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 concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)    
EN 1  EN ANNEX  
 
Entries 4 to 7 in the table in Annex XIV to Regulation (EC) No 1907/2006 are replaced by the following entries:  
Entry  
Nr Substance  Intrinsic  
property(ies) referred 
to in Article 57  Transitional arrangements   Exempted 
(categories of) 
uses Review 
periods  
Latest application date(1) Sunset date(2) 
‘4. Bis(2 -ethylhexyl) phthalate  
(DEHP )  
EC No:  204-211-0 
CAS No:  117-81-7 Toxic for reproduction  
(category 1 B) 
Endocrine disrupting 
properties (Article 57(f) - 
human health)  
Endocrine disrupting 
properties (Article 57(f) - 
environment)  
 (a) 21 August 2013*  
(b) By way of derogation from 
point (a):  
…[OJ please insert the date 
- 18 months after entry into 
force of this amending 
Regulation] for uses in:  
 food contact materials 
within the scope of 
Regulation (EC) No 
1935/2004;  
 immediate packaging 
of medicinal products 
covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, a nd/or 
Directive 2001/83/EC;  
− mixtures containing 
DEHP at or above 
0,1% and below 0,3% 
weight by weight;  
(c) By derogation of point (a):  
27 Novembe r 2023 for uses (a) 21 February 2015**  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
- 36 months after entry into 
force of this  amending  
Regulation] for uses in:  
 food contact materials 
within the scope of 
Regulation (EC) No 
1935/2004;  
− immediate packaging 
of medicinal products 
covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC;  
− mixtures containing 
DEHP at or above 
0,1% and below 0,3% 
weight by weight;  
(c)   By derogation of point (a):  
27 May 2025 for uses in - -  
EN 2  EN in medical devices within 
the scope of  Directives 
90/385/EEC, 93/42/EEC 
and 98/79/EC . medical devices within the 
scope of  Directives 
90/385/EEC, 93/42/EEC 
and 98/79/EC . 
5. Benzyl butyl phthalate  
(BBP )  
EC No:  201-622-7 
CAS No:  85-68-7 Toxic for reproduction  
(category 1 B) 
Endocrine disrupting 
properties (Article 57(f) - 
human health)  (a) 21 August 2013*  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
18 months after entry into 
force  of this amending 
Regulation ] for uses in:  
 immediate packaging 
of medicinal products 
covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC ; 
 mixtures containing 
BBP at or above 0,1% 
and below 0,3% 
weight by weight . (a) 21 February 2015**  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
36 months after entry into 
force  of this amending 
Regulation ] for uses in:  
 immediate packaging 
of medicinal products 
covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC ; 
 mixtures containing 
BBP at or above 0,1% 
and below 0,3% 
weight by weight . - - 
6. Dibutyl phthalate   
(DBP )  
EC No:  201-557-4 
CAS No:  84-74-2 Toxic for reproduction  
(category 1 B) 
Endocrine disrupting 
properties (Article 57(f) - 
human health)  (a) 21 August 2013*  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
18 months after entry into 
force of this amending 
Regulation] for uses in:  
 immediate packaging 
of medicinal products 
covered under (a) 21 February 2015**  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
36 months after entry into 
force of this amending 
Regulation] for uses in:  
 immediate packaging 
of medicinal products 
covered under - -  
EN 3  EN Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC ; 
 mixtures containing 
DBP at or above 0,1% 
and below 0,3% 
weight by weight . Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC ; 
 mixtures containing 
DBP at or above 0,1% 
and below 0,3% 
weight by weight . 
7. Diisobutyl phthalate  
(DIBP)  
EC No:  201-553-2 
CAS No:  84-69-5 Toxic for reproduction  
(category 1 B) 
Endocrine disrupting 
properties (Article 57(f) - 
human health)  (a) 21 August 2013*  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
- 18 months after entry into 
force of this amending 
Regulation] for uses in 
mixtures containing DIBP 
at or above 0,1% and below 
0,3% weight by weight . (a) 21 February 2015**  
(b) By way of derogation from 
point (a):  
… [OJ please insert the date 
- 36 months after entry into 
force of this  amending  
Regulation] for uses in 
mixtures containing DIBP 
at or above 0,1% and below 
0,3% weight by weight . - -’