Tag: cosmetic regulation

  • Fragrance on a Korean Cosmetic Label: The One Word That Needs No Permission, and the One That Does (Ingredient Guide 30)

    Cover image for a guide to how Korean cosmetic labels write fragrance. Article 10 of the Cosmetics Act requires every ingredient used in manufacture to be listed on the package. Annex 4 of the Enforcement Rule then says a fragrance material may be written as the single word fragrance, unless it contains one of the 25 allergens the Minister of Food and Drug Safety has notified, in which case the name itself must be written. The neighbouring item of the same annex is different: to hide any other ingredient a company must submit supporting data to the Minister and, if the Minister accepts that disclosure would seriously harm a legitimate interest, the label may read Other Ingredients. One word needs no permission; the other one does. Dr. J Ingredient Notes cover image.

    🇰🇷 한국어판 (Korean version)

    Hello, this is Dr. J. Today I want to read one entry of a Korean labelling annex line by line, because it answers a question people ask in every market: why does the back of the box say only “fragrance”?

    Here is the part that surprised me. In Korea, “fragrance” is a word you may use without asking anyone. The item sitting immediately beside it in the same annex is the opposite: to hide any other ingredient you have to file supporting data and be told yes.

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    The provisions, if you want them first

    📄 Enforcement Rule of the Cosmetics Act, Annex 4 (labelling standards and method)

    📄 Cosmetics Act Article 10 and Enforcement Rule Article 19 (Korea Cosmetic Association)

    📄 Regulation (EC) No 1223/2009, Articles 19 and 21

    📄 21 CFR 720.8 — trade secret exemption procedure (eCFR)

    The Korean texts are quoted from the attachment file published by the National Law Information Centre. The English wording below is my own rendering of the Korean; where a phrase matters I give it in quotation marks and name the item it comes from.

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    In five lines

    ✔ The rule is every ingredient used in manufacture — Cosmetics Act Article 10
    ✔ A fragrance material may be written as one word — Annex 4, item 3(e)
    ✔ If a notified allergen is in it, the substance is named instead — the proviso to the same item
    ✔ To hide any other ingredient you file data and wait for acceptance — item 3(g)
    ✔ The EU and the US also use one word — ‘parfum’ / ‘aroma’, and ‘fragrance’

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    The rule — ten items, and the third one is the list

    Article 10(1) of the Cosmetics Act sets out what a cosmetic package has to carry. There are ten items; the third is where today’s question starts.

    No. What Article 10(1) requires Note
    1 The name of the cosmetic
    2 The trade name and address of the business operator
    3 Every ingredient used in the manufacture of the cosmetic ★ today’s provision
    4 The volume or weight of the contents
    5 The batch number also on the primary container
    6 The use-by date or period after opening also on the primary container (Guide 17)
    7 The price
    8 The words or mark for a functional cosmetic Guide 16
    9 Precautions for use
    10 Anything else the Prime Minister’s Ordinance prescribes Enforcement Rule Article 19(4)

    Article 10(2) names four items that must appear on the primary container — the tube or jar itself: the name, the trade name, the batch number and the use-by date or period after opening. The ingredient list is not among them. It belongs to the outer box, which is why a bare tube often carries no ingredients at all.

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    Seven items inside one entry — Annex 4 read line by line

    How the ingredients are written is settled by Annex 4 of the Enforcement Rule. Entry 3, “ingredients used in the manufacture of the cosmetic”, holds seven items, (a) to (g). Most articles quote only one of them. Here they all are.

