Comments for Annex XV restriction report

Substance name: Substances used in tattoo inks and permanent make-up

EC Number: -

CAS Number: -

Scope: Restricting the placing on the market of certain chemicals in tattoo inks and permanent make-up.

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SPECIFIC INFORMATION REQUESTS
  1:

The proposed restriction limits the use of a range of chemicals with severe human health hazardous properties in tattoo and permanent make-up inks. For some impurities that are known to be regularly detected in these inks, such as heavy metals, PAHs and methanol, there is a need to carefully consider the feasibility of newly proposed limit values. Will you face difficulties finding or formulating tattoo and permanent make-up inks on the EU market meeting the concentration limits listed in the table below? If you expect to face difficulties, please clarify for which impurity (ies) and what concentration limit(s) would be achievable and what time would be needed to be able to formulate compliant inks.

Substance name EC# CAS# Proposed concentration limit (% w/w)
Mercury 231-106-7 7439-97-6 0.00002
Nickel 231-111-4 7440-02-0 0.001
Tin 231-141-8 7440-31-5 0.005
Antimony 231-146-5 7440-36-0 0.0002
Arsenic 231-148-6 7440-38-2 0.0000008
Barium* 231-149-1 7440-39-3 0.84
Cadmium 231-152-8 7440-43-9 0.00002
Chromium** 231-157-5 7440-47-3 0.00002
Cobalt 231-158-0 7440-48-4 0.0025
Copper* 231-159-6 7440-50-8 0.05
Zinc* 231-175-3 7440-66-6 0.23
Lead 231-100-4 7439-92-1 0.00007
Selenium 231-957-4 7782-49-2 0.0002
Methanol 200-659-6 67-56-1 10.9
Individual polycyclic aromatic hydrocarbons (PAH) with harmonised classification as carcinogenic or mutagenic     0.0002

Notes: *Soluble. **Chromium (VI).

  * COMPULSORY FIELDS

  2: Previous consultations have indicated that there are no technically feasible and safe alternatives for two specific pigments which are covered by the scope of the proposed restriction: Pigment Green 7 (CI 74260, EC 215-524-7, CAS 1328-53-6) and Pigment Blue 15:3 (CI 74160, EC 205-685-1, CAS 147-14-8). Would you agree with this? How long will it take to develop alternatives to these two pigments?
  * COMPULSORY FIELDS

  3:

The colourants listed below are banned in hair dyes (Annex II Cosmetics Regulation). Are they used in tattoo inks or permanent make-up? If so, can these colourants be substituted by safe alternatives available at similar market prices?

Substance name

Substance market name

EC #

CAS #

1,4-bis(p-tolylamino)anthraquinone

Solvent Green 3, CI 61565 

204-909-5

128-80-3

Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino]

(4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]

(3-sulphonatobenzyl)ammonium, disodium salt

Fast Green FCF, CI 42053

219-091-5

2353-45-9

6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)

-4-methylbenzo[b]thiophene-3(2H)-one

VAT Red 1, CI 73360

219-163-6

2379-74-0

Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]

-4-hydroxynaphthalene-1-sulphonate

Red, CI 14700

224-909-9

4548-53-2

N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]

-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide

Pigment Red 5, CI 12490

229-107-2

6410-41-9

Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

Pigment Red 63:1, CI 15880

229-142-3

6417-83-0

1,2-dihydroxyanthraquinone

Pigment Red 83, CI 58000

200-782-5

72-48-0

1-hydroxy-4-(p-toluidino)anthraquinone

Solvent Violet 16, CI 60725

201-353-5

81-48-1

Sodium 4-(2,4-dihydroxyphenylazo)benzenesulphonate

Acid Orange 16, CI 14270

208-924-8

547-57-9

4-(phenylazo)resorcinol

Solvent Orange 1, CI 11920

218-131-9

2051-85-6

Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]

-1-naphthyl]azo]naphthalene-2,7-disulphonate

Food Black 2, CI 27755

218-326-9

2118-39-0

1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085)

and its salts when used as a substance in hair dye products,

1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol and its insoluble barium,

strontium and zirconium lakes, salts and pigments, Pigment red 4

CI 12085/Red

220-562-2,

2814-77-9

Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7

-disulphonate (Acid Red 27; CI 16185) when used as a substance in hair dye products,

Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate

CI 16185 / ACID RED 27

213-022-2

915-67-3

Ethanaminium, N-(4-((4-diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)

-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1)

(Acid Blue 3; CI 42051) when used as a substance in hair dye products,

Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)

