Department for Environment Food & Rural Affairs  (Defra)  
Bis(2 -ethylhexyl) phthalate (DEHP) in ion -selective 
electrodes applied in point of care analysis of ionic 
substances present in human body fluids and/or in 
dialysate fluids (UK-2021 -04) 
Report prepared by: Pearl Nemeth  
Report Approved by: Dr Richard Peagam  
Date : 7th February 2022  
   
 
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Anthesis Consulting Group Ltd has prepared this report for the sole use of the client and for the intended 
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care to such third parti es. 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 adversely affect the recommendations, opinions or findings contained in this report.  
 
   
 
 
Bis(2 -ethylhexyl) phthalate (DEHP) in ion -selective 
electrodes applied in point of care analysis of ionic 
substances present in human body fluids and/or in 
dialysate fluids (UK-2021 -04) 
Anthesis (U K) Limited  
 
Prepared for:   Prepared by:  
Graeme Vickery  Dr Richard Peagam  
Defra  Anthesis (UK) Limited  
Nobel House  Unit J, Taper Studios  
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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  
  
  
  
  
Quality Assurance   
Report checked by:  
Paul  Ashford   
  
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 di scretion 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 t he 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 reflect 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. Consequently, any new exemptions adopted by the 
European Union post 1st Januar y 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 powers to t he 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 (Anthesi s) have 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 ion -selective electrodes applied in point of care analysis of ionic substances present in human body 
fluids and/or in dialysate fluids to be included in Annex I V, entry 45 of The Restriction of Hazardous 
Substances Dir ective (RoHS 2). This exemption is being considered under the  “transitional provisions” 
mentioned above. The Anthesis review has primarily focused on the European Commission’s report 
considering inter alia alignment with UK REACHv; risk characterisation o f 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 ion -selective electrodes applied in point of care analysis of ionic substances present in 
human body fluids and/or in dialysate fluids (An nex IV, entry 45) should be adopted in Great Britain under The  
 RoHS Regulations. Whilst the substitution is theoretically feasible, the reliability of substitutes currently 
cannot be sufficiently ensured and the total negative environmental, health and con sumer 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 the environmental protection.  
 
 
 
 
   
 
Contents  
Disclaimer  ................................ ................................ ................................ ................................ .........................  2 
Anthesis Consulting Group  ................................ ................................ ................................ ...............................  5 
Exec utive summary  ................................ ................................ ................................ ................................ ..............  5 
Background and Objectives  ................................ ................................ ................................ ..............................  5 
Key Findings  ................................ ................................ ................................ ................................ .....................  5 
Table of figures  ................................ ................................ ................................ ................................ ....................  7 
1. Introduction  ................................ ................................ ................................ ................................ .....................  9 
1.1 Adopted EU Delegating Act  ................................ ................................ ................................ ........................  9 
1.2 Project scope and methodology  ................................ ................................ ................................ .................  9 
2. Background to the Exemption  ................................ ................................ ................................ .........................  9 
2.1 Exemption applied for  ................................ ................................ ................................ ..............................  10 
2.2 Additional information considere d ................................ ................................ ................................ ...........  12 
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  ................................ ................................ ................................ ................................ ................................ ...........  18 
2.3 Conclusion  ................................ ................................ ................................ ................................ ................  20 
3. Assessment to the Criteria laid out in Part 2, regulation 5 ................................ ................................ .............  21 
3.1 Links to UK REACH  ................................ ................................ ................................ ................................ .... 21 
3.1.1. Annex 14 (Authorisation)  ................................ ................................ ................................ ................................ ................................ ........  21 
3.1.2. Annex 17 (Restriction)  ................................ ................................ ................................ ................................ ................................ .............  22 
3.1.3 SCIP Database  ................................ ................................ ................................ ................................ ................................ ...........................  22 
3.2 Scientific and technical practicability of substitution  ................................ ................................ ...............  23 
3.3 Environmental and socioeconomic considerations  ................................ ................................ ..................  23 
3.4 Ex emption duration  ................................ ................................ ................................ ................................ .. 24 
4. Recommendation  ................................ ................................ ................................ ................................ ...........  24 
5. Appendix  ................................ ................................ ................................ ................................ ........................  25 
References  ................................ ................................ ................................ ................................ .........................  26 
 
Table of figures  
Figure 1:  Schematic to illustrate the role of DEHP in the PoC analysers.  ................................ ................................ .................  11 
Figure 2 : Illustration of the different levels of substitution: 1:  alternative plasticiser, 2: alternative analysis method, 3: 
alternative analysis technique  ................................ ................................ ................................ ................................ ....................  14 
Figure 3:  Initial drift (mV/min) measured at T = 30 minutes and drift at T = 60 minutes after exposure to aqueous 
solutions for each of the tested plasticizers  ................................ ................................ ................................ ..............................  15  
  
Table 1 : Estimation of the total weight of lead entering the market through replacement of the PoC analy sers currently in 
stock. x ................................ ................................ ................................ ................................ ................................ ..........................  18 
 
 
 
 
 
 
 
   
 
9 
 
 
1. Introduction  
1.1 Adopted EU Delegating Act  
On the 11th August 2021,  a new  entry to Annex IV of the RoHS 2 Directive was adopted by the 
European Union which was expected to be published in the European Official Journal in October 
2021  (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, 45 
Exemption : Exemption for the use of bis(2 -ethylhexyl) phthalate 
(DEHP) in ion -selective electrodes  for analysing 
human body fluids and/or dialysate fluids . 
Duration:  7 years   
Member State adoption & publication:  31st March 2021  
Member State application of provisions:  21st July 2021  
The exemption  was granted , becau se the reliability of substitutes is currently not sufficiently 
ensured and the total negative environmental, health and consumer safety impacts caused by 
substitution are likely to outweigh the total  environmental, health and consumer safety benefitsvi. 
 
