What Must a Cosmetics Responsible Seller Do After Registration?
BySangjin Ji, Administrative Attorney3 years of embassy visa practiceLinkedIn
Your company has registered its cosmetics responsible selling business in Korea and launched its first cream, manufactured by an OEM factory, through an online store. With manufacturing outsourced, can the company now concentrate entirely on sales? Training notices arrive for the designated responsible manager, the factory sends production figures, and an online customer reports a skin reaction.
Registration does not end the responsibilities of a cosmetics responsible seller. Training and annual production reporting have specific deadlines. Ingredient-list reporting, quality records for individual production batches, and post-market safety information must be handled at the appropriate stages of distribution. Replacing the responsible manager or discovering cosmetics subject to a statutory recall triggers other procedures.
Consider Minsu, who sells a whitening and wrinkle-improvement cream manufactured by an OEM factory. His company needs to compare its business registration certificate and manager details, training completion records, the factory's production and quality documents, and earlier regulatory filings. Although these documents concern the same business, the materials required depend on who has the obligation, when the clock starts, and what evidence the company must retain or submit.
Does the brand need to supervise manufacturing records after registration?
Minsu's company has no cosmetics manufacturing facility. It has engaged an OEM factory to combine the ingredients, manufacture the cream, and conduct quality testing. Minsu's company markets the finished product under its own brand.
Does that make the factory responsible for everything connected with manufacturing?
Korea's Cosmetics Act (「화장품법」) distinguishes the obligations of the manufacturer from those of the business that distributes and sells cosmetics under its own responsibility. In this article, that registered business is called the cosmetics responsible seller; its designated statutory manager is called the responsible sales manager.
Article 11 of the Enforcement Rule of the Cosmetics Act (「화장품법 시행규칙」) sets out obligations for manufacturers, while Article 12 establishes requirements for cosmetics responsible sellers.
The manufacturer must produce the cosmetics in accordance with applicable manufacturing and quality-control requirements. The responsible seller must comply with quality-management and post-market safety-management standards and retain required documents obtained from the manufacturer, including product specifications and quality-control records.
Product specifications explain the criteria under which a particular cosmetic is manufactured and controlled. Quality-control records help identify what examinations or tests were carried out on the product, which acceptance criteria applied, and what results were obtained.
Here is why those records matter. Suppose the factory makes Minsu's cream twice. The first production batch bears code A001, and the second bears code A002. Consumers see the same product name, but the batch codes distinguish different production runs.
Now suppose the factory sends a test result showing only the product name and the word “Pass,” without identifying the batch. Minsu cannot tell whether the result relates to A001, A002, or both. A satisfactory result for A001 does not establish the result for A002.
If a quality issue is later identified in products bearing A002, the company first needs to establish when that batch was made, what tests it underwent, and where the affected units were supplied. The batch number, test documents, and shipment records must be linked so that the company can examine the issue and identify which products may be affected.
This is why the brand retains a record-management role even though it does not operate the factory.
If the OEM contract merely says, “The manufacturer is responsible for quality testing,” Minsu should also check how the test results and other supporting documents will reach the brand. For example, can the company obtain batch-specific test results each time production is repeated? What documents will show whether an ingredient or formula has changed?
A manufacturer's detailed formula may involve trade secrets. The obligation to provide particular information and any contractual limits on disclosure must therefore be assessed under the applicable law and agreement.
The division of work is now clearer. The OEM factory manufactures and tests the product under the law and contract. The cosmetics responsible seller obtains and manages the quality information concerning the product it sells and takes the necessary action when safety issues arise after distribution.
Some obligations are periodic. The responsible sales manager must complete statutory training, and the responsible seller must report the preceding year's production by the end of February where the production-reporting rules apply. Other records, including batch-specific quality information and post-market safety reports, must be managed as products move through the market. A change of manager or a statutory recall event requires a separate response.
The company therefore needs to distinguish annual obligations, continuous controls, and event-triggered procedures. We will begin with the two items that require particular attention on the compliance calendar: manager training and the annual production report.
Must the responsible sales manager take training on the same date every year?
When registering his business, Minsu designated himself as the responsible sales manager as well as the company's representative. He met the applicable education or experience requirements and submitted the supporting documents. After sales began, however, he received a notice about mandatory training.
My qualifications were checked at registration. Do I still need training? Must I take it on the same date every year?
Eligibility to serve as a responsible sales manager and completion of statutory training are distinct obligations. Being qualified at registration does not dispense with the training required while carrying out the role.
Article 5(7) of the Cosmetics Act and Article 14(1) of its Enforcement Rule distinguish initial training from refresher training. Initial training must be completed within six months after the person begins performing the responsible manager's duties. Refresher training must then be completed once each year, using the initial training date as the reference point.
The first date to establish is when the manager actually began those duties. If Minsu started in October 2026, his six-month initial-training period runs from the actual commencement date. The company's first product launch is not what starts this period.
Refresher training follows the separate rule based on the date initial training was completed. The company should also check the training provider's timetable and the completion deadline recognized for the relevant year. For instance, the Korea Cosmetic Association indicated that, for its 2026 refresher training, completion by December 31, 2026 was required for recognition as that year's training.
