Skin Brightening Ingredients Explained: What Regulators Allow, What They Ban and Why Mercury Keeps Turning Up in Whitening Creams
Skin brightening is one of the largest skincare categories in Asia and one of the most heavily policed. The same shelf can hold a well-formulated niacinamide serum, a legal arbutin cream and an illegal product laced with mercury or a prescription steroid, and the three can look identical from the front. This article explains how brightening ingredients actually work, which ones Malaysian and ASEAN regulators permit and at what levels, which are banned outright, why mercury and hydroquinone keep appearing in enforcement notices, and what a brand owner should check before putting a brightening claim on a pack.
Quick answer: Legal skin brightening cosmetics work by slowing melanin production or speeding up its removal, using ingredients such as niacinamide, vitamin C and its derivatives, alpha-arbutin, kojic acid, tranexamic acid and licorice extract. In Malaysia and the other ASEAN markets, cosmetics follow the ASEAN Cosmetic Directive, which prohibits hydroquinone, tretinoin, mercury compounds and corticosteroids in cosmetic products; the National Pharmaceutical Regulatory Agency (NPRA) cancels the notification of products found to contain them. The key limitation is that a cosmetic may lighten the appearance of dark spots and even out tone, but it cannot claim to treat melasma or any pigmentation disorder, which is a medicinal claim. A brand owner should ask the manufacturer for the ingredient list with use levels, the raw material specifications and a heavy-metal test for the batch before approving the formula.
Key takeaways
- Melanin is made by tyrosinase in the melanocyte, moved into surrounding skin cells and shed with them. Brightening ingredients interrupt one of those three steps.
- Hydroquinone, tretinoin, mercury compounds and corticosteroids are banned from cosmetics across ASEAN. They remain the four substances most often found in illegal whitening products.
- The EU set new concentration limits in 2024 for kojic acid (1% in face and hand products), alpha-arbutin (2% face, 0.5% body) and arbutin (7% face), effective from February 2025. ASEAN markets have not copied those limits, but they are the benchmark a careful formulator uses.
- Mercury is limited as a contaminant to 1 part per million in ASEAN cosmetics and is banned as a deliberate ingredient worldwide under the Minamata Convention since 2020. It still appears because it works quickly and is cheap.
- “Brightening” and “evens skin tone” are cosmetic claims. “Treats melasma” or “cures pigmentation” are medicinal claims and are not permitted on a cosmetic.
Who this is for: founders and brand managers developing a brightening serum, cream or mask for Malaysia or the wider ASEAN market, buyers comparing manufacturer proposals, and marketers deciding what the pack may say. It explains the ingredient science and the regulatory position; it is not medical advice and does not replace a formal regulatory review.
How does skin brightening actually work?
Every legitimate brightening ingredient acts on one of three steps: how much melanin is made, how it is transferred to skin cells, or how fast those cells are shed. Melanin is produced inside melanocytes by an enzyme called tyrosinase, which converts the amino acid tyrosine into the pigment through a chain of reactions. Packaged melanin is then transferred to the surrounding keratinocytes, where it sits over the nucleus and darkens the visible skin. Finally, pigmented cells move upward and are shed in the normal cycle of a few weeks.
Tyrosinase inhibitors such as kojic acid, arbutin, licorice extract and vitamin C slow the first step. Niacinamide works largely on the second, reducing the transfer of melanin packages into skin cells. Exfoliating acids and retinoids speed up the third step, so existing pigment leaves faster. Tranexamic acid acts differently again, interfering with signals from skin cells and blood vessels that stimulate melanocytes, which is why it has attracted interest for melasma. No cosmetic ingredient removes pigment permanently or changes the number of melanocytes a person has. When the product stops, the skin returns to its baseline over the following months, and the result is always smaller with ongoing sun exposure than without it.
Which brightening ingredients are permitted, and at what levels?