    Item What the provision says What it means in practice
    (a) “The letters shall be at least 5 points in size.” The small print on the back has a floor under it
    (b) “They shall be written in order of decreasing content used in the manufacture of the cosmetic.” With a carve-out: ingredients at 1% or less, fragrance materials and colour materials need not follow the order
    (c) “For a blended raw material, the name of each individual blended ingredient shall be written.” A compound raw material is unpacked into its parts
    (d) “Where a different colour material is used for each shade in colour cosmetics, eye cosmetics, hair dyes or nail products, all the colour materials used may be written together after the mark ‘± or +/-’.” That ± on the back of a lipstick (Guide 24)
    (e) “A fragrance material may be indicated as ‘fragrance’.” ★ today’s one word
    (f) “An ingredient used for the purpose of adjusting pH may be written as the product of the neutralisation reaction instead of the ingredient itself.” What came out is written, not what went in
    (g) “… where it would seriously harm the legitimate interest …, the manufacturer or seller shall submit supporting data …, and where the Minister recognises it, <Other Ingredients> may be written.” ★ today’s neighbouring door

    Four of the seven — (d), (e), (f) and (g) — let the label say something other than the plain ingredient name. Only one of the four asks permission.

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    The exception is a single sentence

    Enforcement Rule of the Cosmetics Act, Annex 4, entry 3, item (e)

    “A fragrance material may be indicated as ‘fragrance’. However, where the constituents of the fragrance material include an allergen notified by the Minister of Food and Drug Safety, it may not be indicated as fragrance and the name of that substance shall be written.”

    The first sentence is the permission; the second takes part of it back. A fragrance accord is often dozens of materials, and the way they are combined is the house’s own formula. The provision covers that whole area with one word.

    What matters for today is what the sentence does not contain. There is no application, no dossier, no decision. The provision opens the door by itself — and that is exactly where item (g) parts company with it.

    Evidence card image for the guide to fragrance labelling in Korea. First, the rule. Article 10 paragraph 1 of the Cosmetics Act lists ten items that must appear on a cosmetic package, the third of which is every ingredient used in manufacture, and Annex 4 orders them by decreasing content, except that ingredients at one percent or less and fragrance and colour materials need not follow that order. Second, the exception, which is a single sentence: a fragrance material may be indicated as fragrance. Third, the proviso inside the exception: if the fragrance contains an allergen notified by the Minister of Food and Drug Safety it cannot be written as fragrance and the name of that substance must be written, above 0.01 percent in rinse-off products and above 0.001 percent in leave-on products, judged substance by substance rather than as a sum. Fourth, the neighbouring item. Where listing an ingredient would seriously harm the legitimate interest of the manufacturer or seller, that company must submit supporting data to the Minister, and where the Minister accepts it the label may say Other Ingredients. Fifth, other countries. The European Union writes parfum or aroma under Article 19 of Regulation 1223 of 2009, and the United States writes fragrance under 21 CFR 701.3, with the phrase and other ingredients at the end of the list where the Food and Drug Administration has accepted an ingredient as exempt from public disclosure. All provisions were read in the original texts.

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    The proviso — when the name has to appear

    Once the proviso bites, “fragrance” is no longer available for that substance and the name itself goes on the label. Korea has notified 25 such substances, and two thresholds decide when they surface.

    Threshold Note
    Rinse-off products above 0.01% body wash, shampoo
    Leave-on products above 0.001% perfume, mist, cream — ten times stricter
    Summed or separate? Separate Korea Cosmetic Association guidance: the figure “refers to the content of each individual substance, so whether to label is judged substance by substance”
    No name on the box does not mean it is absent it may sit under the threshold, or the pack may be small enough to omit
    A name on the box does not mean the product is harsh it means the substance crossed the line and was disclosed

    This is why a perfume or a mist tends to show names like limonene and linalool while a rinse-off product does not. The full list of 25 and the notice behind it are in Ingredient Guide 26.

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    ★ The neighbouring item — where permission is required

    Item (g) of the same entry is a different road altogether. It is not limited to fragrance: it reaches any ingredient required by Article 10(1)3. What it adds is a condition.

