Study to assess one (1) request for renewal of exemption 12 of Annex IV to Directive 2011/65/EU (Pack 19) : final report.
Date: 2020-07-08
Institutions: Directorate-General for Environment
Subjects: directive (EU), economic consequence, electronic equipment, electronic waste, environmental impact, environmental protection, health risk, innovation, product life, regulation (EU), small and medium-sized enterprises, social impact, substitute product, waste management

Study to assess one (1) request for renewal of 
exemption 12 of Annex IV to Directive 
2011/65/EU 
(Pack 19) – Final Report 
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

June 2020 

European Commission  
RoHS Exemptions Evaluation: Pack 19 

Prepared by Oeko-Institut e.V., Institute for Applied 
Ecology, and Fraunhofer-Institut for Reliability and 
Microintegration (IZM) 

Carl-Otto Gensch, Oeko-Institut 

Katja Moch, Oeko-Institut 

Otmar Deubzer, Fraunhofer IZM 

15 June 2020 

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 

Fraunhofer IZM 

Gustav-Meyer-Allee 25 

13355 Berlin, Germany 

Tel.: +49 (0)30 / 46403-157 

Fax: +49 (0)30 / 46403-131 

Web: www.fraunhofer.de 

Acknowledgements 

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

Disclaimer 

Oeko-Institut and Fraunhofer IZM have 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 and Fraunhofer IZM are not responsible for 
decisions or actions taken on the basis of the content of this report.  

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RoHS Exemptions Evaluation: Pack 19 

EUROPEAN COMMISSION 

Directorate-General for Environment 

Directorate B - Circular Economy & Green Growth 

Unit B3 - Waste Management & Secondary Materials 

Contact: Karolina Zázvorková 

E-mail: Karolina.ZAZVORKOVA@ec.europa.eu 

European Commission 

B-1049 Brussels 

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GETTING IN TOUCH WITH THE EU

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the centre nearest you at: https://europa.eu/european-union/contact_en

On the phone or by email

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authors, and the Commission cannot be held responsible for any use which may be made of the information 

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More information on the European Union is available on the Internet (http://www.europa.eu). 

Luxembourg: Publications Office of the European Union, 2020

PDF 

978-92-76-20426-8 

doi:10.2779/393458 

KH-02-20-518-EN-N

© European Union, 2020

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(OJ L 330, 14.12.2011, p. 39 – https://eur-lex.europa.eu/eli/dec/2011/833/oj)

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reuse is allowed, provided appropriate credit is given and any changes are indicated. 

European Commission  
RoHS Exemptions Evaluation: Pack 19 

Table of Contents 

1. 

2. 

3. 

4. 
5. 

Executive summary – English ..................................................................... 7 
1.1.  Background and objectives ..................................................................... 7 
1.2.  Key findings – Overview of the evaluation results ...................................... 8 
Executive summary: French - Note de synthèse: Français .............................10 
2.1.  Contexte et objectifs .............................................................................10 
Les principales conclusions – Synthèse des résultats de l'évaluation ...........11 
2.2. 
Introduction ............................................................................................13 
3.1.  Project scope and methodology ..............................................................13 
3.2.  Project set-up ......................................................................................14 
Links between the RoHS Directive and the REACH Regulation ........................15 
Annex IV, Ex. 12 ......................................................................................20 
5.1.  Background of the Exemption and of the Request .....................................21 
5.1.1.  History of Exemption 12 of Annex IV ................................................21 
5.1.2.  Overview and summary of renewal requests and stakeholder 
contributions ..............................................................................................21 
5.1.3.  Amount of lead used under the exemption ........................................23 
5.2.  Technical description of the requested exemption for SQUIDs (Megin) ........23 
5.3.  Technical description of the requested exemption for MRI and NMR (JASTEC)

5.2. 

5.1. 

27 
Justification for the requested exemption (MEGIN) ...................................29 
5.1.1.  Substitution or elimination of lead ....................................................30 
5.1.2.  Roadmap towards substitution or elimination of lead ..........................35 
5.1.3. 
Environmental arguments ...............................................................36 
5.1.4.  Socioeconomic impacts ...................................................................36 
Justification for the requested exemption (JASTEC) ..................................37 
5.2.1.  Substitution of lead ........................................................................37 
5.2.2. 
Elimination of lead ..........................................................................39 
5.2.3.  Roadmap towards substitution or elimination of lead ..........................40 
Environmental arguments and socioeconomic impacts ........................41 
5.2.4. 
5.3.  Stakeholder contributions ......................................................................42 
5.4.  Critical review ......................................................................................43 
5.4.1.  REACH compliance – Relation to the REACH Regulation .......................43 
5.4.2.  Megin - Lacking stakeholder support for the exemption request ...........44 
5.4.3.  Scientific and technical practicability of substitution or elimination of lead 
in SQUID detectors (MEGIN) ........................................................................45 
5.4.4.  Substitution and Elimination of lead in MRI and NMR devices (JASTEC) .46 
5.4.5.  Overlapping scopes of exemptions 11 and 12 ....................................47 
5.4.6. 
Environmental arguments and socioeconomic impacts ........................48 
5.4.7.  Conclusions ...................................................................................48 
5.5.  Recommendation .................................................................................49 
5.6.  References ..........................................................................................51 
Appendix .........................................................................................................53 

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List of Figures 

Figure 4-1: 

Relation of REACH Categories and Lists to Other Chemical 
Substances .......................................................................... 17 

Figure 5-1: MEG system .............................................................................. 25 

Figure 5-2: Sensor elements installed in the “helmet” (Part 1 in Figure 5-3) ...... 26 

Figure 5-3: Construction of the probe ........................................................... 26 

Figure 5-4: Steps and timelines towards lead-free alternatives ......................... 41 

List of Tables 

Table 1-1:  

Overview of the exemption requests, associated recommendations 
and expiry dates ..................................................................... 9 

Table 5-1: Properties of potential alternative metals for SQUID sensor bonding .. 31 

Table 5-2: Steps towards elimination of lead by OPMs ..................................... 36 

Table 5-3: Comparison of properties of elements and binary solder alloys ......... 38 

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1. 

Executive summary – English 

Under Framework Contract no. ENV.A.2/FRA/2015/0008 of 27/03/2015, a consortium 
led by Oeko-Institut was requested by DG Environment of the European Commission 
to provide technical and scientific support for the evaluation of exemption requests 
under the RoHS 2 regime. The work has been undertaken by the Oeko-Institut and 
Fraunhofer Institute IZM, and has been peer reviewed by the two institutes. 

1.1. 

Background and objectives 

The RoHS 2 Directive 2011/65/EU entered into force on 21 July 2011 and led to the 
repeal 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 and 

electronic equipment (EEE; as referred to in Articles 2(1) and 3(1)); 

  The former list of exemptions has been transformed in to Annex III and may be 

valid for all product categories according to the limitations listed in Article 5(2) of 
the 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 have 
to 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 as 
comprehensive 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 be 
considered. These are detailed below. 

The new Directive details the various criteria for the adaptation of its Annexes to 
scientific 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 one 

of the following three conditions: 
−  Substitution is scientifically or technically impracticable, meaning that a 

substitute 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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RoHS Exemptions Evaluation: Pack 19 

−  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 a 
period 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 of 

substitution 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 of 
the exemption; and 

  A new aspect is that all exemptions now need to have an expiry date and that 

they can only be renewed upon submission of a new application. 

Against this background and taking into account that exemptions falling under the 
enlarged scope of RoHS 2 can be applied for since the entry into force of the Directive 
(21.7.2011), the consultants carried out evaluation of one exemption request in this 
study.  

1.2. 

Key findings – Overview of the evaluation results 

The exemption request covered in this project and the applicant concerned, as well as 
the final recommendation and proposed expiry date are depicted in Table 1-1. The 
reader is referred to the corresponding section of this report for more details on the 
evaluation result.  

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RoHS Exemptions Evaluation: Pack 19 

Table 1-1:   Overview of the exemption requests, associated recommenda-

tions and expiry dates 

Expiry 
date and 
scope 

7 years 

Ex. Req. 
No. 

Current exemption 
wording 

Applicant 

Recommendation 

Existing exemptions 
Annex 
IV, 12 

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

Japan 
Superconductor 
Technology, Inc. 
(JASTEC） 

Lead in metallic bonds 
creating 
superconducting 
electric circuits in 
SQUID detectors. 

In case exemption 11 is 
not renewed, or if the 
scope of exemption 11 
will not be changed to 
include NMR and MRI:  

Lead in metallic bonds 
creating 
superconducting 
electric circuits in MRI 
and NMR (Nuclear 
Magnetic Resonance), 
and in SQUID 
detectors. 

Note: 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 the report as a 
separator. 

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RoHS Exemptions Evaluation: Pack 19 

2. 

Executive summary: French - Note de synthèse: 
Français 

Conformément aux termes du contrat-cadre ENV.A.2/FRA/2015/0008 du 
27/03/2015, un consortium mené par l'Oeko-Institut a été chargé par la direction 
générale (DG) de l'environnement de la Commission européenne afin d'apporter son 
concours technique et scientifique à l'évaluation des demandes d'exemption suivant 
le nouveau régime de la directive RoHS 2. Les travaux ont été réalisés par l'Oeko-
Institut et le Fraunhofer IZM (Institut Fraunhofer pour la fiabilité et la 
microintégration), et fait l'objet d'un examen par des pairs des deux instituts. 

2.1. 

Contexte et objectifs 

La directive RoHS 2011/65/UE est entrée en vigueur le 21 juillet 2011, ce qui a 
entraîné l'abrogation de la directive 2002/95/CE le 3 janvier 2013. Il est possible de 
considérer que la directive a prévu deux régimes qui ont permis de prendre en 
compte 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 sachant 
qu'il englobe l'intégralité des équipements électriques et électroniques (EEE ; tel 
que 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 limitations 
énumérées dans l'article 5(2) de la Directive. L'annexe IV a été ajoutée et 
énumère 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 et 

technique 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 à l'adaptation de ses 
annexes au progrès scientifique et technique. L'article 5(1) énumère les différents 
critères et questions qui doivent être considérés pour justifier l'ajout d'une exemption 
aux annexes III et IV: 

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RoHS Exemptions Evaluation: Pack 19 

  Le premier critère est susceptible d'être perçu comme un critère de seuil et 

renvoie au règlement REACH (1907/2006/CE). Une exemption peut uniquement 
être accordée si elle ne fragilise pas la protection environnementale et sanitaire 
offerte par le règlement REACH; 

  De plus, une demande d'exemption doit être déclarée légitime selon l'une des 

trois 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 sans 
connaître de défaillance pendant une durée comparable à celle de l'application 
dans laquelle la substance d'origine est incluse, est inférieure à celle de 
l'application; 

−  Les impacts négatifs de la substitution sur l'environnement, la santé, et la 

sécurité 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 disponibilité 
des substituts et de l'impact socio-économique de la substitution, ainsi que les 
effets néfastes sur l'innovation et une analyse du cycle de vie concernant les 
impacts globaux de l'exemption; et 

  Le fait que toutes les exemptions doivent désormais présenter une date 

d'expiration et qu'elles peuvent uniquement être renouvelées après soumission 
d'une nouvelle demande, constitue un aspect inédit. 

Face à 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 en vigueur de la directive (le 21 juillet 2011), les experts ont réalisé 
l'évaluation d'un éventail d'exemptions dans le cadre de la présente mission : une 
demandes de renouvellement d’exemption.  

2.2. 

Les principales conclusions – Synthèse des résultats de 
l'évaluation 

La demande d'exemption couvertes par ce projet et le demandeur concerné, ainsi 
que la recommandation finale et la date d'expiration proposée sont résumées dans le 
tableau 1 1. Une demande de renouvellement d'une exemption existante a été 
incluse 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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RoHS Exemptions Evaluation: Pack 19 

Tableau 2-1:  Récapitulatif des demandes d'exemption, des recommanda-

tions associées et des dates d'expiration 

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. Cette 
dernière fait foi. 

Dem. 
ex. n° 

Terme de l'exemption  Demandeur 

Recommandation 

Japan 
Superconducto
r Technology, 
Inc. (JASTEC） 

Exemptions en vigueur 

Annexe 
IV, Ex. 
12 

Le plomb et le cadmium 
dans les liaisons 
métalliques permettant 
de créer des circuits 
magnétiques 
supraconducteurs dans 
les détecteurs IRM, 
SQUID, RMN (résonance 
magnétique nucléaire) 
ou FTMS (spectromètre 
de masse à transformée 
de Fourier).  

Le plomb dans les 
liaisons métalliques 
permettant de créer 
des circuits 
magnétiques 
supraconducteurs 
dans les détecteurs 
SQUID. 

