested scope
applicability

IV-46

Bis(2-ethylhexyl) phthalate (DEHP) in
plastic cable strain reliefs in MRI
detector coils

Applies to category 8 medical devices otherthan in vitro diagnostic medical devices.

24.1.1.

and

dates

of

Expires on 31 December 2026

History of the exemption(Baron et al. 2020) reviewed the exemption request submitted by COCIR andrecommended granting the exemption until 1 January 2024. The Commission (COM)followed the consultants recommendation resulting in the current exemption IV-46. (COCIR2022) requested the renewal of the exemption so that it became due for review.

24.1.2.

Summary of the requested exemption(COCIR 2022) request to extend the time period to replace the existing materials of MRI
coil cable strain reliefs for tests to qualify adequate performance and redesign them, if
necessary, after tests with the new identified materials. In 2019 COCIR submitted therequest for exemption 46 that was then published in 2021 with the validity period expiringon 1 January 2024.
Since then COCIR Companies have made progress according to the indicated timeline.
Alternatives for all plastic parts have been identified and by 2024 all models of nonintegrated coils will be placed on the market with cable covers, fixing belts and mattresses
DEHP free. Alternatives have been identified also for cable strain reliefs and already today
all new models are placed on the European market DEHP free.
Due to unexpected external events, the redesign of old models has been delayed and we
expect a number of coils design will not be available DEHP free by that date (1 Jan 2024).
While limited in number, such coils are still needed by hospitals in EU and due to their older
design cannot be substituted with the newer designs due to compatibility issues. While thenegative health and socio-economic impacts without this exemption are explained in theirrequest, the overall amount of DEHP placed into EU market is going to be minimal.
(COCIR 2022) also note that if exemption 46 was worded using the “DoC approach”
successfully included in exemption 27 and proposed for others, it would not have beenrequired to submit this renewal as companies would have had enough time to phase out
older designs, while ensuring DEHP free new designs.

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24.1.3.

Technical description of the exemption and use of the restricted
substance(COCIR 2022) present the below figure showing an MRI coil for imaging shoulders. The
cable connect to the MRI system which contain the strain reliefs are circled in red.
Figure 24-1: MRI shoulder coil with cable connects containing DEHP

Source: (COCIR 2022)(COCIR 2022) describe MRI and the associated coils as long-lifetime products that must bevery reliable because if a part were to fail so that it is not possible to use the MRI or a coil,the patient who may be very ill, could not be treated. Where flexible cables are attached torigid electrical components such as shown in the above in Figure, they will flex repeatedly
in use. Repeated flexing will cause both the electrical insulation and the internal copper
wires to fracture as a result of mechanical fatigue. This will cause the coil to fail and not be
usable. If the cable jacket breaks due to inadequate strain relief and the conductors are
exposed before hard failure, it results in a safety risk to patient. This failure mode iscommonly prevented in many types of electrical equipment including MRI coils using flexible
plastic components that limit flexing movement. These are often referred to as strain relief
boots or cord guards. There are many designs on the market, but the important property isthat the wire can flex for sufficient times without fracture during the expected lifetime of theequipment. By reducing the angle of movement of the wire where it connects to the rigid
connector (see below), this greatly extends the lifetime of the cable and electrical safety ofconnection.

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Figure 24-2: Effect of cable strain relief on movement of cable at connection toequipment

Source: (COCIR 2022)(COCIR 2022) describe the following requirements for the strain relief.

•

The polymer plus all additives including the plasticiser must be acceptablefor use in medical devices. New materials must comply with biocompatibility
requirements according to ISO 10993 “Biological evaluation of medical
devices”, before they can be used.

•

Lifetime of at least 8 years of frequent use and without failures. This is on
average equivalent to 30,000 repetitive bend cycles.

•

Must not affect MRI image quality, so must be non-magnetic and have a
proton signal emission material / air ratio as low as possible, ideally <1.2, butmust be <4.0 when within the imaging zone (i.e., strain reliefs that are
attached to coils).

•

Coil assemblies must not be damaged when a patient has to be rapidly
removed from an MRI scanner in an emergency, for example, if they suffera heart attack. This is important if coil assemblies have to be redesigned.

•

The strain relief must pass IEC 60601 safety testing for Cord Guard bend/
Cord anchorage requirements.

•

The strain reliefs are external parts and are often close to the patients. The
material selected shall meet Cleaning & Disinfection Spaulding classification
requirements for Intermediate Level Disinfection. Hence the new material
shall meet compatibility with cleaning agents used in hospital environments
and efficacy per ISO ISO17664-2 -2021.

More details as to the technical background of this exemption are available in the report of(Baron et al. 2020).

24.1.4.

Amount(s) of restricted substance(s) used under the exemption(COCIR 2022) indicate 18 kg of DEHP to be placed on the EU market annually due to the
exemption. The underlying calculation of the above volume includes confidential informationand is thus not published.
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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(Baron et al. 2020) indicate the volumes of DEHP with 158 kg per year based on data fromtwo MRI producers with 144 kg and 14 kg of DEHP respectively.
The current 18 kg can thus be assumed to reflect the ongoing substitution or elimination of
DEHP in the strain reliefs.

24.2.
24.2.1.

Justification of the requested exemption
Substitution and Elimination of the restricted substance(COCIR 2022) state that alternatives have been identified and are actually used for newmodels. The same alternatives are not drop-in replacement and cannot be used on older
designs. Partial redesign and then full testing and validation as a new model is required. All
coil assembly designs in companies’ portfolios must be extensively tested with new material
for reliability and performance as each design is different. The extent of movement and thestresses and strain of each strain relief depends on the design of each cable assembly andthe coils vary in size and shape considerably to accommodate different parts of the humanbody. Testing includes repetitive bending, proton image intensity measurement,
biocompatibility, IEC safety testing etc. and also tested with patients before re-approval
under the Medical Devices Regulation can be obtained from an EU Notified Body as well
as approval in other countries outside of the EU.
COCIR Members have been affected by the COVID crisis. Some of them ramped up the
production of COVID critical devices up to 400 % diverting significant resources from otherless critical projects, for instance redesigning older MRI coils.
Another impact of the COVID crisis has been the reduction of physical permanence in thework place that has undermined the availability of technicians for the physical testing ofcoils. The semiconductor scarcity is hitting the sector very badly as even the press reported,
prompting the European Commission to consider taking action to ensure supply for the
production of medical devices. At company level this has caused additional resources andexpertise to be rerouted internally. A company even reported that the launch of their newline of innovative MRI coils also played a role in the delay of the substitution plan; but
considering the benefit such new technology brings to patients, and the already mentioned
constraints, it was not possible to avoid delays.
Due to such external events that were not considered in 2019 (the exemption request wasdeveloped between 2017 and 2019) the roadmap to full substitution has been delayed.
Considering the volatility of the situation, COCIR estimated 1 January 2026 as a reasonable
deadline. Depending on the situation, full substitution could be even achieved earlier but it
is very hard to say.

