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 and further development of EU
waste legislation

February2022

European Commission
RoHS Exemptions Evaluation: Pack 22

Prepared by Oeko-Institut e.V.,
Yifaat Baron
Carl-Otto Gensch
Andreas Koehler
Ran Liu
Clara Loew
Katja Moch

15 February 2022

Oeko-Institut e.V.
Freiburg Head Office, P.O. Box 1771
79017 Freiburg, Germany
Tel.:+49 (0) 761 – 4 52 95-0
Fax +49 (0) 761 – 4 52 95-288
Web: www.oeko.de

Acknowledgements
We would like to express our gratitude towards stakeholders who have taken an activerole in the contribution of information concerning the requests for exemption handled
in the course of this project.

Disclaimer
Oeko-Institut has taken due care in the preparation of this report to ensure 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 Oeko-Institut is not responsible for decisions or actions taken on the basis of thecontent of this report.

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EUROPEAN COMMISSION
Directorate-General for Environment
Directorate B - Circular Economy & Green Growth
Unit B3 - Waste Management & Secondary Materials
Contact: Hendrik Engelkamp
E-mail: ENV-ROHS@ec.europa.eu

European Commission
B-1049 Brussels

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Table of Contents
Table of Contents .............................................................................................. 5
List of Figures ..................................................................................................10
List of Tables ...................................................................................................10
1.
Executive summary – English ....................................................................13
1.1. Background and objectives ....................................................................13
1.2. Key findings – Overview of the evaluation results .....................................14
2.
Executive summary: French - Note de synthèse: Français .............................192.1. Contexte et objectifs .............................................................................192.2. Les principales conclusions – Synthèse des résultats de l’évaluation ...........20
3.
Introduction ............................................................................................27
3.1. Project scope and methodology ..............................................................27
3.2. Project set-up ......................................................................................27
4.
Links between the RoHS Directive and the REACH Regulation ........................28
4.1. REACH compliance – Relation to the REACH Regulation .............................32
5.

The applicability of the Pack 22 exemption conclusions andrecommendations to sub-Cat. 8 in-vitro, sub-Cat. 9 industrial and Cat. 11 ......38
5.1. Applicant and Stakeholder views ............................................................39
5.2. Course of action of the assessment in relation to sub-Cat. 8 in-vitro, sub-Cat.
9 industrial and Cat. 11 ..................................................................................41

6.

Exemption 6(a) & 6(a)-I: Ex. 6(a) for “Lead as an alloying element in steel
for machining purposes and in galvanised steel containing up to 0,35 % leadby weight”, and Ex. 6(a)-I for „Lead as an alloying element in steel formachining 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” ........43
6.1. Background .........................................................................................44
6.2. Leaded steel for machining purposes ......................................................45
6.2.1.
Technical description for leaded steel for machining purposes ..............45
6.2.2.
Amount of lead used under the exemption for leaded steel for machining
purposes 46
6.2.3.
Applicants’ justification for the requested exemption for leaded steel formachining purposes ....................................................................................46
6.2.4.
Stakeholder contributions ................................................................48
6.2.5.
Critical Review for leaded steel for machining purposes .......................50
6.2.6.
Conclusion for leaded steel for machining purposes ............................55
6.2.7.
Recommendation for leaded steel for machining purposes ...................56
6.3. Hot dip galvanised steel ........................................................................57
6.3.1.
Technical description for hot dip galvanised steel ...............................57
6.3.2.
Amount of lead used under the exemption for hot dip galvanised steel..59
6.3.3.
Applicant’s justification for the requested exemption for lead in hot dip
galvanised steel ..........................................................................................59
6.3.4.
Stakeholder contributions ................................................................60
6.3.5.
Critical review for hot dip galvanised steel .........................................60
6.3.6.
Conclusion for hot dip galvanised steel ..............................................63
6.3.7.
Recommendation for hot dip galvanised steel ....................................64

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6.4.
6.5.

Final conclusions ..................................................................................65
Final recommendation ...........................................................................66

7.

Exemptions 6(b) and 6(b)-I: Ex. 6(b) for “Lead as an alloying element inaluminium containing up to 0,4 % lead by weight”; and Ex. 6(b)-I for “Leadas an alloying element in aluminium containing up to 0,4 % lead by weight,
provided it stems from lead-bearing aluminium scrap recycling” ....................68
7.1. Background .........................................................................................68
7.2. Technical description of the requested exemption .....................................69
7.2.1.
Amount of lead in aluminium from lead-bearing Al scrap recycling used
under the exemption ...................................................................................70
7.3. Applicants’ justification for the requested exemption.................................70
7.3.1.
Substitution or elimination of lead in aluminium from lead-bearing Al
scrap recycling ...........................................................................................70
7.3.2.
Environmental arguments ...............................................................71
7.3.3.
Socioeconomic impacts ...................................................................71
7.3.4.
Road map to substitution ................................................................71
7.4. Stakeholder contributions ......................................................................71
7.5. Critical review ......................................................................................73
7.5.1.
REACH compliance – Relation to the REACH Regulation .......................73
7.5.2.
Scientific and technical practicability of substitution ............................73
7.5.3.
Possibilities for reducing lead ...........................................................73
7.5.4.
Environmental arguments and socioeconomic impacts ........................75
7.5.5.
Scope of the Exemption ..................................................................76
7.5.6.
Conclusions ...................................................................................76
7.6. Recommendation .................................................................................77

8.

Exemption 6(b)-II “Lead as an alloying element in aluminium for machining
purposes with a lead content up to 0,4 % by weight”....................................79
8.1. Background .........................................................................................79
8.2. Technical description of the requested exemption .....................................80
8.2.1.
Amount of lead used under the exemption ........................................81
8.3. Applicants’ justification for the requested exemption.................................81
8.3.1.
Availability of alternatives (Substitution or Elimination, roadmap to
substitution, reliability of substitutes) ............................................................81
8.3.2.
Environmental and health arguments (also LCA aspects) .....................82
8.3.3.
Socioeconomic impacts ...................................................................82
8.4. Stakeholder contributions ......................................................................83
8.5. Critical review ......................................................................................85
8.5.1.
REACH compliance – Relation to the REACH Regulation .......................85
8.5.2.
Scientific and technical practicability of substitution ............................85
8.5.3.
Environmental arguments and socioeconomic impacts ........................91
8.5.4.
Scope of the Exemption ..................................................................92
8.5.5.
Conclusions ...................................................................................93
8.6. Recommendation .................................................................................94
8.7. Overview on the recommendations for Exemption 6(b) .............................94

9.
Exemption 6(c) “Copper alloy containing up to 4 % lead by weight” ...............96
9.1. Background .........................................................................................96
9.2. Technical description of the requested exemption .....................................97
9.2.1.
Amount of lead used under the exemption ........................................98
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9.3. Applicants’ justification for the requested exemption.................................99
9.3.1.
Availability of alternatives (Substitution or Elimination, roadmap to
substitution, reliability of substitutes) ............................................................99
9.3.2.
Environmental and health arguments (also LCA aspects) ................... 100
9.3.3.
Socioeconomic impacts ................................................................. 101
9.4. Stakeholder contributions .................................................................... 101
9.5. Critical review .................................................................................... 104
9.5.1.
REACH compliance – Relation to the REACH Regulation ..................... 104
9.5.2.
Scientific and technical practicability of substitution .......................... 104
9.5.3.
Environmental arguments and socioeconomic impacts ...................... 107
9.5.4.
Scope of the Exemption ................................................................ 107
9.5.5.
Conclusions ................................................................................. 108
9.6. Recommendation ............................................................................... 109
10.

Exemption 7(a) “for lead in high melting temperature type solders (i.e. leadbased alloys containing 85 % by weight or more lead)” .............................. 110
10.1. Background ....................................................................................... 111
10.1.1. Overview of the Submitted Exemption Requests............................... 111
10.1.2. History of the Exemption ............................................................... 112
10.2. Technical description of the requested exemption ................................... 112
10.2.1. Specific Properties of lead in LHMPS ............................................... 112
10.2.2. Uses of LHMPS ............................................................................. 113
10.2.3. Amount of lead used under exemption 7(a) ..................................... 120
10.3. Applicants’ justification for the requested exemption............................... 122
10.3.1. Availability of alternatives ............................................................. 123
10.3.2. Environmental and health arguments (also LCA aspects) ................... 125
10.3.3. Socioeconomic impacts ................................................................. 126
10.3.4. Roadmap for Substitution or Elimination of Lead .............................. 126
10.4. Stakeholder contributions .................................................................... 127
10.5. Critical review .................................................................................... 129
10.5.1. REACH compliance – Relation to the REACH Regulation ..................... 129
10.5.2. Scientific and technical practicability of substitution .......................... 129
10.5.3. Environmental arguments and socioeconomic impacts ...................... 132
10.5.4. Increasing certainty for manufacturers and market surveillance ........ 133
10.5.5. Scope of the Exemption ................................................................ 135
10.5.6. Conclusions ................................................................................. 144
10.6. Recommendation ............................................................................... 145
10.6.1. Wording of Exemption 7(a) ............................................................ 145
10.6.2. Applicants’ statements concerning the split of Exemption 7(a) ........... 147
10.6.3. Outlook: Further Specification of Exemption 7(a) ............................. 149

11.

Exemption 7(c)-I “for 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” .............. 150
11.1. Background ....................................................................................... 151
11.2. The history of the exemption ............................................................... 152
11.3. Technical description of the requested exemption ................................... 154
11.3.1. Amount of lead used under the exemption ...................................... 156
11.4. Applicants’ justification for the requested exemption............................... 157

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11.4.1. Substitution or elimination of lead .................................................. 157
11.4.2. Environmental arguments ............................................................. 162
11.4.3. Socioeconomic impacts ................................................................. 162
11.4.4. Road map to substitution .............................................................. 163
11.4.5. The scope of the exemption ........................................................... 163
11.5. Stakeholder contributions .................................................................... 164
11.6. Critical review .................................................................................... 165
11.6.1. REACH compliance – Relation to the REACH Regulation ..................... 165
11.6.2. Scientific and technical practicability of substitution .......................... 165
11.6.3. Environmental arguments and socioeconomic impacts ...................... 168
11.6.4. Socio economic impacts ................................................................ 168
11.6.5. Roadmap to substitution ............................................................... 168
11.6.6. Scope of the Exemption ................................................................ 169
11.6.7. Conclusions ................................................................................. 177
11.7. Recommendation ............................................................................... 179
12.

Exemption 7(c)-II “for lead in dielectric ceramic in capacitors for a rated
voltage of 125 V AC or 250 V DC or higher” ............................................... 181
12.1. Background ....................................................................................... 181
12.2. History of the exemption ..................................................................... 183
12.3. Technical description of the requested exemption ................................... 183
12.3.1. Amount of lead used under the exemption ...................................... 184
12.4. Applicants’ justification for the requested exemption............................... 185
12.4.1. Substitution or elimination of lead .................................................. 186
12.4.2. Environmental arguments ............................................................. 190
12.4.3. Socioeconomic impacts ................................................................. 191
12.4.4. Road map to substitution .............................................................. 191
12.5. Stakeholder contributions .................................................................... 191
12.6. Critical review .................................................................................... 192
12.6.1. REACH compliance – Relation to the REACH Regulation ..................... 192
12.6.2. Scientific and technical practicability of substitution .......................... 192
12.6.3. Environmental arguments and socioeconomic impacts ...................... 194
12.6.4. Scope of the Exemption ................................................................ 195
12.6.5. Conclusions ................................................................................. 196
12.7. Recommendation ............................................................................... 198

13.

References ............................................................................................ 199
Appendix 1: Aspects relevant to the REACH Regulation ............................... 211
Appendix 2: Exemption 7(a) .................................................................... 228

A.2.1 Intended Use and Examples for Related Products in which HMP lead (Pb)solders are utilized ................................................................................. 228
A.2.2 Properties of relevance to applications in scope of Ex. 7(a) (Umbrella Project2021e).................................................................................................. 229
A.2.3 Advantages and Disadvantages of High Temperature Lead-free Solutions ...... 230
A.2.4 Summary of strategies considered in the current review in order to specify
the scope .............................................................................................. 233
Appendix 3: Umbrella Project overview of various types of Exemption 7(c)-I
EE components used in EEE for many categories ........................................ 234

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A.3.1 Annex I – Categorization of electric and electronic components .................... 234

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List of Figures
Figure 4-1:

Relation of REACH Categories and Lists to Other Chemical
Substances ........................................................................ 30

Figure 6-1:

Flows of Pb-containing materials from different sources andhow they are combined in the recycling industry ..................... 58

Figure 8-1:

Recycling circuits in aluminium recycling .......................... 87

Figure 8-2:

Roadmap for substitution in gas valves detailing thedifferent steps that still need to be fulfilled ....................... 90

Figure 10-1: Examples of LHMPS used as combining elements integral toan electrical or electronic component .............................. 115
Figure 10-2: Examples of LHMPS used as combining elements integral toan electrical or electronic component .............................. 116
Figure 10-3: BGA component with HMP balls (left) and cylinder crystal
soldered onto a lead frame using HMP (right) ................. 117
Figure 10-4: LHMPS used in a crystal resonator (left) and a SMD fuse(right) as sealing material ............................................... 118
Figure 10-5: Example of an HID lamp with LHMPS material to connect thelamp cap to the internal electrical wiring of the lamp ...... 119
Figure 10-6: Example of a voice coil ..................................................... 120

List of Tables
Table 1-1:

Overview of the exemptions requested for renewal,
associated recommendations and expiry dates .................. 15

Tableau 2-1: Récapitulatif des demandes d’exemption, desrecommandations associées et des dates d’applications .... 21
Table 4-1:

Assessment of the applicability of REACH Annex XVII entry
63 to the exemptions under assessment ............................ 35

Table 5-1:

Estimation of the number of SMRE parts relying on specificexemptions listed in RoHS Annex III ................................. 40

Table 8-1:

Overview on the recommendations for Exemption 6(b) withnew sub-items ................................................................... 95

Table 10-1:

summarized the trajectory of lead used in HMP in the scopeof exemption 7(a) since the first evaluation .................... 122

Table 10-2:

An Overview of other contributors and main statements inrelation to Ex. 7(a) .......................................................... 127

Table 11-1:

Comparison of properties of glass types in combination with
their fillers ....................................................................... 159

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Table 11-2:

Comparison of properties of glass types in combination with
their fillers ....................................................................... 170

Table 12-1:

Examples of lead-free ceramic capacitors offered by Vishay........................................................................................ 187

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1.

Executive summary – English

With contract No. 070201/2020/8358484/ENV.B.3 implementing Frameworkcontract No ENV.B.3/FRA/2019/0017, a consortium led by Ramboll DeutschlandGmbH, has been requested by DG Environment of the European Commission toprovide technical and scientific support for the evaluation of exemption requests
under the RoHS 2 regime. In the currents study, the work has been undertaken
and peer reviewed by Oeko-Institut.

1.1.

Background and objectives

The RoHS 2 Directive 2011/65/EU entered into force on 21 July 2011 and led to therepeal of Directive 2002/95/EC on 3 January 2013. The Directive can be considered
to have provided for two regimes under which exemptions could be considered, RoHS
1 (the former Directive 2002/95/EC) and RoHS 2 (the current Directive 2011/65/EU).
The scope covered by the Directive is now broader as it covers all electrical andelectronic equipment (EEE; as referred to in Articles 2(1) and 3(1));

The former list of exemptions has been transformed into Annex III and may bevalid for all product categories according to the limitations listed in Article 5(2) ofthe Directive. Annex IV has been added and lists exemptions specific to categories
8 and 9;The RoHS 2 Directive includes the provision that applications for exemptions haveto be made in accordance with Annex V. However, even if a number of points are
already listed therein, Article 5(8) provides that a harmonised format, as well ascomprehensive guidance – taking the situation of SMEs into account – shall be
adopted by the Commission; andThe procedure and criteria for the adaptation to scientific and technical progress
have changed and now include some additional conditions and points to beconsidered. These are detailed below.

The new Directive details the various criteria for the adaptation of its Annexes toscientific and technical progress. Article 5(1)(a) details the various criteria and issues
that must be considered for justifying the addition of an exemption to Annexes III
and IV:The first criterion may be seen as a threshold criterion and cross-refers to the
REACH Regulation (1907/2006/EC). An exemption may only be granted if it does
not weaken the environmental and health protection afforded by REACH;



Furthermore, a request for exemption must be found justifiable according to oneof the following three conditions:−

Substitution is scientifically or technically impracticable, meaning that asubstitute material, or a substitute for the application in which the restricted
substance is used, is yet to be discovered, developed and, in some cases,
approved for use in the specific application;

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The reliability of a substitute is not ensured, meaning that the probability that
EEE using the substitute will perform the required function without failure for aperiod of time comparable to that of the application in which the original
substance is included, is lower than for the application itself;−

The negative environmental, health and consumer safety impacts ofsubstitution outweigh the benefits thereof.

Once one of these conditions is fulfilled, the evaluation of exemptions, including
an assessment of the duration needed, shall consider the availability of
substitutes and the socio-economic impact of substitution, as well as adverse
impacts on innovation, and life cycle analysis concerning the overall impacts ofthe exemption; andA new aspect is that all exemptions now need to have an expiry date and thatthey can only be renewed upon submission of a new application.

Against this background and taking into account that exemptions falling under theenlarged scope of RoHS 2 can be applied for since the entry into force of the Directive(21.7.2011), the consultant carried out an assessment of sixteen requests for the
renewal of nine exemptions in this study.

1.2.

Key findings – Overview of the evaluation results

The exemption requests covered in this project and the name of the applicant
concerned, as well as the final recommendation and proposed expiry date aresummarised in the table below (Table 1-1). Sixteen requests for the renewal of nine
exemptions listed in Annex III were included in the scope of this project. The reader
is referred to the corresponding section of this report for more details on the evaluation results.

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Table 1-1:

Overview of the exemptions requested for renewal, associated recommendations and expiry dates

Ex. Req.
No.

Requested exemption
wording

Applicant/s

Recommendation

Expiry date & scope

Annex III,6(a) and6(a)-I“Lead as an alloying element
in steel for machining
purposes and in galvanised
steel containing up to 0,35
% lead by weight.” and“Lead as an alloying element
in steel for machining
purposes containing up to
0,35 % lead by weight andin batch hot dip galvanised
steel components containing
up to 0,2 % lead by weight”

RÖHM
GmbH;
The
Umbrella
Project

6(a): Lead as an alloying element in steel for machining purposescontaining up to 0,35 % lead by weight and in galvanized steel
containing up to 0,35 % lead by weight— 21 July 2023 forcategory 8 in vitro
diagnostic medical
devices;— 21 July 2024 forcategory 9 industrial
monitoring and control
instruments, and for
category 11

6(a)-I: Lead as an alloying element in steel for machining purposescontaining up to 0,35 % lead by weight

Expires on 21 July 2024
for all categories

6(a)-II: Lead in batch hot dip galvanised steel components containing
up to 0,2 % lead by weight

Expires on 21 July 2026
for all categories“Lead as an alloying element
in aluminium containing up
to 0,4 % lead by weight”
and“Lead as an alloying element
in aluminium containing up
to 0,4 % lead by weight,
provided it stems from leadbearing aluminium scrap
recycling”

European
Aluminium;
The
Umbrella
Project6(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

Expires 12 months after
the decision for all
categories

6(b)-III: Lead as an alloying element in aluminium casting alloys
containing up to 0,3% lead by weight provided it stems from leadbearing aluminium scrap recycling

Expires on 21 July 2026
for all categories

Annex III,
6(b)/6(b)I

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Ex. Req.
No.

Requested exemption
wording

Applicant/s

Recommendation

Expiry date & scope

Annex III,6(b)-II“Lead as an alloying element
in aluminium for machining
purposes with a lead content
up to 0,4 % by weight”

The
Umbrella
Project6(b)-II: Lead as an alloying element in aluminium for machining
purposes with a lead content up to 0,4 % by weight.

Expires 18 months after
the decision for all
categories

6(b)-IV: Lead as an alloying element in aluminium for machining
purposes with a lead content up to 0,4 % by weight in gas valvesapplied in category 1 EEE (large household appliances)

Expires on 31 December
2024

Annex III,6(c)“Copper alloy containing up
to 4 % lead by weight”

Bourns Inc.;
The
Umbrella
Project

6(c): Copper alloy containing up to 4 % lead by weight

Expires on 21 July 2026
for all categories

Annex III,
7(a)“Lead in high melting
temperature type solders(i.e. lead-based alloys
containing 85 % by weightor more lead)”

Bourns Inc.;
The
Umbrella
Project

Lead in high melting temperature type solders (i.e., lead-based alloys
containing 85 % by weight or more lead) (excludes those in the scopeof exemption 24)

For all categories except
applications covered bypoint 24 of this Annex,
expires on 21 July 2024.

Lead in high melting temperature type solders (i.e., lead-based alloys
containing 85 % by weight or more lead) when used for the following
applications (excludes those in the scope of exemption 24):I) for internal interconnections for attaching die, or other components
along with a die in semiconductor assembly with steady state ortransient/impulse currents of 0.1 A or greater or blocking voltages
beyond 10 V, or die edge sizes larger than 0.3 mm x 0.3 mmII) for integral (meaning internal and external) connections of die
attach in electrical and electronic components, if the thermal
conductivity of the cured/sintered die-attach material is >35W/(m*K)
AND the electrical conductivity of the cured/sintered die-attachmaterial shall be >4.7MS/m AND solidus melting temperature has tobe above 260°C

Applies to all categories
except applications
covered by point 24 ofthis Annex, expires on 21
July 2026

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Ex. Req.
No.

Requested exemption
wording

Applicant/s

Recommendation

Expiry date & scopeIII) In first level solder joints (internal or integral connections meaning internal and external) for manufacturing components so that
subsequent mounting of electronic components onto subassemblies(i.e., modules or sub-circuit boards or substrates or point to point
soldering) with a secondary solder does not reflow the first levelsolder. This item excludes die attach applications and hermetic
sealings
IV) In second level solder joints for the attachment of components toprinted circuit board or lead frames:
1. in solder balls for the attachment of ceramic ball-grid-array(BGA)
2. in high temperature plastic overmouldings (> 220 °C)V) as a hermetic sealing material between:
1. a ceramic package or plug and a metal case,
2. component terminations and an internal sub-partVI) for establishing electrical connections between lamp components
in incandescent reflector lamps for infrared heating or high intensity
discharge lamps or oven lampsVII) for audio transducers where the peak operating temperature
exceeds 200°C

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Ex. Req.
No.

Requested exemption
wording

Applicant/s

Recommendation

Expiry date & scope

Annex III,7(c)-I“Electrical and electronic
components containing leadin a glass or ceramic otherthan dielectric ceramic in
ca-pacitors, e.g. piezoelectronic devices, or in a glassor ceramic matrix
compound”

COCIR;SCHOTT AG;
Bourns Inc.;
Photonis
Scientific,
Inc.;
Optical Fiber
Packaging
Ltd; The
Umbrella
Project7(c)-I: Electrical and electronic components containing lead in a glassor ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound

Expires on 21 July 2024
for all categories

7(c)-V: Electrical and electronic components containing lead in a glassor glass matrix compound that fulfils the following functions:
1) protection and electrical insulation in glass beads of high voltage
diodes and glass layers for wafer on the basis of a lead-zincborate or a lead-silica-borate glass body,*2) for hermetic sealings between ceramic, metal and/or glass parts
3) for bonding purposes in a process parameter window for <500°C combined with a viscosity of 1013,3 dPas (so called “glasstransition temperature”)
4) used as resistance materials such as ink, with a resistivity range
from 1 Ohms/square to 1 Mega Ohms/square, excluding trimmer
potentiometers**
5) used in chemically modified glass surfaces for Microchannel
Plates (MCPs), Channel Electron Multipliers (CEMs) and Resistive
Glass Products (RGPs).

Expires on 21 July 2026
for all categories

7(c)-VI: Electrical and electronic components containing lead in aceramic that fulfils the following functions (excluding items covered
under item 7(c)-II, 7(c)-III and 7(c)-IV of this annex):
1) piezoelectric lead zirconium titanate (PZT) ceramics
2) providing ceramics with a positive temperature coefficient (PTC)

Expires on 21 July 2026
for all categories

Annex III,7(c)-II

Note:“Lead in dielectric ceramic in
capacitors for a rated voltage of 125 V AC or 250 V
DC or higher”

The
Umbrella
Project7(c)-II: Lead in dielectric ceramic in capacitors for a rated voltage of
125 V AC or 250 V DC or higher

Does not apply toapplications covered bypoint 7(c)-I and 7(c)-IVof this Annex.
Expires on 21 July 2026
for all categories
As 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 thereport as a separator

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2.

Executive summary: French - Note de synthèse:
Français

Avec le contrat n° 070201/2020/8358484/ENV.B.3 mettant en œuvre le contratcadre n° ENV.B.3/FRA/2019/0017, un consortium dirigé par Ramboll DeutschlandGmbH, a été sollicité par la DG Environnement de la Commission européenne pourfournir un soutien technique et scientifique pour l’évaluation des demandes
d’exemption dans le cadre du régime RoHS 2. Dans l’étude actuelle, le travail a été
entrepris et revu par les pairs par Oeko-Institut.

2.1.

Contexte et objectifs

La directive RoHS 2 2011/65/EU est entrée en vigueur le 21 juillet 2011, ce qui aentraîné l’abrogation de la directive 2002/95/CE le 3 janvier 2013. Il est possible deconsidérer que la directive a prévu deux régimes qui ont permis de prendre encompte les exemptions, à savoir le régime RoHS 1 (l’ancienne directive 2002/95/CE)
et le régime RoHS 2 (la directive actuelle 2011/65/UE).


Le champ d’application couvert par la directive est désormais plus large sachantqu’il englobe l’intégralité des équipements électriques et électroniques (EEE ; telque mentionné dans les articles 2(1) et 3(1));

L’ancienne liste d’exemptions a été transformée en annexe III et est susceptible
de s’appliquer à toutes les catégories de produits conformément aux limitationsénumérées dans l’article 5(2) de la Directive. L’annexe IV a été ajoutée et eténumère les exemptions spécifiques aux catégories 8 et 9;

La directive RoHS 2 inclut la disposition selon laquelle les demandes d’exemption
doivent être déposées conformément aux termes de l’annexe V. Cependant,même si un certain nombre de points sont déjà énumérés dans cette annexe,
l’article 5(8) prévoit qu’un format harmonisé et des lignes directrices détaillées
prenant en compte la situation des PME, seront adoptés par la Commission
européenne; et

La procédure et les critères relatifs à l’adaptation au progrès scientifique ettechnique ont fait l’objet de modifications et comportent désormais certains points
et conditions supplémentaires qu’il est nécessaire de prendre en considération.
Ces derniers sont détaillés ci-dessous.

La nouvelle directive détaille les différents critères relatifs á l’adaptation de ses
annexes au progrès scientifique et technique. L’article 5(1), point a), détaille lesdifférents critères et questions qui doivent être considérés pour justifier l’ajout d’une
exemption aux annexes III et IV:

Le premier critère est susceptible d’être perçu comme un critère de seuil etrenvoie au règlement REACH (1907/2006/CE). Une exemption peut uniquementêtre accordée si elle ne fragilise pas la protection environnementale et sanitaire
offerte par le règlement REACH;

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De plus, une demande d’exemption doit être déclarée légitime selon l’une destrois conditions suivantes:−

Une substitution est irréalisable d’un point de vue scientifique ou technique.
Autrement dit, un matériau de substitution ou un substitut pour l’application
dans laquelle la substance faisant l’objet d’une restriction est utilisée, doit
encore être découvert, développé et, dans certains cas, jugé apte à une
utilisation dans l’application spécifique;−La fiabilité d’un substitut n’est pas garantie. En d’autres termes, la probabilité
que les EEE recourant à un substitut assurent la fonction requise sansconnaître de défaillance pendant une durée comparable à celle de l’application
dans laquelle la substance d’origine est incluse, est inférieure à celle del’application;−

Les impacts négatifs de la substitution sur l’environnement, la santé, et lasécurité des consommateurs l’emportent sur ses avantages.



Dès lors que l’une de ces conditions est remplie, l’évaluation des exemptions,estimation de la durée nécessaire comprise, devra tenir compte de la disponibilitédes substituts et de l’impact socio-économique de la substitution, ainsi que leseffets néfastes sur l’innovation et une analyse du cycle de vie concernant les
impacts globaux de l’exemption.



Le fait que toutes les exemptions doivent désormais présenter une dated’expiration et qu’elles peuvent uniquement être renouvelées après soumissiond’une nouvelle demande, constitue un aspect inédit.

Face á un tel contexte et compte tenu du fait que les exemptions soumises au champ
d’application élargi de la Directive RoHS 2 peuvent être demandées depuis l’entrée envigueur de la directive (le 21 juillet 2011), le consultant a procédé à l’évaluation deseize demandes de renouvellement de neuf exemptions dans le cadre de la présentemission.

2.2.

Les principales conclusions – Synthèse des résultats del’évaluation

Les demandes d’exemption couvertes par ce projet et le nom du demandeur
concerné, ainsi que la recommandation finale et la date d’expiration proposée, sontrésumées dans le tableau ci-dessous (Tableau 2-1). Seize demandes de renouvellement de neuf exemptions énumérées à l’annexe III ont été incluses dans le champ
d’application de ce projet.
Le lecteur est invité à se reporter à la section correspondante du présent rapport
pour plus de détails sur les résultats de l’évaluation.

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Traduction en français fournie par souci de commodité. En cas de contradictions entre la traduction française et la version originale
anglaise, cette dernière fait foi.
Tableau 2-1: Récapitulatif des demandes d’exemption, des recommandations associées et des dates d’applications
Numéro de la
demanded’exemption

Texte de l’exemption demandée

Demandeur/s

Recommendation

Date d’expiration etchamp d’application

Annex III, 6(a) et
6(a)-I“Le plomb en tant qu’élément
d’alliage dans l’acier destiné àl’usinage contenant jusqu’à 0,35 %de plomb en poids” et “Le plomben tant qu’élément d’alliage dansl’acier destiné à l’usinage
contenant jusqu’à 0,35 % deplomb en poids et dans lescomposants en acier galvanisé à
chaud par lots contenant jusqu’à
0,2 % de plomb en poids”

RÖHM GmbH;The Umbrella
Project

6(a) : Le plomb comme élément d'alliage dans l'acierdestiné à l’usinage contenant jusqu'à 0,35 % de plomb
en poids et dans l'acier galvanisé contenant jusqu'à
0,35 % de plomb en poids.

- 21 juillet 2023 pour lesdispositifs médicaux dediagnostic in vitro de lacatégorie 8;- 21 juillet 2024 pour les
instruments desurveillance et decontrôle industriels de lacatégorie 9, et pour lacatégorie 116(a)-I : Plomb comme élément d'alliage dans l'acierdestiné à l'usinage contenant jusqu'à 0,35 % de plomb
en poids.

Expire le 21 juillet 2024
pour toutes les catégories

6(a)-II : Plomb dans les composants en aciergalvanisé à chaud par lots contenant jusqu'à 0,2 % deplomb en poids.

Expire le 21 juillet 2026
pour toutes les catégories

6(b)-I : Plomb en tant qu’élément d'alliage dansl'aluminium contenant jusqu'à 0,4 % de plomb enpoids, à condition qu'il provienne du recyclage dedébris d'aluminium contenant du plomb

Expire 12 mois après ladécision pour toutes lescatégories

Annex III,
6(b)/6(b)-I“Le plomb en tant qu’élément
d’alliage dans l’aluminium
contenant jusqu’à 0,4 % de plomb
en poids” et “Le plomb en tantqu’élément d’alliage dansl’aluminium contenant jusqu’à 0,4

European
Aluminium;
The Umbrella
Project

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Numéro de la
demanded’exemption

Texte de l’exemption demandée

Demandeur/s% de plomb en poids à condition
qu’il provienne du recyclage dedébris d’aluminium contenant duplomb”

Annex III, 6(b)-II

Recommendation

Date d’expiration etchamp d’application

6(b)-III : Plomb comme élément d'alliage dans lesalliages de fonderie d'aluminium contenant jusqu'à 0,3% de plomb en poids, à condition qu'il provienne durecyclage de débris d'aluminium contenant du plomb.

Expire le 21 juillet 2026
pour toutes les catégories

6(b)-II : Plomb en tant qu’élément d'alliage dansl'aluminium destiné à l'usinage contenant jusqu'à 0,4% de plomb en poids.

Expire 18 mois après ladécision pour toutes lescatégories

6(b)-IV : Plomb en tant qu'élément d'alliage dansl'aluminium à des fins d'usinage avec une teneur enplomb allant jusqu'à 0,4 % en poids dans les robinets
à gaz utilisés dans les EEE de catégorie 1 (grosappareils ménagers).

Expire le 31 décembre2024“Le plomb en tant qu’élément
d’alliage dans l’aluminium destiné àl’usinage contenant jusqu’à 0,4 %de plomb en poids”

The Umbrella
Project

Annex III, 6(c)“L’alliage de cuivre contenantjusqu’à 4 % de plomb en poids”

Bourns Inc.;The Umbrella
Project

6(c): L’alliage de cuivre contenant jusqu'à 4 % deplomb en poids.

Expire le 21 juillet 2026
pour toutes les catégories

Annex III, 7(a)“Le plomb dans les soudures à
haute température de fusion(alliages de plomb contenant au
moins 85 % de plomb en poids)”

Bourns Inc.;The Umbrella
Project

Plomb dans les soudures à haute température defusion (alliages de plomb contenant au moins 85 % deplomb en poids) (à l'exclusion de celles relevant del'exemption 24).

Pour toutes lescatégories, à l'exception
des demandes couvertes
par le point 24 de laprésente annexe, expire
le 21 juillet 2024

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Numéro de la
demanded’exemption

Texte de l’exemption demandée

Demandeur/s

Recommendation

Date d’expiration etchamp d’application

Le plomb dans les soudures à haute température defusion (alliages de plomb contenant au moins 85 % deplomb en poids) lorsqu'il est utilisé pour lesapplications suivantes (à l'exclusion de celles relevantde l'exemption 24) :S'applique à toutes lescatégories sauf aux
demandes couvertes parle point 24 de la présente
annexe, expire le 21
juillet 2026

I)

pour les interconnexions internes destinées à
fixer une puce, ou d'autres composants le longd'une puce dans un assemblage de semiconducteurs avec des courants permanents outransitoires/impulsifs de 0,1 A ou plus ou destensions de blocage supérieures à 10 V, ou destailles de bord de puce supérieures à 0,3 mm x
0,3 mmII)pour les connexions intégrales (internes etexternes) de fixation de puce dans lescomposants électriques et électroniques, si laconductivité thermique du matériau de fixationde puce durci/fritté est >35W/(m*K) ET laconductivité électrique du matériau de fixationde puce durci/fritté doit être >4,7MS/m ET latempérature de fusion du solidus doit êtresupérieure à 260°C

III)

Dans les soudures de premier niveau(connexions internes ou intégrales - c'est-à-direinternes et externes) pour la fabrication decomposants, de sorte que le montage ultérieurde composants électroniques sur des sousensembles (des modules ou des cartes de souscircuits ou des substrats ou le soudage point àpoint) avec une soudure secondaire ne provoque

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RoHS Exemptions Evaluation: Pack 22

Numéro de la
demanded’exemption

Texte de l’exemption demandée

Demandeur/s

Recommendation

Date d’expiration etchamp d’application

pas la refusion de la soudure de premier niveau.
Ce point exclut les applications de fixation depuce et les joints hermétiques.
IV)

Dans les brasures de deuxième niveau pour lafixation de composants sur des cartes de circuits
imprimés ou des grilles de connexion :1. dans les billes de soudure pour la fixation desgrilles matricielles à billes en céramique(anglais : ball grid array BGA)
2. dans les surmoulages plastiques hautetempérature (> 220 °C)

V)comme matériau de scellement hermétique entre:
1. un boîtier ou une fiche en céramique et unboîtier métallique,
2. les terminaisons de composants et une souspartie interne.

VI)pour établir des connexions électriques entre lescomposants de lampes dans les lampes àréflecteur à incandescence pour le chauffage
infrarouge ou les lampes à décharge à hauteintensité ou les lampes de fourVII) pour les transducteurs audio dont la température
maximale de fonctionnement dépasse 200 °C.

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Numéro de la
demanded’exemption

Texte de l’exemption demandée

Demandeur/s

Recommendation

Date d’expiration etchamp d’application

Annex III, 7(c)-I“Les composants électriques etélectroniques contenant du plomb
dans du verre ou des matériaux
céramiques autres que lescéramiques diélectriques dans lescondensateurs, (par exemple, lesdispositifs piézoélectriques) ou
dans une matrice en verre ou en
céramique”

COCIR;SCHOTT AG;
Bourns Inc.;
Photonis
Scientific, Inc.;
Optical Fiber
Packaging Ltd;The Umbrella
Project7(c)-I : Les composants électriques et électroniquescontenant du plomb dans un verre ou des matériaux
céramiques autres que les céramiques diélectriques
dans les condensateurs, (par exemple, les dispositifs
piézo-électriques) ou dans une matrice en verre ou en
céramique

Expire le 21 juillet 2024
pour toutes lescatégories.

7(c)-V : Composants électriques et électroniquescontenant du plomb dans un verre ou un composé àmatrice de verre qui remplit les fonctions suivantes :1) protection et isolation électrique dans les perles
de verre des diodes haute tension et dans lescouches de verre pour plaquettes à base d'uncorps en verre plomb-zinc-borate ou plombsilice-borate*.
2) pour les scellements hermétiques entre despièces en céramique, en métal et/ou en verre3) à des fins de collage dans une fenêtre de paramètres de processus pour < 500°C combiné
avec une viscosité de 10 13,3 dPas (appelée"température de transition du verre")4) utilisés comme matériaux de résistance tels
que l'encre, avec une gamme de résistivité de1 Ohms/carré à 1 Méga Ohms/carré, àl'exception des potentiomètres de réglage**.
5) utilisés dans les surfaces en verrechimiquement modifiées pour les plaques àmicrocanaux (MCP), les multiplicateurs

Expire le 21 juillet 2026
pour toutes lescatégories.

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Numéro de la
demanded’exemption

Texte de l’exemption demandée

Demandeur/s

Recommendation

Date d’expiration etchamp d’applicationd'électrons à canaux (CEM) et les produits enverre résistif (RGP).
7(c)-VI : Composants électriques et électroniquescontenant du plomb dans une céramique qui remplit
les fonctions suivantes (à l'exclusion des articles
couverts par les points
7(c)-II, 7(c)-III et 7(c)-IV de la présente annexe) :1) céramiques piézoélectriques en titanate deplomb et de zirconium (PZT)
2) fournissant des céramiques à coefficient detempérature positif (CTP).
Annex III, 7(c)-II“Le plomb dans les céramiques
diélectriques dans lescondensateurs pour une tension
nominale de 125 V CA ou 250 V CC
ou plus”

The Umbrella
Project

Expire le 21 juillet 2026
pour toutes les catégories

7(c)-II : Plomb dans les céramiques diélectriques dansles condensateurs pour une tension nominale de 125 V
CA ou 250 V CC ou plus

Ne s'applique pas aux
demandes couvertes parle point 7(c)-I et 7(c)-IVde la présente annexe.
Expire le 21 juillet 2026
pour toutes les catégories
Notez: Comme dans le texte juridique de la directive RoHS, les virgules sont utilisées comme séparateur décimal pour les formules d’exemption figurant dans ce tableau, contrairement au point
décimal utilisé comme séparateur dans le reste du rapport.

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3.
3.1.

Introduction
Project scope and methodology

The scope of the study covers the evaluation of sixteen requests for the renewal ofnine exemptions. An overview on the exemption requests is given in Table 1-1 in the
Executive Summary.
In the course of the project, a stakeholder consultation was conducted. The stakeholder consultation was launched on 23 December 2020 and was held for duration often weeks thus concluding 3 March 2021.
The specific project website was used in order to keep stakeholders informed on the
progress of work: http://rohs.exemptions.oeko.info. The consultation held during the
project was carried out according to the principles and requirements of the European
Commission. Stakeholders who had registered at the website were informed throughemail notifications about new steps within the project.
Information concerning the consultation was provided on the project website,
including a general guidance document, the applicant’s documents, a specificquestionnaire and a link to the EU CIRCA website. Public contributions submitted were
published on the EU CIRCA website.
Following the stakeholder consultation, an in-depth evaluation of the exemptions
began. The requests were evaluated according to the relevant criteria laid down in
Article 5 (1) of the RoHS 2 Directive, as shown in the section on background andobjectives on page 13.
Aspects related to REACH are detailed under Chapter 54.General arguments raised bystakeholders in relation to all exemptions are addressed under Chapter 5. Each of thechapters thereafter (0 through12) addresses a specific exemption (or in a few cases anumber of exemptions evaluated jointly) evaluated in the course of this study. The
information provided by the applicant and by stakeholders is summarised in the firstsections of the respective chapter. This includes a general description of the application and requested exemption, a summary of the arguments made for justifying the
exemption, information provided concerning possible alternatives and additional
aspects raised by the applicant and other stakeholders. In the Critical Review part, thesubmitted information is discussed, to clarify how the consultant evaluate the various
information and what conclusions and recommendations have been made. The general
requirements for the evaluation of exemption requests as set by the European
Commission may be found in the technical specification of the project. 1

3.2.

Project set-up

Assignment of project tasks to Oeko-Institut, started in 28 October 2020. The overall
study has been led by Yifaat Baron and is managed by Katja Moch.

1

Cf.
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Technical_Specifications_Pack_22.pdf
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4.

Links between the RoHS Directive and the REACH
Regulation

Article 5 of the RoHS 2 Directive 2011/65/EU on “Adaptation of the Annexes toscientific and technical progress” provides for that:“inclusion of materials and components of EEE for specific applications in thelists 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 healthand the environment can be added to the candidate list to be identified as
Substances of Very High Concern (SVHCs). Following the identification as SVHC, a
substance may be included in Annex XIV of the REACH Regulation (Authorisationlist): “List of Substances Subject to Authorisation”. If a 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 22 of 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 andno 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
the environment that it is not adequately controlled, it shall prepare a restriction
dossier. ECHA has also the initiative to prepare a restriction dossier for any
substance in the authorisation list if the use of that substance in articles poses arisk to human health and the environment that is not adequately controlled. The
provisions of the restriction may be made subject to total or partial bans, orconditions for restrictions, based on an assessment of the risks and theassessment of the socio-economic elements.

The approach adopted in this report is that once a substance has been included into
the Annexes related to 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. This is essentially the same approach as it has first been adopted
for the re-evaluation of some existing RoHS exemptions 7(c)-IV, 30, 31 and 40,(Oeko-Institut e.V. and Fraunhofer IZM 2012b) and in the following for the evaluationof a range of requests assessed through previous projects in respect of RoHS 2 (OekoInstitut e.V. and Fraunhofer IZM 2012a). Substances for which an authorisation or
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restriction process is underway may be discussed in some cases in relation to a
specific exemption, in order to check possible overlaps in the scope of such processes
and of requested RoHS exemptions and to identify the need for possible alignments ofthese two legislations. 2
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
well as 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.

2

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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Figure 4-1:

Relation of REACH Categories and Lists to Other Chemical
Substances

Source: Own illustration

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
conducted by the ECHA together with the Member States and different ECHA Expert
Groups. 3 If a Member State evaluates certain substance to clarify whether its use
poses a 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 the substance to verify the suspected concern. Those selected substances arelisted by ECHA in the community rolling action plan (CoRAP). 4 If the Substance
Evaluation concludes that the risks are not sufficiently under control with themeasures already in place and if a Risk Management Option (RMO) analyses does notconclude that there are appropriate instruments by other legislation / actions, thesubstance will be notified in the Registry of Intentions.
The following bullet points explain in detail the above-mentioned lists and where they
can be accessed:


3

4

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 toinform interested parties of the substances for which the authorities intend to
For an overview in these activities and processes see the ECHA webpage at:https://echa.europa.eu/substances-of-potential-concern
Updates and general information can be found under: https://echa.europa.eu/information-onchemicals/evaluation/community-rolling-action-plan/corap-list-of-substances. The list can be found on
the following page: https://echa.europa.eu/information-on-chemicals/evaluation/community-rollingaction-plan/corap-table
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submit Annex XV dossiers and, therefore, to facilitate timely preparation of theinterested parties for commenting later in the process. It is also important to avoid
duplication of work and encourage co-operation between Member States when
preparing dossiers. Note that the Registry of Intentions is divided into two
separate sections: The Registry of SVHC intentions until outcome, available under:
https://echa.europa.eu/de/registry-of-svhc-intentions and the Registry of
restriction intentions until outcome, available under:
https://echa.europa.eu/de/registry-of-restriction-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 athttps://echa.europa.eu/candidate-list-table;



The last step of the procedure, prior to 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 athttps://echa.europa.eu/previous-recommendations;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 this list is prohibited unless an Authorisation for use in a specificapplication has been approved. The Annex can be found in the consolidated
version of the REACH legal text;In parallel, if a decision is made concerning the Restriction on the use of a
substance in a specific article, or concerning the restriction of its provision on theEuropean 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 befound in the consolidated version of the REACH legal text.

As of July 2021, the consolidated version of the REACH legal text, dated 05.07.2021,
was used to reference Annexes XIV and XVII: The consolidated version is available atthe EUR-Lex website: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20210705. Relevant annexes and processes related to the REACH
Regulation have been cross-checked 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 understand where such cases may become relevant in the future.

In this respect, restrictions and authorisations as well as processes that may lead totheir initiation, have been reviewed, in respect of where RoHS Annex II substances are
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RoHS Exemptions Evaluation: Pack 22

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). 5
Compiled information in this respect has been included, with short clarifications where
relevant, in Tables 1 and 2, which appear in Appendix 1.
The information has further been cross-checked in relation to the exemption evaluatedin the course of this project. This has been done to clarify that the Article 5(1)(a)threshold-criteria quoted above is complied with in cases where an exemption is to be
granted / its duration renewed / its formulation amended / or where it is to be
revoked and subsequently to expire as an exemption. The considerations in thisregard are addressed in the following Section 4.1. Where conclusions of this analysis
are to be taken into consideration in the individual evaluation of each assessment, thisis specified in the final recommendations chapter of each exemption specific chapter.

4.1.

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 theenvironmental and health protection afforded by“ the REACH Regulation. The article
details further criteria which need to be fulfilled to justify an exemption, however thereference to the REACH Regulation is interpreted by the consultant as a thresholdcriterion: an exemption could not be granted should it weaken the protection afforded
by REACH. The evaluation thus includes a review of possible incoherence of therequested exemptions with the REACH Regulation.
As all exemption requests under evaluation in Pack 22 concerns the use of lead the
REACH compliance check focused on lead is included here.
Annex XIV of the REACH Regulation lists substances, the use of which would require
an authorisation in the EU. REACH Annex XIV includes three lead compounds:

Lead chromate: According to applications for authorisation under REACH, leadchromate is used in pyrotechnical compositions contained in ammunition for naval
self-protection; 6

Lead sulfochromate yellow: Applications for authorisation under REACH 7 point out
a use as pigment in paints on metal surfaces, or to colour plastic/plasticised
articles for non-consumer use;

Lead chromate molybdate sulphate red: The applications for authorisation refer tothe same uses as pigment lead sulfochromate yellow (pigment powder in an

5

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.
https://echa.europa.eu/de/applications-for-authorisation-previousconsultations?diss=true&search_criteria_ecnumber=231-846-0&search_criteria_casnumber=7758-976&search_criteria_name=Lead+chromate
https://echa.europa.eu/de/applications-for-authorisation-previousconsultations?diss=true&search_criteria_ecnumber=215-693-7&search_criteria_casnumber=1344-372&search_criteria_name=Lead+sulfochromate+yellow

67

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industrial environment into solvent-based paints for non-consumer use; paints on
metal surfaces (such as machines vehicles, structures, signs, road furniture, coilcoating etc.); to colour plastic/plasticised articles for non-consumer use) 8
Annex XVII of the REACH Regulation contains entries restricting the use of leadcompounds. The full wording of the entries is depicted in the Appendix (Aspects
relevant to the REACH Regulation).


Entry 16 restricts the use of lead carbonates in paints; 9Entry 17 restricts the use of lead sulphates in paints; 10Entry 19 refers to arsenic compounds but includes a few lead compounds andrestricts their use as a fouling agent, for treatment of industrial water or fortreatment of wood; 11Entry 28 and 30 stipulate that lead and its compounds shall not be placed on themarket, or used, as substances, constituents of other substances, or in mixtures
for supply to the general public; 12Entry 63 restricts the use of lead and its compounds: 13 in jewellery or in gunshot
in or around wetlands. Furthermore it shall not be placed on the market or used inarticles supplied to the general public, if the concentration of lead (expressed as
metal) in those articles or accessible parts thereof is equal to or greater than 0.05
% by weight, and those articles or accessible parts thereof may, during normal orreasonably foreseeable conditions of use, be placed in the mouth by children.
That limit shall not apply where it can be demonstrated that the rate of lead
release from such an article or any such accessible part of an article, whether
coated or uncoated, does not exceed 0.05 μg/cm² per hour (equivalent to 0.05
μg/g/h), and, for coated articles, that the coating is sufficient to ensure that thisrelease rate is not exceeded for a period of at least two years of normal orreasonably foreseeable conditions of use of the article. There are some derogations
for specific articles e.g. keys and locks, including padlocks. Furthermore, articles
within the scope of the RoHS Directive are derogated.



Entry 72 stipulates that various lead compounds shall not be used in clothing
textiles or footwear. 14

The exemptions under evaluation here concern the use oflead in metal alloys (steel, aluminium and copper) (exemptions 6(a), (b), (c)) orlead in special solders (high melting temperature type solders) (exemption 7(a)) orlead in a glass or ceramic or dielectric ceramic in a specific application (capacitors)(exemptions 7(c)-I and 7(c)-II).

8https://echa.europa.eu/de/applications-for-authorisation-previousconsultations?diss=true&search_criteria_ecnumber=235-759-9&search_criteria_casnumber=12656-858&search_criteria_name=Lead+chromate+molybdate+sulfate+red
https://echa.europa.eu/documents/10162/22dd9386-7fac-4e8d-953a-ef3c71025ad4
https://echa.europa.eu/documents/10162/ffd7653b-98cc-4bcc-9085-616559280314
https://echa.europa.eu/documents/10162/a798c758-371f-41e5-a38d-5f8dc9ba739d
See the conditions of restriction and the various Appendices (substance lists) at:
https://echa.europa.eu/de/substances-restricted-under-reachhttps://echa.europa.eu/documents/10162/851fb88e-9867-c5a0-bf15-2678ad831be6
https://echa.europa.eu/documents/10162/8db10905-d535-0a04-0af5-7628a210dc28

9
10
11
12

13
14

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The requested exemptions do not regard paints or jewellery or textiles, nor components that could be expected to be placed in the mouth by children under normal orforeseeable use. Furthermore, the use of lead in the materials in the scope of theabove-mentioned exemptions is not a supply of lead compounds as a substance,
mixture or constituent of other mixtures to the general public. Rather lead is part ofan article and as such, entry 28 and 30 of Annex XVII of the REACH Regulation would
not apply. It is concluded that a renewal of the exemptions would not result in an
overlap and would therefore not weaken the protection afforded by REACH throughentries 16, 17, 19, 28, 30 and 72.
Entry 63 restricts the use of lead and its compounds in articles supplied to the generalpublic. Articles within the scope of the RoHS Directive benefit from a derogation fromthese provisions. The consultant understands that this is to provide legal coherence as
the RoHS Directive restricts lead with a maximum concentration value tolerated byweight in homogeneous materials of 0.1% and specifies some specific exemptions forthe use of lead. This view is supported in the Common Understanding Communication,
which specifies: “The simplest way to avoid duplications and/or inconsistencies for agiven substance already included in RoHS is, to exclude EEE within the scope of RoHS
from the scope of a proposed REACH restriction also covering EEE”.
However, the Swedish Chemicals Agency KEMI (2021) in its contribution to thestakeholder consultation claimed for the metal alloy exemptions 15, that “RoHS must be
adapted to the corresponding level of protection to human health according to otherregulations. The broad exemptions for lead in RoHS undermine the purpose of the
REACH restriction. The protection for human health in RoHS must be at least
equivalent to the one in REACH. For example, external parts in EEE for use by thegeneral public with a risk of skin contact do not lead to a safe use when an exemptionof lead is applied.”
This view is also reflected in the Common Understanding Communication stating that“in those situations in which the RoHS restriction generally takes into account theprotection of human health and the environment, at all stages, similarly to REACH
restrictions, the latter should exclude EEE from their scope of application, indicatingthat the use of the substance in question in EEE is restricted by the RoHS Directive.”
In this sense, the consultant concludes that EEE do not benefit from an exclusion in
general but rather on the basis that exemptions are expected to be granted (orrenewed) only in cases where a similar level of protection is ensured.
Entry 63 restricts lead and its compounds in articles and their accessible parts with theaim of minimising children’s lead exposure from articles supplied to the general public(ECHA 2020).. Due to their mouthing behaviour, children, especially those under 3
years may be repeatedly exposed to lead or lead compounds released from consumer
articles. Children are especially sensitive to lead exposure as their central nervous
system is still developing, which can result in severe and irreversible neurobehavioral
and neurodevelopmental effects (ECHA 2020). As no threshold has been found for theharmful effects of lead on the central nervous system, and with a view to backgroundexposure from diet and other environmental sources, any relevant lead exposure

15

General comments on the exemption requests for 6a, 6a-I, 6b, 6b-I, 6b-II, 6c
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should be avoided as a matter of principle (ECHA 2020). According to the ECHA
Guideline on the scope of the Entry 63, it is clarified that “an article or accessible partof an article may be placed in the mouth by children if it is smaller than 5 cm in one
dimension or has a detachable or protruding part of that size.” (ECHA Guideline).
The restriction under REACH applies to articles and accessible parts of articles, whichmeet all the 3 following conditions:a. are supplied to the general public and contain lead or lead compounds atconcentrations of lead, expressed as metal, equal to or greater than 0.05 % byweight;b. may be placed in the mouth by small children during normal or reasonably
foreseeable conditions of use;c. are not covered by a derogation.
EEE should in general be kept away from children especially under 3 years, thus itshould not be placed in the mouth by small children during normal or reasonably
foreseeable conditions of use. However, the consultant agrees to the Swedish
Chemicals Agency KEMI (2021) that RoHS exemptions of lead undermines the purposeof the REACH restriction if the application is not specified. This is primarily because

the concentration of lead in the alloys’ exemption under RoHS are greater than thelimits in entry 63 andno threshold has been found for the harmful effects of lead on the central nervous
system.

This means that any relevant lead exposure should be avoided as a matter ofprinciple according to ECHA (2020).

It should be noted that KEMI (2021) even uses the wording “external parts in EEE for
use by the general public with a risk of skin contact do not lead to a safe use when an
exemption of lead is applied” to describe an equivalent level of protection under RoHS.
However, the consultant rather proposes that the wording of REACH should be used if
the applications of the RoHS exemptions are not sufficiently specified to a degree thatallows to conclude that they are not applied in articles or accessible parts of an article
that may be placed in the mouth by children.
The following table compiles the exemptions under review in this study and theirassessed potential to address accessible components / parts.
Table 4-1:
Ex. Req.
No.
Annex III,6(a) and6(a)-I

Assessment of the applicability of REACH Annex XVII entry 63
to the exemptions under assessment
Recommended exemption
wording

Potential for application to be accessible
or to contain accessible components /parts
As an exhaustive list of applications has not been
provided, the use of this exemption for components
in external and potentially accessible parts cannot be
ruled out. This is relevant for EEE categories 1-4, 6
and 7 and 11.

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Ex. Req.
No.

Recommended exemption
wording

Annex III,
6(b)/6(b)I

Annex III,6(b)-II

Potential for application to be accessible
or to contain accessible components /parts
As an exhaustive list of applications has not been
provided, the use of this exemption for components
in external and potentially accessible parts cannot be
ruled out. This is relevant for EEE categories 1-4, 6
and 7 and 11.

“Lead as an alloying element inaluminium for machining
purposes with a lead content
up to 0,4 % by weightfor gas valves for
category 1 (large
household appliances)“Copper alloy containing up to
4 % lead by weight”

No, relevant components are understood to be larger
than specified

Annex III,
7(a)“Lead in high melting
temperature type solders (i.e.
lead-based alloys containing 85% by weight or more lead)”

No potential. Lead-based high melting point solders
are applied in internal electric components of EEE.

Annex III,7(c)-I“Electrical and electronic
components containing lead ina glass or ceramic other thandielectric ceramic in capacitors, e.g. piezoelectronic
devices, or in a glass or
ceramic matrix compound”“Lead in dielectric ceramic in
capacitors for a rated volt-age
of 125 V AC or 250 V DC or
higher”

No potential. Lead is used in glass or ceramiccomponents that are applied in internal electriccomponents of EEE.

Annex III,6(c)Annex III,7(c)-IIFor components with electrical function, no
accessibility is anticipated.
Mechanical components are understood to be specificinternal components. However, as an exhaustive listof applications has not been provided, the use of thisexemption for components in external andpotentially accessible parts cannot be ruled out. Thisis relevant for EEE categories 1-4, 6, 7 and 11.

No potential. Lead is used in capacitors which areinternal electric components of the EEE.

