Cosmetic Prohibited Ingredients: ACD Annex II and Common Pitfalls (Mercury, Hydroquinone)

Cosmetics have a list of prohibited ingredients — anything on the list must not be added under any circumstances. Use one and you are non-compliant: the product will be banned by NPRA, its notification cancelled, and it will be withdrawn; in serious cases legal liability may follow. This list is Annex II of the ASEAN Cosmetic Directive (ACD). This article helps you understand how prohibited ingredients are regulated, which are the most commonly stepped-on landmines, and how to catch them yourself before going to market. (For the full overview, see the Malaysia Cosmetic Regulations and Labelling Guide.)

How are prohibited ingredients regulated?

Malaysia manages this through the list of prohibited ingredients in Annex II of the ASEAN Cosmetic Directive (ACD); ingredients on the list must not be added to cosmetics, with no room for "a slightly lower concentration is fine" — if it appears at all, it is prohibited. This is fundamentally different from "restricted ingredients": a restricted ingredient is "usable under conditions", whereas a prohibited ingredient is "completely unusable". To label and cross-check ingredients correctly, first get to grips with INCI naming and the prohibited/restricted regime (see Cosmetic Ingredients INCI and Prohibited/Restricted Lists).

Why does this list exist?

Prohibited ingredients are mostly substances with a clear health risk: some are neurotoxic or organ-toxic, some carry carcinogenic or sensitising concerns, and some are active ingredients that "belong to medicines in the first place". Cosmetics are positioned for cleansing, care and improving appearance, and must not carry pharmacological therapeutic action; so many ingredients that, under medicines regulation, require a doctor's prescription or pharmacist supervision, once put into a cosmetic amount to letting consumers be exposed long-term without professional supervision — an uncontrollable risk. This is precisely the core reason they are listed in Annex II.

Common landmines banned by NPRA

These four categories are almost entirely concentrated in products marketed for "fast results" — whitening, spot-lightening, anti-acne, rapid resurfacing. The reason is blunt: they work fast, which is exactly why unscrupulous operators add them illegally; but precisely because their pharmacological action is strong, long-term use of mercury accumulates toxicity, and hydroquinone and steroids cause skin damage and dependence. NPRA regularly announces cancellations of notification / bans on products containing these ingredients, which is why "whitening" is a heavily inspected category (see further The Complete Compliance Guide to Whitening Products in Malaysia).

The knock-on effects of being banned

Being placed on a public ban notice is not as simple as "this product is withdrawn". First, the notification is cancelled and the product must immediately stop being sold and imported; stock already distributed must be recalled, and product listings on platforms will be taken down. Second, containing a prohibited ingredient is often regarded as deliberate violation — a heavy blow to the reputation of the brand and holder, and subsequent notifications and inspections of the holder's other products will be scrutinised more strictly. Third, if consumers are harmed by using the product, civil or even criminal liability may follow. In other words, saving the cost of one ingredient cross-check can cost you the entire brand's trust in the Malaysian market — which is exactly why "blocking prohibited ingredients before going to market" is always far more worthwhile than "dealing with it after being caught".

Common mistakes

• An imported formula contains an ingredient prohibited locally without anyone noticing — allowed in the country of origin does not mean allowed in Malaysia.
• Products marketed for "rapid whitening / spot-lightening / acne removal" with hydroquinone, mercury, tretinoin or steroids mixed into the formula.
• Relying only on the supplier's "safe" assurance without cross-checking Annex II item by item yourself.
• Not building ingredient cross-checking into the safety assessment and PIF (see Cosmetic PIF and Safety Assessment).

Pre-market self-check checklist

• [ ] Cross-check every ingredient against ACD Annex II and confirm there are no prohibited ingredients.
• [ ] For imported products, re-check ingredients against Malaysian rules (not the country of origin).
• [ ] For products with "fast-result" claims, specifically re-examine whether medicinal ingredients have been mixed in.
• [ ] The results of the ingredient cross-check are built into the safety assessment and PIF.
• [ ] The ingredient list provided by the supplier matches the actual formula.

Frequently asked questions (FAQ)

Q: Isn't hydroquinone very effective? In Malaysia it is a medicines-controlled ingredient and is prohibited in cosmetics; violating products will be banned. However effective it is, it cannot be used in cosmetics.

Q: How do I make sure my ingredients don't hit a prohibited one? Cross-check each one against ACD Annex II and complete the check within the safety assessment in your PIF; for any doubtful ingredient, assume first that it cannot be used, then verify.

Q: If the country of origin allows it, does Malaysia definitely allow it too? Not necessarily. The prohibited list is governed by Malaysia (ACD); permission in the country of origin cannot serve as a basis for exemption.

Q: What about a prohibited substance present in trace amounts, not deliberately added? A prohibited ingredient must not be added as a formula ingredient; if it is an impurity, it must be controlled within an acceptable range in the specifications and safety assessment, with substantiation provided.

Conclusion

The principle for prohibited ingredients is simple: ACD Annex II must never be used; mercury, hydroquinone, tretinoin and steroids are the most common landmines, and they cluster in whitening and fast-result products. Want to check whether your ingredient list has any problems? Run a free label check now, or get in touch with us.

This article is compiled from official NPRA guidelines and is for reference only; actual compliance is subject to the latest official text and review by the competent authority.