 
EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) No…/..  
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)        
 
  
EN 1  EN ANNEX  
In the table in Annex XIV to Regulation (EC) No 1907/2006, entry 42 concerning 4- (1,1,3,3 Tetramethylbutyl)phenol, ethoxylated (covering well -
defined substances and UVCB substances, polymers and homologues) is  amended as follows : 
(1) the text of column 4 ‘Latest application date’ is replaced by the following text:  
‘(a) 4 July 2019*[ OJ: this is an existing table note ]; 
(b) by way of derogation from point (a) , … [OJ: please enter the date – 18 months after entry into force of this amending 
Regulation]  for use s as follows : 
 for the research, development and production of medicinal products falling within the scope  of Directive  2001/83/EC  or 
medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC , Regulation (EU) 
2017/745, Directive 98/79/EC  or Regulation (EU) 2017/746 of the European Parliam ent and of the Council ** , in view 
of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID -19); 
 in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 
2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 for the diagnosis, treatment or prevention of COVID -19. 
 
** 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 Commissi on Decision 2010/227/EU  (OJ L 117, 5.5.2017, p. 176) .’; 
(2) the text of column 5 ‘ Sunset  date’ is replaced by the following text:  
‘(a) 4 January 2021**[ OJ: this is an existing table note ]; 
(b) by wa y of derogation from point (a) , … [OJ: please enter the date – 36 months after entry into force of this amending 
Regulation]  for use s as follows :  
 for the research  , development and production of medicinal products falling within the scope of Directive 2001/83/EC or 
medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC , Regulation (EU) 
2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use  for the diagnosis, treatment or 
prevention of COVID -19;  
EN 2  EN  in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 
2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID -19.’ 