Malaysia Cosmetic Preservatives Positive List (ACD Annex VI): Limits and Warnings at a Glance

In Malaysia, cosmetic preservatives are not a matter of "add whatever you like." The National Pharmaceutical Regulatory Agency (NPRA) adopts Annex VI of the ASEAN Cosmetic Directive (ACD) as the "positive list" of preservatives—only substances on the list may be used as preservatives, and each has a maximum permitted concentration, use restrictions and warnings that must be printed on the label. Preservatives not on the list may not be added at all; once a limit is exceeded or a warning is missing, NPRA can order a notified product off the shelf or cancel its notification. This article summarises the limits and labelling points for the most commonly used preservatives, but actual formulation must always follow the current Annex VI text.

The positive-list logic of Annex VI

• Part 1 (allowed list) sets out usable preservatives (58 items in rev12); Part 2 (provisionally allowed list) currently contains no items.
• Only listed substances may serve a "preservative function"; items marked (+) on the list may also serve other purposes (e.g. a deodorant in soap, an anti-dandruff agent in shampoo), and the concentration for that purpose may be calculated separately according to how the product is presented.
• Essential oils and some alcohols have antimicrobial activity but are not on this list (Annex VI foreword point 3) and cannot be treated as "registered preservatives."
• The list has clear definitions for "salts" and "esters"; when converting concentrations they must be expressed as the "acid" or the specified basis.

Cosmetic preservatives are also affected by other annexes: if an ingredient appears on the Annex II prohibited list it may not be used at all, and if it has a separate non-preservative restriction on the Annex III restricted list, that must be met too.

Maximum permitted amounts for common preservatives

The above are ACD Annex VI values; for detailed conditions and the other 40-plus items, check against the main text.

Don't miss the "mandatory warnings"

Column e of Annex VI requires certain preservatives to carry a fixed warning on the label; a missing warning constitutes non-compliant labelling:

• Finished products releasing formaldehyde: where free formaldehyde in the finished product exceeds 0.05%, it must be labelled "contains formaldehyde."
• Salicylic acid, IPBC: must add warnings such as "Not to be used for children under 3 years of age."
• Chlorobutanol, Thiomersal, Chloroacetamide, Glutaraldehyde, Benzalkonium, etc.: each has its own dedicated warning (e.g. "Contains chlorobutanol," "Avoid contact with the eyes").

Preservatives are themselves ingredients and must be listed in the ingredient list by their INCI name—you cannot simply write "preservative."

Imports and local products are treated alike

The preservative list and concentrations are ASEAN-harmonised standards: imports and locally manufactured products are subject to the same Annex VI, and the limits do not vary by country of origin. The difference between imports and local products lies in the notification holder, country of origin and language labelling fields—not the preservative limits themselves.

Common mistakes

• Assuming "natural preservation" is exempt from regulation—substances not on the list cannot be used as registered preservatives, and natural antimicrobial activity is often insufficient, leading to microbial exceedances.
• Looking only at the single-ester 0.4% when mixing multiple parabens, forgetting that mixed esters must total 0.8%.
• Directly adopting the latest EU limits—the ASEAN version is not necessarily updated in sync, so always check against the current ACD Annex VI.
• Failing to apply the stricter dedicated limits and prohibitions for children's, oral and eye-area products.

Frequently asked questions (FAQ)

Q: If I just label it "natural, no added preservatives," am I exempt from Annex VI? No. If the product does contain a substance with a preservative function, that substance must still be an Annex VI listed item and meet the concentration limit; and NPRA requires that products containing natural ingredients must not mislead consumers into thinking "natural therefore safe."

Q: Can parabens still be used in Malaysia? Yes. 4-hydroxybenzoic acid esters (commonly methyl/ethyl/propyl/butylparaben) are listed in Annex VI, with a single-ester limit of 0.4% and mixed esters totalling 0.8%. However, some branched and phenyl-type parabens have been placed on the ASEAN Annex II prohibited list, so always check the prohibited list before use.

Q: Can MIT / CMIT be used in leave-on products? Annex VI lists MIT at 0.01% and the CMIT/MIT mixture at 0.0015%. Both are known allergens; even within the limits, the PIF safety assessment must still evaluate their sensitisation risk in leave-on products, and it is advisable to switch leave-on products to another preservative system.

Q: Do preservatives have to be listed in the ingredient list? Yes. Preservatives are ingredients and must be listed by INCI name; some also require an additional fixed warning.

Q: How often is the list updated? The ASEAN Cosmetic Committee (ACC) periodically revises the annexes, adding, amending or deleting items; the Part 2 provisional section is currently blank. Before launch, always rely on the latest version on the NPRA website.

Self-check checklist

• [ ] All preservatives used are Annex VI listed items
• [ ] Concentrations do not exceed the item's limit (mixed esters totalled)
• [ ] Correct limits applied by dosage form (rinse-off / leave-on / oral)
• [ ] Dedicated restrictions applied for children's / eye-area / oral products
• [ ] "Contains formaldehyde" labelled where formaldehyde release >0.05%
• [ ] Other mandatory warnings (salicylic acid, IPBC, etc.) added
• [ ] Preservatives listed by INCI name in the ingredient list

Conclusion

Malaysia runs a "positive list" system for cosmetic preservatives: what you may use, how much, and what warnings you must display are all written into ACD Annex VI. Stick to the three things—use only listed items, stay within the concentration, and carry the warnings—and prepare a safety assessment in the PIF, and you will greatly reduce the risk of a notification being rejected or a product being pulled. For the full notification system, see the cosmetic NPRA guide.

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This article is compiled from official sources for reference only; actual compliance is subject to the latest official texts and reviews of the competent authorities.