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Lip gloss and foundation OEM for Malaysia: how are colourant lists and heavy-metal limits met?

For Malaysia cosmetic listing, OEM colourants and heavy-metal limits must be verified against the NPRA guidelines and the applicable ASEAN directive annexes, which are adopted via the Control of Drugs and Cosmetics Regulations 1984. The formulation must use only colourants on the permitted annex and within restricted levels. All regulatory references must be confirmed against the latest official texts. Final compliance is confirmed through the formal NPRA QUEST 3+ notification.

1Permitted and restricted colourants

All colourants for lip gloss and foundation must be drawn from the latest NPRA colourant annex, aligned with the ASEAN Cosmetics Directive (ACCD). Restricted or prohibited colourants (e.g., some azo dyes, azo reds not on the list) must be excluded. Carmine (CI 75470) requires clear labelling. All entries confirmed against the latest official text.

2Heavy-metal limits and testing

Lead, arsenic, mercury and cadmium are limited to the values specified in the Malaysian cosmetic regulation. Testing via ICP-MS or AAS is required; batch representivity testing recommended. Disperse stability of pigment batches affects lot-to-lot colour consistency; sealed samples must be retained.

3NPRA QUEST 3+ notification pathway

A Malaysian CNH registered with SSM files the pre-market notification via QUEST 3+, valid for 2 years, renewal at least 1 month before expiry. Labels must carry full INCI, country of manufacture and CNH details. Halal claims require JAKIM certification. All regulatory references confirmed against the latest official text.

Follow-up questions

Q:Can the domestic CN colourant list be used directly for Malaysia export?
A:No. The NPRA colourant list and restricted items must be verified individually against the latest Malaysian regulation annex.
Q:How to label Carmine (CI 75470) in a deep-red lip gloss for the Malaysian market?
A:List CI 75470 / Carmine on the INCI label. For halal channels, assess synthetic alternatives. All regulatory references per the latest official text.

Figures sourced from:各国法规 · 马来西亚马来西亚彩妆代工东盟化妆品指令附录配方库

Updated 2026-09-18

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