EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(20..) yyy final 
  
Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council on the Registration, Evalua tion, Authorisation and Restriction of 
Chemicals ("REACH")  
EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council on the Registration, Evalua tion, 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 European Parliament and of the 
Council of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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 C ouncil Directive 76/769/EEC  and Commission 
Directives 91/155/EEC, 93/ 67/EEC, 93/105/EC and 2000/21/EC
1, and in particular Article 58 
and Article 131 thereof, 
Whereas: 
(1) Regulation (EC) No 1907/2006 provides that substances meeting the criteria for 
classification as carcinogenic (category 1 or  2), mutagenic (categor y 1 or 2) and toxic 
to reproduction (category 1 or 2) in accord ance with Council Directive 67/548/EEC of 
27 June 1967 on the approximation of the laws, regulations and administrative 
provisions relating to the classification,  packaging and labe lling of dangerous 
substances2, substances that are persistent, bioa ccumulative and toxic, substances that 
are very persistent and very bioaccumulativ e, and/or substances for which there is 
scientific evidence of probable serious eff ects to human health and environment giving 
rise to an equivalent level of con cern may be subject to authorisation.  
(2) Pursuant to Article 58(4) of Regula tion (EC) No 1272/2008 of the European 
Parliament and the Council of 16 Decem ber 2008 on classification, labelling and 
packaging of substances and mixtures, am ending and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Regulation (EC) No 1907/20063, as from 1 December 
2010 Article 57(a), (b) and (c) of Regulati on (EC) No 1907/2006 shall refer to the 
classification criteria laid down respectivel y in sections 3.6, 3.5 and 3.7 of Annex I to 
                                                 
