Department for Environment Food & Rural Affairs  (Defra)  
Use of bis(2 -ethylhexyl) phthalate (DEHP), butyl 
benzyl phthalate (BBP), dibutyl phthalate (DBP) and 
diisobutyl phthalate (DIBP) in spare parts recovered 
from and used for the repair or refurbishment of 
medical devices  (UK-2021 -03) 
Report prepared by: Pearl  Nemeth  
Report Approved by: Dr Richard Peagam  
Date:  7th February  2022  
   
 
Disclaimer  
Anthesis Consulting Group Ltd has prepared this report for the sole use of the client and for the intended 
purposes as stated in the agreement between Anthesis and the client under which this report was completed. 
Anthesis has exercised due and customary care in preparing this report but has not, save as specifically stated, 
independently verified information provided by o thers. No other warranty, express or implied, is made in 
relation to the contents of this report. The use of this report, or reliance on its content, by unauthorised third 
parties without written permission from Anthesis shall be at their own risk, and Ant hesis accepts no duty of 
care to such third parties. Any recommendations, opinions or findings stated in this report are based on facts 
and circumstances as they existed at the time the report was prepared. Any changes in such facts and 
circumstances may a dversely affect the recommendations, opinions or findings contained in this report.  
 
   
 
 
Use of bis(2 -ethylhexyl) phthalate (DEHP), butyl 
benzyl phthalate (BBP), dibutyl phthalate (DBP) and 
diisobutyl phthalate (DIBP) in spare parts reco vered 
from and used for the repair or refurbishment of 
medical devices  (UK-2021 -03) 
Anthesis (UK) Limited  
 
Prepared for:   Prepared by:  
Graeme Vickery  Pearl Nemeth  
Defra  Anthesis (UK) Limited  
Nobel House  Unit J, Taper Studios  
17 Smith Square  175 Long Lane  
London  London  
SW1P3JR  SE1 4GT  
  
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  
  
  
Quality Assurance   
  
  
Report checked by:  
Paul Ashford , 20th October 2021   
  
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 Eu ropean 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 requested . New and renewal 
exemptions are granted or extended at the discretion of the European Commission . Until 31st December 
2020 , these  have been automatically transposed into UK law as “The Restriction of the Use of Certain 
Hazardous Substances in Electrical a nd Electronic Equipment Regulations 2012” (The RoHS Regulations)ii. Due 
to the United 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 reflec t the rules for placing 
such equipment on the market in Great Britain and in Northern Irelandiii iv. 
The exemptions that  had already been transposed into UK law remain, but several  exemption applications 
were still under review by the European Commission  during the transitional period . 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 regulationsiii repatriate powers 
to the Secretary of State , to be able 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”  v  
Anthesis (UK) Limited (Anthesis) 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 DEHP , BBP, DBP  and DIBP for 
use in spare parts recovered from and used for the repair or refurbishment of medical device s to be included 
in Annex I V of The Restriction of Hazardous Substances Directive (RoHS 2). This exemption is being considered 
under the “transitional provisions” mentioned above. The Anthesis review has focused primarily on the 
European Commission’s repor t considering inter alia alignment with UK REACHvi; 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 Europe an Union  under RoHS 2 for the use of bis(2 -ethylhexyl) 
phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in 
spare parts recovered from and used for the repair or refurbishment of medical devices  (Annex IV, entry 4 7) 
should be adopted in Gr eat Britain under The RoHS Regulations. There are existing scientifically or technically 
practicable  substitutes , however , the total negative environmental, health and consumer safety impacts of 
substitution (i.e., manufacturing new parts) is likely to out weigh the total benefits and leads to the premature 
generation of waste. There is no  conflict  with UK REACH , however, there is a misalignment regarding the EU 
SCIP notification requirement, which  is not mirrored in the GB legislative framework, thus it wil l be easier to 
circulate these old parts in the GB than in the EU . The financial impact to continue the present exemption is 
anticipated to be less than ±£5 million annual net direct cost to business (EANDCB).    
 