24.2.2.

Environmental, health, safety and socioeconomic impacts(COCIR 2022) confirm their estimate in their exemption request reviewed by (Baron et al.
2020) that an impact on healthcare providers in the EU can be expected, even if smaller
than in the original application for exemption 46, if many types of MRI coils cannot bepurchased by EU hospitals. It is also important to note that a too short deadline would force

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manufacturers to drop the project of redesigning some older coils that would become
permanently unavailable for hospitals.
Per 2018 estimate, there are more than 1900 MRI scanners installed in European hospitals(which may correspond to a slightly lower number of EU hospitals) that may be directly
affected by scarcity of MRI coils. While the risk is now lower than previously estimated in
2019, all of these hospitals and their patients are at risk being affected negatively in theirability to provide MRI scan examination to patients if this exemption is not accepted. If
hospitals are unable to buy the current wide range of MRI coils for their MRI scanners thatthey already own, the waiting time for receiving an examination are bound to increase andmany patient’s conditions would be more difficult to diagnose and treat as other less suitable
methods would have to be used, if this is possible. For example, a whole-body coil can beused to examine all parts of a patient’s body, but the detail obtained for a small area suchas a foot is less than that which can be obtained by a dedicated foot coil. Also, the timerequired to obtain a scan of a whole patient is much longer than a foot scan and this cancause delays, as MRI demand often exceeds their availability. Other techniques may not
be suitable, for example, CT (Computed Tomography) is used to obtain 3-dimensional
images of patients, but the information it provides is different from MRI images, not toconsider the unnecessary exposure to radiation.
From online sources132, one MRI scanner typically treats around 4,500 patients per year
(this is old and conservative data from 2004, the number is higher today). The impact
described above on healthcare for patients can therefore affect more than 9,000,000
patients in Europe per year who could not be treated using the most suitable diagnostic
equipment.

24.2.3. Roadmap towards substitution or elimination of the restricted
substance
In their exemption request reviewed by (Baron et al. 2020), COCIR submitted the below
table to show the different steps of substitution or elimination of DEHP.
Table 24-3: Stages for establishment of possible substitute and respective timeframe
needed for completion of such stages

Source: COCIR in (Baron et al. 2020)132 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2645123/; source as referenced by COCIR 2022.

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Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU(COCIR 2022) report that all the stages for identification of a substitute have been
completed. They expect that by 1 January 2026 all remaining steps will have been absolved
and only DEHP-free coils will be placed on the market.

24.3.
24.3.1.

Critical review
REACH compliance – Relation to the REACH Regulation

Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by“ the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
DEHP is listed on Annex XIV so that its use requires authorisation. (COCIR 2024c) confirm
that, like at the time of the last review of the exemption by (Baron et al. 2020), the material
is supplied from outside the EU so that Annex XIV is not applicable.
Additionally, Annex XVII contains several restrictions for DEHP. None of those entries are,however, relevant for the use of lead in the scope of exemption IV-46 (cf. section 4.4 on
page 55 for details).
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH
Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

24.3.2.

Substitution and elimination of the restricted substance(COCIR 2022) confirm that the first stage of their roadmap is achieved, i.e. the identificationof materials that do not require the use of DEHP. The remaining steps in their roadmap (cf.
section 24.2.3 on page 515) are specified as reliability testing of these identified DEHP-freealternatives for the various models of MRI, and their verification and global approvals (ifneeded). This implies that the reliability of the substitutes has to be ensured for which twoyears more are required until 1 January 2026 instead of 1 January 2024 like estimated in
COCIR’s exemption request reviewed by (Baron et al. 2020). (COCIR 2022) justify the delay
with their members having considerably increased their production specifically for thetreatment of COVID.
COCIR stated in the context of earlier exemption requests that redesign of coils requires
highly qualified and specifically trained engineers. The consultants thus wondered how suchhighly specialized design and development engineers could be used to increase theproduction of other medical equipment whose demand had increased in the SARS-CoV2
pandemic, e.g. lung respirators.

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Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU(COCIR 2024a) confirm that the design of MRI coil is performed by very specializedengineers and in fact the work continued but that they claim a little delay in the roadmap tocomplete substitution. Nonetheless some of those engineers have been pulled to the
production of medical devices needed for COVID. Resources and priorities were also
drastically rerouted. Companies went through a storm during the COVID period withdemand for certain devices going out of scale - up to 400 % for ventilators - and companies
struggled to increase production to satisfy the demand. This effort involved re-purposing
production lines of other devices to manufacture and assemble ventilators. Workers,
engineers, technicians, resources were diverted from other business to work on multiple
shifts and to assemble and test ventilators. CT demand increased drastically. The same
happened also for companies with activities in the COVID testing field. (COCIR 2024a)
reference a report on the internet about volunteers volunteering to work in assembly lines.133

The consultants understand that in this situation, all resources were re-allocated toovercome the emergency of missing life-saving equipment, which may imply involving
engineers that are highly qualified for specific tasks into less demanding manufacturing andother activities. It is also plausible that as a further consequence of the SARS-CoV2
pandemic, the reduced physical permanence of technicians in the work place hampered thetesting of coils.
Based on the applicant’s above explanation, the consultants conclude that extending the
expiry of exemption 46 for two years beyond the current expiry date could be justified byArt. 5(1)(a) to ensure the reliability of the substitutes for the various models of MRIs. It is
understood that the exemption is no longer required after this extended validity period andthe exemption can expire at beginning of 2026.

24.3.3.

Environmental, health, safety and socio-economic impacts

COCIR state that coils may not be available to hospitals with adverse impacts on humanhealth if the exemption is not extended for two years beyond 1 January 2024, even though
this risk is lower than at the time when (Baron et al. 2020) reviewed COCIR’s exemption
request.

133 The link provided in the 2022 renewal request (https://www.ge.com/news/reports/all-hands-on-deck-volunteers-rush-in-to-support-24-7-production-of-ventilators-in-wisconsin) is not functional anymore.

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The consultants cannot exclude that such risks may arise at least to a certain degree if thevalidity of the renewed exemption is not extended for two years beyond 1 January 2024 asrequested by the applicant.

24.3.4.

