There are three conditions for animal testing exemption.
First, your product must be general cosmetics. Special cosmetics like sunscreens, whitening cosmetics are still required to be animal tested.
Second, you should provide a certificate of compliance to the good manufacturing practices (GMP) issued by the competent authority of the country of origin.
Third, the safety assessment results can fully confirm product safety.
What may be a little tricky is the GMP certificate issued by the government. For some regions where GMP certificates are generally issued by associations or third-party organizations, their governments are considering introducing solutions to help local manufacturers obtain the certificates.
I suggest stakeholders ensure their certificates can reflect the government’s actual supervision of the entire manufacturing process and quality control system. What’s more, the local manufacturing standards must be equal to or higher than the international GMP standards.
Three cosmetic categories are not allowed to be exempt from animal testing. They are 1) infant and children cosmetics, 2) cosmetics using new ingredients during the monitoring period, and 3) cosmetics whose notifier/RP/manufacturer is listed as a key supervision target by NMPA.
1) Undoubtedly the exemption is a great benefit for international brands, especially those cruelty-free. Brands that have already acquired certain consumer awareness in China, like The Body Shop and Aesop, have long been waiting for policy changes. Now they can open the door to general trade and set up physical stores in China to explore the offline market. We know that Chinese consumers have increasingly favored clean beauty. Cruelty-free cosmetics may quickly occupy the Chinese market with this advantage and create a considerable revenue increase for their parent company, which may affect global cosmetic industry’s structure.
Behind the benefit, we should also realize that the competition of international brands in the Chinese market will become fiercer. It will force companies to conduct R&D and innovation, and launch more competitive products.
In addition, the flood of imported brands is bound to have impact on local Chinese companies.
2) The second impact I want to mention is for brands with multiple manufacturers. The new regulations stipulate that for product manufactured by multiple manufacturers, only if all the manufacturers have obtained GMP certificates issued by the local governments can the product be exempted from animal testing. Therefore, foreign brands with multiple manufacturers may need to transfer their manufacturing sites for cosmetics exported to China to where the GMP certificates have been recognized by NMPA.
3) Also, there will be changes in notification costs. Since the costly animal testing can be exempted, product testing expenditure will be greatly reduced. But the cost of translating safety assessment documents and even re-assessing product safety still needs to be included in the notification cost budget.
4) Animal testing is no longer a mandatory requirement in China. Brands that have already entered China with animal testing may be pressured by public opinions from overseas consumers, then choose to apply for GMP certificates and conduct safety assessments.
The most convenient method is through cross-border e-commerce (CBEC). Cosmetics imported through CBEC are regulated as personal articles and exempt from registration and notification. Thus, no matter special or general cosmetics, animal testing is not required.
For general cosmetics without a recognized GMP certificate, in addition to CBEC, there are two other options.
First one, going local. Overseas companies can set up a factory in China, entrust a Chinese OEM for production, or fill and pack the products in a Chinese factory.
In view of Chinese consumers may prefer imported products, if overseas companies would like to keep their products as imported, they can outsource the production to a country whose GMP certificate is recognized by NMPA.
Animal testing has not been explicitly excluded from post-market testing methods by the regulatory authorities, so the post-market animal testing risk cannot be completely ruled out.
However, as far as we know, the chance of encountering post-market animal testing is quite low and only applicable to those with serious safety risks. Animal testing is not used in post-market surveillance for years. As long as the products’ manufacture and operation comply with Chinese regulations, no need to worry too much about post-market animal testing. Even if it ever does happen, companies are allowed to pull products from shelves rather than enable officials to test products on animals.
About the Expert:
Joanna RuSenior Cosmetic Regulatory Consultant at REACH24H
Joanna has a master’s degree in Chemical Engineering from the University of Ottawa and more than 3 years of experience supporting major cosmetic companies’ regulatory compliance efforts. She mainly focuses on researching Chinese cosmetic regulations, including the finished cosmetic products and new cosmetic ingredients, has assisted loads of clients to obtain pre-market approvals and complete import filing for their cosmetic products, such as La Prairie, REVLON and EOS. Also, she was invited to give presentations on various events and platforms, such as ICMAD, Cosmetic Compliance, as well as ChemLinked. In addition, she is sophisticated in global cosmetic regulations, including ASEAN, Korea and Japan, which provides a professional regulatory information for various cosmetic companies. Joanna’ s global regulatory expertise and strong business acumen afford her a strategic vision to navigate the regulatory and compliance challenges that often accompany new technologies and growth into new markets.