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Amendment Of The Cosmetics Directive

Original Language Title: Änderung der Kosmetikverordnung

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94. Ordinance of the Federal Minister of Health, with which the Cosmetics Regulation is amended

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 n ° 52/2009, shall be ordered:

The cosmetics regulation, BGBl. II No 375/1999, as last amended by the BGBl Regulation. II No 137/2009, shall be amended as follows:

1. § 5 (2) reads:

" (2) Cosmetic products not subject to the BGBl Regulation. II No 94/2010, but to the provisions currently in force, as far as substances in Annex 2, Part I, No 189 to 205, as well as substances of Appendix 2, Part 2, Nos 7, 9, 14, 28, 47, 55 and 58 are concerned, may be produced by 14 May 2010, be introduced or placed on the market. "

2. § 5 (4), 5 and 6 are:

" (4) Cosmetic products not subject to the BGBl Regulation. II No 94/2010, but as far as the substances of Annex 2, Part 1, Part 1, No 8, 8a, 9, 9a and 14 are concerned, the provisions currently in force may be manufactured, imported or placed on the market until 14 July 2010.

(5) Cosmetic products not subject to the BGBl Regulation. As far as substances in Annex 2, Part One, Nos 26 to 43 and 47 and 56 are concerned, the provisions in force until 14 May 2010 correspond to the provisions in force until 14. It was established or introduced in October 2010 and placed on the market until stocks are sold off.

(6) Cosmetic products not subject to the BGBl Regulation. II No 94/2010, but the provisions currently in force, in so far as it concerns substances of Annex 1 No 450 and substances of Annex 2, Part 1, No 130, No 151a and 206, may be manufactured or imported until 14 February 2011 and until 14 February 2011. " It will be placed on the market in August 2011.

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 Directive 2009 /164/EU, OJ L 262, 27.9.2009, p. No. OJ L 344 of 23 December 2009, corrected by OJ L 136, 31.3.2009, p. No. L 3 of 7 Jänner 2010, transposed into Austrian law. "

4. In Appendix 1, the number is 450:

" Essential Oils of the Verbena (Lippia citriodora Kunth.) and their derivatives, excluding pure flowering oil (CAS No. 8024-12-2) when used as a fragrance ingredient "

5. Footnote 1 ) in Appendix 1 shall read:

" 1 ) Numbers in accordance with Directive 76/768/EEC, Annex II, as last amended by Directive 2009 /164/EU. "

6. In Annex 2, Part 1, point 8, the name of the substance shall be:

" N-substituted derivatives of p-phenylenediamine and their salts; N-substituted derivatives of o-phenylenediamine (**), other than those listed elsewhere in this Appendix and those listed in Appendix 1 under current numbers 1309, 1311 and 1312 Derivatives. "

7. In Annex 2, Part 1, point 9, the name of the substance shall be:

" o, m, p-toluylenediamines, their N-substituted derivatives and their salts ( 1 ), with the exception of the substance referred to in this Annex under current point 9a, and the substances listed in Annex II under serial numbers 364, 1310 and 1313 ".

8. In Appendix 2, first part, the entry a) is omitted in columns d and f of the number 14.

9. In Annex 2, first part numbers 26 to 43 and 47 and 56, the phrase after the first sentence in column f is as follows:

" For toothpastes with compounds having a fluorine content in a concentration of 0.1 to 0.15%, calculated as F, which are not already unsuitable for children (e.g. by 'adult'), the following must be: mandatory:

' For children up to 6 years: Use only pea-large amount of toothpaste. If you are taking fluoride, consult the dentist or the doctor. ' "

10. In Annex 2, first part, in column b of paragraph 130, the text shall be replaced by: "Terpene terpenoids sinpine" by the text "Terpenes and Terpenoids" replaced.

11. In Annex 2, the following substances shall be inserted in accordance with their numerical series:

Lfd. No.

Fabric

Application area and/or use

Limits allowed maximum concentration in the

cosmetic

Finished Product

More

Limitations and requirements

Obliga-toric indication of the application conditions and warnings

A

B

C

d

e

F

" 8a

P-phenylenediamine and its salts ( ** )

CAS No. 106-50-3

EINECS No

203-404-7

p-phenyl-HCl

CAS No. 624-18-0

EINECS No

210-834-9

p-phenylsulphates

CAS No. 16245-77-5

EINECS No 240-357-1

Hair dye in oxidative hair dyes

(a) General use

(b) Commercial use

(a) and (b) After mixing under oxidative conditions, the maximum concentration of the application on the hair must not exceed 2%, calculated as the free base.

(a) product may cause an allergic reaction. Contains phenylendia min. Do not use for colouring of eyelashes and eyebrows.

(b) For commercial use only. Contains phenylendia min. Product can cause an allergic reaction. Wear suitable gloves.