Au cas où l’exemption 
11 ne serait pas 
renouvelée, ou si le 
champ d'application 
de la dérogation 11 ne 
sera pas modifié pour 
inclure la RMN et 
l'IRM :  

Le plomb dans les 
liaisons métalliques 
permettant de créer 
des circuits 
magnétiques 
supraconducteurs 
dans les détecteurs 
IRM et RMN 
(résonance 
magnétique nucléaire) 
et SQUID. 

Date 
d'expiration 
et champ 
d'application 

7 ans 

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RoHS Exemptions Evaluation: Pack 19 

3. 

Introduction 

3.1. 

Project scope and methodology 

The scope of the project covers the evaluation of one request for exemption renewal, 
listed in Annex IV, 12 under the current exemption wording “Lead and cadmium in 
metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR 
(Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) 
detectors.” This request was submitted by Japan Superconductor Technology, Inc. 
(JASTEC). The European Commission has received a further application for RoHS 
exemption 12 of Annex IV by Megin Oy and has requested to consider the application 
as a contribution to the evaluation.  

In the course of the project, a stakeholder consultation was conducted. The 
stakeholder consultation was launched on the 10th of January 2020 and ended on the 
20th of February 2020. 

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 through 
email notifications about new steps within the project. 

Information concerning the consultation was provided on the project website, 
including a general guidance document, the applicants’ documents for each of the 
exemption requests, results of earlier evaluations where relevant, a specific 
questionnaire and a link to the EU CIRCA website. The comments that have been 
received on the request for exemption in question have been made available at the 
project website.  

Following the stakeholder consultations, an in-depth evaluation of the exemption 
began. The request was evaluated according to the relevant criteria laid down in 
Article 5 (1) of the RoHS 2 Directive, as shown in the section on background and 
objectives on page 7.  

The evaluation of the exemption appears in sections 5 and 6 of this report. The 
information provided by the applicants and by stakeholders is summarised in the first 
sections of the respective sections. 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 applicants and other stakeholders. In the Critical Review part, 
the submitted information is discussed, to clarify how the consultants evaluate the 
various information and what conclusions and recommendations have been made. The 

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RoHS Exemptions Evaluation: Pack 19 

general requirements for the evaluation of exemption requests as set by the European 
Commission may be found in the technical specifications of the project.1 

3.2. 

Project set-up 

Assignment of project tasks to Oeko-Institut, started in 11 November 2019. The 
overall project has been led by Carl-Otto Gensch. At Fraunhofer IZM the contact 
person is Otmar Deubzer.  

1   Cf. 

https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_18/Technical_Specification_RoH
S_Pack18.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 to 
scientific and technical progress” provides for that: 

“inclusion of materials and components of EEE for specific applications in the 
lists in Annexes III and IV, provided that such inclusion does not weaken the 
environmental and health protection afforded by Regulation (EC) No 
1907/2006”.  

Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) regulates the manufacturing, use or placing on the 
market of chemical substances on the Union market. REACH, for its part, addresses 
hazardous substances through processes of authorisation (substances of very high 
concern) and restriction (substances of any concern):  

  Substances that may have serious and often irreversible effects on human health 

and 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 (Authorisation 
list): “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 the 
Commission only if the risks arising from their use are adequately controlled, 
where this is possible, or the use can be justified for socio-economic reasons and 
no suitable alternatives are available, which are economically and technically 
viable.” 

If a Member States or the European Chemicals Agency (ECHA) upon request of the 
Commission 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 a 
risk 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, or 
conditions for restrictions, based on an assessment of the risks and the 
assessment of the socio-economic elements.  

 

The approach adopted in this report is that once a substance has been included 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 the 
provisions of RoHS. This is essentially the same approach as it has first been adopted 

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RoHS Exemptions Evaluation: Pack 19 

for the re-evaluation of some existing RoHS exemptions 7(c)-IV, 30, 31 and 40,2 and 
in the following for the evaluation of a range of requests assessed through previous 
projects in respect of RoHS 2.3 Substances for which an authorisation or 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 of these 
two legislations. 4 

When evaluating the exemption requests, with regard to REACH compliance, we have 
checked 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   See Zangl, S.; Blepp, M.; Deubzer, O. (2012) Adaptation to Scientific and Technical Progress under 
Directive 2011/65/EU - Transferability of previously reviewed exemptions to Annex III of Directive 
2011/65/EU, Final Report, Oeko-Institut e.V. and Fraunhofer IZM, February 17, 2012, 
http://rohs.exemptions.oeko.info/fileadmin/user_upload/Rohs_V/Re-
evaluations_transfer_RoHS_I_RoHS_II_final.pdf 

3   Gensch, C., Baron, Y., Blepp, M., Deubzer, O., Manhart, A. & Moch, K. (2012) Assistance to the 

Commission on technological, socio-economic and cost-benefit assessment related to exemptions from 
the substance restrictions in electrical and electronic equipment (RoHS Directive), Final Report, Oeko-
Institut e.V. and Fraunhofer IZM, 21.12.2012 
http://rohs.exemptions.oeko.info/fileadmin/user_upload/Rohs_V/RoHS_V_Final_report_12_Dec_2012_
final.pdf  
For further reports, see archive of reports of Oeko-Institut e.V. and Fraunhofer IZM at 
http://rohs.exemptions.oeko.info/index.php?id=164  
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 

4  

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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.5 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 are listed by ECHA in the community rolling action plan (CoRAP).6 If the 
Substance Evaluation concludes that the risks are not sufficiently under control with 
the measures already in place and if a Risk Management Option (RMO) analyses does 
not conclude that there are appropriate instruments by other legislation / actions, the 
substance will be notified in the Registry of Intentions.  

The following bullet points explain in detail the above-mentioned lists and where they 
can be accessed:  

  Member States Competent Authorities (MSCAs) / ECHA, on request by the 

Commission, may prepare Annex XV dossiers for identification of SVHCs, Annex XV 
dossiers for proposing a harmonised Classification and Labelling, or Annex XV 
dossiers proposing restrictions. The aim of the public Registry of Intentions is to 
inform interested parties of the substances for which the authorities intend to 

5  

For an overview in these activities and processes see the ECHA webpage at: 
https://echa.europa.eu/substances-of-potential-concern  

6   Updates and general information can be found under: https://echa.europa.eu/information-on-

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

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submit Annex XV dossiers and, therefore, to facilitate timely preparation of the 
interested 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 three 
separate sections: listing new intentions; intentions still subject to the decision-
making process; and withdrawn intentions. The registry of intentions is available at 
the ECHA website at: https://echa.europa.eu/registry-of-intentions; 

  The identification of a substance as a Substance of Very High Concern and its 

inclusion in the Candidate List is the first step in the authorisation procedure. The 
Candidate List is available at the ECHA website at 
https://echa.europa.eu/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 for 
Annex XIV. The previous ECHA recommendations for inclusion in the Authorisation 
List are available at the ECHA website at 

https://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 specific 
application 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 the 
European market, then a restriction is formulated to address the specific terms, 
and this shall be added to Annex XVII of the REACH Regulation. The Annex can be 
found in the consolidated version of the REACH legal text; and 

As of June 2020, the consolidated version of the REACH legal text, dated 28.04.2020, 
was used to reference Annexes XIV and XVII: The consolidated version is available at 
the EUR-Lex website: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:02006R1907-20200428. 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 health 
protection 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 to 
their initiation, have been reviewed, in respect of where RoHS Annex II substances are 
mentioned (i.e. lead, mercury, cadmium, hexavalent chromium, polybrominated 
biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) as well as bis(2-

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ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), 
diisobutyl phthalate (DiBP).7  

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 evaluated 
in 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 this 
regard are addressed in the separate chapter in which the exemption evaluation is 
documented (Chapter 5) under the relevant section titled “REACH compliance – 
Relation to the REACH Regulation” (Section 5.5.1). 

7  

The four phthalates, DEHP, BBP, DBP and DIBP have been added to the Annex according to 
Commission Delegated Directive (EU) 2015/863 of 31 March 2015.  

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5. 

Annex IV, Ex. 12 

“Lead and cadmium in metallic bonds creating superconducting magnetic circuits in 
MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass 
Spectrometer) detectors”, expires on 30 June 2021 

Declaration 

In the sections that precede the “Critical review” the phrasings and wordings of 
applicants’ and stakeholders’ explanations and arguments have been adopted from the 
documents provided by them 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 

Critical current 

Electrical current above which a superconductor is no longer 
superconducting 

Critical magnetic field  Magnetic field strength above which a superconductor is no 

longer superconducting 

EEE 

fMRI 

Electrical and electronic equipment 

functional Magnetic Resonance Imaging 

JASTEC 

Japan Superconducting Technology Inc. (applicant) 

K 

MEG 

Kelvin, temperature, 0 K is equivalent to around 273.15 °C 

Magnetoencephalography  

MEGIN 

Megin Oy (applicant) 

MRI 

MRI 

Magnet resonance imaging 

Magnetic Resonance Imaging 

Nb3Sn 

Niobium-tin (superconducting material) 

NbTi 

NMR 

OPM 

PET 

SQUID 

RoHS 

Niobium titanium (superconducting material) 

Nuclear Magnetic Resonance  

Optically-pumped magnetometers  

Positron Emission Tomography 

Superconducting Quantum Interference Device 

Directive 2011/65/EU on the restriction of hazardous 
substances in electrical and electronic equipment (RoHS 2) 

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T 

Tc 

Tesla, unit for magnetic flux density/field strength  

critical temperature, temperature below which a material is a 
superconductor 

TRL  

Technology Readiness Level 

5.1. 

Background of the Exemption and of the Request 

5.1.1. 

History of Exemption 12 of Annex IV 

Exemption 12 was listed on Annex IV with the below wording already when the 
European Union (2011) published the recast RoHS Directive (RoHS 2) with expiry in 
July 2021: 

Lead and cadmium in metallic bonds to superconducting materials in MRI 
and SQUID detectors 

In 2012, the Test and Measurement Coalition (TMC8) applied to include NMR devices 
into the scope of exemption 12. The Commission followed the recommendation of 
Gensch et al. 2012 to expand the exemption scope of exemption 12 with a slightly 
different wording:  

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

The exemption expires on 30 June 2021. JASTEC and MEGIN request the renewal of 
the exemption.  

5.1.2. 

Overview and summary of renewal requests and stakeholder 
contributions 

JASTEC (2019 a) applied for the renewal of the exemption with a narrower scope 
excluding FTMS and SQUID detectors, and a validity of 7 years: 

Lead in metallic bonds creating superconducting circuits in MRI (Magnetic 
Resonance Imaging) or NMR (Nuclear Magnetic Resonance) 

Megin (2019) requested the renewal of the exemption with the current wording for 
seven years until 30 June 2028. Megin produces superconducting quantum 
interference devices (SQUIDs).  

COCIR (2020 a) contributed to the stakeholder consultation stating that they “[…] 
have submitted a separate exemption renewal request for exemption 11 ‘Lead and its 

8   C.f. TMC’s exemption request: 

https://rohs.exemptions.oeko.info/fileadmin/user_upload/Rohs_V/Request_13/13_Lead_and_cadmium
_in_metallic_bonds_to_superconducting_magnetic_circuits.pdf  

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alloys as a superconductor and thermal conductor in MRI’9 which is similar in scope. 
Only one of exemption 11 or exemption 12 would appear to be needed to cover lead in 
superconducting bonds.” 

According to JASTEC (2019 a), MRI and NMR manufacturers used an alloy that 
contains both lead and cadmium (Woods metal alloy) when exemption 12 was 
originally added to Annex IV of the RoHS Directive. Research since then has found 
that lead alloys without cadmium are also suitable, and that lead-bismuth alloys 
provide superior performance. Cadmium is therefore no longer used and so does not 
need to be included in the renewed exemption 12. Since JASTEC (2019 a) is 
concerned only with NMR and MRI, it proposes the above revised wording. JASTEC 
(2019 a) explain that NMR spectrometers, used for chemical analysis, and MRI 
scanners, used for medical imaging, use powerful electromagnets made with 
superconducting wires that are connected to each other and to the power supplies 
using superconducting solder bonds. Soldering has been found to be the only 
consistent and reliable method for making electrical connections. Solders based on 
lead are the only materials that have a sufficiently high critical field value (the 
maximum allowable field where superconductivity persists) of over 1 Tesla to be used 
within the electromagnet cryostat. All lead-free solder materials have much lower 
critical field values that are too small for use in this application. JASTEC (2019 a) have 
carried out trials using lead-free solders as substitutes, but the measured critical 
current values (at which non-dissipative current flows) were too low and were smaller 
than the currents typically used for NMR and MRI. Research into alternative bonding 
methods is at an early stage and will take many more years and may prove to be 
unsuitable. 

