Three safety files come before the word "kids"
A children's line looks like a formulation problem, so most brands start by softening the base. Korea wrote the rule on the other side. The moment the pack or the ad says a product is for children, three product-level safety files must already exist, and missing them carries up to a KRW 10 million fine.
Korea requires three product-level safety files to be written and held before a cosmetic is labeled or advertised as being for infants or children. Infants are defined as age 3 and under, children as 4 to 13. The files are kept until one year after the expiry date, or three years after the manufacturing date if the pack carries a period-after-opening mark instead. Failure to hold them carries up to one year in prison or a KRW 10 million fine.
The obligation attaches to the label, not the formula
This is the part most buyers planning a kids line discover late. Korea's children's cosmetics rule does not work by removing ingredients. Article 4-2 of the Cosmetics Act requires the responsible distributor to write and hold product-level safety files before labeling or advertising a product as usable by infants or children.
The scope is drawn around wording. Article 10-2(2) of the Enforcement Rule covers any case where the primary or secondary pack specifically states that the product can be used by infants or children, and it explicitly includes products whose name carries such an expression. On the advertising side the listed media run from newspapers, broadcast and magazines through leaflets, samples and tickets to the internet, posters, signboards, electronic displays, video, recordings and publications. For children's products, only door-to-door and demonstration advertising fall outside.
So two products with an identical formula can sit in different regulatory worlds, and the only difference is the word on the carton. A gentle base with no such wording does not trigger the article at all. Naming and regulatory affairs cannot be two separate meetings.
Two age bands, written into the rule
The age definitions are numbers in the statute, not marketing convention. Infants are age 3 and under; children are 4 to 13. Trade terms like "baby" and "junior" do not line up neatly with that split, so the first step is deciding which band your intended age wording lands in.
The files themselves are fixed at three, and their names tell you the schedule.
| File | Content | Who usually holds it |
|---|---|---|
| Product and manufacturing method description | Formula, process, specifications | The manufacturer (OEM/ODM) |
| Cosmetic safety assessment | Ingredient toxicology and exposure assessment | Manufacturer or an assessment house |
| Efficacy substantiation | Evidence behind the claim wording | Brand and the testing lab |
The third row moves the timeline most. The first two come out of documents the factory already keeps, while efficacy testing cannot start until the claim wording is frozen. That is why it pays to draft the detail-page copy during the sample round rather than after it. To see which claims are actually running on the shelf by category, start from today's ingredient signals.
The retention clock depends on which date you print
Retention is not a single figure. It changes with the date mark you put on the primary pack.
| Primary pack mark | Retention ends | Counted from |
|---|---|---|
| Expiry date | One year after expiry | Last batch manufactured or imported |
| Period after opening | Three years after manufacturing date | Last batch manufactured or imported |
Both clocks start on the day the labeling or advertising begins, and only the end differs. The manufacturing date is the one encoded in the batch number; for imports, the customs clearance date applies. Choosing a period-after-opening mark means holding the paperwork longer, which matters on slow-turning SKUs where the last batch sits in the channel for a while.
The downside of not holding the files is not administrative. Article 37 of the Cosmetics Act provides for up to one year's imprisonment or a fine of up to KRW 10 million for failing to write and keep them, and allows both to be imposed together. Article 39 extends the fine to the company itself.
The EU splits inside the report instead of adding files
The EU does not ask for a separate children's dossier. It asks the Cosmetic Product Safety Report to treat under-threes as their own case. Annex I Part B point 3 of Regulation (EC) No 1223/2009 requires a specific assessment for products intended for use on children under the age of three, and Part A point 3 directs particular attention to under-threes, alongside products used around the eyes, in microbiological quality.
The reason shows up in ratios. EDQM's guide on cosmetics for young children gives the skin surface area to body mass ratio as 2.3 times the adult value at birth, falling to 1.8 at six months, 1.6 at twelve months and 1.5 at five years. Air intake per unit of time and weight is put at roughly three times the adult figure. The same formulation at the same concentration therefore produces a higher systemic exposure once it is divided by a smaller body weight, and the reference margin of safety of 100 can be missed.
Default assumptions in the same guide stay deliberately conservative. Dermal absorption is taken as 100% for buttock products and wherever data are missing, and rinse-off products are given a 10% retention factor unless tested. A formula that cleared for adults often has to come down in concentration to clear for infants, which moves both unit cost and sensory feel. Compare the cost of each build with the product planner before the sample round, not after.
Three markets, three different demands
The United States keeps no separate children's file. MoCRA requires safety substantiation for every cosmetic and applies it more strictly to products for vulnerable groups, children among them. Korea is the one market that writes the file types and the retention period into law as numbers; the EU takes the assessment method instead.
| Market | What children's products add | Form it takes |
|---|---|---|
| Korea | Three product-level safety files, kept 1 or 3 years | Written and held before labeling or advertising |
| EU | Separate under-three assessment, microbiological attention | Sections inside the safety report |
| US | Safety substantiation applied more strictly | No separate dossier |
Opening all three markets with one formula works best when the dossier is built to EU depth and retained to the Korean clock. The reverse fails: a Korean file taken to the EU leaves the under-three assessment blank, and the Responsible Person inside the EU will send it back.
«Takeaways»
- The trigger is labeling and advertising, not the formula. A product name carrying children's wording is enough.
- Infants are 3 and under, children 4 to 13, and the files are description, safety assessment and efficacy substantiation.
- Retention runs to one year after expiry, or three years after the manufacturing date if the pack shows a period after opening.
- Missing files carry up to one year's imprisonment or a KRW 10 million fine, and the company is fined alongside the individual.
*Sources: Cosmetics Act (Korea) Articles 4-2, 37 and 39 and Enforcement Rule Articles 10-2 and 10-3 with Appendix 5, via the Korea Ministry of Government Legislation plain-language service (accessed 2 November 2026) · Regulation (EC) No 1223/2009, Annex I Part A point 3 and Part B point 3 (text as published on legislation.gov.uk) · EDQM, Safe Cosmetics for Young Children, 2nd Edition (2023)*
What this means for your Korean private label product
Rules like this (children's cosmetics) land on the brand owner, but most of the evidence comes from the manufacturer. As a Korean private label (OEM/ODM) partner we prepare the formula data, test reports and label review your filing needs.
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Questions people ask
The label and the advertising, not the formula. It applies when the primary or secondary pack states specifically that the product can be used by infants or children, including when the product name itself carries such wording, and when the product is advertised that way in print, broadcast, online, posters or electronic displays.
A description of the product and its manufacturing method, a cosmetic safety assessment, and substantiation of the product's claimed efficacy. All three must be in hand before the labeling or advertising starts, not assembled afterwards.
If the primary pack carries an expiry date, until one year after the expiry of the last batch manufactured or imported. If it carries a period-after-opening mark, until three years after that batch's manufacturing date. Which date you print decides the retention period.
The EU adds no separate dossier. It requires the safety report to assess under-threes separately: Annex I Part B point 3 calls for a specific assessment of products intended for children under three, and Part A point 3 asks for particular attention to under-threes in microbiological quality.
The EDQM guide puts the skin surface area to body mass ratio at 2.3 times the adult value at birth, 1.8 at six months, 1.6 at twelve months and 1.5 at five years. Divide the same concentration by a smaller body weight and the exposure rises, which is how a formula passes for adults and misses the reference margin of safety of 100 for infants.