 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) No…/..  
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                
   
EN 1  EN ANNEX  
 
In the table in Annex XIV to Regulation (EC) No 1907/2006 , entry nr 4 concerning  the 
substance  bis(2 -ethylhexyl) phthalate (DEHP)  is amended as follows : 
(1) in column 4  ‘Latest application date’ , point (c)  is replaced by the following:  
‘(c) by way of derogation from point (a) : 
1 January 2029 for uses in medical devices within the scope of 
Regulations (EU) 2017/745 and (EU) 2017/746 .’; 
(2) in column 5 ‘Sunset  date’ , point (c)  is replaced by the following:  
‘(c) by way of derogation from point (a):  
1 July 2030 for uses in medical devices within the scope of Regulations 
(EU) 2017/745 and (EU) 2017/746 .’ 