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Order Of February 27, 2013, Amending The Decree Of 6 February 2001 Determining The List Of Substances That Cannot Be Used In Cosmetic Products Apart From The Restrictions And Conditions Laid Down In This List

Original Language Title: Arrêté du 27 février 2013 modifiant l'arrêté du 6 février 2001 fixant la liste des substances qui ne peuvent être utilisées dans les produits cosmétiques en dehors des restrictions et conditions fixées par cette liste

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Texts transposed

Commission Implementing Directive 2012/21/EU Amending, in order to adapt to technical progress, Annexes II and III to Council Directive 76/768/EEC on cosmetics

Summary

Transposition of Commission Directive 2012/21/EU amending, to adapt to technical progress, annexes II and III to Council Directive 76/768/EEC on cosmetics.

Keywords

SOCIAL BUSINESS , EUROPEAN DIRECTIVE , COMPLETE TRANSPOSITION


JORF n°0054 of 5 March 2013 page 3977
text No. 7



Order of February 27, 2013 amending the Order of February 6, 2001 setting the list of substances that cannot be used in cosmetic products outside the restrictions and conditions set out in this list

NOR: AFSP1305692A ELI: https://www.legifrance.gouv.fr/eli/arrete/2013/2/27/AFSP1305692A/jo/texte


Minister of Economy and Finance, Minister of Social Affairs and Health and Minister of Productive Recovery,
Having regard to Council Directive No. 76/768/EEC of 27 July 1976, as amended, on the approximation of the laws of member States relating to cosmetics, including its annex III;
Considering the Commission's Directive 2012/21/EU of 2 August 2012;
Vu le Public Health Codeincluding articles L. 5131-11 and R. 5131-3;
Considering the amended decision of 6 February 2001, setting out the list of substances that cannot enter the composition of cosmetic products;
On the proposal of the Director General of the National Drug and Health Products Safety Agency dated February 5, 2013,
Stop:

Article 1 Learn more about this article...


1. The schedule to the above-mentioned Order dated 6 February 2001 is amended to read:
(a) The following order numbers are added:




RESTRICTIONS
NUMBER
of order
SUBSTANCES
Scope
and/or use
Maximum permissible concentration in finished cosmetic product
Other limitations
and requirements
CONDITIONS
employment
and warning
resume oligatory
on Labelling
a
b
c
d
e
f

253

2.2'– [(4-aminophenyl) imino] bis (ethanol)
N, N-bis (2-Hydroxyethyl)-p-Phenylenediamine Sulfate
CAS number 54381-16-7
EC 259-134-5

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 2.5% (expressed in sulfate):
― not using nitrosation agents
- maximum concentration of nitrosamine: 50 μg/kg
- to be kept in containers without nitrite

See order number 205, column f, point a)

254

4-Chloro-1,3-benzenediol
4-Chlororésorcinol
CAS No. 95-88-5
EC 202-462-0

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 2.5%

See order number 205, column f, point a)

255

2.4.5,6-tetra aminopyrimidine Tetra aminopyrimidine Sulfate
CAS No. 5392-28-9
EC 226-393-0

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 3.4 per cent (expressed in sulfate)

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 3.4% (expressed in sulfate).

(a) See order number 205, column f, point a)

256

3-(2-hydroxyethyl)-p-phenylenediammonium
Hydroxyethyl-p-Phenylenediamine
Sulfate
CAS No. 93841-25-9
EC 298-995-1

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 2.0% (expressed in sulfate).

See order number 205, column f, point a)

257

1H-Indole-5,6-diol
Dihydroxyindole
CAS number 3131-52-0
EC 412-130-9

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 0.5 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 0.5%

(a) See order number 205, column f, point a)
(b) See Order Number 208, Column f

258

Chloride 5-amino-4-chloro-2-
methylphenol5-Amino-4-
Chloro-o-Cresol HCl
CAS No. 110102-85-7

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum applied to the hair should not exceed 1.5 % (expressed in hydrochloride)

See order number 205, column f, point a)

259

1H-Indol-6-ol
6-Hydroxyindole
CAS No. 2380-86-1
EC 417-020-4

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 0.5%

See order number 205, column f, point a)

