Tag: K-beauty regulation

  • Korea Abolished Its Organic Cosmetic Certification: What the 95% and 10% Thresholds Mean Now, and Who Checks Them (Ingredient Guide 18)

    Cover image for a guide to organic and natural cosmetic claims in Korea. Natural cosmetics require 95 percent natural or natural-derived content and organic cosmetics 10 percent organic content, and the government certification scheme ended on 1 August 2025. Dr. J Ingredient Notes, Ingredient Guide 18.

    🇰🇷 한국어판: 유기농 화장품 기준 – 95%와 10%, 그리고 2025년 8월 폐지된 식약처 인증

    Hello, this is Dr. J. If you have been reading about Korean organic cosmetics, almost everything in English still describes a government certification mark. That scheme no longer exists.

    It ended on 1 August 2025. The two definitions left the Cosmetics Act, the certification articles were deleted, and the notification that held the standard was repealed on the same day.

    The thresholds themselves did not change — natural 95%, organic 10%. What changed is who measures them and who checks. This guide walks the regulation, the repeal notices and the industry guide that replaced them, and ends with how the same question is handled in the United States.

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    Read the sources first

    📄 Guide on Labelling and Advertising of Natural and Organic Cosmetics (2025, Korean)

    📄 Repeal of the standard — MFDS Notice 2025-49

    📄 Repeal of the certifying-body rules — Notice 2025-48

    📄 ISO 16128-2:2017 — the index calculation

    📄 FDA — “Organic” Cosmetics — how the United States handles the word

    The Korean-language sources are linked as they stand; the figures below are read from those originals.

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    The five-line version

    ✓ A natural cosmetic needs 95% natural or natural-derived content

    ✓ An organic cosmetic needs 10% organic, plus 95% natural including that share

    ✓ Korea’s government certification ended on 1 August 2025

    ✓ Certificates issued before then run to their expiry

    ✓ ISO 16128 and written substantiation now carry the claim

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    The two thresholds

    Start with what is being claimed. The numbers are unchanged from the repealed notification; the method moved to ISO 16128.

    Natural cosmetic Organic cosmetic
    Natural (or derived) content 95% or more 95% or more, including the organic share
    Organic (or derived) content No separate threshold 10% or more
    How it is measured By weight, ISO 16128-2 By weight, ISO 16128-2
    What counts as natural ISO 16128-1 definitions ISO 16128-1 definitions

    A point worth sitting with: an organic cosmetic can be 10-something per cent organic. That is not a shortcut. It is where the line was drawn, and the remaining 85 per cent or so still has to be natural or natural-derived.

    Evidence figure on organic and natural cosmetic claims in Korea. First, the two thresholds: a natural cosmetic needs 95 percent or more natural or natural-derived content, an organic cosmetic needs 10 percent or more organic content plus 95 percent or more natural content including that organic share, measured by weight and calculated with ISO 16128-2, from the Guide on Labelling and Advertising of Natural and Organic Cosmetics, 2025. Second, government certification ended on 1 August 2025: both definitions left the Cosmetics Act, Articles 14-2 to 14-5 were deleted in the amendment of 31 January 2025, Notification 2019-66 was repealed by Notice 2025-49 and the certifying-body rules by Notice 2025-48, per Korea Cosmetic Association notices and the MFDS Cosmetics Policy Division. Third, what stands in its place: cite the ISO 16128-1 definitions and the 16128-2 index calculation, hold substantiation that the product meets the threshold, use permitted wording such as natural derived index of a given percentage calculated with ISO 16128, and certificates issued before the repeal run to their expiry, under Article 14 of the Cosmetics Act and the industry guide.

