MT
Cosmetic Products (Amendment) Regulations, 2013
Statutory Text (5 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,028, 8 ta’ Frar, 2013 B 627
L.N. 57 of 2013
PRODUCT SAFETY ACT
(CAP. 427)
Cosmetic Products (Amendment) Regulations, 2013
IN exercise of the powers conferred by article 39 of the Product
Safety Act, the Minister for Fair Competition, Small Business and
Consumers, on the advice of the Malta Competition and Consumer
Affairs Authority, has made the following regulations
The title of these regulations is the Cosmetic Products Citation.
(Amendment) Regulations, 2013, and they shall be read and
construed as one with the Cosmetic Products Regulations, hereinafter S.L. 427.58.
referred to as "the principal regulations".
These regulations shall come into force on 1 st Commencement
(a)
and scope.
September 2013.
(b)
These regulations implement the provisions of
Commission Implementing Directive 2012/21/EU of 2 August 2012
amending, for the purpose of adaptation to technical progress,
Annexes II and III to Council Directive 76/768/EEC relating to
cosmetic products.
In the Second Schedule to the principal regulations the Amends the
Second
following entry shall be added
Schedule to the
principal
regulations.
Ref no.
Chemical Name
CAS No./EC No.
CAS No 160219-76-1".
"1373
N-(2-Nitro-4-
aminophenyl)-allylamine
(HC Red No 16) and its
salts
The Third Schedule to the principal regulations shall be Amends the
Third Schedule
amended as follows
to the principal
regulations.
(a)
Part I shall be amended as follows:-
(i)
the following entries shall be added
B B 628 628
Restrictions
Max.
authorised
Field of
concentration Other limitations
Conditions of use and
Ref No.
Substance
application
and
warnings which must be
in the finished
and/or use
requirements
printed on the label
cosmetic
product
"253
2,2′-[(4-
Hair dye
After mixing
As mentioned in reference
Aminophenyl))imi
substance in
under oxidative
number 205, column f (a)
no]bis (ethanol)
oxidative
conditions the
sulphate
hair dye
maximum
products
concentration
N,N-bis(2-
applied to hair
Hydroxyethyl)- p-
must not exceed
Phenylenediamine
2,5% (calculated
Sulfate
as sulphate)
CAS No 54381-16-
-Do not use with
nitrosating
EC No 259-134-5
agents
-Maximum
nitrosamine
content: 50 g/
kg
-Keep in nitrite-
free containers
1,3-Benzenediol,
Hair dye
After mixing
As mentioned in reference
4-chloro-
substance in
under oxidative
number 205, column f (a)
oxidative
conditions the
4-Chlororesorcinol
hair dye
maximum
products
concentration
CAS No 95-88-5
applied to hair
EC No 202-462-0
must not exceed
2,5%
2,4,5,6-
(a) Hair dye
(a) After mixing
(a) As mentioned in
Tetraaminopyrimid
substance in
under oxidative
reference number 205,
ine sulphate
oxidative
conditions the
column f (a)
hair dye
maximum
Tetraaminopyrimid
products
concentration
ine Sulfate
(b) Hair dye
(b) 3,4%
applied to hair
CAS No 5392-28-9
substance in
(calculated as must not exceed
non-
sulphate)
3,4% (calculated
EC No 226-393-0
oxidative
as sulphate)
hair dye
products
3-(2-
Hair dye
After mixing
As mentioned in reference
Hydroxyethyl)-p-
substance in
under oxidative
number 205, column f (a)
phenylenediammo
oxidative
conditions the
nium sulphate
hair dye
maximum
products
concentration
Hydroxyethyl-p-
applied to hair
Phenylenediamine
must not exceed
Sulfate
2,0% (calculated
CAS No 93841-25-
as sulphate)
EC No 298-995-1
1H-Indole-5,6-diol
(a) Hair dye
(a) After mixing
(a) As mentioned in
substance in
under oxidative
reference number 205,
Dihydroxyindole
oxidative
conditions the
column f (a)
CAS No 3131-52-0
hair dye
maximum
products
concentration
EC No 412-130-9
applied to hair
(b) Hair dye
(b) 0,5%
must not exceed
(b) As mentioned in
substance in
0,5%
reference number 208,
non-
column f
oxidative
hair dye
products
Max.
authorised
Field of
concentration Other limitations
Conditions of use and
Ref No.