9a

Toluylene-2,5-diamine and its salts ( 1 )

CAS No. 95-70-5

EINECS No

202-442-1

2,5-diamines sulphates

CAS No. 615-50-9

EINECS No

210-431-8

Hair dye in oxidative hair dyes

(a) General use

(b) Commercial use

(a) and (b) After mixing under oxidative conditions, the maximum concentration of the application on the hair must not exceed 4%, calculated as the free base.

As indicated in current number 9 in column f.

151a

Allyl phenethyl ether

CAS No.: 14289-65-7 EC-Nr. 238-212-2

The proportion of free allyl alcohol in the ether must be less than 0.1% "

(12) The following points shall be added to Annex 2:

Lfd. No.

Fabric

Application area and/or use

Limits allowed maximum concentration in the

cosmetic

Finished Product

More

Limitations and requirements

Obliga-toric indication of the application conditions and warnings

A

B

C

d

e

F

" 189

Trinatrium-5-hydroxy-1-(4-sulfo-phenyl)-4-(4-sulphophenylazo) pyrazole-3-carboxylate and aluminium salt

( 15 )

Acid Yellow 23

CAS No. 1934-21-0

EINECS-Nr.217-99-5

Acid Yellow 23 Alu-minum lake

CAS No. 12225-21-7

EINECS No 235-428-9

CI 19140

Hair dye in non-toxicological hair dyes

0.5%

190

Benzene methanamine, N-ethyl-N-[ 4-[ [ 4-[ethyl]-[ (3)

sulfophenyl)-methyl]-amino]-phenyl] [2-sul-fophenyl) methylene]-2,5-cyclohe-xadiene-1-ylidene]-3-sulfo, internal salt, disodium salt and its ammonium and aluminium salts ( 15 )

Acid Blue 9

CAS No. 3844-45-9

EINECS No 223-339-8

Acid Blue 9 ammonium salt

CAS No. 2650-18-2

EINECS No 220-168-0

Acid Yellow 9 Alu-minum lake

CAS No. 68921-42-6

EINECS No 272-939-6

CI 42090

Hair dye in non-toxicological hair dyes

0.5%

191

Dinatrium-6-hydroxy-5-[(2-methoxy-4-sulfonato-m-tolyl) azo] naphthalene-2-sulfonate ( 15 )

Curry Red

CAS No. 25956-17-6

EINECS No 247-368-0

CI 16035

Hair dye in non-toxicological hair dyes

0.4%

192

Trinatrium-1-(1-naphthylazo) -2-hydroxynaphthalene-4 ', 6,8-trisulfonate and aluminium salt ( ****** )

Acid Red 18

CAS No. 2611-82-7

EINECS No 220-036-2

Acid Yellow 18 Alu-minum lake

CAS No. 12227-64-4

EINECS No 235-438-3

CI 16255

Hair dye in non-toxicological hair dyes

0.5%

193

Hydrogen -3,6-bis (diethylamino)-9-(2,4-disulfonatophenyl) xanthylium, sodium salt ( ****** )

Acid Red 52

CAS No. 3520-42-1

EINECS No 222-529-8

CI 45100

(a) Hair dye in oxidative hair dye

(b) hair dye in non-toxicological hair dyes

(b) 0.6%

(a) After mixing under oxidative conditions,

the maximum concentration of the hair should not exceed 1.5% for use on the hair.

(a) The mixing ratio must be indicated on the label.

194

Dinatrium-5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulfonate ( ****** )

Acid Red 33

CAS No. 3567-66-6

EINECS No 222-656-9

CI 17200

Hair dye in non-toxicological hair dyes

0.5%

195

Sodium -1-amino-4-(cyclo-hexylamino) -9, 10-dihydro-9, 10-dioxoanthracen-2-sulfonate ( ****** )

Acid Blue 62

CAS No. 4368-56-3

EINECS No 224-460-9

CI 62045

Hair dye in non-toxicological hair dyes

0.5%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

196

1-[(2 '-methoxyethyl) amino] -2-nitro-4-[di-(2'-hydroxyethyl) amino] benzene (1-[(2 '-methoxyethyl) amino]-2- ****** )

HC Blue No 11

CAS No. 23920-15-2

EINECS No 459-980-7

Hair dye in non-toxicological hair dyes

2.0%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

197

1,5-bis-(β-hydroxyethyl) amino-2-nitro-4-chlorobenzene ( 15 )

HC Yellow No 10

CAS No. 109023-83-8

EINECS No 416-940-3

Hair dye in non-toxicological hair dyes

0.1%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

198

3-Methylamino-4-nitropheno-xyethanol ( 15 )

3-Methylamino-4-nitropheno-xyethanol (INCI)

CAS No. 59820-63-2

EINECS No 261-940-7

Hair dye in non-toxicological hair dyes

0.15%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

199

2,2 '-[ [ 4-[(2-hydroxyethyl) amino] -3-nitrophenyl] imino] bisethanol ( ****** )

