南宫NG28

An overview of non-compliances identified during the National Medical Products Administration (NMPA) surveillance and inspection of cosmetic products sold in the China market.

As of December 31 2021, the National Medical Products Administration (NMPA) in China has issued a total of 10 announcements regarding non-compliant product investigation results, numbering 234 batches of non-compliant cosmetic products sold nationally in total.

11 product categories were sampled as a part of the market surveillance program, including: hair dye products, make-up products, sunscreen products, perm products, products claiming to be anti-acne, facial mask products, talcum powder products, freckle/whitening products, shampoo and hair care products, general skin care products and hair growth products that claim to be moisturizing.

Note that the NMPA also issued an announcement on counterfeit cosmetics, however the information is not included in the scope of this report’s analysis.

Source: "Cosmetics Announcement Notice" under "Cosmetics" on the official website of the State Drug Administration.

Non-Compliant Product Summary

Non-compliant product categories that were involved in the market surveillance program are detailed in Table 1 below:

Table 1- Statistics on the categories of non-compliant cosmetic products involved in the 2021 national market surveillance and inspection program.

Table 1 also shows the comparative distribution of batches of non-compliant products in each category. For example, it can be seen that the non-compliant batches of five categories of products, including hair dye products, facial masks, make-up products, sunscreen products, and moisturizing skin care products returned significantly higher incidents than other cosmetic categories, accounting for 94.87% of the total  non-compliant batches.

Market Surveillance Program Overview

The China national market surveillance program for cosmetics determine the product category and scope for product sampling. For example, the test results for hair dyes and sunscreen agents should be checked against the limits of market requiements, as well as comparing the performance or composition of the product against the product label, product formula, or marketing claims. The findings are then detailed in a surveillance report that is publicly announced.

In addition, the surveillance program also includes production licenses for cosmetic manufacturing enterprises, licenses, certificates, and other documentation, as well as a copy of the business license of the manufacturer. Documentaiton will be reviewed to verify its validity and whether it is consistent with the products it is manufacturing, as well as whether the labeling and content is consistent with regulatory requirements. As a result of non-compliant finding, and violations of laws and/or regulations are identified, the cosmetic products will be listed as non-compliant and a subsequent recall or financial penalty would be actioned.

In the 2021 report, the test items for non-compliant findings were: labeling problems, microorganism content, preservative levels, heavy metal concentrations, anti-infective drug claims, amongst others detailed in Table 2 below:

Table 2-Project analysis of non-compliant cosmetics in national supervision and sampling inspection in 2021

Cosmetics were earmarked for more comprehensive surveillance and regulatory oversight in 2021, and it was also the first year that a cosmetic-specific market surveillance program was launched. In light of these new regulations being introduced the supervision of cosmetics has become increasingly strict.

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