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Summary of Korea Recent Ingredients Requirement Changes

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...

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

Original version

Revised version

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

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

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

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

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

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

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)

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Catechol (pyrocatechol)

Catechol (pyrocatechol), but used as oxidant in hair dye products less than 1.5% is excluded

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

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

Pyrogallol

Pyrogallol, but used as hair dye substance after mixing in hair dye products less than 2% is excluded

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

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

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

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

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

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

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

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

Lawnaia Inermis leaf extract

Lawnaia Inermis leaf extract, but used as hair dye substance after mixing in hair dye products is excluded

Newly added prohibited ingredients

Toluene-3, 4-diamine

Dutasteride, its salts and derivatives

Bimatoprost, its salts and derivatives

Sennoside

Adapalene

Ibuprofen piconol, its salts and derivatives

Tacrolimus, its salts and derivatives

Finasteride, its salts and derivatives

6- (1-pyrrolidinyl) -2,4-pyrimidinediamine-3-oxide (pyrrolidinyldiaminopyrimidine oxide)

Pimecrolimus, salts thereof and derivatives

1,7-heptanedicarboxylic acid (azelaic acid), its salts and derivatives

Pig lung extract

 

Changes to Restricted Ingredients List

Add conditions for ingredients used in hair dye products

No.

Ingredients Name

Concentration Limit (%)

Remark

1

p-nitro-o-phenylenediamine

Used as hair dye substance in oxidative hair dye agent 1.5%

Prohibited in other products

2

2-Nitro-p-phenylenediamine

Used  as hair dye substance in oxidative hair dye agent 3.0%

Prohibited in other products

3

2-Methyl-5-hydroxyethylaminophenol

Used as hair dye substance in oxidative hair dye agent 0.5 %

Prohibited in other products

4

2-Amino-4-nitrophenol

Used as hair dye substance in  oxidative hair dye agent 2.5 %

Prohibited in other products

5

2-Amino-5-nitrophenol

Used as hair dye substance in oxidative hair dye agent 1.5%

Prohibited in other products

6

5-amino-o-cresol

Used as hair dye substance in oxidative hair dye agent 1.0%

Prohibited in other products

7

m-Aminophenol

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

8

o-Aminophenol

Used as hair dye substance in oxidative hair dye agent 3.0%

Prohibited in other products

9

p-Aminophenol

Used as hair dye substance in oxidative hair dye agent 0.9%

Prohibited in other products

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

11

Toluene-2,5-diamine  hydrochloride

Used as hair dye substance in oxidative hair dye agent 3.2%

Prohibited in other products

12

m-Phenylenediamine dihydrochloride 

Used as hair dye substance in oxidative hair dye agent 0.5%

Prohibited in other products

13

p-phenylene-diamine and its salts

Used as hair dye substance in oxidative hair dye agent 3.3%

Prohibited in other products

14

Toluene-2,5-diamine

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

15

m-phenylenediamine

Used as hair dye substance in oxidative hair dye agent 1.0%

Prohibited in other products

16

p-phenylenediamine

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

17

N-phenyl-p-phenylenediamine sulfate

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

18

PICRAMIC ACID

Used as hair dye substance in oxidative hair dye agent 0.6%  

Prohibited in other products

19

p-nitro-o-phenylenediamine sulfate

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

20

p-Methylaminophenol sulfate

Used as hair dye substance in oxidative hair dye agent 0.68%

Prohibited in other products

21

5-amino-o-cresol Sulfuric acid

Used as hair dye substance in oxidative hair dye agent 4.5%

Prohibited in other products

22

m-Aminophenol sulfate

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

23

o-Aminophenol sulfate

Used as hair dye substance in oxidative hair dye agent 3.0%

Prohibited in other products

24

p-Aminophenol sulfate

Used as hair dye substance in oxidative hair dye agent 1.3%

Prohibited in other products

25

Toluene-2,5-diamine sulfate

Used as hair dye substance in oxidative hair dye agent 3.6%

Prohibited in other products

26

m-phenylenediamine sulfate

Used as hair dye substance in oxidative hair dye agent 3.0%

Prohibited in other products

27

p-phenylenediamine sulfate

Used as hair dye substance in oxidative hair dye agent 3.8%

Prohibited in other products

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

29

2,6-diaminopyridine

Used as hair dye substance in oxidative hair dye agent 0.15%

Prohibited in other products

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

31

1,5-NAPHTHALENEDIOL

Used as hair dye substance in oxidative hair dye agent 0.5%

Prohibited in other products

32

Peakamine acid and its salts

Used as hair dye substance  in oxidative hair dye agent 0.6%

Prohibited in other products

33

2-amino-5-nitrophenol

Used as hair dye substance in oxidative hair dye agent 1.5%

Prohibited in other products

34

2-chloro-p-phenylenediamine sulfate

Used as hair dye substance in oxidative hair dye agent 1.5%

Prohibited in other products

35

1-naphthol (α-naphthol)

Used as hair dye substance in oxidative hair dye agent 2.0%

Prohibited in other products

36

Resorcinol

Used as hair dye substance in oxidative hair dye agent 2.0%

 

37

2-methylresorcinol

Used as hair dye substance in oxidative hair dye agent 0.5%

Prohibited in other products

38

Gallic acid

Used as hair dye substance in oxidative hair dye agent 4.0%

 

39

Catechol

Used as hair dye substance in oxidative hair dye agent 1.5%

Prohibited in other products

40

Pyrogallol

Used in oxidative hair dye agent 2.0%, Used in non-oxidizing hair dye agent 2.0%

Prohibited in other products

41

Sodium perborate, Sodium perborate (monohydrate), hydrogen peroxide, Sodium percarbonate

hydrogen peroxide used as hair dye substance in oxidative hair dye agent 12.0 %

 

Other amendments of restricted ingredients

Resorcinol: used as hair dye substance in oxidative hair dye products 2%, used in other products 0.1%

Lithium hydroxide: if used in hair remover products, the PH of the final product should below 12.7

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%

Thioglycolic acid and its salts: used in hair dye products,1%, used in hair remover products, 5%

 

Calcium hydroxide: if used in hair remover products, the PH of the final product should below 12.7

Potassium hydroxide or sodium hydroxide: if used in hair remover products, the PH of the final product should below 12.7

Inorganic sulphites and hydrogensulphites

SO2 used in oxidative hair dye agent, 0.67%

Prohibited in other products

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

Triclosan

In rinse-off product,0.3%

used as  active ingredients in functional cosmetics, prohibited to use in other products

TRICLOCARBAN (Trichlorocarbanilide)

In rinse-off product, 1.5%

used as  active ingredients in functional cosmetics, prohibited to use in other products

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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