EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
[…](2011) XXX draft 
  
Draft 
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Annex XIV to Regula tion (EC) No 1907/2006 of th e European Parliament and 
of the Council on the Regist ration, Evaluation, Authoris ation and Restriction of 
Chemicals ('REACH') 
(Text with EEA relevance)   
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
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 Articles  
58 and 131 thereof, 
Whereas: (1) Regulation (EC) No 1907/2006 provides that substances meeting the criteria for 
classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) and 
toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 
1272/2008 of the European Parliament and the Council of 16 December 2008 on 
classification, labelling and packag ing of substances and mixtures
2, substances that are 
persistent, bioaccumulative and toxic, substa nces that are very persistent and very 
bioaccumulative, and substances for which th ere is scientific evidence of probable 
serious effects to human health and environm ent giving rise to an equivalent level of 
concern may be subject to authorisation.  
(2) Diisobutyl phthalate (DIBP) meets the criteria for cl assification as toxic for 
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 list in accordance with Article 59 of Regulation (EC) No 
1907/2006. 
(3) Diarsenic trioxide meets the criteria for cla ssification as carcinoge nic (category 1A) 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(a) of 
                                                 
1 OJ L 396, 30.12.2006, p 1. 
2 OJ L 353, 31.12.2008, p.1..   
EN 2   EN that Regulation. It has been identified and in cluded in the candidate list in accordance 
with Article 59 of Regulation (EC) No 1907/2006. 
(4) Diarsenic pentaoxide meets the criteria for classification as carcinogenic (category 1A) 
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(a) of 
that Regulation. It has been identified and in cluded in the candidate list in accordance 
with Article 59 of Regulation (EC) No 1907/2006. 
(5) Lead chromate meets the criteria for clas sification as carcinoge nic (category 1B) and 
toxic for reproduction (cat egory 1A) in accordance with Regulation (EC) No 
1272/2008 and therefore meets the criteria fo r inclusion in Annex XIV to Regulation 
(EC) No 1907/2006 set out in Article 57(a) an d (c) of that Regulation. It has been 
identified and included in the candidate list in accordance with Article 59 of 
Regulation (EC) No 1907/2006. 
(6) Lead sulfochromate yellow (C.I. Pigmen t Yellow 34) meets the criteria for 
classification as carcinogeni c (category 1B) and toxic for reproduction (category 1A) 
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(a) and 
(c) of that Regulation. It has been identif ied and included in th e candidate list in 
accordance with Article 59 of  Regulation (EC) No 1907/2006. 
(7) Lead chromate molybdate sulphate red (C. I. Pigment Red 104) meets the criteria for 
classification as carcinogeni c (category 1B) and toxic for reproduction (category 1A) 
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(a) and 
(c) of that Regulation. It has been identif ied and included in th e candidate list in 
accordance with Article 59 of  Regulation (EC) No 1907/2006. 
(8) Tris (2-chloroethyl) phosphate (TCEP) meets the criteria for classification as toxic for 
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 list in accordance with Article 59 of Regulation (EC) No 
1907/2006. 
(9) 2,4-Dinitrotoluene (2,4 DNT) meets the crit eria for classificat ion as carcinogenic 
(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 Article 59 of Regulation (EC) No 1907/2006. 
(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 17 December 2010
3 in accordance with Article 58 of that 
Regulation. 
                                                 