Summary and conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of the following
criteria134 is fulfilled:
4. their elimination or substitution via design changes or materials andcomponents which do not require any of the materials or substances listed in
Annex II is scientifically or technically impracticable;
5. the reliability of substitutes is not ensured;
6. the total negative environmental, health and consumer safety impacts
caused by substitution are likely to outweigh the total environmental, healthand consumer safety benefits thereof.
The current exemption IV-46 would have expired on 1 January 2024. COCIR requested its
renewal until 1 January 2026 because of delays in the redesign of coils due to theconsequences of the SARS-CoV2 pandemic.
The consultants can follow the applicant’s reasoning. The redesign of coils needs to be
finalized to ensure the reliability of the substitute, and to have the DEHP-free MRI coils
certified where needed. The exemption is no longer required after this extended validity
period so that it can expire at the beginning of 2026.

24.4.

Recommendation

The consultants recommend granting the exemption to enable sufficient time to ensure thereliability of the DEHP-free substitutes in all models of coils. The applicant’s reasoning isplausible that the consequences of the SARS-CoV2-pandemic delayed the finalisation ofthis task for two years beyond the current expiry date on 1 January 2024.
The consultants recommend the below wording for renewed exemption:
No.

Recommended
exemption

Recommended scope and dates of applicability

IV46

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

Applies to categories 8 medical devices other than in vitro
diagnostic medical devices.
Expires on 31 December 2026.

134 Deviating from Art. 5(1)(a), the sub-clauses are numbered to allow addressing them specifically in the text.

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Applicants’ feedback on the recommendation(COCIR 2024b) agreed to the above recommendation.

24.5.

References

Baron et al. (2020): Study to assess one (1) request for a new exemption to Annex IV of Directive
2011/65/EU for bis-(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector
coils(Pack 20) – Draft final Report. Under the Framework Contract: Assistance to the Commission
on technical, socio-economic and cost-benefit assessments related to the implementation andfurther development of EU waste legislation. RoHS 25. In cooperation with Yifaat Baron, Katja
Moch, Öko-Institut und Dr. Otmar Deubzer, Fraunhofer IZM. Publications Office of the EU.
Retrieved from https://data.europa.eu/doi/10.2779/065213.
COCIR (2022): Request for renewal of exemption 46 of Annex IV.
COCIR (2024a): Answers to questionnaire 1 sent via e-Mai by Riccardo Corridori, COCIR, to Dr.
Otmar Deubzer.
COCIR (2024b): Feedback on recommendation for renewal of exemption 46 of Annex IV.
COCIR (2024c): Answers to questionnaire 2 sent via e-Mai by Riccardo Corridori, COCIR, to Dr.
Otmar Deubzer.

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Requested new Exemption 2022-2 of Annex IV: Cd in
Hersch cell oxygen sensors
Declaration
In the sections preceding the “Critical review”, the phrasings and wordings of applicants’and stakeholders’ explanations and arguments have been adopted from the documents
they provided as far as required and reasonable in the context of the evaluation at hand. In
all sections, this information as well as information from other sources is described in italics.
Formulations were altered or completed in cases where it was necessary to maintain thereadability and comprehensibility of the text.

Acronyms and Definitions
Cat.

Category, referring to the categories of EEE specified in Annex II of thecurrent RoHS Directive

COM

European Commission

EEE

Electrical and electronic equipment

IMCI

Industrial monitoring and control instruments

IVD

In-vitro diagnostic medical devices

MOCON

AMETEK MOCONNISTNational Institute of Standards and Technology

RoHS 1

Directive 2002/95/EC of the European Parliament and of the Council of
27 January 2003 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment

RoHS

Directive 2011/65/EU, current RoHS Directive

25.1.

Background and technical information

Annex IV exemption 43 used to cover cadmium in Hersch cells for which the applicant
submitted a renewal request, which was, however, rejected, as it was within 18 months ofthe expiration of exemption 43. Therefore, this request is considered a request of a new
exemption. The previously valid wording and scope of exemption 43 of RoHS Annex IV isdisplayed in Table 25-1.

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Table 25-1: Previously valid wording and scope of the exemption
No.

Exemption

Scope and dates of applicability

IV-43

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

Applies to category 9 industrial
monitoring and control instruments.
Expires on 15 July 2023 for category 9
industrial monitoring and control
instruments.

(MOCON 2022) requested an exemption request for EEE of RoHS Annex I category 9
industrial monitoring and control instrument (IMCI) as displayed in Table 25-2.
Table 25-2: Wording and scope of the requested exemption
No.

Requested Exemption

Requested scope and dates ofapplicability

IV-X

Cadmium in Hersch cells for oxygen
sensors used in industrial monitoring andcontrol instruments, where sensitivity
below 100 ppm is required

Applies to category 9 industrial
monitoring and control instruments.
Expires on [7 years after official
publication of the COM’s decision]

To ensure the availability of Hersch cells on the market, MOCON have, in parallel to thisexemption request, requested the renewal of exemption IV-1(b) to enable them to use leadas anode material in Hersch cells. In that renewal request, MOCON revise some of theinformation provided in this current exemption request form regarding the performance oflead anodes in Hersch cells. This is further discussed in the review of the renewal request
for exemption IV-1(b).

25.1.1. History of the exemption
Exemption 43 of Annex IV was not part of RoHS Directive 2002/95/EC (2003) (RoHS 1). It
was first evaluated by (Gensch et al. 2015) and subsequently listed on Annex IV of RoHS
Directive 2011/65/EU (2011) (RoHS 2) in an amendment dated 19 April 2016 135. At thetime, the consultants concluded that while alternative, lead-free oxygen sensors exist, it canbe followed that alternative technologies do not provide the same sensitivity and accuracy
compared to Hersch cell sensors.
Exemption 43 was set to expire on 15 July 2023. As stated above, the applicants did not
submit a renewal request 18 months before, but within the 18 months window before theexpiry date. Therefore, this request is formally to be considered for a new exemption.

