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 concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  
(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 concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  
(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 Europ ean 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) The substances bis(2 -ethylhexy l) phthalate ( DEHP ), benzyl butyl phthalate ( BBP ), 
dibutyl phthalate ( DBP ) and diisobutyl phthalate (DIBP) are listed in entries 4 to 7 of 
Annex XIV to Regulation (EC) No 1907/2006 because they meet the criteria  set out in  
point (c) of  Article 57 of that R egulation.  In accordance with Article 59 of Regulation 
(EC) No 1907/2006, DEHP has subsequently been additionally identified as meeting 
the criteria set out in point (f)  Article 57 of that Regulation , namely as having 
endocrine disrupting properties for which there is scientific evidence of probable 
serious effects to the environment2. All the  four substances have further been 
identified in accordance with Article 59 of Regulation (EC) No 1907/2006  as meeting 
the criteria set out in  point (f) Article 57 o f that Regulation, namely as having 
endocrine disrupting properties for which there is scientific evidence of probable 
serious effects to human health3. In accordance with Article 58(3) of Regulation (EC) 
No 1907/2006 , on 10 July 2019 t he European Chemical s Agency (‘the Agency’) 
recommended4  the elements  referred to in Article 58(1)  of that Regulation  to be 
specified for each of those substances . 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Decision by the Executive Director of ECHA  of 12 December 2014 , Inclusion of Substances of Very 
High Concern in the Candidate List for eventual inclusion in Annex XIV , (ED/108/2014)  
https://echa.europa.eu/documents/10162/30b654ce -1de3 -487a -8696 -e05617c3173b  
3 Commission Implementing Decision (EU) 2017/1210 of 4 July 2017 on the identification of bis( 2-
ethylhexyl)  phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl 
phthalate (DIBP) as substances of very high concern according to Article 57(f) of Regulation (EC) No 
1907/2006 of the European Parliament and of the Counc il (OJ L 173, 6.7.2017, p. 35 ). 
4 Recommendation of the European Chemicals Agency  of 10 July 2019 to amend the Annex XIV entries 
to REACH  of DEHP, BBP, DBP and DIBP  (List of Substances subject to Authorisation),  EN 2  EN (2) The inclusion of intrinsic properties relating to hazards for the environment in the 
entry for DEHP in Annex XI V to Regulation (EC) No 1907/2006, means that the  uses 
of that substance in  medical devices falling within the scope of   Council Directive 
90/385/EEC5, Council Directive  93/42/EEC6 or Directive 98/79/EC of the European 
Parliament  and of the Council7 are subject to authorisation requirement as the second 
subparagraph of Article 6 0(2) of Regulation (EC) No 1907/2006  provides that the 
Commission shall not consider  risks to human health only arising from  those uses . As 
regards t he uses of that substance in food contact materials within the scope of 
Regulation (EC) No 1935/2004  of the European Parliament and of the Council8, the 
inclusion of intrinsic properties relating to hazards for the environment means that 
those uses  are subject to authorisation require ment as Article 56(5) of Regulation (EC) 
No 1907/2006  no longer applies to them . 
(3) By inclu ding in the entries of DEHP, BBP, DBP and DIBP intrinsic properties referred 
to in point (f) of  Article 57 of Regulation (EC) No 1907/2006, the concentration limit 
applicable to the presence of th ose substances in mixtures for the purposes of the 
exemption set out in Article 56(6) of that Regulation become s 0,1% weight by weight .  
(4) Article 58(1)(e) i n conjunction with Article 58(2) of Regulation (EC) No  1907/2006 
provides for the possibility of exemptions of uses or categories of uses in cases where 
specific Union legislation impos es minimum requirements relating to the protection of 
human health or t he environment ensuring  proper control of the risks. In accordance 
with the information currently available , it is not appropriate to set exemptions based 
on those provisions.  
(5) Commission Regulation (E U) No 143/20119 exempted  from the authorisation 
requirem ent the use of DEHP , BBP  and DBP in the immediate packaging of medicinal 
products  covered by Regulation (EC) No 726/ 2004  of the European Parliament and of 
the Council10, Directive  2001/82/EC  of the European Parliament and of the Council11 
and/or Directive 2001/83/EC  of the European Parliament and of the Council12. The 
judgment of the C ourt of Justice of 13 July 2017 in Case C -651/15 P, VECCO and 
                                                                                                                                                         
 
https://echa.europa.eu/documents/10162/13640/axiv_amend_recommendation_phthalates_july2019_en.
pdf/1889866a -bec3 -fe16-6322 -67c16a13b09d  
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).  