1.2 Project scope and methodology  
The Anthesis  review has primarily focused on the European Commission’s reportvii considering its  
alignment with UK REACHv and the requirements laid out in  The RoHS Regulations.  The application 
submitted by  COCIR (European Coordination Committee of the Radiological, Electromedical 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 h as 
access to information in the public domain,  it has not been  able  to assess any  confidential  
information  referred to in any of the above sourc es. 
This report first summarises 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 characterisa tion 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  
The application for the exemption for the use of bis(2 -ethylhexyl) phthalate (DEHP) in ion -selective 
electrodes for analysing human body fluids (the original wording did no t refer to dialysate fluids )   
 
10 
 
 
was received on 17th July 2018.  The Commission launched a study to carry out the required 
technical and scientific assessment, that included an eight -week public consultation . One 
contribution was receivedix.  The assessment  was undertaken by the Öko -Institut e.V. (Öko -
Institut) and Fraunhofer IZM which was published in April 2020 . The exemption application was an 
agenda item at the 21st October 2019  Member States ’ Expert Group meeting sx, where one 
Member States e xpert highlighted that the exposure of vulnerable patients to phthalates must be 
taken into account ; and ano ther expert stated that the amount of DEHP concerned by the 
exemption requests seems very low in comparison with the DEHP used in other non -electric al 
applications.  The application was also discussed on the  23rd February 2021  Member States ’ Expert 
Group meetingxi, where no questions or comments were raised . After notifying the European 
Council and Parliament , the Commission adopted it as entry 45 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 imminent ly 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  
The applicant, COCIR, applied for a new exemption for the use of DEHP within in -vitro diagnostic 
equipment (Category 8) that measure specific substances in body fluids on the 17th of July 2018.  
The applicant indicated that DEHP is used as a membrane solven t for the io n selective electrode 
(ISE) that are used in point of care (PoC) analysers , to measure concentrations of sodium and 
potassium ions, pH, and partial pressure of CO2 ( pCO2 ) in whole blood and other fluids . The 
applicant  later  clarified this meant serum, plasma, urine, cerebral spinal fluid , and pleural fluid, as 
well as dialysate fluid to aid in blood cleaning during dialysis.  
As COCIR  explained  “Point of Care (PoC) analysers are medical devices used in situations where 
resul ts of body fluid analysis are required in the shortest time possible , in order to enable quick 
therapeutic intervention” , examples include  emergency departments, intensive care units, 
neonatal units and in operating theatres .   
The ISE sensors are supplied  to hospitals as components of disposable cartridges  that contain the 
sensors  required  for the measurements, “the chemicals used for the analysis and carry out 
measurement, washing and waste disposal, aqueous quality controls and electronics” . These 
cartri dges are only compatible with the specific type/model of analysers  used by hospitals . “The 
system utilizes mathematical formulas (algorithms) that are specifically designed for each sensor 
(membrane formulation). Therefore , it is the total integrated syste m (instrument, reagents, sensor 
formulation, algorithms) that is the complete system device which yields clinically acceptable 
performance and result. ”xiii That means, without the exemption , the analysers already on market 
cannot operate as they will not be compatible with any new cartridges that are produced without 
DEHP.  
The following figure illustrates  the role of  DEHP in the analyser and includes information  on the 
equipment ’s features .   
   
 
11 
 
 
 
 
Figure 1: Schematic to illustrate the role of DEHP in the PoC analysers . 
 
The following link illustrates a typical analyser, which  the applicant included  it in its clarification 
documentxiv: RAPIDPoint® 500e Blood Gas System (siemens -healthineers.com)  
According to the  interpretation of the Öko-Institut, “these cartridges containing DEHP are 
consumables of the PoC analysers, which are nevertheless to be considered as electrical and 
electronic equipment (EEE) ”. They are disposed once the chemicals have been consumed , after a 
fixed period of time (e.g. 28 days) or after a specific number of samples have been analysed (e.g. 
750) .  
According to the applicant, the key functions of the cartridge  are the following :  
• ”Must  be able to analyse whole blood directly,  
• Must not affect st ability of membrane or electrodes during use or in storage,  
• Cartridges must be compatible with analysers already on the market and in use within EU 
hospitals,  
• Give analysis results within as short time as possible, ideally within one minute  
• Change -over tim e to replace the used cartridges should be as short as possible, ideally 
less than 30 minutes. “ 
DEHP, as a plasticiser must  have the following technical characteristics:  
• “Be liquid over a wide range of temperatures,  
• Be compatible with, and solvate the other membrane components,  
• Not induce phase separation,  
  