There is a specific exception. Under Article 14(1) of the Enforcement Rule, a qualifying examination passed within one year before commencing the relevant work can count as completion of initial training. This concerns the examination-based qualification for a customized cosmetics preparation manager. It does not mean that an ordinary cosmetics responsible sales manager is automatically exempt merely because the person met an academic or experience-based eligibility requirement.
For a customized cosmetics preparation manager covered by that exception, the date governing refresher training also differs: annual refresher training is reckoned from the first anniversary of passing the examination. Minsu, who is registered as an ordinary cosmetics responsible sales manager, should follow the initial- and refresher-training rules applicable to his position.
How much training is required? Article 14 provides for not less than four and not more than eight hours. The actual course length and completion conditions depend on a training provider designated by the Ministry of Food and Drug Safety (MFDS). The Korea Cosmetic Association offered a six-hour online statutory training course in 2026. Participants must choose the initial or refresher course suited to their training history.
Ordinary professional-development courses about cosmetics are not necessarily the statutory course required of responsible sales managers. Attending a course does not, by itself, establish that the legal training requirement has been fulfilled. The company must check the course's status and the relevant completion record.
Who must attend? If Minsu serves as the manager, Minsu must take the required training. If the business appoints a qualified employee instead, that employee is the person subject to the training requirement; the representative cannot attend on the employee's behalf.
This distinction becomes important when managers change. Suppose Minsu transfers responsibility to a new employee. The company must verify the employee's qualifications and the date the employee begins the role. It must also deal separately with the statutory change-registration requirement. The new manager's training deadline and the business's change-registration deadline are calculated under different provisions.
A practical review starts with the current registration certificate and the training records. Does the manager named on the certificate match the person actually performing the role? When did that person begin, and on what dates were initial and the most recent refresher training completed? If a certificate has been misplaced or its date is unclear, ask the training provider for the attendance or completion history.
Article 5(8) of the Cosmetics Act also permits a separate education order for businesses in specified circumstances, including certain legal violations. That order differs from the manager's ordinary initial and refresher training. When such an order has been issued, its addressee and deadline must be checked separately.
A temporary halt in online sales does not, by itself, terminate the cosmetics business registration or remove every training obligation. The company must examine its actual suspension or closure filings, registration status, and the applicable training requirements.
Minsu's two starting documents are therefore the business registration certificate and the training completion certificates. They reveal who is registered, when the role began, what training has been completed, and what remains to be scheduled.
Source: Cosmetics Act, Article 5(7)–(8); Enforcement Rule of the Cosmetics Act, Article 14; Korea Cosmetic Association, 2026 statutory training course information.
Who reports production when an OEM factory made the cosmetics?
Minsu's company receives finished cream from an OEM factory. Since manufacturing and quality testing are outsourced, it might assume the factory also files the annual production report.
The business that manufactures the product and the business with the statutory reporting obligation are not necessarily the same.
For cosmetics manufactured domestically through an OEM factory and marketed under a registered company's own responsibility, the cosmetics responsible seller is the party responsible for reporting production figures. The factory supplies production information, but the brand company must ensure that the required report is made.
Article 5(5) of the Cosmetics Act, Article 13 of its Enforcement Rule, and Article 2 of the Regulation on Reporting Production and Import Results and Ingredient Lists of Cosmetics require the previous year's production to be reported by the end of February each year.
If the factory produced Minsu's cream in 2026, the relevant 2026 production figures would be reportable by the end of February 2027. Domestically manufactured cosmetics can be reported through the online production-reporting system operated by the Korea Cosmetic Association.
Can Minsu simply copy the figures in the manufacturer's spreadsheet into the report?
First, he needs to verify which product was produced, how much was made, what production value was recorded, and whether the manufacturer's description matches the product identified in the brand's filings.
Suppose the online store sells “Miso Beauty Cream,” while the factory calls the same formula “MC-01” in its internal system. The factory sends production quantity and value for MC-01, but the responsible seller's earlier ingredient-list report identifies the product as Miso Beauty Cream.
The company should confirm that MC-01 and Miso Beauty Cream are indeed the same finished product. Comparing factory codes, product specifications or finished-product names, and the existing ingredient-list filing will establish how the records correspond.
This is not merely a theoretical mismatch. In a notice dated February 25, 2022, the Korea Cosmetic Association instructed reporting companies to correct production-report product names that did not match names previously used in ingredient-list reports. Companies were advised to check the earlier reported name and use the same designation.
Minsu should therefore set the factory's product-level records beside the previous ingredient-list report before entering production figures. This helps avoid duplicate or inconsistent product identities.
Production quantity and sales quantity must also be separated. Suppose the factory produces 2,000 units, but consumers purchase only 800 units in that year. The online store shows 800 units sold; the manufacturing records show 2,000 units produced. The annual production report uses actual production information, not the sales quantity or retail turnover copied from the online store.
Production value is also different from consumer sales revenue. Under the Korea Cosmetic Association's production-reporting guidance, the production unit price is calculated by dividing production value by production quantity. Production value reflects the costs of the cosmetic contents and ancillary materials used to make the products, in accordance with the applicable reporting instructions.
An OEM brand may supply containers or packaging materials itself rather than through the factory. In that case, the brand should verify how those material costs enter the calculation, using the Association's reporting standard and the company's actual manufacturing documentation.
The practical starting documents are the factory's product-by-product production figures and the business's previous filings. Check the product name, manufactured quantity, and production value supplied by the factory, then compare the reported product identity with the earlier ingredient-list records. If the information differs, establish whether it is merely a naming difference or whether further production evidence is missing.
