Cosmetic Recalls in Korea: Who Has to Act, How Fast, and What Gets Reported

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The short answer: the recall duty attaches to a statutory status, not to your contract

There is a question brands usually ask last when they commission development and production. If something goes wrong after launch, who has to take the product back? It is easy to assume the factory handles it because the factory made it. The Cosmetics Act does not divide the duty that way.

Article 5-2(1) of the Act places the recall duty on the "business operator". That term covers the cosmetics manufacturer, the cosmetics responsible distributor and the customised cosmetics seller together. The provision therefore does not pick between the party that commissioned production and the party that carried it out. It attaches the duty to a business operator who learns that a problem product is in distribution. A clause in your contract saying who bears the cost allocates that cost between two companies; it does not change who owes the duty to the regulator.

This article sets out, in the words of the provisions themselves, which cosmetics fall within the recall rules, what the hazard grade changes, what has to be filed and within how many days, and how an administrative sanction changes when a recall is carried out diligently. The scope is the law of the Republic of Korea, and every provision quoted here was read in the original on 28 September 2026. It is not legal advice on any particular matter.

Key takeaways

• The duty holder is the "business operator". It is not pre-allocated to the manufacturer or to the responsible distributor: whichever operator learns that the product is in distribution must act without delay.
• The recall plan is due within five days of the day the operator learns that the product is subject to recall. Before that, the operator must immediately suspend sales and take the other necessary measures.
• Hazard grades run in three steps, A, B and C. What the grade changes is the recall period and whether a newspaper notice can be skipped. Grade A allows 15 days from the start of the recall; grades B and C allow 30 days.
• The recall plan is filed with a copy of the manufacturing or import record and with records of sales volume and sales dates by sales outlet. Those records usually sit on opposite sides of an outsourced arrangement, so five days is short if collection starts after the incident.
• Recovering at least four fifths of the planned recall quantity exempts the operator from the administrative sanction for that violation. Partial recovery can still reduce that sanction, on a scale set in the Enforcement Rule.
• A separate reporting duty sits upstream of any recall. A serious adverse event must be reported within 15 days of the day it becomes known, and other safety information is reported within one month after the end of each half-year.

1. The duty attaches to the "business operator"

Article 5-2(1) of the Act provides that where a business operator learns that a cosmetic which is in breach of Article 9, Article 15 or Article 16(1), and which harms or is likely to harm public health, is in distribution, the operator shall without delay recall the cosmetic or take the measures necessary for its recall.

Three things in that sentence matter. First, the subject is the business operator. Article 5(8) of the Act groups the cosmetics manufacturer, the cosmetics responsible distributor and the customised cosmetics seller under that single term, so the provision reaches any company holding one of those three statuses. Second, the trigger is a breach of three provisions: Article 9 on safety containers and packaging, Article 15 on the prohibition of business operations, and Article 16(1) on the prohibition of sales. Third, the timing is "learns" for knowledge and "without delay" for performance.

Article 5-2(2) provides that an operator intending to recall the cosmetic, or to take the measures necessary for its recall, shall report the recall plan to the Minister of Food and Drug Safety in advance. Article 14-3(1) of the Enforcement Rule of the Cosmetics Act calls that operator the "recall duty holder". A brand that put a product on the market through outsourced manufacturing is ordinarily the cosmetics responsible distributor and can therefore be the recall duty holder, while the company that manufactured the product is within the same provision as a cosmetics manufacturer. Which of them actually runs the recall is settled by the facts and by agreement, but the provision does not release either one.

If you want the division of roles between a brand and its manufacturer first, see what the brand owner still has to do.

2. Which cosmetics are subject to recall

Article 14-2(1) of the Enforcement Rule defines a cosmetic subject to recall as a cosmetic in distribution that falls under one of three subparagraphs.