Table of  Contents  
Disclaimer   ...........  2 
Anthesis Consulting Group   ...........  5 
Executive summary  ................................ ................................ ................................ ................................ ..............  5 
Background and Objectives   ...........  5 
Key Find ings  ...........  6 
Table of figures  ................................ ................................ ................................ ................................ ....................  7 
1. Introduction  ................................ ................................ ................................ ................................ .....................  7 
1.1. Adopted EU Delegating Act   ...........  7 
1.2. Project scope and methodology   ...........  7 
2. Background to the Exemption  ................................ ................................ ................................ .........................  8 
2.1 Exemption applied for   ...........  8 
2.2 Additional information considered   .........  10 
2.2.1. REACH Authorisation, Restriction and SCIP Database   ..............  10 
2.2.2. Medical Device Regulations   ..............  12 
2.2.3. Technical feasibility and availability of substitutes   ..............  13 
2.2.4. E nvironmental considerations   ..............  13 
2.2.5. Socio -economic impacts   ..............  14 
2.3 Conclusion   .........  14 
3. Assessment to the Criteria laid out in Part 2, regulation 5 ................................ ................................ .............  15 
3.1 Links to UK REACH   .........  15 
3.1.1 Annex 14 (Authorisation)   ..............  16 
3.1.2 Annex 17 (Restriction)   ..............  16 
3.1.3 SCIP Database   ..............  17 
3.1.4 Medical Device Regulations   ..............  17 
3.2 Scientific and technical practicability of substitution   .........  17 
3.3 Environmental and socio -economic considerations   .........  17 
3.4 Exemption duration   .........  19 
4. Recommendation  ................................ ................................ ................................ ................................ ...........  19 
5. Appendix  ................................ ................................ ................................ ................................ ........................  19 
6. References  ................................ ................................ ................................ ................................ .....................  21 
 
Table of figures  
Figure 1:  Timeline showing a comparison of the current legal situation regarding spare parts containing DEHP, 
BBP, DBP and DIBP, compared to the situation where the exemption request is adopted.  ..............................  10 
 
   
 
8 
 
 
1. Introduction  
1.1. Adopted EU Delegating Act  
On the 11th of August 2021 , a new entry to Annex IV of the RoHS 2 Directive was adopted by the 
European Union , which is  expected to be published in the European Official Journal  in October 
2021. Directive 2011/65/EU has been updated as follo ws: 
 
Entry:  47 Annex IV, entry 47 
Exemption : For the use of bis(2 -ethylhexyl) phthalate (DEHP), 
butyl benzyl phthalate (BBP), dibutyl phthalate 
(DBP) and diisobutyl phthalate (DIBP) in spare parts 
recovered from and used for the repair or 
refurbishment  of medical devices  . 
Duration:  7 years   
Member  State adoption & publication:  31/03/2022  
Member State application of provisions:  21/0 7/2021  
 
The exemption was granted because  recovered spare parts are often collected for refurbishment 
and further distribution  globally , and it is not feasible to distinguish spare parts by their market of 
origin and to determine th e concentration of phthalates in a non -destructiv e way. Furthermore, 
the existing spare parts provisions do not cover spare parts  recovered from outside the EU. Whilst 
the substitution is  scientifically and technically practi cable , the total negative environmental, 
health and consumer safety  impacts  of substitution  (i.e., manufacturing new parts)  is likely to 
outweigh the total benefits  and leads to the premature ge neration of waste . 
 
1.2. Project scope and methodology  
The Anthesis  review has primarily focused on the European Commission’s reportvii considering its  
alignment with UK REACHvi and the requirements laid out in  The RoHS Regulations.  The 
application submitted by  COCIR  (European Coordination Committee of the Radiological, 
Electro medical and Healthcare IT Industry, the Applicant ) has also been  consulted  (available from 
the Öko-Institut  websiteviii). The Anthesis review is supplemented with further  research to confirm 
the applicability of the exemption request to Great Britain. It should be noted that  Anthesis only 
has access to information in the public domain,  it has not been  able  to assess any  confidential  
information . 
This report first summarise s the exemption request 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 .    
 
9 
 
 
The Anthesis recommendation is given in Section 4.   
 
 
2. Background to the Exemption  
On 17th July 2018, the Commission received an application for an exemption  to allow spare parts  
containing > 0.1% DEHP, BBP, DBP and DIBP,  recovered and used for the repair and refurbishment 
of medical devices, to continue being placed on the mar ket in the EU .  
The Commission launched a study to carry out the required technical and scientific assessment  in 
November 2018, to evaluate th e application for a new exemption . The study , conducted by the 
Öko-Institut,  included an eight -week stakeholder consultation, during which on e response  was 
received , with the study being  concluded in 2020.   
The Commission consulted the Member States’ expert group for delegated acts under the RoHS 2 
Directivei on 23rd February 2021. The minutes from this meeting  report that  one Member State 
expert suggested having a general provision for spare parts in a  closed -loop context,  in Annex II, 
but as the Directive does not allow for  such a provision , the proposal could  not be 
accommodatedix. There was a r eference  made  to the SCIP1 databasex, but the minutes do not 
describe  how this might have impact ed the exemption request, if at all . 
The application was submitted as an amendment to Annex IV entry  31a, however, as the RoHS  2 
Directive  does not have an official procedure to amend an existing exemption, the European 
Commission adopted it as a new exemption  (Annex IV, entry 47)  and ref erred it to the WTO  
Committee  on Technical Barriers to Trade  (TBT)  on 29th June 2021 . The p ublication  of the 
exempt ion request , in the Official Journal , is expected imminently due to th e 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.  v 
 
2.1 Exemption applied for  
According to the Applicant , DEHP, DBP, DIBP and BBP  are added to polymers (including rubber), 
adhesives, sealants, paints , and lacquers for a variety of possible uses a s listed:  
• Plasticiser in PVC wire and cable insulation . 
• Additive in rubber seals and O -rings used in connectors . 
• Additive in rubber grommet s that support  cables . 
• Plasticiser in PVC labels including those used on components such as capacitors . 
• Added to give flexibility to adhesives used to seal capacitors and other electronic 
components . 
• Added to give flexibility to die attach material in  integrated circuit  packages . 
 