135 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. Available: https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=celex%3A32016L1029

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25.1.2. Summary of the requested exemption(MOCON 2022) provided a summary of the exemption as follows:
An exemption is requested for cadmium in Hersch cells for high-sensitivity oxygen sensors
capable of measuring oxygen concentration below 100 ppm. Using a Hersch Cell, the rangeof oxygen detection is from 80 ppt to 70 ppm.
With reference to Article 5.1.(a), this exemption is made for the following reason: theirelimination or substitution via design changes or materials and components which do not
require any of the materials or substances listed in Annex II is scientifically or technicallyimpracticable.
An exemption request for the former Annex IV n. 43 for cadmium in anodes of oxygen
sensors was rejected because the request to extend it was within the 18 month window
before expiration. While lead is less toxic than cadmium, lead anodes are unable to provide
the levels of sensitivity (measurements of tens or hundreds of parts per trillion) and stability
required by certain industries. Therefore, the request is made for cadmium in equipment
designed for sensitivity ranges where lead is unsuitable.
Of the industries requiring high-sensitivity oxygen measurement, the following industries
provide examples where human health or the environment would be placed at risk if thetechnology were to become unavailable:−

Manufacture of certain pharmaceutical products which are sensitive to extremely
low levels of oxygen−

Integrity of food packaging design−

Lifespan of solar panels, which require a high oxygen barrier to ensure component
integrity

The above examples were chosen to identify socioeconomic costs. There are otherindustries requiring highly sensitive oxygen measurements but, there is no other use known
for the Hersch cell outside of analytical equipment. The net environmental benefit to refusing
this exemption request would be minimal, amounting to the removal of at most, 3.101 kg of
cadmium from the European waste stream per year.

25.1.3. Technical description of the exemption and use of the restricted
substance
Types of EEE for which the exemption renewal request is relevant
According to (MOCON 2022), cadmium is present in the anodes of Hersch cells, which areused in specialized, high sensitivity oxygen sensors where parts per trillion (ppt)
measurements are required.
Function of the RoHS-regulated substance used
According to (MOCON 2022), cadmium anodes are used in oxygen sensors for specificapplications when a high degree of sensitivity and long-term instrument stability is required.
Given the absolute nature of the sensor, it is the only possible instrument where no
calibration is necessary.

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There are several properties that are important in the Hersch cell:−Must follow Faraday’s Law−

Flat discharge curve (accuracy)−

Sensor life (charge)−

Inherent method of maintaining electrolyte heath over years−

Absolute method of measurement (Coulometric)−

Temperature independent−

Oxygen efficiency measurement > 95%−

Sensor response (fast)−

Size and format similar to current sensor−

Specific to Oxygen (Limited cross sensitivity)(MOCON 2022) explain that a Hersch cell operates by introducing a sample gas to anelectrolytic solution; in this case it is potassium hydroxide (KOH).
The Coulox oxygen sensor is a fuel cell that performs in accordance with Faraday’s Law.
When exposed to oxygen, the Coulox generates an electrical current that is proportional tothe amount of oxygen entering the sensor.
The Coulox sensor has a carbon cathode and a cadmium anode. The cathodic and anodic
reactions respectively:½O2 + H2O +2e→ 2OH
Cd + 2OH- - 2e→ Cd (OH)2
The electrons create an electrical current, which can be used to calculate the amount ofoxygen entering the Coulox sensor.
As noted, each oxygen molecule entering the Coulox results in four free electrons creating
an electrical current. One mole of oxygen (22.4 litres at 0 ⁰C and 760 mmHg) would produce
four Faradays of current. With one Faraday = 96,500 Ampere-seconds, each mole ofoxygen will produce 4 x 96,500 = 3.86 x 105 Ampere-seconds.
In more practical terms: One cc of oxygen in 24 hours = 0.000199 Amperes of current. Thismeans that the sensor has a sensitivity as little as 100 picoamps and a repeatability of 500
picoamps. To illustrate that; if you were to take the entire population of the world and multiply
it by 40, so 312 billion people, and asked the sensor to find any one specific person it would
pick them out.
This creates a current which is used to coulometrically determine the absolute amount ofoxygen in solution with the electrolyte.
Lead is commonly used as an anode in this application. However, cadmium has specificproperties which are necessary for high-sensitivity applications. Therefore, an application
to extend the exemption for cadmium in anodes of Hersch cells for high-sensitivity oxygen
sensors is requested.

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Characteristics and functions of the RoHS-regulated substance(MOCON 2022) elaborate that the two major reasons why certain industries are unable tosubstitute cadmium Hersch cell oxygen sensors:−

The Hersch cadmium Cell is “Coulometric” and follows Faraday’s Law at ppt levels.
This removes the need to calibrate at these extreme low levels. This is criticalbecause the lowest level of NIST calibration gas is 1 Mole% oxygen (10,000 ppm).
The best “Certified” gas is about 10 ppm (± 20 %) which is still 10,000 times awayfrom where the application requires accurate measurements. Competing
technologies (exempt lead in particular) require calibration at the testing range ofinterest, for which there are no standards below 10 ppm.

−

The solubility of cadmium in KOH (electrolyte) is very low, therefore does not migrate(like other metals) to the sensing electrode, precipitate or block the sensing
electrode sights. This gives the Hersch cadmium cell extraordinary long stablesensitivity life, on the order of years. Other metals do not have the life, sensitivity, or
stability.

25.1.4. Amount(s) of restricted substance(s) used under the exemption(MOCON 2022) indicate that 3.101 kg of cadmium will enter the EU annually.
MOCON add that while the average mass of cadmium sent to the EU over the last three
years was 3.101 kg per year, since 1991 they have had a recycling program where they
instruct their customers to send back the sensors when they are replaced or the instruments
are thrown out. On average MOCON see about 67 % of our sensors which contain thecadmium come back to the US for proper recycling. So, the net result of added cadmium tothe EU averaged 2.07 kg per year. It is important to note this is the maximum amount of
cadmium added per year. This is because many of these instruments may still be in use or
in inventory and not in use. The customer may have also properly recycled the sensor
somewhere else. Therefore, this is worst case scenario.

25.2.

Justification of the requested exemption

25.2.1. Substitution and Elimination of the restricted substance
The applicant currently manufactures several oxygen sensors, not all of which rely on
cadmium. However, the sensors using other anode materials (lead) are suitable only forother applications that do not require the high sensitivity of the cadmium Hersch cellapplication.
(MOCON 2022) state that alternative substances exist and are commonly used in oxygen
sensors. However, for specialized applications where stable sensitivity on the order of parts
per trillion is required, there are no available substitutes. The basic type of oxygen sensor
used is a Hersch Cell. By using cadmium, the instrument is able to measure oxygen
transmission down to 0.0005 cc/m2 x day which equals 170 ppt (parts per trillion) and asensitivity of 0.0001 cc/m2 x day (equal to 34 ppt). Another advantage is the long-term
stability of the sensor sensitivity (years); over which the > 95 % efficiency to oxygen
detection does not change. It should be noted that 70 ppm is the highest level of oxygen524

Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU

measurable and still be linear. It is believed that the technology has another 100 to 1000
times more sensitivity for future development. This level of sensitivity has been requested
by some users of the technology.
It should be noted that the sensor measurement is a direct absolute (Coulometric)measurement of oxygen and follows Faraday’s Law. Second, the cadmium is very specificto oxygen and has very few interfering gases. Third is the sensitivity the cadmium has tooxygen without degrading over long periods of time (years).
According to (MOCON 2022), there are several major reasons why certain industries areunable to substitute Hersch cell oxygen sensors:−

The Hersch cadmium cell is “Coulometric” and follows Faraday’s Law even at ppt
levels. This means calibration is not required at these extreme low levels.