 
12 
 
 
• Not exhibit crystallization,  
• Be lipophilic so it does not leach from the membrane during the use“  
 
 
2.2 Additional information considered  
 
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 Re gulation (EC) No 1907/2006 ” (REACH).  Therefore, the following section 
will look at any potential conflicts with (EU) REACH.  
DEHP is registered in the EU in the 10,000 - 100,000 tonnes per annum volume1. The registered 
uses shall be consistent with Annex XIV and Annex XVII.  
At the time of the adoption and  publication of Directive (EU) 2015/863, REACH  Annex XIV included 
DEHP due to its reproductive effects. There is an exemption for DEHP: Uses in the immed iate 
packaging of medicinal 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 production of spare parts for the repair in certain cases. The applicant 
considers the cartridges consumables rather than spare parts for repair, upgrade or capacity 
expansion;  therefore, this is  not applicable.  
Applications for Authorisation were received for DEHP used in other  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)  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,  its entry was updated with the inclusion of endocrine disrupting for human 
health.  The Annex XIV entr y for DEHP  has 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, 
 
 
1 https://echa.europa.eu/registration -dossier/ -/registered -dossier/15358    
 
13 
 
 
even at that point, there will be no conflict between th is exemption  request  and EU REACH, as the 
substances are already incorporated into the articles  when imported to the EU . The scope of 
Authorisation is the use of substances  on their own or in mixtures , or when  incorporating them 
into articles within the EU. As the applicant states: “ion selective electrode membranes containing 
DEHP are manufactured outside of the EU and so only articles are imported into the EU and DEHP 
is not used as a chemical substance in th e EU.”   
Articles are typically regulated via restrictions (Annex XVII) and although 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/ECxv. Entry 51 was updated to its present form in 
December 2018 via the Commission Regulation (EU) 2018/2005.  Based on its toxic to 
reproduction category 1B classification, entry 30 also applies to DEHP , however, entry 30 restricts 
supply to the public , whilst this application in only sold to professional users (i.e. , health facilities).  
COCIR also mentioned a registry of intentions under REACH  regarding materials with prolonged 
skin contact . The Öko-Institut confirmed , however, that the registry of intentions, to which COCIR 
refers, forms part of the amendment of entry 51 of Annex XVII and does not apply to the 
exemption request. Furthermore, t he cartridges in question are also sealed , thus no prolonged 
skin contact can occur.   
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 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, ISE importers 
might need to submit a notification depending on the concentration of DEHP in the smallest part 
of the complex object that meets the  article  definition . However, from this respect, the exemp tion 
(in our opinion) does not weaken the environmental and health protection in the EU , as the SCIP 
notification requirement is not a restriction .     
 
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 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 (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 r eplace 
the existing directives after a transition period.    
 
14 
 
 
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 
the d evice. 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 scie ntific 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 justificationsxvi. 
 
2.2.3 Technical feasibility and availability of substitutes  
The applicant states that there is currently no practical alternative to the use of DEHP in the ISE 
membrane that would enable the accuracy, co rrect data and efficiency that is provided with the 
use of DEHP. Due to the nature of the use in in-vitro devices, i.e., in critical care and emergency 
situations and the scale of use of these devices, the applicant states that none of the current 
options enable the rapid results that DEHP enables.   
When introducing the alternatives tested  in prior R&D  activities , the applicant discussed  different 
levels of substitution , as illustrated in Figure 2.   
 
Figure 2: Illustration of the different levels of substitution: 1: alternative plasticiser, 2: alternative analysis method, 3: 
alternative analysis technique  
 
1) The first  level  is the substitution of DEHP in the membrane  with alternative 
plasticisers . Several manufacturers of IVD ion selective electrodes (ISE) have 
attempted to replace DEHP  with alternative substance showing similar properties.  For 
example, in one experiment, s ensors using nitrophenyloctylether (NPOE), dioctyl 
sebacate (DOS), dioctyl a dipate (DOA), diundecyl phthalate (DUP), ditridecyl phthalate 
(DTP) resulted in unacceptable drift , which  made it impossible to provide reproducible 
  
 
15 
 
 
and accurate results.  (Drift is a natural phenomenon caused by physical changes and it 
affects the sensor’s  accuracy. ) “This test has shown that DEHP exhibits the best 
balance between initial drift after one hour and reproducibility ” xiii. This  has allowe d 
the technology to meet the needs of the critical care environment in particular a short 
period of time to obtain results and a short time before first measurement with a new 
cartridge.  
 
