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The short answer: labelling a product for infants or children brings three document sets with it

A request to "add a baby lotion line" starts as a formulation conversation, but the first thing Korean law looks at is not the formula. It is the label and the advertising. The moment a product is specifically labelled or advertised as a cosmetic that infants or children may use, the cosmetics responsible distributor has to prepare documents proving the safety and quality of that individual product in advance, and keep them for a set period.

The duty works regardless of how mild the formula is or how much testing was done. Putting "baby" in the product name without changing a single ingredient can bring the product inside the provision, and selling the same bulk under adult-only labelling keeps it outside. The switch sits in the label and the advertising, and that is the defining feature of this regime.

This article reads the provisions as written. Where the age brackets come from, which labelling and which advertising flip the switch, what goes into each of the three document sets, how long they must be kept, what changes on the package and in the formula, and what follows when the duty is missed.

The scope is the law of the Republic of Korea, and every provision quoted here was read in the original on the Korean Law Information Center on 9 October 2026. This is not legal advice on a specific matter, and it makes no claim about EVAS commercial terms, facilities or certifications.

Key points

How old is an infant, and how old is a child

The age brackets are not in the Act. Article 4-2(4) delegates the age of infants or children and the scope of labelling and advertising to Ordinance of the Prime Minister, and Article 10-2(1) of the Enforcement Rule splits it in two. Infants are aged 3 or under; children are aged 4 to 13. The current wording dates from the amendment of 9 July 2024.

The first practical point is that the two brackets are continuous. Put them together and everything up to age 13 sits inside the regime. A plan described internally as "not a baby line, more of an elementary-school line" lands squarely in the children's bracket.

The split matters again later, because the range of advertising media is applied differently to infants and to children.

The switch, part one: labelling

Subparagraph 1 of Article 10-2(2) of the Enforcement Rule defines the labelling side as follows: where the primary packaging or the secondary packaging of the cosmetic specifically indicates that it is a cosmetic usable by infants or children, including where an expression concerning infants or children appears in the name of the cosmetic.

Primary and secondary packaging are defined in Article 2 of the Act. Primary packaging is the packaging container in direct contact with the contents at the time of manufacture; secondary packaging means one or more packagings that hold the primary packaging, together with protective material and packaging for labelling purposes, and it includes accompanying documents. Changing only the carton is still labelling.

The weight in the provision sits on the word "specifically". The provision does not break that test down further into numbers or examples. Whether a particular phrase meets it is therefore hard to settle from the text alone, and borderline wording is best confirmed with the competent regional office of the Ministry of Food and Drug Safety. What the provision does settle is the product name, which it expressly includes, so it is safer to treat the decision as closed at the naming stage.

The switch, part two: advertising

On the advertising side, subparagraph 2 of Article 10-2(2) pulls in specific media and means: the media or means under items (a) through (f) of subparagraph 1 of Attached Table 5, or media or means published by the Minister of Food and Drug Safety as similar to them, where the advertising specifically presents the product as a cosmetic usable by infants or children. A parenthetical proviso follows: for children's cosmetics, item (f) is excluded.

Items (a) through (f) of subparagraph 1 of Attached Table 5 read as follows. Item (a) is newspapers, broadcasting or magazines; item (b) is leaflets, pamphlets, samples or admission tickets; item (c) is the internet or computer communications; item (d) is posters, signboards, neon signs, advertising balloons or electronic display boards; item (e) is video products, sound recordings, books, publications, films or plays; item (f) is door-to-door advertising or advertising by demonstration.

The channels brands actually use most, their own store, marketplace product pages and online advertising, are likely to fall within item (c), the internet or computer communications. In other words, a plan that keeps the package adult-facing but describes the product online as one that infants or children may use can still flip the switch from the advertising side. The prohibitions and compliance duties that apply to labelling and advertising themselves live in separate provisions, so copy work should be read alongside advertising substantiation.

Set one: explanatory materials on the product and its manufacturing method

The detailed drafting method for the three sets sits in the Attached Table to MFDS Notification No. 2020-66, the Regulation on the Preparation and Retention of Safety Materials for Cosmetics Used by Infants or Children. Article 10-3(3) of the Enforcement Rule delegates the details to that notification.

The first set has two branches. The explanatory material on the product is prepared to include detailed information about the product, such as the product name, the efficacy and effects where the product is a functional cosmetic, precautions for use, the names and quantities of raw materials, storage conditions, and the use-by date or the period after opening. The explanatory material on the manufacturing method is prepared to include information on how the product is manufactured up to the finished product.

