Takehome:
Because several types of quasi-drugs converted into functional cosmetics in first half year of 2017, ingredients standard for cosmetics have to revise for the integration. MFDS has revised "Cosmetic Safety Standard" which includes ingredients requirements more than twice recently. Chemlinked help sorted out all these changes in this article.
Changes to Prohibited Ingredients List
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Original version |
Revised version |
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2,7-naphthalenediol and its salts |
2,7-naphthalenediol and its salts, but used as compound in hair dye products less than 1% is excluded |
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1-Naphthol and its salts |
1-Naphthol and its salts, but used as hair dye substance in oxidative hair dye products less than 2% is excluded |
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2-nitro-p-phenylenediamine and its salts (e.g. Nitro-p-phenylenediamine sulfate) |
2-nitro-p-phenylenediamine and its salts (e.g. Nitro-p-phenylenediamine sulfate), but used as hair dye substance in oxidative hair dye products less than 3% is excluded |
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1,5-di-(beta-hydroxyethyl) amino-2-nitro-4-chlorobenzene and salts (e.g. HC yellow No10) |
1,5-di-(beta-hydroxyethyl) amino-2-nitro-4-chlorobenzene and salts (e.g. HC yellow No10), but used as hair dye substance in non-oxidizing hair dye products less than 0.1% is excluded |
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3,5-diamino-2,6-dimethoxypyridine and its salts (e.g 2,6-dimethoxy-3, 5-pyridine diamine hydrochloride) |
3,5-diamino-2,6-dimethoxy-pyridine and its salts (e.g 2,6-dimethoxy-3, 5-pyridine diamine hydrochloride), but used as hair dye substance in oxidative hair dye products less than 0.25% is excluded |
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2,4-diamino-phenoxy ethanol, and its salts |
2,4-diamino-phenoxy ethanol, and its salts, but used as hair dye substance in oxidative hair dye products less than 0.5% is excluded |
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Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,3-cyclohexadien-1-ylidine]-N-ethyl-, and its salts |
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidine]-N-ethyl-, and its salts (basic blue 7) |
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Dihydro-2H-1,4-benzoxazin-6-ol and salts(eg. hydroxybenzomorpholine) |
2,3-dihydro-2H- 6-ol and its salts (eg hydroxybenzomorpholine), but used as hair dye substance in oxidative hair dye products after mixing less than 1.0 % is excluded |
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2,3-dihydro-1H-indole-5,6-diol (e.g. Dihydroxyindoline) |
2,3-dihydro-1H-indole-5,6-diol (e.g. Dihydroxyindoline), but used as hair dye substance in non-oxidizing hair dye products less than 2.0% is excluded |
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1-Methyl-3-nitro-4- (beta-hydroxyethyl) aminobenzene and its salts (e.g. Hydroxy-2-nitro-p-toluidine) |
1-Methyl-3-nitro-4- (beta-hydroxyethyl) aminobenzene and its salts (e.g. Hydroxy-2-nitro-p-toluidine), but used in hair dye products after mixing less than 1.0 % is excluded. |
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2- [3- (methyl) -4-nitro-phenoxy] ethanol, and its salts (e.g. 3-Methylamino-4-nitrophenoxyethanol) |
2- [3- (methyl) -4-nitro-phenoxy] ethanol, and its salts (e.g. 3-Methylamino-4-nitrophenoxyethanol), but used as hair dye substance in non-oxidizing hair dye products less than 0.15% is excluded |
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3-Methyl-1-phenyl-5-pyrazolone and its salts (e.g. Phenyl methyl pyrazolone) |
3-Methyl-1-phenyl-5-pyrazolone and its salts (e.g. Phenyl methyl pyrazolone), but used as hair dye substance in oxidative hair dye products after mixing less than 0.25% is excluded |
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Methylphenylenediamines, N-substituted derivatives and salts (e.g. 2,6-dihydroxyethylaminotoluene) |
Methylphenylenediamines, N-substituted derivatives and salts (e.g. 2,6-dihydroxyethylaminotoluene), but used as hair dye is excluded |
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2 - [(2-methoxy-4-nitrophenyl) amino] ethanol, and its salts (e.g. 2-hydroxyamino-5-nitroanisole) |
2 - [(2-methoxy-4-nitrophenyl) amino] ethanol, and its salts (e.g. 2-hydroxyamino-5-nitroanisole), but used as hair dye substance in non-oxidizing hair dye products less than 0.2% is excluded |
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6-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt |
6-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt, but used as hair dye substance after mixing in hair dye products less than 0.68%, or dihydrochloride less than 1% is excluded |
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1- (β-ureido) amino-4-nitrobenzene and salts |
1- (β-ureido) amino-4-nitrobenzene and salts (e.g. 4-nitrophenylamino urea), but used as hair dye substance in oxidative hair dye products less than 0.25%, or used in non-oxidizing hair dye products less than 0.5% is excluded |
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1-amino-2-nitro-4- (2',3'-dihydroxypropyl) amino-5-chlorobenzene and 1,4-di- (2',3'-dihydroxypropyl) amino-2-nitro-5-chlorobenzene and salts (e.g. HC Red No 10 and HC Red No 11) |
1-amino-2-nitro-4- (2',3'-dihydroxypropyl) amino-5-chlorobenzene and 1,4-di- (2',3'-dihydroxypropyl) amino-2-nitro-5-chlorobenzene and salts (e.g. HC Red No 10 and HC Red No 11), but used as hair dye substance in oxidative hair dye products less than 1% or in non-oxidizing less than 2% is excluded |
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2,2'-[(4-Amino-3-nitrophenyl)imino]bisethanol hydrochloride and its salts (e.g. HC Red No 13) |
2,2'-[(4-Amino-3-nitrophenyl)imino]bisethanol hydrochloride and its salts (e.g. HC Red No 13), but used as used as hair dye substance in oxidative hair dye products less than 1.5%, or in non-oxidizing hair dye products less than 1% is excluded |
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3-amino-2,4-dichlorophenol and its salts |
3-amino-2,4-dichlorophenol and its salts, but used as hair dye substance after mixing in hair dye products less than 1.5% is excluded |
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Ethanol,2-[(4-amino-2-methyl-5-nitrophenol) amino] and salts (e.g. HC Violet No 1) |
Ethanol,2-[(4-amino-2-methyl-5-nitrophenol) amino] and salts (e.g. HC Violet No 1), but used as hair dye substance in oxidative hair dye products less than 0.25%, or used in non-oxidizing hair dye less than 0.28% is excluded |
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2 - [(3-amino-4-methoxyphenyl) amino]ethanol and sulphate (e.g. 2-Amino-4 Hydroxyethylaminoanisole Sulfate) |
2 - [(3-amino-4-methoxyphenyl) amino]ethanol and sulphate (e.g. 2-Amino-4 Hydroxyethylaminoanisole Sulfate), but used as hair dye substance in oxidative hair dye products less than 1.5% is excluded |
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1- (2-aminoamino) amino-4- (2- hydroxyethyl) oxy-2-nitrobenzene and salts (e.g. HC Orange No 2) |
1- (2-aminoamino) amino-4- (2-hydroxy) oxy-2-nitrobenzene and salts (e.g. HC Orange No 2), but used as hair dye substance in non-oxidizing hair dye products less than 1% is excluded |
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4-amino-m-cresol and salts |
4-amino-m-cresol and salts, but used as hair dye substance in oxidative hair dye products less than 1.5% is excluded |
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2-amino-6-chloro-4-nitrophenol and salts |
2-amino-6-chloro-4-nitrophenol and salts, but used as compound in hair dye products less than 2% is excluded |
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Catechol (pyrocatechol) |
Catechol (pyrocatechol), but used as oxidant in hair dye products less than 1.5% is excluded |
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2-Chloro-6-ethylamino-4-nitrophenol and its salts |
2-Chloro-6-ethylamino-4-nitrophenol and its salts, but used in oxidative hair dye products less than 1.5% or used in non-oxidizing hair dye products less than 3% is excluded |
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4-4-[1,3-propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salt (e.g. 1,3-bis- (2,4-diaminophenoxy) propane hydrochloride, 1,3-bis- (2,4-diaminophenoxy) propane hydrochloride) |
4-4-[1,3-propanediylbis (oxy)] bisbenzene-1,3-diamine and its tetrahydrochloride salt (e.g. 1,3-bis- (2,4-diaminophenoxy) propane hydrochloride, 1,3-bis- (2,4-diaminophenoxy) propane hydrochloride), but used as hair dye substance in oxidative hair dye products less than 1.2% is excluded |
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Pyrogallol |
Pyrogallol, but used as hair dye substance after mixing in hair dye products less than 2% is excluded |
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1-hydroxy-3-nitro-4- (3-hydroxypropylamino) benzene and its salts (e.g. 4-hydroxypropylamino-3-nitrophenol) |
1-hydroxy-3-nitro-4- (3-hydroxypropylamino) benzene and its salts (e.g. 4-hydroxypropylamino-3-nitrophenol), but used as hair dye substance after mixing in hair dye products less than 2.6% is excluded |