    Enforcement Rule of the Cosmetics Act, Annex 4, entry 3, item (g)

    “Where writing an ingredient under Article 10(1)3 of the Act would seriously harm the legitimate interest of the manufacturer or the seller, the manufacturer or the seller shall submit the supporting data to the Minister of Food and Drug Safety, and where the Minister recognises that the legitimate interest would be harmed, it may be written as <Other Ingredients>.”

    Put the two side by side and the difference is easy to see.

    ‘Fragrance’ — item (e) ‘Other Ingredients’ — item (g)
    Whose permission Nobody’s The Minister of Food and Drug Safety
    What is filed Nothing Supporting data
    What it covers Fragrance materials — scent only Any ingredient under Article 10(1)3 — not limited to scent
    Is there a proviso Yes — the 25 notified allergens None in the text; the acceptance does that work
    What appears on the label fragrance <Other Ingredients>

    So if you ever meet <Other Ingredients> on a Korean box, it is not a gap in the list. It is a line that was argued for and granted. “Fragrance”, by contrast, was there for the taking.

    ⚠ One oddity worth flagging: item (g) still uses the term “manufacturing and selling business operator”, which the Act itself replaced some years ago with “cosmetics responsible distributor”. I could not establish when the annex was last amended, so I have quoted it as it stands.

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    And some ingredients are not written at all

    “Fragrance” and “Other Ingredients” both rename something. Article 19(2) of the Enforcement Rule does something else again: it lets certain ingredients be left off.

    No. What the provision says Note
    1 “An ingredient that is removed during the manufacturing process and does not remain in the final product” It is not in the product, so it is not on the label
    2 “An incidental ingredient contained in the raw material itself, such as a stabiliser or a preservative, present in a quantity smaller than that which produces its effect” Carried in with a raw material
    3 For packaging of a cosmetic “exceeding 10 millilitres and not exceeding 50 millilitres, or exceeding 10 grams and not exceeding 50 grams”, ingredients other than those listed The exceptions still appear: tar colours, gold leaf, the phosphates in shampoo and rinse, fruit acids (AHA), the efficacy ingredient of a functional cosmetic, and any raw material for which a blending limit has been notified

    Article 19(5) then requires a way back to the full list: either “a telephone number or website address shall be written on the packaging so that consumers can immediately check all the ingredients”, or “printed matter such as a booklet carrying all the ingredients shall be kept at the point of sale at all times”.

    That is why a 30 mL travel size can carry a startlingly short list. It is an abbreviation with a published key, not a secret.

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    Who gives permission — Korea, the EU and the United States

    Writing scent as one word is not a Korean peculiarity. All three systems do it. What differs is the door next to it.

    Korea EU United States
    The word on the label “fragrance” (Annex 4, item 3(e)) ‘parfum’ or ‘aroma’ — “Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’.” (Art. 19(1)(g)) ‘fragrance’ — “except that fragrance or flavor may be listed as fragrance or flavor.” (21 CFR 701.3(a))
    When a name must surface 25 notified allergens above 0.01% / 0.001% Substances whose mention is required under the “Other” column of Annex III (same article) I did not find an equivalent provision while writing this
    Hiding any other ingredient Supporting data → the Minister’s recognition → <Other Ingredients> (item 3(g)) I did not find a labelling omission procedure in the body of the Regulation Where FDA accepts an ingredient as exempt from public disclosure, “the phrase ‘and other ingredients’ may be used at the end of the ingredient declaration” (701.3(a); procedure at § 720.8)
    Order of the list Decreasing content; 1% or less, fragrance and colour materials are free of it “Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.” Ingredients at 1% or less, and colour additives, may be listed without respect to order
    How far disclosure goes The list on the pack; omitted ingredients via phone, website or an in-store booklet Article 21 — “Without prejudice to the protection, in particular, of commercial secrecy …”, and for a fragrance composition the public gets the name and code number of the composition and the identity of the supplier § 720.8(a) describes data “submitted voluntarily to the Food and Drug Administration”

    Read across the last two rows and the axis appears. Every one of the three lets scent be one word; what separates them is who has to say yes before anything else can be hidden. Korea routes it through the Minister, the United States through an FDA acceptance tied to a voluntary filing programme, and the EU handles the same pressure not at the label at all but at the edge of public access — the composition is disclosed as a name, a code number and a supplier.

