EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex XIV to Regulati on (EC) No 1907/2006 of th e European Parliament and 
of the Council concerning the Registration, Evalu ation, Authorisation and Restriction of 
Chemicals (REACH) 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council concerning the Registration, E valuation, 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 Council 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) The substance 1-bromopropane (n-propyl  bromide)  meets the criteria for 
classification as toxic for reproduction (c ategory 1B) in accordance with Regulation 
(EC) No 1272/2008 of the European Parliament and the Council
2 and therefore meets 
the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in 
Article 57(c) of that Regulation. 
(2) The substance diisopentylphthalate 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 inclusi on in Annex XIV to Regulation (EC) No 
1907/2006 set out in Article 57 (c) of that Regulation. 
(3) The substance 1,2-benzenedicarboxylic acid, di-C6-8-branched al kyl esters, C7-rich, 
meets the criteria for classification as toxic for reproduction (category 1B) in 
accordance with Regulation (EC) No 1272/200 8 and therefore meets the criteria for 
inclusion in Annex XIV to Regulation (EC)  No 1907/2006 set out in Article 57(c) of 
that Regulation. 
(4) The substance 1,2-benzenedicarboxylic ac id, di-C7-11-branched and linear alkyl 
esters, meets the criteria for classificati on as toxic for reproduction (category 1B) in 
accordance with Regulation (EC) No 1272/200 8 and therefore meets the criteria for 
inclusion in Annex XIV to Regulation (EC)  No 1907/2006 set out in Article 57(c) of 
that Regulation. 
(5) The substance 1,2-benzenedicarboxylic acid, di pentylester, branched and linear, meets 
the criteria for classification as toxic fo r reproduction (category 1B) in accordance 
                                                
 
1 OJ L 396, 30.12.2006, p. 1.  
2 Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).  EN 3   EN with Regulation (EC) No 1272/2008 and theref ore meets the criteria for inclusion in 
Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation. 
(6) The substance bis(2-methoxyethyl) phthalate meets the criteria fo r classification as 
toxic for reproduction (category 1B) 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 Arti cle 57(c) of that Regulation. 
(7) The substance dipentylphthalate 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 inclus ion in Annex XIV to Regulation (EC) 
No 1907/2006 set out in Article 57(c) of that Regulation. 
(8) The substance N-pentyl-isopentylphthalate meet s the criteria for classification as toxic 
for reproduction (category 1B) in accordan ce with Regulation (EC) No 1272/2008 and 
therefore meets the criteria for inclus ion in Annex XIV to Regulation (EC) 
No 1907/2006 set out in Article 57(c) of that Regulation. 
(9) When containing a certain percentage of be nzo[a]pyrene, the substance anthracene oil 
meets the criteria for classification as car cinogenic (category 1B) in accordance with 
Regulation (EC) No 1272/2008  and therefore me ets the criteria for inclusion in Annex 
XIV to Regulation (EC) No 1907/2006 set out in  Article 57(a) of that Regulation. The 
substance is also persistent, bioaccumulative and toxic, as well as very persistent and 
very bioaccumulative in accordance with th e criteria set out in Annex XIII to 
Regulation (EC) No 1907/2006 a nd therefore meets the criteria for inclusion in Annex 
XIV to that Regulation se t out in Article 57(d) an d (e) of that Regulation. 
(10) The substance pitch, coal tar, high temp. meets the criteria for classification as 
carcinogenic (category 1B) in accordan ce with Regulation (EC) No 1272/2008 and 
therefore meets the criteria for inclus ion in Annex XIV to Regulation (EC) 
No 1907/2006 set out in Article 57(a) of th at Regulation. The substance is also 
persistent, bioccumulative and toxic, as  well as very persistent and very 
bioaccumulative in accordance wi th the criteria set out in Annex XIII to Regulation 
(EC) No 1907/2006 and therefore meets the criter ia for inclusion in Annex XIV to that 
Regulation set out in Article 57 (d) and (e) of that Regulation. 
(11) The substance group 4-(1,1,3,3- tetramethylbutyl)phenol, ethoxylated (covering well-
defined substances and substances of unknown or variable composition, complex reaction products or biological materi als (“UVCB substan ces”), polymers and 
homologues) are substances which thr ough their degradation have endocrine 
disrupting properties for which there is scie ntific evidence of pr obable serious effects 
to the environment. As such, they give rise to an equivalent level of concern to those 
of other substances listed in points (a) to  (e) of Article 57 of  Regulation (EC) No 
1907/2006 and, therefore, meet the criteria for in clusion in Annex XIV to that 
Regulation set out in Article 57(f) of that Regulation.  