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1-hydroxy-2-beta-hydroxyethenylamino-4,6-dinitrobenzene and its salts (e.g. 2-hydroxy picramic acid) |
1-hydroxy-2-beta-hydroxyethenylamino-4,6-dinitrobenzene and its salts (e.g. 2-hydroxy picramic acid), but used in oxidative hair dye products less than 1.5%, or used in non-oxidizing hair dye products less than 2% is excluded |
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Hydroxyethyl-3, 4-methylenedioxyaniline HCL, 2- (1,3-Benzyldioxol-5-ylamino) ethanol hydrochloride and its salts, (e.g. Hydroxyethyl-3, 4-methylenedioxyaniline and its hydrochloride) |
Hydroxyethyl-3, 4-methylenedioxyaniline HCL, 2- (1,3-Benzyldioxol-5-ylamino) ethanol hydrochloride and its salts, (e.g. Hydroxyethyl-3, 4-methylenedioxyaniline and its hydrochloride), but used as hair dye substance in oxidative hair dye products less than 1.5% is excluded |
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4- (2-hydroxyethyl) amino-3-nitrophenol and its salts (e.g. 3-nitro-p-hydroxyethylaminophenol) |
4- (2-hydroxyethyl) amino-3-nitrophenol and its salts (e.g. 3-nitro-p-hydroxyethylaminophenol), but used in oxidative hair dye products less than 3%, or used in non-oxidizing hair dye products less than 1.85% is excluded |
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2,2'- [[4- [(2-hydroxyethyl) amino] -3-nitrophenyl]imino]bisethanol and salts (e.g. HC Blue No2) |
2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol and salts (e.g. HC Blue No2), but used as hair dye substance in non-oxidizing hair dye products less than 2.8% is excluded |
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5-[(2-hydroxyethyl)amino]-o-cresol and salts (e.g. 2-Methyl-5-hydroxyethyl aminophenol) |
5-[(2-hydroxyethyl)amino]-o-cresol and salts (e.g. 2-Methyl-5-hydroxyethylaminophenol), but used as hair dye substance after mixing in hair dye products less than 0.5% is excluded |
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1-(3-Hydroxypropylamino)-2-nitro-4-bis(2-hydroxyethylamino)benzene and salts (e.g. HC violet No.2) |
1-(3-Hydroxypropylamino)-2-nitro-4-bis(2-hydroxyethylamino)benzene and salts (e.g. HC violet No.2), but used as hair dye substance oxidative hair dye products less than 2% is excluded |
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Hydroxypropyl bis (N-hydroxy-p-phenylenediamine and tetrahydro-chloride) |
Hydroxypropyl bis (N-hydroxy-p-phenylenediamine and tetrahydro-chloride), but tetrahydro-chloride used as hair dye substance in oxidative hair dye products less than 0.4% is excluded |
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Lawnaia Inermis leaf extract |
Lawnaia Inermis leaf extract, but used as hair dye substance after mixing in hair dye products is excluded |
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Newly added prohibited ingredients |
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Toluene-3, 4-diamine |
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Dutasteride, its salts and derivatives |
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Bimatoprost, its salts and derivatives |
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Sennoside |
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Adapalene |
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Ibuprofen piconol, its salts and derivatives |
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Tacrolimus, its salts and derivatives |
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Finasteride, its salts and derivatives |
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6- (1-pyrrolidinyl) -2,4-pyrimidinediamine-3-oxide (pyrrolidinyldiaminopyrimidine oxide) |
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Pimecrolimus, salts thereof and derivatives |
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1,7-heptanedicarboxylic acid (azelaic acid), its salts and derivatives |
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Pig lung extract |
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Changes to Restricted Ingredients List
Add conditions for ingredients used in hair dye products
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No. |
Ingredients Name |
Concentration Limit (%) |
Remark |
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1 |
p-nitro-o-phenylenediamine |
Used as hair dye substance in oxidative hair dye agent 1.5% |
Prohibited in other products |
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2 |
2-Nitro-p-phenylenediamine |
Used as hair dye substance in oxidative hair dye agent 3.0% |
