Department for Environment Food & Rural Affairs  (Defra)  
Bis(2-ethylhexyl) phthalate (DEHP) in plastic 
components in magnetic resonance imaging (MRI) 
detector coils  
Report prepared by: Pearl Nemeth  
Report Approved by: Dr Richard Peagam  
Date : 7th February 2022    
Disclaimer  
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and circumstances as they existed at the time the report was prepared. Any changes in such facts and 
circumstances may adversely affect the recommendations, opinions or findings contained in this report.  
 
   
 
Bis(2-ethylhexyl) phthalate (DEHP) in plastic 
components in magnetic resonance imaging (MRI) 
detector coils  
Anthesis (UK) Limited  
Prepared for:   Prepared by:  
Graeme Vickery  Dr Richard Peagam  
Defra  Anthesis (UK) Limited  
Nobel House  Unit J, Taper Studios  
17 Smith Square  175 Long Lane  
London  London  
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Report written by:   Email:  
Pearl Nemeth  Website : www.anthesisgroup.com  
+44 (0)7881  533 937 Tel: 01865 250818  
Pearl.nemeth@anthesisgroup.com  Company Registration : 08425819  
  
  
Analyst  
Emma Holroyd   
  
  
  
  
Report approved by:   
Dr Richard Peagam  7th February 2022   
+44 (0)7824 314 194    
richard.peagam@anthesisgroup.com   
  
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Executive summary  
 
Background and Objectives  
The European Directive on the restriction of the use of certain hazardous substances in electrical and 
electronic equipment (2011/65/EU, RoHS 2i) permits exemptions to be sought. New and renewal exemptions 
are granted or extended at the discret ion of the Commission and until 31st December 2020 have been 
automatically transposed into UK law as “The Restriction of the Use of Certain Hazardous Substances in 
Electrical and Electronic Equipment Regulations 2012” (The RoHS Regulations)ii. With the Uni ted Kingdom’s  
withdrawal from the European Union on 31st January 2020 , and the end of the transition period on 31st 
December 2020 , the UK regulation has been updated to reflect the rules for placing such equipment on the 
market in Great Britain and in Nort hern Irelandiii iv. 
Those exemptions which had already been transposed into UK law remain, but several exemption applications 
were still under review by the European Commission. Consequently, any new exemptions adopted by the 
European Union post 1st January 2021 that were submitted to the European Commission before 1st January 
2021 , require an independent review by Defra before the Secretary of State decides whether to apply that 
exemption to The RoHS Regulations. Amending regulations repatriate powe rs to the Secretary of State to 
consider exemption applications made for the GB market.  They set out transitional arrangements for 
applications that were made to the European Commission before the end of the “transitional period”.  
Anthesis (UK) Limited (A nthesis) has been contracted by Defra , through award of contract No. 59661 to 
review the exemption adopted by the European Union on 11th August 2021 for Bis(2 -ethylhexyl) phthalate 
(DEHP) in plastic components in magnetic resonance imaging (MRI) detector c oils to be included in Annex IV, 
entry 4 6 of The Restriction of Hazardous Substances Directive (RoHS 2). This exemption is being considered 
under the  “transitional provisions” mentioned above. The Anthesis review has primarily focused on the 
European Commi ssion’s report s vi xi considering inter al ia alignment with UK REACHv; risk characterisation of 
the requested use; feasibility of alternatives paying specific attention to their availability in the GB market; 
and consideration of the socio -economic implications from a GB perspective.  
 
Key Findings  
The exemption  request  adopted  in the European  Union  under  RoHS  2 for the use of bis(2 -ethylhexyl)  
phthalate  (DEHP)  in plastic components in magnetic resonance imaging (MRI) detector coils  (Annex  IV, entry  
46), should  be adopted  in Great  Britain  under The RoHS  Regulations.  A practically feasible and reliable 
substitute does exist , but  as “coils are very specifically designed, tested and adjusted to the MRI of the OEM ” xi, 
they are not readily available from other suppliers. Therefore, without the exemption s, a supply gap would  
arise until coils compatible with specific scanners are developed and approved. Based on th e potential impact 
on health services and the environmental and financial impact in case hospitals would need to  prematurely  
dispose and replace their MRI system, it can be concluded that  the total  negative  environmental,  health  and 
consumer  safety  impacts  caused  by substitution  are likely  to outweigh  the total  environmental,  health  and 
consumer  safety  benefits.  There  is no conflict  with  UK REACH,  thus  the exemption  will not weaken  
environmental  protection s. 
 
 
 
   
Contents  
Disclaimer  ................................ ................................ ................................ ................................ .........................  2 
Anthesis Consulting Group  ................................ ................................ ................................ ...............................  4 
Executive summary  ................................ ................................ ................................ ................................ ..............  4 
Background and Objectives  ................................ ................................ ................................ ..............................  4 
Key Findings  ................................ ................................ ................................ ................................ .....................  4 
Table of Figures & Tables  ................................ ................................ ................................ ................................ ..... 6 
1. Introduction  ................................ ................................ ................................ ................................ .....................  8 
1.1 Adopted EU Delegating Act  ................................ ................................ ................................ ........................  8 
1.2 Project scope and methodology  ................................ ................................ ................................ .................  8 
2. Background to the Exemption  ................................ ................................ ................................ .........................  8 
2.1 Exemption applied for  ................................ ................................ ................................ ................................  9 
2.2 Additional information consi dered  ................................ ................................ ................................ ...........  11 
2.2.1 REACH Authorisation, Restriction and SCIP Database  ................................ ................................ ................................ ............................  12 
2.2.2 Medical Device Regulations  ................................ ................................ ................................ ................................ ................................ ..... 13 
2.2.3 Technical feasibility and availability of substitutes  ................................ ................................ ................................ ................................ . 14 
2.2.4 Environmental considerations  ................................ ................................ ................................ ................................ ................................ . 17 
2.2.5 Socio -economic impacts  ................................ ................................ ................................ ................................ ................................ ...........  17 
2.3 Conclusion  ................................ ................................ ................................ ................................ ................  19 
3. Assessment to the Criteria laid out in Part 2, regulation 5 ................................ ................................ .............  20 
3.1 Links to UK REACH  ................................ ................................ ................................ ................................ .... 20 
3.1.1 Annex 14 (Authorisation)  ................................ ................................ ................................ ................................ ................................ .........  20 
3.1.2 Annex 17 (Restriction)  ................................ ................................ ................................ ................................ ................................ ..............  21 
3.1.3 SCIP Database  ................................ ................................ ................................ ................................ ................................ ...........................  21 
3.2 Scientific and technical practicab ility of substitution  ................................ ................................ ...............  22 
3.3 Environmental and socioeconomic considerations  ................................ ................................ ..................  22 
3.4 Exemption duration  ................................ ................................ ................................ ................................ .. 24 
4. Recommendation  ................................ ................................ ................................ ................................ ...........  24 
5. Appendix  ................................ ................................ ................................ ................................ ........................  24 
6. References  ................................ ................................ ................................ ................................ .....................  25 
 
