Can You Import Overseas OEM Cosmetics with Your Existing Korean Registration?
BySangjin Ji, Administrative Attorney3 years of embassy visa practiceLinkedIn
Imagine a Korean skincare brand that already sells a cream manufactured by a domestic OEM factory. The brand now plans to introduce a new serum produced by an overseas manufacturer.
The company has already registered as a cosmetics responsible distributor in Korea. The overseas factory has confirmed that it can manufacture the serum.
Can the company import and sell that serum under its existing registration?
The first question is whether the company's Cosmetics Responsible Distributor registration includes the business category for distributing and selling imported cosmetics.
Korean regulations distinguish between distributing cosmetics manufactured under a domestic contract-manufacturing arrangement and distributing cosmetics imported from abroad.
Even when the appropriate business category is registered, the company must still establish whether the overseas manufacturer can supply the certificates needed for importation.
The required documentation generally includes manufacturing and sales certificates. The importer must also complete the applicable Standard Customs Clearance Forecast Report before customs clearance.
After customs clearance, the company remains responsible for applicable batch-specific quality control, import management records and Korean labeling requirements before selling the products.
Consider the quotation received from the overseas manufacturer.
It clearly states the unit price, minimum order quantity and delivery schedule. Product samples have been reviewed, and the packaging design is nearly complete.
The company may be ready to sign the manufacturing agreement.
However, the quotation does not explain who will obtain the manufacturing and sales certificates required for importation into Korea.
The factory can manufacture the serum, but the availability of a sales certificate for that specific product has not yet been confirmed.
This is an important distinction in overseas OEM projects.
A manufacturer may have the technical capability to produce a cosmetic product without being able to provide every document required for its importation and distribution in Korea.
Does an Existing Cosmetics Registration Include Imported Products?
The company's first cream was manufactured by a domestic cosmetics manufacturer under a contract-manufacturing arrangement.
The new serum will be produced overseas, imported into Korea and sold under the same brand.
Both products fall within the activities of a cosmetics responsible distributor, but the relevant business categories are distinguished under Korean law.
Article 2(2) of the Enforcement Decree of the Cosmetics Act identifies four categories of cosmetics responsible distribution businesses:
- Category (a): Distributing and selling cosmetics manufactured directly by a registered cosmetics manufacturer.
- Category (b): Distributing and selling cosmetics manufactured under contract by a cosmetics manufacturer.
- Category (c): Distributing and selling imported cosmetics.
- Category (d): Facilitating or supplying cosmetics through an import-agency transaction model in electronic commerce.
The existing domestically manufactured cream falls under category (b).
For the new serum, which the company intends to import directly from an overseas manufacturer and sell in Korea, the company must check whether category (c) is included in its registration.
The same brand name does not mean that the two products are covered by the same registered business category.
Must the Company Register the Business Again?
A completely new responsible distributor registration is not necessarily required.
If the existing registration covers category (b) only, the company needs to prepare an amendment to add category (c).
If both categories were already registered, it does not need to add the same import category again.
The relevant document is the Cosmetics Responsible Distributor Registration Certificate.
A business registration certificate may identify the company as a cosmetics retailer, wholesaler or trading business. That information does not automatically establish that the required business category has been registered under the Cosmetics Act.
The company should review the responsible distributor registration certificate for its registration number, business name, registered address, responsible distributor manager and registered business categories.
If the import category is missing, the company needs to address the registration amendment before beginning direct import operations.
When Must a Registration Amendment Be Filed?
Article 5 of the Enforcement Rule of the Cosmetics Act identifies changes to responsible distributor business categories as matters requiring amendment registration.
An application for amendment registration must be filed within 30 days from the date the relevant change occurs.
The 30-day period is calculated from the actual occurrence of the change requiring registration. It does not automatically begin when a quotation is requested or a product sample is received from an overseas factory.
A company preparing to start direct import operations should ensure that the necessary registered category is in place before its first import.
Where an amendment is required, the company prepares the prescribed application under Attached Form No. 6 of the Enforcement Rule, together with its existing registration certificate and other documents required for the specific change.
The application is submitted to the competent Regional Office of Food and Drug Safety.
The Korean government service portal, Government24, identifies a general processing period of 10 days for responsible distributor amendment registration.
These two periods serve different purposes.
The 30-day period concerns the business operator's statutory filing obligation after a relevant change occurs.
The 10-day period refers to the administrative processing time for the application.
They should not be treated as the same deadline.
Once the correct responsible distributor category has been confirmed, the next issue is the documentation that the overseas manufacturer can provide.
Can the Overseas Manufacturer Provide Both Required Certificates?
The overseas manufacturer initially sends a quotation, a serum ingredient list and a product information sheet.
