EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2020) XXX  draft  
ANNEX  
 
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 substances in tattoo inks or permanent 
make -up  EN 1  EN Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:  
(1) the following entry is added:  
‘xx. 
  
 
Substances falling within one 
or more of the following points:   
 
(a) substances classified as any 
of the following in Part 3 of 
Annex VI to Regulation (EC) 
No 1272/2008 : 
- carcinogen  category 1A, 
1B or 2 , or germ cell 
mutagen category 1A, 
1B or 2 , but excluding 
any such substances 
classified due to  effects 
only following exposure 
by inhalation   
- reproducti ve toxicant 
category 1A, 1B or 2 
but excluding any such 
substance s classified 
due to effects only 
following exposure by 
inhalation  
- skin sensitiser category 
1, 1A or 1B 
- skin corrosive category 
1, 1A, 1B or 1C or skin 
irritant category  2 
- serious eye damage  
category 1 or eye 
irritant category 2  
(b) substances listed  in Annex 
II to Regulation (EC) No 
1223/2009  of the European 
Parliament and of the 
Council(*)  
(c) substances listed  in Annex 
IV to Regulation (EC) No 
1223/2009  for which a  
condition is specified in at least 
one of the columns g , h and i of  
1. Shall not be placed on the market in 
mixture s for use for tattooing purposes, 
and mixture s containing any such 
substances shall not be used for tattooing 
purposes, after [OP, please insert the date : 
12 months after the entry into force of this 
amending Regulation ] if the substance  or 
substances  in questi on is or are present  in 
the following circumstances :  
(a) in the case of a substance  classified 
in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 as 
carcinogen category 1A, 1B or 2, 
or germ cell mutagen  category 1A, 
1B or 2 , the substance is  present in 
the mixture in a concentration 
equal to or greater than 0,00005  % 
by weight ;  
(b) in the case of a substance classified 
in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 as 
reproductive toxic ant category 1A, 
1B or 2 , the substance is present  in 
the mixture in a concentration  
equal to or greater than 0,001 % by 
weight ;  
(c) in the case of a substance classified 
in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 as 
skin sensitiser category 1, 1A or 
1B, the substance is present  in the 
mixture in a concentration  equal to 
or greater than 0 ,001 % by weight ;  
(d) in the case of a substance classified 
in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 as 
skin corrosive category 1, 1A, 1B 
or 1C or skin irritant category 2 , or 
as serious eye damag e category 1 
or eye irritant category 2, the 
substance is present in the mixture 
in a concentration equal to or 
greater than : 
(i) 0,1 % by weight, if the EN 2  EN the table in that Annex  
(d) substances listed in 
Appendix [XX]  to this Annex . 
The ancillary  requirement s in 
paragraph s 7 and 8 of column 2 
of this entry apply to all 
mixtures for use for tattooing 
purposes,  whether or not they 
contain a substance falling 
within points (a) to (d) of this 
column  of this entry .  
 