HC Blue No 2

CAS No. 33229-34-4

EINECS No 251-410-3

Hair dye in non-toxicological hair dyes

2.8%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

Product may include:

allergic reaction, causing allergic reactions

200

1-propanol, 3-[ [ 4-[bis (2-hydro-xyethyl) amino]-2-nitrophenyl] amino] ( ****** )

HC Violet No 2

CAS No. 104226-19-9

EINECS No 410-910-3

Hair dye in non-toxicological hair dyes

2.0%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

Product may include:

allergic reaction, causing allergic reactions

201

Phenol, 2-chloro-6-(ethylamine) -4-nitro-( ****** )

2-chloro-6-(ethylamino)-4-nitro-phenol

CAS No. 131657-78-8

EINECS No 411-440-1

Hair dye in non-toxicological hair dyes

3.0%

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

Product may include:

allergic reaction, causing allergic reactions

202

4,4 '-[1,3-propanediylbis (oxy)] bisbenzene-1,3-diamine and its tetrahydrochloride salt ( ****** )

2 1,3-bis-(2,4-diaminophenoxy)-propane

CAS No. 81892-72-0

EINECS No 279-845-4

1,3-bis-(2,4-diaminophenoxy)-propane HCl

CAS No. 74918-21-1

EINECS No 278-022-7

(a) Hair dye in oxidative hair dye

(b) hair dye in non-toxicological hair dyes

(b) 1.2% as free base (1.8% as a tetrahydrochloride salt)

(a) After mixing under oxidative conditions, the maximum concentration of the application on the hair may not exceed 1.2%, calculated as the free base (1.8% as the tetrahydrochloride salt).

(a) The mixing ratio must be indicated on the label.

For (a) and (b):

Product may include:

allergic reaction, causing allergic reactions

203

6-methoxy-N2-methyl-2,3-pyri-dindiamine hydrochloride and di-hydrochloride salt ( ****** )

6-methoxy-2-methylamino-3-aminopyridine HCl

CAS No. 90817-34-8 (HCl)

CAS No. 83732-72-3 (2HCl)

EINECS No 280-622-9 (2HCl

(a) Hair dye in oxidative hair dye

(b) hair dye in non-toxicological hair dyes

(b) 0.68% as free base (1.0% as dihydrochloride)

(a) After mixing under oxidative conditions, the maximum concentration in use on the hair must not exceed 0.68%, calculated as free base (1.0% as di-hydrochloride).

For (a) and (b):

-Do not use together with nitrosating systems

-maximum levels of nitrosamine: 50 μg/kg

-Keep in nitrite-free containers

(a) The Misch-

ratio must be specified on the label.

For (a) and (b):

Product may include:

allergic reaction, causing allergic reactions

204

2,3-dihydro-1H-indole-5,6-diol and its hydrobromide salt ( ****** )

Dihydroxyindoline

CAS No. 29539-03-5

Dihydroxyindoline HBr

CAS No. 138937-28-7

EINECS No 421-170-6

Hair dye in non-toxicological hair dyes

2.0%

Product may include:

allergic reaction, causing allergic reactions

205

4-hydroxy-propylamino-3-nitro-phenol ( ****** )

4-hydroxy-propylamino-3-nitro-phenol (INCI)

CAS No. 92952-81-3

EINECS No 406-305-9

(a) Hair dye in oxidative hair dye

(b) hair dye in

non-toxicological hair-dyeing agents

(b) 2.6%

(a) After mixing under oxidative conditions, the maximum concentration in use on the hair must not exceed 2.6%, calculated as the free base.

For (a) and (b):

-Do not use together with nitrosating systems

Maximum levels of nitrosamine: 50

μg/kg

-Keep in nitrite-free containers

(a) The mixing ratio must be indicated on the label.

206

Pure flowering oil of the Verbena (Lippia citriodora Kunth.)

CAS No. 8024-12-2

0.2% "

13. The following footnote shall be inserted in Annex 2:

" ( ****** ) The free base and the salts of this hair dye are authorised provided that their use is not prohibited in Appendix 1. "

14. In Appendix 2, Part 2, numbers 7, 9, 14, 18, 24, 28, 47 and 58 are deleted.

15. In Appendix 2, second part, entry b) in columns c and d of paragraph 55.

16. In Appendix 2, Part 2, points 3, 4, 5, 6, 10, 11, 12, 16, 19, 20, 21, 22, 25, 26, 27, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 48, 49, 50, 55 and 56, shall be given in column g of the date "31.12.2009" by the date "31.12.2010" replaced.

17. footnote *) in Appendix 4 is:

"(*) numbers in accordance with Directive 76/768/EEC, Annex VII, as last amended by Directive 2009 /164/EU."

Stöger