Cosmetics Industry Awaits ‘Critical’ Safety Assessment Clarification Under China’s New Framework Reg

The China State Council’s January approval of an overarching Cosmetics Supervision and Administration Regulation promises to bring about long-awaited reforms. But draft regulations targeted for release in coming months will be key to the implementation of CSAR provisions, the Personal Care Products Council says.

China’s recently passed Cosmetics Supervision and Administration Regulation is expected to streamline requirements for foreign companies and put them on equal footing with domestic players, aligning China’s regulatory system more closely with how other modern countries oversee cosmetics.

In a January executive meeting, the China State Council officially approved the latest draft of the CSAR, marking a breakthrough for cosmetics industry stakeholders, though the final text has not yet been made public.

Per a release from the State Council, the CSAR will regulate finished cosmetic products and ingredients based on risk, simplify the registration process, and generally improve the safety and quality of cosmetic products in a country where beauty demand has soared in recent years.

Under the revised framework, China will rely more heavily on manufacturers to ensure the safety of cosmetics, shifting government involvement from premarket check points to postmarket surveillance.

Francine Lamoriello, the Personal Care Products Council’s executive vice president of global affairs, said in late January that she anticipated the final text would be released not long after China’s New Year holidays.

However, that was before coronavirus developments led to the cancellation of New Year events and the shuttering of factories and businesses across China in efforts to contain the virus’ spread, factors that are weighing on the world’s second-largest economy, with growing global implications. (Also see "Estee Lauder Companies: Coronavirus Will Drag On Growth Engines In FY 2020 Back Half " - HBW Insight, 7 Feb, 2020.)

“We’re told that we should expect a lot of proposed [implementing] regulations in the next few months, and they may even go into effect in the next year." – Francine Lamoriello 

When the final CSAR does publish, PCPC expects it to hew closely to previous iterations, albeit with some minor changes likely.

“PCPC and its members are all supportive of CSAR. It will be a reform measure that will be very beneficial to industry as well as to Chinese regulators and Chinese industry,” Lamoriello said.

Importantly, the CSAR promises to even the playing field between foreign and domestic companies, for example in the area of premarket notification for non-special-use cosmetics, which currently can be more onerous for imported products and require more extensive safety data, including animal studies.  (Also see "China On Verge Of Large-Scale Cosmetics Reg Reforms – PCPC Exec" - HBW Insight, 31 Dec, 2018.)

Based on the latest public draft of the CSAR, which was released in December 2018, Lamoriello said companies overall will bear more responsibility for product safety and electronic submission of related assessments – potentially facing increased fines and/or other penalties for violations – in exchange for a more hands-off approach from Chinese officials.

She is hopeful that the final CSAR will include a pathway for imported products – at least those deemed to be low-risk – to avoid animal testing. China has shown itself to be increasingly open to such reforms.

Lamoriello affirmed that PCPC filed comments on a 2019 proposal from China’s National Medical Products Administration that would exempt imported non-special-use cosmetics from current pre-market animal-testing requirements if certain terms are met. (Also see "China May Dispense With Animal-Test Requirements For Imported Non-Special-Use Cosmetics" - HBW Insight, 7 Jun, 2019.)

In addition to the CSAR’s formal publication, industry now awaits regulations that must be issued by Chinese authorities to implement various CSAR provisions and clarify some of the finer details.

“We’re told that we should expect a lot of proposed regulations in the next few months, and they may even go into effect in the next year – I predict by the end of the year,” Lamoriello said.

Implementing regulations on the safety assessment component is one of the “most critical” regulations to come, per the exec.

According to Lamoriello, a PCPC delegation had the opportunity to discuss the requirement with Chinese regulators in early January.

The trade association urged Chinese officials to allow firms to follow international best practices for safety assessments, “incorporat[ing] the most modern and advanced safety assessment techniques and tools,” rather than mandating adherence to an “overly prescriptive” model of China’s own design.