 substance is used solely as a 
pH regulator;  
(ii) 0,01 % by weight , in all 
other cases ; 
(e) in the case of a substance listed in 
Annex II to Regulation (EC) No 
1223/2009 (*), the substance is 
present  in the mixture in a 
concentration equal to or greater 
than  0,00005  % by weight ;  
(f) in the case of a substance for which 
a condition of one or more of the 
following kinds is specified in 
column g (Product type, Body 
parts) of the table in Annex IV to 
Regulation (EC) No 1223/2009 , the 
substance is present  in the mixture 
in a concentration equal to or 
greater than 0,00005  % by weight : 
(i) “Rinse-off 
products ”; 
(ii) “Not to be used in 
products applied on mucous 
membranes ”; 
(iii) “Not to be used in 
eye products ”;  
(g) in the case of a substance for which 
a condition is specified in column h 
(Maximum concentration in ready 
for use preparation) or column i 
(Other) of th e table in Annex IV to 
Regulation (EC)  No 1223/2009 , the 
substance is present in the mixture 
in a concentration, or in some other 
way, that does not accord with the 
condition  specified in that column ;  
(h) in the case of a substance listed in 
Appendix [XX] to this Annex, the 
substance is present  in the mixture 
in a concentration equal to or 
greater than the concentration limit  
specified for that substance in that 
Appendix . 
2. For the purposes of this entry  use of a 
mixture ‘for tattooing purposes’ means 
injection or introduction of the mixture EN 3  EN into a person’s dermis, mucous membrane 
or eyeball , by any process or procedure 
(including procedures commonly referred 
to as permanent make -up, cosmetic 
tattooing, micro -blading and micro -
pigmentation),  with the aim of makin g a 
permanent mark or design on his or her  
body . 
3. If a substance not listed in Appendix [XX] 
falls within more than one of points (a) to 
(g) of paragraph 1, the strictest 
concentration limit laid down in the points 
in question shall apply  to that substance . If 
a substance listed in Appendix [XX] also 
falls within one or more of point s (a) to (g) 
of paragraph  1, the concentration limit laid 
down in point (h) of paragraph 1 shall 
apply to that substance . 
4. By way of derogation, paragraph 1 shall 
not apply to the  following substances until 
[OJ, please insert the date: 24 months 
after the entry into force of this amending 
Regulation ]: 
(a) Pigment Blue 15:3 (CI 74160, EC 
No 205-685-1, CAS No 147 -14-8); 
(b) Pigment Green 7 (CI 74260, EC No 
215-524-7, CAS No 1328 -53-6). 
5. If Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  is amended after [OP, 
please insert the date of entry into force of 
this amending Regulation ] to classify or 
re-classify a substance such that the 
substance then becomes caught by point 
(a), (b), (c) or (d) of paragraph 1  of this 
entry , or such that it then falls within a 
different one of those points from the one 
within which it fell previously, and the 
date of application of that new or revised 
classification is after the date referred to in 
paragraph 1 or, as the case may be, 
paragraph 4 of this entry, that amendment 
shall, for the purposes of applyi ng this 
entry to that substance , be treated as taking 
effect on  the date of application of that 
new or revised classification.  
6. If Annex II or Annex IV to Regulation EN 4  EN (EC) No 1223/2009  is amended after [OP, 
please insert the date of entry into force of 
this amending Regulation ] to list or change 
the listing of a substance such that the 
substance then becomes caught by point 
(e), (f) or (g) of paragraph 1  of this entry, 
or such that it then falls within a different 
one of those points from the one within 
which it fell previously, and the 
amendment takes effect  after the date 
referred to in paragraph 1 or, as the case 
may be, paragraph 4 of this entry, that 
amendment shall, for the purposes of 
applying this entry to that substance, be 
treated as taking effect from the date 
falling 18 months after entry into force  of 
the act by which that amendment was 
made .  
7. Suppliers  placing a mixture on the market 
for use for tattooing purposes shall ensure 
that, after [OJ please insert the date: 12 
months after the entry into force of this 
amending Regulation ], the mixture is 
marked with the following information:  
 the statement “Mixture for use in 
tattoos  or permanent make-up”; 
 a reference number to uniquely 
identify the batch;  
 the list of ingredient s. ‘Ingredient’ 
means any substance added during 
the process of formulation and 
present in the mixture for use for 
tattooing purposes. Impurities shall 
not be regarded as ingredients. If 
the name of a substance , used as 
ingredient within the mean ing of 
this entry , is already required to be 
stated on the label in accordance 
with Regulation (EC) No 
1272/2008 , that ingredient does not 
need to  be mark ed  in accordance 
with this Regulation ;  
 the statement  "Contains nickel. 
Can cause allergic reactions." if the 
mixture contains nickel below the 
concentration limit specified in 
Appendix [XX] ; 
 the statement "Contains chromium 
(VI). Can cause allergic reactions." EN 5  EN if the mixture contains chromium 
(VI) below the concentration limit 
specified in Appendix [XX] ; 
 safety  instructions for use  insofar 
as they are not already required to 
be stated on the label by 
Regulation (EC) No 1272/2008.  
The information shall be clearly visible, 
easily legible and marked in a way that is 
indelible .  
The information shall be written in the 
official language(s) of the Member 
State(s) where the mixture is placed on the 
market, unless the Member State(s) 
concerned provide(s) otherwise.  
Where necessary bec ause of the size of the 
package, the  information listed in the first 
subparagraph shall be included instead in 
the instructions for use.  
Before using a mixture for tattooing  
purposes , the person using the mixture 
shall provide the person undergoing the 
procedure with the information marked on  
the package  or included in the instructions 
for use pursuant to this paragraph .  
8. Mixtures that do not contain the statement 
‘Mixture for use in tattoos  or permanent 
make -up’ shall not be used for tattooing 
purposes.   
9. This entry  does not apply to substances 
that are gases at temperature of 20  °C and 
pressure  of 101,3  kPa, or generate a 
vapour pressure of more than 300 kPa at 
temperature of 50  °C, with the exception 
of formaldehyde ( CAS No 50 -00-0, EC No 
200-001-8). 
10. This entry  does not apply to the placing on 
the market of a mixture for use for 
tattooing purposes, or to the use of a 
mixture for tattooing purposes, when 
placed on the market  for exclusively 
medical purposes , within the meaning of 
Regulation (EU) 2017/745 , or when used 
exclusively for medical purposes, within 
the same meaning . Where the placing on 
the market or use may be for both , medical 
and non -medical purposes, the EN 6  EN requirements of Regulation (EU) 2017/745 
and of this Regulation shall apply 
cumulatively.   
 
