Most foreign brands assume that a formula cleared for sale in the EU, Korea, Japan or the United States will be acceptable in Malaysia, and it usually is. The problem is the exceptions, and the fact that they are only discovered at a timeline that is too late.
Malaysia controls cosmetic ingredients through a set of annexes to the Guidelines for Control of Cosmetic Products in Malaysia, published by the National Pharmaceutical Regulatory Agency (NPRA). These annexes are aligned with the ASEAN Cosmetic Directive rather than with any single Western regime, and they are revised regularly.
The current versions of the prohibited, restricted, colouring agent and preservative annexes were released on 10 June 2026. The UV filter annex was released on 12 December 2025. Any screening carried out against an earlier version shall be considered being out of date.
This article explains which annexes apply, how they change, what the transition periods mean for products already on the market, and how to screen a formula before it goes into production.
The Six Ingredient Annexes
| Annex | Covers | Current release |
| Annex II | Substances which must not form part of the composition of cosmetic products | 10 June 2026 |
| Annex III | Substances which cosmetic products must not contain except subject to restrictions and conditions laid down | 10 June 2026 |
| Annex IV | Colouring agents allowed for use in cosmetic products | 10 June 2026 |
| Annex V | Substances excluded from the scope of the Directive | May 2010 |
| Annex VI | Preservatives which cosmetic products may contain | 10 June 2026 |
| Annex VII | UV filters which cosmetic products may contain | 12 December 2025 |
The distinction between Annex II and Annex III is the one that matters most in practice.
Annex II is absolute. A substance on this list cannot be present in a cosmetic product placed on the Malaysian market. There is no concentration at which it becomes acceptable.
Annex III is conditional. These substances are permitted, but only within stated concentration limits, only in stated product types, and often only where a specified warning appears on the label. A formula can clear the concentration limit and still fail because the label does not carry the required wording. The condition and the limit are part of the same entry, and both have to be met.
Annexes IV, VI and VII work as positive lists. A colouring agent, preservative or UV filter must appear on the relevant annex to be used at all, and then within the conditions given there.
Annex V is the outlier. It has not been revised since 2010 and covers substances excluded from the scope of the Directive rather than substances controlled by it.
Why Home-Market Compliance Does Not Transfer
Malaysia follows the ASEAN Cosmetic Directive, which has its own committee structure and its own review cycle. The annexes often track EU amendments closely, because ASEAN frequently adopts EU scientific opinions, but they do so on a delay and not always in full.That produces three situations foreign brands run into.
A substance may be restricted in Malaysia but unrestricted at home, so nothing in your existing documentation flags it.
A substance may be prohibited in Malaysia later than it was prohibited in the EU, which means an older EU formula reformulated years ago is fine, while a formula built to a different regional standard may not be.
Most commonly, a substance is acceptable in both places but at different concentration limits or in different product categories. A leave-on limit and a rinse-off limit are not the same, and a substance permitted in a rinse-off product may be restricted or prohibited in a leave-on one.
None of these show up unless the formula is screened against the Malaysian annexes specifically.
How the Annexes Change
The mechanism is worth understanding, because it determines how much notice you get.Amendments originate at the ASEAN Cosmetic Committee (ACC), which meets periodically with the ASEAN Cosmetic Scientific Body. Decisions taken there are then adopted into Malaysian practice by NPRA, which issues a circular announcing the updated status of substances in the annexes and republishes the affected annexes.
Recent examples give a sense of the pace:
Circular 2/2023, issued July 2023, added 19 substances to the prohibited list and introduced restrictions on several others, including salicylic acid.
Circular 1/2025, issued July 2025, followed the 41st ACC meeting and added further entries to the prohibited and restricted lists.
Circular 1/2026, issued February 2026, followed the 42nd ACC meeting held in Jakarta in November 2025. It added 4-methylbenzylidene camphor to the prohibited list, and prohibited miconazole and miconazole nitrate.
Circular 2/2026, issued July 2026, updated the prohibited, restricted, colouring agent and preservative annexes, including further restrictions on anti-fungal agents and concentration limits on ingredients used in skin-lightening formulations.
The practical point is that this happens roughly once or twice a year, without much warning, and it applies to products already notified as well as to new ones.
Transition Periods
When a substance is newly prohibited or newly restricted, NPRA usually sets out what happens to products already on the market. This is where the detail matters.Some changes take effect immediately from the date of the circular. In Circular 1/2026, miconazole and miconazole nitrate fell into this category, meaning affected products were no longer permitted on the market from the date of issuance.
Other changes come with a transition period, during which products already notified and containing the substance may remain on sale until a stated date. In the same circular, 4-methylbenzylidene camphor was given a transition running to 17 November 2028.
Two things follow from this.
First, a transition period is not an extension of compliance. It is considered a grace period. Manufacturing and importing new stock containing the substance is generally not what the grace period is for, and the end date arrives sooner than it appears when you are managing a product portfolio.
Second, and more importantly, the Cosmetic Notification Holder is the party responsible for acting on these changes. No member at NPRA will contact you to say that one of your notified products now contains a prohibited substance. The obligation to review the portfolio after each circular sits with the notification holder, and where that holder is a distributor rather than a party you control, it is worth confirming that the review is actually being done.
Beyond the Annexes
Two further sets of limits sit outside the ingredient annexes and are missed regularly.Heavy metals and microbiological limits. Annex I Part 14 of the guidelines sets out heavy metal and microbiological test limits for cosmetic products. These are not formula-composition questions but finished-product specifications, and they are typically demonstrated through testing rather than through raw material documentation. Contract manufacturers do not always test to Malaysian limits by default.
Non-permissible product names. Annex I Part 2 lists product names that are not acceptable for cosmetics. This interacts with ingredient choice more often than brands expect, because a name implying a therapeutic action can move the product out of the cosmetic category regardless of what is actually in it.