These documents help the Korean company understand the price, basic formulation and characteristics of the proposed product.
They do not establish that the documentary requirements for importing the finished cosmetic product have been met.
The Korea Pharmaceutical Traders Association (KPTA) identifies the responsible distributor registration certificate, business registration certificate, manufacturing certificate and sales certificate among the documents generally required for the Standard Customs Clearance Forecast Report for imported cosmetics.
Depending on the product, additional documentation may be required for functional cosmetics or BSE/TSE-related matters.
Two documents deserve particular attention during overseas OEM negotiations: the manufacturing certificate and the sales certificate.
What Information Must the Manufacturing Certificate Contain?
A manufacturing certificate is issued by the overseas manufacturer to document the manufacturing information of the cosmetic product.
According to KPTA guidance, the certificate must include the relevant signature of a responsible person at the manufacturing company.
It must also contain the required information concerning the product name, ingredient names, ingredient quantities, ingredient specifications and supporting information for those specifications.
The applicable notarization requirements must also be satisfied.
Where an ingredient is subject to restrictions on use in Korea, its concentration or quantity must be verifiable.
Suppose the overseas factory provides a formulation sheet containing ingredient names only.
The Korean company can identify which ingredients the serum contains. However, if one of those ingredients is subject to a concentration limit under Korean regulations, its name alone is insufficient to assess whether the applicable limit has been observed.
The actual concentration must also be checked.
Instead of requesting every technical document held by the manufacturer, the company should distinguish between the information required for the manufacturing certificate and any additional information needed to assess compliance with Korean ingredient restrictions.
Preparing documentary evidence and performing a technical safety assessment are separate tasks.
The identity of the actual manufacturer is equally important.
For example, the Korean brand may sign its contract with an overseas company responsible for product development and commercial negotiations.
The serum itself may be manufactured at a different facility operated by another company.
In that arrangement, the contracting company and the actual manufacturing company are not necessarily the same entity.
KPTA guidance indicates that where a contract-manufacturing company issues the manufacturing certificate, the name and address of the subcontracted manufacturer must also be stated.
The Korean company should therefore check which entity issues the manufacturing certificate and whether the document properly identifies the actual manufacturing facility.
This allows the company to compare the contracting party, manufacturing certificate and actual production information.
What Happens If the Serum Is Developed Exclusively for Korea?
The sales certificate serves a different purpose from the manufacturing certificate.
The manufacturing certificate documents the product's manufacturing information.
The sales certificate is intended to establish that the product is sold in the relevant manufacturing or sales country.
KPTA guidance identifies certificates issued by government or public institutions in the manufacturing or sales country.
Cosmetics associations and chambers of commerce may also be recognized as issuing bodies.
The certificate must contain the required manufacturer and product identification information.
If the overseas manufacturer already produces and sells the serum in its domestic market, the Korean importer can ask which institution is able to issue the relevant sales certificate.
The situation may be different when a completely new serum is developed exclusively for the Korean brand.
The overseas factory may be able to manufacture and export the product even though it has never been sold locally under that product name.
In this situation, the company must establish whether the relevant sales certificate can actually be issued.
A lack of local sales history does not, by itself, establish that importation into Korea is categorically impossible.
The applicable documentary requirements depend on the actual manufacturing and sales structure, the issuing institution's rules and the requirements governing the importation of that product.
If the certificate cannot be obtained through the ordinary procedure, the company should explain the circumstances to KPTA and confirm what documentation and handling procedures are recognized for the particular case.
The company should not assume that an alternative certificate or substitute document will be accepted without confirmation.
Before signing the OEM agreement, the Korean brand can ask the manufacturer:
- Can a sales certificate be issued for the exact serum being developed?
- Which institution will issue it?
- Will it identify the product under the name used for importation into Korea?
- What supporting documents or notarization will be required?
- When can the certificate be provided?
The ability to manufacture a product and the ability to obtain its required import certificates should be verified separately.
Is an Emailed PDF Sufficient?
An overseas manufacturer may send copies of its manufacturing and sales certificates by email.
However, receiving PDF copies does not necessarily complete the relevant document submission process.
KPTA provides guidance on online document submission and submission of original documents by post.
Original manufacturing and sales certificates may be required in particular circumstances, including an importer’s first imported item, documents involving bundled notarization, seals or notarization on the reverse side, and cases requiring additional examination.
The importer should check whether original documents are required for its particular application.
Where originals are necessary, the company should arrange how and when the manufacturer will deliver them.
The delivery date for the cosmetic products does not have to be the same as the delivery date for their supporting certificates.
What matters is ensuring that the documents can be obtained in time for the relevant import procedure.
