Cosmetic Restricted Ingredients and Concentration Limits (ACD Annex III)

Some ingredients are not banned outright but may only be used under conditions — they carry a concentration limit, a restricted scope of use, or must have a warning on the label. These "restricted ingredients" are listed in Annex III of the ASEAN Cosmetic Directive (ACD). Unlike prohibited ingredients, which "must never be used", restricted ingredients are "lawful if you keep within the conditions, non-compliant if you cross the line" — and where things go wrong most often is not the ingredient itself, but exceeding the concentration or omitting a required warning. This article helps you understand the three main restrictions in Annex III and the key labelling points. (For the full overview, see the Malaysia Cosmetic Regulations and Labelling Guide.)

How are restricted ingredients regulated?

Under Annex III of the ASEAN Cosmetic Directive (ACD), restricted ingredients are given three kinds of restriction, which may appear singly or together:

• Concentration limit: must not exceed the prescribed maximum concentration of use.
• Scope / conditions of use: for example, rinse-off products only, or not for use on mucous membranes or specific age groups.
• Corresponding warning: must be labelled as prescribed, to remind consumers of correct and safe use.

In other words, the same ingredient may be allowed in a rinse-off product but restricted in a leave-on one; usable in an adult product but not in a product for young children. Judging compliance cannot be based only on "is this ingredient present", but on "where is it used, how much, and is the required warning labelled as prescribed".

Why restrict rather than prohibit outright?

These ingredients have genuine practical value — preserving, exfoliating, colouring, hair dyeing — and are only risky at high concentrations or in specific situations. Rather than banning them outright, it is better to frame them within safe conditions of use, balancing function and safety. This is also why the safety assessment is so crucial: a qualified person must confirm that your amount and manner of use both fall within the frame of Annex III (see Cosmetic PIF and Safety Assessment).

Common examples

Take AHA / fruit acids as an example: they involve concentration and pH, and also require reminding users to protect against the sun — three conditions to be met at once; without the sun-protection warning, even a compliant concentration counts as non-compliant. Hair-dye ingredients commonly have "concentration limit + allergy test / allergy warning" together. Many of these warnings cross over with sun-protection and restricted-ingredient topics; for SPF products, see also Sunscreen UV Filters and SPF Labelling.

Labelling notes

When a product contains a restricted ingredient that requires a warning, the warning must actually be labelled on the product (see Cosmetic Mandatory Labelling Items: Annex I Part 7); omission is non-compliance. In practice, the three most common errors are:

1. The concentration is compliant, but the required warning is not labelled.
2. An imported product's original label does not add the corresponding warning as required by Malaysian rules.
3. The warning is labelled, but the type is too small or the position too inconspicuous for the consumer to actually see.

The purpose of a warning is for the consumer to "see it before use", so being clear, legible and in a reasonable position matters just as much as being correct in content.

How to gate-keep restricted ingredients one by one?

In practice it is advisable to break the restricted-ingredient check into three steps. First, once you have the complete formula, cross-check every ingredient against Annex III and list all the "conditional" ingredients — don't just pick a few from memory. Second, for each restricted ingredient, check three things at once: is the concentration over the limit; do the use / age group / rinse-off or leave-on type meet the conditions; and is there a required warning. Third, write these judgements into the safety assessment and PIF, so that the records and the label match. The benefit of doing this is that even if you later switch supplier or fine-tune the formula, you can quickly go back and compare which condition has been affected, rather than re-checking the whole batch. Violations of restricted ingredients are often not "not knowing it can't be used" but "knowing it can be used, yet failing to keep within the conditions" — the key to gatekeeping is putting every condition into practice on the label and in the documentation.

Pre-market self-check checklist

• [ ] Cross-check every ingredient against ACD Annex III and list all restricted ingredients.
• [ ] The concentration of every restricted ingredient is within its limit.
• [ ] The scope / age restriction matches the product type (e.g. rinse-off, products for young children).
• [ ] All warnings required by Annex III are labelled on the product and are clear and legible.
• [ ] Concentrations and conditions are built into the safety assessment and PIF.

Frequently asked questions (FAQ)

Q: What happens if the concentration limit is exceeded? It is non-compliant; the notification can be cancelled and the product withdrawn. Concentration limits leave no room for "a little over is fine".

Q: Must restricted ingredients always carry a warning? Where Annex III prescribes a warning, it must be labelled; where no warning is prescribed, you must still comply with the concentration and conditions of use.

Q: Are the restrictions on the same ingredient the same in different products? Not necessarily. The restrictions on the same ingredient may differ between rinse-off and leave-on, and between adult and children's products, so compare against Annex III according to the actual use.

Q: For imported products, can the warning be in the original language only? The label must comply with Malaysia's labelling rules, and the corresponding warning must be understandable to local consumers; for details, see the article on mandatory labelling items.

Conclusion

The three yardsticks for restricted ingredients: the concentration limit + conditions of use + corresponding warning in ACD Annex III — all three must be attended to. The most common failure is not using the wrong ingredient, but exceeding the concentration or omitting a warning. Want to check whether your formula concentrations and warnings are in place? Run a free label check now.

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.