EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
on the identification of dicyclohexyl phthalate (DCHP) as a substance of very high 
concern according to Article 57(c) and (f) of Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
on the identification of dicyclohexyl  phthalate (DCHP) as a substance of very high 
concern according to Article 57(c) and (f) of Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Fun ctioning 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 (REACH), establishing a Euro pean 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/E C1, and in particular Article 
59(9) thereof,  
Whereas:  
(1) In accordance with Article 59(3) of Regulation (EC) No 1907/2006, on 17 February 
2016 Sweden  submitted to the European Chemicals Agency ( 'the Agency ') a dossier 
prepared in accordance with Annex XV to t hat Regulation ( 'Annex XV dossier ') for 
the identification of dicyclohexyl phthalate (DCHP) (EC No. 201 -545-9, CAS No. 84 -
61-7) as a substance of very high concern in accordance with Article 57 (c) and (f) of 
that Regulation , due respectively  to its classification as toxic for reproduction category 
1B under Regulation (EC) No 1272/20082, and  to its endocrine disrupting properties 
for which there is scientific evidence of probable serious effects to human health  or the 
environment which give rise to a n equivalent level of concern to those of other 
substances listed in paragraphs (a) to (e) of Article 57.  
(2) On 9 June 2016  the Member State Committee of the Agency ( MSC ) adopted its 
opinion3 on the Annex XV dossier. Before the MSC adopted its opinion , Sweden  
withdrew its proposal to identify DCHP under Article 57(f) of Regulation (EC) No 
1907/2006 due to its endocrine disrupting properties for which there is scientific 
evidence of probable serious effects to the environment , in order to further elaborate 
on the justifications provided in the dossier . 
(3) The MSC reached a unanimous agreement on the identification of DCHP  as a 
substance of very high concern because it meets the criteria of Article 57(c) of 
Regulation (EC) No 1907 /2006 . 
(4) The MSC unanimously acknowledged that for D CHP  there is scientific evidence on 
the endocrine activity and on the link between this activity and the adverse effects to 
                                                 
1 OJ L 396, 30.12.2006 , p. 1.  
2  OJ L 353, 31.12.2008, p. 1 . 
3 https://echa.europa.eu/documents/10162/a0ed7099 -d284 -45e4 -87ae -9984c71024c8  EN 3   EN human health , and, further, that the substance  can be considered an endocrine disruptor  
for human health as it fulfil s the WHO/IPCS defini tion for an endocrine disruptor . 
(5) However, the MSC did not reach unanimous agreement on the identification of DCHP  
under Article 57(f) of Regulation (EC) No 1907/2006 as giving rise to an equivalent 
level of concern to those of other substances listed in points (a) to (c) of that Article 
due to endocrine disrupting properties in relation to human health. According to five 
members of the MSC , the effects for human health pointed out in the Annex XV 
dossier were the same effects, caused by the same mode of action, as those already 
taken into account in the dossier for identification of the substance as a substance of 
very high concern in accord ance with Article 57(c) due to the adverse effects on 
development . 
(6) On 22 June 2016 , pursuant to Article 59(9) of Regulation (EC) No 1907/2006, the 
Agency referred the MSC opinion to the Commission for a decision on the 
identification of DCHP on the basis o f Article 57(f).  
(7) The Commission notes the unanimous agreement in the MSC that DCHP  has 
endocrine disrupting properties and that the adverse effects caused by this mode of 
action are the same effects that led to its classification as toxic for reproduction and to 
the proposal for its identification as  a substance 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 effec ts 
is equivalent to those of substances referred to in Article 57 (a) to (e).  
(8) The Commission notes that Article 57 does not preclude identifying a substance as 
being of very high concern several times based on more than one intrinsic property 
causing the s ame effect on human health.  
(9) Therefore D CHP  should be identified under Article 57  (c) as a substance of very high 
concern meeting the criteria for classification as toxic for reproduction category 1B 
under Regulation (EC) No 1272/2008 and under Article 57(f ) due to its endocrine 
disrupting properties with probable serious effects to human health.  
(10) This Decision is without prejudice to the outcome of the on -going activities related to 
the definition of criteria for the identification 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/EEC4, and Regulation (EU) No 528/2012 concerning the making available on 
the ma rket and use of biocidal products.5 
(11) 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,  
HAS ADOPTED THIS DECISION:  
Article 1  
1.  Dicyclohexyl phthala te (DCHP) (EC No. 201 -545-9, CAS No. 84 -61-7) is identified in 
accordance with  Article 57(c) of Regulation (EC) No 1907/2006 due to its  classification as 
toxic for reproduction category 1B under Regulation (EC) No 1272/2008, and  in 
accordance with Article 57(f) of Regulation (EC) No 1907/2006, due to its  endocrine 
disrupting properties with probable serious effects to human health .  
                                                 
4 OJ L 309, 24.11.2009, p. 1.  
5 OJ L 167, 27.6.2012, p. 1.  EN 4   EN 2. The substance shall be included in the candidate list referred to in Article 59(1) of 
Regulation (EC) No 1907/2006  with the  following indication under “Reason for 
inclusion”:  “Toxic for reproduction (Article 57(c) ); endocrine disrupting properties 
(Article 57(f) - human health )”. 
 
This Decision is addressed to the European Chemicals Agency . 
 
Done at Brussels,  
 For the Commission  
 Elżbieta BIEŃKOWSKA  
 Member of the Commission