Most companies preparing to enter the Malaysian market have their formulas concluded and their launch dates fixed prior to determining what should the label on their product state. Quite often than not, the packaging has already been printed by then.
That sequence is the primary source of labelling problems we see. Formula issues get picked up during ingredient screening, and classification issues get picked up during preparation, but labelling issues tend to surface late, sometimes only when a shipment has already arrived. The remedies at that stage are re-labelling, over-stickering or writing off the stock, and all three are more expensive than getting the artwork right in the first place.
The requirements themselves are published by the National Pharmaceutical Regulatory Agency (NPRA) in the Guidelines for Control of Cosmetic Products in Malaysia. They apply to any cosmetic product sold or supplied here, imported products included, and they have to be satisfied before the product reaches the market.
This article sets out what the label must carry, the rules that catch importers out most often, and a checklist to run through before artwork goes to print.
What Must Appear on the Label
Nine particulars are required on the outer packaging, or on the immediate packaging where there is no outer packaging.| # | Requirement | Notes |
| 1 | Name of the product and its function | Function may be omitted only where it is clear from the presentation |
| 2 | Instructions for use | May be omitted only where clear from the product name or presentation |
| 3 | Full ingredient listing | Ordering rules apply, see below |
| 4 | Country of manufacture | |
| 5 | Name and address of the Cosmetic Notification Holder | The Malaysian CNH, not the overseas brand owner |
| 6 | Contents by weight or volume | Metric, or metric and imperial together |
| 7 | Manufacturing batch number | |
| 8 | Manufacturing or expiry date | See the 30-month rule below |
| 9 | Special precautions, where applicable | Including warnings mandated by the ingredient annexes |
Everything above has to be easily legible, clearly comprehensible and indelible, and the information must be in Bahasa Malaysia and/or English. English on its own is acceptable.
It is worth noting that two of the nine requirements set out above cause more trouble than the rest.
- The fifth requirement is the name and address of the Cosmetic Notification Holder, which means the Malaysian entity holding the notification rather than the brand owner overseas. This has a consequence that is easy to miss at the artwork stage. If you later move the notification to a different holder, for instance because you are ending a relationship with a distributor who has been holding it, the artwork has to change with it. Deciding who holds your notification is therefore also a decision to make prior to printing your label.
- The fourth is country of manufacture, which is not the same as country of brand. A Korean brand manufactured in China shall state the country of manufacture as China.
The Ingredient Listing
This is where imported artwork most commonly fails, because the ordering rules are more specific than brands expect.Ingredients are declared in descending order of weight at the time they are added. Anything present below 1% may be listed in any order, provided it comes after the ingredients present above 1%. Colouring agents may be listed in any order after all other ingredients, using the colour index number or the denomination given in the relevant annex.
Perfume and aromatic compositions, and the raw materials that go into them, can be declared simply as “perfume”, “fragrance”, “aroma” or “flavour” rather than broken down.
For decorative cosmetics sold across several shades, all the colouring agents used in the range may be listed together, as long as the list is preceded by “may contain” or “+/-”.
Nomenclature
Ingredient names must come from recognised standard references. These include the International Cosmetic Ingredient Dictionary and Handbook, pharmacopoeias such as the BP or USP, and Chemical Abstract Services names.Botanicals and botanical extracts have to be identified by genus and species, though the genus may be abbreviated. This one catches a lot of imported artwork, which often lists a plant by its common name and nothing else.
What is not counted as an ingredient
Three categories are excluded from the listing: impurities in the raw materials, subsidiary technical materials used during preparation but not present in the finished product, and materials used in strictly necessary quantities as solvents or carriers for perfume and aromatic compositions.Declaring Ingredients of Animal Origin
This requirement is specific to Malaysia and imported products miss it regularly.Where a product contains ingredients of animal origin, the label must carry a statement signaling that they are present. The format of the statement is not prescribed, so there is some flexibility in how it is worded. However, ehere an ingredient is of bovine or porcine origin, the specific animal has to be declared.