To conclude, in order to ensure the same level of protection to human health asprovided by REACH the consultant proposes that the following phrase should be addedfor precautionary reasons to the exemption wording to exclude the use in:“article or accessible part of an article that may be placed in the mouth by children; if
it is smaller than 5 cm in one dimension or has a detachable or protruding part of thatsize except where it can be demonstrated that the rate of lead release from theaccessible component /part, whether coated or uncoated, does not exceed
0,05 μg/cm2 per hour (equivalent to 0,05 μg/g/h), and, for coated articles, that thecoating is sufficient to ensure that this release rate is not exceeded for a period of atleast two years of normal or reasonably foreseeable conditions of use of the article”.
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Alternatively, it could be added as a footnote to exemptions where this aspect isrelevant.
It should be noted here, that other stakeholders whose products originally fall in scopeof entry 63, such as the watches industry has already implemented this concept; e.g.
Federation of the Swiss Watch Industry FH (2021a) states that “the watch industry
has already substituted a long time ago lead alloys in external watch components. Forinternal components of the watch movement, substitution is more challenging.”
To conclude, no other entries, relevant for the use of lead in the requested exemptions
could be identified in Annex XIV and Annex XVII (status July 2021). Based on thecurrent 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. A renewal of the exemptions could be granted taking into accountall consideration discussed above if other criteria of Art. 5(1)(a) apply.

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5.

The applicability of the Pack 22 exemption
conclusions and recommendations to sub-Cat. 8
in-vitro, sub-Cat. 9 industrial and Cat. 11

The RoHS Directive makes a distinction between eleven EEE categories (from here onreferred to as Cat.) which are named in Annex I of the Directive. Certain provisions
address some of these Cat. in a different way than they do others. To begin with, Cat.
8, Cat. 9 and Cat. 11 came into the scope of the Directive at a later point in time thanthe other categories, meaning among others that the substance restrictions need to becomplied with by EEE under these categories at a later time. This is referred to under
Article 4(3), which states:“Paragraph 1 shall apply to medical devices [Cat. 8 - consultants addition] andmonitoring and control instruments [Cat. 9 - consultants addition] which areplaced on the market from 22 July 2014, to in vitro diagnostic medical devices([Cat. 8 in-vitro - consultants addition] which are placed on the market from 22
July 2016, to industrial monitoring and control instruments [Cat. 9 industrial consultants addition] which are placed on the market from 22 July 2017, and to allother EEE that was outside the scope of Directive 2002/95/EC and which is placedon the market from 22 July 2019 [Cat. 11 - consultants addition].”Respectively, Article 5(2), last paragraph specifies that:“For the exemptions listed in Annex III as at 21 July 2011, unless a shorter
period is specified, the maximum validity period, which may be renewed, shall be:(a) for categories 1 to 7 and category 10 of Annex I, 5 years from 21 July 2011;(b) for categories 8 and 9 of Annex I, 7 years from the relevant dates laid down in
Article 4(3); and(c) for category 11 of Annex I, 5 years from 22 July 2019.
For the exemptions listed in Annex IV as at 21 July 2011, the maximum validity
period, which may be renewed, shall be 7 years from the relevant dates laid downin Article 4(3), unless a shorter period is specified.”
Whereas the exemptions under assessment in this study are set to expire for Cat. 110 by 21 July 2021, later expiration dates apply to three categories as specified
below:For Cat. 8 in-vitro EEE the exemption is specified to expire on 21 July 2023;

For Cat. 9 industrial and Cat. 11 the exemption is specified to expire on 21 July
2024.

There has thus been uncertainty as to whether the current assessment shall also
concern these categories and whether its recommendations should apply to thesecategories in the same way that they do to others. This is reflected both in therequests of applicants as also in a few of the contributions made to the stakeholder
consultation, which are summarised in the next section.

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5.1.

Applicant and Stakeholder views

The “RoHS Umbrella Industry Project” (hereafter Umbrella Project or UP) who has
submitted requests for all of the exemptions under assessment in this study initiallyrequested the renewal of the exemptions for Cat. 1-10 (see for example (Umbrella
Project 2020e)). After further consideration, a set of applications almost identical incontent were submitted for the same exemptions, requesting also the renewal for Cat.
11 (see for example (Umbrella Project 2020g)). It can be understood that theUmbrella Project members have deemed it necessary to submit this second set of
applications for reasons of legal certainty for their products. The Commission accepted
the applications and included Cat. 11 in the current assessment.
SEMI EUROPE (2021b) is understood to represent among others manufacturers ofequipment for the manufacture of semiconductors, which they explain to fall underCat. 11. SEMI EUROPE (2021b) explains that it expects the current studies to only be“related to exemptions which expire shortly (e.g., July of 2021), and that no reduction
will be made to the later expiry dates or the categories of equipment they cover”.
SEMI (2021b) explains that many parts used in Semiconductor-Manufacturing (andRelated) Equipment (SMRE) rely on some of the exemptions currently under review.
Even in the case that a change in an exemption does not require a redesign of thepart, i.e. the exemption formulation remains the same but the expiry dates changes,
SEMI explains such changes to result in a cost: “Even in the simplest scenario, the
new RoHS-compliant part that does not depend on the exemption will have to begiven a new part number, and the ‘where-used’ assemblies and related drawings andbill of materials will also have to be revised as an engineering action. Even one such
simple change could require 8 to 32 or more hours of engineering time (depending on
the project management and review systems in place for the SMRE manufacturer),
which, when realistically distributed into a normal work schedule in parallel with otherprojects, could require one to three weeks of real calendar time”. This is understood toillustrate the cost of needing to change the documentation of a part which no longer
needs to refer to a certain exemption, resulting in a net cost of 8-32 person hours,
which however could require up to 3 calendar weeks for implementation. If arequalification of the part is needed “to demonstrate there is no significant impact tocustomer processes. Such requalification projects can in, the best case, require manyweeks of planning an analysis and potentially tens of thousands of dollars in machine
time, employee time, and test work-piece costs.”
SEMI EUROPE (2021b) provides a table, listing parts it has identified that depend on
exemptions covered under the current study. The detailed table can be found in thecontribution. In summary, the number of parts specified in relation to each of the
exemptions under review is as follows:

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Table 5-1:

Estimation of the number of SMRE parts relying on specificexemptions listed in RoHS Annex III

Ex. No.

6a

6b

6c

7(a)

7(c)-I7(c)-II

No. of parts estimated

24

16

148

12

30

2

Source: SEMI EUROPE (2021b)

The Test and Measurement Coalition (Test & Measurement Coalition 2021) provide
similar argumentation. On the exemptions currently under review, TMC states “Weunderstand that certain exemption applications include uses relevant to category 9
industrial monitoring and control equipment […]industrial monitoring and control
producers have extended validity periods of their exemptions until 21 July 2024 due tothe complexity of our products; the scale of our portfolios; and the length and breadthof our supply chain. We would like reiterate the critical importance of Annex III
exemptions for category 9 industrial and to stress the need to retain each exemption
as originally published in both definition and expiry date for our sector […] The legally
established expiry dates for Category 9 industrial monitoring and control equipment
shall be respected in order to guarantee legal certainly and predictability and avoid
undesirable socioeconomic impacts. […] Questioning of the initial validity period of
RoHS exemptions could be envisaged only in case of proven scientific progress whichmakes earlier successful substitution possible for the specific product category.
Test & Measurement Coalition (2021) states that “any additional and unforeseen
disruption, such as premature shortening of exemption validity periods will be
extremely detrimental to our sector and will result in negative socio-economic impact.
Unforeseen workload will divert workforce from product development and slow down
innovation”. As for possible socio-economic impacts of such so-called prematurechange of the exemptions for sub-Cat. 9-industrial, TMC provides two examples,
explaining that both are considered to introduce additional risk to compliance with noperceivable benefit:Data management and Enterprise Resource Planning (ERP 16) Solution reengineering to segregate existing supplier declarations from those of the new
Exemption takes IT investment, time and 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;

TMC was asked to elaborate as to how RoHS exemptions are referred to in supplierdeclarations (declaration of conformity) in order to allow understanding what types ofchanges may require updates of such documentation. TMC (2021) explains:

16

In a later communication TMC (2021) explains ERP examples to be “offerings from Oracle, SAP, 3DX
Enovia, etc. Such tools are configured to manage all aspects of product configuration and engineering
information through to customer orders. For business in our sector, the complexities of both product andportfolio require the use of such solutions to manage our businesses. Data relating to part compliancestate links to any applied exemption numbering. Changes cause a massive IT effort to reconfigure andre-collect data. Justifiable for planned changes, unacceptable for changes triggered by other sectors thatshould not impact Industrial Cat 9 conformity”.
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European Commission
RoHS Exemptions Evaluation: Pack 22“EEE producers must decide whether exemptions stated by component producers areapplicable to the category of equipment they market. These must then be collectively“rolled-up” to cover all components on the EEE bill of materials to declare the relevant
Exemptions applied at the finished equipment level. Given the complexity of equipment produced by T&M Coalition members, this necessitates the use of ERP solutions
to manage such activities. Such solutions must be configured to recognize acceptableand valid exemptions as well as be capable of importing component data via international schema. There is a significant range of data on exemptions presented bycomponent manufacturers.
In many cases, it is simply an exemption number,Some provide the exemption description: Some describe if full, others only provide
selected text,

Next to no information is provided on applicability by sector or expiry date since
this is not the responsibility of the component producers,Some provide no statement at all on whether an exemption has been applied ornot, simply stating the component is “RoHS Compliant”,

Declarations provided at many different levels (part, family, business group,
corporation)“.

From their contribution it can be understood that Fresenius Kabi (2021) manufactures
instruments that fall under Cat. 8 and 9, of which at least some equipment would be
categorised as sub-Cat. 8 in-vitro or sub-Cat. 9 industrial. Fresenius does not refer tothe above aspect, but rather only specifies its support of the renewal of the various
exemptions requested. In a few cases, its contribution refers to exemptions that are
currently only available to Cat. 8, 9 and 11. In other cases, Fresenius refers to its
agreement to include Cat. 8 and 9 in the exemptions addressed but does not mention
aspects specific to sub-Cat. 8 in-vitro or sub-Cat. 9 industrial or Cat. 11.

5.2.

Course of action of the assessment in relation to sub-Cat. 8
in-vitro, sub-Cat. 9 industrial and Cat. 11

Assessing whether sub-Cat. 8 in-vitro, sub-Cat. 9 industrial and Cat. 11 should be
subject to this assessment and affected by its recommendations is beyond the
mandate of this study. Nonetheless, the consultant would like to raise a few points ofrelevance to this issue.
Recital 19 of the Directive requires exemptions to “be limited in their scope andduration”. To this end, over the years, the Oeko-Institut has sought to specify
exemptions as needed so that they reflect the current state of science and technology.
Along with this approach, considerations have also been included to merge exemptions
where it could be clarified that the scopes of certain exemptions overlap or whereparallel exemptions had been granted to similar applications of different technologies.
This for example led in past assessments to a recommendation to split the originalAnnex III Ex. 18b for lead as an activator in BSP (BaSi2O5:Pb) sun tanning lamps into
two items, one for sun-tanning lamps and one for medical therapy lamps. It was also
recommended at the time to consider merging these exemptions with Annex IV Ex. 34
when the latter was due for assessment.

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The consultant sees a benefit in merging exemptions or at least ensuring their proximity in the annexes through a mutual exemption number, when a similar technology
or application is addressed and where the justification of the exemption is based on
similar technical or scientific arguments. This approach increases the probability thatwhen one exemption is under assessment, it is also reviewed whether overlaps exist
with other exemptions that could create uncertainty in the implementation of the
Directive and in some cases also loop-holes. To this end, merging categories under
exemptions with a single expiration period is also considered to serve this purpose. It
is also noted that this approach can be in conflict with the aim to specify exemptions
in relation to specific applications. This is the case for some exemptions listed in the
Directive and addressing a material which is widely applied for different purposes. To
this end, where a specification and a narrowing of scope is sought, instead of merging
exemptions, a proximity in the location in the annex could be sought through listing ofspecific application areas as sub-items of a certain exemption.
The consultant sought advice from the European Commission on this aspect in orderto clarify whether to assess the exemptions for all categories or to exclude EEE wherelater dates apply. It was clarified that “the evaluation of all categories should be
combined in one evaluation procedure, to be oriented at the closest expiry date of thecategories it relates to”. For this purpose, where it was aware of stakeholders representing such categories, Oeko-Institut informed representatives of this approach andrequested information specific to their categories to try to get a broad picture of thestate of substitution for the various types of EEE. As a general approach, where
specific information was made available, this is relayed in the exemption specificreports and considered as in the assessment of the specific exemption. Where no
specific data was provided, these categories are included into general recommendations.

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6.

Exemption 6(a) & 6(a)-I:
Ex. 6(a) for “Lead as an alloying element in steel
for machining purposes and in galvanised steel
containing up to 0,35 % lead by weight”, andEx. 6(a)-I for „Lead as an alloying element insteel 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”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings ofstakeholders’ explanations and arguments have been adopted from the documents
provided by the stakeholders as far as required and reasonable in the context of theevaluation at hand. Formulations were only altered or completed in cases where it wasnecessary to maintain the readability and comprehensibility of the text. These sections
are based exclusively on information provided by applicants and stakeholders, unlessotherwise stated.
Acronyms and definitions
Bi

Bismuth

11SMn30

Lead-free cutting steel containing high sulphur and also manganese

11SMn37

Same as 11SMn30 but with a higher Mn content

CoRAP

Community Rolling Action Plan

CRM

Critical Raw Material

EEEElectrical and Electronic Equipment

EGGA

European General Galvanizers Association

EUROFER

European Steel Association

KEMI

Kemikalieninspektionen, Swedish Chemicals Agency

OEMoriginal equipment manufacturer

Pb

Lead

RoHS 2

Directive 2011/65/EU on the restriction of hazardous substances inelectrical and electronic equipment

SVHC

Substance of very high concern

TMC

Test and Measurement Coalition

UP

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6.1.

Background

Regarding the history of the exemption, following an assessment held in 2009,
exemption 6 was split into three exemptions 6a, 6b and 6c in order to cover steel,aluminium and copper alloy with a separate wording respectively. Exemption 6(a)covers different uses of lead: The use of lead added as an alloying element in steel formachining purposes and the presence of lead in galvanised steel. Ex. 6(a) was
reviewed in 2015/16 (Gensch et al. 2016). The split of Ex. 6(a) and 6(a)-I was theconsequence of specifying different thresholds for lead in galvanised steel components
for categories 1-7 and 10 on the one hand (Ex. 6(a)-I) and categories 8 and 9 on theother hand (remaining Ex. 6(a)) as detailed below.
The renewal of exemption 6(a) & 6(a)-I was applied for by the RoHS Umbrella
Industry Project (Umbrella Project 2020a), hereafter ‘the Umbrella Project’ or shortly
the ‘UP’. The Umbrella Project’s Working Group on Exemption 6(a) and 6(a)-I isrepresented by EUROFER (the European Steel Association) and EGGA (the European
General Galvanizers Association), who both applied individually for a renewal of
exemptions 6(a) and 6(a)-I in 2015/16. Röhm GmbH has also requested a renewal of
the exemption as explained below.
The UP’s application (Umbrella Project 2020a) covers Ex. 6(a) and Ex. 6(a)-I that bothallow the use of lead in steel for machining purposes and for lead in hot dip galvanised
steel. The difference between the two exemptions is the content of lead in batch hot
dip galvanised steel components and the applicability to different EEE categories.
Based on the current listing in annex III of the Directive:

6(a) ‘[…] galvanised steel containing up to 0,35 % lead by weight’,−

expires on 21 July 2021 for categories 8 and 9 other than in vitro diagnostic
medical devices and industrial monitoring and control instruments;−

on 21 July 2023 for category 8 in vitro diagnostic medical devices; and−on 21 July 2024 for category 9 industrial monitoring and control instruments,and for category 11.

6(a)-I ‘[…] galvanised steel components containing up to 0,2 % lead by weight’,−

expires on 21 July 2021 for categories 1-7 and 10.

The Umbrella Project (Umbrella Project 2020a) applies for a renewal of the exemptions
6(a) and 6(a)-I with regards to EEE categories 1-10. A second request addresses therenewal for Cat. 11 (Umbrella Project 2020b). The applicant proposes that all EEE
categories covered under Ex. 6(a) would be merged into Ex. 6(a)-I in the future (thencovering all EEE categories). The feasibility of this request in relation to Cat. 8 in-vitro
diagnostic medical devices, Cat. 9 industrial monitoring and control instruments andCat. 11 EEE is discussed in chapter 5.1 on the applicability of the Pack 22 exemption
conclusions and recommendations to these categories of EEE.
UP refers to the wording of Ex. 6(a)-I as the requested wording and requests the
maximum validity periods foreseen in the RoHS 2 Directive (which means 7 years forCat. 8 and Cat. 9 EEE and 5 years for all other categories).
The second applicant, Röhm GmbH, applies for exemption 6(a) (Röhm GmbH 2020).
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consultant has concluded that the application relates to Ex. 6(a)-I with regards to leadin steel for machining purposes. The applicant has not provided any alternative
wording for the exemption, however, lead in steel for hot dip galvanized steel is notaddressed by the Röhm application. The requested duration of the exemption is 5
years.
As the wording of the exemption refers to two different application areas, that is two
different groups of uses of lead, the following chapters are divided into two
subchapters referring each to one of these groups.

6.2.
6.2.1.

Leaded steel for machining purposes
Technical description for leaded steel for machining purposes

According to the applications and information provided by British Steel (2021) during
the stakeholder consultation, lead in steel provides a lubricant effect to the hostmaterial that results in a good chip crack performance, stability and smooth surface.
For machining processes, this allows a higher cutting speed, a higher stability (a lower
spindle stress) and a longer tool life. The steel is used in a ‘diverse range of final
applications within EEE including finished products and fixed installation of which an
exhaustive list is not feasible’, states the UP application. (Umbrella Project 2020a)
The different relevant types of low carbon steel where lead is used for machining
purposes are according to the Umbrella Project (2021c):

Free-cutting steel: the primary requirement is machinability. Such alloys are
typically used for manufacturing where part of the material is removed to obtainmachined parts. Therefore, besides lead, these steels also contain >0.1% sulphur
to enhance machining performance along with other elements such as, oxygen andphosphor. In 2018, 89% of the total supply of low carbon free-cutting steel of aEuropean steel manufacturer was the leaded version in contrast to the non-leaded
version;

Steel for quenching and tempering/ heat treatable steel: the primary
requirement is the ability to maintain or achieve a certain combination of
mechanical properties after thermal treatment, and ‘machinability is enhanced
primarily through the additions of low levels of sulphur (<0.1%) and, in somegrades, Ca, Bi or Pb. Typically, customers only require the highest levels ofmachinability (i.e., leaded variants) where particularly demanding machining
operations, such as high tolerance deep hole drilling, are undertaken’ (Umbrella
Project 2020a);Carburising steel is applied when high toughness parts with hard surfaces are
required. Machinability enhancers can be low levels of sulphur (<0.1%), Ca, Bi, Te
or Pb; as is the case for quenching and tempering steel, leaded variants are also
more common in use for carburising steel.

Low carbon steels are the most widely used steel grade. Amongst the low carbon
steels, free-cutting steels are the most common use scenario of leaded-steel alloys.
‘They are typically used for the manufacture of machined parts where the amount ofmaterial removed is high or machined tolerance specifications are demanding andwhere service conditions do not result in the application of high levels of stress’, states
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the UP (2021c). It is assumed that low carbon free-cutting steel is used in drill chucks
for power tools, however, this was not confirmed by Röhm GmbH (Röhm GmbH 2021)
despite being asked.
6.2.2.

Amount of lead used under the exemption for leaded steel formachining purposes

In 2020, Röhm GmbH placed ~ 1.2 tons of lead as an alloy in steel for machining
purposes on the market worldwide through their specific application, i.e. approx. 1.2
tons per year are placed on the global market (drill chucks, which are applied in power
tools of EEE category 6 (Röhm GmbH 2021).
Based on the input of the Umbrella Project, it is understood that 146 to 255 tons perannum of lead are placed on the market through all types of leaded steel applications
for machining purposes (all EEE categories, based on numbers from 2013). Thereof,
EEE (in addition to automotive applications) is only a part and the Umbrella Project
cannot specify the share of steel used in EEE compared to other applications.
(Umbrella Project 2020a)
6.2.3.

Applicants’ justification for the requested exemption for leaded
steel for machining purposes

This chapter provides the UP’s as well as Röhm GmbH’s justifications for the requested
exemption.
Substitution or elimination of leadWith regards to substitution, the UP refers to study results that were alreadypresented in the exemption’s review process in 2015/16. The application outlines theefforts taken by the EU steel industry with regards to alternatives to lead as
machinability enhancer in steels. Machinability enhancing additives (lead, bismuth,
increased sulfur, sulfuric tellurid, tin, phosphorus and calcium) were tested in threedifferent steels (11SMn30, C45 and 16MnCr5) in a project in the early 2000s(European Commission 2005). Reynolds et al. showed that ‘of the alternatives,
bismuth is able to substitute for lead under certain conditions, although the cost of theaddition may take it uneconomic, particularly for large-scale application. Calcium canalso substitute in C45 steels for use at higher cutting speeds. Steels containing tin
generally did not show good performance. The alternative grades generally showed
equivalent fatigue performance to the leaded grades’ 17. It is concluded that lead ispreferred due to higher production rates, reduced cutting forces, lower tool wear
rates, more finely broken chip morphology and improved surface finish. Bismuth being
the best available substitute so far does not show the same hot workability, or hot
ductility, which makes it only a theoretical substitute. The aspect of ‘hot workability’ ismost important according to the UP (2020a), e.g. to roll the steel. Details on thereliability of bismuth, calcium and sulphur as alternative machinability enhancing
additives are outlined by explaining the disadvantages of these substances.

17

Link specified in UP (2021c) as: https://op.europa.eu/en/publicationdetail/-/publication/6b46dd1c-594448d7-8c4c-e009d62ca1ba (last accessed on 13.08.2021)
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Röhm GmbH provides information on two different steel alternatives (11SMn30 &11SMn30-EM + C) that have been tested in 2019 (Röhm GmbH 2020). On the former
it was concluded that substitution would technically not be feasible with regards to therequired characteristics for the application of drill chucks. The latter shows sometechnical difficulties in tests (chip fracture behaviour, machine stability, life-time), but
the main concerns remain with regards to availability and reliability given that theapplicant claims to remain as last producer of the drill chucks in Europe. In a later
communication, Röhm explains that there is only one supplier on the market of thisalternative lead-free steel, the market acceptance with regards to product quality andprice is unclear. ‘If this supplier decide to stop the production or delivery problems
occur, we […] could not produce the needed volume if we switch to this source’ (RöhmGmbH 2021). It was also clarified that for performing the same process, a tool withcomponents from lead-free steel (in comparison with one with leaded-steel) needs
more rotations per minute, resulting in consumption of more energy, with impacts on
the lifetime of the tool and its components. Röhm GmbH specifies that more technicaltests must be carried out once the lead-free material reaches a comparable quality tothat of leaded steel and is available on the market from more than one supplier. When
asked as to the lead-free alternative 11SMn30-EM + C presented by Röhm GmbH, theUP states that it could not conclude as to its suitability due to a lack of information.
Since leaded steels are more expensive than non-leaded versions, according to UP,
the manufacturers of parts from steel use leaded steels only where it is economicallyfeasible and where ‘significant improvements in machining performance are required’.
(Umbrella Project 2021c)
Environmental arguments
The UP application considers environmental implications of bismuth by providing thefollowing references:


An LCA provided by the UP (referenced in UP (2020a) as Nuss and Eckelman(2014)) comparing cradle-to-gate impacts at the life cycle stages mining, purification, and refining of different metals is provided to support the argumentation
against bismuth in favour of lead. In all five categories evaluated, the impact ofbismuth was found higher than the impact of lead: Factors of higher impacts forbismuth are 10, 37, 14, 45, and 2 for Freshwater eutrophication [kgP-eq/kg],
cumulative energy demand [MJ-eq/kg], terrestrial acidification [kg SO2 eq/kg],
global warming potential [kg CO2 eq/kg] and human toxicity [CTUh/kg] 18,
respectively.

Furthermore, an LCA on environmental impacts of leaded and non-leaded low
carbon free-cutting steels including energy used during machining was provided as
an Annex to the application (Umbrella Project 2020c; Coleman et al. 2015). The
system boundaries include raw material extraction and production, steel manufacturing, component machining and electricity production. The study concludes

18

As to this impact category, Nuss and Eckelman write, that ‘while USEtox [the chosen method] isrecommended as the latest model for modeling human toxicity in LCA, metals are included only withinterim characterization factors with high uncertainties (several orders of magnitude). The results of
Figure 3d [human toxicity comparison] should therefore be treated as a first indication of potential
impacts to human toxicity.’
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RoHS Exemptions Evaluation: Pack 22that ‘for the part considered in the machining trials the global warming potential of
the final part was ~9% lower for the leaded steel compared to a non-leaded steel’.
Thus, in general, lead-free steels require less energy mainly in component
machining, no quantified conclusions can be drawn for steel objects that have notbeen tested.
The UP (Umbrella Project 2020c) concludes, that ‘since lead additions result in lower
cutting forces, the energy required to machine leaded steels should be lower than that
required to machine the equivalent steels without lead additions’. Thus, the effectdescribed by Coleman et al. (2015), lower energy consumption during machining
becomes especially relevant when a lot of steel has to be removed until a part ismanufactured.
Socioeconomic impacts
No specific information has been submitted on socio-economic effects of substitution
by Röhm GmbH or the Umbrella Project. As for general economic impacts, the UP
emphasizes that bismuth is considered one of the 30 critical raw materials which are
limited in supply (European Commission 2020a). ‘This is the main reason why bismuth
can’t replace lead for the whole global production of free-cutting steels and engineering steels with improved machinability’ (Umbrella Project 2021c). Moreover,bismuth is produced as a by-product of lead, ‘if the usage of lead were to decline in
the future, production rates of bismuth would be proportionately impacted.’ (Umbrella
Project 2020a)
6.2.4.

Stakeholder contributions

In total, eight individual contributions have been submitted during the consultation
period from 23 December 2020 to 03 March 2021.
Specifically in relation to exemption 6(a)/6(a)-I, British Steel has expressed its views:
British Steel supports the renewal of the exemption, as they “do not believe viable
alternatives exist that would provide up 75 % higher cutting speed and also assure
more than a 2 times higher tool life”. The consultants are unable to understand theapplicability of these numbers as it is unclear what is being compared to what. As tothe function of lead in steel, British Steel explains that ‘lead in steel provides a
lubrication function and aids machining and processing of steel reducing power
requirements during machining. This also allow up 73% higher cutting speed’. It is
expected that leaded steel is compared to non-leaded steel, however, no concrete
information as to this comparison is detailed by British Steel. ‘The use of lead in steel
promotes: 1. Lower energy costs and a reduction in CO2 emissions during machining,
2. Lower manufacturing cycle times, 3. Long machine tool life, 4. Improved surface
finish, 5. Promotes chip breaking during the machining process.’ (British Steel 2021)
Another seven contributions were submitted addressing all exemptions or the alloy
exemptions under assessment in this study.


The Federation of the Swiss Watch Industry FH (2021a) supports the UP’srequest for renewal of 6(a)/6(a)-I (as well as 6(b)-II and 6(c)). They explain theirview based on specific material requirements in watches. ‘The watch industry has
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already substituted a long time ago lead alloys in external watch components. Forinternal components of the watch movement, substitution is more challenging […]’
Projects exist as to the substitution of lead-containing internal brass components
of watches. For details of this specific application example, please refer to thecontribution provided by the Federation of the Swiss Watch Industry FH (2021a).
The Swedish Chemicals Agency KEMI (2021) addresses in a general comment
all alloy exemptions under review (6b, 6b-I, 6b-II, 6c) and also exemption 6(a)and 6(a)-I. KEMI claims that the exemptions should be adapted to the corresponding level of the REACH restriction entry 63 (for further information see section
4.1). Furthermore, KEMI states that the exemption formulation should specify boththe material or component and the specific applications. With regards to the hot
dip galvanisation, KEMI refers to a conflict of interests with regards to energy
savings by recycling of metals containing lead compared to the production of leadfree virgin metal on the one hand side, and placing hazardous substances (here:lead) on the market as long as recycling of the lead-containing metal continues. In
KEMI’s view, neither is preferred over the other, rather it is said that “one way to
get around this in the long run could be to recycle metals containing lead in one
loop while metals without lead is recycled in another loop so as not to contaminate
all recycled metals.’

The Norwegian Environment Agency (2021) expresses similar arguments to
the Swedish Chemicals Agency: Based on Recital (19) of the RoHS Directive(2011/65/EU) that ‘exemptions from restrictions for certain specific materials orcomponent should be limited in their scope’, it is put forward that ‘the material orcomponent and the specific application need to be defined in the description of an
exemption’. Thus, the exemptions should be ‘narrowed down to a scope’.



Test and Measurement Coalition (2021), see chapter 5.1



SEMI Europe (2021b), see chapter 5.1

Fresenius Kabi (2021), see chapter 5.1



The contribution of Huawei (Andrae 2020) consists of a paper of A. S. G. Andrae(2020) on the analysis of environmental implications of RoHS exemptions 4f, 6a,6b, 6c, 7a, 8b, 15(a), 15 and 34 of Annex III. As for leaded steel, the work
compares four proxies of environmental impact (e.g. abundance in earth’s crustand in the oceans) only to the point of the alloy composition. Impacts at other lifecycle stages or aspects such as e.g. different machining properties of the alloys are
not considered.

In addition, eighteen organisations have expressed their support of the request for
renewal of this exemption but did not provide any further detail: Arco Armaturenfabrik
Obrigheim KG; Swiss Steel Group (Swiss Steel AG, Steeltec GmbH and Steltec AG);
Trautwein Präzisionsdrehteile GmbH; Hacker-Feinmechanik; CARL DILLENIUS
METALLWAREN GmbH & Co. KG; STERO GmbH & Co. KG; HEINRICH MUELLER GMBH;
HUGO KARRENBERG & SOHN GMBH & CO. KG; Wilhelm Schauerte GmbH & Co. KG;
Julius Klinke GmbH & Co. KG; Carl Leipold GmbH; wafi Walter Fischer GmbH & Co.
KG; Heinrichs & Co. KG; Güntert Präzisionstechnik GmbH; Eisenhardt Metallteile
GmbH; Paul Weber GmbH & Co.KG; Maier GmbH & Co. KG Präzisionstechnik; Fischer
Automaten-Drehteile GmbH & Co. KG.

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6.2.5.

Critical Review for leaded steel for machining purposes

REACH compliance – Relation to the REACH Regulation
See section 4.1 for details.
Scientific and technical practicability of substitution
Based on the information provided through the two applications, possible alternatives
are a one-to-one substitution in the alloy composition of lead through bismuth, and ashift from leaded free-cutting steels to another type of free-cutting steel which is leadfree, i.e. 11SMn30-EM + C, at least for some applications which are however not
further detailed by providing e.g. examples.
Regarding other types of free cutting steel, the contribution of British Steel (2021) tothe stakeholder consultation supports a renewal of the exemption with regards to leadin steel for machining purposes. British Steel ‘does not believe 11SMn30-EM + C is a
viable alternative to leaded steel grades’, however there is no evidence provided tosupport this statement. British Steel states that they ‘routinely investigate improvements in steel making techniques including the use and alternatives to alloying
elements.’ No additional information was provided as to concrete activities, nor whenalternatives to lead as an alloying element could be expected on the market. The
consultant understands that a one-to-one substitution will not provide the mentioned
improvements with regards to phase-out of lead in steel for machining purposes as
British Steel also mentions that ‘all [alternative alloying elements] provide poorer
results in terms of benefits for machinability and tool wear’.
Regarding bismuth as substitute, the UP explained that in specific cases (which are notdetailed), bismuth could technically be used as a machinability enhancer: ‘Bismuth has
been able to substitute for lead under certain conditions, although the reduced hot
ductility and the increased cost of Bi additions may make it uneconomic’ (Umbrella
Project 2021c). The UP relativized the statement ‘that the applicant is aware ofexamples of successful substitution using bismuth and that those examples are only
hindered by economics.’ (Umbrella Project 2021j) by explaining that this was amisunderstanding, instead ‘there may be certain conditions under which the (downstream) machinability of bismuth steels in final application can be viable, but theadverse impacts of reduced hot ductility during the rolling processes carried out by the(upstream) steelmaker make the substitution by bismuth steels non-viable due tosignificantly lower material efficiency within the supply chain.’ (Umbrella Project2021j). To conclude, though the UP mentioned bismuth as a substitute for lead insteel. However, additional clarifications provided in September 2021 revealed thatbismuth technically has no potential at all for substituting lead due to upstream
technical needs regarding hot ductility in steel manufacture. Despite the fact that
substituting lead through bismuth is technically not practical, the UP still discusses
adverse environmental and socioeconomic impacts of bismuth.
In the earlier evaluation in 2015/16, various stakeholders provided insights on theirdevelopments towards lead-free steel, e.g. resulfurised steel by Nippon Steel and
Sumitomo Metal Corporation (NSSMC). At that time, NSSMC supplied material in the
Asian market, but not in Europe. It is assumed that this has not changed since they
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did not contribute during the current review of Ex. 6(a). In 2015/16, PennEngineering
stated that they had started to test rephosphorised and resulfurised lead-free freecutting steel in 2012 but did not reveal details of the technical changes in order toprotect the ‘significant investment in preparing for the eventual removal of RoHS
Exemption 6a’ (Gensch et al. 2016). PennEngineering (2021a) affirmed that they “nolonger use leaded steel for any product machined from steel bar. We no longer use
exemption 6a and would have no issue if it were not renewed.“ PennEngineering is amanufacturer of specialty fasteners. “The lead-free steel fasteners are made possible
by applying new materials, processes, and tool technologies without compromising
fastener quality and performance.” 19 PennEngineering did not reveal the identity of thesubstitute but pointed out that is not bismuth based (PennEngineering 2021b).
Besides the fact that very little information on possible substitutes for lead in steel formachining purposes was provided by the applicants or stakeholders, the consultant
identifies three main gaps and shortcomings:(1)
The applications did not specify any efforts to reduce lead levels in steels forcertain applications. Compared to the previous review for a renewal of this exemption
in 2015/16, the applicants did not show any new studies or projects to work towards
reducing or substituting lead. The progress of initiatives of lead-free steel by NSSMC
also remains unclear.
(2)
Additionally, the explanations and argumentation provided by the UP’s
application stay generic in nature. As Röhm GmbH only applies for a renewal of the
exemption for a very specific application, i.e. drill chucks, provided arguments relate
to this application of leaded steel specifically, in contrast to the UP’s application which
does not detail any information for specific applications.
(3)
The UP proposes bismuth as a substitute based on similar machining
performances in the machining of final steel parts (supply chain tier 2), however, also
explains that bismuth has no potential to technically substitute lead due to limitations
in hot ductility needed for the steel making (tier 1), esp. in rolling. In the opinion of
the consultant, this would suggest that industry does not continue to research bismuth
as a potential substitute.
The Swedish Chemicals Agency KEMI supported by the Norwegian Environment
Agency does not agree to the broad scope of the exemption: ‘Article 5 in the RoHS
directive (2011/65/EC) stipulates that exemptions can be included in Annexes III andIV for materials and components of EEE for specific applications. Our interpretation isthat both the material or component and the specific applications need to be definedin the description of an exemption. Otherwise, the need for an exemption cannot be
assessed.’ (KEMI 2021; Norwegian Environment Agency 2021)
In this review process, neither the applicants, and specifically the UP, nor any otherstakeholders provided enough information to allow concluding as to the developmentsof lead-free steels, roadmaps towards a reduction of lead, single applications wherelead could be substituted through bismuth or the like. In 2016, Gensch et al. concluded that machining companies might be the right stakeholders for providing more

19

https://www.pemnet.com/pennengineering-announces-expanded-lead-free-initiative-promotingenvironmental-sustainability-and-marketplace-objectives/#more-26274
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precise information. These supply machined parts to EEE manufacturers. Both, EEE
manufacturers 20 as well as machining companies 21, are members of the Umbrella
Project. Though this may explain why they did not participate in the stakeholder consultation separately, the consultant cannot identify any reflections of EEE manufacturers in this direction in the application. At this point of time, the consultant concludes
that there is not enough information available to be able to narrow down the scope ofthe exemption which is viewed as very wide.
The consultant sees the European Commission’s intention to monitor more closely
substances such as critical raw materials (CRMs), substances of very high concern(SVHC) in articles, and other listed substances, e.g. within the activities of theCommunity Rolling Action Plan (CoRAP). More explicitly, EEE manufacturers are
obliged from 05.01.2021 onwards to report to the SCIP database 22 if the application
contains substances from the REACH candidate list. In addition, original equipment
manufacturers (OEMs) are requested more and more to communicate along the supply
chain. It is assumed that this is also true for UP members. The consultant recommends that the applicants prepare a more detailed list as to their products (and theirlead content) based on such information which is expected to be available throughtheir supply chain communication activities in the future. Against the background thatthe scope of the exemption is viewed as very wide, based on the above-mentioned listof different applications, industry should be able to provide an overview in the future
in order to justify the broad scope or where this is not possible to provide sufficient
data for considering how the scope could be redefined according to the main areas ofuse. Otherwise it is not considered justifiable to keep the exemption’s wording withregards to leaded steel for machining purposes in the next evaluation.
However, for drill chucks for which Röhm GmbH requests the renewal of the exemption, the consultant recognizes the applicant’s concerns with regards to reliability andavailability of the potential substitute (11SMn30-EM + C). As to the reliability in combination with environmental arguments, the consultant understands from Röhm’s
justification that a power tool with components from lead-free steel needs more rotations per minute, thus more energy, with additional impacts on the lifetime of tool andits components. As no measurement data was provided the consultant cannot notverify this claim. As to the aspect of availability, see socio-economic implications
below.
Environmental arguments and socioeconomic impacts
Energy savings for machining leaded vs. non-leaded steal as well as generalenvironmental impacts of lead vs. bismuth (separately from steel) are the twoenvironmental aspects presented as relevant for this evaluation.

20

21

22

For example: ZVEI German Electrical and Electronic Manufacturers’ Association; EPTA European Power
Tool Association; NECA Nippon Electric Control Equipment Industries; Digital Europe; etc.
For example: EPCIA European Passive Components Industry Association; ESIA European Semiconductor
Industry under the legal entity of European Electronic Component Manufacturers Association; FIM
Fédération des Industries Méchaniques; WSM Wirtschaftsverband Stahl- und Metallverarbeitung e.V. etc.
Database for information on Substances of Concern In articles as such or in complex objects (Products)
established under the Waste Framework Directive; https://echa.europa.eu/en/scip
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The Umbrella Project (2020a) raises general environmental arguments, i.e. that ‘lower
energy consumption of machining leaded steels means that there is a potential benefitof reduced electricity consumption and CO2 emissions in fabrication’. This is supported
by LCA studies provided that deal with the comparison of the manufacture of a leaded
and non-leaded steel component (2015).
Nuss and Eckelman (2014) compare impacts of extraction and refining of different
metals, showing a preference for lead over bismuth in all of the evaluated impact
categories which was found the best substitute for some applications from atechnical perspective.

The study provided by Huawai (Andrae 2020) as a contribution to the stakeholder
consultation compares 11S30Mn (the most common type of free-cutting steel) with
0.35wt% Pb vs. 0.3wt% Bi with regards to cumulative energy demand, abundance
and two economic impact categories 23. Due to shortcomings in the description of
the methodology, it is difficult to follow Andrae’s conclusion: ‘the increase isinsignificant for energy demand and eco-cost but very high for relative resource
scarcity (abundance) and potential for future sustainable production (EPS).’ Bothreferences indicate a preference for lead over bismuth. However, no cradle-tograve LCA was provided that would have taken into account the end-of-life impacts
of products containing lead, e.g. impacts on human health from releases of lead in
the end-of-life, compared to non-toxic bismuth. As measures were deemed‘necessary to reduce the waste management problems associated with the heavy
metals’ (Recital 7, RoHS 2 2011), the end-of-life is considered an important lifephase for a comprehensive comparison. The consultant cannot conclude whether
the total negative environmental, health and consumer safety impacts caused bybismuth (higher at early life cycle stages compared to lead) are comparable to thetotal environmental, health and consumer safety impacts caused by lead (possibly
higher at end-of-life compared to bismuth) or not.

In relation to the critical raw material character, which has been acknowledged by theEC 24, the consultant understands this to refer mainly to the risk of future supply. Thisis concluded as the applicants did not raise particular environmental aspect that havebeen taken into consideration in the analysis performed to identify bismuth as a CRM.
The consultant considers the identification of bismuth as a CRM as a serious issue.
Nonetheless, the economic aspects that are understood to contribute to the categorisation of a material as having supply risks do not relate to the three main criteria of
Article 5(1)(a) but rather only to the secondary criteria of availability. The information
provided furthermore does not allow to assess the severity of this risk and how it
could affect the market in the future should bismuth be found beneficial as a substitute for lead in steel alloys in certain applications. In so far, the political relevance of
the identification of bismuth as a CRM is not further investigated as it is considered to23

24

Environmental Priority Strategy (EPS); Steen B. Calculation of monetary values of environmental
impacts from emissions and resource use—The case of using the EPS 2015d impact assessment method.
J Sustain Dev 2016; 9: 15. https://doi.org/10.5539/jsd.v9n6p15) & Endpoint modelling (Itsubo N,
Murakami K, Kuriyama K, Yoshida K, Tokimatsu K, Inaba A. Development of weighting factors for G20
countries—explore the difference in environmental awareness between developed and emerging
countries. Int J Life Cycle Assess 2018; 23: 2311-2326. https://doi.org/10.1007/s11367-015-0881-z)
See: https://ec.europa.eu/growth/sectors/raw-materials/specific-interest/critical_en
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be beyond the mandate of this review which is based on the Article 5(1)(a) criteria forjustifying exemptions.
Even though this cannot be brought forward as a main part of the argumentation, it isnoted, that the presence of lead in steel is known for a long time. ‘The steel industry
has in place the appropriate practice and processes to ensure that metals like lead arerecovered and made available for recycling and reuse’ (Umbrella Project 2020a).
Industrial emissions e.g. from steel manufacture are controlled through the corresponding legislation (Industry Emissions Directive), and it can be assumed thatworkers’ health measures are in place, at least in the EU.
As to the aspect of availability of the potential substitute (11SMn30-EM + C) provided
by Röhm GmbH, i.e. that there is only one supplier on the market, and market acceptance with regards to product quality and price is unclear, such arguments are notapplicable for justifying RoHS exemption evaluations according to the Article (5)(1)(a)criteria, i.e. the primary criteria. However, in addition to these primary criteria,‘decisions on the inclusion of materials and components of EEE in the lists in Annexes
III and IV and on the duration of any exemptions shall take into account the availability of substitutes and the socioeconomic impact of substitution.’ (RoHS 2 2011)
Information to conclude on the aspect of availability is only partially available. The
consultant wonders whether this substitute has limited availability due to low market
uptake, seeing as it is relatively unknown and the UP members could not provide any
information as to this steel (‘UP Exemption #6a WG Participants do not have enoughinformation on this alternative so far, so we cannot conclude if it can be used for all
specific applications’ (Umbrella Project 2021c)). The consultant recommends thatindustry consider this alternative steel and the identification of those applications
where it could be used in the next few years. Should this prove a viable alternative insome applications, it would not only allow reducing the total amount of lead used insteel alloys, but could also contribute to an increase in the demand for this materialand subsequently also in its supply in the future.
It should be noted, that it is not expected that a one-fits-all solution will be found forlead in steel alloys used in machined parts but rather that different substitutes can beapplied to different groups of applications which thus can be separated from eachother. A distinction between future substitute candidates and their range 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 of thelead alloy required for machining or different properties required for the operation of
the EEE component parts made of such alloys.
Scope of the Exemption
In steel, where it is used for machinability, lead is intentionally added to the alloy. In
machinability applications, the lead reduction potential is lower compared to hot dip
galvanisation. The consultant does not see a possibility to reduce the threshold withregards to lead in steel for machinability based on the information provided by the
Umbrella Project (see above), however, it is definitely necessary for the industry tosupport the exemption evaluation through close collaboration on identifying those
applications, sectors and EEE categories, for which this exemption is essentially

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needed. The example of PennEngineering shows that substitution is basically possible
but needs adaptations in machining processes and tools.
As the consultant does not see a possibility for narrowing down the scope of the
exemption in this evaluation, the consultant concludes that the exemption should only
be renewed to allow EEE manufacturers to compile the information in order to specify
the applications where they need leaded steel for machining purposes. In order to put
higher pressure on the members of the UP’s consortium for this collaboration, theconsultant concludes that an exemption for lead in steel for machining purposes
should only be granted for a short period of time.
6.2.6.

Conclusion for leaded steel for machining purposesWith regards to lead in steel for machining purposes, it is claimed that bismuth andother types of non-leaded machinability enhancers in steel are technically unsuitablein the majority of cases. However, no example was provided where substitution may
be technically possible. The consultant emphasizes that no progress at all has been
made compared to the last evaluation. Compared to the evaluation in 2015/16, hardly
any new information (e.g., pictures, statistics, etc.) have been presented to support
this claim. Furthermore, despite the fact that only at a late stage of the evaluation it
became clear that Bi technically has no potential to substitute lead due to its disadvantageous hot ductility, from the available information it is additionally not possible
to conclude as to the best environmental option when comparing the bismuth withlead. As to the type of non-leaded steel provided as an alternative by Röhm GmbH,
this type of steel is understood to have not been rejected for use in drill chucks from atechnical point of view (figures, statistics, etc., were not provided in this respect), butrather in light of availability concerns. The UP was not able to conclude as to thesuitability of this substitute. Substitution with bismuth may also be constrained from atechnical as well as an availability perspective due to bismuth being identified as a
critical raw material by the European Commission 25. The current formulation of the
exemption is considered to be too wide as it could be used both when substitutes areavailable as well as when they are not. The example of PennEngineering shows that
substitution is possible.
Nonetheless, stakeholders did not provide sufficient data to allow a reformulation. Thissituation is very similar to the state of the exemption in the last review performed in
2015/2016 by Oeko-Institute (Gensch et al. 2016).
Revoking the exemption is not considered pragmatic as it would de facto require atransition in a very short time and is likely to result in withdraw of products where
substitutes still need to be developed, where a design adjustments must be madeand/or where the availability of substitutes is not sufficient to allow a quick transitionof the whole EEE sector. Nonetheless the current Directive does not provide for alonger transition period. A short-termed exemption is therefore considered necessary.
Should industry fail to provide sufficient and relevant data in the next assessment,
than it would be recommended to withdraw the exemption, possibly allowing a longer
25

See “Fourth list of CRMs” published in 2020 in a European Commission communication on critical raw
materials, COM(2020) 474 final
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applying for new and specific exemptions. A short-termed exemption shall allow
industry to gather information as to lead content and EEE components that need theexemption for leaded steel for machinability purposes based on supply chain communication which is expected to exist anyway. This may include an analysis of the SCIP
Database. The consultant expects from an application for renewal for this exemptionthat it clearly elaborates the supply chain from sourcing of raw materials to machinedparts, and that the technical practicability and reliability of presented alternatives to
the RoHS substance is comprehensively discussed for the various steps of the supply
chain. Initial results provided by the industry working group or associations shalltrigger individual industry stakeholders, such as machining companies, to specificallycomment and complement the list of applications (see also the final conclusion andrecommendation, i.e. chapters 6.4 and 6.5, including expected tasks to be fulfilledduring this shortened extension of the exemption). In light of the information
presented during the evaluation of the exemption request in 2015/16, e.g. photos,
technical characteristics of steel components with different lead contents, moredetailed listing of different steel compositions etc., and seeing that the conclusion of
the evaluation report in 2016 states that ‘the current scope is not justified’ andsuggesting to ‘conduct a survey amongst EEE component manufacturers ‘in order tonarrow the scope of the exemption to a comprehensive list of applications’ (Gensch etal. 2016), it is crucial that data of relevance is provided which allows the consultant todraw evidence-based conclusions that are in line with the targets of the RoHS
Directive.
In the last evaluation, it was already recommended to split the exemption andseparate an item for lead in steel for machining purposes which was not followed by
the European Commission. The split is urgently recommended again because it would
allow to better focus on the substitution needs of relevant applications. For lead insteel for machining purposes, industry is urged to generate input that would allow
narrowing the scope of the exemption to a comprehensive list of applications.
6.2.7.

Recommendation for leaded steel for machining purposes

It is recommended to split the two applications covered by Exemption 6(a) and 6(a)-I.
It is further recommended in order to avoid future co-existence of several sub-itemswith slightly different scopes to align all categories in terms of the validity period,
seeing as stakeholders did not provide information to show that technical differences
exist between categories regarding the substitution of lead in steel. For further details
on this view, see chapter 6.5.
As for leaded steel for machining purposes, all EEE Categories should be covered by
an exemption item dedicated to this application group to be listed in the Directive inthe future:

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6(a)I

6.3.
6.3.1.

Exemption formulation

Duration

Lead as an alloying element in steel formachining purposes containing up to 0,35
% lead by weight

Expires on 21 July 2024 for all
categories

Hot dip galvanised steel
Technical description for hot dip galvanised steel

According to the applicant (Umbrella Project 2020a), components are batch galvanised
to provide highly durable corrosion protection, resistance to mechanical damage,increased durability allowing lighter steel sections, with another advantage (or ratherside effect) being recyclability within existing steel recycling circuits.
The galvanization process results in a zinc coating on iron and steel products byimmersion of the material in a bath of liquid zinc. Lead is present as an impurity
related to the use of recycled material and remelts of the entrained zinc from thegalvaniser’s ash for the baths of liquid zinc used in the galvanisation process. During
the galvanising reaction, zinc-iron alloys are formed on the surface of galvanised
products. Due to the low solubility of lead in the zinc-iron alloys, lead concentrations
within the coating on the product are typically half as much as the lead present in theprocess bath. The lead content of a coating depends on the steel type’s reactivity withmolten zinc, on the technical features of the plant (related to the age of the plant) andthe concrete galvanisation process. During recycling in electric arc furnaces, the zincin the steel volatilizes quickly compared to the steel core (RED STEEL 2018). The zincis collected, recycled and returned to zinc production.
Usually, primary zinc does not contain lead impurities (green arrows and Galvanising
Plant Situation B in Figure 6-1 below). The background for lead in galvanised steel isgenerally that:

in some case secondary zinc is used which often contains lead, e.g. zinc fromroofing includes leaded solders, and contributes to the contamination of thegalvanised layer; (Galvanising Plant Situation C in Figure 6-1)

in some cases lead is still contained in the galvanisation baths as a residue fromearlier batches, also leading to contamination; (Galvanising Plant Situation C in
Figure 6-1)

in other cases, clients ask for lead to be added to the baths to ensure high qualityof the coating through lead-initiated drainage of superfluous material. This is
typical for applications with small details in their geometry. (Galvanising Plant
Situation A in Figure 6-1)

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Figure 6-1:

Flows of Pb-containing materials from different sources andhow they are combined in the recycling industry

Abbreviations: SHG = Special High Grade
Source: EGGA (19.08.21) on behalf of the UP

Lead has no beneficial (or adverse) effect on the coated product but influences thegalvanization as such: As indicated, it has a positive effect on the drainage of coating
material which is especially good in the case of complex geometries where adverse
surface finishes can be avoided through a lead-mediated drainage. It can beunderstood that mainly, the batch galvanised non-EEE components profit from thiseffect. Thus the UP still claims that at present, some plants intentionally add lead tothe zinc bath for improvement of drainage of the coating of the galvanised product‘which is rapidly declining due to technical innovation’ (Umbrella Project 2020a).
Presenting an exhaustive list of applications is not feasible; components include
brackets, fixings, fasteners, ancillary items but also large structural steelwork of up to
25m length and ‘lighting units that require high levels of durability in outdoor andaggressive environments’. A total of 7 million tonnes of steel is batch galvanized inEurope, the volume of components in the scope of RoHS and ELV ‘is extremely small’.
(Umbrella Project 2020a)
Asked as to the use of batch galvanised components in EEE Categories 8 and 9, the UP(2021f) explains that ‘no detailed information is available on the use of batch galvanized steel in these applications. However, it is highly probable that batch galvanizedsteel is not used in Category 8 uses (medical devices). It is possible that batch
galvanized steel is used for fasteners, brackets and support structures in industrial
monitoring equipment which falls in Category 9.’

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6.3.2.

Amount of lead used under the exemption for hot dip
galvanised steel

For batch galvanised steel, ‘the amount of Pb metal used intentionally for applicationsin the scope of WEEE/ROHS is estimated to be less than 1 tonne p.a.’ (Umbrella
Project 2020a). Being asked as to what ‘used intentionally for applications in scope of
WEEE/RoHS’ means, the UP clarified that less than 1 annual ton of lead is intentionallyadded to the galvanisers melts (Umbrella Project 2021f). In contrast, for lead entering
the markets from recycled zinc sources, the UP estimates ~ 0.4 ton/year 26.
6.3.3.

Applicant’s justification for the requested exemption for lead in
hot dip galvanised steel

It is noted that lead in hot dip galvanized steel is in scope of the Umbrella Project’s
application but not in scope of the Röhm application. This chapter thus only
summarises the UP’s justification for the requested exemption.
Substitution or elimination of lead
Substitution of lead in zinc originating from recycled zinc is not applicable. The UP(2020a) states that the intentional use of lead is now limited to a narrow set ofprocesses. Research on ‘new zinc-based alloys for general galvanising’ is ongoing.
Asked to specify these processes, the UP (2021c) states: ‘The processes are those
operated by galvanizing plants that would process, on a sub-contract basis, EEE
products for which the technical features are required (e.g. complex parts requiring
fluidity). These plants will not only be processing these EEE products and for trade andopen competition reasons the processing of EEE should not be restricted to specificgalvanizing plants. Hence, the separate processes are not identifiable as such.’
Additionally, it is explained (Umbrella Project 2021f) that ‘batch galvanising plants willserve a wide range of customers that will send a wide range of steel products to begalvanised’. Compared to components for construction, engineering, agriculture, andrenewable energy, EEE only have a ‘small proportion of the overall work’. From thefact that ‘there remain a small number of plants for which substitutes or omissions oflead additions are not feasible based on their typical work mix’, it is understood thatcertain batch galvanizing plants are specialised in producing galvanizing products withcomplex geometry. In contrast, ‘most plants will have lower demands on fluidity andhave therefore been able to switch to alternative approach or substitutes.’ (Umbrella
Project 2021f)
According to the UP (2020a), the galvanisation sector is an important user of meltsfrom recycled zinc e.g. from roofing applications with Pb-containing solders andgalvanizers’ ashes. However, ‘customer-driven requirement for lower lead levels inmarkets outside EEE/ELV and the occasionally higher price of lead than zinc (affecting
intentional use)’ are factors reducing the lead in galvanised coating. In the long term,

26This is based on the assumptions that ‘2000 tonnes of steel EEE products galvanized in plants using thehighest typical level of Pb in the bath of 0.7% arising from inputs of recycled zinc to the bath; Pb
retained in the coating is ~50% of the bath concentration; and Zinc pick-up on the steel is 6% of steel
weight (2000 x 0.06)x 0.0035 = 410kg)’ Umbrella Project (2021f)
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30-50 years due to the lifetime of products going into recycling, lead in recycled zinc
will be diluted.
Asked whether the Pb amount in the exemption formulation could be lowered, UP
states that ‘the European secondary zinc industry may be able to reduce the Pb levels
in recycled zinc available to batch galvanising industry by channelling recycled zincwith high Pb levels into sectors where the technical demand for Pb-containing zincremains.’ And further: ‘The reductions compared to 2016 levels may as high as 25%
although its impact on the exemption threshold is not directly transposed in the same
proportions’. (Umbrella Project 2020a; 2021c) As to the reductions of lead introduced
into the galvanisation bath by remelts from galvanizers’ ashes, the UP explains that‘lead accumulates at the base of the galvanizing bath and takes many years (5-7
years and sometimes longer) to be lowered to de minimums levels after additions
have been terminated.’ (Umbrella Project 2021f)
To sum up the justification provided, the UP states that ‘whilst the primary justification
for the exemption is the need to avoid disruption to established recycling loops, there
remain a small number of plants that require the intentional additions of lead to thegalvanizing bath for technical reasons’. (Umbrella Project 2021f)
Environmental arguments
The UP argues that the use of recycled / secondary zinc is more energy efficient thanthe use of primary zinc, and that there is no technique available to separate Pb in /from the zinc melt of recycled zinc, rather the applicant expects a dilution of Pb overtime. Thus, no benefit was identified for changing the existing practice for galvanisation. (Umbrella Project 2020a)
Socioeconomic impacts
UP does not specifically refer to socio-economic effects of substitution.
However, when asked as to their view on amending the exemption in a way that aims
at the maintenance of established recycling loops (from secondary zinc as well as
remelts) but excluding intentional use of lead for increased fluidity, the UP strongly
disagrees: if plants intentionally adding lead for processing non-EEE components ofcomplex geometry were precluded from the processing of EEE, this would lead tomarket distortion and/or increased transport distances (Umbrella Project 2021f).
6.3.4.

Stakeholder contributions

See chapter 6.2.4
6.3.5.

Critical review for hot dip galvanised steel

REACH compliance – Relation to the REACH Regulation
See section 4.1 for details.