Table of Figures  & Tables  
Figure 1:  MRI Coil for the shoulder; the four strain relief boots are circled in red. Source: GE Healthcare Application.  ..... 10 
Figure 2:  The role  of flexible strain relief in ensuring longevity of connections of wires to MRI equipment, taken from GE 
Healthcare Application. vii ................................ ................................ ................................ ................................ ............................  10 
Figure 3:  Diagram from COCIR application showing functional uses of materials containing DEHP -PVC within MRI coils. viii
 ................................ ................................ ................................ ................................ ................................ ................................ ...... 11  
Figure 4 : Summary table of COCIR and GE Healthcare's estimates for substitution timelines. Source: Öko -Institut and 
Fraunhofer IZM. x ................................ ................................ ................................ ................................ ................................ .........  16 
 
Table 1:  Summary of suggested substitution mechanisms proposed in GE Healthcare and COCIR applications. .................  15 
Table 2:  Estimates of the number of MRIs within GB, based on the proportions of GE Healthcare and COCIR MRI scanners 
in the EU.  ................................ ................................ ................................ ................................ ................................ ......................  22 
 
 
 
 
 
 
   
 
8 
 
 
1. Introduction  
1.1 Adopted EU Delegating Act  
On the 11th August 2021 , a new entry to Annex IV was adopted by the European Union and was 
expected to be  published in October the European Official Journal  (however,  at the time  of writing  
this report  has not yet been  published) . Directive 2011/65/EU has been updated as follows:  
 
Entry:  Annex IV, ent ry 46 
Exemption : Exemption for bis(2 -ethylhexyl) phthalate (DEHP) in 
plastic components in magnetic resonance imaging 
(MRI) detector coils  
Duration:  2.5 years  
Member State adoption & publication:  Expected 31/10/2021  
Member State application of provisions:  Expected 21/07/2021  
 
The exemption was granted because  the reliability of substitutes is not sufficiently ensured and 
the total negative environmental, health and consumer safety impacts of substitution are likely to 
outweigh the total environ mental, health and consumer safety benefits.  
 
1.2 Project scope and methodology  
The Anthesis  review has primarily focused on the European Commission’s report svi xi, considering 
the exemption’s  alignment with UK REACH  and the requirements laid out in  The RoHS Regulations.  
The application s and additional information submitted by  GE Healthcarevii and COCIRviii (European 
Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry) have also 
been  consulted  (available from the  Öko-Institut website). The Anthesis review is supplemented 
with further research to confirm the applicabil ity of the exemption request to Great Britain . It 
should be noted that  Anthesis only h as access to information in the public domain,  it has not been  
able  to assess any  confidential  information  submitted during the European proceedings . 
This report first su mmarises the exemption request s and the decision reached by the 
European  Commission, Council and Parliament (Section 2). Section 3 reviews the exemption 
request within the context of Great Britain,  considering :  
• The risk characterisat ion of the requested use,  
• The feasibility of alternatives , paying specific attention to availability in the GB market , 
and; 
• Consideration of the socio -economic implications , from a GB perspective.  
The Anthesis recommendation is given in Section 4.  
 
2. Background to the Exemption  
GE Healthcare submitted  an application  for an exem ption for  the use of ‘Bis-(ethylhexyl)  phthalate 
(DEHP) in plastic strain relief devices used to prevent damage to cable connections to MRI imaging   
 
9 
 
 
coils ’, on the 12th of September 2018. A second application, with a broader scope, was then  
submitted  by COCIR  on the 2nd of October 2019 , for the use of ’Bis(2-ethylhexyl) phthalate (DEHP) 
in plastic components  in magnetic resonance imaging (MRI) detector coils ’. 
Due to the similarit ies between the two requests, the Commission decided (upon discussion with 
GE Health care ) to suspend the evaluation and finalise the assessment together with the COCIR 
application.  
The GE Healthcare exemption request was discussed in the Member States’  Expert Group meeting 
of 21st October 2019ix, during which one expert highlighted a concern related to the  exposure of 
vulnerable patients to DEHP within devices,  however, it was also highlighted that the amounts of 
DEHP used are much lower in comparison to the amounts of DEHP used in other non -electrical 
applications.  Both exemption requests were raised in the Member States’ Expert Group meeting 
of 23rd February 2021  x, however, no questions or comments were raised.  
After t he Öko-Institut  and Fraunhofer IZM conducted their reviewxi of both applications and 
notifying  the European Council and Parliament, the Comm ission adopted it as  entry  46 in Annex 
IV of the RoHS 2 Directive  and referred it to the WTO Committee on Technical Barriers to Trade 
(TBT) on 29th June 2021. The publication of the exemption request, in the Official Journal, is 
expected imminently due to the 22nd of July 2021 deadline in (EU) 2015/863 (the exemption will 
apply retroactively from this date) and the much -reduced commenting window by the WTO TBT of 
15 days.  xii  
 
2.1 Exemption applied for  
As explained above, two exemption re quest s have been submitted for DEHP with similar scope.  
GE Healthcare  requested an exemption for the use of Bis-(ethylhexyl) phthalate (DEHP) in plastic 
strain relief devices used to prevent damage to cable connections to magnetic resonance imaging 
(MRI) coils. This application was submitted on the 12th September 2018 and  requested exemption 
until January 2024.  
A second  applicant (COCIR) applied for a n exemption for the use DEHP in plastic components in 
MRI detector coils  on 2nd October 2019 . COCIR originally requested that this exemption would be 
valid until January 2025 , however during the evaluation, reduced it to two years  stating that there 
are “new information and developments of research. Companies are now more confident all the 
test and valid ation could be completed in 2 years (July 2023) ”xi. Whilst DEHP is  used in both 
application s as a plasticiser in polyvinyl chloride ( PVC), the COCIR application extends the scope of 
the exemption to different parts of the MRI coils . 
“Magnetic Resonance Imaging (MRI) is a medical imaging technique used to examine the human 
soft tissue. In MRI, the patient is exposed to a strong magnetic field and radio waves. The human 
tissue then emits weak radio frequency signals that are received by  antennas – the coils – located 
in close proximity to the part of the human body that is examined. The received signal is used to 
generate detailed three -dimensional  images of the human body, including e.g. muscles, blood 
vessels and internal organs. There  are a number of different coils depending on the specific part of 
the body that is scanned e.g ., shoulder, head, hand, knee, foot, breast etc.  
One of the essential characteristics of the coils and the electronic circuitry that is connected to 
each coil is that the materials used must be non -magnetic because any magnetic materials 
degrade the weak RF signals emitted by the human tissue resulting in distorted MRI images .” xi  
   
 
10 
 
 
According to GE Healthcare , the technical function  of DEHP  in the MRI devices  is to enable 
flexibility of PVC in the  strain relief mechanism for the point of connections between MRI 
equipment and cables.  
 