Preparing those records ahead of the following year's deadline also makes it easier to identify what additional documents the factory must provide.
What if the company produced nothing?
Imagine that Minsu completed registration in 2026 but an OEM production delay meant no cosmetics were manufactured that year. Neither production nor sales appears in the records. Does that mean there is no filing?
Where a cosmetics responsible seller is subject to the production-reporting requirement, a year with no production still requires a “no production” report. The Korea Cosmetic Association provides a “Report No Production” function in its production-reporting system and separately explains how to report no production without filing ingredient lists for products that have not been manufactured.
The business should examine its registration category and determine whether it is required to make a no-production filing. Having no sales does not, by itself, eliminate the reporting obligation.
The authorities also strengthened the procedure for identifying businesses that have not reported. On May 13, 2026, MFDS amended the Regulation on Reporting Production and Import Results and Ingredient Lists of Cosmetics (Notice No. 2026-38). The amended provisions allow the relevant organization receiving reports to contact non-reporting businesses by post, telephone, email, text message, or fax to establish the circumstances.
They also allow the competent regional food and drug authority to conduct a site visit to determine, among other matters, whether an unreported business actually exists at its registered address or has closed.
For a company already manufacturing products, the starting point is the factory's production figures reconciled with earlier filings. For a company that has registered but not manufactured anything, it is the registration status and the no-production reporting requirement. The absence of sales alone does not answer the reporting question.
There is also a second type of reporting with a different timetable. The annual production report covers the previous year, while ingredient lists must be reported before the products are distributed or sold. These deadlines must be managed separately.
Source: Enforcement Rule of the Cosmetics Act, Article 13; MFDS Notice No. 2026-38 (May 13, 2026); Korea Cosmetic Association guidance on production and ingredient-list reporting.
Can ingredient lists wait until the following February?
As described above, annual production results are reported by the end of February for the preceding year. Does the same deadline apply to the list of ingredients used in manufacturing?
No. Under Article 13(2) of the Enforcement Rule of the Cosmetics Act, a cosmetics responsible seller must report the ingredients used to manufacture a product before its distribution or sale. A previously reported ingredient list must also be reported again when the reported list changes, before the affected product is distributed or sold.
A practical question arises when the factory makes a second batch: must the company file the ingredient list again every time?
Not if the previously reported list remains unchanged. Suppose the factory labels the first batch A001 and the subsequent batch A002. They are separate production runs but may use the same ingredients. A new batch number, by itself, does not change the reported ingredient list.
Now suppose the factory decides to add panthenol, which was absent from the original cream. The finished product is still marketed as Miso Beauty Cream, but the ingredients used in manufacturing are different. The company must compare the revised formula with its earlier reported ingredient list and report the change before the altered product is distributed or sold.
Minsu should obtain the final list of materials or a clear record of what changed for the new production run. Has an ingredient been added or removed? Is the change to the ingredient itself, or only to its supplier or internal material batch number? If the factory calls something a “change,” that description alone does not settle the filing requirement. The issue is whether the list actually reported to the authority has changed.
A line-by-line comparison can show whether the existing reported list remains valid or an amended filing is needed for the changed product. It also avoids confusion where the factory announces an internal change but the names appearing on the ingredient list remain the same.
The sequence matters. An annual production report is filed after the relevant year has ended. An ingredient-list report is required before distribution or sale. Even for a product already manufactured, its ingredient list must be reported before market release. If ingredients change, the amendment must likewise be reported before the changed product is released.
Waiting until the following February to review ingredient lists could mean the legally required reporting point has passed. The brand should therefore establish with the factory when it will receive the final ingredient information for both initial and changed production.
The discussion so far concerns a business distributing and selling domestically manufactured OEM cosmetics under its own responsibility. Importers of finished products may be subject to a separate exception. Under Article 13(3) of the Enforcement Rule, a responsible seller importing cosmetics after making a standard customs pre-clearance report through electronic trade documents may omit the import-results and ingredient-list reports described in paragraphs (1) and (2).
An importer should therefore verify its actual import structure and whether the standard customs pre-clearance report has been made, rather than applying the domestic OEM reporting process without distinction.
What records must the brand obtain when quality testing is outsourced?
Minsu's OEM contract states that manufacturing and quality testing are the factory's responsibility. The manufacturer tests each production run and says it delivers only products that meet the applicable standards.
Is the factory's assurance that testing was completed enough for the brand?
Outsourcing manufacturing and testing does not remove the responsible seller's own statutory quality-management obligations. Article 12 of the Enforcement Rule requires the business to follow quality-management and post-market safety-management standards and retain the necessary product specifications and quality-control records obtained from the manufacturer.
Where manufacturing is outsourced, the responsible seller must also supervise whether the factory's manufacturing and quality-management work is carried out properly and obtain the relevant manufacturing and quality records required for that oversight.
Two types of documents help clarify the task.
Product specifications set out the criteria for manufacturing and controlling the particular cosmetic. They help the business understand the relevant product characteristics and the manufacturing and quality standards to be applied.
Quality-control records concern the actual tests and examinations conducted on a manufactured product and the recorded results. The important question is not merely whether someone said the product passed, but which production batch was tested and against which criteria.