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Scientific and technical practicability of substitution
Lead is both intentionally and unintentionally present in galvanisation processes where
it is introduced through recycled zinc in the latter case. As indicated (chapter 6.3.2),
the Umbrella Project estimates ~ 1 annual ton and ~ 0.4 ton / year for intentional andunintentional addition of lead, respectively.
Small amounts of lead in the melt are not disadvantageous from a technical point ofview, the exceeding coating material can run off better due to the lubricating effect of
Pb. Therefore, there is no interest of the galvanisers in the substitution of lead in themelts nor in separation of leaded and non-intentionally leaded zinc recycling streams.
Batch galvanising plants that do not use recycled zinc in their input material, or that
do not process components of complex geometry ‘would comply with the [RoHS]
default requirements’. It is understood that this refers to a content of lead below 0.1%
by weight which is the maximum concentration value tolerated by weight in homogeneous materials for restricted substances in Annex II RoHS Directive (Umbrella
Project 2020a). It can be concluded that it is not technically useful to substitute thelead in hot dip galvanised steel, additional considerations relate to environmental
aspects.
Asked whether the Pb amount in the exemption formulation could be lowered, theargumentation of the UP does not provide a specific answer to this question, rather
the explanation can be understood as a suggestion to remain with the current 0.2 %threshold. The available information does not support that lowering of the Pb threshold in Ex. 6(a)-I would be feasible at this time.
Environmental arguments and socioeconomic impacts
Material flows for supply and recycling of zinc in galvanisation are detailed in Figure
6-1.
It is understood that the unintentional introduction of lead is merely a result of leadoriginating from lead solders in zinc roofing and remelts from galvanisers’ ashes, thus,
being present in the secondary zinc. Already mentioned by KEMI (2021), there is a
conflict of interests whether to save energy through the use of recycled zinc containing
lead or whether to reduce the presence of lead in products using virgin material at thesame time taking into account high energy consumption during the production ofvirgin material. The consultant agrees on the existence of the above-mentioned
conflict of interest. However, there is the potential that the intentional additions oflead may be reduced, and that concentrations may decrease over time as the less leadis introduced by recycled zinc the further it is diluted. Thus, the consultant can follow
the argumentation that the recycling of zinc scrap and its reuse is a positive practice,as it enables a reuse of resources. This opinion hasn’t changed since the evaluation of
the exemption in 2016 (Gensch et al. 2016).
However, some plants remain with the practice of intentionally adding lead ascomponents of complex geometry are part of their typical work mix. It is understoodthat the majority of such components is from non-EEE sectors. The consultants
acknowledge that amending the exemption in a way that aims at the maintenance of
established recycling loops (from secondary zinc as well as remelts) but excluding
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intentional use of lead for increased fluidity could result in ‘market distortion’ which
was brought forward by the Umbrella Project (2021f). Not extending the exemption
for intentional use of lead in galvanising processes would mean that the EEE clients
could only make orders with galvanisers that do not intentionally add lead whenmanufacturing parts for other than EEE clients. There is no information on the numberof such plants. Given that EEE parts are understood to represent a very small share of
the galvanised part market, it is assumed that the EEE sector would have little
influence over galvanisers. It is unclear if the number of galvanisers willing to commit
to no longer adding lead would have future impacts on the EEE sector or not. It is
however assumed that galvanisers that deal with components for EEE as a small partof their mix, would not be willing to “sacrifice” clients from other sectors that have alarger market share as this could affect their viability. In addition, the consultant
considers ‘increased transport distances’ possible ‘if these plants were precluded fromthe processing of EEE’. (Umbrella Project 2021f)
However, the UP (2021c) states that the secondary zinc industry could already achieve
lower lead concentrations today, although exact concentrations are not known. UP
adds that ‘higher Pb-containing recycled zinc may be channelled to other sectors
where the technical demand for Pb-containing zinc remains.’ (Umbrella Project 2021c)
This is in line with KEMI’s proposal ‘to recycle metals containing lead in one loop while
metals without lead is recycled in another loop so as not to contaminate all recycled
metals’ (KEMI 2021).
If the amounts of lead intentionally added were lower, or if zinc ashes from galvanisation plants intentionally adding lead were treated/recycled separately from the ashes
from plants that do not add lead intentionally, it could be assumed that the amount oflead in recycled zinc decreases over time when zinc scrap that no longer contains lead
will also be recycled. However, as this is currently not the case, ‘dilution is not yet inevidence’ (Umbrella Project 2021c). In the view of the consultant, a separation ofleaded and non-leaded material streams should be envisaged for both unintentional
and intentional presence of lead in galvanised steel, to determine e.g. whether it ispossible for EEE manufacturers to avoid galvanisers that still add Pb purposefully andbased on the portfolio of galvanisers intentionally adding lead identifying the share of
EEE components amongst their typical work mix of those galvanisers (seerecommendations listed in the conclusion for hot dip galvanised steel, chapter 6.3.6).
Scope of the Exemption
The UP was asked whether in analogy to exemption 6(b)-I, an alternative wording for6(a)-II could be used: “lead as an alloying element in galvanized steel containing up
to 0,2 % lead by weight, provided it stems from lead-bearing zinc scrap recycling”.
The UP strongly disagrees: if plants intentionally adding lead for processing non-EEE
components of complex geometry were precluded from the processing of EEE, thiswould lead to ‘market distortion and/or increased transport distances’ (Umbrella
Project 2021f). From the perspective of an EEE manufacturer who needs a supply of
hot dip galvanised steel parts, the availability of galvanisers operating lead-free islimited. In most cases, the parts will be galvanised in baths, that use secondary zinc(from scrap or galvanisers’ ashes). In some cases, e.g. due to proximity to the manufacturing plant, galvanisation of EEE components will take place in baths where lead is
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intentionally added. For those galvanisers intentionally adding lead, EEE components
represent a small part of their work mix. Therefore, as long as galvanisers do not haveto substitute or reduce lead for steel parts from non-EEE sectors, EEE manufacturers
will not have a high economic power to push towards lead reductions. It is concluded
with regards to the scope of the exemption for lead in batch galvanised steel, that theintentional addition of lead to the melt should not be treated differently than unintentional presence of lead for the time being.
When asked if Cat. 8 and Cat. 9 EEE covered under Ex. 6(a) until July 2021 shouldbe merged into Ex. 6(a)-I in the future, the UP replied that ‘all EEE Categories andsubcategories covered under Ex. 6(a) would be merged into Ex. 6(a)-I in the future[…]’ with the following proposed wording for all EEE categories and subcategories‘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’. This would effectively reduce lead as an alloying element ingalvanized steel from 0.35 % to 0.2% for Cat. 8, Cat.9 and Cat. 11. However, it isassumed that based on UP (2021f) hot dip galvanised steel parts do not play any rolein Cat. 8 and a minor role in Cat. 9. COCIR, an association with members producing
Cat. 8 devices is part of the Umbrella Project, thus of the applicant consortium which
apply for the renewal of the exemption. Furthermore, the supplies for Cat. 8 and Cat.
9 devices are expected to be the same supply as for the other EEE Categories. Thus, if
the market is ready to supply galvanised steel with a max. of 0.2% of lead, thismaterial should be usable for Cat. 8 and Cat. 9.
Argumentation that a reduction of the threshold would not be feasible for Cat. 8 orCat. 9 EEE has also not been included in the submissions to the stakeholder consultation nor raised as a technical argument by stakeholders.
6.3.6.

Conclusion for hot dip galvanised steel

It is understood that there are two cases for the presence of lead. In some plants,
lead is present in the galvanisation baths due to the use of recycled zinc or galvanisers’ ashes as it precipitates from secondary zinc added to the process. There areother cases where lead may be added to facilitate the galvanising process of certain
parts (for example steel mesh used for construction) which has rather limited relevance for EEE parts. However, the galvanisation of parts for EEE is performed in thesame baths. This is because for EEE component manufacturers, it is not a decision
criterion whom they commission their orders to, i.e., whether the galvaniser uses leadintentionally or not. In both cases, the presence of lead in some cases cannot be
excluded, but lead is understood not to serve a functional purpose in the galvanisationof steel parts for EEE.
From the available information it is concluded that substituting the lead originatingfrom recycled zinc is not intended due to the benefits of using secondary raw material,
and that the demarcation between galvanisers using recycled zinc and thosegalvanisers adding lead intentionally, i.e. to avoid the latter, is not practical. In
galvanisation, the EEE segment is too small compared to other sectors, in order totrigger lead reduction or substitution for non-EEE components in galvanisation
processes where lead is intentionally added.
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In the 2015/16 evaluation, it was concluded that ‘that the lead is mostly not intentionally added (or not added for intentions of relevance to the EEE part properties)[…]. The intentional addition of lead to a galvanizing bath where it is technicallyrequired could not be separated for EEE specific processes or products, which are
understood to have only a small share of all galvanised parts’ (Gensch et al. 2016).
Based on the provided input, the situation has not really changed. Surveying EGGA’smembers as to their actual contents of lead in the galvanization baths and on thesurface of galvanized parts, would have been desirable, as an option of how industry
would have been able to justify the exemption comprehensively.
The only way to remove lead from WEEE containing galvanised steel, i.e. remove therisk of lead contamination, would be to commission EEE parts only to those operatorsthat neither use lead intentionally nor use recycled content, and are thus lead free.
Based on the available information it is not possible to conclude if such operators exist
nor if there are enough operators that do not add lead intentionally, for the exemption
to be able to expire. This should be investigated by industry until the next review.
For the next evaluation of the exemption for lead in hot dip galvanization, industry is
recommended to:provide measurement data as to the content of lead in different types ofgalvanisation plants;clarify to which extent Pb levels could be lowered when lead-containing recycled
zinc would be channelled into those loops that have higher needs to takeadvantage of the Pb in recycled zinc;clarify under which circumstances, it would be possible for EEE manufacturers to
avoid galvanizers that still add Pb purposefully;carry out an analysis of the portfolio of galvanisers intentionally adding lead, i.e.
identifying the share of EEE components amongst the typical work mix of thosegalvanisers;

clarify if the use of galvanised steel is evenly distributed between the EEE
categories or if only certain categories need the exemption; and

describe in detail the efforts made to reduce the use of lead in galvanisation.

This would additionally contribute to be able to exclude consumer products from theexemption which is in line with REACH restriction entry 63 which specifies among
other things that, under certain circumstances, lead and its compounds shall not be
placed on the market or used in articles supplied to the general public.
6.3.7.

Recommendation for hot dip galvanised steel

It is recommended to split the two applications covered by Exemption 6(a) and 6(a)-I.
It is further recommended in order to avoid future co-existence of several sub-itemswith slightly different scopes to align all categories in terms of the validity period,
seeing as stakeholders did not provide information to show that technical differences
existed between categories regarding the substitution of lead in steel. For further
explanation, see chapter 6.5.

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As for hot dip galvanised steel, all EEE Categories should be covered by adding a new
exemption item to RoHS Annex III:

6(a)II

6.4.

Exemption formulation

Duration

Lead in batch hot dip galvanised steel
components containing up to 0,2 % lead byweightExpires on 21 July 2026 for all
categories

Final conclusions

Article 5(1)(a) 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 isscientifically or technically impracticable;

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 andconsumer safety benefits thereof.

Applying these criteria to lead in steel for machining purposes, it is concluded thatpossible alternatives are a shift from leaded free-cutting steels to another type of freecutting steel which is lead-free, 11SMn30-EM + C, at least for some applications whichhave not been detailed by the applicant. E.g. PennEngineering completed substitution
in specialty fastener (PennEngineering 2021a; 2021b).
There remain applications for which substitution is claimed not to be technicallypracticable or reliable. A one-to-one substitution in the alloy composition of leadthrough bismuth was excluded due to technical impracticability.
As almost the same conclusion was drawn in the last assessment, a renewal of the
exemption should only be granted for a very short duration in order to clarify theseremaining applications. A future application for a renewal of the exemption should beapplication specific.
As to lead in batch galvanised steel, the presence of lead is both intentional andnon-intentional; it is unclear if avoidance of galvanisers intentionally adding lead islogistically practical. From an environmental point of view, seeing that secondary zincfrom zinc scrap and galvanisers’ ashes is one of the main sources of lead, andadditionally seeing that distinguishing those cases where lead is intentionally present
is not practical, the use of secondary material should be preferred.
In both applications of lead in steel, no progress has been presented, neither data has
been gathered as to derive a roadmap and present a way forward. As already done in

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the 2015/2016 assessment of the exemption, this review also recommends differentiating between the two uses of lead in steel. The two uses differ in the direction ofsubstitution or reduction efforts. For lead in steel for machining purposes, narrowing
the scope of the exemption to a comprehensive list of applications should be the next
step. For lead in hot dip galvanized steel, the possibility to manage material streams
and recycling loops is understood to allow a phase out of the exemption.
As long as both uses of lead in steel remain under one exemption, it is also likely thatless information per application is presented in future exemption requests.
When asked for a split in two entries, UP makes clear their interest in the numberingof the new exemptions: ‘In principle, our response to a similar proposal in 2015/16
remains the same. This may create unnecessary complexity to established supply
chain compliance systems’ (Umbrella Project 2021f). The consultant can follow that a
split of the exemption could result in an administrative burden not related to actual
environmental benefit. Nonetheless, the consultant interprets recital 19 27 to mean thatthe scope of an exemption should be developed in relation to a confied group of applications for which the justification and allowed thresholds for the substance from RoHS
Annex II is the same. Moreover, in light of the current RoHS Directive’s review andpossible consequenses thereof for overall legal structureing and text, the consultant
points out that most likely, industry will need to adapt their supply chain compliancesystems in the near-future in any case.
For each of these application groups a different strategy is proposed:

For the case of lead in steel for machining purposes, it would be beneficial toformulate an exemption in relation to (remaining) applications where substitution
has not yet been accomplished.

A future exemption on batch hot dip galvanised steel should consider whether theconcentration of lead has decreased, whether reorganisation of material flows ofrecycled zinc is practical, and whether the exemption threshold limit can belowered accordingly.

A split of the exemption according to these two uses is strongly recommended.

6.5.

Final recommendation

It is recommended to grant the exemption with the formulation specified below.

27‘Exemptions from the restriction for certain specific materials or components should be limited in theirscope and duration, in order to achieve a gradual phase-out of hazardous substances in EEE, given thatthe use of those substances in such applications should become avoidable.’ RoHS 2 (2011).
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Exemption formulation

Duration6(a): Lead as an alloying element
in steel for machining purposescontaining up to 0,35 % lead byweight and in galvanized steel
containing up to 0,35 % lead byweight— 21 July 2023 for category 8 in vitro
diagnostic medical devices;6(a)-I: Lead as an alloying element
in steel for machining purposescontaining up to 0,35 % lead byweightExpires on 21 July 2024 for all categories

6(a)-II: Lead in batch hot dip
galvanised steel components
containing up to 0,2 % lead byweightExpires on 21 July 2026 for all categories— 21 July 2024 for category 9 industrial
monitoring and control instruments, and for
category 11.

While for most categories exemption 6(a) is set to expire on 21 July 2021, for category 8 in vitro diagnostic medical devices it is valid until 21 July 2023, and for category 9 industrial monitoring and control instruments and category 11 EEE on 21 July
2024. As explained in Section 5, the applicability of these recommendations to EEE in
categories which benefit from the validity of Ex. 6(a) beyond July 2021 is not completely clear from a legal perspective. To avoid future co-existence of several subitems with slightly different scopes it is recommended to align all categories in termsof the validity period, seeing as stakeholders did not provide information to show thattechnical differences existed between categories regarding the substitution of lead insteel. This will be more pragmatic for market surveillance and will with time lower theadministrative burden of stakeholders and the European Commission with regards torenewed exemption requests for the coexisting exemptions.
To furthermore ensure that RoHS provides a similar level of environment and healthprotection as that of the REACH Regulation, and with entry 63 of Annex XVII in mind,
it is recommended to add the following phrase for precautionary reasons to the
exemption wording: “The exemption shall not be applicable to articles or accessible
parts of an article that may be placed in the mouth by children; if it is smaller than 5
cm in one dimension or has a detachable or protruding part of that size, except where
it can be demonstrated that the rate of lead release from the accessible component/part, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent
to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that
this release rate is not exceeded for a period of at least two years of normal orreasonably foreseeable conditions of use of the article”. Alternatively, this addition
could be added as a footnote to the exemption.

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7.

Exemptions 6(b) and 6(b)-I:
Ex. 6(b) for “Lead as an alloying element inaluminium containing up to 0,4 % lead byweight”; and Ex. 6(b)-I for “Lead as an alloying
element in aluminium containing up to 0,4 % leadby weight, provided it stems from lead-bearingaluminium scrap recycling”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings of stakeholders’ explanations and arguments have been adopted from the documents provided
by the stakeholders as far as required and reasonable in the context of the evaluation
at hand. Formulations were only altered or completed in cases where it was necessary
to maintain the readability and comprehensibility of the text. These sections are based
exclusively on information provided by applicants and stakeholders, unless otherwise
stated.
Acronyms and definitions
Al

AluminiumCat.

Category (referring to the EEE Categories outlined in Annex

CLPClassification, Labelling and Packaging

EEE

Electrical and Electronic Equipment

Pb

Lead

RoHS

Directive 2011/65/EU on the Restriction of Hazardous Substances inElectrical and Electronic Equipment

UP

Umbrella Project

RoHS 2

Directive 2011/65/EU on the restriction of hazardous substances inelectrical and electronic equipment

SVHC

Substance of very high concern

7.1.

BackgroundTwo applicants, EU Aluminium and the “RoHS Umbrella Industry Project” (hereafterreferred to as “Umbrella Project” or “UP”) represented by COCIR, HARTING Stiftung &Co and Pepperl + Fuchs AG, have submitted requests for the renewal of the abovementioned exemptions. A renewal of exemption 6(b)-I is requested by both applicants; in addition, the Umbrella Project applies for a renewal of exemption 6(b). (EUAluminium 2019; Umbrella Project 2020c; 2020d)

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Exemption 6(b) has been reformulated following its last assessment in 2015/2016(Gensch et al. 2016), which resulted in a split of 6(b)-I and 6(b)-II differentiating
between applications of aluminium alloys where lead is unintentionally present(casting alloys under 6(b)-I) and applications where lead provides necessary properties (wrought alloys under 6(b)-II). Applications that use casting alloys have a higher
tolerance for alloying elements than wrought alloys, i.e. the alloys can contain higher
concentration of the alloying element (with alloy content up to 20% by weight)(Paraskevas et al. 2013). 28 Exemption 6(b), however is still valid for categories 8 and
9 until July 2021 and will remain valid afterwards for category 8 in vitro diagnostic
medical devices (21 July 2023), for category 9 industrial monitoring and control
instruments and for category 11 (21 July 2024).
Exemption 6(b) covers the two main application areas of exemption 6(b)-I and
exemption 6(b)-II. Therefore, the request for renewal of Ex 6(b) is considered in thecourse of the assessments of exemption 6(b)-I (this chapter) and exemption 6(b)-II(see chapter 8), but is not reported on its own. This is related among others to thecategories for which the applicants apply for the renewal and the recommendation tomerge all categories under one exemption as far as possible.
The review therefore focuses on 6(b)-I.
EU Aluminium requests exemption 6(b)-I to be renewed for 5 years for all EEE
categories, however, proposing to narrow the scope by lowering the allowance for Pb
given in the exemptions to 0.3% lead by weight, and to casting alloys. The UP
requests the renewal of the exemption with the current wording for the maximum
validity periods foreseen in the RoHS 2 Directive (which means 7 years for Cat. 8 andCat. 9 EEE and 5 years for all other categories). UP initially submitted the request for
renewal for Cat. 1-10 in January 2019. In October 2020 a very similar request was
submitted for Cat. 11 as well.

7.2.

Technical description of the requested exemption

This exemption covers applications of aluminium alloys where lead is unintentionallypresent. This is the case for casting alloys 29 where lead is present due to the use of
secondary raw material from aluminium scrap. ‘Due to the longevity of aluminium
products and higher lead limits in the past, different amounts of lead are embedded in
the scrap.’ (EU Aluminium 2021a).
In order to produce aluminium cast alloy components, different basic alloys are melted
together with recycled aluminium. The properties of the casting alloy can be controlled
by adding elements such as copper, silicium or manganese to the melt. There arevarious casting processes through which the components of interest can be produced.
The finished parts are no longer machined to the extent that would require additives

28

29

For an overview on the recycling circuits, see Figure 8-1: Recycling circuits in aluminium recycling insection 8.5.2.
The term cast alloy refers to alloys that are melted in a furnace and poured (or casted) into a mould andallowed to cool. In contrast, the term wrought alloy is used when the alloy is worked in the solid form.
This can be done by applying various machining processes with the help of specific tools like stamping,bending, rolling, extrusion, etc. These manufacturing processes yield materials with different properties.
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for enhancing machinability. Thus, the use of lead (often used as a machinability
enhancer) can be avoided in the case of casting alloys.
Relevant applications in which such alloys are used include e.g. frameworks of lamps
and lights, heat sinks, electrical and electronic items in housing etc. (EU Aluminium
2019, p.5). The UP provides a non-exhaustive long list of applications: “Recycled
aluminium is used to make castings which have a wide variety of uses in all types of
EEE. For example, the production of pinons, gears for chains, various machinerycomponents, lawnmowers, brush cutters, lawn trimmers, scarifies and hedge
trimmers, combustion engines, garden and outdoor equipment, petrol chainsaw,
power cutters, pistons, flywheel, cylinders, medical devices (e.g. MRI and CT
scanners), monitoring and control instruments, frameworks of lamps and lights, heatsinks, electrical and electronic items in housing and industries etc.” (Umbrella Project
2020c, p. 7)
7.2.1.

Amount of lead in aluminium from lead-bearing Al scrap
recycling used under the exemption

The share of recycled Al from all Al used in EU end-use applications is estimated tohave been 26 % in 2000 (EU Aluminium), 37% in 2013 (UP) and is estimated to reach
50% in 2050 (EU Aluminium). This information is understood to concern the generaluse of Al in the EU and not only the use of EEE articles. As for the amount of Pb
entering the market through this exemption, both applicants state that it is notpossible to derive the amount of lead associated with the use of recycled aluminium.

7.3.
7.3.1.

Applicants’ justification for the requested exemption
Substitution or elimination of lead in aluminium from leadbearing Al scrap recycling

The substitution of unintentionally present lead in aluminium originating from Al scrap
recycling is explained not to be appropriate. Technological alternatives for removing
the lead in the melting and refining step of the Al recycling process have been tested
in 2012 without finding a technically feasible way. Both applicants refer to a study on‘Existing technologies for lead removal from Aluminium melts’, carried out by MIMI
Tech UG and finalized in June 2012. The study shows that only few methods could befound and were assessed, i.e. Phase separation, Electrolysis and Vacuum distillation.
These methods are either not approved above lab-scale or not feasible from anenvironmental / economical perspective. The only alternative is to dilute the metal
with primary aluminium. This would result in higher environmental impacts due to thefact that the production of primary aluminium is energy intensive. Both applicants
state that a dilution of Pb takes place over time with no “new” Pb being added to thematerial stream as aluminium produced with primary material enters the waste phaseand is recycled. They stress the environmental benefits of using recycled material ascompared to virgin resource extraction. (EU Aluminium 2019; Umbrella Project 2020c)
The UP states that a closed loop system exists for Al as “in 2017, collection rates foraluminium were over 95% for new scrap and 70% for old” (Umbrella Project 2020c).

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EU Aluminium proposes to lower the lead threshold in the exemption formulation, see
the arguments summarised and evaluated in the course of the critical review inchapter 7.5.3:
Lead as an alloying element in aluminium casting alloys containing up to 0,3%
lead by weight provided recycled lead-bearing aluminium scrap is the only sourceof the lead.
7.3.2.

Environmental arguments

The applicants argue that health and environmental impacts of recycled aluminium
lead to a lower total impact than the use of primary aluminium. This is based on
several LCA studies.
7.3.3.

Socioeconomic impacts

The UP argue in favour of the exemption explaining that without such an exemption it
results in a decrease in recycling of aluminium scrap, which will impact the EU circular
economy and limit economic growth and jobs. Whether aluminium scrap can be used
or not (in light of lead impurities) also affects the dependency of the EU on primaryaluminium for which imports remain very high.
7.3.4.

Road map to substitution

No roadmap to substitution was provided given the fact that there are no practical,
environmental or other arguments to substitute lead in aluminium alloys where thelead stems from recycled aluminium.

7.4.

Stakeholder contributions

In total, seven individual contributions have been submitted during the consultation
period from 23 December 2020 to 03 March 2021.
European Aluminium has expressed its views during the consultation. Since European Aluminium is one of the applicants for the renewal of Ex. 6(b)-I, the contribution
can be interpreted as an additional clarification of the application: In a foreword, EU
Aluminium clarifies the differences between RoHS Ex. 6(b)-I and 6(b)-II based on two
categories of aluminium alloys, namely casting and wrought alloys, to justify that both
exemptions are treated separately. The exemption that is under review in this chapter(6(b)/6(b)-I) covers the casting alloys. EU Aluminium clarifies that in requesting a
potential 5-year transition period to allow adaption of the supply chain to meet thetargets of lower lead levels in recycled aluminium, it means that the proposed lower
threshold level for lead in recycled aluminium should already be incorporated in the
exemption wording that “should immediately follow the present 6(b)-I expiring on 21
July 2021”. (EU Aluminium 2021a). As to the actual levels of lead in recycled aluminium currently supplied to the market, EU Aluminium responds that its members ‘areable to supply casting alloys according to EN 1676:2020 and EN 1706:2020 with amaximum Pb limit of 0.29% since 2020’.
Another six contributions were submitted with regards to aspects of relevance to allof the exemptions or to the alloy exemptions evaluated under this study.
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

The Swedish Chemicals Agency KEMI (2021) addresses in a general comment
all alloy exemptions under review (6b, 6b-I, 6b-II, 6c) and also exemption 6(b)and 6(b)-I covering steel products. KEMI claims that the exemptions should be
adapted to the corresponding level of the REACH restriction entry 63 (for further
information see section 5.2). Furthermore, KEMI states that the exemption
formulation should specify both the material or component and the specificapplications.
KEMI acknowledges the conflict of interests with regards to energy savings
related to using secondary aluminium on the one side and combining material
streams of which one contains hazardous substances on the other side. KEMI
proposes: “One way to get around this in the long run could be to recycle metals
containing lead in one loop while metals without lead is recycled in another loop so
as not to contaminate all recycled metals. Furthermore, these different metals
should be used in different applications in a well-controlled manner.”

The Norwegian Environment Agency (2021) expresses similar arguments to
the Swedish Chemicals Agency: Based on Recital (19) in the RoHS Directive(2011/65/EU) that ‘exemptions from restrictions for certain specific materials orcomponents should be limited in their scope’, it is put forward that ‘the material orcomponent and the specific application need to be defined in the description of an
exemption’. Thus, the exemptions should be ‘narrowed down to a scope’.



Test and Measurement Coalition (2021), see chapter 5.1

Fresenius Kabi (2021), see chapter 5.1



The contribution of Huawei consists of a paper of Andrae (2020) titled ‘Does the
Restriction of Hazardous Substances (RoHS) Directive Help Reduce Environmental
Impacts?’ which contains an analyses of environmental implications of RoHS
exemptions 4f, 6a, 6b, 6c, 7a, 8b, 15(a), 15 and 34 of Annex III (Andrae 2020).
As for lead in recycled aluminium, the work emphasises the negativeenvironmental impacts of diluting secondary aluminium with primary aluminium inorder to lower the lead content if the exemption is revoked. This contribution will
not further be considered as this aspect has been raised and described in detail by
the applicants already.



SEMI Europe (2021b), see chapter 5.1
In addition, the following eleven organisations have expressed their support of therequest for renewal of this exemption but did not provide any further detail:













Trautwein Präzisionsdrehteile GmbH;
Hacker-Feinmechanik;
CARL DILLENIUS METALLWAREN GmbH & Co. KG;
STERO GmbH & Co. KG;
HEINRICH MUELLER GMBH;
HUGO KARRENBERG & SOHN GMBH & CO. KG;
Wilhelm Schauerte GmbH & Co. KG;
Julius Klinke GmbH & Co. KG;
Carl Leipold GmbH;wafi Walter Fischer GmbH & Co. KG;
Heinrichs & Co. KG;
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7.5.
7.5.1.

Critical review
REACH compliance – Relation to the REACH Regulation

See section 4.1 for details.
7.5.2.

Scientific and technical practicability of substitution

Due to the unintentional presence of lead, the target of restricting hazardous
substances is a question of elimination or reduction rather than substitution. The
substitution of lead in the Al recycling stream does not seem to be technically practicable: there exist substitution processes for lead at laboratory scale which have notreached industrial scale since 2012. Moreover, the actual amount of lead in secondary
aluminium and thus also on Al cast alloys decreases with time due to the dilution
processes. This is detailed in the next section.
7.5.3.

Possibilities for reducing lead

EU Aluminium explains that as recycled lead-bearing aluminium scrap is the only
source of lead in cast alloys, the lead content is decreasing. Furthermore, the amendments of the EU Standards EN 1676:2020 30 and EN 1706:2020 31 require industry to
reduce the Pb content to 0,29% by weight voluntarily, based on a compromise
between stakeholders. According to EU Aluminium (2021b), also Member States havebeen involved in the discussion. The standards are available for purchase since April
2020 and EU Aluminium suggest making use of the standards which are voluntary as
long as they are not referred to in legal texts (EU Aluminium 2021b with a reference
to www.CEN.eu).
EU Aluminium proposes to lower the exemption’s threshold to 0.3% by weight (EUAluminium 2019; 2021a; 2021b). This reduction of the lead threshold in Ex. 6(b)-I is
supported by the Swedish Chemicals Agency (2021). More precisely, EU Aluminium
proposes an adapted wording of the exemption as follows:
Lead as an alloying element in aluminium casting alloys containing up to 0,3%
lead by weight, provided recycled lead-bearing aluminium scrap is the only sourceof the lead
EU Aluminium raise the following additional argument: The health classification of lead
metal as defined by Regulation (EC) No 1272/2008 (CLP) is based on a concentrationlevel of 0.3% of lead (metal) w/w. ‘Considering that for the time being the regulatory
procedures addressing lead as a Substance of Very High Concern (SVHC) see thatvalue as a reference, it would make sense to promote alignment in this regard. Doingso would help approach the two positions and, in the event of a potential inclusion oflead metal in the authorisation list under REACH, would help maintaining coherence inthe threshold values.’ (EU Aluminium 2021b)

30
31

EN 1676:2020 ‘Aluminium and Aluminium alloys. Alloyed ingots for remelting. Specifications’
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The Umbrella Project states that ‘there is no evidence that it would be possible tolower the limit from 0.4% for the time being’ (Umbrella Project 2020c). ‘Given thatalloy compositions of up to 0.4% lead by weight are currently permissible, there is
extremely limited amount of information on the actual lead composition, rather
component and equipment manufacturers only know that it is conformant to the RoHS
Directive’ (Umbrella Project 2021g). For casting alloys, the UP is not aware of any
international standard, but claims a rather high dependency of the EEE industry on the
global supply chain. ‘Global customer specifications cannot be changed unilaterally by
European aluminium alloys suppliers’ (Umbrella Project 2021d). The Swedish
Chemicals Agency KEMI has an opposing opinion and emphasizes the leading role ofEurope with regards to ‘better protection for human health and the environment’: ‘The
EU legislation should lead the development of new solutions […] we should not take
into account the level of lead in aluminium scrap recycled outside the EU.’ The
consultant could not follow the argumentation presented by UP, because thestatement was not substantiated with figures and data on the content of lead inrecycled aluminium. This is further supported by the comments made by KEMI cited
above regarding the focus on developments in rather than outside the EU.
The UP contends that a transition period would be needed before lowering the limit oflead in exemption 6(b)-I. This is to allow ‘Time for reducing the level of lead to 0.29%+ time needed for the global supply chain to exhaust the stock + time for recertification/re-validation’ (Umbrella Project 2021d). After a renewal of the exemption with
0.4% Pb for all categories for five more years, ‘the reduction to 0.3% is appropriate.’(Umbrella Project 2021g) Reacting on the arguments regarding the slowness of global
supply chains, EU Aluminium states that ‘whilst it is paramount to grant transition
time to these systems it is also important to make progress in line with the politicalwave of the Green Deal and the Zero Pollution Action Plan’ (EU Aluminium 2021b).
Since the beginning of RoHS 1 Directive in 2002 the allowed level of lead in aluminium
alloys was not lowered 32, neither was it changed in 2015/16. The consultant thus
believes that the concentration of lead in recycled Al should have decreased throughdilution throughout this period. Thus, the consultant can follow EU Aluminium’s
statement that ‘it is important to make progress’ not only against the background ofcurrent political priorities but even more in light of the targets of the RoHS Directive.
The UP points out the risk that if the threshold was lowered, the lower lead concentration could be achieved by diluting the Al scrap with non-leaded Al. In the EU nonleaded Al is understood to stem from secondary sources but it is not clear whether alowered threshold introduced by this exemption would result in a dilution of the Al
scrap with primary aluminium outside the EU. According to the UP, the use of primaryaluminium bears various environmental disadvantages (Umbrella Project 2021g).
Asked whether it is correct to understand that globally, the lead content in recycled
aluminium may not yet be below 0.4%, EU Aluminium answered that ‘the maximum

32

The wording of exemption 6 was as follows: “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 by weight”; http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32002L0095&from=EN
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lead level in ISO 17615:2007 33 and ISO 3522:2007 34 was already 0.35% since 2007.
So, even at the global level, we believe that the maximum level of lead can be
reduced to 0.3%’ (EU Aluminium 2021c). This contradicts the UP’s statement that
there are no international standards for casting alloys.
In the view of the consultant, the UP’s argumentation is less substantial compared tothe arguments put forward by European Aluminium. It is acknowledged that Al scrap
should not be diluted with primary non-leaded Al only for the reason of complying with
new RoHS restrictions, however, the risk for this to happen is estimated to be rather
low. The consultant concludes that globally, Al alloy contents up to 0.3% lead byweight can be achieved given that the two ISO standards have already been adopted
in 2007 and that it can be assumed that the lead content in recycled Aluminium has
decreased since then through dilution.
7.5.4.

Environmental arguments and socioeconomic impacts

Theoretically, the lead content in recycled aluminium could be lowered by diluting the
Al scrap with non-leaded primary Al. However, from an environmental perspective,
two arguments speak in favour of allowing the use of secondary aluminium withcertain lead levels instead of primary aluminium. First, seeing that the alternative ofusing recycled Al bearing lead in casting alloys is the use of primary Al, it is agreed by
the stakeholders that the use of secondary Al has an energy-efficiency related advantage over the use of raw aluminium (Umbrella Project 2020d; EU Aluminium 2019).
Second, the EU Circular Economy has the aim to use materials already in the material
cycle for as long as possible. Thus, using secondary raw material generally is in linewith the closed loop targets of the Circular Economy (European Commission 2020b).
As already noted by KEMI (2021), there is a conflict of interests here, whether to saveenergy through the use of recycled material containing lead or whether to reduce thepresence of lead in products using virgin aluminium at the same time taking into
account the high energy consumption associated to the production of virgin aluminium.
Throughout the course of the project, EU Aluminium has brought forward the EN andISO standards related to Al casting alloys. These standards specify the acceptablelevels of lead. They are reviewed from time to time, and, if the market allows, thelevels of hazardous substances present in the Al casting alloys can be lowered, e.g. Pblevels were lowered in the EN standard revision for Al casting alloys in 2019/2020.
Thus, it can be assumed that besides exemption requests for renewal of this specificexemption, there exist additional drivers to track the market’s possibilities to reduce
the lead content in recycled aluminium.
It is further understood that the use of secondary lead in the production of Al alloys
for casting allows a significant reduction in the energy consumed to produce the alloys(i.e. the energy associated with the manufacture of primary Al is significantly

33
34

ISO 17615:2007 ‘Aluminium and aluminium alloys - Alloyed ingots for remelting – Specifications’ISO 3522:2007 ‘Aluminium and aluminium alloys - Castings - Chemical composition and mechanicalproperties’
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reduced). In the consultant’s view, lead as an impurity is thus to be accepted alsoseeing as the level of impurities in alloys is controlled and shall decrease with time.
For absolute lead amounts used under this exemption, both applicants specify certain
shares of primary versus secondary Al used across all sectors. However, both applicants state that no information can be derived on the share of secondary Al in the EEE
sector. While the consultant can follow that the share of secondary raw material specifically used in the EEE sector is difficult to assess as manufacturers of components
may not monitor their sales according to sectors, the consultant identifies a lack of
substantiation with figures and data on the content of lead in recycled aluminium. This
was already mentioned under chapter 7.5.3 in relation to the statement of the UP that‘there is extremely limited amount of information on the actual lead composition’(Umbrella Project 2021d; 2021g). However, it is acknowledged that without any information on the share of secondary Al used in the EEE sector, numbers on the exact
lead content cannot help to derive an absolute lead amount used under thisexemption.
7.5.5.

Scope of the Exemption

EU Aluminium proposed to specify casting aluminium in the wording of Ex. 6(b)-I.
After first refusing to comment (Umbrella Project 2021d), in a later communication the
UP finally agreed to the specification (Umbrella Project 2021g).
Applications which consist of or include parts fabricated from casting aluminium alloys
based on the input provided from applicants are frameworks of lamps and lights, heatsinks, electrical and electronic items in housing, pinons, gears for chains, various
machinery components or garden and outdoor equipment, petrol chainsaw, power
cutters, pistons, flywheel, and cylinders (see chapter 7.2).
According to the UP, this list also includes/applies to medical devices (e.g. MRI and CT
scanners), and monitoring & control instruments. Stakeholders supplying Cat. 8 & 9
products that participated in the stakeholder consultation such as TMC and Fresenius
did not specifically mention the need of a longer validity period. The consultant
assumes that this is due to the fact that the material used in casting alloys supplied on
the market are the same for all EEE regardless of category and sub-category.
7.5.6.

Conclusions

Article 5(1)(a) 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 isscientifically or technically impracticable;

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 andconsumer safety benefits thereof.

From the available information the following conclusions can be drawn:
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In the case of exemption 6(b)-I, the substitution of lead in aluminium alloys wherelead stems from Al scrap has neither major environmental advantages nor is it technically feasible on a large industrial scale. An approach in which the lead threshold valueof the exemption is adapted to the current situation on the market is viewed as preferable, while closing the door to alloys with higher lead contents that remain available
on the market but do not serve a functional purpose. In order to achieve the mostprecise wording, EU Aluminium proposed to specify the applicability of 6(b)-I to‘casting alloys’, to which the second applicant, UP, agreed (Umbrella Project 2021g).
Technically, this does not change in the material covered by the exemption, rather it
provides legal clarity and prevents steps backwards in the future.
On the basis of developments in the EN standardisation process for aluminium alloys
and based on the fact that the international standards for aluminium alloys alreadyhave lower lead thresholds than the reviewed RoHS exemption, the consultant
concludes that the content of lead allowed as an alloying element in aluminium,provided it stems from lead-bearing aluminium scrap, should be lowered to 0.3% leadby weight. Although, according to UP, no exact data for lead content in the international supply chain is known, the consultant believes that the limit value of 0.3% can becomplied with internationally, because a lead content of 0.35% has already been
specified in the international standards since 2007. Thus, the availability of suitable
aluminium alloys is assumed to be given.
EU Aluminium requested to specify the scope of exemption 6(b)-I to casting alloys andto reduce the maximum lead limit to 0.3% not only for Ex. 6(b)-I but also for Ex. 6(b).
Data was not made available to suggest that the situation could differ between the
categories for which the exemption has an expiration date specified as July 2021 andbetween categories or sub-categories with a later date.
Overall, the consultant concludes that the exemption could be renewed for 5 years
accepting the changes proposed by EU Aluminium and supported by stakeholders. The
following wording is suggested for a renewed exemption 6(b)-I:
Lead as an alloying element in aluminium casting alloys containing up to 0,3%
lead by weight provided it stems from lead-bearing aluminium scrap recycling

7.6.

Recommendation

It is recommended to grant the exemption with the following formulation:
Exemption formulation

Duration

6(b)I

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

Expires 12 months after thedecision for all categories

6(b)III

Lead as an alloying element in aluminium
casting alloys containing up to 0,3% leadby weight provided it stems from leadbearing aluminium scrap recycling

Expires on 21 July 2026 for all
categories

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A uniform validity period is recommended for all EEE Categories, thus, it is notrecommended to split the validity period of the exemption between Categories 1-7 &10 and Cat. 8 & 9 for several reasons even though 7 years instead of 5 years
exemption duration can be granted for the latter categories. It should be avoided thatslightly different exemption formulations coexist in order to avoid confusion (seechapter 5), to ensure market surveillance and to lower the administrative burden of
stakeholders and the European Commission with regards to renewed exemption
requests for the coexisting exemptions. Especially with regards to the casting alloys
targeted by Ex. 6(b)-I, the consultant believes that the material supplied on themarket are the same for all EEE regardless of category and sub-category.
The original exemption 6(b) remains unchanged and retains its expiry dates.
To furthermore ensure that RoHS provides a similar level of environment and healthprotection as that of the REACH Regulation, and with entry 63 of Annex XVII in mind,
it is recommended to add the following phrase for precautionary reasons to the
exemption wording: “The exemption shall not be applicable to articles or accessible
parts of an article that may be placed in the mouth by children; if it is smaller than 5
cm in one dimension or has a detachable or protruding part of that size, except where
it can be demonstrated that the rate of lead release from the accessible component/part, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent
to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that
this release rate is not exceeded for a period of at least two years of normal orreasonably foreseeable conditions of use of the article”. Alternatively, this addition
could be added as a footnote to the exemption.

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8.

Exemption 6(b)-II “Lead as an alloying element
in aluminium for machining purposes with a leadcontent up to 0,4 % by weight”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings ofstakeholders’ explanations and arguments have been adopted from the documents
provided by the stakeholders as far as required and reasonable in the context of theevaluation at hand. Formulations were only altered or completed in cases where it wasnecessary to maintain the readability and comprehensibility of the text. These sections
are based exclusively on information provided by applicants and stakeholders, unlessotherwise stated.
Al

Aluminium

COCIR

European Coordination Committee of the Radiological, Electromedicaland Healthcare IT Industry

CRM

Critical Raw Material

EEEElectrical and Electronic Equipment

Pb

Lead

RoHS

Directive 2011/65/EU on the Restriction of Hazardous Substances inElectrical and Electronic Equipment

UP

Umbrella Project

8.1.

BackgroundOn behalf of the “RoHS Umbrella Industry Project” (hereafter referred to as “Umbrella
Project”) COCIR, HARTING Stiftung & Co and Pepperl + Fuchs AG have submitted arequest for the renewal of exemption 6(b)-II of Annex III of the RoHS Directive with
its current wording (Umbrella Project 2019a):„Lead as an alloying element in aluminium for machining purposes with a leadcontent up to 0,4 % by weight“
The Umbrella Project (2019a) argues that lead in aluminium alloys improves
machinability by acting as a lubricant. Through the presence of lead, better chip
fracturing and surface finish as well as higher cutting speeds and a longer tool life areachieved. In a later communication (Umbrella Project 2021l), the Umbrella Project
points out that the renewal request is mainly based on the 3rd criterion of Art. 5(1)(a)namely that the total negative environmental, health and consumer safety impacts
caused by the substitution of lead with bismuth are likely to outweigh the total
environmental, health and consumer safety benefits thereof. The Umbrella Project(2019a) requests the applicability of the exemption for the categories 1 to 10.
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Wrought alloys: Al alloys primarily used for wrought products; they have an alloy
content up to 10% and therefore strict and very low compositional tolerance limits
for the alloying elements. Wrought alloys are designated with a four-digit number
according to the alloy designation system. Wrought alloys intentionally containing
lead for machining purposes.

Cast alloys: Al alloys primarily used for the production of castings; cast alloys
have much higher compositional tolerance limits for alloying elements; the alloy
concentration is of up to 20%. For cast alloys, a different designation system withfive digits is used. Cast alloys unintentionally contain lead, due to the use of Al
scrap for the manufacture of such alloys.

Exemption 6(b) has been split after the last evaluation to properly address thepresence of lead being intended or not (Gensch et al. 2016).

8.2.

Technical description of the requested exemption

The Umbrella Project (2019a) states that leaded aluminium is still required for someso called “niche” applications but on the other hand that an exhaustive list of
applications cannot be provided due to the diverse nature of the end products which
utilise components with leaded aluminium. In the answer on the clarificationquestions, the Umbrella Project (2021l) specifies the following applications whereleaded aluminium is still required:Cast and machined aluminium gear boxes from handheld tools made of the Al alloy
EN AC-46000-D-F;



Charge holders for MEMS sensor applications made of EN AW 2007 that are cut offrom a rod and must run at accelerated temperature;Stand-offs and spacers that are used to electrically connect parts in medical
equipment.

The Umbrella Project (2019a) explains the required use with technical characteristics
that relate in part to manufacturing and in part to the manufactured components:


Micro‐machining;Electrical conductivity;

Galvanic corrosion prevention;

Corrosion resistance against e.g. chemicals;

Mechanical relaxation;

Tribological behaviour;−Superior machinability due to factors such as chip fracturing and surface finish;−

Enhanced cutting tool lifetime;−

Better wear resistance of components made of leaded aluminium as it reduces
friction and wear of surfaces that slide against others (such as connectors);

Ability to form lightweight, intricate shape parts.
The Umbrella Project (2019a) does not provide performance indicators for thesecharacteristics / functionalities.

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8.2.1.

Amount of lead used under the exemption

The applicant does not specify the volume of lead to be placed on the EU market
through the exemption (Umbrella Project 2019a). Rather the applicant provides estimates that are based on general considerations on the European Al production and theshare thereof for industrial sectors. The estimations provided by the Umbrella
Project 35 are hard to follow and suggest that an estimated annual amount of lead of
about 90 tonnes is not recycled. The Umbrella Project states generally that only a very
low amount of leaded aluminium is still required for some niche applications. No moredetailed information is provided.

8.3.

Applicants’ justification for the requested exemption

The Umbrella Project claims that no suitable alternative exists for all applications andargues that “until all applications are able to trial lead free alloys then the reliability is
not ensured.” (Umbrella Project 2019a).
8.3.1.

Availability of alternatives (Substitution or Elimination,
roadmap to substitution, reliability of substitutes)

The Umbrella Project mentions cadmium, tin, bismuth and beryllium as possible
substitutes (Umbrella Project 2019a):

Cadmium is not further detailed because it is itself RoHS restricted.

Tin is mainly argued as providing less favourable mechanical properties to thematerial (causing cracking in machined parts when exposed to stress and hightemperature; causing surface darkening on annealing and increasing the susceptibility to corrosion).



Bismuth is the main substitute; the Umbrella Project states that “based on the
feedback of a few companies, about 2/3 of aluminium parts have already beentransferred from leaded to unleaded aluminium. In these cases, bismuth is usedinstead.” However, the Umbrella Project further argues that bismuth has limited
availability due to its being defined as a critical raw material. The Umbrella Project
claims that Bismuth has a more negative overall health and environmental impact(see further details in section 8.3.2).
On the machinability level, the Umbrella Project states that the manufacturabilityof bismuth alloys for some alloy types is similar to lead containing alloys:“However to fully understand the quality of a machined surface after machining it
is essential to know for each alloy type the microstructure which has not been fully
investigated for all alloys and uses.”

Beryllium is also not further detailed because the Umbrella Project concludes thatit has similar toxicity to lead and limited availability.

35“ In Europe about 7,7 million tonnes of Aluminium were produced in 2018. Assuming that about 4,5
million tonnes are in industrial sectors, out of this (based on statistical assumptions) about 450000
tonnes (10 %) is not recycled. However, not all of these applications would contain lead up to 0,4 %,assuming that 5 % of the unrecycled material includes lead up to 0,4 % results in 22500 tonnes ofaluminium containing lead. Consequentially, this would result in 90 tonnes of lead which is not recycled.
In the overall scheme this will have minimal impact as it results in 0,3 % of the EU total aluminium
production.”
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The Umbrella Project provides a list of some lead-free aluminium wrought alloys
designated with a four-digit number according to the alloy designation system. The
Umbrella Project depicts the composition ranges of bismuth and tin, arguing that thesealloys rely on bismuth and / or tin. There is no further assessment of technicalperformance presented. Rather general statements are given such as (Umbrella
Project 2019a):“In some alloys tin is used as a substitute to lead often in combination withbismuth. However, in turning and machining tests long and continuous stripes
were observed which cause very poor machinability.”“The lack of availability of bismuth and lead-free aluminium alloys would support
the assessment that the technical performance of tin alloys is not as closely
matched to the traditional lead containing aluminium alloys.”“Some alloys have been substituted by lead free compositions like e.g. AW-6026 toAW-6026LF as lead free alternative with high bismuth content. However, this is notpossible for all applications currently.”

Another substitution option is indicated as aluminium foam compositions (without theinclusion of lead), however without giving further information. UP explains thataluminium foam compositions are currently only available as sheets and that testing isneeded for complex structures (Umbrella Project 2019a).
As for the reliability of substitutes, the Umbrella Project claims that some products
need to be requalified such as e.g. medical devices where the Medical Devices
Regulation requires a re-approval by a Notified Body. The roadmap for substitution is
also specified for medical devices, indicating a total time of 5 years.
8.3.2.

Environmental and health arguments (also LCA aspects)

The UP claims that there are negative environmental and health impacts of bismuth
and refers to an LCA that compares the life cycle stages mining, purification, andrefining of different metals (Umbrella Project 2019a). According to the Umbrella
Project (2019a), the total negative environmental, health and consumer safety
impacts caused by substitution with bismuth are likely to outweigh the total environmental, health and consumer safety benefits thereof (Umbrella Project 2019a).
Furthermore, the UP claims that the use of bismuth containing alloys can negatively
affect recycling of aluminium and might increase the waste to be landfilled, however
without providing further information.
8.3.3.

Socioeconomic impacts

The UP expects an increase in direct production costs because lead-free alloys may
require more energy for machining, cause greater tool wear and create more scrap.
Further the UP claims that bismuth is around 7 to 17 times more expensive than leadand states that “if the demand for bismuth increases and the demand for leaddecreases, the price of bismuth may become even higher.” The UP also claims that for
medical devices this could impact on EU patients’ health, but without giving further
information (Umbrella Project 2019a).

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8.4.

Stakeholder contributions

Twelve individual contributions have been submitted during the consultation period
from 23 December 2020 to 03 March 2021. The arguments of the individual contributions are summarized in the following.
The Swedish Chemicals Agency KEMI (2021) addresses in a general comment
all alloy exemptions including exemption 6(b)-II. KEMI claims that the exemptions
should be adapted to the corresponding level of the REACH restriction entry 63 (forfurther information see section 4.1). Furthermore, KEMI states that the exemption
formulation should specify both the material or component and the specificapplications.



The Norwegian Environment Agency (2021) expresses similar arguments as
KEMI: Referring to Recital (19) in the RoHS Directive (2011/65/EU) (‘exemptions
from restrictions for certain specific materials or component should be limited intheir scope’), the Norwegian material Agency claims that ‘the material or component and the specific application need to be defined in the description of an
exemption’.



The Federation of the Swiss Watch Industry FH (2021a) supports the requestfrom the Umbrella project regarding all alloy exemptions. They explain in a general
way that lead-free alloys are harder to work and their electrical conductivity is also
worse. Besides, the Federation of the Swiss Watch Industry FH claims that leaded
alloys in external watch components have already been substituted and that forinternal components of the watch movement, substitution is more challenging.
They furthermore refer to the derogation made in REACH entry 63 for internal
components of watch timepieces inaccessible to consumers.

European Aluminium (2021a), the association of European Aluminium manufacturer states that an extension of exemption 6(b)-II is not necessary because there
is no technical need for lead-containing aluminium alloys as lead-free wrought
aluminium alloys with high machinability have been developed with properties
compatible with lead-containing alloys in use for any kind of application. European
Aluminium provides a compilation of leaded and lead-free aluminium alloys. 36 The
alloys contain a wide variety of metallic elements, e.g. iron, silicon, copper,
magnesium, manganese and zinc as well as bismuth and lead. The overview on thealloy compositions shows that leaded aluminium alloys also contain bismuth inquantities between 0.2 and 1.5 %. Thus, bismuth cannot be considered as thedrop-in or one-by-one substitute. Tin is also used as replacement, alone or in
combination with bismuth in tens of alloys. It is explained that tin cannot be usedon higher temperature applications, but it is an excellent chip-forming element.
European Aluminium (2021a) estimates that a replacement of a leaded Al alloy bya lead-free alloy would take from 6 months to some years, depending on thequantity of components.

According to International Registration Records and the Addenda at
https://www.aluminum.org/standards- Teal Sheets (Wrought Aluminum International Alloy Designations & Chemical Composition Limits) and- Addendum to Teal Sheets.
36

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According to European Aluminium (2021a), the lead-free Al alloys are globally
available on the market.


EURAL® GNUTTI S.p.A. (2021b), one aluminium manufacturer, expresses similararguments as European Aluminium. EURAL® GNUTTI S.p.A. (2021b) provides dataon the volume of lead used by the Eural Gnutti in 2018; accordingly alloys withlead content in the quantity of almost 40.000 tons have been manufactured that
results in a use of lead in a quantity of about 205 tons in 2018; “that means thatin our factory we must have in our warehouse a minimum quantity of 20-30 tonsof pure Lead, we cannot have any less in order to guarantee the regular flow of
production. Such number is comparable with many Extruders and Rollers in
Europe”. Both, European Aluminium and Eural Gnutti heavily refer to workers
protection against pure lead metal as it causes health problems for the workers.

Mondragón Componentes S. Coop. (2021a) applies for the renewal of the
exemption for category 1 (large household appliances) referring to “Aluminium gas
valves for gas control and regulation in gas household appliances, including hobs,
free standing cookers, industrial appliances, home comfort appliances andbarbecues” as specific application. Mondragón claims to have difficulties in
obtaining lead-free material for industrial trials. This is explained to delay theadaptation process for which Mondragón estimates to need around 5 years, global
approvals included. The alloys already tested have not given expected results interms of machinability. Mondragón explains that as gas valves are guaranteeing
safety in appliances, the dimensional aspects of the components must be carefully
taken care of.



The contribution of Huawei (Andrae 2020) consists of a paper of Andrae as aanalyses of environmental implications of RoHS exemptions 4f, 6a, 6b, 6c, 7a, 8b,
15(a), 15 and 34 of Annex III. 37 As for leaded aluminium alloys, the work refers to
the initial exemption wording 6(b) that does not differentiate between aluminium
alloys that is manufactured using scrap and the exemption 6(b)-II that refers toalloys being manufactured with primary aluminium due to their low tolerance limits
for the alloying elements. The assumptions made in the paper are not applicable to
the RoHS exemption 6(b)-II.

Furthermore, there were three contributions referring to a renewal of the exemption
for specific categories:

Test and Measurement Coalition (2021), see section 5.1.

SEMI Europe (2021b), see section 5.1.

Fresenius Kabi (2021), see section 5.1.

Aside from the contributions specified above, the following 14 organisations haveexpressed their support of the request for renewal of this exemption but did notprovide any further detail: Trautwein Präzisionsdrehteile GmbH; Hacker-Feinmechanik; CARL DILLENIUS METALLWAREN GmbH & Co. KG; STERO GmbH & Co. KG;
HEINRICH MUELLER GMBH; HUGO KARRENBERG & SOHN GMBH & CO. KG; Wilhelm
Schauerte GmbH & Co. KG; Julius Klinke GmbH & Co. KG; Carl Leipold GmbH; wafi

37

Anders S.G. Andrae Does the Restriction of Hazardous Substances (RoHS) Directive Help Reduce
Environmental Impacts? In: International Journal of Green Technology, 2020, 6, 24-37.
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Walter Fischer GmbH & Co. KG; Heinrichs & Co. KG; Maier GmbH & Co. KG Präzisionstechnik; Fischer Automaten-Drehteile GmbH & Co. KG; Grieshaber GmbH & Co. KG

8.5.
8.5.1.

Critical review
REACH compliance – Relation to the REACH Regulation

See section 4.1 for details.
8.5.2.

Scientific and technical practicability of substitution

From the information provided by the aluminium manufacturers, the consultant
concludes that lead-free aluminium alloys are available providing comparable
machining properties: “All kind of machining processes are perfectly suitable for leadfree alloys, in particular turning, drilling, milling” (European Aluminium 2021a).
Experiences exist and are made available by the alloy manufacturer on adaptions ofmachining parameters and tools to achieve high productivity in all kinds of machining
operations (EURAL® GNUTTI S.p.A. 2021a). Also for the properties of the final component, the alumnium manufacturers state that lead free wrought aluminium alloys havepassed all field tests when it is needed to have a good response in anodizing, lowroughness on the surface, high mechanical properties, good welding attitudes,
resistance in contact with fluids, including brake fluids, at high temperatures (for Leadand Tin Free alloys). From the information provided by European Aluminium (2021a;
2021b), it becomes obvious that within the AlMgSi alloys (6xxx series) and AlCu alloys(2xxx series) already a number of alloys with a lead content <0.1% is available sincequite some time: According to the Aluminum Teal Sheet, where the year ofregistration of each alloy is indicated, the first alloys in the 2xxx and 6xxx series havebeen registered between 1993 and 1999 (four alloys registered), from 2000 to 2006
seventeen new alloys were registered and from 2016 to 2020 four additional alloys
were registered. As for specific components where the various substitutes have been
applied successfully, the alumnium manufacturer lists “pistons and cylinders for brakesystems, pistons and covers for brake disks (calipers), transmission valves, all kind ofvalves for pneumatic and oleo-hydraulic systems, threaded parts, high precision
machined parts, connectors, bolts, nuts.”
The consultant understands from this information summarized above that there arelead-free alternatives on the market that are reliable according to aluminium producers.
For the EEE manufacturers, the Umbrella Project (2019a) argued in the beginning thatthe machining properties of leaded aluminium alloyys are favourable, however, without providing further details and claimed that an exhaustive list of applications could
not be provided due to the diverse nature. Parallely, the Umbrella Project (2019a)
describes that only niche applictions still need leaded aluminium alloys. After a set offirst clarification questions, the Umbrella Project (2021l) describes three niche applications. During the stakeholder consultation another specific application was submitted by Mondragón Componentes S. Coop. (2021a).
When asked to specify the applications for leaded aluminium alloys in watches, theFederation of the Swiss Watch Industry FH (2021b) revoked the request for renewal of
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exemption 6(b)-II. The Federation of the Swiss Watch Industry FH (2021b) states that“after studying the possibilities of substitution of the lead aluminium alloys in our
industry, it appears that they can be substitued by other alloys, wether based onaluminium or not. Thus, we want to withdraw our request for an extension of the
exemption 6(b)-II. However, we maintain the requests for exemptions 6(a)/6(a)-I and
6(c), because we need them.”
The four remaining specific applications of leaded aluminium alloys in EEE that wereapplied in the course of this evalution are disccused in the following.
Cast and machined aluminium gear boxes from handheld tools made of the Al
alloy EN AC-46000-D-F
According to the alloy designation 38 the alloy is a cast alloy which is not in scope of the
exemption here at hand.
During the last evaluation (Gensch et al. 2016), it was proposed to split the exemption
for lead in aluminium alloys in order to differentiate between cast aluminium alloys
where lead is unintentionally present and between applications where lead provides
necessary properties (wrought alloys).
Cast alloys are primarily used for the production of castings and have much higher
tolerance limits for alloying elements. They unintentionally contain lead, due to theuse of Al scrap for the manufacture of such alloys.

