Amendment Of The Cosmetics Directive

Original Language Title: Änderung der Kosmetikverordnung

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28. Ordinance of the Federal Minister of Health, amending the Cosmetics Regulation

Due to § 20 of the Food Safety and Consumer Protection Act-LMSVG, BGBl. I n ° 13/2006, as last amended by the Federal Law BGBl. I No 95/2010, shall be arranged:

The cosmetics regulation, BGBl. II No 375/1999, as last amended by the BGBl Regulation. II No 60/2012, shall be amended as follows:

1. § 5 (2) reads:

" (2) Cosmetic products which meet the requirements of the BGBl Regulation. II No 60/2012, may be placed on the market until 31 August 2013, with the exception of substance No 12 of Appendix 2, Part One. "

2. § 5 (3) to (8) deleted.

3. § 6 reads:

" § 6. This Regulation repeals Directive 76 /768/EEC, OJ L 73, 27.4.1976, p. No. OJ L 262 of 27 September 1976 on the approximation of the laws of the Member States relating to cosmetic products, as last amended by the implementing Directive 2012 /21/EU, OJ L 327, 28.12.2012, p. No. L 208 of 3 August 2012, transposed into Austrian law. "

4. In Appendix 1 the following substances shall be inserted in accordance with their alphabetical order:

" 1373. N-(2-nitro-4-aminophenyl)-allylamine (HC Red No. 16) and its salts (CAS No. 160219-76-1) "

5. footnote 1) in Appendix 1 is:

"(1) numbers in accordance with Directive 76/768/EEC, Annex II, as last amended by the implementing Directive 2012 /21/EU."

(6) In Annex 2, Part One, the number 12 is as follows:

" Lfd. No.

Fabric

Application
field and/or use

Restrictions
Maximum permissible concentration in the
cosmetic
Finished
Product

More
Limitations and requirements

Mandatory indication of the application conditions and warnings

A

B

C

d

e

F

12

Hydrogen peroxide and other hydrogen peroxide-releasing compounds or mixtures, carbamide peroxide and zinc peroxide

(a) Hair-treatment

a) 12% H 2 O 2 (40 volume pro-zent), contained therein or released therefrom

(a) Wearing suitable gloves.

a) b) c) e) Contains hydrogen peroxide. Avoid contact with your eyes. Immediately rinse eyes in case the product has come into contact with the eyes.

(b) Skin care products

(b) 4% H 2 O 2 , contained therein or released from it

(c) mixtures for the curing of the nail

c) 2% H 2 O 2 , contained therein or released from it

(d) oral hygiene products (including mouthwashes, toothpaste and dental brighteners and bleach)

(d) ≤ 0.1%
H 2 O 2 , contained therein or released from it

(e) Dental Brighteners and bleaching agents

e) > 0.1% ≤ 6% H 2 O 2 , contained therein or released from it

(e) may only be delivered to dentists. In each application cycle, the first application must always be a dentist within the meaning of Directive 2005 /36/EC on the recognition of professional qualifications, OJ L 327, 30.4.2005, p. No. OJ L 255 of 30 September 2005, as last amended by Regulation (EU) No 623/2012, OJ L 206, 22.7.2012, p. No. L 180 of 12 July 2012, or under its direct supervision, if an equivalent level of safety is guaranteed. After that, the means must be provided to the consumer for the remaining application cycle. Do not apply to people under 18 years of age

(e) in which it contains or has been released
H 2 O 2 -Concentration as a percentage. Do not apply to persons under 18 years of age. May only be delivered to dentists. In each application cycle, the first application must always be reserved for a dentist, or under the direct supervision of the dentist, if an equivalent level of safety is guaranteed. After that, the means must be provided to the consumer for the remaining application cycle. "

7. The following points shall be added to the first part of Annex 2:

" Lfd. No.

Fabric

Application
field and/or use

Maximum permissible concentration in the finished cosmetic product

Other limitations and requirements

Mandatory indication of the application conditions and warnings

A

B

C

d

e

F

253

2,2 '-[(4-Aminophenyl)) imino] bis (ethanol) sulphate

N, N-bis (2-hydroxyethyl)-p-phenyl-sulphates

CAS No. 54381-16-7

EC No 259-134-5

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in use on the hair must not exceed 2.5% (calculated as sulphate).

