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SFDA Consults: Proposals for Testing Methods of 7 Prohibited chemicals in Cosmetics and 39 Restricted hair dyes
On 4 November 2011, China's State Food and Drug Administration (SFDA) issued two draft proposals for the testing methods on 7 prohibited chemicals used in cosmetics and 32 restricted/prohibited dye materials used in hair products. Public comments on the two testing methods are welcomed by SFDA until 20 November 2011. Click here for China's SFDA notice.
The first draft proposal specifies the testing method of assaying hydrocortisone and another 6 prohibited chemicals in cosmetics by adopting the liquid chromatography-tandem mass spectrometry (LC/MS/MS) method.
All of the seven chemicals can contribute to hair growth and six chemicals also have wrinkle prevention and acne treatment properties. According to the Hygienic Standard for Cosmetics 2007, it is prohibited to have them as cosmetic ingredients. These chemicals are:
|
Name |
CAS No. |
Molecular formula |
|
Minoxidil |
38304-91-5 |
C9H15N5O |
|
Hydrocortisone |
50-23-7 |
C21H30O5 |
|
Spironolactone |
52-01-7 |
C24H32O4S |
|
Estrone |
53-16-7 |
C18H22O2 |
|
Canrenone |
976-71-6 |
C22H28O3 |
|
Triamcinolone acetonide acetate |
3870-07-3 |
C26H33FO7 |
|
Progesterone |
57-83-0 |
C21H30O2 |
The Detection Limit (DL), Limit of Quantification (LOQ), the Detectable Concentration (DC) and the Quantitative Concentration (QC) values when taking 1 gram samples are shown below:
|
Compounds |
DL (ng) |
LOQ (ng) |
DC (ng/g) |
QC (ng/g) |
|
Minoxidil |
0.5 |
1 |
10 |
25 |
|
Hydrocortisone |
1 |
2 |
25 |
50 |
|
Spironolactone |
0.5 |
1 |
25 |
50 |
|
Estrone |
50 |
100 |
500 |
1000 |
|
Canrenone |
0.5 |
1 |
10 |
25 |
|
Triamcinolone acetonide acetate |
0.1 |
0.2 |
5 |
10 |
|
Progesterone |
0.2 |
0.5 |
10 |
25 |
The second draft proposal applies to the testing of 32 restricted or prohibited dye materials in hair products using the method High Performance Liquid Chromatography (HPLC).
The 2007 Hygienic Standard for Cosmetics lists 93 ingredients of hair colorants but only recommends a very small proportion of testing methods. So the SFDA is considering the establishment of more complete testing methods to cover the remainder of the dye ingredients.
The Detection Limit (DL), Detectable Concentration (DC), Low Limit of Quantification (LLOQ), and Minimum Quantitative Concentration (MQC) values are shown below:
|
Code |
INCI name (International Nomenclature Cosmetic Ingredient) |
DL/ µg |
DC/ (µg/g) |
LLOQ/ µg |
MQC/ (µg/g) |
|
3 |
1,5-Naphthalenediol |
5.0´10-3 |
20 |
1.5´10-2 |
60 |
|
5 |
1-Naphthol |
3.0´10-3 |
12 |
1.0´10-2 |
40 |
|
8 |
2,4-Diaminophenoxyethanol HCl |
8.0´10-3 |
32 |
2.5´10-2 |
100 |
|
10 |
2,6-diaminopyridine |
1.5´10-2 |
60 |
5.0´10-2 |
200 |
|
13 |
2,7-Naphthalenediol |
3.0´10-3 |
12 |
1.0´10-2 |
40 |
|
15 |
2-amino-3-hydroxypyridine |
1.3´10-2 |
52 |
4.0´10-2 |
160 |
|
21 |
2-Chloro-p-phenylenediamine sulfate |
1.5´10-2 |
60 |
5.0´10-2 |
200 |
|
24 |
2-Methylresorcinol |
1.3´10-2 |
52 |
4.0´10-2 |
160 |
|
25 |
2-Nitro-p-phenylenediamine |
5.0´10-3 |
20 |
1.5´10-2 |
60 |
|
31 |
4-Amino-2-hydroxytoluene |
6.5´10-3 |
26 |
2.0´10-2 |
80 |
|
32 |
4-Amino-3-nitrophenol |
6.5´10-3 |
26 |
2.0´10-2 |
80 |
|
33 |
4-Amino-m-cresol |
8.0´10-3 |
32 |
2.5´10-2 |
100 |
|
34 |
4-Chlororesorcinol |
5.0´10-3 |
20 |
1.5´10-2 |
60 |
|
36 |
4-Nitro-o-phenylenediamine |
1.5´10-2 |
60 |
5.0´10-2 |
200 |
|
40 |
6-Amino-m-cresol |
1.0´10-2 |
40 |
3.0´10-2 |
120 |
|
42 |
6-Hydroxyindole |
3.0´10-3 |
12 |
1.0´10-2 |
40 |
|
61 |
Hydroquinone |
3.0´10-3 |
12 |
1.0´10-2 |
40 |
|
67 |
m-Aminophenol |
6.5´10-3 |
26 |
2.0´10-2 |
80 |
|
70 |
m-Phenylenediamine |
8.0´10-3 |
32 |
2.5´10-2 |
100 |
|
72 |
N,N-Bis(2-hydroxyethyl)-p- phenylenediamine sulfate |
2.5´10-2 |
100 |
7.5´10-2 |
300 |
|
73 |
N,n-Diethyl-p-phenylenediamine sulfate |
2.5´10-2 |
100 |
7.5´10-2 |
300 |
|
74 |
N,n-Diethyltoluene-2,5-diamine HCl |
2.0´10-2 |
80 |
6.0´10-2 |
240 |
|
78 |
N-Phenyl-p-phenylenediamine |
2.5´10-3 |
10 |
8.0´10-3 |
32 |
|
81 |
o-Aminophenol |
6.5´10-3 |
26 |
2.0´10-2 |
80 |
|
83 |
p-Aminophenol |
6.5´10-3 |
26 |
2.0´10-2 |
80 |
|
85 |
Phenyl methyl pyrazolone |
2.0´10-2 |
80 |
6.0´10-2 |
240 |
|
87 |
p-Methylaminophenol sulfate |
1.0´10-2 |
40 |
3.0´10-2 |
120 |
|
88 |
p-Phenylenediamine |
1.2´10-2 |
48 |
3.5´10-2 |
140 |
|
91 |
Resorcinol |
8.0´10-3 |
32 |
2.5´10-2 |
100 |
|
95 |
Toluene-2,5-diamine sulfate |
2.0´10-2 |
80 |
6.0´10-2 |
240 |
|
96 |
Toluene-3,4-diamine |
8.0´10-3 |
32 |
2.5´10-2 |
100 |
|
OPD |
o-Phenylenediamine |
8.0´10-3 |
32 |
2.5´10-2 |
100 |
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