Megin (2019) use lead in their SQUIDs. Like JASTEC, they do not use cadmium 
anymore. They sum up their request explaining that superconducting quantum 
interference devices (SQUIDs) are used to measure extremely weak magnetic fields. 
Megin (2019) use SQUID detectors in magnetoencephalography (MEG) systems, i.e. in 
devices that non-invasively measure brain activity. Their application does not refer to 
NMR, MRI, or FTMS. SQUIDs are, for example, applied MEGs in pre-surgical mapping 
of brain tumors or epilepsy in medical diagnostics as well as brain research. SQUID 
detectors require the use of lead containing bonds as part of the superconducting loop 
which are immersed in liquid helium at 4.2 K. The bonds are required to be 
superconducting to allow the operation of the SQUID detector. They must exhibit a 
high degree of durability to withstand immersion in liquid helium, and reliability as it is 
not possible to build in redundancy into the system to compensate for bond failures. 
Megin (2019) put forward that potential alternative solutions to substitute or eliminate 
lead are either not superconducting at the temperatures required or have reduced 
reliability either due to the inadequately robust bond formation or potentially due to 
the formation of tin pest. Megin (2019) research via the “macQsimal” project, an EU-
funded Horizon 2020 research project, alternative technologies which do not rely on 
lead. There are, however, a number of technical challenges which will take a number 
of years to complete in order to demonstrate that Optically-Pumped Magnetometers 

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(OPM) are a viable alternative. It also currently seems unlikely that OPM-based 
devices will be able to replace all uses due to their smaller bandwidth. Applications 
that require > 100 Hz detection will continue to require SQUID based systems. 

5.1.3. 

Amount of lead used under the exemption 

JASTEC (2019 a) use a lead-bismuth alloy. They estimate the amount of lead used 
under the requested exemption to be around 1.2 tonnes per year in the EU. They base 
this estimate on the below deliberations: 

  NMR devices 
 

JASTEC estimate that 200 NMR superconducting magnets (120 of 400 MHz, 40 of 
500 MHz and 40 of 600 MHz) are sold in the EU annually and contain 0.3 kg lead 
(400 MHz), 0.7 kg lead (500 MHz) or 1.3 kg lead (600 MHz). This results in 116 kg 
of lead for the EU.  

  MRI devices 
  Based on OECD data, BMI research "Worldwide medical devices market forecasts 

to 2021”, annual sales of superconducting magnets for MRI sold in the EU are 600 
per year. JASTEC estimate that the average amount of lead metal per MRI is 
1.8 kg. This sums up to 1080 kg of lead in the EU.  

The total lead uses amount to around 1.2 tonnes per year in the EU.  

Megin (2019) use tin-lead and tin-lead-indium solders with around 37 % to 88 % of 
lead in superconducting connections of detector circuits in superconducting quantum 
interference device (SQUID) for magnetoencephalography (MEG). They estimate that 
68 mg of lead will be used in the EU under the requested exemption, without 
providing further details due to confidentiality reasons. 

5.2. 

Technical description of the requested exemption for SQUIDs 
(Megin) 

Superconducting quantum interference devices (SQUIDs) according to Megin (2019) 
are used to measure extremely weak magnetic fields. The sensitivities of the present 
SQUID detectors are of the order of a couple of femtotesla (10-15 T). Megin (2019) use 
SQUID detectors in magnetoencephalography (MEG) systems, i.e. in devices that 
measure non-invasively brain activity. Their application does not refer to NMR, MRI, or 
FTMS. They use tin-lead and lead-indium alloys for superconducting solder 
connections in these SQUID detector circuits.  

The magnetic field density generated by the brain activity is in the order of 10-13 T 
when measured outside the head. The magnetic field arises directly from the neurons 
activated during, for example, physical processes like e.g. moving an arm. Unlike the 
other functional imaging techniques (fMRI10 or PET11), where the capability to measure 
brain activity is based on the relatively slow changes of blood flow in the brain, 
magnetoencephalography (MEG) and electroencephalography (EEG) measure directly 

fMRI = functional Magnetic Resonance Imaging 

10  
11   PET = Positron Emission Tomography 

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the activation of neurons, offering millisecond-scale time resolution. The MEG signals, 
however, in comparison with EEG, are not distorted by the skull or tissue surrounding 
the brain, allowing superior localization capability of the active brain areas. The 
combination of high temporal and spatial resolution offered by MEG is unique among 
the functional brain imaging techniques. Therefore, the SQUID detectors employed in 
MEG are crucial for medical diagnostics and basic brain research. Megin (2019) 
provide some examples of their current and future applications: 

  MEG is increasingly being used in the pre-surgical mapping of patients with, e.g. 

brain tumors or epilepsy, due to its high spatial and temporal resolution. It is used 
for the accurate localization of visual, somatosensory and auditory cortices as well 
as complex cognitive functions like language processing; 

  MEG is used in epilepsy diagnostics. It is able to detect epileptic “spikes” (very fast 
waves in brain activity) in about 75 % of patients whereas EEG detects them in 
about 60 %. When combined, the two technologies can detect almost all spikes; 

  MEG has been utilised to identify biomarkers of auditory and speech deficits in 
autism spectrum disorders and Alzheimer’s. The technology can also be used in 
other applications such as for the measurement of muscular activity of heart with 
magnetocardiography (MCG). MCG offers advantages over Electrocardiogram 
(ECG) which include vector field measurement including all three components in 
comparison with scalar field surface-restricted measurements and the ability to 
undertake fetal MCG. Although MCG is not as well established as MEG, it is a 
growing field with examples in the literature where the technology is proving to be 
critical for certain applications. 

The MEG system manufactured by Megin (2019) uses an array of 306 individual 
SQUID detectors located in 102 sensor modules to map precisely the pattern of the 
electromagnetic fields generated by brain activity, and, by the analysis, to precisely 
determine the parts of the brain which are functionally active. The measurements are 
taken with millisecond time resolution. The locations of the functionally active parts of 
the brain as a function of time can be accurately superimposed onto an MRI or 
computer tomography (CT) images to provide information about the anatomy and 
function of the brain. MEG allows insights into sensory processing, motor planning and 
action, cognition, language perception and production, social interaction, and various 
brain disorders which otherwise would not be possible. It can localize active brain 
areas inside the brain with a few mm accuracy. 

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Figure 5-1: MEG system 

Source: Megin (2019) 

Megin (2019) describe that SQUID detectors use Josephson junctions to detect a 
change of magnetic field as much as 100 billion times weaker than the magnetic field 
of the earth that moves a compass needle. The Josephson junction consists of two 
superconductors separated by a thin insulating layer which allows superconducting 
electron pairs to pass through. 

Megin (2019) further on explicate that the SQUID detectors employed in MEG are 
made on silicon wafers using semiconductor fabrication techniques. Each detector 
comprises a superconducting sensing coil and a SQUID connected. The sensor array 
comprising 102 three-channel sensor modules is cooled to 4.2 K by immersion in liquid 
helium in a vacuum-insulated vessel such that the sensing coils and SQUIDs are 
superconducting. The sensors (Figure 5-2) containing the lead solder are mounted in 
the helmet of the MEG (Part 1: wiring unit with sensor elements, in Figure 5-3).  

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Figure 5-2: Sensor elements installed in the “helmet” (Part 1 in Figure 5-3) 

Left: detector array, side view.  
Right: Triple sensor detector unit.  
All dimensions in millimetres 
Note: the sensor coils are shown schematically, not to scale. 

Figure 5-3: Construction of the probe 

1: Wiring unit with sensor elements 
2: Wiring, 
3: Neck plug   

4: Preamplifiers 
5: Dewar with vacuum insulation 
6: Liquid helium 

Sources: Megin (2019), Megin (2020 b), for Figure 5-2 and Figure 5-3 

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According to Megin (2019), the array built from 102 sensor modules to map brain 
activity in three dimensions contains several tin-lead alloy bonds per SQUID detector, 
all of which play a critical role in the technology and so have to be reliable.  

5.3. 

Technical description of the requested exemption for MRI 
and NMR (JASTEC)  

JASTEC (2019 a) says that MRI are used in hospitals for the generation of 3-
dimensional images of the insides of human patients as well as of animals for 
veterinary examinations. MRI can image soft tissues such as the internal organs, 
muscles and blood vessels. MRI with powerful magnetic fields (1.5 and 3 Tesla are 
commonly used) require superconducting magnets. NMR spectroscopy instruments are 
used for chemical analysis. Various designs are produced with a wide range of 
electromagnetic field strengths. NMR with less powerful magnetic fields are simpler 
and therefore cheaper to buy and use, and are suitable for analysis of relatively simple 
compounds. These might be used by students as well as professional researchers. 
NMR with powerful superconducting magnets can analyse more complex substances, 
mixtures of substances and substances present at low concentrations, but due to the 
greater skill and experience needed to use them, these tend to be used only by 
professionals.  

JASTEC (2019 a) explains that NMR and MRI both use superconducting electromagnet 
coils, although the designs are different. The coils are made from niobium-titanium 
(NbTi) and niobium-tin (Nb3Sn) alloy wires which are superconducting at temperatures 
below about 9 to 18 K. NbTi has a critical temperature Tc of 10 K, and Nb3Sn of 
18.3 K. While MRI uses NbTi superconductor wires only, NMR spectrometers combine 
NbTi in an outer coil with Nb3Sn in an inner coil to achieve the highest possible 
magnetic field strength inside the bore, especially those with high field strength of 10 
Tesla. Nb3Sn has a higher critical field, so can achieve more powerful magnetic fields 
than NbTi alone, although it is more difficult to make very low resistance bonds to 
Nb3Sn wire. The Nb3Sn coil wires of NMR have to be bonded to the NbTi coil’s wires 
using a superconducting material to ensure that the entire conductor coil remains 
superconducting. NMR electromagnets will have multiple joints. JASTEC (2019 a) 
reports of one published example with10 joints in a 9.4 Tesla NMR and 100 A electrical 
current.12  

According to JASTEC (2019 a), MRI are usually made using single lengths of copper 
clad NbTi superconductor with electrical connections at each end, but more powerful 
magnets may have two or more lengths of NbTi connected by superconducting bonds.  

JASTEC (2019 a) says that, in order to maintain a sufficiently low temperature to 
ensure that the electromagnet wires are superconducting, these are cooled with liquid 
helium which boils at 4.2 K. The MRI and NMR coils are used to create a very powerful 
magnetic field which is used with MRI for imaging parts of the human body and with 
NMR for chemical analysis. The more powerful the magnetic field, the better the MRI 
image quality and the more detailed the NMR spectrum. To obtain a powerful 

12   Persistent current joints between technological superconductors, Greg Brittles, et. al., article in 

Superconductor Science and Technology · September 2015; source as referenced by JASTEC 2019 a. 

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magnetic field, a large current is passed through the coil, typically of many hundreds 
of Amperes. With this size of current, any electrical resistance would result in 
resistance heating that could raise the temperature of the bonds and the coil to 
temperatures where the materials are not superconducting and the temperature rise 
can destroy the coils. According to JASTEC (2019 a), the heat generated is calculated 
from: 

Power = current squared x resistance (I2.R) 

JASTEC (2019 a) adds that a magnetic field decay due to resistance in the 
superconducting circuit is a problem since NMR and MRI require a highly stable 
magnetic field. If a superconducting bond has a small electrical resistance, it causes 
current consumption in the superconducting circuit and consequently reduces the 
current flow in the circuit.  

As a result, JASTEC (2019 a) concludes, it is essential that the materials used to make 
electrical connections to the superconducting coils are also superconducting materials; 
lead alloys are used because of the overall performance they provide. 
Superconducting solders for connecting magnet conductors need to stay 
superconducting at the operating temperature and magnetic field. At a reasonable 
distance from the magnet, the magnetic field decays to less than the critical field of 
lead-bismuth alloy. This makes lead-bismuth alloy suitable as a superconducting 
bonding material, whereas no other solder materials have a sufficiently high critical 
field to place them within a magnet cryostat. 

JASTEC (2019 a) states that the superconducting alloys NbTi and Nb3Sn are hard 
brittle materials that are difficult to make electrical connections. In MRI and NMR, 
these alloy wires are embedded in copper with many superconductor wires encased in 
copper which is then drawn down to the required thickness so that the NbTi and Nb3Sn 
wires are present inside the copper cable as very thin wires. The simplest and most 
reliable method of making electrical connections to the ends of the coil is by soldering. 
In the soldering process, the copper matrix is removed and then the superconductor 
filaments are soldered tightly. Lead alloys such as lead-bismuth solders are ductile at 
low temperatures, are superconductors at liquid helium temperature in the presence 
of the strong magnetic field which arise when passing very large currents, and are 
sufficiently robust to withstand the severe vibrations that occur in the superconductors 
in the presence of the high magnetic fields of NMR and MRI.  

