Buyer questions · Purchase decisions
Lip gloss and foundation OEM for the United States: how are colourant lists and heavy-metal limits met?
In the US market, color cosmetics must use FDA-approved color additives. Since mineral pigments and talc have inherent heavy-metal backgrounds, batch-level testing for elements like lead is mandatory. Additionally, talc requires batch-specific asbestos testing. Given that e-commerce invariably exposes products to California, the Prop 65 risk must be assessed by comparing ingredients, limit values, and exposure levels, in accordance with the latest official regulatory texts.
1Color additive compliance
All synthetic colorants used in lip gloss and foundation must be FDA-approved color additives for cosmetic use. Unapproved pigments risk the product being deemed adulterated, leading to customs holds or platform removals.
2Heavy metals and asbestos testing
Mineral pigments, clays, and botanics inherently contain heavy metals. Batch-level lead test data from suppliers is required. If talc is present, batch-specific asbestos testing must also be documented.
3California Prop 65 risk check
E-commerce to the US inevitably exposes products to California. Prop 65 risk must be assessed by checking if exposure exceeds safe-harbor levels; conservative label space for a warning should be reserved.
Follow-up questions
- Q:Can BIOSPHERE provide test reports directly?
- A:BIOSPHERE's 36-item QC covers basic tests, but batch-specific heavy metal and asbestos testing must be done by third-party labs; terms are subject to quote.
- Q:How to handle a Prop 65 notice?
- A:The factory will not reply directly; the buyer must immediately forward it to US counsel, while BIOSPHERE only provides supporting records.
Figures sourced from:各国法规 · 美国美国彩妆代工FDA 化妆品禁用与限用成分、色素添加剂配方库
Updated 2026-09-18
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