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    What was removed, and when

    What went Instrument Date
    The definitions of natural and organic cosmetics, Cosmetics Act Article 2 Act No. 20767 amended 31 Jan 2025
    Articles 14-2 to 14-5 — certification, validity, certification mark, accredited bodies same Act amended 31 Jan 2025
    Article 13(1)3 and parts of the penalty articles same Act amended 31 Jan 2025
    Notification 2019-66, the standard for natural and organic cosmetics Repeal Notice 2025-49 1 Aug 2025
    The rules on designating certifying bodies Repeal Notice 2025-48 1 Aug 2025

    The Act was amended on 31 January 2025 and the two repeal notices took effect on 1 August 2025. Both notices were posted, with the ministry’s covering document, by the Korea Cosmetic Association.

    The stated reason was to remove duplicate certification. Private schemes were already doing the work, so the government stepped out of it.

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    Old certificates are still running

    A repeal does not void what was already issued. Certificates remain valid until they expire, and the old validity period was three years.

    So a Korean shelf right now holds two kinds of product: ones carrying the old government mark, and ones labelled against the industry guide with no mark at all. Neither is better by definition — the guarantor is different, and that is the thing to notice.

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    Before and after, side by side

    Before — Notification 2019-66 Now — industry guide, 2025
    Who set it Ministry of Food and Drug Safety Self-regulatory body for cosmetic labelling and advertising, at the Korea Cosmetic Association
    Natural content 95% or more 95% or more
    Organic content 10% or more 10% or more
    Synthetic ingredients allowed Up to 5%, of which petrochemical moiety 2% or less No such list — ISO 16128 calculation takes its place
    Manufacturing processes Permitted processes listed as physical, chemical and biological Not listed in the guide
    Who checks A certifying body designated by the ministry The company, holding substantiation on file

    The thresholds did not move. The checking did.

    One consequence is easy to miss. The repealed notification carried a 5% cap on synthetic ingredients, with the petrochemical moiety held to 2%, and a list of permitted manufacturing processes. The industry guide has no such list — the ISO 16128 calculation stands in for it. If you find those older figures quoted as current Korean rules, they are out of date.

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    What carries the claim now

    Two things. The ISO 16128 pair, and substantiation.

    ISO 16128-1:2016 defines which ingredients count as natural, derived natural, organic or derived organic. ISO 16128-2:2017 sets out how to calculate the indexes. The 95 and the 10 are outputs of that calculation.

    The guide also fixes the permitted wording. What a company may print is a phrase of the form “natural (derived) index XX% (calculated under ISO 16128)” — the claim carries its own method. What it may not print, when the product misses the threshold, is a line like “contains natural ingredient X” leaning on a single component.

    And the evidence has to exist on paper:

    Cosmetics Act, Article 14 (Substantiation of labelling and advertising)

    (1) A business operator or seller shall be able to substantiate matters of fact in its own labelling or advertising.

    (3) … shall submit the substantiating material to the Minister of Food and Drug Safety within 15 days of the request.

    Paragraph (4) requires the ministry to order the labelling or advertising stopped if the material is not filed in time and the claim continues. Certification is gone; the checking is not.

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    Article 13 did not go away

    The definitions and the certification articles were deleted. The prohibition on misleading claims was not.

    Cosmetics Act, Article 13(1) — prohibited labelling and advertising

    1. Labelling or advertising likely to be mistaken for a medicine

    2. … likely to be mistaken for a functional cosmetic when it is not

    3. Deleted <31 Jan 2025>

    5. Any other labelling or advertising likely to deceive consumers or cause them to be mistaken, contrary to fact

    Item 3 was the natural-and-organic provision. Item 5 now covers that ground. The MFDS labelling and advertising guidance of 14 August 2025 also lists, among prohibited expressions, natural or organic wording on a product that does not meet the industry guide.

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    The private route: COSMOS

    With the state out of it, the scheme most visible on Korean packaging is COSMOS — a non-profit standard built by five European organisations: BDIH (Germany), Cosmebio and Ecocert (France), ICEA (Italy) and the Soil Association (United Kingdom).

