EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) XXX  draft  
 
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, Evaluation, Authorisation 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 concerning the Registration, Evaluation, 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 Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing C ouncil 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/EC1, and in particular 
Article s 58 and 131  thereof,  
Whereas:  
(1) The subs tance s 1,2 -benzenedicarboxylic acid, dihexyl ester, branched and linear , and   
dihexyl phthalate and the substance group 1,2 -benzenedicarboxylic acid, di -C6-10-
alkyl esters; 1,2 -benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters 
with ≥ 0 ,3% of dihexyl phthalate  meet the criteria for classification as toxic for 
reproduction (category 1B) in accordance with Regulation  (EC) No 1272/2008  of the 
European Parliament and of the Council2 and therefore meet 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  trixylyl phosphate  meets the criteria for classification as toxic for 
reproduction (category 1B) in accor dance 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 Regulation.  
(3) The substance s sodium perborate; perboric acid, sodium salt and sodium 
peroxome taborate  meet the criteria for classification as  toxic for reproduction 
(category 1B) in accordance with Regulation  (EC) No 1272/2008 and therefore meet 
the criteria for inclusion in Annex XIV to Regulation (EC) No  1907/2006 set out in 
Article 57(c) of tha t Regulation . 
(4) The substance s 5-sec-butyl -2-(2,4-dimethylcyclohex -3-en-1-yl)-5-methyl -1,3-dioxane 
[1], 5 -sec-butyl -2-(4,6-dimethylcyclohex -3-en-1-yl)-5-methyl -1,3-dioxane [2] 
(covering any of the individual stereoisomers of [1] and [2] or any combination 
thereof) (‘karanal group’) are very persistent and very bioaccumulative 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 2  EN with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore 
meet the criteria for inclusion in Annex XIV to that Regulation set out in Article 57( e) 
of that Regulation.  
(5) The substance s 2-(2H-benzotriazol -2-yl)-4,6-ditertpentylphenol (UV -328); 2,4-di-tert-
butyl -6-(5-chlorobenzotriazol -2-yl)phenol (UV -327); 2-(2H-benzotriazol -2-yl)-4-(tert-
butyl) -6-(sec-butyl )phenol (UV -350) and 2-benzotriazol -2-yl-4,6-di-tert-butylphenol 
(UV-320) are persistent, bio accumulative and toxic  and/or  very persistent and very 
bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation 
(EC) No 1907/2006 and therefore meet the crit eria for inclusion in Annex XIV to that 
Regulation set out in Article 57(d) and /or (e) of that Regulation.  
(6) All the above -mentioned  substances  have been identified and included in the candidate 
list in accordance with Article 59 of Regulation (EC) No 1907/2 006. They have 
furthermore been prioritised for inclusion in Annex XIV to Regulation (EC) 
No 1907/2006 by the European Chemicals Agency ( ‘the Agen cy’) in its 
recommendation s of 10 November 20163 and 5 February 20184, in accordance with 
Article 58 (3) and (4)  of that Regulation. In addition, the Commission has received 
submissions from interested parties to calls for information on the possible economic, 
social, health and environmental impacts (costs and benefits) of the inclusion in Annex 
XIV to Regu lation (EC) No 1907/2006 of the substances proposed by the Agency in 
its draft recommendations .  
(7) The substance diazene -1,2-dicarboxamide (C,C' -azodi(formamide)) (ADCA) meets 
the criteria for classification as a respiratory sensitiser (category 1)  in accord ance with 
section 3.4 of Annex I to Regulation (EC) No 1272/2008 . This substance has been 
identified in accordance with Article 57(f) of Regulation (EC) No 1907/2006 due to its 
respiratory sensitising properties, for which there is scientific evidence of p robable 
serious effects to human health which give rise to an equivalent level of concern to 
those of other substances listed in points (a) to (e) of Article 57 of that Regulation. 
This substance was included in the candidate list in accordance with Articl e 59 and 
prioritised for inclusion in Annex XIV to that Regulation by the Agency's 
recommendation of 6 February 20145, in accordance with Article 58 (3) and (4)  of that 
Regulation . In Commission Regulation (EU) 2017/9996 it was decided  to postpone the 
inclu sion of this substance  in Annex XIV  to Regulation (EC) No 1907/2006 as the 
experience for handling authorisation applications covering broad ranges of uses was 
still limited at that time . In the light of the experience gained in processing 
applications for authorisation regarding substances with very diverse uses, the 
                                                 
3
 https://echa.europa.eu/document s/10162/13640/7th_axiv_recommendation_november2016_en.pdf/3e11
377b -edd8 -46d3 -a29c -1978c41db3ad  
4
 https://echa.euro pa.eu/documents/10162/13640/8th_axiv_recommendation_february2018_en.pdf/10a99
e7d-0fac-ff1d-7f17-910d6edb61b9   
5
 https://echa.europa.eu/documents/10162/13640/5th_a_xiv_recommendation_06feb2014_en.pdf/17ab77
22-0164 -4fe8-80b6 -8b4ac76e8f0f  
 