 
1 Substances of Concern In articles as such or in complex objects ( Products) . Since the 5th of January 2021 , article 
suppliers are required to notify articles containing substances of very high concern ( SVHCs ) above 0.1  % (w/w) to the 
SCIP database, to improve information in the value chain and specifically to assist waste operators .    
 
10 
 
 
• As a processing aid in polymer mouldings.  
In the exemption request,  COCIR also lists a few examples of applications of relevance for medical 
devices (MD ):  
• Printed circuit boards (PCBs) . 
• X-ray tubes (including PCBs, cables, housing, etc.) . 
• Magnetic resonance imaging  (MRI) coils . 
• Detectors and components of detectors ( e.g.,  radiation detectors) . 
• Transducers with associated cables.  
 
The Applicant  explains that in the medical device market, there is already a rather  mature 
recov ery and distribution system for spare parts to be used for refurbishment, repair, servicing , or 
maintenance (RRSM) . There are several  reason s for this . Due to the high reliability requirements 
for the Notified Body approval of medical devices , as required by the medical devices regulation s, 
medical equipment  has a long lifetime. It is e asier to recover parts , as they don’t need re -approval , 
compared to  produc ing new parts and it is also economically more viable . Manufacturing new 
spare parts (without phthalates) would also lead to longer downtimes for hospitals  (new 
manufacture is estimated to take about 8 months) , especially immediately after 2021 , when most 
parts would still contain phthalates. Furthermore, manufacturing parts to old m odels that are 
already obsolete is not always possible. The w ell-established  global collection and distribution 
system ensures fast allocation, thus  short downtime  for hospitals for these (often) critical medical 
equipment . 
There are several legislation s that already allow the use of spare parts under certain 
circumstances;  however, the exemption request goes further in some respects . Article 4(5) of the 
RoHS 2 Directive (as amended by Directive (EU) 2017/2102)  allows using spare parts recovered 
from medical devices placed on the market prior 2014, until 2024. Compared to this, t he 
exemption would extend the period until which spare parts can be recovered from medical 
devices placed on the EU market from 2014 to  2028 and the period until the harvested spare 
parts can be used in the refurbishment from 2024 to 2028.  
Directive  (EU) 2015/863,  that introduced the restriction of the four phthalates (DEBP, BBP, DBP 
and DIBP) in medical devices  (categories 8 (Medical de vices) and category 9 (Monitoring and 
control instruments including industrial monitoring and control instruments)  from 21st July 2021 , 
also allows  that, spare parts (containing either of the four phthalates) placed on the EU market 
before July 2021 can st ill be recovered and used for repair and refurbishment of medical devices . 
Neither Article 4(5) of the RoHS 2 Directive, nor Directive (EU) 2015/863 allows for spare parts to 
be recovered from medical devices not previously placed on the EU market. However , the 
Applicant  states  that, due to the complexity of the medical devices in question  and the ir global 
supply chain, it is not always clear to medical equipment manufacturers  whether a certain part 
was originally placed on the market in the EU or outside the EU, before or after 2021 , when the 
phthalate restriction became applicable ; and testing of the products is not possible  in a non -
destructive way .  
Therefore, the applicants require  the exemption as with the exemption, parts previously not 
place d on the EU market can be used and the period until which spare parts can be harvested 
would be extended from 2021 to 2028. This second criteria is more important for the non -EU   
 
11 
 
 
parts again, as those might still contain phth alates even if they were placed on the market after 
2021.   
The following figure  aims to explain the difference between the status quo and the exemption 
application, i.e., the exemption would help medical device suppliers by :  
• Extending the periods when spare parts potentially containing DEHP, BBP, DBP and DIBP 
can be recovered from medical devices for repair and refurbishment and,  
• Allowing the recovery of spare parts from medical devices, that have not previously been 
placed o n the EU market (thus potentially containing the restricted  phthalates).  
 
Figure 1: Timeline showing a comparison of the current legal situation regarding spare parts containing DEHP, BBP, DBP 
and DIBP, compared to the situation where the exemption request is adopted.  
 