Consider Minsu's cream again. The first run was assigned batch A001, and after sales increased the factory manufactured another run labeled A002. Both have the same name, quantity per package, and exterior design. Consumers purchase both as Miso Beauty Cream, but the two batch numbers identify different production runs.
A satisfactory test result for A001 does not establish that the A002 batch has been examined or passed. Suppose the brand has documentation for A001 but nothing for A002. After Minsu asks, the factory replies that both batches were tested. What he needs next is evidence showing whether A002 was tested, what was examined, and what the actual results were.
Review the quality-control records and, where applicable, the test certificate provided by the factory. Can the company identify the product name, batch number, test date, test items and acceptance criteria, and recorded results? Do those details match the products actually delivered?
Now suppose the certificate refers to batch A002, while the product received bears batch A003. Minsu should first establish with the factory which batch was actually supplied. The certificate and the delivered goods may concern different production runs. Reconciliation of the batch number against the test records makes it possible to identify whether the documents kept by the responsible seller really concern the product being sold.
Those records also become useful if a quality issue is later raised. When a complaint concerns a particular batch, the brand must be able to locate its manufacturing and testing information and work out which further records are needed to examine the product and the potential scope of the issue.
This does not mean that the responsible seller must automatically repeat every test carried out by the factory. Article 12, item 5 of the Enforcement Rule requires distribution following batch-specific quality testing but provides circumstances in which the responsible seller need not conduct the tests itself. These include the situation in which manufacturer and responsible seller are the same entity, or where testing has been entrusted to an institution covered by the provision and batch-specific results are available.
If legally qualifying outsourced test results have been obtained, the responsible seller does not necessarily have to repeat the same testing. The obligation to supervise the outsourced activity appropriately and obtain and retain the necessary records remains.
For an OEM contract, that distinction is practical. If the agreement only says “The manufacturer performs quality testing,” check whether it specifies when batch-specific results will be delivered and what quality-management documents the brand can request. Does the factory provide a test result after each additional run? If the brand requests the quality records, what documentation must be supplied?
The same issue arises when ingredients or the formula change. If the manufacturer replaces an ingredient in an existing cream, the brand must establish what was changed in order to compare the new product information with the ingredient list already reported and with the other records it retains.
The allocation of testing responsibilities and the arrangements for receiving the evidence of testing should therefore be considered together.
The factory is not necessarily obliged to disclose every manufacturing record or every detail of a proprietary formula without qualification. Article 11(1), item 6 of the Enforcement Rule addresses the submission of information necessary for quality management and contains exceptions. In particular, where a manufacturer itself designs, develops, and produces the cosmetics, it may be able to withhold trade-secret information under the parties' agreement to the extent that doing so does not affect product quality and safety management.
Minsu should check both what records the contract requires the factory to provide and whether the brand actually has the records it needs to discharge its own obligations. Calling a document a trade secret does not, by itself, remove the responsible seller's statutory duties.
Another requirement concerns stability-testing documentation for products containing specified ingredients. Article 12, item 11 of the Enforcement Rule addresses products containing at least 0.5% of ingredients covered by that provision, including retinol and its derivatives, ascorbic acid and its derivatives, tocopherol, peroxide compounds, and enzymes. The applicable stability-testing records must be retained for one year after the expiration date of the finished product.
Suppose Minsu plans to launch a separate cream containing retinol. He should first obtain the final formula information from the factory and identify the actual concentration of retinol or the relevant derivative. If the finished product contains a covered ingredient at or above the statutory 0.5% threshold, the relevant stability-testing recordkeeping requirement applies.
The brand should ask whether the manufacturer already holds the required stability data and how the responsible seller will obtain and retain the necessary documentation.
A stability test addresses how the product's characteristics and quality are maintained over time or under different storage conditions. That is distinct from a human application or efficacy study intended to substantiate an advertising claim.
A study supporting a claim that a cream helps improve wrinkles does not necessarily meet the legal requirement to retain stability-testing information. Conversely, stability data alone does not prove the effectiveness claimed in advertising. The underlying ingredient, its concentration, the purpose of each test, and the required retention period must all be considered separately.
The review therefore proceeds from confirmation that the factory has tested the product to verification that the results identify the same batches the company sells and that the brand can obtain and manage the documents required by law.
These are not records to look for only when annual production reporting is due. They may be needed each time the factory makes an additional batch or changes the manufacturing details.
And responsible selling duties continue after shipment. Even a batch that passed its quality tests may later be the subject of a consumer report about a skin reaction.
What should an online seller record when a customer reports a skin reaction?
Suppose a customer sends a message through Minsu's online store:
“My skin became red and stung after I used the cream. I would like a refund.”
The customer-service employee checks the order and prepares to explain the refund procedure. Is a refund-service record enough?
A cosmetics responsible seller must also collect and manage relevant safety information after a product has been placed on the market. A customer inquiry might be only about a refund, but where the account includes information concerning product safety, the responsible sales manager must be able to review it.
Article 12 of the Enforcement Rule and the MFDS Regulation on the Management of Cosmetics Safety Information govern the collection and reporting of relevant post-market safety information.
One term used in this field is an adverse event: an unintended and undesirable sign or symptom occurring while a cosmetic is being used. Redness or stinging reported during use may therefore be information that needs to be collected and examined. Whether a particular case is legally reportable is a separate determination.
Minsu's company should first establish which product the customer used and what the customer actually experienced. In addition to the product name, customer service should ask for the batch number shown on the container or carton if possible.