260

1H-Indole-2,3-dione
Isatine
CAS No. 91-56-5
EC 202-077-8

Substance used in non-oxidizing hair dyes

1.6 per cent


See Order Number 208, Column f

261

2-Aminopyridine-3-ol 2-Amino-3-Hydroxypyridine
CAS number 16867-03-1
EC 240-886-8

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 1.0%

See order number 205, column f, point a)

262

Acetate
2-methyl-1-
naphthalenol 1-Acetoxy-2-
Methylnaphthalene
CAS No. 5697-02-9
EC 454-690-7

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 2.0% (when both substances 2-Methyl-1-Naphthol and 1 ― Acetoxy-2-Methylnaphthalene are present in a hair dye preparation, the maximum content of 2-Methyl-1-Naphthol applied to the hair should not exceed 2.0%

See order number 205, column f, point a)

263

1-Hydroxy-2-methylnaphthalene
2-Methyl-1-Naphthol
CAS No. 7469-77-4
EC 231-265-2

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair should not exceed 2.0% (when both substances 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in hair dye preparation, the maximum content of 2-Methyl-1-Naphthol applied to the hair should not exceed 2.0%)

See order number 205, column f, point a)

264

5.7-Dinitro-8-oxydonaphthalene-2-sulfonate disodium
Acid Yellow 1
CAS number 846-70-8
EC 212-690-2 CI 10316

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 0.2 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 1.0%

(a) See order number 205, column f, point a)
(b) See Order Number 208, Column f

265

4-Nitro-1,2-phenylenediamine
4-Nitro-o-Phenylenediamine
CAS No. 99-56-9
EC 202-766-3

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 0.5%.

See order number 205, column f, point a)

266

2-(4-Amino-3-nitroanilino) ethanol
HC Red No. 7
CAS number 24905-87-1
No. EC 246-521-9

Substance used in non-oxidizing hair dyes

1.0%

Do not use with nitrosation agents
Maximum concentration in nitrosamine: 50 μg/kg
Store in containers without nitrite

See Order Number 208, Column f

267

2-[bis (2-Hydroxyethyl) amino]-5-nitrophenol
HC Yellow No. 4
CAS number 59820-43-8
EC 428-840-7

Substance used in non-oxidizing hair dyes

1.5 per cent

Do not use with nitrosation agents
Maximum concentration in nitrosamine: 50 μg/kg
Store in containers without nitrite


268

2-[(2-Nitrophenyl) amino] ethanol
HC Yellow No. 2
CAS number 4926-55-0
EC 225-555-8

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 1.0 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 0.75%.
For (a) and (b):
― not using nitrosation agents
- maximum concentration of nitrosamine: 50 μg/kg
- to be kept in containers without nitrite

(a) See order number 205, column f, point a)

269

p-[(o-Nitrophenyl) amino] phenol
HC Orange No. 1
CAS number 54381-08-7
EC 259-132-4

Substance used in non-oxidizing hair dyes

1.0%



270

2-Nitro-N-phenyl-benzene-1,4-diamine HC Red No. 1
CAS number 2784-89-6
EC 220-494-3

Substance used in non-oxidizing hair dyes

1.0%


See Order Number 208, Column f

271

1-methoxy-3-(― aminoethyl) amino-4-nitrobenzene
HC Yellow No. 9
CAS number 86419-69-4
EC 415-480-1

Substance used in non-oxidizing hair dyes

0.5% (expressed in hydrochloride)

Do not use with nitrosation agents
Maximum concentration in nitrosamine: 50 μg/kg
Store in containers without nitrite


272

1-(4'-Aminophenylazo)-2-methyl-4-(bis-hydroxyethyl) aminobenzene
HC Yellow No. 7
CAS No. 104226-21-3
EC 146-420-6

Substance used in non-oxidizing hair dyes

0.25%



273

4-(2'-Hydroxyethyl) amino-3-nitrotrifluoromethylbenzene
HC Yellow No. 13
CAS No. 10442-83-8
EC 443-760-2

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 2.5 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 2.5%
For (a) and (b):
― not using nitrosation agents
- maximum concentration of nitrosamine: 50 μg/kg
- to be kept in containers without nitrite

