EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards bis(2 -ethylhexyl) phthalate (DEHP), 
dibutyl phthalate ( DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP)  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards bis(2 -ethylhexyl) phthalate (DEHP), 
dibutyl phthalate (DBP), be nzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP)  
(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 European 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 Co mmission 
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 
68(1)  thereof,  
Whereas:  
(1) Bis(2 -ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate 
(BBP) and diisobutyl phthalate (DIBP) ('the four phthalates') are listed in Annex XIV 
to Regulation (EC) No 1907/2006 as substances toxic for reproduction, category 1B, 
with a sunset date of 21 February 2015, specified in acco rdance with Article 
58(1)(c)(i) of t hat Regulation . 
(2) After the sunset date referred to in Article 58(1)(c)(i) for a substance listed in Annex 
XIV, Article 69(2) of Regulation (EC) No 1907/2006 requires the European 
Chemicals Agency ('the Agency') to conside r whether the use in articles of substances 
listed in Annex XIV to that Regulation poses a risk to human health or the 
environment that is not adequately controlled and, if the Agency considers that it does, 
to prepare a dossier for a restriction proposal which conforms to the requirements of 
Annex XV to Regulation (EC) No 1907/2006 ('the Anne x XV dossier') . 
(3) On 1 April 2016, the Agency, in cooperation with Denmark, prepared an Annex XV 
dossier for the four phthalates2. The dossier built on a previous restri ction proposal 
submitted by Denmark in 2011 in relation to which the Agency's Risk Assessment 
Committee (RAC) and Socio -Economic Analysis Committee (SEAC) adopted 
opinions3 based on which the Commission decided not to amend Annex XVII to 
Regulation (EC) No  1907/20064 on the grounds that the data available at the time did 
not indicate that combined exposure to the four phthalates presented a risk. The 2016 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 https://echa.europa.eu/previous -consultations -on-restriction -proposals/ -/substance -rev/13919/term  
3 2012 RA C and SEAC Opinion on an Annex XV dossier proposing restr ictions on the four phthalates:  
https://echa.europa.eu/documents/10162/58050be8 -f7be-4b55 -b106 -76dda4989dd6  
4 Commission Communication 2014/C 260/01.   
EN 2  EN Annex XV dossier took into account new information on exposure from different 
sources including human b iomonitoring data from the Union -wide DEMOCOPHES 
project5 which measures the presence of the four phthalates in urine samples.  
(4) The four phthalates are found in a wide variety of articles as they are commonly 
present in plasticised materials. Exposure may o ccur through the ingestion of food and 
dust, the placing of articles in the mouth, the inhalation of air and dust in indoor 
environments, and contact of dust and articles with human mucous membranes and 
skin.  
(5) The Annex XV dossier proposed to restrict the p lacing on the market of articles 
containing the four phthalates in a concentration equal to o r greater than 0,1 % by 
weight individually or in any combination of such plasticised materials. The dossier 
suggested exemptions for articles exclusively for open  air use, certain articles 
exclusively for industrial and agricultural use, measuring devices, articles covered by 
existing Union legislation and articles already placed on the market in the Union.  
(6) On 10 March 2017, RAC adopted its opinion concluding that the proposed restriction 
is the most appropriate Union -wide measure to address the identified risks arising 
from these substances in terms of effectiveness in reducing those risks.  
(7) RAC considered that a combined concentratio n of the four phthalates of 0,1 % or less 
in plasticised materials in articles is required to address the risk to human health. 
Furthermore, this concentration limit would effectively discourage the use of the four 
phthalates in articles within the scope of the restriction.  
(8) On 15 June 20 17, SEAC adopted its opinion, indicating that the proposed restriction, 
as modified by RAC and SEAC, is the most appropriate Union -wide measure to 
address the identified risks in terms of its socio -economic benefits and socio -economic 
costs.  
(9) SEAC concurred  with the conclusions in the Annex XV dossier that a deferral of 36 
months of the application of the restriction seems reasonable and sufficient in order to 
enable actors involved in the supply chains to comply with it. SEAC also concurred 
with the exempti ons suggested in the Annex XV dossier. In addition, due to socio -
economic considerations based on additional information provided by the automotive 
and aircraft sectors during the public consultation, SEAC suggested certain 
derogations for these sectors.  
(10) The Agency's Forum for Exchange of Information on Enforcement ('Forum'), referred 
to in Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted on the 
proposed restriction and its recommendations have been taken into account.  