MRI (and NMR) coils can experience severe vibration due to the effect of “gradient 
coils” that are placed around the parts of patient’s being scanned, or around samples 
to be analyzed. To prevent damage from vibration as well as the stresses that occur 
when coils are cooled from ambient temperature to 4 K, the coils are impregnated 
with resins that prevent movement that would otherwise damage the superconducting 
coils. When exemption 12 was originally added to Annex IV of the RoHS Directive, MRI 
and NMR manufacturers used an alloy that contained both lead and cadmium (Woods 
alloy). Cadmium is no longer used and so does not need to be included in the renewed 
exemption 12. 

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5.1. 

Justification for the requested exemption (MEGIN) 

Megin (2019) use tin-lead lead-indium solders for connections in SQUID detectors as 
these alloys have the following technical properties: 

  Superconducting below its Tc of 7.3 K.  

 

 

 

Few other metals are superconducting at or above this temperature that are also 
suitable for soldering, other than lead and its alloys. The whole detector loop is 
required to be superconducting with zero electrical resistance, or at worst down to 
the nano-Ohm level resistance as any higher values negatively affect the 
measurements of the SQUID detector; 

Ideally, the critical superconducting temperature (Tc) of the bonding material 
should be as high as possible as this would allow designs with less liquid helium to 
be used; 
 Resistance to oxidation both in service and during manufacturing is critical to 
ensure low/zero electrical resistance and the formation of clean metal-to-metal 
contacts; 
 The bonds must have a high degree of proven reliability as it is not possible to 
build in redundancy into the system to compensate for bond failure. Therefore, 
there is the requirement for 100 % bond reliability. If any bonds were to fail, they 
would not be able to be repaired at operating temperature, but the whole detector 
array would need to be warmed up to room temperature for repair. Bond failure 
would negatively impact image quality in a section of the brain, as well as increase 
the likelihood of other bonds failing due to the large temperature changes that 
occur during warming and cool-down required by the repair, potentially causing 
further bond failures. If bonds cannot be made reliably and more fail during the 
repair process, it will be impossible to build a properly functional MEG; 

  Lead is the most effective additive that inhibits tin pest phase transformation 

occurring with tin and its alloys at low temperature; 

 

If repair is required, this will cause the MEG to be unavailable for medical 
diagnostics for patients and research activities, and patients cannot be measured 
for 1 – 2 weeks who will suffer as a result; 

  Durability of the bonds is crucial as the SQUID detector is cycled from room 

temperature to 4.2 K during the annual servicing of the MEG system. The bonds 
have to be ductile and flexible as well as being reasonably strong to ensure they 
are not damaged in service or when boiling liquid helium is introduced which 
creates an extremely turbulent environment around the SQUID detector circuits;  

  Manufacturability requires various specific conditions to be fulfilled: 

−  The process of application of the connectors to the sensors needs to be able to 

be applied at less than 200 °C to avoid damaging other electrical components 
of the circuit; and 

−  The ability to be soldered without the use of flux which would impact the 
conductivity and therefore the signal measured by the detector; and 

−  The bond between the connector and the surfaces of the circuits needs to have 

sufficient material compatibility to ensure that a good bond is formed. 
Parameters such as differential thermal expansion between various 
construction materials (e.g. silicon, lead, niobium wire, printed circuit board 

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made of fibre glass) need to be considered to minimise mechanical stresses 
which could lead to failures. 

Megin (2019) state that the normal lifetime of SQUID detectors is between 10 to 15 
years, with known examples of products being used for over 20 years.  

Megin (2019) point out that MEG systems are a very expensive diagnostic tool which 
limits its availability and so manufacturers are carrying out research into alternative 
designs that avoid the need for liquid helium cooling. These alternatives may also 
avoid the need for superconducting bonds made of tin-lead.  

Megin (2019) want any alternative substance or technology in addition to meeting the 
required functionality and requirements to maintain or increase the operational 
temperature in order not to increase the need of liquid helium. Helium is a very scarce 
element on the Earth with the demand for the element expected to rise dramatically 
over the coming years. Anything which reduces the requirement for helium will ensure 
that capabilities such as SQUID detectors, and other applications not covered in this 
application (such as MRI) are able to be supported, and the environmental impact 
arising from the extraction, processing and use of this very scarce element is reduced. 

5.1.1. 

Substitution or elimination of lead 

Potential candidate metals and alloys for substituting lead solders 

Megin (2019) claim to have considered alternatives to lead in SQUID detectors. Table 
5-1 below lists metallic elements that are low temperature superconductors with 
comments on their suitability as substitutes with view to the required properties 
explained in section 5.1 above.  

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Table 5-1: Properties of potential alternative metals for SQUID sensor 

bonding 

Source: Megin (2019) 

Megin (2019) states that there are no other naturally occurring superconducting 
elements with critical temperatures above 5 K other than those listed in the table 

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above. Technetium has a critical superconducting temperature (Tc) of 7.7 K but is a 
radioactive man-made element. It cannot be used for this reason, and it would also be 
too hard.  

Bismuth-tin-indium (BiSnIn) alloys 

Megin (2019) mention that alloys can have higher or lower Tc than the elements. 
Megin currently considers Bismuth-tin-indium alloys, which are being investigated for 
MRI applications as a potential substitute for future systems. Solders based on indium 
are susceptible to oxidation and corrosion and so are difficult to solder unless a 
corrosive flux is used. The use of corrosive fluxes is not acceptable as these can cause 
corrosion which causes failures to the very small bonds. Lead-free tin alloys are also 
potentially susceptible to “tin pest” (described below).  

Megin (2019) explicate that the addition of bismuth makes the alloy brittle and hard 
which is a significant disadvantage during the rapid cool down in liquid helium. Cool 
down and heat up will cause stresses due to thermal expansion mismatch as well as 
stresses from the churning, boiling liquid helium that could cause fracture of brittle 
bonds. According to Megin (2020 h), even though InSn is the most promising lead-
free alloy, bismuth is added nevertheless, among other reasons, to improve the critical 
current. Megin (2019) sees tin pest as a potential a problem with indium tin whereas 
addition of bismuth should reduce its susceptibility.  

Megin (2019) is aware of confidential information yet to be published indicating that 
bonds trialed with BiInSn and SnBi have demonstrated a small, but still too large 
amount of electrical resistance in liquid helium which will need further investigation as 
it would make the alloy unsuitable for MEG applications. 13  

Megin (2019) explains the role of the tin pest, which has been known for many 
decades, with most research having been carried out at temperatures between -50 
and -30 °C, which is the temperature range where the transformation occurs most 
rapidly. Megin (2020 h) considers tin pest as a serious reliability concern in MEG, as in 
a single Megin MEG system there are 612 bond wires with 1224 bonds, all of which 
have to tolerate numerous coolings and warm-ups from the room temperature to 
4.2 K during the system lifetime of more than 10 years. According to Megin (2019), 
testing at liquid helium temperatures is very difficult to carry out. The rate of tin pest 
transformation is highly complex and dependant on a variety of complex factors but 
Megin (2019) describes them as depending on two distinct processes occurring: 

  First nucleation where minute α-phase particles are formed within the β -phase. 

The driving force for nucleation is the difference in temperature between 13 °C and 
the actual temperature and so the driving force for nucleation increases as the 
temperature drops. Nucleation usually requires a defect such as a grain boundary 
or a particle of impurity but the time for nucleation to occur varies considerably. 
  The second process is phase transformation where the α-phase grows from the 
initial nucleation sites. The rate at which this occurs also varies considerably 

13   This information has been confirmed by JASTEC, c.f. section 5.2.1 

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depending on the alloy composition and its history as this affects crystal structure, 
as well as the temperature. 

Megin (2019) claims that research therefore needs to be carried out for periods that 
are similar to the lifetime of the Megin products and to temperature histories during 
the use phase, which can be up to ten or more years. Tin/lead alloys have been used 
for several decades at liquid helium temperatures in MEG and in MRI without tin pest 
failures. Therefore the reliable lifetime is uncertain for all other tin alloys, especially if 
they have been shown to suffer from tin pest more rapidly than tin/lead. Testing of 
lead-free solders has been published and one researcher14
 found that they suffer from 
tin pest significantly sooner than tin/lead although this work is with bulk samples and 
there is evidence that very small solder bonds may behave differently. Testing of very 
small solder bonds made with lead-free solders (for >10 years) has not been 
published and has probably not been carried out as most University research projects 
are limited to about 3 years.  

Elimination of lead via niobium wire bonds 

Megin (2019) reports ultrasonic niobium wire bonding research by Megin’s subsidiary 
as part of their in-house testing of alternatives. The niobium bonding was tested on 
the MEG system without helium submersion of the sensors to investigate the reliability 
of the bonds using this alternative material and bonding method. Niobium wire was 
used because it is a superconductor and is used for the SQUID magnetic field detector 
loops. The testing revealed that the reliability of the bond for the niobium wire 
between the niobium loop and the chip pads was inadequate with only 70-80 % 
achieving the required properties, i.e. good very low resistance bonds. More than 
20 % of the bonds were unsatisfactory, differently from the lead-tin to lead-indium 
alloys where 100 % of bonds can be manufactured to the required standard. The 
ultrasonic niobium bonding method could not be considered as an alternative to lead 
alloy bonding. 

Further on, Megin (2019) observed that some sensors employing niobium wire bonds 
exhibited a small electrical resistance in the sensor coil-SQUID connection. This was 
demonstrated by a low-frequency drift in the output signal from the superconducting 
loop after a change of ambient magnetic field due to, e.g. shielded room door closure, 
rather than a stable measurement which is required to be achieved. MEG must be 
used in a shielded room because the brain signals being measured are much smaller 
than the earth’s magnetic field and the electromagnetic interference originating from 
other electrical equipment. Opening and closing the room door should not affect the 
SQUID detector’s output. 

14   W. J. Plumbridge, “Further Observations on tin pest formation in solder alloys”, J. Electronic Materials, 

Vol 39(4), p 433, 2010; source as referenced by Megin 2019. 

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Elimination of lead via replacing superconductor technology by optically-
pumped magnetometers (OPMs) 

Megin (2019)15 are part of the macQsimal project; an EU-funded Horizon 2020 
research project16 which has two of the total of three years remaining at the time of 
submission of this exemption request end of 2019. The objective of the project is, 
among others, to design, develop, and validate OPMs for measuring low frequency 
magnetic fields in biomagnetic, scientific, and medical applications. The project will be 
a sensor technology demonstration, equating to a technology readiness level (TRL) of 
4-5 and, therefore, will require considerable further development once it is completed. 
OPMs are being developed as a potential alternative to cryogenic, superconducting 
MEG systems. They do not require cooling, and, therefore, potentially allowing sensors 
to be placed closer to the head increasing the sensitivity in comparison with SQUID 
detectors. There would also be the significant advantage of lower costs, which would 
allow this technique to be more widely adopted by EU hospitals than at present. 
Optical pumping refers to the use of a light source such as a laser or discharge lamp 
to cause absorption or emission of energy by a sample at a precisely defined 
frequency, changing the sample's quantum state. Although this technology showed, in 
late 1950s and early 1960s, that optical pumping can be used for inducing a 
magnetically sensitive state in an atomic system and, therefore, allow for the 
measurement of weak magnetic fields, the technology still faces significant technical 
challenges before it can be deployed. Megin (2019) list the following outstanding 
technical considerations which need resolution: 

  One of the most significant issues, which may not be able to be resolved with this 

technology, is the reduction in bandwidth of OPM in comparison with SQUID 
detectors. The present OPM sensors have sufficient sensitivity up to around 100 
Hz, while SQUID-based detectors are capable of measuring signals at several kHz, 
with an example from Megin offering 1.6 kHz as standard. A large bandwidth is 
particularly important for some applications such as brain stem measurements. 
The bandwidth of the brain signals spans typically from 0.1Hz up to 600-800Hz, 
some of which would be unable to be measured by OPM. 

  Clinically relevant high frequency oscillation at about 200Hz relating to epilepsy 

would also be unable to be conducted with the OPM bandwidth currently available; 
brain research undertaken with SQUID detectors often require the broadest range 
of bandwidth, which would be unable to be supported with the OPM bandwidth 
currently offered. Currently around 50 % of Megin’s SQUID detector MEGs are sold 
for research applications, and, therefore, the limited bandwidth of the OPM sensors 
would negatively affect multiple research applications. 