 
Figure 3: Initial drift (mV/min) measured at T = 30 minutes and drift at T = 60 minutes after exposure to aqueous 
solutions for each of the tested plasticizers  
 
2) The applicant introduces several alternative analysis methods  to measure the same 
analytes such as ion chromatography, flame pho tometry, atomic adsorption 
spectroscopy and glass pH electrodes for pH.  Most of these are , however,  laboratory -
based methods (i.e. , the sample would need to be sent to hospital’s laboratory and 
testing would take several hours instead of minutes), often ne ed a skilled operator, 
more sample  material  (e.g. , pH electrode needs to be immersed), and take 
significantly more  time . The applicant also notes that “that Ion chromatography, 
Flame Photometry and Atomic Adsorption Chromatography all yield the total 
conce ntration of the analyte. The physiological and clinical relevant result is only the 
ion activity, which is the portion which is ionized and free in the sample.” Due to the 
critical limitations, none of these were found to be acceptable.  
3) COCIR also suggest ed an alternative analysis technique , the so -called “lab-on-a-chip” . 
According to COCIR, “this is the main focus  of IVD equipment manufacturers. This 
technique is likely to use ion selective electrodes but these, the chemical pumps and 
analysis electronics are miniaturised so that only very small samples are required and 
analysis can be fairly rapid.”   
 
In terms of the time required to develop and implement the above alternatives,  the applicant 
estimates about 7 -8 years for development and 2 years for regulatory (re -)approval for  replacing 
DEHP and reformulating the membrane but using the current design. The modified  ISE modules, 
however, would not work with the current analysers.   
For the development of  the lab -on-chip technology, the applicant estimated about 8 -10 years. In a 
response to the first clarification questionnaire, COCIR clarified that the work on this a lternative 
began before 2015, it “is in feasibility phase and will take 8 to 10 years before complete 
  
 
16 
 
 
replacement will be possible”.  During the stakeholder consultation  Radiometer stated the 
following: “To Radiometer’s knowledge the ‘lab-on-chip’ technolog y will not be available for the 
foreseeable future.”   
COCIR explaine d that the exemption is needed for analysers placed on the market post 2021 , but 
before the alternative is available (expected in about 8 -10 years) and to assure reverse -
compatibility for analysers already at hospitals and only compatible with DEHP ISE. Considering 
that hospitals and clinics in the EU already using devices that require DEHP -membranes on its ISEs 
would need to obtain consumables until the analysers reach end of life, the app licant estimate d 
that: “cartridge consumables will be needed in the EU at least until 2030 and so this exemption 
will be needed for these until this date.”   
During the stakeholder consultation, Radiometer Medical ApS submitted a contribution  that 
claimed t hey have an ongoing project for substituting DEHP in ISE . Their plan at that time was to 
substitute DEHP before 21st July 2021, however at the time of submission , they were not able to 
point to a suitable substitute. Anthesis has reached out to Radiometer to confirm whether they 
have accomplished  the successful substitution , they confirmed that they were not able to 
complete their substitution plan yet.  
Based on exemption 41 of Annex IV for lead in blood gas analysis c artridges, the Öko-Institut 
established that there are at least four manufacturers placing equipment in the EU market (Roche, 
Siemens, Instrumentation Laboratories and Radiometer), and thus concluded that three of the at 
least four manufacturers of blood a nalysis devices have not achieved substitution and would need 
the exemption.  The fo rth company is Radiometer  who  stated in their contribution to the 
stakeholder consultation that  they plan to substitute before July 2021 . During th e clarification 
phase, the  applicant stated that they were unaware whether other manufacturers were using 
DEHP in analytes . 
Based on their research , the Öko -Institut concluded, that “even though a broad range of RoHS 
compliant plasticisers exist and have been tested, the compatibil ity with the intended use of the 
sensors in PoC situations, makes time and precision of results a critical feature that needs to be 
ensured for the ISE application described by the applicant”.   
In their assessment, Öko-Institu t had also reached out Professor Mark Meyerhoff from the 
University of Michigan  regarding the technical feasibility to substitute DEHP in polymer membrane 
ISEs. Based on his input, Öko-Institu t concluded that the substitution of DEHP “is in principle a 
feasible process ”. As a technical consultant on the electrochemical sensor technology with more 
than 30 years of experience, Profe ssor Meyerhoff confirm ed that in his opinion “ it is possible that 
all ISE sensors within other whole blood analysers can indeed be prepared without the need to 
employ DEHP in the sensing membranes”  vi 
When asked to respond to this, COCIR provided the following comment : “There are complex 
interactions between the sensor membrane formulations, internal electrolyte formulations, 
system calibration reagent surfactants, calibration reagent preservatives and compatibility with 
internal system materials used to house the sensors. The membrane formulations are specifically 
optimized to function within the system and all components that contac t the sensors. All these 
aspects need to be addressed to yield a stable, reproducible , and useful system. In our exemption 
request we also noted that the system utilizes mathematical formulas (algorithms) that are 
specifically designed for each sensor (mem brane formulation). Therefore,  it is the total integrated 
system (instrument, reagents, sensor formulation, algorithms) that is the complete system device 
which yields clinically acceptable performance and results .” xiii   
 
