EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
as regards the substance bis(2 -ethylhexyl) phthalate (DEHP) in medical devices  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
as regards the substance bis(2 -ethylhexyl) phthalate (DEHP) in medical devices  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to  Regulation (EC) No 1907/2006 of the European Parliamen t and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 a nd Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and  2000/21/EC1, and in particular Article s 
58 and 131 thereof,  
Whereas:  
(1) Commission Regulation (EU) 2021/20452 amending Annex XIV to Regulation (EC) 
No 1907/ 2006  sets 27 May 2025 as sunset date and 27 November 2023 as latest 
application date for  uses of the substance bis(2 -ethylhexyl) phthalate (DEHP) in 
medical devices . In accordance with Article 56(1) of Regulation (EC) No 1907/2006, 
such uses of DEHP are not allowed after the sunset date unless an authorisation has 
been granted for a particular use, or unless an application for authorisation for a given 
use was submitte d before the latest application date and a decision on the application 
has not yet been taken .  
(2) The sunset date and the latest application date for DEHP in Regulation (EU) 
2021/2045 were aligned with  the transitional provisions laid down in Regulation s 
(EU) 2017/7453 and (EU) 2017/7464 of the European Parliament and of the Council . 
Those transitional provisions provided that medical devices with a valid certificate 
issued under Council Directives 90/385/EEC5 and 93/42/EEC6 or Directive 98/79/EC 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation 
(EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration,  
Evaluation, Authorisation and Restriction of Chemicals (REACH)  (OJ L 418, 24.11.2021, p. 6 ). 
3 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/ 2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).  
4 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro 
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 
(OJ L 117, 5.5.2017, p. 176).  
5 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating to active implantable medical devices (OJ L 189, 20 .7.1990, p. 17).  
6 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).   
EN 2  EN of the Europ ean Parliament and the Council7 could be placed on the market  until 26 
May 202 4 and continue to be made available on the market or put into service until 26 
May 2025 . 
(3) For certain in vitro diagnostic medical devices, Regulation (EU) 2022/112 of the 
European  Parliament and the Council8 has extended the transition al period laid down 
in Regulation (EU) 2017/746 until 26  May 2025 for high risk in vitro diagnostics, until 
26 May 202 6 for medium risk in vitro diagnostics , until 26 May 2027 for lower risk in 
vitro diagnostic s, and until 26 May 2028 for certain provisions concerning devices 
manufactured and used in health institutions.  
(4) In addition,  Regulation (EU) 2023/607 of the European Parliament and of the Council9 
has extend ed the transitional period laid down in Regulation (EU) 2017/745 applicable 
to certain medical devices until 31 December  2027 for devices with a higher risk  and 
until 31 December 2028  for medium and lower risk devices , subject to certain 
conditions . It has also extend ed the validity  of the certificates issued under Directives 
90/385/EEC and 93/42/EEC , if the legal conditions are fulfilled . Those measures are 
intended to  ensure that notified bodies can complete the conformity assessment and 
issue the certificates in accordance with th e requirements under Regulation (EU) 
2017/745 , to ensure a high level of protection of public health and patient safety and to 
avoid shortages of medical devices needed for health services and patients , without 
lowering current quality and safety requirements .  
(5) Pursuant to Article 55 of Regulation (EC) No 1907/2006 , DEHP is to be progressively 
replaced by suitable alternatives.  In accordance with the transitional provisions laid 
down in Regulations (EU) 2017/745 and (EU) 2017/746 , if there is a significant 
change in the design or intended purpose of the device , which could be a result of 
DEHP replacement by an alternative, the application of the transitional period , 
including the extended validity of the certificate s, is to cease . That could mean that a 
medical device , which is subject to a significant change due to the replacement of 
DEHP with an alternative substance , could only be placed on the market when a new 
certificate is issued by a notified bod y in accordance with Regulations (EU) 2017/745 
or (EU) 2017/746 . It is therefore  of major interest for public health and patient safety 
in the Union t o allow  production  of medical devices  containing DEHP until the 
conformity assessment procedure for DEHP -free medical devices has been finalised 
and notified bodies have issue d the relevant certificates within  the new transition al 
periods  provided for in Regulation s (EU) 2017/745 and 2017/746 . 
(6) Delays caused by the limited capacity of notified bodies should  not penalise 
companies in the process of substitut ing DEHP in medical devices . The alignment  of 
the latest application date and sunset date  in Regulation (EC) No 1907/2006 for uses 
of DEHP in medical devices is needed  to allow companies  first to meet the 
requirements of the regulatory framework for medical devices, prior to deciding on the 
need for an application for authorisation , as that would only be needed  in case the 
DEHP -free alternative  medical device  is not ready . 
                                                 
7 Directive 98/79/EC of the European Parliament and the Council  of 27 October 1998 on in vitro 
diagnostic medical devices  (OJ L 331, 7.12 .1998, p. 1 ). 
8 Regulation (EU)  2022/112 of the European Parliament and of the Council of 25 January 2022 amending 
Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical 
devices and the deferred application of conditions for in -house devices (OJ L 9, 28.1.2022, p.3).  
9 Regulation (EU) 2023/ 607 of the European Parliament and of the Council  of 15 March  2023 amending 
Regulation s (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medi cal 
devices and in vitro diagnostic medical devices (OJ L 80, 20.3.2023, p. 24 ).  
EN 3  EN (7) To remain consistent with the intention of the legislat or when authorisation 
requirements became applicable to the use s of DEHP in medical devices, it is 
appropriate ,  as an exceptional measure, to postpone the latest application date and the 
sunset date set for  such uses, and align th em, once again  with th e transitional periods  
in Regulation s (EU) 2017/745  and (EU) 2017/746 .  
(8) Regulation (EC) No 1907/2006 should therefore be amended accordingly . 
(9) In order to provide clarity to companies that, due to the postponement of  the latest 
applica tion date and the sunset date, may no longer be required to prepare an 
application for an authorisation for uses of DEHP in medical devices by the 
approaching deadline of 27 November 2023, it is appropriate to ensure the entry into 
force as soon as possibl e. This Regulation should enter into force as a matter of 
urgency on the day following its publication in the Official Journal of the European 
Union . 
(10) The measures provided for in this Regulation are in accordance with the opinion of the  
Committee  established by Article 133 of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2 
This Regulation shall enter into force on th e day following that of its publication in the 
Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN