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Niacinamide, tranexamic acid and other brightening actives: levels, limits and claims

What niacinamide, tranexamic acid, arbutin, alpha-arbutin, kojic acid and licorice do, how much goes into a product, what the EU, US, Canada, Korea, Japan and China allow, and why "brightening" and "whitening" are different claims.

Not legal adviceThis guide summarizes published rules and studies as of October 2026. Your safety assessor, importer or the regulator has the final word for your product and market.

Short answer

Niacinamide (2% to 5% in most studies, often 10% in products) and tranexamic acid are the two best supported cosmetic brighteners, and neither has an EU limit. Since Regulation (EU) 2024/996, the EU allows alpha-arbutin up to 2% in face cream and 0.5% in body lotion, arbutin up to 7% in face cream and kojic acid up to 1% in face and hand products, in force for all products sold since 1 November 2025. Hydroquinone is banned from EU skin care and no over-the-counter hydroquinone lightener can be legally sold in the US since the CARES Act. "Brightens the look of skin" is a cosmetic claim in the US and EU, while "whitening" is a regulated functional claim in Korea, a quasi-drug claim in Japan and a special cosmetic in China.

The brightening actives at a glance

Dark spots form when melanocytes (pigment cells) make melanin and pass it to the surrounding skin cells. Brighteners work at different steps: tyrosinase inhibitors (arbutin, kojic acid, some vitamin C forms) slow melanin production, niacinamide slows its transfer, and tranexamic acid calms the signals that switch production on. Exfoliating acids remove pigmented surface cells.

Active (INCI)	How it works	Levels studied or allowed	EU	Korea whitening report route
Niacinamide	Slows melanosome transfer	2% to 5% studied; Korea 2% to 5%	No limit	Yes, 2% to 5%
Tranexamic Acid	Blocks plasmin signals that drive pigmentation	2% in Japanese evidence summary	No limit	No (full review needed)
Alpha-Arbutin	Tyrosinase inhibitor	EU 2% face cream, 0.5% body lotion	Annex III entry 377	No (only arbutin is listed)
Arbutin	Tyrosinase inhibitor	EU 7% face cream; Korea 2% to 5%	Annex III entry 378	Yes, 2% to 5%
Kojic Acid	Tyrosinase inhibitor	EU 1% face and hand products	Annex III entry 375	No
Glycyrrhiza Glabra (licorice) Root Extract	Glabridin inhibits tyrosinase; soothing	Korea: oil-soluble licorice extract 0.05%	No limit	Yes, oil-soluble extract 0.05%
Vitamin C derivatives	Tyrosinase inhibition, antioxidant	See our vitamin C guide	No limit	Four derivatives listed
Hydroquinone	Strong melanocyte inhibitor	Drug only	Banned in skin care	Banned

The other Korean listed whitening ingredients are paper mulberry extract (닥나무추출물) 2% and alpha-bisabolol 0.5%. All Korean report-route products must be lotion, liquid, cream, solid or soaked-mask forms.

Niacinamide

Niacinamide (INCI: Niacinamide) is a water-soluble form of vitamin B3 that stays stable in most formulas.

Evidence: niacinamide gave 35% to 68% inhibition of melanosome transfer in a cell model and reduced facial hyperpigmentation versus vehicle after 4 weeks in clinical studies (Hakozaki 2002). In a 12-week split-face study, 5% niacinamide reduced fine lines, spots, red blotchiness and yellowing and improved elasticity (Bissett 2005). A 2021 review summarizes its anti-aging and pigment evidence (Boo 2021). Evidence level: good for a cosmetic.
Levels: 2% to 5% in the key studies and in Korea's functional list. Many products use 10%, and some use 20%; those levels have less published support for extra benefit and can sting some users.
The flushing myth: the "niacin flush" comes from oral nicotinic acid (niacin), a different form of vitamin B3. Redness after a high-percentage niacinamide serum is usually irritation; test the finished product and suggest a patch test.
Rules: no limit in the EU, US, Canada or Korea. Japan approved niacinamide as a quasi-drug whitening active in 2007. In Korea, 2% to 5% qualifies for the whitening functional report route.
Pairing: works with tranexamic acid, licorice, vitamin C derivatives, zinc PCA (oily skin), peptides and retinoids.

Tranexamic acid

Tranexamic acid (INCI: Tranexamic Acid, often called TXA) is a synthetic derivative of the amino acid lysine. As a medicine it stops bleeding; in skin it blocks plasmin, which reduces the prostaglandin and other signals that drive pigment production after UV exposure.

Evidence: an expert consensus published in 2023 supports topical TXA, alone or combined, as an option for melasma patients, including those who cannot use hydroquinone (Desai 2023). A Japanese review rates topical TXA at 2% as having published human data on pigment spots. Oral and injected TXA have stronger data, but those are medical treatments. Evidence level: moderate for topical use.
Levels: 2% in the Japanese evidence summary; our library's tranexamic acid serum uses 5%. There is no EU, US or Canadian cosmetic limit.
Japan: approved as a quasi-drug whitening active in 2002 (developed by Shiseido), and a cetyl ester form in 2008.
Korea: not on the banned or restricted ingredient lists in the 2026 safety standard, but not on the whitening report-route list either. A product can contain it as a general cosmetic; a whitening functional claim needs a full MFDS review with efficacy data.
US: a cosmetic when claims stay on appearance ("evens the look of skin tone"). Topical TXA is not an FDA-approved treatment for melasma, so "treats melasma" is a drug claim.

Arbutin and alpha-arbutin

Arbutin (INCI: Arbutin, the beta form, from bearberry and other plants) and alpha-arbutin (INCI: Alpha-Arbutin, made by enzymes) are glucose-bound forms of hydroquinone. They inhibit tyrosinase without being hydroquinone, but they can release small amounts of it, which is why regulators set limits.

Rule	Alpha-arbutin	Arbutin
EU Annex III (Reg. 2024/996)	(a) Face cream 2%; (b) body lotion 0.5%	Face cream 7%
EU condition	"Hydroquinone levels shall remain as low as possible ... and shall not be higher than the unavoidable trace level"
EU dates	Non-compliant products not placed on the market from 1 February 2025 and not sold at all from 1 November 2025
Korea	Not on the whitening report-route list; a claim needs full review	Whitening functional at 2% to 5%; at 2% or more the label must carry a caution that papules and mild itching were reported in human application tests
Japan	Not on the approval list in the cited review	Quasi-drug whitening active since 1989
US and Canada	No specific limit found; appearance claims only

Two practical points. The EU entries name only "face cream" and "body lotion", so ask your EU safety assessor in writing how they treat an alpha-arbutin serum, toner or mask before you print. And ask the raw material supplier for a hydroquinone specification and test result, because the EU condition is about the finished product.

Kojic acid

Kojic acid (INCI: Kojic Acid) comes from fermentation by the fungi used to make soy sauce and sake. It inhibits tyrosinase and is used for spots and uneven tone (review: Saeedi 2019).

EU: Annex III entry 375, added by Regulation (EU) 2024/996: face and hand products only, maximum 1%. Same dates as arbutin: in force for all products sold since 1 November 2025. Body products with kojic acid are not covered by the entry.
Japan: approved as a quasi-drug whitening active in 1988. The health ministry suspended its use in March 2003 after a mouse study, then allowed it again in November 2005 after further safety data.
Korea: not on the whitening report-route list.
Stability: kojic acid can discolor with light and metal traces, so opaque packaging and chelating agents help. Our library has no ready kojic acid formula; we can check a custom brief.

Licorice and other plant brighteners

Licorice root extract (INCI: Glycyrrhiza Glabra Root Extract) contains glabridin, which inhibits tyrosinase and calms redness. Korea lists "oil-soluble licorice extract" at 0.05% for the whitening report route. Most evidence for glabridin is from lab studies (narrative review: Nie 2026), so keep claims to appearance. Rice, mulberry, glutathione and centella appear in many K-beauty brightening products; see our Korean ingredient glossary and the ingredient finder.