(12) The substance group 4-nonylphenol, bran ched and linear, ethoxylated (including 
substances with a linear and/or branched  alkyl chain with a carbon number of 9 
covalently bound in position 4 to phenol , ethoxylated covering UVCB- and well 
defined substances, polymers and homologues,  which include any of the individual 
isomers and/or combinations thereof), are substances which through their degradation 
have endocrine disrupting properties for which there is scientific evidence of probable 
serious effects to the environment. As such, they give rise to an  equivalent level of EN 4   EN concern to those of other substances list ed in points (a) to (e) of Article 57 of 
Regulation (EC) No 1907/2006 and, therefore, meet the criter ia for inclusion in Annex 
XIV to that Regulation set out in Article 57(f ) of that Regulation. 
(13) Those substances have been identified and in cluded in the candidate list in accordance 
with Article 59 of Regulation (EC) No  1907/2006. They have furthermore been 
prioritised for inclusion in Annex XI V to Regulation (EC) No 1907/2006 by the 
European Chemicals Agency ("the Agency") in its recommendations of 6 February 2014
3 and 1 July 20154, in accordance with Article 58 of that Regulation. In addition, 
the Commission has assessed the socio-economic  impacts of the possible inclusion of 
those substances in Annex XIV based on information contained in numerous 
submissions received from stakeholders after receipt of the Agency's fifth 
recommendation or provided through a public  consultation that was conducted in 
parallel with the Agency's public consultati on on its draft sixth recommendation. It is 
therefore appropriate to include those substances in that Annex. 
(14) It is appropriate to indicate the dates refe rred to in Article 58(1)(c)(ii) of Regulation 
(EC) No 1907/2006 in line with the Agency's recommendations of 6 February 2014 and of 1 July 2015. Those dates have been iden tified on the basis of the estimated time 
that would be required to prepare an app lication for the authorisation, taking into 
account the information available on the di fferent substances and the information 
received during the public consultation carried out in accordance with Article 58(4) of Regulation (EC) No 1907/2006. To that purpo se, the Agency's capacity to handle 
applications in the time provided for in Regulation (EC) No 1907/2006 should also 
been taken into account, as provided in  Article 58(3) of that Regulation.  
(15) For each of those substances listed in the Annex to this Regulation there are no 
reasons why the date referred to in Arti cle 58(1)(c)(i) of Regulation (EC) No 
1907/2006 should be set later than 18 months after the date referred to in Article 
58(1)(c)(ii) of th at Regulation.  
(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 
specific Union legislation imposes minimum re quirements relating to the protection of 
human health or the environment ensuring 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. In accordance with  Article 60(8) of Regulation (EC) No 
1907/2006 review periods are to be determ ined on a case-by-case basis taking into 
account inter alia the risks posed by the us es of the substance, the socio-economic 
benefits arising from its use and the analysis of alternatives or any substitution plan submitted for uses for which authorisation is requested. In instances where there is no suitable alternative, the risk s posed by the use are limited by appropriate and effective 
risk management measures, and when the bene fits arising from the use are expected to 
be high, as could be the case for uses in  the production of me dicinal products or 
medical devices, review periods could be long. 
                                                
 
3 http://echa.europa.eu/documents/10162/13640/5th_a_xiv_recommendation_06feb2014_en.pdf    
4 http://echa.europa.eu/documents/10162/13640/6th_a_xiv_recommendation_01july2015_en.pdf   EN 5   EN (19) In order to avoid the premature obsolescen ce of articles that are no longer produced 
after the sunset dates refe rred to Annex XIV to Regul ation (EC) No 1907/2006, some 
substances (by themselves or in mixtures) in cluded in that Annex need to be available 
for the production of spare parts for the repair  of those articles, where those articles 
cannot function as intended without those sp are parts, as well as where some Annex 
XIV substances (by themselves or in mixtur es) are necessary for the repair of such 
articles. To that end, applications for au thorisation for the use of an Annex XIV 
substance for the production of such spare pa rts and for the repair of such articles 
should be simplified. The tran sitional arrangements appli cable to the substances 
concerned by those uses should be extende d in order to allow for the adoption of 
implementing measures for such simplif ied applications fo r authorisation.  
(20) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
(21) N,N-Dimethylformamide (DMF) 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 inclus ion in Annex XIV to Regulation (EC) 
No 1907/2006 set out in Article 57(c) of that Regulation. It has also been identified 
and included in the candidate list in accord ance with Article 59 of  Regulation (EC) No 
1907/2006 and prioritised for inclusion in Annex XIV to that Regulation by the 
Agency's recommendation of 6 February 2014 in accordance with Article 58 of that Regulation. DMF has similar intrinsic proper ties to those of N,N-dimethylacetamide 
(DMAC) and N-methyl-2-pyrrolidone (NMP ) and the three substances may be 
considered as potential alternatives for some of their major uses. NMP is the subject of 
an on-going restriction procedure in accordance with Article 69 of Regulation (EC) No 1907/2006. In view of the similarities of th e three substances, both regarding their 
intrinsic properties and their industrial applic ations, and in order to  ensure a consistent 
regulatory approach, the Commission consider s it appropriate to postpone the decision 
on the inclusion of DMF in Annex XIV as has already been done for DMAC when the 
Commission considered the Agency's recommendation of 17 January 2013.  