Prohibited in other products |
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3 |
2-Methyl-5-hydroxyethylaminophenol |
Used as hair dye substance in oxidative hair dye agent 0.5 % |
Prohibited in other products |
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4 |
2-Amino-4-nitrophenol |
Used as hair dye substance in oxidative hair dye agent 2.5 % |
Prohibited in other products |
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5 |
2-Amino-5-nitrophenol |
Used as hair dye substance in oxidative hair dye agent 1.5% |
Prohibited in other products |
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6 |
5-amino-o-cresol |
Used as hair dye substance in oxidative hair dye agent 1.0% |
Prohibited in other products |
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7 |
m-Aminophenol |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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8 |
o-Aminophenol |
Used as hair dye substance in oxidative hair dye agent 3.0% |
Prohibited in other products |
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9 |
p-Aminophenol |
Used as hair dye substance in oxidative hair dye agent 0.9% |
Prohibited in other products |
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10 |
2,4-diaminophenoxyethanol, its hydrochloride and its sulphate |
Used as hair dye substance in oxidative hair dye agent 0.5% |
Prohibited in other products |
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11 |
Toluene-2,5-diamine hydrochloride |
Used as hair dye substance in oxidative hair dye agent 3.2% |
Prohibited in other products |
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12 |
m-Phenylenediamine dihydrochloride |
Used as hair dye substance in oxidative hair dye agent 0.5% |
Prohibited in other products |
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13 |
p-phenylene-diamine and its salts |
Used as hair dye substance in oxidative hair dye agent 3.3% |
Prohibited in other products |
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14 |
Toluene-2,5-diamine |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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15 |
m-phenylenediamine |
Used as hair dye substance in oxidative hair dye agent 1.0% |
Prohibited in other products |
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16 |
p-phenylenediamine |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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17 |
N-phenyl-p-phenylenediamine sulfate |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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18 |
PICRAMIC ACID |
Used as hair dye substance in oxidative hair dye agent 0.6% |
Prohibited in other products |
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19 |
p-nitro-o-phenylenediamine sulfate |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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20 |
p-Methylaminophenol sulfate |
Used as hair dye substance in oxidative hair dye agent 0.68% |
Prohibited in other products |
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21 |
5-amino-o-cresol Sulfuric acid |
Used as hair dye substance in oxidative hair dye agent 4.5% |
Prohibited in other products |
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22 |
m-Aminophenol sulfate |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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23 |
o-Aminophenol sulfate |
Used as hair dye substance in oxidative hair dye agent 3.0% |
Prohibited in other products |
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24 |
p-Aminophenol sulfate |
Used as hair dye substance in oxidative hair dye agent 1.3% |
Prohibited in other products |
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25 |
Toluene-2,5-diamine sulfate |
Used as hair dye substance in oxidative hair dye agent 3.6% |
Prohibited in other products |
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26 |
m-phenylenediamine sulfate |
Used as hair dye substance in oxidative hair dye agent 3.0% |
Prohibited in other products |
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27 |
p-phenylenediamine sulfate |
Used as hair dye substance in oxidative hair dye agent 3.8% |
Prohibited in other products |
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28 |
N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate |
Used as hair dye substance in oxidative hair dye agent 2.9% |
Prohibited in other products |
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29 |
2,6-diaminopyridine |
Used as hair dye substance in oxidative hair dye agent 0.15% |