What Should an Overseas OEM Agreement Cover Beyond Price?
Once the roles of the manufacturing and sales certificates are understood, the original quotation can be reviewed from a different perspective.
The unit price, minimum order quantity and delivery schedule may be clear.
However, responsibility for obtaining the Korean import documents may remain undefined.
The parties can address these issues when negotiating their manufacturing agreement.
First, they can identify which documents the manufacturer can issue directly and which must be obtained from competent authorities or other recognized institutions.
They can then agree on who will arrange the required notarization and original document delivery, where applicable.
The timing of document delivery is also important.
A company preparing its first import should establish whether the necessary evidence can be obtained in accordance with the import schedule.
Changes to the manufacturing arrangements require particular attention.
Suppose the overseas manufacturer proposes replacing an ingredient after the original formulation has been agreed upon.
The product may retain the same brand name and packaging design, while its actual ingredient composition changes.
That change may affect the ingredient information and previously prepared import documents used in Korea.
If the Korean company is not informed, it may continue preparing the import application using an outdated ingredient list or manufacturing certificate.
The parties can therefore discuss how changes to ingredients, concentrations, the actual manufacturing site or product specifications will be communicated and documented.
Batch-specific quality records should also be considered.
If the manufacturer produces the same serum in several production batches, those batches may have different batch numbers.
The Korean responsible distributor must be able to obtain the information necessary for batch-specific quality control and import management records.
The company should establish what test information is available for each batch and when it can be provided.
These arrangements are not identical mandatory statutory clauses for every overseas OEM contract.
The appropriate terms depend on the manufacturing structure, the parties' responsibilities, the documents necessary for Korean importation and legitimate protection of the manufacturer's confidential technical information.
However, agreeing on documentary responsibilities before production is completed can reduce the need to renegotiate those matters later.
Are Ingredients Permitted Overseas Also Permitted in Korea?
Once the manufacturing certificate and final ingredient information have been obtained, the company must compare the formulation against Korean cosmetics requirements.
A manufacturer may explain that the serum is already sold in its home market and meets the requirements of that country.
That does not establish that the formulation complies with Korean regulations.
Article 8 of the Cosmetics Act and the relevant Ministry of Food and Drug Safety (MFDS) notice, Standards for Cosmetic Safety, establish requirements concerning prohibited ingredients and ingredients subject to restrictions on use.
Separate rules also apply to permitted colorants.
For example, an ingredient may be permitted only for a particular purpose or below a specified concentration.
Its presence in the formula does not establish compliance unless the applicable conditions are examined.
How Should the Overseas Ingredient List Be Compared?
The first step is to identify the actual substances listed in the manufacturer's documents.
An overseas formulation sheet may use international ingredient terminology or internal manufacturing names.
For the Korean import documentation, the company must identify the ingredients using the applicable standardized ingredient names.
An unfamiliar English ingredient name is not necessarily the name of a substance prohibited in Korea.
The company should identify the substance and compare it with the ingredient terminology and requirements used under Korean rules.
Where the ingredient is restricted, its concentration must also be examined.
For example, the general ingredient list may identify the ingredient, while the manufacturing certificate contains the actual amount used.
If Korean rules restrict that substance by concentration or intended purpose, the company must examine the relevant conditions.
Comparing the ingredient list with the manufacturing certificate helps identify which information is available and which details must be requested from the factory.
What If the Manufacturer Changes the Formula?
Suppose the Korean company begins preparing its import documents based on the first ingredient list.
The overseas factory then informs the company that an ingredient has been replaced.
The brand name and packaging remain unchanged.
However, the actual contents of the product are different.
The importer should obtain the final formulation information and establish whether the manufacturing certificate and ingredient list reflect the same version of the product.
This also affects the ingredient list code used in the import reporting process.
KPTA guidance provides for the creation of a new ingredient list code where the ingredients, their quantities or other relevant import information change.
If the formula has changed, the importer must prepare the ingredient information using the final manufacturing details.
If only the internal product code or product name has changed, the importer should first establish whether the actual ingredients and their quantities have changed.
Changes to the product name or actual manufacturer may also affect whether the existing imported-item code can continue to be used.
Comparing ingredient names and quantities is not a substitute for a technical safety assessment.
Safety evaluations and necessary testing must be performed by appropriate qualified institutions in accordance with the relevant standards.
Separately, the Korean importer must ensure that the product name, manufacturing information and ingredient details used in its administrative documents are consistent with the actual imported product.
What If the Serum Is a Functional Cosmetic?
Suppose the overseas manufacturer offers a serum marketed for wrinkle improvement.
It also states that supporting efficacy test data are available.
The Korean brand intends to sell the serum as a functional cosmetic in Korea.
