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Product Safety Act (Cap. 427) The Cosmetic Products (Amendment) Regulations, 2008 (L.N. 22 Of 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>-
1. The title of these regulations is the Cosmetic Products (Amendment) Regulations, 2008, and they shall be read and construed as one with the Cosmetic Products Regulations, 2004, hereinafter referred to as “the principal regulations”.
2. (1) Regulations 3 and 4 of these principal regulations shall enter into force on 18th June 2008. These regulations implement the provisions of Commission Directive 2007#54#EC of the 29th 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 19th January 2009. This regulation implements the provisions of Commission Directive 2007#53#EC of the 29th August, 2007 (OJ L 226,
30.8.2007, p. 19 - 20).
3. In the Second Schedule to the principal regulations, the following reference numbers 1244 to 1328 are added>

Citation.

L.N. 424 of 2004

.

Commencement and scope.

Amends the Second Schedule to the principal regulations.

B 226

Ref. No

Chemical name/INCI-name

“1244

1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance

in hair dye products

1245

2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in

hair dye products

1246

5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in

hair dye products

1247

3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair

dye products

1248

3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair

dye products

1249

Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye

products

1250

3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in

hair dye products

1251

2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a

substance in hair dye products

1252

C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye

products

1253

1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a

substance in hair dye products

1254

1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye

products

1255

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

1256

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

1257

4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair

dye products

1258

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

1259

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

1260

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

1261

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

1262

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

1263

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

1264

2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as

a substance in hair dye products

1265

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

1266

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

B 227

Ref. No

Chemical name/INCI-name

1267

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

1268

(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

1269

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

1270

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

1271

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

1272

3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts,

when used as a substance in hair dye products

1273

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

1274

Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in

hair dye products

1275

Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a

substance in hair dye products

1276

Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair

dye products

1277

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

1278

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

1279

Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance

in hair dye products

1280

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

1281

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

1282

4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair

dye products

1283

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

1284

N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a

substance in hair dye products

1285

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

1286

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

1287

2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a

substance in hair dye products

1288

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

1289

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

B 228

Ref. No

Chemical name/INCI-name

1290

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

1291

(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

1292

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

1293

m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance

in hair dye products

1294

1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye

Products

1295

2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its

salts, when used as a substance in hair dye products

1296

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

1297

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

1298

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

1299

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

1300

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

1301

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

1302

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

1303

1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a

substance in hair dye products

1304

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

1305

[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

1306

Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye

Products

1307

4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair

dye Products

1308

5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as

a substance in hair dye products

1309

4,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair

dye products

1310

4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair

dye products

1311

N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in

hair dye products

1312

N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in

hair dye products

B 229

Ref. No

Chemical name/INCI-name

1313

Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye

products

1314

2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a

substance in hair dye products

1315

6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye

Products

1316

Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a

substance in hair dye products

1317

2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye

Products

1318

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

1319

2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair

dye products

1320

Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a

substance in hair dye products

1321

6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair

dye products

1322

Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair

dye products

1323

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

1324

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

1325

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

1326

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

1327

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

1328

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”

B 230

Amends the Third Schedule to the principal regulations.

Further amends the Third Schedule to the principal regulations.

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.” ”.

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

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