Cosmetic Products (Amendment) Regulations, 2006
Table of Provisions (6)
Statutory Text (6 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,868, 20 ta’ Jannar, 2006
L.N. 16 of 2006
PRODUCT SAFETY ACT
(CAP. 427)
Cosmetic Products (Amendment) Regulations, 2006
IN exercise of the powers conferred by article 39 of the Product
Safety Act, the Minister for Competitiveness and Communications has,
on the advice of the Malta Standards Authority, made the following
regulations>–
The title of these regulations is the Cosmetic Products Citation and
coming into force.
(Amendment) Regulations, 2006, and they shall be read and construed
as one with the Cosmetic Products Regulations, 2004 hereinafter referred L.N. 424 of 2004.
to as “the principal regulations”.
As from the 20th January, 2006, cosmetic products that fail to
comply with the provisions of these regulations shall not be placed on
the market by manufacturers or importers.
These regulations implement the provisions of Commission Scope.
Directive 2005#52#EC of the 9 th September, 2005.
For Part 2 of the Third Schedule to the principal regulations, Amends the Third
Schedule to the
there shall be substituted the following>–
principal
regulations.
Allowed until
08.2006
31.08.2006
31.12.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
Can cause allergic
(a) (b) Can cause
(a) (b) Can cause
allergic reaction
allergic reaction
F
reaction
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
concentration upon
requirements
maximum use
E
tration upon
tration upon
application
application
List of Substances provisionally allowed
is 1.5 %
is 1.5 %
Maximum authorized
concentration in the
finished cosmetic
“PART 2
Restrictions
product
(a) 3.0 %
(b) 3.0 %
(a) 3.0 %
(b) 3.0 %
0.2 %
D
1.0 %
agents for hair dyeing
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
Oxidising colouring
(b) Non-oxidising
(b) Non-oxidising
and/or use
Non-oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
(CAS No 603-85-0) and
(CAS No 610-81-1) and
(CAS no 582-17-2) and
2-Amino-3-nitrophenol
4-Amino-3-nitrophenol
Basic Blue 7 (CAS No
2,7-Naphthalenediol
Substance
B
2390-60-5)
its salts
its salts
its salts
Reference
Number
A
Allowed until
31.12.2006
31.12.2006
31.12.2006
31.08.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
Can cause allergic
Can cause allergic
Can cause allergic
(a) (b) Can cause
(a) (b) Can cause
allergic reaction
allergic reaction
F
reaction
reaction
reaction
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
application is 0.5 %
application is 1.0 %
application is 1.0 %
concentration upon
concentration upon
requirements
maximum use
maximum use
E
tration upon
tration upon
application
application
is 2.6 %
is 1.5 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 5.2 %
(b) 2.6 %
(a) 3.0 %
(b) 2.0 %
D
2.0 %
2.0 %
3.0 %
agents for hair dyeing
agents for hair dyeing
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
Oxidising colouring
Oxidising colouring
colouring agent for
(b) Non-oxidising
(b) Non-oxidising
and/or use
Non-oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
4-Hydroxypropylamino-
(CAS no 591-27-5) and
(CAS No 84540-47-6)
(CAS No 92952-81-3)
(CAS No 69825-83-8)
(CAS No 23920-15-2)
2,6-Dihydroxy-3,4-
Substance
dimethylpyridine
m-Aminophenol
pyridinediamine
HC Blue No 11
B
3-nitrophenol
6-Nitro-2,5-
and its salts
and its salts
and its salts
and its salts
its salts
Reference
Number
A
Allowed until
31.12.2006
31.12.2006
31.12.2006
31.08.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
Can cause allergic
Can cause allergic
(a) (b) Can cause
(a) (b) Can cause
allergic reaction
allergic reaction
F
reaction
reaction
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
application is 1.5 %
application is 1.5 %
concentration upon
