Scalp care is the one place in beauty where the marketing, the regulator and the science are currently telling three different stories — and a brand only finds out on the day artwork goes to print. The trend itself is real and well-evidenced: consumers across Asia-Pacific have stopped treating shampoo as a cleaning product and started treating the scalp as skin, which is why exfoliating scalp serums, microbiome-balancing tonics and barrier-repair pre-wash oils now sit in briefs that used to say “anti-dandruff, cherry scent.” What travels less well is everything underneath the concept. In Malaysia, the most persuasive sentences in a scalp pitch are on the regulator’s unacceptable-claims list. The single most established anti-dandruff active is legal here and banned in Europe. And the most recent microbiome work quietly undermines the one-active-one-villain story that most scalp products are still sold on. This piece maps those three collisions for the person who has to sign the purchase order.
Written and researched by Priya Nair, Indie Beauty Brand Strategist · Article type: Independent Editorial · Scope: claims, ingredient-eligibility and sourcing implications of the scalp-care direction in hair care, with Malaysian, ASEAN and European Union reference points · Research period: September 2026 · Last reviewed: September 2026 · Corrections: via the site contact page.
Quick answer: what can a scalp care brand actually claim and use?
In Malaysia a cosmetic scalp product may claim to control, reduce or prevent dandruff, to reduce hair fall caused by physical factors such as breakage, and to strengthen or nourish the hair root — but it may not claim to stimulate or promote hair growth, to permanently eliminate dandruff, to reverse hair loss, or to treat seborrhoeic dermatitis or cradle cap. On ingredients, zinc pyrithione remains permitted in ASEAN as a preservative in rinse-off hair products up to 1.0 per cent, while the European Union has prohibited it in cosmetics since 1 March 2022. The practical consequence is that a scalp product built for Malaysia is not automatically a product that can be exported. Decide the destination market before the formula is locked, not after.
Key takeaways
- The National Pharmaceutical Regulatory Agency (NPRA) publishes a claims table with a row specifically for hair and scalp care products. It is short, blunt, and it rules out most of the language a scalp-care trend deck uses.
- “Stimulate or promote hair growth” is unacceptable. “Helps to strengthen or nourish the hair root or hair follicle” is acceptable. The distance between those two sentences is the entire commercial argument of the category.
- Dandruff and hair loss are recognised in Malaysia only as acceptable secondary claim areas — a minor function alongside a cosmetic primary one, not the product’s reason for existing.
- Zinc pyrithione was added to the European Union’s prohibited list by Regulation (EU) 2021/1902 and has been unusable in EU cosmetics since 1 March 2022, on a reproductive-toxicity classification rather than a finding of in-use harm.
- The same molecule sits in the ASEAN Cosmetic Directive’s preservative annex at 1.0 per cent for hair products, rinse-off only. One region’s workhorse is the other region’s prohibited substance.
- A 2025 multi-omics study of oily scalps found Staphylococcus at 58.70 per cent in dandruff-affected scalps against 23.85 per cent in healthy oily scalps, with Cutibacterium falling from 63.24 to 27.87 per cent — while Malassezia restricta barely moved.
- That finding matters commercially: if dandruff is a community shift rather than one fungus, single-active efficacy stories are weaker evidence than the supplier deck implies, and the testing bill is larger.
- Rinse-off versus leave-on is not a format preference. It changes which actives are legal at what level, and it is the first question a buyer should settle.
Who this is for
This is written for indie founders, private label buyers and category managers who have a scalp-care concept in hand — usually a serum, a pre-wash treatment or an exfoliating scalp scrub — and now have to decide what to commission, which market to build for, and what the carton may legally say. It is a claims and sourcing view rather than a formulation tutorial. If you are still choosing a manufacturing partner, our list of hair care manufacturers in Malaysia is the better starting point; if you have not yet mapped what testing a first batch requires, the pre-first-batch testing checklist sets out the work this article assumes you will be paying for.
Why is scalp care being briefed like skincare?