  Related to limited bandwidth, the sensitivity over the bandwidth for OPM is not 
constant, which requires compensation. Although this issue in time could be 
resolved, this will require the use of negative feedback technology which has not 
been used so far with OPM-based sensors. 

15   Megin originally joined the macQsimal project under the legal entity name as Elekta Oy. However, the 

legal entity name was recently changed to Megin Oy. 

16   For details see https://www.macqsimal.eu/  

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  The OPM sensors that are sensitive enough for MEG applications have the 

requirement for zero field operation as they are absolute field sensors, requiring 
extremely good shielding from the earth’s magnetic field and disturbance from 
electrical sources. To be able to achieve the required level of shielding, active field 
compensation is required, which is still in development. In comparison, SQUID-
based sensors require a constant but not a zero field which is achieved inside a 
shielded room. 

  The signal is currently affected by higher noise generation, which could be 

compensated by a closer proximity to the patient. However, the high power 
demands currently required by the technology generate large amounts of heat in 
the system, which impacts the allowable proximity to the patient;  

  There are also current limitations on the proximity of sensors to each other due to 
cross talk issues, meaning that the sensors interact if placed too close to each 
other. This interaction affects the signal and, therefore, reduces the useful signal 
produced by the detector. 

These technological challenges are addressed in the macQsimal project. Once this 
project has ended, Megin (2019) expect considerable further work for developing a 
system level solution 17 (technology readiness level (TRL) 8-9) and establishing 
sufficient system level data on reliability to gain global regulatory approvals before 
launching the new technology. It currently seems unlikely that OPM-based MEG 
systems can replace all SQUID-based MEG systems due to their smaller bandwidth. 
Therefore, SQUID-based MEG systems will probably also be needed for the medical 
and research applications that require more than 100 Hz detection. 

Overall, Megin (2019), the technological demands of finding an alternative to lead as a 
connective material in SQUID detectors are high. Megin is committed to only using 
RoHS exemption requests when necessary and has ensured that the number utilised is 
minimised. Megin has modified all their electronics to be RoHS compliant and has 
developed alternative pin connections such that it no longer relies on Exemption 25 of 
Annex IV. Megin has also monitored the supply chain removal of lead in cryocoolers 
(exemption 29 of Annex IV). According to Megin (2020 g), MEGIN has started using a 
cryocooler model that is RoHS compliant without exemption 29.  

Megin (2019) claims that these applications have removed much larger quantities of 
lead from the MEG system than is used in SQUID detectors. Megin is carrying out 
extensive research to replace lead but this involves many very significant technology 
challenges that need to be resolved. 

5.1.2. 

Roadmap towards substitution or elimination of lead 

Megin (2019) points out that magnetic field sensors are the core technology of the 
MEG due to the high sensitivity requirement. Changes that might have an impact on 
the reliability require extensive testing. Changes in the key technologies, specifications 

17   For details concerning the technology readiness levels (TRLs) see 

https://ec.europa.eu/research/participants/data/ref/h2020/wp/2014_2015/annexes/h2020-wp1415-
annex-g-trl_en.pdf  

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and operating principles (e.g., change from SQUIDs to OPMs) require clinical trials 
before regulatory approvals can be submitted. 

Table 5-2: Steps towards elimination of lead by OPMs 

Source: Megin (2019); Note of the consultants: the blackened fields cover confidential information 

Megin (2020 f) states that the overall time required for the development of lead-free 
alternatives will be more than seven years.  

5.1.3. 

Environmental arguments 

Megin (2019) put forward that helium is a very scarce element on the Earth with the 
demand for the element expected to rise dramatically over the coming years. Anything 
which reduces the requirement for helium will ensure that capabilities such as SQUID 
detectors, and other applications not covered in this application (such as MRI) are able 
to be supported, and the environmental impact arising from the extraction, processing 
and use of this very scarce element is reduced. 

5.1.4. 

Socioeconomic impacts 

Megin (2019) is afraid that without this exemption, reliable SQUID-based MEG 
systems could not be sold in the EU, which would be a significant disadvantage to EU 
hospitals and research institutions as a key diagnostic ability would be lost and 
research efforts would also be impeded. The annual cost to society of brain disorders 
in Europe has been estimated at 800 billion Euros 18. Much of the cost is due to 
inadequate diagnostics and lack of early intervention, e.g. in epilepsy or 
neurodegenerative pathologies, leading to institutionalisation and/or inability to work. 
In Europe there are 6 million children suffering from brain disorders, and the cost of 
their care is 21 billion Euros.19 Due to the ionising radiation used for the most common 
brain function imaging tool, PET, this is of limited use with children. PET requires that 
patients consume radioactive isotopes that are used for imaging. 

18   The economic cost of brain disorders in Europe. European Journal of Neurology, 2012, 19:155-162 
19   Cost of disorders of the brain in Europe 2010. European Neuropsychopharmacology, 2012, 21:718-779 

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According to Megin (2019), many if not most brain disorders involve dynamic aspects 
and connectivity dysfunction;20 these cannot be studied with conventional means such 
as CT, MRI, or PET. MEG, with its exceptional spatial and temporal accuracy, offers a 
solution to this problem but is reliant on the use of lead in superconducting 
connections. If manufacturers were forced to replace lead without a fully developed 
alternative including time for reliability testing, three scenarios could result: 

1.  They would not gain Notified Body approval so MEG could not be sold in the EU; 

2.  If an alternative technology were used, but reliability is found in the future to be 
inferior, unexpected failures would cause inferior data quality and delays in 
medical diagnosis with resultant negative health impacts and unexpected delays in 
research programs. Repairs of detectors take 1 – 2 weeks in which time, the MEG 
cannot be used; or 

3.  If lifetimes were very much shortened by detector failures, this would very 

significantly increase costs incurred by EU hospitals and research institutions due 
to the need for more regular maintenance and replacement. The estimated cost to 
fix 2-3 channels due to the failure of a connection would be thousands of euros 
each time. 

5.2. 

Justification for the requested exemption (JASTEC) 

5.2.1. 

Substitution of lead  

JASTEC (2019 a) explains that superconducting electrical connections to the 
superconducting electromagnet coils must have a high critical current (i.e. they must 
be able to pass a high current without losing superconductivity) at an operating 
temperature lower than their critical temperature (Tc) and at an operating magnetic 
field lower than the bonding material’s critical field. Only a few metallic elements and 
alloys have Tc values that are significantly higher than the boiling temperature of 
liquid helium (4.2 K), sufficiently high critical field strengths, and melting points below 
400 °C so that they can be used as solders. Table 5-2 shows illustrative examples.  

20   Dynamical diseases. Nature, 1978, 272:673–674 

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Table 5-3: Comparison of properties of elements and binary solder alloys 

* The boiling temperature of Helium is 4.2 K. 
Source: Persistent current joints between technological superconductors, Greg Brittles, et. al., 
article in Superconductor Science and Technology · September 2015; source as referenced in 
JASTEC (2019 a)  

JASTEC (2019 a) reports trials with InSnBi and SnBi solders as superconducting 
bonding materials which JASTEC had carried out. They were, however, unsuccessful as 
the bonds were found to have a small electrical resistance at liquid helium 
temperatures and the measured critical current was too low at only 30 – 40 A to be 
practical for use in MRI and NMR, which typically use 100 – 1000 A. Further research 
is needed to determine the cause of the small resistance as the cause is not clear, but 
the insufficiently high critical current will be difficult or impossible to overcome. 

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JASTEC (2019 a) further explain that pure bismuth was recently discovered to be 
superconductive at 0.00053 K, which is much too low to be of any use in MRI or NMR, 
which operate at about 4 K. Cadmium has a Tc of 0.52 K and gallium of 1.08 K, so are 
also both unsuitable as metallic elements for bonding. 

Lead, according to JASTEC (2019 a) has a critical temperature of 7.2 K and some 
additive elements such as arsenic, bismuth and antimony increase Tc, although 
arsenic is very toxic and antimony will make the alloy very hard and brittle, especially 
at low temperatures. Arsenic increases Tc to 8.4 K at 10 atomic %.  

What JASTEC (2019 a) deems most important for MRI and NMR however is the critical 
magnetic field of materials. At about 4 K, niobium has a thermodynamic critical field of 
0.165 T, lead of 0.07 T, tin of less than 0.01 T, and indium is 0 T. Lead is therefore 
the most suitable solderable material in powerful magnetic fields for bonding. Niobium 
cannot be used for bonding as its melting point is higher than that of copper and the 
superconducting niobium alloys.  

The critical current, JASTEC (2019 a) continues to explain, decreases as the critical 
magnetic field decreases. The performance of NMR and MRI increases as magnetic 
field strength increases and so it is important that a very large current can be used to 
generate a very powerful magnetic field, and this depends on the choice of 
superconducting bond material. Some research on ternary alloys has also been 
published. These tend to be multiphase alloys where each phase has different Tc and 
critical field values. In-Sn-Bi alloys have much smaller critical field values than Pb-Bi 
alloys.  

JASTEC (2019 a) puts forward that another limitation of bonding alloys is that they 
must be ductile at very low temperatures. This is because bonds are made between 
the solder and copper/niobium superconductor wire at about 200 °C and then are 
cooled to the operating temperature of about 4 K (minus 269 °C). Copper and lead 
alloy solders will not have the same thermal expansion coefficient. For example, 
copper is 17 x 10-6 K-1, bismuth is 13 x 10-6 K-1 and lead is 29 x 10-6 K-1, although 
these values vary with temperature. As the bonds cool through ca. 470 °C, any 
mismatch in contraction on cooling will induce a stress on the bond. Unless relieved by 
the ductility of the solder, this could cause bond delamination and so failure would 
result as copper/ NbTi is much less ductile than PbBi. Lead and its alloys with bismuth 
are relatively ductile at low temperatures and so are suitable bonding materials. 

5.2.2. 

Elimination of lead 

Diffusion bonding 

According to JASTEC (2019 a), diffusion bonding can be used to connect pairs of 
mechanically soft NbTi wires together, but it is not suitable for bonding to hard and 
brittle Nb3Sn. Diffusion bonding occurs when two oxide-free metal surfaces are placed 
in contact, usually with a large contact force that deforms the material to create 
intimate metal to metal contact. Higher melting point metals bond more easily if 
heated as long as this does not cause excessive oxidation. Diffusion bonding is 
relatively easy with soft metals such as indium which can easily be bonded at room 

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temperature with a fairly small force. NbTi is much harder than indium and has a thin 
but very stable surface oxide that prevents diffusion bonding from occurring. Nb3Sn 
also has a thin and stable oxide but being hard it requires a very high force to achieve 
an intimate metal to metal bond. Copper from the supporting sheath is first removed 
such as by dissolution in nitric acid or in a bath of liquid tin. Next, to enable diffusion 
bonding the surface oxide and any residual copper must be removed and this is 
possible only with hydrofluoric acid (HF). HF is very hazardous and is used under 
strictly controlled conditions by the semiconductor industry, but manufacturers always 
avoid using it wherever possible because skin contact has caused worker deaths and 
serious injuries.  

JASTEC (2019 a) concludes that bonding requires a controlled contact force and very 
low electrical resistance values have been obtained, although results were found to be 
inconsistent, probably because very little diffusion bonding occurred. No successful 
diffusion bonding has been reported with Nb3Sn. 

Welding 

JASTEC (2019 a) informs that with welding, bonds have been achieved with NbTi, but 
due to chemical reactions that occur at high temperature, this was not suitable for 
Nb3Sn. Bonding between NbTi filaments is possible but only after removal of copper to 
expose the filaments. Filaments can be bonded to niobium foil or twisted together 
before bonding. Results with twisted wires showed that the critical current ratio (CCR) 
was only 10 % of unbonded wires, which is unsuitable. Results showed that when 
copper sheet is used for thermomechanical support for the NbTi wires, copper 
infiltrates the NbTi and some oxidation also occurs but much higher CCRs were 
achieved. High temperatures can, however, negatively affect the nanostructure of the 
NbTi wires and detrimentally affect the superconducting properties.  

JASTEC (2019 a) concludes that welding is a promising technique, but it will be 
difficult to use consistently in a production line to produce reliable bonds. Spot welding 
is therefore currently not used commercially for NMR or MRI. 

5.2.3. 

Roadmap towards substitution or elimination of lead 

JASTEC (2019 a) put forward that it seems to be very unlikely that a substitute solder 
will be identified because all low melting point metals and alloys that are suitable for 
solder bonding and which will create ductile bonds have been considered. Only alloys 
containing lead give sufficiently high magnetic field strength for use in NMR and MRI. 
All potential substitute materials have significantly lower Tc and critical field values 
compared with lead alloys, so it appears that a substitute material does not exist. 