2.2 Additional information considered  
 
2.2.1.  REACH  Authorisation, Restricti on 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 1907/200 6” (REACH).  Therefore, the following section 
will look at any potential conflicts with (EU) REACH.  
At the time of the adoption and  publication of Directive (EU) 2015/863, REACH  Annex XIV included 
these phthalates , due to their reproductive effects.  There is an exemption for DEHP , BBP and DBP : 
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 . Applications for Authorisat ion 
were received for DEHP and DBP  for uses in EEE. As no applications were received for either  BBP 
and DIBP , these  substances  could not be placed on the market as the substances themselves or in 
                                                                                   
            
          
         
           
                                               
                  
                     
                
           
                           
                      
                       
                          
                                                                                       
     
        
                         
                    
     
          
        
       
          
       
                                                                                 
                 
                                             
                                             
                                         
          
           
                                                       
                   
                                                 
          
                                   
                                  
                                     
                                       
 
12 
 
 
mixtures on the EU market for use on their own, in mixtures or used  to produce  articles  in the EU  
after 21st February 2015 (so -called sunset date) as per (EU) No 143/2011 and (EU) No 125/2012.   
Commission Regulation (EU) 2020/171 amended the  Annex XIV  entries and allows that even after 
the sunset date, the use of the four phthalates  is allowed until 1st March 2023 in the following two 
cases:   
• In the production of spare parts for the repair of articles the production of which ceased 
before the sunset date , where : 
o the substance was used in  the production of those articles and  
o these cannot function 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 complex products 
and  
o they cannot be repaired otherwise than by using that substance.  
However, these do not apply for the current exemption as feasible alte rnatives exist for DEHP , 
BBP, DBP and DIBP.  
None of the  Authorisation applications submitted consider  the use of phthalates in  medical 
devices , due to the exemption afforded by  Article 60 (of REACH). Article 60(2)  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.  Furth ermore , 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, though, DEHP was identified as a  substance of  very high concern ( SVHC ) for its 
equivalent level of concern , based on  its potential for endocrine disruption properties for the 
environment . In 2017 , all four phthalates were further identified as SVHCs , owing  to their 
endocrine disrupting properties for human health. The Annex XIV entries for these substances 
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 the 
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 th at point, there will be 
no conflict between the exemption and EU REACH, as the substance s are already incorporated 
into the articles  (as the spare parts already exist ), whilst the scope of Authorisation is to use 
substances own their own or in mixtures or incorporating them into articles  within the EU . Indeed, 
if medical device  items are imported as finished articles into  the EU, then they would be exempt 
from needing an Authorisation , this is the case for  what  placed originally on market outside the EU 
and now used as spare parts .  
Articles are typically regulated via restrictions (Annex XVII) and although DEHP, DBP, BBP and DIBP  
are 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/ECxi. Entry 51 was updated to its 
present form in December 2018 via the Commission Regulation (EU ) 2018/2005.  Based on their 
toxic to reproduction category 1B classification, entry 30 applies to each of the phthalates,   
 
13 
 
 
however, entry 30 restricts supply to the public . The supply of spare parts recovered from and 
used for the repair or refurbishment of  medical devices must  take place in a closed -loop business -
to-business return system, i.e., they are not supplied to the general public.  
COCIR also mention ed a registry of intentions under REACH: “A restriction on materials with 
prolonged skin contact has been proposed. Most parts of medical devices do not have prolonged 
or frequent skin contact and so would be out of scope. If this restriction enters force in  the future, 
any parts which have PVC that may be used with prolonged skin contact will not be reused” . Öko-
Institu t confirmed that the registry of intentions , to which COCIR refers , forms  part of the 
amendment of entry 51 of Annex XVII  so does not apply t o the exemption request.  
The revised Waste Framework Directive mandated the European Chemicals Agency ( ECHA ) in 
2018 to establish a database of articles that contain SVHCs 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 accessible to consumers . The notification obligation for article suppl iers 
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  
(including  spare parts)  they place on the market , in the event that  they contain  more than  0.1% of 
an SVHC.  Recovered parts do not require SCIP notification if they were originally placed on the 
market in Europe . However, the Applicant  claims that due to the global nature of the  collection 
and distribution of used spare parts, there is no way of knowing the origin (EU or non -EU) of the 
collected spare parts. It is also not possible to determine the concentration of the SVHC in a non -
destructive way . Furthermore, the Applicant  specifically states that at the time of submission , i.e., 
in 2018 , there was insufficient information available in the supply chain to verify if DEHP, DBP, BBP 
or DIBP  were  used in concentrations greater than 0.1%  prior to the introduction of the restriction 
via Directive (EU) 2015 /863 . Therefore, while the exemption (in our opinion) does not weaken the 
environmental and health protection in the EU , as the SCIP notification  requirement  is not a 
restriction ; it may form a practical barrier to refurbishment and maintenance with spare parts 
potentially containing the restricted  phthalates , even when  the exemption would allow it.    
 
2.2.2.  Medical Device Regulations  
The European regulatory framework ensures the safety and efficacy of m edical 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 Directive 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 (E U) 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 progressivel y 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  released from   
 
14 
 
 
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 disrupt ors or other SVHCs identified under 
REACH, where justified.  
Furthermore, the Commissi on mandated a scientific committee to prepare a guideline specifically 
on phthalates , including a benefit -risk assessment of the presence of phthalates , considering the 
intended use of the device and available alternatives . This guideline may be consulted for the 
above -mentioned justificationsxii. 
 