Figure 1: MRI Coil for the shoulder; the four strain relief boots are circled in red. Source: GE Healthcare Application.  
Over the coil’s lifetime, there are about  30,000 repetitive bend cycles . Without the flexible strain 
relief mechanism , the lifetime of the MRI coil would be reduced as repeated flexing movement 
would lead to damage at the point of connection. Therefore, ‘strain relief boots’ are used at the 
point of connection , as shown in Figure 1  and 2 . These boots are made of DEHP -PVC; DEHP 
enables the flexibility of PVC  to ensure strain relief in connections, without disrupting the function 
of the MRI equipment  or alter the image quality .  
 
 
Figure 2: The role of flexible strain relief in ensuring longevity of connections of wires to MRI equipment, taken from GE 
Healthcare Application. vii 
The COCIR application has a broader use, as DEHP is used in other parts of the MRI coils  shown in 
Figure 3. These parts include cable covers, bushings , fixing belt  and mattress covers. The purpose 
  
 
11 
 
 
of DEHP within PVC in each of these components is to act as a plasticiser  (same as in c ase of the 
GE Healthcare application)  that enable s the flexibility required  for components within  MRI coils. 
 
 
Figure 3: Diagram from COCIR application showing functional uses of materials containing DEHP -PVC within MRI coils. viii 
 
 
2.2 Additional information conside red 
Legal considerations  
Annex II of the RoHS 2 Directive specifies that “The restriction of DEHP, BBP, DBP and DIBP shall 
not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or 
upgrading of capacity of […] medical  devices, including in vitro medical devices, and monitoring […] 
placed on the market before 22 July 2021” . 
According to Art. 3(27), “‘spare part’ means a separate part of an EEE that can replace a part of an 
EEE. The EEE cannot function as intended withou t that part of the EEE.  The functionality of EEE is 
restored or is upgraded when the part is replaced by a spare part”.  COCIR explained in their 
answers to the Öko-Institut ’s questions that whilst  faulty coils may be replaced , hospitals  can 
always expand their capabilities by buying new types of coils for specific body parts. In this case 
these new and additional coils are not considered spare parts. COCIR further explained  that the 
specific type of coil is plugged into the MRI scanner wh en it is being used and then disconnected  
and stored elsewhere, far from the MRI as they could interfere with image quality. Endorectal 
coils and full body coils  vary in shape and function . While the spare part clause would allow 
replacement of dysfunction al coils, the exchange of coils with different ones, or the addition of 
new types of coi l cannot be considered a “replacement”.  
 
  
 
12 
 
 
2.2.1 REACH Authorisation, Restriction and SCIP Database  
In accordance with the criteria  laid out  in Article 5  (1)(a)  of RoHS 2, the ability to grant an 
exemption  by adapting Annexes III and IV should not  “weaken  the environmental and health 
protection afforded by Regulation (EC) No 1907/2006 ” (REACH).  Therefore, the following section 
will consider  any potential conflicts with (EU) REACH.  
At the time of the adoption and  publication of Directive (EU) 2015/863, REACH  Annex XIV included 
DEHP , due to its reproductive toxic ant effects.  There is an exemption for DEHP: Uses  in the 
immediate packaging of me dicinal products covered under Regulation (EC) No 726/2004, Directive 
2001/82/EC, and/or Directive 2001/83/EC .  
Commission Regulation (EU) 2020/171 amended the  Annex XIV  entry and allows that even after 
the sunset date, the use of DEHP  is allowed until 1st March 2023 in the following two cases:  
• In the production of spare parts for the repair of articles where  production ceased before 
the sunset date, if: 
o the substance was used in the production of those articles and  
o these cannot funct ion as intended without those spare parts and  
o spare part cannot be produced without that substance  
• Use (on its own or in a mixture) for the repair of such articles or complex products, 
where:  
o that substance was used in the production of those articles or c omplex products 
and  
o they cannot be repaired otherwise than by using that substance.  
The applicant s explained th at hospitals purchase specific coils beyond repair and refurbishment, 
therefore, th ey still need the exemption.     
Applications for Authorisation were received for DEHP for uses in EEE. None of the  Authorisation 
applications submitted consider  the use of DEHP  in medical devices , due to the exemption 
afforded by  Article 60 (of REACH). Article 60(2) , which  specifically  exempts the need for 
Authorisation of use  within medical devices , when the intrinsic properties of the substance 
identified has hazards  that only affect human health.   
Furthermore , Article  62(6)  states that applications do not need to  include risks to human  health 
arising from medical devices.  This is because the Medical Devices Regulation (EU) 2017/745, 
repealing Directives 90/385/EEC and 93/42/EEC and effective from 26th May 2020 and the in vitro 
Medical Devices Regulation (EU) 2017/746 repealing Directive  98/79/EC with effect from 26 May 
2022,  specifically identifies phthalates and assesses the risk of those uses .  
In late 2014, DEHP was identified as a  substance of very high concern ( SVHC ) for its equivalent 
level of concern , based on  its potential for en docrine disruption properties for the environment . 
The Annex XIV entries for DEHP  have yet to be amended , but the    draft regulation  was adopted 
on the 23rd November 2021 and will  enter into force on the 20th day after its publication in the 
Official Journal.  Once derogation for the use of DEHP in medical devices expires on 27th May 2025 , 
further applications for Authorisation for DEHP might be expected, as Articles 60(2) and 62(6) will 
not provide full exemption for DEHP to be used in medical  devices. In our opinion, even at that 
point, there will be no conflict between the exemption and EU REACH, as the substances are 
already incorporated into the articles  when they enter the EU. Whilst the scope of Authorisation is 
to use substances on their  own or in mixtures or incorporating them into articles within the EU. 
Indeed, i f medical device  items are imported as finished articles into  the EU, then they would be 
exempt from needing an Authorisation .   
 
13 
 
 
Articles are typically regulated via restrictions  (Annex XVII) and while  DEHP is included in entry 51 
of Annex XVII , it neither applies to EEE within the scope of RoHS  2 nor medical devices regulated 
by 90/385/EEC, 93/42/EEC , and 98/79/ECxii. Entry 51 was updated to its present form in December 
2018 via the Commission Regulation (EU) 2018/2005.  Based on its toxic to repr oduction category 
1B classification, entry 30 applies to DEHP , however, entry 30 restricts supply to the public.  
The revised Waste Framework Directive mandated the European Chemicals Agency (ECHA) in 
2018 to establish a database of articles that contain S VHCs in greater than 0.1% concentration. 
This database, called SCIP ( Substances of Concern In articles as such or in complex objects 
(Products), aims to provide transparency primarily for waste operators, to ensure safe recycling. 
The information is also a ccessible to consumers. The notification obligation for article suppliers 
entered into force on 5th January 2021, so it was not effective  when the Öko-Institut prepared 
their assessment.  
Any European medical device producer or importer must submit a SCIP -notif ication for  the articles 
they place on the market, if they contain more than 0.1% of an SVHC.  Therefore, while the 
exemption (in our opinion) does not weaken the environmental and health protection in the EU , 
as the SCIP notification requirement is no t a restriction; it may cause  an additional administrative 
burden  for manufacturers .  
 
