EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION DECISION  
of XXX  
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 Council   EN 2   EN COMMISSION DECISION  
of XXX  
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 Council  
THE EUROPEAN COMMISSION,  
Having regar d 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 (R EACH), 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/EE C, 93/105/EC and 2000/21/EC1, and in particular Article 
59(9)  thereof,  
Whereas:  
(1) Bis(2 -ethylhexyl) phthalate (DEHP), (EC No. 204 -211-0, CAS No. 117 -81-7), dibutyl 
phthalate (DBP) (EC No. 201 -557-4, CAS No. 84 -74-2), benzyl butyl phthalate (BBP) 
(EC No. 201 -622-7, CAS No. 85 -68-7) and diisobutyl phthalate (DIBP) (EC No. 201 -
553-2, CAS No. 84 -69-5) are included in the candidate list referred to in Article 59(1) 
of Regulation (EC) No 1907/2006 as substances toxic for reproduction (category 1B) 
according to Arti cle 57(c) of that Regulation. Those substances are also listed in 
Annex XIV to that Regulation.  
(2) In accordance with Article 59(3) of Regulation (EC) No 1907/2006, on 26 August 
2014 Denmark submitted to the European Chemicals Agency (hereinafter referred to 
as "the Agency") four dossiers in accordance with Annex XV to that Regulation 
(hereinafter referred to as “Annex XV dossiers”) for the identification of DEHP, DBP, 
BBP and DIBP as substances of very high concern under Article 57(f) of that 
Regulation due t o their endocrine disrupting properties for which there is scientific 
evidence of probable serious effects to human health or the environment which give 
rise to an equivalent level of concern to those of other substances listed in paragraphs 
(a) to (e) of Article 57.  
(3) Before the four Annex XV dossiers were considered by the Member State Committee 
of the Agency (“MSC”), they were split into two each, with one dossier covering the 
human health part and the other dossier covering the environmental part of the o riginal 
dossier, respectively.  
(4) The Annex XV dossiers for identification of DBP, BBP and DIBP as substances 
having endocrine disrupting properties whose effects in relation to the environment 
give rise to an equivalent level of concern according to Article 57(f) of Regulation 
                                                 
1 OJ L 396, 30.12.2006 , p. 1.  EN 3   EN (EC) No 1907/2006 were subsequently withdrawn by the dossier submitter, in order to 
further elaborate on the justifications provided in the documentation.  
(5) On 11 December 2014 the MSC adopted its opinions2 on the remaining Annex XV 
dossi ers. The MSC reached a unanimous agreement on the identification of DEHP as 
having endocrine disrupting properties whose effects in relation to the environment 
give rise to an equivalent level of concern according to Article 57(f) of Regulation 
(EC) No 190 7/2006.  
(6) The MSC unanimously acknowledged that for DEHP, BBP, DBP and DIBP there is 
scientific evidence on endocrine disrupting activity and on the causal link between this 
activity and adverse effects on human health.  
(7) However, the MSC did not reach unanimous agreement on whether the effects of the 
four substances give rise to an equivalent level of concern to those of other substances 
listed in points (a) to (c) of Article 57 of Regulation (EC) No 1907/2006 due to 
endocrine disrupting properties in r elation to human health. According to four 
members of the MSC the effects for human health pointed out in the Annex XV 
dossiers were the same effects, caused by the same mode of action, as those already 
taken into account when the substances were included in the candidate list due to their 
toxicity for reproduction according to Article 57(c) of that Regulation.  
(8) On 20 February 2015, pursuant to Article 59(9) of Regulation (EC) No 1907/2006, the 
MSC referred its opinion to the Commission for a decision on the  identification of the 
four substances as having endocrine disrupting properties for human health giving rise 
to an equivalent level of concern according to Article 57(f).  
(9) The Commission notes the unanimous agreement in MSC that the four substances 
have en docrine disrupting properties and that the adverse effects caused by this mode 
of action are the same effects that led to their classification as toxic for reproduction 
and their identification as substances of very high concern according to Article 57(c) 
of Regulation (EC) No 1907/2006. The  Commission also notes that the majority of 
members of the MSC considered that the level of concern of those effects is 
equivalent.  
(10) The Commission notes further that Article 57 does not preclude identif ying a 
substance a s being of very high concern based on the same  effect on human health  
several times , in order to specify the mode of action . 
(11) This Decision is without prejudice to the outcome of the on -going activities related to 
the definition of criteria for the identifi cation of endocrine disruptors in accordance 
with the provisions of Regulation (EC) No 1107/2009 concerning the placing of plant 
protection products on the market and repealing Directives 79/117/EEC and 
91/441/EEC3, and Regulation (EU) No 528/2012 concerni ng the making available on 
the market and use of biocidal products.4 
(12) The measures provided for in this Decision are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006,  
                                                 
2 http://echa.europa.eu/role -of-the-member -state-committee -in-the-authorisation -process/svhc -opinions -
of-the-member -state-committee   
3 OJ L 309, 24.11.2009, p. 1.  
4 OJ L 167, 27.6.2012, p. 1.  EN 4   EN HAS ADOPTED THIS DECISION:  
Article 1  
1. The following substances are identified as substances having endocrine disrupting 
properties whose effects to human health give rise to an equivalent level of concern according 
to Article 57(f) of Regulation (EC) No 1907/2006:  
 
- Bis(2 -ethylhe xyl) phthalate (DEHP), (EC No. 204 -211-0, CAS No. 117 -81-7) 
- Dibutyl phthalate (DBP) (EC No. 201 -557-4, CAS No. 84 -74-2) 
- Benzyl butyl phthalate (BBP) (EC No. 201 -622-7, CAS No. 85 -68-7)  
- Diisobutyl phthalate (DIBP) (EC No. 201 -553-2, CAS No. 84 -69-5) 
 
2. The entry of the substances specified in paragraph 1 in the candidate list referred to in 
Article 59(1) of Regulation (EC) No 1907/2006 shall be amended by adding, under “Reason 
for inclusion”, “Equivalent level of concern having probable serious effec ts to human health”.  
 
This Decision is addressed to the European Chemicals Agency . 
 
Done at Brussels,  
 For the Commission  
 Elżbieta BIEŃKOWSKA  
 Member of the Commission