Because consumers stopped separating the two, and the category followed them. Across Asia-Pacific the demand pattern in hair care has shifted from cosmetic outcomes — shine, softness, hold — towards scalp condition as the thing being bought, which is the shift Azelis describes in its review of what APAC consumers now demand in hair care. The practical expression of that shift is a vocabulary transplant. Salicylic acid, niacinamide, hyaluronic acid, ceramides, prebiotics and postbiotics have all moved from facial skincare briefs into hair care briefs, and the formats have moved with them: leave-on serums, essences, ampoules and overnight treatments in a category that was structurally rinse-off for a century.
The logic is sound. The scalp is skin, with a higher density of sebaceous glands, a distinctive microbial population and a barrier that behaves much like facial skin under stress. Treating it as skin is a defensible position, and it is why the category has grown fast enough to justify dedicated supplier ranges. The problem is that the vocabulary transplant carried the marketing across but left the regulatory framework behind. A facial serum and a scalp serum are governed by the same cosmetic rules — but the claims those rules permit for a hair and scalp product are narrower and more specifically enumerated than most brand teams expect, and the ingredient eligibility differs by format in ways that a skincare-trained team has never had to think about.
What may a scalp product legally claim in Malaysia?
Malaysia answers this unusually directly. Annex I Part 8 of the Guidelines for Control of Cosmetic Products in Malaysia sets out a five-step decision process for whether a proposition is a cosmetic at all, then gives worked examples of acceptable and unacceptable claims by product type. Hair and scalp care products are the first row of that table. Unlike most regulatory documents, it names the exact phrases.
| Common scalp-care phrasing | Status in Malaysia (Annex I Part 8) | What may be said instead |
|---|---|---|
| Stimulates / promotes hair growth | Unacceptable | Helps to strengthen or nourish the hair root or hair follicle |
| Permanently eliminates or stops dandruff | Unacceptable | Controls, reduces or prevents dandruff |
| Hair loss can be arrested or reversed | Unacceptable | Anti-hair-fall, or control of hair fall due to a physical factor such as breakage |
| Treats hereditary or hormonal hair loss, baldness, alopecia | Unacceptable | No cosmetic equivalent — this is a medicinal proposition |
| Prevents or treats cradle cap or seborrhoeic dermatitis | Unacceptable | No cosmetic equivalent — naming the condition moves the product out of cosmetics |
| Restores hair cells | Unacceptable | Promotes healthy hair |
| Prevents grey hair | Unacceptable | No cosmetic equivalent |
| Thickens hair / adds volume | Acceptable with a caveat | Increase hair volume, where this is the physical effect of the product — temporarily adding volume and body to thin or flat hair |
Two structural points sit behind that table and matter more than any individual phrase. The first is the asterisk. The guideline permits “anti-hair loss / hair fall” only where the loss is attributable to a physical factor such as hair breakage, and permits “increase hair volume” only where the volume is the physical effect of the product. In both cases the acceptable claim is describing a cosmetic, mechanical outcome. The moment the mechanism being implied is biological — follicle activity, growth cycles, cellular restoration — the claim has crossed into territory the guideline reserves for medicinal products.
The second point is easy to miss and shapes the whole brief. The guideline lists dandruff and hair loss among acceptable secondary claim areas: a minor function outside the main cosmetic scope that a product may also address. A cosmetic’s main function must still be to clean, perfume, change appearance, correct body odour, or protect and keep the relevant body part in good condition. A product whose entire identity is the treatment of dandruff, presented as its purpose rather than an additional benefit, is walking towards decision point four of the guideline — whether the product is presented as treating or preventing disease — and that is where cosmetic status ends. This is the same structural line we mapped for skin longevity claims, and scalp care approaches it from the other direction.
Why is the same anti-dandruff shampoo legal in Malaysia and illegal in Europe?