2.2.2 Medical Device Regulations  
The European regulatory framework ensures the safety and efficacy of medical devices and 
facilitates patients’ access to devices in the European market. Medical devices within the EU are 
currently regulated by 1 Regulation and 3 Directives:  
• Regulation (EU) 2017/745 on medical devices (MDR);  
• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990);  
• Council Direc tive 93/42/EEC on Medical Devices (MDD) (1993); and  
• Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic 
Medical Devices (IVDMD).  
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5th April 2017 on in 
vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 
2010/227/EU will apply from 26th May 2022. The two new Regulations will  progressively replace 
the existing directives after a transition period.  
Regulation (EU) 2017/746 requires that medical devices shall be designed and manufactured in 
such a way as to reduce as far as possible the risks posed by substances that may be rel eased from 
the device. Devices from which such a release might cause a prolonged exposure may only contain 
substances that are CMR category 1A or 1B, endocrine disruptors or other SVHCs identified under 
REACH, where justified.  
Furthermore, the Commission mandated a scientific committee to prepare a guideline specifically 
on phthalates, including a benefit -risk assessment of the presence of phthalates (including DEHP), 
considering the intended use of the device and available alternatives. This guideline may  be 
consulted for the above -mentioned justificationsxiii. 
   
 
14 
 
 
2.2.3 Technical feasibility and availability of substitutes  
There are several requirements that all components  in MRI equipment  must have  due to the strict 
requirements associated with medical imagin g and diagnosis . GE Healthcare states that the 
following characteristics are required  vii: 
• “The p olymer plus all additives including the plasticiser  must be acceptable for use in 
medical devices. New materials must comply with biocompatibility requirements according 
to ISO 10993 “Biological evaluation of medical devices”, before they can be used.  
• Lifetime of at least 8 years of frequent use and without failures. This is on average 
equivalent to 30,000 repetitive bend cycles  
• Must not affect MRI image quality, so must be non -magnetic and have a proton signal 
emission material / air ratio as low as possible, ideally <1.2, but must be <4.0  when withi n 
the imaging zone (i.e. , strain reliefs that are attached to coils) . 
• Coil assemblies must not be damaged when a patient has to be rapidly removed from a n 
MRI scanner in an emergency, for example, if they suffer a heart attack. This is important if 
coil as semblies have to be redesigned.”  
 
Across the range of components, COCIR (2019b) specifies the following requirements  for the 
plastic components containing DEHP as a plasticiser:  
• Easy fabrication by solvent and heat welding; formation of complex parts with  defined 
quality , 
• Mechanical properties: Besides durability, mechanical properties differ between the 
different components, e.g. , good flexibility is important for cable covers, tensile properties 
are important for bushings, robust barrier to prevent burns  is mentioned for cable covers 
and mattresses, electrical insulation is specified for cable covers and bushings.  
• DEHP plasticized polymer is durable to sweat and sanitizing agents ,  
• Material needs to fulfil biocompatibility requirements for human skin con tact according to 
ISO standard 10993 on “Biological evaluation of medical devices” , and  
• Material must not have adverse effect on the image quality which implies the following 
requirements:  
o Low proton signal to avoid interfering with the MRI image,  
o Low dis tortion of magnetic fields to avoid interfering with the magnets that align 
the protons in the body, and − The material shall not build up electrostatic energy 
that could be released during imaging which would hamper the MRI causing 
distortion of the image . 
Also as stated in the COCIR application, the Medical Devices Regulation would not permit 
producing coils that are knowingly less reliable, and EU approval withdrawal could occur if 
substitutions that are less reliable are put in place.  
 
In the ir application document  vii, GE Healthcare refers to several potential alternatives , and state s 
that many of the strain relief boots sold in the EU are made using PVC containing DEHP. They also 
state that alternative materials used in such boots for other electrical equipment are not always   
 
15 
 
 
appropriate for medical devices due to additional requireme nts for approval for materials used in  
human skin contact in a medical setting.  According to GE Healthcare , there are three potential 
options to avoid DEHP use in MRI coils , COCIR identified only the first two as pote ntial options : an 
alternative polymer, alternative plasticiser or the redesign of the coil that avoid ed the need for 
strain relief . 
 
Table 1: Summary of suggested substitution mechanisms proposed in GE Healthcare and COCIR applications.  
 GE Healthcare  COCIR  
Alternative polymers  Nylon has been suggested by GE 
Healthcare as an alternative to DEHP -
plasticised PVC within the strain 
boots, however the applicant states 
that testing found nylon to be less 
flexible, and therefore reduced the 
lifetime of the part in comparison to  
DEHP -plasticised PVC.  
 COCIR also provides analysis of three 
potential alternative  polymer s 
(ethylene -propylene diene monomer 
rubber (EPDM), urethane rubber and 
silicone rubber), however, they state 
that these polymers led to reduced 
image quality, stati ng “Testing was 
undertaken to measure the proton 
signal of alternative polymer using field 
echo sequence with shot echo time with 
Table 4 detailing the "relative image 
intensity ratio" from the polymer versus 
air. The larger the ratio the more 
distortion to the MRI image with any 
increase in ratio of the alternative 
negatively impacting image quality and 
performance of the MRI.”  Table 4 
referred to by COCIR  lists the 
alternative polymers as Ethylene -
Propylene  diene monomer rubber  
(EDPM) , Food gr ade EDPM, Urethane 
rubber and silicone rubber , and 
assesses their advantages and 
disadvantages . 
PVC using alternative 
plasticisers  GE Healthcare states that 
Diethylhexyl  terephthalate -PVC is 
being considered as a potential 
alternative, however initial tests 
appear to suggest it does not 
perform as well as DEHP -PVC and 
inferior image quality could occur. 
Alternatives have not yet been 
approved and further testing of 
altern atives is required.  The COCIR application refers to the 
same testing as GE Healthcare’s 
application included.  
 
Avoid the need for 
strain relief boots by 
redesign  GE Healthcare refers to potential 
alternative designs of the coil that are 
under  consideratio n. One of these is  
a digital coil design created by 
Phillips. However, at the time of the 
application, these innovations were COCIR did not  provide detail on new  
design options  in their application .   
 
16 
 
 
not commercially available , 
therefore, information on these 
developments remain confidential. xiv 
GE Healthcare  estimated: “the 
market is 5 -8 years away from 
implementation providing they make 
a commitment to pursue.” xiv 
They also stated that  every coil 
assem bly would need to be 
redesigned and to go through the 
process of regulatory approval.  GE 
Healthcare also state in their 
application that there are over 70 
different coil designs (specific to 
different purposes and body parts) vii. 
 
Both  applicants  provided a summary of the potential timelines that would be required for the 
testing stages of any alternative, which is summarised  in Figure 4. These estimates vary slightly , 
due to the different applications and complexity of multiple components in the COCIR application , 
however both consider the substitution for only one coil . Replacing multiple coils would require 
more time.  
  
