Cosmetic Products (Amendment) (No. 3) Regulations, 2009

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,495, 16 ta’Ottubru, 2009

Taqsima B

A.L. 266 ta’ l-2009

PRODUCT SAFETY ACT

(CAP. 427)

Cosmetic Products (Amendment) (No. 3) Regulations, 2009

IN exercise of the powers conferred by article 39 of the Product

Safety Act, the Minister of Finance, the Economy and Investment

has, on the advice of the Malta Standards Authority, made the

following regulations:-

The title of these regulations is the Cosmetic Products Citation.

(Amendment) (No. 3) Regulations, 2009 and they shall be read and

construed as one with the Cosmetic Products Regulations, hereinafter S.L. 427.58

in these regulations referred to as "the principal regulations".

(1)

These regulations shall apply as from 15th May, Commencement

and scope.

2010. (2) These regulations implement the provisions of

Commission Directive 2009/36/EC of 16 April 2009 amending

Council Directive 76/768/EEC, concerning cosmetic products, for the

purpose of adapting Annex III thereto to technical progress.

(1) In Part 1 of the Third Schedule to the principal Amends the

regulations the following reference numbers 189 to 205 shall be Third

to the principal

added immediately after entry 188

regulations.

Restrictions

Refe-

Substance

Field of

Maximum

Other

Conditions of

application

authorised

limitations and

use and

rence

and/or use concentration

requirements

warnings

Number

in the finished

which must

cosmetic

be printed on

product

the label

a

b

c

d

e

f

" 189

Trisodium 5-hydroxy-1-(4- Hair dye

0.5 %

sulphophenyl)-4-(4-

substance in

sulphophe-nylazo)

non-

pyrazole-3-carboxylate and oxidative

aluminium lake (15)

hair dye

products

Acid Yellow 23

CAS 1934-21-0

EINECS 217-699-5

Acid Yellow 23 Aluminum

lake

CAS 12225-21-7

EINECS 235-428-9

CI 19140

Benzenemethanaminium, Hair dye

0.5 %

N-ethyl-N-[4-[[4-[ethyl-[(3- substance in

sulfo-phenyl)-methyl]-

non-

amino]- phenyl] [2-

oxidative

sulfophenyl)- methylene]- hair dye

2,5-cyclohexadien- 1-

products

ylidene]-3-sulfo, inner salt,

disodium salt and its

ammonium and aluminium

salts (15)

Acid Blue 9

CAS 3844-45-9

EINECS 223-339-8

Acid Blue 9 Ammonium

salt

CAS 2650-18-2

EINECS 220-168-0

Acid Blue 9 Aluminum lake

CAS 68921-42-6

EINECS 272-939-6

CI 42090

Disodium 6-hydroxy-5-[(2- Hair dye

0.4 %

methoxy-4-sulphonato-m- substance in

tolyl)azo]naphthalene-2-

non-

sulphonate (15)

oxidative

hair dye

Curry Red

products

CAS 25956-17-6

EINECS 247-368-0

CI 16035

Trisodium 1-(1-

Hair dye

0.5 %

naphthylazo)-2-

substance in

hydroxynaphthalene-4′,6,8- non-

trisulphonate and

oxidative

aluminium lake ( 15 )

hair dye

products

Acid Red 18

CAS 2611-82-7

EINECS 220-036-2

Acid Red 18 Aluminum

lake

CAS 12227-64-4

EINECS 235-438-3

CI 16255

Hydrogen 3,6-bis(diethy- (a) Hair dye

(a) After

(a) The

lamino)-9-(2,4-

substance in

mixing under mixing ratio

disulphonato-phenyl)

oxidative

oxidative

must be

xanthylium, sodium salt (15) hair dye

conditions the printed on

products

maximum

the label.

concentration

Acid Red 52

applied to hair

CAS 3520-42-1

must not

(b) Hair dye (b) 0.6 %

exceed 1.5%.

EINECS 222-529-8

substance in

non-

CI 45100

oxidative

hair dye

products

Disodium 5-amino-4-

Hair dye

0.5 %

hydroxy- 3-

substance in

(phenylazo)naphthalene-

non-

2,7- disulphonate (15)

oxidative

hair dye

Acid Red 33

products

CAS 3567-66-6

EINECS 222-656-9

CI 17200

Sodium 1-amino-4-

Hair dye

0.5 %

- Do not use

(cyclohexy-lamino)-9,10-

substance in

with

dihydro-9,10-

non-

nitrosating

dioxoanthracene-2-

oxidative

systems

sulphonate (15)

hair dye

- Maximum

products

Acid Blue 62

nitrosamine

content: 50 µg/

CAS 4368-56-3

kg

EINECS 224-460-9

- Keep in

CI 62045

nitrite-free

containers

1-[(2′-Methoxyethyl)

Hair dye

2.0 %

- Do not use

amino]-2-nitro-4-[di-(2′-

substance in

with

hydro-xyethyl)amino]

non-

nitrosating

benzene ( 15 )

oxidative

systems

hair dye

HC Blue No 11

- Maximum

products

nitrosamine

CAS 23920-15-2

content: 50 µg/

EINECS 459-980-7

kg

- Keep in

nitrite-free

containers

1,5-Di-(ß-

Hair dye

0.1 %

- Do not use

hydroxyethylamino)- 2-

substance in

with

nitro-4-chlorobenzene (15)

non-

nitrosating

oxidative

systems

HC Yellow No 10

hair dye

- Maximum

CAS 109023-83-8

products

nitrosamine

EINECS 416-940-3

content: 50 µg/

kg

- Keep in

nitrite-free

containers

3-Methylamino-4-

Hair

dye 0.15 %

- Do not use

nitrophenox-yethanol (15)

substance in

with

non-

nitrosating

3-Methylamino-4-

oxidative

systems

nitrophenox-yethanol

hair

dye

(INCI)