Wrought alloys or Al alloys intentionally containing lead for machining purposes:
Wrought alloys have strict and very low tolerance limits for the alloying elements.

The Umbrella Project (2021k) claims that the exemption 6(b)-II does not make areference to the source of the aluminium and only relates to the reason for lead
addition into aluminium. Though it might be that also an aluminium cast undergoes amachining process, basically the two alloy types can clearly be distinguished by theirdesignation. However, for further clarification, in the assessment for Ex. 6(b)-I
included in this report (see section 7) it is proposed to refine the wording of the
exemption by adding the term “for casting alloys”. It is further planned to propose adecrease in the lead threshold of this exemption, meaning that the use of recycled
aluminium would not necessarily suffice for achieving properties where a specificfunction is needed.
The Umbrella Project (2021k) further claims that also for the production of wrought
alloys, scrap can also be used as input. The consultant understands from the input inthe last evaluation that for wrought alloys, the lead might not always be “newly”
added but present at a sufficient concentration in Al used for production that mightalso stem from scrap. Taking into account the strict chemical composition of wrought
38

The EN designation system for cast alloy composition is made up of the following:
EN for European standard,
Letter A for aluminium
Letter C for casting
Alloy composition is specified either by a) numericals (5 digits) or b) by chemical symbols, followed
by a letter for the casting process and possibly by a letter and/or digit(s) for temper designation;
https://www.european-aluminium.eu/media/1533/aam-materials-3-designation-system.pdf
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alloys, it is understood that if scrap is used as input it has to be strictly sorted wrought
alloy scrap. The following figure illustrates these material flows.
Figure 8-1:

Recycling circuits in aluminium recycling

Source: (Paraskevas et al. 2013)

Therefore, the consultant concludes here that a refined wording of 6(b)-I respectively
the new item 6(b)-III that adds the term “in aluminium casting alloys” might prevent
such misunderstanding in the future. Besides, the application of this cast alloy does
not have to be further considered here.
Charge holders for MEMS sensor applications made of EN AW 2007 that are
cut off from a rod and have to run at accelerated temperature
The wrought alloy EN-AW 2007 has according to the International Registration
Records and the Addenda 39 a chemical composition with a lead content in the range of
0.8 to 1.5 %. Thus, the use of this alloy is not allowed under RoHS. Confronted with
this, the Umbrella Project (2021h) argues that this particular charge holder is a fixture
used for processing purpose in manufacturing processes and is not part of an electrical
tool. As it is supplied to the end user as a standalone mechanical article it is not in
scope of the RoHS Directive. The Umbrella Project (2021h) states that this application
does not require the exemption here at hand. This application will also not further beconsidered. Whether this application is in scope of the RoHS Directive or not has notbeen investigated.

39

International Registration Records and the Addenda at https://www.aluminum.org/standards:- Teal Sheets (Wrought Aluminum International Alloy Designations & Chemical Composition Limits) and- Addendum to Teal Sheets.
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Stand-offs and spacers that are used to electrically connect parts in medical
equipment
According to the Umbrella Project (2021h), a number of different alloy specifications
are used for the above mentioned application, however the specific alloys could not be
identified. The Umbrella Project (2021h) specifies that the lead-free aluminium alloy
6061 has been in the focus of investigation into alternatives, “however it has demonstrated insufficient deformation behaviour to allow the complex geometrical shapes tobe achieved.” The Umbrella Project (2021h) further specifies thermal conductivity andperformance of the heat sinks as being important parameters. However, performanceindicators and ranges have not been indicated by the Umbrella Project. The Umbrella
Project (2021h) states that “once a suitable alternative is identified recertification will
be required to be undertaken by the MDR, which is estimated to take 1-2 years tocomplete.”
As the identity of the leaded aluminium alloy is not revealed by the Umbrella Project,
the availability of suitable alternatives cannot be concluded here. Based on an additionnal internet research 40, the consultant understands that stand-offs and spacers areoffered in varying materials, e.g. stainless steel, brass, ceramics, nylon and also
aluminium, where also for example stand-offs of lead-free aluminium EN AW 6060 isoffered. The consultant can therefore not follow that stand-offs and spacers are a
specific application where lead cannot be reliably substituted.
Gas valves for category 1 (large household appliances)
The application for “gas valves for gas control and regulation in gas household appliances, including hobs, free standing cookers, industrial appliances, home comfort
appliances and barbecues” was specified in the contribution of Mondragón
Componentes S. Coop. (2021a) and further elaborated in Mondragón Componentes S.
Coop. (2021c). According to Mondragón Componentes S. Coop. (2021a), the gas
valves have formerly been produced with leaded brass. The consultant understands
the switch to leaded aluminium therefore as an overall lead reduction as the leadcontent in brass is higher (up to 4 % according to RoHS exemption 6(c)) then in
leaded aluminium under the exmeption here at hand. Such an overall lead reduction
approach was also mentioned by other stakeholders 41 where the exchange of leaded
brass by leaded aluminium was performed to reduce the overall amount of lead used
in a specific sector.
Mondragón Componentes S. Coop. (2021a) explains that they are in migration processfrom brass to aluminium components, and at the same time trying to adapt to a lead
free aluminium alloy. Mondragón explains to obtain good process results, however
certifications and customer approvals would take at least 5 years. According to
Mondragón Componentes S. Coop. (2021c), the performance of the gas valves forhousehold appliances depends on the achievment of surfaces that generate an airtightsealing in the assembly to prevent gas leakages without the need of an excessive
40

41

For example: https://www.ettinger.de/en/products/fastening-technology/standoffs/, https://uk.rsonline.com/web/generalDisplay.html?id=ideas-and-advice/spacers-standoffs-guide,
https://www.mouser.com/Electromechanical/Hardware/Standoffs-Spacers/_/N-aictf
E.g. during the online meeting hold for RoHS exemption 6(c) on 9 June 2021.
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contact pressure between them, so that the valve can be opened and closed with ahand torque. The gas-tight seal must endure in time without getting damaged.
This requires a very strict machining tolerance and surface quality. Mondragón has
tested different lead-free Al alloys, e.g. 6026, 2033, 2041 and 2077. Results for test
pieces are explained to be “satisfactory and promising” however, series production has
not yet been achieved. As the alloy 2077 that showed good hot workability andmachinability is only registered since 2020, the consultant can follow that validation
tests are still ongoing.
The statement on the substitution efforts presented by Mondragon has been verified
by Miele & Cie. KG (2021), another manufacturer of gas household appliances.
To achieve the substituion, Mondragón Componentes S. Coop. (2021c) provides aroadmap that is shown in the follwing figure.

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Figure 8-2:

Roadmap for substitution in gas valves detailing the different steps that still need to be fulfilled

Source: (Mondragón Componentes S. Coop. 2021c)

To summarise, the roadmap presented above suggests that time is needed to complete the substitution process. It was agreed with
Mondragón Componentes S. Coop. (2021b) on an expiry date of 31 December 2024.

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Initial conclusion
The consultant concludes that the applications provided by the Umbrella Project are
not sufficiently detailed so that it can not be followed why substitutes are not comparable in performance in the specific applications. The consultant reminds the clear
statement made in the recommendation of the last evaluation where a short review
period was recommended to allow industry a longer transition period as well as
providing time to apply for new exemptions should substitutes not be comparable inperformance for specific applications (Gensch et al. 2016).
The application specifed by Mondragón is supported with detailed evidence. The initialapproach of the manufacturer was to shift to leaded aluminium alloys instead ofleaded brass, leading to a reduction in the total amount of lead used. Lead-free Al
alloys have been identified that could potentially eliminate the use of lead in thisapplication, however require some additional time to complete the substitution
process. Should Ex. 6(b)-II be revoked, the manufacturer could revert back to leaded
brass to allow the further marketing of the application until substitution with lead-freealuminium alloys is completed. With the pending renewal of Ex. 6(c) recommended inthis report (see section 9) in mind, as an overall lead reduction is achieved in thisapplication by susbtituting leaded brass with leaded alumnium alloys the consultant
recommends to allow this use for a limitted period, to allow the completion of thesubstitution with lead-free alloys.
The following point should be noted regarding the availability of lead-free alloys:
Mondragón Componentes S. Coop. (2021c) mentions “very long delivery dates, forexample for alloy 2077” and further states that for “Ø10.5mm aluminium coil” there is
no lead-free alternative on the market. This is in contrast to the statement made byaluminium manufacturers e.g. EURAL® GNUTTI S.p.A. (2021b) that “the aluminium
industry is immediately able to supply any quantity needed of Lead-free alloys”. The
available evidence does not allow concluding whether there is a supply risk that would
affect the availability of substitute alloys and thus also the ability of the EEE
manufacturers to transition to such alternatives where they are applicable.
8.5.3.

Environmental arguments and socioeconomic impacts

In response to first clarification questions, the Umbrella Project (2021l) points out that“the renewal request for exemption 6bII, submitted by the Umbrella Project is mainly
based on the 3rd criterion listed in RoHS article 5.1.a): the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweighthe total environmental, health and consumer safety benefits thereof. In the renewal
dossier we highlight the higher environmental impact of bismuth compared to lead.”
The Umbrella Project (2019a) supports this claim refering to the EU COM decision todefine bismuth as a critical raw material (CRM) and refering to an LCA (Nuss undEckelman 2014) that compares the life cycle stages mining, purification, and refiningof different metals by means of the LCA impact categories such as human toxicity,
fresh water eutrophication, cumulative energy demand, terrestrial acidification andglobal warming potential. However, higher values in the above-mentioned LCA impact

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categories for bismuth compared to lead that hold for a few life-cycle stages would notjustify a renewal of the exemption in the consultant’s view.
European Aluminium (2021a) and EURAL® GNUTTI S.p.A. (2021b) provide an
overview on the chemical composition of the leaded and lead-free alloys that showsthat bismuth is also present in the leaded aluminium alloys. Both state that bismuth is
not the substitute element in the lead-free alloys. The Umbrella Project (2021l)
continues argueing that “lead and tin free machinable alloys tend to have higher
bismuth specification ranges, up to 1.5% than alloys than most leaded alloys.”
The consultant can not follow this argumentation, also seeing that bismuth has noclassificication for any enviromental or human health hazard 42 in contrast to lead.
Identification of a resource as a CRM reflects its economic importance and possible
risks to its supply, but does not necessarily imply that its sourcing results in negative
impacts on the environment or health. Though the European Commission has classified bismuth as a CRM, considering whether such risks are of higher relevance thanthose related to the continued use of lead is not related to the three primary RoHS
criteria and is thus beyond the mandate of the consultant.
The consultant concludes that the 3rd criterion is not fulfilled and cannot follow theargumentation of the Umbrella Project (2021l) that a renewal of the exemption isjustified on the background of the higher environmental impact of bismuth comparedto lead described in an LCA study on metal extraction.
8.5.4.

Scope of the Exemption

The consultant concludes that the exemption in its current formulation should be
revoked because there are reliable lead-free aluminium alloys on the market. The
consultant reminds here that the last evaluation report already clearly expressed that
this exemption is to expire and recommended renewing the exemption only for a shortperiod, to allow EEE manufacturers a sufficient transition period for applying lead-freealloys available on the market. It was further clearly stated in the last evaluation thatfurther exemptions for specific applications shall only be justified where there issufficient evidence that lead cannot be reliably substituted.
However, it is understood from the numerous organisations, especially German
SMEs, 43 that expressed their support of the request for renewal of this exemption but
did not provide any further detail that for some applications produced by SMEs in
Europe substitution with lead-free aluminium alloys might still not be completed.
Taking the situation of the SMEs into account, the consultant recommends the longest
transition period that is possible. According to Article 5(6) of the RoHS Directive, thisis a period of 18 months calculated from the date when the EU takes a decision. Until
the date of the decision, the current exemption remains also valid.

42

43

ECHA CL Inventory for bismuth at: https://echa.europa.eu/de/information-on-chemicals/cl-inventorydatabase/-/discli/details/15811;
Bismuth has not harmonized hazard classification and by most notfiers is also not classified; a minority
of notifiers classify bismuth being may cause long lasting efefects to aqiatic life (Aquatic Chronic 4,H413) and being a Flammable Solid 2 (H228).
See the names at section 8.4.
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For the application of gas valves applied in category 1 equipment (large household
appliances, the case is different and a short termed exemption could be granted tosupport the completion of the shift to lead-free alloys, also avoid the risk of a temporary shift back to copper alloys that use higher amounts of lead, should 18 months not
be sufficient for the transition. This means that the scope of the exemption could benarrowed down to this specific application.
8.5.5.

Conclusions

Article 5(1)(a) 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 isscientifically or technically impracticable;

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 andconsumer safety benefits thereof.

It can be followed that substitutes are available on the market for which reliability isclaimed by aluminium alloy producers. It has also been demonstrated that most ofthese alloys were already available on the market in 2016 when the last review of thisexemption was finalised. This availability is understood to have allowed substitution inmost applications, leaving only some niche applications where the process may still be
ongoing. The consultant concludes that the current scope of the exemption is nolonger justified and should be revoked, providing an extended transition period to
support the smooth phase-out of lead-free alloys where this is still ongoing.
As for niche applications, where additional time may be needed, the evidence provided
in the course of this assessment refers only one application where the consultant
agrees that the phase in of lead-free alloys needs additional time. This is the case forgas valves for gas control and regulation in gas household appliances, including hobs,
free standing cookers, industrial appliances, home comfort appliances and barbecues.
These components could also be manufactured by leaded brass. Thus, the switch toleaded aluminium alloys until substitution with lead free ones can be implemented isconsidered to provide an overall lead reduction and thus to be the “lesser evil”. The
shift to lead-free aluminium alloys is claimed to need additional time for testing until
July 2025; at the end of 2024, the first steps to achieve serial production are to becompleted.
The applicant raised concerns related to the 3rd criterion, according to which 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 in light of the presence of bismuth. However, the consultant cannot follow thisargumentation as the information on the compositions provided by European
Aluminium (2021a) shows that both lead and lead-free Al alloys contain a similar
content of bismuth.

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8.6.

Recommendation

It is recommended to renew the exemption with a narrowed scope, as specified in thefollowing table. It is further recommended, that for all other applications, theexemption shall expire at the latest possible date (18 months, after the date of thedecision).
Exemption formulation

Duration6(b)-II

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

Expires 18 months
after the decision
for all categories

6(b)-IV

Lead as an alloying element in aluminium formachining purposes with a lead content up to 0,4 %by weight in gas valves applied in category 1 EEE(large household appliances)

Expires on 31
December 2024

As explained in Section 5, the applicability of these recommendations to EEE in categories, which benefit from the validity of Ex. 6(b) beyond July 2021 is not completely
clear from a legal perspective. Industry did not provide specific evidence to show thatthe suitability of lead-free Al alloys used for machining purposes differs between EEE
in Cat. 8 in-vitro, Cat. 9 industrial and Cat. 11 and between other EEE. Seeing as it
has been shown that Al alloy suppliers have developed alternatives with performancecomparable to most uses of leaded-alloys, it is conceivable that manufacturers of such
EEE should also be able to phase-in such alternatives where this has not already been
performed. Given that these categories have expiration dates in the short term (July2023 or 2024), it is also assumed that where this is not the case, they have alreadystarted to prepare applications for renewal where the exemption is still needed. Suchapplications would need to be submitted at least 18 months ahead of expirationaccording to Article 5(5), i.e., by January 2022 or 2023 at the latest. 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 towhy available substitutes are not applicable for specific EEE.

8.7.

Overview on the recommendations for Exemption 6(b)The following table provides an overview on exemption 6(b) on lead as an alloying
element in aluminium and the associated new items and expiry dates that arerecommended.

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Table 8-1:

Overview on the recommendations for Exemption 6(b) withnew sub-items

Ex. No.

Exemption wording

Expiry date & scope

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

6(b)-I

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

Expires 12 months after thedecision for all categories

6(b)-II

Lead as an alloying element
in aluminium for machining
purposes with a leadcontent up to 0,4 % byweight.

Expires 18 months after thedecision for all categories

6(b)-III

Lead as an alloying element
in aluminium casting alloys
containing up to 0,3% leadby weight provided it stems
from lead-bearingaluminium scrap recycling

Expires on 21 July 2026 forall categories

6(b)-IV

Lead as an alloying element
in aluminium for machining
purposes with a leadcontent up to 0,4 % byweight in gas valves appliedin category 1 EEE (large
household appliances)

Expires on 31 December
2024

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9.

Exemption 6(c) “Copper alloy containing up to
4 % lead by weight”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings ofstakeholders’ explanations and arguments have been adopted from the documents
provided by the stakeholders as far as required and reasonable in the context of theevaluation at hand. Formulations were only altered or completed in cases where it wasnecessary to maintain the readability and comprehensibility of the text. These sections
are based exclusively on information provided by applicants and stakeholders, unlessotherwise stated.
C36000 / CuZn39Pb3
Leaded copper alloy, CuZn39Pb3 with a lead content between 2.5 3.5%
CuZn21Si3P Lead-free silicon-containing copper-zinc alloy
CuZn37Mn3Al2PbSi
Copper alloy with 0.2 to 0.8% Pb
CuZn42

Lead-free copper alloy with a higher zinc content

ECHA

European Chemicals Agency

EEE

Electrical and Electronic Equipment

KEMI

Kemikalieninspektionen, Swedish Chemicals Agency

MMC

Mitsubishi Materials Corporation

Pb

Lead

UP

Umbrella Project

RoHS 2

Directive 2011/65/EU on the restriction of hazardous substances inelectrical and electronic equipment

TMC

Test and Measurement Coalition

tpa

tons per annuum = tons per year

9.1.

BackgroundTwo applicants, Bourns Inc. and the “RoHS Umbrella Industry Project” (in thefollowing “Umbrella Project (2020f)”), represented by Rosenberger Hochfrequenztechnik and PHOENIX CONTACT, request the renewal of exemption 6(c) for:“Copper alloy containing up to 4 % lead by weight”

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Lead is embedded as tiny nodules in the matrix of copper alloys. It thereby improves
the machinability by acting as an internal lubricant and chip breaker and by preventing
cracks of the material. Lead also improves the technical performance of parts e.g.
increases corrosion resistance and influences stress relaxation behaviour or mechanical deformation.
According to the Umbrella Project (2020f), the exemption covers the following copper
alloys:

Leaded brass: copper-zinc-lead alloys are the most used leaded copper alloys;
among them the alloy CuZn39Pb3 as a standard alloy of copper and zinccontaining 3.3% lead is most commonly used.

Other leaded copper alloys are used in smaller amounts than brass:

Leaded bronze: copper-tin-lead alloys;

Leaded nickel silver: copper-nickel-zinc-lead alloys;

Leaded copper beryllium: copper-beryllium-lead alloys.

The Umbrella Project (2019a) claims that electrical or thermal conductors are themajority of applications of leaded copper alloys in EEE, e.g. all kinds of connections forthe transfer of data, signal or power. Furthermore, leaded copper alloys are widelyused for specifically designed mechanical parts with small scale features like e.g. cableglands, housing parts, filigree formed accessory parts, etc.
Bourns Inc. (Bourns Inc. 2020a) is a manufacturer of small passive electronic components for which the following components of leaded copper alloys are needed:bushings, shafts, terminals, terminal strip and rivets. Bourns Inc. explains that leaded
copper alloys can be precisely processed in fast screw machines.
The Umbrella Project applies for the renewal of the above-mentioned exemption forelectrical and electronic equipment (EEE) of category 1 to 10 with the maximum
validity periods. The Umbrella Project additionally applied for category 11 on 9
October 2020, which was also included in this evaluation. Bourns Inc. applies for EEE
of category 1-11 “depending on EEE manufacturer using electronic components aspart of their assembly” as well with the maximum validity period.
There is a corresponding exemption in the end-of-life vehicles (ELV) Directive
2000/53/EC (listed in Annex II as exemption 3) with the same wording “Copper alloy
containing up to 4% lead by weight”. This exemption has recently been reviewed 44 as
its mandatory review date is in 2021 however, the report has so far not been
published (September 2021). A harmonisation of the exemptions should be considered
once the assessment report is published.

9.2.

Technical description of the requested exemption

The Umbrella Project (2020f) generally claims that copper alloys are neither cheap nor
light materials and assumes that they will only be used when needed. The Umbrella
Project argues that the machinability of the leaded copper alloys is important to44

See information at https://elv.biois.eu
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produce a specific component/part and makes substitution impracticable as components/parts made of leaded copper alloys have essential properties e.g. conductivity,
relaxation, corrosion, lubricity, for which substitutes have not shown comparable
performance.
According to the Umbrella Project (2020f), electrical or thermal conductors are themajority of applications of leaded copper alloys in EEE, e.g. all kinds of connections forthe transfer of data, signal or power. Furthermore, leaded copper alloys are widelyused for specifically designed mechanical parts with small scale features like e.g. cableglands, housing parts, filigree formed accessory parts, etc. The Umbrella Project does
not provide further specifications for the components made of leaded brass besides
examples where substitution has shown special problems, e.g. crimp connections,knurls, gas nozzles and retaining heads.
Bourns Inc. manufactures electronic components such as precision potentiometers,
encoders, panel controls, rotary sensors, and trimming potentiometers for which theyneed leaded copper-zinc alloys (or the “free cutting brass C36000”, CuZn39Pb3) for
the following parts:


Encoders: (shafts, terminals, terminal strip);

Panel Controls: (brass shafts, strips, rivets);Precision Potentiometers: (wiper terminal, terminal, shafts, bushings);

Rotary Sensors: (bushings);

Slide Potentiometers (rivets); andTrimming Potentiometers (shafts).

Bourns Inc. explains that the brass can be precisely processed in fast automatic screwmachines.
9.2.1.

Amount of lead used under the exemption

Both applicants are not able to give an estimation on the amount of lead placed on the
EU market through leaded copper alloys:


The Umbrella Project states that nearly no “new” lead from primary sources willenter the EU market as the alloys (especially brass) are made from recycledmaterial. The Umbrella Project confirms the numbers reported in the lastevaluation in 2015/2016 on “ca. 2500 tpa [tons per year] lead based on a use
amount of leaded alloys in EEE of 100,000 tpa with 2.5% lead threshold isassumed.” But it adds that due to slightly smaller production volumes also theamounts have slightly decreased.



Bourns explains that their electronic components are sold by distribution so thatthey do not know the number of components including the leaded copper alloy
C36000 (CuZn39Pb3 45) brass entering the EU.

However, Bourns Inc. specifies the use of lead by providing a list of the different
models of the electrical components that Bourns manufactures, with unit weight in
45

The material designation of this alloys is: CuZn39Pb3 with the number CW614N; the alloys contain
2.5-3.5% lead.
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grams and the share of lead of the total unit weight based on the C36000 composition. The finished units contain between 0,0003 and 0,33 gr lead.

9.3.

Applicants’ justification for the requested exemption

The Umbrella Project (2020f) has reviewed European standards defining thecomposition of copper alloys and identified four commercially available lead-freecopper-zinc alloys (brass), which have different mechanical properties compared toleaded brass:

CuZn21Si3P, is defined with a lead content ≤ 0.1% w/w; this silicon brass, also
called Ecobrass, has a lower electrical and thermal conductivity than leaded brass.



Three Copper-Zinc alloys with a lead content ≤ 0.1% w/w and a higher zinccontent: CuZn40, CuZn42 and CuZn38As. These alloys do not contain a chipbreaker such as lead or silicon.

The Umbrella Project concludes that no new lead-free copper alloy became available in
the last five years since the last evaluation of the exemption in 2015/2016. The
Umbrella Project (2021e) further pointed out that other lead-free copper alloys areunder development and have been tested by partnering companies/associations, butthat these alloys mostly only exist on lab scale and research is ongoing.
Bourns Inc. argues that no substitutes have been identified that showed the samemachinability in automatic screw machines; the machinability is not further specified
e.g. by speed or tool life.
9.3.1.

Availability of alternatives (Substitution or Elimination,
roadmap to substitution, reliability of substitutes)

The Umbrella Project (2020f) specifies the less favourable properties of the lead-freebrass alloys as follows:The high zinc content in the alloys CuZn37, CuZn40 and CuZn42 cause several
changes to the mechanical behaviour e.g.:−

The higher hardness together with long chip formation causes a higher wear ora break of tools: Special tools with chip breaker partly help to overcome theproblems, however, for the occurrence of chatter marks, burrs or edges nosolutions were found.

−A lower cold forming ability makes the material unsuitable for crimping as
cracks from the conductor until the edge of the connection and at the outside
surface were reported from several manufacturers.

The silicon brass (Ecobrass) CuZn21Si3P has a lower electrical and thermal
conductivity and can therefore not be used for electrical or thermal conductors. In
mechanical parts/components, the machinability of CuZn21Si3P is indicated at 70– 75% of the leaded copper alloy CuZn39Pb3/C36000. For drilling of small bores,
no practicable solution has yet been found. A five-step drilling strategy as
proposed by the Ecobrass manufacturer allows a maximum number of 25,000
bores by one drill whereas the Umbrella Project specifies the requirement to be at
1.000.000 bores before a drill change. Therefore, Ecobrass was not found to bepracticable. Since the last evaluations of this exemption in 2015/2016, possible
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adaptations in the machining processes were used by companies for in-houseresearch and development but no working solution was reported to the Umbrella
Project (Umbrella Project 2021e).
For Bourns, the use of Ecobrass is not possible for the reason that the distributor of
Ecobrass only provides bars with the smallest diameter of 0.250 inches. However,Bourns require a much smaller diameter size of 0.075. Using 0.250 bars would resultin 91% waste if machined down to 0.075.
Other substitutes mentioned by the applicants but not further explored are thefollowing:

The alloy CuZn38As is applied in some drinking water applications as Arsenichinders de-zincification; this requirement is not relevant in EEE; regardless of thehigh toxicity of arsenic, this alloy is not used in EEE.



Lead-free alloys with high copper content, e.g. C18625 with 99.4 % w/w copper
are much softer than brass which results in a lower strength and shows long chip
formation.



Stainless steel has a lower machinability of 40-50 % compared to leaded brass.

Bourns Inc. mentions different material such as aluminium, zinc die cast and nickel
silver but state that all three alternatives have a higher raw material cost and aslower machining rate which reduces the overall capacity the company canmanufacture and shortens tool life.

The Umbrella Project dedicates one chapter of the application to “Examples for
Successful Substitution” where feedback from a survey among the 50+ partnering
associations of the Umbrella Project is cited.
The electrical and electronic manufacturers’ associations reported no
examples of successful substitutions. One citation states that this topic should bebetter addressed directly to the members of metal industry associations andcomponent manufacturers within the Umbrella project.

From mechanical engineering associations, statements indicate that one
company was able to mostly substitute leaded copper alloys, another partly andstill another company applies low leaded copper alloys for some applications. When
asked for clarification, the Umbrella Project specifies the following components/
parts where substitution could be achieved: for mechanical parts, bearings,
housings, couplings and spindles and by another company cast or forged andmachined counterweights used in air conditioning and refrigeration compressors
when space allows the use of lead-free material.

9.3.2.

Environmental and health arguments (also LCA aspects)

The Umbrella Project claims that for leaded copper alloys a closed loop exists and thatsemi-finished goods of leaded brass are nearly entirely produced from recycledmaterial. The Umbrella Project claims that a sudden restriction of leaded brass would
cause an adverse effect as the required material could not be made by direct recycling
anymore.

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Bourns Inc. refers to information e.g. to a life cycle assessment (LCA) on metals
covering the life cycle stages mining, purification and refining (Nuss und Eckelman2014) and to the comments of the European Copper Institute on the socio-economic
analysis on classification and labelling of lead in copper alloys, which is however not
relevant in an exemption evaluation under RoHS.
9.3.3.

Socioeconomic impacts

Both applicants mention direct costs related to substitution but without further
substantiating their statements:


The Umbrella Project claims that investments in new machines would be difficult
for small and medium sized enterprises; changes in the production process might
require additional manual work that further increases direct costs (“especiallyproblematic for companies in regions with high salaries”).

Besides, the Umbrella Project also raises the aspect of the direct recycling of chipsthat are a pre-consumer waste of the machining processes. According to theUmbrella Project, mixing of silicon brass and leaded brass chips would impede adirect recycling; they argue that a parallel use of both alloys is not practicable.

Bourns Inc. mentions as direct costs a higher raw material price, higher prices if
machining is slower and/or tool life shortened.

9.4.

Stakeholder contributions

Twelve individual contributions have been submitted during the consultation period
from 23 December 2020 to 03 March 2021. The arguments of the individual
contributions are summarized in the following.


Mitsubishi Materials Corporation (2021b), a material manufacturer, provides
information on the lead-free silicon-based brass, Ecobrass. Mitsubishi Materials
Corporation describes Ecobrass as−

having equivalent machinability and productivity to C36000;−

providing equivalent surface quality and dimensional precision to components
made of C36000 even though it depends on machining conditions; and−providing a better surface roughness than C36000.

Mitsubishi Materials Corporation provides information on the test machining of 15
small components weighing from 0.4 to 10 g that included different machining
methods, e.g. turning, drilling, threading, knurling, and grooving and concludes
that the tools incurred only minor damage.
As for the disposal of chips, no specific problem occurred.
Ecobrass is so far applied in various drinking water-related and automobile
components, e.g. Small Car Air-Conditioner Components.
Furthermore, Mitsubishi Materials Corporation announced the development ofanother silicon-based brass called “GloBrass” that has a higher electricalconductivity then Ecobrass and thus would be applicable for electrical/electronicparts.
In a separate Annex, Mitsubishi Materials Corporation (2021a) provides technicalinformation on continuous micro-drilling of Ecobrass and the availability of
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Ecobrass material, where Mitsubishi Materials Corporation proposes to supply“more slender” bars upon request.
The input of Mitsubishi Material Corporation is further discussed in section 8.5.1.


The Swedish Chemicals Agency KEMI (2021) addresses in a general comment
all alloy exemptions including exemption 6(c). KEMI claims that the exemptions
should be adapted to the corresponding level of the REACH restriction entry 63 (forfurther information see section 4.1). Furthermore, KEMI states that the exemption
formulation should specify both the material or component and the specificapplications.



The Norwegian Environment Agency (2021) expresses similar arguments as KEMI.
Referring to Recital (19) in the RoHS Directive (2011/65/EU) (‘exemptions fromrestrictions for certain specific materials or component should be limited in theirscope’), the Norwegian material Agency claims that ‘the material or component
and the specific application need to be defined in the description of an exemption’.



The Federation of the Swiss Watch Industry FH (2021a) supports the requestfrom the Umbrella project regarding all alloy exemptions. They explain in a general
way that leadfree alloys are harder to work and their electrical conductivity is also
worse. Besides, the Federation of the Swiss Watch Industry FH claims that leaded
alloys in external watch components have already been substituted and that forinternal components of the watch movement, substitution is more challenging.
They furthermore refer to the derogation made in REACH entry 63 for internal
components of watch timepieces inaccessible to consumers.



FRANCÉCLAT, the French Watch, Clock, Jewellery, Silverware, Tableware
Committee, contributed specifically to exemption 6(c) referring to the complex
structure of a great number of small and extremely small parts with tolerances in
the micro-range: “major difficulties were encountered during machining of thedriving and regulating parts, e.g. the dimensions, tolerances and surface quality
requirements are not met. The absence of equivalent quality for these parts has anegative impact on the primary functions of a watch, namely the precise timemeasuring function and the service life. Moreover, potential alternative materials
currently don’t meet other manufacturing criteria such as the productivity, the tool
life, the energy consumption and therefore generate additional production costs inan already severe context of competition with countries where labour costs are
low.”



FMTI - Austrian Association of Metaltechnology Industries supports therenewal request for 6(c) and refers to the recent re-evaluation of the European
Chemicals Agency ECHA of the derogation for keys and locks, including padlocks inentry 63 of REACH Annex XVII (ECHA 2020). Keys, locks and padlocks are
derogated from the lead restriction in articles because the decreased sliding
behaviour of potential alternatives, that results in inferior surface quality. Leadprovides properties such as improving sliding/ gliding property of keys in lockcylinders and padlocks when these locks are not lubricated; less brittle material,
which is of importance for keys not breaking, and also for improving resistanceagainst certain burglary attacks on cylinders.



The EVVA Sicherheitstechnologie GmbH, a manufacturer of building hardware(e.g., locks, locking cylinders, keys, door handles, padlocks), expresses similararguments as the Austrian Association of Metal technology Industries.
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Rudolf Riester GmbH explains that “Ecobrass is not machinable and does nothave the electrical conductivity we require; the material should be machinable by
CNC-lathe and milling machines and should be correspond with lead-containing inelectric conductivity; if we have alternative material, we could switch to it within 5
to 10 years. Because in the medical industry, we have to revise the risk
assessment documentation for every part. And there are thousands of parts thatneed to be changed to a new material”.

The contribution of Huawei (Andrae 2020) consists of a paper of Andrae as aanalyses of environmental implications of RoHS exemptions 4f, 6a, 6b, 6c, 7a, 8b,
15(a), 15 and 34 of Annex III. 46 As for leaded copper alloys, the work compares
four proxies of environmental impact (e.g. abundance in earth’s crust and in the
Oceans) only to the point of the alloy composition. Aspects such as e.g. different
machining properties of the alloys are not considered. Thus, the work is not of
relevance for the current assessment.

Furthermore, there were three contributions referring to a renewal of the exemption
for specific categories:•••

Test and Measurement Coalition (2021), see chapter 5.1.
SEMI Europe (2021b), see chapter 5.1.
Fresenius Kabi (2021), see chapter 5.1.

Aside from the contributions specified above, the following 12 organisations haveexpressed their support of the request for renewal of this exemption but did notprovide any further detail: Trautwein Präzisionsdrehteile GmbH; Hacker-Feinmechanik; CARL DILLENIUS METALLWAREN GmbH & Co. KG; STERO GmbH & Co. KG;
HEINRICH MUELLER GMBH; HUGO KARRENBERG & SOHN GMBH & CO. KG; Wilhelm
Schauerte GmbH & Co. KG; Julius Klinke GmbH & Co. KG; Carl Leipold GmbH; wafi
Walter Fischer GmbH & Co. KG; Heinrichs & Co. KG; Paul Weber GmbH & Co.KG
After the consultation was closed, GEM Terminal IND. CO., LTD (2021b) submitted arequest to the EU COM to revoke exemption 6(c) of Annex III RoHS. GEM Terminal
IND. CO., LTD (2021c) describes to have developed a custom model alloy “GEM19589” that is a C2800 low-lead copper material produced by VIETNAM GEM
ELECTRONIC AND METAL CO.,LTD.; GEM Terminal specifies the composition as
follows: “Composition: Cu: 58~63.5%, Pb: less than 0.08%, Fe: less than 0.07%, Zn:
Allowance, no Bismuth-containing” and has more favourable machining properties.
Two different components, copper tubes/rods and hollow copper tubes/rods,
manufactured in high-speed turning machines with specialized/customized cutting tool
for terminals, electrical plug brackets and high-precision special-shaped contour strips
materials.

46

Anders S.G. Andrae Does the Restriction of Hazardous Substances (RoHS) Directive Help Reduce
Environmental Impacts? In: International Journal of Green Technology, 2020, 6, 24-37.
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9.5.
9.5.1.

Critical review
REACH compliance – Relation to the REACH Regulation

See section 4.1 for details.
9.5.2.

Scientific and technical practicability of substitution

As in the last evaluation of this exemption, Mitsubishi Materials Corporation (2021b;
2021a; 2021c) submitted a contribution to the consultation pointing out the lead-freecopper alloy Ecobrass as a substitute material for many components where electricalconductivity is not critical although it is not possible for Ecobrass to replace all leaded
copper alloy. Besides, Mitsubishi Materials Corporation presented a newly developed
silicon brass called “Globrass” that has a higher electrical conductivity compared to
Ecobrass. The Umbrella Project (2021i) stated that its members so far have noexperience with Globrass but will test it.
In the course of the evaluation, an online meeting was held on 9 June 2021 to clarify
areas where conflicting views exist with regards to the machinability of Ecobrass. At
the online meeting also the information from GEM Terminal IND. CO., LTD (2021a) on
the successful substitution in elements for electrical contact was presented to theUmbrella Project and the Umbrella Project was given the opportunity to comment on
this case of successful substitution.
It has to be noted that the Umbrella Project (2021c) basically agreed on aclassification of components according to the main function that usually is either ofelectrical or mechanical nature. Whereas for components with electrical function, no
successful substitution was reported by the Umbrella Project (2021c), for mechanicalcomponents, the Umbrella Project (2021b) reported some cases of successful
substitution. The two groups of application are discussed separately in the following.
Components with electrical function
Thanks to the advance of the company GEM Terminal IND. CO., LTD (2021b), one
example of successful substitution for electric elements was made public: GEM
Terminal IND. CO., LTD (2021c) has developed a customized model of the high zincalloy CuZn40 (C2800) to manufacture copper rods and hollow copper rods for e.g.
plugs and terminals.
The Umbrella Project (2021b) referred to limitations of this example, e.g. thecomponents have a simple geometry and do not need any bore, cut, knurl, cold
forming steps and relaxation, and that the components are for transfer of power only.
However, the Umbrella Project (2021k) generally agreed that “for parts with more
simple manufacturing or component characteristics it will be earlier possible tosubstitute leaded copper alloys.” The Umbrella Project (2021b) further argued that theachievements presented by GEM Terminal IND. CO., LTD (2021b; 2021c; 2021a) arebasically in line with their findings: “For electrical and electronic applications, e.g. allkinds of connections for the transfer of data, signal or power, the discussed brass
types without chip breaker (e.g. CuZn42) seems at the moment to be the mostpromising material (e.g. CuZn42)”
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The consultant therefore concludes that in the next assessment of the exemption,industry will be able to provide a classification for those components where asubstitution is possible or will be possible in a defined period of time.
For more complex components / parts, it is understood that the high zinc brass types
without chip breaker (e.g. CuZn42) are technically impractical because insufficientstress relaxation and crimp ability of the material are often safety relevant (Umbrella
Project 2020f). The Umbrella Project also describes that due to the lower machinability
the material cannot be processed with standard tools. These applications where
substitution is stated to be more challenging (Umbrella Project 2021k) are understood
to be the following:components / parts with more complex manufacturing characteristics (e.g. withboring, cutting, knurling, cold forming, etc.) or(more) complex component characteristics (e.g. transfer of data or signal,
relaxation requirements, etc.)

To conclude for the next review, industry is expected to elaborate a classification of
applications for which an earlier substitution is possible and of applications where
additional substitution will still need more time so that the scope of the exemption canbe narrowed down in the next evaluation.
Mechanical components
For mechanical components, the Umbrella Project (2021e) states that cases ofsuccessful substitution have been reported by their members. The alternatives usedwere mainly Ecobrass but some members did not reveal the identity of the alloy type
(Ecobrass or CuZn37/CuZn40/CuZn42) due to confidentiality. Based on their internalsurvey, the Umbrella Project (2021e) estimates that 4% of leaded brass can besubstituted by Ecobrass in the field of mechanical engineering companies and provides
the following examples: bearings, housings, couplings and spindles. All are from themechanical engineering sector. One partnering company named cast or forged andmachined counterweights used in air conditioning and refrigeration compressors whenspace allows the use of lead-free material. For these cases, adaptions in the
production process like feed rate and speed have been mentioned without providing
further specific information. The Umbrella Project (2020f) claims an increase of costs
and refers to a calculation by Schultheiss et al. (2018). There, an increase in
manufacturing cost by 77% was claculated for substitution with the low lead siliconbrass CuZn21Si3P in a Swedish SME producing thermostatic radiator valves, radiator
manifolds, fittings, and control values for heating of buildings. The Umbrella Project(2021e) states that answers received from the partnering associations support thisfinding but do not allow a quantification as information required therfore (e.g.
production amounts or market share of the companies) are confidential. The Umbrella
Project concludes this cost increase as being far beyond everything acceptable forseries production. The consultant understands herefrom that substitution might betechnically reliable on more cases then initially concluded by the Umbrelly Project butthat socio-economic implications are at least in some cases the real reason why
substitution is not completed.

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Responding to the information provided by Mitsubishi Material Corporation, theUmbrella Project (2021k) argues that components manufacturers have to perform
additional reliability testing which cannot be overseen by the material manufacturer;
e.g. “is the component reliabel under lab and field conditions and can the required
shape be formed under series production conditions”. The Umbrella Project was asked
to provide examples to substantiate this claim. According to the Umbrella Project(2021k), the publication of research on alternatives are usually confidential businessinformation where also the fact that certain materials are tested can provide insights
to competitors. Some examples have been compiled by the Umbrella Project(Umbrella Project 2021k) and four companies have sent confidential information
directly to the consultant. According to this information, Ecobrass has been tested but
also additional materials such as bronze alloys as well as specific coatings on steel
parts. Information on substituion tests made available by the Umbrella Project(2021k) which are not confidential comprised the following components: solenoid
valves, hydraulic pumps/motors, nut inserts that slide on a threaded spindle andnozzle housings.
The consultant concludes that a specification of the applications where the substitution
with Ecobrass is basically possible still remains open. This should be tackeled in a
future assessment to clarify whether differentiation between e.g. simple geometry
versus complex shapes, low geometric tolerances etc. could help to narrow down thescope. It should be clarified by industry in future evaluations where substitution istechnically practicable and where socio-economic considerations are the actual
obstacle for performing further reliablity testing.
Initial conclusion
The reporting of the RoHS Umbrella Industry Project is partially hampered by the factthat companies did not report on their research and development efforts due tomarket competition but rather claimed the information to be confidential businessinformation. At one stage in the evaluation process, some companies directly reported
on their component testing and the failure of alternative alloys. Such input is essential
to the assessment to substantiate claims alongside aggregated information provided
by the Umbrella Project. However, the input remains exemplary and the consultant
could not gain a conclusive overview.
The consultant understands that there is no “one-fits all” substitute for all EEE
applications. In principle, lead-free alloys are available, but their applicability is limited
to specific cases and does not allow a demarcation of applications that could be
excluded from the exemption. Furthermore, the substitutes that are so far available
cannot be used as simple” drop-in” but need further adaptations in the alloy composition and/or in the machining processes to allow their successful implementation.
The application of the Umbrella Project overall presents the failures of potential substitutes and does not provide any insights as to the general substitution efforts nor
provide data on the overall lead reduction. The UP explains that this is very much due
to confidential business information where single companies do not want to reveal any
elements regarding their substitution strategy. As for electrical elements, it can be

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followed that Ecobrass is not a suitable all-round alternative due to its low conductivity.
It has to be noted that the Umbrella Project (2021c) basically agrees with the need for
an approach based on the classification of components according to the main functionof lead, which is usually either of electrical or mechanical nature. Whereas for mechanical components, the Umbrella Project (2021b) reported some cases of successful
substitution, for components with electrical function no successful substitution
examples have been reported by the Umbrella Project (2021c) or its individual
members.
It should be noted here, that the newly developed silicon brass “Globrass” by
Mitsubishi Materials Corporation (2021b) might allow new substitution options and test
results are expected for the next review.
9.5.3.

Environmental arguments and socioeconomic impacts

In the context of environmental impacts, the closed loop for copper recycling was
brought forward by the applicants because a mixture of lead- and silicon-containing
scraps cannot allegedly be remelted but has to undergo an energy intensive recycling
via smelter.
It is understood that this is relevant for component manufacturers that sell back thescrap to the material supplier directly: Through the machining processes, a substantial
proportion of the ingoing material is transformed into industrial scrap in the form ofchips which are cleaned from oil and lubricants by the component manufacturers toallow its recycling and reuse. Thus, the prevention of a potential contamination ofleaded brass would need a separate cleaning and storing chip cycle where both alloy
types are applied. This is understood to be feasible in theory, however in practice it
implies investment and would hinder a partial or sequential use of e.g. Ecobrass within
one SME.
As already mentioned above, the Umbrella Project (2021e) claims an overall andunacceptable cost increase when substituting leaded brass CuZn39Pb3 by
CuZn21Si3P. However, it is understood that the information only applies to the level of
specific components and not to the final EEE. The impact of such a cost increase on
the final EEE cost has not been demonstrated. Detailed information on higher costs is
exemplary and does not allow a conclusion as to the severity of such impacts.
9.5.4.

Scope of the Exemption

The scope of the current exemption is wide and consequently the contributions of theSwedish Chemicals Agency KEMI and the Norwegian Environment Agency claim aspecification of the exemption for materials and components of EEE and for specificapplications. This could basically be achieved by a split of the exemption into several
items for specific applications where it has been verified that feasible alternatives are
currently not available or reliable. The consultant generally agrees with the need tonarrow the scope of the exemption, however, concludes that it is not possible on thebasis of the evidence made available during this assessment.

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Though industry agrees to a differentiation between two big application groups(components with electrical function and mechanical components), this does not allow
narrowing down the exemption’s scope in a way that would exclude applications fromthe exemption where substitutes are available. A future possibility might be to base agrouping on geometry or properties of the final component (for components withelectrical function this could be e.g. transfer of power versus transfer of data). Thus,
the consultant concludes that industry should provide a proposal for an approach tonarrow down the scope in the next review.
Finally, the consultant urges other material manufacturer to take a more active role,e.g. the European Copper Institute or the Copper Development Association Inc. (CDA)
in communicating further steps and visions for copper alloy development.
9.5.5.

Conclusions

Article 5(1)(a) 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 isscientifically or technically impracticable;

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 andconsumer safety benefits thereof.

The consultant understands from the different information provided that there aresubstitutes available that could at least be used for some applications. However, theuse of alternatives (e.g. Ecobrass) requires adaptations in the machining process.
Consequently, substitution with Ecobrass is currently understood to have restrictions
limiting its applicability to only certain applications.
As for components with electrical function, it is further understood that lead-freecopper alloys (high zinc alloys) are applicable for components with a simple geometry
and transferring power. This application group should be confirmed or revised byindustry for the next review.
It is noted that though the applicants and stakeholders provide some details as totheir efforts towards substitution, in most cases information remains exemplary anddoes not allow an overview as to the substitution efforts and problems, e.g. economic
considerations that might prevent further reliability testing.
The consultant concludes that the current general scope is not justified, however
demarcating applications where substitutes are available was not possible on the basisof the data made available during the assessment. Industry is urged to generate inputthat would allow narrowing the scope of the exemption to a comprehensive list of
applications.
It is also noted that an alignment of the exemption with results of the evaluation
under ELV should be considered.
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9.6.

Recommendation

It is recommended to renew the exemption with the current formulation.
As for the duration, the exemption currently has a different validity for the various
RoHS Annex I EEE categories. While for most categories, it is set to expire on 22 July
2021, for category 8 in vitro diagnostic medical devices it is valid until 21 July 2023,
and for category 9 industrial monitoring and control instruments and category 11 EEE
on 21 July 2024. To avoid future co-existence of several sub-items with slightly
different scopes it is recommended to align all categories in terms of the validity
period, seeing as stakeholders did not provide information to show that technicaldifferences existed between categories regarding the substitution of lead in copper
alloys.

6(c)Exemption formulation

Duration“Copper alloy containing up to 4 % lead byweight”

Expires on 21 July 2026 for all
categories

To furthermore ensure that RoHS provides a similar level of environment and healthprotection as that of the REACH Regulation, and with entry 63 of Annex XVII in mind,
it is recommended to add the following phrase for precautionary reasons to the
exemption wording: “The exemption shall not be applicable to articles or accessible
parts of an article that may be placed in the mouth by children; if it is smaller than 5
cm in one dimension or has a detachable or protruding part of that size, except where
it can be demonstrated that the rate of lead release from the accessible component/part, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent
to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that
this release rate is not exceeded for a period of at least two years of normal orreasonably foreseeable conditions of use of the article”. Alternatively, this addition
could be added as a footnote to the exemption.

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10.

Exemption 7(a) “for lead in high melting
temperature type solders (i.e. lead-based alloys
containing 85 % by weight or more lead)”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings of stakeholders’ explanations and arguments have been adopted from the documents provided
by the stakeholders as far as required and reasonable in the context of the evaluation
at hand. Formulations were only altered or completed in cases where it was necessary
to maintain the readability and comprehensibility of the text. These sections are based
exclusively on information provided by applicants and stakeholders, unless otherwise
stated.
Acronyms and definitions
BGA

Ball Grid Array

BournsBourns, Inc.

DA5

Die Attach 5, a consortium established to develop a Pb-free dieattach solution consisting of STMicroelectronics, NXP
Semiconductors, Infineon Technologies, Bosch (Division Automotive
Electronics), and Nexperia

DCB

Direct copper bonding

EEEElectrical and Electronic Equipment

ESD

Electro-Static Discharge

HID

High Intensity Discharge

HMP

High melting point

HMPS

High melting point solders

IC

Integrated circuit

LED

Light emitting diode

LHMPSHigh melting point solders with a lead content of at least 85 %

Pb

Lead

PCB

Printed Circuit Board

RoHS

Directive 2011/65/EU on the Restriction of Hazardous Substances inElectrical and Electronic Equipment

SMD

Surface Mount Device

TFCB

Thick film copper bonding

TLPS

Transient liquid phase sintering

THT

Through hole technology

UP

Umbrella Project: A large number of company/businessorganizations/business associations that are participants in the
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10.1.
10.1.1.

Background
Overview of the Submitted Exemption Requests
Three applications (Bourns Inc. 2020c; Umbrella Project 2020e; 2020g) were
submitted for the renewal of Ex. 7(a) for:“Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 %by weight or more lead)”.
Both applicants (Bourns Inc. and the Umbrella Project) request the renewal of the
exemption for categories 1-11 with its current wording for the maximum duration
allowed by Article 5 of the Directive.
Bourns Inc. (hereinafter referred to as Bourns) requests the exemption explaining thatlead enables soldering at higher temperatures, while maintaining the reliability of theconnection. Lead-containing high melting point solders with a lead content of at least
85 % (LHMPS) are used in electronic components to maintain the integrity of thejoints between the die and lead-frame at the board level assembly. Bourns argues that
substitutes are currently not available, explaining that alternative solders must haveproperties to protect the solder from melting, thereby creating a failure situation.
(Bourns Inc. 2020c)
STMicroelectronics srl and Infineon Technologies AG apply for the exemptions renewal
on behalf of a large number of company/business organizations/business associations
that are participants in the RoHS Umbrella Industry Project (Umbrella Project,hereinafter referred to as UP). Their first request was submitted for categories 1-10 ofAnnex I of the RoHS Directive and the second for category 11. The UP specifies a wide
range of applications where LHMPS are still needed, claiming that though research into
possible substitutes has been underway for many years, suitable substitutes are yet tobe identified. In essence, alternative technologies with similar ductility and strength tothat of lead (Pb) alloys and that can survive a standard reflow process (or several) on
printed circuit board with either leaded or unleaded solder are as yet unavailable.
(Umbrella Project 2020e; 2020g)
In the later rounds of clarification questionnaires, Bourns participated in the UP
Group’s discussions regarding the extension of this exemption and in preparation of
responses to some clarification questions. Bourns agrees with the points addressed in
the UP submission with the addition of the individual Bourns-relevant inputs.

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10.1.2.

History of the Exemption

Exemption 7(a) for “Lead in high melting temperature type solders (i.e. lead-based
alloys containing 85 % by weight or more lead)” was initially listed in Directive
2002/95/EC (RoHS 1) 47, when it was published in 2003. The exemption was assessed
twice to establish its continuous justification (Gensch et al. 2009; Gensch et al. 2016).
In both assessments it was concluded that the exemption was still justified as
substitutes were not available for the full range of relevant applications. However, it
was also concluded that the exemption wording created a loophole, as its formulation
did not restrict the application of the exemption only to areas where substitutes were
not available. Evidence for this was provided already in the first assessment, wherestakeholder information showed that in some cases, LHMPS are applied also in cases
where solders with a lower lead content can be used.
An effort was made in the past (Gensch et al. 2016) to develop an exemption wordingthat would apply only to areas where the use of LHMPS could not be avoided, however
this attempt did not culminate in a formulation that was adopted into Annex III of the
Directive (see details in (Gensch et al. 2016)).
It is noted that Delegated Directive (EU) 2018/742 of 1 March 2018, which presents
the final decision regarding the prior evaluation of this exemption, constitutes thelegal renewal of Ex. 7(a) with its initial wordi
ng. At that time, the document was based, among other things, on the following
rationale: “no reliable alternatives are available on the market or are likely to beavailable on the market in the near future, a renewal of the exemption with a validity
period until 21 July 2021 is justified, while nonessential splitting of the wording and ashorter period could generate unnecessary administrative burden for the industry.”

10.2.
10.2.1.

Technical description of the requested exemption
Specific Properties of lead in LHMPS

Bourns and UP present the required properties of lead in HMPS which can be demonstrated by the following performance: high melting point (>260°C), thermal conductivity, ductility, electrical conductivity, electrical resistivity, corrosion resistance, resistance to thermal oxidation. Lead is still the only known element which gives all theseproperties (Umbrella Project 2020g; 2020e). Other factors include the manufacturability, reliability factors in a harsh environment and cost effectiveness. For lead-containing solders, the historical data of over 50 years of usage provides proven reliability(Bourns Inc. 2020c).
A more detailed description of specific properties of lead can be found in the lastevaluation report (Gensch et al. 2016).

47

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 1,
European Union (13 February 2003)
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10.2.2.

Uses of LHMPS

Bourns Inc. (2020c) specifies that LHMPS can be applied in various equipment andrefers to the medical equipment, aerospace, automotive and military sectors as theircustomers. Semiconductor products use high-lead solder as a die attach material
and/or as internal electrical interconnections within components including diodes,
transistors, clip bonding of discrete devices and for surface mount and insertion
components. Bourns refers to specific applications many of which are components that
inherently protect EEE from irregularities in power supply such as Electro-Static
Discharge (ESD), electricity surges, voltage level irregularities and overcurrent
situations. Among the equipment and components that need to be protected fromsuch impacts, Bourns mentions appliances in general, light emitting diode (LED)lighting and batteries in both vehicles and EEE such as mobile phones and medical
equipment. In relation to fuses for protecting battery packs, it is mentioned that these
are typically used in a harsh, extreme heat environment, where the solders must thus
have properties to protect the solder from melting thereby creating a failure situation.
It is not clear if these environmental operation conditions apply to all applications
mentioned by Bourns.
UP (2020e; 2020g) also described that high-melting point solders (85% by weight ormore lead) are used in a wide range of electronic components as well as tomanufacture equipment. This exemption is required in many types of electrical andelectronic equipment applications (in all RoHS categories). UP provided a nonexhaustive list of application areas of LHMPS as below (Umbrella Project 2020e;
2020g):
combining elements integral to an electrical or electronic component such as:−

a functional element (e.g. die, lamp socket) with a functional element, or,−a functional element with wire/terminal/heat sink/substrate, etc.



mounting electronic components onto sub-assembled modules or sub-circuitboards;

sealing materials between a ceramic package or plug and a metal case,connecting magnet wire coil to flexible conductor in high power transducers (bothlow and high frequency) used for professional sound application.

LHMPS are said to have excellent wettability, reliability due to ductility and no remelting during PCB reflow process. Components containing high lead solder are
reflowed up to 260°C without melting the inner component solder which will soften at
about 300°C. Semiconductor-type devices require these high temperature solders tomaintain the integrity of the joint between the die and lead-frame at board level
assembly (Bourns Inc. 2020c; Bosch, STMicroelectronics, Infineon, NXP, Nexperia
2021b; Umbrella Project 2020e; 2020g)
Intended use and examples for related products in which HMP lead (Pb) solders
utilized are shown in Appendix A.2.1.
In a later communication (The RoHS Umbrella Project 2021a) a table was provided toshow the properties provided through the use of Pb that are of relevance to thevarious applications in the scope of the exemption. The table is reproduced in the
appendix A.2.2. It is noted that few thresholds were provided in that table, which was

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intended to be used to understand the performance range in which LHMPS applications
would be considered.
LHMPS used as combining elements integral to an electrical or electronic
component
Plenty of microelectronic components are given as examples 48 by applicants, which
need LHMPS. The Umbrella Project (2020e; 2020g) provides figures to illustrate that
LHMPS are used to combine elements integral to an electrical or electronic component.
The figures below (Figure 10-1 and Figure 10-2) are selected and reproduced fromthe UP application to demonstrate different usage of LHMPS. Generally, LHMPS is used
for connection between two functional elements (e.g. semiconductor chips) or afunctional element and carriers (i.e. printed circuit boards, lead frames, wire,
terminals, substrates or other final assemblies). It can be seen that the LHMP solders
are used either in internal connections inside the components or in integral
connections where the LHMPS is inside the component but also visible from theoutside. The difference between „internal“ and “integral” was raised in the lastevaluation report (Gensch et al. 2016), it was discussed that “integral” covers all
joints which are connections that are partly within the space envelope of a single
component (i.e., non-visible in part from the outside) but also partly external to thatspace, i.e. visible in part from the outside.