Does possession of the overseas test report complete the Korean functional cosmetics procedure?
Article 4(1) of the Cosmetics Act requires the applicable product-specific examination or submission of a report when a cosmetic is to be recognized and sold as a functional cosmetic.
Examination and reporting are distinct regulatory pathways.
Where the product satisfies the conditions for the prescribed reporting route, the relevant report may be submitted.
Where those reporting conditions are not met, the company must determine whether the product requires an individual examination.
A product's overseas marketing claims or the existence of foreign test data do not automatically establish compliance with Korean functional cosmetics requirements.
The Korean company should examine the final formulation, the functional ingredients and their concentrations, and the effects it intends to claim in Korea.
For example, an overseas manufacturer may describe a serum as having wrinkle-improvement benefits, while the available study concerns a product manufactured using a different formulation.
The company must establish whether those data can properly be used for the serum that will actually be imported.
If the brand intends to rely on information from a previously examined or reported product in Korea, it must also determine whether the applicable legal requirements are satisfied.
Relevant matters may include the functional ingredients, concentrations, intended effects and manufacturing conditions.
A similar product name or the use of the same functional ingredient does not by itself establish that an existing examination or reporting record can be reused.
Imported functional cosmetics must also be addressed in the Standard Customs Clearance Forecast Report.
According to KPTA guidance, the report for a functional cosmetic must reflect the relevant efficacy information and examination or reporting number and date, as applicable.
If the company has completed the required functional cosmetics reporting procedure for the serum, it should use the corresponding information when preparing the import report.
For a product that has undergone individual examination, the applicable examination documentation must be used.
The functional cosmetics procedure and the Standard Customs Clearance Forecast Report serve different purposes.
Completing the Korean functional cosmetics examination or reporting procedure does not eliminate the separate import reporting requirement.
What Information Must Match Before the Standard Customs Clearance Forecast Report?
Once the business registration and overseas manufacturing documents have been reviewed, the company can prepare its Standard Customs Clearance Forecast Report.
This is a pre-clearance reporting procedure covering the importer, the product and the required supporting information.
Article 12(9) of the Enforcement Rule of the Cosmetics Act requires responsible distributors of imported cosmetics to comply with the relevant import and export requirements and submit the report using electronic trade documents under the Electronic Trade Facilitation Act.
KPTA also provides guidance that the report must be completed before customs clearance for each import.
This procedure is separate from the production-performance and ingredient-list reporting arrangements for domestically manufactured cosmetics, which are handled through the Korea Cosmetic Association.
What Information Goes into the Importer Management Card?
A business using the KPTA import reporting system for the first time must prepare the relevant importer management card.
The information should reflect the company that is actually importing the cosmetics.
This includes the company name, representative, address, business registration number and Cosmetics Responsible Distributor registration number.
The importer should compare this information with its business registration certificate and responsible distributor registration certificate.
Consider a company that has recently moved to a new business address.
Its business registration certificate may already show the new address, while the responsible distributor registration certificate still shows the previous address.
Before entering the new address in the import reporting system, the company must determine whether the required responsible distributor amendment registration has been completed.
Updating an address in the importer management card does not itself amend the registered information under the Cosmetics Act.
The overseas exporter's name, address and country must also be recorded accurately.
Where the contracting party and actual manufacturing facility are different companies, the exporter and manufacturer should be identified separately.
How Is the Ingredient List Code Prepared?
KPTA requires the ingredient information for imported cosmetics to be registered so that an ingredient list code can be generated.
The code is then used in the Standard Customs Clearance Forecast Report.
The Korean importer should refer to the final ingredient information and manufacturing certificate for the specific serum it intends to import.
KPTA guidance instructs importers to use standardized ingredient names, taking account of the ingredient information presented in the manufacturing certificate.
Where an ingredient is subject to restrictions on use, the required concentration information must also be entered.
If the initial ingredient list and the final manufacturing certificate differ, the importer should establish whether both describe the same formulation.
Where ingredients or quantities have actually changed, the final manufacturing information must be used.
KPTA provides for a new ingredient list code when relevant ingredients, quantities or other import information have changed.
Conversely, a new batch number does not necessarily mean that the product's ingredients have changed.
The company should distinguish between a change in batch identification and a change in the actual formulation.
What If the Quotation and Manufacturing Certificate Use Different Product Names?
The factory's quotation may use an internal development code.
The manufacturing certificate may identify the serum under an English product name.
The Korean packaging artwork may carry a separate Korean retail name.
The company must establish that the documents identify the same finished product.
Different internal and Korean retail names may be legitimate, but the English product name used in the import report must be checked against the actual product and the relevant manufacturing and sales certificates.