• A cosmetic in breach of Article 9 of the Act
• A cosmetic in breach of Article 15 of the Act that falls under one of the items of subparagraph 2
• A cosmetic in breach of Article 16(1) of the Act

The middle one, subparagraph 2, then divides into six items. Item (a) covers cosmetics under Article 15, subparagraph 2 or 3 of the Act, that is, cosmetics wholly or partly spoiled and cosmetics contaminated with pathogenic micro-organisms. Item (b) covers cosmetics under Article 15, subparagraph 4 with foreign matter mixed in or attached, but only those likely to cause a public-health hazard. Item (c) covers cosmetics under Article 15, subparagraph 5 in two sub-items: sub-item 1) is a cosmetic using an ingredient that may not be used in cosmetics under Article 8(1) or 8(2) of the Act, and sub-item 2) is a cosmetic that does not meet the safety management standards for distributed cosmetics under Article 8(8) of the Act. Sub-item 2) carries a parenthesis excluding the part of those standards that concerns content volume. Item (d) covers cosmetics under Article 15, subparagraph 9, where the use-by date or period after opening, including any concurrently stated manufacturing date, has been forged or altered. Item (e) covers Article 15, subparagraph 10, cosmetics likely to be misused as food.

Item (f) is different in kind. It covers any other cosmetic that the business operator has itself judged to require recall because it is likely to harm public health. It is the route by which an operator can enter the recall procedure without a finding by the authorities, and in the hazard grading below it falls into grade C.

How to check whether an ingredient may be used and at what limit is set out in choosing cosmetic ingredients in Korea.

3. Three hazard grades, and what the grade changes is recall speed and publication

Article 14-2(2) of the Enforcement Rule sorts cosmetics subject to recall into grades A, B and C in descending order of hazard. The classification works by redistributing the subparagraphs of Article 14-2(1).

• Grade A: cosmetics under subparagraph 2, item (c), sub-item 1) of Article 14-2(1). These are products using an ingredient that may not be used.
• Grade B: cosmetics under subparagraph 1, or under subparagraph 2, item (c), sub-item 2) or item (e), of that paragraph. Breaches of the safety container and packaging requirement, failures against the safety management standards for distributed cosmetics, and products likely to be misused as food sit here. Within sub-item 2), however, cases where the content of the principal active ingredient giving a functional cosmetic its function falls short of the standard are excluded.
• Grade C: cosmetics under subparagraph 2, items (a), (b), (c) sub-item 2), (d) or (f), or under subparagraph 3, of that paragraph. Sub-item 2) here means only the case just excluded above, namely a shortfall in the principal active ingredient of a functional cosmetic.

Read the point where one cause splits across grades carefully. A failure against the safety management standards for distributed cosmetics is grade B as a rule, but where that failure is a shortfall in the principal active ingredient of a functional cosmetic it is grade C.

4. There are two clocks: five days, then 15 or 30

Article 14-3(1) of the Enforcement Rule provides that the recall duty holder shall immediately suspend sales of the cosmetic and take the other necessary measures, and shall submit a recall plan to the head of the competent Regional Food and Drug Administration within five days of the day it learns that the product is a cosmetic subject to recall. The form is attached Form 10-2. The proviso to the same paragraph provides that where the operator judges it difficult to submit the recall plan by the deadline, it shall state the reasons to the head of the Regional Food and Drug Administration and request an extension of the submission deadline.

The second clock is the recall period. Article 14-3(2) requires the recall plan to state a recall period within the following ranges.

• Grade A cosmetics: within 15 days of the day the recall starts
• Grade B or grade C cosmetics: within 30 days of the day the recall starts

That paragraph has its own proviso. Where the operator judges it difficult to complete the recall within the recall period, it may state the reasons to the head of the Regional Food and Drug Administration and request an extension of the recall period. The wording differs between the two: extending the submission deadline is "shall request", while extending the recall period is "may request".

Article 14-3(3) allows the head of the Regional Food and Drug Administration to order the recall duty holder to supplement a recall plan judged to be inadequate.

5. The documents attached to the plan already sit in two companies

The subparagraphs of Article 14-3(1) of the Enforcement Rule list three documents to attach to the recall plan.

• A copy of the manufacturing or import record for the item concerned
• Records of sales volume and sales date by sales outlet
• A document stating the reason for the recall

This is where an outsourced structure actually stalls. The manufacturing or import record sits with whoever carried out manufacture or import, and the sales volumes and dates by sales outlet sit with whoever runs distribution. When the two sets of records live in different companies' systems, assembling them into one filing within five days takes longer than expected.

That the law already requires these records can be used to your advantage. Article 11(1), subparagraph 2 of the Enforcement Rule requires a cosmetics manufacturer to prepare and keep a manufacturing control standard document, a product standard document, manufacturing control records and quality control records. Article 12, subparagraph 3 requires a cosmetics responsible distributor to keep the product standard document and quality control records received from the manufacturer, and Article 12, subparagraph 6 requires it, where it outsources manufacture or outsources quality testing to a manufacturer under Article 6(2), subparagraph 2, item (b), to supervise the contractor thoroughly and to receive, maintain and manage the records on manufacture and quality control. That does not mean all three attachments to a recall plan already exist in finished form. It does mean the manufacturing and quality records behind them are already required to be prepared and kept, so the real question is whether they can be handed over when they are needed.

How to settle in advance which technical data moves between the parties and on what terms is covered in who owns the formula.

6. From notification to the closing report

Article 14-3(4) to (9) of the Enforcement Rule set out how a recall is carried out.

Paragraph (4) requires the recall duty holder to notify the recall plan to sellers of the cosmetic subject to recall and to others who handle it in the course of business, by visit, post, telephone, telegram, electronic mail, fax or public announcement through the media, and to keep material proving that notification for two years from the date the recall ends.

Paragraph (5) requires those notified to return the cosmetic subject to recall to the recall duty holder and to prepare and send a recall confirmation. The form is attached Form 10-3.

Paragraph (6) covers disposal of recalled product. The operator must submit a disposal application to the head of the Regional Food and Drug Administration with a copy of the recall plan and a copy of the recall confirmation attached, and must dispose of the product in the presence of the competent public officials in accordance with the environmental legislation. Paragraph (7) requires a recall duty holder that has carried out disposal to prepare a disposal confirmation and keep it for two years.

Paragraph (8) requires an operator that has completed the recall to submit a recall completion report attaching a copy of the recall confirmation, a copy of the disposal confirmation where disposal took place, and a copy of the evaluation report. Paragraph (9) provides that on receiving that report the head of the Regional Food and Drug Administration shall confirm in writing that the recall has ended where the recall is judged to have been carried out properly, and shall order further measures where the recall is judged not to have been effective.

7. Public notice starts with a separate order

A recall and a public notice are not one procedure. Article 23-2(1) of the Act provides that the Minister of Food and Drug Safety may order a business operator to publish the facts where the Minister has received a recall plan under Article 5-2(2) of the Act, or where the Minister has received a recall plan under Article 23(3) of the Act. Filing a recall plan therefore does not carry an automatic publication requirement; the duty arises when the publication order is issued.

Article 28(1) of the Enforcement Rule requires an operator that has received a publication order to publish, without delay, either the fact that a hazard has occurred or the matters listed in the subparagraphs of that paragraph. Publication must appear in at least one general daily newspaper registered under Article 9(1) of the Act on the Promotion of Newspapers and circulated nationwide, meaning the entire edition printed and distributed that day, and on the operator's own website; the operator must also request publication on the website of the Ministry of Food and Drug Safety. The listed matters are a headline stating that the cosmetic is being recalled, the product name, the manufacturing number of the cosmetic subject to recall, the use-by date or period after opening including any concurrently stated manufacturing date, the reason for the recall, the recall method, the name of the recalling business operator, and that operator's telephone number and address together with other matters necessary for the recall.

The proviso to that paragraph is the second effect of the grade. Where the cosmetic is graded C under Article 14-2(2), subparagraph 3 of the Enforcement Rule, publication in the general daily newspaper may be omitted. That does not mean the website publication is omitted as well. Article 28(3) requires an operator that has published to notify the head of the Regional Food and Drug Administration without delay of the publication result, including the publication date, the medium used, the number of publications, and a copy or the content of the published text.

8. A reporting duty sits upstream of any recall

A reporting duty can arise well before a problem reaches the point of recall. Article 12, subparagraph 10 of the Enforcement Rule requires a cosmetics responsible distributor, on learning of new data or information that may directly affect public health in relation to the safety or efficacy of a product, including cases of side effects from use of a cosmetic, to report it as prescribed by the Minister of Food and Drug Safety and to prepare the necessary safety measures.

That notice is the Regulations on the Management of Cosmetics Safety Information. Article 5(1) of the notice requires a cosmetics responsible distributor and a customised cosmetics seller, on learning of either of the following, to report it promptly to the Minister of Food and Drug Safety within 15 days of the day it becomes known.

• A serious adverse event, or a case where the Minister of Food and Drug Safety has directed that it be reported
• A measure by a foreign government equivalent to a sales suspension or a recall, or a case where the Minister of Food and Drug Safety has directed that it be reported

Brands that export should look closely at the second of those. A destination-country measure equivalent to a sales suspension or a recall can create a prompt-reporting duty in Korea.

Article 2, subparagraph 2 of the same notice defines a serious adverse event in five cases: one that results in death or threatens life, one that requires hospitalisation or the extension of hospitalisation, one that results in persistent or significant disability or functional impairment, one that results in a congenital anomaly or defect, and any other medically important situation. Article 2, subparagraph 1 defines an adverse event as an undesirable and unintended sign, symptom or disease occurring during use of a cosmetic, and adds that it need not necessarily have a causal relationship with that cosmetic. In other words, an event does not fall outside the reporting scope merely because causation has not been established.

Article 6(1) requires safety information not reported promptly under Article 5 to be reported within one month after the end of each half-year. A proviso exempts a cosmetics responsible distributor with two or fewer regularly employed workers that sells only soap it has manufactured itself.

9. That report is absent from the manufacturer's list of duties

Article 11(1) of the Enforcement Rule lists the matters a cosmetics manufacturer must observe in eight subparagraphs. Subparagraph 1 requires it to follow the guidance, supervision and requests of the cosmetics responsible distributor under the quality control standards in attached Table 1; subparagraph 2 requires it to prepare and keep a manufacturing control standard document, a product standard document, manufacturing control records and quality control records; subparagraph 3 requires it to keep the manufacturing site, facilities and equipment hygienically managed and free from contamination so that no public-health hazard arises. Subparagraph 6 then requires it to submit to the cosmetics responsible distributor those of the subparagraph 2 documents that are necessary for quality control, subject to a proviso allowing two cases in which submission may be omitted.

Those eight subparagraphs contain no duty to report safety information. The reporting duty in Article 12, subparagraph 10 just described sits only in the list of duties of the cosmetics responsible distributor. The scope of this statement is limited to the subparagraphs of Article 11(1) of the Enforcement Rule. It does not mean a manufacturer stands apart from recalls, because as seen above the recall duty in Article 5-2 of the Act reaches business operators generally. Looking only at the two parties to an outsourced manufacturing arrangement, the channel that carries an early signal to the regulator is designed on the responsible distributor's side rather than the manufacturer's, while the recall itself does not distinguish by status. That is why writing down the route by which information first noticed on the production floor reaches the brand stops being a formality in the contract.

10. A diligent recall reduces the sanction

Article 5-2(3) of the Act provides that the Minister of Food and Drug Safety may reduce or waive, as prescribed by Ordinance of the Prime Minister, the administrative sanction under Article 24 of the Act that a business operator would incur for the cosmetic concerned, where that operator has diligently carried out the recall or the measures necessary for it.

Article 14-4 of the Enforcement Rule sets that scale.

• Where at least four fifths of the planned recall quantity in the recall plan is recovered: the administrative sanction for that violation is waived.
• Where at least one third of the planned recall quantity is recovered, other than in the case just described: if the standard sanction is cancellation of registration, the sanction becomes a business suspension of between two and six months, and if it is a business suspension or a suspension of the manufacture, import or sale of an item, the suspension period is reduced by up to two thirds.
• Where at least one quarter but less than one third of the planned recall quantity is recovered: if the standard sanction is cancellation of registration, the sanction becomes a business suspension of between three and six months, and if it is a business suspension or a suspension of the manufacture, import or sale of an item, the suspension period is reduced by up to one half.

The base of the calculation matters. The denominator is the planned recall quantity stated in the filed plan, not everything ever shipped. That is what makes the recall confirmations under paragraph (5) and the records attached to the recall completion report under paragraph (8) the evidence on which a waiver or reduction rests.

11. What follows if these duties are not met

Article 24(1) of the Act allows the Minister of Food and Drug Safety, where a business operator falls under one of its subparagraphs, to cancel the registration, order closure of the place of business, prohibit the manufacture, import and sale of an item, or order a full or partial suspension of business for a fixed period of up to one year. Its proviso, however, requires cancellation of the registration or closure of the place of business where subparagraph 1-2, 3 or 14 applies, except where the suspension ordered is limited to advertising work. The recall breaches are not within that proviso. Subparagraph 6-2 of that paragraph covers a breach of Article 5-2(1) of the Act by failing to recall a cosmetic subject to recall or to take the measures necessary for its recall, and subparagraph 6-3 covers a breach of Article 5-2(2) by failing to report a recall plan or reporting one falsely.

The detailed sanction standards sit in attached Table 7, prescribed by Article 29(1) of the Enforcement Rule. Items (k) and (l) of subparagraph 2 of the individual standards set the same range for those two breaches. A first violation draws a suspension of sales or manufacturing operations for one month, a second three months, a third six months, and a fourth or further violation cancellation of registration.

There are separate penal provisions. Article 38, subparagraphs 1-2 and 1-3 of the Act provide that a person who violates Article 5-2(1) or Article 5-2(2) shall be punished by a fine not exceeding two million won. Article 39 is a joint penalty provision: where a representative, agent, employee or other worker of a corporation or individual commits a violation in connection with the business of that corporation or individual, the corporation or individual is also fined under the relevant provision in addition to the punishment of the offender, unless it has not been negligent in exercising due care and supervision to prevent the violation.

One more point is succession. Article 26-2 of the Act provides that where the status of a business operator is succeeded to, the effect of an administrative sanction under Article 24 imposed on the former operator passes to the successor for one year from the day the sanction period ends, and that where sanction proceedings are under way they may be continued against the successor. That does not apply where the successor proves that it did not know of the sanction or the violation at the time of succession.

12. What to settle in the development agreement

A statutory duty cannot be moved by contract, but the procedures that make the duty possible to perform can be. These are worth confirming before development starts.

• Have you fixed the deadline and the contact point for telling the other party once either side learns of a signal? The five days and the 15 days both run from the day of knowledge, so time lost between the companies is time taken out of the statutory window.
• To what extent and in what format can you obtain manufacturing and quality records by manufacturing number? The first document attached to a recall plan is a copy of the manufacturing or import record.
• Can sales volumes and sales dates by sales outlet be traced by manufacturing number? Where several distribution channels are involved, that traceability determines the scope of the recall.
• How are logistics and disposal costs divided when a recall is carried out? Who owes the duty to the regulator and who bears the cost are separate questions.
• Who prepares and keeps the proof of recall-plan notification and the disposal confirmation? Article 14-3(4) of the Enforcement Rule requires the proof of notification to be kept for two years from the date the recall ends, and Article 14-3(7) requires the disposal confirmation to be kept for two years.
• If a publication order arrives, have you agreed in advance whose website carries what? Article 28(1) of the Enforcement Rule names the website of the business operator concerned.
• If part of the volume is exported, which side monitors measures by the destination government? Article 5(1), subparagraph 2 of the notice makes such a measure a ground for prompt reporting.

How development timelines and quality records are built up in sequence is set out in our process and in the formula development library, and if a live project needs a closer look, contact us.

13. Frequently asked questions

If the contract says the manufacturer bears recall costs, does the recall duty move to the manufacturer?

It does not. Article 5-2(1) of the Act fixes the duty holder as the business operator. The status of a cosmetics manufacturer or a cosmetics responsible distributor comes from registration under Article 3 of the Act, and the status of a customised cosmetics seller from notification under Article 3-2. A contract allocates cost and roles between two companies.

Does a report have to be filed while it is still unclear whether the product is subject to recall?

Keep the two procedures separate. The recall plan is due within five days of the day the operator learns that the product is a cosmetic subject to recall. Independently of that, prompt reporting under Article 5(1) of the Regulations on the Management of Cosmetics Safety Information is due within 15 days of the day a serious adverse event or the other listed information becomes known, and Article 2, subparagraph 1 of the same notice states that an adverse event need not necessarily have a causal relationship with the cosmetic.

Who decides the hazard grade?

Article 14-2(2) of the Enforcement Rule sets the classification criteria in the text itself. The grade is not negotiated; it is the result of sorting the recall grounds in Article 14-2(1) through the criteria in the subparagraphs of Article 14-2(2). What the grade changes is the recall period and, for grade C, the option of omitting publication in a general daily newspaper.

If the full volume cannot be recovered, is a reduction lost?

The denominator is the planned recall quantity, not everything shipped. Article 14-4 of the Enforcement Rule waives the sanction at four fifths or more of that quantity, reduces it at one third or more, and reduces it by a smaller margin at one quarter or more but less than one third.

Do the recall provisions apply to a product sold only abroad?

Article 30 of the Act sets aside a listed group of provisions for products that are not sold domestically and are intended solely for export, and Article 5-2 is not on that list. Because Article 5-2 is triggered by breaches of Article 9, Article 15 and Article 16(1), however, how far it reaches in practice depends on whether those provisions apply. That structure is covered in more detail in export-only cosmetics.