In this rapidly (d)evolving world, things change very quickly. For China’s cosmetics industry, it’s the combination of quickly evolving regulation and supply chain issues. When I connect the dots in the beauty industry, playing it safe seems to the underlying trend among cosmetics marketers and their suppliers.

Regulations continue to be in the news. Administrative Measures for Monitoring Adverse Reactions to Cosmetics was issued on February 21. It will be enforced on October 1. It aims to improve safety evaluation and, ultimately, cosmetic quality, according to the National Medical Product Association (NMPA).

In essence, the new measure requires companies that have filed or registered cosmetic products, or are in the process of doing so, must establish post-registration monitoring systems for adverse cosmetic reactions. Any suspected case of a cosmetic product causing harmful effects on human health should be reported to the authority, in a timely and proactive way. It is similar to what we’ve seen in China’s pharmaceutical and medical device sectors.

According to the measure, an adverse cosmetic reaction is defined as a pathological change in skin and its appendages, as well as health damage on part or the whole human body, resulting from normal cosmetic use. Reactions are classified into three types based on the severity: normal, severe and extremely severe. Adverse cosmetic reaction monitoring refers to the whole process of collecting, reporting, analyzing/evaluating, investigating and dealing with the information on suspected cases. While normal adverse reactions must be reported to the authority within 30 days following initial detection, severe ones must be reported within 14 days. Those which might cause extremely severe reactions must be reported in no more than three days. 

While proponents say there may be a long-term gain, the short-term pain for the industry is inevitable; an extra burden on many companies already stressed by a flurry of stringent regulations and supply chain disruptions. According to some industry experts, it would be time- and cost-consuming to establish a monitoring system from scratch. Another real challenge is regarding implementation. Compliance
The monitoring system aside, another great headache regarding the regulatory compliance is writing the safety assessment report. These reports, requested by Technical Guidelines for Cosmetic Safety Assessment, went into effect Jan. 1, 2022. It takes tremendous effort to search scientific evidence and data on ingredient safety, which has created a cottage industry—compiling and writing such reports by a third party.

This development makes sense if considering the importance of safety assessment reports in today’s product registration/filing. According to the new regulation, companies will be ordered to correct violations and suspend sales of related cosmetic products if:

1. The safety assessment report is not provided accordingly;
2. The safety evaluation materials in the report do not meet the requirements and affect the determination of product safety;
3. The ingredient specifications on quality and safety are not provided accordingly;
4. Lack of safety evidence for ingredient applications in baby/children care products; and
5. Other in-compliance affecting the determination of product safety. A formal safety assessment report will be required by May 1, 2024.

In an attempt to facilitate compliance, on February 24, NMPA issued a draft for public comment, Key Outlines of Safety Assessment Report (simplified version) for General Cosmetic. It aims to complement Technical Guidelines for Cosmetic Safety Assessment enacted at the beginning of 2022. It provides guidance on writing and submitting safety assessment reports as well as reviewing them on standardized criteria.


Ingredients to Watch

With “safety first” top-of-mind, the players in China’s cosmetic market seek active ingredients with clear action mechanisms backed by comprehensive scientific data. Those borrowed from the food industry seem to be winning, partly because the existing assessment on such ingredients in food applications lends weight to cosmetic ones during the registration/filing process.

For example, N-Acetylneuraminic acid (NANA, SA) is associated with edible bird’s nest. Now, a recent development in the NMPA’s new cosmetic ingredient registration is Beta-Nicotinamide Mononucleotide (β-NMN), another ingredient that originated within the food and nutraceutical category. β-NMN has been a buzzword in the wellness food industry since 2020. I remember vividly when visiting several food tradeshows then, the heavy marketing of it as “the next generation of anti-aging agent” in dietary supplements. However, the frenzy cooled down when the State Administration for Market Supervision (SAMR) issued a statement last year, noting that NMN has not gained official approval for use in nutraceuticals.

While there is scientific research demonstrating its health benefits (mainly anti-aging) and safety in oral administration, I’m trying to get my head around this latest development of β-NMN in cosmetic applications. So far no technical specification is revealed in the NMPA’s publication on β-NMN, such as INCI name or original sources.

What is known so far is that it has been filed by Yuyao Lifespan Health Technology Co Ltd., and the ingredient has already been incorporated into a facial mask collection under a brand GeneHarbo, which is owned by GeneHarbor Investment Limited (a stakeholder of the filer). Generally, the electronic filing certificate will be issued if passing the review of submitted dossiers by NMPA.

Under constantly-evolving environment, this “play-it-safe” mindset is reshaping the industry, which has been witnessing the brands and manufacturers alike, along with testing service providers all vigorously up the ante for the assessment of cosmetic safety and efficacy. And this has inevitably led to a talent war and sent costs soaring. How this will play out in the market? Big players seem to be the winners.

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Ally Dai
Freelance Writer
allisondai@126.com
allydai73@gmail.com
 
Ally Dai is a freelance writer/independent consultant based in Shanghai. She has covered the beauty industry for more than 15 years. Previously a senior editor and industry researcher, she now works on content creation with publishing houses, event organizers and PR companies in the personal care and life science industries.