Most of the brightening ingredients used in notified cosmetics in Malaysia are permitted without a specific concentration limit under the ASEAN Cosmetic Directive, but several now carry formal limits in the European Union that serve as the practical benchmark. The table below summarises the position for the ingredients a brand is most likely to meet in a manufacturer’s proposal. Regulatory positions change; a formulator should confirm the current annexes before finalising a formula.
| Ingredient | Main mechanism | ASEAN / Malaysia position | EU position | Typical cosmetic use level |
|---|---|---|---|---|
| Niacinamide | Reduces melanin transfer; supports barrier | Permitted, no specific limit | Permitted, no specific limit | 2% to 5% |
| Vitamin C (ascorbic acid and derivatives) | Tyrosinase inhibition; antioxidant | Permitted, no specific limit | Permitted, no specific limit | 10% to 20% L-ascorbic acid; 1% to 5% derivatives |
| Alpha-arbutin | Tyrosinase inhibition | Permitted, no specific limit | Restricted: 2% face cream, 0.5% body lotion (from Feb 2025) | 1% to 2% |
| Arbutin (beta) | Tyrosinase inhibition | Permitted, no specific limit | Restricted: 7% in face cream (from Feb 2025) | 2% to 7% |
| Kojic acid | Tyrosinase inhibition (copper chelation) | Permitted, no specific limit | Restricted: 1% in face and hand products (from Feb 2025) | 0.5% to 1% |
| Tranexamic acid (topical) | Reduces melanocyte stimulation | Not in the ASEAN annexes; status varies by country, confirm before use | Permitted, no specific limit | 2% to 5% |
| Licorice extract (glabridin) | Tyrosinase inhibition; anti-inflammatory | Permitted, no specific limit | Permitted, no specific limit | 0.05% to 0.5% extract |
| Hydroquinone | Tyrosinase inhibition; melanocyte toxicity | Prohibited in cosmetics; prescription medicine in Malaysia | Prohibited except in professional artificial nail systems | Not applicable |
| Tretinoin | Accelerates cell turnover | Prohibited in cosmetics; prescription medicine | Prohibited in cosmetics | Not applicable |
| Mercury compounds | Blocks melanin formation (toxic) | Prohibited as an ingredient; 1 ppm trace limit | Prohibited as an ingredient | Not applicable |
Positions summarised from the ASEAN Cosmetic Directive annexes as applied by NPRA, and from EU Regulation 2024/996. Use levels are typical industry ranges, not legal limits, and depend on the product type and the rest of the formula.
Two of these entries deserve a closer look. Arbutin and alpha-arbutin are glycosides of hydroquinone, which means they can release small amounts of hydroquinone as they break down in the formula or on the skin. The EU Scientific Committee on Consumer Safety accepted both as safe at the limits above on the condition that the free hydroquinone in the product stays very low, which is why a good manufacturer specifies a hydroquinone impurity limit on the arbutin raw material and tests the finished product during stability. Kojic acid was reviewed by the same committee in 2022; the SCCS opinion published by the European Commission concluded that 1% in face and hand creams is safe, and the EU regulation that followed in 2024 wrote that figure into law. Kojic acid is also notoriously unstable, turning yellow or brown as it oxidises, so formulas that use it need chelators, antioxidants and opaque, airless packaging to keep the product looking like the one that was tested.
Why are hydroquinone, tretinoin and steroids banned from cosmetics?
These three are banned not because they fail to lighten skin but because they lighten it too well, with effects that need medical supervision. Hydroquinone was the standard dermatological treatment for melasma for decades, usually at 2% to 4% under a doctor’s care. Used without supervision, at unknown strength and for months on end, it is associated with exogenous ochronosis, a blue-black discolouration that is very hard to reverse, as well as irritation and rebound pigmentation. In Malaysia it is a scheduled poison that may only be supplied as a medicine, and across ASEAN it is prohibited as a cosmetic ingredient outright, with the single exception in the EU of professional artificial nail products at trace level.
Tretinoin, the prescription retinoid, accelerates cell turnover so strongly that it causes peeling, redness and photosensitivity in a large share of users, and it carries warnings for use in pregnancy. Cosmetics may use retinol and retinyl esters, which the skin converts gradually, but not tretinoin itself; the difference between those forms is explained in the article on retinol and retinoids in skincare. Corticosteroids such as betamethasone and clobetasol are the most dangerous of the group. They produce a rapid, visible lightening by suppressing inflammation and thinning the skin, which is exactly why illegal manufacturers add them. Prolonged use thins the skin permanently, causes visible blood vessels, acne and stretch marks, and, with strong steroids over large areas, can suppress the body’s own hormone production.
