Recent changes to cosmetic regulations have sparked rumours that companies could finally enter the Chinese market without animal testing. While new cosmetic ingredients can now be registered with alternative methods, all foreign cosmetic companies still have to test their products on animals in the final stages of cosmetic registration.
After China’s Food and Drug Administration (CFDA) released an official notification concerning the approval of the in-vitro 3T3 NRU phototoxicity test as an alternative to animal testing of cosmetic ingredients in November 2016, there has been much confusion surrounding the truth behind the topic. Is there finally a way into China without animal testing?
In short — no. The phototoxicity test is specially approved as a method to test new cosmetic ingredients not yet approved for use by the CFDA. This does not affect the approved testing methods for finished products, which require animal testing. During the mandatory registration process, products (including any new ingredients approved with the phototoxicity test) will undergo animal testing.
All products entering the market, unless they are domestically products with a certain classification, must first meet testing standards which include animal testing. The exemption of non-special use domestic cosmetics from animal testing, as well as the approval of the phototoxicity test as an alternative for new cosmetic ingredient testing, are steps towards a cosmetics market without animal testing in China. But they are considerably small steps — there is still a far way to go before all cosmetics are able to completely avoid animal testing.
new ingredient approval
If a company wants to import a cosmetic product, they must first make sure all their ingredients are approved by the CFDA. If any ingredient in the product is not already on the approved ingredients list for cosmetics, the company must either apply for CFDA approval of said ingredient or remove or replace the ingredient with one that is already approved. The new phototoxicity test affects the testing of new ingredients applying for CFDA approval.
Considering the process for new ingredient approval typically takes over a year, Knudsen&Co generally recommends their clients replace or remove unapproved ingredients rather than apply for new ingredient CFDA approval.
Once all ingredients are certified, every finished product must apply for registration before entering the market.
finished product registration
Here the procedure gets even more complicated. Finished cosmetic products can be divided into four categories: domestic non-special use cosmetics, domestic special use cosmetics, imported non-special use cosmetics, and imported special use cosmetics. All categories, except domestic non-special use cosmetics, require animal testing to get CFDA approval.
Special use cosmetics, both domestic and imported, consist of products with nine different functions: hair perm products, hair removal products, hair dyes, hair growth products, breast beauty products (like breast enlargement creams), body beauty products (like cellulite removal lotions), anti-spot treatments, sunscreens, and deodorants. All other products, including all makeup products, are considered non-special use cosmetics.
Domestic special use cosmetics and imported non-special and special use cosmetics must undergo administration approval to officially register with the CFDA as a finished product. This process includes meeting certain testing standards — which require animal testing. For domestic non-special use cosmetics, the approval process takes around 9 months, while imported products typically take around 8-12 months.
aVOIDING ANIMAL TESTING
As of last year products classified as domestic non-special use cosmetics must undergo a different approval process known as filing, which only takes 2-4 months. These standards do not require animal testing — and is currently the only method in the Chinese cosmetics industry that does not require animal testing. This means all products not classified as domestic non-special use cosmetics must undergo animal testing, even if a new ingredient is approved using the photoxicity test.
International companies could hypothetically take advantage of this classification if they imported their product in bulk for final processing (typically this means repackaging) in Mainland China. Knudsen&Co estimates setting up an effective repacking process in China would take at least 2 years.
Foreign companies could also set up manufacturing facilities in the Mainland and claim domestic production. Many of the foreign brands that sell successfully in China have established their own domestic production facilities. Companies like L’Oreal and Estee Lauder not only produce their products on the Mainland, but have set up research and development centers in the country to create products specifically designed for Chinese consumers. By producing domestically, these companies are able to avoid the lengthy and complicated registration and certification processes imposed on imported cosmetics.
Considering the time requirements associated with establishing a production facility, Knudsen&Co estimates this process to take a minimum of several years.
Previously, cross-border e-commerce (CBEC) was a popular alternative for companies wanting to avoid animal testing. Products sold through CBEC were not required to have CFDA approval or undergo CFDA testing. However, with the 2016 announcement of the ‘Customs Clearance of Entry Commodity,’ products imported through CBEC will require the same CFDA registration as traditional retail channels. In effect, CBEC is no longer a method into the Chinese market that does not require animal testing. The grace period for CBEC products to achieve CFDA approval ends with 2017, as explained in this Knudsen&Co article.
The announcement of the In Vitro 3T3 NRU phototoxicity test as an alternative to animal testing of new cosmetic ingredients and the exemption of domestic non-special use cosmetics from animal testing are indeed steps toward a cosmetic industry without animal testing in China. However these are very small steps. There is still a long way to go before cosmetics, especially imported products, are able to avoid animal testing on the Chinese market.
While western companies — and consumers — tend to see animal testing as a moral detriment, in a market plagued by product safety scandals animal testing is considered a consumer safety measure. China’s cosmetic market’s safety standards have not yet developed a level of maturity seen in the west. Animal testing requirements serve to ensure product safety where consumers see harmful and misleading products frequently and are increasingly concerned with product quality.
Imported products are perceived by consumers as premium products. Consumers trust the safety of foreign brands and this in part drives the high demand for imported products. With Chinese cosmetics purchases topping 204.9 billion RMB in 2015, foreign companies are well aware of the huge opportunity in the market. Kline&Co estimates the cosmetic market to grow at an average of 10% in the coming years. 80% of this sales volume is attributed to foreign products. Large international companies like Estee Lauder, Lancome, Chanel, Dior, Maybelline, and MAC are already taking advantage of China’s consumers.