Request a Demo
Takehome:
The major reasons for cosmetic inspection failure are the use of banned ingredients, inconsistencies between cosmetic ingredients, labels and administrative license and false production date.
On Jul 18, Jul 20 and Aug 1, 2018, SAMR released 3 announcements detailing data derived from a national cosmetic market sampling and inspection program. A total of 27 cosmetic products were found unqualified. Acne products, sunscreens and hair dyes accounted for the majority of inspection failures. Reasons for inspection failures mainly included the use of banned ingredients, inconsistencies between cosmetic ingredients, labels and administrative license and false production date. The following table shows details:
|
No. |
Product |
Subject |
Inspection Result |
Problem |
|
1 |
Aloe acne cream |
Miconazole |
0.51μg/g |
Detection of banned ingredients |
|
Griseofulvin |
1.02μg/g |
|||
|
2 |
Acne clean lotion |
Ofloxacin |
17.3μg/g |
|
|
3 |
Anti-acne cream |
Metronidazole |
6789μg/g |
|
|
4 |
Acne clean essential oil |
Ofloxacin |
1684μg/g |
|
|
5 |
Oil control and anti-acne cream |
Metronidazole |
4132μg/g |
|
|
Ofloxacin |
5877μg/g |
|||
|
6 |
Acne treatment gel |
Metronidazole |
8024μg/g |
|
|
7 |
Sunscreen |
Butyl methoxydibenzoylmethane |
No detection |
Absence of butyl methoxydibenzoylmethane and octocrylene which are claimed on administrative license and labels |
|
Octocrylene |
||||
|
8 |
Sunscreen |
Butyl methoxydibenzoylmethane |
No detection |
Absence of butyl methoxydibenzoylmethane and bis-ethylhexyloxyphenol methoxyphenyl triazine which are claimed on administrative license and labels |
|
Bis-ethylhexyloxyphenol methoxyphenyl triazine |
||||
|
9 |
Sunscreen |
Bis-ethylhexyloxyphenol methoxyphenyl triazine |
0.24% |
Contain bis-ethylhexyloxyphenol methoxyphenyl triazine which is not listed on the label and administrative license |
|
10 |
Sunscreen |
Benzophenone-3 |
No detection |
Absence of benzophenone-3, 4-methylbenzylidene camphor, Butyl methoxydibenzoylmethane and Ethylhexyl salicylate which are claimed on administrative license and labels |
|
4-methylbenzylidene camphor |
||||
|
Butyl methoxydibenzoylmethane |
||||
|
Ethylhexyl salicylate |
||||
|
11 |
Sunscreen |
Butyl methoxydibenzoylmethane |
No detection |
Absence of butyl methoxydibenzoylmethane and ethylhexyl methoxycinnamate which are claimed on administrative license and labels |
|
Ethylhexyl methoxycinnamate |
||||
|
12 |
Sunscreen |
Benzophenone-3 |
No detection |
Absence of benzophenone-3, 4-methylbenzylidene camphor and Butyl methoxydibenzoylmethane which are claimed on administrative license and labels |
|
4-methylbenzylidene camphor |
||||
|
Butyl methoxydibenzoylmethane |
||||
|
13 |
Sunscreen |
/ |
/ |
The production date on administrative license is inconsistent with the actual |
|
14 |
Sunscreen |
/ |
/ |
|
|
15 |
Sunscreen |
/ |
/ |
|
|
16 |
Sunscreen |
/ |
/ |
|
|
17 |
Sunscreen |
Ethylhexyl salicylate |
Detection |
Contain ethylhexyl salicylate and homosalate which is not listed on the label and administrative license |
|
Homosalate |
||||
|
4-methylbenzylidene camphor |
No detection |
Absence of 4-methylbenzylidene camphor which is claimed on administrative license and labels |
||
|
18 |
Hair dye |
M-aminophenol |
No detection |
|
|
P-phenylenediamine |
||||
|
Resorcinol |
||||
|
19 |
Hair dye |
P-phenylenediamine |
Detection |
Contain P-phenylenediamine, M-aminophenol and Resorcinol which are not listed on the label and administrative license |
|
M-aminophenol |
||||
|
Resorcinol |
||||
|
4-amino-2-hydroxytoluene |
No detection |
Absence of 4-amino-2-hydroxytoluene and 1-naphthol which are claimed on administrative license and labels |
||
|
1-naphthol |
||||
|
20 |
Sunscreen |
4-methylbenzylidene camphor |
2% |
|
|
Butyl methoxydibenzoylmethane |
2% |
|||
