Tag: functional cosmetics

Functional Cosmetics in Korea: The 11 Categories, the Notified Ingredients, and What the Label Certifies (Ingredient Guide 16)

Cover image for a guide to functional cosmetics in Korea, explaining the eleven categories set by the Cosmetics Act and its Enforcement Rule and what the words on the package certify. Ingredient Guide 16 from Dr. J Ingredient Notes.

🇰🇷 한국어판: 기능성화장품 뜻과 종류 11가지 – 무엇을 보증하나

Hello, this is Dr. J. If you have ever turned over a Korean cream and seen the words 기능성화장품 — functional cosmetics — this post is about what that line actually certifies.

It is not a marketing word. It is a legal category, with a fixed list of eleven things a product is allowed to be, a fixed set of ingredients and amounts, and a fixed sentence the package has to carry. Once you know where the line comes from, the shelf reads differently.

There is one more reason this is worth reading if you are outside Korea. The EU forbids exactly what Korea requires. Under EU rules, a cosmetic label may not claim that an authority approved it. In Korea, that approval is the label. Same bottle, two opposite drawers — the table further down sets them side by side.

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📄 The original documents

📄 Regulation on the Review of Functional Cosmetics, Annex 4 (Korean)

📄 Enforcement Rule of the Cosmetics Act, Annex 4 — labelling standards (Korean)

📄 21 CFR 333.310 — US acne treatment active ingredients

📄 Commission Regulation (EU) No 655/2013 — common criteria for cosmetic claims

📄 Regulation (EC) No 1223/2009 on cosmetic products

🏠 FDA — Is It a Cosmetic, a Drug, or Both?

The two Korean links download the annex tables themselves. They give the ingredient, the amount, the permitted form, the claim wording and the directions for use, one line each.

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The short version

✔ The Act names five groups; the Enforcement Rule splits them into eleven categories

✔ Build a product to a notified ingredient at a notified amount and you file a report instead of a full review

✔ Annex 4 lists 9 whitening ingredients, 4 for wrinkles, 29 UV filters and one for acne

✔ The package carries the words and the reviewed claim, in type at least as large

✔ Hair loss, acne, barrier and stretch marks also carry “not a drug”

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Five groups in the Act, eleven categories in the Rule

Article 2(2) of the Cosmetics Act defines functional cosmetics as products falling under one of five items, “as prescribed by Ordinance of the Prime Minister”. That ordinance is the Enforcement Rule, and its Article 2 is where the list becomes eleven.

Cosmetics Act, Article 2(2)	Enforcement Rule, Article 2 — the eleven categories
a. Helps whiten the skin	1. Prevents melanin from settling, so freckles and dark spots are held back 2. Lightens melanin that has already settled
b. Helps improve wrinkles	3. Firms the skin so wrinkles are eased or improved
c. Helps tan the skin evenly, or protects it from UV	4. Shields from sunlight for an even tan 5. Blocks or scatters UV to protect the skin
d. Helps change, remove or nourish hair colour	6. Changes hair colour, or bleaches and strips it 7. Removes body hair (physical removal excluded)
e. Helps prevent or improve dryness, cracking, falling out or keratinization caused by weakened skin or hair function	8. Eases hair loss symptoms (coating and other physical methods excluded) 9. Eases acne-prone skin (cleansing products) 10. Restores barrier function so itching improves 11. Improves the red lines of stretch marks

Read the table left to right and one thing stands out. Four categories came out of a single item — item e. Hair loss, acne, barrier repair and stretch marks all sit under a sentence about dryness, cracking, falling out and keratinization. Those same four are the ones that must carry the “not a drug” sentence, which we will get to.

Anything outside these eleven cannot be sold as a functional cosmetic. A Korean pack may still shout about pores or firmness in large type — that is ordinary advertising copy, not this category.

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A review, or a report

Article 4(1) of the Act: “A cosmetics manufacturer, a cosmetics responsible distributor, or a university or research institute prescribed by Ordinance of the Prime Minister that intends to sell a product recognised as a functional cosmetic shall, for each item, either undergo a review by the Minister of Food and Drug Safety as to safety and efficacy, or submit a report to the Minister.”

The review route asks for a good deal. Article 4 of the Regulation on the Review of Functional Cosmetics sets out what has to be filed:

✔ Origin and development history

✔ Safety — single-dose toxicity, skin irritation, sensitisation, photo-toxicity, human patch testing

✔ Efficacy or function — efficacy testing, human application testing, hair-dye efficacy testing

✔ Supporting data for the SPF, water resistance and PA figures

✔ Specifications and test methods, with samples

The report route replaces all of that in three situations: the ingredient, amount, claim, directions, specifications and test methods are already notified; the product is identical in every one of those respects to something already reviewed; or it mixes a reviewed product with a notified one. Article 6 of the same Regulation is the hinge — meet Annex 4 and the data requirement falls away.

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Annex 4 — read its title slowly

The table is called “Types of functional cosmetics for which data submission is omitted”. So the amounts in it are not ceilings, and they are not “the dose that works best”. They are the amounts at which you no longer have to prove anything new.

Group in Annex 4	Ingredients	Forms and product type	Claim wording
Even tanning · UV protection	29 filters with maximum levels benzophenone-3 5% · zinc oxide 25% · titanium dioxide 25% and others	Lotion, cream and oil; basic and colour make-up product types	Carried by the SPF and PA figures
Skin whitening	9 ingredients	Lotion, liquid, cream and sheet mask	“Helps whiten the skin”
Wrinkle improvement	4 ingredients	Lotion, liquid, cream and sheet mask	“Helps improve skin wrinkles”
Hair colour change	Dyes, bleaches and strippers	Set out by form in the table	Dyeing, bleaching, stripping
Hair removal	As listed in the table	Liquid, cream, lotion, aerosol	“Depilation (removal of body hair)”
Acne-prone skin relief	Salicylic acid 0.5% — the only one listed	Cleansing product type (soap-based); liquid, lotion, cream	“Helps ease acne-prone skin” Directions: “rinse off immediately with water”

The acne row is the one people misread. The directions column says “rinse off immediately with water”, and the product type is a cleansing preparation. That is why so many Korean products with an acne functional claim are face washes rather than leave-on serums.

Notice also what is not in Annex 4: hair loss, barrier repair and stretch marks. No ingredient has been notified for those three, so a product claiming them goes down the review route. How those individual reviews are decided in practice is something I could not open a source for, so I will leave it there.

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The nine and the four, by name

This is the table to hold against a back label. If one of these names appears and the front says functional cosmetic, the product was most likely built to the notified amount and reported.

Whitening (9)	Amount	Wrinkle improvement (4)	Amount
Broussonetia extract	2%	Retinol	2,500 IU/g
Arbutin	2–5%	Retinyl palmitate	10,000 IU/g
Ethyl ascorbyl ether	1–2%	Adenosine	0.04%
Oil-soluble licorice extract	0.05%	Polyethoxylated retinamide	0.05–0.2%
Ascorbyl glucoside	2%	—	—
Magnesium ascorbyl phosphate	3%	—	—
Niacinamide	2–5%	—	—
Alpha-bisabolol	0.5%	—	—
Ascorbyl tetraisopalmitate	2%	—	—

Both groups also have fixed forms: lotion, liquid, cream and sheet mask. The claim wording is fixed too, and so are the directions (“apply an appropriate amount evenly to the skin”; sheet masks are removed after 10 to 20 minutes).

That form restriction has a practical edge. The same ingredient at the same percentage in an essence or ampoule falls outside the table, and the product has to be reviewed rather than reported.

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Korea, the United States and the EU — three different drawers

If you buy Korean skincare from abroad, this is the part worth keeping. The same tube can be a state-reviewed “functional cosmetic” in Seoul, an ordinary cosmetic in Paris, and, depending on what the label says, a drug in the United States.

	Korea	United States	European Union
Is there a category for this?	Yes — “functional cosmetics”, defined in the Cosmetics Act	No. A product that claims to affect the structure or function of the body becomes a drug under the FD&C Act	No. Everything is a cosmetic product under Regulation 1223/2009
Who checks before it is sold?	MFDS review, or a report, product by product (Act Article 4)	No premarket approval for cosmetics. OTC drugs may follow a monograph instead	A responsible person must be designated (Art. 4) and the product notified to the Commission (Art. 13)
Where do the numbers come from?	Annex 4 — whitening 9, wrinkles 4, UV filters 29, acne salicylic acid 0.5%	Monograph ranges — for acne, salicylic acid 0.5 to 2% (21 CFR 333.310)	The Annexes restrict what may be used; they do not set amounts for efficacy
May the label say a public authority approved it?	Yes — the words on the pack are exactly that	There is no approval to point to	Not allowed. “Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed” (Reg. 655/2013)
What else must the label carry?	The reviewed claim with directions; four categories add “not a drug for preventing or treating disease”	A Drug Facts panel when the product is an OTC drug	Claims must be legal, truthful, evidenced, honest, fair and clear (the six common criteria)

The last two rows are where the systems genuinely collide. The EU’s common criteria open with this: “Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed.” The whole point of the Korean line is the opposite — it tells you the Ministry looked at it.

The US draws its line somewhere else again. FDA’s own wording is that cosmetics are “intended to be rubbed, poured, sprinkled, or sprayed on… for cleansing, beautifying, promoting attractiveness, or altering the appearance”, while a drug is “intended to affect the structure or any function of the body”. Claim the second thing and the product changes category. FDA also notes that “cosmeceutical” has no meaning under the law.

So a Korean whitening cream with adenosine at 0.04% is not “approved” anywhere else — the category it belongs to simply does not exist outside Korea. That is worth knowing before you read too much into the words.

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What has to be on the package

✔ The words 기능성화장품, or the symbol the Minister designates — Act Article 10(1)8

✔ The claim and the directions that were reviewed or reported

✔ For hair loss, acne, barrier and stretch marks: “not a drug for the prevention or treatment of disease”

✔ For products labelled for infants (3 and under) or children (4 to 13): the preservative content

The placement is fixed as well. Annex 4 of the Enforcement Rule says the sentence goes directly beneath the words 기능성화장품, in type at least as large. So if you can see the words but not the claim, look again just under them.

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How I read the label after that

I treat the line as an answer to one question: which of the eleven, and did it clear the procedure for that one? It is a good answer, and it is a narrow one.

It does not tell you how much the product will do. The notified amount is the amount that lets a company skip new data, not the amount chosen for the strongest result. So the next thing I look at is the amount and the form.

For wrinkles, is adenosine there at 0.04%? For whitening, is arbutin or niacinamide in the 2–5% band? And where does that name sit in the ingredient list? Remember that below 1% the order stops meaning anything (Ingredient Guide 14).

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Five things to check when buying

✔ Is what you want one of the eleven — whitening, wrinkles, sun, and so on

✔ Does the claim directly under the words match it

✔ Is a notified ingredient in the list — adenosine 0.04%, arbutin 2–5%

✔ Is the form lotion, liquid, cream or sheet mask (for whitening and wrinkles)

✔ For sun care, are the SPF and PA figures printed alongside

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One line

“Functional cosmetic” means the product cleared a review or a report for one of eleven named claims. Read the sentence under the words first; then read the amount and the form.

Next up: expiry dates and period-after-opening — the two dates on a Korean package, and what the open-jar symbol means (Ingredient Guide 17).