(22) Diazene-1,2-dicarboxamide (C,C'-azodi(forma mide)) (ADCA) meets the criteria for 
classification as a respiratory sensitise r (Resp. Sens.1). Taki ng into account all 
available information about the intrinsic properties of ADCA and about its adverse 
effects, the Agency concluded that it can be  regarded as a substance for which there is 
scientific evidence of probable serious effects to human health which give rise to an equivalent level of concern to  those of other substances li sted in points (a) to (e) of 
Article 57 of Regulation (EC) No 1907/2006 and therefore meets the criteria for 
inclusion in Annex XIV to that Regulation set out in Article 57(f) of  that Regulation. It 
has also been identified and included in the candidate list in accordance with Article 
59 of Regulation (EC) No 1907/2006 and prioritised for in clusion in Annex XIV to 
that Regulation by the Agency's recomme ndation of 6 February 2014 in accordance 
with Article 58 of that Re gulation. Uses of ADCA are very diverse and concern a 
broad range of different manufacturing indust ries, expected to lead to a very high 
workload for the Agency and the Commissi on as regards the number and complexity 
of applications for authorisation. As  currently the expe rience for handling 
authorisation applications c overing broad ranges of uses is still limited, it is 
appropriate to postpone the decision on the in clusion of ADCA in Annex XIV, for the 
time being. Moreover, new information has been submitted on the classification of 
ADCA which could be relevant for its respiratory sensitiser properties as well as for 
the identification of this substance unde r Article 57(f) of Re gulation (EC) No 
1907/2006, and is currently being examined by a Member State. EN 6   EN (23) Certain aluminosilicate refractory cer amic fibres (Al- RCF) and zirconia 
aluminosilicate refractory ceramic fibres (Z r-RCF) meet the criteria for classification 
as carcinogenic (category 1B) in accorda nce with Regulation (EC) No 1272/2008 and 
therefore meet the criteria for inclus ion in Annex XIV to Regulation (EC) 
No 1907/2006 set out in Article 57(a) of th at Regulation. They have also been 
identified and included in the candidate list in accordance with Article 59 of 
Regulation (EC) No 1907/2006 an d prioritised for inclusi on in Annex XIV to that 
Regulation by the Agency's recommendation of 6 February 2014 in accordance with 
Article 58 of that Regulation. The actual fi bres are manufactured at a very limited 
number of industrial sites and are in gene ral directly transfor med within the same 
manufacturing process into articles that ar e subsequently used in a broad range of 
industrial equipment for high-temperature insulation, which can potentially lead to 
significant worker exposure. However, the use of articles made of the fibres is not 
subject to authorisation under Regulation (EC) No 1907/2006. In order to decide on 
the most relevant regulatory approach, the Commission considers it appropriate to 
postpone the decision on the inclusion of Al-RCF and Zr-RCF in Annex XIV to 
Regulation (EC) No 1907/2006 for the time being. 
(24) Boric acid, disodium tetraborate (anhydr ous), diboron trioxi de, and tetraboron 
disodium heptaoxide (hydrat e) meet the criteria for cl assification as toxic for 
reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meet the criteria for inclus ion in Annex XIV to Regulation (EC) 
No 1907/2006 set out in Article 57(c) of th at Regulation. They have also been 
identified and included in the candidate list in accordance with Article 59 of 
Regulation (EC) No 1907/2006 an d prioritised for inclusi on in Annex XIV to that 
Regulation by the Agency's recommendation of  1 July 2015 in accordance with Article 
58 of that Regulation. Furthermore, the uses of these substances are very diverse and 
concern a broad range of different manufacturin g industries, expected to lead to a very 
high workload for the Agency and the Commission as regards the number and complexity of applications for authorisati on. As currently the e xperience for handling 
authorisation applications c overing broad ranges of uses is still limited, it is 
appropriate to postpone the decision on the inclusion of these substances in Annex 
XIV for the time being. 
(25) The measures provided for in this Regula tion are in accordance with the opinion of 
the  Committee established under Arti cle 133 of Regulati on (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 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. EN 7   EN Done at Brussels, 
 For the Commission 
 The President 
 Jean-Claude JUNCKER