2.2.3.  Technical feasibility and availability of substitutes  
Substitution is scientifically and technically  practicable , in fact, the Applicant  states that the 
number of parts containing the  restricted  phthalat es “has already started to decrease as 
phthalates have been gradually phased out to meet the 2021 deadline and to meet national 
initiatives on green public purchasing. The fact that no exemption  (request s) for phthalates, 
except 2 very specific cases submi tted by COCIR and a COCIR Member, have been submitted, 
proves  that phthalates were being already substituted wherever possible well before 2018.” . 
Despite the availability of the alternatives, the Applicant  reasoned that the exemption should be 
granted by giv ing more relevance to the environmental benefits of using spare parts . The 
application aims to make sure immediate availability of spare parts (that can be legally used for 
repair and refurbishments) aft er the 2021 -restriction enters into force.  
 
2.2.4.  Environmental considerations  
The Applicant  argues, that as  the exemption request relates to pre -existing components, there are 
two meaningful scenarios that can be compared to assess the environmental impact s of the 
exemption:  
• One where parts  are used again  (but potentially contain phthalates)  
• One where new  phthalate -free parts are produced , and the old  ones  are (prematurely) 
disposed . 
According to the Applicant , this second scenario might also lead to fewer medical devices being  
refurbished , as some older parts might  have been discontinued  or it is simply not economically 
viable to manufacture a new part for refurbishment.  
The Applicant  confirmed that  the collection and refurbishment  take place  in the  required  closed -
loop business -to-business return systems , as manufacturers make great effort to collect their own 
parts and because the Medical Device Regulation requires that only approved parts are used.  
COCIR argues that “Allowing all recovered spare parts to be reused, provides a net environmental 
and health benefit and is paramount to establish a proper circular economy business model.”   
COCIR provided full LCAs to support their claims  and estimated that an additional 2 ,200 tonnes of 
new parts would need to b e produced if the exemption was not granted . Based on the extensive 
information on the environmental impact s that  were  provided  by the Applicant , the Öko-Institut 
considered the exemption justified under  the Article 5(1)(a) of the RoHS Directive on adaptation 
to scientific and technical progress.  
   
 
15 
 
 
2.2.5.  Socio -economic impacts  
Due to the restriction on phthalates, any returned parts that contain phthalates could not 
currently be legally  used for  refurbish ment . COCIR highlighted that the most significant  
socioeconomic implications of this would be  the higher cost of producing new  spare parts not 
containing the restricted  phthalates  (it did  not estimate what these might be ); and these not being 
immediately available after 2021  which  would lead to longer downtime of  essential medical 
devices and delay s in urgent medical treatment.  In their own words: “[…] the global logistic 
created by manufacturers allows spare parts to be delivered worldwide to hospitals to RRSM 
medical devices to ensure the shortest possible downt ime for the benefit of patients’ health. 
Medical devices manufactured by COCIR’s members are critical devices used in ER departments 
and other critical care facilities ”. 
Furthermore, consequently , refurbished equipment would not be available in the EU, even though  
“refurbishment is a key element of the strategy to allow EU hospitals to renew their equipment in 
an affordable way”xiii . 
Whilst there was no monetary estimation provided and there were a few assumptions in the 
argumentation that could  not be substantiated, the Applicant  provided a broad range of 
arguments on the health and socioeconomic impacts.  
During t he stakeholder consultation, there was one submission made  by MedTech  Europe , and 
this reinforce d the above arguments . MedTech Europe also  provided concrete  estimation for the 
potential  cost reduction through reuse and refurbishment , illustrated in the case of  a specific type 
of medical device , resonators :  
• From an installed base of 600 resonators in the EU, 2 refurbished ones are placed in the 
market per month. These are almost never sc rapped and instead are refurbished and sent 
back out in an exchange pool,  
• The difference between a refurbished and a new resonator is about 20,000 USD,  
• Without access to RoHS compliant spare parts, this company would incur in costs of about 
500,000 USD m ore per year in comparison to now.  xiv 
The application provided sufficient evidence on the benefits for the European health system, 
along with the environmental benefits of not needing to produce new parts . It should be also 
recalled, that even without the exemption, it is possible to use parts containing phthalates 
originally placed on the market before July 2021 as per Directive (EU) 2015/863 (31/03) . 
 
2.3 Conclusion  
The evaluation of the exemption application concluded that the  negative environmental and 
health impacts of substituting refurbished parts containing DEHP, BBP, DBP and DIBP with new 
phthalate -free refurbished parts , are likely to outweigh the total environmental and health 
benefits. However, to ensure a high level of  protection for the environment, health and consumer 
safety, reuse should take place in auditable closed -loop business -to-business return systems and 
the reuse of spare parts should be notified to the customer.   
It was concluded that  the exemption is consi stent with REACH and thus does not weaken 
environmental and health protection s, therefore, the exem ption was granted . As noted above the 
SCIP notification requirement (that entered into force in 2021) might now provide a barrier to use 
spare parts for refu rbishment as allowed by the exemption.     
 
