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China FDA’s Cosmetics Proposal Could Herald Historic Regulatory Reform

This article was originally published in The Rose Sheet

Executive Summary

China’s food, drug and cosmetics authority has released proposed changes that would overhaul regulation of the cosmetics industry. The Personal Care Products Council says the draft plan would give manufacturers and distributors “primary responsibility” for product safety substantiation, aligning China’s oversight system more closely with those in the U.S. and EU.

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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.

China’s Overhaul Of Cosmetics Regs Would Promote Level Competition

A revised Cosmetics Hygiene Management Regulation in China likely would extend streamlined pathways to market, currently available to domestic manufacturers, to foreign companies, according to the Personal Care Products Council’s Francine Lamoriello, VP of global strategies. In an April 21 interview, she offered perspective on the proposal under consideration, as well as other recent work to align China’s regulatory framework more closely with that in the U.S. and EU.

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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.

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