Department for Environment Food & Rural Affairs  (Defra)  
Review of the inclusion of Phthalates in The RoHS 
Regulations in medical devices and monitoring and 
control instruments  
Report prepared by: Helen Kean  
Report Approved by:  Dr Richard Peagam  
Date : 22/09/21  
   
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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 adversely affect the recommendati ons, opinions or findings contained in this report.  
 
   
 
Review of the inclusion of Phthalates in The RoHS 
Regulations in medical devices and monitoring and 
control instruments  
Anthesis (UK) Limited   
 
Prepared for:   Prepared by:  
Graeme Vickery  Dr Helen Kean  
Defra  Anthesis (UK) Limited  
2 Marsham Street  Unit J, Taper Studios  
London  175 Long Lane  
SW1P 4DF  London  
 SE1 4GT  
  
Report written by:   Email:  
Helen Kean  Website : www.anthesisgroup.com  
+44 (0)78 24 444 643  Tel: 01865 250818  
helen.kean@anthesisgroup.com  Company Registration : 08425819  
  
  
Quality Assurance   
  
Report checked by:  
Richard Pea gam, 2nd July 2021  
Paul Ashford, 5th July 2021   
  
Report approved by:   
Dr Richard Peagam , 22/09/21   
+44 (0)7824 314 194   
richard.peagam@anthesisgroup.com  
  
Signature   
  
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Executive summary  
 
Background and Objectives  
When Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 (RoHS 2) (1) 
entered into force on 21 July 2011 only six substances1 were restricted from use in electrical and electronic 
equipment (EEE) and included in Annex II. Article 6  of this Directive , however, provide s the ability for  the 
substances in Annex II to be reviewed and amended . The first such review was mandated to be no later than 
22nd July 2014. Accordingly, during late 2012 and into 2013, 56 substances were reviewed for potential 
inclusion in Annex II . This led to a delegated Directive ( (EU) 2015/863 ) being adopted  on 31st March 2015 to 
expand the list of restricted substances. The revised Annex II included  four phthalates (Bis(2 -ethylhexyl) 
phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP)) with 
deferred effective dates for their use in medical devices  (category 8 ) and monitoring and control instruments 
(category 9) until  22nd July 2021.  
With 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 “The Restriction of the Use of Certain Hazardous 
Substances in Electrical and Electronic Equipment Regulations 2012” (The RoHS Regulations)  (2) has been 
updated to reflect the rules for placing such equipment on the market in Great Britain and in Northern Ireland  
(3) (4). However, The RoHS Regulations have yet to be updated with respect to the restrictions pertaining to 
the four phthalates used in medical devices  and monitoring and control instruments . 
Anthesis (UK) Limited (Anthesis) has been contracted by Defra through award of contract No. 59661 to review 
the appropriateness for The RoHS Regulations to be updated to include phthalates such as they pertain to 
medical devices and monitoring  and control instrumentation.  
 
Key Findings  
The inclusion of Bis(2 -ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and 
Diisobutyl phthalate (DIBP) in Annex II of  The RoHS regulation is recommended. Their inclusion in  RoHS 2 has 
triggered four exemption requests to the European Commission for medical devices (category 8) and 
monitoring and control instruments including industrial monitoring and control instruments (category 9) . The 
 
 
1 lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers  number is small , as expec ted, because of the transition times afforded by  the long lead times for  regulatory 
change  brought through (EU)2015/863  and concerns around the use of phthalates more generally.  REACH is 
able to regulate substances of concern via Authorisation and Restrict ion but these processes  have their 
limitations , thus extending the restriction of phthalates in EEE  ensures imported articles are considered. 
Further more,  their inclusion in The RoHS Regulations  is anticipated to bring about additional worker 
protection, p articularly for waste operators , and to reduce  emissions to the environment. Industry has been 
working on finding alternatives to phthalates for several years  and the exemptions  requested in the EU should 
be seen as “bridging ” requests , whilst the alternatives are validated. The financial impact to includ e phthalates 
in categories 8 and 9 is anticipated to be less than ±£5 million annual net direct cost to business (EANDCB).  
 
