MT
The Cosmetic Products (Amendment) Regulations, 2008
Statutory Text (4 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,176, 22 ta’ Jannar, 2008
L.N. 22 of 2008
PRODUCT SAFETY ACT
(CAP. 427)
The Cosmetic Products (Amendment) Regulations, 2008
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.
(Amendment) Regulations, 2008, and they shall be read and construed
as one with the Cosmetic Products Regulations, 2004, hereinafter L.N. 424 of 2004.
referred to as “the principal regulations”.
(1) Regulations 3 and 4 of these principal regulations shall Commencement and
scope.
enter into force on 18 th June 2008. These regulations implement the
provisions of Commission Directive 2007#54#EC of the 29 th August,
2007 (OJ L 226, 30.8.2007, p. 21 - 27 and OJ L 258, 4.10.2007, p. 44 -
44).
(2) Regulation 5 of these regulations shall enter into force
on 19 th January 2009. This regulation implements the provisions of
Commission Directive 2007#53#EC of the 29 th August, 2007 (OJ L 226,
8.2007, p. 19 - 20).
3. In the Second Schedule to the principal regulations, the Amends the Second
Schedule to the
following reference numbers 1244 to 1328 are added>
principal
regulations.
1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance
in hair dye products
2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in
hair dye products
5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in
hair dye products
3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair
dye products
3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair
dye products
Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye
products
3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in
hair dye products
2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a
substance in hair dye products
C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye
products
1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a
substance in hair dye products
1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye
products
Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine
(CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a
substance in hair dye products
N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethano-
lamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair
dye products
4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair
dye products
3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its
salts, when used as a substance in hair dye products
3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its
salts, when used as a substance in hair dye products
2,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-
8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products
Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl-and its
salts, when used as a substance in hair dye products
2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7)
(Pigment Yellow 73) and its salts, when used as a substance in hair dye products
2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No
6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as
a substance in hair dye products
2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-
25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products
3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and
its salts, when used as a substance in hair dye products
2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-
sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products
(μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-
sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products
3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-
naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a
substance in hair dye products
2-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-
sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in
hair dye products
Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-
Nethyl-and its salts, when used as a substance in hair dye products
3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts,
when used as a substance in hair dye products
3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when
used as a substance in hair dye products
Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in
hair dye products
Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a
substance in hair dye products
Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair
dye products
6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8)
(Solvent Yellow 44) and its salts, when used as a substance in hair dye products
1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and
its salts, when used as a substance in hair dye products
Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance
in hair dye products
Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1)
and its salts, when used as a substance in hair dye products
4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used
as a substance in hair dye products
4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair
dye products
1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and
its salts, when used as a substance in hair dye products
N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a
substance in hair dye products
N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and
its salts, when used as a substance in hair dye products
N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC
Yellow No 3) and its salts, when used as a substance in hair dye products
2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a
substance in hair dye products
N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts,
when used as a substance in hair dye products
3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5)
and its salts, when used as a substance in hair dye products
4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts,
when used as a substance in hair dye products
(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except
Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in
hair dye products
5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as
a substance in hair dye products
m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance
in hair dye products
1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye
Products
2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its
salts, when used as a substance in hair dye products
4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1)
(Basic Brown 4) and its salts, when used as a substance in hair dye products
Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl
and its salts, when used as a substance in hair dye products
Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl
and its salts, when used as a substance in hair dye products
Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-
Nethyl- and its salts, when used as a substance in hair dye products
9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and
its derivatives and salts, when used as a substance in hair dye products
1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its
salts, when used as a substance in hair dye products
1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse
Blue 7) and its salts, when used as a substance in hair dye products
1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a
substance in hair dye products
N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide
(CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye
Products
[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS
No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products
Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye
Products
4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair
dye Products
5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as
a substance in hair dye products
4,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair
dye products
4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair
dye products
N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in
hair dye products
N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in
hair dye products
Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye
products
2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a
substance in hair dye products
6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye
Products
Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a
substance in hair dye products
2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye
Products
2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when
used as a substance in hair dye products
2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair
dye products
Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a
substance in hair dye products
6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair
dye products
Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair
dye products
3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-
54-2) and its salts, when used as a substance in hair dye products
3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC
Yellow No 6) and its salts, when used as a substance in hair dye products
2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its
salts, when used as a substance in hair dye products
3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No
173994-75-7) and its salts, when used as a substance in hair dye products
3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-
41-1) and its salts, when used as a substance in hair dye products
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-
cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products”
4. Part 1 of the Third Schedule to the principal regulations is
amended as follows>
(a) in column b of reference number 8, the words “p-
Phenylenediamine, its N-substituted derivatives and its salts< N-
substituted derivatives of o-Phenylenediamine, with exception of
those derivatives listed elsewhere in this Annex” are replaced by
the following “p-Phenylenediamine, its N-substituted derivatives
and its salts< N-substituted derivatives of o-Phenylenediamine, with
the exception of those derivatives listed elsewhere in this Annex
and under reference numbers 1309, 1311, and 1312 in Annex II”<
and
(b) in column b of reference number 9, the words
“Methylphenylenediamines, their N-substituted derivatives and
their salts with the exception of substance No 364 in Annex II” are
replaced by the following “Methylphenylenediamines, their N-
substituted derivatives and their salts with the exception of
substances under reference numbers 364, 1310 and 1313 in Annex
II”< and
5. In reference numbers 26 to 43, and reference numbers 47 and
56 of Part 1 of the Third Schedule to the principal regulations, the
following text is added after each entry in column f>
“For any toothpaste containing 0,1 to 0,15 % fluoride unless
it is already labelled as contra-indicated for children (e.g. “for adult
use only”) the following labelling is obligatory>
“Children of 6 years and younger> Use a pea sized amount
for supervised brushing to minimize swallowing. In case of intake
of fluoride from other sources consult a dentist or doctor.” ”.
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