concentration upon
requirements
maximum use
maximum use
E
tration upon
tration upon
application
application
is 1.0 %
is 1.5 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 2.0 %
(b) 1.0 %
(b) 2.0 %
(a) 3.0%
D
3.0 %
3.0 %
2.0 %
Field of application
agent for hair dyeing
agent for hair dyeing
colouring agents for
colouring agents for
colouring agents for
colouring agents for
Oxidising colouring
Oxidising colouring
colouring agent for
(b) Non-oxidising
(b) Non-oxidising
and/or use
Non-oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
acid (CAS No 99610-72-
2-Hydroxyethylpicramic
(CAS No 150-75-4) and
(CAS No 100418-33-5)
(CAS No 141614-05-3)
CAS No 104226-19-9)
methylphenoxyethanol
p-Methylaminophenol
Substance
Hydroxyethyl-2-
nitro-p-toluidine
HC Violet No 2
2,4-Diamino-5-
7) and its salts
B
and its salts
and its salts
and its salts
its salts
Reference
Number
A
Allowed until
31.08.2006
31.12.2006
31.08.2006
31.12.2006
31.12.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
Can cause allergic
Can cause allergic
Can cause allergic
Can cause allergic
(a) (b) Can cause
allergic reaction
F
reaction
reaction
reaction
reaction
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
In combination with
application is 1.0 %
application is 1.0 %
application is 1.0 %
concentration upon
concentration upon
concentration upon
requirements
maximum use
maximum use
maximum use
maximum use
E
tration upon
application
is 0.75 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 1.5 %
(b) 1.5 %
D
3.0 %
2.0 %
2.0 %
2.0 %
0.5 %
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
Field of application
colouring agents for
colouring agents for
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
colouring agent for
(b) Non-oxidising
and/or use
Non-oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
pyrazolone (CAS No 89-
81892-72-0) and its salts
(CAS No 122252-11-3)
(CAS No 104516-93-0)
CAS No 113715-25-6)
(CAS No 61693-43-4)
Hydroxyethyl-2,6-
dinitro-p-anisidine
Substance
propane (CAS No
25-8) and its salts
diaminophenoxy)
HC Blue No 12
2,4-Diamino-5-
methylphenetol
dichlorophenol
Phenyl methyl
B
3-Amino-2,4-
1,3-Bis-(2,4-
and its salts
and its salts
and its salts
and its salts
Reference
Number
A
Allowed until
31.12.2006
31.12.2006
31.08.2006
31.12.2006
31.12.2006
31.12.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
Can cause allergic
Can cause allergic
Can cause allergic
Can cause allergic
F
reaction
reaction
reaction
reaction
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
application is 0.25 %
application is 0.25 %
In combination with
In combination with
In combination with
In combination with
In combination with
application is 1.0 %
application is 1.0 %
application is 0.5 %
concentration upon
concentration upon
concentration upon
concentration upon
concentration upon
requirements
maximum use
maximum use
maximum use
maximum use
E
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 0.5 %
D
2.0 %
2.0 %
1.0 %
0.2 %
0.5 %
1.0 %
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
Field of application
colouring agents for
colouring agents for
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
and/or use
Non-oxidising
Non-oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hydroxyethylaminophenol
Hydroxybenzomorpholine
HC Violet No 1 (CAS No
(CAS No 575-38-2) and
(CAS No 109023-83-8)
(CAS No 55302-96-0)
(CAS No 26021-57-8)
(CAS No 85679-78-3)
(CAS No 85765-48-6)
1,7-Naphthalenediol
2,6-Dimethoxy-3,5-
Substance
HC Yellow No 10
HC Orange No 2
pyridinediamine
B
2-Methyl-5-
and its salts
and its salts
and its salts
and its salts
and its salts
its salts
Reference
Number
A
Allowed until
31.12.2006
31.12.2006
31.12.2006
31.08.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
F