48

Umbrella Project (2020e), (2020g): Resistors, capacitors, chip coil, resistor networks, capacitor
networks, leaded inductors, power semiconductors, discrete semiconductors, microcomputers, ICs, LSIs,
chip EMI, chip beads, chip inductors, chip transformers, power transformers, lamps, resistancetemperature devices (RTD), electromechanical relays for automotive (just as reference) and industrialuse, etc
Bourns Inc. (2020c): Components include Transient Voltage Suppressor Diodes, Fast Response Rectifier
Diodes, High Voltage Rectifier Diodes, Schottky Barrier Rectifier Diodes, Power TVS Diodes, Telecom
CPTC Resettable Fuses, Thick Film Molded DIP/SIP, Thin Film Molded SIP, Thin Film Wide Body Gull Wing
Resistor Network, Thick Film Surface Mounted Body Wide Resistor Network, Thyristor Surge Protector(SMA and SMB packages), Telecom Ceramic PTC Resettable Fuse, Fast Acting Precision SMD fuse, Single
Blow Fuse for Overcurrent Protection, High Inrush SMD Fuse, Telecom Protectors, High Surge, Time Lag& Low Power SMD fuse. These electronic components are typically used on circuit boards and otherinternal electronics of the various categories used by our customers.
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Figure 10-1: Examples of LHMPS used as combining elements integral to anelectrical or electronic component

Source: (The RoHS Umbrella Project 2021d; Umbrella Project 2020e; 2020g)

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Figure 10-2: Examples of LHMPS used as combining elements integral to anelectrical or electronic component

Source: (The RoHS Umbrella Project 2021d; Umbrella Project 2020e; 2020g)

Another example raised by Umbrella Project (2020e) is ribbon cable connections tocapacitors in medical devices (category 8). It is described that a medical device
manufacturer connects capacitors to ribbon cables using a HMP solder which are then
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reflow soldered to a printed circuit board (PCB) using lead-free solder. The higher
melting point of the HMP solder is essential to prevent the bonds to the capacitors
failing during reflow of the PCB, which is typically at 240 - 260°C. The medical device
manufacturer is evaluating alternative lead-free solders, but has not found any reliable
alternative to date. If standard lead-free solders are used to connect to capacitors,
these melt and de-bond when the cables are soldered to the PCB.
Further detailed description of the technical background can be found in the lastevaluation report by Gensch et al. (2016) and contributions of applicants.
LHMPS used as mounting electronic components onto sub-assembled
modules or sub-circuit boards
This application group refers to components that are externally mounted onto e.g. PCBor lead frames by using LHMPS solders. Solder joints are visible from the outside.
Examples of related products are hybrid IC, modules, optical modules, etc (Umbrella
Project 2020e; 2020g).
Figure 10-3 shows examples for how LHMPS are used to mount electronic components
onto sub-assembled modules or sub-circuit boards. With respect to second level solder
joints, two concrete cases can be identified:I) solder balls for the attachment of ceramic ball-grid-array (BGA)
II) when attaching high temperature plastic overmouldings (> 220 °C)
Regarding item I), a graphic (Figure 10-3, left) can be found in the evaluation reportof 2009 (Gensch et al. 2009). With respect to item II), one use case provided is plastic
molded timing devices (like i.e. crystals, oscillators), where the cylinder crystal issoldered onto a lead frame using LHMPS (The RoHS Umbrella Project 2021d). The
RoHS Umbrella Project (2021e) clarifies that LHMPS is used to solder components onto
printed circuit boards or lead frames, which afterwards are overmoulded with hightemperature plastics.
Figure 10-3: BGA component with HMP balls (left) and cylinder crystal
soldered onto a lead frame using HMP (right)

Source: left (Gensch et al. 2009); right (The RoHS Umbrella Project 2021d)

Further detailed description of the technical background can be found in the lastevaluation report by Gensch et al. (2016).

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LHMPS used as sealing materials
Examples of related products are SAW (Surface Acoustic Wave) filter, crystal resonators, crystal oscillators, crystal filters, etc (Umbrella Project 2020e; 2020g).
LHMPS is used for sealings between a ceramic package or plug and a metal case. In alater communication, Bourns Inc. (2021d) added that LHMPS is also used for sealing
between component terminations and internal sub-parts.
Figure 10-4 illustrates examples of these two cases, in which Pb (>85%) is used as ahermetic sealing material. The left figure shows the use of LHMPS for sealings between
a ceramic package or plug and a metal case in a crystal resonator. The right figure
demonstrates that LHMPS is used as a hermetic sealing material between component
terminations (electrode) and an internal sub-part (fuse element) in a SMD fuse.
Figure 10-4: LHMPS used in a crystal resonator (left) and a SMD fuse (right)
as sealing material

Source: left (Umbrella Project 2020e); right (Bourns Inc. 2021e)

LHMPS used in lamps
Oven lamps are commonly used in various household ovens. (Umbrella Project 2020g;
2020e) explains that the temperature of the lamp can reach >250°C during the baking
process and it may reach 300°C during the oven cleaning cycle, the so-called pyrolysis. The electrical contact between lamp and lamp socket is provided by mechanicalcontact of the solder in the lamp base with a spring in the lamp socket. Any oxidation
between these parts will cause an increased electrical resistance that may result inelectrical arcs which poses a safety risk. In the later communication, The RoHS
Umbrella Project (2021d) explains that LHMPS materials in lamps are mainly used forsoldering a solid electrical connection between electrical (lamp) components (and notin or inside lamp components). The solder point connection in many cases is visible
from the outside, e.g. when used to connect the lamp cap to the internal wires (Figure10-5).

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Figure 10-5: Example of an HID lamp with LHMPS material to connect thelamp cap to the internal electrical wiring of the lamp

Source: (The RoHS Umbrella Project 2021d)

LHMPS used in audio transducers
Audio transducers, e.g. voice coils, are used to measure flow and density properties inindustrial measurements in combination with a permanent magnet. The application
includes chemical plants, refineries, food and beverage, pharmaceutical industries,
etc. Industrial equipment that uses voice coils and magnet wire include magnetic flow
meters, Coriolis flow meters, density meters, and many others. Additionally, solenoid
valves and other types of valves also use voice coils and LHMPS. In these examples,
process temperatures can extend into areas where LHMPS is required. Additionally,
many applications use steam and/or heated liquid cleaning which also requires use of
LHMPS. Termination of magnet wire is required of many other types of components(The RoHS Umbrella Project 2021d).
The RoHS Umbrella Project (2021d) explains that LHMPS is needed where the peak
operating temperature exceeds the melt point of lead-free solders. Because thesesolder joints are on the moving voice coil, they have very high acceleration forces onthem when they are being driven at levels high enough to reach the peak operating
temperatures. Any softened or molten solder will be thrown from the electricalconnection in those cases. The solder joint will then either open electrically or it canalso start arcing due to the very high voltage potential. Both conditions cause field
failures, the arcing can also lead to things such as arc tracking and combustion issues.
An example of a voice coil is shown Figure 10-6.

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Figure 10-6: Example of a voice coil
Das verknüpfte Bild kann nicht angezeigt werden. Möglicherweise wurde die Datei verschoben, umbenannt oder gelöscht. Stellen Sie sicher, dass die Verknüpfung auf die korrekte Datei und den korrekten Speicherort zeigt.

Source: (The RoHS Umbrella Project 2021d; Umbrella Project 2020e; 2020g)

Further detailed description of the technical background can be found in the lastevaluation report by Gensch et al. (2016) and contribution by applicants.
10.2.3.

Amount of lead used under exemption 7(a)The content of lead for HMPS applications is 85% or more by weight of thehomogeneous material based on (Umbrella Project 2020e; 2020g) and 88%-95.5%(Bourns Inc. 2020c).
In relation to the amounts of lead placed on the market in LHMPS used in EEE, the2015/2016 report (Gensch et al. 2016) specifies around 11,000 t corresponding toaround 9,400 t of lead globally for 2000. For 2009 it refers to a JBCE statement,
estimating LHMPS put on the EU market with 3,600 t/year corresponding to at least
3,100 t of lead. This figure is understood to have not included the LHMP solders
contained in products imported into the EU market. In 2015/16 Freescale/NXP et al.
estimated the amount of LHMPS put on the EU market with around 2,700 t, whichcorresponds to at least 2,300 t of lead. This figure was also understood to not include
the lead from LHMPS used in products imported into the EU.
In the current review, Bourns estimated the worldwide amount of lead from LHMPS
based on its own products at around 0.838 tonne (Bourns Inc. 2021c). Bourns Inc.
(2021c) adds generated information that the metric tons average, based on parts
shipped to the European market (including the UK), for the last three years is 0.15
metric tons of Pb from high temp solder.
The Umbrella Project estimated the amount to range between a few kg and 31 tonnes
per year (Umbrella Project 2020e). However, this is understood to be based on
answers of individual member companies of this working group that participated in asurvey, i.e., representing amounts for single companies and not an aggregation
representative for all members let alone for the complete market.
Based on data provided by stakeholders, the contractor attempted to estimate theamount of Pb in HMP solders using the following information/assumptions:15.02.2022 - 120

European Commission
RoHS Exemptions Evaluation: Pack 22“the amount of Pb in HMP solders for EEE is estimated to be less than 0.2% of thetotal Pb placed on the market per year” 49.

“According to the International and Lead Zinc Study Group, in 2015, around
10,000 tons of lead were used in the EU for ‘miscellaneous’ uses which includes
leaded alloys and solders, presumably including those going into the electronics
sector. This amount represents approx. 1% of the total EU usage of lead peryear” 50.



the amount of Pb per year in HMP solders in the EU: 10,000 tonnes / 1%
*0.2%=20,000 tonnes

The applicants and contributors were asked to comment on the above estimations. UP
commented that they do not have a reliable estimate on the total LHMPS in EEE in
Europe. However, UP states that these estimations with 20,000 tonnes are excessive
based on a new UP estimation, which is described below (The RoHS Umbrella Project
2021c; 2021d):
an estimation of the total scrap WEEE collected in EU accounts for 15 Million t/a
Urban based on Urban Mine platform 2020



PCB are estimated to be 1 % of the total waste scrap, this accounts for 150,000 t
PCB/a.

according to Swiss Federal Office for the Environment (FOE) - Substance flows inSwiss e-waste, 11.000 ppm (= 1,1 %) of Pb in PCB are mainly used related to thesoldering of packages onto the PCB. The FOE study was based on E-scrap before
RoHS entered into force. UP estimates that the average amount of lead in PCBs
has reduced by around 90 % by introducing lead-free soldering of PCBs following
the RoHS lead ban.

Hence, the estimated amount of Pb soldered to PCBs in the EU would be:150,000 t
PCB/y*1,1%*(1-90%) ≈150 tonnes Pb/year.

When asked whether the estimation of 150 tonnes/annum covers LHMPS used for all
applications, e.g. sealing materials, UP explains that all devices soldered to a PCB arecounted for in the estimated 150 tonnes/annum. This estimation includes sealing
applications. A typical value for sealing of a ceramic housing encapsulating a die
structure is 2 mg per component (The RoHS Umbrella Project 2021d).
The consultant notes that this estimation is based on the amount of WEEE collected.
In 2018, the collection rate of WEEE was 47 % in the European Union 51. In this sense,
this estimation may still represent only part of the WEEE placed on the market.
Table 10-1 summarizes the trajectory of lead used in HMP in the scope of exemption
7(a) since the last evaluation.

49
50
51

Umbrella Project (2020e), Page 11
Umbrella Project (2020e), Page 28
See: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Waste_statistics__electrical_and_electronic_equipment#Electronic_equipment_.28EEE.29_put_on_the_market_and_WEE
E_collected_by_country
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Table 10-1:

summarized the trajectory of lead used in HMP in the scope of
exemption 7(a) since the first evaluation

In the scope of
exemption 7(a)Lead brought on
the global
market in
LHMPS

Lead brought on the EU
market in LHMPS

2000 (Gensch et al. 2016)

9,400 tonnes

unknown

2008/2009 (Gensch et al.
2016)

unknown

3,100 tonnes (This figure did notinclude the LHMP solders
contained in products imported
into the EU market.)2016 (Gensch et al. 2016)

unknown

2,300 tonnes (this figure did notinclude the lead from LHMPS in
products imported into the EU.)

Current assessment: 2020
own estimation

unknown

20,000 tonnes

Current assessment: 2020
estimated (The RoHS
Umbrella Project 2021c;
2021d))

unknown

150 tonnes

The figures differ depending on the applied calculation base and product spectrum aswell as assumptions taken into account. The estimation made often have a degree of
uncertainty and do not allow concluding as to the total amount of lead. However, one
issue is clear, i.e. the amount of lead used under this exemption is NOT negligible.

10.3.

Applicants’ justification for the requested exemption

Bourns (2020c) explains that Bourns is still researching and testing alternative solders
or processes to eliminate LHMPS in applications in some cases. Additional detail is notprovided as such information is regarded as proprietary; however, this effort is
explained to relate to a specific product line and Bourns states that it may not provide
a solution for other product lines.
The Umbrella Project (2020e) explains that substitution is currently not possible,
mentioning the various properties required from substitutes. Alternative technologies
are not yet available that have the combination of ductility and strength of Pb while
retaining reliability during one or several reflow processes (melting of solder) which
would otherwise weaken the bond.

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10.3.1.

Availability of alternatives

Lead-free Solders
Bourns Inc. (2020c) refers to a few potential substitutes in its application including
gold, zinc, bismuth or tin/ antimony-based solders. Potential substitutes are explained
to have reliability issues including voiding/cracking/disruption after stress, growth ofbrittle intermetallics at high temperature and disruption during temperature cycling.
For gold-based solders low ductility and a low melting point is explained to be adisadvantage in comparison to LHMPS. For the other mentioned candidates there islimited experience with alternatives regarding their reliability.
The Umbrella Project (Umbrella Project 2020e; 2020g) refers to two additional sourcesof information related to alternatives for die-attach applications: Vishay and the DA5
consortia. Vishay is said to have evaluated lead-free materials for internal die-attach,including solder pastes and solder wires based on the BiAg, AuSn and SnAgCu systems
as well as silver sinter pastes, sinter epoxy and silver epoxy from several suppliers.
None of the evaluated materials have proved capable of replacing HMP lead (Pb)solder in terms of manufacturability, quality and reliability. Detail given in the
Umbrella Project applications provides a summary of experience with some alloys(reproduced in Appendix A.2.3). Bosch, STMicroelectronics, Infineon, NXP, Nexperia(2021b) provides similar information as the last evaluation. Advantages anddisadvantages of alternative solders are shown in Appendix A.2.3 to justify thatalternative Pb-free HMP materials currently available on the market do not meet or
exceed the required functionality and reliability for the various uses.
Conductive Adhesives
Advantages and disadvantages of conductive adhesives are shown in Appendix A.2.3.
More detailed information is presented in the section on “Efforts of the Die Attach 5(DA5)” in the Umbrella Project applications (2020e; 2020g). However, it is very
similar information to that in the application submitted to the 2015/2016 assessment.
As of mid-2019, the DA5 consortia are not aware of any solution (glue or othermaterials) that can replace HMP lead (Pb) solder, for the time being. HMP solders andadhesives belong to completely different material classes and perform very differently.
Some adhesives constituents are classified as CMR 52 (Umbrella Project 2020g; 2020e).
For conductive adhesives, these are said to have the same or better mechanical,
thermal, and electrical properties compared to solder, and can be used in die bondequipment for dispensing, chip placement, and curing of the material (Drop-In
Solution) (Bosch, STMicroelectronics, Infineon, NXP, Nexperia 2021b). As it is also
specified that, depending on package type and die size, these can pass automotive
environment stress test conditions (AEC-Q100, AEC-Q101) (Bosch, STMicroelectronics,
Infineon, NXP, Nexperia 2021b). The consultant assumes that at least in some cases,
conductive adhesives provide sufficient reliability. In this respect, limitations are
specified to possible applications with the following aspects that also have quantified

52

Assumed to refer to “carcinogen, mutagen or reprotoxic”, hazardous properties of a substance
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thresholds (additional aspects can be viewed in (Bosch, STMicroelectronics, Infineon,
NXP, Nexperia 2021b)):


the maximum die size (~50 mm²), which is strongly dependant on package
design, bill of materials and inclusion of a backside metal,

Use is currently only possible when the die thickness is >120 μm (though theUmbrella Project (2020e) mentions that adhesives are the typical solution for verythin lead-frames (~200μm) due to unacceptable lead-frame bending after a hightemperature soldering process),The moisture sensitivity level, which is greater than MSL3/260°C, is a limitation forhigh power devices. However, from past information application in low andmedium power devices is understood to be possible,



Information provided during the last assessment (Gensch et al. 2016) further
clarifies that adhesives cannot be used for products with a high junction
temperature (>175°C), as organic components of the glue tend to degrade at suchtemperatures,

Umbrella Project (2020e; Umbrella Project) also indicates that adhesives can be asolution for packages which don’t need to be exposed to the higher soldering
temperature (~400°C soldering temperature versus ~150°C glue curing
temperature). E.g. Ball Grid Array (BGA) packages with organic substrates use
adhesives for die-attach. Furthermore, adhesives are explained to have a bigger
process window as compared to solder and can be used also for non-metalized chipbacksides.

TLPS sintering
New information (Bosch, STMicroelectronics, Infineon, NXP, Nexperia 2021b) on
transient liquid phase sintering (TLPS) suggests that these could be used for smaller
dies but have potential incompatibility for dies above 50 mm2 due to high modulus anddelamination risk. Potential reliability issues related to the formation of cracks are
related to Kirkendall voids that form during IMC (consultant addition - intermetallic
compounds) growth at 175°C during HTSL (consultant addition - high temperaturestorage life). A risk of oxidation of copper is also mentioned if the oxygen
concentration exceeds 300 ppm during sintering under nitrogen. In summary, thoughthese materials are considered to have potential for use in SiP (system-in-package)and clip packages, the maturity of the technology is still low and requires additional
research to establish reliability, which appears to be dependent on the package / leadframe material. Potential use for thin die (thickness <100μm) is also not yet clear.
DCB (direct copper bonding)
The last evaluation report in 2016 (Gensch et al. 2016) concluded that DCB (direct
copper bonding) technology, sometimes also named “direct bonded copper (DBC)” caneliminate the use of lead in LHMPS at least in specific cases, but these are restricted toceramic substrates, and surface mount technology (SMT) components require LHMPSin the internal interconnects. Gold-silicon DCB is applicable for die size less than 3
mm. The AuSi eutectic die attach on a bare copper lead frame may have a risk ofbrittleness. Littelfuse Inc. corporation (2021) confirms in this current evaluation phasethat this knowledge is still valid. A full switch for lead free soldering for all products is
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still not possible. As for asking for specifying application areas with a combination ofcorresponding technical parameters where the usage of DCB is possible and reliable,
no further information is provided. The UP was asked to provide more information on
application areas with a combination of corresponding technical parameters where theusage of DCB would be possible and reliable but did not provide further information.
Thick film copper bonding (TFCB)The RoHS 2 assessment of exemption 7(a) in 2016 (Gensch et al. 2016) described
thick film copper bonding (TFCB) in the context of die attach. This information was
submitted by TT Microelectronics/AB Mikroelektronik GmbH (AB) at the time. TFCB
could partially replace LHMPS and thus eliminate the use of lead. The relevant
description is reproduced below from the 2016 assessment report: “According to AB,
thick film substrates are sintered structures so there is more flexibility in comparison
to the laminated DCB substrates. This flexibility reduces stresses in the die attachmaterials as well as the large area soldering joint needed to contact to the heatsink orbaseplates. In general, the thick film substrates can be directly substituted for a DCB
for instance, when higher current applications demand thicker copper conductors
electrically and thermally. AB has successfully tested TFCB on AlN (aluminium nitride
ceramic) and Al2O3 (aluminium oxide ceramic) substrates. Organic substrates such as
FR4 have not been tested as of yet, but the processing requires high temperatures ofmore than 800 °C. AB are a supplier to the automotive industry, and they have asister company working in the aerospace industry, where TFCB has proven to be more
effective concerning lifetime between zero and 350 °C.”
The Umbrella project was asked to comment on TFCB technology. UP Exemption # 7a
WG Participants understand that the thick film copper bonding (TFCB) technology
mentioned is limited to a narrow subset of substrate and not suitable to all electronic
components. The higher mechanical stress acting on dies is caused by the mismatch
between the coefficients of thermal expansion of silicon and copper, which does notchange when using TFCB instead of copper lead frame (The RoHS Umbrella Project2021b). UP are not aware of any specific EEE product groups where this technology
can be used as an alternative to LHMP.
10.3.2.

Environmental and health arguments (also LCA aspects)

Bourns Inc. (2020c) refers to the carcinogen properties of Pb and Pb soldering being
considered an activity with a risk of exposure. However, hazardous properties are alsomentioned for silver, copper and tin as comparison. Regarding the possible preparation for reuse or recycling of waste, Bourns Inc. (2020c) states that as a component
manufacturer it is not aware of the treatment of e-waste. In the US, the EPA classifies
electronic waste as universal waste and requires specific handling.
The Umbrella Project (2020e) does not raise environmental arguments, explainingthat as long as a suitable substitute is not identified, assessment data cannot beprovided. Nonetheless it is mentioned that a proposed alternative contains dibutyltin
dilaurate (CAS# 77-58-7) which is a REACH SVHC, while other materials under current
evaluation are also under assessment for possible hazardous properties like silver andantimony. Concerning the reuse or recycling issue, Umbrella Project (2020e) explainsthat no closed loop system exists specifically for HMP lead (Pb) solders as most
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component and equipment suppliers do not take back their own products at the end oflife. HMP lead (Pb) solders are incorporated into the larger EEE and should be recycledaccording to the requirements of the WEEE Directive and EU waste legislation.
Umbrella Project (2020e) concludes based on a few references (see detail in section 5of application document) that recovery and recycling of lead is well established for thelarger flow of WEEE where these solders are used.
10.3.3.

Socioeconomic impacts

Bourns Inc. (2020c) states that alternatives for LHMPS with high gold content are
typically high priced. For example, if a gold material was a potential substitute, it may
drive the cost of the finished components up where it is difficult to be competitive.
Equipment and/or process changes could be necessary in case that substitutes
become available, currently however such substitutes do not exist.
The Umbrella Project (2020e) does not raise socio-economic arguments, explainingthat as long as a suitable substitute is not available, assessment data cannot beprovided. It is however explained that a very large proportion of the electricalequipment currently used in the EU could not be sold in the EU, should the exemption
not be renewed, which would have adverse impacts on the EU’s economy.
10.3.4.

Roadmap for Substitution or Elimination of Lead

Bourns Inc. (2021e) explains that it continue to view potential substitute claims but,so far, they cannot compare to the properties and reliability of the LHMPS. Bourns
continues to follow up on these potential substitutes with the intention of finding
alternatives that can meet or beat the current LHMPS but also continue to be costeffective. Bourns does not yet have a definitive timetable since current potential
alternatives do not seem to exist at this point in time.
The RoHS Umbrella Project (2021d) describes that material suppliers are working on
alternatives for LHMPS to address the requirements of industry. High temperatureadhesives and Transient Phase Liquid Sinter materials are showing particular hope forthe future, but there is nothing now that meets all the technical requirements that
LHMPS meets. Umbrella Project (2020e) states that various efforts are undertaken by
the EEE industry to find substitutes for LHMPS, which currently have not concluded.
The applicant explains the typical time scale from identification of a suitable substitutematerial to commercial use in electrical equipment as follows: Research and development of candidate materials lasts 4 years on average. If successful, an additional 6
years is considered necessary for the next phases up to mass production.
Information on efforts related to die attach is provided on the basis of the Die Attach 5
consortia which has been working with suppliers for several years to identify andevaluate alternatives to LHMPS. DA5 (2020) have evaluated a variety of new materials
available from global suppliers of solders, high thermal conductive adhesives, silver(Ag) sintering and transient liquid phase sintering (TLPS) materials. DA5 recognize(Bosch, STMicroelectronics, Infineon, NXP, Nexperia 2021a) that substantial development efforts have been running for more than 11 years. 145 materials from more than
13 suppliers were evaluated. Close to 50 of those materials were selected for exten-

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sive testing by DA5 member companies. Although some promising results were identified in specific applications, none of the materials proved suitable as a general Pbreplacement solution. While the DA5 consortium has not yet found a reliable lead-freepackage technology for power semiconductor components, the research is promising
for long-term solutions (Bosch, STMicroelectronics, Infineon, NXP, Nexperia 2021a).

10.4.

Stakeholder contributions

The exemption was subject of a stakeholder consultation, where contributions were
submitted by Huawei, SEMI Europe, Test Measurement Coalition, Fresenius Kabi,
Norwegian Environment Agency, Hitachi, Lucky Forests Corporation Ltd. Seven
individual contributions have been submitted during the consultation period from 30
March 2021 to 08 June 2021. The individual contributions are summarized in Table
10-2 below.
IXYS Semiconductor GmbH who submitted a request for the renewal of Ex. 7(a) in2014 which was included in the last assessment did not participate in the consultation.
Due to their past involvement and indications that they were looking into substitutes,
IXYS was asked if they had substituted LHMPS in their applications or still needed theexemption. The company responded that it became part of Littelfuse Inc. corporationin 2017 and still need the exemption.
Table 10-2:

An Overview of other contributors and main statements inrelation to Ex. 7(a)Contributors
for exemption
renewal

Relevant
EEE
categories

Relevant
components/applications

Remarks

SEMI Europe(2021)(support
renewal)

Not indicated• AMPLIFIER, SENSOR, CCD
MICROMETER

support applications
made on the behalfof the Umbrella
Project Participants• TOWER, COMPUTER• CONVERTER, PNP OUTPUT• CRYSTAL 24MHZ SMD /CRYSTAL OSC 1.8432MHZ SMD• DIODE,3A / DIODE,P6KE15CA.
• FUSEHOLDER + FUSE 2A SMD• I/O UNIT, SEQ CONTR• IC REG POS VOLT 1A 5V D2PAK

Test &
Measurement
Coalition(support
renewal) (Test& Measurement
Coalition 2021)

Cat. 9:industrial
monitoring
and control
equipment

Not indicatedmaintaining the
exemption’sreferences
unchanged, i.e.
application will be
submitted 18 months
before the expiry
date of 21 July 2024;

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Contributors
for exemption
renewal

Relevant
EEE
categories

Relevant
components/applications

Remarks(ABB Power
Grids
Switzerland
Ltd.,
Semiconductors
2021a)(support
renewal)Cat. 8 and 9High Power Semiconductors areused and installed in rush
environments. These modules are
not defined as EEE, as they are
specified for high-power
applications exempted per
definition in Article 3(1). We need
the exemption 7(a) to prove theconformity with the directive forour end customers in the Railway-,
Energy Distribution-, and with new
designs in the Medical Industry.

• The uniqueproperties such as
the high melting
point and thermal
conductivity of thehigh-lead alloys
are necessary forthe level ofreliability required.

TVS and Zener Diode (power
rating: 1.5 Watt-15000 Watt):
Solder and Electrical and electronic
components containing lead in aglass

No suppliers can befound to deliver leadfree solutions.

• so far, no lead-freesolution has been
identified

Lucky Forests
Corporation
Ltd. (support
renewal)(Lucky Forests
Corporation Ltd
2021a)

Cat. 1-11,
depending on
the EEE in
which theelectronic
component isused in an
assembly

Fresenius Kabi
(2021)

Agrees with the scope statements in the Bourns and first Umbrella Projectapplication

Huawei(Andrae 2020)

Provides indicative calculation of environmental impacts of Sn-95Pb
compared to lead-free alternative solders.

NorwegianEnvironment
Agency (2021)• Article 5(1)(a) in the RoHS Directive (2011/65/EC) stipulates thatexemptions can be included in Annexes III and IV for materials andcomponents of EEE for specific applications. Our interpretation is thatboth the material or component and the specific applications need to be
defined in the description of an exemption.
• With the current wording of exemption 7(a), it is almost impossible toperform enforcement activities, since it is unclear when it is justified totake advantage of this exemption.

Littelfuse Inc.
corporation(Littelfuse Inc.
corporation
2021)• After inquiring: IXYS Semiconductor GmbH being since 2017 part of the
Littelfuse Inc. corporation, does still need the exemption 7(a).

The Swedish
Chemicals
Agency, KEMI
(2021)• KEMI states that the current wording of exemption 7(a) makes it almost
impossible to perform enforcement activities, since it is unclear when it
is justified to take advantage of the exemption.

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Contributors
for exemption
renewal

Relevant
EEE
categories

Relevant
components/applications

Remarks• To improve the situation KEMI proposes that manufacturers be required
to justify the use of such exemptions in the technical documentation of
the application (component/EEE). For this purpose, KEMI further
proposes to investigate whether it is possible, to add requirements forsuch a justification in standards or in module A in Annex II in
768/2008/EC 53.

10.5.
10.5.1.

Critical review
REACH compliance – Relation to the REACH Regulation

See section 4.1 for details.
10.5.2.

Scientific and technical practicability of substitution

The core of the applications submitted for renewal of Ex. 7(a) and of the stakeholder
contributions submitted to the consultation focus on the difficulties of substitution. In
general, it is claimed that available substitute candidates have various limitations anddo not provide the combination of technical properties and high reliability that LHMPS
do. In relation to some of the candidate alternatives, it can be understood that use
may be possible for certain applications, some of which are understood to be in therange of the current exemption:For conductive adhesives that can be used in die bond equipment for dispensing,chip placement, and curing of the material it is specified that, depending on
package type and die size, these can pass automotive environment stress test
conditions (AEC-Q100, AEC-Q101) (DA5 2021a). From the consultants experience,
automotive applications often have quite high reliability specification and so thoughadditional research may be needed, the consultant would assume that at least insome cases, the reliability of conductive adhesives would suffice also for EEE
applications, though certain limitations were mentioned,

For TLPS sintering it was mentioned that these could be used for smaller dies but
have potential incompatibility for dies above 50 mm2 and the maturity of thetechnology is still low and requires additional research to establish reliability(Bosch, STMicroelectronics, Infineon, NXP, Nexperia 2021b),

The last evaluation report in 2016 (Gensch et al. 2016) already concluded that
DCB technology, can eliminate the use of lead in LHMPS at least in specific cases,
which are restricted to ceramic substrates,It was understood in the past that TFCB could partially replace LHMPS and that thecompany AB had successfully tested TFCB on ceramic substrates.

However, it is claimed that this is not the case for most of the application range, i.e.
that substitutes are not available for applications for which the renewal of the
exemption is requested. The consultant understands this to mean that in some specific53

Decision No 768/2008/EC on a common framework for the marketing of products, available under:
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32008D0768&from=DE
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cases it was possible to apply substitutes for certain applications. This is also assumed
to be represented in the communicated decrease over time in the amount of leadplaced on the market through this exemption. Stakeholders were asked to provide
positive experiences of substitution of LHMPS. Bourns Inc. (2021e) and The RoHS
Umbrella Project (2021d) stated that at the current state there are no examples of
direct substitution. This seems to contradict other statements made by some of the
stakeholders.
Only little information is provided as to research into substitutes and further planned
actions, concerning only a few application areas like die attach and research on leadfree solders by Vishay. Nonetheless, Annex V of RoHS specifies the minimum
information requirements for exemption applications, specifying that these should
detail among others “g) the proposed actions to develop, request the development
and/or to apply possible alternatives including a timetable for such actions by theapplicant”. For most application areas, such information has only been provided invery general terms and does not clarify to what degree industry is actually engaged in
the search for substitutes.
The applicants claim that LHMP solders are used for a wide variety of applications. The
Umbrella Project (2020e) states that no new lead-free HMP solder alloys have been
discovered since the last exemption 7a renewal request was submitted in January 2015.
They argue that this is hardly surprising as extensive research was carried out when
RoHS was adopted in 2002 and all possible combinations and permutations of chemicalelements available in the periodic table have been evaluated. Industry continues toresearch novel substitute technologies. However, only little new information is provided
by applicants as compared to the last evaluation.
Three potential lead-free solders (Bi System, BiAgX and Au-Sn) have a melting
temperature above 260°C, which could be comparable to LHMPS. The consultant
therefore asked for the concrete physical properties of certain lead-free solders
compared to the performance of lead-based HMPS. No values on physical properties
were provided, although the disadvantages are generally described by applicants(reproduced in Appendix A.2.3). The consultant assumes that not all properties referred
to are relevant to all applications of LHMPS. In this sense, there may be areas where acertain alternative could be relevant for a narrow set of applications that only require a
few of the properties provided by lead and that are thus also provided by a candidate
alternative. When asked for examples of concrete applications, in which BiAgX could
successfully replace LHMPS, The RoHS Umbrella Project (2021c) states that they do nothave concrete application examples and explains that the material is not suitable formass production due to low yield. Trials were stopped due to low performances. In any
case this material cannot replace LHMPS, it can be used in case the product would havelower requirements, as it can happen with glues and conductive solid adhesives. The
consultant contacted Indium Corporation as suppliers of one potential substitute, BiAgX,
hoping to get a better understanding of physical characteristics and in which
components and in which concrete applications BiAgX can be applied without any lossof reliability. Though the company responded to a first inquiry, it did not provide
additional detail and did not respond to further requests.
As for any new knowledge or findings concerning the applicability of DCB technology
as a substitute, The RoHS Umbrella Project (2021b) states that they have no evidence
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of new findings concerning the usage of DCBs in combination with Gold Silicon solder(IXYS technology). DCB technology has limitations (such as significantly lower thermal
conductivity than Copper-based alloys) which make it unsuitable for replacing copper
alloy-based lead frames in SMD devices.
Lead used in oven lamps
Constrained by the operating temperature, currently available lamp technologies(Incandescent, CFL, LED lamps) are unable to apply any reliable or safe alternatives
for light sources using HMP lead (Pb) solders (Umbrella Project 2020e; 2020g).
Umbrella Project (2020e; 2020g) claims that various combinations of solder andspring materials have been proven in use for a long time in existing oven technologies.
No reliable solution has been found. Commonly available Pb free solders (SnxAgyCuz)
usually exhibit melting points up to 230°C, and thus will melt under maximum
temperature regimes in ovens. After cooling down to ambient temperature, the again
hardened solder will have established a permanent mechanical fixation of the lampbase with the spring in the lamp socket. The limited time and resources available forthe review of this exemption did not allow further discussions with the applicants tofind out whether melting point of lead is the only essential property considered in thisspecific application, since other alternatives e.g. BiAgX solder has a melting
temperature (s. Appendix A.2.3) above 320°C. In addition, The RoHS Umbrella Project(2021d) confirmed that the lamp types in which the current application of LHPMS isneeded can be considered as conventional lamp technologies. These include
incandescent and halogen lamps and high intensity discharge lamps (ceramic metal
halide lamps, quartz metal halide lamps and high-pressure sodium lamps). The
consultants are aware that such technologies are older and are being replaced where
possible by light emitting diodes (LED) and organic LED (OLED) where possible or by
future innovations. UP (2021d) states that current LED and OLED technologies are notable to withstand the heat occurring in this specific application and therefore cannot
be applied to eliminate the use of lead.
Lead in high power audio transducers
The RoHS Umbrella Project (2021d) explains plausibly why LHMPS is still needed inhigh or low frequency audio transducers. Regarding the definitions of “low frequency”
and “high frequency” transducers, The RoHS Umbrella Project (2021b) explains that
there are not fixed rules. Generally, “low frequency” transducers are up to around
2kHz, while “High frequency” transducers are usable in the 1kHz to 20kHz range. It isnoted that these are general frequency ranges and should not be used as a fixed
definition. The RoHS Umbrella Project (2021d) further explains that the low frequency
transducer versus the high frequency transducer does not directly affect the peak
operating temperatures. It can have an effect on the heating mechanism, but the peak
operating temperatures remain around the same. The reason for the separation is thatthe options for designing the need for LHMPS out of the high frequency transducer ismore limited than in the low frequency transducer. For example, one of the best ways
to remove the need for LHMPS in an audio transducer design is to move the location of
the solder joint far enough away from the coil of wire that drives the transducer so theheat generated in that coil cannot overheat the solder. In a high frequency transducer
this is not easy to accomplish. The high frequency transducer is very sensitive to mass
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RoHS Exemptions Evaluation: Pack 22changes in the voice coil and the dimensions are very small. There physically is notenough distance available on the entire coil structure to move the solder joint far
enough away to make a difference in temperature. Moving the solder joint off the coilmeans that the very fine gauge magnet wire will have to extend through the area ofthe moving structure in the transducer that operates as the compliance in themechanism. That “Suspension” area is basically the flexible hinge point that allows forthe diaphragm of the transducer to move axially. This magnet wire often must bealuminum for mass reasons and as such it is even more susceptible to fatigue failuremodes from the flexing. In current typical designs Bosch solders either a beryllium
copper or phosphor bronze strip of wire to the coil wire on the coil form and then thismore flexible material is what passes through the suspension area.
Bosch has developed a way of producing low frequency transducer coils that moves
the solder joint far enough away from the coil windings to make the use of lead-freesolder possible. Bosch is in the process to industrialize these new coils in one of its
factories. There are a small number of cases where the new coil is not capable ofmatching the performance of the current coil made using LHMPS and in those cases
Bosch is committing to phasing these products out of production over the coming 5
years. This is a somewhat lengthy process because Bosch must engineer new systems
to replace those current systems in the market place (The RoHS Umbrella Project
2021d). In addition, Bosch also states that they have also made progress in removing
the need for LHMPS in high frequency transducers and are committing to making
these changes in all products where it is possible and to phasing out any products
where the changes are not possible.
The RoHS Umbrella Project (2021b) considers that some legacy products will NOT beable to be converted. The reason for this is that making those changes would too
dramatically change the products performance and specifications making it no longer
viable as a product and/or incompatible with existing products and installations. Boschis asking for transducers related LHMPS exemption to be renewed for a period of 5
years to allow for this industrialization, re-engineering, and phasing out process to becompleted (The RoHS Umbrella Project 2021d; 2021b).
10.5.3.

Environmental arguments and socioeconomic impacts

Generally, no environmental and socioeconomic impacts are raised by the Umbrella
project, since no suitable substitutes exist at present. Bourns mentions the hazardous
properties for silver, copper and tin as comparison. Regarding the reuse or recycling at
the end-of-life, both applicants argue that HMP lead (Pb) solders are incorporated into
the larger EEE and components manufacturers do not take back their products. In thelater communication, The RoHS Umbrella Project (2021c) argues that they do notbelieve that LHMPS used in Europe ends up untreated in Europe since 1) EEE from
Europe are sold everywhere and 2) EEE are separately collected and treated according
to the WEEE recycling scheme. The consultant does not agree with these statements.
According to Eurostat data 54, in 2018 for most of the Member States collection rates of
54

EUROSTAT Website: Total collection rate for waste electrical and electronic equipment (EEE), 2018(env_waselee), https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Waste_statistics__electrical_and_electronic_equipment#Electronic_equipment_.28EEE.29_put_on_the_market_and_WEE
E_collected_by_country , last viewed 24.9.21
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WEEE were still below 60% and even below 40% for around a third of the MS. Thissuggest that still a significant amount of waste is not disposed of properly. Regarding
the second point, the consultant is aware that in some cases the illegal export of toxic
electronic waste to developing countries still takes place 55, whereas developing
countries often do not have recycling technologies and schemes comparable to thoseof the EU or US.
Andrae (2020) provides a contribution with indicative LCA calculations. Results showthat revoking exemption 7(a) would likely cause considerably higher environmental
impacts, around 872 times higher. The scope of the investigation is limited to the
production of materials, i.e. production of single individual metal. The environmental
impacts are then calculated based on the different composition of solders investigated.
Other life stages, such as processing of solders (use of other process chemicals likeflux) as well as use and end-of-life are not considered.
The focus of RoHS is to avoid hazardous substances in the use and waste phase andas such in the consultants view these life cycle stages would need to be considered toallow a comprehensive conclusion.
10.5.4.

Increasing certainty for manufacturers and market
surveillance

In the discussions on the scope of the exemption (see Section 10.5.5) the consultant
stated that part of the motivation to specify the exemption has to do with the difficulties encountered with its enforcement and the possibility of misuse that the current
exemption wording enables. UP responded to this that “Considering the exemption has
been around for 10 years, as correctly stated in this questionnaire, UP Exemption # 7a
WG Participants are not aware of any case where enforcement has been difficult or
impossible due to wording or where the exemption has been misused. If misuse orenforcement difficulties have been encountered by control authorities, a better solution to splitting the wording could be to work with industry to develop a guidance on
enforcement” (The RoHS Umbrella Project 2021c).
During the stakeholder meeting, a few cases of uncertainty were presented to shownas evidence for the difficulties of enforcement and possible misuse.
An inquiry made in March to the European Commission by the Danish Ministry ofEnvironment and Food - Environmental Protection Agency (DEPA) as to compliancewith Ex. 7a stated the following:

55[…] a company […] that their products contain lead above the thresholdconcentrations […] would like to know […] whether their product is exempted fromthe RoHS-limitations on lead in accordance with annex III exemption 7a. The lastmentioned company has sought clarification on this, both from their supplier and a
consultant company. However, the two disagree on the scope of exemption 7a.
The supplier argues that we are within the scope, as the factory producing the
product uses high melting temperatures for reasons of production efficiency. The

https://www.theguardian.com/environment/2019/feb/07/uk-worst-offender-in-europe-for-electronicwaste-exports-report, last viewed 20.09.21
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consultant company argues that we are not within the scope, as it is not necessary
for the correct functioning of the lamp that the solders are of the type that canwithstand high temperatures. […]This has led us to the following question […] When would this exemption beinapplicable, where high melting temperature type solders are used or are wecorrect in assuming that the applicability of exemption 7a depends solely on
whether or not the type of solders being used contain 85% lead by weight or more
– independent of the reason for using such solder?” (specified in a communication
sent to the European Commission March 24, 2021.)

This information makes clear that neither market surveillance nor various actors of the
supply chain are in agreement as to the scope of the exemption and what types ofuses are considered to be in or outside of the exemption scope. The following evidence
also suggests potential misuse of the exemption:


A stakeholder sent the EC the following inquiry: “[…] Now we meet a problem
about the use of RoHS exemption 7a. This exemption is something about the useof lead in high melting solder. As we know the lead content exceed 85 % in highmelting solder should be exempted taken literally. But we think not all the highmelting solder lead exceed 85 % can be exempted. We also found some recall casein RAPEX 56 the solder contain lead exceed 85 % […] Otherwise it would be a freepass to use high melting solder everywhere and always, even on circuit boards andcables, as long as the lead content is high enough.”The stakeholder attached a RAPEX notification – the content is anonymized todemonstrate the case of a musical toy surveyed in 2019 in two Member states:“The solders contain lead (measured value up to 93.5 % by weight) in concentrations above limit values. Lead poses a risk to the environment. The product does
not comply with the requirements of the Commission Directive on the restriction of
the use of certain hazardous substances in electrical and electronic equipment(RoHS 2 Directive)”.

It is not clear from the notification if the product claimed use of Ex. 7(a) or not, nor
the component in which it was used. However, this shows again that there is notclarity as to when the use of LHMPS is justified.
KEMI (2021) and the Norwegian Environment Agency (2021) also referred to thedifficulty that the current exemption formulation leads to in market surveillance intheir contributions, further affirming that enforcement may be hindered.
Though in the consultants’ view, evidence exists as to enforcement difficulties andpossible misuse, stakeholders were still asked to explain how they decide whichapplications are in the scope of the exemption and which are not.
How to interpret the exemption and what applications benefit from it, as opposed tothose that do not, is understood by the consultant to be both a problem for market
surveillance as well as for EEE manufacturers when purchasing certain components
from the supply chain. Whereas OEMs seek assurance that the use of the exemption is

56

RAPEX is the EU rapid alert system for dangerous non-food products
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correct in supplied components, suppliers may be requested to justify the use of the
exemption in such cases.
DA5 provides a confidential document and states that in DA5 Material Requirement
Specification there is a clear specification what requirements are valid for LHMPS (TheRoHS Umbrella Project 2021d). No other stakeholders provided examples of guidance
or instructions which are used to support the understanding of which applications
would be considered in scope of the exemption and which would not (e.g., otheralternatives available). The RoHS Umbrella Project (2021d) states that UP Exemption#7a WG Participants would be at the disposal of Oeko and the Commission to provide
their expertise in developing such guidance.
KEMI (2021) has made a similar proposal, that manufacturers be required to justify
the use of such exemptions in the technical documentation of the application. KEMI
refers in this context to the Conformity Assessment Procedures specified undermodule A in Annex II of Decision 768/2008/EC on the common framework for themarketing of products.
In the consultant’s view, such a requirement would not suffice on its own but would
need to be supported with some kind of guidance or standardisation that would specify
in more detail cases where the use of LHMPS is considered necessary in lack ofsuitable substitutes. This would create a common understanding both for manufacturers and enforcement as to the actual scope of application of the exemption. Developing such a standard or guidance, however, requires sufficient time to clarify thestate of technical progress and to come to a mutual agreement of involved stakeholders. From prior knowledge of the consultant, developing a standard as well asassurance and certification systems to accompany it can easily require 4-5 years.
Though this direction could be of interest if further specification of the exemption isseen as unfeasible, time would be required until it results in a solution for enforcement. The consultant has made an attempt to split the exemption into separate items
for its various application areas (see Section 10.5.5) and would recommend following
this approach. However, should it prove to be unfeasible, developing such guidance oreven a standard to clarify the full spectrum of applications where there are no alternatives for LHMPS could be a way to allow more certainty for the various stakeholders.
10.5.5.

Scope of the Exemption

Potential strategies for specification considered
Exemption 7(a) is requested for all categories (1 – 11). As described in the previous
evaluation reports, the consultant considers the scope of the exemption 7(a) wording
to be very wide as it is not limited to a specific application but rather describes amaterial that can be used for various applications. This is not consistent with theintention of the RoHS Directive embodied among others in recital 19 57. The exemption
should only be available for specific applications and technologies where it is deemed

57

Directive 2011/65/EU, Recital 19: Exemptions from the restriction for certain specific materials orcomponents should be limited in their scope and duration, in order to achieve a gradual phase-out of
hazardous substances in EEE, given that the use of those substances in such applications should become
avoidable.
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justified based on Art. 5(1)(a). Usually this means for applications where no lead-freealternatives are available. The current exemption wording has been available for over
10 years. Industry has communicated that where substitutes were suitable, they havebeen applied, however has not given indication as to application areas that could be
excluded from the exemption. The scope of the exemption should be targeted andfocused on application fields and technologies where it is necessary. This would ensure
a higher certainty among companies and market surveillance as to when the
exemption is used properly and when it is misused, despite the existence of alternatives.
The broad formulation results in the exemption assessments being focused on how toreformulate the wording in relation to areas where LHMPS is applied instead of in
relation to the actual progress of substitution efforts which remains vague. In thissense, a splitting of the wording would also allow a higher focus on specificapplications in future assessments as each separate item would be assessed
separately.
The consultant has considered a few strategies for specifying the exemption
formulation:Strategy 1: the application approachStrategy 2: the functional purpose of lead (properties, performance) approachStrategy 3: Category approach

Various considerations lead the consultant to pursue the exemption specification basedon the first strategy. Considerations regarding the other strategies are summarized inAppendix A.2.4.
Specifying the scope and rewording of Exemption 7(a)With respect to the concrete wording proposed, the consultant has had exchanges
with applicants through three clarification rounds via questionnaires and one
workshop. The following section provides a summary of the main aspects discussed
and their relation to application groups considered to be in scope of Ex. 7(a) and how
they have been termed as a means of including such applications in a more specificwording.
Based on information provided by the applicants in this review and in previous
exemption assessments, the consultant formulated an initial wording proposal which
was sent to stakeholders for commenting. This allowed a first fine tuning of the
proposal which together with stakeholder responses was discussed in a technicalworkshop with a view to establish a better understanding of the applications in scopeof the exemption and how they could be formulated into a concise wording. Based on
the discussions, a further proposal was prepared by the consultant and sent tocommenting. A few last considerations were made and consulted on with UP and
Bourns before arriving at the wording recommended for the future exemption in
Section 10.6.
Disclaimer: It is noted that Bourns, UP, and the Test and Measurement Coalition(TMC) have explicitly stated that they do not agree with the exemption splitting. SEMIEUROPE (2021a) also supports this view. They advocate the renewal of exemption
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7(a) with its current wording. The reasons are summarised in the separate section (s.
10.6.2). Insofar, in the section below, when the agreement of stakeholders is referred
to, it means that stakeholders agreed (or did not) that the wording principally covered
the applications it was intended to. Where stakeholders provided an alternative
proposal, this is only to be understood as a wording that describes certain
applications. This is not to be confused with stakeholders being in agreement with thegeneral formulation or the need to split the exemption or prosing a split of the
exemption.
In the following, the application areas identified as the application groups that should
be covered by the exemption either prior to the first proposal or in the discussion
process are listed. These are considered application areas of “Lead in high melting
temperature type solders (i.e., lead-based alloys containing 85 % by weight or more lead)used”. For each application area, the summary explains the main points of discussion,
how these were concluded upon and how this was taken up in the final proposal made.
Internal interconnections in electrical and electronic components
The initial proposal referred to 4 sub-items under the general term “internalinterconnections”. This included a sub-item for internal connections of die attach andone for other than die attach as well as a sub-item for lamps that was later excluded(see discussion under last section) and a sub-item for other applications that was
assumed to catch everything else (see discussion under next section). The first twoitems were initially specified as follows:a-I) for die attach in power semiconductors with steady state or transient/impulse
currents of 1 A or greater and/or blocking voltages beyond 200 V, or die edge sizes
larger than 0.5 mm x 0.5 mm

a-II) in components with steady state currents of more than 1 A and/or blocking
voltages beyond 200 V other than die attach

Stakeholders (Lucky Forests Corporation Ltd 2021b; The RoHS Umbrella Project
2021c; Bourns Inc. 2021d; ABB Power Grids Switzerland Ltd., Semiconductors 2021b)
commented on three parameters (i.e., transient/impulse/steady state currents,
voltage and die edge size) specified in the two sub-items and the threshold levels thatthey refer to. The consultant suggested various changes to these parameters and also
asked stakeholders to comment whether applications raised in the 2015-2016
assessment by Freescale/NXP were covered by one of the two sub-items. It was alsoquestioned whether only one parameter or all three would need to be fulfilled for anarticle to be in scope and how this affected the semantic relation of the threeparameters.
In a later communication on the first item, the The RoHS Umbrella Project (2021d)
explained that the phrase “die attach” usually has a narrow meaning of die bottomside to the lead frame/substrate attach but also attaching components on the top andbottom sides of the die is possible. They proposed a revised formulation for this item:“for attaching die, or other components along with a die in semiconductor device withsteady state or transient/impulse currents of 0.1 A or greater and/or blocking voltages
beyond 10 V, or die edge sizes larger than 0.5 mm x 0.5 mm.” UP explained the15.02.2022 - 137

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removal of the reference to power semiconductors with the lacking definition of thisterm as well as since “Not all uses of LHMPS are in power devices”.
As for the second item, stakeholders provided examples of articles that would still not
be covered in light of the thresholds set. Further correspondence looked into theseexamples and whether they would be covered by the first or second item. The RoHS
Umbrella Project (2021e) referred to most of the examples, explaining that they would
not be covered without a change of the die attach size threshold. A threshold of
0.3 mm x 0.3 mm was proposed. Applications included:

Zener diodes which have die sizes smaller than 0.5 mm x 0.5 mm, use LHMPS in
die attach and are not intended to block voltages but only to regulate it,Some transient voltage suppressors also use LHMPS in die attach. These may use
currents below 0.1 A and have die sizes smaller than 0.5 mm x 0.5mm,

Integrated Circuits, such as voltage regulators and references and current
monitors use LHMPS in die attach and do not block voltages,

Self-protected MOSFETs use LHMPS in die attach and are not covered by the Oeko
proposed wording;

SMD and axial diodes with die attaches of a size < 0.5 mm x 0.5mm

UP also confirmed in this last correspondence that the word device that they initiallyused in the formulation could be replaced with the term “assembly” to prevent false
interpretations of device to mean EEE.
This means that many of the examples initially assumed to be covered under item II
would be covered by item I should the thresholds be changed. UP did not provide aclear answer as to whether this meant that item II was redundant. Though there may
be internal connections that do not include die attach this is uncertain. To cover suchitems, the formulation of item c was adjusted, and it is proposed to limit item a to thedie attach applications.
The following wording is thus proposed:“a. for internal interconnections for attaching die, or other components alongwith a die in semiconductor assembly with steady state or transient/impulse
currents of 0.1 A or greater or blocking voltages beyond 10 V, or die edge sizes
larger than 0.3 mm x 0.3 mm
Aside from the examples mentioned above, stakeholders also mentioned three
additional examples.
Products with life-time expectation above 2000 h of product use and products whereoperating conditions exceed 60°C were two of these examples. Though it can befollowed that products with higher reliability requirements may need LHMPS in certain
cases, additional detail was not provided as to the exact applications, nor to clarify
why these thresholds would be considered to require a high reliability. A life-time
expectation for 2000 h can be very long if the product is used only a few minutes a
day or very short if it is in constant operation (ca. 80 days). It is also not clear if atemperature of 60 °C and above refers to the general operating conditions as in thecase of ovens or to internal conditions in which case this threshold would not
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necessarily mean that the internal heat would lead to a melt of the solder. In the
consultant’s view, including such vague descriptions into an exemption formulation
would again create uncertainty and allow misuse. UP was asked for further detail inthis respect but did not provide further elaboration.
A further example, which is not die attach referred to crystals parts that use LHMPS
internally to solder the crystal element to the package. In reference to the illustrationin Figure 10-4 (left figures), UP was asked if the use of LHMPS in this case was as forhermetic sealing, covered by one of the other items. The RoHS Umbrella Project(2021e) clarified that some crystal parts are using LHMPS in three different areas thatneed to be covered by the exemption:

as a hermetic sealing material

as a connecting material for the crystal chip to the plug, which is a 1st level solder
joint



as connection material between lead frame and plug which is a 2nd level solder
jointThis example shows the complexity of this exemption. It seems that even for industry
there is no consensus or standardized definition, as to how to assign the usage of leadto a certain application type. Though the initial proposal has items for hermetic
materials as well as for first and second level connections, it is not clear that thesewould cover these applications and UP did not provide further detail to support afurther adjustment of the wording. The reference to these three applications does notallow concluding whether they would be considered to be internal and to fall under thisitem or to fall under a different one. The consultant assumes this not to be the only
case that a single component may have multiple uses of different nature of LHMPS,
but also assumes that an EEE making use of LHMPS in different ways could still do so,
as long as the different uses are covered by various items of the revised exemption. In
the consultant’s opinion, this is comparable to the case of a specific component or EEE
benefiting from of a number of RoHS exemption (e.g., from both the LHMPS
exemption and from the exemption for lead in copper). Though the split of Ex. 7(a) into different items may add to the complexity of compliance, addressing suchapplications under a single and general formulation does not only contradict the
principle of exemptions being specific to an article and a material but also does notsupport a clear understanding of the different application types and their technicaljustifications for using RoHS substances such as lead in LHMPS.
Integral connections of die attach in electrical and electronic components
In the first proposal a sub-item was included under the item for internal interconnects
for “other integral interconnections in electrical and electronic components excluding
those in the scope of exemption 24”. In the consultant’s view this item is vague andwould basically allow the use of LHMPS in any “integral interconnection”. Seeing thatan integral joint was considered one in which the connection is partly within the spaceenvelope of a single component (i.e., non-visible in part from the outside--> henceinternal) but also partly external to that space, (i.e. visible in part from the outside -> hence external). (i.e., external – see section 10.2.2), it was also suggested to

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exclude this item from the one for internal interconnects. Stakeholders were asked toprovide information as to applications that would fall under this item.
Some of the examples specified by stakeholders demonstrate this aspect:Bourns (2021e) states that many of their models included applications using
internal connections that would be included under this entry but not limited to.
Several examples were provided: ceramic PTC fuses, SMD fuses, diodes including
many TVS and Rectifier models, Resistor Networks.



UP (2021d) also states that some such applications would be internal connections
in numerous passive electrical components such as fuses, relays, sensors,transformers, crystals, oscillators, resistors, capacitors, etc. which are designed for
SMD assembly.