(a) See order number 205, column f, point a)

274

Chloride
3-[(4,5-dihydro-3-methyl-
5-oxo-1-phenyl-1H-
pyrazole-4-yl) azo]-N, N, N-trimethylanilinium
Basic Yellow 57
CAS number 68391-31-1
EC 269-943-5

Substance used in non-oxidizing hair dyes

2.0 per cent



275

2.2'-[4-[(4-Aminophenyl) azo] phenyl] imino] biséthanol
Disperse Black 9
CAS number 20721-50-0
EC 243-987-5

Substance used in non-oxidizing hair dyes

0.3 % (a mixture in ratio 1:1 of 2.2'– [4-(4 ― aminophenylazo) phénylimino] diéthanol and lignosulfate)



276

1.4-bis [2,3,-Dihydroxypropylamino]-9,10-anthracènedione
HC Blue No. 14
CAS No. 99788-75-7
EC 421-470-7

Substance used in non-oxidizing hair dyes

0.3 per cent

Do not use with nitrosation agents
Maximum concentration in nitrosamine: 50 μg/kg
Store in containers without nitrite


277

1-Methyl-3-nitro-4-(-hydroxyethyl) aminobenzene
Hydroxyethyl-2-Nitro-p-Toluidine
CAS No. 100418-33-5
EC 408-090-7

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 1.0 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 1.0%
For (a) and (b):
― not using nitrosation agents
- maximum concentration of nitrosamine: 50 μg/kg
- to be kept in containers without nitrite

(a) See order number 205, column f, 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 number 95576-89-9 + 95576-92-4

(a) Substance used in oxidizing hair dyes
(b) Substance used in non-oxidizing hair dyes


(b) 2.0 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 1.0%.
For (a) and (b):
― not using nitrosation agents
- maximum concentration of nitrosamine: 50 μg/kg
- to be kept in containers without nitrite

(a) See order number 205, column f, point a)


(b) Order numbers 16 and 22 are replaced by the following numbers:



RESTRICTIONS
NUMBER
of order
SUBSTANCES
Scope
and/or use
Maximum permissible concentration in finished cosmetic product
Other limitations
and requirements
CONDITIONS
employment
and warning
resume oligatory
on Labelling
a
b
c
d
e
f

16

1-Naphthalenol
1-Naphthol
CAS number 90-15-3
EC 201-969-4

Substance used in oxidizing hair dyes


After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 2.0%.

See order number 205, column f, point a)

22

1.3-Benzènediol
Resorcinol
CAS No. 108-46-3
EC 203-585-2

(a) Substance used in oxidizing hair dyes
1. General use
2. Professional use
(b) Hair lotions and shampoos


(b) 0.5 per cent

(a) After mixing in oxidation conditions, the maximum grade applied to the hair shall not exceed 1.25 %

(a) 1. Contains resorcin.
Rinse the hair after application.
Do not use for coloring eyelashes and eyebrows.
Rinse the eyes immediately if the product comes into contact with them.
See order number 205, column f, point a)
2. Reserved for professionals.
Contains resorcin.
Rinse the eyes immediately if the product comes into contact with them.
See order number 205, column f, point a)
(b) Contains resorcin.


2. The provisional schedule of the above-mentioned order of 6 February 2001 is amended to read:
In the second part, the order numbers 10 and 50 are deleted.

Article 2 Learn more about this article...


The provisions of Article 1 come into force on September 1, 2013.

Article 3 Learn more about this article...


The Director General of Competition, Consumer Affairs and the Suppression of Frauds, the Director General of Health, the Director General of Competitiveness, Industry and Services, and the Director General of the National Agency for the Safety of Medicine and Health Products are responsible, each with regard to the performance of this Order, to be published in the Official Journal of the French Republic.


Done on 27 February 2013.


Minister of Social Affairs

and Health,

For the Minister and by delegation:

Deputy Director of Policy

health and quality products

practices and care,

C. Choma

Minister of Economy and Finance,

For the Minister and by delegation:

Director General

competition, consumption

and the suppression of fraud,

N. Homobono

Minister of Productive Recovery

For the Minister and by delegation:

The Chief of Industry Service,

Y. Robin


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