maximum use concen-
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
requirements
E
tration upon
tration upon
tration upon
application
application
application
is 0.25 %
is 1.25 %
is 1.0 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(b) 0.5 %
(a) 2.0 %
(b) 1.0 %
(a) 2.5 %
(b) 2.5 %
D
1.0 %
1.0 %
1.0 %
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
Oxidising colouring
(b) Non-oxidising
(b) Non-oxidising
(b) Non-oxidising
and/or use
Non-oxidising
Non-oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
phenylene-diamine (CAS
82576-75-8) and its salts
2-Hydroxy-ethylamino-
(CAS No 59820-63-2)
(CAS No 66095-81-6)
(CAS No 94158-13-1)
nitro-phenoxyethanol
1,5-Naphthalenediol
No 50610-28-1) and
2-Chloro-5-nitro-N-
3-Methylamino-4-
Substance
hydroxyethyl-p-
HC Red No 13
B
5-nitroanisole
and its salts
and its salts
and its salts
its salts
Reference
Number
A
Allowed until
31.12.2006
31.08.2006
31.12.2006
31.12.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
Can cause allergic
F
reaction
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
In combination with
application is 0.5 %
application is 1.5 %
application is 1.0 %
application is 1.5 %
application is 2.0 %
concentration upon
concentration upon
concentration upon
concentration upon
concentration upon
requirements
maximum use
maximum use
maximum use
maximum use
maximum use
maximum use
E
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
D
3.0 %
2.0 %
3.0 %
4.0 %
2.0 %
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
Field of application
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
and/or use
C
(CAS No 83-56-7) and its
(CAS No 95-55-6) and its
(CAS No 2835-95-2) and
Diaminophenoxyethanol
CAS No 128729-30-6)
(CAS No 66422-95-5)
pphenylenediamine)
(CAS No 608-25-3)
2-Methylresorcinol
Hydroxypropyl bis
Substance
N-hydroxyethyl-
o-Aminophenol
hydroxytoluene
B
4-Amino-2-
and its salts
and its salts
and its salts
its salts
salts
salts
2,4-
Reference
Number
A
Allowed until
31.12.2006
31.12.2006
31.08.2006
31.08.2006
31.08.2006
31.08.2006
G
be printed on the label
Conditions of use and
warnings which must
F
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
In combination with
In combination with
application is 1.0 %
application is 1.5 %
application is 1.5 %
application is 1.0 %
application is 1.5 %
application is 1.5 %
concentration upon
concentration upon
concentration upon
concentration upon
concentration upon
concentration upon
requirements
maximum use
maximum use
maximum use
maximum use
maximum use
E
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
D
3.0 %
3.0 %
2.0 %
3.0 %
3.0 %
3.0 %
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
agents for hair dyeing
Field of application
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
Oxidising colouring
and/or use
C
CAS No 83763-47-7) and
(CAS No 2835-99-6) and
hydroxyethylaminoanisol
3,4-Diaminobenzoicacid
(CAS No 619-05-6) and
(CAS No 17672-22-9)
(CAS No 79352-72-0)
methyl-paminophenol
Hydroxyethylamino-
4-Amino-m-cresol
Substance
6-Amino-o-cresol
2-Aminomethyl-
paminophenol
B
2-Amino-4-
and its salts
and its salts
its salts
its salts
its salts
e
Reference
Number
A
Allowed until
31.12.2006
31.08.2006
31.08.2006
31.12.2006
31.12.2006
G
be printed on the label
Conditions of use and
warnings which must
F
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
application is 1.5 %
application is 1.5 %
application is 1.0 %
concentration upon
concentration upon
concentration upon
requirements
maximum use
maximum use
maximum use
E
tration upon
tration upon
application
application
is 0.15 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 0.3 %
(b) 0.3 %
(a) 6.0 %
(b) 6.0 %
D
3.0 %
2.0 %
2.8 %
agents for hair dyeing
agents for hair dyeing
