Taiwan Amended Standard for Usage and Maximum Concentration of Preservatives

New Added Ingredients and Modifications

No.

Name

Limitation and requirements

1

Alkylisoquinolinium bromide (Lauryl isoquinolinium bromide) (2 -Dodecylisoquinolin -2- iumbromide)

a). in instant rinsed products, maximum: 0.5%;  

b). other products, maximum: 0.05%                    

Note: avoid contact with eyes

2

Alkyl (C12-22)trimethy ammonium bromide and chloride

0.1%

8

2-Benzy1-4-chlorophenol

0.2%

9

Cetypyridinium chloride

a). in instant rinsed products, maximum: 5%;    

b). in mucous membranes exposure products, maximum:0.01%                                    

c). other products, maximum: 1%                      

Note: avoid contact with eyes

10

Benzenesulfonamide

a). in instant rinsed products, maximum: 0.3%;  

b). other products, maximum: 0.1% 

17

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, Monohydrate

0.2% (equivalent with silver 0.0024%)              

(prohibited in mucous membranes and eye contacting products)          

18

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3, 3-dimethylbutan-2-one

0.5%                                                                  

Note: avoid using more than three kinds of Climbazole in one not instant rinsed products

21

6,6-Dibromo-4, 4-dichloro-2,2'-methylene diphenol

0.1%

22

1,2-Dibromo-2, 4-dicyanobutane

0.1% (only limited to instant rinsed products)

23

3,3'-Dibromo-4,4'-hexamethylene dioxydibenzamidine and its salts(including isethionate)

0.1%

24

2,4-Dichlorobenzyl alcohol

0.15%

25

Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride

0.4% (prohibited in oral, lips and spraying products)

27

Formic acid and its sodium salt

0.5% (take acid into calculation)

29

Halocarban

0.3%

32

4-Chlorophenol

0.25%  used be to 0.2%

33

Inorganic sulphites and hydrogensulphites

0.2% (take free SO2 into calculation)

34

3-Iodo-2-propynylbutylcarbamate

a). in instant rinsed products, maximum: 0.02%;                                                    

(prohibited in oral and lips products)                  

(prohibited in cosmetics of children under 3, except for shampoo and body wash)              

b). in not instant rinsed products, maximum: 0.01%                                                            

(prohibited in oral and lips products)                  

(prohibited in body lotion and body creams)    

c). in antiperspirant and deodorant agent, maximum: 0.0075%                                                 

(prohibited in oral and lips products)                  

((prohibited in cosmetics of children under 3)    

Note: avoid apply to children under 3

36

2-Methyl-2H-isothiazol-3-one

0.01%                                                              

(limited to instant rinsed products)                      

(prohibited in mucous membranes exposure products)

38

Biphenyl-2-ol, and its salts

0.2% (take phenol into calculation)       used to be 0.3%

41

Thiazolium, 3-heptyl-4-methyl-2-[2-(4-dimethylaminophenyl) ethenyl]-, iodide

0.0015%   (prohibited in mucous membranes exposure products)

43

2-Phenoxyethanol

1%

44

1-Phenoxypropan-2-ol

1% (limited to instant rinsed products)

45

Phenylmercuric salts (including borate)

in eye cosmetics, maximum: 0.007% (take Hg into calculation)                                              

Note: including Phenylmercuric compounds

46

Photosensitizing dyes

0.001%

0.005%

0.005%

0.004%

47

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2 pyridon and its monoethanolamine salt

a). in instant rinsed products, maximum: 1%;    

b). other products, maximum: 0.5% 

48

Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl]amino]-, dihydrochloride

0.3%

49

Resorcinol

0.1%

56

Thiomersal

in eye cosmetics, maximum: 0.007% (in total)(take Hg into calculation)                                      

Note: including Thiomersal

57

5-Chloro-2-(2,4-dichlorophenoxy)
phenol

0.3%                                                              

(limited to hand wash, soap/body wash, deodorant(exclude spraying agent), powder, foundation, manufacturing nail cleanser)

58

1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea

0.2%

60

Pyrithione zinc

a). in instant rinsed products, maximum: 1%;    

b). other products, maximum (exclude oral products): 0.5% 

61

Phenylmethoxymethanol

0.15% (limited to instant 

Cosmetics including these ingredients as preservatives may generate Free Formaldehyde, which cannot exceed 1000 ppm

67

Methenamine (Hexamethylenetetramine)

0.15%

Note: preservatives ingredients not listed above shall follow the requirements announced by Europe, US and Japan. If requirements in these three countries are different, Taiwan FDA will follow the safest standard.