−

This is critical because the lowest level of NIST calibration gas is 1 Mole% oxygen(10,000 ppm). The best “Certified” gas is about 10 ppm (± 20%) which is still 10,000
times away from where the user needs to measure accurately. All competing
technologies require calibration at the testing range of interest, which there are nostandards below 10 ppm.

−

The solubility of cadmium in KOH (electrolyte) is very low, therefore does not migrate(like other metals) to the sensing electrode, precipitate or block the sensing
electrode sights. This gives the Hersch cadmium cell extraordinary long stablesensitivity life (years). Other metals do not have the life, sensitivity or stability.

−

It is recognised by ASTM (D-3985, F-1307, F-1927), ISO (15105-2), JIS (K 7126-2),
DIN (53380-3), GB/T (GB/T 19789, GB/T 31354), and other standards worldwide.

(MOCON 2022) emphasize that available technologies for oxygen sensors are describedby Dr. Paul Goodman in section 10.1.3 of “Reliability and Failure Analysis: Review of
Directive 2002/95/EC (RoHS) Categories 8 and 9 – Final Report”136. In the context of leadas an anode material in electrochemical oxygen sensors, Dr. Goodman investigates several
possible materials. He evaluates several possible Pb substitutes and concludes that:−

Zn is unsuitable due to its high corrosion rate. This provides an unpredictablereference current and therefore precludes its use in anything but rudimentarymeasurements.

−

Sn, Al, and In self-passivate, which prevents reaction from continuing after a shortperiod.

−Ni, Cu, Fe are unsuitable due to the necessity of adding an external power supply.

−

Au, Pt, Ag are unsuitable due to electrode potential issues.

According to (MOCON 2022), sensor technologies discussed in ERA Report 2006-0383“Alternative types of sensors”137 are comparator type sensors which do not have thesensitivity, accuracy or the Coulometric characteristics the Hersch Cell has. To accurately

136 Retrieved from http://ec.europa.eu/environment/waste/pdf/era_study_final_report.pdf 2013-01-30
137 Dr. Paul Goodman: Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Final Report. Available:

https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf

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measure oxygen (gas) permeation through packaging barrier material below 0.001 cc/m2∙day (0.36 ppb v/v) with an upper range of 200 cc/m2 ∙day (72 ppm v/v). The Food,
Pharmaceutical, Solar and OLED industries also need the permeation measurements to be
NIST traceable. This method needs to be robust, economical and good response (minutes
to T99).
All other sensor technologies require that a membrane be present to keep the electrolyte
from leaving the sensor. When the membrane is present the sensors no longer directly
measure all of the oxygen. This requires that the sensor be calibrated. MOCON explain indetail that to accurately calibrate the sensors a NIST [National Institute of Standards andTechnology, the consultants] traceable gas must be used. However, As of October 8, 2014,
the lowest NIST Standard Reference Material which is available for purchase from NIST is
2 Mole % (20,000ppm). (MOCON 2022) conclude that clearly, if there is no calibration gas(or film) near 1 ppb, some other accurate (absolute) low level (ppb) oxygen measurement
is required.
Further discussing the coulometric concept, (MOCON 2022) state that several
electrochemical oxygen technologies are fundamentally Coulometric, but when reduced topractice (sensor) they all have oxygen barriers or restrictions to the electrodes, therefore
only measuring a fraction (< 0.001%) of the total oxygen present. Inherently, this means
they are far less sensitive to oxygen, and they are not measuring all the analyte (O2), which
is a critical Coulometric requirement. If a sensor does not collect and measure all theanalyte, then it needs to be calibrated because the sensor is only measuring some unknown
fraction of the total oxygen. Life of the sensor is the primary reason why electrochemicalsensors have oxygen barriers or restrictions to the electrodes.
Discussing a number of elements as anode materials, (MOCON 2022) state:−

Cadmium is the current anode used in today’s oxygen Coulox sensor. It has a long
history of accepted performance and ruggedness. Multiple sources in the required
plaque format improve availability. The voltage discharge level is the flattest of theelectrochemical sensors which gives the Coulox its accuracy and consistentmeasurements throughout its life. Cadmium doesn’t meet the RoHS directives.

−

Lead could substitute for cadmium as an anode, and it is available in plaque form.
Its voltage discharge level is almost as flat as cadmium but has a significant andsooner drop at end of discharge. Substituting cadmium with lead does not makesense regarding the goals of the RoHS Directive.

−

Zinc anodes would give a similar output as Cadmium; however, has a non-linear
voltage discharge curve. In effect, this gives the appearances that the accuracy issignificantly changing throughout the sensor’s life. Zinc can be found in many
formats, but plaque is more difficult to find. Some testing with Zinc/air batteries in a
starved condition (as a sensor) says the concept may work. However, at low oxygen
levels the sensors generate hydrogen and in a sealed condition this causes thesensor to burst.

−

Lithium anodes would give similar output as Cadmium; however, it has a non-linear
voltage discharge curve, about half as much as Zinc. In effect, this gives theappearances that the accuracy is significantly changing throughout the sensor’s life.
Like Zinc, Lithium can be found in many formats, but plaque is more difficult to find.
Most important, Lithium and water is explosive, therefore aqueous electrolytes are

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not allowed. This leaves organic electrolytes and the evaporation of their solvents.
As of now we don’t know how to replenish these solvents.
−

Exotic Materials: MOCON has contacts with other sensor manufactures and has
discussed other anode material. One of the bigger problems is finding a metal/alloythat uses gases oxygen as a fuel and meets RoHS directives.

(MOCON 2022) explain that there are other technologies which have been researched but
they too have their own limitations. In fact, MOCON uses several of these other technologies
in other less sensitive instruments. They include Pb, ZrO2 and Optical Fluorescence. These
technologies all measure oxygen as low as single ppm levels and all require frequentcalibration with certified gases. Other technologies have been researched but have been
met with their own limitations. These include Tunable Laser Diodes, Pb, ZrO2, otherelectrochemical sensors and Optical Fluorescence. They all have to be calibrated because
there is no direct measurement of oxygen taking place.

25.2.2. Environmental, health, safety and socioeconomic impacts
According to (MOCON 2022), there are several users of high-sensitivity oxygen sensors
requiring ppt measurements. Applications affecting human health and the environment
include:•The pharmaceutical industry uses Hersch cell sensors to ensure certain medications
are protected from oxygen. This is required to maintain strength, and therefore public
safety. The high instrument sensitivity is required to manufacture some medicines
which are very sensitive to even trace amounts oxygen.

•

Freshness and Safety in food packaging design, which requires ppt sensitivity, is thelargest application of Hersch cell sensor technology. This affects consumer safety
and potentially human health.

•The solar panel industry relies on ppt oxygen sensors instruments to measure theirhigh oxygen barriers. Oxygen barriers are required to prolong the lifetime of thepanels. Long-lasting Solar Panels are necessary to generate “green” energy, which
results in benefits for the environment.

•

Similarly, the OLED industry requires oxygen barriers to create OLED screens. Only
very sensitive instruments using Hersch cells are capable of measuring at the levels
they require.

(MOCON 2022) claim that the substitution of Hersch cells with lead-based instruments
would result in (among other impacted industries):•

Specific medicines being unable to be reliably manufactured•

Loss of integrity in food packaging design•

Decreased lifespan of solar panels

This is compared to the net gain of eliminating 3.101 kg of cadmium annually from theEuropean market.

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25.2.3. Roadmap towards substitution or elimination of the restricted
substance
Actions that have been taken to develop further possible alternatives
According to (MOCON 2022), since the original exemption they have tested 2 different
galvanic cell combinations, and 2 different fuel cell designs. Both fell short of efficiency andsensitivity. The applicant is investigating 6-12 other materials. So far, none have been foundto be an equivalent replacement for the cadmium. This has been a considerable effort oftime and resources due to the degree of difficulty of these designs.
The length of a sensor development project can be 1 year or 10 years or never. The lastelectrochemical sensor development took 6-7 years. The last improvement (not the sameas development) made in the cadmium (Cd) Coulox sensor took 3 years (only one
component changed). The length of development depends on how many components ormaterials or geometries have to be changed to accommodate the new anode.
(MOCON 2022) state that it is very possible that they will never be able to find a successful
substitution option.
Stages necessary for establishment of possible substitutes and timeframes needed
According to (MOCON 2022), at this time, it cannot be confidently stated that an alternative
material exists. None is currently known. An analysis performed for the European
Commission in which the consultant explores various metals which can potentially be used
as anodes in oxygen sensors137. The conclusion is that lead and cadmium comprise theonly two viable metals for scientific reasons.
As is shown elsewhere in this request, lead is unsuitable for ppt measurements.

25.3.

Critical review

25.3.1. REACH compliance – Relation to the REACH Regulation
Art. 5(1)(a) of the RoHS Directive specifies that exemptions from the substance restrictions,for specific materials and components in specific applications, may only be included in
Annex III or Annex IV “provided that such inclusion does not weaken the environmental andhealth protection afforded by” the REACH Regulation. The article details further criteria
which need to be fulfilled to justify an exemption, however the reference to the REACH
Regulation is interpreted by the consultants as a threshold criterion: an exemption could not
be granted should it weaken the protection afforded by REACH. The first stage of theevaluation thus includes a review of possible incoherence of the requested exemption with
the REACH Regulation.
Several restrictions of cadmium and its compounds are listed on Annex XVII (cf. section 4.1
on page 48). None of those, however, is applicable to the use of cadmium and cadmium
compounds in the scope of the requested exemption.
Based on the current status of Annexes XIV and XVII, granting the requested exemption
would not weaken the environmental and health protection afforded by the REACH

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Regulation. An exemption could therefore be granted if the respective criteria of Art. 5(1)(a)apply.