Alternative bonding methods such as spot welding may eventually be possible, but this 
is far from certain. The influence of the magnetic behaviour of the superconductor on 
the shape of the magnetic field from the superconducting magnet is critical for 
achieving optimal performance of NMR and MRI. Any distortion of the magnetic field 
will impair MRI imaging and NMR analysis sensitivity and accuracy. Therefore, even if 
better consistency can be achieved and the process scaled up for manufacturing the 
impact of the high temperature on the flux pinning nanostructure of the NbTi filaments 

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needs to be resolved before commercialisation. Also, bonding of NbTi to Nb3Sn by 
welding is not technically possible. JASTEC estimate that this research will take at 
least five years and may not be feasible. JASTEC (2020 c) presents the below steps 
and timelines.  

Figure 5-4: Steps and timelines towards lead-free alternatives 

Lead free alloy material development

2020

2021

2022

2023

2024

2025

2026

Process development

Validation on real magnets

Production starts

Source: JASTEC (2020 c) 

According to JASTEC (2020 c), the technology development for lead-free 
superconducting bonds to electromagnets used for MRI and NMR would follow the 
same timeline. If JASTEC develops the technology making superconducting joints 
without lead, that would be applicable for both NMR and MRI. The above timeline of 
five years covers the bond technology alone. JASTEC (2020 c) is a producer of NbTi 
and Nb3Sn superconducting wire, NMR and MRI magnets, and of component parts and 
accessory for superconducting magnets, but does not produce MRI and NMR 
equipment. Additional time will be needed for NMR and MRI equipment manufacturers 
to adapt the technology in their MRI and NMR devices. JASTEC (2020 c) does not 
know how long NMR and MRI manufacturers will need to develop new designs of NMR 
and MRI using a new lead-free technology, but it estimates that this could require at 
least a further 5 years. Finally, not all NMR or MRI manufacturers may be able to use 
this technology since each company has its own superconducting joint technology and 
almost all technology is strictly confidential.  

5.2.4. 

Environmental arguments and socioeconomic impacts 

JASTEC did not raise environmental arguments in the context of its exemption 
request.  

JASTEC (2019 a) apprehends that if this exemption is not renewed, hospitals will not 
be able to buy new MRI scanners and universities and research institutes would not be 
able to buy new high-performance NMR spectrometers. 

As to MRI, currently 7,500 are estimated to be in use in the EU21 according to JASTEC 
(2019 a), to diagnose and treat the EU’s population of over 500 million people. OECD 
data indicates that about 14 million MRI scans are carried out annually in the EU. As 
the currently used MRI become older and begin to fail and cannot be repaired, so 

21   https://data.oecd.org/healthcare/magnetic-resonance-imaging-mri-exams.htm; source as referenced 

by the applicant 

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become unusable, this number of scans will inevitably decrease as the number of 
usable MRI decreases, so that eventually, many millions of EU citizens will not have 
their illnesses diagnosed as early as possible or at all. As a result, some will die e.g. 
due to detecting cancer later than is possible with MRI and the treatment times for 
some patients will be longer as they become more serious due to later diagnosis using 
less appropriate techniques. Longer treatment times will result in increased costs for 
hospitals which EU governments will not fund and also patients’ outcomes may be 
inferior. 

For NMR, JASTEC (2019 a) estimates that there are about 3000 NMR spectrometers in 
the EU with superconducting magnets. These are used by research establishments 
such as for pharmaceuticals, food, chemistry and industrial product research. Many 
thousands of researchers at R&D laboratories and at universities will be at a very 
significant disadvantage compared with those at non-EU establishments and many will 
as a result lose their jobs. It is also inevitable that many company research 
laboratories will be forced to relocate outside of the EU in order to be able to use the 
best performing NMR and this will negatively impact on EU competitiveness and there 
would be a significant loss of jobs. R&D accounts for over 2 % of GDP in the EU and 
employed 1.2 % of the EU labour force22 in 2016, equivalent to 2.7 million jobs. 23 A 
significant proportion of these jobs would be at risk if exemption 12 is not renewed.  

Further on, JASTEC (2019 a) puts forward that as possible social impacts external to 
the EU, EU citizens may need to travel to non-EU countries to use MRI for medical 
treatment. Researchers and EU research facilities may relocate to non-EU countries. 

5.3. 

Stakeholder contributions 

COCIR (2020 a) stated in the stakeholder consultation that it “[…] submitted a 
separate exemption renewal request for exemption 11 ‘Lead and its alloys as a 
superconductor and thermal conductor in MRI’ which is similar in scope. Only one of 
exemption 11 or exemption 12 would appear to be needed to cover lead in 
superconducting bonds.”  

Further on, COCIR (2020 a) supports JASTEC’s exemption request claiming that “[…] 
lead containing alloys are essential to create reliable bonds for MRIs. […] COCIR 
represents multiple MRI device manufacturers, all of whom require an exemption for 
lead in superconducting bonds to MRI magnets.”  

COCIR (2020 a) also states that lead-free solutions that might be available for FTMS 
and for SQUID detectors could not be used for MRI as the requirements are very 
different. COCIR (2020 a) say that they cannot comment on NMR.  

22   GDP = Gross Domestic, data from Product from 

https://ec.europa.eu/eurostat/statisticsexplained/index.php/Europe_2020_indicators_-
_R%26D_and_innovation; source as referenced by the applicant 

23   EU employment is estimated to be 228.7 million employees, 

https://www.statista.com/topics/4095/employment-in-europe/; source as referenced by the applicant 

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5.4. 

Critical review 

5.4.1. 

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 the 
environmental and health protection afforded by“ the REACH Regulation. The article 
details further criteria which need to be fulfilled to justify an exemption, however the 
reference to the REACH Regulation is interpreted by the consultants as a threshold 
criteria: an exemption could not be granted should it weaken the protection afforded 
by REACH. The first stage of the evaluation thus includes a review of possible 
incoherence of the requested exemption with the REACH Regulation.  

Lead is a substance of very high concern but so far, aside from a few specific 
compounds, has not been adopted to REACH Annex XIV as an element. The fact that 
lead is a candidate substance therefore at the time being does not weaken the 
environmental and health protection afforded by“ the REACH Regulation.  

Annex XIV of the REACH Regulation lists a few substances, the use of which would 
require an authorisation in the European Economic Area: 

  Lead chromate – used in printing inks, paints and to colour vinyl, rubber and 

paper24; 

  Lead sulfochromate yellow –used as a pigment, a dye and as a paint and coating 

additive25; 

  Lead chromate molybdate sulphate red –understood to be used as a pigment; 

As the exemption for lead in solders used within the scope of the requested exemption 
does not regard pigments nor substances used in paints and dyes, it is concluded that 
a renewal of the exemption would not weaken the protection afforded by the listing of 
substances on the REACH Authorisation list (Annex XIV). 

Annex XVII of the REACH Regulation also contains entries restricting the use of lead 
compounds: 

  Entry 16 restricts the use of lead carbonates in paints;  
  Entry 17 restricts the use of lead sulphates in paints; 
  Entry 19 refers to arsenic compounds but includes a few lead compounds and 
restricts their use as a fouling agent, for treatment of industrial water or for 
treatment of wood;  

  Entry 63 restricts the use of lead and its compounds in jewellery and in articles or 

accessible parts thereof that may, during normal or reasonably foreseeable 
conditions of use, be placed in the mouth by children;  

24   Data on uses from Pubchem:   

https://pubchem.ncbi.nlm.nih.gov/compound/lead_chromate#section=Top  

25   Data on uses from Pubchem: https://pubchem.ncbi.nlm.nih.gov/compound/53488191#section=Use-

and-Manufacturing  

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  Entry 28 and entry 30 stipulate that various lead compounds shall not be placed on 

the market, or used, as substances, constituents of other substances, or in 
mixtures for supply to the general public;  

  Entry 72 stipulates that various lead compounds shall not be used in clothing. 

The exemption for lead in solders used within the scope of the requested exemption 
does not regard paints or jewellery, nor components that could be expected to be 
placed in the mouth by children under normal or foreseeable use. Furthermore, the 
use of lead in solders in the scope of the requested exemption is not a supply of lead 
compounds as a substance, mixture or constituent of other mixtures to the general 
public. Lead is part of an article and as such, the above entries of Annex XVII of the 
REACH Regulation would not apply.  

No other entries, relevant for the use of lead in the requested exemption could be 
identified in Annex XIV and Annex XVII (status March 2020). Based on the current 
status of Annexes XIV and XVII of the REACH Regulation, the requested exemption 
would not weaken the environmental and health protection afforded by the REACH 
Regulation. An exemption could therefore be granted if other criteria of Art. 5(1)(a) 
apply. 

5.4.2. 

Megin - Lacking stakeholder support for the exemption request 

No stakeholders contributed to the online consultation to either contradict or support 
Megin’s exemption request. The absence of supporting contributions which raises the 
question whether other manufacturers of SQUID-based MEGs may have lead-free 
solutions that would render exemption 12 obsolete for this application. When asked for 
other MEG manufacturers that make MEGs with SQUIDs available on the European 
Economic Area, Megin (2020 b) explained that “[…] the present situation is unclear. To 
our knowledge, at the moment there are no other MEG-device manufacturers that 
would sell new whole-head MEG instruments based on SQUID technology in the 
European Economic Area (EEA) due to lacking the CE-mark.” Megin (2020 c) do not 
know whether other manufacturers’ MEGs will obtain the CE-mark in the foreseeable 
future so that they can place MEGs on the EEA market. According to Megin (2020 d) 
“[…] there are at least Compumedics (Australia) and Ricoh (Japan) that sell new 
SQUID-based MEG-devices. However, based on the public tenders, it seems that they 
are concentrating to the US and East Asian markets. […] There is a third company, 
CTF (Canada), but we are not certain if they really manufacture new systems, or only 
re-furbish & upgrade their older systems. CTF went out of business in 2006, and sold 
all the manufacturing equipment.” Megin (2020 c) notes that “[…] Compumedics has 
started developing and manufacturing MEG only recently and has sold 1 system so far 
(USA). Megin (previously under names Elekta and Neuromag) has manufactured more 
than 100 systems since 1994.”  

The consultants contacted Compumedics and Ricoh via e-mail and phone, but could 
not reach out to the competent departments and persons in those enterprises. 
Questions sent by e-mail to the respective departments were not answered. COCIR 
(2020 c) has no knowledge either of the EU MEG market or of any companies planning 
to sell MEG in the EU since none of its members produce MEG devices. No further 
clarification of the situation was possible within the available time frame.  

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The lacking comments from other manufacturers for Megin’s exemption request thus 
cannot be interpreted that the substitution or elimination of lead in applications in the 
scope of exemption 12 are practicable and that the exemption may be obsolete since 
it cannot be excluded that they do not serve the EU/EEA market. 

5.4.3. 

Scientific and technical practicability of substitution or 
elimination of lead in SQUID detectors (MEGIN) 

Substitution of lead 

The SQUID detectors in MEGs are operated immersed in liquid helium of 4.2 K as part 
of the superconducting loop. Table 5-1 on page 31 presents potential candidates to 
substitute lead. Their critical temperature is, however, either too low so that they are 
not superconductive at 4.2 K, or they are not appropriate to be used as solders. The 
information is congruent with the arguments provided by JASTEC as justification for 
their exemption. It is plausible that with these substances, substitution of lead is 
scientifically and technically impracticable.  

Further on, Megin (2019) mention that it is currently working on bismuth-tin-indium 
alloys under investigation for MRI devices as potential candidates replacing lead 
solders in SQUID-based MEGs. JASTEC (2019 a), too, mentions this alloy as the most 
promising lead-free alternative for NMR and MRI. Among other obstacles to overcome, 
both applicants point out recent findings showing that these alloys are not completely 
superconductive under the operation conditions in SQUID detectors, MRI and NMR, 
which limits or even disqualifies them for th uses in the scope of exemption 12.  

At the time being, the argument can be followed that substitution of lead in SQUID 
detectors is not feasible in the foreseeable future.  

Elimination of lead 

Lead can be evaluated via bonding technologies other than soldering, i.e. via 
ultrasonic niobium wire bonding, and by an alternative sensor technology which does 
not depend on superconductor elements.  

As to alternative bonding technologies, Megin’s tests of niobium wires revealed that 
more than 20 % of the bonds were unsatisfactory, differently from the lead-tin to 
lead-indium alloys where 100 % of bonds can be manufactured to the required 
standard. The consultants can therefore follow the argument that ultrasonic niobium 
bonding method cannot be considered as an alternative to lead alloy soldering since 
the reliability is insufficient.  