 
Figure 4: Summary table of COCIR and GE Healthcare's estimates for substitution timelines. Source: Öko-Institut  and 
Fraunhofer IZM. xi 
COCIR also recognised in its application that if there are difficulties in testing, their estimated 
timeline of ~3 years could be extended as new materials would need to be identified, hence the 
extended exemption request until 2025.  However, during the evaluation, they reduced  it to two 
years stating that there are “new information and developments of research. Companies are now 
more confident all the test and validation could be completed in 2 years (July 2023)”xi. GE 
Healthcare estimat ed that the process w ould  take around 4 years  following the identification of a 
suitable substitution material.  
The re port  by Öko-Institut  summarises that neither GE Healthcare nor COCIR considered  the 
alternative polymers or the alternative plasticiser they tested as feasible substitutes. However, 
they also concluded , that the fact that neither of the applicants requested the maximum of 7 
years duration for the exemption , suggest ing that both applicants have a concrete view on how to 
substitute DEHP in the plastic  parts of the MRI coils .   
  
 
17 
 
 
 
Stakeholder Contributions  
Several MRI manufacturers contributed  to the stakeholder consultation s, incl uding Philips who 
stated that they are currently working with suppliers to phase out DEHP containing strain reliefs, 
however they were not certain at the time whether this would be possible before the restriction 
of phthalates in medical devices enters int o force xi.  
Canon Medical Systems Corporation (CMSC)  also provided input, stating that they also used 
equipment containing DEHP within the strain relief devices and were working on identifying 
possible alternatives. CMSC also referred to the potential development of digital wireless coils as 
an alternative , that would eliminate the need for a cable with strain relief . However,  stated that 
they believe such equipment would take a long  time to develop.   
COCIR stated  in the stakeholder consultation of the original GE Healthcare exemption request that 
a member w as able to manufacture MRI coils that did not contain DEHP, due to a n entirely 
different design  that elim inated  the need for DEHP as a plasticiser  in PVC. This means that the 
substitution is technically practica ble and reliable . However, they also state th at this manufacturer 
supported the exemption request as they recognise the challenges associated with finding 
alternatives . This member is likely Siemens as they  provided  a contribution to sta keholder 
consultation directly,  stating that they did not use DEHP  as plasticiser  within their MRI coils and so 
are not directly impacted by the restriction . However, they acknowledge the difficulty in designing 
new coils  that does not contain DEHP  and points out th at these would not be  compatib le with the 
existing e quipment.  
 
2.2.4 Environmental considerations  
The total amount of DEHP entering the EU market (via the two exemptions),  is 158 kg annually. 
Both applicants provided confidential data to support their estimate , that were considered 
plausible by the Öko -Institut.  
Neither applicant submitted any environmental considerations  with their application s, though GE 
Healthcare provided estimat es of the impact of premature waste generation when asked by the 
Öko-Institut via the clarification process . However, it has been established by the Öko -Institut, 
that even a forced substitution scenario would not lead to the premature replacement of coils  
(unless a hospital decides to immediately  replace their MRI system, the coils could be used until 
end-of-life). It is no t clear if any of the MRI scanners would need to be disposed or relocated to 
outside of the EU in a forced substitution scenario.  
GE Healthcare states that the devices cannot be recycled and are instead either sent for energy  
recovery or landfil l. During the incineration of PVC strain reliefs, copper, lead, gold, and other 
metals can be safe ly recovered from wires. COCIR indicated that MRI coils can be also returned to 
the manufacturer for refurbishment and reuse.  
 
 
2.2.5 Socio -economic impacts  
Human Healt h Impacts  
Both applicants state that there will be a negative impact on healthcare in the EU if this exemption 
is not granted , as there aren’t any approved substitutes, therefore hospitals will not be able to   
 
18 
 
 
purchase specific  new  MRI coils . GE explained that typically, coils are produced by the same 
suppliers as the MRI scanners, however, “if products are not available and a market exists, 
suppliers will address the demand”  xi. However, this would need a certain transition period e.g. , for 
approval. Both applicants claim that if the exemption is not granted, “ many types of coils for 
specific body parts will no longer be available to EU hospi tals.” xi If hospitals  cannot  buy specific 
type of coils,  this will reduce  the ability for hospitals to diagnose specific conditions, as COCIR 
explains: “If hospitals are unable to buy the current wide range of MRI coils for their MRI scanners 
that they already own, the waiting times for receiving an examination are bound to inc rease and 
many patient’s conditions would be more difficult to diagnose and treat as other less suitable 
methods would have to be used, if this is even at all possible. For example, a whole -body coil can 
be used to examine all parts of a patient’s body, bu t the detail obtained for a small area such as a 
foot is significantly less than that which can be obtained by a dedicated foot coil. In addition, the 
time required to obtain a scan of a whole patient is much longer than a foot scan and this can 
cause dela ys in treating other patients, as MRI demand often exceeds their availability.”  viii 
Both GE Healthcare and COCIR s ubmitted estimates for the number of patients that would be 
impacted if the exemption request is not granted .  
• GR Healthcare calculated 9 million patients, based on 1,900 GE MRI scanners in Europe 
and typical treatment of 4,500 patients per year (estimate taken from 2004 data ) 
• COCIR estimated over 2 million patients  potentially impacted  based on  270 MRI scan ners, 
each used to diagnose 7,300 patients per year  (more recent UK data ).   
This amounts to a total  of 11 million patients  that would not be diagnosed with the most 
appropriate equipment , annually . Patients might be  redirected to other hospitals, which would 
lessen th e impact, but as COCIR stated there is already a long waiting list for MRI scans.  
The COCIR application notes  that there have been no  reports of adverse effects to patients due to  
exposure to DEHP -PVC viii. A report by The Scientific Committee on Medicinal Products and 
Medical Devices  conclude d that no adverse impacts were found  due to medical devices containing 
DEHP as a plasticiser, even in ne onates or groups exposed to high levels of DEHPxv.  
 
Economic Impacts  
It is not clear how probable it is t hat a hospital would need to replace their MRI scan ner with a 
competitor’s equipment, or how much of the existing equipment base would be affected . 
However, in such a case, the financial impact would be severe  potentially leading to reallocation 
of funds, thus affecting other  facilities at hospitals . Beyond the cost of the MRI scan ner (COCIR 
states €1.5-3 million  (£1,252,707 -2,505,4141, GE Healthcare indic ated $1.2 -3 million  (£886,986 -
2,217,4652)), there would be training  needs , installation and potentially even adjustment of  the 
building  to the new system . GE Healthcare estimate $40,000 for training, assuming 10 MRI 
technicians  and 40 hour s’ worth of work lost for at $100/hour.  
The economic impact on the m anufacturers would be also significant, GE Healthcare indicated 
market share loss (especially considering the long li fetime of MRI scan ners of around  30 year s) 
 
 
1 https://www.google.com/intl/en/googlefinance/disclaimer/  (06/01/2022)  
2 https://www.google.com/intl/en/googlefinance/disclaimer/  (06/01/2022)    
 
19 
 
 
and reputation risk being t he key impacts  if they would not be able to supply the coils to the  MRI 
scans already in place.    
The GE Healthcare application states that potential substitution costs would make production  
costs economically unviable  and state that: “It would be unreasonable to significantly increase 
prices of coils to fund substitution research as EU hospitals all have limited funds and would not be 
able to buy coils that are considerably more expensive.”    
 