In the consultant’s view, the only way to understand these statements in relation tothis item is to assume that some of these components would have more than one
application of LHMPS, with at least one application of LHMPS being internal andanother being integral (i.e., internal and external). This was later confirmed by UP
who stated that “For what concerns LHMPS in fuses, in general, UP Exemption #7a WG
Participants would like to clarify that LHMPS can be used as interconnection or sealingmaterials. Both uses need to be covered by the exemption” (The RoHS Umbrella
Project 2021e).
The consultant suggested creating a separate item for “integral connections” to cover
the other components which currently are not included under item a) with thefollowing wording: “for integral connections of die attach in electrical and electronic
components, if the thermal conductivity of the cured/sintered die-attach material is>35W/(m*K) AND the electrical conductivity of the cured/sintered die-attach material
shall be >4.7MS/m AND solidus melting temperature has to be above 260°C. This
item excludes those in the scope of exemption 24.”
UP was asked to comment on this proposal and stated that they “do not agree withthis new Oeko wording proposal since this changed wording would only cover dieattach, and thus would exclude other applications like the connection of a crystal chip
to the plug for crystals and oscillators and many more […]. A huge number of passive
electrical components not limited to fuses, relays, sensors, transformers, crystals,
oscillators, resistors, capacitors, would not be covered.”Though the consultant agrees that the proposed wording is limited to die attach, otherintegral joints are understood to be covered by the next item for “integral connections
for components other than die to be mounted to sub-assemblies”.
The RoHS Umbrella Project (2021e) clearly states that it does not agree with thecurrent proposal wording, explaining that “uses needing to be covered are bothinternal and integral. As integral is intended to be any connection made as a part ofthe component manufacture”. Though the consultant agrees that in principle an“integral” component is also “internal”, and for that matter also external, the idea
behind this categorization is to allow a clear distinction between different applications.
In other words – an item would either be internal, external or integral, the lattermeaning that it is both internal and external.
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In the consultant’s view, this clear cut would mean that items for integral connections
could not be a sub-item of an item for internal connections. To ensure clarity, theformulation now clearly states what is meant by integral.
UP did not respond to the parameters and thresholds suggested in the formulation and
it remains unclear if they would be sufficient for integral connections to die attach ornot. One option would be to adopt the item as proposed, with a short-termed
exemption for the original formulation aimed at allowing the identification of
applications currently not covered. In that case, the following wording could be used:“b) for integral (meaning internal and external) connections of die attach inelectrical and electronic components, if the thermal conductivity of thecured/sintered die-attach material is >35W/(m*K) AND the electrical conductivityof the cured/sintered die-attach material shall be >4.7MS/m AND solidus melting
temperature has to be above 260°C.
A second option would be to simplify the wording by removing the thresholds asfollows:“b) for integral (meaning internal and external) connections of die attach inelectrical and electronic components.
A third option for specification would be to combine this item with the item for“Integral connections for components other than die” under one simplified item. This
option is discussed under the next item.
Given that “integral” can also be interpreted differently, it would also be possible torefer connections (or joints) that are both internal and external to the component
being connected.
Given that Ex. 24 is not related to die attach, the exclusion of such items, if proposed
to be related to Ex. 7(a), ensures no overlapping.
Integral connections for components other than die to be mounted to subassemblies (first level solder joints)
The proposal initially included an item for covering LHMPS when used “for mounting
electronic components onto subassemblies (first level solder joint), i.e. modules or
sub-circuit boards”. Hitachi asked to add substrates as a further example of a subassembly in this wording. Following the discussions on internal items, it was alsodecided to add “internal” first level applications under this exemption, to ensure thatsuch applications would not be excluded from the exemption altogether. Die attach
applications are excluded here as they are understood to be covered under items aand b. Hermetic sealings are also excluded as these would be covered under item e.
Should industry come forward with additional types of hermetic sealings, a sub-itemshould be added there.
The following wording is proposed:“c) In first level solder joints (internal or integral connections - meaninginternal and external) for manufacturing components so that subsequent mounting
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of electronic components onto subassemblies (i.e., modules or sub-circuit boards
or substrates or point to point soldering) with a secondary solder does not reflow
the first level solder. This item excludes die attach applications and hermetic
sealings.”
Here too, to avoid the introduction of a new term, the word integral could be omitted,
referring to joints that are either internal or both internal and external.
As explained above, due to the uncertainties raised by stakeholders in relation to theitem for “Integral connections of die attach”, it could also be considered to simplify
and merge these items a, b and c together. Though in the consultant’s view, this is
not the preferred course of action, in this case, the following wording could be used:
In first level solder joints (integral connections - meaning internal and external)
for manufacturing components so that subsequent mounting of electronic
components onto subassemblies (i.e., modules or sub-circuit boards or substrates
or point to point soldering) with a secondary solder does not reflow the first levelsolder.
Second level solder joints for the attachment of components to printed circuitboard or lead frames
In the initial proposal two items were included that referred to different types ofsecond level solder joints: solder balls used for attaching ceramic ball-grid-array andsolders used to attach components to PCBs overmoulded with plastic. Stakeholders
made a number of comments on the carriers to which the components were being
connected to and clarified that in both cases PCBs and lead frames were meant. Dueto the similarity in the item wordings and with the purpose of simplifying the wording,the two items were included as sub-items under a single item for second level solder
joints. In the case of plastic overmouldings, it was also clarified that the overmoulding
did not refer to the component being connected but rather to the “printed circuitboards or lead frames, which afterwards are overmoulded with high temperatureplastics” (The RoHS Umbrella Project 2021e).
The following wording is finally proposed after being confirmed by stakeholders:“d) In second level solder joints for the attachment of components to printed circuitboard or lead frames:I) in solder balls for the attachment of ceramic ball-grid-array (BGA)
II) in high temperature plastic overmouldings (> 220 °C)”
In this respect, UP (The RoHS Umbrella Project 2021e) also explains that LHMPS is
also “needed to connect components to multi-stranded connecting cables of hightemperature applications such as stoves and ovens. This use that is covered by thecurrent wording must be covered by any Oeko proposed new wording”. UP did notprovide further detail and it thus remains unclear whether this statement was made toclarify that this application would be covered by the above item (d-II) or not. Though
item d-II refers to a connection of “components to printed circuit board or leadframes”, it is not clear to what cables UP refers, though a cable could be connected toa socket plug on one end and to a PCB or a lead frame on other end.
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Hermetic sealing materials
Whereas the initial proposal only referred to hermetic sealings “between a ceramic
package or plug and a metal case”, Bourns Inc. (2021d) requested an extension ofthis item to the use of hermetic sealings “between component terminations and aninternal sub-part”.
The following wording is finally proposed after being confirmed by stakeholders:“e) as a hermetic sealing material between:I) a ceramic package or plug and a metal case,II) component terminations and an internal sub-part”
LHMPs in lamps
A sub-item was initially included under the first item for internal interconnections tocover HID lamps and oven lamps. As the schematic illustrations of lamps (see Figure10-5) and their use of LHMPS showed that not all uses of the solder material wereinternal to the lamp body, stakeholders were asked to consider addressing suchapplications in a separate item. Stakeholders clarified that the use of LHMPS material
for lamps should not be considered as “internal interconnections” in electrical orelectronic components, since the solder point connection in many cases is visible fromthe outside. UP (The RoHS Umbrella Project 2021c) also specified another lamp typethat would not be covered by this wording: incandescent reflector lamps for infrared
heating. Stakeholders proposed a revised wording for the lamp applications as aseparate item as below:“for establishing electrical connections (between lamp components) inincandescent reflector lamps for infrared heating or high intensity discharge lamps
or oven lamps”.
Though the justification for all lamp types is assumed to be similar, it is noted thatstakeholders did not provide clarification as to why an infrared lamp or high intensity
discharge (HID) lamps are assumed to be exposed to similar temperatures as thosethat an oven lamp would be exposed to, i.e. temperatures that would melt a bond withalternative solders. The consultant is aware from earlier exemptions that heat may
build up in the body of a HID luminaire during operation. However, how thesetemperatures correspond to the different solders is not known. Nonetheless, it is
proposed to include this item in the final exemption, to ensure that such items,
understood to currently benefit from the exemption, would still be covered by a future
exemption. The differences between the various lamp applications should beconsidered in the next assessment to ensure that all applications are justified
according to the article 5(1)(a) criteria.
Audio transducers
This application area was not initially included in the first proposal but identified as ashortcoming in the first round of comments. After consultation with stakeholders it
was considered more appropriate to add this as a separate item, also in light of the
expected phase-out of LHMPS in this application within the next five years. After
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phase-out is accomplished, this approach would allow the removal of such applications
from an exemption to remain valid.
The following wording is finally proposed after being confirmed by stakeholders:“f) for audio transducers where the peak operating temperature exceeds 200°C”
10.5.6.

Conclusions

Article 5(1)(a) provides that an exemption can be justified if at least one of thefollowing criteria is fulfilled:a)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;b)the reliability of substitutes is not ensured;c)the total negative environmental, health and consumer safety impacts caused bysubstitution are likely to outweigh the total environmental, health and consumer
safety benefits thereof.

The information made available to the consultant suggests that the substitution andelimination of lead in LHMPS generally is still scientifically and technically impracticableso that granting an exemption could be justified by Art. 5(1)(a). Though in somecases, information suggests that alternatives could be used in a small set of specificcases, information was not provided to allow demarcating such application areas.
Based on the current evaluation and previous evaluations, it is clear that there is no“one-size-fits-all” solution due to the broad application fields and also the different
properties of lead required depending on the applications. As already described in thelast evaluation report (Gensch et al. 2016), in the consultant’s understanding, itcannot be concluded that all applications of LHMPS will have a lead-free solution basedon the same basic material and technology. The requirements in the various LHMPS
applications are different, even though they all use LHMPS at present. For the various
applications, different individual or combined properties of LHMPS are relevant to adifferent degree, and it is reasonable to assume that this requires different alternative
solutions and thus also application-specific research to substitute or eliminate lead.
An encouraging example is audio transducers, in which design is being changed to
new lead-free solutions. For the use of LHMPS in high power audio transducers, theinformation submitted plausibly explains that LHMPS is currently still required.
Progress was made both in high and low frequency transducers. Substitution of leadmay become scientifically and technically practicable over the next five years.
As for other application areas, there are very few prospects that suggest that thissituation will change within the next five years, thus it is recommended to continue
the exemption for five years.
As it could be understood that for many applications, alternatives were currently not
viable, an approach was taken to specify the exemption wording in relation to thevarious application areas for which information was provided. The consultant
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understands that specifying the exemption wording is a task of technical complexity
due to the large variety of applications in its scope. Industry argues that in someareas substitutes are not yet available. Nonetheless, it can also be understood that
where lead-free solders (or solders with less lead) could be used, that these havebeen applied to substitute LHMPS. The current wording, however, does notdifferentiate between such cases and could potentially allow misuse. The current
wording also does not provide certainty for the market surveillance (or for that matterindustrial actors) as to where LHMPS can be used in EEE and where substitutes areavailable and should be applied (s. chapter 10.5.4). Hence, the assessment tried todemarcate the applications for which the exemption is necessary, in contrast to thosewhere LHMPS is not used. Specifying the wording in a concrete way might not reduce
the use of lead under this exemption in the short term (assuming all manufacturers
surely differentiate where LHMPs should be used and where not). But without a clear
targeted wording, the implementation of market surveillance is very difficult. It is also
assumed that an application-based formulation shall also serve to communicate moreclearly where additional research into alternatives is needed, motivating the researchcommunity to develop substitutes in relevant areas.
In summary, a clear reformulation to specify components and applications where
LHMPS is really needed is very difficult due to the complexity of technical issues, broad
applications and limited time and resources. However, in the consultant’s opinion, thefirst step has to be taken after more than ten years usage of this vague formulation of
the exemption, especially seeing as certain applications (e.g. lamps, audio
transducers) have achieved a clear formulation this time and in the latter also showprospect of a phase-out of LHMPS. The consultant believes that specifying components
and applications is an ongoing process. Besides, a clear formulation of applications canfacilitate examining the possible potential substitutions in the future review.
Industry has raised concern that in some cases, components exist that make use ofdifferent applications of LHMPS. From the various discussions on the scope of the
exemption, it is the consultant’s impression that industry’s intent was to retain asituation in which only one of the newly proposed exemption items would cover alluses of LHMPS in a specific component. The motivation for this approach is understood
to be the burden of updating compliance declarations for components, where somemanufacturers specify all exemptions that apply. The consultant agree that a change
from a single simplified exemption to sub-items, where more than one could apply,
may result in a burden for updating declarations. Nonetheless, the situation that morethan one exemption applies to a single exemption is not new and the consultant sees
no limitation to declaring the use of a few of the Ex. 7(a) items when LHMPS is used in
multiple applications that have all been shown to be justified.

10.6.
10.6.1.

Recommendation
Wording of Exemption 7(a)It is recommended to renew exemption 7(a) with a new and specified wording, giventhat substitutes are still understood to be mostly unavailable. The proposed split has
attempted to incorporate stakeholder proposals as far as possible, provided that it
could be followed why various adaptations were needed. Some aspects could be
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specified further, however this would extend beyond the time restrictions of theassessment. In some cases, changes have been made to the proposed formulation toensure that items currently benefiting from Ex. 7(a) would still benefit from the newitems in the future.
It is noted that though stakeholders confirmed that certain groups of articles would becovered by the new items of the exemption, for the most part they do not support a
split of the exemption as explained below (see 10.6.2).
Recognising that there may still be some applications that are not covered by the newitems proposed, a short-term exemption is also recommended for the current
exemption, to allow stakeholders to submit applications for the inclusion of additional
application groups (or for further fine tuning of the existing items), provide that insuch cases, it can be shown that the use is justified in relation to Article 5(1)(a).
Exemption formulation 7(a)Lead in high melting temperature type solders (i.e.,
lead-based alloys containing 85 % by weight or morelead) (excludes those in the scope of exemption 24)

Lead in high melting temperature type solders (i.e.,
lead-based alloys containing 85 % by weight ormore lead) when used for the following applications(excludes those in the scope of exemption 24):I) for internal interconnections for attaching die, orother components along with a die insemiconductor assembly with steady state ortransient/impulse currents of 0.1 A or greater orblocking voltages beyond 10 V, or die edge sizes
larger than 0.3 mm x 0.3 mmII) for integral (meaning internal and external)
connections of die attach in electrical and electronic
components, if the thermal conductivity of thecured/sintered die-attach material is >35W/(m*K)
AND the electrical conductivity of thecured/sintered die-attach material shall be>4.7MS/m AND solidus melting temperature has tobe above 260°C
III) In first level solder joints (internal or integral
connections - meaning internal and external) for
manufacturing components so that subsequent
mounting of electronic components onto
subassemblies (i.e., modules or sub-circuit boards
or substrates or point to point soldering) with asecondary solder does not reflow the first levelsolder. This item excludes die attach applications
and hermetic sealingsIV) In second level solder joints for the attachment ofcomponents to printed circuit board or lead frames:

Duration
For all categories except
applications covered bypoint 24 of this Annex,
expires on 21 July
2024.
Applies to all categories
except applications
covered by point 24 ofthis Annex, expires on
21 July 2026.

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Exemption formulation 7(a)Duration

1. in solder balls for the attachment of ceramicball-grid-array (BGA)
2. in high temperature plastic overmouldings (>220 °C)V) as a hermetic sealing material between:
1. a ceramic package or plug and a metal case,
2. component terminations and an internal subpartVI) for establishing electrical connections between
lamp components in incandescent reflector lamps
for infrared heating or high intensity discharge
lamps or oven lampsVII) for audio transducers where the peak operating
temperature exceeds 200°C
As raised in Section 10.5.4, should the European Commission decide against such a
specification, it is recommended to develop guidance and possibly even a standard toaddress the many technical aspects and specific properties of the various applicationsof LHMPS. Although development of such standards is a long process, it would allow a
clear communication of application areas, properties and cases where the applicationof LHMPS is considered to be justified, which would serve both the EEE sector in its
communication in the supply chain as well as the enforcement of Ex. 7(a). Suchguidance could be referred to in a future exemption to allow retention to a generalwording that will limit the administrative burden for the various parties, while also
allowing a clear demarcation of areas where LHMPS can be used.
10.6.2.

Applicants’ statements concerning the split of Exemption 7(a)The applicants disagree with the splitting of the wording, which has been explicitly
expressed in the third, fourth, and fifth questionnaires. Applicants’ arguments andconcerns are summarised below:


The LHMPS materials are used in a huge variety of applications. Therefore, it is
impossible to list them all and address specifically. In short the requirements arelinked to the material itself and not to its application. There is a risk thatsplitting/renumbering/itemization of the exemptions would unintentionally exclude
necessary applications from its current scope.



Splitting the exemption will not eliminate existing functional requirements for
LHMPS, nor will it improve the availability for Pb-free alternatives.



Stakeholders fear that specifying the wording will lead to significant unnecessary
burden for industry including thousands of SMEs (manufacturers and importers) atlarge without commensurate benefits.



Any change to the current wording would likely divert resources to rework theexisting EEE material content reports and conformity declarations in support of CE
marking declaration. This might reduce resources from investigating technicalsolutions.

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The use of LHMPS is critical to situations were reflow is necessary in PCB build; but
is only applied where necessary due to the additional costs, process controls andreliability risks in comparison with the application of a lead-free solder.



Stakeholders have also identified that this approach will result in a single
component claiming multiple exemptions due to the use of LHMPS in different roles
within the component. The implications cannot be assessed at the moment and it
should be avoided that there is an interruption in availability of electronics in the
EU market and competitiveness is damaged.



As the applicants cannot support this sub-split of a yet sharp cut exemptions andbeing aware that the demands for each PCB design are different and numerous,
they claim that it would be of limited benefit to give examples. In addition, there
are different specific PCB requirements in terms of lifetime and temperature andenvironmental load. This is in our opinion very complex and at the moment wehave to state that we are not able to give an expertise, covering all uses. Not all isdisclosed by non-EU companies and companies that are not a member of thisapplicant group. Therefore, it might be that during WTO notification suchstakeholders would claim market distortion. The clarification regarding thefeasibility of narrowing the scope of the exemption as suggested will require a
global dialogue in the world-wide connected and complex supply chain. The
applicants estimate that this will take at least 1 year to be realized.



The RoHS Umbrella Project (2021e) argues that this sub-split will cause alegislation which is not implementable and cause high administrative burden only.
UP Exemption #7a WG Participants in view of the implementation of theharmonized standard EN IEC 63000 would like to emphasise that the split of the
exemption wording would lead to the situation that more evidence is required
whether the application of the solder is justified

Bourns and UP suggest conducting representative material analysis every 5 years, ofthe end-of-life product stream for electrical and electronic products. They are
confident that these procedures will testify that intentional lead uses are on very low
levels and continuously decreasing.

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10.6.3.

Outlook: Further Specification of Exemption 7(a)The following aspects are considered to be relevant for providing a good basis for the
next review of this exemption:
1) More detailed information should be provided on what has been researched in thelast 5 years, supported with clear evidence.
2) The consultant has put a large focus on the specification of the scope of the
exemption in the current review process due to the limited time and resources. In
future assessments, a larger focus could be put on better understanding cases inwhich the use of alternatives is scientifically and technically practical and where
their reliability has been ensured. This would require defining performancebenchmarks for available alternatives and where they can be applied so that thesecan be excluded from the scope of Exp. 7(a).
3) Classification of different individual or combined properties of LHMPS for specificapplication groups,
4) Following up on the practical implementation of the recommendation of theUmbrella Project, representative material analysis should be conducted by industry
on a routine basis to shed light on the amounts of LHMPS found in WEEE, on typicalapplication areas and on the changing trends of use of this material.
5) Threshold set in item a) and b) of the proposed exemption should be considered inrelation to the applications making use of these items to consider if they need to befine-tuned.
6) The differences between the various lamp applications should be considered in thenext assessment.

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11.

Exemption 7(c)-I “for 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”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings ofstakeholders’ explanations and arguments have been adopted from the documents
provided by the stakeholders as far as required and reasonable in the context of theevaluation at hand. Formulations were only altered or completed in cases where it wasnecessary to maintain the readability and comprehensibility of the text. These sections
are based exclusively on information provided by applicants and stakeholders, unlessotherwise stated.
Acronyms and definitions
ALD

Atomic layer deposition

BournsBourns Incorporated

CEM

Channel Electron Multipliers

CTE

Coefficient of thermal expansion

EEE

Electrical and Electronic Equipment

EHS

Environmental Health and Safety

LMP

Low-melting point

MCP

Micro-channel plates

Pb

Lead

PhotonisPhotonis Scientific, Inc.

PTC

Positive Temperature Coefficient

PZT

Lead zirconium titanate

OFP

Optical Fiber Packaging Ltd

RGP

Resistive Glass Product

RoHS

Directive 2011/65/EU on the Restriction of Hazardous Substances inElectrical and Electronic Equipment

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11.1.

Background

Seven organisations (Schott AG, Bourns Inc., COCIR, Optical Fiber Packaging Ltd,
Photonis Scientific, Inc. and the RoHS Umbrella Project represented by Murata
Electronics Europe B.V. and VISHAY BC components BEYSCHLAG GmbH) havesubmitted requests for the renewal of the above-mentioned exemption. A few
stakeholders submitted applications for the renewal of the exemption as theircontribution to the stakeholder consultation that took place in the course of this study.
These were submitted by: Branson Ultrasonic Corp., Lucky Forests Corporation Ltd,and Bandelin electronic GmbH & Co. KG.
The applicants apply for exemption 7(c)-I of Annex III of the RoHS Directive:“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”
Applies to categories 1-7 and 10 (except applications covered under point 34) andexpires on 21 July 2021.
For categories 8 and 9 other than in vitro diagnostic medical devices and industrial
monitoring and control instruments expires on 21 July 2021.
For category 8 in vitro diagnostic medical devices expires on 21 July 2023.
For category 9 industrial monitoring and control instruments, and for category 11
expires on 21 July 2024.
All applicants request the renewal of the exemption with its current wording and forthe maximum duration possible (5 to 7 years depending on the EEE category). The
applicants identify several applications for which they argue that the exemption is stillneeded because no lead-free alternatives are currently available, so lead has not yet
been replaced or eliminated in applications such as those outlined below.
Applications of lead-based glass, used to connect and seal two elements made ofglass, metal or ceramic materials are addressed in the applications of Schott AG(Schott 2020), Optical Fiber Packaging (Optical Fiber Packaging Ltd 2020) and theUmbrella Project (2020h). These applications are also termed by some applicants as
lead-glass sealing materials, lead-glass solders or low-melting point (LMP) glass
solders and are used to connect elements on the one side, but usually also to ensure ahermetic sealing, which protects from ingress of external elements such as humidity,
acidity, etc. Schott (2020) explains that lead-glass solders are needed to manufacturehigh-quality hermetic housing components for optoelectronic applications, forpassivation and encapsulation of semiconductor components and to hermeticallyconnect power electronics. OFP (2020), which requests the exemption only for
category 3 (IT and telecommunications equipment) use the LMP glass to manufacture
miniature hermetic seals to optical fibres contained within small metallic tubes. The
small seal subassembly is then used to allow optical fibres to hermetically penetrate
into an ‘optical module’.

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Bourns Inc. (2020b) refers to use of lead-containing glass in thick film inks/
glazes used in electronic components. Thick film is a resistive and conductive film
greater than 0.0001” thick resulting from firing a paste or ink that has been deposited
on a ceramic substrate. This is also called a glass frit and is used in several applications as barrier layers for stopping the migration of silver or as a sealing material for
ensuring hermetic packages. The Umbrella Project (2020h) refers to chip resistors,
which are widely used in all types of EEE for current control, current detection, voltage
division, amplification ratio determination, termination, dumping, pull-up and discharge applications in E&E devices. The resistor elements of these chip resistors
consist of mixed sintered bodies of conductive particles which contain lead. In
distinction from lead-glass solders, here lead-containing glass is understood to be
used for encapsulating semiconductor components, which is also mentioned by
SCHOTT (2020).
COCIR (2020) request the exemption for Category 8 medical devices for the use oflead zirconium titanate (PZT) as a piezoelectric material. The request mainly deals
with the use of PZT in polycrystalline ultrasound transducers but also mentions otherelectronic components that contain lead in glass or ceramics that are applied in medical devices. The Umbrella Project (2020h) also mentions PZT components used intransducers used in ultrasonic sensor applications for distance measurement toobjects, crack detection in concrete and metal, detection of foreign bodies inside foodas well as every type of life-saving medical diagnosis.
Photonis Scientific, Inc. (2020) requests the exemption only for medical devices ofCat. 8 and monitoring and control instruments of Cat. 9. The Photonis request focuseson lead-oxide based glasses termed “electronic glasses” used to provide the electrical characteristics necessary for electron multiplication to occur. Such materials areneeded both for the forming and the proper operation of Microchannel Plates (MCPs),
Single Channel Electron Multipliers (CEMs) and Resistive Glass Products (RGPs).
According to the Umbrella Project (2020h) the exemption is also needed for PTC(Positive Temperature Coefficient) thermistors which make use of semiconductor
ceramics having the property that their electrical resistance increases as temperaturerises. These are used for temperature/current control and protection of circuits fromabnormal heating and overcurrent. In PTC thermistors, materials become semiconductive by the addition of rare earth elements, etc. to barium titanate, however inorder to ensure the thermal characteristics and resistive value stability it is necessary
to add lead.

11.2.

The history of the exemption

When Directive 2002/96/EC (RoHS 1 2003) was published in 2003, two exemptions
covered applications in scope of Ex. 7(c)-I. Exemption 5 allowed the use of lead inglass and exemption 7d covered the use of lead in ceramics of electronic components.
An additional exemption for “Lead in cermet-based trimmer potentiometer elements”
was added to the Directive as exemption 34 following a request made in 2006, after
the applicant argues that the homogeneous material in this case, the thick-film layer
containing the lead, in itself is neither a glass nor a ceramic material. Nonetheless, in
2007/2008, Exemption 11 of Annex II in Directive 2000/53/EC (ELV Directive), which
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is equivalent to exemption 7c-I of RoHS Annex III, was reviewed and it was decided
that it also covered lead in cermet-based trimmer potentiometer elements. Following
the review of exemption 7d in 2007/2008, the ELV wording was adopted as thecurrent Ex. 7(c)-I to eliminate uncertainties.
Ex. 7(c)-I was last reviewed in 2015/2016 (Gensch et al. 2016). It was concluded that“the substitution of lead in ceramics is scientifically and technically still impractical in
the majority of applications” though practical to a certain degree in some cases, but it
could not be clarified whether this would justify and enable narrowing the scope of the
exemption. For lead in glass or in a matrix of glass or ceramic compounds, it was
concluded that it was still scientifically and technically impracticable to substitute lead.
During the assessment, an effort was made to specify the exemption into these two
sub-groups of applications, however the discussions with stakeholders did not allow
concluding this process. The following exemption specification was recommended as astarting point for the current assessment of exemption 7(c)-I. Exemptions 7(c)-II,7(c)-III and 7(c)-IV were integrated into this wording proposal 58:
Lead ini)piezoelectric ceramics in electrical and electronic components, i.e.
ferroelectric ceramics

pyroelectric ceramics

other piezoelectric ceramicsii) positive temperature coefficient (PTC) ceramics in electrical and electronic
componentswith TC < 120 °C (TC: Curie temperature) and resistivity of less than <1000 Ωcmwith TC < 120 °C and resistivity of 1,000 Ωcm and morewith TC ≥ 120 °C and resistivity of less than 1,000 Ωcmwith TC ≥ 120 °C and resistivity of 1,000 Ωcm and moreiii) dielectric ceramics in discrete capacitor components for a rated voltage of
125 V AC or higher, or for a rated voltage of 250 V DC or higheriv) dielectric ceramic in discrete capacitor components for a rated voltage ofless than 125 V AC, or for a rated voltage of less than 250 V DC; for use inspare parts of EEE placed on the market before 1 January 2013v) PZT-based dielectric ceramic materials for capacitors which are part ofintegrated circuits or discrete semiconductorsvi) other ceramicsvii) in glass or in a glass or ceramic matrix compound

58

used for protection and electrical insulation

In other words, the formulation includes applications covered by other exemptions listed under Annex
III, as part of an effort to ensure that possible overlaps in the various items are avoided.
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



11.3.

−

in glass beads of high voltage diodes on the basis of a zinc-borate
glass body−in other electrical and electronic components

used as resistance material−

in cermet-based trimmer potentiometers−

other electrical and electronic components

used for bonding purposes in electrical and electronic components−

for hermetic sealings between ceramic packages and glass or ceramic
lids in electrical and electronic components−

used for any other purposes in electrical and electronic components

Technical description of the requested exemption

In general, a differentiation can be made between applications where lead is part of a
glass material or part of a ceramic material. In this respect, lead used in a glass
atop a ceramic material would be included in the first group:
Lead in glass materials and components:
Low-melting point (LMP) glass solders – SCHOTT (2020) explains that lead isessential for realisation of low working temperatures. In optoelectronic components,
solder glasses are needed as otherwise excessive process temperatures would lead tothe destruction of the component (glass window or lens, semiconductor and otherapplications that are manufactured using glass solder). This is also mentioned for thefollowing component encapsulation applications. The Umbrella Project (2020h)
specifies that lead-containing glasses have melting temperatures of about 300 to
340°C. Important properties mentioned include excellent wettability with both metals
and ceramics which is important for bonding different materials, weather andcorrosion resistance due to the chemical stability of lead, less susceptibility todielectric breakdown under high electric loads and high mechanical strength due to thesmall thermal expansion coefficients of lead and its crack resistance. OFP (2020)
further explains that the presence of lead supports several important functions in suchapplications:

Significantly reducing the melting point of the glass (from 1000°C to 270°C),
which is important to maintain the optical fibre coating (typically acrylate) during
production.

Significantly reduces the viscosity of glass mix (by about 100 times), allowing
melted glass to flow into very tight spaces required for reliable fibre optics glass
seal. Furthermore, for achieving a vacuum-tight seal, the seal must not containbubbles. Low viscosity of PbO based glass mix allows bubbles to escape before
solidifying the glass.

Allows varying and precisely matching the coefficient of thermal expansion (CTE)of the glass to match those of metal and fibre optics glass (or other materials).
When the CTEs do not match, this can induce breakage upon cooling or result in a
non-hermetic seal.



Allows wetting of the metal surface (or other materials) to create a proper physicalbond and vacuum tight sealing.
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Glass frit, chip resistors and lead-containing glass used for encapsulating ofsemiconductor components – Bourns (2020b) explains that lead oxide is used tolower melting temperature and viscosity for processing below 550°C and to raise
dielectric strength. The lead oxide content of the glass can be adjusted to control theCTE which is favourable for high sintering temperature operations.
Electronic glasses used for producing MCPs, CEMs and RGPs - Lead oxide, as a glass
constituent, is responsible for providing crucially necessary current flow within signal
multiplying detection devices to accomplish electron multiplication, or in other words
for providing the electrical properties to the glass. This is provided through positive
lead ions which agglomerate on the glass during the production process and later act
as electron donors leading to the conduction property. The presence of Pb in the glass
melt also decreases the viscosity of the glass at high temperatures, making it suitable
for the complex forming operations required to make these products. (Photonis
Scientific, Inc. 2020)
Lead in ceramic materials and components:
Piezoelectric materials – COCIR (2020) mentions five properties as importantpiezoelectric parameters:

Coupling factor – this is the efficiency of the material’s ability to convert
mechanical energy from vibrations into an output electrical charge and vice-versa.
It is explained as the most critical property as it is impossible to compensate forinferior coupling factors by design change.



Piezoelectric constant - this defines the properties of the material and thus also its
performance.

Dielectric constant – this affects the impedance of a transducer element. Low
values can be somewhat compensated by changing the electrical control circuitdesign and using multilayer piezoelectric materials. The best single crystal
materials have relatively higher values.



Insertion and other losses - insertion loss is proportional to the material’s
sensitivity and is thus important for image quality. A loss in performance can be
dealt with by increasing power, but this can cause heating which will in turndecreases performance. Losses cannot be zero but should not be greater than10%.



Depoling and Curie temperatures - above the Curie temperature, PZT materials
lose their ferroelectric properties due to the depoling process, which makes them
unusable for ultrasound transducer applications. This can be accompanied by acorresponding strain and results in cracking or change of the PZT properties.
Piezoelectric materials with low phase transition temperatures show unstableperformance during operation and can depole during shipping or storage in areas
with a hot environment, affecting the performance of ultrasound transducer. Curie
temperature should be sufficiently high so that solder bonding, use and storage do
not degrade performance.



Velocity - Low ultrasound velocity requires a thinner transducer, but thinnermaterials have higher capacitance, which is good for smaller piezoelectricelements, however making fabrication more difficult.

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Positive Temperature Coefficient thermistors – Lead is added to ensure thethermal characteristics and resistive value stability of the ceramic material, thus also
related to the electric resistance of the material remaining stable under changing
temperatures (Umbrella Project 2020h).
11.3.1.

Amount of lead used under the exemption

Consultants Note: The terms tonne and ton are used below as they appear in theoriginal documents. An American ton consists of ca. 907 kg whereas a British tonne
consists of ca. 1016 kg. A metric tonne consists of 1000 kg. It is not clear what units
are meant in the entries below and how this would affect the total amount of leadplaced on the market through this exemption. This could lead to small variations in the
total amount but is considered negligible in the context of the amounts estimated andtheir effect on the results of this assessment.
Schott (2020) estimates that the lead consists of up to 75% of the glass solder forconnecting glass windows and lenses or between 5% and 50% when encapsulating
semiconductor components. Schott estimates the lead consumption for industrial
applications placed on the European market in 2018 to be between 550t ~ 750t but
explains this to be a rough estimation for reference purposes only. The Umbrella
Project (2020h) refers to the same reference estimation, but states that up to 93 wt%
lead is used for the various applications. The estimation is based on a survey
performed by ZVEI in which 14 member companies provided data on lead use inindustrial applications.
In its response to first clarification questions consultation, Umbrella Project ((Umbrella
Project 2021m) quotes ZVEI and JEITA (2019), who re-estimate the amount of leadused in EEE components for applications under the scope of the RoHS exemption 7(c)I as in the range of 350 tons to 400 tons per annum in 2018. Around 90% of thatfigure comprises of lead in ceramic and 10% is lead in glass and glass-ceramic matrix
compounds.
Regarding the lead content of glass frit substrate, Bourns Inc. (2020b) states that thehomogeneous glass included in thick film ink or encapsulation materials varies and canrange from 1-75% of the glass. The total ink/encapsulation including the glass isgenerally <1% of the finished part. Bourns Inc. was unable to determine the total
amount of lead in glass for all EEE products entering the EU market because thecompany does not have information on how EE components, claiming exemption 7(c)I, are incorporated in assemblies of other goods and eventually placed on the EU
market by downstream actors in the value chain. Bourns Inc. however asserts that amisuse of the exemption 7(c)-I appears unlikely since component manufacturers
consider that lead is used only where necessary for given applications.
For medical ultrasound piezoelectric dielectrics, COCIR (2020) estimates that 64 wt%of the PZT is lead. 4.2 kg of lead is estimated by an ultrasound probe manufacturer toenter the EU market annually through the lead in medical ultrasound transducers
based on numbers of equipment sold in the EU, average mass of lead per probe andthe market share of the manufacturer.

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OFP (2020) estimates that 0.1% of lead is contained in the LMP glass used to
manufacture miniature hermetic seals for optical fibres and that 50 kg of lead enter
the EU market through this application.
Photonis (2020) states that the glass used to make MCPs, CEMs and RGPs are leadsilicate glasses containing between 47.5 to 58 % by weight (26.5 to 31.5 % by mol) of
lead oxide (PbO) (in another place 44 %-54 % Pb is specified). An estimation ofamounts is provided on p. 8 of the application for the three uses. In total, Photonis
estimates that 133 kg of Pb are placed on the global market through theseapplications (in another place 145 kg is mentioned) annually, with a rough estimationof the European share being 25 % or ~36kg per year.
Looking at the various values reported by the various applicants, it is not clear if
750 tons per annum represents the top range for all possible applications or only forcertain applications (i.e. for industrial applications of Ex. 7(c)-I, whereas some of theapplicants mention also uses in non-industrial applications i.e., private consumer
applications). Nonetheless the above data gives an indication of the amounts placedon the EU market for articles in the scope pf Ex. 7(c)-I.

11.4.
11.4.1.

Applicants’ justification for the requested exemption
Substitution or elimination of lead

Looking at the candidates for substitution, the applicant’s argumentation is mainly
based on why the lead substitutes investigated so far are not considered sufficient intheir intended field of application.
Low-melting point (LMP) glass solders – The Umbrella Project (2020h) mentionedthat the melting temperatures of lead-free glasses are about 120-160°C higher thanthose of lead-based glasses. This means a higher bonding temperature which causes
larger stress due to the larger difference in the extent of thermal expansion that will
be generated and can result in cracks and difficulties to maintain the sealing/bonding
and electrical insulation. This will increase the risk for malfunctions over time. The
increase in the glass bonding temperature also has a negative effect on the wettabilityof the glass on the metal surface resulting in bonding strength degradation andleading to solder bonding failures. OFP (2020) also argues along these lines,
explaining that over the last 20+ years multiple attempts to create alternative low
melting point glass mixes, such as β-eucryptite, zirconium vanadate (ZrV2C>7), andzirconium tungstate (ZrW208) or BaO(SrO,CaO)-B2O3-Bi2O3 systems, for example,
have been made. However, these materials resulted in non-homogeneous or
crystalized seals or did not wet to metals, thus not creating reliable seals or actuallyeven vacuum tight seals.
OFP (2021) states that alternatives for the use of lead in such applications currently
do not exist and are not expected to become available for many years to comebecause a substitute needs to meet many important parameters. A reduction of leadin sealings of optical fibers and wires might be achieved by engineering measures, e.g.
increasing the efficiency of the use of the leaded glass used per optical or electricalchannel.

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Schott (2020) mentions two approaches for substitution, though not explaining how
they differ. The one refers to the use of BeO or UO2 and is said to not be functionalfrom an environmental health and safety (EHS) perspective though without detailingwhy. The other is not specified, though requirements and limitation of various glass
alternatives are provided in table on page 6 of the application. For the second
approach it is explained that intermediate soldering and high CTE sealing have beenfound suitable in some cases, due to the general nature of the glasses. Specificcompositions are not mentioned in this respect, but it is explained that those withhigher melting temperatures generally exhibit a low CTE. Existing PbO-free glasses
can be used almost exclusively in specially processed components (extremely fast
soldering by induction or laser) and/ or in special, encapsulated environments, but
usually do not fulfil all requirements, thus PbO glass solders usually still need to be
used.
Glass frit, chip resistors and lead-containing glass used for encapsulating andpassivation of semiconductor components - The Umbrella Project (2020h) states thatbased on research, lead-free resistor element materials have low moisture resistanceduring load heating and low mechanical strength during overload heating, leading toinferior reliability. Resistance value variations, exceeding those of the present leadcontaining resistors, will occur over time or in sudden outbreaks, depending on theresistance value range for the EEE. This is problematic for uses where power is applied
at high-temperatures or in a high-humidity environment or where pulse overloads areapplied such as in switching power supplies widely used in EEE. In light emitting
diodes, this can lead to shortening of service life or to a decrease in illumination
intensity. In current detection applications this can lead to heat damage to the motor
or complete failure. Solving such issues would require hermetic sealing of the EEE,
which however is often not practical due to size, resulting overheating of circuits andthe increase in the consumption of energy and resources during the life cycle. Bourns
states that it has been experimenting with various non-lead glass formulations. While
success for low to mid-level resistance values have been implemented on someindividual models, other potential alternatives are still in the design/test stage. Schottexplains that for passivation, the glass systems meet a higher tolerance of processtemperature (glass systems which have lower CTEs at higher melting temperatures).
The ZnO-B2O3 systems are promising candidates but need optimization with regard totheir chemical resistance. For diode passivation, the current PbO-free development
glasses still show undesirable interactions with the semiconductor, which reduce theelectric strength below an acceptable level. A Pb-free glass for bonding NiFe alloys andother materials that meets the requirements for chemical resistance in long-term use
at an equivalent level to that of leaded glass is yet to be found.
In a later communication, Bourns Inc. (2021) refers to an example of experimental
studies to substitute lead-free glass for leaded substrate in trimming potentiometers.
A substitution of lead-containing glass in thick film inks, encapsulating glazes andother similar inks does not appear to be suitable in a variety of applications, such as
chip arrays, chip resistors, diodes, other trimming potentiometers, precisionpotentiometers, resistor networks, power resistors and other Bourns’ products. It isalso noted that the results of those experiments are at a very early testing stage andcannot be generalized or utilised for other models.

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Schott (2021) provides additional information following clarification questions, where it
specifies the technical properties that are required of passivation glasses and soldering
applications. A comparison of lead-containing glass types and lead-free candidates for
substitution materials (see Table 11-1) shows that “none of the characterized glass
families has so far shown a sufficiently adapted property profile that a complete
substitution can be regarded as successful even in only one field of application. Even
the overall consideration of partial solutions via the coupling of different new families
cannot yet completely cover all applications.” Despite partial successes in lead
substitution having been demonstrated for some soldering applications, “complete
substitution of all lead-containing glass families in the scope of RoHS is unfortunately
not to be expected.” The applicant stresses that several lead-free candidate materials
themselves pose environmental and health risks, making them unacceptable as
substitutes for lead.
Table 11-1:

Comparison of properties of glass types in combination with
their fillers

Glass family

CTE

Melt-down
temperature< 500°C

Remarks

Lead-Borates

5 - 15
ppm/K

Lead-AlkalinePhosphates

13 - 20
ppm/K< 500°CNo fillers needed due to intrinsicallymatching CTE

Zincphosphates

13 – 16*
ppm/K

450 - 600 °C

Crystallization tendency is inacceptable highthat not even a minimum process window
would be left

Due to sufficient crystallization stability theaddition of CTE-reducing fillers is possible.

Source: (SCHOTT AG 2021)*no filler

Electronic glasses – Photonis (2020) details limitations of alternatives in relation to
the three application types. For micro channel plate (MCP) in particular the high length
to diameter ratios and the small channel size (2.5 to 25 microns) required cannot be
achieved with non-glass material. A few alternatives for substituting the type of glass,explaining their limitations, are presented. These include the use of soda-lime glass,borosilicate glass, crystalline or amorphous silicon and ceramics. Only borosilicate
glass allows producing applicable alternatives for MCP. Despite the hollow-draw
process used for production leading to hexagonal channel shapes and significant
channel deformation at the boundaries of the multifibres, these glasses are still
suitable for large area MCPs, however these are explained to cover only a small shareof all MCPs. Most of MCPs are 25mm diameter small channel MCPs used for image
intensifier tubes.
On the technological level, atomic layer deposition (ALD) is mentioned as aprospective candidate for MCP. In this process a series of independent, selfterminating gas reactions of alternating precursor gases are used to build up a filmwith a desired chemistry one atomic layer at a time. The composition of the film isdetermined by the chemical components of the precursor gases, and these precursors
must be carefully selected to produce films with the desired final chemistry. For lead

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glass MCPs, the manufacturing steps for producing the resistive and emissive layers
are inter-dependent processes, so that properties of resistive and emissive layers canbe selected and adjusted independently. Though promising developments are
mentioned, these are still being researched. Progress has been made in the last ten
years. The projected future of ALD development leads Photonis to estimate that it willtake at least 5 more years for this process to become sufficiently reliable forcommercial manufacturing of MCPs as particle detectors. Applications for night visionequipment are estimated to require a longer time to develop. (Photonis Scientific, Inc.
2020)
Photonis (2020) has also used the ALD technology to create functional CEMs as part ofits research and development programs. These detectors demonstrate that ALD can beused to make CEMs, but the full range of characteristics for this type of CEM have notyet been studied. Photonis mentions limitations of ALD, which are not reproduced here
as the technology is understood to be under development.
Additional technological alternatives (discrete dynode multiplier, photodiodes,
photomultiplier tube and Electron-bombarded CCD) are compared in relation toapplication areas of MCPs and CEMs in table 1 of section 6.1.3 of the application.
Unique properties of MCPs are shown on p. 15, explaining that alternate detectors do
not possess all of these properties, but could eventually allow for eliminating the needfor lead-glass MCPs. (Photonis Scientific, Inc. 2020)
ALD is also considered for resistive film for resistive glass capillary inlet tubes (RGP).
The ALD coating of resistive glass capillaries inlet tubes has produced tubes with poor
resistance uniformity along the length of the inlet tube. The films produced by ALD
deposition on capillary inlet tubes were not stable over the broad temperature range(350°C-450°C) and eventually failed and became non-conducting after a few hours attemperatures >200°C. There are three main alternatives to resistive glass capillary
inlet tubes, non-conducting glass tubes, metal tubes, and orifices. Non-conducting
glass tubes transport ions in a similar fashion to resistive glass tubes, but the fact thatthey do not conduct electricity limits their performance in two key areas. The first isthat the build-up of charge on the inside of the tube leads to decreased ionstransmission compared to resistive glass capillary inlet tubes. The second is the speed
at which the inlet can be electrically switched between positive and negative ion
modes. Metal tubes and orifices do not have the switching time limitations of the glass
tubes, but cannot support a voltage drop, which means the two sides must be at thesame potential. This can complicate the post capillary ion-neutral atom separation
process. (Photonis Scientific, Inc. 2020)
In a late communication Photonis (2021c) states that “it is conceivable that somelead-glass components could be made with thin functional lead-glass surfaces rather
than fabricated entirely out of lead-glass. The rationale would be that only a few
microns of material near the surface are responsible for the electrical conductivity andenhanced electron emission properties of reduced lead-glass”. This option is howeverunderstood to refer to a possible future development and not an alternative alreadyapplied on the market.

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To summarise, though Photonis (2020) shows that many candidates are underconsideration, it is explained that none are currently mature enough to allow for
substitution in most of the application range of MCPs, CEMs and RGPs.
Piezoelectric materials – On the substance substitution level, COCIR (2020) statesthat extensive research has been carried out into lead-free piezoelectric materials, but
still giving very inferior performance. Table 1 of the application compares properties ofpossible PZT alternatives and Figure 1 of the application compares the dielectric
constant of lead-free and lead based materials. Reference to a review by Taghaddos is
also made, which looks at additional materials and devices. The bottom line is thatthese are inferior to PZT in performance, whereas there is a risk that the use of leadfree transducers might entail medical misdiagnosis and is thus not practical for
medical applications.
An alternative technology mentioned by COCIR (2020) is capacitive Micromachined
Ultrasonic Transducers (cMUT), which do not contain lead. cMUTs have the potential to
be a lead-free alternative for ultrasound imaging with potentially wider bandwidths
and smaller feature size. However, cMUT technology has yet to overcome significant
technical limitations necessary to be a clinically viable alternative, including output
pressure, reliability and linearity. Information from studies is provided to allow a
comparison between the technologies in relation to insertion loss and reliability
results. Recognizing these limitations, researchers have focused their investigations on
applications that play to the strengths of cMUTs, namely their ability to produce smallfeature sizes and wide bandwidths. These applications include catheters, endoscopic
probes, high frequency linear arrays and probes with wide clinical coverage.
Transducers for these applications cannot be fabricated easily using PZT or single
crystal technology and therefor accept the reduced acoustic output performanceassociated with cMUTs. This technology is still in development, but it is consideredhighly unlikely by COCIR that sufficient performance will be obtained in the next 5-10
years (COCIR 2020).
The Umbrella Project (2020h) refer to the MRS Bulletin 59 and explains that though it
would be scientifically and technically possible to use lead-free piezoelectric material,
the actual physical properties such as dielectric properties and elasticity as well as
their temperature dependence will be significantly different to those of lead-containing
material. There are two prominent lead-free piezo materials: Potassium Sodium
Niobate (KNN) and Bismuth Sodium Titanate (BNT) / Sodium Bismuth Titanate (NBT).
Compared to PZT, lead-free piezoelectric ceramics like (K,Na)NbO3 (KNN) ceramics
have several disadvantages:
59

Low piezoelectric performance (piezoelectric constant), so in order to achieveequivalent electrical performance it is necessary to increase the element size
several times (i.e. component will not fit in current designs of printed wiringboards, a particular disadvantage for medical devices that need to be inserted into
the body);

Cited as: MRS Bulletin, 43 (8). pp. 581-587, A. J. Bell and O. Deubzer
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

Low depolarization temperature, so operating temperatures must be lowered inorder to achieve the required electrical functions. (e.g. cooling of EEE will benecessary);

Inferior fatigue properties and mechanical strength result in the reduction of theservice life of EEE within a range from several tens to several hundreds of times(e.g. a few months service time instead of 10 years approximately).



A more complex sintering process with lower yields is necessary. Moreover,niobium is a critical raw material and presents a supply risk.

To further support the justification for the exemption, two stakeholders that produce
PZT components stated in confidentiality that ceramic materials tend to be thecostliest components in an application. Their long-time experience shows that if there
is a non-ceramic solution that can be realised, it will be applied.
Positive Temperature Coefficient (PTC) thermistors - The Umbrella Project
asserts that industry has conducted research and development activities to findmaterials that are candidates for lead-free PTC thermistors, such as alkali metals,
alkali earth metals and bismuth as additive elements in substitution of lead. Under
actual operation conditions, part of the alkali metals will precipitate in the crystal grainboundary and cause the electrical resistance to change, hindering the long-term
stability of electrical functions and reliability. Service life is also reduced to one tenthof the original lifespan (Umbrella Project 2020h).
11.4.2.

Environmental arguments

The Umbrella Project (2020h) assures that the use of lead-containing glass andceramics helps saving energy and resources along the entire product lifecycle. This
encompasses the production and use phase of EEE, where lead-containing ceramics
show high efficiency even when reduced in size and thickness. The use of lead alsoachieved long service life and high reliability, which results in higher resource
efficiency. Results of a Life Cycle Assessment of lead-free piezo-electrics (by IbnMohammed et al.) are quoted to illustrate some of the environmental impacts of PZTand its alternatives, referring to strengths and weaknesses of the alternatives
compared.
11.4.3.

Socioeconomic impacts

COCIR (2020) explains that, if the exemption was withdrawn, some uses of ultrasoundtransducers could be substituted by MRI. However, this would impose additional costs
to medical facilities and is not considered a practical solution (MRI typically cost €2
million each compared to less that €20,000 for ultrasound, MRI also requires more
space and have much higher running costs). This could affect the level of available
services for some EU patients possibly also with impacts on diagnosis and treatment.
Optical Fiber Packaging Ltd (2020) warns that its core business would be badly
affected if the exemption is not renewed with over 100 jobs at stake. More than 90%
of OFP’s products use the current low melting point glass.
DxTx Medical (DxTx Medical 2021) expresses its concern that without the exemption,
the quality of medical diagnostic equipment could be compromised if certain EEE
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components have to be replaced. This could lead to compatibility problems withexisting devices.
SEMI (SEMI EUROPE 2021b) notes that replacing lead-containing parts with RoHScompliant parts would impose an additional administrative burden on industry. The
simultaneous redesign of several products would require the industry to implement
significant engineer projects.
11.4.4.

Road map to substitution

Bourns Inc. (Bourns Inc. 2021a), points out that a roadmap for lead-substitution inglass cannot be provided because the research and development of lead-freesubstitutes has not yet resulted in a suitable candidate material. While some leadcontaining component types might be phased out of current production during thenext years there is still a need to maintain the availability of spare parts for servicing
EEE products.
11.4.5.

The scope of the exemption

The current exemption formulation is understood to be relatively broad, allowing any
kind of application of lead in glass, ceramic or glass-ceramic matrix materials in EEE.
Considering that a specification of the exemption could prevent its misuse, applicants
were asked to propose possible approaches, either referring to specific properties or to
specific application areas. The following reproduces some of the aspects mentioned inthis respect.
COCIR (2021) specifies that in relation to PZT materials the exemption renewal is only
requested for medical ultrasound transducers, though piezoelectric ultrasoundtransducers may also be used in Cat. 9 EEE. Furthermore, PZT materials are explained
to also be used in types of electronic components used in all EEE such as ceramic
filters, ceramic resonators, buzzers, etc. Reference is made to SVHC statement
submitted by MURATA with regards to other components. COCIR also need theexemption for leaded glass hermetic encapsulation which is used in high voltage
diodes of Cat. 8 devices: Defibrillator / Monitor and Automated External Defibrillators.
Photonis (2021b) emphasizes that CEMs and RGPs (and also MCPs) are all applications
based on resistive glass, where lead is necessary to realize stable quality for the
resistive properties required in current market applications. Lead also enables theprovision of current flow, the crack resistance of the glass, and the reduced melting
temperature and viscosity of the glass.
Later Photonis (Photonis 2021a) explains the primary technical specifications for theuse of the lead glass in the production of chemically modified surfaces for MCPs, CEMs
and RGPs. Photonis does not see a way to exclude such applications from theexemption or provide examples of applications falling in the scope of exemption 7(c)-I
where the use of lead is avoided. A possibility to reduce the lead content of thesecomponents could be to fabricate few microns-thick functional lead-glass layers on thesurfaces of lead-free glass components to create electrical conductivity and enhanced
electron emission properties. However, this option is currently at a low technology
readiness level.
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OFP (2021b) request the exemption for hermetic sealing and Cat. 3 and Cat. 8
applications of fixing of optical fibers and electrical conductors into metal alloys,
ceramics and other glasses. OFP further explains its technologies to rely on: Lead inglass matrix materials with melting points of 270-320°C, containing a 70% to 85%
lead oxide formulation for the purpose of hermetically sealing of optical fibers andelectrical conductors into metal alloy, ceramics and glass components.
In a later correspondence, OFP (OFP 2021a) disagrees with a proposed wording for7(c)-I because it narrows that scope of Low Melting Point glass (LMP) material in a
way that would exclude OFP‘s products, specifically hermetic sealing and fixing of
optical fibers and electrical conductors into metal alloys, ceramics and other glasses.
The applicant cannot provide an adequate wording proposal that narrows the scope of7(c)-I without excluding the use of lead in above mentioned applications.
Umbrella Project (2021m) stated that they do not believe the exemption is misused,since the addition of lead causes variations in the electrical/mechanicalfunctions/properties of electrical and electronic components, making them
incompatible with the relevant EEE specification requirements, component
manufacturers consider that lead is used only where necessary for given applications.
The Umbrella Project (Umbrella Project 2021a) later stresses that the current wordingof exemption 7(c)-I covers a plethora of technical applications of lead in glass or
ceramic materials in EEE relevant for their proper function. In a legal text, thecomplex interrelations of various technical parameters cannot be described in a more
specific language as it is deemed impossible in practice to exhaustively present all
applications and cases. In support of this point of view, Bourns Inc. presents a nonexhaustive selection of examples where the required technical performanceparameters necessitate the continued use of lead-containing materials in EEEcomponents under 7(c)-I (Bourns Inc. 2021b). It is emphasized that it is considered
impractical to define specific technical parameters in the wording of 7(c)-I because
they are too heterogeneous.

11.5.

Stakeholder contributions

The following 6 organisations have expressed their support of the request for renewalof this exemption in the course of the stakeholder consultation:


A manufacturer of finished medical devices that asked to remain anonymous
supports the exemption request for 7(c)-I. It has identified a few EE-components
within its product portfolio, that depend on Ex. 7(c)-I. Efforts have been made in
the past to replace or eliminate lead-containing components, but no lead-freesubstitute could be found. At present, the company has no defined roadmap to
substitute the parts.

Fresenius Kabi USA, LLC (Fresenius Kabi 2021) agrees with the exemption
request for 7(c)-I. No substitution or elimination possibilities for lead containing
components have been identified.

Japanese electric and electronic industrial associations (Japan 4EE 2021)
agrees with the exemption request for 7(c)-I and suggests that the current legal
text should be maintained. Japan 4EE has not found materials for which leadelimination or substitution is scientifically or technically feasible, or a substitute for15.02.2022 - 164

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which reliability can be ensured. Since there is a huge number of EE componentsthat require lead in glass or ceramics, only examples can be provided for materials
that depend on Ex. 7(c)-I. Japan 4EE sees no prospect of replacing the leadcontaining parts with lead-free ones and therefore cannot provide a roadmap for
the further substitution of lead in the field of EE components in the scope of 7(c)-I.
SEMI (SEMI EUROPE 2021b) notes that replacing lead-containing parts with RoHScompliant parts would impose an additional administrative burden on industry,including the assignment of a new part number, revision of related drawings andbill of materials. SEMI estimates that “even one such simple change could require
8 to 32 or more hours of engineering time [...], which could require one to three
weeks of real calendar time.“ Depending on the role of the part within theequipment, redesign of surrounding components might also be required. The
simultaneous redesign of several products would require the industry to implement
significant engineer projects.



Test and Measurement Coalition (2021), see chapter 5.1



YAGEO Corporation (Yageo 2021) states, that at the present stage, marketavailable lead-free raw materials do not fulfil all required technical performanceparameters. Several of Yaego‚s product series in mass production are alreadycompliant with RoHS (Lead content <1000 ppm) or samples available. However,
the majority of components are still in a stage of feasibility study based on the
progress of raw material development.

11.6.

Critical review

11.6.1.

REACH compliance – Relation to the REACH Regulation

See section 4.1 for details.
11.6.2.