The ingredients that usually trigger this include gelatine, collagen, stearic acid and stearates, glycerin, tallow derivatives, keratin, lanolin, squalene, some emulsifiers, and certain capsule and gel components. Several of these can be either plant or animal derived depending on the supplier, which is why the question is worth putting to your manufacturer in writing rather than assuming. It is a difficult one to answer retrospectively once artwork has been signed off.
It is worth being clear that this is a labelling obligation under the cosmetic guidelines and is separate from halal certification which is administered by a different authority. A company meeting the labelling obligation is mandatory, on the other hand obtaining a halal certification is a commercial decision. The two are sometimes confused.
Dating the Product
The label must show either the manufacturing date or the expiry date. Dates are expressed as month and year, or as day, month and year in that order.Where a product has a minimum durability of less than 30 months, showing the expiry date is mandatory rather than optional. The expiry date should be preceded by the words “expiry date” or “best before”. Where particular storage conditions are needed for the product to last as long as the label claims, those conditions have to be stated alongside.
The date of minimum durability is the date up to which the product, stored appropriately, continues to do what it is supposed to do and remains in conformity with safety requirements.
Precautions and Professional Use
Special precautions are required where applicable, and this includes any warning specified in the ingredient annexes under the conditions of use. It is worth checking the annex entry for each restricted ingredient in your formula, not just the concentration limit. Clearing the limit and missing the accompanying label text is a common oversight, and the two are listed together for that reason.Products packaged in a vial or ampoule must be labelled “for external use only”.
Professional use refers to application by someone in the course of their professional activity, for example hair salons, nail salons, spas and skin clinics. A product supplied for professional use should not then be sold on by the professional to the consumer. If your product is intended for salon channels, both the labelling and the distribution arrangement need to reflect that.
Small Packaging and Bulk Shipments
Where the size, shape or nature of the container genuinely does not allow the nine particulars to be displayed, they can be carried on a leaflet, pamphlet, hang tag, display panel, shrink wrap or similarly. In that case the immediate packaging still has to show the product name and the manufacturing batch number as a minimum.This is a useful provision for sachets, lipsticks, sample sizes and single-use products. However, it is worth noting that this is an allowance for real space constraints rather than a general shortcut, and applying this to a normal-sized package is not likely to be accepted by the authorities.
Where a cosmetic product is imported in a bulk container, that container has to show the product name, the manufacturer's name and the manufacturing batch number.
What You Do Not Need to Print
The notification number does not go on the label. This has been the position since January 2008, but brands still delay artwork waiting for a number they will never print.The practical value of knowing this is in scheduling. Artwork can be finalised and printed as soon as the formula, claims, CNH details and ingredient listing are settled. It does not have to wait for the notification to complete, which means labelling and notification can run in parallel rather than in sequence.
Getting the Order of Work Right
Most labelling problems are really sequencing problems. The order that avoids reprints looks like this.Confirm the classification first, because a product presented as treating or preventing a condition is not a cosmetic and the labelling question becomes moot. Screen the formula against the ingredient annexes next, noting any on-label warnings attached to restricted ingredients rather than just the concentration limits. Confirm the animal-origin status of every ingredient with your supplier, and get the answer in writing.
Then decide who the Cosmetic Notification Holder will be, since you cannot finalize artwork without knowing whose name and address appears on it. Draft the Malaysian label against the nine particulars, review the claims against the evidence you actually hold, and only then approve for printing.
Notification and PIF compilation follow, and the PIF shall include copies of the outer and inner labels.
In practice the first four of those steps are often run in parallel with artwork rather than ahead of it. That is where reprints occur.
Where Imported Artwork Usually Goes Wrong
The most frequent problem is simply using the overseas label unchanged. A European, Korean or Japanese label will not carry the Malaysian CNH details, and the ingredient ordering may not match what is required here.Close behind is printing before the notification holder is appointed, which results in artwork that cannot be used. Then there are the smaller technical failures: botanicals listed by common name without genus and species, a missing animal origin declaration where the supplier was never asked, and an annex-mandated warning left off because only the concentration limit was checked.
We also see the ingredient list treated as a marketing element, with a hero ingredient moved to the front of the list where the descending-order rule would put it further down. That one usually comes from the brand side rather than the regulatory side, which is why it helps to have marketing and regulatory looking at the same artwork.
