The cosmetic product session at CRAC-HCF 2020 Virtual Forum hosted by REACH24H was successfully concluded on Dec. 8, 2020. This informative online conference attracted the attendance of international cosmetic companies, chemical companies, NGOs and other experts across a wide array of industries. During the session, the following three speakers shared their insights on China's cosmetic notification, efficacy evaluation and label requirements.
He Yifan, Department of Cosmetics Regulation of NMPA
Wu Jinhao, Beijing Daily Chemical Association
Yuan Ren, Chinese Center for Disease Control and Prevention
We at ChemLinked have selected 6 Q&As we believe would help our clients.
1. As per the existing regulations, products submitted for notification will receive a format review by provincial medical product administrations. However, the format review no longer exists with the release of the CSAR according to our understanding, right? And why is the format review canceled?
He Yifan: Yes, the notification will be completed upon submission of notification documents. We also notice that notified products are not subject to technical review and will directly proceed to post-market supervision. As for the reasons, first of all, I think this is good news for the cosmetics industry. Cosmetics are fashion products and seasonable products. For low-risk products, the practice that cosmetics will be on market once notified will promote industrial development to some extent because consumer demands for cosmetics will be better met and more cosmetic products in different varieties will be seen in the market.
From another perspective, notifiers and registrants shall be responsible for the authenticity and scientificity of the notification and registration documents in a serious and strict manner. If any non-compliance is found during the inspection, such as any inconsistency between registered and stated technical data and actual technical process during production, the enterprises will be published based on corresponding rules. In summary, the notifiers and registrants should submit registration documents based on authenticity and reliability requirements.
2. For the Guidance of Cosmetic Efficacy Claim Evaluation, the first draft mentions that for the freckle-removing and whitening products from the same enterprise, the enterprise can perform human trials for the efficacy of representative products, and evaluate the efficacy of other freckle-removing and whitening products through cross-references. But the second draft has deleted this provision. Why was this provision revised in the new standard? For cosmetics enterprises, if several products use the same whitening ingredient that has passed efficacy verification, does it mean that all products must pass human trials for efficacy?
Wu Jinhao: Yes, this is indeed a great change. The new standard has deleted cross-references. Previously, given enterprise costs, cross-references are acceptable to support the freckle-removing and whitening efficacy of products. However, there may be some discussions later and it is finally deemed that the human efficacy trials must be done for all special products.
The second question is about the ingredients. The new regulations mentioned that all cosmetics with special purposes such as freckle-removing and whitening must go through human trials in specified institutions with the methods specified by the NMPA. Then, the cosmetics can be granted a license and sold in the market.
All freckle-removing and whitening products must go through human efficacy trials. However, products using physical covering for whitening can be exempted from publishing the abstract of the basis for product efficacy claim evaluation.
3. The regulation also mentions that if the enterprise adopts a self-developed or established method, the method shall be scientific and reliable and be validated by two or more testing institutions. Would you please introduce the validation process by two or more testing institutions from your professional perspective? Or, what result can be deemed as validated?
Wu Jinhao: For example, for some common methods, you can refer to some literature such as overseas literature standards. And new evaluation methods may be developed with scientific advancement. For some unfamiliar methods, some methodological study is required. We have done some similar studies before including those for the freckle-removing, whitening and anti-hair loss products. Only with the feasibility being validated, companies can use the method to support the development of products.
4. Is it possible for China to accept foreign efficacy evaluation basis in the future? From your years of experience, will there be any difference in different humans for the same cosmetic efficacy?
Wu Jinhao: The product efficacy definitely differs in different human groups and different races. We can see that there is a change in the Working Rules for Cosmetic Registration and Filing Testing issued in September last year. Previously, for some cosmetics with special purposes such as sunscreen products, the SPF report and PA report issued by foreign institutions can be accepted. However, since last year, all imported products must go through SPF and PA tests in China. From this point, we can see a trend.
It is hard to say whether foreign efficacy evaluation basis is accepted. We need to wait for the implementation of specific regulations. Only with the official implementation of the new regulation next year, we will have a formal answer.
5. According to the draft for comments in the Administrative Measures on Cosmetic Labeling, products in boxes should also be labelled with the name of the product and the expiry date at least on the packaging container in contact with contents. Currently, the registration documents submitted only have requirements on external packages of products. As we can see, for most imported product packages, the bottles only have an English name and production batch number. Could you please tell us that does it mean that inner packages and bottles must be attached with Chinese labels of corresponding information and above complementary information?
Yuan Ren: Yes. You are right. Article 14 stipulates the requirements for visible surfaces and packaging containers in direct contact with contents. Therefore, Chinese labels must be attached if the expiry date is not indicated for the imported products.
6. The fact that the claims of the original package of imported cosmetics do not comply with cosmetics regulations in China still exists despite the narrowing difference between Chinese cosmetics regulations with those of Japan, Korea and other countries in EU. For example, the claims stating that products are free of some ingredients or organic claims are not allowed in China. For some original packages, it is acceptable. We’d like to know that can the package with such claims be accepted? Or, will it require that related claims should be removed and a special package should be designed for China?
Yuan Ren: This is a good question. This is about the requirement for imported cosmetic package requirements. According to the requirements in China, the claims stating that products are free of some ingredients, as I mentioned, are not acceptable because it is deemed as disparaging compliant products.
If such a claim is on the original package, companies need to design a special package for the Chinese market in accordance with Chinese regulations.
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