Employment  
GE Healthcare states that employment ( manufa cturing and supply chain  included ) will be 
impacted , however, does not provide further detail s on the extent . However, if a competitor can 
provide compliant coils, that might offset some of the negative effects on employment .  
 
2.3 Conclusion  
Based on the contribution from Siemens, stating that they eliminated the need for DEHP in MRI 
coils via an entirely different design  with no need for cable strain relief , it can be stated that a 
practically feasible and reliable substitute does exist. However , as “ coils are very specifically 
designed, tested and adjusted to the MRI of the OEM ” xi, they are not readily available from other 
suppliers . Therefore, without the exemptions, a supply gap would arise until coils  compatible with 
the specific scan ners are developed and approved. Furthermore, in some cases there are 
additional barriers to us ing other supplier’s coil s, e.g. , if the hospital’s  internal regulations or the 
guarantee does not allow it.  
Impacts  on health services would also occur, i.e. potentially 11 million patients wo uld not be 
diagnosed with the most appropriate equipment annually , if alternatives are not developed, 
tested , and approved, either by the applicants, or their competitors . Hospitals would face 
significant financial burden s if they need to replace their MRI  system s, in additional to the 
environmental impact should current  MRI system s would be disposed ahead of end -of-life; and 
manufacturers would  face reputation al risks and losses to  their market share . Considering the 
long  lifetime of MRI scan ners, this impact would be long -term. The Öko-Institu t estimated that the 
two exemption request s would affect approximately 24% of the MRI scan ners in the EU.  These 
socioeconomic impacts ( particularly the  possible health impacts) were considered significant 
enough to grant the exemption.  
MRI producers are still in the process of identify ing and test ing possible alternatives , therefore, 
these two applications are essentially bridging the gap  until the alternative is identified, tested , 
and approved . The fact that neither applicant requested the maximum duration for their 
exemption suggests that they have a clear view on how to substitute DEHP in the plastics 
components of the MRI .  
Whilst GE Healthcare requested a longer exemption period, it was decided to  extend this duration 
to both applications , as some stakeholders use the terms bushing and strain relief  
interchangeably, thus COCIR might inadvertently benefit  from the longer exemption period  of GE 
Healthcare . From the envir onmental impact perspective, there is little difference, as bushings are 
rather rigid, therefore, the concentration of DEHP tends to be lower. For practicality reasons the 
exemption was granted until 01 January 2024  with a scope covering both applicat ions, following 
the conclusion that the reliability of substitutes is not sufficiently ensured and the total negative 
environmental, health and consumer safety impacts of substitution are likely to outweigh the total 
environmental, health and consumer safe ty benefits.      
 
20 
 
 
 
3. Assessment to the Criteria laid out in Part 2, regulation 5  
Regulation 5 of The RoHS Regulations  permits an exemption to be granted if the following  are 
satisfied:   
• The exemption does not weaken the  environmental or health protection afforded by UK 
REACH; and   
• The elimination or substitution of the material or component, via design changes or use of 
materials or components which do not include any restricted substances, is scientifically 
or technically  impracticable.   
• The re liability of substitute materials or components is not ensured; or   
• The total negative environmental, health and consumer safety impacts caused by 
substitution of another material or component is likely to outweigh the total 
environmental, health and consu mer safety benefits of  that substitution.   
 
The following assessment reviews each of these elements.   
 
3.1 Links to UK REACH  
On 1st January 2021 , UK REACH  v entered into force and substances manufactured or imported >1 
tonne per annum (tpa) in Great Britain require registration, before being placed on the market.  
To minimise disruption to businesses and supply chains at the end of the transition period , 
existing GB downstream users who were, at any time in the 2 -year period before 1 st January 
2021, already a downstream user under EU REACH could submit a Downstream User Import 
Notification (DUIN). The deadline for the notification was 27th October 2021. This effectively 
defers their registration responsibilities for up to six years depe nding on the tonnage band and 
hazard profile of the substance. Consequently there is currently no publicly available database of 
all substances likely to be registered in Great Britain. The Government recently set out its 
intention to consult on extending the transitional deadlines for full registrationxvi. A list of 
substances for which information has been submitted to the Health and Safety Executive (HSE) 
under Article 127B(4)(a) of the UK REACH Regulation (initial transitional data) was published in 
Sept ember 2021xvii This is not a verified list of registrations that were transferred into UK REACH 
from EU REACH under Article 127A (1) (transferred registrations), only a list of substances for 
which information has been submitted to the HSE under Article 127B (4)(a) of the UK REACH 
Regulation (initial transitional data).  
DEHP is not listed, which  means we do not have information that any companies would 
manufacture or import DEHP in greater than 1 tonne per annum, however, as explained above, 
currently no info rmation  is available to confirm this.   
The Statutory Instruments for UK REACH also laid out transitional measures for the Authorisation 
and Restriction processes within UK REACH and these are discussed in the following section.  
 
3.1.1 Annex 14 (Authorisat ion) 
Substances included in Annex XIV of REACH were transposed to UK REACH, with effect from 1st 
January 2021.  Currently, the substances included in UK REACH Annex 14 are the same as those in 
the EU equivalent Annex XIV and therefore, this include s DEHP  due to its intrinsic hazard as toxic 
to reproduction.     
 
21 
 
 
The transitional arrangements provided for by UK REACH require d GB-based holders of EU 
Authorisations, or GB downstream users relying on another ’s Authorisation, to confirm the 
Authorisation, to the HSE by 1st March 2021. Where an Authorisation decision was still pending  
from the EU, then other transitional measures exist. The HSE has initiated its first public 
consultation for an Authorisation application concerning DEHP. It concerns the extensio n of the 
Authorisation originally granted to Rolls Royce in 2014xviii, but this is out of the scope of this report 
as it is not used in medical devices.  
As noted above,  applications for Authorisations  would not be anticipated for medical devices  all 
the while Annex 14 only includes DEHP  for its reproductive toxicity and not as suspected 
endocrine disruptors for the environment.    
The Candidate List  (the list of substances of very high concern (SVHCs)  is the precursor  for 
including substances on An nex 14.  The Candidate List was transposed on 1st January 2021 to UK 
REACH and  includes  those substances added to the List up  to and including June 2020xix: 
thus,  DEHP is included for its endocrine disrupting properties for human health and DEHP is also 
included as endocrine disruptor for the environment . If the   Annex 14 entries  are amended in UK 
REACH in a similar way to EU REACH , then medical devices containing DEHP will be in scope 
of Authorisation . As stated earlier, in our opinion even at that point there will be no conflict 
between the exemption and UK REACH, as the substances are already incorporated into the 
articles when imported, whilst the scope of Authorisation is to use substances on their o wn or in 
mixtures or incorporating them into articles within GB.   
The UK REACH work programme for 2021/2022 states that the UK will present its first 
recommendation of priority substances to be included in Annex 14, but this does not include 
DEHP , as they focused on ECHA’s 10th and 9th recommendations, whilst amending th e Annex XIV 
entry for DEHP  was included in the 8th recommendationxx. Therefore, at the time of writing the 
report, it is not known when the UK will move forward with updating Annex 14.   
 
