EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XIV to Regulation (EU) No 1907/2006 of the European Parliament and 
of the Council as regards the substance group 4 -(1,1,3,3 -Tetramethylbutyl)phenol, 
ethoxylated (covering well -defined substances and substances of unknown or variable 
composit ion, complex reaction products or biological materials, polymers and 
homologues)  
(Text with EEA relevance)  
  
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XIV to Regulation (EU) No 1907/2006 of the European Parliament and 
of the Council as regards the substance group 4 -(1,1,3,3- Tetramethylbutyl)phenol, 
ethoxylated (covering well -defined substances and substances of unknown or variable 
composition, complex reaction products or biological materials, polymers and 
homologues)  
(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 Parliament 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 and 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) Coronavirus disease (COVID -19) is an infectious disease caused by a newly 
discovered coronavirus. On 30 January 2020, the World Health Organization declared 
the outbreak of COVID- 19 a public health emergency of international concern and on 
11 March 2020 it characterised COVID -19 as a pandemic.  
(2) The substance group 4-(1,1,3,3- tetramethylbutyl)phenol, ethoxylated  (covering well -
defined substanc es and substances of unknown or variable composition, complex 
reaction products or biological materials, polymers and homologues)  (‘the substance 
group’ ) meet s the criteria set out in Article 57(f) of Regulation (EC) No 1907/2006 
and is listed in Annex XIV to that Regulation.  
(3) The latest application date  for th e substance  group was 4 July 2019 and the sunset date 
is set at 4 January 2021 . In accord ance with Article 56(1) of Regulation  (EC) No 
1907/2006, uses of th e substance group are not allowed after th e sunset date unless an 
authorisation has been granted for a particular  use, an application for authorisation for 
a given use was submitted before the latest application date but a decision on the 
applic ation has not yet been taken or the  use is covered by an exemption in accordance 
with th at Regulation.  
(4) The COVID -19 pandemic has created an unprecedented public health emergency. In 
addition, the measures that Member States have had to adopt to contain the  spread of 
COVID- 19 have inflicted major disruptions to national economies and to the Union as 
a whole. 
                                                 
1 OJ L 396, 30.12.2006, p. 1.   
EN 2  EN (5) Potential treatments and vaccines to combat COV ID-19 are being developed . The 
substance group is used in the diagnosis of COVID -19 and in the production of tools 
for that purpose . Currently it is used for the production of  in-vitro diagnostic kits. The 
substance group is also used in the development of vaccines  to combat COVID -19 and 
is expected to be used in their production. Furthermore , it cannot be ex cluded that the 
substance group is used for  the development  and the production of active 
pharmaceutical ingredients and finished dosage forms  to combat COVID- 19. 
(6) In this situation of public health emergency, it is of major interest for the Union that 
safe and efficacious  medicinal products , safe medical devices and accessories to 
medical devices, suitable for the diagnos is, treatment  or prevent ion of COVID- 19 can 
be developed, produced,  made available and used in the Union as soon as possible.  
(7) However, as the latest application date o f 4 July 2019 passed  before the onset of the 
COVID- 19 pandemic , applications for authorisation for the uses of the substance 
group for  the diagnosis , treatment or prevent ion of  COVID- 19 could not have been 
submitted  before  that date and therefore such uses cannot lawfully continue after the 
sunset date . 
(8) It is therefore  of paramount importance to ensure that the substance group  can 
continue to be used  for the research , development and production  of medicinal 
products , medical devices or accessories to medical devices, including in vitro 
diagnostic medical devices, and for use in  such medical devices or accessories in view 
of their use for the diagnos is, treat ment  or prevent ion of  COVID- 19 after the sunset 
date as currently set  in Annex XIV to Regulation (EC) No 1907/2006, as an 
exceptional measure for the protection of public health . 
(9) Furthermore, allowing the continued  use of th e substance group for those  specific 
purpose s after 4 January 2021 would contribute to the fulfilment of the objectives of  
the ‘EU Strategy for COVID -19 vaccines ’2. 
(10) It is therefore  appropriate to  postpone  the latest application date and the sunset date  
set for th e substance group with regard to the  uses for the research, devel opment  and 
production of medicinal products , medical devices, or accessories to medical devices,  
including in vitro diagnostic medical devices, for the diagnos is, treatment  or 
prevent ion of COVID- 19 and use in such medical devices or accessories. A 
postponement of the latest application date until 18 months after the entry into force of 
this Regulation is necessary in order to allow for the preparation of applications for 
authorisation for thos e uses  and accordingly, it is appropriate to postpone the sunset 
date until 36 months after its entry into force .    
(11) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(12) As the latest date of application for the substance group has already passed  before the 
outbreak of COVID -19, in order to avoid a gap in the period during which  
applications for uses for the research, development and production of medicinal 
products , medical devices or accessories to medical devices, including in vitro 
diagnostic medical devices,  in view of their use for  the diagnosis , treatment or 
prevention of that disease and use in such medical devices or accessories can be 
validly submitted  so that the use is covered by point (d) of Article 56(1) of Regulation 
(EC) No 1907/2006, it is necessary to provide for an urgent entry into force of this 
                                                 
2 Communication f rom the Commission t o the European Parliament, t he European Council, t he Council 
and the European Investment Bank of 17 June 2020 EU Strategy for COVID -19 vaccines , COM (2020) 
245 final.   
EN 3  EN Regulation and for its retroactive application as from 4 July 2019. In addition, this 
Regulation should enter into force as a matter of urgency and should apply 
retroactively  in order to ensure the continued use of the  substance group after 4 
January 2021 for the  same uses.  
(13) 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 R egulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation. 
Article 2  
This Regulation shall enter into force on the day following that of its publication in the 
Official Journal of the European Union. 
It shall apply from 4 July 2019. 
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