China: Rabbits Rejoice – End of PRC Animal Testing Requirements Nears

Last Updated: 20 January 2014
Article by Mark Schaub and David Hong

There is little that China's big cities' retail scene cannot offer the eager shopper – flagship stores, bright lights, long lines ... However, the long term China expat will still often miss specific items – the lack of a Body Shop ... the quirky soaps manufactured by Lush ...

The reason that some brands are not found in China is that a number of cosmetics and body care companies have a corporate policy against animal testing. To date, China has basically required that such products conduct animal testing as part of an overall consumer safety policy. This practice is now changing ... in part.

Chinese rabbits and mice are set to rejoice due to the "Notice on the Adjustment of Cosmetics Registration and Filing Administration" ("Notice") which was posted on the website of the China Food and Drug Administration ("CFDA") on December 16, 2013. The Notice states that starting from July 2014 animal toxicological testing for "non-specialized cosmetics produced in China" will no longer be mandatory provided a risk assessment has been carried out. Chinese manufacturers of such non-specialized cosmetics will be able to evidence product safety by using existing data or European Union-validated non-animal tests and can avoid government conducted tests.

The basic risk assessment procedure requires i) identifying the potential harm, ii) describing the potential harmful effects, iii) an exposure assessment, and iv) a description of the probability and scope of harm of the product. If it is determined that there are no safety risks associated with use of the cosmetic, the manufacturer will then submit a letter of commitment describing the analysis process used to determine that there is no risk of harm and justification for the same. However, if after conducting a risk assessment, the manufacturer determines that the product poses a potential risk, then it must submit a risk assessment report.

For any substances that are already regulated in China, risk assessment materials are not required to be provided; however, for any substances not currently regulated, but safety regulations for said substance are addressed by any foreign authority, then an assessment report by the foreign authority is all that is required to be submitted. For all other substances, a risk assessment report must be submitted, which includes the sources of the subtance, an introduction to the substance and its properties, and other pertinent information.

The change had been expected as the CFDA had previously issued a proposal on its website in November 2013 regarding cosmetics registration and filing. After one month's public consultation, the proposal was considered as having been approved.

Previously, Chinese regulations had required all cosmetics to undergo a lengthy approval process, including "toxicological testing", which typically involved testing on animals such as rabbits, pigs and mice. Although the PRC regulations did not specify animal testing as a requirement of such toxicological testing, in practice this was often the case.

Chinese regulations separate cosmetics into two main categories. The first category is "non-specialized cosmetics", which refers to cosmetics with no medicinal effects, such as hair care products (e.g. shampoo, conditioner, styling agent etc), skin care products (e.g. skin cleanser, skin toner, moisturizer etc), make-up (e.g. foundation, rouge, mascara etc), lip care products, nail care products and perfumes. For this category of cosmetics, the procedure involved is rather simple, the applicant only has to register with CFDA (SFDA) and obtain a Registration Filing of Imported Cosmetics for Non-Special Purpose.

The second category is "special purpose cosmetics", which refers to cosmetics for a special purpose meeting the requirement for Chinese labeling and in compliance with China's National Standard. These products include products for hair growth, fitness (slimming), breast shaping (or enhancement), hair dye, hair perm, sun block, deodorizing, spot removal and hair removal. For this category of products, an application for approval and a Health Certificate for a Special Purpose are required.

Other tests that may be required, depending on the type of cosmetics, include:

In accordance with the "Risk Assessment Guide on Possible Safety Risk Substances in Cosmetics" if the risk assessment can ensure consumer safety, then such non-specialized cosmetics are no longer required to conduct toxicological testing. However, it should be noted that special cosmetics made in China and cosmetics produced outside of China, regardless whether special or not, will not fall under the new regulation.

Why now? Undoubtedly efforts by PETA and the Humane Society were influential. In particular, PETA funded scientists to provide guidance to Chinese counterparts on alternative testing processes. However, in the end it may well be that the practice of testing cosmetics on animals is increasingly considered old fashioned and China wishes to follow international practices. In March 2013, European Union regulators announced a ban on the import and sale of cosmetics containing ingredients tested on animals and pledged to push other parts of the world, like China, to accept alternatives. This announcement may also have played a role.

Summary

At present the new regulation will allow domestically manufactured non-specialized products to avoid animal testing. Accordingly, although a positive step, it falls very much short of what animal rights organizations would hope for but is an important first step.

If implementation proceeds smoothly, then it would be reasonable to expect that this policy will in time be extended to imported products and also specialized cosmetics.

Although many rabbits in China will rejoice at the news, it is likely that Chinese consumers may still need to wait awhile before they will be able to buy imported Peppermint Cooling Pumice Foot Scrub on Huaihai Road or Wang Fujing.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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