NPRA publishes cancellation notices when a notified cosmetic is found to contain any of these substances. The agency’s cosmetic pages list the products withdrawn and the substance detected, and hydroquinone, tretinoin, mercury and corticosteroids account for most entries year after year. Because cosmetics in Malaysia are notified rather than pre-approved, the brand owner, not the regulator, is responsible for what is in the jar, and the notification holder bears the consequences when a test comes back positive.
Why does mercury keep appearing in whitening creams?
Mercury persists in illegal whitening products because it is cheap, fast-acting and invisible to the user, and because enforcement reaches a product only after it has been sold. Inorganic mercury salts block the enzyme that makes melanin and also kill melanocytes, so a cream containing them lightens skin within weeks. The World Health Organization’s guidance on mercury in skin lightening products describes the consequences: kidney damage, skin rashes and discolouration, reduced resistance to skin infections, and, in long-term use, effects on the nervous system. Mercury also passes through skin into the household, contaminating the hands, towels and children of the person using it.
The regulatory position is unambiguous. The Minamata Convention on Mercury, an international treaty that Malaysia has ratified, required its parties to end the manufacture, import and export of cosmetics containing more than 1 part per million of mercury, including skin lightening soaps and creams, by 2020. The ASEAN Cosmetic Directive prohibits mercury compounds as ingredients and allows only 1 part per million as an unavoidable trace from raw materials. That trace limit is tested as part of the heavy-metal screen described in the article on heavy metals and microbial limits, and a certificate of analysis for a brightening product should show mercury well below it, not simply “complies”.
What keeps the problem alive is the supply chain outside the notified system. Products sold through social media and marketplaces, repackaged bulk creams with no ingredient list, and “traditional” night creams from small workshops do not pass through any manufacturer’s quality system. For a legitimate brand the lesson is to make the difference visible: a complete ingredient list, a notification number that can be checked on the NPRA product search, and batch test results that the brand can produce on request.
How should a brand owner formulate a brightening product that works and stays legal?
The reliable approach is to combine two or three permitted actives that work on different steps of pigmentation, at levels supported by evidence, in a formula engineered to keep them stable. A common structure pairs niacinamide at 4% to 5% for melanin transfer with a tyrosinase inhibitor such as alpha-arbutin at 1% to 2% or a stabilised vitamin C derivative, adds a soothing extract such as licorice, and relies on daily sunscreen to protect the result. That combination is gentler than any single ingredient at a high dose, and the published evidence for niacinamide and arbutin at these levels is reasonable, if modest, with most studies showing a measurable reduction in the appearance of dark spots over eight to twelve weeks rather than a dramatic change.
Percentages are only part of the story. A vitamin C serum that oxidises in a clear bottle or a kojic acid cream that browns on the shelf has lost the active the label promises, which is why the article on active ingredient percentages in skincare argues that the stability data matters more than the headline number. Brightening formulas also sit close to the boundary with dermatology. When a brand wants higher active loads, acids at lower pH or an exfoliating component alongside the brighteners, the irritation and safety assessment needs to be done properly, and this is the kind of product that benefits from a manufacturer whose dermatology and aesthetic skincare development work already includes patch testing and clinical-style evaluation as a routine step rather than an afterthought.
Three specifications should appear in the development brief and the raw material documents. First, an impurity limit for free hydroquinone on any arbutin material, with a finished-product test at release and at the end of stability. Second, heavy-metal limits for mercury, lead and arsenic on the finished product, with the batch result reported numerically. Third, a colour and assay specification across the shelf life for any oxidation-prone active, so the product the customer opens in month eighteen still contains what was tested in month one.
What can the pack say, and what crosses into medicinal territory?
A cosmetic may claim to brighten, to even skin tone and to reduce the appearance of dark spots, but it may not claim to treat melasma, cure hyperpigmentation or alter skin colour permanently. Under the ASEAN claims framework that NPRA applies, the dividing line is whether the product is presented as preventing or treating a disease or as modifying a physiological function. Melasma, post-inflammatory hyperpigmentation and other pigmentation disorders are medical conditions, so a product that promises to treat them is making a medicinal claim and would need to be registered as a medicine, not notified as a cosmetic. The general rules are set out in the article on what health and beauty brands can legally say.