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📌 Earlier posts

📌 Arbutin vs Alpha-Arbutin: What Korea’s 2–5% Means (Ingredient Guide 15)

📌 Adenosine 0.04%: Who Decided That Number (Ingredient Guide 12)

📌 How to Read a Korean Cosmetic Ingredient List (Ingredient Guide 14)

📌 Sunscreen SPF and PA: How to Read the Numbers (Ingredient Guide 11)

📌 Niacinamide: How Much Is Enough (Ingredient Guide 2)

About the author · Dr. J

MS in Veterinary Medicine, PhD in Life Sciences. I worked as a researcher at the Korea Research Institute of Bioscience and Biotechnology (KRIBB) and now run Beaurea, a cosmetics manufacturing company, where I write the formulas myself. This blog reads the research papers and the regulatory documents and turns them into plain-language criteria for choosing ingredients. I don’t recommend specific products here – only criteria that apply to any product.

📄 Sources

· Cosmetics Act (Korea), Articles 2(2), 4 and 10(1)8

· Enforcement Rule of the Cosmetics Act, Articles 2, 9 and 10, and Annex 4 (labelling standards)

· Regulation on the Review of Functional Cosmetics (MFDS Notice No. 2023-61), Articles 4 and 6, Annex 4

· 21 CFR 333.310 — Acne treatment active ingredients (eCFR)

· Regulation (EC) No 1223/2009, Articles 4, 13 and 20

· Commission Regulation (EU) No 655/2013, Annex — common criteria

· US FDA, “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”

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This post summarises statutes and regulatory notices and is not a substitute for diagnosis or treatment. If something about your skin worries you, please talk to a professional.

— Dr. J Ingredient Notes

September 30, 2026

Acne Skincare Ingredients: What Korea’s 0.5% Salicylic Acid Rule Means, and Four Ingredients with Human Trials

Cover image for an article on acne skincare ingredients. It covers the one ingredient Korea's functional cosmetics notice lists for acne, salicylic acid at 0.5 percent, and four more ingredients with human trials: glycolic acid, niacinamide, tea tree oil and green tea EGCG.

🇰🇷 한국어판: 여드름 화장품 성분 다섯 – 고시가 정한 0.5%와 사람 대상 연구 네 편

Hello, this is Dr. J. Today we look at acne skincare ingredients — and only at what a regulation or a human trial actually says about them.

An acne aisle in Korea will show you twenty ingredient names. Exactly one of them is listed in the country’s functional cosmetics notice for acne. For the other four in this article, I opened the trials one by one.

This is also a good article for reading a Korean label from outside Korea, because the Korean rule and the American rule treat the same molecule in two different ways. Salicylic acid is a cosmetic ingredient here and an over-the-counter drug there, and the concentration ranges are different too. There is a table for that below.

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📄 The sources, first

📄 Korea — Functional Cosmetics Review notice, Annex 4 (the acne row is here)

📄 Korea — Cosmetic Safety Standard, Annex 2 (restricted raw materials)

📄 United States — 21 CFR 333.310, acne active ingredients

📄 Abels 2011 — glycolic acid 10% cream, 120 people, 90 days

📄 Draelos 2006 — niacinamide 2% and facial sebum production

📄 Enshaieh 2007 — tea tree oil 5% gel, 60 people, 45 days

📄 Yoon 2013 — green tea EGCG, 35 people, 8 weeks, split-face

The two Korean annexes download as plain text from those links, with the dosage form and the wash-off instruction written out line by line.

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In a hurry? Five lines

✔ Korea lists one acne ingredient: salicylic acid at 0.5%

✔ That product is rinsed off right after use, by the notice’s own wording

✔ The United States treats the same acid as an OTC drug at 0.5 to 2%

✔ For leave-on cosmetics, glycolic acid has a 90-day placebo-controlled trial

✔ Niacinamide was measured on sebum, not lesions, and two studies split

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Five ingredients in one table, with what each was compared against

Ingredient	Source	People · length	Compared with	What was found
Salicylic acid 0.5% rinse-off	Korean notice, Annex 4	—	Not a trial — a notice	The one ingredient listed for acne-prone skin
Glycolic acid (AHA) 10%	Abels 2011	120 enrolled, 115 analysed · 90 days	Placebo cream, double-blind	Split from placebo from day 45; adverse events alike
Niacinamide 2%	Draelos 2006	Japan 100, 4 weeks / US 30, 6 weeks	Placebo moisturizer	Japan: sebum rate down 21.8% (placebo 10.7%). US: no significant difference
Tea tree oil 5%	Enshaieh 2007	60 people · 45 days	Placebo gel, double-blind	Total lesion count 3.55x placebo; severity index 5.75x
Green tea EGCG 1% / 5%	Yoon 2013	35 finished · 8 weeks	The other half of the same face (3% ethanol vehicle)	Inflammatory lesions 10.0 to 1.1 in the 1% group

The column worth reading twice is «compared with». Two products can both say «improved» and mean very different things, depending on what sat on the other side of the comparison.

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Korea and the United States: the same acid, two systems

	Korea	United States
What salicylic acid is for acne	A functional cosmetic ingredient	An OTC drug active ingredient
Where it is written	Functional Cosmetics Review notice, Annex 4	21 CFR 333.310, acne monograph
Concentration	0.5%, one figure	0.5 to 2%, a range
How it is used	Applied, then rinsed off right away	Leave-on products are covered too
Wording on the pack	「Helps relieve acne-prone skin」	Drug Facts label, «for the treatment of acne»
Other listed actives	None for acne	Benzoyl peroxide 2.5–10%, sulfur 3–10%, resorcinol 2% with sulfur

This is the part that surprises people who read Korean labels from abroad. In Korea, a product that carries the acne functional cosmetic claim is, by the notice’s own wording, a product you wash off right away — which is why so many of them are cleansers. In the United States, the same molecule sits in 21 CFR 333.310 as an acne drug active, at 0.5 to 2 percent, and leave-on products are ordinary there.

So «Korean acne cleanser with 0.5% salicylic acid» and «American 2% BHA leave-on» are not the same category of product wearing different labels. They are two regulatory systems that decided to file the same ingredient in different drawers.

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What Korea’s notice actually says

Annex 4 of the Functional Cosmetics Review notice is a list of the cases where a company does not have to submit new efficacy data. Whitening has nine ingredients on that list, wrinkle improvement has four, and acne has one:

✔ Ingredient and amount — salicylic acid 0.5%

✔ Dosage forms — solution, lotion, cream

✔ Claim — «helps relieve acne-prone skin»

✔ Directions — «take an appropriate amount, apply to the skin, then rinse off with water right away»

There is a second Korean line worth knowing, in the Cosmetic Safety Standard, Annex 2: salicylic acid is capped at 0.5% and may not be used in products for infants, or in products labelled as suitable for children aged 13 or under — shampoos excepted. If you are buying for a younger teenager, that is the line to check.

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A leave-on option with a trial behind it: glycolic acid 10%, 90 days

Abels and colleagues, 2011. 120 people with mild acne (Leeds 0.25–1, mean age 21±5.8) were randomised; 115 made the final analysis. They applied a 10% glycolic acid oil-in-water emulsion once every evening for 90 days, as monotherapy, with cleansing standardised.

The treated group separated from placebo from day 45 at the 5% significance level, and the difference held to day 90. Adverse events did not differ significantly between the groups.

Two things are useful here. First, this is a cream you leave on, not a peel — I keep peeling and dermabrasion studies out of cosmetic articles. Second, day 45 is a reasonable answer to «how long before I judge it». Two weeks is not.

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Niacinamide 2%: read what it actually measured

Draelos, Matsubara and Smiles, 2006, ran two studies in two countries. In Japan, 100 women over 4 weeks: the sebum excretion rate fell 21.8% against 10.7% for placebo (at 2 weeks, 21.3% against 8.6%).

In the United States, 30 Caucasian women over 6 weeks: casual sebum levels trended down but only reached p=0.055, and the sebum excretion rate did not reach statistical significance.

«Niacinamide reduces oil» is repeated everywhere. The paper says two more things that rarely travel with it: it measured sebum output rather than acne lesions, and the two populations did not agree. Both belong in the sentence.

Why not a niacinamide acne trial instead? Because most of them compare it with clindamycin gel, a prescription antibiotic. I do not line cosmetics up against prescription drugs in these articles, so I used the sebum study and said so.

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Two with placebo-controlled trials: tea tree oil and green tea

Tea tree: Enshaieh and colleagues, 2007. 60 people with mild to moderate acne, randomised double-blind, 30 per group, 45 days with checks every 15 days. Improvement in total lesion count was 3.55 times that of placebo, and in the acne severity index 5.75 times. Side effects were comparable and tolerable in both groups.

Green tea: Yoon and colleagues, 2013. Thirty-seven enrolled, 35 finished 8 weeks. A randomly allocated half of each face received 1% (17 people) or 5% (18 people) EGCG solution twice daily; the other half received the vehicle, 3% ethanol only.

In the 1% group, inflammatory lesions went from 10.0±3.1 to 1.1±0.5 and non-inflammatory lesions from 53.8±19.8 to 15.6±6.2. A split-face design removes a great deal of person-to-person noise, which is what makes a 35-person study worth reading.

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How to read «it improved»

Compared with	How to read it	In this article
The same product minus the ingredient	Only that ingredient is left to explain the difference — the cleanest comparison	Glycolic acid, tea tree, niacinamide
The other half of the same face	Everything that differs between people is held still; the two halves can still influence each other	Green tea EGCG
The starting point (before and after)	The season and the person’s routine move too, so this alone is weak	Where an abstract gives no placebo figure
A notice	Not the size of an effect — the right to make a claim	Salicylic acid 0.5%

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What I left out, and why

✔ Trials against prescription drugs — most niacinamide acne trials compare it with clindamycin gel. A cosmetic article should not be read as putting a cream next to a prescription

✔ Peels and dermabrasion — salicylic and glycolic acid both have large peel literatures. That is a procedure, not a product on a shelf

✔ Bakuchiol — there is an acne study, but I could not confirm from the source whether it was placebo-controlled, so it waits

✔ Mechanism — how salicylic acid loosens keratin, or what EGCG does inside a cell, needs review articles I could not open today

Writing down what was left out is the point of the exercise: it shows you the rule I used, so you can apply the same rule to the next ingredient someone recommends.

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So where do you look?

✔ Breakouts often — start from a rinse-off product with salicylic acid 0.5%

✔ You want something you leave on — glycolic acid, and give it 45 days

✔ Oiliness is the complaint — niacinamide, knowing it was measured on sebum

✔ You want the gentler end — tea tree and green tea both have placebo-controlled trials

✔ Buying for a young teenager — check the Annex 2 age line

✔ Do not stack all five at once — one at a time, in the evening

I read the claim and the trial as two separate things. A functional cosmetic claim in Korea means a listed ingredient at a listed amount; it does not tell you the size of the effect. What comes next is whether that ingredient has a human trial, and what sat on the other side of the comparison.

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One line

Korea lists exactly one acne ingredient — salicylic acid 0.5%, rinsed off — and the other four earn their place from placebo-controlled trials. Read the claim and the trial side by side.

Next: five ingredients for dark spots, starting from the nine on Korea’s whitening list.

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📌 Previously

📌 Salicylic Acid (BHA): 0.5% vs 2%, Explained

📌 AHA vs BHA: Is Glycolic Acid an AHA?

📌 Niacinamide: How Much Is Enough

📌 How to Read a Korean Cosmetic Ingredient List

📌 Skin Concern Ingredient Map

About the author · Dr. J

📄 References

· Korea MFDS, Regulation on the Review of Functional Cosmetics, Annex 4

· Korea MFDS, Regulation on Safety Standards for Cosmetics, Annex 2

· 21 CFR 333.310 — Acne active ingredients (US FDA OTC monograph)

· Abels C, Kaszuba A, Michalak I et al., J Cosmet Dermatol 2011;10(3):202-209

· Draelos ZD, Matsubara A, Smiles K, J Cosmet Laser Ther 2006;8(2):96-101

· Enshaieh S, Jooya A, Siadat AH et al., Indian J Dermatol Venereol Leprol 2007;73(1):22-25

· Yoon JY, Kwon HH, Min SU et al., J Invest Dermatol 2013;133(2):429-440

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This article summarises published regulations and research for information only; it does not replace diagnosis or treatment. If a skin problem persists, please see a professional.

— Dr. J Ingredient Notes

September 29, 2026

Korea’s Nine Approved Brightening Actives: What the Human Studies Show for Melasma and Dark Spots

Cover image for an article on the five ingredients to look for in melasma and dark spot care. Korea's functional cosmetics notification lists nine approved brightening actives with set concentrations, and this article reads the human studies for niacinamide, arbutin, magnesium ascorbyl phosphate and alpha-bisabolol, from Dr. J Ingredient Notes.

🇰🇷 한국어판: 기미 화장품 성분 다섯 – 미백 고시 아홉 가지에서 고르는 법

Hello, this is Dr. J. Today we are choosing brightening ingredients for melasma and dark spots the way a formulator does: from the regulation first, then from the human studies.

Here is the part that surprises people outside Korea. In Korea, “brightening” is not a free marketing word. It is a functional claim, and there is an official list of actives with the amounts written next to them. The list has nine entries. I read the human evidence for each one, and I could open full abstracts for four. I will say that plainly as we go.

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Primary sources

📄 Regulation on Review of Functional Cosmetics, Annex 4 (MFDS notification) — the nine actives, their amounts, dosage forms and claim wording

📄 Niacinamide and cutaneous pigmentation (Hakozaki 2002)

📄 Arbutin 2.51% cream, 8 weeks (Morag 2015)

📄 Magnesium ascorbyl phosphate and melanogenesis (Kameyama 1996)

📄 Alpha-bisabolol in Asian women (Lee 2010)

📄 EU SCCS opinion on alpha-arbutin and beta-arbutin (SCCS/1642/22, 31 January 2023)

The Korean annex opens directly as an attachment file. It is worth opening once: the amounts are printed in a single line each, so you can hold the page next to a product’s back label.

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In short, five lines

✔ Korea’s functional list has nine brightening actives, with the amounts fixed

✔ I could open full human-study abstracts for four of them

✔ Niacinamide separated from vehicle at 4 weeks, arbutin at 8 weeks

✔ The alpha-bisabolol trial was run on the back, not the face

✔ Tranexamic acid is not on the list, and its topical trials run 12 weeks

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Nine actives, and what the amounts actually mean

The annex is titled “Types of functional cosmetics for which data submission is omitted”. Read that title before you read the numbers. The concentrations are not upper safety limits. They are the amounts at which a company does not have to submit new efficacy data, because the authority has already accepted the evidence for that active at that amount.

No.	Active	Amount	Study opened here
1	Broussonetia (mulberry) extract	2%	—
2	Arbutin	2–5%	Morag 2015 · 102 women, 8 weeks
3	Ethyl ascorbyl ether	1–2%	—
4	Oil-soluble licorice extract	0.05%	—
5	Ascorbyl glucoside	2%	—
6	Magnesium ascorbyl phosphate	3%	Kameyama 1996 · 19 of 34
7	Niacinamide	2–5%	Hakozaki 2002 · 18 and 120 people
8	Alpha-bisabolol	0.5%	Lee 2010 · 28 women, 8 weeks
9	Ascorbyl tetraisopalmitate	2%	—

The annex also fixes the dosage forms — lotion, liquid, cream and sheet mask — and the exact claim wording, which translates as “helps brighten the skin”. Even the directions are written down: apply an appropriate amount and spread evenly, and for a sheet mask, remove the sheet after 10 to 20 minutes and spread what is left. A product that follows all of this files a report instead of a full review.

The five rows marked “—” are the ones where I could not open a human study abstract today. That is not the same as saying no study exists. It is a note about what I verified, and I would rather write it than leave you guessing.

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The four, in one table — including what each was compared with

A percentage means very little on its own. What it was measured against is where the value sits: the same cream without the active, a different product, untreated skin, or simply the starting point.

Active	Study	People · duration	Compared with	What was found
Niacinamide 5%	Hakozaki et al. 2002	18 with hyperpigmentation	vehicle moisturiser, paired on the same person	Significant drop in pigmentation and rise in lightness at 4 weeks
Niacinamide 2% with sunscreen	same paper	120 with facial tanning	vehicle, sunscreen alone	Better than vehicle on skin colour measures
Arbutin 2.51%	Morag et al. 2015	102 women · 8 weeks 54 active · 48 placebo	placebo cream, double-blind	Lightening in 75.86% of melasma, 56.00% of solar lentigo placebo figures not in the abstract
Magnesium ascorbyl phosphate	Kameyama et al. 1996	34 with pigmentation duration not in the abstract	baseline pigmentation	19 of 34 improved significantly · 3 of 25 with normal skin
Alpha-bisabolol concentration not in the abstract	Lee et al. 2010	28 women · 8 weeks · back	vehicle cream on the same women	Significant lightening in most subjects
Tranexamic acid not on the list	covered in guide 9	trials run 12 weeks	varies by trial	Topical-only results were not statistically clear

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Niacinamide 2–5% — the point where it separated from vehicle was 4 weeks

Hakozaki 2002 carried two human trials in one paper. In the first, 18 people with facial hyperpigmentation used a 5% niacinamide moisturiser and a vehicle moisturiser in a paired design — both products on the same face, one per side. In the second, 120 people with facial tanning were each assigned two of three treatments: vehicle, sunscreen, or 2% niacinamide plus sunscreen.

Changes were quantified by computer analysis of high-resolution facial images and by visual grading. After 4 weeks, niacinamide significantly decreased hyperpigmentation and increased skin lightness compared with vehicle alone. The paired design is the part I like: season, sleep and sun exposure are held constant because both sides belong to the same person.

The same paper ran cell work. Niacinamide gave 35–68% inhibition of melanosome transfer in a keratinocyte and melanocyte co-culture, and reduced pigmentation in a reconstructed epidermis model. It had no effect on mushroom tyrosinase activity or on melanin production in cultured melanocytes. Worth keeping those in their own lane: a co-culture is not a face, and I would not carry the 35–68% figure over to what happens on your cheek.

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Arbutin 2–5% — 102 women, 8 weeks, and a different number in the EU

Morag 2015 was a double-blind, placebo-controlled randomised trial in 102 women aged 26 to 55 with melasma or solar lentigo. Fifty-four used a cream containing 2.51% arbutin twice daily for 8 weeks; 48 used placebo.

Lightening was seen in 75.86% of the melasma cases and 56.00% of the solar lentigo cases. The placebo-arm figures are not given in the abstract, so I have not carried them over. Read the percentage as “how many in the active arm showed lightening”, not as “how much better than placebo”.

Europe looked at the same molecule from the safety side, which is a different question from efficacy. The SCCS adopted its opinion on 31 January 2023.

What the number decides	Korea · Annex 4	EU · SCCS/1642/22 (2023)
Nature of the figure	efficacy data can be omitted	safety assessment
Arbutin (beta)	2–5%	safe in face creams up to 7%
Alpha-arbutin	not named in the annex	safe in face creams up to 2%, body lotions up to 0.5%
Hydroquinone content	not the subject of this annex	“as low as possible… not higher than the unavoidable traces in both arbutins” LOQ 3 ppm · LOD 1 ppm

So a Korean product and a European product can both be correct and still print different percentages, because the two numbers answer different questions. And on a back label, “arbutin” and “alpha-arbutin” are two different names — the annex lists the first one. Guide 15 goes through that comparison in detail.

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Vitamin C derivatives — 19 of 34, and only 3 of 25

Four of the nine entries are vitamin C derivatives: ethyl ascorbyl ether 1–2%, ascorbyl glucoside 2%, magnesium ascorbyl phosphate 3% and ascorbyl tetraisopalmitate 2%. Pure ascorbic acid is unstable in a finished formula, so the molecule is modified and the skin’s enzymes are expected to release it.

Of those four, the one I could open was magnesium ascorbyl phosphate. Kameyama 1996 reported that 19 of 34 patients with chloasma or senile freckles showed significant lightening. In the same paper, among 25 people with normal skin, only 3 did.

Put those two numbers side by side and you get a way to read them: this is an ingredient that earns its place where the pigment already is. Expect it to work on the dark patch rather than to change your overall complexion. The trial duration is not stated in the abstract, which is worth knowing before you set a deadline for it.

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Alpha-bisabolol 0.5% — the trial was not run on faces

Lee 2010 tested a base cream containing alpha-bisabolol on 28 female subjects, applied once a day for 8 weeks. The application site was pigmented skin on the back, and the same women also applied a vehicle control cream. Results were assessed by clinical and biophysical methods, and after 8 weeks most subjects showed significant lightening.

Two honest notes. The concentration of alpha-bisabolol in the cream is not given in the abstract, and the back is not the face: thicker stratum corneum, different sun exposure, different pigment history. The annex figure of 0.5% is what Korea accepted for the claim; the trial figure is simply not stated. Knowing that keeps the expectation the right size.

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The one that is not on the list — tranexamic acid

Tranexamic acid does not appear among the nine. A Korean product carrying the brightening claim with tranexamic acid has therefore been through an individual review with its own safety and efficacy dossier, rather than the report route that the listed actives allow.

The trials are built around 12 weeks, and when the topical route is pooled on its own the result was not statistically clear. Guide 9 sets out those numbers, including the confidence interval, and it is the honest place to start if a tranexamic acid serum is already in your routine.

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What is not in this article, and why

✔ Comparisons with hydroquinone or prescription creams — a cosmetics article should not line itself up against a drug

✔ Laser and chemical peel trials — procedures are a separate conversation from ingredients

✔ Retinol for pigmentation (Kafi 2007) — I opened the abstract and it reports fine wrinkles and collagen markers, with no pigmentation outcome, so it is out

✔ Mechanism paragraphs — where I could not open the review, I stopped at what the abstract itself states

✔ Claims that circulate online — “vitamin C erases melasma”, “use brighteners at night only” — no primary source, so no sentence

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Four things to check when you buy

✔ Whether the carton carries the functional cosmetics mark, with the claim wording printed underneath in the same size or larger

✔ Which of the nine names appears in the ingredient list

✔ Whether the format is a lotion, liquid, cream or sheet mask

✔ Whether there is enough product for 4 to 12 weeks, since that is the length the trials ran

Whichever active you choose, daytime sunscreen travels with it. Pigment darkens again in sunlight, and the 120-person arm of Hakozaki 2002 was itself run on top of a sunscreen. Guide 11 covers how to read SPF and PA labels.

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One line

Pick a name from the list of nine, give it 4 to 12 weeks, and wear sunscreen while you do.

The next guide takes on organic and natural cosmetic labelling — what those words are allowed to certify under the Korean standard.

📌 Related guides

📌 Niacinamide: How Much Is Enough (Guide 2)

📌 Arbutin vs Alpha-Arbutin: Korea’s 2–5% and the EU limits (Guide 15)

📌 Tranexamic Acid Cream: What the Melasma Trials Found (Guide 9)

📌 Adenosine 0.04%: Who Decided That Number (Guide 12)

📌 How to Read a Korean Cosmetic Ingredient List (Guide 14)

📌 Sunscreen SPF and PA: How to Read the Numbers (Guide 11)

About the author · Dr. J

📄 References

· Regulation on Review of Functional Cosmetics, Annex 4 — Types of functional cosmetics for which data submission is omitted (MFDS notification)

· Hakozaki T, Minwalla L, Zhuang J, et al. Br J Dermatol 2002;147(1):20-31

· Morag M, Nawrot J, Siatkowski I, et al. J Cosmet Dermatol 2015;14(3):185-190

· Kameyama K, Sakai C, Kondoh S, et al. J Am Acad Dermatol 1996;34(1):29-33

· Lee J, Jun H, Jung E, et al. Int J Cosmet Sci 2010;32(4):299-303

· SCCS Opinion on alpha-Arbutin and beta-Arbutin, SCCS/1642/22, adopted 31 January 2023

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This article summarises a public regulation and published research. It is information, not a diagnosis or a treatment plan. The figures are as written in the notification and in each abstract, and results differ from person to person. If a pigment change worries you, please speak with a professional.