6  Commission Regulation (EU) 2017/999 of 13 June 2017 amending Annex XIV to Regulation (EC) No 
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) (OJ L 150, 14.6.2017, p. 7).   
EN 3  EN Commission considers it appropriate to now include this substance in Annex XIV to 
Regulation  (EC) No 1907/2006. 
(8) For each o f the substances included in Annex XIV to Regulation (EC) No 1907/2006  
by this Regulation a date from which the placing on the market and the use of the 
substance shall be prohibited unless an authorisation is granted should be set as 
required by  Article 5 8(1)(c)(i) of Regulation (EC) No 1907/2006 , taking into account 
the Agency’s capacity to handle applications for authorisation. For each of those 
substances there are no  reasons why the date referred to in Article 58(1)(c)(i i) of 
Regulation (EC) No 1907/20 06 should be set earlier  than 18 months before  the date 
referred to in Article 58(1)(c)(i) of that Regulation.  
(9) Article 58(1)(e) in conjunction with Article 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 requirements 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.  
(10) As there is no  information justifying the need for an exemptio n for product and 
process orientated research and development , it is not appropriate to consider any such 
exemption .  
(11) As the available information on the uses of the proposed substances  is limited,  it is not 
appropriate to set review periods  at this stage,  pursuant to Article 58(1)(d) of 
Regulation (EC) No  1907/2006 .  
(12) The substances tetralead trioxide sulphate; pentalead tetraoxide sulphate; orange lead 
(lead tetroxide) and lead monoxide (lead oxide)  meet the criteria for classification as 
toxic for reprod uction (category 1 A) in accordance with Regulation  (EC) No 
1272/2008 and therefore meet  the criteria for inclusion in Annex XIV to Regulation 
(EC) No  1907/2006 set out in Article 57(c) of that Regulation. They  have also been 
identified and included in the candidate list in accordance 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 10 No vember  2016  in accordance 
with Article 58 (3) and (4) of that Regulation . The use of lead and its compounds is 
covered by  Council Directive 98/24/EC7 and to some extent by  Directive 2010/75/EU  
of the European Parliament and of the Council  and its implementing measures 
establishing Best Available Techniques (BAT) conclusions. Further more the current 
Union binding occupational limit value and binding biological limit value for lead 
compounds under Directive 98/24/EC will be reviewed. Therefore, and in view of 
possible adoption of more stringent measures at the workplace, it is appropri ate to 
postpone a decision on the inclusion of those substances in Annex XIV to Regulation 
(EC) No 1907/2006 . In addition, through implementation of Directive 2010/75/EU and 
its predecessors, emissions of lead and its compounds to the environment have 
decreased  and continue to decrease as shown by the European Pollutant Release and 
Transfer Register (E -PRTR) reporting and further reductions are expected as new BAT 
conclusions are adopted and as permits are updated to reflect them . 
                                                 
7  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from 
the risks related to chemical agents at work  (fourteenth individual Directive within the meaning of 
Article 16(1) of Directive 89/391/EEC)  (OJ L 131, 5.5. 1998, p. 11).   
EN 4  EN (13) All uses of 1-methyl -2-pyrrolidone (NMP)  are restricted in accordance with Annex 
XVII to Regulation (EC) No 1907/2006.  NMP has  similar intrinsic properties to those 
of N,N -dimethylacetamide (DMAC) and N,N-Dimethylformamide (DMF), and the 
three substances  have similar industrial uses and may be considered as 
interchangeable, at least for some uses , even if in general  they cannot be considered 
‘drop-in’ alternatives . In view of the similarities of the three substances in order to 
ensure a consistent regulatory approach8, the decision on the inclusion of NMP in 
Annex XIV  to Regulation (EC) No 1907/2006  should be postponed , as has been done 
for DMAC  and DMF  when the Commission considered the Agency's 
recommendation s of 17 January 20139 and of 6 February 201410, respectively .  
(14) In order to avoid the premature obsolescence of articles or complex products that are 
no longer produced after the sunset dates referred to in Annex XIV to Regulation (EC) 
No 1907/2006, some substances (by themselves or in mixtures) included in that Annex  
need to be available for the production of spare parts as articles or as complex products 
for the repair of those articles or complex products, where those articles or complex 
products cannot function as intended without those spare parts, as well as wher e some 
Annex XIV substances (by themselves or in mixtures) are necessary for the repair of 
such articles or complex products. In order to facilitate application for authorisation 
for those uses, the existing transitional arrangements should be extended, al lowing the 
adoption of implementing measures for simplified application for authorisations in 
such cases. In addition, the wording of the notes to the table of Annex XIV to 
Regulation (EC) No 1907/2006  should be revised in order to ensure consistency of th e 
terminology as regards articles and complex products in the light of the judgement of 
the Court of Justice in Case C -106/1411. 
(15) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(16) The measures provided for in this Regulation 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 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.  
                                                 
8 https://echa.europa.eu/rmoa/ -/dislist/details/0b0236e181ffe81a  
9       https://echa.europa.eu/documents/10162/13640/4th_a_xiv_recommendation_17jan2013_en.pdf/cfa 4a66b -
9d82 -4e45 -8cb7 -920593db92c1  
10 https://echa.europa.eu/documents/10162/13640/5th_a_xiv_recommendation_06feb2014_en.pdf/17ab7722 -
0164 -4fe8-80b6 -8b4ac76e8f0f  
11  Judgment of the Court of Justice of 10 September 2015, Fédération des entreprises du commerce  et de 
la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison 
(FMB), C -106/14, ECLI:EU:C:2015:576.   
EN 5  EN Done at Br ussels,  
 For the Commission  
 The President  
 Jean-Claude JUNCKER