Substance
application
and
warnings which must be
in the finished
and/or use
requirements
printed on the label
cosmetic
product
Hair dye
After mixing
As mentioned in reference
5-Amino-4-chloro-
substance in
under oxidative
number 205, column f (a)
2-methylphenol
oxidative
conditions the
hydrochloride
hair dye
maximum
5-Amino-4-
products
concentration
Chloro-o-Cresol
applied to hair
HCl
must not exceed
CAS No 110102-
1,5% (calculated
85-7
as
hydrochloride)
1H-Indol-6-ol
Hair dye
After mixing
As mentioned in reference
substance in
under oxidative
number 205, column f (a)
6-Hydroxyindole
oxidative
conditions the
CAS No 2380-86-1
hair dye
maximum
products
concentration
EC No 417-020-4
applied to hair
must not exceed
0,5%
1H-Indole-2,3-
Hair dye
1,6%
As mentioned in reference
Dione
substance in
number 208, column f
non-
Isatin
oxidative
CAS No 91-56-5
hair dye
EC No 202-077-8
products
2-Aminopyridin-3-
Hair dye
After mixing
As mentioned in reference
ol
substance in
under oxidative
number 205, column f (a)
oxidative
conditions the
2-Amino-3-
hair dye
maximum
Hydroxypyridine
products
concentration
CAS No 16867-03-
applied to hair
must not exceed
EC No 240-886-8
1,0%
2-Methyl-1-
Hair dye
As mentioned in reference
naphthyl acetate
substance in
number 205, column f (a)
oxidative
1-Acetoxy-2-
hair dye
Methylnaphth-
products
alene
CAS No 5697-02-9
EC No 454-690-7
Max.
authorised
Field of
concentration Other limitations
Conditions of use and
Ref No.
Substance
application
and
warnings which must be
in the finished
and/or use
requirements
printed on the label
cosmetic
product
1-Hydroxy-2-
Hair dye
After mixing
As mentioned in reference
methylnaphthalene
substance in
under oxidative
number 205, column f (a)
2-Methyl-1-
oxidative
conditions the
Naphthol
hair dye
maximum
products
concentration
CAS No 7469-77-4
applied to hair
must not exceed
EC No 231-265-2
2,0% (When
both 2-Methyl-
1-Naphthol and
1-Acetoxy-2-
Methylnaphthale
ne are present in
a hair dye
formulation, the
maximum
concentration on
the head of 2-
Methyl-1-
Naphthol should
not exceed
2,0%.)
Disodium 5,7-
(a) Hair dye
(b) 0,2%
(a) After mixing
(a) As mentioned in
dinitro-8-oxido-2-
substance in
under oxidative
reference number 205,
naphthalenesulfona
oxidative
conditions the
column f (a)
te
hair dye
maximum
products
concentration
(b) As mentioned in
Acid Yellow 1
(b) Hair dye
applied to hair
reference number 208,
CAS No 846-70-8
substance in
must not exceed
column f
EC No 212-690-2
non-
1,0%
CI 10316
oxidative
hair dye
products
4-Nitro-1,2-
Hair dye
After mixing
As mentioned in reference
phenylenediamine
substance in
under oxidative
number 205, column f (a)
oxidative
conditions the
4-Nitro-o-
hair dye
maximum
Phenylenediamine
products
concentration
CAS No 99-56-9
applied to hair
EC No 202-766-3
must not exceed
0,5%
2-(4-Amino-3-
Hair dye
1,0%
-Do not use with
As mentioned in reference
nitroanilino)
substance in
nitrosating
number 208, column f
ethanol
non-
agents
oxidative
-Maximum
HC Red No 7
hair dye
nitrosamine
CAS No 24905-87-
products
content: 50 g/
kg
EC No 246-521-9
-Keep in nitrite-
free containers
Hair dye
1,5%
-Do not use with
2-[bis(2-
substance in
nitrosating
Hydroxyethyl)ami
non-
agents
no]-5- nitrophenol
oxidative
-Maximum
HC Yellow No 4
hair dye
nitrosamine
CAS No 59820-43-
products
content: 50 g/
kg -Keep in
EC No 428-840-7
nitrite-free
containers
Max.
