EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) XXX  draft  
ANNEX 1  
 
ANNEX  
 
to the  
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 certain substances classified as 
carcinogenic, mutageni c or toxic for reproduction (CMR), category 1A or 1B    
2 
  
ANNEX  
Annex XVII to Regulation (EC) No 1907/2006  is amended as follows:  
 
(1) the following entry is added:    
' [XX ][To be completed with 
correct number before 
publication]  
The substance s listed  in column 
1 of the Table in Appendix 12  1. Shall not be placed on the market after [OP: 
please insert date – twenty -four months after 
the entry into force of this Regulation ] in any of 
the following:  
(a) clothing  or related accessories ,  
(b) textile s other than clothing which, under 
normal  or reasonably foreseeable 
conditions of use , come into contact 
with human skin to an extent similar to 
clothing , 
(c) footwear ,  
if the clothing, accessory, textile or footwear is 
for use by consumers  and the substance is 
present in a concentration , measured in 
homogeneous material,  greater than that 
specified for that substance in Appendix 1 2. 
2. By way of derogation , in relation to the 
placing on the market of formaldehyde  [CAS 
No 50-00-0] in jackets , coats  or upholstery , the 
relevant concentration for the purposes of 
paragraph 1 shall be 300 mg/kg during the 
period between [OP: please insert date – 
twenty -four months  after the entry into force of 
this Regulation ] and [OP: please insert date – 
sixty months after the entry into force of this 
Regulation ]. The concentration specified in 
Appendix 12 shall apply  thereafter . 
3. Paragraph 1 shall not apply to :  
a) clothing , related accessories  or 
footwear , or parts of clothing , related 
accessories  or footwear , made 
exclusively of natural leather, fur or 
hide; 
b) non-textile fasteners and non-textile 
decorative attachments ;  
c) second -hand clothing, related 
accessories, textiles other than clothing  
3 
 or footwear . 
4. Paragraph 1 shall not apply to clothing,  
related accessories,  textiles  or footwear within 
the scope of Regulation (EU ) 2016/425 of the 
European Parliament and of the Council (*) or 
Regulation  (EU) 2017 /745 of the European 
Parliament and of the Council (**). 
5. Paragraph 1(b) shall not apply to disposable 
textiles . 'Disposable textiles' means textiles that  
are designed to be used only once or for a 
limited time  and are not intended for subsequent 
use for the same or a similar purpose . 
6. Paragraph s 1 and 2 shall apply without 
prejudice to the application of any stricter 
restrictions set out in this Annex or in other 
applicable Union legislation.  
 
(*) Regulation (EU) 2016/425 of the European 
Parliament and of the Council of of 9 March 
2016 on personal protective equipment and 
repealing Council Directive 89/686/EEC  (OJ L 
81, 31.3.2016, p. 51 ). 
(**) Regulation (EU) 2017/745 of the European 
Parliament and of the Council of 5 April 2017 
on medical devices, amending Directive 
2001/83/EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009 and repealing 
Council Directives 90/385/EEC and 93/42/EE C 
(OJ L 117, 5.5.2017, p. 1 ).' 
 