    For a brand selling into Korea there is a practical consequence. The fragrance word is free, and the other door is paperwork. If a formula depends on keeping one non-fragrance ingredient off the list, that is a filing to plan for, not a labelling style to choose.

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    Four things to check on the box

    ✔ Find the single word “fragrance” near the end of the list
    ✔ If unfamiliar names sit beside it, they are among the 25 — disclosed because they crossed a threshold
    ✔ An absent name does not mean an absent substance — it may be under the threshold, or the pack may be small
    ✔ <Other Ingredients> means a filing was made and accepted

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    One line

    “Fragrance” is not a secret kept; it is a bundle the rule allows. “Other Ingredients” is a bundle someone had to ask for. If a particular scent material has bothered your skin before, write the name down and read for it — the 25 are there precisely so that you can.

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    What I did not write, and why

    ✔ The names and CAS numbers of the 25 allergens — they are already set out in Ingredient Guide 26, so I linked rather than repeated
    ✔ A product that actually carries <Other Ingredients> — I found no example, so I have described the road and stopped there
    ✔ Whether the EU retains a confidentiality route for the label — I did not find one in the body of Regulation 1223/2009, and I could not open the corresponding provision of the former Directive, so I am not claiming that none exists
    ✔ The full text of 21 CFR § 720.8 — I read paragraph (a) and did not read (b) to (g)
    ✔ The amendment history of Annex 4 — which would explain the superseded term in item (g)
    ✔ Claims that “more fragrance names means harsher” — no primary source supports that reading

    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.

    📌 Related posts

    📌 Korea’s 25 Fragrance Allergens (Ingredient Guide 26) — the proviso in full, with the list

    📌 How to Read a Korean Cosmetic Ingredient List (Guide 14) — where the order stops at 1%

    📌 Cosmetic Color Additives in Korea (Guide 24) — the neighbouring item, and that ± mark

    📌 Preservative Limits in Korean Cosmetics (Guide 25) — another place where one grouped name carries many substances

    📄 References

    · Cosmetics Act (Korea), Article 10 — paragraph 1, items 1 to 10; paragraph 2, the primary container
    · Enforcement Rule of the Cosmetics Act, Article 19 (paragraphs 2 and 5) and Annex 4, entry 3, items (a) to (g)
    · Notice on precautions for use and labelling of fragrance allergens, Annex 2 · Korea Cosmetic Association ingredient dictionary Q&A
    · Regulation (EC) No 1223/2009, Article 19(1)(g) and Article 21
    · 21 CFR 701.3(a) and 21 CFR 720.8(a)

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    This article summarises statutes and notices and does not replace diagnosis or treatment. The Korean provisions were opened on the day of writing in the attachment published by the National Law Information Centre and on the Korea Cosmetic Association’s text page; the EU and US provisions on EUR-Lex and the eCFR. Item 3(g) is quoted with the superseded term it still carries. English renderings of the Korean text are mine and are offered for reading, not as an official translation.

    — Dr. J Ingredient Notes

  • Preservative Limits in Korean Cosmetics: Why Parabens Sit on One Grouped Line, and How the EU Splits It in Two (Ingredient Guide 25)

    Cover image for an article on preservative limits in Korean cosmetics. Article 8 of the Cosmetics Act has the Minister of Food and Drug Safety designate conditions of use for raw materials that need special restrictions, such as preservatives, colorants and UV filters, so a preservative works from an allowed list. Annex 2 of the Cosmetic Safety Standards sets parabens at 0.4 percent as acid for a single ingredient and 0.8 percent for a mixture, and phenoxyethanol at 1.0 percent.