Product-specific guidelines also apply in some categories. Sunscreens, hand sanitisers and antibacterial hygiene wash products each have their own guideline within Annex I, and these carry requirements over and above the general annexes.
Screening a Formula in Practice
The sequence that works, in the order that avoids rework.Start with the full quantitative formula, not the INCI list from the pack. You need concentrations, because Annex III is entirely concentration-dependent. A qualitative list tells you which substances to look up but not whether they pass.
Confirm the product category and how it is used. Leave-on and rinse-off are treated differently, and several annex entries are restricted to particular product types. The same substance at the same concentration can pass in one category and fail in another.
Check every substance against Annex II first. This is the cheapest check and the one with no way back. Anything on the prohibited list ends the discussion.
Then check against Annex III, and read the full entry rather than the concentration column alone. Note any label warnings, any product-type restrictions, and any conditions of use. These become artwork requirements, which is why this step has to happen before artwork is drafted.
Check colourants, preservatives and UV filters against Annexes IV, VI and VII. These are positive lists, so absence from the list is itself a failure.
Confirm the annex versions you used. Record the release dates. If your screening was done six months ago and a circular has been issued since, the screening needs revisiting.
Check the finished-product specifications against the heavy metal and microbiological limits, and confirm your manufacturer can supply testing to those limits.
Keep the screening record. It forms part of the safety assessment within the Product Information File, and it is what you will want on hand if a substance in your formula is affected by a future circular.
Where Foreign Brands Come Unstuck
Screening against an outdated annexure. The prohibited, restricted, colourant and preservative annexes were all reissued on 10 June 2026. Screening carried out before then needs redoing.Checking the concentration but not the condition. An Annex III entry usually carries a permitted concentration, a product-type restriction and a mandatory label warning. Meeting one of the three shall not be considered being in compliance.
Assuming the supplier has checked. Raw material suppliers work to their own market's standards. A material declared compliant for the EU may not be compliant with the ASEAN annexes.
Screening the INCI list rather than the formula. Without concentrations, Annex III cannot be applied at all.
Ignoring product category. Leave-on, rinse-off, oral, eye area and mucous membrane products are treated differently under several entries.
Treating notification as the end of the obligation. The annexes change after your product is on the market, and the notification holder carries the duty to act.
Leaving screening until after manufacturing. A restricted ingredient found in finished stock is a write-off. Found in a formula on paper, it is a reformulation.
Overlooking the positive lists. Brands check for banned substances and forget that colourants, preservatives and UV filters must be affirmatively permitted.
Frequently Asked Questions
1. Where are Malaysia's cosmetic ingredient lists published?In the annexes to the Guidelines for Control of Cosmetic Products in Malaysia, published by NPRA. Annex II covers prohibited substances, Annex III restricted substances, Annex IV colouring agents, Annex VI preservatives and Annex VII UV filters.
2. How current are the annexes?
The prohibited, restricted, colouring agent and preservative annexes were released on 10 June 2026. The UV filter annex was released on 12 December 2025. Foreign companies are advised to confirm the current release dates on the NPRA website before relying on any screening.
3. If an ingredient is permitted in the EU, is it permitted in Malaysia?
Not necessarily. Malaysia follows the ASEAN Cosmetic Directive. The lists overlap substantially but not completely, and concentration limits and permitted product categories can differ.
4. What is the difference between Annex II and Annex III?
Annex II is a prohibition with no permitted concentration. Annex III permits the substance subject to concentration limits, product-type restrictions and conditions of use, which often include a mandatory label warning.
5. What happens to my product if an ingredient in it is newly prohibited?
It depends on the circular. Some prohibitions take effect immediately from the date of issuance. Others allow products already notified to remain on the market until a stated date. The Cosmetic Notification Holder is responsible for reviewing the portfolio and acting.
6. Who is responsible for checking after an update?
The Cosmetic Notification Holder. NPRA does not notify individual holders that a notified product is affected.
7. Do I need concentrations to screen a formula?
Yes. Annex III entries are concentration-dependent, so an INCI list without percentages cannot be screened properly.
8. Are there limits beyond the ingredient annexes?
Yes. Annex I Part 14 sets heavy metal and microbiological test limits for finished products, and certain categories such as sunscreens and hand sanitisers have their own product-specific guidelines.
9. How often do the annexes change?
Typically once or twice a year, following ASEAN Cosmetic Committee meetings, though the timing is not fixed.
10. Does a restricted ingredient affect my label?
Often, yes. Many Annex III entries require a specific warning on the label, which is why ingredient screening should be completed before artwork is finalised.
Conclusion
Ingredient screening is the cheapest compliance step in a Malaysian cosmetic launch and the most expensive one to skip. A restricted substance identified on paper costs a reformulation. The same substance identified in a container of finished goods costs the stock.Three points are worth carrying away. Screening has to be done against the Malaysian annexes specifically, because home-market clearance does not transfer. It has to be done against the current release of those annexes, which changed on 10 June 2026. And it has to be repeated, because the obligation does not end at notification and the duty to act on changes sits with the notification holder rather than with the regulator.
For brands whose notification is held by a distributor, that last point deserves a direct question: who is reviewing the portfolio after each circular, and how would you know if they were not?
Need a formula screened before you manufacture?
We screen cosmetic formulas against the current ASEAN Cosmetic Directive annexes as adopted by NPRA, covering prohibited and restricted substances, colouring agents, preservatives and UV filters, together with the label warnings that restricted ingredients carry.We also provide independent Cosmetic Notification Holder services, NPRA notification through Quest 3+, label and artwork review, and Product Information File compilation, including ongoing portfolio review as the annexes are updated.
Contact us to discuss your formula before it goes into production.