Scientific and technical practicability of substitution

Six applicants have requested the renewal of Ex. 7(c)-I and multiple stakeholders
provided information in support of the renewal for a few application groups in thescope of the exemption that can be categorised into two groups:Lead used in glass or in a glass matrix:−

Lead-based glass, used to connect and seal, also referred to as low-melting
point (LMP) glass solders,−

Lead-containing glass in thick film inks/glazes, also referred to as glass frit,chip resistors and lead-containing glass used for encapsulating ofsemiconductor components,−

Electronic glasses

Lead in ceramic or in a ceramic matrix:−

Piezoelectric materials,−

Positive Temperature Coefficient thermistors

In lead-based glass, used for connecting components, for sealing and for
encapsulation and passivation, the presence of Pb lowers the processing
temperature of the glass and thus ensures that the components being connected or
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coated are not destroyed during the manufacturing process. Lead-containing glasses
are said to have melting temperatures of about 300 to 340°C, good wettability withboth metals and ceramics which is important for bonding different materials, weather
and corrosion resistance due to the chemical stability of lead, high mechanicalstrength due to the small thermal expansion coefficients of lead and its crack resistance and less susceptibility to dielectric breakdown under high electric loads. The
Umbrella Project states that lead-free alternatives have melting temperatures that areabout 120-160°C higher than that of lead glasses, affecting the process window andthe wettability of the glass to other materials. Use of such alternatives could result instress in the connecting material due to the differences in CTE of the lead-free glassand the materials it is used to bond or coat. This can lead to cracking and malfunctionof the bond or seal or faults in its electrical insulation properties. OFP mentions low
melting point glass mixes, such as β-eucryptite, zirconium vanadate (ZrV2C>7), andzirconium tungstate (ZrW208) or BaO(SrO,CaO)-B2O3-Bi2O3 that have been
experimented with, but that did not provide comparable performance to that of leadbased glasses, affecting the reliability of the bond or coating. Schott explains thatPbO-free glasses can be used in specially processed components (extremely fast
soldering by induction or laser) or in special, encapsulated environments, but claimthat such alternatives usually do not fulfil all requirements, thus PBO glass solders
usually still need to be used. As for glasses used for encapsulation and passivation,
the Umbrella Project contends that lead-free resistor element materials have inferiorreliability due to low moisture resistance during load heating and low mechanicalstrength during overload heating. This is not suitable for applications where power isapplied at high-temperatures or in a high-humidity environment or where pulse
overloads are applied such as in switching power supplies widely used in EEE or inlight emitting diodes where this may shorten the service life through the decrease inillumination intensity. The moisture resistance can be increased through sealing of theEEE, however this is often not practical and also increases the use of resources.
Bourns explains that its investigation of possible alternatives shows some success for
low to mid-level resistance values, however this refers to solutions for specificelements that could not be applied in other cases without requiring further adjustments. Schott mentions that glass systems with lower CTEs at higher melting temperatures like ZnO-B2O3 systems as promising candidates but need optimization of
their chemical resistance. PbO free glasses experimented with for diode passivation
are said to have undesirable interactions with the semiconductor, which reduces theelectric strength below an acceptable level.
To summarise, available substitutes are understood not to provide comparable
performance, not allowing application or resulting in bonds and seals of lower
reliability. Some of these may still have potential to develop into practical alternatives
in some applications, however the properties of the material or of how it is appliedmust still be optimised. This is not expected to happen in the short-term. It can also
be assumed from the information provided that a single solution shall probably not besuitable for all applications of Pb-glasses used for connecting, sealing, encapsulationor passivation and rather that specific solutions will need to be developed on a caseby-case basis.
The lead present in electronic glasses provides the property of current flow to theglass, which is necessary in applications based on signal multiplication and detection.
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Positive lead ions agglomerate on the glass during the production process and later act
as electron donors leading to this conduction property. The presence of lead also
contributes to glass viscosity which supports the complex forming of such components. Photonis claims that for MCPs in particular the high length to diameter ratios
and the small channel size (2.5 to 25 microns) required cannot be achieved with nonglass material. Technological alternatives for MCPs and CEMs (discrete dynode multiplier, photodiodes, photomultiplier tube and Electron-bombarded CCD) do not possess
all of the unique properties of MCPs and CEMs and would not allow elimination atpresent. Though borosilicate glass is explained to allow fabrication of the channel
form, these show deformation at the outer boundaries and are only suitable for large
area MCPs said to have only a small market share. Atomic layer deposition is underinvestigation for both MCP and CEM applications but explained to still require five
years or more for development before commercialisation may be possible.
To summarise, though many candidates are under consideration, none is understoodto currently be mature enough to allow for substitution in most of the application
range of MCPs, CEMs and RGPs. The arguments of the applicant can be followed.
The use of lead in piezoelectric materials is explained to be important for provisionof five main properties: the coupling factor of the glass; the piezoelectric constant; thedielectric constant; low insertion losses (between 0-10%); high Curie temperature to
avoid depoling and performance degradation during solder bonding, storage and use;and suitable velocity. COCIR states that though extensive research has been carriedout into lead-free piezoelectric materials, these still give inferior performance. Usingsuch alternatives in existing applications, e.g., the use of lead-free transducers inexisting devices, could entail medical misdiagnosis and is thus not practical for medical
applications. On the technical level, though COCIR mentions capacitive Micromachined
Ultrasonic Transducers as a possible lead-free alternative for ultrasound imaging, it isexplained to still have limitations hindering its clinical application including output
pressure, reliability, and linearity. Though this technology has been applied in someareas, these are areas where PZT materials cannot be fabricated easily and thus
where the lower performance is acceptable. The Umbrella Project explains that thoughlead free PZT materials exist, these differ from lead-based ones in dielectric properties, elasticity, and temperature dependence. Both technical properties and manufacturing limitations are mentioned as some of the areas where such substitutes cannot
compare with lead-based PZTs.
To summarise, though various materials for substitution of lead in piezoelectricmaterials have been considered, at present none is comparable in terms of performance to provide a suitable substitute.
In positive temperature coefficient thermistors, lead enables the thermal
characteristics and resistive value stability of the ceramic material, which allow thematerial to remain stable under changing temperatures. Alkali metals, alkali earth
metals and bismuth can be used as additive elements to substitute of lead. However,the Umbrella Project explains that under actual operation conditions, part of the alkali
metals will precipitate in the crystal grain boundary and cause the electrical resistanceto change. This subsequently affects the long-term stability of electrical functions and15.02.2022 - 167

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also reduces service life, meaning that the reliability of such substitutes is inferior to
the use of lead in these ceramic materials.
To summarise, for the various application groups mentioned, though various
alternatives have been investigated, it can be followed that these could not be appliedat present to substitute lead-based applications due to inferior performance in relation
to various properties. The consultant concludes that in some cases, such alternatives
will not allow the fabrication of the applications mentioned above, whereas in others,
fabricated elements have a lower reliability and lead to early malfunction. Both ofthese result in the situation in which lead-based applications must still be placed on
the market to allow the production of various EEE.
11.6.3.

Environmental arguments and socioeconomic impacts

The Umbrella Project refers to the environmental advantages of lead in terms ofenergy and resource consumption. In some cases, examples are given to substantiatethese claims, referring for example to components that would need to be fabricated inlarger size, leading to a need for additional resources and/or cooling requirements.
These arguments may be plausible, but have not been reviewed in detail, seeing as
the main justification for the exemption relates to the lack of available substitutes ortheir inferior reliability.
11.6.4.

Socio economic impacts

Some of the applicants provide indication as to possible socio-economic costs in thecase that the exemption was to be revoked. The information is partial and has notbeen reviewed in detail seeing as the main argumentation to justify the exemption
is not focused on socio-economic arguments.
11.6.5.

Roadmap to substitution

Neither the applicants nor any other interested parties have provided a roadmap forthe substitution of lead in the applications covered by exemption 7(c)-I. Nonetheless, available publications show that the research community is still active indeveloping materials that could provide substitutes for the applications of lead inscope of Ex. 7(c)-I in the future.
Research and development in the piezoelectric materials family has been documented over the past decade in the form of books and publicly available research
reports as well as patents. (Wu 2018) p34 for example points out that “some physical properties [of lead-free piezoelectric materials] are comparable to those of PZT”
and that their key properties have been greatly enhanced, such as piezoelectriccoefficients (dij), electromechanical coupling (kij), ferroelectric remanent polarization (Pr) and dielectric permittivity (εr).” (Wu 2018) believes “that these advances in
lead-free piezoelectric materials can transfer them into the real practical applications in the future.”
Asked to comment on these findings, industry still maintains that the materials
under consideration do not match the specific performance characteristics of PZT.
Although applicants and stakeholders point to ongoing and future research projects
in materials science, they seem to have little optimism that viable substitutes for
PZT will be ready for the market in the short term.
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As far as lead-containing electronic glasses for frit sealing, soldering, passivation
and resistive coatings, etc. are concerned, material research and development has
been carried out and reported in a large number of papers and reports. However,there does not appear to be a breakthrough solution in terms of viable, generalpurpose substitute materials for leaded glass in the 7(c)-I application area.
According to the applicants and other interested parties, it seems to be difficult tomatch the properties of substitute materials with the technical performancerequirements of EE components, as the latter are very heterogeneous. While leadcontaining glasses cover a broad range of parameters, the lead-free substitutes
would need to be identified and tested one-by-one for each application. From thebackground of the plethora of EE components affected, their lead-free redesign
would require industry to allocate substantial capital and human resources.
It can be followed that possible candidates will still require research and development before they can be applied in applications to be placed on the market and that
this could require additional time, particularly as development and optimisation willprobably need to be approached on a case-by-case basis. Nonetheless, the multitude of applications and the limited data as to the set of properties and the respective performance window needed for different applications make it difficult toconsider if in some areas lead-free alternatives might come to market faster thanothers.
11.6.6.

Scope of the Exemption

The exemption is currently formulated as follows:“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”
This formulation exempts the use of lead where it is used in one of a few materials:
glass, glass matrix, ceramic, ceramic matrix. Though it can be followed that theproperties of lead of relevance to these applications are similar, in each area, theapplications necessitate a different set of properties, as observed in Table 11-2 below.

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Table 11-2:

Comparison of properties of glass types in combination with
their fillers

Source: Information compiled by Oeko from the various applicant documents

According to the information provided by the various parties, the technical justificationin each of these application areas is different and it stands to reason that substitutes
will also differ in this respect. Furthermore, the current wording would also allow theuse of lead in other areas, provided it is in a glass or ceramic material. The applicantsand stakeholders involved in the assessment claim, as in the past review, that the listof applications is not exhaustive, and they recommend not changing the wording so as
not to deny market access to such applications. However, the input received in thecurrent assessment and in the past does not provide sufficient evidence why the
exemption would be justified in other application areas. Options have therefore been
considered to narrow the scope of exemption 7(c)-I to applications for which aplausible justification has been specified. Based on the available information and on
past efforts in this direction, the following formulation was devised as an alternative tothe current wording of Ex. 7(c)-I. It is based on an initial split of the current
exemption into two exemptions, one for lead in glass and glass matrix materials andone for lead in ceramic and ceramic matrix materials:
1) “Electrical and electronic components containing lead in a glass or glass matrix
compound that fulfils the following functions:a) protection and electrical insulation in glass beads of high voltage diodes on thebasis of a zinc-borate glass body,b) for hermetic sealings between ceramic packages and glass or ceramic lids

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RoHS Exemptions Evaluation: Pack 22c) for bonding purposes in a process parameter window for [PLEASE SPECIFYTEMPERATURE AND VISCOSITY]d) used as resistance material in cermet-based trimmer potentiometers in aparameter window [PLEASE SPECIFY RESISTIVITY]e) used in chemically modified glass surfaces for Microchannel Plates (MCPs),
Single Channel Electron Multipliers (CEMs) and Resistive Glass Products(RGPs).
2) “Electrical and electronic components containing lead in a ceramic that fulfils thefollowing functions:a) piezoelectric lead zirconium titanate (PZT) ceramics for polycrystalline
ultrasound transducers in medical devices (Category 8).
b) piezoelectric lead zirconium titanate (PZT) ceramics for ultrasonic sensor
applicationsc) providing ceramics with a positive temperature coefficient (PTC)i) with TC < 120 °C (TC: Curie temperature) and resistivity of less than <1000 Ωcmii) with TC < 120 °C and resistivity of 1,000 Ωcm and moreiii) with TC ≥ 120 °C and resistivity of less than 1,000 Ωcmiv) with TC ≥ 120 °C and resistivity of 1,000 Ωcm and more
Stakeholders and applicants were asked to comment on this proposal and also toprovide input as to the performance window for which the exemption would beneeded. The following summarises their comments and the consultant’s conclusions
for each article. Six stakeholders provided information in confidentiality. This has beentaken into consideration below where the information could be specified in ananonymous way.
The Umbrella Project (2021a) provide a general statement on the effort to specify thecurrent exemption wording, explaining that the wording should provide “a sound basis
for communication between stakeholders, consultants and finally the legislators:
I. An attempt to change structure or wording of RoHS exemptions shall be done underdue consideration that the RoHS and its Annexes are a legal text and not ascientific or technical publication, thus, the wording shall:be unambiguous and inclusive, creating legal certainty,



not discriminate or exclude market participants,

enable transparency along the supply and value chain, and finally,

enable producers of EEE and authorities to provide the proof of compliance of
products.

II. In addition, such changes should:

create environmental, health and consumer safety benefitstake into account the availability of substitutes and the socioeconomic impact of
substitution.

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III.
In order to achieve the above targets, the structure of exemptions had beensuccessfully set: as toprovide a generic exemption for a material in a group of applications as a first
step,



exclude specific applications, where substitution is scientifically and technicallypossible in a second step.

[…] The current wording of the exemption reflects the reality, and does not “appear to
be too broad, as the technical requirements that can only be met by using leadcontaining materials are described too generically.” Specifically, lead is used, if anessential technical need for it exists to fulfil the required characteristics, performance,and reliability”. The UP provide an overview of the various types of EE components
used in EEE of which Exemption 7(c)-I is relevant for many categories. This overview
is reproduced in Appendix A.3.0) to this report. The UP further explain that “Details ofmaterial composition and properties, processing parameters, etc. normally arecompany secrets and not available in public specifications. Thus, these data cannot be
used to assess the compliance to RoHS, as such information is not publicly available”.
1) “Electrical and electronic components containing lead in a glass or glass
matrix compound that fulfils the following functions:a) protection and electrical insulation in glass beads of high voltage diodeson the basis of a zinc-borate glass body,
Schott (2021) propose to make a few changes in item 1(a) so that it would read”protection and electrical insulation in glass beads of high voltage diodes and glass
layers for wafer on the basis of a lead-(zinc/silica)-borate glass body”.
Further comments were not proposed for this entry. Though the consultant appreciates the further specification of the type of glass bead, the glass type is not completely clear, and it is thus proposed to specify the two glass types, i.e., lead-zincborate and lead-silica-borate. The opposite is true for the reference to glass layers for
wafer, which is understood to extend the scope to an additional application area.
It is noted that Ex. 37 of Annex III of the Directive currently reads “Lead in the plating
layer of high voltage diodes on the basis of a zinc borate glass body” (time of writing
14.12.2021). This exemption is understood to have expired for all categories on 22
July 2021, except for Cat. 8-in-vitro, Cat. 9-industrial and Cat. 11, for which the
exemption will remain valid until July 2023 and 2024, respectively. Looking at thesimilarity of these exemptions, the consultant assumes that Ex. 37 as a minimum
would overlap with Ex. 7(a) in relation to high voltage diodes when these areprotected or insulated with a glass bead with a zinc-borate composition. Ex. 37
applications could be excluded from the current exemption to avoid uncertainties
resulting of an application covered under two exemptions. It is however not clear if Ex.
37 is still used to place articles on the market in practice or rather that stakeholders
make use of Ex. 7(c)-I instead for such applications. Rather than excluding Ex. 37
applications of Cat. 8-in-vitro, Cat. 9-industrial and Cat. 11, it would be recommended
to merge Ex. 37 into Ex. 7(a) if industry requests the renewal of Ex. 37 for thesecategories or the renewal of Ex. 7(a) for high voltage diodes with a zinc-borate body.
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This would avoid the situation of having two exemptions that cover the same applications depending on the category of use and would ensure that future assessments are
conducted together.
b) for hermetic sealings between ceramic packages and glass or ceramic lids
OFP (2021c) explains that this formulation would not cover their use of the exemption
in optical fibre applications. OFP defines its application of the exemption as “hermetic
sealing and fixing of optical fibers and electrical conductors into metal alloys, ceramics
and other glasses.” It explains that “the wording being proposed will exclude the useof LMP glass for hermetic sealing with metal alloys and other glasses. This would
result in catastrophic damage to OFP’s core business with closure of the company’s
manufacturing and the loss of over 100 jobs. More than 90% of OFP’s overall,
products use the current low melting point glass for the applications described above”.
This would furthermore subsequently affect OFP’s OEM customers and the products,
many of with are understood to be telecommunication application in scope of RoHS.
Schott (2021) also refer to the formulation of item 1(b), and provide the following
proposal: “for hermetic sealings between ceramic, metal and/or glass parts”.
The consultant can follow the need to extend the formulation so that it allows sealing
applications of lead-based glass between the three materials and does not exclude theintroduction of a hermetic seal and bond between metal and glass or between thesematerials and ceramic parts. The consultant is of the opinion that this proposed
formulation would cover both the sealing of such parts and their fixing but does notthink that this needs to be made explicit in the formulation.
A further response made in confidentiality also supports that this entry should coveralso hermetic sealings between metal and glass.
c) for bonding purposes in a limited process parameter window
Bourns (2021) confirms that lead in glass is used for bonding purposes but contends
that limiting the scope to specific temperatures and/or viscosity will greatly limit theuse of this entry. “Depending on component type and materials included in thatcomponent makes it difficult to create a viable range of temp and viscosity that will
not exclude existing products”.
In contrast, Schott (2021) provide a proposal for item 1(c) that would limit the scope
to a certain performance range for temperature and viscosity. “for bonding purposesin a process parameter window for < 500°C and 1013,3 dPas 60 (so called “glasstransition temperature”)”. Nonetheless, this is explained to be a process window for
the glass itself, whereas inclusion of possible additives may “have an impact on theprocess parameters specified here”.

60

The specified unit 1013.3 dPas indicates the viscosity of the molten glass, i.e. the shear pressures required
to move the melt at a certain temperature. Since glass does not have a melting point (solid glass is, in asense, also liquid) its “melting point” is called glass transition temperature Tg. The unit dPas indicatesthe force required to deform the melt at the glass transition temperature: dPas = deci Pascal * second.
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It is not clear whether the parameters specified by Schott would be sufficient to coverapplications using glass-lead for bonding purposes. Though it is assumed that Schottis aware of the temperatures applied in its own glasses, it is possible that where othersuppliers use other glasses, i.e., with other additives, that this parameter window may
not suffice. This is also reflected in Bourn’s appeal not to specify the temperature andviscosity parameters. Though the proposed thresholds could be tested in a further
consultation, this could also be investigated in more detail in a future assessment
where only this item is under assessment.
d) used as resistance material in cermet-based trimmer potentiometers
According to Bourns (2021) the scope of this entry needs to allow the use of lead notjust in cermet-based trimmer potentiometers but also in other resistor applications
used in other parts including: Resistor Networks, Power Resistors, Chip
Resistors/Arrays, Fuel cards, PTCs, Sensors, and Diodes to name some examples ofother Bourns applications. This is not an exhaustive list and does not leave room for
new products. For these examples the ink resistivity range may be from 1
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.
The consultant can follow that additional applications aside from cermet-based
trimmer potentiometer rely on the use of lead in glass for resistance materials. Adding
the parameter specification of the resistivity could allow confining this entry to somedegree, though it is not clear whether this range is suitable or not.
It is noted that in a separate study, exemption 34 is also under assessment forpossible renewal. This exemption reads as follows:“Lead in cermet-based trimmer potentiometer elements”

Bournes has signalled that it places trimmer potentiometers on the market throughEx. 7(c)-I and not through Ex. 34, this despite the wording of Ex. 34 which clearlyaddresses such applications. The assessment of Ex. 34 among others investigatedwhether lead must indeed be used in all cermet-based trimmer potentiometers or not(the assessment refers to two types of applications for which the justification of an
exemption may differ). A first recommendation is to renew the exemption for a shortperiod until July 2024 to allow “the industry to compile input that would allow
narrowing the scope of the exemption to specific use conditions or type of equipment”,
however a decision as to this exemption is currently pending.
Depending on the conclusions of this process, it may be relevant to exclude cermetbased trimmer potentiometers or a sub-group thereof from Ex. 7(c)-I to eliminate
possible overlaps. Should the exemption be requested for renewal, it could be addedin the future as a further item of Ex. 7(c) to ensure mutual assessments in the future.
This would ensure that the specification achieved through exemption 34 is not lost (inline with the current effort to specify the exemption). In parallel, assuming that somestakeholders did not participate in the assessment as they assumed that Ex. 7(c)-I
covered this application, they would still benefit from the exemption for a short timeto allow further substantiation of its justification.
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RoHS Exemptions Evaluation: Pack 22e) used in chemically modified glass surfaces for Microchannel Plates(MCPs), Single Channel Electron Multipliers (CEMs) and Resistive Glass
Products (RGPs).
Photonis (2021c) suggests removing the word “Single” from the text in article 1(e),explaining that “the term Single Channel Electron Multipliers should be changed to
Channel Electron Multipliers since there is a long established history of channel
electron multipliers with more than one channel.” Photonis further details two primary
technical specifications for the use of lead glass under this entry:An electrically conductive surface with sheet resistance values that can be varied
between 1E4 and 1E18 ohms.

An electron emission coefficient >1.5 for primary electrons with energies of 30eVor higher.

The consultant can follow the removal of the word “Single” from the formulation inlight of the existence of both single and multiple channel electron multipliers. As to thefurther proposed specifications, though the add to the confinement of the wording, inthe consultants view the entry refers already to very specific applications. The
additional detail would add to the complexity of the formulation, and in considered toonly become relevant in the future as a means of further specification when certain
parts of the application range maybe no longer need the use of lead in glass and when
this can be described with the above parameters.
2) “Electrical and electronic components containing lead in a ceramic that
fulfils the following functions:a) piezoelectric lead zirconium titanate (PZT) ceramics for polycrystalline ultrasoundtransducers in medical devices (Category 8).
b) piezoelectric lead zirconium titanate (PZT) ceramics for ultrasonic sensor
applications
A response provided by a manufacturer of ultrasonic cleaning devices was made inconfidentiality and clarifies that PZT ceramics are used also in such devices. For
this purpose, high-power transducers use PZT ceramic rings clamped between
metal front and back masses. The stakeholder stresses the importance of PZT
ceramics in transducer applications which are used not only for medical
applications.
A further confidential response clarifies that PZT ceramics are also used in vortex
meters. The component is detailed as an accelerometer, which was alsomentioned by a further stakeholder as a component using PZT ceramics. Thissuggests that PZT components may be needed for other than ultrasonic sensor
and ultrasound transducer applications. The stakeholder mentions additional
applications where it uses PZT components in additional EEE such as electrical andultrasonic transducers, ultrasonic level switch and density meters and in ultrasonicflow meters. Other confidential inputs refer not only to ultrasonic cleaning but also
to ultrasonic welding and cutting as areas of PZT applications
The above information refers to both item 2(a) and 2(b) and clarifies that there may
be other applications of PZT beyond those described in the proposed items. PZT
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ceramics can be understood to be used in ultrasound transducers both in medical andin other equipment, whereas it is not clear that all of these are polycrystalline
ultrasound transducers. Additional applications are also understood to be relevant
such as accelerometer. Based on the understanding that PZT materials are relatively
costly and thus used only where other alternatives do not exist, it is considered more
appropriate at this time not to confined the use of PZT materials to specificapplications but rather to focus on this in the future when the item is assessed as asingle exemption.
c) providing ceramics with a positive temperature coefficient (PTC)i) with TC < 120 °C (TC: Curie temperature) and resistivity of less than < 1000
Ωcmii) with TC < 120 °C and resistivity of 1,000 Ωcm and moreiii) with TC ≥ 120 °C and resistivity of less than 1,000 Ωcmiv) with TC ≥ 120 °C and resistivity of 1,000 Ωcm and more
Bourns (2021) refers to item 2(c) and states that the various items include the various
temperature and resistivity values. Though item 2(c)-i fits to many of Bourns PTCs,
concern is raised that the specificity of the exemption language may exclude new
innovative products or specific needs of customer applications.
The consultant does not share the opinion that the four sub-items would exclude
certain applications seeing as the reference to the parameters at his time would stillallow the use of lead-based ceramics in all combinations. Nonetheless, the consultant
is of the opinion that this added complexity should only be included after a specificassessment of this article in the future, should it be shown that the actual range ofapplications is more confined, i.e., eliminating one of the sub-items or confining its
parameters further.
As a last point it is noted that Annex III of RoHS includes the following three
exemptions that may have some overlap with the proposed specification:
Ex. 7(c)-II: Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC
or 250 V DC or higher – this exemption has also been assessed as part of thecurrent study.



Ex. 7(c)-III: Lead in dielectric ceramic in capacitors for a rated voltage of less than
125 V AC or 250 V DC – this exemption expired in 2013 and is only available forspare parts.

Ex. 7(c)-IV: Lead in PZT based dielectric ceramic materials for capacitors which arepart of integrated circuits or discrete semiconductors – a request for renewal has
not been submitted for this exemption and it is understood to only be valid for Cat.
8-in-vitro, Cat. 9-industrial and Cat. 11 EEE.

To avoid possible overlaps, it is recommended to exclude these items from the future
item for ceramic materials ether by referring to the exemptions or by excluding
capacitors altogether.

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11.6.7.

Conclusions

Article 5(1)(a) 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 andcomponents which do not require any of the materials or substances listed in
Annex II is scientifically or technically impracticable;

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 andconsumer safety benefits thereof.

From the available information, it can be concluded that for a number of applications,lead is used in glass or glass ceramic materials as well as in ceramic or ceramic matrix
materials. The different applications depend on various properties of lead to provide
certain functions or properties to the material in which it is being used.
This includes in the case of lead-based glass applications:

reduction of the material melting point,

improved wettability of the glass to various materials,decreased viscosity,adjustment of the CTE of glass to the materials it is used to bond or coat,

dielectrical strength,increased chemical and corrosion resistance

and higher strength and crack resistance,provision of current flow within the glass,high curie temperature.

Different applications of glass are based on different combinations of these properties,
also making the identification and implementation of substitutes a complex and casesensitive process. It can be followed that though research continues to find various
candidates that could be considered as potential substitutes for lead in glass
applications in the future, at present lead-free glass materials available on the market
would not provide suitable substitutes for most of the applications for which suchmaterials are used.
The situation is similar for applications in which lead is applied in a ceramic or ceramic
matrix material. Here lead is added to achieve combinations of the following properties
in the ceramic material:dielectric strength (decreased susceptibility to dielectric breakdown),higher strength and crack resistance,high curie temperature and depolarisation control under changing temperature
conditions,high piezoelectric constants (charge and voltage), andhigh coupling factor.

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Overall, the consultants conclude that the exemption is justified as available substitutes are either not suitable and cannot be fabricated into lead-free 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.
That said, in the consultant’s view, the current exemption wording is not confined to
specific applications and furthermore leads to uncertainty as to whether lead can beused only in glass or ceramic materials or also in ceramic-glass matrix materials. The
existence of many different applications results in the assessment focusing on how
these relate to each 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 the applications and its specific obstacles to substitution. Specifying the
exemption to a confined set of application would allow a more detailed assessment in
the future and shall also add certainty to market surveillance in considering in whichcases the exemption is applied properly. That said, it is difficult to conclude as to thedegree of detail that would result in a clear demarcation of applications where lead is
actually needed and used and where it is not. A proposal for exemption specification
was circulated to stakeholders and after integrating their views, a more detailed
exemption formulation could be as follows:
Option 1
1) “Electrical and electronic components containing lead in a glass or glass matrix
compound that fulfils the following functions:a) protection and electrical insulation in glass beads of high voltage diodes andglass layers for wafer on the basis of a lead-zinc-borate or a lead-silica-borate
glass body,b) for hermetic sealings between ceramic, metal and/or glass partsc) for bonding purposes in a process parameter window for < 500°C combinedwith a viscosity of 1013,3 dPas (so called “glass-transition temperature”)d) used as resistance materials such as ink, with a resistivity range from 1
Ohms/square to 1 Mega Ohms/square, excluding trimmer potentiometers*e) used in chemically modified glass surfaces for Microchannel Plates (MCPs),
Channel Electron Multipliers (CEMs) and Resistive Glass Products (RGPs).
2) “Electrical and electronic components containing lead in a ceramic that fulfils thefollowing functions (excluding items covered under item 7(c)-II, 7(c)-III and7(c)-IV of this annex):a) piezoelectric lead zirconium titanate (PZT) ceramicsb) providing ceramics with a positive temperature coefficient (PTC)*The exclusion of trimmer potentiometers is under the assumption that Ex. 34 shall berenewed for a short period and covers these applications. Nonetheless, for some items
it is not completely clear if the last adjustments could exclude applications in whichlead cannot be avoided. The following formulation is a bit more simplified. Though it
might leave more room for using the exemption where it is not necessarily needed,
this could be focused on more carefully in future assessments while reducing the riskof certain applications where lead cannot be avoided being denied market entry:
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Option 2
1) “Electrical and electronic components containing lead in a glass or glass matrix
compound that fulfils the following functions:a) protection and electrical insulation in glass beads of high voltage diodes andglass layers for wafer on the basis of a lead-zinc-borate and lead-silica-borate
glass body,b) for hermetic sealings between ceramic, metal and/or glass partsc) for bonding purposesd) used as resistance material, excluding trimmer potentiometers*e) used in chemically modified glass surfaces for Microchannel Plates (MCPs),
Channel Electron Multipliers (CEMs) and Resistive Glass Products (RGPs).
2) “Electrical and electronic components containing lead in a ceramic that fulfils thefollowing functions (excluding items covered under item 7(c)-II, 7(c)-III and7(c)-IV of this annex):a) piezoelectric lead zirconium titanate (PZT) ceramicsb) providing ceramics with a positive temperature coefficient (PTC)*The exclusion of trimmer potentiometers is under the assumption that Ex. 34 shall be renewed for a shortperiod and covers these applications.

The first alternative specifies process windows for some of the application areas and in
this sense is considered to be narrower in scope. As the duration of the assessment
did not allow a final check of this formulation with industry, it is not completely certainthat the specific thresholds may not exclude certain articles where lead is not
avoidable. Coupling this formulation with a short-termed renewal for the current
formulation of Ex. 7(c)-I would give industry time to apply for the exemption for
additional applications or for applying for amendments of the current proposal.
Alternatively, the second formulation which is considered to have more certainty inrelation to covering the various applications that make use of Ex. 7(c)-I could beapplied, not renewing the current exemption for categories where it is currently
specified to be valid until July 2021.

11.7.

Recommendation

Lead provides glass and ceramics with unique properties for various application. Given
that for many of these, substitutes are understood not to be available (or to provide
inferior performance and reliability, it is recommended to grant the exemption withthe following formulation:

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Ex. No

Exemption formulation

Duration7(c)-IElectrical 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

Expires on 21 July 2024 forall categories

7(c)-VElectrical and electronic components
containing lead in a glass or glass matrix
compound that fulfils the following functions:

Expires on 21 July 2026 forall categories

1) protection and electrical insulation inglass beads of high voltage diodes and glass
layers for wafer on the basis of a lead-zincborate or a lead-silica-borate glass body,*2) for hermetic sealings between ceramic,
metal and/or glass parts
3) for bonding purposes in a processparameter window for < 500°C combinedwith a viscosity of 1013,3 dPas (so called“glass-transition temperature”)
4) used as resistance materials such as ink,
with a resistivity range from 1 Ohms/squareto 1 Mega Ohms/square, excluding trimmer
potentiometers**
5) used in chemically modified glass surfaces
for Microchannel Plates (MCPs), Channel
Electron Multipliers (CEMs) and Resistive
Glass Products (RGPs).
7(c)-VI

Electrical and electronic components
containing lead in a ceramic that fulfils thefollowing functions (excluding items covered
under item 7(c)-II, 7(c)-III and 7(c)-IV ofthis annex):

Expires on 21 July 2026 forall categories

1) piezoelectric lead zirconium titanate (PZT)
ceramics
2) providing ceramics with a positive
temperature coefficient (PTC)*Item 7(c)-V should be merged in the future with remaining applications covered by Ex. 37 should arenewal be requested of this exemption or of Ex. 7(a) for high voltage diodes with a zinc-borate glass body.
** The exclusion of trimmer potentiometers is under the assumption that Ex. 34 shall be renewed for ashort period and covers these applications.

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12.

Exemption 7(c)-II “for lead in dielectric ceramic
in capacitors for a rated voltage of 125 V AC or
250 V DC or higher”

Declaration
In the sections that precede the “Critical review” the phrasings and wordings ofstakeholders’ explanations and arguments have been adopted from the documents
provided by the stakeholders as far as required and reasonable in the context of theevaluation at hand. Formulations were only altered or completed in cases where it wasnecessary to maintain the readability and comprehensibility of the text. These sections
are based exclusively on information provided by applicants and stakeholders, unlessotherwise stated.
Acronyms and definitions
AC

Alternating Current

CRM

Critical raw materials

DC

Direct current

EEE

Electrical and Electronic Equipment

GDP

Gross domestic product

LCA

Life cycle assessment

ZrSrTi

Zirconium strontium titanate

ZrBaTi

Zirconium barium titanate

Pb

Lead

RoHS 2

Directive 2011/65/EU on the Restriction of Hazardous Substances inElectrical and Electronic Equipment

UP

A large number of company/business organizations/businessassociations that are participants in the RoHS Umbrella Industry
Project, also referred to as the Umbrella Project

V

Volt

12.1.

Background

Discrete ceramic high voltage capacitors (with a rated voltage ≥ 125 V AC / 250 V DC)
are incorporated in a wide range of EEE to store and release electric charges. Thisfunction is necessary for the products to function as needed. Capacitors are electronic
components that can store electrical charge in the form of an electric field between
electrodes. The components are used in EEE to add capacitance to an electric circuit. A
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capacitor consists in principle of two electrically conductive electrodes that are
separated by an electrically insulating spacer, a so-called dielectric material. The lattercan consist of various non-conductive substances. Ceramics represent one class ofmaterials generally used in capacitors as a dielectric. Ceramics based dielectrics, suchas lead-containing ones, provide very good charge separating properties so that theelectric field is enhanced and this enables for small package volumes of suchcapacitors.
The current state of technology is that most ceramic capacitors are already produced
from lead-free dielectric materials. The applicant informs that “industry managed to
substitute an estimate of 99% ’lead in dielectric ceramic in capacitors for a rated
voltage of less than 125 V AC or 250 V DC‘ by lead free alternatives” (Umbrella Project
2019b). However, for some applications, capacitors are needed that provide specificproperties. High voltage rating ceramic capacitors require a dielectric material thatprovides high dielectric constant at high operating voltage. High dielectric constantand low leakage at high temperatures are necessary properties of the material inorder to obtain components with high energy storage capability. Such properties cancurrently only be achieved by using lead titanate as a constituent of the dielectric
ceramic (ibid).
Murata Electronics Europe B.V, on behalf of 37 industry organisations, which are partof the RoHS Umbrella Industry Project requests the extension of the existing
exemption with its current wording for the maximum duration allowed by Article 5 of
the Directive (Umbrella Project 2019b).
“Lead in dielectric ceramic in
Does not apply to applications
capacitors for a rated voltage of 125 covered by point 7(c)-I and 7(c)-IV
V AC or 250 V DC or higher”
of this Annex. Expires on:— 21 July 2021 for categories 1-7
and 10;— 21 July 2021 for categories 8 and9 other than in vitro diagnostic
medical devices and industrial
monitoring and control instruments;

The applicant addresses lead-containing ceramic capacitors for a rated voltage of 125
V AC or 250 V DC or higher. The original application submitted 19 December 2019 has
been extended (submitted 9 October 2020) to cover Category 11 (other EEE), in
addition to Categories 1-10 for which the renewal was originally requested.
Such capacitors are used in various categories of EEE, including consumer andhousehold equipment as well as monitoring and control instruments in industry andmedical devices. Discrete ceramic capacitors for high voltage are used in high voltage
electronic circuits, usually power electronic inverters, power electronics and specificappliances (Umbrella Project 2019b).

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The Umbrella Project asserts, that there are currently no alternative materials
available that provide the same combination of dielectric properties and thermal
stability as lead titanate (Umbrella Project 2021o). Up to now and within the foreseeable future, alternatives to allow substitution are not expected to become available
on the market. Thus, the applicant asks for an extension of the existing exemption in
Annex III for the respective maximum validity periods foreseen in the RoHS 2
Directive.

12.2.

History of the exemption

The exemption for lead in dielectric ceramic capacitors has been evaluated twice since
the Directive2002/96/EC (RoHS 1) was first published in 2003. The original exemption
7d was entitled “Lead in electronic ceramic parts (e.g. piezo electronic devices)”. In
2008/2009, the first review of this exemption concluded that lead can be substituted
in low voltage dielectric ceramic capacitors. As a consequence, a change in the title
and the number of the exemption was adopted to the Annex of RoHS 1. Since then,high voltage capacitors were addressed by the new exemption 7(c)-II titled: “Lead indielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher”.
The low voltage ceramic capacitors were addressed by exemption 7(c)-III titled: “Leadin dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V
DC”. Exemption 7c-III was transferred without changes from the Annex of RoHS 1 toAnnex III of RoHS 2 and expired on 1 January 2013 because lead-free alternatives
have become available for low-voltage ceramic capacitors. Exemption 7c-II was transferred without changes from the Annex of RoHS 1 to Annex III of RoHS 2 because
lead-free alternatives were not available for high voltage dielectric ceramic capacitors.
In 2015, Murata Elektronik GmbH applied for a further extension of exemption 7c-II. A
change in the wording of exemption 7c-II was requested to disambiguate the scopefrom exemption 7(c)-I. The assessment of the request (Gensch et al. 2016) concluded
that the exemption was still justified, as substitutes were not available for applicationin high voltage ceramic capacitors. However, the extension of the exemption wasrecommended for only three years because the applicant could not demonstrate thatthe substitution of lead in the applications concerned was scientifically and technicallyimpracticable. The 2016 evaluation concluded that “Should industry fail then again toprovide substantiated information about specific research and available lead-free HVCin the future, the consultants recommend cancelling the exemption in the next
review.” The wording of the exemption has not changed since 2016. The present
request, submitted on 19 December 2019 by Murata Elektronik GmbH on behalf of 37
industry organisations, aims at extending the existing exemption for lead in highvoltage ceramic capacitors for the second time (Murata Electronics Europe B.V. 2019).
A change in the wording is not proposed again.

12.3.

Technical description of the requested exemption

Discrete ceramic high voltage capacitors (>= 125 V AC / 250 V DC) are incorporated ina wide range of EEE to store and release electric charges, which is necessary for the
products to function as needed. The capacitors provide their function (capacitance) inhigh voltage circuits and withstand also elevated temperature without drop in energy
storage capability and leakage of the stored charge (Umbrella Project 2019b).

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Application areas of high-voltage capacitors are mainly power supply devices andprotection devices that are stated to be part of almost all of the RoHS Annex I EEE
categories. UP refers to the following EEE as examples where the Exemption isneeded: power electronic inverters, pulsed power electronics, pulse forming networks,
capacitive discharge units, transient high voltage suppression, magnetization / demagnetization devices, plasma generators, high-energy flash lamps, radio frequency
interference suppression and electrical safety devices.
The RoHS substance in question – lead (Pb) - influences the electromagnetic propertiesof the solid-state dielectric (ceramic material), in particular capacitance and dielectriclosses of capacitors. The ceramics contain lead in concentrations of 0.1- 60 wt% (%weight) of the homogeneous material. Lead-containing ceramic high voltage capacitors
are explained to be indispensable components in EEE that provide stable electric
properties even at high voltage and frequencies as well as elevated temperatures. In
high-temperature applications, the component must withstand elevated temperaturesthat build up inside the EEE housing. In the design of electrical and electronic equipment,a safety margin of 1.5 to 2 times the nominal temperature is usually applied to safeguard
against abnormal operating conditions. This requires high temperature components that
operate safely at 130 °C or higher (ibid).
12.3.1.

Amount of lead used under the exemption

According to the applicants, there is an annual amount of 7 tonnes of lead placed on
the EU market in the form of lead titanate ceramics as a constituent of capacitors,
used in EEE (Umbrella Project 2019b). The amount is calculated based on economic
allocation of global amounts to the EU market (global GDP ratio of Europe (22%)).
Concrete EU-specific consumption data is difficult to calculate as most of the leadcontaining high-voltage capacitors are produced and incorporated into EEE outside theEU so that data are not readily available.
The previous exemption request from 2015 estimated the amount of lead placed on
the EU market in the form of ceramic capacitors (as of 2013) as 11.3 tons per year.
This was already a lower amount compared to 30 t of lead placed on the EU market in
the same application area in 2007. (Gensch et al. 2016)
The applicant (Umbrella Project 2019b) further states that the overall use of leadcontaining high-voltage capacitors is expected to have declined over the past decade
as a result of technical trends in the design of electrical and electronic equipment(reduction of the operating voltage of mounted devices). However, for certain areas orapplications, such as power supplies and inverters in high voltage energy systems,
lead containing high voltage capacitors gains importance. Thus, a further reduction of
the amount of lead in this application area is not expected from today’s perspective
because practical substitution technologies are not available at the present stage (seesection 12.4.1).
The #7(c)-II technical Working Group of the Umbrella Project (Umbrella Project
2021o), notes that EU-specific consumption data for lead in high-voltage capacitors
falling within the scope of exemption 7(c)-II is difficult to calculate, as most leadcontaining components are manufactured outside the EU and then placed on the EU

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market as part of EEE. Therefore, the consumption estimates provided in the application form (Umbrella Project 2019b) cannot be further substantiated. The decline in theuse of lead-containing capacitors observed since 2013 can be attributed to thetechnical trends in EEE design to reduce the operating voltage of the mounted devices.
As a result, the number of high-voltage devices installed in EEE appears to havedecreased, which has led to a proportional decrease in the number of high-voltage
capacitors containing lead. Hence, the Umbrella Project concludes that previous lead
reductions have been the result of technical design changes rather than a replacementof lead-containing high-voltage capacitors by lead free high-voltage dielectrics.

12.4.

Applicants’ justification for the requested exemption

The applicant explains that, to date, no lead-free dielectric ceramics have been foundfor high-voltage capacitor applications that have the required technical characteristics(Umbrella Project 2019b). According to the applicant, lead-free substitutes are notconsidered to provide the same performance as compared to lead-containing
ceramics, specifically:High dielectric constant at high operating voltage,High energy storage capability (also at high temperatures),

Low leakage at high voltage and high temperatures, andLow loss at high current, frequency, and temperatures.

The applicant asserts that since 2015, industry, represented by the Umbrella Project,
has been investigating the availability of lead-free materials that could replace lead indielectric ceramics. Thus far, no technical alternative has been found for thisapplication and there are no indications that lead-free ceramic materials will be foundfor high-voltage capacitors in the near future.
The exemption request specifies the unique properties of lead-containing dielectric
ceramics, which makes their use in high voltage capacitors indispensable (Umbrella
Project 2019b):


Low Energy Loss Properties: The use of leaded ceramic suppresses thermal
vibration of the dielectric material, especially if high-frequency alternating currents
are applied. Lead-free dielectrics vibrate stronger at high-frequencies and thus
cause larger energy dissipation in the form of heat. This would be detrimental tothe proper function of modern telecommunications and computing equipment thatwork at high frequency.



Thermal Properties: Leaded dielectric ceramics exhibit both low capacitance variation with temperature changes and high Curie temperatures 61 (above 130°C).
Lead-free materials do not allow the design of high-voltage devices for hightemperature operating conditions because the capacitance decreases at higher
temperature. Regarding the specific performance parameters that can only beachieved with leaded dielectrics, the UP states in a later communication that thedielectrics of high-voltage capacitors must have a high temperature stability, which

61

The „Curie Temperature“ refers to a material-specific temperature at which the materials’ magnetic
properties change abruptly.
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is 1.5 to 2 times the rated temperature stability of the entire component (Umbrella
Project 2021p). This operating safety margin requires the use of leaded dielectrics
that can withstand a temperature of 130 °C or more.
Capacitance: At a high voltage, the dielectric is subject to mechanical stress due toits piezoelectric properties. This effect (electrostriction) causes lead-free dielectric
ceramics to become destabilized and in the worst case lose their functions. In
contrast, lead-containing dielectric ceramics suppress this effect so that they canbe safely used for high-voltage devices even if they have high capacitance.
12.4.1.

Substitution or elimination of lead

According to the Umbrella project, no suitable substitutes are available that combine
the required properties: high dielectric constant, high energy storage capability, lowleakage, and low loss at high current, frequency, and temperatures (Umbrella Project
2019b; 2021o).
The applicant explains that initial efforts of industry accomplished the substitution of
approximately 99% of lead in dielectric ceramic high voltage capacitors after the
adoption of the RoHS Directive in 2003 (ibid). Ever since, the remaining uses of leadcontaining ceramic high voltage capacitors remained largely unchanged because
industry has not been able to find lead-free substitute materials that provide the samecombination of desired properties. Thus, no further efforts have been made to phaseout lead-containing ceramic high voltage capacitors from EEE products despiteindustry having continued to monitor publicly available scientific literature that
address possible substitute candidates. The applicant also asserts that industry-run
substitution research has continued with no viable results. Evidence of unsuccessful
search for technical alternatives cannot be published because of the competitive
disadvantage of such disclosure. The exemption request illustrates the industries’
unsuccessful efforts in lead-free substitution research by means of illustrative cases:
Addition of zirconium to ceramics consisting of strontium titanate or barium
titanate: the dielectric constant decreased so that the resulting capacitance wasless than one-tenth that of the leaded capacitors. ZrSrTi or ZrBaTi based
capacitors would therefore require a tenfold larger package volume.

Strontium titanate has been investigated as a potential lead-free dielectric
ceramics substitute, since it has small energy loss and no electrostriction.
However, the capacitance is less than one tenth that of lead-added barium
titanate. Attempts to use strontium titanate for the design of high-voltage
capacitors failed to provide the desired capacitance at small size required for
applications in power supplies for household and industrial electrical equipment.
The power output of the attached AC adapters becomes unstable and can cause
the EEE to malfunction.

Technical redesign of EEE towards the usage of lead-free high-voltage capacitors:
The consequences would be increased product size and weight due to the necessity
to size up not only the capacitors but also circuit boards, cooling mechanisms etc.
This would contradict the overarching trend towards device miniaturisation in the
EEE sector.

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In addition to the above-mentioned substitution approach at the material level, there
are further possibilities to reduce the use of lead-containing capacitors at the technicallevel or at the level of circuit development. The applicant points to technical options
that have been explored to design EEE in such ways to avoid the build-up of hightemperatures (i.e. >130°C) in the proximity of high voltage capacitors within EEE
housing. The (Umbrella Project 2021o) specifies the following possibilities, but refrainsfrom outlining their practical relevance in the industry and giving a timetable for
implementation:(1) Reduction of the operating current/voltage of the device - Joule heatdecreases, and operating temperature is lowered,(2) Increase of the distance between electronic components heated to hightemperatures and the other electronic components,•

This option may not be applicable since it may have an adverse effect oncontrol in analogue circuits.

•

It may not be applicable to heat-generating parts themselves either.

(3) Passive cooling: Addition of heat sinks and heat dissipation sheets tocomponents and boards,(4) Forced cooling: Wind blowing with a blower or fan.
A non-exhaustive online literature review, conducted by the consultant, showed thatnumerous ceramic capacitors, advertised as lead-free and RoHS-compliant, arecommercially available on the market covering a wide range of technical specifications.
For instance, the product portfolio of a major component supplier contains data sheetsfor various types of lead-free ceramic capacitors in a wide range of technicalparameters (see Table 12-1).
Table 12-1:

Examples of lead-free ceramic capacitors offered by VishayType

Capacitance

Rated voltage

Operatingtemperature
range (°C)

AC Line Rated Ceramic Disc
Capacitor 62
High Voltage Class 1 Ceramic
AC and DC Disc Capacitors 63
High Voltage Ceramic DC Disc
Capacitors 64
Surface Mount Multilayer
Ceramic Chip Capacitors forHigh Temperatures 65

9 nF to 0.1 μF

400 VAC, 50 Hz-30 to +125

560 pF to 1700 pF-30 to +85

100 pF to 3300 pF

10 kVDC to 50 kVDC /7 kVAC to 34 kVAC
10 kVDC to 15 kVDC

0.1 pF to 3300 pF

25 kVDC to 500 kVDC

-55 to +200

62
63
64
65

-25 to +105

https://www.vishay.com/docs/23107/20vl.pdf
https://www.vishay.com/docs/22210/715c-kt.pdf
https://www.vishay.com/docs/23119/615rseries.pdf
https://www.vishay.com/docs/45239/vjhifreqht.pdf
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Type

Capacitance

Rated voltage

Operatingtemperature
range (°C)

AC Line Rated Ceramic Disc
Capacitors Class X2, Highreliability 66
AC Line Rated Disc
CapacitorsClass X1, Y2 67

9000 pF to
100000 pF

400 VAC-25 to +125

1.0 nF to 0.01 μF

250 VAC to 400 VAC-30 to +125

Source: (Vishay)

The above shown examples illustrate the principal availability of lead-free ceramic highvoltage capacitors on the industrial supply market. They cover a wide spectrum oftechnical specifications, including capacitance, frequency, sizes and temperature
rating. However, the rated temperature of lead-free capacitors appears to be limited
to a maximum of 125° C, which does not meet the necessary temperature requirements in all EEE applications. As the Umbrella Project explained upon request, highvoltage capacitors can heat up internally due to energy dissipation through electric
current flows. This can cause the internal temperature (inside the component housing)to exceed the rated temperature in the EEE housing, as specified in the technical data
sheets, by factor 1.5 to 2 (Umbrella Project 2021o). Therefore, UP argues that“components that can withstand a high temperature environment of 130° C or higher
are required” for safety reasons.
Another brief review of the scientific literature carried out by the consultant identified
a wealth of research and development work that has been carried out in the field ofadvanced materials over the last decade, addressing candidate lead-free dielectric
ceramics. This is evidenced by numerous publications in peer-reviewed scientificjournals. To name a few, below are some examples of lead-free dielectrics reported in
the scientific literature.
(Dittmer et al. 2011) investigated a group of materials 1–x 0.94Bi1/2Na1/2TiO3 –0.06BaTiO3_–xK0.5Na0.5NbO3 (BNT–BT–xKNN) as potential candidates for hightemperature capacitors with a working temperature far beyond 200 °C. The
researchers conclude that the tested compositions present a good starting point forthe development of high-temperature capacitor materials.

(Correia et al. 2013) demonstrate a very high energy density and hightemperature stability capacitor based on SrTiO3 substituted BiFeO3 thin films. The
lead-free material is evaluated as a promising candidate for high temperatureapplications in power electronics up to 200 °C.

(Kumar et al. 2015) report the development of multilayer ceramic capacitors basedon relaxor BaTiO3-Bi(Zn1/2Ti1/2)O3 (BT-BZT) for high temperature applications,which were evaluated in a temperature range of 50 to 350 °C.

(Sun et al. 2017) describe the fabrication of lead-free BaZr0.2Ti0.8O3 epitaxial thinfilms on Nb doped SrTiO3 substrates. The authors assert that this material exhibits
good properties (referring to thermal stability, break down voltage and fatigue
endurance) compared to other BaTiO3-based energy storage capacitor materials

66
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https://www.vishay.com/docs/23107/20vl.pdf
https://www.vishay.com/docs/23104/30lvs.pdf
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and even Pb-based systems, making it a good candidate in the application ofmodern EEE.


(Yang et al. 2017) present results for the lead free ceramics (1-x)SrTiO3xBi0.5(Na0.82K0.18)0.5Ti0.96Zr0.02Sn0.02O3. These results indicate that the (1-x)STxBNKTZS ceramics may be promising lead-free materials for high energy storage
capacitors.

(Correia et al. 2017) investigate a lead-free BiFeO3-SrTiO3 ceramic that exhibits
low dielectric loss and high thermal stability, while maintaining high energy densityand fast discharge rates up to 200 °C. The researchers conclude that these uniqueproperties clearly outperform other state of the art ceramics and potentially create
significant new markets for high capacity ceramic capacitors at high frequencies
and high temperature operations.

(Jia et al. 2018) review various contemporary lead-free dielectrics for ceramic
capacitors with upper operating temperatures far beyond 200°C. The authors
compare various lead-free perovskite capacitor dielectrics based on BT, BNT, BKT,and KNN and summarise their properties. They discuss the trade-offs between
frequency stability, loss factor and resistivity at high temperature. An outlook on
further research needs is provided to overcome prevailing obstacles in theirtechnical applicability and fabrication technologies.

(Cai et al. 2019) describe a two-step sintering process for the production of leadfree multilayer capacitors based on lead-free relaxor ferroelectric ceramic
0.87BaTiO3-0.13Bi(Zn2/3(Nb0.85Ta0.15)1/3)O3 (BT-BZNT). The fabricated dielectric
exhibits high energy density of 8.13 J cm-3 and a high efficiency of 95% at atemperature range up to 170 °C.

(X. Li et al. 2020) prepare a novel lead-free 0.88BaTiO3-0.12Bi(Li1/3Zr2/3)O3(0.12BLZ) relaxor ferroelectric ceramic for dielectric capacitor application. The
material reportedly shows good frequency and temperature stability in different
frequencies and temperatures (25–140 °C).

(Wang et al. 2020a) demonstrate that lead-free capacitors can be made from (0.7x)BiFeO3–0.3BaTiO3–xBi(Li0.5Nb0.5)O3 (BF–BT–xBLN). The multilayer ceramics showpromise for practical use in capacitors for pulsed power systems.

(Wang et al. 2020b) describe a method for the fabrication of Ca0.5Sr0.5Ti0.97Sn
0.03O3 (SnCST3) ceramics with enhanced energy storage performance. The material

is a competitive candidate for the application in lead-free high-power capacitors.
While the research cited above does not suggest that these lead-free dielectric
ceramics are immediately suitable for the substitution of lead-containing dielectrics
addressed in the current 7(c)-II exemption, it does show that a variety of promising
candidate materials and fabrication methods are available.
In a second round of consultation, stakeholders were asked to explain the relevance ofthe various candidate materials, identified in materials research literature, to theindustrialisation of lead-free substitutes for capacitors in the scope of Ex. 7(c)-II.
The Umbrella Project (Umbrella Project 2021p) replied in summary that the above
cited examples of scientific materials research results on the development of lead-freesubstitution candidates for lead-containing dielectrics represent a very low level of

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technological maturity (laboratory-scale). None of the lead-free substitution
candidates is considered practically ready for industrial use for several reasons:

The candidate materials have not been evaluated as materials in terms of the fullelectromechanical property matrix, the aging characteristics, electrodecompatibility, machinability, and process costs.

The materials in question have not yet been brought to a higher technological level
and there is no mass production to ensure a stable supply of commerciallyavailable semi-finished products.



The materials under consideration have several physical-technical deficiencies,
including being highly volatile and volatilising alkali metal elements, which lead toa change in composition during ceramic production, which in turn leads to achange in the electronic properties of the ceramics.



Further, some of the candidate materials contain critical raw materials (CRM), suchas niobium and bismuth, which have a resource supply problem.

Some of the manufacturing processes used in the fabrication of capacitor fromcandidate materials are extremely poor in productivity which would be an obstacle
to mass production.



As supplementary information, UP provides a number of technical data sheets forcapacitors out of the product portfolio of its participant organizations. The data
sheets are for fast-switching semiconductors and ceramic insulated disc type
capacitors for low dissipation. These data sheets show some of the properties ofcomponents for which the exemption is made use of but do not suffice to allow an
overview of such a range of properties.
12.4.2.

Environmental arguments

The exemption request suggests that the use of lead-containing high voltage
capacitors helps lowering the resource and energy consumption throughout the
lifecycle of an EEE product (Umbrella Project 2019b).


Leaded dielectric ceramics can be sintered at even lower temperatures than leadfree alternatives (1000°C instead of 1300°C). This reduces the energy
consumption for production and allows for a reduced carbon footprint. The
exemption request specifies the energy saving potential with 1 MWh per million
components produced (in total 220 MWh for all components placed on the EU
market per year)The reduced size and thickness of leaded high voltage capacitors is explained tosave the use of resources in comparison to the production of larger sized lead-freecomponents. The miniaturisation also helps to design smaller printed wiring boards
and housings, which contributes to material savings.

It is also stated (Umbrella Project 2019b) that the separate collection and recycling of
discrete ceramic high voltage capacitors is considered unfeasible because thesecomponents are closely incorporated into WEEE. There is no practical way to identify
and recover capacitors exclusively during the end of life treatment of WEEE.

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12.4.3.

Socioeconomic impacts

No detailed socioeconomic assessment is provided, however the applicant refers to therule of diminishing return on investment, explaining that “the efforts still necessary inorder to substitute all devices incorporating lead in the scope of 7(c)-II will be manytimes what has already been spent in materials research.” (Umbrella Project 2019b).
12.4.4.

Road map to substitution

Neither the applicants nor other interested parties have provided a roadmap for thesubstitution of lead in the applications covered by exemption 7c II.
Upon request (clarification questions), the applicant provided a confidential response
outlining several approaches to developing lead-free dielectric ceramics for use inhigh-voltage capacitors. The first example showcases a comparison of the electricalperformance parameters of a lead-containing versus a lead-free sample material. UP
concludes that the lead-free material exhibits poor performance characteristics, which
render it inadequate for the intended application in high-voltage capacitors. In asecond example that concerns a different physical parameter, a lead-free dielectric
ceramic sample with a different composition is compared with a lead-containing
sample. The results show that the lead-free dielectric has inferior properties.
Supplementary information provided by (Umbrella Project 2021n) illustrates highly
aggregated results from research projects on internal materials, conducted to develop
lead-free dielectrics for use in high-voltage applications. The information presented
indicates that it is possible in principle to improve certain properties of lead-freematerials, but generally at the expense of other important characteristics.
The (Umbrella Project 2021o) emphasizes that the past trend of lead-reduction in
high-voltage capacitors has now come to an end, as industry has not been able todevelop practical technologies that can replace specific areas and applications of
power supplies and inverters in high voltage energy systems. UP concludes that “afurther reduction of the amount of lead is not expected from today’s perspective“.
A stakeholder manufacturing components states that “a feasible alternative to solve
our technical issues is not in sight and we expect that an undefined period of time isstill ahead of us until practical solutions come on the horizon.”

12.5.

Stakeholder contributions

During the stakeholder consultation, the following organisations have expressed theirsupport of the request for renewal of this exemption.


Fresenius Kabi (Fresenius Kabi 2021) supports the application for a renewal of
the exemption (see chapter 5.1) but does not provide specific information
concerning Ex. 7(c)-II. When asked for further detail, (Fresenius Kabi USA 2021)
assures that the use of lead-containing capacitors in medical devices is not anecessity per se but they are contained in certain commoditised sub-assemblies.
Fresenius specifies five EE assemblies used in the manufacture of its productportfolio that invoke exemption 7(c)-II for compliance with the RoHS Directive.
The assemblies are sourced from several suppliers and Fresenius Kabi relies on the
suppliers’ technical data sheets for information on the content of lead-containing
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components. Enquiries with the respective suppliers revealed that one of theassemblies in question had since been redesigned using lead-free components,
making the need for a renewal of Exemption 7c-II obsolete in this particular case.
Another supplier provided technical considerations for a possible redesign of its
assemblies. Fresenius Kabi points out that it would not be a problem to incorporate
redesigned lead-free assemblies into medical devices if suppliers were able toredesign their assemblies so that they did not invoke Exemption 7(c)-II.


SEMI (SEMI EUROPE 2021b) supports the application for a renewal of the
exemption (see chapter 5.1) because the exemption is actively used for the
manufacturing of tower computers but no more specific information concerning Ex.
7(c)-II were provided.



Test and Measurement Coalition (2021) supports the application for a renewalof the exemption (see chapter 5.1) but does not provide specific information
concerning Ex. 7(c)-II.

After the consultation closed, a further stakeholder understood to be a member of theUmbrella Project initiative provided information independently as a response toclarification questions sent to UP:A stakeholder manufacturing components states that efforts have been made to
develop lead-free alternatives with the same main composition as existing leadcontaining dielectric materials. However, the results obtained during material
research have shown inferior properties, such as relative permittivity and selfheating characteristics, compared to currently used lead-containing material.
Therefore, TDK has been unable to progress to further development steps, such asreliability evaluation under continually applied high-frequency voltage. Hence, TDK
sees no perspective for a lead substitution in dielectric ceramics in the foreseeable
future.