authorised
Field of
concentration Other limitations
Conditions of use and
Ref No.
Substance
application
and
warnings which must be
in the finished
and/or use
requirements
printed on the label
cosmetic
product
2-[(2-Nitrophenyl)-
(a) Hair dye
(a) After mixing
(a) As mentioned in
amino] ethanol
substance in
under oxidative
reference number 205,
oxidative
conditions the
column f (a)
HC Yellow No 2
hair dye
maximum
CAS No 4926-55-0
products
concentration
(b) Hair dye
(b) 1,0%
applied to hair
EC No 225-555-8
substance in
must not exceed
non-
0,75%
oxidative
For (a) and (b)
hair dye
-Do not use with
products
nitrosating
agents -
Maximum
nitrosamine
content: 50 g/
kg -Keep in
nitrite-free
containers
4-[(2-
Hair dye
1,0%
Nitrophenyl)amino
substance in
]phenol
non-
oxidative
HC Orange No 1
hair dye
CAS No 54381-08-
products
EC No 259-132-4
2-Nitro-N1-
Hair dye
1,0%
As mentioned in reference
phenyl-benzene-
substance in
number 208, column f
1,4- diamine
non-
oxidative
HC Red No 1
hair dye
CAS No 2784-89-6
products
EC No 220-494-3
1-Methoxy-3-(β-
Hair dye
0,5%
- Do not use
aminoethyl)
substance in
(calculated as
with nitrosating
amino-4-
non-
hydrochl-
agents -
nitrobenzene,
oxidative
oride)
Maximum
hydrochloride
hair dye
nitrosamine
products
content: 50 g/
HC Yellow No 9
kg - Keep in
CAS No 86419-69-
nitrite-free
containers
EC No 415-480-1
1-(4’-
Hair dye
0,25%
Aminophenylazo)-
substance in
2-methyl- 4-(bis-2-
non-
hydroxyethyl)
oxidative
aminobenzene
hair dye
products
HC Yellow No 7
CAS No 104226-
21-3
EC No 146-420-6
Max.
authorised
Field of
concentration Other limitations
Conditions of use and
Ref No.
Substance
application
and
warnings
which must be
in the finished
and/or use
requirements
printed
on the label
cosmetic
product
N-(2-
(a) Hair dye
(a) After mixing (a) As mentioned in
Hydroxyethyl)-2-
substance in
under oxidative reference number 205,
nitro-4-
oxidative
conditions the
column f (a)
trifluormethyl-
hair dye
maximum
aniline
products
concentration
(b) Hair dye
(b) 2,5%
applied to hair
HC Yellow No 13
substance in
must not exceed
CAS No 10442-83-
non-
2,5%
oxidative
For (a) and (b)
EC No 443-760-2
hair dye
-Do not use with
products
nitrosating
agents
-Maximum
nitrosamine
content: 50 g/
kg -Keep in
nitrite-free
containers
Benzenaminium, 3-
Hair dye
2,0%
[(4,5-dihydro- 3-
substance in
methyl-5-oxo-1-
non-
phenyl-1H-
oxidative
pyrazol-4-yl)azo]-
hair dye
N,N,Ntrimethyl-,
products
chloride
Basic Yellow 57
CAS No 68391-31-
EC No 269-943-5
Ethanol, 2,2′-[[4-
Hair dye
0,3% (of the
[(4-aminophenyl)
substance in
mixture in the
azo]phenyl]imino]
non-
ratio 1:1 of
bis-
oxidative
2,2’-[4-(4-
hair dye
aminophenyla
Disperse Black 9
products
zo)phenylimi
CAS No 20721-50-
no] diethanol
and
EC No 243-987-5
lignosulfate)
9,10-
Hair dye
0,3%
-Do not use with
Anthracenedione,
substance in
nitrosating
1,4-bis [(2,3-
non-
agents
dihydroxypropyl)a
oxidative
-Maximum
mino]-
hair dye
nitrosamine
products
content: 50 g/
HC Blue No 14
kg
CAS No 99788-75-
-Keep in nitrite-
free containers
EC No 421-470-7
Max.