JASTEC reports spot welding as a further tested alternative, which possibly could also 
be an alternative to lead solders in SQUID detectors. The results of JASTEC’s tests are, 
however, negative and further development is needed so that, given the similar 
technological background of the exemption requests for MRI and SQUIDs, the same 
can be concluded for the use of spot welding in MEGs.  

Finally, optically pumped magnetometers are a potential alternative which would 
eliminate the use of lead in the scope of exemption 12. As described in the section 

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“Elimination of lead via replacing superconductor technology by optically-pumped 
magnetometers (OPMs)” of chapter 5.1.1 on page 34, this technology is still under 
development and not yet mature to replace SQUIDS in MEGs.  

The consultants found one publication about mini sensors for MEGs which can be 
operated at room temperature. 26 Megin (2020 c), when asked to comment on this, 
explained that these mini sensors are one example of an OPM with the before-
mentioned shortcomings which still have to be overcome before they can be used in 
MEGs.  

Overall, the situation shows that currently and in the foreseeable future, the 
elimination of lead in SQUID detectors is scientifically and technically impracticable. 

5.4.4. 

Substitution and Elimination of lead in MRI and NMR devices 
(JASTEC) 

Lacking stakeholder support for use of lead in NMR devices 

While COCIR representing, among others, MRI manufacturers, supports JASTEC’s 
exemption request for MRI devices, there is no such support for NMR equipment. 
JASTEC (2020 d) says that JASTEC manufactures not only superconductors but also 
superconducting magnet used for NMR and MRI. JASTEC makes superconducting 
magnets for NMR using homemade superconductor. JASTEC supplies these magnets to 
JEOL, and JEOL sells JEOL sells NMR spectrometer. Bruker is doing similar thing. They 
make superconducting magnets which they use for their NMR superconductors which 
they integrate into their NMR spectrometers. JASTEC (2020 d) thinks that Bruker is 
the largest superconductor supplier for NMR and MRI.  

An internet investigation showed that Agilent also offers NMR devices. The consultants 
contacted Bruker and Agilent via e-mail and phone asking whether they actually use 
exemption 12 in their NMR devices but did not receive any feedback. The consultants 
also contacted the Test and Measurement Coalition (TMC), which in 2012 has 
requested the inclusion of NMR devices into the scope of exemption 12. TMC (2020) 
replied stating that their members do not produce equipment utilizing NMR devices. It 
is thus actually not clear whether all NMR manufacturers actually require the 
exemption which JASTEC asks to be continued.  

Looking at the situation that, based on the available information, MRI device 
manufacturers depend on this exemption, and the congruent scientific and technical 
background of the exemption for NMR and MRI, it is not plausible to assume that the 
exemption would only be required in MRI, but not in NMR equipment. The consultants 
can therefore not exclude that lead-free solutions might be available but deem it 
improbable that this might actually be the case. It might nevertheless be considered 
that for future exemption requests, applicants are required to organize a broader 

26   NIST: NIST Mini-sensor Measures Magnetic Activity in Human Brain, 2012, c.f. 

https://www.nist.gov/newsevents/news/2012/04/nist-mini-sensor-measures-magnetic-activity-human-
brain  

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stakeholder support for their requests at the time of the application already as clearer 
evidence that the exemption is actually required.  

Substitution of lead 

If appropriate lead-free solders were found, they could substitute lead. JASTEC 
discusses several potential alternatives, which, however, exhibit too low critical 
temperatures and critical currents. Trials with InSnBi and SnBi solders were 
unsuccessful since the solders were found to develop small electrical resistances at the 
operating temperatures of around 4 K used in MRI and NMR.  

The consultants can therefore follow the applicant’s argument that substitution of lead 
is scientifically and technically not yet practicable.  

Elimination of lead 

In its exemption request, JASTEC discusses diffusion bonding and spot welding as 
potential alternative bonding technologies to eliminate lead. Spot welding may be 
feasible in principle for bonding to NbTi, however, to date, this technique has not 
given consistent results and the process is possible only under controlled laboratory 
conditions. Due to the material properties, spot welding cannot be used for contacting 
Nb3Sn, which is used in NMR.  

Taking into account the overall situation, the consultants conclude that substitution of 
lead in the applications in the scope of exemption 12 in MRI and NMR is scientifically 
and technically not yet practicable.  

5.4.5. 

Overlapping scopes of exemptions 11 and 12 

COCIR raised concerns about overlapping scopes between exemption 11 and 12 of 
Annex IV for applications in MRI devices.27 The consultants share these concerns and 
therefore proposed changes to separate the scopes. 

COCIR (2020 c) and JASTEC (2020 b) agreed to exclude MRI from the scope of 
exemption 12 so that the lead applications in MRI are only covered by exemption 11 
provided this exemption would be renewed as COCIR has already requested. JASTEC 
can then contribute to the upcoming stakeholder consultation for exemption 11 to be 
involved in the review process.  

The consultants further on propose to integrate NMR into the scope of exemption 11 
as well. MRI devices use NbTi coils only, while NMR equipment additionally uses 
Nb3Sn coils, and MRI scanners produce images of human bodies while NMR devices 
record spectra of atomic nuclei allowing the identification of elements. Otherwise, 
however, both NMR and MRI are built on the same superconductor technologies, which 
is in the focus of JASTEC’s exemption request for MRI and NMR, and both devices 
experience, differently from MEGs, severe vibrations during their operation. JASTEC 
(2020 b) agrees to this change provided NMR will actually be adequately included into 

27   Current wording of exemption 11 of Annex IV: Lead in alloys as a superconductor and thermal 

conductor in MRI 

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the scope of exemption 11. Exemption 12 would thus in future cover SQUID detectors 
only resulting in a clear demarcation of the scopes of these two exemptions.  

5.4.6. 

Environmental arguments and socioeconomic impacts 

As long as the substitution or elimination of lead is scientifically and technically 
impracticable, manufacturers of MRI, MEGs and NMR devices could no longer place 
their equipment on the EEA market. The applicants arguments is comprehensible that 
this would cause severe impacts in the health sector as well as in those research and 
development activities which depend on the use of NMR devices.  

5.4.7. 

Conclusions 

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

 

 
 

their elimination or substitution via design changes or materials and components 
which do not require any of the materials or substances listed in Annex II 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 and 
consumer safety benefits thereof.  

The applicants MEGIN and JASTEC plausibly explain the scientific and technical 
impracticability of lead use in the scope of exemption 12. COCIR, representing several 
MRI equipment manufacturers, supports the exemption request, while no stakeholder 
comments were received as to the applications NMR devices and SQUID detectors. For 
the latter, it is well possible that MEGIN currently is the only producer serving the 
EU/EEA market with SQUID-based MEGs, which would explain the lacking stakeholder 
comments. For NMR, it is technically plausible that the exemption is essential for NMR 
devices if it is indispensable for MRI equipment since both are based on a very similar 
superconductor technology.  

Taking into account the overall situation, including the technical aspects as well as the 
potential severe impacts on health care and research in the EU/EEA should the 
exemption not be granted, the consultants recommend renewing the exemption.  

To avoid overlapping scopes of exemptions 11 and 12, it was agreed with JASTEC and 
COCIR to recommend shifting MRI and NMR appliances from exemption 12 into the 
scope of exemption 11, provided the Commission will renew this exemption. 
Exemption 11 specifies the function of lead as superconductor and thermal conductor 
and therefore is more specific for MRI and NMR than exemption 12. COCIR has 
submitted an exemption request for its renewal already so that the review of 
exemption 11 is to be expected in the near future. NMR devices should then be 

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integrated adequately 28 into the scope of exemption 11 with JASTEC participating as 
stakeholder in the evaluation process.  

SQUID detectors should remain in the scope of exemption 12 with the following 
recommended wording: 

Lead in metallic bonds creating superconducting electric circuits in SQUID 
detectors. 

This is a slight deviation from the current wording since “magnetic circuits” is replaced 
by “electric circuits” as suggested by COCIR and agreed with MEGIN. The 
reformulation better reflects the actual situation, which is that lead bonds are applied 
to create superconducting electric circuits which produce magnetic fields.  

In case exemption 11 is not renewed, or if the Commission should not agree to 
shifting NMR and MRI devices into the scope of exemption 11, the consultants 
recommend renewing exemption 12 with the following wording:  

Lead in metallic bonds creating superconducting electric circuits in MRI and 
NMR, and in SQUID detectors.  

A comma was inserted after “NMR”, since the exemption could otherwise be 
interpreted as covering detectors in MRI, NMR and SQUIDs, whereas only the SQUIDs 
can be understood as detectors.  

Since the available information suggests that neither substitution nor elimination of 
lead in the applications in scope of exemption 12 are foreseeable in the near future, 
the consultants recommend granting the renewed exemption 12 for the maximum 
seven years.  

5.5. 

Recommendation 

The consultants recommend renewing the exemption. The scientific and technical 
information submitted by the applicants allows concluding that substitution or 
elimination of lead in the applications in scope of exemption 12 are currently and in 
the foreseeable future scientifically and technically impracticable. The renewal of the 
exemption would therefore be in line with the requirements for exemptions stipulated 
in Art. 5(1)(a).  

In alignment with the involved stakeholders, the consultants propose excluding MRI 
equipment from the scope of exemption 12 since it is included in exemption 11 whose 
renewal is already requested. Otherwise, the scopes of both exemptions are 
overlapping for MRI equipment. Since NMR and MRI are based on a very similar 

28  JASTEC 2020 b actually agreed to the shift provided the wording of exemption 11 

would be “Lead in alloys as a superconductor and thermal conductor in MRI and NMR”. 
The future wording of exemption 11 will, however, have to be assessed reflecting the 
current state of science and technology taking into account the findings of this review 
process. 

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superconductor technique and the technical requirements on which the exemption is 
based are almost identical, all stakeholders agreed to recommend shifting NMR 
equipment into the scope of the future exemption 11.  

The following wording for exemption 12 was agreed with the stakeholders:  

Lead in metallic bonds creating superconducting electric circuits in SQUID 
detectors. 

In case exemption 11 is not renewed, or if the Commission does not agree to shifting 
NMR and MRI devices into the scope of exemption 11, the consultants recommend 
renewing exemption 12 with the following wording:  

Lead in metallic bonds creating superconducting electric circuits in MRI and 
NMR, and in SQUID detectors. 

The available information suggests that neither substitution nor elimination of lead in 
the applications in scope of exemption 12 are foreseeable in the near future. The 
consultants therefore recommend a validity of seven years for the future exemption 
12.  

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5.6. 

References 

COCIR (2020 a): Answers to questionnaire 1 (consultation questionnaire) as 

contribution to the stakeholder consultation, document 
"Response_to_JASTEC_ex12-COCIR.pdf". Answers to questionnaire 1 
(consultation questionnaire). Online verfügbar unter 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_19/Respo
nse_to_JASTEC_ex12-COCIR.pdf. 

COCIR (2020 c): Answers to questionnaire 3, received from Riccardo Corridori, COCIR, 
by Dr. Otmar Deubzer, Fraunhofer IZM, via e-mail on 7 May 2020, document 
"Ex12_AnnexIV_Questionnaire-3_COCIR v2.docx". Answers to questionnaire 2. 

European Union (2011): 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 (recast). RoHS 2. European 
Union. Online verfügbar unter http://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:32011L0065, zuletzt aktualisiert am 01.07.2011, 
zuletzt geprüft am 05.10.2012. 

Gensch et al. 2012: Assistance to the Commission on technological, socio-economic 
and cost-benefit assessment related to exemptions from the substance 
restrictions in electrical and electronic equipment (RoHS Directive). Final Report 
RoHS 5. Unter Mitarbeit von Carl-Otto Gensch, Yifaat Baron, Markus Blepp, 
Andreas Manhart, Katja (Öko-Institut) Moch und Otmar (Fraunhofer IZM) 
Deubzer. Carl-Otto GenschYifaat BaronMarkus BleppAndreas ManhartKatja Moch. 
Online verfügbar unter https://circabc.europa.eu/sd/a/42ccb088-4c26-4e3a-
8a0c-218ea738964c/RoHS_V_Final_report_12_Dec_2012_Final.pdf. 

JASTEC (2019 a): Exemption request, document 

"Application_JASTEC_RoHS_Exemption_Request_Exemption_12.pdf". Online 
verfügbar unter 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_19/Applica
tion_JASTEC_RoHS_Exemption_Request_Exemption_12.pdf. 

JASTEC (2020 b): Answers to questionnaire 3, received from Saito Kazuyoshi, 

JASTEC/Kobelco, via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 7 May 
2020, document "Ex12_AnnexIV_Questionnaire-3_JASTEC.DOCX". Answers to 
questionnaire 3. 

