Animal-Test Alternatives Progress In China Despite Regulatory Uncertainty

China took steps earlier this year to begin phasing out required animal-testing for selected cosmetic products; however, the Chinese government has yet to approve any alternative assessment methods. Nonprofit organizations and leading firms such as L’Oreal are focused on helping stakeholders to incorporate in vitro test methods internally and develop their scientific and technical know-how as the regulatory picture crystallizes.

Despite evolving infrastructure for alternative cosmetic testing in China, the regulatory climate remains hazy, according to L’Oreal SA, which recently obtained a license to market Episkin reconstructed skin models in the country for testing substances without the use of animals.

“Today there are no regulatory alternative methods accepted in China,” a L’Oreal rep said in an email to “The Rose Sheet.”

Moreover, there are “no specific guidelines to define which tests could be accepted. Discussions are ongoing between industry associations and authorities to clarify this point,” the rep added.

L’Oreal subsidiary Shanghai Episkin Biotechnology Ltd. announced Sept. 29 its receipt of a business license from China’s State Administration for Industry and Commerce to sell Episkin in vitro testing technology, described as “a human epidermis model reconstructed from Asian keratinocytes.”

The method can be used to assess skin corrosion, irritation and phototoxicity, among other safety and efficacy endpoints, according to SkinEthic Laboratories, a Nice, France-based leader in tissue engineering that L’Oreal acquired in 2006 to advance its commitment to the development of alternative testing strategies.

According to the L’Oreal rep, the firm will not seek the China Food and Drug Administration’s approval of Episkin as an accepted alternative test in the cosmetics sector “because at this point CFDA does not have any specific guidelines to accept any data coming from alternative methods.”

The European Center for the Validation of Alternative Methods formally validated the Episkin model for skin-irritation testing in 2007 (Also see "ECVAM Validates Non-Animal Test Methods For Assessing Cosmetics Safety" - HBW Insight, 7 May, 2007.).

In an Oct. 15 post to its ChemLinked website, consulting firm REACH24 acknowledged that the Episkin model could be a viable alternative to replace animal-based cosmetics safety assessments, but expressed reservations about the technology’s usefulness in the current Chinese regulatory environment.

“Without the support of CFDA, it is not worth spending money to buy the model which has no regulatory precedent,” REACH24H asserts.

L’Oreal Targets Episkin For Internal Use

While authorities in China appear to be warming to the prospect of using alternative test methods to curtail animal use in the cosmetics industry, regulatory impediments continue to pose challenges.

A rule implemented at the end of June 2014 lifted China’s requirement for finished-product animal testing as it relates to non-special-use cosmetics manufactured domestically, including shampoo, makeup, perfume and many skin-care products. (Also see "In Brief: OTC Monograph Feedback Wanted; China Animal Testing; More" - HBW Insight, 7 Jul, 2014.).

However, firms are required to demonstrate products’ safety, and as of now the CFDA has not approved any alternative tests for doing so.

Given the lack of regulatory clarity in China, L’Oreal currently is targeting Episkin to companies for use in their internal research programs independent of oversight requirements.

According to a Sept. 29 release, the firm started producing reconstructed Asian skin in China in 2008. L’Oreal notes that its research laboratories in Shanghai observe the same production and quality-control standards as the firm’s Gerland, France-based Predictive Evaluation Center.

“Once the [China] subsidiary is set and the tissues are being produced and sold, all companies will have these tissues available for a wide variety of applications following their needs – safety evaluation, efficacy evaluation, fundamental research, etc.,” the L’Oreal rep said.

L’Oreal recently conducted a study with four laboratories affiliated with China’s AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) in its work toward validating Episkin for skin-irritation endpoints in line with Organization for Economic Co-operation and Development guidance, the rep noted.

“This is the very first validation of standardized and normative animal testing alternative methods in accordance with international standards in China,” L’Oreal said. The study offers a solid foundation for future expansion of non-animal testing based on the Episkin model, according to the firm.

However, the rep was clear that while the study could “influence the CFDA and its experts towards a better understanding and favorable attitude to the non-animal testing recognition in the future, it does not imply a current situation for technical approval and acceptance by CFDA.”

According to the Gaithersburg, Md.-based Institute for In Vitro Sciences, Episkin could have a significant impact on the Chinese market even without CFDA’s approval.