The factory made the cream in batches A001 and A002. They share a product name but have different manufacturing histories. The batch number helps the responsible manager find the relevant quality-testing and manufacturing records. If the customer cannot locate the number, the company may ask for a photo of the relevant label.
Timing matters as well. Did redness begin after the first application, or after several days of use? Record, as reported by the consumer, when the symptoms started, how long they lasted, whether they are continuing, and whether anything changed after the product was discontinued. If the customer says they sought medical treatment, the company can confirm what information or supporting documentation the customer is able to provide.
Those details should not remain solely within customer service. The responsible sales manager needs them to consider the reporting category and any action required. The business should distinguish the date it received information from the date of product purchase or the date symptoms first appeared.
Does every report of skin redness have to be sent to MFDS within 15 days?
The legal reporting category depends on the nature and outcome of the event. Article 5 of the Regulation on the Management of Cosmetics Safety Information requires expedited reporting for specified types of information, including serious adverse events.
Serious adverse events include circumstances identified in the regulation such as death, a threat to life, hospitalization or a prolonged hospital stay, and persistent or significant functional impairment. A report of temporary redness is different from a report that use of a cosmetic was followed by symptoms requiring hospitalization. In the latter case, the company should establish the hospitalization details and relevant course of events and assess whether the serious-adverse-event criteria are met.
Where information falls within a legally reportable expedited category, the obligation must be considered even if a causal relationship between the cosmetic and the symptoms has not yet been established. The rule also addresses other specified information, including cases in which MFDS directs reporting and certain foreign-government measures comparable to a suspension of sale or product recall.
When a cosmetics responsible seller learns of safety information covered by this expedited-reporting rule, it must report to MFDS within 15 days from the date it became aware of that information. The reference date is not automatically the product purchase date or the date on which the symptoms first arose. The intake date and the content communicated to the company must therefore be documented.
What happens to safety information that does not fall into a 15-day expedited reporting category?
Article 6 of the same regulation requires periodic reporting of cosmetics safety information not reported through the expedited route within one month after the end of each half-year. In practice, information collected from January through June and subject to periodic reporting is reported in July; reportable information collected from July through December is reported in the following January.
For example, if Minsu's company receives a skin-reaction report in October 2026 and that information is subject to periodic rather than expedited reporting, it belongs to the second-half 2026 reporting period, with reporting due by the end of January 2027.
Even a company with no relevant consumer reports should examine its periodic-reporting obligation. According to the reporting method conveyed by the Korea Cosmetic Association at MFDS's request, businesses subject to the periodic system are instructed to submit a “nothing to report” return when there is no safety information to report for the period.
An exception applies to certain responsible sellers with no more than two regular employees who sell only cosmetic soap that they manufacture themselves, as specified in Article 6. Both the staffing condition and the condition about the product and direct manufacture matter. A small business selling an ordinary OEM cream cannot use the exception merely because it has very few employees.
A consumer's skin-reaction message is therefore both a customer-service matter and potential post-market safety information. Customer service records what the customer says about the purchase, product, batch, symptoms, and timing; the responsible sales manager reviews the information for reporting requirements and any necessary steps.
Batch information also helps the business check whether similar reports concern the same production run. The company can locate the corresponding factory records and quality-test results for further examination, rather than relying on the product name alone.
A useful record distinguishes the complaint receipt date, product name and batch, the consumer's account of symptoms and their course, what was passed to the responsible manager, whether a report was necessary, and how the matter proceeded. Completing a refund does not necessarily discharge safety-information obligations.
If the information is subject to expedited reporting, the 15-day deadline runs from when the responsible seller became aware of the reportable information. If the company's review establishes that the product falls within a statutory recall category, the recall rules must be considered separately from these regular reporting cycles.
Source: Enforcement Rule of the Cosmetics Act, Article 12; Regulation on the Management of Cosmetics Safety Information, Articles 2, 5 and 6 (MFDS Notice No. 2022-12); Korea Cosmetic Association, notice on MFDS cooperation regarding cosmetics safety-information reporting (July 4, 2025).
Can a statutory product recall wait until the year-end report?
Imagine the OEM manufacturer contacting Minsu to say it has identified a quality problem in a particular production batch of his cream. The factory is reviewing its manufacturing and testing records. Some of those products have already been sold through Minsu's online store, and others have been delivered to retailers.
What should the responsible seller do first?
The company must establish what problem was found and whether the affected cosmetics fall within a statutory recall category. Article 5-2 of the Cosmetics Act and Article 14-2 of its Enforcement Rule govern the duty to recall hazardous cosmetics and the products covered by that duty.
Examples include products made with ingredients that may not be used in cosmetics and products contaminated with pathogenic microorganisms, as specified by the applicable provisions. A general complaint or a manufacturer's report of a problem must be assessed against the actual testing information, nature of the defect, and the legal recall criteria.
Once the responsible party knows that the product is subject to a statutory recall, it cannot wait for the next annual report. Under Article 14-3(1) of the Enforcement Rule, the recall-obligated party must take necessary action immediately, including suspension of sale. It must also submit a recall plan with the required documents to the competent regional office of MFDS within five days from the day it became aware that the products were subject to recall.