Hydroquinone: banned or a drug

Market	Hydroquinone status
EU	Prohibited (Annex II entry 1339), except in professional artificial nail systems at 0.02% (Annex III entry 14)
United States	Under the CARES Act of 27 March 2020, OTC skin lighteners with hydroquinone are new drugs that need FDA approval; unapproved products had to leave the market by 23 September 2020, and FDA sent warning letters to 12 companies in April 2022. The approved hydroquinone product FDA names is prescription only.
Canada	Allowed in cosmetics only in hair dyes, nail products and eyelash adhesives, not in skin care
Korea	On the list of ingredients banned from cosmetics

KoreanOEM does not make hydroquinone products. If a competitor's product contains it, that is not a model to copy.

Brightening vs whitening claims per market

Market	Cosmetic wording	Regulated wording and route
United States	"Brightens the look of skin", "evens the look of skin tone", "reduces the look of dark spots"	FDA says products intended as skin lighteners are drugs; "lightens", "bleaches", "removes melasma" are drug claims
EU and UK	Appearance claims supported by evidence under the common criteria for claims (Reg. 655/2013)	Treating a condition such as melasma makes it a medicinal product
Canada	Appearance claims	Claims to treat pigment disorders are drug claims
Korea	General cosmetic: "brighter-looking skin" style wording	"Helps whiten skin" (피부의 미백에 도움을 준다) only as a functional cosmetic, by report with a listed ingredient and level, or by full review
Japan	Cosmetic claims within the approved cosmetic efficacy list	"Prevents spots and freckles by suppressing melanin production" is a quasi-drug claim that needs product approval
China	General cosmetics cannot make whitening claims	Freckle-removing and whitening products are special cosmetics that need NMPA registration (Article 16, Cosmetic Supervision and Administration Regulation); whitening claims need a human efficacy test

Ad platforms also review this wording; "whitening" can trigger rejections in Western markets. The full rules are in our cosmetic vs drug guide and the claims guide.

Formulation, stability and pairing

Pick one or two hero actives
A common K-beauty pairing is tranexamic acid with niacinamide and licorice; our library serum uses exactly that. Stacking six brighteners at low levels mostly adds cost and irritation.
Set the pH for the active
Niacinamide, tranexamic acid and arbutin work at skin-friendly pH. Pairing them with low-pH L-ascorbic acid or strong acids in one product raises irritation.
Protect from light
Kojic acid and some vitamin C forms discolor; arbutin can release hydroquinone over time, so stability testing should include appearance and, for arbutin products, a hydroquinone check where required.
Always pair with sunscreen
Every brightening routine fails without daily UV protection. Say so in directions.
Test the finished product for claims
For "visibly reduces dark spots in 8 weeks", run a clinical test on the product. See our efficacy testing guide.

ExampleA 30 mL dark-spot serum for the US and EU: tranexamic acid, niacinamide 4% and licorice root extract, no arbutin or kojic acid, so no EU Annex III limits apply to the actives. US and EU claims: "reduces the look of dark spots and evens skin tone". For a Korean launch, the 4% niacinamide lets the importer file a whitening functional report and print "helps whiten skin".

Common mistakes

Selling an alpha-arbutin serum above 2%, or a kojic acid body lotion, in the EU after 1 November 2025.
Not asking the arbutin supplier for hydroquinone data, when the EU sets a trace-level condition on the finished product.
Printing "whitening" or "skin lightening" on US packs, which makes the product a drug in FDA's view.
Assuming tranexamic acid or alpha-arbutin can use Korea's whitening report route; they are not on the list.
Missing Korea's arbutin caution label when arbutin is 2% or more.
Copying a "melasma treatment" claim from a clinic product onto a cosmetic.
Putting 20% niacinamide in a product for sensitive skin without a patch test or tolerance data.
Leaving sunscreen advice out of a brightening product's directions.