— Dr. J Ingredient Notes

September 29, 2026

Arbutin vs Alpha-Arbutin: What Korea’s 2–5% Means, and How the EU Limits Differ (Ingredient Guide 15)

Cover image for a Dr. J Ingredient Notes guide on arbutin, ingredient guide 15. Korea's Ministry of Food and Drug Safety lists arbutin at 2 to 5 percent among its brightening functional ingredients; the guide covers who set that number, a trial in which 102 women used a 2.51 percent arbutin cream for 8 weeks, and the European Union limits for alpha-arbutin and arbutin.

🇰🇷 한국어판: 알부틴 효능과 2~5%의 뜻 (성분 백과 ⑮)

Hello, I’m Dr. J. If you have compared arbutin and alpha-arbutin on Korean skincare labels and wondered where the numbers come from, here is the short answer: in Korea, arbutin at 2–5% is written into a government table, and in the EU, both forms have had legal concentration limits since 2025. This is Ingredient Guide 15.

Those two sets of numbers look like they answer the same question. They don’t. The Korean range tells a manufacturer how much arbutin it can use to make a brightening claim without submitting new efficacy data. The EU numbers are safety ceilings. Reading a label well starts with knowing which kind of number you are looking at.

Below: the Korean table itself, the human trial that used a concentration inside that range, the EU entries for arbutin and alpha-arbutin, and why every one of these documents also mentions hydroquinone.

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📄 If you’d rather read the primary sources

📄 Korea — Regulation on Review of Functional Cosmetics, Annex 4: brightening ingredients (Korean)

📄 Morag et al. 2015 — arbutin 2.51% cream, 102 women, 8 weeks (PubMed)

📄 EU — SCCS Opinion on alpha-arbutin and beta-arbutin, SCCS/1642/22 (2023)

📄 EU — Commission Regulation (EU) 2024/996, Annex III entries 377 and 378 (EUR-Lex)

📄 US — FDA on OTC skin lightening products (April 2022)

📄 Korea — survey of 40 arbutin brightening products (J Soc Cosmet Sci Korea, 2019)

The Korean annex lists nine brightening ingredients with their amounts and allowed product forms on a single page; the EU regulation gives both arbutins a row of their own, with dates.

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The short version

✔ Korea lists arbutin at 2–5% as one of nine brightening ingredients for functional cosmetics

✔ Made within that range and form, a product needs no new efficacy data for its brightening claim

✔ A double-blind trial had 102 women use a 2.51% arbutin cream or placebo for 8 weeks

✔ The EU caps face creams at 2% alpha-arbutin and 7% arbutin, applied from 2025

✔ Every one of these texts watches hydroquinone, because arbutin can break down into it

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Who set 2–5%? Korea’s nine brightening ingredients

Korea’s Ministry of Food and Drug Safety (MFDS) runs a functional cosmetics system. A product that claims to brighten the skin, smooth wrinkles or protect against UV is reviewed before it can carry that claim. To keep the process simple for well-studied ingredients, the Regulation on Review of Functional Cosmetics has an annex that lists ingredients and amounts that can be used without new efficacy data. For brightening, the list is nine lines long.

No.	Ingredient (Korean label name)	Amount
1	Paper mulberry (Broussonetia) extract · 닥나무추출물	2%
2	Arbutin · 알부틴	2–5%
3	Ethyl ascorbyl ether · 에칠아스코빌에텔	1–2%
4	Oil-soluble licorice extract · 유용성감초추출물	0.05%
5	Ascorbyl glucoside · 아스코빌글루코사이드	2%
6	Magnesium ascorbyl phosphate · 마그네슘아스코빌포스페이트	3%
7	Niacinamide · 나이아신아마이드	2–5%
8	Alpha-bisabolol · 알파-비사보롤	0.5%
9	Ascorbyl tetraisopalmitate · 아스코빌테트라이소팔미테이트	2%

The same table fixes three more things:

✔ Product forms — lotion, liquid, cream and sheet mask

✔ Claim wording — “helps brighten the skin” (피부의 미백에 도움을 준다)

✔ Directions — spread an appropriate amount evenly; masks come off after 10–20 minutes

The annex title is worth reading twice: “types of functional cosmetics for which data submission is waived.” So 2–5% is not really a safety ceiling. It is the range inside which a company can use the pre-approved claim without proving efficacy again. A combination outside the list needs its own data. On a Korean label, the words 기능성화장품 (functional cosmetic) together with the brightening claim tell you the product sits inside this framework.

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Does arbutin work? What the human trial shows

Among published trials on arbutin in people, one stands out for this question because it used a concentration inside the Korean range and compared it with a placebo.

✔ Who — 102 women aged 26–55 with melasma or solar lentigo (sun spots)

✔ Design — randomised, double-blind, placebo-controlled

✔ What they used — a plant-extract cream containing 2.51% arbutin (54 women) or a placebo cream (48 women)

✔ How long — twice a day on the discoloured areas, for 8 weeks

✔ Result — lightening in 75.86% of the women with melasma and 56.00% of those with solar lentigo in the cream group; 66.67% of the cream group overall

Morag M, Nawrot J, Siatkowski I, Adamski Z, Fedorowicz T, Dawid-Pac R, Urbanska M, Nowak G. Journal of Cosmetic Dermatology 2015;14(3):185-90

Two caveats belong next to those numbers. First, the abstract does not report the placebo group’s figures, so this article does not say how much better than placebo the cream did. Second, the cream was a plant extract that contained arbutin, so the extract’s other components can’t be separated out. What makes the study useful is that it tested a realistic concentration over a realistic period on the kinds of spots people actually buy these products for.