 
  
----------------  
(*) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 
November 2009 on cosmetic products (OJ L 342, 22.12.2009, p.59). ’; 
 
 
(2) the following Appendix [XX]  is added:  
 
‘Appendix [XX]  
Entry xx - List of substances with specific concentration limits : 
Substance name  EC No CAS  No Concentration limit  (by 
weight ) 
Mercury  231-106-7 7439 -97-6 0,00005%  
Nickel  231-111-4 7440 -02-0 0,0005%  
Organometallic tin  231-141-8 7440 -31-5 0,00005%  
Antimony  231-146-5 7440 -36-0 0,00005%  
Arsenic  231-148-6 7440 -38-2 0,00005%  
Barium**  231-149-1 7440 -39-3 0,05%  
Cadmium  231-152-8 7440 -43-9 0,00005%  
Chromium‡  231-157-5 7440 -47-3 0,00005%  
Cobalt  231-158-0 7440 -48-4 0,00005%  
Copper**  231-159-6 7440 -50-8 0,025%  
Zinc**  231-175-3 7440 -66-6 0,2%  
Lead  231-100-4 7439 -92-1 0,00007%  
Selenium  231-957-4 7782 -49-2 0,0002%  EN 7  EN Substance name  EC No CAS  No Concentration limit  (by 
weight ) 
Benzo[a]pyrene  200-028-5 50-32-8, 63466 -71-
7 0,0000005%  
Polycyclic -aromatic 
Hydrocarbons (PAH), 
classified in Part 3 of 
Annex VI to Regulation 
(EC) No 1272/2008 as 
carcinogen or germ cell 
mutagen categor y 1A, 
1B or 2   0,00005% (individual 
concentrations)  
Methanol  200-659-6 67-56-1 11%  
o-Anisidine**  201-963-1 90-04-0 0,0005%   
o-toluidine**  202-429-0 95-53-4 0,0005%   
3,3'-
dichlorobenzidine**  202-109-0 91-94-1 0,0005%   
4-methyl -m-
phenylendiamine**  202-453-1 95-80-7 0,0005%   
4-chloroaniline**  203-401-0 106-47-8 0,0005%   
5-nitro -o-toluidine**  202-765-8 99-55-8 0,0005%   
3,3'-
dimethoxybenzidine**  204-355-4 119-90-4 0,0005%   
4,4’-bi-o-toluidine**  204-358-0 119-93-7 0,0005%   
4,4'-Thiodianiline**  205-370-9 139-65-1 0,0005%   
4-chloro -o-toluidine**  202-441-6 95-69-2 0,0005%   
2-naphthylamine**  202-080-4 91-59-8 0,0005%   
Aniline**  200-539-3 62-53-3 0,0005%   
Benzidine**  202-199-1 92-87-5 0,0005%   
p-toluidine**  203-403-1 106-49-0 0,0005%   
2-methyl -p-
phenylenediamine**  202-442-1 95-70-5 0,0005%   
Biphenyl -4-ylamine**  202-177-1 92-67-1 0,0005%   EN 8  EN Substance name  EC No CAS  No Concentration limit  (by 
weight ) 
4-o-tolylazo -o-
toluidine**  202-591-2 97-56-3 0,0005%   
4-methoxy -m-
phenylenediamne**  210-406-1 615-05-4 0,0005%   
4,4'-
methylenedianiline**  202-974-4 101-77-9 0,0005%   
4,4'-methylenedi -o-
toluidine**  212-658-8 838-88-0 0,0005%   
6-methoxy -m-
toluidine**  204-419-1 120-71-8 0,0005%   
4,4'-me thylenebis[2 -
chloro aniline]**  202-918-9 101-14-4 0,0005%   
4,4'-oxydianiline**  202-977-0 101-80-4 0,0005%   
2,4,5 -
trimethylaniline**  205-282-0 137-17-7 0,0005%   
4-Aminoazobenzene**  200-453-6 60-09-3 0,0005%   
p-Phenylenediamine**  203-404-7 106-50-3 0,0005%   
Sulphanilic acid**  204-482-5 121-57-3 0,0005%   
4-amino -3-
fluorophenol**  402-230-0 399-95-1 0,0005%   
2,6-xylidine  201-758-7 87-62-7 0,0005%   