Checklist for a brightening product

Markets listed, and the claim word chosen per market (brightening, whitening, functional).
Actives chosen by INCI name with their real percentages.
EU levels checked: alpha-arbutin 2% face cream or 0.5% body lotion, arbutin 7% face cream, kojic acid 1% face and hand.
EU product type confirmed with the safety assessor for any serum, toner or mask with arbutin or kojic acid.
Hydroquinone specification from the arbutin or alpha-arbutin supplier.
Korea route decided: report (listed active and level, allowed form) or full review.
Korea arbutin caution on the label at 2% or more.
No hydroquinone, mercury or prescription actives anywhere in the formula.
Stability test in the final pack, including appearance.
Directions with daily sunscreen and a patch test suggestion.
Claims reviewed for US drug words: lighten, bleach, remove, treat.

How KoreanOEM helps

KoreanOEM is a Korean skincare OEM and private label manufacturer: we develop your formula and produce it in Korea. Our formula library has ready brightening formulas:

Tranexamic acid serum (5% TXA with niacinamide and licorice root) and a niacinamide spot serum with tranexamic acid and licorice.
Alpha-arbutin serum with niacinamide and hyaluronic acid (we set the level for your markets, including the EU 2% face limit).
Niacinamide 20% serum, a niacinamide gel cream, eye cream and neck cream, rice brightening toners, pads, sheet masks and sleeping masks, and glutathione serums, ampoules and creams.
For a Korean whitening functional level or a different active, an adjusted library formula is USD 399 per SKU with first samples and 3 revision rounds, credited against your first order. A serum starts from about USD 3.40 per unit at 500 units.
Our label proof check reviews claims words, warnings and the ingredient list for your target market before printing.

Get a free quote Order a sample box

Frequently asked questions

Is 10% or 20% niacinamide too strong?

The best studies used 2% to 5%, and Korea's whitening functional list uses 2% to 5%. Higher levels are legal in the EU, US and Korea but have less published evidence of extra benefit and can sting sensitive skin, so test tolerance on the finished product.

Is tranexamic acid allowed in cosmetics?

Yes. The EU, US and Canada set no cosmetic limit, Japan has approved it as a quasi-drug whitening active since 2002, and Korea allows it in general cosmetics, though a Korean whitening functional claim with it needs a full MFDS review.

What is the EU limit for alpha-arbutin?

Under Regulation (EU) 2024/996, alpha-arbutin is allowed up to 2% in face cream and 0.5% in body lotion, and arbutin up to 7% in face cream, with hydroquinone kept at unavoidable trace levels. Non-compliant products cannot be sold in the EU since 1 November 2025.

Is kojic acid banned in the EU?

No, but since Regulation (EU) 2024/996 it is restricted to face and hand products at a maximum of 1%. Non-compliant products cannot be sold in the EU since 1 November 2025.

Can I sell hydroquinone skin lightener in the US?

Not over the counter. Since the CARES Act of 2020, OTC hydroquinone skin lighteners need FDA approval, unapproved products had to leave the market by 23 September 2020, and FDA sent warning letters to 12 companies in April 2022.

What is the difference between brightening and whitening?

"Brightening" describes appearance, such as radiance and an even-looking tone, and is a cosmetic claim in the US and EU. "Whitening" is a regulated claim in Korea (functional cosmetic), Japan (quasi-drug) and China (special cosmetic), and "lightening" is a drug claim in the US.

Does niacinamide cause flushing?

The well-known flush comes from oral nicotinic acid (niacin), a different form of vitamin B3. Redness after a strong niacinamide product is usually irritation, so patch test and choose a moderate level for sensitive skin.

Can I combine niacinamide and tranexamic acid?

Yes. They work at different steps of pigmentation and are combined in many products, including our library's tranexamic acid serum with niacinamide and licorice root.

Sources

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.