The Attached Table also leaves substitutes open. Where the content is included, the product explanation may be replaced by a copy of the product standard document under subparagraph 3 of Article 12 of the Enforcement Rule or a copy of the import management record under subparagraph 4 of the same Article, and the manufacturing explanation by a copy of the manufacturing control standards document under subparagraph 2 of Article 11, a copy of the product standard document under subparagraph 3 of Article 12, or a copy of the import management record under subparagraph 4 of the same Article. The import management record carries a parenthetical limit: imported cosmetics only.

Set two: cosmetic safety assessment materials

The second set breaks into three parts. First comes the review material on raw materials. It is prepared to include information such as the physicochemical properties and toxicity of each raw material used in the product, together with the specification information for each raw material. Ingredients removed during the manufacturing process and not remaining in the finished product are excluded.

Next comes the review material on the finished product. It is prepared to include material reviewing the finished product's conformity with the safety control standards for distributed cosmetics under Article 6 of the Regulation on Safety Standards for Cosmetics. Which items a finished-product test report should cover is set out separately in batch release testing.

The third part concerns adverse events after use. It is prepared to include the expedited and periodic reporting under the Regulation on the Management of Cosmetic Safety Information, the review and evaluation of safety information, and the follow-up measures taken. The product safety assessment result is then written on the basis of the raw material, finished product and adverse event materials. How far supplier paperwork on raw materials actually proves anything is covered in raw material documents.

Set three: materials proving efficacy and effects

The third set also has two branches. Where the product is a functional cosmetic, it includes the review result materials under Article 9 of the Enforcement Rule, and where a report was submitted under Article 10 of the Enforcement Rule, it includes the submitted report. What changes once a functional claim goes on a product was covered once in functional claims.

The other branch is substantiation. For matters of fact requiring substantiation among the labelling and advertising of a cosmetic used by infants or children, it includes substantiation materials under the Regulation on Substantiation of Cosmetic Labelling and Advertising.

One point is worth reading closely here. The third set is open to products that are not functional cosmetics. Even without a functional review, if the labelling or advertising carries a factual claim that requires substantiation, that substantiation material belongs in this bundle.

"In advance" is the operative phrase

Article 10-3(1) of the Enforcement Rule provides that a responsible distributor intending to label or advertise the cosmetic must prepare in advance all of the product-specific safety materials under subparagraphs 1 through 3 of Article 4-2(1) of the Act. Launching with two of the three sets and completing the rest afterwards does not match the wording.

That single phrase has schedule consequences. Raw material toxicity information and specifications, the conformity review against the safety control standards for distributed cosmetics, and the substantiation materials are documents whose content, in practice, is usually filled in only once the formula and the testing have progressed. Put the printing deadline and the product page launch ahead of the document completion date, and it is the provision, not the schedule, that gets in the way.

It is easier to fix that order while the brief is being written. How to write that document is set out in the product brief.

The retention period splits on the primary packaging

Article 10-3(2) of the Enforcement Rule sets the retention period in two branches. The dividing line is what the primary packaging shows.

Where the use-by date is shown on the primary packaging, the period runs from the day the product was labelled or advertised as a cosmetic usable by infants or children until one year after the expiry of the use-by date of the last manufactured or imported product. Where a period after opening is shown on the primary packaging, it runs from the day of that labelling or advertising until three years after the manufacturing date of the last manufactured or imported product.

In both subparagraphs the period starts on the day of the labelling or advertising, and in identifying the last manufactured or imported product, manufacture is measured by the manufacturing date under the cosmetic's lot number and import by the customs clearance date. The choice between a use-by date and a period after opening was covered in shelf life and period after opening, but it is this provision that first shows the choice also changing how the retention period is calculated.

Storage and disposal

Article 4(1) of the notification requires the responsible distributor to keep the product-specific safety materials safely, in printed form or using electronic media, and provides that in that case the responsible distributor may create and maintain copies, backup materials and the like in preparation for damage to or loss of the materials. The medium is not restricted to paper, and the backup is written as a permissive rule rather than a requirement.

The preparation and management procedure is not left open either. Article 3(2) of the notification requires the product-specific safety materials to be prepared, revised, approved and otherwise managed under the document and record control procedures in subitem 5) of item (a) of subparagraph 3, and in subparagraph 7, of the quality control standards in Attached Table 1 of the Enforcement Rule. In other words, they come inside the quality documentation system the responsible distributor already runs.

Disposal has its own provision. Article 4(2) provides that documents kept under paragraph 1 may be disposed of under the responsibility of the responsible distribution manager under Article 3(3) of the Act, after being kept for the period under Article 10-3(2) of the Enforcement Rule. The wider set of duties sitting with the business side, including the responsible distribution manager, is covered in what the brand owner still has to do.

One more line on the package: preservative content

A labelling duty is added as well. Subparagraph 8 of Article 19(4) of the Enforcement Rule requires that, where a product is to be specifically labelled or advertised as usable by infants or children, the content of any preservative among the raw materials whose usage standards have been designated and published under Article 8(2) of the Act be entered on the packaging. That paragraph is made under the delegation in subparagraph 10 of Article 10(1) of the Act.

This is a different requirement from the full ingredient list. The ingredient list carries names; this provision requires a quantity, and only for preservatives. Its scope is also narrower than every preservative-functioning material: it covers preservatives among the raw materials whose usage standards have been designated and published.

Discovering this at the printing stage means remaking the carton and the label, so the preservative choice and its level are best settled before the package design is locked. When the container has to be fixed against the formula is covered in packaging compatibility.

Raw materials that get checked first at the formulation stage

Attached Table 2 of the Regulation on Safety Standards for Cosmetics (MFDS Notification No. 2026-19) sets out raw materials subject to restrictions in table form, and the remarks column of some entries records a ban on use in infant and child products. Two stand out.

Salicylic acid and its salts appear in the preservative table with a usage limit of 0.5 per cent as salicylic acid, and the remarks column states that use is prohibited in infant and toddler product categories, and in products specifically labelled as usable by children aged 13 or under. A parenthetical proviso follows: shampoo is excluded. The same raw material also appears outside the preservative table with its own usage limits, and those remarks carry a ban to the same effect with the same shampoo proviso.

Iodopropynyl butylcarbamate has a limit of 0.02 per cent in rinse-off products and 0.01 per cent in leave-on products, with a proviso of 0.0075 per cent where it is blended into a deodorant. Its remarks column contains one entry prohibiting use in products applied to the lips, aerosol products limited to sprays, and body lotions and body creams, and another prohibiting use in infant and toddler product categories, and in products specifically labelled as usable by children aged 13 or under. That second entry carries a parenthetical exclusion for bath products, shower gels and shampoos.

One caution when reading these. The remarks are worded as "children aged 13 or under", while the age brackets for product-specific safety materials are the infants aged 3 or under and children aged 4 to 13 of Article 10-2(1) of the Enforcement Rule. Separate provisions define their own subjects in their own words, so it is better not to read one as the other. The general order of checks when selecting raw materials is set out in ingredient selection.

Child-resistant packaging is a separate provision

Children appear in one more provision, on child-resistant packaging. Article 9(1) of the Act requires cosmetics responsible distributors and customized cosmetics sellers, when selling cosmetics, to use child-resistant packaging so that accidents harming the human body through misuse of cosmetics by children do not occur.

Article 18(1) of the Enforcement Rule lists three categories of covered items: nail enamel removers and nail polish removers containing acetone; non-emulsion liquid products such as children's oils containing 10 per cent or more hydrocarbons per individual package with a kinematic viscosity of 21 centistokes or less; and liquid products containing 5 per cent or more methyl salicylate per individual package. The kinematic viscosity is measured at 40 degrees Celsius. The proviso to the same paragraph excludes single-use products, spray container products whose container mouth is operated by a pump or a trigger, and compressed spray container products, with aerosol products and the like given in parentheses as examples.

The standard is in the provision as well. Article 18(2) of the Enforcement Rule requires child-resistant packaging to be such that it is not difficult for an adult to open but is difficult for a child under 5 years of age to open, and provides that the specific standard for that degree of difficulty and the test method follow what the Minister of Trade, Industry and Energy publishes.

The two regimes do not substitute for each other. A product outside the child-resistant packaging list still needs product-specific safety materials once it carries infant or child labelling, and a product with no such labelling still needs child-resistant packaging if the item falls within Article 18(1).

If the materials are not prepared or not kept

Two tracks of sanction run together. On the administrative side, subparagraph 5-2 of Article 24(1) of the Act lists the failure to prepare or keep product-specific safety materials under Article 4-2(1) as a ground for disposition, and the same paragraph allows cancellation of registration, closure of the place of business, prohibition of the manufacture, import and sale of the item, or suspension of business for a fixed period within one year.

The specific level sits in Attached Table 7 of the Enforcement Rule. For a failure to prepare or keep the product-specific safety materials under Article 4-2(1) of the Act, a first violation draws a one-month suspension of sales or of sales of the item concerned, a second violation three months, a third six months and a fourth twelve months.

There is a criminal penalty as well. Article 37(1) of the Act provides that a person who violates Article 4-2(1) is punishable by imprisonment for not more than one year or a fine not exceeding 10 million won, and Article 37(2) allows imprisonment and a fine to be imposed concurrently. The recall procedure that applies after distribution is covered separately in cosmetic recalls.

Export-only products, and the amendments not yet in force

Export-only products have a broad exception. It is worth reading the list in that exception directly. The current text of Article 30 of the Act provides that, for products not sold domestically and intended solely for export, Article 4, Articles 8 through 12, Article 14, subparagraphs 1 and 5 of Article 15, subparagraphs 2 and 3 of Article 16(1) and Article 16(2) do not apply, and the regulations of the importing country may be followed instead. Article 4-2(1) is not on that list.

The amendment of 30 December 2025 adds Article 4-2(1) and Article 4-3(1) to Article 30, but those parts carry their own enforcement dates. The part concerning Article 4-3(1) takes effect on 1 January 2029, and the part concerning Article 4-2 is split across 1 January 2028, 1 January 2030 and 1 January 2031 depending on the business's annual production or import value, whether it registered after promulgation, and the product type. Building an export-only plan on that exception today is therefore premature. What the export-only exception waives and what still binds is set out separately in export-only cosmetics.

The article numbers themselves are moving too. Under the same amendment, the provision on the management of cosmetics used by infants or children moves from Article 4-2 to Article 4-3, and a new Article 4-2 is inserted under the title of cosmetic safety assessment. Article 4-3 takes effect on 1 January 2028, and the new Article 4-2 carries enforcement dates split across 2028, 2030 and 2031 by business size, registration timing and product type. The provision to cite today is Article 4-2; all that needs remembering is that the number may differ in later documents.

What tends to get settled before development starts

The items below are not duties the provisions place directly on a manufacturing or development partner. The duty holder for product-specific safety materials is the cosmetics responsible distributor, and the provisions do not tell the manufacturing side to produce them. They are listed here because meeting the provisions above on time usually means a brand asks its development partner for these items, so the editorial team has arranged them in working order.

These are request items, not a transfer of legal responsibility. The duty to prepare and keep the materials stays with the cosmetics responsible distributor throughout. If you want to talk through what has to be settled together at the development stage, tell us.

Frequently asked questions

If I change only the product name to "baby" without changing the formula, do I need the materials?

Subparagraph 1 of Article 10-2(2) of the Enforcement Rule sets the scope as specific labelling on the primary or secondary packaging, and states that it includes the case where an expression concerning infants or children appears in the name of the cosmetic. Because the provision expressly includes the name, a change of name alone can bring the product inside the scope. Whether a particular phrase qualifies is best confirmed with the competent regional office of the Ministry of Food and Drug Safety.

If manufacturing is outsourced, does the manufacturer prepare the materials?

Article 4-2(1) of the Act names the cosmetics responsible distributor as the duty holder. The provision does not divide that by whether manufacturing was outsourced. The Attached Table to the notification does allow the explanatory materials to be replaced by a copy of the product standard document or the manufacturing control standards document, so in practice they are often assembled from manufacturing-side documents. To sort out who holds the registration in the first place, see business registration.

Does the retention period end when the product is discontinued?

Article 10-3(2) of the Enforcement Rule starts the clock on the day of the labelling or advertising and calculates the end point from the last manufactured or imported product. If the primary packaging showed a use-by date, it runs to one year after that date expires; if it showed a period after opening, to three years after the manufacturing date. The remaining period therefore runs from the last manufacture or import, not from the day sales stopped.

If the product is not a functional cosmetic, can the efficacy materials be left empty?

Item 3(a) of the Attached Table to the notification covers review result materials and reports where the product is a functional cosmetic, and item 3(b) covers substantiation materials for matters of fact requiring substantiation among the labelling and advertising. The second item does not limit its scope by functional status. If you are making labelling or advertising claims that require substantiation, that material belongs in this bundle.

Do export-only products need the materials?

Article 4-2(1) is not among the provisions whose application is excluded by the current text of Article 30 of the Act. The amendment of 30 December 2025 adds it, but that part carries staged enforcement dates from 1 January 2028. Judge on the current wording, and confirm specific export cases with the competent authority.

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