6-amino -2-
ethoxynaphthaline   293733 -21-8 0,0005%   
2,4-xylidine  202-440-0 95-68-1 0,0005%   
Pigment Red 7 
(PR7)/CI 12420  229-315-3 6471 -51-8 0,1%  
Pigment Red 9(PR9)/CI 
12460  229-104-6 6410 -38-4 0,1%  
Pigment Red 15 
(PR15)/CI 12465  229-105-1 6410 -39-5 0,1%  
Pigment Red 612-766-9 61932 -63-6 0,1%  EN 9  EN Substance name  EC No CAS  No Concentration limit  (by 
weight ) 
210(PR210)/CI 12477  
Pigment Orange 74 
(PO74)   85776 -14-3 0,1%  
Pigment Yellow 65 
(PY65)/CI 11740  229-419-9 6528 -34-3 0,1%  
Pigment Yellow 74 
(PY74)/CI 11741  228-768-4 6358 -31-2 0,1%  
Pigment Red 12 
(PR12)/CI 12385  229-102-5 6410 -32-8 0,1%  
Pigment Red 14 
(PR14)/CI 12380  229-314-8 6471 -50-7 0,1%  
Pigment Red 17 
(PR17)/CI 12390  229-681-4 6655 -84-1 0,1%  
Pigment Red 112 
(PR112)/CI 12370  229-440-3 6535 -46-2 0,1%  
Pigment Yellow 14 
(PY14)/CI 21095  226-789-3 5468 -75-7 0,1%  
Pigment Yellow 55 
(PY55)/CI 21096  226-789-3 6358 -37-8 0,1%  
Pigment Red 2 (PR2)/ 
CI 12310  227-930-1 6041 -94-7 0,1%  
Pigment Red 22 
(PR22)/ CI 12315  229-245-3 6448 -95-9 0,1%  
Pigment Red 146 
(PR146)/ CI 12485  226-103-2 5280 -68-2 0,1%  
Pigment Red 269 
(PR269)/ CI 12466  268-028-8 67990 -05-0 0,1%  
Pigment Orange16 
(PO16)/ CI 21160  229-388-1 6505 -28-8 0,1%  
Pigment Yellow 1 
(PY1)/ CI 11680  219-730-8 2512 -29-0 0,1%  
Pigment Yellow 12 
(PY12)/CI 21090  228-787-8 6358 -85-6 0,1%  EN 10  EN Substance name  EC No CAS  No Concentration limit  (by 
weight ) 
Pigment Yellow 87 
(PY87)/ CI  21107:1  239-160-3 15110 -84-6, 
14110 -84-6 0,1%  
Pigment Yellow 97 
(PY97)/ CI 11767  235-427-3 12225 -18-2 0,1%  
Pigment Orange 13 
(PO13)/ CI 21110  222-530-3 3520 -72-7 0,1%  
Pigment Orange 34 
(PO34)/ CI 21115  239-898-6 15793 -73-4 0,1%  
Pigment Yellow 83 
(PY83)/ CI 21108  226-939-8 5567 -15-7 0,1%  
Solvent Red 1 (SR1)/ 
CI 12150  214-968-9 1229 -55-6 0,1%  
Acid Orange 24 
(AO24)/ CI 20170  215-296-9 1320 -07-6 0,1%  
Solvent Red 23 (SR23)/ 
CI 26100  201-638-4 85-86-9 0,1%  
Acid Red 73 (AR73)/ 
CI 27290  226-502-1 5413 -75-2 0,1%  
Disperse Yellow 3/ CI 
11855  220-600-8 2832 -40-8 0,1%  
Acid Green 16  603-214-8 12768 -78-4 0,1%  
Acid Red 26  223-178-3 3761 -53-3 0,1%  
Acid Violet 17  223-942-6 4129 -84-4 0,1%  
Basic Red 1  213-584-9 989-38-8 0,1%  
Disperse Blue 106  602-285-2 12223 -01-7 0,1%  
Disperse Blue 124  612-788-9 61951 -51-7 0,1%  
Disperse Blue 35  602-260-6 12222 -75-2 0,1%  
Disperse Orange 37  602-312-8 12223 -33-5 0,1%  
Disperse Red 1  220-704-3 2872 -52-8 0,1%  
Disperse Red 17  221-665-5 3179 -89-3 0,1%  EN 11  EN Substance name  EC No CAS  No Concentration limit  (by 
weight ) 
Disperse Yellow 9  228-919-4 6373 -73-5 0,1%  
Pigment Violet 3  603-635-7 1325 -82-2 0,1%  
Pigment Violet 39  264-654-0 64070 -98-0 0,1%  
Solvent Yellow 2  200-455-7 60-11-7 0,1%  
**Soluble. ‡Chromium VI ’