Three dates are worth distinguishing: the date the factory contacted the brand, the date the responsible party became aware that the products were legally subject to recall, and the date the actual recall began. The five-day deadline for the recall plan runs from awareness of the statutory recall status. The period allowed for carrying out the recall runs from the start of the recall itself.
How should the recall plan be prepared?
A blank form from the factory is not enough. The plan must identify which products will be recovered, how many units were supplied, which retailers or customers received them, and how the company will conduct the recall. Article 14-3(1) specifies supporting documents, including copies of the relevant manufacturing or import records, records of quantities and sales dates by sales outlet, and documentation stating the reason for recall.
Consider a specific example from Minsu's company. Suppose 1,000 units of batch A001 were manufactured and that batch has been confirmed as subject to a statutory recall.
Of those 1,000 units:
- 300 units were shipped to consumers through the online store.
- 500 units were supplied to other retail outlets.
- 200 units remain in the company's warehouse.
All carry batch number A001, but they are in different locations and stages of distribution.
The remaining 200 warehouse units must be prevented from being shipped out. For the 500 units supplied to other retailers, the company must identify which outlets received them, when deliveries occurred, and in what quantities, and communicate the recall plan to the affected parties. For the 300 online sales, order and shipment records are needed to determine how consumers can be informed and how the affected products will be recovered.
The OEM factory's manufacturing record establishes the relevant batch and total quantity. The brand's shipment and sales records identify where the goods went. If the factory confirms that it made 1,000 A001 units but the brand has no distribution breakdown, the company cannot readily set out the quantities to recover from each outlet. Delivery notes, dispatch records, and online order and shipping histories become essential to reconstruct that information.
In other words, the recall plan depends on connecting two bodies of evidence: what the manufacturer produced and what the responsible seller distributed.
The plan must also state the period in which the recall will be carried out. The applicable period depends on the product's hazard grade. Article 14-2 classifies cosmetics subject to recall into Grades A, B, and C, in descending order of risk. Article 14-3(2) provides these limits for the period specified in the recall plan:
- Grade A: within 15 days from the date the recall began.
- Grade B or Grade C: within 30 days from the date the recall began.
If A001 falls within Grade A, the planned recall period must be set within 15 days after commencement. That is separate from the five days allowed to submit the recall plan, which begins when the party learns that the product is subject to recall.
Where a statutory reason makes timely completion of the recall difficult, the party may request an extension of the recall period from the competent regional office, stating the reason. If timely submission of the recall plan itself is difficult for a qualifying reason, a separate extension request may also be made. Neither type of extension is automatic.
Submitting the recall plan does not end the procedure. The recall-obligated party must communicate the plan to sellers and other persons who handle the products in their business. The Enforcement Rule provides methods such as in-person notice, postal mail, telephone, email, fax, and announcements in the media.
If Minsu's company emails the plan to a retail outlet, it should retain records showing what was sent and when. Under Article 14-3(4), evidence proving that the recall plan was communicated must be kept for two years from the date the recall is completed.
Documentation is also required when products are returned. A seller or other recipient of the recall notice must return the affected cosmetics to the recall-obligated party and send a recall confirmation prepared on the prescribed form. Those confirmations help the company establish which outlets returned the goods.
Disposal is subject to a further procedure. If the recall-obligated party is to destroy recovered cosmetics, it must submit a disposal application with the prescribed supporting documents, including copies of the recall plan and recall confirmations, to the regional office. Disposal must take place under the observation of the relevant public official and in accordance with applicable law. The disposal confirmation prepared after destruction must also be retained for two years.
When the recall activity has finished, a recall-completion report must be submitted with the required attachments. These include recall confirmations, an assessment report, and, if the products were destroyed, the relevant disposal confirmation. The competent regional authority reviews the submitted evidence and recall performance before determining whether the recall is complete.
A hazardous-cosmetics recall is therefore more than retrieving boxes from retailers. The business needs to identify batch numbers and manufacturing quantities, reconcile deliveries to each sales outlet, notify relevant persons, record what was recovered, document any disposal, and prepare the necessary administrative filings.
The factory and brand have different tasks. The factory supplies the relevant manufacturing and test records relating to the problematic batch. The brand checks its distribution and sales information and, where it is the recall-obligated party, carries out the applicable statutory recall requirements.
Determining whether a product is legally subject to recall, how it should be classified by hazard grade, and which units must be covered depends on the actual violation and quality and safety evidence assessed under the applicable law. Technical testing and specialized hazard assessment belong to the competent specialists or institutions.
Preparation of documents for a public authority is a distinct part of the work. It may involve reconciling manufacturing records with quantities distributed to each retailer and organizing the product identifiers and recall reasons for a recall plan. An Administrative Attorney may prepare administrative documents and perform filing or submission tasks where permitted by Article 2 of the Administrative Attorneys Act and other applicable laws.
This is one reason to keep batch-specific quality records and distribution records while the products are selling normally: when a problem arises, the business can trace the potentially affected goods and prepare the evidence needed for the applicable procedure.
Annual training and reporting obligations do not replace the immediate measures required when a product is subject to statutory recall. Other events, including changes to the registered responsible manager or business information, trigger separate deadlines as well.
Source: Cosmetics Act, Article 5-2; Enforcement Rule of the Cosmetics Act, Articles 14-2 and 14-3.
Can a company postpone a manager-registration change until training is complete?
Suppose Minsu has been both the company's representative and its responsible sales manager. He now appoints a qualified employee as the new manager. The company arranges the employee's training but plans to change the name on the business registration certificate at year-end.