 
 
 
   
Table of contents  
Disclaimer  ................................ ................................ ................................ ................................ .........................  2 
Anthesis Consulting Group  ................................ ................................ ................................ ...............................  4 
Executive summary  ................................ ................................ ................................ ................................ ..............  4 
Background and Objectives  ................................ ................................ ................................ ..............................  4 
Key Findings  ................................ ................................ ................................ ................................ .....................  4 
Table of contents  ................................ ................................ ................................ ................................ .................  6 
Table of figures  ................................ ................................ ................................ ................................ ....................  6 
Table of tables ................................ ................................ ................................ ................................ ......................  6 
1 Introduction  ................................ ................................ ................................ ................................ .............  7 
1.1 Legislative context  ................................ ................................ ................................ ...............................  7 
1.2 Project scope and methodology  ................................ ................................ ................................ ..........  7 
2 Background to Directive (EU) 2015/863  ................................ ................................ ................................ .. 7 
3 Developments within the EU since 2015  ................................ ................................ ...............................  11 
3.1 EU REACH Authorisation  ................................ ................................ ................................ ....................  11 
3.2 Exemption requests under Article 5 of RoHS 2  ................................ ................................ ..................  12 
4 Impact of adopting (EU) 2015/863 in Great Britain  ................................ ................................ ...............  14 
4.1 Links to UK REACH ................................ ................................ ................................ ..............................  14 
4.2 Medical Device Regulations  ................................ ................................ ................................ ...............  15 
4.3 Expected response by industry  ................................ ................................ ................................ ..........  15 
5 Recommendation ................................ ................................ ................................ ................................ ... 16 
6 References  ................................ ................................ ................................ ................................ .............  17 
 
Table of figures  
Figure 1: Overview of regulatory activities on phthalates (DEHP, BBP, DBP and DIBP) within REACH and RoHS 2.  .............  11 
 
Table of tables  
Table 1:  Overview of the Commission’s Assessment to include phthalates in Annex II of RoHS 2.  ................................ ....... 10 
Table 2: Overview of exemption requests received for phthalates for use in categories 8 and 9.  ................................ ........  13 
   
 
7 
 
 
1 Introduction  
1.1 Legislative context  
Annex II of Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 
(RoHS 2) (1) governs those substances restricted for use within electrical and electronic 
equipment. Article 6 of the Directive provides the ability for further substances to be added to 
Annex II and was specific that a review and amendment of Annex II should be consi dered by the 
Commission no later than the 22nd July 2014. This review was undertaken in period November 
2012 – May 2014 and resulted in the adoption  of the D elegated Directive (EU) 2015/863  on 31st 
March 2015 to expand the list of substances in Annex II. T he revised Annex II included four 
phthalates (Bis(2 -ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate 
(DBP) and Diisobutyl phthalate (DIBP)) with deferred effective dates for their use in medical 
devices (category 8) and monitor ing and control instruments including industrial monitoring and 
control instruments (category 9) until 22nd July 2021.  
The RoHS Regulations (2) have been amended several times following various European Directives  
amending Dir ective 2011/65/EU  and have been preserved in Great Britain through the EU 
Withdrawal Act 2018 with  subsequent Statutory Instruments to correct deficiencies arising from 
the UK leaving the EU . The amending regulations , Regulation 3 , (4) repatriate powers to the 
Secretary of State to consider amending the list of restricted substances and their maximum 
concentrations to be permitted in homogeneous materials which may be contained in EEE . Such 
amendments mu st consider UK REACH , the potential impact  of exposures to workers involved in 
waste EEE management and processing , environmental e xposures and releases , as well as the 
availability of substitutes or alternative technologies. This scenario is thus applicab le to the 
inclusion phthalates as they pertain to categories 8 and 9  as restricted substances  and to align 
with the EU .  
 
1.2 Project scope and methodology  
Anthesis ’ review has focused on understanding the European Commission’s rationale to include  
the four phthalates in Annex II of RoHS 2  in 2015.  This review has been complimented with an 
analysis of regulatory developments for these substances both within the scope of REACH ((EU) 
1907/2006) and exemption requests under RoHS 2.  Informal o utreach to sector trade associations 
was made to assess industry’s response to the restriction of phthalates in medical devices and 
control and monitoring instruments , as well as a review of UK REACH (5) with respect to the  
substances.  
The full assessment reports on each phthalate were not available to Anthesis at the time of the 
review, except for DIBP, but Anthesis does not see this as critical in its assessment of whether The 
RoHS Regulations should be extended to include the restrictio n of phthalates in medical devices 
(category 8) and monitoring and control instruments including industrial monitoring and control 
instruments (category 9).  
 
