China Puts Numbers on "Three-Year Safe-Use History" in Draft Ingredient Data Rules

Original headline (CN): 中检院征求《化妆品原料数据使用指南（征求意见稿）》意见

The National Institutes for Food and Drug Control released a draft revision of the Cosmetics Ingredient Data Use Guide on November 4, with comments closing November 30. The guide is what brands lean on when they claim an ingredient has a three-year safe-use history instead of commissioning fresh toxicology, and the draft makes that shortcut harder to take casually by attaching quantities: at least 10,000 units of cumulative terminal retail sales, or indirect sales data covering at least 30,000 units, over three years. Two further changes matter. The exemption from systemic-toxicity data for ingredients with a safe edible history now extends to production involving only physical processing, not just food-adjacent manufacturing. For whitening and anti-hair-loss actives, four evidence routes are spelled out — international assessments, authority-set limits, three-year use history and edible history — with the caveat that whitening ingredients unable to exclude long-term skin risk must add a human long-term trial. Filing teams should expect to re-audit dossiers before the window closes. Detail --- Draft guide, published Nov 4 2026 Closes November 30, 2026 10,000 cumulative units over 3

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