    Finished products carry COSMOS ORGANIC or COSMOS NATURAL; raw materials are COSMOS CERTIFIED or COSMOS APPROVED. In Korea the certifying bodies are KTR (Korea Testing & Research Institute) and Control Union Korea.

    A company holding one of these may print it alongside the index wording. It is worth knowing, though, that this is a private guarantee, not a government one.

    ※ The organic-content percentages behind each COSMOS grade were not stated on the public overview page, so they are not quoted here.

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    Korea and the United States, side by side

    The word “organic” is handled very differently in the two markets, and a Korean product sold in the US runs into the second column.

    Korea United States
    Is there a government definition? There was one in the Cosmetics Act. It was deleted on 31 January 2025 No. FDA says the term is not defined in the laws it enforces
    Who certifies Nobody, since 1 August 2025. Private schemes such as COSMOS continue USDA under the National Organic Program, for agricultural ingredients
    What sets the threshold An industry guide citing ISO 16128-1 and -2 — natural 95%, organic 10% NOP rules for the organic claim; FDA rules still apply to labelling and safety
    What the company must hold Substantiation, due within 15 days of a request (Cosmetics Act Art. 14) Certification records for the NOP claim

    The FDA’s position is blunt: “The term ‘organic’ is not defined in either of these laws or the regulations that FDA enforces.” The definition and the certification sit with the USDA’s National Organic Program, which certifies agricultural ingredients. And a cosmetic bearing an organic claim “must comply with both USDA regulations for the organic claim and FDA regulations for labeling and safety requirements.”

    So the two countries arrived at a similar place from opposite directions. The United States never defined the word for cosmetics. Korea defined it, certified it for years, then handed the measuring to an international standard and the checking to the companies themselves.

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    What ISO 16128-2 does not cover

    One caution, and it is in the standard’s own scope. ISO 16128-2 is a method for calculating indexes. The overview states that it does not address:

    ✓ Product labelling

    ✓ Human safety

    ✓ Environmental safety

    ✓ Fair trade and other regulatory requirements

    So a high natural index is not a gentleness rating. It counts how much of the formula came from nature, which is a different question from how your skin will respond. For reactive skin, the ingredient list is the more useful page.

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    What to check on the box

    ✓ Whether a number and a method sit beside the words “natural” or “organic”

    ✓ Whether the wording follows the “natural (derived) index XX% (ISO 16128)” form

    ✓ Whether a private scheme such as COSMOS is named, together with its certifier

    ✓ If a Korean government mark is shown, whether the product’s certificate is still inside its term

    “Contains natural ingredients”, with no number and no scheme, tells you nothing about how much. Turn the box over and read the ingredient list instead — the front of it answers the question faster.

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    What I left out, and why

    ✓ The repealed notification’s process annex — no longer in force; it appears only in the before-and-after table

    ✓ How many products had been certified, and any revocations — I could not open a primary source

    ✓ The ISO 16128 formulas and the treatment of water — the standard itself is paywalled, so this stops at “a method for calculating indexes”

    ✓ Per-grade organic percentages for COSMOS — not stated on the public overview

    ✓ “Natural means gentle” — no primary source, and it sits against what the ISO scope says

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    One line

    Natural 95%, organic 10% — and in Korea you now read the wording rather than look for a mark.

    Substantiation came up more than once above. What a cosmetic advertisement may and may not say in Korea is set out in its own guide (Ingredient Guide 19).

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    📌 Previous guides

    📌 How to Read a Korean Cosmetic Ingredient List (Guide 14) — where to look when there is no index

    📌 Arbutin vs Alpha-Arbutin: What Korea’s 2–5% Means (Guide 15) — another number fixed by notification

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

    📌 Skin Concern Ingredient Map

    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

    · Self-Regulatory Body for Cosmetic Labelling and Advertising, Guide on Labelling and Advertising of Natural and Organic Cosmetics, 2025

    · MFDS Repeal Notices 2025-49 and 2025-48, effective 1 August 2025

    · Cosmetics Act (Act No. 20767, amended 31 January 2025), Articles 13 and 14

    · ISO 16128-1:2016 and ISO 16128-2:2017

    · U.S. FDA, “‘Organic’ Cosmetics”, page updated 25 February 2022

    · COSMOS-standard AISBL, public overview

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    This article summarises statutes, notices and published guidance, and does not recommend a particular product. Rules change; please check the originals before relying on any of it for a decision.

    — Dr. J Ingredient Notes

  • Children’s Cosmetics in Korea: What the Label Triggers, and Why the Box Prints a Preservative Percentage (Ingredient Guide 20)

    Cover image for a guide to Korea's rules for children's cosmetics, Ingredient Guide 20 from Dr. J Ingredient Notes. Infants are three years of age and under and children are four to thirteen, and once a product says so on the label three rules follow.

    🇰🇷 한국어판: 어린이 화장품 기준 – 「어린이용」이라 적으면 따라오는 것, 그리고 상자의 보존제 함량

    Hello, this is Dr. J. Today I want to read Korea’s rules for children’s cosmetics straight from the statute, because one of them changes what is printed on the box.

    Most countries regulate what may go into a product for a child. Korea does that too, but it adds something unusual: once a product says it is for children, the outer package has to carry the amount of preservative in it, as a number, separate from the ingredient list. I have not found that requirement anywhere else.

    And the trigger is not the formula. It is the label. That is the part worth understanding first, so let me start there.

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    The sources, if you would rather read them first

    📄 Korea Ministry of Government Legislation — cosmetics for infants and children — the age brackets and the three documents

    📄 Safety Standards for Cosmetics, Annex 2 — the entries that carry an age condition

    📄 Commission Regulation (EU) No 1004/2014 — parabens and the nappy area

    📄 US FDA — Summary of Cosmetics Labeling Requirements — what a US label has to carry

    The Korean annexes open as attachment files, so the text comes up directly rather than through a search form.

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    Five lines, if you are in a hurry

    ✔ Korean law splits the two groups by age — an infant is 3 and under, a child is 4 to 13

    ✔ The rules attach the moment the package, the product name or an advertisement says the product is for them

    ✔ Three safety documents must be written and kept, for a year past the expiry date or three years past the manufacturing date

    ✔ The outer package gains one line — the content of the preservatives, printed apart from the ingredient list

    ✔ Salicylic acid and iodopropynyl butylcarbamate step out of products labelled for under-13s

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    Two age groups, written into the statute

    Article 4-2 of the Cosmetics Act and Article 10-2 of its Enforcement Rule define the two groups by age. An infant is three years of age and under. A child is four to thirteen.

    The upper bound is worth noticing. Thirteen takes in primary-school age, so a lotion or a lip balm marketed to a nine-year-old sits inside the same rules as a baby lotion. In several other markets the special category stops at three.

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    The rule starts at the label, not at the formula

    This is the part that surprises people. The obligations do not attach because of what is in the bottle. They attach because of what the company says about who it is for.

    Where What makes the rules attach
    Packaging The inner or outer package states, specifically, that the product may be used by an infant or a child
    Product name The name of the cosmetic itself carries a reference to infants or children — the name alone is enough
    Advertising Newspapers, broadcast, magazines, the internet, posters and signboards, video or film, stating it specifically

    So a very mild formula with no such wording stays outside the rules, and an ordinary formula with the wording falls inside them. The word the statute uses is “specifically”: a vague impression that a child might use it is not the test — naming the group is.

    ※ This is why the phrase on the front of a Korean box is a regulatory statement rather than a marketing flourish.

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    Three documents, and how long they are kept

    Once that wording is used, the responsible distributor has to prepare and keep product-specific safety documentation. Enforcement Rule Article 10-3 lists three items and sets the retention period.

