An Analysis of National Cosmetic Market Sampling Inspection Data

Takehome:

On Apr 9 and Jun 25, 2018, SAMR released 2 announcements detailing data derived from a national cosmetic market sampling and inspection program. 125 hair dye and 27 cosmetic products were found unqualified. Rectifiable mislabeling issues, use of illegal/banned ingredients and violation of acceptable microbial contamination limits are all highlighted.

The primary legal references used to manage cosmetics circulating in China’s markets are "Regulations concerning the Hygiene Supervision over Cosmetics" and "Administrative Measures on Cosmetics Labeling (draft)". According to the stipulations outlined in Chinese regulations, circulation of products which violate the requirements articulated within these 2 key references 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.

The major reasons for hair dye products inspection failure:

1. The label or product name is inconsistent with the approval documents
2. Detection of hair dyes that are unmarked on the label or the approval documents
3. Hair dyes claimed on the label or the approval documents are not detected
4. Hair dye ingredient list is unmarked on product packaging or label
5. The approval documents have expired
6. The ingredient used in the product exceeds the limit (Phenyl methyl pyrazolone ≤ 0.25%);
7. Detection of the banned ingredients (2-Aminophenol);

Tips for Enterprises:

1. The main problem of unqualified hair dye products found in this sampling inspection is that ingredients claimed on label or approval documents did not correspond to the actual products. According to “Requirements for Application and Acceptance of Administrative Licensing for Cosmetics”. 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.
2. 2-Aminophenol was a permissible hair dye in “Hygienic Standard for Cosmetics” (2007 edition), but “Safety and Technical Standards for Cosmetics” (2015 edition) adjusted requirements for some restricted ingredients. Now 2-Aminophenol is a banned ingredient that cannot be used in cosmetics.

The major reasons for cosmetic products inspection failure:

1. The total number of colony-forming unit(CFU) exceeds the limit;
2. The total number of mold and yeast exceeds the limit;
3. Detection of the banned ingredients (Fluocinolone acetonide, Betamethasone, Clobetasol propionate, Hydrocortisone valerate).

Tips for Enterprises:

1. CFU is an indicator of the total number of microorganism and is an important index to assess the degree of contamination and sanitary conditions during the cosmetic manufacturing process. According to “Safety and Technical Standards for Cosmetics” (2015 edition), for eye products, oral mucosa products and infant or children cosmetics, CFU should be no more than 500 CFU/ml (g), for ordinary products, CFU should be no more than 1000 CFU/ml (g);
2. Molds and yeasts are microorganisms that widely exist in nature. Molds and yeasts are generally used as indicators for evaluating the quality of cosmetic hygiene. “Safety and Technical Standards for Cosmetics” (2015 edition) stipulates that molds and yeasts in cosmetics should be no more than 100 CFU/ml(g);
3. Glucocorticoids belong to steroid hormones and are used as anti-inflammatory agents. They are commonly used in the treatment of allergic skin diseases. Long-term use of cosmetics containing glucocorticoids interferes with collagen production and results in striae, black spots, atrophy and thinning of facial skin, as well as hormone-dependent dermatitis. “Safety and Technical Standards for Cosmetics” (2015 edition) stipulates that use of these substances is banned in cosmetics.