2 Background to Directive (EU) 2015/863  
As mentioned in Section 1, Article 6 of RoHS 2  provides the ability for further substances to be 
added to Annex II and was specific that a review and amendment of Annex II should be considered 
by the Commission no later than the 22nd July 2014. Furthermore Recital 10 highlighted four   
 
8 
 
 
substances2 whic h were to be given priority for review. They had not been included at the time of  
the recasting of RoHS as there was insufficient information available on the environmental, 
economic and social impacts as well as the  potential substitutes  (6). Accordingly, the Environment 
Agency Austria, Umweltbundesamt (AUBA) was contracted by the Commission , firstly to develop a 
methodology for identifying and assessing substances for restriction under RoHS  2, and secondly 
to apply that method ology to the identified substances including those called out in Recital 10. 
This work was undertaken between  November 2012 and December 2013 and the final reported 
published by the Commission on 4th February 2014  (6). It inclu ded stakeholder consultations; the 
fourth of which was specific to those substances in Recital 10.  
AUBA assessed the potential inclusion of 56 substances which included 11 elements (metals) , 
phthalates, brominated flame retardants, chlorinated flame retard ants and chloroalkanes. Four 
phthalates – Bis (2 -ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutyl 
phthalate (DBP)  and Diisobutyl phthalate  (DIBP) – were ranked as having the highest priority for 
further assessment together with 4 othe r substances. AUBA went on to assess DEHP, BBP and DBP 
in more detail and DIBP was assessed by the Öko -Institut (7). 
Table 1 summarises the key conclusions for the four phthalates. AUBA’s assessments  were  based 
on the conditions set out in RoHS 2 Article 5  (1)(a) , i.e. to ensure there would be no weaken ing of  
enviro nmental and health protection , specifically during EEE waste management operations  and 
releases from disposal , the availability and reliability of substitutes and the socioeconomic impacts  
of a restriction .  
It was noted by AUBA that there was a limited am ount of information about the use  of these 
phthalates in EEE . AUBA had relied on modelling of worker and environmental exposure s owing  to 
the lack of available monitoring data and true operating conditions , but where such data did exist  
for DEHP , exposure s had exceeded the Derived No Effect Concentration (DN EC) advised by the 
Committee for Risk Assessment (RAC)  (8). AUBA also noted that the release  estimates  were likely  
underesti mates  but were dependent on the actual quantities of phthalates used in EEE, lifespan 
and collection rates  of the EEE . Taking account of the precautionary principle , the risks arising 
from similarly  acting phthalates should also be considered . Finally, alt hough there would be some 
negative impacts by restricting these phthalates from use in EEE the overall  health and 
environmental  benefits outweighed these . Therefore, inclusion of these substances within Annex 
II was seen as a measure to reduce the impact on the environment and human health by reducing 
the amount of hazardous waste  and the amount available in the  recycling loop.  
Although DEHP, BBP and DBP were identified  to be potentially used within EEE, no evidence was 
found for the use of DIBP in EEE.  However, owing  to its similar functional properties  and hazard 
profile with respect to reproductive toxicity, the risk of DIBP being used as an alternative  was 
foreseen  and thus recommended  to be included in Annex II at the same time.  
Further justification for the inclusion of these phthalates in Annex II was to align with REACH 
Annex XVII, entry 51 specifically for toys to avoid double regulation (8).  
At the time of the adoption and publication of (EU) 2015/86 3, REACH  Annex XIV included these 
phthalates due to their reproductive effects. Applications for Authorisation were received for 
DEHP and DBP  for uses in EEE. As no applications were received for either BBP and DIBP these 
 
 
2 Hexabromocyclododecane (HBCDD), Bis (2 -ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutyl 
phthalate (DBP)    
 
9 
 
 
substances could not be placed as the substances themselves or in mixtures on the EU market for 
use or used for the production of articles in the EU after 21st February 2015 (so -called Sunset 
Date)  as per (EU) No 143/2011 and (EU) No 125/2012.  
The Commission also advised that the compliance date of 22nd July 2021  should apply to Annex I 
categories 8 and 9 to respect the higher reliability requirements and longer innovation cycles of 
products falling within these categories  and avoid legal uncertainty . The extension of Annex II 
woul d not exclude the ability for operators to apply for exemptions as per Article 5(1).    
 
10 
 
 
 