    Document Content Kept until
    ① Product and method A description of the product and of how it is manufactured Products labelled with an expiry date — one year after the expiry date of the last batch made or imported

    Products labelled with a period after opening — three years after the manufacturing date of the last batch
    ② Safety assessment A safety assessment of the cosmetic product
    ③ Evidence of effect Evidence for the efficacy or effect claimed for the product

    The retention clock keeps running after the product has left the shelves — a year past the expiry date of the final batch. Failure to prepare or keep the documents carries up to one year of imprisonment or a fine of up to ten million won, and a company can be fined alongside the individual.

    ※ A shopper cannot ask to see this file. What is useful to know is that the phrase “for children” on a Korean box has a dossier sitting behind it.

    Chart of what Korea asks of a children's cosmetic. First, two age groups set by law: an infant is three years of age and under, a child is four to thirteen, and the rules attach once the label, the product name or an advertisement says so, under Cosmetics Act Article 4-2 and Enforcement Rule Article 10-2. Second, three safety documents: the product and its manufacturing method, a safety assessment of the product, and evidence for the claimed effects, kept one year past the expiry date or three years past the manufacturing date for products labelled with a period after opening, under Enforcement Rule Article 10-3. Third, one extra line on the box: the content of preservatives whose limits are set by notification, printed as a number apart from the ingredient list, under Cosmetics Act Article 10 and Enforcement Rule Article 19. Fourth, two ingredients step out: salicylic acid at 0.5 percent is not allowed in infant products or products labelled for under-thirteens, shampoo excepted, and iodopropynyl butylcarbamate carries the same ban with bath products, shower gels and shampoos excepted, under Annex 2 of the Safety Standards for Cosmetics. Fifth, the European Union draws a different line: propylparaben and butylparaben are capped at 0.14 percent as the sum on an acid basis and are not for leave-on products for the nappy area of children under three since 16 April 2015, under Regulation 1004/2014 Annex V entry 12a, while the United States sets no amount on the label at all.

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    One extra line on the box — the preservative content

    Here is the part a shopper can actually see. Where a product is labelled or advertised specifically for infants or children, the outer package must carry “the content of preservatives among the raw materials whose standards of use are designated and published”.

    Compare that with the ordinary ingredient list. Ingredients are listed in order of how much is present, and in Korea anything at or below 1% may be listed in any order. No amounts appear. On a children’s product, the preservatives come back with a number attached — “phenoxyethanol 0.4%”, printed in its own line.

    Two things follow from that line. First, its presence tells you the product is formally labelled for children. Second, it tells you which preservative is in there and how much. If no preservative is used, there is nothing to declare and the line is simply absent.

    ※ The basis is Article 10 of the Act with Article 19 of the Enforcement Rule. Look for it beside the ingredient list, not inside it.

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    Two ingredients that step out

    Annex 2 of the Safety Standards for Cosmetics sets a maximum for each restricted raw material. Two of those entries carry an age condition, and I opened both.

    Ingredient Limit Age condition
    Salicylic acid and its salts 0.5% as salicylic acid Not to be used in products for infants, or in products labelled specifically as usable by children aged 13 or under
    (shampoo excepted)
    Iodopropynyl butylcarbamate (IPBC) 0.02% rinse-off · 0.01% leave-on · 0.0075% in deodorants The same prohibition
    (bath products, shower gels and shampoos excepted)

    Read the two columns together. 0.5% is the adult ceiling; in a children’s product the ingredient is not permitted at all, not permitted at a lower level. The exceptions in brackets follow the same logic in reverse — products that are rinsed off are treated differently from products that stay on the skin.

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    Fragrance allergens: 25 names, the same thresholds

    If a Korean ingredient list ends with limonene, linalool, citronellol and a few more, those are the fragrance allergens that must be named separately rather than hidden inside “fragrance”. There are 25 of them.

    The thresholds are above 0.01% in rinse-off products and above 0.001% in leave-on products. They are not lowered for children’s products — the annex carries no age clause at all.