The company should deal with the change-registration deadline now, rather than waiting for the training course.
Article 5 of the Enforcement Rule of the Cosmetics Act identifies changes that require a registration amendment. They include replacement of the responsible sales manager, changes to the responsible seller or a corporate representative, changes to the business name, changes to the registered business location, and changes to the types of responsible selling business.
An application must ordinarily be made within 30 days of the event giving rise to the change. The Rule provides a 90-day exception for a change of location attributable to an administrative reorganization of district boundaries.
Manager training is scheduled independently. Under Article 14, the initial course is due within six months from the start of the manager's duties, and refresher training is required once each year using the date of initial training as the reference. If the newly designated employee has previously completed relevant training, that training history should be checked. The pending training date does not extend the separate 30-day deadline for change registration.
In Minsu's case, the first comparison is between the manager named on the current registration certificate and the person who has actually taken over the position. He should establish the date of that change and obtain evidence that the replacement manager meets the qualifications.
Article 5(2) requires a change-registration application, the existing registration certificate, and documents appropriate to the particular change to be submitted to the competent regional food and drug authority. For replacement of the responsible sales manager, the company must also prepare the documentation substantiating the new manager's qualifications.
Other changes require the same care. If the company moves offices, amending its tax or general business registration does not automatically establish that the cosmetics responsible selling registration shows the new location. A change of the corporate representative is also distinct from merely changing the person who receives routine contact messages.
Before Minsu postpones the paperwork until year-end, he should establish the actual date the responsible manager changed, not merely the planned date of the new manager's training.
Source: Enforcement Rule of the Cosmetics Act, Articles 5 and 14.
Why did a local license-tax notice arrive after sales stopped?
Suppose Minsu temporarily stops selling cosmetics through his online store. He places no new orders and marks the listed products as unavailable. Because there will be no revenue for a while, he assumes there is nothing further to do.
Then, in January of the following year, a notice for the local registration and license tax arrives. Why would the company owe a tax if it was not selling any products?
The license portion of Korea's local registration and license tax is not calculated from the number of cosmetics sold or the revenue earned. It is a local tax associated with holding certain registrations, licenses, or permits under the applicable law. Stopping online sales does not automatically change the company's cosmetics responsible selling registration to a closed-business status.
The first distinction is between taking a temporary break from selling products and ending the registered cosmetics business itself.
Article 6 of the Cosmetics Act requires reporting when a cosmetics responsible seller suspends business, closes business, or resumes business following suspension. The law provides specified exceptions to the notification obligation, including circumstances involving a suspension of less than one month or a suspension and resumption during such a period.
If Minsu pauses sales for a few days and resumes them, he should establish whether the statutory exception applies. If he intends to wind down the cosmetics business permanently, he must prepare a closure filing. A longer period without operations requires assessment of the intended period, the actual business activity, and the applicable suspension-reporting obligations.
There is a prescribed form. Article 15 of the Enforcement Rule of the Cosmetics Act requires cosmetics responsible sellers to submit the Business Closure, Suspension or Resumption Report, Form No. 11, to the competent regional food and drug authority. A closure or suspension filing must be accompanied by the cosmetics responsible selling registration certificate, except where the certificate was issued electronically.
The form records information such as the company name, registration number, and address, together with the relevant closure date, anticipated suspension period, or reason for suspension, depending on the filing. The Government24 public-service information lists no application fee and a seven-day processing period for this service.
What if the company has already filed a general business-closure notice with the tax office?
General business registration is governed by the Value-Added Tax Act, whereas cosmetics responsible selling registration is governed by the Cosmetics Act. The two systems are administered under different legal provisions.
There is, however, a procedure connecting their closure reports. Under Article 15 of the Enforcement Rule of the Cosmetics Act, if the competent tax-office chief forwards a closure notice made under the Enforcement Decree of the Value-Added Tax Act to the regional food and drug authority, the cosmetics-law closure report is also treated as submitted. MFDS may also cancel a cosmetics responsible selling registration on specified grounds associated with a tax-office closure filing or cancellation of the general business registration.
If Minsu reported closure to the tax office, the next question is therefore whether the notification was forwarded and how the cosmetics registration was actually processed. Comparing the tax office's certificate of business closure with the receipt and processing information held by the regional food and drug authority can show which steps were completed.
How does that affect the tax notice?
Article 35(2) of the Local Tax Act treats a license whose validity is indefinite or exceeds one year as renewed on January 1 each year for purposes of the regular license tax.
Suppose Minsu's cosmetics registration is still active on January 1 and the company closes in February. Closure in February does not automatically cancel the regular license-tax charge for that year simply because the company has since stopped operating.
But the assessment may differ if the business actually closed by December 31 of the preceding year.
Article 40(2), item 4 of the Enforcement Decree of the Local Tax Act provides for non-taxation of a qualifying license for a business that was closed on January 1 and for which the required closure filing under the Value-Added Tax Act was made. The provision also covers qualifying closure notifications made by January 25 of the same year, under the conditions prescribed in law.
For example, if the company genuinely ceased operations before the beginning of the new year and submitted the required closure filing by January 25, it may be possible to establish that the business was already closed on January 1 and examine whether the regular license-tax exemption applies. Merely writing an earlier date on a closure form does not, by itself, prove that the business actually closed on that date. The timing and evidence of the actual cessation of business matter.