Because the two regimes assessed zinc pyrithione against different questions and reached opposite conclusions. Zinc pyrithione has been the default anti-dandruff active for more than six decades, and for a Malaysian or ASEAN scalp brief it remains available: the ASEAN Cosmetic Directive’s Annex VI list of permitted preservatives carries it at a maximum of 1.0 per cent in hair products and 0.5 per cent in other products, restricted to rinse-off products only and excluded from oral hygiene products.
In the European Union it is prohibited. Commission Regulation (EU) 2021/1902 added zinc pyrithione to Annex II, the list of substances banned in cosmetic products, with effect from 1 March 2022 — a prohibition that applied to stock already on shelves, not only to new launches. The reasoning is the part buyers should understand, because it is not what most people assume. The ban followed the substance’s harmonised classification as toxic for reproduction category 1B under the European Union’s chemicals rules. Under the Cosmetics Regulation, a substance carrying that classification is prohibited by default and can only stay in use through a narrow derogation that requires, among other things, evidence that no suitable alternative exists. Zinc pyrithione did not clear that bar. Notably, the European Union’s own Scientific Committee on Consumer Safety had concluded in 2020 that use in rinse-off hair products below 1 per cent was safe for consumers. It was banned anyway, on classification and substitutability grounds rather than a finding of consumer harm.
For a buyer this produces one very concrete rule: the destination market has to be decided before the formula is locked. A Malaysian-market anti-dandruff shampoo built around zinc pyrithione is a compliant, unremarkable product at home and an unsellable one in Europe. Reformulating later is not a substitution exercise — the replacement actives behave differently in surfactant systems, carry their own restriction levels, and reopen preservative-efficacy and stability testing. That is real money and real weeks, spent twice. If Europe or the United Kingdom is anywhere in the three-year plan, brief the alternative chemistry now. Our guide to substantiating clean and sustainable claims covers the same trap in a different category: the cost of a claim is nearly always the evidence, and the cost of an ingredient is nearly always the market it closes.
One caution on currency. Annex listings are amended periodically by the ASEAN Cosmetic Committee, and the version referenced here is the release available publicly at the time of writing. Ingredient eligibility is exactly the kind of fact that should be confirmed against the current annex release and with your manufacturer’s regulatory contact before a formula is committed, not taken from an article — including this one.
Does the science still support the single-active dandruff story?
Less than the category’s marketing assumes. The conventional model is straightforward: Malassezia yeast metabolises scalp sebum, the by-products irritate, flaking follows, so an antifungal active fixes it. That model built the anti-dandruff aisle and it is not wrong. It is, on the current evidence, incomplete in a way that changes how a brand should read an efficacy claim.
A 2025 multi-omics analysis of oily scalps published in Frontiers in Microbiology compared healthy and dandruff-affected scalps and found the sharpest differences on the bacterial side. Yu and colleagues reported Staphylococcus at 58.70 per cent in the dandruff group against 23.85 per cent in healthy oily scalps, with Cutibacterium moving the other way — 63.24 per cent in healthy oily scalps down to 27.87 per cent in the dandruff group. Malassezia restricta, the organism the whole category is built around, differed far less: 3.39 per cent in the dandruff group against 4.32 per cent in healthy oily scalps. The authors’ reading is that dandruff on an oily scalp reflects an imbalanced microbial community rather than a single causative organism. A 2025 review of seborrhoeic dermatitis and its interplay with Malassezia reaches a similarly qualified conclusion: the yeast is involved, but host factors, sebum composition and the surrounding bacterial community determine whether its presence produces symptoms.
Three commercial consequences follow. First, an ingredient story built on “this active reduces Malassezia” is answering a narrower question than the consumer’s. Second, if the target is a community shift, the honest efficacy endpoint is a clinical or consumer-perception outcome on flaking, itch and sebum — not a laboratory kill-rate on one organism, which is what suppliers most often supply. Third, and most usefully, this is precisely why microbiome-balancing positioning has commercial room: the science genuinely points that way. It is also why the substantiation is expensive, because measuring a community shift is a sequencing study, not a plate count. Expect that gap to appear between the supplier’s data pack and what your claim actually needs.