Two further points catch brightening brands in particular. Before-and-after imagery and percentage claims (“reduces dark spots by 40%”) must be supported by a study on the actual product, held in the product information file, and the study design must match the claim. And ingredient-led claims such as “with 2% alpha-arbutin” commit the brand to that level at the end of shelf life, not just at manufacture. Where a brand is unsure whether a planned claim, a new active or an unusual concentration sits inside the cosmetic boundary in a given market, a regulatory review before the artwork is finalised is far cheaper than a withdrawn product, and the same review is where the ingredient list is checked against the current annexes.
Frequently asked questions
Is hydroquinone legal in Malaysia?
Not in cosmetics. Hydroquinone is a scheduled poison in Malaysia and may only be supplied as a registered medicine, typically on prescription for conditions such as melasma. Any product notified as a cosmetic that is found to contain it has its notification cancelled by NPRA. Brands wanting a legal alternative generally use alpha-arbutin, kojic acid, niacinamide or vitamin C derivatives, which act on the same pathway more gently.
Is arbutin safe if it releases hydroquinone?
At the levels the EU has now set, the Scientific Committee on Consumer Safety considers alpha-arbutin and arbutin safe, provided the free hydroquinone in the product stays very low. The practical safeguards are a hydroquinone impurity specification on the raw material, a stable formula and a finished-product test. A brand should ask the manufacturer for those three documents rather than taking the ingredient’s general safety on trust.
How can a consumer or retailer tell if a whitening cream is illegal?
Warning signs are no ingredient list, no NPRA notification number, results promised within days, a greyish or metallic sheen to the cream, and sale through informal channels at a price that does not match the claims. The notification number can be checked on NPRA’s product search. None of these signs proves contamination, and a laboratory test for mercury, hydroquinone, tretinoin and corticosteroids is the only definitive check.
Can a cosmetic claim to treat melasma?
No. Melasma is a medical condition, so a claim to treat, cure or prevent it is a medicinal claim and cannot be made on a cosmetic in Malaysia, the EU or most other markets. A cosmetic may claim to brighten, even skin tone or reduce the appearance of dark spots, provided it holds evidence for those claims. The boundary is about how the product is presented, not just what it contains.
Why do the EU limits matter for a brand selling only in Malaysia?
Because they are the most recent, evidence-based safety assessments available for these ingredients, and because many raw material suppliers and multinational buyers now treat them as the default. ASEAN has not adopted the same numerical limits for kojic acid or arbutin, so a Malaysian product above them is not automatically non-compliant, but a formulator who stays within them has a safety file that will travel to export markets without reformulation.
Do brightening ingredients work on all skin tones?
They act on the same melanin pathway in every skin tone, but the visible result and the risk profile differ. Deeper skin tones produce more melanin and are more prone to post-inflammatory hyperpigmentation, so an irritating formula can darken the very spots it was meant to fade. Gentler combinations at moderate levels, with daily sunscreen, generally give better outcomes across tones than aggressive single actives.
Sources and further reading
- World Health Organization, Mercury in skin lightening products (preventing disease through healthy environments series).
- Minamata Convention on Mercury, convention text, Annex A, Part I (mercury-added products subject to phase-out, including cosmetics above 1 ppm).
- National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, cosmetic regulatory pages, including the Guidelines for Control of Cosmetic Products in Malaysia and cancellation notices.
- European Commission, Scientific Committee on Consumer Safety, Opinion on kojic acid, 2022.
- European Union, Commission Regulation (EU) 2024/996 amending the Cosmetics Regulation for vitamin A, alpha-arbutin, arbutin, kojic acid and other substances.
Limitations: this article summarises regulatory positions as publicly documented at the time of writing; annexes and national lists are amended regularly and should be checked directly before a formula is finalised. Use-level ranges are typical industry practice, not legal limits. The article does not address prescription treatments or give medical advice.
Creaton Poh is the pen name of Poh Tze Kheng, founder of ORIZI Group — one of Malaysia's most comprehensive one-stop OEM, ODM, private label and contract manufacturing groups, spanning skincare, cosmetics, personal care, perfume and fragrance, supplements, functional food and nutrition, pet care, home care and medical devices. Across six specialised companies and three manufacturing divisions, the Group brings together 20+ years of industry experience, 5,000+ formulations, and internationally recognised quality, manufacturing and regulatory standards. These articles are written to educate, not to promote.
Written by Creaton Poh
Industry Researcher • Author • Vlogger • Manufacturing Strategist
Turning ideas into products. Turning experience into knowledge.
Connect with Poh Tze Kheng on LinkedIn.
Comments
Post a Comment