Prohibited in other products |
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30 |
2,4-Diaminophenoxyethanol, its hydrochloride and its sulphate |
Used as hair dye substance in oxidative hair dye agent 0.5% |
Prohibited in other products |
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31 |
1,5-NAPHTHALENEDIOL |
Used as hair dye substance in oxidative hair dye agent 0.5% |
Prohibited in other products |
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32 |
Peakamine acid and its salts |
Used as hair dye substance in oxidative hair dye agent 0.6% |
Prohibited in other products |
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33 |
2-amino-5-nitrophenol |
Used as hair dye substance in oxidative hair dye agent 1.5% |
Prohibited in other products |
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34 |
2-chloro-p-phenylenediamine sulfate |
Used as hair dye substance in oxidative hair dye agent 1.5% |
Prohibited in other products |
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35 |
1-naphthol (α-naphthol) |
Used as hair dye substance in oxidative hair dye agent 2.0% |
Prohibited in other products |
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36 |
Resorcinol |
Used as hair dye substance in oxidative hair dye agent 2.0% |
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37 |
2-methylresorcinol |
Used as hair dye substance in oxidative hair dye agent 0.5% |
Prohibited in other products |
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38 |
Gallic acid |
Used as hair dye substance in oxidative hair dye agent 4.0% |
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39 |
Catechol |
Used as hair dye substance in oxidative hair dye agent 1.5% |
Prohibited in other products |
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40 |
Pyrogallol |
Used in oxidative hair dye agent 2.0%, Used in non-oxidizing hair dye agent 2.0% |
Prohibited in other products |
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41 |
Sodium perborate, Sodium perborate (monohydrate), hydrogen peroxide, Sodium percarbonate |
hydrogen peroxide used as hair dye substance in oxidative hair dye agent 12.0 % |
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Other amendments of restricted ingredients
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Resorcinol: used as hair dye substance in oxidative hair dye products 2%, used in other products 0.1% |
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Lithium hydroxide: if used in hair remover products, the PH of the final product should below 12.7 |
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Zinc Pyrithione used in products of shampoo that relieves dandruff and iching, 1% |
Revised as Zinc Pyrithione used in products of shampoo that relieves dandruff , iching and relieves hair loss, 1% |
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Thioglycolic acid and its salts: used in hair dye products,1%, used in hair remover products, 5%
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Calcium hydroxide: if used in hair remover products, the PH of the final product should below 12.7 |
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Potassium hydroxide or sodium hydroxide: if used in hair remover products, the PH of the final product should below 12.7 |
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Inorganic sulphites and hydrogensulphites |
SO2 used in oxidative hair dye agent, 0.67% |
Prohibited in other products |
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Salicylic acid and its salts |
In rinse-off product, salicylic acid 2%; In rinse-off hair product, salicylic acid 3% |
children under 3 are not allowed to use (except for hair products), used as active ingredients in functional cosmetics, prohibited to use in other products |
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Triclosan |
In rinse-off product,0.3% |
used as active ingredients in functional cosmetics, prohibited to use in other products |
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TRICLOCARBAN (Trichlorocarbanilide) |
In rinse-off product, 1.5% |
used as active ingredients in functional cosmetics, prohibited to use in other products |
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Antibacterial preservative and salts |
Salts: Sodium, potassium, calcium, magnesium, ammonium, and ethanolamine as cationic salts, chloride, bromide, sulfate, acetate |
Revised as examples of salts include sodium, potassium, calcium, magnesium, ammonium, ethanolamine, chloride, bromide, sulfate, acetate, betaine, etc. |
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