    ※ A long tail of names is disclosure, not concealment. For a child who reacts to fragrance, that tail is the part of the label worth reading.

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    Korea, the EU and the US, side by side

    Three regulators, three different places to put the line. Korea hangs its rules on the label, the EU writes age into individual ingredient entries, and the US asks for no amounts on the label at all.

    Where What applies to a children’s product Source
    Korea Infant 3 and under, child 4 to 13. Label or advertise it as such and three safety documents follow, plus the preservative content printed on the package Cosmetics Act Art. 4-2, Art. 10
    Enforcement Rule Art. 10-2, 10-3, 19
    European Union Propylparaben and butylparaben capped at 0.14% as the sum (as acid), and “not to be used in leave-on products designed for application on the nappy area of children under three years of age”; such products carry “Do not use on the nappy area” Reg. (EU) No 1004/2014
    Annex V entry 12a, applying from 16 April 2015
    United States “The ingredients must be declared in descending order of predominance”, and “color additives and ingredients present at one percent or less may be declared without regard for predominance”. No amount has to be shown US FDA, Summary of Cosmetics Labeling Requirements

    The contrast worth taking away is the middle column of the first row. A Korean children’s box tells you how much preservative is in the product. A European or American one does not, however carefully it is labelled otherwise.

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    What to check on the box

    ✔ Does the package say, in so many words, that it is for children? That is what puts it inside these rules

    ✔ Is there a preservative line separate from the ingredient list, and which preservative is named

    ✔ If salicylic acid appears, is the product one that gets rinsed off

    ✔ For a child who reacts to scent, read the names after “fragrance”

    ✔ Is the expiry date on the container itself, which survives after the box is thrown away

    ※ A printed line is easier to verify than a claim such as “no preservatives”. Choose on what is written.

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    What I left out, and why

    ✔ Whether Korea restricts parabens by age. The EU does. In the extract of Annex 2 I was able to open, the paraben entries carried no age condition — but I could not confirm the full entry, so I am not claiming Korea has no such rule

    ✔ The sub-paragraph numbers for the preservative-content requirement. Different official sources number it differently, so I cite the Act’s Article 10 with Article 19 of the Enforcement Rule and stop there

    ✔ “Baby products should be fragrance-free and preservative-free.” There is no primary source for that as a rule, and removing preservatives moves the microbiological question elsewhere rather than removing it

    ✔ Product names. This blog does not recommend particular products

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    In one line

    In Korea, the rules for a children’s cosmetic begin with the words on the label, not with the formula inside. Say it, and a dossier follows — and the box gains a line telling you how much preservative is in there.

    Next in this series: what a “vegan” claim on a cosmetic certifies, which in Korea runs through an industry self-review rather than a government mark — a companion to the organic and natural guide (Ingredient Guide 21).

    📌 Earlier guides

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

    📌 Salicylic Acid (BHA): 0.5% vs 2%, Explained (Guide 8)

    📌 Ceramides: the Cholesterol and Fatty Acid Ratio (Guide 4)

    📌 Niacinamide: How Much Is Enough (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.

    📄 References

    · Cosmetics Act of Korea, Articles 4-2 and 10

    · Enforcement Rule of the Cosmetics Act, Articles 10-2, 10-3 and 19

    · Safety Standards for Cosmetics, Annex 2 (restricted raw materials)

    · Notification on precautions and fragrance allergen labelling, Annex 2 (25 substances)

    · Commission Regulation (EU) No 1004/2014, Annex Ⅴ entry 12a

    · U.S. FDA, Summary of Cosmetics Labeling Requirements

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    This article summarises public statutes and regulatory documents and is not a substitute for diagnosis or treatment. Quoted sentences are as they appear in the law and the notifications, and labelling practice varies between products. If a child’s skin reacts, stop using the product and speak to a professional.

    — Dr. J Ingredient Notes