KPTA guidance requires the English product name in the report to match the product identification shown in the actual product and supporting certificates.
For example, an internal development code in the quotation may refer to the same serum identified under a consistent English name on the manufacturing certificate and finished container.
However, if the manufacturing certificate and finished container display different English product names, the importer should establish which document accurately identifies the final product.
It should clarify the difference with the overseas manufacturer rather than arbitrarily selecting a name for the application.
The actual manufacturing company must also be correctly identified.
If the contractual seller and actual factory are different entities, the manufacturer information in the import report should correspond to the underlying manufacturing arrangement and documentary evidence.
How Are Product Size and Import Quantity Distinguished?
Suppose the importer plans to bring 500 bottles of a 30-milliliter serum into Korea.
The two numbers describe different things.
Thirty milliliters is the volume of the contents in each bottle. It identifies a product specification.
Five hundred bottles is the number of finished units being imported.
KPTA guidance requires the quantity of finished cosmetic products to be recorded using units such as EA (individual units) or SET (sets), as applicable.
Volume units such as milliliters and liters cannot be used as the import-quantity unit for finished cosmetic products.
The importer must therefore distinguish between the product specification and the actual number of units.
For cosmetic sets, the company should also verify the composition and the relevant quantity units.
The actual import quantity should be checked against the final shipment information rather than relying solely on the original quotation.
For example, the quotation may refer to an order of 500 bottles, while the final shipment contains a different quantity.
The import report must reflect the actual goods being imported.
The financial information must also be compared with the commercial invoice.
The invoice identifies the products, unit prices, quantities and amounts involved in the shipment.
KPTA guidance requires the payment amount in the report to correspond to the invoice and provides for checking item quantities and unit prices.
Where there is an actual difference between the reported payment amount and the sum of the individual item amounts, the relevant difference and reason must be addressed as required.
Batch numbers and manufacturing dates must also be checked.
Even where the product name is unchanged, different production runs may carry different batch numbers.
The company should compare the batch numbers shown on the actual products and the manufacturer's shipment records before completing the relevant application information.
Does Completing the Pre-Clearance Report Finish Customs Clearance?
Once the importer and product information have been prepared, the Standard Customs Clearance Forecast Report is submitted through the applicable electronic document system.
KPTA identifies electronic submission channels including Korea Customs Service UNI-PASS, Import EDI and Help Trade.
The required manufacturing and sales certificates, together with other applicable supporting documents, must be submitted in accordance with the relevant procedures.
After the association reviews the submitted information and issues the report, the customs import declaration and clearance procedures can proceed.
These are separate regulatory processes.
The Standard Customs Clearance Forecast Report concerns the import requirements applicable to the cosmetic product.
The customs import declaration is the procedure carried out for the imported goods under the Customs Act and related legislation.
Issuance of the pre-clearance report does not mean that the customs import declaration and customs clearance have already been completed.
Commercial invoices, packing lists, transport documents and other trade information may be required in the customs process.
Professional work involving customs declarations, tariff classification and customs duties must be handled within the qualifications and legal scope prescribed by the relevant customs legislation.
Is Reimporting the Same Serum Treated as a New Item?
Suppose the Korean company successfully imports its first serum shipment and later places another order with the same overseas manufacturer.
The business already has an imported-item code and an ingredient list code.
Can it reuse them?
Where the same responsible distributor imports the same previously registered item again, KPTA provides a reimport procedure using the existing item code.
However, the company should confirm that the newly imported serum is actually the same product as the one described in the previously submitted documentation.
The same brand name and packaging do not necessarily mean that the product information is unchanged.
What If the Formula Has Changed?
Suppose the overseas manufacturer replaces one of the ingredients in a subsequent production run.
The serum still has the same brand name and container design.
However, the final manufacturing certificate and ingredient information show a different formulation.
KPTA guidance provides for new-item reporting not only for products imported for the first time but also for certain changes to previously reported product information, including product names, ingredients, ingredient quantities and manufacturers.
Where the ingredients have actually changed, a new item code is required under the applicable procedure.
The ingredient list code must also be considered.
If the ingredients or their quantities have changed, a new ingredient list code must be generated using the updated manufacturing information.
If the ingredients remain unchanged but the product name or manufacturer has changed, the company must determine whether a new item code is needed.
It should separately consider whether the original ingredient list code remains applicable.
The two codes have different purposes.
The item code identifies the imported cosmetic item, while the ingredient list code is linked to its ingredient information.
What If Only the Product Size Changes?
Now consider a different situation.
The company originally imported a 30-milliliter serum.
It later decides to add a 50-milliliter version of the same formulation.
The ingredients and their quantities remain unchanged. Only the product size is different.
