Tag: EU cosmetics regulation

  • Customized Cosmetics in Korea: What a Shop May Mix, Who May Mix It, and Why Nothing Is Mixed in Advance (Ingredient Guide 22)

    Cover image for an article on customized cosmetics in Korea. It notes that the Cosmetics Act splits them into two kinds, mixing and decanting, that the Safety Standards Regulation keeps three groups of raw materials out of what a shop may mix, and that a shop cannot be notified without a licensed customized cosmetics compounding manager. Dr. J Ingredient Notes, Ingredient Guide 22.

    🇰🇷 한국어판: 맞춤형화장품이란 – 매장에서 섞는 범위와 조제관리사

    Hello, this is Dr. J. Today I want to explain customized cosmetics in Korea — the counter where someone mixes a product for you, and what the law lets them do there.

    Start with the part most summaries miss. Nothing has to be mixed at all. Decanting a product into a smaller jar is already a customized cosmetic under Korean law. The Act splits the category into two items, (a) and (b), and the second one is just moving contents from one container to another.

    This matters beyond Korea, because Korea built something most markets did not: a separate business type in the statute, a national qualification for the person who mixes, and a short list of raw materials that may never be mixed at the counter. The United States and the European Union answer the same question in completely different places. I put all three side by side at the end.

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    Primary sources

    📄 Cosmetics Act of Korea (Korea Legislation Research Institute, Korean and English) — Arts. 2, 2-2, 3-2, 3-4, 5

    📄 Notification of a customized cosmetics selling business (Korea Ministry of Government Legislation)

    📄 Regulation on Obligations of Customized Cosmetics Sellers — MFDS Notice No. 2022-2

    📄 21 U.S.C. § 364 — definition of “facility” (MoCRA)

    📄 Regulation (EC) No 1223/2009 on cosmetic products — Arts. 4 and 6

    All of these were opened on 7 October 2026. The Cosmetics Act text is the version in force from 2 April 2026 (Act No. 20901, amended 1 April 2025).

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    Five lines, if you are in a hurry

    ✔ A customized cosmetic is either mixed or decanted — both count

    ✔ The shop cannot be notified without a licensed compounding manager on site

    ✔ Preservatives, UV filters and colorants may not be mixed at the counter

    ✔ Nothing may be mixed or decanted in advance and kept on a shelf

    ✔ A shop may not arbitrarily mix or decant finished products it sells, and must report its raw-material list once a year

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    Two kinds, by law

    Article 2, subparagraph 3-2 of the Cosmetics Act writes the category out in two items. Most English coverage renders “customized cosmetics” as bespoke blending, which is only half of it.

    Item What the Act says What it looks like in the shop
    (a)
    mixing    		 A cosmetic made by adding the contents of another cosmetic, or a raw material the Minister of Food and Drug Safety designates, to the contents of a manufactured or imported cosmetic Two serums blended into one bottle; an active added to a base
    (b)
    decanting    		 A cosmetic made by decanting the contents of a manufactured or imported cosmetic
    Simply decanting a solid facial soap and the like is excluded    		 Contents moved from a large container into a smaller one for you

    The exclusion is telling. Cutting a bar of solid soap is not a customized cosmetic. The line is not drawn around the act of dividing something up — it is drawn around handling the contents of a product.

    Article 2-2 then lists three business types: cosmetics manufacturing, cosmetics responsible distribution, and customized cosmetics selling. Customized selling is a selling business, not a manufacturing one. Korea did not treat the counter as a small factory; it treated it as a point of sale where someone is allowed to touch the product.

    Evidence figure on customized cosmetics in Korea. First, two kinds by law, Cosmetics Act Article 2 subparagraph 3-2: item a, a cosmetic made by adding the contents of another cosmetic or a raw material designated by the Minister of Food and Drug Safety to the contents of a manufactured or imported cosmetic; item b, a cosmetic made by decanting the contents of a manufactured or imported cosmetic; simply decanting a solid facial soap is excluded. Second, three groups a shop may not mix, Regulation on Safety Standards for Cosmetics Article 5: Annex 1 raw materials that may not be used in cosmetics; Annex 2 raw materials that need use restrictions, which is where preservatives, ultraviolet filters and colorants sit; and notified raw materials that deliver a functional cosmetic effect, except where the responsible distributor supplying the raw material has had it reviewed or filed a report under Article 4. Third, Korea, the United States and the European Union: Korea lists customized cosmetics selling as one of three business types and requires a national qualification; in the United States a beauty shop or a retailer that sells directly to consumers at that location is not a facility under 21 United States Code section 364; in the European Union a distributor who modifies a product already placed on the market becomes the responsible person under Regulation 1223 of 2009 Article 4 paragraph 6.

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    What a shop may not mix

    Article 5 of the Regulation on Safety Standards for Cosmetics is written backwards, and that is the interesting part. It does not list what may be used. It says everything except the following three groups may be used in a customized cosmetic.

    Kept out What sits there So at the counter
    1. Annex 1
    raw materials that may not be used in cosmetics    		 The prohibited list Never allowed in a cosmetic in the first place
    2. Annex 2
    raw materials needing use restrictions    		 Preservatives, UV filters and colorants, plus every ingredient with a concentration cap This is why “could you leave the preservative out?” and “could you add sun protection?” are both no
    3. Notified functional actives The brightening and wrinkle actives Korea notifies by name and concentration (arbutin, niacinamide, retinol, adenosine and the rest) With a proviso — see below

    The third row carries the condition that decides most real cases. The Regulation adds: “except where the cosmetics responsible distributor supplying the raw material to the customized cosmetics seller has had a functional cosmetic including that raw material reviewed, or has submitted a report, under Article 4 of the Cosmetics Act.”

    In plain words — if the company supplying the active already carried it through functional-cosmetic review or filing, the counter may mix it. So if a shop offers to add a brightening or wrinkle active, asking whether that review or report exists is a fair and ordinary question. It is not a gotcha; the rule is built so that someone can answer it.

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    Two more duties people rarely mention

    Both sit in Article 5 of the Cosmetics Act, the article on operators’ duties.

    ✔ Paragraph 3 (inserted 17 August 2021) — a customized cosmetics seller shall not arbitrarily mix or decant cosmetics that are distributed and sold to consumers

    ✔ Paragraph 6 — the seller shall report a list of every raw material used in customized cosmetics, once a year, to the Minister of Food and Drug Safety

    Paragraph 3 closes the obvious shortcut: taking a finished product off the retail shelf and blending it. The contents and raw materials have to have arrived for that purpose. Paragraph 6 means a shop’s raw-material list leaves the shop once a year — this is not a closed counter.

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    The person, the paperwork and the room

    Customized cosmetics selling is a notified business, not a licensed one (Article 3-2, inserted 13 March 2018). But the notification only goes through once the person and the space are already in place.

    What What the rules fix
    Filing Notification form + a copy of the compounding manager’s certificate + a specification of the facilities, to the regional MFDS office
    Certificate of notification Carries the notification number and date, the operator, the shop’s name and address, and the compounding manager’s name and certificate number
    Facilities The mixing and decanting space must be separated or partitioned from space used for anything else
    Qualifying exam Held by the Minister at least once a year, announced 90 days in advance, four subjects (law and institutions / manufacturing and quality control and raw-material standards / distribution and safety control / the character of customized cosmetics)
    Pass mark 60% of the total across all subjects and 40% of the marks in every single subject
    Cheating The exam is stopped or the pass is voided, and the person is barred for three years (Article 3-4)
    Changes A change of operator, shop name or address, or compounding manager must be notified
    Disqualification A person under adult guardianship or an undischarged bankrupt; anyone serving a custodial sentence; anyone in a suspended sentence period; anyone whose shop was closed down less than a year ago

    The certificate naming the compounding manager is the hinge. Change the person and you change the notification — the shop and the qualification are tied together on one piece of paper.

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    “Separated” and “partitioned” are not the same word

    The Enforcement Rule only says the mixing and decanting space must be separated or partitioned. The MFDS guideline for customized cosmetics selling businesses, issued in 2020, split the two terms:

    ✔ Separated — a line or a mesh, leaving enough distance

    ✔ Partitioned — a wall, a screen, an air curtain and the like, in a state that prevents cross-contamination and outside contaminants from entering

    This is something a customer can see. The mixing should not be happening on a corner of the till. (Confirmed through Cosin Korea’s report of 14 May 2020 on the guideline.)

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    Nothing is mixed in advance

    MFDS Notice No. 2022-2 (14 January 2022) and Article 12-2 of the Enforcement Rule set the working routine. These are the lines that a customer actually feels.

    When What is fixed
    Before mixing Check the certificate of analysis for the contents and raw materials · confirm the raw material meets the cosmetic safety standards · check the use-by date and the period after opening
    While mixing Do not set the product’s date beyond the raw material’s own use-by date (unless there is scientific ground) · inspect and clean the equipment
    After mixing Keep leftover raw material in a sealed container · do not mix or decant in advance and store it before the consumer has chosen
    After selling Record lot number, use-by date and date of sale in a sales ledger · explain the contents and cautions to the consumer · report adverse events

    That is why there is a wait at the counter, and why the jar you are handed carries a lot number and a date. The record has to exist.

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    Korea, the United States and the European Union

    Here is the part that is hard to find in English. The same question — who may mix a cosmetic in front of a customer, and under what conditions — lands in three different places.

    Korea United States European Union
    Where the rule lives Cosmetics Act Art. 2-2, 3-2, 3-4; Safety Standards Reg. Art. 5; MFDS Notice 2022-2 FD&C Act as amended by MoCRA — 21 U.S.C. § 364 Regulation (EC) No 1223/2009, Arts. 4 and 6
    Is counter mixing its own category? Yes — one of three business types, with its own notification No — there is no separate retail-compounding regime No — the Regulation does not address point-of-sale mixing
    Does the shop register? It must notify the regional MFDS office before operating A facility registers, but “facility” excludes “beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location” and cosmetic product retailers “unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location” No registration for the act of mixing; products are notified centrally by the responsible person
    Who carries the duty? The seller, with a licensed compounding manager named on the certificate The responsible person — “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label” The responsible person; and “the distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected” (Art. 4(6))
    Is there a list of what may not be mixed? Yes — three groups, by regulation No such list; prohibited and restricted substances apply to the product, not to the counter No such list; Annexes II–VI apply to the product

    Read the US row again, because it is the sharpest contrast. In the United States a salon or a shop that mixes a product and hands it straight to the customer at that location falls outside the definition of a registrable facility. Korea took the opposite route: it treated that exact act as its own regulated business and attached a state exam to it.

    The EU sits in between, and it does so without ever naming the practice. Article 4(6) simply says that whoever modifies a product already on the market becomes the responsible person for it. A European shop that blends two products has not broken a rule about blending — it has quietly inherited the whole compliance file for what it just made.

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    Reading the numbers carefully

    ✔ “At least once a year” is the regulation’s phrase, not a schedule. The exam has run more often than that. Dates change each year, so check the announcement rather than any article

    ✔ A concentration cap is not a statement about what is in a product. An ingredient sitting in Annex 2 means it may not be mixed at the counter — it says nothing about how much of it a finished product contains

    ✔ “Functional actives may be mixed” is conditional. The review or report has to already exist upstream, at the supplying responsible distributor. It is not something a shop decides

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    What I left out, and why

    ✔ The 2026 exam dates — the trade coverage I found carried last year’s schedule, so I kept to the Enforcement Rule’s “at least once a year, announced 90 days ahead”

    ✔ The compounding manager’s continuing-education hours — I confirmed the legal basis (Act Art. 5, Enforcement Rule Art. 14, Notice 2022-2) and the fine’s basis (Act Art. 40, Enforcement Decree Annex 2), but could not open a primary source giving the hours or the amount

    ✔ “Customized means it suits your skin better” — there is no primary source for that. What the Act and the notices fix is raw materials, a person and a room, not the size of an effect

    ✔ The notice number and effective date of the Safety Standards Regulation — I could not open a route that serves the body of that notice, so I cite the article number only

    ✔ MoCRA’s small-business exemptions and the FDA’s guidance detail — out of scope here; the row above quotes only the statutory definition of “facility”

    ✔ The penalty for operating without notification — the figure is carried in the Act’s penal provisions, which the bilingual text I used does not serve, so I leave the amount out rather than quote it second-hand

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    Five things to check in the shop

    ✔ Is the certificate of notification on the wall? The compounding manager’s name is printed on it

    ✔ Is the mixing area actually partitioned — a wall or screen, not a line on the counter?

    ✔ Does the jar you receive carry a lot number and a date?

    ✔ If a brightening or wrinkle active is offered, is there a review or report behind that raw material?

    ✔ Were the contents and cautions explained to you? The notice requires it

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    One line

    A customized cosmetic in Korea is not a counter where anything can be mixed. It is a selling business in which the raw materials, the person and the room are all fixed by law. Three things are visible to a customer: the certificate, the partition, and the number on the jar.

    Next in this series: Korea’s ban on animal-tested cosmetics — the six exceptions, and why “cruelty-free” is a phrase Korean labels cannot use (Cosmetics Act Art. 15-2).

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    📌 Related posts

    📌 How to Read a Korean Cosmetic Ingredient List (Ingredient Guide 14) — where you check what was mixed in

    📌 Salicylic Acid (BHA): 0.5% vs 2%, Explained (Ingredient Guide 8) — an Annex 2 ingredient, seen up close

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

    📌 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 of Korea, Arts. 2(3-2), 2-2, 3-2, 3-4, 5 (Act No. 20901, amended 1 Apr 2025; in force 2 Apr 2026)

    · Enforcement Rule of the Cosmetics Act, Arts. 8-2 to 8-5 and 12-2

    · Regulation on Safety Standards for Cosmetics, Art. 5 (raw materials usable in customized cosmetics)

    · Regulation on Obligations of Customized Cosmetics Sellers, MFDS Notice No. 2022-2 (14 Jan 2022)

    · MFDS guideline for customized cosmetics selling businesses (2020), as reported by Cosin Korea, 14 May 2020

    · 21 U.S.C. § 364 — definition of “facility” (FD&C Act as amended by MoCRA)

    · Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products, Arts. 4 and 6

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    This article summarises statutes and administrative notices and is not a substitute for diagnosis or treatment. The provisions were checked on 7 October 2026; rules change, and so does what they require. Please speak to a professional about any symptom that worries you.

    — Dr. J Ingredient Notes

  • 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.

    Evidence figure on where arbutin's 2 to 5 percent comes from. First, arbutin at 2 to 5 percent is one of nine brightening ingredients listed in Annex 4 of Korea's Regulation on Review of Functional Cosmetics, alongside niacinamide 2 to 5 percent, paper mulberry extract 2 percent, ascorbyl glucoside 2 percent and oil-soluble licorice extract 0.05 percent. Second, the same annex fixes the product forms, lotion, liquid, cream and sheet mask, and the claim wording, helps brighten the skin, and products made this way need no new efficacy data. Third, 102 women aged 26 to 55 with melasma or solar lentigo were randomised and double-blinded to a cream with 2.51 percent arbutin, 54 women, or placebo, 48 women, twice a day for 8 weeks; lightening was seen in 75.86 percent of women with melasma and 56.00 percent with solar lentigo in the cream group, Morag and colleagues, Journal of Cosmetic Dermatology 2015. Fourth, the European Union limits alpha-arbutin to 2 percent in face creams and 0.5 percent in body lotions and arbutin, the beta form, to 7 percent in face creams, with hydroquinone no higher than unavoidable traces, SCCS opinion 2023 and Regulation (EU) 2024/996; these are safety limits, not a verdict on efficacy.

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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

    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.

    📄 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