|
Ethylhexyl methoxycinnamate |
4% |
|||
|
21 |
Sunscreen |
4-methylbenzylidene camphor |
No detection |
|
|
Butyl methoxydibenzoylmethane |
||||
|
Octocrylene |
||||
|
Ethylhexyl methoxycinnamate |
||||
|
22 |
Sunscreen |
Benzophenone-3 |
No detection |
|
|
4-methylbenzylidene camphor |
||||
|
Butyl methoxydibenzoylmethane |
||||
|
Ethylhexyl salicylate |
||||
|
23 |
Sunscreen |
Octocrylene |
No detection |
|
|
24 |
Sunscreen |
Ethylhexyl salicylate |
4% |
Contain ethylhexyl salicylate which is not listed on the label |
|
25 |
Hair dye |
P-phenylenediamine |
0.013% |
Contain p-phenylenediamine which is not listed on the label |
|
26 |
Hair dye |
4-chlororesorcinol |
0.059% |
1. Contain p-phenylenediamine which is not listed on the label 2. Administrative license has expired |
|
27 |
Hair dye |
M-aminophenol |
0.12% |
Contain m-aminophenol and 1-naphthol which are not listed on the label |
|
1-naphthol |
0.051% |
Circulation of products which violate the requirements articulated within "Regulations concerning the Hygiene Supervision over Cosmetics" and "Administrative Measures on Cosmetics Labeling (draft)" mandate that all associated distributors/retailers should immediately cease sales activities and issue an immediate recall. If the product label can be amended in such a way that the new label and ingredients comply with Chinese regulatory requirements it can be marketed again.
Tips for Enterprises:
- Antibiotics are mainly secondary metabolites or synthetic analogues produced by bacteria, mold or other microorganisms, and are mainly used to treat various bacterial infections or fungal infections. Long-term exposure to antibiotic-containing cosmetics can sensitize individuals and cause contact dermatitis and antibiotic allergy, and increase the likelihood of pathogens developing resistance. Drug residues can also cause allergic reactions. Safety and Technical Standards for Cosmetics 2015 stipulates that use of antibiotics is banned in cosmetics.
- According to “Regulations concerning the Hygiene Supervision over Cosmetics”, acne products, sunscreens and hair dyes are special use cosmetics, which can only be manufactured after obtaining an administrative license. Any change/reformulation of ingredients has the potential to impact cosmetic safety and other indexes and requires submission of a new filing/registration application as a new product. The main problem of non-compliant acne, sunscreen and hair dye products found in this sampling inspection is that the actual detected ingredients are inconsistent with the ingredients claimed on the administrative license or labels, and violates "Regulations concerning the Hygiene Supervision over Cosmetics" and "Administrative Measures on Cosmetics Labeling (draft)".
Annex:
Exact Standard of Sunscreen and Hair Dyes Ingredients Mentioned in this News
|
No. |
English/INCI Name |
Maximum concentration used in cosmetics |
Instruction on Labels |
|
1 |
Butyl methoxydibenzoylmethane |
5% |
/ |
|
2 |
Octocrylene |
10% (acid) |
/ |
|
3 |
Bis-ethylhexyloxyphenol methoxyphenyl triazine |
10% |
/ |
|
4 |
Benzophenone-3 |
10% |
Contains benzophenone-3 |
|
5 |
4-methylbenzylidene camphor |
4% |
/ |
|
6 |
Ethylhexyl salicylate |
5% |
/ |
|
7 |
Ethylhexyl methoxycinnamate |
10% |
/ |
|
8 |
Homosalate |
10% |
/ |
|
9 |
M-aminophenol |
1.0% ( Oxidation hair dyes) |
/ |
|
10 |
P-phenylenediamine |
2.0% ( Oxidation hair dyes) |
Contains phenylenediamins |
|
11 |
Resorcinol |
0.5% ( Only applicable in hair lotion and shampoo) |
Contains resorcinol |
|
1.25% ( Oxidation hair dyes) |
|||
|
12 |
4-amino-2-hydroxytoluene |
1.5% ( Oxidation hair dyes) |
/ |
|
13 |
1-naphthol |
1.0% ( Oxidation hair dyes) |
Contains 1-naphthol |
|
14 |
4-chlororesorcinol |
0.5% ( Oxidation hair dyes) |
/ |
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