17 
 
 
“Overall system stability and availability is very important to enable quick treatment of patients. In 
our exemption request we showed data that alternative plasticizers do not enable a stable system 
and will result in delayed treatment of patients. This delay can negatively impact patient 
outcomes. We also showed data that alternative plasticizers yield sensors with more variability. 
This can cause low quality clinical results leading to improper treatment of patients. The 
conclusion of our data was the following:  “DEHP exhibits the best balance of initial drift after one 
hour and reproducibility and is therefore the preferred plasticizer. This has allowed the 
technology to meet the nee ds of the critical care environment in particular a short period of time 
to obtain results and a short time before first measurement with a new cartridge.”  xiii  
Based on Radiometer’s contribution  to the stakeholders’ consultation , the Öko-Institut concluded  
that substitution is possible in the timeframe before the restriction is entering into force, but 
“finding a compatible substitute may be more time -consuming for some manufacturers as it is a 
trial-and-error  process.” Thus some manufacturers will still need the exemption to complete their 
substitution plan. Furthermore, as ment ioned above, Radiometer confirmed recently that they 
were not able to implement an alternative as they suggested during the European public 
consultation.  
 
2.2.4 Environmental considerations  
In terms of environmental risks, the applicant states that without the exemption, the in -vitro 
diagnostic analysers would need to be disposed of prematurely, increasing  electrical equipment 
waste . In the answers to the clarification questionnaire  xiv, COCIR provided estimates of  the 
possible amounts of waste generated through a forced substitution.  This was estimated to be > 
1,000 t onnes per annum , relating  to the substitution of blood analysis devices already operating 
on the market  and considering all associated consumables , based on  the following assumptions:  
• 30,000 analysers already on the EU market x 16 kg ≈ 500 t  
• 12 cartridges per analyser per year x 1.34 kg ≈ 500 t  
COCIR also stated that the manufacture of new alternatives would have negative environmental 
impacts , i.e., in resources used before the analysers reach their full potential .  Furthermore , the 
applicant also indicated, that “Replaci ng these 500t by new devices would also lead to additional 
RoHS substances entering the EU market (e.g. , lead in steel up to 0.35%, lead in aluminium with 
up to 1.5%, lead in copper with up to 4%)2. Assuming that 20% steel, 10% aluminium and 5% 
copper are  being used, with a lead content of 0.35% in steel, 1.5% in aluminium and 4% in copper, 
the total weight of additional lead put on the market would be 2,100 kg (compared to a saving of 
2.2 kg DEHP)”. It should be  noted that this would be realised  irrespect ive of the exemption, when 
new equipment will be installed , however, in case the exemption is rejected, this impact would be 
accelerated. This data is summarised in Table 1 . 
 
 
2 Using lead in ion selective electrode is covered under a separate application for exemption    
 
18 
 
 
Table 1: Estimation of the total weight of lead entering the market through replacement of the PoC analysers currently in 
stock.   
 
 
The Öko-Institut raised the possibility of selling  surplus  consumables outside  of the EU, but COCIR 
indicated it is not possible “as there are other distribution centres w hich support the rest of the 
world. Manufacturing production and distribution centres are pre stocked based on forecast 
demand,  so all material is accounted for. In addition , there is a limited shelf life so all stock would 
go to waste.”  Due to the limited  shelf -life (9 months) , it is also not possible to stock up on 
cartridges for hospitals  for the entire lifetime of their analysers . However , it is assumed that at 
least some of the  500 tonnes of c onsumables could be still used, even in a  forced substitution  
scenario .  
Regarding the  potential 500t wasted analysers , it is important to note,  that not granting the 
exemption would only mean premature  obsolescence  (emphasis added by Anthesis) , i.e., no 
additional waste would be generated , but rather th at the waste of such devices shall be generated  
before they reach their full potential. “The average life -time of ISE PoC Analyzer is 9.7 years, with 
>50% of the install base older than 10 years .” xiii 
Radiometer stated in their contribution to the public consultation that  up to 2019  they placed 
approximately 7 ,800 analysers on the market. They estimated the weight of  analysers at risk to be 
potentially wasted  be 73 tons.  
The applicant highlights that in contrast,  not granting the exemption would help to avoid entering 
2.2 kg DEHP to the European market. (This will decrease when alternatives enter the market ). The 
Öko-Institut also added, that in contrast to the 2.2kg, DEHP is currently registered in 10,000 -
100,000 tonnes in the EU.  
Finally, as ISE is considered biohazard , thus sent to incineration as medical waste,  not granting an 
exemption is not expected to lead to environmental benefits in the form of reducing emissions  
and health risks in EEE waste management facilities .  
 
2.2.5 Socio -economic impacts  
Human health impact :  
As the devices are used in critical care diagnostic equipment,  if there is no suitable alternative 
readily available, a significant  impact on human health  is expected . If not granted, the applicant 
states that it is likely that there would be serious negative imp acts on human health, due to the 
inability to rapidly assess ion levels using the DEHP -ISE analysers. If results are inaccurate or 
  
 
19 
 
 
delayed, this could lead to incorrect diagnosis, or further illness/death; however, the applicant 
states that the actual quan titative impact in terms of human health would be difficult to measure .  
Based on the  approximately  30,000 instruments currently in the EU , it is estimated that between 
90 and 120 million patients could be affected  if the exemption is not granted. These es timates 
account for the number of cartridges and samples taken per year that are reported and calculated 
by the manufacturers.  However, it can be assumed that there would be a requirement for 
manufacturers to inform hospitals and that they would take appro priate action  in due time  to 
minimise this impact . Even so, there would be an indirect impact on services due to the unplanned 
investment of purchasing new equipment. COCIR states that the additional investment that would 
be required by hospitals to replac e equipment would affect  patient care in hospitals due to 
reduced resource during training, and due to the  redistribution of funds.  Is also not clear  whether  
alternatives are available already .  
 