Substance  Sources of concern  Likely use areas  Availability of substitutes  
Bis (2 -ethylhexyl) 
phthalate (DEHP)  • Environmental releases during WEEE treatment notably to air 
(0.9 - 6.8 tonnes/annum) and wastewater (235 kg/annum) . 
Releases could arise from landfill and inc ineration as well as 
shredding of PVC cables.  
• Potential for secondary poisoning.  
• Potential exposure of workers above the DNEC advised by 
RAC during mechanical treatment of WEEE and in plastics 
recycling.  
• Negative impacts on waste management due to reduced 
recycling possibilities  (due to REACH)  & collection of 
hazardous waste.  
• Concerns of endocrine dis ruption properties without 
threshold for safe use.  • In PVC as a plasticiser.  
• Not considered essential within EEE  but 
niche applications could not be excluded.  • DINP (Di -isononyl phthalate ) & DIDP (Diisodecyl 
phthalate)  
• DINCH (Di -isononyl cycl ohexane -1,2-
dicarboxylate) and ASE  (Alkylsulfonic phenyl 
ester)  identified to be available and technically 
feasible and have lower toxicity profiles  and are 
reported to be used already . 
• Safe alternatives within the medical sector 
unknown.  
Butyl benzyl 
phthalate (BBP)  • Environmental releases during WEEE treatment notably to air 
(0.06 – 0.56 tonnes/annum ). Releases could arise from 
landfill and incineration as well as shredding of PVC cables.  
• Potential risk to worker s in shredder plants . 
• Concerns of  endocrine disruption properties without 
threshold for safe use.  • In PVC as a plasticiser.  
• Not as widely used in EEE as DEHP but 
niche applications could not be excluded.  As for DEHP plus DGD (Dipropylene  glycol di -
benzoate) and GTA (Glycerol triacetate) . 
Dibutyl phthalate 
(DBP)  • Environmental releases during WEEE treatment notably to air  
(0.15 - 1.4 tonnes/annum ). Releases could arise from landfill 
and incineration as well as shredding of PVC cables.  
• Risk to workers of systemic toxicity due to repeated dermal 
exposure arising from aerosol forming activities & local 
effects to the respiratory tract due to repeated inhalation 
exposure . 
• Concerns of endocrine disruption properties without 
threshold  for safe use.  • Not as widely used in EEE as DEHP but 
niche applications could not be excluded.  As for DEHP .  
Diisobutyl phthalate 
(DIBP)  Exposure to the environment and human health were not 
assesses in the context of EEE due to its limited or non -use. Understood to not be used in EEE  but 
cannot be excluded from  the scope of RoHS 
2. DBP 
Table 1:  Overview of the Commission’s Assessment to include phthalates in Annex II of RoHS 2.  
 
11 
 
 
 
3 Developments within the EU since 2015  
In the last six years there have been a number of regulatory developments with respect  to the 
four phtha lates included in RoHS 2 Annex II . The timeline of the developments  within RoHS 2 and 
REACH are shown in the schematic in Figure 1 and are discussed in the following paragraphs as 
these are seen to be relevant within the context of this review.  
 
Figure 1: Overview of regulatory activities on phth alates (DEHP, BBP, DBP and DIBP) within REACH and RoHS 2.  
 
3.1 EU REACH Authorisation  
As remarked  in Section 2 , applications for Authorisation  had been made for DEHP and DBP 
concerning EEE  ahead of the Latest Application Date (LAD) of 21st August 2013 . Anthesis’ own 
analysis shows that applications included the use of DEHP or DBP as a plasticiser  for PVC to be 
formed into articles as well as one use of DEHP to assist in the production of capacitors and 
lambda sensor elements  which have been identified for use within the manufacture of computer, 
electronic and optical products, as well as wider electrical equipment  (9). In this latter use, 
though, the applicant states that DEHP is not detectable in the final product  as it is  thermically 
decomposed during the product ion process of the ceramic article (11). 
None of the authorisation applications considers 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 an 
authorisation for uses within medical devices when the intrinsic properties of the substance 
identified has hazards only affecting human health. Further more Article 62(6) states 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 a nd the in vitro Medical Devices Regulation (EU) 2017/746 repealing 
Directive 98/79/EC with effect from 26 May 2022 , specifically identify phthalates and assesses the 
risk of those uses.  
In late 2014, though, DEHP was identified as an SVHC for its equivalen t level of concern based on  
its potential for endocrine disruption properties for the environment and in 2017 all four 
phthalates were further identified as SVHCs owing  to their endocrine disrupting properties for 
human health. The Annex XIV entries for th ese substances have yet to be amended but the 
  
 
12 
 
 
comitology process is already underway. Anthesis has confirmed that the WTO TBT was consulted 
(November 2020 – January 2021) (10) and the REACH Committee took a written vote on 5th March 
2021 and approved the amendments with 26 Member States in favour and 1 abstention (11). The 
draft regulation must next be submitted to the European Parliament and Council for scrutiny and 
adoption before publication in t he Official Journal. MedTech Europe anticipate that adoption will 
be in Q3 2021 which would mean the Latest Application Date  would be in Q1 2023 based on an 
18-month transition and the sunset date a further 18 months thereafter (12). 
According to MedTech Europe , DEHP is used as a plasticiser in blood bags and intravenous bags, 
tubing, respiratory masks, nutrition pockets, catheters and disposable gloves (12).  
If these medical device items are imported as finished articles into the EU  then they would be 
exempt from needing an authorisation , as indeed would other imported articles containing 
phthalates . Authorisation only controls the use of the substance or the substance in a mixture and 
not the article itself unless that article is produced within Europe. 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/EC (13). Entry 51 was updated to its present form in December 
2018 via the Commission Regulation (EU) 2018/2005.  
 
