Break into the China market – China Cosmetics Animal Testing FAQ

OKOMP Marketing • 11 June, 2015

Recently I have received numerous enquiries on animal testing in relation to Chinese cosmetics. For ease of reference, I have compiled all of the answers to these questions in one article.

I sourced these answers from Humane Society International (HSI)’s documents on Animal Testing, from China’s latest FDA regulations, effective from 30th June 2014.

What are the changes to the animal testing of Chinese cosmetics since the new policy came into effect?

Before 30th June 2014: The law has required that a sample of every new cosmetic product formulation intended for domestic sale be submitted to the government for (predominantly animal-based) testing. The government also carries out post-market animal testing of cosmetic products after they’ve been put on sale.

From 30th June 2014: Companies manufacturing ordinary, or “non-special-use”, cosmetics inside China will no longer be legally required to conduct, or provide samples of new products to the government for, animal testing. Instead, they now have the option to provide a product risk assessment using ingredient safety data, including when necessary the results of validated and internationally recognised non-animal test methods.

Does this mean China has banned animal testing for cosmetics?

No, and this remains Be Cruelty-Free China’s ultimate goal that we will continue to campaign for. However, it is the first time that China has amended China cosmetics animal testing rules in more than 20 years, so it’s pretty significant.

Does this apply to all cosmetics?

No. The amendment does not apply to cosmetics manufactured outside of mainland China for sale inside China. Nor does it apply to “special-use cosmetics” such as hair dyes, antiperspirants, sunscreens or skin-whitening products.

Does this mean cruelty-free companies can now sell in China through the traditional channel?

No. Firstly, the new change only applies to companies manufacturing cosmetics inside China for sale in China. For most cruelty-free companies, manufacturing inside China is not an option. As the rule change does not yet apply to cosmetics imported into China from third countries, foreign cruelty-free companies would still be subject to pre-market finished product animal testing requirements. The potential exception from the pre-market requirement would be if a foreign company bulk imported all its ingredients into China and manufactured the products in China, which would meet the Chinese definition of a domestic product. However, this scale of manufacturing is unlikely to be a viable option for most companies. Moreover, animal testing for individual raw ingredients would only be avoided if the ingredient was already listed on the government’s official Inventory of Existing Cosmetics Ingredients in China (IECIC).

Secondly, and regardless of any changes to pre-market testing, the Chinese government still carries out post-market animal testing of cosmetic products. This is where cosmetics are chosen at random and removed from shop shelves for “confirmatory” animal testing (i.e. to confirm that the product on sale to consumers is the same as the formulation approved for sale). Chinese authorities have indicated that they intend to increase the level of post-market testing following the 30 June policy change for domestically manufactured non-special-use cosmetics, to ensure a consistent level of consumer protection. Thus, even if a cosmetic company manages to avoid pre-market animal testing, it is impossible for it to guarantee it will also avoid post-market animal testing, and indeed the risk of post-market animal testing remains high. HSI believes that until this is no longer the case, no cosmetics company can sell its products in China and credibly purport to be cruelty-free.

What about e-commerce?

Pre- and post-market testing requirements do not apply to cosmetics ordered by customers via an e-commerce website if the website and fulfilment is outside of mainland China, and products posted direct to the customer in China. So, a cruelty-free company could sell products to Chinese customers via a website without concern for animal testing.

What about selling in Chinese airports?

Although Chinese law does not explicitly waive the animal testing requirement for cosmetics sold as duty free in its airports, in practice such pre-market animal testing may be avoided. However, there is no such routine exemption from post-market animal testing. Therefore, cosmetics sold as duty-free in China’s airports still risk being subject to random post-market animal testing by the Chinese government, and as noted above, the level of post-market testing is likely to increase from 30th June 2014. This means that cruelty-free companies cannot sell in Chinese airports and guarantee that their products will never be animal tested, with or without their knowledge.

Will foreign-owned cosmetics companies manufacturing and selling in China now be able to be cruelty-free?

No, for two reasons. Firstly, to avoid pre-market animal testing, a company would have to:

1. Produce only “non-special-use” cosmetics
2. Rely exclusively on ingredients already listed in the Inventory of Existing Cosmetics Ingredients in China (ICCEC)
3. Be able to carry out a full product risk assessment based on existing ingredient data

Cruelty-free companies utilise the many thousands of existing, safe cosmetics ingredients, which is how they develop new products without new animal testing. However, not all of these ingredients are necessarily listed in the 2014 ICCEC, meaning that regardless of their history of safe use in other parts of the world, such use may not be permitted in China without an extensive safety dossier, which may require new animal testing to satisfy Chinese regulatory requirements. This is especially so for many of the market leading cosmetics brands, which choose to develop or purchase and use “new-to-the-world” ingredients in order to give them market advantage. Such ingredients will not have pre-existing safety data, and because non-animal test methods do not yet exist for all toxicity endpoints, such as chronic health concerns, for which data may be required by regulators — or equally, that not all available non-animal tests are yet accepted by China — some new animal testing would almost inevitably be conducted in accordance with Chinese regulations for new chemicals.

And secondly, there is still the problem of post-market animal testing.

So in summary, what animal tests will be required in China after 30 June 2014?

All newly imported “non-special-use” cosmetics, such as shampoos and lipstick, will still be required to undergo pre-market animal testing by Chinese laboratories, including the following specific tests:

• Eye irritation
• Acute skin irritation
• Repeat skin irritation

Chinese companies producing non-special-use cosmetics for sale in China will now have the option to satisfy regulatory safety requirements for finished products without new animal testing if they are able to substantiate product safety based on ingredient data. Although this is standard practice in most parts of the world, it has never before been permitted in China, and it is unclear whether Chinese companies have the training or experience to conduct such ingredient-based risk assessments. Moreover, if a company uses a new ingredient for which no existing data are available, animal testing will be required.

Both foreign imported and domestically produced “special-use” cosmetics are subject to the following tests for all finished products:

• Eye irritation
• Acute skin irritation
• Repeat skin irritation
• Skin sensitisation
• Skin phototoxicity (could be in vitro or in vivo)

“Non-special-use” cosmetics manufactured in China for export purposes only do not have to undergo any animal testing under Chinese law.

If cosmetics animal testing hasn’t ended in China, why is this rule change important?

It’s very important, because it demonstrates that the Chinese government is receptive to moving in the right direction, away from animal testing. Change in China will inevitably be slower paced than elsewhere; it will be incremental, rather than sweeping changes. But this rule change is the very first time in more than 20 years that China has made a substantive amendment to its cosmetics regulation. Seen within the global context of a general shift away from animal testing, it is important that we acknowledge this as a first step in a multi-step journey towards ending cosmetics cruelty in China.

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Currently, in order to enter into the market, worldwide cruelty-free cosmetic companies are eagerly awaiting the Chinese government to ban animal testing. However, it is feared that if action is only taken at that time, it will be too late. By preparing your brand and your product for the China market, and by increasing awareness and reputation online in advance, you will have a massive advantage over your the competition.

At present, an e-commerce platform is the obvious solution for cruelty-free cosmetics companies to avoid animal testing and start selling their products in the China market. As such, I will be producing a separate article to explain how cosmetics companies can use an e-commerce platform to enter the China market.

The FAQ above is from HSI, an organisation that has been advocating and working towards the protection of all animals through the use of science, open debate, education and hands-on programmes. They have significantly canvassed the China FDA, adjusting animal testing regulations. We are looking forward to the China FDA’s steps to implement industry-wide cruelty-free practice soon.

If you have any questions, please feel free to contact me on: [email protected]