(11) On 29 August 2017, the  Agency submitted the opinions of RAC and SEAC6 to the 
Commission. Based on those opinions concluding on the combined exposure via 
various routes to these four phthalates that adversely affect human health, the 
Commission concluded that the four phthalates  pose an unacceptable risk to human 
health when present in any plasticised material in articles at a concentration equal to or 
greater than 0,1 % by weight of any of such material. For the purposes of this 
restriction, plasticised materials are materials t hat may contain phthalates for which 
there is great potential for combined exposure, via various routes, of both consumers 
and workers. Those materials include polyvinyl chloride (PVC) polymer , other 
                                                 
5 http://www.eu -hbm.info/democophes/project -partners  
6 https://echa.europa.eu/documents/10162/a265bf86 -5fbd-496b -87b4 -63ff238de2f7   
EN 3  EN polymers such as polyvinylidene chloride (PVDC)  and polyvinyl acetate (PVA) , as 
well as  any other plastics, except polyolefins where phthalates are not usually present, 
rubber, except silicone rubber and natural latex coatings where phthalates are not 
present, polyurethanes and any other foam rubber or foam pla stic, surface coatings, 
non-slip coatings, finishes, decals, printed designs, adhesive, sealants, inks and paints. 
The Commission considers that the risk needs to be addressed on a Union -wide basis.  
(12) Annex XVII to Regulation (EC) No 1907/2006 already bans t he placing on the market 
of toys and childcare articles containing DEHP, DBP and BBP under certain 
conditions which fall within the scope of the proposed restriction. In addition, in view 
of both the opinion of RAC that DIBP presents a similar risk to DBP and can replace it 
in all uses and the recommendation of the Forum, the Commission takes the view that 
the placing on the market of toys and childcare articles containing DIBP should also 
be restricted. In addition, the placing on the market of the four ph thalates in toys and 
childcare articles should be subject to updated conditions.  
(13) In the case of articles exclusively for industrial and agricultural use, or for open air 
use, the proposed restriction should only apply to those articles containing plasticis ed 
material that comes into contact with human mucous membranes or into prolonged 
contact with the skin, because such contacts lead to exposure which poses risk to 
human health.  
(14) The proposed restriction should not apply to articles regulated by other Union  
legislation, such as materials and articles intended to come into contact with food 
within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of 
the Council7 and Commission Regulation (EU) No 10/20118, medical devices within 
the scop e of Council Directives 90/385/EEC9 or 93/42/EEC10, or Directive 98/79/EC 
of the European Parliament and of the Council11, or components for such devices, 
articles within the scope of Directive 2011/65/EU of the European Parliament and of 
the Council12 or the  immediate packaging of medicinal products within the scope of 
Regulation (EC) No 726/2004 of the European Parliament and of the Council13 or of 
Directives 2001/82/EC14 or 2001/83/EC15 of the European Parliament and of the 
Council.  
                                                 
7 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Dir ectives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).  
8 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact with food (OJ L 12, 15.1.2011, p. 1).  
9 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).  
10 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).  
11 Direc tive 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).  
12 Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the  use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 
88) 
13 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 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).  
14 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).  
15 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 4  EN (15) The proposed restriction sh ould also not apply to measuring devices for laboratory use 
or articles that form part of such devices and to articles placed on the market prior to 
the date of entry into application of the restriction, for practicality and enforceability 
reasons. Moreove r, certain derogations should apply for motor vehicles and aircraft. 
First, a longer deferral of application of the restriction for motor vehicles and an 
indefinite exemption for articles used in the maintenance or repair of those vehicles, 
where the vehic les cannot function as intended wit hout those articles, are justified i n 
consideration of the specific economic implications of this sector. A longer deferral of 
application of the restriction for  certain aircraft and an indefinite exemption for articles 
used in the maintenance or repair of those aircraft where these are essential for safety 
and airworthiness, are justified on the basis that aircrafts have a very long useful life , 
their airworthiness may be jeopardis ed if parts meeting the design specificat ions are 
not available and the time lines needed for requa lification are very long.  
(16) Taking into account the Annex XV dossier as well as the opinions of RAC and SEAC, 
the Commission considers that the proposed restriction would address the identified 
risks w ithout imposing significant burden on industry, supply chain or consumers and 
concludes that the restriction proposed, is an appropriate Union -wide measure to 
address the identified risk.  
(17) Stakeholders should be allowed sufficient time to take appropriate m easures to comply 
with the proposed restriction and 18 months is sufficient to this end. Therefore there 
should be a general deferral of its application by 18 months. A longer specific deferral 
of 60 months should apply to address the particular cases of c ertain motor vehicles and 
aircraft.  
(18) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(19) The measures provided for in this Regulation are in accordance with the opinion of 
the Committee  established under Article 133 of Regulation (EC) No 1 907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII 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 Member States.  
Done at Brussels,   
EN 5  EN  
 For the Commission  
 The President  
 Jean -Claude Juncker