KPTA guidance provides for the creation of a new item code when a new specification or size is added to an existing imported product.
Where the ingredient information is identical, the existing ingredient list code can be used.
In this situation, the 50-milliliter product requires a new item code, while the previously generated ingredient list code may remain applicable.
If both the product size and formulation change, the actual manufacturing changes must also be considered when determining the appropriate ingredient list code.
What If Only the Batch Number Changes?
When a factory manufactures the same serum again, the new production run may receive a different batch number.
A new batch number does not, by itself, establish that the ingredients or their quantities have changed.
The importer should compare the previous import report with the final product information for the new shipment.
The comparison should cover the product name, actual manufacturer, ingredient composition, quantities, size and specification.
Even when an existing item code can be reused, the Standard Customs Clearance Forecast Report must still be completed for each import.
Reusing an item code does not remove the requirement to report the new import transaction.
Can the Serum Be Sold Immediately After Customs Clearance?
Suppose the serum has arrived in the Korean warehouse after completion of customs clearance.
The product photographs are ready, and the online store is prepared for launch.
Can sales begin immediately?
Customs clearance does not by itself establish that all obligations governing domestic distribution have been satisfied.
The responsible distributor must comply with the applicable quality control requirements, maintain import management records and verify the required Korean labeling before sale.
Does Overseas Quality Testing Eliminate the Need for Korean Testing?
Article 12(5) of the Enforcement Rule of the Cosmetics Act requires responsible distributors to conduct thorough quality testing by manufacturing batch before distribution.
A batch number distinguishes one production run from another.
Suppose the overseas factory manufactures the same serum in two batches.
The first batch is identified as A001, and the second as A002.
The products have the same brand name and volume, but they are distinct manufacturing batches.
If the overseas manufacturer provides a test certificate covering A001 only, that certificate does not by itself establish the test results for A002.
The company should verify that the relevant quality test information is available for each batch actually imported.
Does this mean that the importer must always repeat every test in Korea?
The Enforcement Rule provides specified exceptions under which the responsible distributor may not need to conduct testing directly.
Article 12(5) includes circumstances involving a manufacturer and responsible distributor that are the same business, or eligible outsourced testing institutions under Article 6(2)(2), where the relevant batch-specific results are obtained.
Separate exceptions also apply to imported cosmetics.
Under Article 12(7), where the overseas manufacturer's quality management standards are recognized through mutual recognition between countries or as equivalent to or exceeding the level of Korea's applicable Good Manufacturing Practice standards for cosmetics, domestic quality testing may be omitted under the prescribed conditions.
In the relevant circumstances, the overseas manufacturer's test certificate may be used in place of the quality management record.
Where the importer seeks to rely on this exception, it must also examine the conditions under Article 12(8), including the applicable overseas manufacturing-site inspection arrangements.
Possession of an overseas manufacturer's test certificate alone does not automatically establish an exemption from domestic quality testing.
The company must determine which statutory route applies and whether the relevant requirements have been met.
Technical testing and assessment of test results must be performed by appropriately qualified institutions under the applicable standards.
What Must the Import Management Record Contain?
After reviewing the quality testing information, the importer must consider its import management records.
An import management record documents what cosmetics were imported, when they entered Korea, what quality testing was performed and where the products were subsequently supplied.
Article 12(4) of the Enforcement Rule of the Cosmetics Act requires the preparation and retention of the prescribed import management records.
For the serum, the relevant information includes the product name or name used for domestic sale, specifications and quantities of ingredients, manufacturing country, manufacturer name and manufacturing-site address.
Where applicable, relevant functional cosmetics examination documents, manufacturing and sales certificates, and a Korean-language product information specimen must also be considered.
The Enforcement Rule provides an exception allowing manufacturing and sales certificates to be omitted from these records where all applicable statutory requirements are satisfied.
The company must separately establish whether that exception applies.
The records must also include information such as the first customs clearance date, import date and quantity by batch, quality test date and results by batch, and sales dates and quantities by customer or sales destination.
Return to the A001 and A002 example.
If the company imports both batches, it should be able to identify when each batch was imported, how many units were received and which quality test results relate to each batch.
Suppose the overseas test documents distinguish A001 from A002, but the Korean warehouse records only the total quantity of serum received.
The company would need sufficient information to establish how much of each batch actually entered its inventory.
The same records matter when a quality issue is identified.
If an issue concerns batch A002, the company should be able to review the relevant test results, import quantity and the destinations to which units from that batch were supplied.
Maintaining import management records therefore involves more than storing customs documents and laboratory reports in the same folder.
The batch identifiers, actual import information, quality test results and distribution records must be managed so that the relevant products can be traced.