Rinse-off or leave-on: the decision that sets everything else
Settle this first, because it silently determines ingredient eligibility. The scalp-care trend pushes towards leave-on formats — serums, tonics, pre-wash oils — because that is how facial skincare works and because a leave-on product has a longer contact time and a higher perceived value. But several of the restrictions that matter in this category are written specifically for rinse-off products. Zinc pyrithione’s ASEAN preservative entry is rinse-off only. Salicylic acid, the exfoliant most often requested for scalp “skinification” briefs, carries its own restriction levels and a standing caution about use in products for young children. A brief that says “a leave-on version of our anti-dandruff shampoo” is not a line-extension request. It is a request for a different formula with a different active system, different preservation, and its own stability and compatibility work.
| Decision | Why it is settled early | What it changes downstream |
|---|---|---|
| Destination markets, including three-year plan | Ingredient eligibility diverges between ASEAN and the EU/UK | Active selection, preservative system, whether one formula can serve both |
| Rinse-off or leave-on | Several restrictions are written by format, not by product name | Which actives are permitted and at what level; contact time; irritation testing |
| Primary versus secondary claim | Dandruff and hair fall are acceptable only as secondary claim areas | Whether the product remains a cosmetic; how the pack front is written |
| Claim wording, checked phrase by phrase | The guideline names specific unacceptable phrases | Artwork, e-commerce copy, influencer briefs, and reprint cost |
| Efficacy endpoint and who pays for it | Community-level microbiome claims need community-level evidence | Testing budget, timeline, and whether a claim survives scrutiny |
What to ask a manufacturer before committing
The questions below are the ones that surface disagreement early, while it is still cheap. Ask them in writing and keep the answers.
- Which markets is this formula compliant for, and which does it close? Ask for the answer by market, not as a general assurance. Specifically ask whether the anti-dandruff or anti-hair-fall active is permitted in the European Union and the United Kingdom.
- Is the active present as a preservative or as a functional active, and at what percentage? The same molecule can be permitted for one purpose and restricted for another, and the annex entry differs accordingly.
- Which of our proposed claims have you seen challenged before? A manufacturer that regularly handles notification in Malaysia has watched wording get pushed back. That experience is worth more than a compliance checklist.
- What evidence supports the efficacy claim — and what exactly was measured? Ask whether the study measured a single organism in vitro, or a clinical or consumer-perception outcome on real scalps. Ask for the sample size and duration.
- If we move this from rinse-off to leave-on, what changes? If the answer is “nothing much,” ask again. The correct answer names the actives affected and the retesting required.
- Who signs off the artwork against the claims guideline, and at what stage? The expensive failure in this category is not a rejected formula. It is a printed carton.
Two red flags are worth naming. A supplier presentation that uses “stimulates growth,” “regrowth,” or names a condition such as seborrhoeic dermatitis is either selling into a different regulatory regime or has not read the Malaysian table — either way, verify everything else in the deck. And an efficacy pack consisting only of in-vitro antifungal data for a product positioned on microbiome balance is a mismatch between what was measured and what is being claimed. Neither is disqualifying. Both need a conversation before a deposit.
Frequently asked questions
Can a Malaysian scalp serum say it reduces hair fall?
Yes, within limits. The NPRA claims guideline lists “anti-hair loss / hair fall” and “treatment or control of hair loss / hair fall” as acceptable, with the qualification that the loss is due to a physical factor such as hair breakage. What it does not permit is a claim to arrest or reverse hair loss, or any reference to hereditary or hormonal loss, baldness or alopecia. In practice this means the claim should be framed around reducing breakage-related fall rather than around growth or regrowth. Have the exact sentence checked against the guideline before it reaches artwork.
Is zinc pyrithione banned in Malaysia?