3.2 Exemption requests  under Article 5 of RoHS 2  
The purpose of RoHS 2 is to res trict “the use of hazardous substances in electrical and electronic 
equipment (EEE) with a view to contributing to the protection of human health and the 
environment, including the environmentally sound recovery and disposal of waste EEE” (Art. 1). 
Article  5 permits exemptions to be sought where the amount of the restricted substance exceeds 
the concentration specified in Annex II and i nclusion would  not weaken the  provisions set out 
within REACH  and where any substitute is scientifically or technically  impracticable, the reliability 
of the substitute is in question  and socioeconomic benefits can be justified. New and renewal 
exemptions are granted or extended at the discretion  of the Commission.  
An exemption request was received and granted in 2019  for the use of DEHP in rubber parts in 
category 11 ((EU) 2019/1845 ) which was in line with the deadlines in (EU) 2015/863 . The 
exemption was granted due to the uncertainty of the availability of alternatives beyond July 2019 . 
At the time of the RoHS 2 application n o application for authorisation had been  received for the 
use of DEHP in rubber products  and it was concluded based on the applicant’s justification that 
the finished articles were imported  and thus no authorisation was required and granting t he 
exemption would not be in c onflict with REACH Annex XVII.  
(EU) 2015/863 provided a transition period for phthalates in EEE fa lling within categories 8 and 9 
until 22nd July 2021. With this impending deadline f our exemption requests have been received by  
the Commission and have been reviewed by the contractor Öko -Institut and their assessments 
and recommendations published in 2020 (14) (15). Table 2 provides an overview of the 
recommendations made by Öko -Institut, which were  in principle to agree with the applicants’ 
requests. In the case of the application submitted as an amendment to Annex IV number 31a the 
Öko-Institut foresaw two possible options for modifying the present exemption but did not 
suggest a preferred mechanism as this was considered out of scope.  Referral by the European 
Commission to the WTO Committee on Technical Barriers to Trade (TBT) on 29th June 2021 has 
confirmed that the Commission has decided upon a new exemption (Annex IV, entry 47 ).   
 
13 
 
 
Publication of these three exemption requests in the Official Journal is expected imminently due 
to the 22nd July 2021 deadline  in (EU) 2015/863 and much re duced commenting window by the 
WTO TBT of 15 days.  
All three exemptions were discussed at the Member States Expert Group for RoHS on 23rd 
February 2021 . The minutes from this meeting report that there was some discussion on spare 
parts as relevant to entry  Annex IV,  31a but as the Directive does not allow for such a provision 
the proposal could  not be accommodated  (17). Reference to the SCIP database was also made  but 
the minutes do not describe how this might impact the exempt ion request , if at all . Since 5th 
January 2021 article suppliers are required to notify articles containing SVHCs above 0.1  % (w/w)  
to the SCIP database to improve information in the value chain and specifically to assist waste 
operators (17), Anthesis therefore assumes this was mentioned during the meeting if only to 
record that information about WEEE would be better informed  going forward about SVHCs 
therein.  
Entry No.  Recommended exemption  Expiry Date (recommended)  
Annex IV, 31a  
 
To be granted  
as Annex IV, 
47 (text in 
bold)  Either as a new exemption: Bis (ethylhexyl ) 
phthalate, dibutyl phthalate, diisobutyl 
phthalate and benzyl butyl phthalate in spare 
parts recovered from and used for the repair 
or refurbishment of medical devices, 
including in vitro diagnostic medical devices, 
and their accessories, provided that t he 
reuse takes place in auditable closed -loop 
business -to-business return systems and that 
each reuse of parts is notified to the 
customer.  
Or as an amendment to the existing entry: 
Bis (ethylhexyl) phthalate, dibutyl phthalate, 
diisobutyl phthalate, benzy l butyl phthalate, 
lead, cadmium, hexavalent chromium, and 
polybrominated diphenyl ethers (PBDE) in 
spare parts recovered from and used for the 
repair or refurbishment of medical devices, 
including in vitro diagnostic medical devices, 
and their accessories , provided that the 
reuse takes place in auditable closed -loop 
business -to-business return systems and that 
each reuse of parts is notified to the 
customer.  7 years – 21 July 2029  
 
 
 
 
 
 
 
 
 
 
Various due to the current 
exemption  
2019 -1 Bis (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.  7 years  
2019 -2 
merged with 
2019 -4 Bis-(2-ethylhexyl) phthalate (DEHP) in plastic 
compon ents in MRI detector coils.  1 January 2024  
Table 2: Overview of exemption requests received for phthalates for use in categories 8 and 9.  
   