Can the Overseas Label Simply Be Translated into Korean?
The overseas manufacturer may supply finished serum bottles bearing an English product name and instructions in another language.
The Korean brand may plan to translate the existing text into Korean.
However, translation alone does not establish compliance with Korea's labeling requirements.
Article 10 of the Cosmetics Act and Article 19 of its Enforcement Rule prescribe information that must appear on cosmetic packaging and the relevant labeling methods.
Applicable items include the product name, business operator's name and address, ingredients, net contents, batch number, expiration date or period after opening, and necessary precautions for use.
Functional cosmetics may be subject to additional labeling requirements.
The information that must appear, and where it must appear, may vary according to the packaging configuration and product size.
Korean rules distinguish between primary packaging, which directly contains the cosmetic product, and secondary packaging, such as an outer carton.
For example, if the serum is supplied in a glass bottle inside a paper box, the company must consider the requirements applicable to each level of packaging.
The primary packaging must contain the information prescribed by law, including the cosmetic product name, business operator name, batch number, and expiration date or period after opening, as applicable.
The secondary packaging must also be reviewed for the information required in the particular case.
The Enforcement Rule provides certain labeling exceptions for small-volume cosmetics and other qualifying products.
The applicable requirements should therefore be determined from the actual product and packaging configuration.
The expiration date and period after opening must also be distinguished.
The expiration date refers to the period during which the cosmetic product may be used under the prescribed storage conditions.
The period after opening refers to the period during which the product may be used after its container has been opened.
Where the period after opening is displayed, the manufacturing date must also be indicated.
If the overseas packaging artwork identifies only the period after opening, the company must check the corresponding Korean requirement for the manufacturing date.
The importer should compare the manufacturing certificate, final ingredient list, actual products and Korean label artwork.
It should confirm that the product names refer to the same cosmetic, the ingredient information matches the final formulation, and the batch numbers correspond to the import management records.
The responsible distributor information should also agree with the company's current registered information.
For functional cosmetics, the claimed effects must be compared with the information established through the applicable Korean examination or reporting procedure.
Advertising statements supplied by the overseas manufacturer must also be assessed against Korean cosmetics labeling and advertising requirements.
The fact that a statement appears on the overseas packaging does not establish that the same claim may be used in Korea.
Must Imported Cosmetics Be Reported Again in Annual Import and Ingredient Reports?
The Korean brand may sell both its domestically manufactured cream and its imported serum.
The two products are subject to different reporting arrangements.
For cosmetics manufactured domestically, the responsible distributor must report the previous year's production performance by the end of February of the following year.
The ingredient list must be reported before distribution and sale.
Where an already reported ingredient list changes, the relevant changes must also be reported before distributing or selling the changed product.
Does the imported serum require the same separate annual performance and ingredient reporting?
Korean law provides a conditional exception for qualifying imported cosmetics.
Article 13(3) of the Enforcement Rule of the Cosmetics Act and Article 2(5) of the MFDS Notice on Reporting Production and Import Performance and Ingredient Lists of Cosmetics provide that a responsible distributor that completes the Standard Customs Clearance Forecast Report through electronic document interchange under the Electronic Trade Facilitation Act and actually imports the cosmetics may omit separate import-performance and ingredient-list reporting.
The conditions are important.
The importer must have completed the report through the prescribed electronic document interchange method and must have actually imported the products.
Importation alone does not mean that every reporting obligation has been removed.
The exception concerns separate import-performance and ingredient-list reporting.
It does not automatically exempt the company from batch-specific quality control, import management recordkeeping, Korean labeling or other applicable requirements.
The domestic OEM cream remains subject to the reporting rules for domestically manufactured cosmetics.
Accordingly, a business selling both domestic and imported products should keep the relevant reporting records separately.
For the domestically manufactured cream, it should review the production-performance and ingredient-list reporting records submitted through the Korea Cosmetic Association.
For the imported serum, it should review the Standard Customs Clearance Forecast Reports submitted through KPTA.
The same company may sell both products under one brand, but the applicable reporting processes and responsible institutions differ according to how the cosmetics are manufactured and supplied.
What Should Be Checked Before the First Overseas OEM Order?
Return to the original quotation received from the overseas factory.
The product price, minimum order quantity and delivery schedule have already been discussed.
Before committing to the first production order, the company should also establish what is required to import and sell the serum in Korea.
The first issue is the existing Cosmetics Responsible Distributor registration.
If the import distribution category is already included, the same category does not need to be added again.
If only the domestic contract-manufacturing distribution category is registered, the company should prepare the necessary amendment.
The next issue is the overseas manufacturer's ability to supply the required certificates.
The company should confirm whether the manufacturing and sales certificates can be obtained and when they can be delivered.