3.1.2 Annex 17 (Restriction)   
REACH  Annex XVII , as of 31st December 2020 , was transposed to UK REACH  and included all EU 
restrictions that  had entered into force  including  any in their transit ional periodxxi. Thus , DEHP  is 
included as entry 51 with the same conditions as the EU.  The legislation allows for  further 
restrictions to be imposed  if relevant chemicals  pose an unacceptable risk to human health or the 
environment. The UK Government  announced its first plans for restrictions under  UK REACH on 
23rd March 2021xxii, and has since created a  Registry of restriction  intentionsxxiii. To date only 2 new 
restrictions are proposed, above and beyond those already transposed,  and these do 
not concern  either  uses in scope of  The RoHS regulations or DEHP.    
 
3.1.3 SCIP Database  
In November 2020 , Defra  confirmed that it will not transpose the SCIP provisionsxxiv, but was 
considering how to identify and track chemicals of concern in articles to reduce barriers to reuse 
and recycling. At that time, Defra indicated that the UK’s approach will probably be com municated 
in its chemicals strategy, that was planned  to be published in 2022. The notifications of SVHCs in 
articles according to article 7(2) exists but only applies above 1 tonnexxv. The Agency for UK REACH 
Work Programme 2021/2022 does not mention SCIPxxvi.  
This means  that whilst the SCIP notification might create some addi tional administrative burden 
for manufacturers placing on the market MRI scan ners and coils in the EU, i n the UK, no such   
 
22 
 
 
requirements are foreseen  (for the time being) . It will therefo re be easier to import articles 
containing DEHP on the UK market  than to the EU .  
 
3.2 Scientific and technical practicability of substitution  
Based on the contribution from Siemens, stating that they eliminated the need for DEHP in MRI 
coils via an entire ly different design that does not need  cable strain relief , a practically feasible and 
reliable substitute does exist. However, as “ coils are very specifically designed, tested and adjusted 
to the MRI of the OEM ” xi, alternatives are not readily available from other suppliers. Therefore, 
without the exemptions, a supply gap would arise until coils compatible w ith the specific scanners 
are developed and approved. Furthermore, in some cases there are additional barriers to using 
other supplier’s coils, e.g., if the hospital’s internal regulations or the guarantee does not allow it.  
Several entities of GE registe red medical devices with the MHRA including GE Healthcare Coils , a 
Division of USA Instruments Inc. Siemens Healthcare Diagnostics Inc, Philips Medical Systems  and 
Canon Medical Systems Corporation  also submitted registrations . The database does not specif y 
the type of equipment supplied  to the UK in all cases; however, it can be assumed that  some of  
these companies would be affected by the two exemption requests  (as they either applied or 
contributed with comments during the European evaluation process) . Whilst Siemens stated their 
coil design does not require DEHP , this  doesn’t mean  that their product  can be used by hospitals 
who own  MRI scan ners  produced by different manufactur ers.  
  
3.3 Environmental and socioeconomic considerations  
As the UK was a member of the EU during the period of research conducted by the Öko-Institut , 
the data described  in the report would have included GB. Therefore,  the environmental and 
socioeconomic considerations are likely to reflect the GB situation  as w ell. However, b ased on 
published  statistics relating to the number of MRI scan ners per million inhabitants,  it is possible to 
estimate the number of MRI scan ners in GB and the number of MRI scan ners impacted by the two 
exemption requests.   
Table 2 shows an estimate of the number of MRI scanners placed on the market by GE Healthcare 
and the companies represented by COCIR in GB, based on the methodology used in the Öko-
Institut ’s report. GE Healthcare placed 1 ,900 MRI scan ners on the EU market , COCIR members 
represented  270 of these , equating to  24% of all the MRIs in the EU. If we assume that they have  
similar market share, that means about 100 MRI scanners would be impacted by the two 
exemptions in GB .  
 
Table 2: Estimates of the number of MRIs within GB, based on the proportions of GE Healthcare and COCIR MRI scanners 
in the EU.  
 EU27 Estimates (Methodology 
from Co mmission ’s Report) xi Great Britain Estimates (based 
on Co mmission ’s 
methodology)  
MRI Devices per million 
inhabitants (2016)xxvii 17.4  7.2 
Number of Inhabitants  512 million  60 million xxviii   
 
23 
 
 
Estimated number of MRI 
Scanners  8,900  432 
GE Healthcare MRIs in EU  1,800 (20.2%)  87.2 ( assuming 20.2%)  * 
COCIR MRIs in EU  270 (3.0%)  13 (assuming 3.0%)  * 
*Estimated  based on the proportions of population . 
 
Environmental Impacts  
The total amount of DEHP entering the EU market , via the two exemption requests is  estimated to 
be 158kg annually. Based on the above, it can be estimate d that about 7.63kg of DEHP would 
enter the UK if the two exemption s are extended  to GB.  
It has been established by the Öko -Institut, that even a forced substitution scenario would not 
lead to the premature replacement of coils. MRI coils can be  also returned to the manufacturer 
for refurbishment, but this is something that is  possible anyway a s there is a  derogation for spare 
parts, irrespective of whether the exemption requests are granted.  
As explained above, it is not clear how many MRI scan ners would need to be disposed prior end -
of-life, in a forced substitution scenario.    
 
Human Health Impacts  
Based on the estimates described above in Table 2, we can calculate the potential impacts on 
health services  within the UK . Assuming 100 MRI scanners  are impacted by the exemption already 
on the  UK market and using the statistics provided by COCIR, i.e. , that one MRI scanner  typically 
can be used to diagnose around 7,300 patients per year , approximately 730,000  patients might be 
affected per year  by being  treated without  the most suitable diagnostic equipment . 
 
Economic Impacts  
It is estimated that there are around 400 MRI scan ners in the UK , 100 of these could be impacted  
by the two exemptions (assuming similar market share) , however, it is not possible to judge  how 
many of these would need to be replaced  prematurely  due to the exemption not being granted.  
The economic impact on the manufacturers would be also significant  (e.g.  market share loss and 
reputation al risk, if they would not be able to supply the MRI coils to the meeting their existing 
clients’ needs).   Several entit ies of GE registered medical devices with the MHRA, including GE 
Healthcare Coils a Division of USA Instruments Inc.  Other companies that submitted comments to 
the stakeholder consultation , also registered medical equipment with the MHRA  in the UK : 
Siemens  Healthcare Diagnostics Inc , Philips Medical Systems , Canon Medical Systems Corporation . 
The database does not specify the type of equipment in all cases;  however, it can be assumed that  
some of  these companies  would be affected by the two exemption requests.  
To further assess the impact on hospitals in GB and their planned actions to overcome the 
potential supply gap, Anthesis have contacted the, the Royal College of Radiologists and the  
National Institute for  Health Research  but received no further information .  
   