 
14 
 
 
4 Impact of adopting (EU) 2015/863 in Great Britain  
4.1 Links to UK REACH  
On 1st January 2021 UK REACH  (5) 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 allow for continuity of supply, transitionary measures h ave been put into place enabling prior 
supply chains to initially notify the substance(s) concerned followed by full registration within 2 to 
6 years depending on the volume and/or hazards associated with the substance(s). These 
notifications can be made u ntil 27th October 2021 and as a consequence there is currently no 
equivalent publicly available database of those substances registered in Great Britain.   
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.  
 
4.1.1 Annex 14 (Authorisation)  
Substances included on 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 thus include DEHP, BBP, DBP and DIBP due to their intrinsic 
hazard as toxic to reproduction.  
The transitional arrangements pro vided for by UK REACH required 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 awaited 
from the EU, then o ther 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 2014 (16) but is out of scope of this report.  
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 disrup tors for the environment.  Similarly , as only one application for 
authorisation for electrical equipment was identified and described in Section 3.2  it is more likely 
that phthalates will be contained in imported articles, if at all , and would  thus be gover ned by 
Annex 17 . 
The Candidate List (the list of substances of very high concern (SVHCs )) is the precursor for 
including substances on Annex 14 and at the t ime of writing it is not known when the UK will 
move forward with updating Annex 14 and whether it w ill consider previous ECHA 
recommendations. T he Candidate List was transposed on 1st January 2021 to UK REACH and 
includes  those substances added up to and including June 2020 (19) : thus , the phthalates are 
included for their endocrine disrupting properties for human health and the environment.  If the 
Secretary of State’s decision agree s with ECHA’s recommendation  (17) to amend the Annex 14 
entries, then medical devices will be in scope of Authorisation .  
 
4.1.2 Annex 17 (Res trictions)  
REACH Annex XVII as of 31st December 2020 was transposed to UK REACH and included all EU 
restrictions that had entered into force which included any in their transitional period (18). 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   
 
15 
 
 
risk to human health or the environment. To date there have been no proposals from the UK 
Government to revise the present restriction for these phthalates . 
 
4.2 Medical Device Regulations  
The Medical Device Regulations (UK MDR 200 2 (19)) 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 medical devices in January 2021  (20). 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 devices in 
critical circumstances . The medic al 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, t he guidance 
does encourage operators to find alternatives to DEHP.  
 
4.3 Expected response by industry  
COCIR is the European Trade Association representing the medical imaging, radiotherapy, health 
ICT and electromedical industries . COCIR was the applicant for the current exemption requests in 
the EU  (see Table 2). The inclusion of the phthalates in Annex XIV owing  to their endocrine 
properties to the environment will impact its Members’ suppliers rather than the Members  
themselves , as the Members  purchase components containing DEHP. However, the membership 
has been working to substitute phthalates from the components and the exemptions have been 
sought under RoHS 2 to bridge the gap between Annex II restrictions applying to categories 8 and 
9 and replacement components being approved (e.g. in MRI coils) or better technologies with 
greater sensitivities for in vitro diagnostic  devices being available to the market. COCIR’s present 
concern is that the formal adoption and publication in the Official J ournal will not be achieved by 
22nd July 2021 for the new exemption requests (2019 -1 and 2019 -2/4), therefore they are working 
with the Commission to avoid having to stop selling such devices until the decision is in force (21). 
Anthesis has identified a  number of UK trade bodies supporting the medical devices industry and 
control instrumentation. A brief description of these is given below.  
• AXREM is UK trade association representing the interests of suppliers of diagnostic 
medic al imaging, radiotherapy, healthcare IT and care equipment in the UK.  Members 
supply the majority of diagnostic medical imaging and radiotherapy equipment installed in 
UK hospitals.  They are an associate member of COCIR.  
• Association of British HealthTech I ndustries (ABHI) and British In Vitro Diagnostics 
Association  (BIVDA) are both UK national association members  of M edTech Europe . 
MedTech Europe  is the European trade association for the medical technology industry 
including diagnostics, medical devices an d digital health . 
• British Healthcare Trade Association ( BHTA ) represent s the healthcare 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 i nstrumentation, control, automation and 
laboratory technology . 
Anthesis was able to engaged in some informal discussions with each.  Neither BHTA ’s nor PAGB ’s 
members are  concerned by phthalate s and their inclusion in The RoHS Regulations . BHTA cla rified   
 