For a newly developed serum intended exclusively for Korea, particular attention should be given to the availability of the sales certificate.
If the ordinary certificate cannot be obtained, the relevant documentary requirements and available handling procedure should be confirmed with KPTA before relying on an unverified alternative.
Once the certificates have been obtained, the company can compare the product and manufacturer information across the documents.
The quotation's internal code, manufacturing certificate's product name and finished packaging should identify the same product.
The final ingredient information should reflect the actual formulation.
When preparing the Standard Customs Clearance Forecast Report, the company should also compare the registered importer information, ingredient list code, finished-product specifications, quantities and amounts against the actual shipment records.
After customs clearance, the focus shifts to batch-specific quality information, import management records and the Korean labeling of the finished product.
The appropriate next step therefore depends on the company's current position.
Before signing the OEM contract, the priority may be establishing whether the required certificates can be issued.
After production, it may be comparing the certificates with the final manufacturing information.
During import preparation, it may be reconciling the application information with the actual shipment.
After customs clearance, it may be ensuring that the necessary quality control, records and labeling requirements have been addressed.
Not every company needs to restart every procedure.
The existing registration, available documents and actual stage of importation determine which matters still need attention.
What Administrative Work Can Be Entrusted to an Administrative Attorney?
Preparing an overseas OEM cosmetics import involves several kinds of work.
Some information can be reviewed directly by the business operator.
Other tasks involve preparing administrative documents or submitting them under the applicable laws and procedures.
Article 2 of Korea's Administrative Attorneys Act permits an Administrative Attorney, within the scope allowed by that Act and other applicable laws, to prepare documents submitted to administrative agencies and carry out certain authorized application, notification and document-submission work on behalf of a client.
Tasks restricted by other legislation remain outside that permitted scope.
For example, if the company's responsible distributor registration does not include the import category, an amendment may be necessary.
An Administrative Attorney may review the registered business information and prepare the required entries and supporting documents for an amendment application.
Where legally permitted, the relevant application and submission work may also be undertaken.
The information supplied by the overseas manufacturer may require similar documentary preparation.
Suppose the quotation contains an internal product code, the manufacturing certificate uses an English product name, and the finished serum carries another name.
The company must establish that these descriptions refer to the same product.
If the manufacturing certificate identifies a different company from the actual production facility, the relationship between the entities must also be clarified.
If the original ingredient list differs from the final manufacturing information, the correct version of the product documents must be established.
An Administrative Attorney may assist with comparing these records and organizing the business names, product identifiers and manufacturing information needed for the permitted administrative documentation.
However, the scope of any work involving the Standard Customs Clearance Forecast Report must be checked against the applicable procedure, delegation rules and governing legislation.
Customs import declarations and professional customs clearance work are separate matters subject to customs legislation and the relevant professional qualifications.
Technical product safety assessments and laboratory quality testing must likewise be performed by suitably qualified institutions.
Preparing administrative documents does not guarantee functional cosmetics approval, a positive technical safety assessment or completion of customs clearance.
For a business preparing an overseas OEM import, the practical starting point is to identify the documents already available and the matters that remain unresolved.
A company that has not signed its manufacturing contract may need to establish whether the required certificates can be issued.
A company whose product has already been manufactured may need to compare the certificates with the final formulation and manufacturing information.
A company preparing the pre-clearance report may need to reconcile its registered importer details and product information with the relevant supporting documents.
These comparisons help distinguish information the business can verify itself from administrative-document work that may be entrusted to a qualified professional.
Where separately commissioned administrative-document drafting or submission is legally permitted, the actual scope of work and fees should be agreed upon independently.
If you are preparing to import overseas OEM cosmetics, you may request a free preliminary review from Ethos Administrative Attorney Office using the documents you already hold, such as your Cosmetics Responsible Distributor registration certificate, available manufacturing or sales certificates or issuance details, and final product and ingredient information, to identify whether an import-category amendment may be required, which document details need clarification, and what additional information should be requested from the overseas manufacturer or relevant institution.
Three-point summary
Before directly importing and selling overseas OEM cosmetics, confirm that the existing Cosmetics Responsible Distributor registration includes the imported-cosmetics business category and prepare an amendment where required.
Obtain the applicable manufacturing and sales certificates and final ingredient information, complete the Standard Customs Clearance Forecast Report before customs clearance, and address batch-specific quality control, import management records and Korean labeling before sale.
Where cosmetics are imported after a qualifying electronic document interchange report, separate import-performance and ingredient-list reporting may be omitted under the statutory conditions. Permitted administrative-document drafting or submission can be entrusted separately, while customs brokerage and technical testing remain distinct professional tasks.