    🇰🇷 국문판 (Korean version)

    Hello, this is Dr. J. Today we are reading the preservative limits in Korean cosmetics — the numbers behind parabens and phenoxyethanol.

    Here is the part that surprises people first. The Korean notice never uses the word “paraben.” Several parabens sit on one grouped line, and the salts ride that line too.

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    The primary sources

    📄 Cosmetics Act Article 8 (Korea Cosmetic Association)

    📄 Annex 2, raw materials needing restricted use (Korea Law Information Center)

    📄 KCIA ingredient dictionary — ethylparaben

    📄 Commission Regulation (EU) No 1004/2014 · No 358/2014

    📄 Parabens in Cosmetics (U.S. FDA)

    Annex 2 gives each preservative a line of its own: the name, the ceiling, and the condition attached. Find the preservative on your label in that table and you can read off how much is allowed and in which kind of product.

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    If you are in a hurry — five lines

    ✔ Preservatives work from an allowed list, the way colorants do

    ✔ The paraben line reads 0.4% single, 0.8% mixture (as acid)

    ✔ Phenoxyethanol is 1.0%

    ✔ The EU cuts butyl- and propylparaben to 0.14% inside the same group

    ✔ The United States has no rule aimed at preservatives

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    Article 8 names preservatives first

    Korea’s Cosmetics Act splits raw materials into two kinds. Some may never be used. Others may be used under conditions.

    Paragraph What it does Text
    Article 8 (1) Designates the raw materials that may not be used “The Minister of Food and Drug Safety shall designate and announce the raw materials that may not be used in the manufacture of cosmetics.”
    Article 8 (2) Sets conditions of use for preservatives, colorants and UV filters For raw materials that need special restrictions, “such as preservatives, colorants and ultraviolet blocking agents”, the Minister shall designate and announce the conditions of use, and a preservative, colorant or UV filter whose conditions of use have not been announced may not be used.
    Article 8 (5) Reviews those conditions periodically The Minister shall periodically review the safety of the announced conditions of use, and may change them according to the result.

    Of the three named in paragraph (2) — preservatives, colorants and UV filters — preservatives come first. And the paragraph closes by barring anything outside the announced list. So a preservative in Korea works from an allowed list, not a banned one: a substance with no announced condition of use cannot go in the bottle at all.

    Paragraph (5) adds one more layer. The ceilings are reviewed periodically and may be changed. That is exactly what happened in Europe, twice, to the same group of parabens — these numbers are reviewed values, not fixed ones.

    Evidence figure on preservative limits in Korean cosmetics. First, Article 8 of the Cosmetics Act names preservatives first among the raw materials that need special restrictions, and a preservative with no announced condition of use cannot be used. Second, the Korean notice does not use the word paraben; it reads p-hydroxybenzoic acid, its salts and esters, excluding phenyl among the esters, at 0.4 percent as acid for a single ingredient and 0.8 percent for a mixture, and salts such as sodium propylparaben follow the same ceiling. Third, other ceilings on the same table are phenoxyethanol 1.0 percent, sorbic acid 0.6 percent, benzoic acid 0.5 percent and 2.5 percent in rinse-off products, salicylic acid 0.5 percent, benzyl alcohol 1.0 percent, phenoxyisopropanol 1.0 percent in rinse-off products only, and the CMIT MIT three to one mixture at 0.0015 percent in rinse-off products only. Fourth, the European Union splits the same group in two: Annex V entry 12 keeps 0.4 and 0.8 percent, entry 12a cuts butylparaben and propylparaben to 0.14 percent as acid from 16 April 2015 and bars them from leave-on products for the nappy area of children under three, while the United States has no rule aimed at preservatives.

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    Parabens sit on one grouped line

    Open the preservative table in Annex 2 and the word “paraben” is not there. This is what you find instead.

    How the notice writes it What that one line covers Limit
    “p-hydroxybenzoic acid, its salts and esters
    (excluding phenyl among the esters)”
    The esters — methyl-, ethyl-, propyl-, butylparaben
    The salts — sodium methylparaben, sodium propylparaben
    The acid itself
    0.4% (as acid) for a single ingredient
    0.8% (as acid) for a mixture
    What the bracket takes out Phenyl, among the esters Not on this line

    One group name carries three things at once: the acid itself, the esters, and the salts. So when you see sodium propylparaben on a Korean label, it is not a different substance that slipped past the rule — it is the same line and the same ceiling.

    The bracket takes out one ester: phenyl. Europe takes out five. That difference is the next table.

    You can see the grouping for yourself in the Korea Cosmetic Association’s ingredient dictionary: open ethylparaben and sodium propylparaben separately and both carry the same notice name and the same figures.

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    The rest of the preservative table — the conditions matter as much as the numbers

    A preservative line is rarely a number on its own. Most of them also say which kind of product the substance may go into.

    Preservative Limit Condition attached
    p-hydroxybenzoic acid, its salts and esters (parabens) 0.4% single · 0.8% mixture As acid · phenyl ester excluded
    Phenoxyethanol 1.0% —
    Sorbic acid 0.6% —
    Benzoic acid 0.5% 2.5% in rinse-off products
    Salicylic acid 0.5% Not for products for infants, or labelled as usable by children aged 13 or under (shampoo excepted)
    Benzyl alcohol 1.0% 10% as a solvent in hair dyes
    Phenoxyisopropanol 1.0% Rinse-off products only · banned in all others
    CMIT / MIT mixture 0.0015% As a 3:1 mixture · rinse-off only · banned in all others
    MIT alone 0.0015% Rinse-off only · not to be combined with the mixture above · banned in all others

    Three shapes show up. A plain ceiling (phenoxyethanol, sorbic acid). A ceiling that changes with the product (benzoic acid). And a ceiling that comes with a product type attached (phenoxyisopropanol, the isothiazolinones) — for those, “rinse-off only” is the whole point of the line.

    Salicylic acid carries an age condition: it is not for products for infants, or for products labelled as usable by children aged 13 or under, with shampoo excepted. That is the same rule that shapes Korea’s children’s cosmetics regime (Ingredient Guide 20).

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    The EU splits the same group in two

    Entry 12 of Annex V to Regulation (EC) No 1223/2009 opens with almost the same sentence as the Korean notice: “4-Hydroxybenzoic acid and its salts and esters, other than the esters of isopropyl, isobutyl, phenyl, benzyl and pentyl”. Same grouping habit, same 0,4% / 0,8%.

    What differs is whether the group gets divided again.

    Korea European Union United States
    How parabens are written One grouped line — “p-hydroxybenzoic acid, its salts and esters (excluding phenyl among the esters)” Two entries — Annex V 12 and 12a No list of its own
    Limit 0.4% single · 0.8% mixture (as acid) 12 keeps 0,4% / 0,8%
    12a sets butyl- and propylparaben at 0,14% (as acid)
    No figure set
    Esters barred outright Phenyl Isopropyl, isobutyl, phenyl, benzyl and pentyl — five (Reg. 358/2014, applied 30 Oct 2014) —
    Age or body-area condition None on the paraben line 12a — “Not to be used in leave-on products designed for application on the nappy area of children under three years of age” (Reg. 1004/2014, applied 16 Apr 2015) —
    Shape of the rule A preservative needs announced conditions of use before it can be used A preservative has to be listed in the annex FDA — “FDA doesn’t have special rules that apply only to preservatives in cosmetics.”

    Europe moved in two steps. From 30 October 2014, five esters were moved out of entry 12 and into the banned annex (Regulation 358/2014) — and that regulation states in its recitals that “measures on propylparaben and butylparaben are under preparation”. From 16 April 2015, those two were cut to 0,14% and given the nappy-area condition (Regulation 1004/2014).

    The regulation also explains where 0,14% comes from. The SCCS figure was 0,19% expressed as esters; because entry 12 is written “as acid”, the Commission converted it to 0,14% as acid so the two entries could be read together. The science did not change between those numbers — the unit did.

    The United States draws no such line. FDA states plainly that it “doesn’t have special rules that apply only to preservatives in cosmetics”, and that cosmetic ingredients other than color additives do not need FDA approval before going on the market.

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    One substance, three ways of drawing the line

    Korea European Union United States
    Allowed list, by notice under Article 8 (2) Allowed list, Annex V No preservative-specific rule
    Parabens grouped on one line, salts included Same group, split into 12 and 12a Methyl-, propyl-, butyl- and ethylparaben named as the most common, with no limit set
    Conditions attach product types (rinse-off only) and ages (salicylic acid) Conditions attach product types, body areas and ages Safety rests on the manufacturer; FDA may act on a marketed product

    This is the part worth carrying away. A Korean label and a European label can show the same preservative at the same percentage and still sit under different rules — and a U.S. label sits under none written for preservatives at all. The number on the back of the bottle does not tell you which system you are reading.

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    What to check on the box

    ✔ Preservative names sit near the end of the ingredient list, around the 1% mark

    ✔ For parabens, read methyl-, ethyl-, propyl-, butyl- and the salt names such as sodium methylparaben

    ✔ Some ceilings apply to rinse-off products only, so check whether the product stays on the skin

    ✔ On products labelled for children, Korean packaging prints the preservative content as its own line

    ✔ A ceiling is the upper bound, not the amount in the jar — two different things

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    What I left out, and why

    ✔ The notice number and effective date — Korea’s law portal was unreachable on the day this was written, so I could not confirm the current number of the Cosmetic Safety Standards. Only the article numbers and the annex name are given here

    ✔ The full Annex 2 preservative table — same reason. The figures above come from the text obtained on 20 September 2026, cross-checked in the KCIA ingredient dictionary

    ✔ The paraben safety debate — I did not open the review papers or the opinions themselves. What the EU changed, and what FDA says, is the range of this article

    ✔ The EU figure for phenoxyethanol — a secondary source gives 1.0%, but I could not obtain the annex table itself, so it is not in the comparison

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    In one line

    A preservative is used from a list, within the stated ceiling, in the stated kind of product. Where that line gets drawn is what changes between countries.

    Next: the 25 fragrance allergens — why those names are printed separately on the box.

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    📌 Related reading

    📌 How to Read a Korean Cosmetic Ingredient List (Ingredient Guide 14) — where preservative names sit

    📌 Salicylic Acid (BHA): 0.5% vs 2% (Ingredient Guide 8) — a preservative on the same annex

    📌 Sunscreen SPF and PA (Ingredient Guide 11) — the third material named in Article 8 (2)

    📌 AHA vs BHA: Is Glycolic Acid an AHA? (Ingredient Guide 13)

    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, Article 8 — paragraphs (1), (2) and (5)

    · Regulation on Cosmetic Safety Standards, Annex 2 (raw materials needing restricted use), preservatives

    · Korea Cosmetic Association ingredient dictionary — ethylparaben, sodium propylparaben, phenoxyisopropanol, methylisothiazolinone, methylchloroisothiazolinone

    · Commission Regulation (EU) No 1004/2014 and No 358/2014 (EUR-Lex) · Regulation (EC) No 1223/2009, Annex V entry 12

    · U.S. FDA, Parabens in Cosmetics (updated 18 November 2025)

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    This article summarises statutes and official notices and is not a substitute for diagnosis or treatment. Korea’s law portal was unreachable on the day of writing, so the Annex 2 figures were matched against text obtained earlier and cross-checked in the Korea Cosmetic Association ingredient dictionary; the current notice number is not stated. EU and U.S. material is taken from each authority’s current public text.

    — Dr. J Ingredient Notes