Foreign firms that complete the manufacturing process for their ordinary-use cosmetics in China or have an office in the country often are exempt from animal-testing requirements under the relaxed stance China FDA adopted last year for domestics, according to Cruelty Free International's Director of Policy Nick Palmer.

"For instance, if you manufacture in America but you have it bottled in China, that counts as Chinese-produced," he said in a Sept. 2 interview. "The authorities basically say, 'If you say your products are safe, then unless there's a public health alarm about it, we're willing to accept [non-animal safety data].'"

This "liberal interpretation" of China's cosmetic regulations effectively evens the playing field for many foreign entities compared with domestic manufacturers of ordinary-use cosmetics, which include most hair- and skin-care products, makeup, nail care and fragrances.

CFDA announced the final revision to its record-keeping requirements for cosmetic firms in June 2014 amid pressure to reform its animal-testing policy, which previously mandated animal tests conducted by Chinese laboratories for all cosmetic products, deterring "cruelty-free" brands and posing challenges for multinationals subject to the EU's ban on cosmetic animal testing.

While the formal exemption was limited to domestic manufacturers, Palmer says it has ushered in a more lenient position on imported ordinary-use cosmetics, which CFDA increasingly is allowing to be registered and marketed on the basis of companies' own safety data derived from in vitro tests and other alternative methods.

The key consideration is whether importers have representation or manufacturing links in China that provide access to Chinese authorities, Palmer said.

"[CFDA] decided that for now they want to have a physical presence in China for the companies using the new system, so that they have someone local to approach. The new system essentially comes down to the local company office having a Product Information File with safety data that the local FDA can inspect if they wish. If the company doesn't have a local presence then that's not possible."

According to Palmer, multinationals are capitalizing on the option, though visibility is limited as to how widespread the practice is among foreign players with business in China, as companies tend to exercise discretion in their activities due to competitive concerns.

While the development signals promising movement in China away from mandatory animal testing, companies still have to provide safety data to CFDA as part of the registration process for ordinary cosmetics, and it remains hazy what specific alternative test methods are being accepted.

In November, L'Oreal SA said it would not seek CFDA approval of its Episkin reconstructed skin models as an accepted alternative test in the cosmetics sector – despite receiving a license from China’s State Administration for Industry and Commerce to sell the in vitro testing technology in the country – due to the absence of guidelines from the agency specifying criteria for acceptance Also see "Animal-Test Alternatives Progress In China Despite Regulatory Uncertainty" - HBW Insight, 12 November, 2014..

A L'Oreal rep told "The Rose Sheet" at the time that "there are no regulatory alternative methods accepted in China" and “no specific guidelines to define which tests could be accepted," adding that discussions between industry associations and authorities were ongoing to clarify the issue.

Palmer suggested that alternatives commonly utilized in Europe and the U.S. are likely to be accepted in China, but Cruelty Free advises companies to discuss their plans with CFDA before proceeding.

Proposed updates to China's overarching cosmetics regulation, recently released in revised draft form for comment, would further align the country's requirements with international standards, but according to the Personal Care Products Council it's still unclear how animal-testing alternatives would fit into the revamped framework for safety substantiation ([A#02150831006]).

In its comments, the trade group is urging CFDA to provide clarification on the matter, particularly whether alternative test methods could suffice to substantiate safety of new cosmetic ingredients under a proposed new approach that would substantially ease burdens associated with China's notoriously challenging new-ingredient review process.

Cruelty Free is advocating in its feedback on the latest draft proposal for the animal-testing exemption to be extended formally to imports, as well as to special-use cosmetics, which include whitening skin-care products, hair dyes and perms and sunscreens.

Alternatives Training In Progress

Part of the delay in China's acceptance of animal-test alternatives is attributed to insufficient, but developing, scientific infrastructure.

Palmer noted that earlier this year he co-hosted a seminar in Beijing with 40 leaders from Chinese research institutions, in coordination with officials from China's National Institute for Food and Drug Quality Control, focused on cosmetic animal-testing alternatives.

Attendees responded very positively to the seminar, which was designed to familiarize them with the range of alternative test methods available so they are better prepared to engage with the technologies when Chinese regulatory authorities take steps to formally accept them.

Palmer believes regulatory momentum will pick up now that Chinese laboratories have undergone training sessions of this sort.

In a June blog post on the seminar, the exec said China's revised policy enabling domestic producers of ordinary cosmetics to substantiate product safety using their own data has "paved the way for ethical cosmetic companies to develop in the Chinese market without causing suffering to animals. However," he noted, "it is vital that companies know that the official institutions will accept the alternatives, hence our decision to organize this event with our Chinese partners to spread the latest information widely.”

U.S.-based nonprofit Institute for In Vitro Sciences also has been working to educate Chinese scientists on alternative methods.

Most recently, the group trained two scientists from CFDA's Institute for Food and Drug Control in Zhejiang "to assist the agency in adopting non-animal methods as a means to evaluate and monitor cosmetics products manufactured in the Zhejiang province."

“We know it is essential that Chinese laboratories be able to provide non-animal testing methods before the CFDA will approve their use in regulatory submissions,” IIVS co-founder and President Erin Hill says in an Aug. 31 release, adding that the provincial FDA center's goal is to be recognized as a key laboratory for non-animal methods.

China Coming Around To Animal Test Alternatives, Cruelty Free Says

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