 
24 
 
 
3.4 Exemption duration  
In the EU,  both  exemption s were granted until 01 January 2024 , as there are not enough reliable 
alternatives and the total negative environmental, health and consumer safety imp acts of 
substitution are likely to outweigh the overall  environmental, health and consumer safety 
benefits.   
 
 
4. Recommendation  
If the exemptions are not extended to GB, there could be a significant financial impact on 
hospital s and negative impact s on health services  more generally . Furthermore, the potential 
environmental impact would be also significant, should any of the existing  MRI system s need to be 
disposed ahead of their expected end -of-life. Therefore , it can be concluded that the  total 
negative environmental, health and consumer safety impacts caused by substitution are likely to 
outweigh the total environmental, health and consumer safety benefits, therefore, it  is 
recommended to extend the exemption, Annex IV, entry 4 6 granted under RoHS 2 in EU -27 to 
Great Britain.   As the EIF of the restriction of  DEHP  is aligned with the EU, it is reasonable to adopt 
the exemption and with the same application date.    
 
 
 
5. Appendi x 
 
    
 
25 
 
 
6. References  
 
 
i 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 equipmen t, https://eur -
lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32011L0065&from=EN  
 
ii The Restriction of the Use of Certain Hazardous Subst ances in Electrical and Electronic Equipment 
Regulations 2012 (UK) https://www.legislation.gov.uk/uksi/2012/3032/contents  
 
iii The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regul ations 2019 
https://www.legislation.gov.uk/uksi/2019/188/contents  
 
iv The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 
2020 https://www.legislation.gov.uk/uksi/2020/1647/contents/made  
 
v The REACH etc. (Amendment) Regulations 2021 
https://www .legislation.gov.uk/uksi/2021/904/contents/made  
 
vi Öko-Institut, Fraunhofer IZM, European Commission. Study to assess three (3) exemption requests relating 
to Annex IV to Directive 2011/65/EU  https://op.europa.eu/en/publication -detail/ -/publication/df0ab036 -
8b52 -11ea -812f -01aa75ed71a1/language -en/format -PDF/source -235265133  
 
vii GE Healthcare (2018), Exemption Request for the use of Bis-(ethylhexyl) phthalate  (DEHP) in plastic strain 
relief devices used to prevent damage to cable connections to  MRI imaging  coils. 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_17/application_GE_Global_Operatio
ns_RoHS_17_Application_Form_Strain_relief_DEHP_201 80912.pdf  
 
viii COCIR (2019), Exemption Request for the use of Bis -(2-ethylhexyl) phthalate (DEHP) in plastic 
components in MRI detector coils  
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_20/Application_COCIR_DEHP_in_MR
I_coils_ -_0102019.pdf  
 
ix Expert Group for RoHS 2 adaptation and enforcement (21st October 2019) 
https://ec.europa.eu/transparency/expert -groups -register/core/api/front/document/59277/download  
 
x EU Commission RoHS 2 Expert Group Meeting Minutes: https://ec.europa.eu/transparency/expert -groups -
register/screen/meetings/consult?lang=en&meetingId=23745&fromExpertGroups=true  
 
xi Oko-Institut, Fraunhofer IZM, European Commission (2020),  Study to assess one (1) request for a new 
exemption to Annex IV of Directive 2011/65/EU for bis -(2-ethylhexyl) phthalate (DEHP) in plastic 
components in MRI detector coils (Pack 20)  https://op.europa.eu/ga/publication -detail/ -
/publication/185e9d5b -d5fc -11ea -adf7 -01aa75ed71a1/language -en 
 
xii ECHA. Annex XVII to REACH - Conditions of  restriction - Entry 51. [Online] [Cited: 28 May 2021.] 
https://echa.europa.eu/documents/10162/aaa92146 -a005 -1dc2 -debe -93c80b57c5ee  
 
xiii Scientific Committee on Healt h, Environmental and Emerging Risks (SCHEER)  and European Commission 
(2019): Guidelines on phthalates in medical devices 
https:// ec.europa.eu/health/scientific_committees/consultations/public_consultations/scheer_consultation
_08_en  
   
 
26 
 
 
 
 
 
xiv Oko-Institut (2019), GE Healthcare Answers to Clarification Questions 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_17/clarification_GE_Ex_2019 -
2_RoH S17_1st_round_GE_Plastics_final_answers.pdf  
 
xv Opinion on Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk 
from DEHP Toxicity. Adopted by The Scientific Committee on Medicinal Products and Medical Devices On 26 
September 2002.  
https://ec.europa.eu/health/archive/ph_risk/committees/scmp/documents/out43_en.pdf  
 
xvi https://www.gov.uk/government/news/deadline -for-uk-reach -to-be-
extended?utm_medium=email&utm_campaign=govuk -notifications&utm_source=08ca2b1e -8012 -40ab -
9088 -8a2dd84b0bab&utm_content=immediately  
 
xvii https://www.gov.uk/government/publications/uk -reach -grandfathered -registrations -notified -substances -
list?utm_medium=emai l&utm_campaign=govuk -notifications&utm_source=932a92ff -5368 -4203 -97f2 -
9ea9f3adcfc2&utm_content=immediately  
 
xviii https://consultations.hse.gov.uk/crd -reach/reach -afa-001-01/ 
 
xix https://www.hse.gov.uk/reach/candidate -list.xlsx  
 
xx https://www.hse.gov.uk/reach/resources/draft -recommendation -2021.pdf  
 
xxi HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm . 
 
xxii Defra.  News story:  Restrictions  under  new  chemical  regime.  [Online]  [Cited:  26 March  2021.]  
https://www.gov.uk/government/news/restrictions -under -new -chemical -regime -announced -for-first-time  
 
xxiii HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm  
 
xxiv Chemical Watch. [Online] [Cited: 21 October 2021] https://chemicalwatch.com/183888/uk -will-not-
transpose -the-waste -framework -directives -scip-provisions  
 
xxv https://www.hse.gov.uk/reach/substance -in-articles -notification.htm  
 
xxvi https://www.hse.gov.u k/reach/resources/work -programme -2021 -22.pdf  
 
xxvii Number of magnetic resonance tomographs in selected European countries in 2016(per million 
inhabitants) Statista (2016): 
https://de.statista.com/statistik/daten/studie/182664/umfrage/kernspintomographen -anzahl -in-europa/  
 
xxviii Office for National Statistics: United Kingdom population mid -year estimate (2016) 
https://www.ons.gov.uk/peoplepopulationan dcommunity/populationandmigration/populationestimates/ti
meseries/ukpop/pop