Finally, brands sometimes forget that a change of notification holder brings a change of artwork with it. It is a structural decision with a printing cost attached, and it is cheaper to get right at the outset than to unwind later.
Pre-Print Checklist
Run through this before artwork is approved.| Check | Confirmed |
| Product name and function stated, or function clear from presentation | ☐ |
| Instructions for use stated, or clear from name or presentation | ☐ |
| Full ingredient list in descending order of weight | ☐ |
| Ingredients under 1% placed after those over 1% | ☐ |
| Colouring agents listed last, with correct index numbers | ☐ |
| “May contain” or “+/-” used for multi-shade ranges | ☐ |
| Botanicals identified by genus and species | ☐ |
| Approved nomenclature used throughout | ☐ |
| Country of manufacture stated | ☐ |
| Malaysian CNH name and address stated | ☐ |
| Contents by weight or volume, metric | ☐ |
| Manufacturing batch number present | ☐ |
| Manufacturing or expiry date, correctly formatted | ☐ |
| Expiry date included where durability is under 30 months | ☐ |
| “Expiry date” or “best before” wording used where applicable | ☐ |
| Storage conditions stated where needed for product durability | ☐ |
| Animal origin declared, with bovine or porcine specifically named | ☐ |
| All annex-mandated warnings for restricted ingredients included | ☐ |
| “For external use only” on vials and ampoules | ☐ |
| Text in Bahasa Malaysia and/or English | ☐ |
| All text legible, comprehensible and indelible | ☐ |
| Claims reviewed and substantiated | ☐ |
Frequently Asked Questions
1. Can I use my existing overseas label in Malaysia?Usually not without changes. The Malaysian Cosmetic Notification Holder's name and address must appear, the ingredient ordering rules apply, and an animal origin declaration may be required. Some brands add a compliant sticker or outer sleeve rather than reprinting the primary artwork.
2. Does the label have to be in Bahasa Malaysia?
The information must be in Bahasa Malaysia and/or English. English alone is acceptable.
3. Does the notification number need to be printed on the label?
No. This has not been required since January 2008.
4. What if the container is too small for everything?
The immediate packaging must show at least the product name and the manufacturing batch number, with the remaining particulars carried on a leaflet, hang tag, display panel, shrink wrap or similar.
5. How should ingredients be ordered?
In descending order of weight at the time of addition. Ingredients below 1% may appear in any order after those above 1%, and colouring agents may appear in any order after all other ingredients.
6. Do I need to declare animal-derived ingredients?
Yes. A statement signalling their presence is required, and where an ingredient is of bovine or porcine origin the specific animal must be named.
7. Is an expiry date always required?
Either the manufacturing date or the expiry date must appear. Where the minimum durability is less than 30 months, showing the expiry date is mandatory.
8. Is halal certification required?
No. Halal certification is administered separately and is voluntary. The animal origin declaration under the cosmetic labelling requirements is a separate and mandatory obligation.
9. Can I print artwork before the notification is complete?
Yes, provided the formula, claims, CNH details and ingredient listing are settled. The notification number is not printed on the label.
10. What happens if a product on the market is found to be mislabelled?
Non-compliant products may be subject to enforcement action under post-market surveillance, which can include cancellation of the notification and product recall.
Conclusion
Malaysian cosmetic labelling is not complicated in principle, but it is detailed, and the details tend to be discovered late. Satisfying the nine particulars is straightforward when the label is drafted before artwork rather than alongside it.Three requirements account for most of the problems on imported products. The Cosmetic Notification Holder's details cannot be finalised until the notification structure is settled. The ingredient listing rules differ from those in several other markets. And the animal origin declaration has no equivalence on most overseas labels, so there is nothing to prompt it.
Settle those three early and the rest of the label tends to follow without difficulty.
Reviewing artwork for a Malaysian launch?
We support foreign cosmetic brands with label and artwork review in accordance to NPRA requirements, ingredient screening in accordance to the ASEAN Cosmetic Directive annexes, claim substantiation review, independent Cosmetic Notification Holder services, NPRA notification through Quest 3+, and Product Information File compilation.A review before printing costs considerably less than a reprint afterwards. Contact us to discuss your product.
