China's Draft Cosmetic Regs Would Relax New-Ingredient Oversight

A revised draft of China's Cosmetics Supervision and Administration Rule reflects regulatory practices in the West, proposing that manufacturers be primarily responsible for substantiating the safety of cosmetic products. Most importantly, the updated framework would require notification, rather than premarket approval, of many new cosmetic ingredients, addressing a notoriously onerous market impediment in the country, according to Personal Care Products Council exec Francine Lamoriello.

The latest draft of China's Cosmetics Supervision and Administration Rule proposes a risk-based approach to regulating new ingredients in the country, among other changes that would reduce administrative red tape and more closely align China's oversight system with internationally accepted strategies.

China's FDA submitted the revised CSAR, formerly the Cosmetic Hygiene Management Regulation, to the State Council on July 20 and accepted public comments on the draft through Aug. 20.

In an Aug. 20 interview with "The Rose Sheet," Francine Lamoriello, executive vice president for global affairs at the Personal Care Products Council, said the proposed system for managing new cosmetic ingredients in China is the "biggest, most significant and important change" in the revised draft.

Under China's current regime, all ingredients that are considered new – even if they have market experience in other countries – need to be approved by CFDA, a notoriously long and burdensome process (Also see "Victor In China’s Cosmetic-Ingredient Approval Process Tells His Story" - HBW Insight, 29 Apr, 2013.).

Under the overhauled CSAR, cosmetic manufacturers in most cases would notify CFDA of new-ingredient use. The agency then would launch a public comment period and review available scientific information to determine if the ingredient poses safety concerns, Lamoriello explained.

Companies would be subject to a three-year reporting period, submitting findings annually to CFDA from their post-market monitoring programs to identify potential safety issues.

While optimistic about the proposed changes, Lamoriello noted that it could take a year or two for the draft to be polished and accepted, and then there likely will be a grace period before the updated regulations come into effect.

The revised approach is part of a larger shift in the draft CSAR recast to make cosmetic manufacturers primarily responsible for substantiating the safety of their products.

Only new ingredients deemed high-risk, including preservatives, sunscreens, hair colorants and whitening agents, would be ineligible for use via the streamlined pathway. The revised CSAR draft is still murky on requirements for high-risk ingredients – i.e., the information companies would have to submit and criteria CFDA would use to evaluate safety, according to the PCPC exec.

In its comments to the agency, the trade group requested clarification on those points and offered suggestions for harmonizing China's requirements with other regulatory frameworks around the globe.

"We want to make sure that the text of the law itself includes very specific and scientifically based criteria as to what would constitute a new high-risk ingredient," she said.

Moreover, the group seeks assurance that firms will be allowed to conduct their own safety assessments using internationally recognized best practices, including the use of animal-testing alternatives, she said.

"That's never stated in the text. … We want to make sure that if you do those safety assessments, you also don't have to have your products or ingredients tested in Chinese labs," she said.

At the same time, flexibility should be built into the regulation to account for the diversity of companies that stands to be affected, Lamoriello suggested. "For companies in China that may not have the ability to conduct their own high-level safety assessments, that would prefer to go get testing done at Chinese labs, that should be an option."

Changes Are Promising, But Could Be Slow To Arrive

Overall, PCPC is highly encouraged by the proposed CSAR revision, which reflects stakeholder comments submitted against a previously released draft.

That iteration, made available in November 2014, similarly proposed making product-safety substantiation largely the responsibility of manufacturers, but came up short in some key areas, from industry's perspective (Also see "China FDA’s Cosmetics Proposal Could Herald Historic Regulatory Reform" - HBW Insight, 21 Nov, 2014.).

The newly issued draft "made tremendous progress from the draft that was issued in November in resolving some of the outstanding issues in places where China's regulations were really out of step with international good regulatory practices and international cosmetics regulations," Lamoriello said.

She continued: "We think it really reflects the needs of a more modern industry and an evolution of an industry that is becoming more and more global."