authorised
Field of
concentration Other limitations
Conditions of use and
Ref No.
Substance
application
and
warnings which must be
in the finished
and/or use
requirements
printed on the label
cosmetic
product
2-(4-Methyl-2-
(a) Hair dye
(b) 1,0%
(a) After mixing
(a) As mentioned in
nitroanilino)ethano
substance in
under oxidative
reference number 205,
l Hydroxyethyl-2-
oxidative
conditions the
column f (a)
Nitro-p-Toluidine
hair dye
maximum
products
concentration
CAS No 100418-
(b) Hair dye
applied to hair
33-5
substance in
must not exceed
EC No 408-090-7
non-
1,0%
oxidative
For (a) and (b)
hair dye
- Do not use
products
with nitrosating
agents
- Maximum
nitrosamine
content: 50 g/
kg
- Keep in nitrite-
free containers
1-Amino-2-nitro-4-
(a) Hair dye
(a) After mixing
(a) As mentioned in
(2′,3′-
substance in
under oxidative
reference number 205,
dihydroxypropyl)a
oxidative
conditions the
column f (a)"
mino-5-
hair dye
maximum
chlorobenzene +
products
concentration
1,4-bis-(2′,3′-
(b) Hair dye
(b) 2,0%
applied to hair
dihydroxypropyl)a
substance in
must not exceed
mino-2-nitro- 5-
non-
1,0% For (a) and
chlorobenzene
oxidative
(b)
hair dye
-Do not use with
HC Red No 10 +
products
nitrosating
HC Red No 11
agents
CAS No 95576-89-
-Maximum
9 + 95576- 92-4
nitrosamine
content: 50 g/
kg
-Keep in nitrite-
free containers
(ii) the entries with reference numbers 16 and 22 shall be substituted with
the following
Restrictions
Max.
authorised
Other
Field of
concentrati
Ref No.
Substance
application
on in the
limitations and
Conditions of use and warnings
and/or use
finished
requirements
which must be printed on the label
cosmetic
product
"16
1-Naphthalenol
Hair dye
After mixing As mentioned in reference number
substance
under
205, column f (a)
1-Naphthol
in
oxidative
CAS No 90-15-
oxidative
conditions the
hair
dye
maximum
products
concentration
EC No 201-969-
applied to hair
must
not
exceed 2,0%
Max.
authorised
Field of
concentrati
Other
Ref No.
Substance
application
on in the
limitations and
Conditions of use and warnings
and/or use
finished
requirements
which must be printed on the label
cosmetic
product
(a) 1. Contains resorcinol Rinse
1,3-benzenediol
(a)
Hair
(a)
After
dye
mixing under
hair well after application.
Resorcinol
substance
oxidative
Do not use to dye eyelashes or
CAS No 108-
conditions the
eyebrows. Rinse eyes immediately
in
46-3
oxidative
maximum
if product comes into contact with
hair
dye
concentration
them. As mentioned in reference
EC No 203-585-
applied to hair
number 205, column f (a).
products 1.
general use
must
not
2.professio
exceed 1,25%
nal use
(b) Contains resorcinol."
(b)
Hair
lotions and (b) 0,5%
shampoos
(b) in Part 2 the entries with reference numbers 10 and 50 shall be deleted.
€0.36