“The availability of these reconstructed human skin and eye models are incredibly important tools for cosmetics and personal care, chemicals [firms] – all sorts of companies to use – to ultimately replace animal testing,” the nonprofit group’s Vice President of Program Development Erin Hill said in an interview.

At the same time, she said firms can use Episkin for internal purposes, “in product development and screening of materials and things like that, but until there’s been this official acceptance, it would have limited utility.”

CFDA’s plan and timeline for approving alternative cosmetic-testing methods is unknown.

“Like any regulatory setting, the process can be quite lengthy at times,” Hill said. “On the other hand, in China things can move very quickly. If somebody within the CFDA decides that they really want to move this forward, I think this could move much faster than it has.”

She continued: “I have faith that they will start to accept these methods that have been approved by the OECD, and those will probably be the first tests that they approve. Once the first one is done, hopefully it will be easier and faster for the others to be approved.”

China Authorities Building Expertise

Meanwhile, Chinese regulators are investing in research and training to enhance their scientific and technical expertise in the area of non-animal testing methods.

IIVS recently signed a memorandum of understanding with CFDA division the National Institute for Food and Drug Control (NIFDC) to work collaboratively on projects focused on cosmetic safety testing that incorporates and promotes in vitro techniques.

Last year, IIVS conducted a training workshop at NIFDC’s Beijing laboratory to educate Chinese regulators on alternative testing methods for evaluating cosmetics safety, with plans to hold annual training sessions going forward.

“The NIFDC has a great responsibility to introduce in vitro techniques to a large number of regulators within China,” Hill says in a release. “IIVS is honored to assist them in achieving this goal. Additionally our expertise in validation projects will be helpful as new in vitro methods are developed within China.”

In an interview, she added: “We are putting our efforts into technically training the scientists so that they’re able to more quickly adopt in vitro methods. We don’t prescribe what a country should do or how they should implement them, we just help technically to support their efforts to review a method that they’re interested in,” Hill said.

IIVS notes that NIFDC’s Institute for Food and Cosmetic Control has been responsible for testing cosmetics for pre-market approval, post-market surveillance and enforcement investigations since 2012. IFCC currently is constructing a new in vitro laboratory to advance its alternative-testing platform.

“With our expanded laboratory space and support from IIVS experts, we will be able to organize workshops to train many more scientists within China on the use of in vitro methods for testing of cosmetics,” says IFCC Director Wang Gangli.

According to Hill, the response to the workshops and training in China has been overwhelming.

“The scientific community both within government, within industry, even the academics that we meet, are really excited about in vitro technology,” she said. “There’s a lot of enthusiasm. I think people are really waiting for some official approval of the methods so they can be used more widely, but the scientific interest is really incredible.”

Market Shaped By Animal-Testing Policy

According to market research firm Organic Monitor, China’s mandatory animal-testing policy for many cosmetic products has limited the market for natural and organic personal care in the country.

Foreign manufacturers of ordinary-use cosmetics, and all marketers of special-use cosmetics, must subject their finished products to animal testing under Chinese regulations, representing a marked divergence from oversight in Europe and animal-friendly movement around the globe.

As a result, growth in the natural and organic cosmetics segment has dwindled, with avowed cruelty-free brands deciding not to enter China or exiting the market due to associated PR challenges.

In the past 18 months, natural and organic cosmetics brands Weleda, Lavera, Pangea Organic, Logona and Juice Beauty have removed their products from the Chinese market as a protest against mandatory animal testing, Organic Monitor notes.

The exodus has China ceding market share for natural and organic cosmetic products to other Asian countries, such as India, Thailand and Singapore, the consulting firm suggests.

India has taken strides of late to address animal-testing concerns, banning domestic animal testing in the cosmetics sector and prohibiting the import of animal-tested cosmetics starting in November (Also see "In Brief: India Animal Test Ban; Lauder Acquires Le Labo; More" - HBW Insight, 20 Oct, 2014.).

While local Chinese players are free to register ordinary-use cosmetics without animal testing if they have qualifying safety data from other sources, few are taking on the natural and organic market, largely due to ingredient-sourcing issues, according to Organic Monitor.

“There is low availability of certified organic ingredients and natural extracts, which are mainly imported into China,” the market research firm says. “Formulators and product developers also lack technical expertise in removing synthetic ingredients from cosmetic formulations.”