25.3.2. Substitution and elimination of the restricted substances
MOCON explained that to ensure the availability of Hersch cells on the market, while theexemption for cadmium anodes in Hersch cells (IV-43) expired on 15 July 2023, they aredeveloping a Hersch cell oxygen sensor with a lead anode, for which MOCON also
requested a renewal of exemption IV-1(b).
When asked how the substitution of cadmium with lead was achieved, (MOCON 2024a)
elaborated that the properties of lead are the most similar to the original design of cadmium,
however, lead has distinct different technical parameters compared to cadmium. Importantly
however, it still offers the necessary technical performance, especially when compared toalternatives that are free of RoHS restricted substances. Work to develop a fully RoHS
restricted substance free alternative is still on-going but requires more time. The process tomove from cadmium to lead is expected to take 24 to 36 months in total, with thedevelopment of the lead sensor still ongoing. It is important to note that due to the larger
fundamental differences in properties between RoHS restricted substances and alternative,
RoHS-compliant substances, the timeframe to qualify the latter is expected to be longer,
and it is still not clear if they will be able to offer all of the necessary technical performance
characteristics.
When first investigating a cadmium replacement, as well as RoHS compliant alternatives,
an important item that must be considered is thermodynamic nobility. Thermodynamic
nobility of any metal is assessed in contrast to the standard hydrogen electrode (0 V). Metals
with a higher equilibrium reaction potential are considered more noble thus being less likely
to corrode and poor anode candidates. Lead's thermodynamic nobility is quite similar to thatof Cadmium, with standard reduction potentials of (-0.58 V) and (-0.81 V), respectively.
Specific capacity (mAh/g) or the amount of charge that can be held per gram of material isanother characteristic that must be considered for replacement sensors. The specificcapacity of lead is lower than cadmium meaning more material is required to achieve thesame level of performance. As the amount of material is changed, considerations must be
made for the anode area available within the sensor, as well as the amount of electrolyte
used per sensor. Too much electrolyte per unit area of anode material reduces response
time, while insufficient electrolyte reduces sensor efficiency.
(MOCON 2024a) further note that the quantity of electrolyte is one of many items that impact
sensor response and efficiency. For example, the solubility of reaction products can also
impede the reaction kinetics as well as contaminate the electrolyte both slowing down thesensor and making it less efficient.
Lastly, according to (MOCON 2024a), all of these parameters and others discussed in the
renewal application require testing, and hence why the transition from cadmium to lead took
some time to complete.
The consultants noted that MOCON relied on the report by (Goodman 2006) when
discussing the potential to substitute cadmium with alternative substances, which was
published in 2006, i.e. approximately 18 years ago. When asked whether tests had been
carried out using other potential substitutes for lead since then, (MOCON 2024a) confirmed
this, stating: MOCON continues to research potential anode substitutes for both cadmium
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and lead based Hersch sensors. However, due to the demanding technical requirements ofa Hersch cell, any change can have a detrimental impact on performance. For example,
changing a single component in the cadmium version of the Hersch cell took 3 years toundertake and fully qualify. As a result, the development of a RoHS compliant Hersch cellrequires meticulous and time-consuming attention to detail. To date, many development
activities have taken place many of which were highlighted in our lead extension application.
Since then, additional theoretical and experimental work has been conducted to narrow
down potential candidates. Based on theoretical cell potentials, only seven metals exhibit
characteristics that could work inside a Hersch Coulometric Cell (Alkaline Electrolyte).
Three of these have been the focus of ongoing experimental investigations as they havethe most similarities to lead and cadmium. However, experiment results have still not led toa suitable substitute. Shifting to an acidic electrolyte could open new options, which will be
studied if no encouraging progress is made with the current alkaline one. The move to an
acidic electrolyte would trigger the need for more extensive testing and potentially designchanges of the sensor. Overall, this would have the impact of creating an even longer
timeline to qualify a RoHS-substance free alternative, and why this has not been trailed at
this point.
(MOCON 2024a) conclude that it is still uncertain whether a RoHS compliant alternative
anode material will be able to offer the necessary technical performance we require of the
Hersch Cell. Even with the most recent developments in technology, there are no othertechnologies which can detect oxygen to the very low concentrations which Hersch cells
are able to detect.
Given that MOCON had both requested this exemption for the use of cadmium in Herschcells and requested a renewal of exemption IV-1(b) to use lead in Hersch cells, theconsultants inquired whether both variants would be needed on the market.
(MOCON 2024a) explained that the application for lead was submitted to ensure that
Hersch cell devices, as MOCON is the only manufacturer worldwide of such devices, wereable to be placed on the market. This is due to the consideration that the timeframe to renew
the use for cadmium had passed and we were informed that this would be treated as a new
application not benefiting from continued validity while the application was reviewed. The
transition to lead ensures that the critical functions that Hersch cells provide are still able tobe provided, although there are manufacturability concerns as outlined in our answer above.
(MOCON 2024b) added that as long as there is an exemption permitting the use of Herschcells on a continuing basis, only one or the other exemption would need to be granted tocover the necessary uses. However, it is essential that the lead-based exemption is not
rejected until the cadmium based exemption is fully implemented, such that devices areable to be continually sold in the EU.
MOCON had stated that cadmium is more toxic than lead. When asked whether this shouldmean that the phasing out of cadmium in favour of lead-based Hersch cells would be
preferable, (MOCON 2024b) stated that it would be their preference that the exemption for
cadmium be granted over lead due to the reduction in manufacturability of the lead sensors(~20 % reduction in sensors which meet performance criteria). Due to these manufacturingissues, there is an increase in scrap of such sensors from this, and therefore an increase in
the use of lead overall to meet the customer demand for sensors of this type. It is also
worthwhile noting that there is a difference between the amount of lead required for a
cadmium sensor and a lead sensor, so this should be considered when reviewing the530Study to assess requests for new and renewals of exemptions under Directive 2011/65/EU

potential environmental impact. The cadmium Hersch sensor uses at least 24 % less byweight than the lead Hersch sensor.
In light of the applicant‘s above explanations, the consultants conclude that the substitutionof cadmium by lead may not involve any environmental or health benefits. RoHS Art. 4(2)sets a threshold value of 0.01 % for cadmium in homogeneous materials compared to 0.1 %for lead. This may be interpreted that cadmium is more toxic than lead. The lower amountsof cadmium in Hersch cells with cadmium anodes compared to the amount of lead in Herschcells with lead anodes, and the reduced manufacturability of the latter, may, at least in part,compensate the lower toxicity of lead. This raises, however, the question whether an
additional exemption for lead in Hersch cell as requested by the applicant is actuallyrequired. 138
The consultants noticed that MOCON requested an exemption wording which does notmatch the wording of exemption IV-43, which previously covered cadmium-based Herschcells. The wording of exemption IV-43 set a sensitivity threshold of “below 10 ppm”, while(MOCON 2022) requested the wording with a threshold of 100 ppm. When asked for therationale for this requested change, (MOCON 2024b) stated that Hersch sensors are able
to measure to 100 ppm, with the useable range of sensor between 200 ppt to 70 ppm. As
such, although both values are technically correct, it is most accurate to say that the sensor
is able to measure to 100 ppm and below.
Given that the useable range of Hersch sensors is between 200 ppt and 70 ppm, theconsultants understand that confusion may arise regarding whether the sensors arecovered by the exemption or not when the criterion for coverage is defined by “where
sensitivity below 10 ppm is required”. In the consultants’ view, the function of the sensitivity
threshold in the exemption wording is not entirely clear. Due to the fact that Hersch cells
are explicitly mentioned in the wording, and MOCON are the only manufacturer of Herschcells, it does not seem necessary to exclude other sensor technologies via a sensitivity
threshold. However, it is also not detrimental to the definition of the exemption and its scope
to maintain a sensitivity threshold as part of the wording. In the consultants’ view, whether
the threshold is set at 10 ppm or 100 ppm is not expected to make a difference regarding
the range of equipment covered by the exemption. Therefore, the argument that setting thesensitivity threshold at 100 ppm to ensure the entire useable range of Hersch sensors iscovered, thereby avoiding uncertainty that arises from a threshold that covers only a part of
the range, can be followed in the consultant’s opinion.
MOCON applied for this exemption using the wording “Cadmium in Hersch cells for oxygen
sensors used in industrial monitoring and control instruments, where sensitivity below
100 ppm is required”. In parallel, MOCON applied for a renewal of exemption IV-1(b) withthe wording “Lead anodes in electrochemical Hersch cells for oxygen sensors formeasurement of permeation”. When asked whether, in their view, differing wording isrequired under exemption IV-1(b) and the current exemption request, with the obvious
difference in the material, (MOCON 2024b) responded that the differences in the requested
exemption wording is a reflection of their thinking at the time in which the exemptions were
submitted and not a reflection of technical differences. As such, either wording would cover
their applications.

138 This question was addressed in the review of MOCON’s renewal request for lead anodes in Hersch cells

under exemption IV-1(b)531Study to assess requests for renewal of 12 exemptions to Annex III of Directive 2011/65/EU

In the consultants’ view, the information provided by the applicants plausibly shows that
only Hersch cells are capable of measuring the extremely low oxygen concentration ranges,
and that, thus far, only lead- and cadmium-based anodes are capable of achieving this.
Therefore, it seems reasonable to the consultants that the substitution and elimination of
cadmium are technically and scientifically not yet practicable. Further, to ensure that Herschcells continue to be available on the market, it appears reasonable to renew exemption 1(b)to cover lead-based Hersch cells until a new exemption for cadmium-based Hersch cells
can be granted.