 Economic impact :  
The applicant , COCIR,  states that there will be an increase in fixed costs for new devices  due to  the 
need for substitution, as research for alternatives needs funding and new production equipment 
will be needed to build the substitute analysers.  
The applicant  estimated that h ospitals would be faced with costs greater than  €250 million  
(£208,896,250xvii) to replace all the existing equipment on the EU market.  COCIR also refers to  the 
decision -making process and associated time and economic burdens, as described in Gensch et al. 
(2019)xviii. The unanticipated investment for a single ho spital is estimated to cost over €300,000  
(£250,675), with an additional cost of integration  of new instruments wit h existing information 
systems (estimated at €20,000  (£16,711)). Furthermore, training for new equipment should be 
considered as loss of work, a hospital in Germany estimated that this could result in 1,200 hours 
of unproductive work time  xviii. According to Gensch et al. (2019),  the blood analysers in German 
hospitals are the same model and vendor to ensure standardisation and harmonised training.  
The consultant’s report stated that  “This unplanned investment may affect the general ability to 
provide patients with other services in light of limited budget, but it cannot be followed that 
medical facilities would not replace equipment as qui ckly as possible.”  As previously stated, it also 
cannot be assumed that all analysers  and all consu mables would be wasted , therefore,  the €250 
million  (£208,896,250) should be considered a s a high estimate.  
Radiometer estimated the total replacement cost including training to amount to approximately 
€130 million  (£108,626,050). 
Finally, it is important to note, that  “This exemption is justified on the basis that substitution is not 
technically practical and does not rely on socio -economic issues to justify  the maximum validity 
period ”. 
 
Employment : 
The consultant’s  report states that “COCIR refers to negative impacts along a range of industries 
e.g., manufacturing, supply chain, service, R&D, marketing, quality, regulatory,  information 
technology, associated distributors, medical services and hospitals.”  The Öko-institut assumes in 
case  there will be at least one company that reaches compli ance  (e.g. , Radiometer) “some 
negative effects on employment might be offset by the in dustry sector which has reached 
compliance” .   
 
20 
 
 
 
 
2.3 Conclusion  
Article 5(1)(a)  of RoHS 2  provides that an exemption can be justified if at least one of the following 
criteria is fulfilled:  
i. Elimination or substitution via design changes , or materials and components which do not 
require any of the materials or substances listed in Annex II , is scientifically or technically 
impracticable . 
ii. The reliability of substitutes is not ensured . 
iii. The total negative environmental, health and consumer safety impacts caused by 
substitution are likely to outweigh the total environmental, health and consumer saf ety 
benefits thereof.  
The independent assessment concluded that exemption can be granted based on the third criteria 
of article 5 (1)(a)  above in case the health and environmental impacts  of using DEHP in this specific 
application is compared to the “genera l scenario of substitution”, i.e. , when the substance cannot 
be used anymore. Typically, this criteria can be fulfilled by comparing the impact of the RoHS 
substance with the impact of the substitute, however, in this case no reliable substitute has been 
identified.  Öko-Institut considered  the first two criteria not to be fulfilled , as a reliable substitute 
was expected to be available by the time the restriction enters into force based on Radiometer’s 
contribution. However, this  assumes that Radiometer’s s ubstitution plan will  succeed , and 
Anthesis confirmed that this is not the case . Furthermore, this substitute would not be compatible 
with the analysers already on the market and used by hospitals. Therefore, not granting the 
exemption would inevitably lea d to “a decrease in health services to patients, either directly 
where analysis devices are not available to provide the services currently available at facilities or 
through funding being allocated from other services towards purchase of new analysis devi ces”. 
Considering the significant impact on hospitals and the early scrapping of equipment, Öko -Insitut 
recommended the maximum of 7 years for the duration of the exemption.  
The Delegated Act follows this recommendation, with the following reasoning: “the reliability of 
substitutes is currently not sufficiently ensured and the total negative environmental, health and 
consumer safety impacts caused by substitution are likely to outweigh the total environmental, 
health and c onsumer safety benefits thereof.”  vi In the interest of legal certainty and f or 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 entered into force.   
 