No. Zinc pyrithione appears in the ASEAN Cosmetic Directive’s preservative annex at up to 1.0 per cent in hair products and 0.5 per cent in other products, restricted to rinse-off products and excluded from oral hygiene products. It is the European Union that prohibited it, from 1 March 2022, under Regulation (EU) 2021/1902. Because annex listings are amended periodically, confirm the current position against the latest annex release and with your manufacturer’s regulatory contact before locking a formula for any market.
Does a scalp product need different testing from a face serum?
Often yes, and the differences are usually underestimated. Contact time, rinse-off versus leave-on status, the surfactant system and the higher sebum load all affect both irritation potential and preservative efficacy, so a facial protocol does not transfer unchanged. If a claim concerns dandruff, flaking or the scalp microbiome, the endpoint has to match the claim — a consumer-perception or clinical measure rather than a single-organism laboratory result. Agree the protocol and who pays for it before development starts.
Can one scalp formula serve both Malaysia and the European Union?
Sometimes, but only if it is designed that way from the start. The divergence on zinc pyrithione is the clearest example: a formula built around it is compliant in Malaysia and prohibited in the European Union. Building a single dual-market formula generally means choosing actives and preservatives that clear the stricter regime, which usually costs more per unit and may perform differently. The decision is a commercial one, and it belongs at the briefing stage rather than after the first production run.
Is “microbiome-friendly” a claim a brand can safely make?
It is not a defined regulatory term, which cuts both ways. It is not on Malaysia’s unacceptable list, but an unsubstantiated claim is still a problem, and the guideline directs the regulator to weigh promotional material, packaging and target audience alongside the label. If the claim is made, it should rest on evidence that actually measured a microbial community rather than a single organism. The safer commercial position is to describe what the product does — soothes, balances sebum, reduces flaking — and reserve microbiome language for cases where a sequencing-based study genuinely supports it.
Sources and further reading
- National Pharmaceutical Regulatory Agency, Guidelines for Control of Cosmetic Products in Malaysia, Annex I Part 8 — Guideline for Cosmetic Claims (Second Edition, August 2022).
- Commission Regulation (EU) 2021/1902 amending Annexes II, III and V of Regulation (EC) No 1223/2009 as regards CMR substances.
- ASEAN Cosmetic Directive, Annex VI — list of preservatives which cosmetic products may contain (Version 2021-1, 15 November 2021).
- Yu H, Li J, Wang Y, Zhang T, Mehmood T, Habimana O, “Dysbiosis and genomic plasticity in the oily scalp microbiome: a multi-omics analysis of dandruff pathogenesis”, Frontiers in Microbiology 16:1595030 (2025).
- “Seborrheic Dermatitis: Exploring the Complex Interplay with Malassezia” (2025 review).
- Source / inspired by: Azelis Personal Care, “In tune with tresses: what APAC consumers demand in hair care”, part of the Azelis Personal Care inspiration hub.
- Further reading, manufacturer’s perspective: ORIZI Group, “Why a Scalp Serum Brief Often Becomes Two Different Products” — the same decisions seen from inside a contract manufacturer.
Limitations
This is a desk review of published regulatory documents and peer-reviewed literature, not a laboratory assessment or a legal opinion. Annex listings under the ASEAN Cosmetic Directive and the European Union Cosmetics Regulation are amended periodically, and the versions cited here are those publicly available at the time of writing; ingredient eligibility should be confirmed against the current release before a formula is committed. The claims examples are drawn from Malaysia’s published guideline and describe how the regulator has framed acceptable and unacceptable wording — individual assessments can still turn on packaging, promotional material and product presentation as a whole. The microbiome findings cited come from specific study populations and should not be read as universal. No manufacturer, supplier or ingredient producer contributed to or reviewed this article.
Update history
September 2026 — first published.
This article is general information for brand owners and sourcing teams. It is not regulatory, medical or legal advice. Claim acceptability and ingredient eligibility depend on the specific product, its presentation and the market it is placed on — verify both with the relevant authority and your manufacturer’s regulatory contact before committing to a formula or to artwork.