16 
 
 
that in vitro and monitoring and control instruments are not within their scope  and PAGB’s 
website would suggest that the nature of the self -care medical devices is not of the type to be 
covered  by The RoHS Regulations . 
GAMBICA had evaluated the impact of the inclusion of phthalates prior to 2015  to their sector s. 
Their members  had been proactive in asking their component suppliers to ensure that the 
restricted substances , including phthalates were not contained in their products . They also 
contributed to the drafting of the RoHS harmonised standard, EN IEC 63000:2018 which defi nes 
the tasks expected of a manufacturer to comply with the r estriction of hazardous substances . 
Even though some of GAMBICA’s  action pre -dated the UK’s referendum to leave the EU, 
approximately one -third of GAMBICA’s members ’ products are exported to the EU , so compliance 
with RoHS 2 is still require d. The industry has had six years to remove phthalates from the supply 
chain and many supply chains adjusted before 2019 when the phthalates restriction in the other 
RoHS 2 categor ies came into effect  (26). 
The length of the  implementation timeframe , and thus the fact compliance should not be a 
surprise for anyone  was echoed by MedTech Europe. The representative also indicated that their 
members support  harmonisation between jurisdictions  as this means members  have greater 
ability to supply single products globally without considering regulatory nuances between 
jurisdictions.  Even COCIR who have supported the pending e xemption requests , have members 
who have been reformulating or sourcing alternative products w here possible . Furthermore, 
Great Britain’s own guidance  is worded to imply that medical devices and monitoring and control 
instruments will be in scope after the  22nd July 2021 (27). 
Anthesis estimates that the economic impact of including the restriction of phthalates in 
categories 8 and 9 is likely to be low, i.e. less than ±£5 million annual net direct cost to business  
(EANDCB) not least as the exemption requests are less than the 10 years required to be 
considered with an Impact Assessment  (27). In fact, through the informal discussions with the 
trade associations, Anthesis learned that  a greater financial impact would be incurred if The RoHS 
Regulations did not follow t hose of RoHS 2 in the EU.  
 
5 Recommendation  
The decision to extend the scope of RoHS 2 Annex II and include phthalates in EEE  is not new. 
Since the publication of RoHS 2 in 20 11 these substances have always been a target for further 
review and with the developments under REACH to include them in Annex XIV industry has been  
aware of the growing concern about the safe use of these substances.  Evidence suggests  that 
industry has a lready moved away from their use in EEE , given  the few exemption requests 
received by the European Commission for the use of phthalates above 0.1%  (w/w)  in medical 
devices ( Category  8) and monitoring and control instruments including industrial monitoring and 
control instruments  (Category 9) . 
The modification  to accommodate the whole of scope of (EU)2015/ 863 in The RoHS Regulation is 
anticipated to have little negative impact on operators or society, but rather, as anticipated by the 
EU, a positive impact  protecting human health and the environment. It is therefore  recommended 
to include the restriction of phthalates in medical devices (Category 8) and monitoring and control 
instruments including industrial monitoring and control instrume nts (Category 9) in The RoHS 
Regulations . 
   
 
17 
 
 
6 References  
1. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the 
restriction of the use of certain hazardous substances in electrical and electronic equ ipment 
(recast). [Online] 2011.  
2. The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic 
Equipment Regulations 2012. [Online] [Cited: 26 March 2021.] 
https://www.legislation.gov.uk/uksi/2012/3032/contents. SI 2012 No. 303 2. 
3. The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 2019. [Online] [Cited: 26 
March 2021.] https://www.legislation.gov.uk/uksi/2019/188/contents. SI 2019 No. 188.  
4. The Hazardous Substances and Packaging (Legislative Functions and Ame ndment) (EU Exit) 
Regulations 2020. [Online] [Cited: 26 March 2021.] 
https://www.legislation.gov.uk/uksi/2020/1647/contents/made. SI 2020 No. 1647.  
5. The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 and 2020. [Online] [Cited: 26 
March 2021.] SI 2019 No. 758 & SI 2020 No. 1577.  
6. Umweltbundesamt. Study for the Review of the list of Restricted Substances under RoHS2. 
[Online] December 2013. https://op.europa.eu/en/publication -detail/ -/publication/39eb0f95 -
27a8 -4ae6 -8ec3 -627c7336ae65.  
7. Öko -Instit ut e.V. RoHS Annex II Dossier for DIBP. [Online] May 2014. [Cited: 28 May 2021.] 
https://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/20140520_DIBP_AnnexII_Dossi
er_final.pdf.  
8. ECHA. 24th Meeting of the Committee for Risk Assessment. [Online] 2 013. 
https://echa.europa.eu/documents/10162/21961120/rac_24_dnel_dehp_comments_en.pdf/e05
06f6b -35f7 -433e -99da -
35464a26e2df#:~:text=Derivation%20of%20reference%20DNELs%20for%20DEHP&text=As%20th
e%20DNELs%20are%20based,most%20sensitive%20endpoint%20for%20DEHP .. 
9. European Commission. Commission Delegated Directive ../.../EU of 31.3.2015 amending Annex II 
to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of 
restricted substances. 2015.  
10. ECHA. Adopted opinions and prev ious consultations on applications for authorisation. [Online] 
2021. https://echa.europa.eu/applications -for-authorisation -previous -
consultations?diss=true&search_criteria_ecnumber=204 -211-0&search_criteria_casnumber=117 -
81-7&search_criteria_name=Bis%282 -ethylhexyl%29+phthalate.  
11. DEZA, a.s. Analysis of alternatives - non-confidential report - DEHP Use 3. [Online] [Cited: 29 
June 2021.] https://echa.europa.eu/documents/10162/a85d2e25 -5cef -41be -9089 -cd83cc3d6718.  
12. DG GROW. Draft Commission Regulation am ending Annex XIV to Regulation (EU) No 
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) (5 page(s), in English; 4 page(s), in . [Online] 
2020. [Cited: 01 Jun e 2021.] https://ec.europa.eu/growth/tools -
databases/tbt/en/search/?tbtaction=search.detail&Country_ID=EU&num=760&dspLang=en&basd
atedeb=&basdatefin=&baspays=EU&basnotifnum=&basnotifnum2=&bastypepays=ANY&baskeyw
ords=.  
13. Register, Comitology. Formal result s of voting on COMMISSION REGULATION (EU) …/… of XXX 
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the   
 