-2,5-cyclohexadien-1-ylidene)-N-ethylhydroxide, inner salt, calcium salt (2:1)

and its insoluble barium, strontium and zirconium lakes, salts and pigments

CI 42051 / ACID BLUE 3

222-573-8

3536-49-0

2-(6-Hydroxy-3-oxo-(3H)xanthen-9-yl)benzoic acid; Fluorescein

and its disodium salt (Acid Yellow 73 sodium salt; CI 45350)

when used as a substance in hair dye products,

Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate

CI 45350/ Yellow

208-253-0

518-47-8

CI 45350/ Yellow

219-031-8

2321-07-5

4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]

-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) and its disodium salt (CI 45370)

when used as a substance in hair dye products,

4',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),

9'-[9H]xanthene]-3-one and its insoluble barium,

strontium and zirconium lakes, salts and pigments

CI 45370 / SOLVENT RED 72/ Orange

209-876-0

596-03-2

 

224-468-2

4372-02-5

2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)benzoic acid;

Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43),

its disodium salt (Acid Red 87; CI 45380) and its aluminium salt

(Pigment Red 90:1 Aluminium lake) when used as a substance

in hair dye products, Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)

benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments

CI 45380/ Red

239-138-3

15086-94-9

CI 45380 / PIGMENT RED 90:1 ALUMINUM LAKE

240-005-7

15876-39-8

CI 45380 / ACID RED 87

241-409-6

17372-87-1

2′,4′,5′,7′-Tetraiodofluorescein, its disodium salt (Acid Red 51; CI 45430)

and its aluminium salt (Pigment Red 172 Aluminium lake)

when used as a substance in hair dye products,

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)

benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments

CI 45430 / PIGMENT RED 172 ALUMINUM LAKE

235-440-4

12227-78-0

CI 45430 / ACID RED 51

240-474-8

16423-68-0

Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate

CI 15865/Red

222-642-2

3564-21-4

 

  * COMPULSORY FIELDS

  4:

Are the following colourants used in tattoo inks or permanent make-up? Do they have substitutes at similar market prices? How long will it take to identify substitutes? Is it possible for industry to comply with the proposed concentration limits for these pigments?

Substance name

Other regulatory process names

EC#

CAS#

Proposed concentration limit

Acid Green 16

sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)cyclohexa-2,5-dien-1-ylidene]methyl}naphthalene-2,7-disulfonate

603-214-8

12768-78-4

0.1% w/w

Acid Red 26

Disodium 1-(2,4-dimethylphenylazo)-2-hydroxynaphthalene-3,6-disulphonate

223-178-3

3761-53-3

0.1% w/w

Acid Violet 17

Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt

223-942-6

4129-84-4

0.1% w/w

Basic Red 1 , Basic red 1

9-[2-(ethoxycarbonyl)phenyl]-3,6-bis (ethylamino)-2,7-dimethylxanthylium chloride

213-584-9

989-38-8

0.1% w/w

Disperse Blue 106

Ethanol, 2-[ethyl[3-methyl-4-[2-(5-nitro-2-thiazolyl)diazenyl]phenyl]amino]-

602-285-2

12223-01-7

0.1% w/w

Disperse Blue 124

Disperse Blue 124

612-788-9

61951-51-7

0.1% w/w

Disperse Blue 35

C.I. Disperse Blue 35

602-260-6

12222-75-2

0.1% w/w

Disperse Orange 37

Propanenitrile, 3-[[4-[2-(2,6-dichloro-4-nitrophenyl)diazenyl]phenyl]ethylamino]-

602-312-8

12223-33-5

0.1% w/w

Disperse Red 1

2-[ethyl[4-[(4-nitrophenyl)azo]phenyl]amino]ethanol

220-704-3

2872-52-8

0.1% w/w

Disperse Red 17

2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol

221-665-5

3179-89-3

0.1% w/w

Disperse Yellow 9

N-(2,4-dinitrophenyl)benzene-1,4-diamine

228-919-4

6373-73-5

0.1% w/w

Pigment Violet 3

4-[(4-Aminophenyl)-(4-methyliminocyclohexa-2,5-dien-1-ylidene)methyl]aniline

603-635-7

1325-82-2

0.1% w/w

Pigment Violet 39

Methanaminium, N-[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, molybdatephosphate

264-654-0

64070-98-0

0.1% w/w

Solvent Yellow 2

4-dimethylaminoazobenzene

200-455-7

60-11-7

0.1% w/w

  * COMPULSORY FIELDS

  5: Do you have information on the percentage of tattoo inks that are already compliant with the proposed restriction, national legislation already in place or the Council of Europe resolution ResAP(2008)1?
  * COMPULSORY FIELDS

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