-

Maximum

products

nitrosamine

CAS 59820-63-2

content: 50 µg/

EINECS 261-940-7

kg

- Keep in

nitrite-free

containers

2,2′-[[4-[(2-hydroxyethyl)

Hair

dye 2.8 %

- Do not use Can cause

amino]-3-

substance in

with

allergic

nitrophenyl]imino]bi-

non-

nitrosating

reaction

sethanol ( 15 )

oxidative

systems

hair

dye

HC Blue No 2

-

Maximum

products

nitrosamine

CAS 33229-34-4

content: 50 µg/

EINECS 251-410-3

kg

- Keep in

nitrite-free

containers

1-Propanol, 3-[[4-[bis(2-

Hair dye

2.0 %

- Do not use Can cause

hydro-xyethyl)amino]-2-

substance in

with

allergic

nitropheny-l]amino] (15)

non-

nitrosating

reaction

oxidative

systems

HC Violet No 2

hair dye

- Maximum

CAS 104226-19-9

products

nitrosamine

EINECS 410-910-3

content: 50 µg/

kg

- Keep in

nitrite-free

containers

Phenol, 2-chloro-6-(ethyl- Hair dye

3.0 %

- Do not use Can cause

amino)-4-nitro- (15)

substance in

with

allergic

2-Chloro-6-ethylamino-4- non-

nitrosating

reaction

oxidative

systems

nitro-phenol

hair dye

- Maximum

CAS 131657-78-8

products

nitrosamine

EINECS 411-440-1

content: 50 µg/

kg

- Keep in

nitrite-free

containers Can

cause allergic

reaction

4,4′-[1,3-

(a) Hair dye

(a) After

(a) The

Propanediylbis(oxy)]-

substance in

mixing under mixing ratio

bisbenzene-1,3-diamine and oxidative

oxidative

must be

its tetrahydrochloride salt hair dye

conditions the printed on

(15 )

products

maximum

the label.

concentration

1,3-bis-(2,4-

applied to hair

Diaminophenoxy)- propane

must not

CAS 81892-72-0

exceed 1.2%

EINECS 279-845-4

(b) Hair dye (b) 1.2 % as

For (a) and

calculated as

substance in free base (1.8

(b): Can

1,3-bis-(2,4-

free base

Diaminophenoxy)- propane non-

% as tetrahy-

cause

(1.8% as

oxidative

drochloride

allergic

HCl

tetrahydroch-

hair

dye

salt)

reaction

CAS 74918-21-1

loride salt).

products

EINECS 278-022-7

6-Methoxy-N2-methyl-2,3- (a) Hair dye

(a) After

(a) The

pyri-dinediamine

substance in

mixing under mixing ratio

hydrochloride and

oxidative

oxidative

must be

dihydrochloride salt ( 15 )

hair dye

conditions the printed on

products

maximum

the label.

concentration

6-Methoxy-2-methylamino-

applied to hair

3- aminopyridine HCl

must not

CAS 90817-34-8 (HCl)

exceed 0.68%

CAS 83732-72-3 (2HCl)

(b) Hair dye (b) 0.68 % as

For (a) and

calculated as

substance

in

free

base

(b): Can

EINECS 280-622-9 (2HCl)

free base

non-

(1.,0% as

cause

(1.0% as dihy-

oxidative

dihydro-

allergic

drochloride).

hair dye

chloride)

reaction

For (a) and

(b)

- Do not use

with

nitrosating

systems

- Maximum

nitrosamine

content: 50µg/

kg

- Keep in

nitrite-free

containers

2,3-Dihydro-1H-indole-5,6- Hair dye

2.0 %

Can cause

diol and its hydrobromide substance in

allergic

salt (15)

non-

reaction

oxidative

Dihydroxyindoline

hair dye

CAS 29539-03-5

products

Dihydroxyindoline HBr

CAS 138937-28-7

EINECS 421-170-6

4-Hydroxypropylamino-3-

(a) Hair dye (b) 2.6 %

(a) After

(a) The

nitrophenol (15)

substance in

mixing under mixing ratio

oxidative

oxidative

must be

4-Hydroxypropylamino-3-

hair dye

conditions the printed on

nitrophenol (INCI)

products

maximum

the label.

CAS 92952-81-3

concentration

(b) Hair dye

EINECS 406-305-9

applied to hair

substance in

must not

non-

exceed 2.6 %

oxidative

calculated as

hair dye

free base.

products

For (a) and

(b)

- Do not use

with

nitrosating

systems

- Maximum

nitrosamine

content: 50 µg/

kg

- Keep in

nitrite-free

containers

(15 ) The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are

permitted for use. " .

(2) In columns ‘c’ and ‘d’ of entry 55 of Part 2 of the Third

Schedule, section b shall be deleted.

(3) In Part 2 of the Third Schedule, reference numbers 7, 9, 14,

18, 24, 28, 47 and 58 shall be deleted.