-Do not use together with nitrosating agents
-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

As indicated in column f of serial No 205 (point (a))

254

1,3-benzenediol, 4-chloro-

4-Chlororesorcinol

CAS No. 95-88-5

EC No 202-462-0

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 2.5%.

As indicated in column f of serial No 205 (point (a)).

255

2,4,5,6-tetraaminopyrimidine-sulfate

Tetraaminopyrimidinesulphates

CAS No. 5392-28-9

EC No 226-393-0

(a) Hair dye in oxidative hair dye







(b) hair dye in non-toxicological hair dyes











(b) 3.4% (calculated as sulphate)

(a) After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 3.4% (calculated as sulphate).

(a) As indicated in column f of current number 205 (point (a)).

256

3-(2-hydroxyethyl)-p-phenylenediammonium sulphate

Hydroxyethyl-p-phenylsulphates

CAS No. 93841-25-9

EC No 298-995-1

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 2.0% (calculated as sulphate).

As indicated in column f of serial No 205 (point (a))

257

1H-indole-5,6-diol

Dihydroxyindole

CAS No. 3131-52-0

EC No 412-130-9

(a) Hair dye in oxidative hair dye







(b) hair dye in non-toxicological hair dyes











(b) 0.5%

(a) After mixing under oxidative conditions, the maximum concentration in use on the hair must not exceed 0.5%.

(a) As indicated in column f of current number 205 (point (a)).




(b) As indicated in column f of serial number 208.

258

5-Amino-4-chloro-2-methylphenol-hydrochloride

5-Amino-4-Chloro-o-CresolHCl

CAS No. 110102-85-7

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in use on the hair must not exceed 1.5% (calculated as the hydrochloride)

As indicated in column f of serial No 205 (point (a))

259

1H-Indol-6-ol

6-Hydroxyindole

CAS No. 2380-86-1

EC No 417-020-4

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 0.5%.

As indicated in column f of serial No 205 (point (a)).

260

1H-Indole-2,3-dione

Isatin

CAS No. 91-56-5

EC No 202-077-8

Hair dye in non-toxicological hair dyes

1.6%

As indicated in column f of serial number 208.

261

2-aminopyridin-3-ol

2-Amino-3-Hydroxypyridine

CAS No. 16867-03-1

EC No 240-886-8

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 1.0%.

As indicated in column f of serial No 205 (point (a)).

262

2-methyl-1-naphthyl acetate

1-acetoxy-2-methyl-

CAS No. 5697-02-9

EC No 454-690-7

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 2.0%. (If the formulation of a hair dye composition contains both 2-methyl-1-naphthol and 1-acetoxy-2-methylenol, the maximum concentration of 2-methyl-1-naphthol at the head should not exceed 2.0%.)

As indicated in column f of serial No 205 (point (a))

263

1-hydroxy-2-methylnaphthalen

2-methyl-1-naphthol


CAS No. 7469-77-4

EC No 231-265-2

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 2.0%. (If the formulation of a hair dye composition contains both 2-methyl-1-naphthol and 1-acetoxy-2-methylenol, the maximum concentration of 2-methyl-1-naphthol on the head should not exceed 2.0%.)

As indicated in column f of serial No 205 (point (a))

264

Dinatrium-5,7-dinitro-8-oxide-2-naphthalenesulfonate


Acid Yellow 1

CAS No. 846-70-8

EC No 212-690-2

CI 10316

(a) Hair dye in oxidative hair dye





(b) hair dye in non-toxicological hair dyes









(b) 0.2%

(a) After mixing under oxidative conditions, the maximum concentration of the application on the hair must not exceed 1.0%.

(a) As indicated in column f of current number 205 (point (a)).


(b) As indicated in column f of serial number 208.

265

4-nitro-1,2-phenylenediamine

4-nitro-o-phenylenediamine

CAS No. 99-56-9

EC No 202-766-3

Hair dye in oxidative hair dyes

After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 0.5%.

As indicated in column f of serial No 205 (point (a)).

266

2-(4-Amino-3-nitroaniline) ethanol

HC Red No. 7

CAS No. 24905-87-1

EC No 246-521-9

Hair dye in non-toxicological hair dyes

1.0%

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

As indicated in column f of serial number 208.

267

2-[bis (2-hydroxyethyl) amino] -5-nitrophenol

HC Yellow No. 4

CAS No. 59820-43-8

EC No 428-840-7

Hair dye in non-toxicological hair dyes

1.5%

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

268

2-[(2-Nitrophenyl) amino] ethanol

HC Yellow No. 2

CAS No. 4926-55-0

EC No 225-555-8

(a) Hair dye in oxidative hair dye








(b) hair dye in non-toxicological hair dyes












(b) 1.0%

(a) After mixing under oxidative conditions, the maximum concentration in the application on the hair must not exceed 0.75%.