There is a separate non-taxation rule for certain suspended businesses. Article 40(2), item 5 of the same Enforcement Decree addresses licenses for businesses proven to have been effectively suspended for at least one year as of January 1. A brief sales pause must therefore be distinguished from a business that has genuinely been inactive for a year or longer and can substantiate that status.
Return to the notice that Minsu received. The first things to check are the tax year and the license identified on the notice. Is it for the cosmetics responsible selling registration, or a different license or registration such as mail-order selling? Each license may have a separate competent authority and its own closure record.
Next, compare the actual date sales stopped and the business closed with the date the closure notice was filed with the tax office and the filing and processing dates recorded by the regional food and drug authority. Depending on the case, supporting documents may include general business-registration records, the cosmetics responsible selling registration certificate, proof that the closure notice was received, and the certificate of business closure.
Those materials can be presented to the appropriate local government's tax department to ask about the basis of the assessment and whether a statutory non-taxation provision applies. The tax authority determines the actual tax treatment under the applicable rules.
The dates and business identities also matter when preparing administrative forms. Does the registered cosmetics business correspond to the taxpayer identified in the closure notice? What closure date appears on the form, and what processing result is recorded? Reviewing the evidence helps identify what needs to be included in any required filing. Preparation and submission of administrative documents may be separately delegated only within the scope permitted by the Administrative Attorneys Act and other applicable laws.
The answer to Minsu's tax notice is therefore not simply that he stopped making sales. It depends on the company's actual registered status, when operations ended or were suspended, and how that status was reported to and processed by the relevant authorities.
A business that has already received a notice should verify the tax year, the type of license, and the dates connected with closure or suspension, and ask the competent local tax department to determine whether non-taxation applies.
Source: Cosmetics Act, Article 6; Enforcement Rule of the Cosmetics Act, Article 15; Local Tax Act, Article 35(2); Enforcement Decree of the Local Tax Act, Article 40(2), items 4 and 5.
One year after registration, which records should the company review first?
While Minsu's first cream is on sale, the OEM factory is preparing another production run. The business is also receiving training reminders and consumer inquiries. Rather than putting every document aside until year-end, it should start by identifying its present business situation.
The company is registered but has not begun production
Check the type of responsible selling business and the designated manager on the registration certificate. Establish when the manager began performing the role and check initial and refresher training records. If the business is subject to domestic production reporting, verify whether a “no production” filing is required for the preceding year despite the absence of manufacturing activity. Reporting follows the applicable calendar-year period and statutory deadline, not the first anniversary of registration.
The company is manufacturing and selling domestic OEM products
Compare the factory's production quantity and production value for each product with earlier ingredient-list filings, purchase orders, and delivery records. Confirm that “Miso Beauty Cream,” the name used in the online store, corresponds to factory code “MC-01.” Locate the quality-test records for batches A001 and A002 separately. If the reported ingredient list has changed, determine whether an amendment must be reported before the affected cosmetics are distributed or sold.
If an online consumer reports skin irritation, preserve the product name, batch number, the date the company learned of the information, and the symptoms and course described by the consumer. The responsible sales manager should then assess the relevant reporting category. If a statutory recall condition is established, actions such as suspension of sale and preparation of a recall plan must be dealt with separately from the annual production report.
The designated manager or company registration details have changed
Review the previous registration certificate, the actual change date, and documents establishing the new manager's qualifications, or the business-name or location changes as applicable. The 30-day registration-amendment period for a replacement responsible manager is not calculated by waiting for that manager to complete training or for the next annual production report.
What the business can check and which document tasks can be delegated
The company can begin with the registration certificate's business and manager details, training certificates, factory production information, and its previous production and ingredient-list reporting records. When information differs, it can identify the affected product or business detail and establish which evidence is needed for an amendment application or another document submitted to the competent authority.
Under Article 2 of the Administrative Attorneys Act and other applicable laws, an Administrative Attorney may prepare documents for submission to administrative authorities, organize the relevant facts and evidence, and carry out submission tasks where legally permitted. Whether a particular reporting document may be prepared or submitted by a delegate depends on the procedure and applicable rules.
The manager's own statutory training, the manufacturer's technical quality tests, and medical assessments of causation between a product and symptoms remain the work of the relevant individuals or competent specialists. Preliminary review of records must also be distinguished from separately agreed paid document-preparation or submission work.
If you share the documents you already have—such as your cosmetics responsible selling registration certificate, responsible manager training records, or recent production reports—Ethos Administrative Attorney Office can offer a free preliminary review to identify which obligations and deadlines should be checked first, where registration or reporting details do not match, and what additional records to request from the factory or competent authority; any separately commissioned preparation or legally permitted submission of administrative documents is subject to an agreed scope and fee.
Three-point summary
- A responsible sales manager must complete initial training within six months of beginning the role and refresher training once a year based on the initial-training date; responsible sellers subject to annual reporting must report the preceding year's production by the end of February.
- Ingredient lists must be reported before distribution or sale, while batch-specific quality records and post-market safety information require ongoing management; the 15-day expedited safety-reporting deadline and the five-day recall-plan deadline have different starting points.
- Comparing the registration certificate, training history, factory production and quality records, and previous reports helps distinguish obligations the company can address itself from permitted administrative document-preparation and submission services.