18 
 
 
Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH). [Online] 2021 . [Cited: 01 June 2021.] https://ec.europa.eu/transparency/comitology -
register/screen/documents/072339/1/consult?lang=en.  
14. MedTech Europe. REACH Authorisation for DEHP in Medical Devices Factsheet. [Online] 
September 2020. [Cited: 28 May 2021.] https:// www.osservatoriobiomedicaleveneto.it/wp -
content/uploads/2020/09/200921_MTE_DEHP -factsheet_FINAL -DRAFT.pdf.  
15. ECHA. Annex XVII to REACH - Conditions of restriction - Entry 51. [Online] [Cited: 28 May 
2021.] https://echa.europa.eu/documents/10162/aaa92146 -a005 -1dc2 -debe -93c80b57c5ee.  
16. European Commission. Study to assess three (3) exemption requests relating to Annex IV to 
Directive 2011/65/EU: request for amendment of existing exemption 31a; request for a new 
exemption for bis - (ethylhexyl) phthalate (D EHP) in ion selective electrodes for point of care an. 
May 2020.  
17. —. Study to assess one (1) request for a new exemption to Annex IV of Directive 2011/65/EU 
for bis -(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils (Pack 20) – 
Draft final Report. June 2020.  
18. Minutes: Meeting of the Expert Group for RoHS 2 adaption and enforcement Sug -grouo 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.  
19. ECHA. SCIP. [Online] https://echa.europa.eu/scip.  
20. HSE. REACH - Application for authorisation AFA001 -01 - Review Report. [Online] 2021. [Cited: 
28 May 2021.] https://consultations.hse.gov.uk/crd -reach/reach -afa-001-
01/?utm_source=govdelivery&utm_medium= email&utm_campaign=chemicals -
guidance&utm_term=consultation&utm_content=reach -19-may -21. 
21. ECHA. Recommendation of the European Chemicals Agency of 10 July 2019 to amend the 
Annex XIV entries to REACH of DEHP, BBP, DBP and DIBP. [Online] 10 July 2019.  
22. HSE. Restrictions under REACH. [Online] [Cited: 30 April 2021.] 
https://www.hse.gov.uk/reach/restrictions.htm.  
23. The Medical Devices Regulations 2002. [Online] 
https://www.legislation.gov.uk/uksi/2002/618/contents/made. SI 2002 No. 618.  
24. 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.  
25. COCIR, Private Communicati on -.  
26. GAMBICA, Private Communication.  
27. Office for Product Safety & Standards. The Restriction of the Use of Certain Hazardous 
Substances in Electrical and Electronic Equipment Regulations 2012 (as amended): As they apply 
to equipment being supplie d in or into Great Britain from 1 January 2021. [Online] January 2021.  
28. Department for Business, Energy & Industrial Strategy. Better Regulation Framework: Interim 
guidance. [Online] March 2020. [Cited: 12 July 2021.] 
https://assets.publishing.service. gov.uk/government/uploads/system/uploads/attachment_data/fi
le/916918/better -regulation -guidance.pdf.    
 
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