New China Regulations and the Need for Outreach Programs

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In the Spotlight

New China Regulations and the Need for Outreach Programs

Brian Jones, Institute for In Vitro Sciences (IIVS)

Published: May 29, 2012

It was not until January 1990 that the China Ministry of Health first implemented their view on cosmetic products with Regulations on the Hygiene Supervision Over Cosmetics (China Ministry of Health, 1990). Cosmetic regulation continued very slowly in China over the next fifteen years until about 2007. During that time, China became the third largest market of cosmetics, behind only the United States and Japan (Kline and Company, 2006). Subsequently, China has established one of the most complicated, frequently-changing, and extensive requirements for the registration of cosmetics in the world. And since the beginning of China safety regulations for cosmetics, there has been the requirement for using animal models for toxicological endpoints.

In February 2012, the China State Food and Drug Administration (sFDA) made the most significant change to its regulations since 1990. That action – the issue of a Comment Letter on the Management of Ordinary Cosmetics (China sFDA, 2012a) – affected nearly all cosmetic products in China. It created a new category of “Type II” special use cosmetics which include children’s and mother’s products, lip and eye-area products, acne, dandruff, new technologies, and ingredients determined by the sFDA to be related to “efficacy.” This last addition was done to keep companies from avoiding testing, including animal testing, by eliminating certain special use claims on their packaging while still utilizing materials that are commonly used for such special use benefits. This was a common practice to speed a product through the review process at the provincial level since special use products may take six months or more to be reviewed at the State (national Government) level. Although some animal testing requirements were reduced, the overall effect was a significant increase in animal testing in China. Now, many additional categories of cosmetics require animal testing – including some of the largest categories, eye and lip products. Anti-aging products are now also required to have some animal testing where before this may not have been needed for provincial review.

Prior to this modification, cosmetics were classified into two categories, ordinary cosmetics and special-use cosmetics (China Ministry of Health, 2007). Special use cosmetics, also known as “functional cosmetics,” made specific claims for sunscreens, body shaping, hair growth, hair dyes, and freckle “whitening” products. These products required a more formal State-level registration process and review which included animal testing for eye and skin irritation, acute oral, dermal sensitization, and phototoxicity. On the other hand, ordinary cosmetics would be reviewed at the provincial level and often could be sold without the need for animal testing. The change made earlier this year was introduced by the sFDA to strengthen the safety of ordinary cosmetics based on their claims and safety risk, including the need for animal testing on products which could previously be sold without such testing.

Why would a country which has gone through such modernization want to “step back” into more animal testing when nearly all other countries are moving away from animal testing? It comes down to lack of familiarity with (and consequently comfort with) non-animal methods and consumer risk. Over the past few years, China has faced several scandals regarding product safety. It would be difficult to find a consumer in the West who has not read in the press of concern regarding Chinese-based children’s products or tainted milk. The Chinese sFDA has the responsibility to protect their citizens just as Western agencies, such as the USFDA, protect theirs. The difference is that China has not had the same opportunity for understanding toxicology, establishing safety checkpoints, and conducting extensive risk assessments, which over the years have provided other countries the comfort to accept alternatives to traditional animal-based toxicology. However, the changes within the sFDA review process are not all bad news for the cosmetic industry and non-animal replacements. To summarize a statement by sFDA Director Tong Min, the person in charge of the department that regulates China cosmetics: China has only had a brief exposure to toxicology and cosmetics. The West has had decades to develop these methods and experts in the field. These experts are needed to help train China in alternatives.

Encouragingly, the sFDA has seen the need to move forward to newer methods of safety assessment and has asked for assistance. As many have already heard, the sFDA recently issued a draft guideline for the in vitro 3T3 NRU Phototoxicity assay as their first non-animal replacement (China sFDA, 2012b). Additionally, the sFDA has internally-issued a five-year program on implementing alternatives into the review process along with a training program (Personal Communication, February 2012). These alternatives are focused on OECD in vitro test guideline methods either issued or under review. This is where efforts such as the IIVS International Outreach Program (IIVS, 2012), and others, become crucial to help provide training to Chinese laboratory-based scientists, provide guidance to product safety reviewers to interpret such data, and instill confidence within sFDA management that the Chinese consumer is as well, if not better, protected than with animal testing.

However, if we can learn anything from the past, it is that any effort in China needs to be frequent, sustained, detailed, and without judgment. Too often meetings with Chinese scientists or regulators were “one meeting and done” or without sufficient detail to allow changes to be actually implemented within China. After decades of working on non-animal methods in the US and Europe, these methods have become relatively common place, but this experience does not currently exist in China. Just think of the questions for setting up an in vitro testing laboratory today. How does one obtain and use the proper equipment? How does one properly obtain bovine eyes for the Bovine Cornea Opacity and Permeability (BCOP) assay? What values should be expected for positive and negative controls for a given assay? What are the proper application techniques for volatiles, surfactants, and viscous materials? What about exposure times? And so on and so on. Why should we expect that by simply having a protocol or test guideline available that it would mean an immediate acceptance by the sFDA or the ability to run the assay within China?

The call for assisting China in developing a non-animal methods program has been made by many Chinese agencies (International Symposium on Technology and Application of Alternatives to Animal Testing, 2011), including the sFDA (First International Symposium on Cosmetics, 2011). However, anyone or any program that wishes to go into China and move non-animal methods forward should develop a strategy that has been well thought through (including all the endless, but very necessary, details). Outside groups or individuals need to be committed to be in China often enough to help provide guidance as new difficulties emerge, and they should have resources available to work out unforeseen and complicated situations. It will not be a short or easy process, but one that is difficult, sometimes frustrating, but rewarding all the same. It will require companies, laboratories, and many government and non-government organizations to begin to work in a more cohesive faction. Just as there has been an extraordinarily rapid rise in the China marketplace for cosmetics, there could possibly be as equally an impressive growth in accepting non-animal methods should this opportunity be given the care and commitment it needs.

References
China Ministry of Health. (1990). Regulations on the Hygiene Supervision Over Cosmetics. (Order 3 MOH) January 1, 1990.

China Ministry of Health. (2007). Hygienic Standard for Cosmetics. (2007 Edition, MOH).

China sFDA. (2012a). Comment Letter on Alternative Method of Phototoxicity Study Through 3T3 Neutral Red. (Letter no. 45).

China sFDA. (2012b) Comment Letter on the Management of Ordinary Cosmetics. (Letter no 57).

First International Symposium on Cosmetics – Alternatives to Animal Experimentation for Cosmetics.(2011). China Cosmetics Research Center (CCRC) of the Beijing Technology and Business University with major support from the Food Licensing Department of the SFDA, Beijing, China.

IIVS. (2012) IIVS Expands International Outreach Program for Acceptance of Non-Animal Testing For Cosmetic Products. http://www.iivs.org/news-events/press-releases/iivs-expands-international-outreach-program-for-acceptance-of-non-animal-testing-for-cosmetic-products/.

International Symposium on Technology and Application of Alternatives to Animal Testing. (2011). The Center for Disease Control (CDC) and Prevention of Guangdong Province and the Laboratory Animal Center of Southern Medical University. Guangzhou, China.

Kline and Company. (2006). Global Cosmetics and Toiletries.

Personal communication with Dr. He Zhengming. (February 2012).