3 http://echa.europa.eu/chem_data/ authorisation_process/annex_xiv_r ec/second_annex_xiv_rec_en.asp  
EN 3   EN (11) 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.  
(12) 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. 
(13) The European Chemicals Agency recommendation of 17 December 2010 has 
identified different latest application date s for the substances listed in the Annex to 
this Regulation. These dates should be set on  the basis of the estimated time that 
would be required to prepare an application for the author isation, taking into account 
the information available on the different substances and the information received 
during the public consultati on carried out in accordance  with Article 58(4) of 
Regulation (EC) No 1907/2006. The Agency's ca pacity to handle applications in the 
time provided for in the Regulation (EC)  No 1907/2006 should also  be taken into 
account. 
(14) In accordance with Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006, the latest 
application date is to be set at leas t 18 months before the sunset date. 
(15) Diisobutyl phthalate is a potential alternativ e to other phthalate substances which are 
included in Annex XIV to Regulation (EC)  No 1907/2006. The latest application date 
set out for those phthalate substances shoul d therefore also be taken into account in 
setting the latest application date for this substance.  
(16) Article 58(1)(e) in conjunction with Artic le 58(2) of Regulation (EC) No 1907/2006 
provides for the possibility of exemptions of uses or categories of uses in cases where 
there is specific EU legislation imposi ng minimum requirements relating to the 
protection of human health or the environment that ensures proper control of the risks. 
In accordance with the information currently  available it is not appropriate to set 
exemptions based on those provisions. 
(17) On the basis of the information currently  available it is not appropriate to set 
exemptions for product and process orie ntated research and development. 
(18) On the basis of the information currently avai lable it is not appropr iate to set review 
periods for certain uses. 
(19) 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.  
EN 4   EN 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 . 
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 5   EN ANNEX  
In the table in Annex XIV to Regulation (EC)  No 1907/2006 the following entries are added: 
   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 
"7. Diisobutyl phthalate (DIBP) 
EC No : 201-553-2 
CAS No : 84-69-5  Toxic for reproduction  
(category 1B) 
 [Date of entry into 
force + 18 months or 
21 August 2013, 
whichever is the latest] [Date of entry into 
force + 36 months or 
21 February 2015, 
whichever is the latest] - - 
8. Diarsenic trioxide  
EC No : 215-481-4 
CAS No : 1327-53-3 
 Carcinogenic (category 1A)  [Date of entry into 
force + 21 months or 21 November 2013, 
whichever is the latest] [Date of entry into 
force + 39 months or 21 May 2015, 
whichever is the latest] 
- -  
EN 6   EN  
9. Diarsenic pentaoxide 
EC No : 215-116-9 
CAS No : 1303-28-2 Carcinogenic 
(category 1A) 
 [Date of entry into 
force + 21 months or 
21 November 2013, whichever is the latest] [Date of entry into 
force + 39 months or 
21 May 2015, whichever is the latest] - - 
10. Lead chromate 
EC No : 231-846-0 
CAS No : 7758-97-6 Carcinogenic 
(category 1B) 
Toxic for reproduction  
(category 1A)  [Date of entry into 
force + 21 months or 
21 November 2013, 
whichever is the latest] [Date of entry into 
force + 39 months or 
21 May 2015, 
whichever is the latest] - 
 - 
11. Lead sulfochromate yellow 
(C.I. Pigment Yellow 34)  
EC No : 215-693-7 
CAS No : 1344-37-2 Carcinogenic 
(category 1B) 
Toxic for reproduction  
(category 1A) 
 [Date of entry into 
force + 21 months or 
21 November 2013, 
whichever is the latest] [Date of entry into 
force + 39 months or 
21 May 2015, 
whichever is the latest] - 
 -  
EN 7   EN  
12. Lead chromate molybdate sulphate red 
(C. I. Pigment Red 104)  
EC No : 235-759-9 
CAS No : 12656-85-8 Carcinogenic 
(category 1B) 
Toxic for reproduction  (category 1A) 
 [Date of entry into 
force + 21 months or 
21 November 2013, whichever is the latest] [Date of entry into 
force + 39 months or 
21 May 2015, whichever is the latest]  
 
13. Tris (2-chloroethyl) phosphate 
(TCEP)  EC No
: 204-118-5 
CAS No : 115-96-8 Toxic for reproduction  
(category 1B)  [Date of entry into 
force + 24 months or 21 February 2014, 
whichever is the latest] [Date of entry into 
force + 42 months or 21 August 2015, 
whichever is the latest]  
 
14. 2,4-Dinitrotoluene (2,4-DNT) 
EC No : 204-450-0 
CAS No : 121-14-2  Carcinogenic 
(category 1B) 
 [Date of entry into 
force + 24 months or 
21 February 2014, 
whichever is the latest] [Date of entry into 
force + 42 months or 
21 August 2015, 
whichever is the latest]   
 
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.