12.6.
12.6.1.

Critical review
REACH compliance – Relation to the REACH Regulation

See section 4.1 for details.
12.6.2.

Scientific and technical practicability of substitution

Based on the information provided by the applicant and the stakeholder contributions
received in the course of the consultation, the consultant concludes that the market
availability of lead-free ceramic capacitors for a rated voltage of 125 V AC or 250 V DC
or higher appears to be very limited so far. This indicates that suppliers are still
actively using Ex. 7c-II, although only few electrical and electronic devices 68 seem tocontain capacitors based on the Ex. 7c-II. For example, according to SEMI (SEMI
EUROPE 2021b) such capacitors are used in only two parts known to be used insemiconductor-manufacturing and related equipment. Fresenius Kabi USA (2021) also
refers to only five EE assemblies where such capacitors are used in the manufacture of68

SEMI indicates that only two types wo tower computers are reliant to Ex. 7(c)-II
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its product portfolio, for which it is later understood that one has been substituted
with a lead-free capacitor.
The pace of innovation in the development of lead-free substitutes for capacitors
under Ex. 7(c)-II appears to be slowing after earlier successes in developing lead-freesubstitutes for ceramic dielectrics for low-voltage capacitors with rated temperatures
below 130°C having been adopted by industry. There are several possible
explanations:First, in the applicant‘s point of view (Umbrella Project 2019b; 2021o), thedevelopment of lead-free dielectrics that can replace for lead-containing dielectrics
is challenging. It can be deduced from this that the industry is looking formaterials that have the same or a similar combination of physical/chemical andelectronic properties as lead-containing ceramics. So far, however, the industry
has not succeeded in finding a universal substitute that matches the wide range ofproperties known from lead-containing dielectrics. The candidate materials
investigated so far provide promising results in terms of some of the desired
properties, but not in their combination.

Second, documented information on attempts to ramp up the industrial
manufacturing of high-voltage ceramic capacitors based on lead-free substitution
candidates was not found in the public domain. Therefore, such components are
not readily available on the market. As the Umbrella Project (Umbrella Project
2021p) points out, the materials under consideration have in some cases physicaland technical problems that stand in the way of reliable and competitive mass
production. In other cases, it can be understood that a full evaluation of suitability
has not been undertaken or that the materials would need further development
and research to allow mass production. It is also stated that some of the
manufacturing processes used in the production of capacitors from lead-freematerials “are extremely unproductive”.

Nevertheless, there are examples of successful eliminations of lead-containing capacitors under the scope of 7(c)-II from EE devices that contained them prior to aredesign. (Fresenius Kabi USA 2021) explains that inquiry with a supplier of subassemblies revealed that parts of newer design no longer contain leaded capacitors, sothat use of the Ex 7(c)-II is no longer necessary in this case. It can be understoodfrom the Fresenius information that at least some suppliers are proactive in phasingout the use of lead containing capacitors from their products. This illustrates that asubstitution of such components is possible. It is not clear if this is specific to theapplication area or if further research and testing of candidate alternatives, possibly
on a case-by-case basis would also allow further progress in other application areas.
In summary, the combination of the above reasons appears to have stalled the innovation process towards further reducing the lead content of capacitors in the scope of
Ex. 7(c)-II. The consultation process for this assessment revealed little evidence of
proactive and supply chain-wide R&D efforts to develop and industrialize substitutes.
It is not clear if this means that only few EE component suppliers and manufacturers
are active in such efforts or rather that it is not reported on in the publicly available
literature. Apart from general information provided by the applicant on a confidential
basis, there was nothing to suggest that the diverse research results on a laboratory
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scale have been followed up and developed to a higher technology readiness level thatwould be a prerequisite for their practical use in EEE. The answers provided by UP
make the impression that may be monitoring the international market for lead-free EEhigh-voltage capacitors to become available, however it is not clear how active thevarious stakeholders are in the development of such solutions.
Though not necessarily of technical relevance, it should also be noted that the information provided in technical datasheets of ceramic capacitors is often not free of
ambiguity. Several component suppliers advertise high-voltage ceramic capacitors as“RoHS-compatible” or “conform to RoHS Directive”. This wording is understood torefer to the applicability of Ex. 7(c)-II rather than the lead-free nature of the component. In some cases, the technical data sheet specifies that the capacitor contains alead-based material, however also stating that the component is “RoHS-compatible”.
The use of these terms differs among suppliers and may also contribute to the use of
Ex. 7(c)-II capacitors in applications where they are not necessarily needed, i.e., as it
is warranted by the current exemption formulation. This aspect is further touched
upon in section 12.6.4.
12.6.3.

Environmental arguments and socioeconomic impacts

With regard to the environmental impact of replacing lead in high-voltage capacitorswith currently available substitute materials, the applicant argued that this would
make EEE larger and less energy efficient as lead free dielectric ceramics tend to heat
up when a high voltage is applied (Umbrella Project 2019b). This would lead to anincrease of the environmental load due to the consumption of energy and resources
related to the production and disposal of larger equipment. UP extrapolates the additional power consumption due to a substitution of lead-containing capacitors in EEE torise by 220 MWh per year in Europe (ibid). Almost all types of EEE would be affected,
as the capacitors covered by Ex.7(c)-II are mainly used in power supply equipment
and protective devices. The information is not further substantiated to allow an understanding of the range of actual environmental impacts that lead-free substitutes would
result in. This aspect was not further investigated seeing as the main argumentation
to justify the exemption is focused on the lack of suitable substitutes on the market.
Socioeconomic aspects have not been addressed in detail and are also not further
reviewed.
The Umbrella Project (Umbrella Project 2021p) noted that some substitution candidate
materials rely on the use of critical raw materials (CRM), such as niobium andbismuth, which have a resource supply problem. In relation to the critical raw material
character and scarcity of these materials, which has been acknowledged by the EC 69,
the consultant understands this to refer mainly to the risk of future supply as theapplicants did not raise particular environmental aspects in this concern. The consultant considers the identification of CRM as a serious issue. Nonetheless, the economic
aspects that are understood to contribute to the categorisation of a material as having
supply risks do not relate to the three main criteria of Article 5(1)(a) but rather only tothe secondary criteria of availability. The information provided furthermore does not

69

See: https://ec.europa.eu/growth/sectors/raw-materials/specific-interest/critical_en
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allow to assess the severity of this risk and how it could affect the market in the future
should such CRMs be found beneficial as substitutes for lead in Ex. 7(c)-II capacitors
used in certain applications. In so far, the political relevance of the identification ofcertain substitute candidates as CRMs is not further investigated as it is considered tobe beyond the mandate of this review which is based on the Article 5(1)(a) criteria forjustifying exemptions.
12.6.4.

Scope of the Exemption

The current formulation of exemption 7(c)-II covers a wide scope of ceramic highvoltage capacitors for a rated voltage of 125 V AC or 250 V DC or higher. The
formulation limits the use of lead to the dielectric ceramic material. While the focus of
this exemption on the ceramic dielectric materials appears unambiguous, the second
condition “for a rated voltage of 125 V AC or 250 V DC or higher” leaves some room
for potential misuse of the exemption. The technical justification for the use of leaded
dielectrics in high-voltage capacitors does not sufficiently exclude the use of a highvoltage rated component in low-voltage circuits. In addition, research results indicatethat there are lead-free ceramic dielectrics that could, in principle, be used for highvoltage capacitors, even if these materials do not achieve all the performance parameters of leaded ceramics (such as high temperature stability). However, the current
wording of the exemption does not specify any parameters other than the rated
voltage. Thus, leaded capacitors, which could be replaced by lead-free ones in certain
applications (e.g. devices operating at low temperatures), continue to fall under thecurrent exemption. This does not give priority to avoid the use of lead-containing
capacitors in EEE in areas where it is technically possible.
Given the wide range of technical parameters, such as relative dielectric constant andself-heating characteristics, which determine the applicability of high-voltage capacitors in concrete EEE products, as well as the specific design parameters of how thehigh-voltage capacitors are integrated into the EEE, it is not clear if demarcating
specific application areas where lead can be avoided and where it cannot be would bepossible. It seems more plausible that the approach to substitution needs to be morecase by case oriented, allowing not just for the phase-in of lead-free ceramic dielectricmaterials, but also for small adaptations in the design of the specific EE assembly. For
example, the replacement of lead-containing high-voltage capacitors with larger leadfree capacitors could be considered for internal power supplies of large household
appliances, while external power supplies are less likely to be accepted in the market
if this makes them bulkier. Whether such aspects could be considered to exclude
certain areas of application from the scope of the exemption remains unclear. When
asked for example in which high temperature applications the use of leaded highvoltage capacitors remains essential and whether such high temperature applications(i.e. >130°C) are relevant across all EEE categories, UP answered (Umbrella Project
2021o) the following: “high temperature applications refer to the temperatures thatthe component must withstand inside the equipment housing. When an electric
current flows through a conductor, Joule heat is generated. If heat dissipation does
not occur, the interior of the EEE housing will inevitably reach high temperatures. The
rated temperature of the high-voltage device inside the EEE housing is generally
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temperatures from 1.5 to 2 times that of the rated temperature. Therefore, components that can withstand a high temperature environment of 130°C or higher are
required. This is common for all categories of EEE. High voltage capacitors have tofulfil the safety requirements related to the EEE where they are incorporated even incase of fault condition, e.g. short circuit or overheating. Thus, high temperature
performance is essential for electrical safety of the EEE.”
To conclude, the information provided by the Umbrella Project does not allow demarcating between applications for which the use of lead is needed and those where
alternatives could be applied. This is not clear in relation to alternatives currently
available on the market, nor in relation to those that would require further development.
The consultant recommends maintaining the existing formulation of Ex. 7(c)-II.
However, consideration should be given as to how industry could be further motivatedto phase-out lead where can be avoided through a combination of other materials anddesign adaptations.
12.6.5.

Conclusions

Article 5(1)(a) 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 andcomponents which do not require any of the materials or substances listed in
Annex II is scientifically or technically impracticable;

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 andconsumer safety benefits thereof.

From the available information, the following conclusions can be drawn in the case of
exemption 7(c)-II:The substitution of lead in ceramic dielectrics for high-voltage capacitors is scientifically possible in some cases, but not yet practicable from an industrialised technicalpoint of view. The lead-free dielectric ceramics available to date, such as zirconium
added strontium titanate ceramics and barium titanate ceramics, have several shortcomings when it comes to the full range of properties to be used as a replacement
material for high-voltage capacitors. Although design changes in high-voltage circuits
could circumvent some of the disadvantages of lead-free dielectrics (e.g., compensating for the low dielectric constant by using larger components), this does not appear
to be practical for many modern EEE. To this end, the first criterion of Article 5(1)(a)is understood to be fulfilled, at least in some cases.
The second criterion of Article 5(1)(a) - lacking reliability of substitutes – isconcluded to also apply in this case. This is against the understanding that lead-free
capacitors heat up when high voltage is applied. As a consequence, they become
unstable above 130°C and, in the worst-case lead to premature failures (e.g. theceramic cracks) in EEE.
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The third criterion of Article 5(1)(a) has not been assessed in detail due to lack of
information regarding the environmental, health and consumer safety impacts ofcandidate materials. However, it is plausible that the design of small and energyefficient power supply units, especially for mobile devices, requires the use of highvoltage capacitors that have low internal energy dissipation, i.e., lead-containing
capacitors, in order to meet their functional requirements (long term reliability in use)
as well as the design expectations of contemporary users on external power supplies(e.g. small, lightweight, no bulky ventilation).
Overall, the consultants conclude that though it may be possible to develop lead-freedielectric ceramic solutions for capacitors with a higher rated voltage, at least in somecases, this would probably need to be performed on a case-by-case basis. The current
state of the market does not allow for a short-term phase-out of lead in the full rangeof this application, seeing as specific materials and probably also design adjustments
would need to be tested before lead-free alternatives could be applied. As UP points
out “candidate materials have not been evaluated as materials in terms of the fullelectromechanical property matrix, the aging characteristics, electrode compatibility,
machinability, and process costs” It is also plausible that this development still needs
time.
Nonetheless, in the consultants’ view, the argumentation brought forward by the
stakeholders is not new. The same argumentation was brought forward in the lastassessment performed in 2015-2016, and yet it remains generic and does not provide
specific detail to allow clarifying in which types of applications substitution could be
addressed with materials and technologies on the market (as is understood to be thecase for one of the Fresenius assemblies) as opposed to where the differences
between lead-based and lead free materials make substitution challenging also in thelong term. The criteria specified in the Article 5(1)(a) criteria and the need to arrive ata wording that is practicable for enforcement seem to support the low activity fromindustries’ side to develop substitutes. Currently, there seems to be too little proactive
effort towards further innovation in substitution development. The criteria used tojustify an exemption under Article 5(1)(a) quoted above act as a barrier to further
innovation, as the extended granting of exemption 7(c)-II does not put pressure onindustry to invest more in substitution efforts. The fact that the use of lead-containing
dielectrics in the application area of high-voltage capacitors is exempt from thesubstance restrictions under RoHS may further discourage innovators from investingin the research, development, testing and industrial upscaling of lead-free substitutes.
This is especially of note for those candidate substitutes whose properties fulfil only asubset of the properties of lead-based dielectrics. Since such lead-free dielectrics canonly be considered for a small number of uses, their potential market size is smaller
and thus less economically attractive in a competitive market. Though this aspect does
not play a role in the justification of exemptions per se, it inevitably leads to thesituation where a “one size fits all solution” or in some cases a few sizes solution issought but does not promote search for case specific solutions in most cases. Were along-term transition period possible, this might on the one side put pressure onindustry to consider and implement case by case solutions given the expected
expiration of the exemption where possible and on the other side enable submission
for requests for new exemptions for applications where technical evidence can beprovided in more detail as to the obstacles to substitution.
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Although a long transition period may be helpful to put pressure on industry to further
develop and apply substitutes and later to apply for more specific exemptions in cases
where substitution is not possible, the Directive does not provide a transition period of
more than 18 months, which would not be sufficient to allow industry to makeprogress and identify which areas are not yet covered by available substitutes.
Therefore, a duration of 5 years is recommended for all EEE categories.
While the consultants recommend renewing the exemption due to the lack of sufficient
alternatives, it must also be considered how the exemption mechanism could be
rethought to encourage innovation and industrial uptake of lead-free substitutes inareas where the low-hanging fruits have been harvested. This is of particularimportance in cases where the exemption wording is not specific enough to limit use
only to areas where the RoHS substance cannot be avoided, but specification of the
exemption is communicated to be too complex.

12.7.

Recommendation

It is recommended to grant the exemption with the following formulation:
Exemption formulation

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

Does not apply to applications covered bypoint 7(c)-I and 7(c)-IV of this Annex.
Expires on 21 July 2026 for all categories

While for most categories exemption 7(c)-II is set to expire on 21 July 2021, forcategory 8 in vitro diagnostic medical devices it is valid until 21 July 2023, and for
category 9 industrial monitoring and control instruments and category 11 EEE on 21
July 2024. As explained in Section 5, the applicability of these recommendations to
EEE in categories which benefit from the validity of Ex. 7(c)-II beyond July 2021 is notcompletely clear from a legal perspective. To avoid future co-existence of several subitems with slightly different scopes it is recommended to align all categories in termsof the validity period, seeing as stakeholders did not provide information to show thattechnical differences existed between categories regarding the substitution of lead insteel. This will be more pragmatic for market surveillance and will with time lower theadministrative burden of stakeholders and the European Commission with regards torenewed exemption requests for the coexisting exemptions.

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13.

References

ABB Power Grids Switzerland Ltd., Semiconductors (ed.) (2021a): Hitachi.
Contribution to stakeholder consultation on Ex. 7(a), 2 Mar 2021.
ABB Power Grids Switzerland Ltd., Semiconductors (ed.) (2021b): Hitachi. Response
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Bosch, STMicroelectronics, Infineon, NXP, Nexperia (ed.) (2021b): DA5. Die Attach 5
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ns/7a/Application_Exemption_extension_ap_7a_1-6-2020_final.pdf.
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for Ex. 7(a), 24 May 2021.
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Bourns Inc. (ed.) (2021e): Bourns Inc. Response to 4th round of clarification questions
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electronic equipment, RoHS 1. In: OJ L 073 13.2.2003. Online available athttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0095.
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as well as the availability of alternatives to these materials and to certain articles
exempted by paragraph 8 of entry 63 of Annex XVII of REACH to enable theCommission to conduct the required review of the restriction, European Chemicals
Agency. Online available athttps://echa.europa.eu/documents/10162/13641/rest_lead_articles_review_public_en.pdf/8e75d28e-04f1-bf3c-b8a0-a2d079fe3987.
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equipment (RoHS Directive) for “Pack 22”, submitted 02.03.2021, 2021. Online
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GEM Terminal IND. CO., LTD (2021a): Case of successful substitution in elements forelectrical contact, Presentation at the online meeting on 9 June 2021, 9 Jun 2021.
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4(a), no. 4(b), no. 4(c), no. 4(e), no. 4(f), no. 5(b), no. 6(a), no. 6(b), no. 6(c),no. 7(a), no. 7(c) - I, no. 7(c) - II, no. 7(c) - IV, no. 8(b), no. 9, no. 15, no. 18b,no. 21, no. 24, no. 29, no. 32, no. 34, no. 37] - Pack 9.
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Lucky Forests Corporation Ltd (ed.) (2021a): Lucky. Contribution to stakeholder
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to exemptions from the substance restrictions in electrical and electronic equipment(RoHS Directive), Final Report. In collaboration with Gensch, C., Baron, Y., Blepp,
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RED STEEL (2018): Recycling Zinc and Galvanized Steel RED STEEL (ed.). Online
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The RoHS Umbrella Project (ed.) (2021a): Umbrella Project. Response to 1st round ofclarification questions for Ex. 7(a). In collaboration with Umbrella Project,
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Umbrella Project (2020e): Application for renewal of exemption 7(a) of Annex III,
Directive 2011/65 for Categories 1-10, 15 Jan 2020. Online available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Exemptio
ns/7a/Application_UP_7_a__Exemption_Request__31012020_final.pdf.
Umbrella Project (2020f): Umbrella Project. Application for renewal of exemption 6©
of Annex III, Directive 2011/65, 15 Jan 2020.
Umbrella Project (2020g): Umbrella Project. Application for renewal of exemption 7(a)of Annex III, Directive 2011/65 for Category 11, 9 Oct 2020. Online available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Exemptio
ns/Renewal_Application_Exemption_7a_Cat11.pdf.
Umbrella Project (2021a): Answers on 2nd Clarification Questionnaire Exemption Ex.
No. 7(c)-I, received 04.08.2021, 4 Aug 2021.
Umbrella Project (2021b): Presentation at the Ex. 6c online stakeholder meeting, 9
Jun 2021.
Umbrella Project (2021c): Response to 1st round of clarification questions for Ex.
6(a)/6(a)-I, submitted XXX, 2021. Online available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Exemptio
ns/6a/Ex_6a6aI__Applicant_2_Umbrella_Project_Response_Clarification_Questions_final.pdf,
last accessed on 17 May 2021.
Umbrella Project (2021d): Response to 1st round of clarification questions for Ex.
6(b)/6(b)-I, submitted 29.01.2021, 29 Jan 2021, last accessed on 7 Jul 2021.
Umbrella Project (2021e): Response to 1st round of clarification questions for Ex. 6(c),20 Jan 2021. Online available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Exemptions/
6c/Ex_6c_Applicant_2_Umbrella_Project_Response_Clarification_Questions_29Jan202
1.pdf.
Umbrella Project (2021f): Response to 2nd round of clarification questions for Ex.
6(a)/6(a)-I, submitted 02.08.2021, 2 Aug 2021, last accessed on 12 Aug 2021.
Umbrella Project (2021g): Response to 2nd round of clarification questions for Ex.
6(b)/6(b)-I, submitted 31.05.2021, 31 May 2021.
Umbrella Project (2021h): Response to 2nd round of clarification questions for Ex.
6(b)-II, submitted 16.06.2021, 16 Jun 2021.
Umbrella Project (2021i): Response to 2nd round of clarification questions for Ex. 6(c),9 Jun 2021.
Umbrella Project (2021j): Response to 3nd round of clarification questions for Ex.
6(a)/6(a)-I, submitted 03.09.2021, 3 Sep 2021.
Umbrella Project (2021k): Response to 3rd round of clarification questions for Ex. 6(c),9 Jul 2021.
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Umbrella Project (ed.) (2019b): Umbrella Project. Application for extension ofexemption 7©-II: Request Form. Represented by Murata, 19 Dec 2019.
Umbrella Project (ed.) (2020h): Umbrella Project. Exemption Request Form RoHS 7©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”, Revised version of application submitted 19 December
2019. In collaboration with Murata Electronics Europe B.V. and VISHAY BC
components BEYSCHLAG GmbH. The RoHS Umbrella Project, 31 Jan 2020.
Umbrella Project (ed.) (2021l): Umbrella Project. Response to 1st round of clarificationquestions for Ex. 6(b)-II, submitted 29.01.2021. The RoHS Umbrella Project, 29
Jan 2021. Online available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Exemptio
ns/6b_II/Ex_6bII_Applicant_1_Umbrella_Project_Response_Clarifiaction_Questions_28012020_final.pdf.
Umbrella Project (ed.) (2021m): Umbrella Project. Response to 1st round ofclarification questions for Ex. 7(c)-I. The RoHS Umbrella Project, January 2021. Online
available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Exemptions/
7c_I/Ex_7cI_Applicant_5_Umbrella_Project_Response_Clarification_Questions_final_V2.pdf.
Umbrella Project (ed.) (2021n): Umbrella Project. Response to 1st round of clarificationquestions for Ex. 7(c)-II. Represented by Murata Manufacturing Co., Ltd, 7 Mar 2021.
Umbrella Project (ed.) (2021o): Umbrella Project. Response to clarification questions
for Exemption 7(c)-II. Represented by Murata Manufacturing Co., Ltd, 2021.
Umbrella Project (ed.) (2021p): Umbrella Project. UP Exemption 7©-II - 2ndquestionnaire - answers by UP. Represented by Murata Manufacturing Co., Ltd, 16
Jun 2021.
Vishay: Products » Capacitors. Online available at https://www.vishay.com.
Wang, G.; Lu, Z.; Yang, H.; Ji, H.; Mostaed, A.; Li, L.; Wei, Y.; Feteira, A.; Sun, S.;
Sinclair, D. C.; Wang, D.; Reaney, I. M. (2020a): Fatigue resistant lead-free
multilayer ceramic capacitors with ultrahigh energy density. In: J. Mater. Chem. A 8(22), pp. 11414–11423. DOI: 10.1039/D0TA00216J.
Wang, W.; Pu, Y.; Guo, X.; Shi, R.; Yang, M.; Li, J. (2020b): Combining high energy
efficiency and fast charge-discharge capability in calcium strontium titanate-based
linear dielectric ceramic for energy-storage. In: Ceramics International 46 (8), pp.
11484–11491. DOI: 10.1016/j.ceramint.2020.01.174.
Wu, J. (2018): Advances in Lead-Free Piezoelectric Materials. Singapore: Springer.
X. Li; Xiuli Chen; Jie Sun; Mingxing Zhou; H. Zhou (2020): Novel lead-free ceramic
capacitors with high energy density and fast discharge performance. In: Ceramics
International 46, pp. 3426–3432.
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Yageo (2021): Contribution to stakeholder consultation on Ex. 7(c)-I, 8 Feb 2021.
Online available athttps://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_22/Contributions/Ex_7c-I_Contribution_Yageo_contribution.pdf.
Yang, H.; Yan, F.; Lin, Y.; Wang, T. (2017): Improvement of dielectric and energy
storage properties in SrTiO3-based lead-free ceramics. In: Journal of Alloys andCompounds 728, pp. 780–787. DOI: 10.1016/j.jallcom.2017.09.022.

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Appendix 1: Aspects relevant to the
REACH Regulation
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), pg. 1)

Where processes related to the REACH regulation should be followed to understandwhere such cases may become relevant in the future;

Compiled information in this respect has been included, with short clarifications where
relevant, in the following tables:
Table A-1 lists those substances appearing in Annex XIV, subject to Authorisation,
which are relevant to the RoHS substances dealt with in the requests evaluated in thisproject. As can be seen, at present, exemptions have not been granted for the use of
these substances.
Table A-1:

Relevant entries from Annex XIV: List of substances subject toauthorisation

Designation of the substance, of thegroup of substances, or of the
mixtureTransitional arrangements

Exempted(categoriesof) uses

Latestapplication
date ( 1 )Sunset date(2)

4. Bis(2-ethylhexyl) phthalate (DEHP)
EC No: 204-211-0
CAS No: 117-81-7

21 August
2013(*)

21 February
2015
(**)

5. Benzyl butyl phthalate (BBP)EC No: 201-622-7
CAS No: 85-68-7

21 August
2013(*)

21 February
2015
(**)

6. Dibutyl phthalate (DBP)EC No: 201-557-4
CAS No: 84-74-2

21 August
2013(*)

21 February
2015
(**)

7. Diisobutyl phthalate (DiBP)EC No: 201-553-2
CAS No: 84-69-5

21 August
2013(*)

21 February
2015
(**)

10. Lead chromate
EC No: 231-846-0
CAS No: 7758-97-6

21 Nov 2013(*)

21 May 2015(**)-

11. Lead sulfochromate yellow(C.I. Pigment Yellow 34)
EC No: 215-693-7
CAS No: 1344-37-2

21 Nov 2013(*)

21 May 2015(**)-

Uses in theimmediatepackaging of
medicinal
products
covered
under
Regulation(EC) No
726/ 2004,
Directive
2001/82/EC,
and/orDirective
2001/83/EC

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Designation of the substance, of thegroup of substances, or of the
mixtureTransitional arrangements

Exempted(categoriesof) uses

Latestapplication
date ( 1 )Sunset date(2)

12. Lead chromate molybdate sulphate
red(C.I. Pigment Red 104)
EC No: 235-759-9
CAS No: 12656-85-8

21 Nov 2013(*)

21 May 2015(**)-

16. Chromium trioxide
EC No: 215-607-8
CAS No: 1333-82-0

21 Mar 2016(*)

21 Sep 2017(**)-

17. Acids generated from chromium
trioxide and their oligomers
Group containing:
Chromic acid
EC No: 231-801-5
CAS No: 7738-94-5
Dichromic acid
EC No: 236-881-5
CAS No: 13530-68-2
Oligomers of chromic acid and dichromicacid
EC No: not yet assigned
CAS No: not yet assigned

21 Mar 2016(*)

21 Sep 2017(**)-

18. Sodium dichromate
EC No: 234-190-3
CAS No: 7789-12-0
10588-01-9

21 Mar 2016(*)

21 Sep 2017(**)-

19. Potassium dichromate
EC No: 231-906-6
CAS No: 7778-50-9

21 Mar 2016(*)

21 Sep 2017(**)-

20. Ammonium dichromate
EC No: 232-143-1
CAS No: 7789-09-5

21 Mar 2016(*)

21 Sep 2017(**)-

21. Potassium chromate
EC No: 232-140-5
CAS No: 7789-00-6

21 Mar 2016(*)

21 Sep 2017(**)

22. Sodium chromate
EC No: 231-889-5
CAS No: 7775-11-3

21 Mar 2016(*)

21 Sep 2017(**)

28. Dichromium tris(-chromate)
EC No: 246-356-2
CAS No: 24613-89-6

22. Jul 2017(*)

22 Jan 2019(**)

29. Strontium chromate
EC No: 232-142-6 CAS
CAS No: 7789-06-2

22 Jul 2017(*)

22 Jan 2019(**)

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Designation of the substance, of thegroup of substances, or of the
mixtureTransitional arrangements
Latestapplication
date ( 1 )Sunset date(2)

30. Potassiumhydroxyoctaoxodizincatedichromate
EC No: 234-329-8
CAS No: 11103-86-9

22 Jul 2017(*)

22 Jan 2019(**)

31. Pentazinc chromate octahydroxide
EC No: 256-418-0
CAS No: 49663-84-5

22 Jul 2017(*)

22 Jan 2019(**)

Exempted(categoriesof) uses(*) 1 September 2019 for the use of the substance in the production of spare parts for the repair ofarticles the production of which ceased or will cease before the sunset date indicated in the entry forthat substance, where that substance was used in the production of those articles and the latter cannot
function as intended without that spare part, and for the use of the substance (on its own or in a
mixture) for the repair of such articles where that substance on its own or in a mixture was used in the
production of those articles and the latter cannot be repaired otherwise than by using that substance.
(**) 1 March 2021 for the use of the substance in the production of spare parts for the repair ofarticles the production of which ceased or will cease before the sunset date indicated in the entry forthat substance, where that substance was used in the production of those articles and the latter cannot
function as intended without those spare parts, and for the use of the substance (on its own or in a
mixture) for the repair of such articles, where that substance was used in the production of thosearticles and the latter cannot be repaired otherwise than by using that substance.
For the substances currently restricted according to RoHS Annex II: cadmium,hexavalent chromium, lead, mercury, polybrominated biphenyls and polybrominateddiphenyl ethers and their compounds, as well as bis(2-ethylhexyl) phthalate (DEHP),
butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DiBP), we
have found that some relevant entries are listed in Annex XVII of the REACH
Regulation. The conditions of restriction are presented in Table A-2 below.

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Table A-2:

Conditions of Restriction in REACH Annex XVII for RoHS Substances and Compounds

Designation of the substance,group of substances, or mixture

Conditions of restriction

8. Polybromobiphenyls;
Polybrominatedbiphenyls (PBB) CAS
No 59536-65-1

1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to comeinto contact with the skin.
2. Articles not complying with paragraph 1 shall not be placed on the market.

16. Lead carbonates:(a) Neutral anhydrous carbonate(PbCO 3 )CAS No 598-63-0
EC No 209-943-4(b) Trilead-bis(carbonate)dihydroxide 2Pb CO 3 -Pb(OH) 2
CAS No 1319-46-6
EC No 215-290-6

Shall not be placed on the market, or used, as substances or in mixtures, where the substance or
mixture is intended for use as paint.
However, Member States may, in accordance with the provisions of International Labour Organization(ILO) Convention 13, permit the use on their territory of the substance or mixture for the restoration andmaintenance of works of art and historic buildings and their interiors, as well as the placing on themarket for such use. Where a Member State makes use of this derogation, it shall inform theCommission thereof.

17. Lead sulphates:(a) PbSO 4
CAS No 7446-14-2
EC No 231-198-9(b) Pb x SO 4
CAS No 15739-80-7
EC No 239-831-0

Shall not be placed on the market, or used, as substances or in mixtures, where the substance or
mixture is intended for use as paint.
However, Member States may, in accordance with the provisions of International Labour Organization(ILO) Convention 13, permit the use on their territory of the substance or mixture for the restoration andmaintenance of works of art and historic buildings and their interiors, as well as the placing on themarket for such use. Where a Member State makes use of this derogation, it shall inform theCommission thereof.

18. Mercury compounds

Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture
is intended for use:(a) to prevent the fouling by micro-organisms, plants or animals of:the hulls of boats,
cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,
any totally or partly submerged appliances or equipment;(b) in the preservation of wood;(c) in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;(d) in the treatment of industrial waters, irrespective of their use.

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18a. Mercury
CAS No 7439-97-6
EC No 231-106-7

1. Shall not be placed on the market:(a) in fever thermometers;(b) in other measuring devices intended for sale to the general public (such as manometers, barometers,
sphygmomanometers, thermometers other than fever thermometers).
2. The restriction in paragraph 1 shall not apply to measuring devices that were in use in the Community
before 3 April 2009. However, Member States may restrict or prohibit the placing on the market of suchmeasuring devices.
3. The restriction in paragraph 1(b) shall not apply to:(a) measuring devices more than 50 years old on 3 October 2007;(b) barometers (except barometers within point (a)) until 3 October 2009.
5. The following mercury-containing measuring devices intended for industrial and professional uses shallnot be placed on the market after 10 April 2014:(a) barometers;(b) hygrometers;(c) manometers;(d) sphygmomanometers;(e) strain gauges to be used with plethysmographs;(f) tensiometers;(g) thermometers and other non-electrical thermometric applications.
The restriction shall also apply to measuring devices under points (a) to (g) which are placed on themarket empty if intended to be filled with mercury.
6. The restriction in paragraph 5 shall not apply to:(a) sphygmomanometers to be used:(i) in epidemiological studies which are ongoing on 10 October 2012;(ii) as reference standards in clinical validation studies of mercury-free sphygmomanometers;(b) thermometers exclusively intended to perform tests according to standards that require the use of
mercury thermometers until 10 October 2017;(c) mercury triple point cells which are used for the calibration of platinum resistance thermometers.
7. The following mercury-using measuring devices intended for professional and industrial uses shall not
be placed on the market after 10 April 2014:(a) mercury pycnometers;(b) mercury metering devices for determination of the softening point.
8. The restrictions in paragraphs 5 and 7 shall not apply to:(a) measuring devices more than 50 years old on 3 October 2007;

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23. Cadmium
CAS No 7440-43-9
EC No 231-152-8 and its compounds

For the purpose of this entry, the codes and chapters indicated in square brackets are the codes andchapters of the tariff and statistical nomenclature of Common Customs Tariff as established by Council
Regulation (EEC) No 2658/87 (1).
1. Shall not be used in mixtures and articles produced from the following synthetic organic polymers(hereafter referred to as plastic material):• 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 ofthe plastic material.
By way of derogation, the second subparagraph shall not apply to articles placed on the market before
10 December 2011.
The first and second subparagraphs apply without prejudice to Council Directive 94/62/EC (13) and acts
adopted on its basis.
By 19 November 2012, in accordance with Article 69, the Commission shall ask the European Chemicals
Agency to prepare a dossier conforming to the requirements of Annex XV in order to assess whether the

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use of cadmium and its compounds in plastic material, other than that listed in subparagraph 1, should
be restricted.
2. Shall not be used or placed on the market in paints with codes [3208] [3209] in a concentration(expressed as Cd metal) equal to or greater than 0,01 % by weight.
For paints with codes [3208] [3209] with a zinc content exceeding 10 % by weight of the paint, theconcentration of cadmium (expressed as Cd metal) shall not be equal to or greater than 0,1 % byweight.
Painted articles shall not be placed on the market if the concentration of cadmium (expressed as Cd
metal) is equal to or greater than 0,1 % by weight of the paint on the painted article.’
3. By way of derogation, paragraphs 1 and 2 shall not apply to articles coloured with mixtures containing
cadmium for safety reasons.
4. By way of derogation, paragraph 1, second subparagraph shall not apply to:— mixtures produced from PVC waste, hereinafter referred to as ‘recovered PVC’,— mixtures and articles containing recovered PVC if their concentration of cadmium (expressed as Cd
metal) does not exceed 0,1 % by weight of the plastic material in the following rigid PVC applications:—(a) profiles and rigid sheets for building applications;(b) doors, windows, shutters, walls, blinds, fences, and roof gutters;(c) decks and terraces;(d) cable ducts;(e) pipes for non-drinking water if the recovered PVC is used in the middle layer of a multilayer pipe andis entirely covered with a layer of newly produced PVC in compliance with paragraph 1 above.
Suppliers shall ensure, before the placing on the market of mixtures and articles containing recovered
PVC for the first time, that these are visibly, legibly and indelibly marked as follows: ‘Contains recovered
PVC’ or with the following pictogram:

In accordance with Article 69 of this Regulation, the derogation granted in paragraph 4 will be reviewed,
in particular with a view to reducing the limit value for cadmium and to reassess the derogation for theapplications listed in points (a) to (e), by 31 December 2017.
5. For the purpose of this entry, ‘cadmium plating’ means any deposit or coating of metallic cadmium ona metallic surface.

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Shall not be used for cadmium plating metallic articles or components of the articles used in the following
sectors/applications:(a) equipment and machinery for:— food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [847611]— agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436]— cooling and freezing [8418]— printing and book-binding [8440] [8442] [8443](b) equipment and machinery for the production of:— household goods [7321] [8421 12] [8450] [8509] [8516]— furniture [8465] [8466] [9401] [9402] [9403] [9404]— sanitary ware [7324]— central heating and air conditioning plant [7322] [8403] [8404] [8415]
In any case, whatever their use or intended final purpose, the placing on the market 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.
6. The provisions referred to in paragraph 5 shall also be applicable to cadmium-plated articles orcomponents of such articles when used in the sectors/applications listed in points (a) and (b) below andto articles manufactured in the sectors listed in (b) below:(a) equipment and machinery for the production of:— paper and board [8419 32] [8439] [8441] textiles and clothing [8444] [8445] [8447] [8448] [8449][8451] [8452](b) equipment and machinery for the production of:— industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431]— road and agricultural vehicles [chapter 87]— rolling stock [chapter 86]— vessels [chapter 89]
7. However, the restrictions in paragraphs 5 and 6 shall not apply to:— articles and components of the articles used in the aeronautical, aerospace, mining, offshore andnuclear sectors whose applications require high safety standards and in safety devices in road andagricultural vehicles, rolling stock and vessels,— electrical contacts in any sector of use, where that is necessary to ensure the reliability required of theapparatus on which they are installed.
8. Shall not be used in brazing fillers in concentration equal to or greater than 0,01 % by weight.

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Brazing fillers 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.
For the purpose of this paragraph brazing shall mean a joining technique using alloys and undertaken at
temperatures above 450 °C.
9. By way of derogation, paragraph 8 shall not apply to brazing fillers used in defence and aerospace
applications and to brazing fillers used for safety reasons.
10. Shall not be used or placed on the market if the concentration is equal to or greater than 0,01 % byweight of the metal in:(i) metal beads and other metal components for jewellery making;(ii) metal parts of jewellery and imitation jewellery articles and hair accessories, including:— bracelets, necklaces and rings,— piercing jewellery,— wrist-watches and wrist-wear,— brooches and cufflinks.
11. By way of derogation, paragraph 10 shall not apply to articles placed on the market before 10
December 2011 and jewellery more than 50 years old on 10 December 2011.
28. Substances which are classified
as carcinogen category 1A or 1B inPart 3 of Annex VI to Regulation(EC) No 1272/2008 and are listed inAppendix 1 or Appendix 2,
respectively.
29. Substances which are classified
as germ cell mutagen category 1A or
1B in Part 3 of Annex VI to
Regulation (EC) No 1272/2008 andare listed in Appendix 3 or Appendix
4, respectively.
30. Substances which are classified
as reproductive toxicant category 1A
or 1B in Part 3 of Annex VI to
Regulation (EC) No 1272/2008 andare listed in Appendix 5 or Appendix
6, respectively.

Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30:
1. Shall not be placed on the market, or used,— as substances,— as constituents of other substances, or,— in mixtures,for supply to the general public when the individual concentration in the substance or mixture is equal toor greater than:— either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No
1272/2008, or,— the relevant concentration specified in Directive 1999/45/EC where no specific concentration limit isset out in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
Without prejudice to the implementation of other Community provisions relating to the classification,
packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on themarket that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as
follows:‘Restricted to professional users’.
2. By way of derogation, paragraph 1 shall not apply to:(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;(b) cosmetic products as defined by Directive 76/768/EEC;

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RoHS Exemptions Evaluation: Pack 22(c) the following fuels and oil products:— motor fuels which are covered by Directive 98/70/EC,— mineral oil products intended for use as fuel in mobile or fixed combustion plants,— fuels sold in closed systems (e.g. liquid gas bottles);(d) artists’ paints covered by Directive 1999/45/EC;(e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11,
column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the saiddate.
47. Chromium VI compounds

1. Cement and cement-containing mixtures shall not be placed on the market, or used, if they contain,
when hydrated, more than 2 mg/kg (0,0002 %) soluble chromium VI of the total dry weight of thecement.
2. If reducing agents are used, then without prejudice to the application of other Community provisions
on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before
the placing on the market that the packaging of cement or cement-containing mixtures is visibly, legibly
and indelibly marked with information on the packing date, as well as on the storage conditions and thestorage period appropriate to maintaining the activity of the reducing agent and to keeping the content
of soluble chromium VI below the limit indicated in paragraph 1.
3. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for, and use in,controlled closed and totally automated processes in which cement and cement-containing mixtures arehandled solely by machines and in which there is no possibility of contact with the skin.
4. The standard adopted by the European Committee for Standardization (CEN) for testing the watersoluble chromium (VI) content of cement and cement-containing mixtures shall be used as the test
method for demonstrating conformity with paragraph 1.
5. Leather articles coming into contact with the skin shall not be placed on the market where they
contain chromium VI in concentrations equal to or greater than 3 mg/kg (0,0003 % by weight) of thetotal dry weight of the leather.
6. Articles containing leather parts coming into contact with the skin shall not be placed on the market
where any of those leather parts contains chromium VI in concentrations equal to or greater than 3
mg/kg (0,0003 % by weight) of the total dry weight of that leather part.
7. Paragraphs 5 and 6 shall not apply to the placing on the market of second-hand articles which were in
end-use in the Union before 1 May 2015.

51. The following phthalates (orother CAS and EC numbers covering
the substance):
Bis (2-ethylhexyl) phthalate (DEHP)
CAS No 117-81-7

1. Shall not be used as substances or in mixtures, individually or in any combination of the phthalates
listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of theplasticised material, in toys and childcare articles.

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EC No 204-211-0
Dibutyl phthalate (DBP)CAS No 84-74-2
EC No 201-557-4
Benzyl butyl phthalate (BBP)CAS No 85-68-7
EC No 201-622-7
Diisobutyl phthalate (DiBP)CAS No.: 84-69-5
EC No.: 201-553-2

2. Shall not be placed on the market in toys or childcare articles, individually or in any combination of thefirst three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 %by weight of the plasticised material.
In addition, DiBP shall not be placed on the market after 7 July 2020 in toys or childcare articles,
individually or in any combination with the first three phthalates listed in column 1 of this entry, in aconcentration equal to or greater than 0,1 % by weight of the plasticised material.
3. Shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of
the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % byweight of the plasticised material in the article.
4. Paragraph 3 shall not apply to:(a) articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided
that no plasticised material comes into contact with human mucous membranes or into prolonged contact
with human skin;(b) aircraft, placed on the market before 7 January 2024, or articles, whenever placed on the market, foruse exclusively in the maintenance or repair of those aircraft, where those articles are essential for thesafety and airworthiness of the aircraft;(c) motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of
thosevehicles, where the vehicles cannot function as intended without those articles;(d) articles placed on the market before 7 July 2020;(e) measuring devices for laboratory use, or parts thereof;(f) materials and articles intended to come into contact with food within the scope of Regulation (EC) No
1935/2004 or Commission Regulation (EU) No 10/2011(*);(g) medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof;(h) electrical and electronic equipment within the scope of Directive 2011/65/EU;(i) the immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004,
Directive 2001/82/EC or Directive 2001/83/EC;(j) toys and childcare articles covered by paragraphs 1 or 2.
5. For the purposes of paragraphs 1, 2, 3 and 4(a),(a) ‘plasticised material’ means any of the following homogeneous materials:— polyvinyl chloride (PVC), polyvinylidene chloride (PVDC),polyvinyl acetate (PVA), polyurethanes,— any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubberand natural latex coatings,— surface coatings, non-slip coatings, finishes, decals, printed designs,— adhesives, sealants, paints and inks.
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RoHS Exemptions Evaluation: Pack 22(b) ‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration orintermittent contact over a period of 30 minutes, per day.
(c) ‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feedingof children or sucking on the part of children.
6. For the purposes of paragraph 4(b), ‘aircraft’ means one of the following:(a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No
216/2008 or with a design approval issued under the national regulations of a contracting State of theInternational Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been
issued by an ICAO contracting State under Annex 8 to the Convention on International Civil Aviation,
signed on December 7, 1944, in Chicago;(b) a military aircraft.
(*) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles
intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).’62.
(a) Phenylmercury acetate
EC No: 200-532-5
CAS No: 62-38-4(b) Phenylmercury propionate
EC No: 203-094-3
CAS No: 103-27-5(c) Phenylmercury 2-ethylhexanoate
EC No: 236-326-7
CAS No: 13302-00-6(d) Phenylmercury octanoate
EC No: CAS No: 13864-38-5

1. Shall not be manufactured, placed on the market or used as substances or in mixtures after 10
October 2017 if the concentration of mercury in the mixtures is equal to or greater than 0,01 % byweight.
2. Articles or any parts thereof containing one or more of these substances shall not be placed on themarket after 10 October 2017 if the concentration of mercury in the articles or any part thereof is equal
to or greater than 0,01 % by weight.

(e) Phenylmercury neodecanoate
EC No: 247-783-7
CAS No: 26545-49-3
63. Lead
CAS No 7439-92-1
EC No 231-100-4
and its compounds

1. Shall not be placed on the market or used in any individual part of jewellery articles if theconcentration of lead (expressed as metal) in such a part is equal to or greater than 0,05 % by weight.
2. For the purposes of paragraph 1:

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RoHS Exemptions Evaluation: Pack 22(i) ‘jewellery articles’ shall include jewellery and imitation jewellery articles and hair accessories,
including:(a) bracelets, necklaces and rings;(b) piercing jewellery;(c) wrist watches and wrist-wear;(d) brooches and cufflinks;(ii) ‘any individual part’ shall include the materials from which the jewellery is made, as well as theindividual components of the jewellery articles.
3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellerymaking.
4. By way of derogation, paragraph 1 shall not apply to:(a) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC (*);(b) internal components of watch timepieces inaccessible to consumers;(c) non-synthetic or reconstructed precious and semiprecious stones (CN code 7103, as established byRegulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixturescontaining these substances;(d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals
melted at a temperature of at least 500 °C.
5. By way of derogation, paragraph 1 shall not apply to jewellery articles placed on the market for the
first time before 9 October 2013 and jewellery articles produced before 10 December 1961.
6. By 9 October 2017, the Commission shall re-evaluate paragraphs 1 to 5 of this entry in the light of
new scientific information, including the availability of alternatives and the migration of lead from thearticles referred to in paragraph 1 and, if appropriate, modify this entry accordingly.
7. Shall not be placed on the market or used in articles supplied to the general public, if theconcentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or
greater than 0,05 % by weight, and those articles or accessible parts thereof may, during normal orreasonably foreseeable conditions of use, be placed in the mouth by children. That limit shall not apply
where it can be demonstrated that the rate of lead release from such an article or any such accessible
part of an article, whether coated or uncoated, does not exceed 0,05 μg/cm 2 per hour (equivalent to
0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is notexceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of thearticle. For the purposes of this paragraph, it is considered that an article or accessible part of an article
may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or
protruding part of that size.
8. By way of derogation, paragraph 7 shall not apply to:(a) jewellery articles covered by paragraph 1;

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RoHS Exemptions Evaluation: Pack 22(b) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/ EEC;(c) non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established byRegulation (EEC) No 2658/ 87) unless they have been treated with lead or its compounds or mixturescontaining these substances;(d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineralmelted at a temperature of at least 500 ° C;(e) keys and locks, including padlocks;(f) musical instruments;(g) articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal)in the brass alloy does not exceed 0,5 % by weight;(h) the tips of writing instruments;(i) religious articles;(j) portable zinc-carbon batteries and button cell batteries;(k) articles within the scope of: (i) Directive 94/62/EC; (ii) Regulation (EC) No 1935/2004; (iii) Directive
2009/48/EC of the European Parliament and of the Council (**); (iv) Directive 2011/65/EU of theEuropean Parliament and of the Council (***)
9. By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry
in the light of new scientific information, including the availability of alternatives and the migration oflead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if
appropriate, modify this entry accordingly.
10. By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time
before 1 June 2016.
11. Doing either of the following acts after 15 February 2023 in or within 100 metres of wetlands is
prohibited:(a) discharging gunshot containing a concentration of lead (expressed as metal) equal to or greater than
1 % by weight;(b) carrying any such gunshot where this occurs while out wetland shooting or as part of going wetlandshooting.
For the purposes of the first subparagraph:(a) “within 100 metres of wetlands” means within 100 metres outward from any outer boundary point ofa wetland;(b) “wetland shooting” means shooting in or within 100 metres of wetlands;(c) if a person is found carrying gunshot in or within 100 metres of wetlands while out shooting or as partof going shooting, the shooting concerned shall be presumed to be wetland shooting unless that person
can demonstrate that it was some other type of shooting.

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The restriction laid down in the first subparagraph shall not apply in a Member State if that Member State
notifies the Commission in accordance with paragraph 12 that it intends to make use of the option
granted by that paragraph.
12. If at least 20 % in total of the territory, excluding the territorial waters, of a Member State arewetlands, that Member State may, in place of the restriction laid down in the first subparagraph ofparagraph 11, prohibit the following acts throughout the whole of its territory from 15 February 2024:(a) the placing on the market of gunshot containing a concentration of lead (expressed as metal) equal
to or greater than 1 % by weight;(b) the discharging of any such gunshot;(c) carrying any such gunshot while out shooting or as part of going shooting.
Any Member State intending to make use of the option granted by the first subparagraph shall notify theCommission of this intention by 15 August 2021. The Member State shall communicate the text of thenational measures adopted by it to the Commission without delay and in any event by 15 August 2023.
The Commission shall make publicly available without delay any such notices of intention and texts ofnational measures received by it.
13. For the purposes of paragraphs 11 and 12:(a) “wetlands” means areas of marsh, fen, peatland or water, whether natural or artificial, permanent or
temporary, with water that is static or flowing, fresh, brackish or salt, including areas of marine water
the depth of which at low tide does not exceed 6 metres;(b) “gunshot” means pellets used or intended for use in a single charge or cartridge in a shotgun;(c) “shotgun” means a smooth-bore gun, excluding airguns;(d) “shooting” means any shooting with a shotgun;(e) “carrying” means any carrying on the person or carrying or transporting by any other means;(f) in determining whether a person found with gunshot is carrying gunshot “as part of going shooting”:(i) regard shall be had to all the circumstances of the case;(ii) the person found with the gunshot need not necessarily be the same person as the person shooting.
14. Member States may maintain national provisions for protection of the environment or human healthin force on 15 February 2021 and restricting lead in gunshot more severely than provided for inparagraph 11. The Member State shall communicate the text of those national provisions to theCommission without delay. The Commission shall make publicly available without delay any such texts ofnational provisions received by it.
--(*) OJ L 326, 29.12.1969, p. 36.
(**) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safetyof toys (OJ L 170, 30.6.2009, p. 1).

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RoHS Exemptions Evaluation: Pack 22(***) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174,
1.7.2011, p. 88).
67. Bis(pentabromophenyl)ether(decabromodiphenyl ether;
decaBDE)
CAS No 1163-19-5
EC No 214-604-9

1. Shall not be manufactured or placed on the market as a substance on its own after 2 March 2019.
2. Shall not be used in the production of, or placed on the market in:(a) another substance, as a constituent;(b) a mixture;(c) an article, or any part thereof, in a concentration equal to or greater than 0,1 % by weight, after
2 March 2019.
3. Paragraphs 1 and 2 shall not apply to a substance, constituent of another substance or mixture that is
to be used, or is used:(a) in the production of an aircraft before 2 March 2027.
(b) in the production of spare parts for either of the following:(i) an aircraft produced before 2 March 2027;(ii) motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry vehicles
within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council(*) or machinery within the scope of Directive 2006/42/EC of the European Parliament and of
the Council (**), produced before 2 March 2019
4. Subparagraph 2(c) shall not apply to any of the following:(a) articles placed on the market before 2 March 2019;(b) aircraft produced in accordance with subparagraph 3(a);(c) spare parts of aircraft, vehicles or machines produced in accordance with subparagraph 3(b);(d) electrical and electronic equipment within the scope of Directive 2011/65/EU.
5. For the purposes of this entry ‘aircraft’ means one of the following:(a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EU) No
216/2008 of the European Parliament and of the Council (***) or with a design approval issued under
the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO),
or for which a certificate of airworthiness has been issued by an ICAO contracting State under Annex
8 to the Convention on International Civil Aviation; (b) a military aircraft.
(*) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on
the approval and market surveillance of agricultural and forestry vehicles (OL L 60, 2.3.2013, p. 1).
(**) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machineryand amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
(***) Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008
on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and15.02.2022 - 226

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repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L
79 19.3.2008, p. 1).
72. The following substances which
are classified as carcinogenic,
mutagenic or toxic for reproduction,category 1A or 1B
The substances listed in column 1 of
the Table in Appendix 12.

1. Shall not be placed on the market after 1 November 2020 in any of the following:(a) clothing or related accessories;(b) textiles other than clothing which, under normal or reasonably foreseeable conditions of use, comeinto contact with human skin to an extent similar to clothing;(c) footwear;
if the clothing, related accessory, textile other than clothing or foot wear is for use by consumers and thesubstance is present in a concentration, measured in homogeneous material, equal to or greater thanthat specified for that substance in Appendix 12.
2. By way of derogation, in relation to the placing on the market of formaldehyde [CAS No 50 -00 -0] injackets, coats or upholstery, the relevant concentration for the purposes of paragraph 1 shall be 300
mg/kg during the period between 1 November 2020 and 1 November 2023. The concentration specified
in Appendix 12 shall apply thereafter.
3. Paragraph 1 shall not apply to:(a) clothing, related accessories or footwear, or parts of clothing, related accessories or footwear, madeexclusively of natural leather, fur or hide;(b) non-textile fasteners and non-textile decorative attachments;(c) second-hand clothing, related accessories, textiles other than clothing or footwear(d)wall-to -wallcarpets and textile floor coverings for indoor use, rugs and runners.
4. Paragraph 1 shall not apply to clothing, related accessories, textiles other than clothing, or footwear
within the scope of Regulation (EU) 2016/425 of the European Parliament and of the Council or
Regulation (EU) 2017/745 of the European Parliament and of the Council.
5. Paragraph 1(b) shall not apply to disposable textiles. ‘Disposable textiles’ means textiles that aredesigned to be used only once or for a limited time and are not intended for subsequent use for the sameor a similar purpose.
6. Paragraphs 1 and 2 shall apply without prejudice to the application of any stricter restrictions set out
in this Annex or in other applicable Union legislation.
7. The Commission shall review the exemption in paragraph 3(d) and, if appropriate, modify that pointaccordingly.

As of July 2021, the REACH Regulation Candidate list includes various substances of relevance for RoHS. Proceedings concerning theaddition of these substances to the Authorisation list (Annex XIV) have begun and shall be followed by the evaluation team todetermine possible discrepancies with future requests of exemption from RoHS (new exemptions, renewals and revocations).

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Appendix 2: Exemption 7(a)A.2.1 Intended Use and Examples for Related Products inwhich HMP lead (Pb) solders are utilized
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A.2.2 Properties of relevance to applications in scope of Ex.
7(a) (Umbrella Project 2021e)

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A.2.3 Advantages and Disadvantages of High Temperature
Lead-free Solutions
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Evaluation results concerning lead free materials replacing lead HTM internal solder by
VishayThe following tables are from the Umbrella Project application (Umbrella Project
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A.2.4 Summary of strategies considered in the current review
in order to specify the scopeStrategy 1: the application approach−

Connecting applications of parts integral or external to an electrical orelectronic component or connecting components;−

Mounting applications of electronic components onto other assemblies;−

Sealing applications between various materials.

Strategy 2: the functional purpose of lead (properties, performance) approach−Melting temperatures; thermal conductivity; electrical conductivity, ductility;
electrical resistivity, corrosion resistance; resistance to thermal oxidation

Strategy 3: Category approach: Restriction to specific Annex I categories (e.g., 8
and 9 with requirement on high reliability) or exclusion e.g. consumer products

Strategy 2 is difficult to be followed, since underlying information on LHMPS and leadfree solders is missing. The idea of strategy 2 was to identify the essential physicalproperties of LHMPS (Note: not elemental Pb) with corresponding technical parameters. As described previously, Pb in LHMPS makes these alloys very unique andreliable based on many properties: high melting point, thermal conductivity, ductility,
electrical conductivity, electrical resistivity, corrosion resistance, resistance to thermaloxidation. Hence, understanding physical parameters of these high lead-containing
solders would be an underlying basis to identify the applications. However, stakeholders provided the physical properties for the most part on the element basis (e.g. Pb
vs. other single elemental metals). On the level of comparison of one solder toanother (e.g. Sn-85Pb vs. Lead-free alternatives) only partial information is available.
Substantiation was requested but not received and thus this direction was abandoned.
Strategy 3 was found to be unpractical, since the components in which LHMPS must
be applied could be distributed in different categories. For instance, stakeholders wereasked to explain whether LHMPS are applied in consumer equipment or whether such
equipment (or equipment with lower service life) could be excluded from the scope ofthe exemption. The RoHS Umbrella Project (2021b) explains that LHMPS are used
often in low-level electrical and electronic components. UP provides an example thatthe same SMD fuse may be used in a medical device as well as in consumer products.
Thus, UP is against an approach to exclude EEE categories from the scope.

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Appendix 3: Umbrella Project
overview of various types of Exemption7(c)-I EE components used in EEE for many
categories
The following list was provided in a communication from Umbrella Project (2021a)
commenting on the option of specifying the wording of exemption 7(c)-I:

A.3.1 Annex I – Categorization of electric and electronic
components
A rough categorization can be found for example in catalogues of component
distributors, like Digikey, as shown in the example below, copied from Website:
https://www.digikey.de/en. In total (“View All”) it lists more than 42 000 different
items:
Products View All
Semiconductors
Development Boards, Kits, Programmers

DiscreteEmbedded ComputersIntegrated Circuits (ICs)

Isolators



LED/Optoelectronics

RF, Wireless

Sensors, Transducers

PassivesCapacitors

Crystals, Oscillators



FiltersInductors, Coils, ChokesPotentiometers, Variable ResistorsResistors



Thermal Management

Electromechanical


Audio

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

Fans



Motors, Solenoids, Driver

Relays

Switches

Power, Circuit ProtectionBattery Products

Circuit ProtectionLine Protection

Power Supplies

Transformers

Automation and Control
Connectors, Interconnect
Cables, Wires
Test Products
Tools

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