 
 
    
 
21 
 
 
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 ch anges or use of 
materials or components which do not include any restricted substances, is scientifically 
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 REACH  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 fo r 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 registrationxix.. 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  xx.  This is not a verified list of registrations that were transferred into UK REACH 
from EU REACH under Article 127 A (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, this means there is no  information to sug gest that any companies would 
manufacture or import D EHP in greater than 1 tonne per annum .  
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, this include s DEHP  due to its 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   
 
22 
 
 
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 
Autho risation originally granted to Rolls Royce in 2014xxi, 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 , as 
long as  Annex 14 only i ncludes 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 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 2020xxii: 
thus,  DEHP is included for its endocrine disrupting properties for human health and 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 ( cartridges ) when imported , 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 2 021/2022 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 the Annex XIV 
entry for DEHP  was included in the 8th recommendationxxiii. 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 periodxxiv. Therefore,  
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 2021xxv, and has sin ce created a  Registry of restriction intentionsxxvi. 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 2 020 the Defra  confirmed that it will not transpose the SCIP provisionsxxvii, 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 pr obably be communicated 
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 tonnexxviii. The Agency for UK 
REACH Work Programme 2021/2022 does not mention SCIPxxix. This means, that the import of 
DEHP in cartridges into GB does not require a notification  similar to the one to the SCIP database 
in the EU.   
   
 
23 
 
 
 
3.2 Scientific and technical practicability of substitution  
At the time of submitting the request for exemption in the EU, at least three  European 
manufacturers of blood analysis devices have not achieved substitution and need ed the 
exemption. A fourth  company, Radiometer  stated in their contribution to the stakeholder 
consultati on that  they plan to substitute DEHP before July 2021. Anthesis has reached out to 
Radiometer to confirm whether they have accomplished the successful substitution , and they 
confirmed that this is not the case.  During the clarification phase, the applicant  stated that they 
were unaware whether other manufacturers were using DEHP in analytes.  
Based on their  assessment, including a discussion with technical consultant on the 
electrochemical sensor technology with more than 30 years of experience, Professor Me yerhoff 
from the University of Michigan , the  Öko-Institut concluded that the substitution of DEHP “is in 
principle a feasible process” , however,  “finding a compatible substitute may be more time -
consuming for some manufacturers as it is a trial -and-error process.” The Delegated Act granted 
the exemption  because  “the reliability of substitutes is currently not sufficiently ensured and the 
total neg ative environmental, health and consumer safety impacts caused by substitution are 
likely to outweigh the total environmental, health and consumer safety benefits thereof.”  
Based on the information Anthesis received from Radiometer, it has been confirmed t hat, a 
suitable alternative has not been developed by the time this report is prepared . However, even if 
Radiometer succeeded,  the analyser equipment the hospitals already own would not be 
compatible with this.  
 
3.3 Environmental and socioeconomic conside rations  
At the time of the application , the GB would have been  included in the EU figures  describing the 
environmental impact of the exemption not being granted:  
• 500 tonnes of analyser equipment  and some of the associated 500 tonnes consumables  to 
be prematurely wasted  
• Approximately 2,100 kg of lead entering the market as part of the new equipment  
The amount of DEHP entering the market in the ISE cartridges  was estimated to be 2.2 kg per 
year, again, part of this would be placed on the GB marke t.   
Anthesis have not identified any information related to the proportion of the 30,000 analysers 
that are placed on the GB market, thus it is not possible to estimate the concrete numbers should 
the exemption applied to the GB .  
The same applies for the  financial burden of hospitals, without knowing how many analysers are 
placed on the GB market, it is not possible to estimate the total cost hospitals will face to replace 
their equipment. Anthesis have reached out COCIR to understand the size of the GB ma rket, but 
COCIR indicated this type of information is usually sensitive. Anthesis also enquired to COCIR for 
confirmation of  the three companies have s ales activities in the GB or providing an estimate for 
the analysers based on the GB market but have not received a response by the time of this 
report’s completion.  Anthesis also approached AXREM, who directed us to ABHI and BIVDA, but 
they have not respo nded by the time of submitting this report.  
Based on the review of the medical devices registered with  the UK Medicines & Healthcare 
products Regulatory Agency, there are at least two manufacturers placing SE kits  on the market :   
 
24 
 
 
Randox Laboratories Limited  and Siemens Healthcare Diagnostics Inc.xxx Based on the clarification 
document , xiv Siemens estimated that by 2020 >3500 central lab -type instrument s will be in place 
in the EU by 2020, manufactured by Siemens. COCIR estimates typically 3 instruments are used on 
each  site.  
This means at least some of the hospitals  in GB  will be affected , as they  use ISE equipment 
manufactured by or Siemens  Healthcare  Diagnostics . Anthesis has no information about the 
technology used by Randox Laboratories Limited.   
Gensh et al. (2019) xviii  estimated the unanticipated investment for a single hospital to cost over 
€300,000, with an additional cost of integration of new instruments with existing information 
systems (estimated at €20,000). Furthermore, training for new equipment should be considered 
as loss of work, a hospital in Germany estimated that this could result in 1,200 hours of 
unproductive work time xviii. According to Gensch et al. (2019), the blood analysers in German 
hospitals are the same model and vendor to ensure standardisation and harmonised training.  
The impact of health services is expected to be significant , due to the inability to rapidly assess ion 
levels using the DEHP -ISE analysers in case the consumable cannot be used after the restriction 
enters into force and due to the indirect effects of redistributing funds to purchase new 
equipment (if alternative  is available), loss of time due to training, etc.  
Increased fixed costs  are expected  irrespective if this exemption is adopted in the GB, as 
manufacturers  need  to fund the research and development activity to identify and implement an  
alternative , and to produce new equipment using the alternative technology . According to 
COCIRxiv, Siemens’ diagnostics business earned approximately $1.5 bn in  the EU in 2018, therefore 
approximately $0.45 bn can be attributed to POC assuming 30% contribution.  Again, no 
information on how much of their business in the GB contributes to this.  
The impact on employment and the health services can be reduced by alte rnatives entering the 
market, however, Anthesis has no information if any exist to date.  
 
