Recently, two bans concerning the animal testing of cosmetic products were introduced in the European Union ("EU"), the first being effective from 11 March 2009, and the second coming into effect from 11 March 2013. EU based cosmetics manufacturers and distributors will cease using animals for testing and the importation of cosmetics tested on animals outside the EU, and be committed to the development of non-animal based alternatives instead.

Such legislative changes in the EU have alerted the cosmetics industry in China to the need for change, because animal based testing is still the prevailing method of cosmetics testing in China, and the first related legal framework dates back to 1999.

The Ministry of Health of PRC ("MOH") released the Hygiene Standards for Cosmetics ("Standards") in 1999 to ensure high safety standards for the animal testing of cosmetic products, and have updated the Standards respectively in January 2002 and 2007.

The latest edition of the Standards effective on 1 July 2007 has been updated based on the EU legislation including Council Directive 76/68/EEC and the relating amendments until 21 November 2005. The 2007 Standards provides for more specific general principles, requirements and methods for using animals in compulsory tests of toxicity, such as acute oral toxicity test, acute dermal toxicity test, dermal irritation/corrosion test, acute eye irritation/corrosion test, skin sensitisation test, skin phototoxicity test, subchronic oral toxicity test, subchronic dermal toxicity test, teratogenicity test, and combined chronic toxicity/carcinogenicity test.

Alternative non-animal based tests are still in their preliminary stage of development in China. On 8 September 1997, the Ministry of Science and Technology of the PRC ("MOST"), MOH, the Ministry of Agriculture of PRC ("MOA") and the State of Food and Drug Administration ("SFDA") jointly issued "Several Opinions of Development For Animal Testing", which first demonstrated the Chinese government's desire to promote non-animal based testing.

In September 2006, MOST issued "Guidance Opinions for Being Kind to Animal Test Subjects", which was designed to encourage a reduction in the use of animals for testing, and a commitment to further develop alternative methods. However, so far there is no unified and specific legal framework to regulate non-animal based in China.

It must be noted that the overseas cosmetic products that would be suitable for undergoing testing, via the non-animal based alternatives, are currently hard to import into the Chinese market. This is because the overseas manufacturers of such products, not only seek assurance that such testing will be non-animal based, but also that the relating testing facilities meet certain standards in adherence with their own code of ethics.

As long as there will be a lack of both accepted legislation in the area of non-animal safety testing and testing facilities qualified for non-animal based testing in China, the ability to move forward will be hindered. This is a situation that China currently seeks to rectify and hopefully trigger a decrease in the use of animals based testing. This in turn could ensure the further opening of the Chinese market to overseas cosmetics manufacturers.

Furthermore, until recognised legislation for good non-animal based testing practices are in place and the relating testing facilities are set up in China, the export of domestic cosmetic products to these overseas markets, such as the EU and indeed all markets with blanket bans on animal tested products will ultimately be blocked. The only way to effectively penetrate such markets for China based manufacturers and distributors is to ultimately ensure guidelines are brought into line with the aforementioned territories.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

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The original publication date for this article was 05/05/2009.