16 
 
 
For avoiding disruption , the Commission decided that the Directive should enter into force as a 
matter of urgency and should apply with retroactive effect from 21st July 2021  when the 
restriction of the substances en tered into force.   
Whilst COCIR selected both category 8 (Medical devices) and category 9 (Monitoring and control 
instruments including industrial monitoring and control instruments) in their application, the 
information provided (incl. the stakeholder consultation) was not considered sufficient by the 
Öko-Institut to support exem ption in catego ry 9.  
 
3. Assessment to the Criteria laid out in Part 2, regulation 5  
Regulation 5 of The RoHS Regulationsii  permits an exemption to be granted if the following  are 
satisfied :  
• The exemption d oes 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 scientifi cally 
or technically  impracticable.   
• The reliability 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 consumer safety benefits of  that substitution.   
 
The following assessment reviews each of these elements.   
 
3.1. Links to UK REACH  
On 1st January 2021 UK REACHvi 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 business es 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). T he deadline for the notification was 27th October 2021. This effectively 
defers their registration responsibilities for up to six years depending 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 registrationxv. 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 
September 2021  xvi.  This is not a verified  list of  registrations that were transf erred into UK REACH 
from EU REACH under Article 127A  (1) (transf erred 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) .  
Out of the four phthal ates in question,  only  DIBP is listed. This means at least one company 
manufactures or imports DIBP in greater than 1 tonne  per annum , however, no information is 
available to confirm whether it is used in medical devices.     
 
17 
 
 
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 (Authorisation)  
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,  these include DEHP, BBP, DBP and DIBP due to their 
intrinsic hazard as toxic to reproduction.   
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 extension of the 
Authorisation originally granted to Rolls Royce in 2014xvii, but this is out of the scope of this report  
as it is not used in medical d evices . 
As noted above,  applications for Authorisations  would not be anticipated for medical devices  all 
the while Annex 14 only includes these phthalates for their 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 Annex 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 2020xviii: thus,  the 
phthalates are included for their 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 incorp orated into the 
articles (as the spare parts already exist), whilst the scope of Authorisation is to use substances 
own their own or in mixtures or incorporating them into articles within GB.  
The UK REACH work programme for 2021/2022 states that the UK wi ll present its first 
recommendation of priority substances to be included in Annex 14 , but this  does not include the 
four phthalates , as they focused on ECHA’s 10th and 9th recommendations, whilst amending the 
Annex XIV entries for the four phthal ates was included in the 8th recommendationxix. Therefore, at 
the time of writing the report , it is not known when the UK will move forward with updating 
Annex 14.   
Moreover , as only one application for Authorisation for electrical equipment was identified  in the 
EU, it is more likely that phthalates will be  contained in  imported articles, if at all,  and would  thus 
be governed by Annex 17.v 
 
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 periodxx. Thus DEHP , 
BBP, DBP and DIBP are 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   
 
18 
 
 
human health or the environment. The UK Government  announced its first plans for restrictions 
under  UK REACH on 23rd March 2021xxi, and has since created a  Registry of restriction intentionsxxii. 
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 any of the 
four phthalates .   
 
3.1.3.  SCIP Database  
In November 2020 the Defra  confirmed that it will not transpose the  SCIP  provisionsxxiii, 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 communicated 
in its chemicals strategy, that was planned  to be published in 2022 . The notifications of SVHCs i n 
articles according to article 7(2) exists, but only applies above 1 tonnexxiv. The Agency for UK 
REACH Work Programme 2021/2022 does not mention SCIPxxv.  
This means, that whilst the SCIP notification might create a barrier for the reuse of spare parts 
cont aining phthalates as the Applicant  states there is no way of knowing if the parts contain any 
phthalates and at what concentration level . In the UK, no such requirement s are foreseen  (for the 
time being) . It will therefore be easier to circulate spare parts  on the UK market, introducing  the 
environmental and health impact s of using parts that may contain phthalates, whilst  improving  
the socioeconomic benefits, such as lower refurbishment costs for hospitals and shorter 
downtime for patients .  
 
3.1.4.  Medical D evice Regulations  
The Medical Device Regulations (UK MDR 2002 )xxvi require  any materials presenting a hazard to be 
replaced as soon as alternatives with a more positive risk -to-benefit balance are available.  The 
Medicines & Healthcare products  Regulatory  Agency  (MHRA)  provided  guidance  on the use of 
DEHP phthalates in me dical devices  in January 2021xxvii. The update was in response to  potential 
concerns about the possibility of DEHP leaching from the PVC into solutions  and the intrinsic 
reproductive effects , but concluded that the DEHP may be essential in some medical device s in 
critical circumstances.  The medical devices cited were not EEE and  as such would not fall within 
the scope of  RoHS 2. However, in accordance with the objectives of UK MDR 2002, the guidance 
does encourage operators to find alternatives to DEHP.   
 