PCPC objects to a proposal that would require firms to provide information to a public database substantiating the benefit claims they make in advertising, which would undermine confidentiality and potentially confuse consumers, the group suggests.

The revised draft's reform measures would help address the evolving needs of Chinese consumers, facilitate foreign manufacturers' access to the Chinese marketplace and give China's own industry improved opportunities to be global players, Lamoriello said.

However, she cautioned that finalization and implementation of the proposed changes likely will take time. It's unclear what priority level the CSAR revamp will have with the State Council, the chief administrative authority in China, and once an official consultation launches, relevant ministries will have the opportunity to weigh in, she noted.

All told, it could take a year or two for the draft to be polished and accepted, and then there likely will be a grace period before the new regulations come into effect, according to Lamoriello.

"We're enthusiastic about the potential for real reform that this proposal reflects, but it's not going to change overnight; this is going to take a bit of time," she said. "We're very encouraged and want to look for ways to support CFDA as they make these very significant changes."

Leveling The Playing Field

PCPC is pleased that Chinese authorities are recognizing the viability of controlling cosmetic risks by entrusting industry with product safety assessments and employing post-market surveillance mechanisms to shore up manufacturers' own safety-assurance work.

If the proposed reforms go through, greater emphasis will be placed on adverse-event reporting, post-market sample testing and other monitoring efforts, compared with the current system that relies heavily on time- and resource-consuming pre-market approvals, according to Lamoriello.

PCPC also applauds proposed CSAR changes that would balance China's regulatory treatment of imported and domestically manufactured cosmetic products.

The exec noted that currently, China's requirements for ordinary cosmetics – which cover most cosmetic categories, excluding hair dyes and perms, whitening skin-care products and sunscreens – are different for manufacturers within its borders, which can register products at the provincial CFDA level, compared with importers, whose products are subject to "a more rigorous approval process at the central level."

Under the new CSAR draft, manufacturers of imported products would continue to register items with CFDA's central unit, but "all the notification information, deadlines, process is all the same" as for domestic firms registering through provincial offices, the exec explained.

The latest revision also seems to have resolved a controversial proposal in the previous draft that would have banned "overlabeling," the practice of placing a sticker of a product label in Chinese overtop of a label from another country.

"We really advocated very strongly that a ban on the overlabel would have really been a trade barrier. It would have required companies to have special product packaging for China and would have delayed product launches," she said, adding that the new draft permits label stickering according to accepted international practices.

Draft Calls For Public Claims Substantiation

PCPC is optimistic that CFDA will rethink a proposal in the latest CSAR draft that would make data substantiating advertising claims available for public scrutiny.

Concerns about exaggerated benefit claims prompted a provision that would require firms to provide information to a public database in support of the assertions they make in advertising.

"This is a very competitive business, and that's considered confidential business information," Lamoriello explained. Moreover, "we made the point that that kind of data is very confusing for consumers; they wouldn't necessarily know how to interpret that."

While firms substantiate their claims as a matter of routine practice and have related documentation available for regulators upon request, "we object to publishing that on a national database," the exec said.

Additionally, the revised regulation in its current form would bring oral care into CFDA's regulatory ambit. While consistent with the previously released draft, the proposal remains an unwelcome change from industry's point of view.

Oral-care products to date have been subject only to the supervision of China's Quality Inspection Department, a system that PCPC believes has proven adequate for managing risks. Classifying the products as cosmetics would mean tighter oversight and potentially needless burdens for manufacturers, she suggested.

In parallel with its CSAR reform efforts, CFDA released Aug. 12 a new draft of the Cosmetic Safety Technical Standard, previously called the Hygienic Standard for Cosmetics.

Much of the regulation comprises lists of ingredients approved or not approved for use in China and lays out safety requirements for finished cosmetic products, according to Lamoriello.

While PCPC is still working through the draft, the exec said it appeared to be similar to a previous draft released in April, which updated the lists of banned and restricted ingredients (Also see "China’s Overhaul Of Cosmetics Regs Would Promote Level Competition" - HBW Insight, 28 Apr, 2015.).

Comments will be accepted through Sept. 1.