JASTEC (2020 c): Answers to questionnaire 4, received from Saito Kazuyoshi, 

JASTEC/Kobelco, via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 14 May 
2020, document "Ex12_AnnexIV_Questionnaire-4_JASTEC.DOCX". Answers to 
questionnaire 4. 

JASTEC (2020 d): Answers to questionnaire 5, received from Saito Kazuyoshi, 

JASTEC/Kobelco, via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 15 May 
2020, document "Ex12_AnnexIV_Questionnaire-5_JASTEC.DOCX". Answers to 
questionnaire 4. 

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Megin (2019): Exemption request received by the European Commission requested to 

be considered as a contribution to the evaluation, document 
"contribution_Megin_RoHS19_V_Application_Form-12-
SQUID_FINAL_V2.2_public.pdf". Online verfügbar unter 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_19/contrib
ution_Megin_RoHS19_V_Application_Form-12-SQUID_FINAL_V2.2_public.pdf. 

Megin (2020 b): Answers to questionnaire 2, received from Petteri Laine, Megin Oy, 
via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 28 April 2020, document 
"Ex12_AnnexIV_Questionnaire-2_Megin_FINAL_public.pdf". Answers to 
questionnaire 2. 

Megin (2020 c): Answers to questionnaire 3, received from Petteri Laine, Megin Oy, 
via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 4 May 2020, document 
"Ex12_AnnexIV_Questionnaire-3_Megin_PUBLIC.pdf". Answers to questionnaire 
3. 

Megin (2020 d): Answers to questionnaire 4, received from Petteri Laine, Megin Oy, 

via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 4 May 2020, document 
"Ex12_AnnexIV_Questionnaire-4_Megin.pdf". Answers to questionnaire 4. 

Megin (2020 f): Answers to questionnaire 6, received from Petteri Laine, Megin Oy, via 
e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 11 May 2020, document 
"Ex12_AnnexIV_Questionnaire-6_Megin.pdf". Answers to questionnaire 6. 

Megin (2020 g): Answers to questionnaire 7, received from Petteri Laine, Megin Oy, 
via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 14 May 2020, document 
"Ex12_AnnexIV_Questionnaire-6_Megin.pdf". Answers to questionnaire 7. 

Megin (2020 h): Answers to questionnaire 8, received from Petteri Laine, Megin Oy, 
via e-mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 14 May 2020, document 
"Ex12_AnnexIV_Questionnaire-6_Megin.pdf". Answers to questionnaire 8. 

TMC (2020): Answers to questionnaire 1, received from Meglena Mihova, EPPA, via e-
mail by Dr. Otmar Deubzer, Fraunhofer IZM, on 11 May 2020. Answers to 
questionnaire 1. 

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Appendix 

Aspects relevant to the REACH Regulation 

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 health 
protection afforded by Regulation (EC) No 1907/2006” (Article 5(1)(a), pg. 1) 
  Where processes related to the REACH regulation should be followed to understand 

where 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 this 
project. 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 to 

authorization 

Designation of the substance, of the 
group of substances, or of the 
mixture 

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

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

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

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

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

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

Transitional arrangements 

Latest 
application 
date ( 1 ) 

Sunset date 
( 2 ) 

21 August 
2013 
(*) 

21 August 
2013 
(*) 

21 August 
2013 
(*) 

21 August 
2013 
(*) 

21 February 
2015 
(**) 

21 February 
2015 
(**) 

21 February 
2015 
(**) 

21 February 
2015 
(**) 

Exempted 
(categories 
of) uses 

Uses in the 
immediate 
packaging of 
medicinal 
products 
covered 
under 
Regulation 
(EC) No 
726/ 2004, 
Directive 
2001/82/EC,  
and/or 
Directive 
2001/83/EC 

21 Nov 2013 
(*) 

21 May 2015 
(**) 

21 Nov 2013 
(*) 

21 May 2015 
(**) 

- 

- 

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Designation of the substance, of the 
group of substances, or of the 
mixture 

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

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

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 dichromic 
acid 
EC No: not yet assigned 
CAS No: not yet assigned 

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

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

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

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

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

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

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

Exempted 
(categories 
of) uses 

- 

- 

- 

- 

- 

- 

Transitional arrangements 

Latest 
application 
date ( 1 ) 

21 Nov 2013 
(*) 

Sunset date 
( 2 ) 

21 May 2015 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

21 Mar 2016 
(*) 

21 Sep 2017 
(**) 

22. Jul 2017 
(*) 

22 Jan 2019 
(**) 

22 Jul 2017 
(*) 

22 Jan 2019 
(**) 

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Designation of the substance, of the 
group of substances, or of the 
mixture 

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

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

Transitional arrangements 

Latest 
application 
date ( 1 ) 

22 Jul 2017 
(*) 

Sunset date 
( 2 ) 

22 Jan 2019 
(**) 

Exempted 
(categories 
of) uses 

22 Jul 2017 
(*) 

22 Jan 2019 
(**) 

(*) 1 September 2019 for the use of the substance in the production of spare parts for the repair of articles 
the production of which ceased or will cease before the sunset date indicated in the entry for that 
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 of articles the 
production of which ceased or will cease before the sunset date indicated in the entry for that 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 those articles 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 polybrominated 
diphenyl 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 come 
into 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 

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 

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 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 and 
maintenance of works of art and historic buildings and their interiors, as well as the placing on the 
market for such use. Where a Member State makes use of this derogation, it shall inform the 
Commission thereof. 

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 and 
maintenance of works of art and historic buildings and their interiors, as well as the placing on the 
market for such use. Where a Member State makes use of this derogation, it shall inform the 
Commission thereof. 

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 such 
measuring 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 shall 
not 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 the 
market 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; 
(b) measuring devices which are to be displayed in public exhibitions for cultural and historical purposes. 

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Designation of the substance, 
group of substances, or mixture 

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

Conditions of restriction 

For the purpose of this entry, the codes and chapters indicated in square brackets are the codes and 
chapters 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 of 
the 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. 

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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

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 
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, the 
concentration of cadmium (expressed as Cd metal) shall not be equal to or greater than 0,1 % by 
weight.  
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 and 
is 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 the 
applications listed in points (a) to (e), by 31 December 2017. 

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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

5. For the purpose of this entry, ‘cadmium plating’ means any deposit or coating of metallic cadmium on 
a metallic surface. 

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] [8476 
11] 
— 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 or 
components of such articles when used in the sectors/applications listed in points (a) and (b) below and 
to 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: 

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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

— articles and components of the articles used in the aeronautical, aerospace, mining, offshore and 
nuclear sectors whose applications require high safety standards and in safety devices in road and 
agricultural vehicles, rolling stock and vessels, 
— electrical contacts in any sector of use, where that is necessary to ensure the reliability required of the 
apparatus on which they are installed. 
8. Shall not be used in brazing fillers in concentration equal to or greater than 0,01 % by weight. 
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 % by 
weight 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. 

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 to 
or greater than: 
— either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 
1272/2008, or, 

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28. Substances which are classified 
as carcinogen category 1A or 1B in 
Part 3 of Annex VI to Regulation 
(EC) No 1272/2008 and are listed in 
Appendix 1 or Appendix 2, 
respectively:  
Cadmium carbonate 
Cadmium chloride 
Cadmium dihydroxide  
Cadmium dinitrate 
Cadmium fluoride 

 
 
 
 
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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

— the relevant concentration specified in Directive 1999/45/EC where no specific concentration limit is 
set 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 the 
market 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; 
(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 said 
date. 

Cadmium hydroxide  
Cadmium (pyrophoric)  
Cadmium nitrate 
Cadmium oxide 
Cadmium Sulphate 
Cadmium sulphide 
Chromium (VI) trioxide 
Zinc chromates including zinc 
potassium chromate 
Nickel Chromate 
Nickel dichromate  
Potassium dichromate  
Ammonium dichromate 
Sodium dichromate  
Chromyl dichloride; chromic 
oxychloride  
Potassium chromate  
Calcium chromate  
Strontium chromate  
Chromium III chromate; chromic 
chromate  
Sodium chromate 
Lead Chromate 
Lead hydrogen arsenate  
Lead Nickel Salt 
Lead sulfochromate yellow; C.I. 
Pigment Yellow 34; 
Lead chromate molybdate sulfate 
red; C.I. Pigment Red 104; 

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Designation of the substance, 
group of substances, or mixture 

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 and 
are listed in Appendix 3 or Appendix 
4, respectively:  
Cadmium carbonate 
Cadmium chloride 
Cadmium dihydroxide  
Cadmium dinitrate 
Cadmium fluoride 
Cadmium hydroxide  
Cadmium nitrate 
Cadmium Sulphate 
Chromium (VI) trioxide  
Potassium dichromate  
Ammonium dichromate 
Sodium dichromate  
Chromyl dichloride; chromic 
oxychloride  
Potassium chromate  
Sodium chromate  

30. Substances which are classified 
as reproductive toxicant category 1A 
or 1B in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 and 
are listed in Appendix 5 or Appendix 
6, respectively.’Toxic to 
reproduction: category 1A or 1B or 
toxic to reproduction category 1 or 2  
According to Appendices 5 and 6:  
Cadmium chloride 
Cadmium fluoride 

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Designation of the substance, 
group of substances, or mixture 

Cadmium Sulphate 
Potassium dichromate  
Ammonium dichromate 
Sodium dichromate  
Sodium chromate  
Nickel dichromate 
Lead compounds with the exception 
of those specified elsewhere in this 
Annex  
Lead Arsenate 
Lead acetate  
Lead alkyls  
Lead azide 
Lead Chromate  
Lead di(acetate)  
Lead hydrogen arsenate 
Lead 2,4,6-trinitroresorcinoxide, lead 
styphnate  
Lead(II) methane- sulphonate  
Trilead bis- (orthophosphate) 
Lead hexa-fluorosilicate  
Mercury 
Silicic acid, lead nickel salt 

47. Chromium VI compounds 

Conditions of restriction 

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 the 
cement. 
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 the 
storage 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. 

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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

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 are 
handled 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 water-
soluble 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 the 
total 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.  

1. Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the 
plasticised material, in toys and childcare articles.  
2. Toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by 
weight of the plasticised material shall not be placed  
on the market. 
4. For the purpose of this entry ‘childcare article’ shall mean any product intended to facilitate sleep, 
relaxation, hygiene, the feeding of children or sucking on the part of children. 

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 % by 
weight.  
2. Articles or any parts thereof containing one or more of these substances shall not be placed on the 
market 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. 

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51. The following phthalates (or 
other CAS and EC numbers covering 
the substance):  
(a) Bis (2-ethylhexyl) phthalate 
(DEHP)  

CAS No 117-81-7  
EC No 204-211-0  

(b) Dibutyl phthalate (DBP)  

CAS No 84-74-2  
EC No 201-557-4  
(c) Benzyl butyl phthalate (BBP)  
CAS No 85-68-7  
EC No 201-622-7 

62.  
(a) Phenylmercury acetate  
EC No: 200-532-5  
CAS No: 62-38-4  

(b) Phenylmercury propionate  

EC No: 203-094-3  

 
 
 
 
 
 
 
 
 
 
 
 
 
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Designation of the substance, 
group of substances, or mixture 

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  

(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 

Conditions of restriction 

1. Shall not be placed on the market or used in any individual part of jewellery articles if the 
concentration 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: 
(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 the 
individual components of the jewellery articles.  
3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-
making.  
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 by 
Regulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixtures 
containing 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. 

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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

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 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 the 
articles 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 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 or 
reasonably 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 not 
exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the 
article. 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; 
(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 by 
Regulation (EEC) No 2658/ 87) unless they have been treated with lead or its compounds or mixtures 
containing these substances;  
(d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral 
melted 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 the 
European Parliament and of the Council (***)  

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Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

67. Bis(pentabromophenyl)ether  
(decabromodiphenyl ether; 
decaBDE)  
CAS No 1163-19-5  
EC No 214-604-9 

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 of 
lead 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.  
--- 
(*) 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 safety 
of toys (OJ L 170, 30.6.2009, p. 1).  
(***) 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). 

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.  

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RoHS Exemptions Evaluation: Pack 19 

Designation of the substance, 
group of substances, or mixture 

Conditions of restriction 

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 machinery, 
and 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, and 
repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 
79 19.3.2008, p. 1). 

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RoHS Exemptions Evaluation: Pack 19 

As of June 2020, the REACH Regulation Candidate list includes various substances of 
relevance for RoHS. Proceedings concerning the addition of these substances to the 
Authorisation list (Annex XIV) have begun and shall be followed by the evaluation 
team to determine possible discrepancies with future requests of exemption from 
RoHS (new exemptions, renewals and revocations)). 

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