3.2. Scientific and technical practicability of substitution  
As the restriction  of the four phthalates for categories 8 and 9 is not a new concept, many 
manufacturers have already switched to the use of alternative parts that do not use these four 
phthalates  in new part production . As such, the substitution is scientifically and technically 
practicable . However, the purpose of this exemption is to enable the reuse of parts potentially 
containing phthalates, due to the costs  and environmental impacts  of manufactu ring new parts  
shown in Life Cycle Assessments . 
 
3.3. Environmental and socio -economic considerations  
The Applicant confirmed that the collection and refurbishment take place in the required closed -
loop business -to-business return systems , thus exposure is mini mised . They estimated that an   
 
19 
 
 
additional 2,200 tonnes of new parts would need to be produced if the exemption was not 
granted . At the time of the application  the UK would have been  included in these figures. As 
discussed above, granting the exemption would  only extend the lifetime of parts potentially 
contain DEHP , BBP, DBP and DIBP, not manufacturing new equipment or parts  containing  these, 
therefore, the environmental benefit of keeping these in circulation compared to producing new 
parts expected to overweigh the risk s.  
Anthesis believes that adopting the exemption in the UK would not lead to  the loss of innovation 
or pushing alternative s out of the market  during the period of the exemption (i.e. , until 2028) , due 
to the high market barrier to  the medical device market (given the high reliability requirements ) 
and the long innovation period  associated with it . As the Applicant  point ed out “all substitutes 
must provide the same or better performance as the old part  in order to obtain Notified Body 
approval of medical devices as required by the Medical Devices Regulation” .  MedTech  Europe 
stated in their  submission to the stakeholder con sultation , that  it takes 3 to 7 years (up to 10 years 
for IVD ) to bring a new MD to the market  xiv. Furthermore, the Applicant  highlighted that new 
parts are made by the same manufacturers that make the medical devices, until the production of 
the individual designs  cease , although sufficient stocks for warranty periods of 2 -5 years are 
available . 
Anthesis has identified several  UK trade bodies supporting the medical devices industry and 
control instrumentation. A brief description of these is given below  v.  
• AXREM is UK tr ade association representing the interests of suppliers of diagnostic 
medical imaging, radiotherapy, healthcare IT and care equipment in the UK.  Members 
supply most  diagnostic medical imaging and radiotherapy equipment installed in UK 
hospitals.  They are a n associate member of COCIR.  
• Association of British HealthTech Industries (ABHI) and British In Vitro Diagnostics 
Association  (BIVDA) are both UK national association members of M edTech Europe .  
• British Healthcare Trade Association (BHTA) r epresent s the he althcare and assistive 
technology industry . 
• PAGB, the consumer healthcare association represents manufacturers of branded OTC 
medicines, self -care medical devices and food supplements in the UK.  
• GAMBICA  is the UK trade association for instrumentation, cont rol, automation and 
laboratory technology.  
Based on earlier engagement with BHTA and PAGB, neither are concerned with the phthalate 
restriction at all. As AXREM is a n associate  member of COCIR , whilst both BIVDA and ABHI  are 
members of MedTech Europe, the ir members  should be aligned with the exemption request. 
These statistics  may have changed due to Brexit, but historically,  approximately one -third of 
GAMBICA’s members’  products are exported to the EU,  so compliance with  RoHS 2 is required.xxviii. 
Thus , they probably support harmonisation  between jurisdictions  as this means members  have  
greater ability to supply  single products globally without considering  regulatory  nuances between  
jurisdictions ; MedTech Europe pointed out  the same .  
Adopting the exemption should  help the members to maintain their continuous refurbishment 
and repair services without delays post the 2021 restriction . That in turn helps to  exten d the 
lifetime of the medical equipment that is both environmentally and economically beneficial , not to 
mention the benefits for the healthcare system by being able refurbish existing equipment with 
existing spare parts . Anthesis  estimates that the  economic impact of the exemption  is likely to be 
low, i.e., less than  ±£5 million annual net direct cost to business  (EANDCB)  not least as the 
exemption request is  for less than the  10 years required to be considered with an Impact 
Assessmentxxix .   
 
20 
 
 
 
3.4. Exemption duration  
Seven  years , the maximum exemption duration  perm itted for EEE in category  8 (Regulation 
5(7)(b))  seems reasonable for the exemption application and should start retroactively from  the 
EIF date of the restriction, i.e. , 22nd July 2021 , to avoid legal uncertainty.   
 