 
3.4 Exemption duration  
The exemption  period granted by the EU is for 7 years  and will therefore expire on the 21st July 
2028.  Based on i nformal discussion between Anthesis and COCIR, even if the applicants have 
made progress with the substitution  up to date , the maximum period is required for the hospitals 
to change the analyse rs, as the substitution will inevitably mean new technology , not compatible 
with their existing equipment .  
 
 
4. Recommendation  
A reliable alternative  has not been identified  and any new technology  would not be compatible 
with the analysers owned currently by hospitals, leading to potentially significant financial impact 
on hospitals , along with negative impact on health services. 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 45  granted under RoHS 2 in  EU-27 to   
 
25 
 
 
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 
 
 
    
 
26 
 
 
References  
 
 
 
i Directive 2011/65/EU of the European Parliament and of the Council of 8 June 20 11 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/?ur i=CELEX:32011L0065&from=EN  
 
ii The Restriction of the Use of Certain Hazardous Substances 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) Regulations 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 https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=PI_COM%3AC%282021%295868&qid=1635946952184  
 
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 -01aa75ed71a1/language -en/format -PDF/source -235265133  
 
viii COCIR (2018) Application for an Exemption Request  for Bis (ethylhexyl) -phthalate (DEHP) in ion selective 
electrodes for point of care analysis of ionic substances in human body fluids 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_17/application_COCIR_RoHS17_DEH
P_Phthalates_in_ion_selective_electrods_20180708.p df 
 
ix https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_17/ 
contribution_Radiometer_medical_RoHS17_Ex_2019_1_DEHP_20190516_ public.pdf  
 
x European Commission Expert Group for RoHS 2: 21st October 2019 Meeting Minutes: 
https://ec.europa.eu/transparency/expert -groups -
register/screen/meetings/consult?lang=en&meetingId=15850&fromExpertGroups=true  
 
xi European Commission Expert Group for RoHS 2: 23rd February 2021 Meeting Minutes:  
https://ec.europa.eu/transpare ncy/expert -groups -
register/screen/meetings/consult?lang=en&meetingId=23745&fromExpertGroups=true  
 
xii 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/support ing_documents/Anthesis%20UK%20RoHS%20Phthalates%20Report.pdf  
 
xiii Personal communication by email submitted to the Öko -Institut on 2.10.2019  
 
   
 
27 
 
 
 
 
xiv Clarifications on COCIR Application from Öko -Institut 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_17/clarification_COCIR_Ex_2019 -
1_RoHS17_1st_round_Cons_2019_1_FINAL_Response.pdf  
 
xv 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 -93c80b5 7c5ee  
 
xvi Scientific Committee on Health, 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  
 
xvii Google Finance (Accessed 6/1/2022): https://www.google.com/intl/en/googlefinance/disclaimer/  
 
xviii Gensch, C. -O.; Baron, Y.; Deubzer, O. (2019): Study to assess eight (8) exemption requests in Annexes III 
and IV to Directive 2011/65/EU: “Renewal of exemptions III.41, IV.37, IV.41, and requests for new 
exemptions for lead and DEHP in certain NRMM engines applications, lead in solder and hexavalent 
chromium to be used in mass spectrometers, lead in certain thermal cut -off fuses and lead in solders of 
certain applications used to identify radiation” (Pack 14) – Final -amended,. Online available at 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/RoHS_Pack -14_final_ 
report_amended_20190305.pdf, last accessed on 23 Aug 2019.  
 
xix https://www.gov.uk/governme nt/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  
 
xx https://www.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  
 
xxi https://consultations.hse.gov.uk/crd -reach/reach -afa-001-01/ 
 
xxii https://www.hse.gov.uk/reach/candidate -list.xlsx  
 
xxiii https://www.hse.gov.uk/reach/resources/draft -recommendation -2021.pdf  
 
xxiv HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm . 
 
xxv 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  
 
xxvi HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm  
 
xxvii Chemical Watch. [Online] [Cited: 21 October 2021] https://chemicalwatch.com/183888/uk -will-not-
transpose -the-waste -framework -directives -scip-provisions  
 
   
 
28 
 
 
 
 
xxviii https://www.hse.gov.uk/reach/substance -in-articles -notification.htm  
 
xxix https://www.hse.gov.uk/reach/resources/work -programme -2021 -22.pdf  
 
xxx 
https://aic.mhra.gov.uk/era/pdr.nsf/devicecode?openpage&RestrictToCategor y=Ion%20selective%20electr
ode%20(ISE)%20reference%20solution%20IVD,%20reagent&start=1&count=200  [Online] [Cited: 15 
November 2021]