1 OJ L 396, 30.12.2006, p 1. 
2 OJ 196, 16.8.1967, p.1.  
3  OJ L 353, 31.12.2008, p.1.  
EN 3   EN Regulation (EC) No 1272/2008. Therefore, re ferences in this Regulation to the 
classification criteria referred to in Ar ticle 57 of Regulation (EC) No 1907/2006 
should be made in accord ance with that provision. 
(3) 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) is very persistent and very 
bioaccumulative in accordance with the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Anne x XIII to that Regulation. It has been 
identified and included in the candidate lis t in accordance with Article 59 of that 
Regulation. 
(4) 4,4’-Diaminodiphenylmethane (MDA) meets the criteria for cl assification as 
carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and 
therefore meets the criteria for inclusio n in Annex XIV to Regulation (EC) No 
1907/2006 set out in Article 57(a) of that Regulation. It has been identified and 
included in the candidate lis t in accordance with Artic le 59 of that Regulation. 
(5) Alkanes, C10-13, chloro (Short Chain Chlori nated Paraffins – SCCPs) are persistent, 
bioaccumulative and toxic, and very pers istent and very bioaccumulative in 
accordance with the criteria for inclusi on in Annex XIV to Regulation (EC) No 
1907/2006 set out in Annex XIII to that Regul ation. They have b een identified and 
included in the candidate lis t in accordance with Artic le 59 of that Regulation. 
(6) Hexabromocyclododecane (HBCDD) and the diastereoisomers alpha-, beta- and 
gamma-hexabromocyclododecane are persis tent, bioaccumulative and toxic in 
accordance with the criteria for inclusi on in Annex XIV to Regulation (EC) No 
1907/2006 set out in Annex XIII to that Regul ation. They have b een identified and 
included in the candidate lis t in accordance with Artic le 59 of that Regulation. 
(7) Bis(2-ethylhexyl) phthalate (DEH P) meets the criteria for classification as toxic to 
reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and 
therefore meets the criteria for inclusio n in Annex XIV to Regulation (EC) No 
1907/2006 set out in Article 57(c) of that Regulation. It has been identified and 
included in the candidate lis t in accordance with Artic le 59 of that Regulation. 
(8) Benzyl butyl phthalate (BBP ) meets the criteria for cl assification as toxic to 
reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and 
therefore meets the criteria for inclusio n in Annex XIV to Regulation (EC) No 
1907/2006 set out in Article 57(c) of that Regulation. It has been identified and 
included in the candidate lis t in accordance with Artic le 59 of that Regulation. 
(9) Dibutyl phthalate (DBP) meets the criteria for classification as toxic to reproduction 
(category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in 
Article 57(c) of that Regulat ion. It has been identified an d included in the candidate 
list in accordance with Artic le 59 of that Regulation.  
EN 4   EN (10) The above mentioned substances have been prioritised for inclus ion in Annex XIV to 
Regulation (EC) No 1907/2006 by the Eur opean Chemicals Agency in its 
recommendation of 1 June 20094. 
(11) In December 2009, SCCPs were included as a persistent organic pollutant under the 
1998 Protocol on Persistent Organic Po llutants to the 1979 Convention on Long-
Range Transboundary Air Pollu tion. The inclusion of SCCP s in this Protocol has 
triggered additional obligations for the European Union under Regulation (EC) No 
850/2004 of the European Parliament and the Council of 29 April 2004 on persistent 
organic pollutants and am ending Directive 79/117/EEC5 that could have an impact on 
the inclusion at this stag e of SCCPs in Annex XIV to Regulation (EC) No 1907/2006.  
(12) For each substance listed in Annex XIV to Regulation (EC) No 1907/2006, where the 
applicant wishes to continue to use the substance or place the substance on the market, it is appropriate to set a date by which appl ications must be received by the European 
Chemicals Agency, in accordance with Ar ticle 58(1)(c)(ii) of  that Regulation.  
(13) For each substance listed in Annex XIV to Regulation (EC) No 1907/2006 it is 
appropriate to set a date from which the us e and placing on the mark et is prohibited, in 
accordance with Article 58(1)(c )(i) of that Regulation. 
(14) The European Chemicals Agency recomm endation of 1 June 2009 has identified 
different latest application dates for the substances listed in the Annex to this 
Regulation. These dates should be set on the ba sis of the estimated time that would be 
required to prepare an application for the authorisation, taking into account the 
information available on the different subs tances and specifically the information 
received during the public consultation carri ed out in accordance with Article 58(4) of 
Regulation (EC) No 1907/2006. Factors such as  the number of actors in the supply 
chain, their homogeneity or heterogeneity, th e existence of ongoing substitution efforts 
and information on potential alternatives  and the expected complexity of the 
preparation of the analys is of alternatives should be taken into account.  
(15) In accordance with Article 58(1)(c)(ii) of  Regulation (EC) No 1907/2006, there should 
be at least 18 months before the latest  application date a nd the sunset date. 
(16) Article 58(1)(e) in conjunction with Ar ticle 58(2) of Regul ation (EC) 1907/2006 
provides for the possibility of exemptions of uses or categories of uses in cases where 
there is specific Community legislation imposing minimum requirements relating to 
the protection of human health or the enviro nment that ensures proper control of the 
risks.  
(17) DEHP, BBP, and DBP are used in the imme diate packaging of medicinal products. 
Aspects of safety of the immediate packag ing of medicines are covered by 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
6 and Directive 
2001/83/EC of the European Parliament a nd of the Council of  6 November 2001 on 
                                                 
4  http://echa.europa.eu/chem_data/auth orisation_process/annex_xiv_rec_en.asp 
5 OJ L 158, 30.4.2004, p.7. 
6 OJ L 311, 28.11.2001, p. 1.  
EN 5   EN the Community code relating to medicinal products for human use7. That legislation of 
the Union provides for a framework to pr operly control risks of such immediate 
packaging materials by imposing requirement s on the quality, stabi lity, and safety of 
the immediate packaging materials. It is th erefore appropriate to exempt the use of 
DEHP, BBP, and DBP in the immediate packaging of medicinal products from 
authorisation under Regulation (EC) No 1907/2006.  
(18) In accordance with Article 60(2) of Re gulation (EC) No 1907/2006, the Commission 
should not consider, when granting authorisat ions, the human health risks associated 
with the use of substances in medica l devices regulated by Council Directive 
90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating to active implantable medical devices8, Council Directive 93/42/EEC of 14 
June 1993 concerning medical devices9, or Directive 98/79/EC of the European 
Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
10. In addition, Article 62(6) of Regul ation (EC) No 1907/2006 provides that 
applications for authorisation should not incl ude the risks to human health arising from 
the use of a substance in a medical device regulated under those Di rectives. It follows 
that an application for an authorisation s hould not be required for a substance used in 
medical devices regulated under Direct ive 90/385/EEC, Directive 93/42/EEC, or 
Directive 98/79/EC if such a substance has been identified in Annex XIV to Regulation (EC) No 1907/2006 for human h ealth concerns only. Therefore, an 
assessment as to whether th e conditions for an exemp tion under Article 58(2) of 
Regulation (EC) No 1907/2006 apply is not necessary. 
(19) On the basis of the information currently  available it is not appropriate to set 
exemptions for product and process orie ntated research and development. 
(20) On the basis of the information currently avai lable it is not appropr iate to set review 
periods for certain uses. 
(21) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006,   
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 third day following that of its publication in the 
Official Journal of the European Union . 
                                                