25.3.3. Environmental, health, safety, and socio-economic impacts
Given that Hersch cells have unique characteristics, particularly the measurement of
extremely low oxygen concentration ranges, which cannot be matched by other oxygen
sensor technologies, it cannot be excluded that the impacts described by the applicants
may occur in case the exemption was not granted.

25.3.4. Summary and conclusions
Cadmium anodes in Hersch cell oxygen sensors were in the past covered by exemption 43,
which expired on 15 July 2023. The sole manufacturer of Hersch cells, MOCON, requested
the renewal of exemption 43 within 18 months before the expiry date. Therefore, theirrequest cannot be considered a renewal request but is instead treated as a request for a
new exemption. In practice, MOCON is therefore not able to place cadmium-based Herschcells on the market at this time.
Hersch cells have unique properties. They allow for absolute measurements of oxygen that
requires no calibration, and they are capable of measuring extremely low oxygen
concentration ranges down to 200 ppt that cannot be matched by any other oxygen sensor
technology.
To ensure the availability of Hersch cells on the market, as they are needed for permeation
measurements in industries such as food and pharmaceutical packaging, MOCON isdeveloping Hersch cells using lead anodes instead of cadmium anodes. In parallel to thisexemption request, they have therefore also requested a renewal of exemption 1(b) thatcovers lead anodes in electrochemical oxygen sensors. Exemption 1(b) therefore covers
lead anodes in Hersch cells while it is being reviewed in parallel with this new exemption
request for cadmium anodes in Hersch cells.
MOCON have provided plausible arguments that cadmium (and lead) are the only materials
that are currently capable of achieving the unique technical specifications of Hersch cells.
Therefore, in the consultants’ view, substitution or elimination of cadmium with substances
not restricted under RoHS are scientifically and technically still impracticable, and a renewalof the exemption for Hersch cells appears to be justified in line with Art. 5(1)(a).
MOCON requested an exemption (IV-2022-2) to cover cadmium-based Hersch cells for the
maximum validity period of 7 years. Given the lack of substitution and elimination
possibilities at the current time, the consultants consider the timeframe proposed for theuse of cadmium in Hersch cells justified.
As stated, MOCON also requested a renewal of exemption IV-1(b) until January 2028 tocover lead-based Hersch cells while cadmium-based Hersch cells are not covered by any

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exemption. The consultants consider it may be appropriate to cover both exemptions for
Hersch cells within the same exemption series, such as under exemption IV-1(b), which is
specific to electrochemical oxygen sensors, albeit thus far only covering lead.
The previous exemption covering cadmium anodes in Hersch cell sensors set a sensitivity
threshold of 10 ppm. However, this covers only a part of the useable range of Hersch cellsensors, being 200 ppt up to 70 ppm, which may lead to confusion regarding the coverageof Hersch cells. The consultants do not consider a risk of broadening the scope when thethreshold would be changed to 100 ppm as requested by MOCON, given that Hersch cells
are explicitly mentioned in the exemption wording, i.e. other sensor technologies will notbenefit from the exemption either way.
Regarding the exemption wording, the consultants considered proposing a technologically
open phrasing that restricts the scope of the exemption to oxygen sensor technologies thatare capable of absolute measurements of oxygen at extremely low concentrations, without
explicitly mentioning Hersch cells, which are a proprietary technology of one individual
manufacturer. However, this would allow other manufacturers to develop and market sensor
technologies to use cadmium, and lead under exemption 1(b), which may not be a desirable
outcome when considering the goals of the RoHS Directive. Therefore, to keep the scopeof the exemption as narrow as possible, the consultants consider maintaining a wordingthat explicitly mentions Hersch cells may be most suitable.
In case future reviews of this exemption are conducted, the consultants consider a reneweddiscussion of the progress of efforts to qualify alternative materials not restricted by the
RoHS Directive as anode materials is needed.

25.4.

Recommendation

The consultants recommend granting the exemption. However, instead of granting a new
exemption with a new numbering, it may be more appropriate to grant an exemption for
cadmium in Hersch cells as a new exemption under exemption IV-1(b). Exemption IV-1(b)is recommended by the consultants to be split into a number of exemption 1(b) series onlead in different oxygen sensor technologies, including lead in Hersch cells.
Therefore, if the COM decides to follow the consultants’ recommendations, it isrecommended using the wording and scope as shown in the below table, to align with thewording of related exemptions under exemption 1(b):No.

Exemption

Scope and dates of applicability

IV-1(b)(V)Cadmium anodes in Hersch cells foroxygen sensors where sensitivity below
100 ppm is required.

Applies to cat. 9 including industrial
monitoring and control instruments andexpires on-[7 years after official publication of
the COM’s decision]

Applicants’ feedback on the recommendation(MOCON 2024c) stated to agree with the above recommendation.

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25.5.

References

Gensch et al. (2015): Assistance to the Commission on Technological Socio-Economic and CostBenefit Assessment Related to Exemptions from the Substance restrictions in Electrical andElectronic Equipment (RoHS Directive). Final Report -Pack 6. RoHS 11, Pack 6. In cooperation
with Carl-Otto Gensch, Yifaat Baron, Moch, Katja, Öko-Institut e. V. und Dr. Deubzer, Otmar,
Fraunhofer IZM. Retrieved from https://data.europa.eu/doi/10.2779/44395.
Goodman (2006): Review of Directive 2002/95/EC (RoHS) Categories 8 and 9. Final Report July
2006, amended 19 Sep 2006. ERA Report 2006-0383. In cooperation with Paul Goodman, ERA
Technology Ltd. ERA Technology Ltd. Retrieved fromhttps://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf.
MOCON (2022): RoHS Annex V Exemption Request Form. RoHS Pack 27. MOCON (RoHS 29).
Retrieved from https://rohs.biois.eu/RoHS_V_Application_Form_MOCON_2023.pdf.
MOCON (2024a): Answers to questionnaire 2 sent by Emily Jones, RINA, to Christian Clemm via
e-mail. RoHS Pack 27. MOCON (RoHS 29).
MOCON (2024b): Answers to questionnaire 3 sent by Emily Jones, RINA, to Christian Clemm via
e-mail. RoHS Pack 27. MOCON (RoHS 29).
MOCON (2024c): Comments on recommendations sent by Maitheya Riva, RINA, to ChristianClemm via e-mail. RoHS Pack 27. MOCON (RoHS 29).

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