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
Oxidising colouring
Oxidising colouring
(b) Non-oxidising
(b) Non-oxidising
and/or use
Non-oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hydroxyethylaminophenol
(CAS No 5307-14-2) and
(CAS No 110952-46-0)
No 33229-34-4) and its
methylenedioxyaniline
(CAS No 81329-90-0)
(CAS No 65235-31-6)
No 3618-58-4) and its
Acid Black 52 (CAS
HC Blue No 2 (CAS
Hydroxyethyl-3,4-
Substance
phenylenediamine
B
and its salts
and its salts
and its salts
2-Nitro-p-
3-Nitro-p-
its salts
salts
salts
Reference
Number
A
Allowed until
31.12.2006
31.12.2006
31.08.2006
31.08.2006
G
be printed on the label
Conditions of use and
warnings which must
F
maximum use concen-
maximum use concen-
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
requirements
E
tration upon
tration upon
tration upon
tration upon
application
application
application
application
is 0.25 %
is 3.0 %
is 1.0 %
is 1.0 %
is 0.5 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 0.5 %
(b) 0.5 %
(a) 2.0 %
(b) 1.0 %
(a) 2.0 %
(b) 1.0 %
(a) 1.0 %
(b) 0.5 %
D
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
(b) Non-oxidising
(b) Non-oxidising
(b) Non-oxidising
(b) Non-oxidising
and/or use
(a) Oxidising
(a) Oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
104333-00-8) and its salts
HC Red No 10 + HC Red
89-9 + 95576-92-4) and
No 11 (CAS No 95576-
Yellow No 6 (CAS No
(CAS No 27080-42-8)
(CAS No 59320-13-7)
Substance
HC Yellow No 12
aminoethylurea
4-Nitrophenyl
B
and its salts
and its salts
its salts
Reference
Number
A
Allowed until
31.08.2006
31.08.2006
31.12.2006
31.12.2006
31.08.2006
G
be printed on the label
Conditions of use and
warnings which must
F
maximum use concen-
maximum use concen-
maximum use concen-
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
hydrogen peroxide the
Other limitations and
In combination with
In combination with
In combination with
In combination with
In combination with
application is 1.0 %
application is 1.5 %
concentration upon
concentration upon
requirements
maximum use
maximum use
E
tration upon
tration upon
tration upon
application
application
is 1.0 %
is 1.0 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(a) 2.0 %
(b) 1.0 %
(a) 3.0 %
(b) 3.0 %
(a) 2.0 %
(b) 2.0 %
(a) 0.5 %
D
2.0 %
agents for hair dyeing
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
Oxidising colouring
(b) Non-oxidising
(b) Non-oxidising
(b) Non-oxidising
and/or use
(a) Oxidising
(a) Oxidising
(a) Oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
No 114087-47-1) and its
2-Chloro-6-ethylamino-
(CAS No 102767-27-1)
(CAS No 131657-78-8)
No 6358-09-4) and its
HC Blue No 9 (CAS
Basic Blue 26 (CAS
4-nitrophenol (CAS
44045) and its salts
2-Amino-6-chloro-
No 2580-56-5) (CI
Substance
HC Blue No 10
B
4-nitrophenol
and its salts
and its salts
salts
salts
Reference
Number
A
Allowed until
31.12.2006
31.08.2006
31.08.2006
G
be printed on the label
Conditions of use and
warnings which must
F
maximum use concen-
hydrogen peroxide the
Other limitations and
In combination with
requirements
E
tration upon
application
application
is 0.25 %
is 0.15 %
Maximum authorized
concentration in the
finished cosmetic
Restrictions
product
(b) 0.5 %
(a) 0.3 %
(b) 0.3 %
D
2.0 %
2.0 %
Field of application
colouring agents for
colouring agents for
colouring agents for
colouring agents for
colouring agents for
(b) Non-oxidising
(b) Non-oxidising
and/or use
Non-oxidising
Non-oxidising
(a) Oxidising
C
hair dyeing
hair dyeing
hair dyeing
hair dyeing
hair dyeing
(CAS No 632-99-5)
17200) and its salts
14700) and its salts
Acid Red 33 (CAS
No 3567-66-6) (CI
No 4548-53-2) (CI
Ponceau SX (CAS
Substance
(CI 42510) and its
Basic Violet 14
B
salts
Reference
Number
A
”.
Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press