4. Recommendation  
It is recommended to  extend the exemption, Annex  IV, entry 47  granted under RoHS 2 in  EU-27 to 
Great Britain.   As the EIF of the restriction of DEHP , BBP, DBP and DIBP is aligned with the EU, it is 
reasonable to adopt the exemption and with the same application date.  
 
5. Appendi x 
 
    
 
21 
 
 
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 Substances in Electrical and Electronic Equipment 
Regulations 2012, https://www.legislation.gov.uk/uksi/2019/188/contents  
 
iii The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 
2020, https://www.legislation.gov.uk/uksi/2020/1647/contents/made  
 
iv The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 2019, 
https://www.legislation.gov.uk/uksi/2019/188/contents  
 
v Review of the inclusion of Phthalates in The RoHS Regulations in medical devices and monitoring and  
control instruments : https://consult.defra.gov.uk/waste -and-recycling/consultation -on-amendments -to-the-
restriction -of-t/supporting_documents/Anthesis%20UK%20RoHS%20Phthalates%20Report.pdf  
 
vi The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 and 2020, https://www.gov.uk/eu -
withdrawal -act-2018 -statutory -instruments/the -reach -etc-amendment -regulations -2021  
 
vii 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 -01aa 75ed71a1/language -en/format -PDF/source -235265133  
 
viii Öko-Institut e.V. COCIR Application. [Online] XXX. [Cited: 28 May 2021.]  
https://rohs.exempti ons.oeko.info/exemption -consultations/2019 -consultation -1/annex -iv-ex-31a 
   
ix Minutes: Meeting of the Expert Group for RoHS 2 adaption and enforcement Subgroup  for RoHS 
Delegated Acts. [Online] 23 February 2021. [Cited: 25 June 2021.] 
https://ec.europa.eu/transparency/expert -groups -
register/screen/meetings/consult?lang=en&meetingId=23745&fromExpertGroups=true.  
 
x ECHA SCIP Database  [Cited: 19 October 2021] : https://echa.europa.eu/scip -database  
 
xi 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 -93c8 0b57c5ee  
 
xii Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)  and European Commis sion 
(2019): Guidelines on phthalates in  medical devices 
https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scheer_consultation
_08_en  
 
   
 
22 
 
 
 
 
xiii Oeko -Institut e.V. and Fraunhofer -Institut IZM (ed.). Online available at 
https://rohs.exemptions.oeko.info/f ileadmin/user_upload/RoHS_Pack_17/ 
clarification_COCIR_Ex_31a_RoHS17_1st_round_Cons_2019_1_final_ 20190311.pdf, last accessed on 22 
Aug 2019  
 
xiv MedTech Europe (2019): Contribution of MedTech Europe, Response to stakeholder consultation on 
RoHS Pack 17 (Re quest for renewal of Annex IV exemption 31a submitted by COCIR). submitted on 
13.05.2019. In collaboration with Nathalie Buijs, MedTech Europe. MedTech Europe (ed.). Online available 
at 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_17/c larification_COCIR_Ex_31a_RoH
S17_1st_round_Cons_2019_1_final_20190311.pdf , last accessed on 22 Aug 2019.  
 
xv 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  
 
xvi https://ww w.gov.uk/government/publications/uk -reach -grandfathered -registrations -notified -substances -
list?utm_medium=email&utm_campaign=govuk -notifications&utm_source=932a92ff -5368 -4203 -97f2 -
9ea9f3adcfc2&utm_content=immediately  
 
xvii https://consultations.hse.gov.uk/crd -reach/reach -afa-001-01/ 
 
xviii https://www.hse.gov.uk/reach/candidate -list.xlsx  
 
xix https://www.hse.gov.uk/reach/resources/draft -recommendation -2021.pdf  
 
xx HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm . 
 
xxi 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  
 
xxii HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm  
 
xxiii Chemical Watch. [Online ] [Cited: 21 October 2021]  https://chemicalwatch.com/183888/uk -will-not-
transpose -the-waste -framework -directives -scip-provisions  
 
xxiv https://www.hse.gov.uk/reach/substance -in-articles -notification.htm  
 
xxv https://www.hse.gov.uk/reach/resources/work -programme -2021 -22.pdf  
 
xxvi The Medical Devices Regulations 2002. [Online] 
https://www.legislation.gov.uk/uksi/2002/618/contents/made. SI 2002 No. 618  
 
   
 
23 
 
 
 
 
xxvii Medicines & Healthcare products Regulatory Agency. Guidance DEHP phthalates in medical devices. 
[Online] 26 January 2021. https ://www.gov.uk/government/publications/dehp -phthalates -in-medical -
devices/dehp -phthalates -in-medical -devices . 
 
xxviii GAMBICA, Private Communication  
 
xxix Office for Product Safety & Standards. The Restriction of the Use of Certain Hazardous Substances in 
Electrica l and Electronic Equipment Regulations 2012 (as amended): As they apply to equipment being 
supplied in or into Great Britain from 1 January 2021. [Online] January 2021.