(2) the following Appendix  12 is added:  
'Appendix 12 
Entry [XX][To be completed with correct number before publication ]– restricted substances 
and maximum concentration limits  by weight in homogeneous materials : 
Substances  Index - No CAS No  EC No  Concentration limit 
by weight  
Cadmium and its compounds 
(listed in Annex XVII, Entry 
28, 29, 30, Appendices 1 -6) - - - 1 mg/kg (expressed 
as Cd metal that can 
be extracted from 
the material)   
Chromium VI compounds - - - 1 mg/kg (expressed  
4 
 (listed in Annex XVII, Entry 
28, 29, 30, Appendices 1 -6) as Cr VI  that can be 
extracted from the 
material)  
Arsenic compounds (listed in 
Annex XVII, Entry 28, 29, 30, 
Appendices 1 -6) - - - 1 mg/kg (expressed 
as As metal that can 
be extracted from 
the material)  
Lead and its compounds (listed 
in Annex XVII, Entry 28, 29, 
30, Appendices 1 -6) - - - 1 mg/kg (expressed 
as Pb  metal that can 
be extracted from 
the material)  
Benzene  601-020-00-8 71-43-2 200-753-7 5 mg/kg  
Benz[ a]anthracene  601-033-00-9 56-55-3 200-280-6 1 mg/kg  
Benz[ e]acephenanthrylene  601-034-00-4 205-99-2 205-911-9 1 mg/kg  
benzo[ a]pyrene; 
benzo[ def]chrysene  601-032-00-3 50-32-8 200-028-5 1 mg/kg  
Benzo[ e]pyrene  601-049-00-6 192-97-2 205-892-7 1 mg/kg  
Benzo[ j]fluoranthene  601-035-00-X 205-82-3 205-910-3 1 mg/kg  
Benzo[ k]fluoranthene  601-036-00-5 207-08-9 205-916-6 1 mg/kg  
Chrysene  601-048-00-0 218-01-9 205-923-4 1 mg/kg  
Dibenz[ a,h]anthracene  601-041-00-2 53-70-3 200-181-8 1 mg/kg  
α, α,α,4-tetrachlorotoluene; p -
chlorobenzotrichloride  
 602-093-00-9 5216 -25-1 226-009-1 1 mg/kg  
α, α,α -trichlorotoluene; 
benzotrichloride  602-038-00-9 98-07-7 202-634-5 1 mg/kg  
α-chlorotoluene; benzyl 
chloride  602-037-00-3 100-44-7 202-853-6 1 mg/kg  
Formaldehyde  605-001-00-5 50-00-0 200-001-8 75 mg/kg   
1,2-benzenedicarboxylic acid; 
di-C 6-8-branched alkylesters, 
C 7-rich 607-483-00-2 71888 -89-6 276-158-1 1000 mg/kg  
(individually or in 
combination with 
other phthalates in 
this entry or in 
other entries of 
Annex XVII  that 
are classified in  
Part 3 of Annex VI 
to Regulation (EC) 
No 1272/2008  in 
any of the hazard 
classes 
carcinogenicity, 
germ cell 
mutagenicity  or 
reproductive 
toxicity, category 
1A or 1B   
Bis(2 -methoxyethyl) phthalate  607-228-00-5 117-82-8 204-212-6 1000 mg/kg 
(individually or in 
combination with 
other phthalates in 
this entry or in 
other entries of 
Annex XVII that 
are classified in 
Part 3 of Annex VI  
5 
 to Regulation (EC) 
No 1272/2008 in 
any of the hazard 
classes 
carcinogenicity, 
germ cell 
mutagenicity  or 
reproductive 
toxicity , category 
1A or 1B  
Diisopentylphthalate  607-426-00-1 605-50-5 210-088-4 1000 mg/kg 
(individually or in 
combination with 
other phthalates in 
this entry or in 
other entries of 
Annex XVII that 
are classified in 
Part 3 of Annex VI 
to Regulation (EC) 
No 1272/2008 in 
any of the hazard 
classes 
carcinogenicity, 
germ cell 
mutagenicity or 
reproductive 
toxicity, category 
1A or 1B  
Di-n-pentyl phthalate  (DPP)  607-426-00-1 131-18-0 205-017-9 1000 mg/kg 
(individually or in 
combination with 
other phthalates in 
this entry or in 
other entries of 
Annex XVII that 
are classified in 
Part 3 of Annex VI 
to Regulation (EC) 
No 1272/2008 in 
any of the hazard 
classes 
carcinogenicity, 
germ cell 
mutagenicity  or 
reproductive 
toxicity, category 
1A or 1B  
Di-n-hexyl phthalate (DnHP)  607-702-00-1 84-75-3 201-559-5 1000 mg/kg 
(individually or in 
combination with 
other phthalates in 
this entry or in 
other entries of 
Annex XVII that 
are classified in 
Part 3 of Annex VI 
to Regulation (EC)  
6 
 No 1272/2008 in 
any of the hazard 
classes 
carcinogenicity, 
germ cell 
mutagenicity  or  
reproductive 
toxicity , category 
1A or 1B  
N-methyl -2-pyrrolidone; 1 -
methyl -2-pyrrolidone (NMP)  606-021-00-7 872-50-4 212-828-1 3000 mg/kg  
N,N-dimethylacetamide 
(DMAC)  616-011-00-4  127-19-5 204-826-4 3000 mg/kg  
N,N-dimethylformamide; 
dimethyl formamide  (DMF)  616-001-00-X 68-12-2 200-679-5 3000 mg/kg  
1,4,5,8 -
tetraaminoanthraquinone ; C.I. 
Disperse Blue 1  611-032-00-5 2475 -45-8 219-603-7 50 mg/kg  
Benzenamine, 4,4'-(4-
iminocyclohexa -2,5- 
dienylidenemethylene)dianiline 
hydrochloride; C.I. Basic Red 9   611-031-00-X 569-61-9 209-321-2 50 mg/kg  
[4-[4,4'-
bis(dimethylamino)benzhydryli
dene]cyclohex a-2,5-dien-1-
ylidene] dimethylammonium 
chloride ; C.I. Basic Violet 3 
with ≥ 0,1 % of Michler's 
ketone (EC no. 202 -027-5) 612-205-00-8 548-62-9 208-953-6 50 mg/kg  
4-chloro -o-toluidinium chloride  612-196-00-0 3165 -93-3 221-627-8 30 mg/kg  
2-Naphthylammoniumacetate  612-071-00-0 553-00-4 209-030-0 30 mg/kg  
4-methoxy -m-phenylene 
diammonium sulphate ; 2,4-
diaminoanisole sulphate  612-200-00-0 39156 -41-7 254-323-9 30 mg/kg  
2,4,5 -trimethylaniline 
hydrochloride  612-197-00-6 21436 -97-5 - 30 mg/kg  
Quinoline  613-281-00-5 91-22-5 202-051-6 50 mg/kg '