For a and b the following shall apply:

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

(a) As indicated in column f of current number 205 (point (a)).

269

4-[(2-Nitrophenyl) amino] phenol

HC Orange No. 1

CAS No. 54381-08-7

EC No 259-132-4

Hair dye in non-toxicological hair dyes

1.0%

270

2-nitro-N1-phenyl-benzene-1,4-diamine

HC Red No. 1

CAS No. 2784-89-6

EC No 220-494-3

Hair dye in non-toxicological hair dyes

1.0%

As indicated in column f of serial number 208.

271

1-methoxy-3-(β-aminoethyl) amino-4-nitrobenzene, hydrochloride

HC Yellow No. 9

CAS No. 86419-69-4

EC No 415-480-1

Hair dye in non-toxicological hair dyes

0.5% (calculated as hydrochloride

-Do not use together with nitrosating agents

Maximum levels of nitrosamine: 50 μg/kg '

-Keep in nitrite-free containers

272

1-(4 '-Aminophenylazo) -2-methyl-4-(bis-2-hydroxyethyl)-aminobenzene

HC Yellow No. 7

CAS No. 104226-21-3

EC No 146-420-6

Hair dye in non-toxicological hair dyes

0.25%

273

N-(2-hydroxyethyl) -2-nitro-4-trifluoromethylaniline

HC Yellow No. 13

CAS No. 10442-83-8

EC No 443-760-2

(a) Hair dye in oxidative hair dye








(b) hair dye in non-toxicological hair dyes












(b) 2.5%

(a) After mixing under oxidative conditions, the maximum concentration in use on the hair must not exceed 2.5%.


For a and b the following shall apply:

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

(a) As indicated in column f of current number 205 (point (a)).

274

Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl) azo] -N, N, Ntrimethyl, Chlorid

Basic Yellow 57

CAS No. 68391-31-1

EC No 269-943-5

Hair dye in non-toxicological hair dyes

2.0%

275

Ethanol, 2,2 '-[ [ 4-[(4-aminophenyl) azo] phenyl] imino] bis-[ [4-(4-aminophenyl) azo] phenyl]-

Disperse Black 9

CAS No. 20721-50-0

EC No 243-987-5

Hair dye in non-toxicological hair dyes

0.3% (of the mixture in the ratio 1: 1 from 2,2 '-[4-(4-aminophenylazo) phenylimino] diethanol and lignosulfate

276

9,10 -Anthracenedione, 1,4-bis [(2 ,3-Dihydroxypropyl) amino]-

HC Blue No.14

CAS No. 99788-75-7

EC No 421-470-7

Hair dye in non-toxicological hair dyes

0.3%

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

277

2-(4-methyl-2-nitroaniline) ethanol

Hydroxyethyl-2-nitro-p-toluidine

CAS No. 100418-33-5

EC No 408-090-7

(a) Hair dye in oxidative hair dye









(b) hair dye in non-toxicological hair dyes













(b) 1.0%

(a) After mixing under oxidative conditions, the maximum concentration of the application on the hair must not exceed 1.0%.



For a and b the following shall apply:

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

(a) As indicated in column f of current number 205 (point (a)).

278

1-amino-2-nitro-4-(2 ', 3'-dihydroxypropyl) amino-5-chlorobenzene + 1,4-bis-(2 ', 3'-dihydroxypropyl) amino-2-nitro-5-chlorobenzene

HC Red No. 10 +
HC Red No. 11

CAS No. 95576-89-9 + 95576-92-4

(a) Hair dye in oxidative hair dye









(b) hair dye in non-toxicological hair dyes













(b) 2.0%

(a) After mixing under oxidative conditions, the maximum concentration of the application on the hair must not exceed 1.0%.


For a and b the following shall apply:

-Do not use together with nitrosating agents

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

(a) As indicated in column (f) of heading 205 (point (a)). "

8. In Appendix 2, Part 2, numbers 10 and 50 are deleted.

9. footnote *) in Appendix 4 is:

'*) numbers in accordance with Directive 76/768/EEC, Annex VII, as last amended by the Implementing Directive 2012 /21/EU.'

Stöger