 
7 OJ L 311, 28.11.2001, p. 67.  
8 OJ L 189, 20.7.1990, p. 17.  
9 OJ L 169, 12.7.1993, p. 1. 
10 OJ L 331, 7.12.1998, p. 1.  
EN 6   EN  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
  The President    José Manuel Barroso 
EN 7   EN ANNEX  
In Annex XIV to Regulation (EC) No 1907/2006 the following ta ble is inserted: 
"   Transitional arrangements   
Entry 
Nr Substance Intrinsic 
property (ies) 
referred to in 
Article 57 Latest application 
date(1) Sunset date(2) Exempted 
(categories of) 
uses Review periods 
1. 5-tert-butyl-2,4,6-trinitro-m-xylene 
(Musk xylene ) 
EC No : 201-329-4 
CAS No : 81-15-2  vPvB [Date of entry into 
force + 24 months] [Date of entry into 
force + 42 months] - - 
2. 4,4’-Diaminodiphenylmethane  
(MDA) 
EC No : 202-974-4 
CAS No : 101-77-9 
 Carcinogenic (category 1B) [Date of entry into 
force + 24 months] [Date of entry into 
force + 42 months] 
- - 
3. Hexabromocyclododecane ( HBCDD ) 
EC No : 221-695-9, 
 247-148-4, PBT [Date of entry into 
force + 27 months] [Date of entry into 
force + 45 months] - -  
EN 8   EN CAS No : 3194-55-6 
 25637-99-4 
alpha-hexabromocyclododecane  CAS No
: 134237-50-6, 
beta-hexabromocyclododecane  
CAS No : 134237-51-7 
gamma-hexabromocyclododecane  
CAS No : 134237-52-8 
4. Bis(2-ethylhexyl) phthalate 
(DEHP )  
EC No : 204-211-0 
 
CAS No : 117-81-7 Toxic to reproduction  
(category 1B) [Date of entry into 
force + 30 months] [Date of entry into 
force + 48 months] Uses in the immediate 
packaging of medicinal products covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC. 
  
5. Benzyl butyl phthalate 
(BBP )  
EC No : 201-622-7 
 
CAS No : 85-68-7 Toxic to reproduction  
(category 1B) [Date of entry into 
force + 30 months] [Date of entry into 
force + 48 months] Uses in the immediate 
packaging of medicinal 
products covered under Regulation (EC) No 
726/2004, 
Directive 2001/82/EC, and/or Directive 
2001/83/EC. 
   
EN 9   EN 6. Dibutyl phthalate  
(DBP )  
EC No : 201-557-4 
 
CAS No : 84-74-2  Toxic to reproduction  
(category 1B) [Date of entry into 
force + 30 months] [Date of entry into 
force + 48 months] Uses in the immediate 
packaging of medicinal 
products covered under Regulation (EC) No 
726/2004, 
Directive 2001/82/EC, and/or Directive 
2001/83/EC. 
 
  
 
Notes: 
(1) Date referred to in Article 58(1)( c)(ii) of Regulation (EC) No 1907/2006. 
(2) Date referred to in Article 58(1)( c)(i) of Regulation (EC) No 1907/2006."