7 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro  
diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).  
8 Regulation (EC) No  1935/2004 of the European Parliament and of the Council of 27  Octo ber 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4 ). 
9 Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation 
(EC) N o 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (‘REACH’) (OJ L 44, 18.2.2011, p. 2).  
10 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 Ma rch 2004 laying 
down Community procedures for the authorisation and supervision of medicinal products for human 
and veterinary use and establishing a European Medicines Agency  (OJ L 136, 30.4.2004 , p. 1).  
11 Directive 2001/82/EC of the European Parliament a nd of the Council of 6 November 2001 on the 
Community code relating to veterinary medicinal products  (OJ L 311, 28.11.2001 p . 1). 
12 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001 p. 67).  EN 3  EN Others v. Commission13, provided clarifi cations on  certain aspects of  Article 58(2) of 
Regulation (EC) No 1907/2006 for granting an exemption  from the authorisation 
requirement .  The Commission has re -assessed the exemption set out in Annex XIV  to 
that Regulation  and has concluded that it does not meet the conditions in Art icle 58(2). 
In particular, in the light of that judgement, Regulation (EC)  No 726/2004, and 
Directives 2001/82/EC and 2001/83/EC do not constitute existing specific Union  
legislation imposing minimum requirements relating to the protection of human health 
or the environment for the use of DEHP, BBP  and DBP in intermediate packaging of 
medicinal products within the meaning of Article 58(2) of Regulation No 1907/2006  
since they do not contain provisions specific to those substances  imposing such 
requirements .. Furthermore, Regulation (EC) No 726/2004  and Directive s 2001/82/EC 
and 2001/83/EC  lay down requirements  relate d to the protect ion of human health  only, 
while,  as regards DEHP, intrinsic properties relating to hazards for the environment 
have been include d in the entry for that substance  in Annex XIV to Regulation (EC) 
No 1907/2006 . Those exemptions are therefore  not justified and should be deleted . 
(6) For the uses of DEHP, BBP, DBP and DIBP  that will no longer be exempted from the 
authorisation requirement, it is appropriate to indicate the dates referred to in point (i) 
of Article 58(1)(c)  of Regulation (E C) No 1907/2006, taking into account the  
Agency's recommendation of 10 July 2019  and i ts capacity to handle applications  for 
authorisations . As regards uses of DEHP in medical devices, the dates should also  take 
into account the transitional provisions  for the application of Regulation s (EU) 
2017/74514 and (EU) 2017/74615 of the European Parl iament and of the Council . 
(7) For each of the uses of DEHP, BBP, DBP and DIBP  that will no longer be exempted 
from the authorisation requirement, there are no reasons for which the date referred to 
in point (ii) of Article 58(1)(c) of Regulation (EC) No 1907/2006  should be set earlier  
than 18  months than the date referred to in Article  point  (i) 58(1)(c) of that Regulation.  
(8) During the public consultation  conducted by the Agency on its draft recommendation , 
no specific comments were submitted with regard t o possible exemptions for product 
and process orientated research and development . As there is no information justifying 
the need for such an exemption, the exemption  was not consider ed.   
(9) As the available information on the uses of the substances concerne d by this 
Regulation is limited, it is not appropriate to set review periods at this stage, pursuant 
to point (d) of Article 58(1) o f Regulation (EC) No  1907/2006 .  
(10) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(11) 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 , 
                                                 
13 Judgment of the Court of Justice of 13 July 2017, Verein zur Wahrung von Einsatz und Nutzung von 
Chromtrioxid und anderen Chrom -VI-Verbindungen in der Oberflächentechnik eV (VECCO) and 
Others  v European Commission , C-651/15 P, ECLI:EU:C:2017:543.  
14 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).  
15 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 Comm ission Decision 2010/227/EU 
(OJ L 117, 5.5.2017, p. 176).  EN 4  EN 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 the twentieth 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 Memb er States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN