Cosmetics Safety Assessment and Safety Information Management in Korea

Common situations

Pick the question closest to your case: each one gives the conclusion first, then what changes it, the documents involved and the expected timeline.

1. When does a smaller existing cosmetics responsible seller in Korea have to start the cosmetics safety assessment?

   Short answer Businesses with annual production and import value under KRW 1 billion are covered from 1 January 2031. The threshold is not turnover but the sum of production value and import value for the year before the amended Act's promulgation date.

   • Production plus import value is under KRW 1 billion (not turnover) Prepare safety assessment data for products manufactured or imported and sold from 1 January 2031.
   • The sum is KRW 1 billion or more (not turnover) Prepare on the basis of 1 January 2028 for functional cosmetics reviewed or reported, 1 January 2030 for new launches, and 1 January 2031 otherwise.
   • A full previous year cannot be calculated because of a new business or suspension Convert the actual operating period of the previous year to a one-year basis.

   Documents

   Previous year's production and import records, product list (functional cosmetics review or report, launch dates)

   Timeline

   Not yet in force / start dates 1 January 2028, 1 January 2030 or 1 January 2031 depending on business and product

2. We newly registered as a cosmetics responsible seller in Korea. When does the safety assessment apply to us?

   Short answer Businesses registered after the amended Act was promulgated (30 December 2025) follow the earlier start-date categories regardless of production or import value: 1 January 2028 for functional cosmetics reviewed or reported, 1 January 2030 for products first manufactured or imported and launched, and 1 January 2031 otherwise.

   • Selling products that passed functional cosmetics review or filed a report after promulgation Have safety assessment data for those products from 1 January 2028.
   • Selling products first manufactured or imported and launched after promulgation Prepare on the basis of 1 January 2030.

   Documents

   Responsible seller registration certificate, product launch plan, functional cosmetics review result notice or report

   Timeline

   Not yet in force / applies to products manufactured or imported and sold after each start date

3. Do functional cosmetics that passed MFDS review also need separate cosmetics safety assessment data?

   Short answer A business selling products that passed functional cosmetics review or filed a report after the amended Act was promulgated is covered from 1 January 2028 if its production and import value is KRW 1 billion or more (not turnover) or it registered after promulgation. Functional review and the safety assessment are separate duties.

   • Production and import value of KRW 1 billion or more (not turnover), or registered after promulgation Prepare safety assessment data for those products manufactured or imported and sold from 1 January 2028.
   • An existing business under KRW 1 billion (not turnover) Prepare on the basis of 1 January 2031.

   Documents

   Functional cosmetics review result notice or report, ingredient safety data, product standard document

   Timeline

   Not yet in force / earliest start date 1 January 2028

4. If a cosmetic's name includes words like 'baby' or 'kids', do we need product-level safety data in Korea?

   Short answer The rule covers specifically labelling the primary or secondary packaging as for infants or children, including where the product name contains an expression about infants or children. In that case all product-level safety data must be prepared and kept before labelling.

   • The packaging or product name uses an infant or children's expression Prepare the three types of product-level safety data before labelling.
   • Only advertising (internet, leaflets, etc.) specifies use by infants or children, with no packaging label Advertising is also covered, so prepare the same data before advertising (door-to-door advertising and demonstrations are excluded for children's cosmetics).

   Documents

   Description of the product and manufacturing method, safety assessment data for the cosmetic, proof of efficacy and effects, draft label and advertising

   Timeline

   Prepare in advance of labelling or advertising (in force now)

5. How long must safety data for infant cosmetics be kept in Korea?

   Short answer Where the primary packaging shows an expiry date, keep it from the labelling or advertising date until one year after the expiry date of the last product manufactured or imported; where it shows a period after opening, until three years after the manufacturing date of the last product.

   • The primary packaging shows an expiry date Keep until one year after the expiry date of the last product manufactured or imported.
   • The primary packaging shows a period after opening Keep until three years after the manufacturing date of the last product manufactured or imported.

   Documents

   Product-level safety data, manufacturing date records by batch number (manufacture), customs clearance date records (import)

   Timeline

   Counted from the manufacturing date by batch number for manufacture and the customs clearance date for import

6. What safety documents do we need to import and sell children's cosmetics in Korea?

   Short answer Prepare and keep all three before labelling or advertising: a description of the product and manufacturing method, safety assessment data for the cosmetic, and proof of efficacy and effects. Children means ages 4 to 13 and infants age 3 and under.

   • Data can be obtained from the overseas manufacturer Obtain manufacturing method and ingredient data and organise it into Korean-language documents.
   • Proof of efficacy and effects is insufficient Adjust the labelling or advertising claims to what the data can prove, or consider tests by a testing institution.

   Documents

   Description of the product and manufacturing method, safety assessment data for the cosmetic, proof of efficacy and effects, import management record

   Timeline

   Prepare before labelling or advertising / in practice, time for the overseas manufacturer's reply is added

7. A consumer says they were hospitalised after using our cosmetic. How many days do we have to report to MFDS?

   Short answer Hospitalisation or extended hospitalisation is a serious adverse event, so file a rapid report to the Minister of Food and Drug Safety with a cosmetics adverse event report within 15 days of becoming aware. It can be reportable even if a causal link with the product is not proven.

   • A serious adverse event such as death, a life-threatening condition, hospitalisation or persistent loss of function File a rapid report with the cosmetics adverse event report within 15 days.
   • A non-serious adverse event Include it in the cosmetics safety information list for the half-yearly periodic report.

   Documents

   Cosmetics adverse event report, product name, batch number and expiry date, period of use and symptom information

   Timeline

   Within 15 days of becoming aware

8. Do minor skin irritation complaints also have to be reported to MFDS as cosmetics safety information?

   Short answer Safety information not subject to a rapid report is compiled into the cosmetics safety information list and reported periodically to the Minister of Food and Drug Safety within one month after the end of each half-year.

   • A general cosmetics responsible seller or customized cosmetics seller Prepare and file the list every half-year.
   • Two or fewer regular employees selling only cosmetic soap made in-house The periodic report may be skipped.

   Documents

   Cosmetics safety information list (including an electronic file)

   Timeline

   Within one month after the end of each half-year

9. A cosmetic we sell in Korea was suspended from sale abroad. What do we have to report?

   Short answer On becoming aware of a foreign government measure equivalent to a sales suspension or recall, file a rapid report to the Minister of Food and Drug Safety with a cosmetics safety information report within 15 days of becoming aware.

   • A foreign government took a measure equivalent to a sales suspension or recall File the safety information report within 15 days and consider safety measures for stock distributed in Korea.
   • Products distributed in Korea are cosmetics posing a risk Proceed with the recall procedure, including filing a recall plan.

   Documents

   Cosmetics safety information report, documents on the foreign government measure, domestic sales status

   Timeline

   Within 15 days of becoming aware

10. We found a prohibited ingredient in a cosmetic on sale in Korea. When must the recall plan be filed?

    Short answer Take immediate measures such as suspending sales and submit a recall plan to the head of the regional MFDS office within 5 days of learning that the product is subject to recall. Cosmetics using prohibited ingredients are hazard grade A, so state a recall period within 15 days from the start of recall.

    • Hazard grade A Prepare the recall plan with a recall period within 15 days.
    • Hazard grade B or C Prepare it with a recall period within 30 days.
    • Filing or recall within the deadline is difficult Request an extension from the head of the regional MFDS office, giving reasons.

    Documents

    Recall plan, copy of the manufacturing or import record for the item, records of sales volume and dates by buyer, statement of recall reason

    Timeline

    Recall plan within 5 days / recall period within 15 days for grade A and 30 days for grades B and C

11. To estimate the cost of a cosmetics safety assessment in Korea, which preparation items should we look at first?

    Short answer The scope of preparation depends on the number of products, whether ingredient safety data can be obtained, and whether safety assessor review and additional testing are needed. The scope and retention period of the assessment data are to be set by Ordinance of the Prime Minister, so for now start by organising the product list and the status of ingredient data.

    • Data can be obtained from ingredient suppliers and manufacturers Build the data list and supplement only the missing items.
    • Ingredient data is lacking or testing is needed Consider commissioning a testing institution (testing is not part of our work).

    Documents

    Product list, full ingredient list and ingredient specifications, ingredient safety data, product standard document

    Timeline

    Not yet in force / in practice, collecting ingredient data takes the longest

12. What does an administrative agent in Korea actually do for cosmetics safety data preparation?

    Short answer Under a written mandate, we review timing, organise data lists and collect ingredient data, support preparation of product-level safety data for infant products, prepare and file safety information reports and recall forms, and handle supplementation. We do not perform the safety assessor's review, testing or inspection, or medical assessment of the causal link of adverse events.

    • Preparing for the safety assessment start date We organise the start-date category and product data lists.
    • A report such as an adverse event or recall is required We prepare the report and attachments and support filing within the deadline.

    Documents

    Letter of authorisation, product list, ingredient and manufacturing data, adverse event intake records, sales records

    Timeline

    Within the reporting deadlines (15 days, one month after each half-year, 5 days)

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