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Arbutin vs alpha-arbutin: Korea, the EU and the US side by side

On an ingredient list, Arbutin is the beta form and alpha-Arbutin is its alpha isomer — the same two building blocks, hydroquinone and glucose, joined by a different type of bond. The EU’s safety committee assessed them separately and the EU now limits them separately. Here is how the three markets compare.

Item	Korea	EU	US
Arbutin (beta)	2–5% for the pre-approved brightening claim	Face cream up to 7% (Annex III, entry 378)	No arbutin-specific limit found in the FDA rules I checked
Alpha-arbutin	Not named in the brightening annex	Face cream 2%, body lotion 0.5% (entry 377)	Same as above
Hydroquinone	Checked in market surveys (see below)	“As low as possible”, no higher than unavoidable traces, in both entries	OTC hydroquinone lighteners need an approved new drug application (FDA, 2022)
What the number is	A data-waiver range for a claim	A safety ceiling (the SCCS did not assess efficacy)	—
Since	—	Not placed on the market from 1 Feb 2025; not made available from 1 Nov 2025 if non-compliant	CARES Act 2020; FDA notice 19 Apr 2022

The key point: Korea’s 2–5% and the EU’s 7% were not measured on the same scale. One answers “how much lets you skip efficacy data for a brightening claim”; the other answers “how much is still safe”. The SCCS opinion says plainly that it contains no evaluation of efficacy.

On the US side, the FDA’s April 2022 notice concerns hydroquinone rather than arbutin: after the CARES Act, it says, “all OTC skin lightening products require an FDA approved new drug application before they can be legally marketed.” I did not find an arbutin-specific rule in the FDA material I checked, so the table says exactly that and no more. I also could not confirm from primary sources how an alpha-arbutin product would qualify as a brightening functional cosmetic in Korea, so I have not guessed.

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Why hydroquinone keeps coming up: a survey of 40 Korean products

The SCCS describes beta-arbutin as a glucose derivative of hydroquinone that can be hydrolysed by acid or by enzymes back into hydroquinone. That is why both EU entries carry the same condition, and why Korean researchers have tested products on the shelf.

The Incheon Metropolitan City Institute of Public Health and Environment analysed 40 arbutin-containing brightening functional cosmetics sold in Korea.

✔ Hydroquinone detected in 9 products

✔ 7 of them within the standard (0.3–0.9 ppm)

✔ 2 above it (8.4 ppm and 50.5 ppm)

✔ The authors attributed the hydroquinone to arbutin breaking down and called for better quality control

Cho JH, Kim JH, Eom SA et al. Investigation on the Safety of Hydroquinone and Preservatives among Whitening Functional Cosmetics Containing Arbutin in Korea. Journal of the Society of Cosmetic Scientists of Korea 2019;45(4):399-408 (in Korean)

Read the other way, 38 of the 40 products were within the standard. What I take from the survey is narrower: with arbutin, what happens after the product is made matters. So I look at the expiry date on arbutin products and don’t keep an opened jar for months.

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Who it suits, and in what order

✔ Uneven tone and dark spots are the natural fit; the trial enrolled women with melasma and sun spots

✔ I put sunscreen first — preventing new pigment before fading what is there. See the SPF and PA guide below

✔ Choose a texture you will use twice a day for 8 weeks; that is what the trial asked of people

✔ If you already use niacinamide from the same Korean list, I found no trial showing what layering the two adds

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What this article leaves out, and why

✔ How arbutin reduces pigment — I could not open the review I would have relied on, so there is no mechanism section

✔ Trials comparing arbutin products with prescription creams — they read as drug comparisons, which is outside a cosmetics guide

✔ “Never use arbutin with vitamin C” and similar rules — I found no primary source for them

✔ How alpha-arbutin qualifies in Korea — not confirmed from primary sources, so not stated

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Five things to check on the label

✔ 기능성화장품 + the brightening claim — on a Korean product, the sign it sits inside the MFDS framework

✔ Position in the list — at 2% or more, arbutin should appear above the ingredients used at 1% or less (Ingredient Guide 14)

✔ Arbutin or alpha-Arbutin — match the name letter by letter; the limits differ

✔ Product form — lotion, cream, liquid or sheet mask on the Korean list

✔ Expiry date — use within it and don’t keep an opened product for months

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In one line

Korea’s 2–5% is a claim-and-data rule; the EU’s 2% and 7% are safety ceilings. On the label, check the functional-cosmetic mark, the exact name, the position in the list and the expiry date.

Next in the series: what the Korean “functional cosmetic” mark actually certifies (Ingredient Guide 16).

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📌 Earlier guides

📌 Niacinamide: How Much Is Enough

📌 How to Read a Korean Cosmetic Ingredient List — Where the Order Stops at 1%

📌 Adenosine 0.04%: Who Decided That Number

📌 Tranexamic Acid Cream: What the Melasma Trials Found

📌 Sunscreen SPF and PA: How to Read the Numbers

About the author · Dr. J

📄 References

· Korea — MFDS Regulation on Review of Functional Cosmetics, Annex 4: functional cosmetics for which data submission is waived

· Morag M et al., J Cosmet Dermatol 2015;14(3):185-90 (PMID 26119285)

· Scientific Committee on Consumer Safety, Opinion on alpha-arbutin and beta-arbutin, SCCS/1642/22 (adopted 31 January 2023)

· Commission Regulation (EU) 2024/996 of 3 April 2024 — Regulation (EC) No 1223/2009, Annex III entries 377 and 378

· US FDA, “FDA works to protect consumers from potentially harmful OTC skin lightening products” (19 April 2022)

· Cho JH et al., J Soc Cosmet Sci Korea 2019;45(4):399-408

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This article summarises regulatory texts and published research. It is information, not a diagnosis or a treatment plan. If something about your skin worries you, please talk to a professional.

— Dr. J Ingredient Notes

September 22, 2026