Does Your Korean OEM Cream Need Functional Cosmetics Review?
BySangjin Ji, Administrative Attorney3 years of embassy visa practiceLinkedIn
Imagine developing a skin-brightening and wrinkle-improvement cream with an OEM manufacturer in South Korea. You like the samples, the product name is settled, and the packaging team is preparing a claim that the cream offers both functions. Production appears to be the next step.
Then the manufacturer tells you it already has a similar cream that went through a regulatory review. Perhaps, the factory suggests, your brand can use the existing documentation rather than start again.
That possibility is worth exploring. But a previous review held by the same OEM factory does not automatically cover your new product. Before selling the cream in Korea as a functional cosmetic, the relevant product must either undergo an individual review or qualify for a legally prescribed category in which a report is submitted instead.
The distinction is not decided by the factory's assurances, the brand name, or the presence of a familiar ingredient. It depends on the final formula, the intended functional claims, the applicable product category, and the legal relationship between the previously reviewed product and the new one. Comparing those details early gives the brand a practical basis for choosing the correct filing route.
Can a cream claim both brightening and wrinkle improvement just because it contains the right ingredients?
Consider a brand called Miso Beauty preparing a new cream. Its OEM manufacturer proposes niacinamide for skin brightening and adenosine for wrinkle improvement. The brand team sees the two ingredients and prepares packaging describing the product as having dual functional benefits.
There is an important distinction between using ingredients associated with a function and having a finished product that may legally be marketed as a functional cosmetic.
Article 2, item 2, of Korea's Cosmetics Act (「화장품법」), together with Article 2 of the Enforcement Rule of the Cosmetics Act (「화장품법 시행규칙」), defines the scope of functional cosmetics. The relevant categories include products intended to help prevent the accumulation of melanin or lighten existing pigmentation, and products intended to help improve or reduce wrinkles through effects on skin elasticity.
The manufacturer therefore needs to explain more than the ingredient names. Which functional ingredients are in the final product, in what quantities, and for which claimed effects? Does the finished formula meet the statutory conditions for the particular category?
A more useful question than "Does this contain niacinamide?" is: "Which functional-cosmetics category notified by the Ministry of Food and Drug Safety (MFDS) does this exact formula meet?" That answer identifies the standard against which the product should be checked.
Individual review or review-exempt reporting: what is the difference?
Under Article 4(1) of the Cosmetics Act, cosmetics manufacturers, cosmetics responsible distributors, and certain universities or research institutions specified by law must obtain a product-specific review or submit a report for functional cosmetics they intend to have recognized for sale in Korea.
For an individual review, Article 9 of the Enforcement Rule provides for a functional-cosmetics review application and the relevant supporting materials. The National Institute of Food and Drug Safety Evaluation examines the submitted information, including matters concerning the product's safety and efficacy.
For review-exempt reporting, a product meeting one of the conditions in Article 10(1) may be reported instead of going through an individual review. The filing is a report for a functional cosmetic exempt from individual review; "exempt" does not mean that no regulatory step is required.
This is why a brand should not select a form before examining the product. In particular, two potential reporting routes deserve attention: matching a category already notified by the MFDS, or satisfying the legal conditions for using a previously reviewed functional cosmetic as the reference product. If neither route applies, the brand must consider whether an individual review is required.
A notified ingredient does not automatically make every combination reportable
Article 10(1)(1) of the Enforcement Rule concerns products whose functional ingredients and their quantities, claimed effects, directions and dosage, and standards and testing methods match those of a notified functional-cosmetics category.
MFDS Notice No. 2025-89, concerning standards and testing methods for functional cosmetics, addresses skin-brightening products in Annex 2, wrinkle-improvement products in Annex 3, and products combining the two functions in Annex 5.
For Miso Beauty's cream, the issue is not simply whether niacinamide and adenosine each appear in an MFDS standard. The brand needs to compare the finished combination and the applicable quantities with the conditions of the category on which it intends to rely.
A published administrative response illustrates why that distinction matters.
On February 25, 2026, a public inquiry through Korea's e-People petition system asked whether a cream with the following functional ingredients could be reported as a brightening and wrinkle-improvement cosmetic:
- Adenosine: 0.04%
- Niacinamide: 2%
- Alpha-bisabolol: 0.5%
In its response dated March 9, 2026, the Cosmetics Review Division of the National Institute of Food and Drug Safety Evaluation explained that the formula did not meet the reporting condition under consideration because two ingredients, niacinamide and alpha-bisabolol, were being used for the same brightening effect. An individual functional-cosmetics review was therefore required for the formula presented.
That response applies to the stated formulation and the rules applicable in February 2026. It is not a blanket finding that every formula using two brightening ingredients must follow exactly the same route under every set of circumstances. A different composition needs to be checked against its own applicable notification and reporting conditions.
The practical question for the factory is specific: "Which annex and which notified product category will you use for this formula?" The ingredient combination, concentrations, claimed effects, directions and dosage, and testing standards should be compared with that category. If the formula does not match, another lawful reporting route can be examined before preparing an individual review application.
Source: Public e-People inquiry and response, Cosmetics Review Division, National Institute of Food and Drug Safety Evaluation, March 9, 2026.
Can the brand use a cream the OEM manufacturer previously had reviewed?
Suppose the manufacturer has already obtained a functional-cosmetics review for another cream. It suggests making the new product under a different brand name using the same underlying formulation. That may create a possible reporting route, but the previous review certificate alone does not settle the question.
Article 10(1)(2) of the Enforcement Rule sets conditions for reporting a new product by reference to an existing reviewed product. First, the legal relationship between the earlier review holder and the new product must qualify.
Where the route depends on the same cosmetics manufacturer, that manufacturer must have directly designed, developed and produced the product. There are separately prescribed cases involving the same cosmetics responsible distributor or the same qualifying research institution.
For example, imagine the factory simply manufactured a formula designed by another company. The fact that both creams come off the same production line would not by itself demonstrate that the manufacturer satisfies the direct design-and-development condition. The brand needs to look at the identity of the original review holder and at who actually developed and manufactured the reference product.
Next comes the comparison of the products themselves. The statutory matching criteria include:
- The types, specifications and quantities of functional ingredients, or their concentrations for liquids
- Claimed efficacy and effects
- Standards and testing methods
- Directions and dosage
- Dosage form
This is a narrower and more precise test than assuming that every difference in a full ingredient list automatically requires a fresh review. Conversely, a difference in a legally prescribed matching field, such as the functional ingredients or their quantities, cannot simply be ignored.
The rule also contains important exceptions. The pH criterion is excluded when assessing identity within the standards and testing methods. For functional cosmetics falling within the specified categories in Article 2, subparagraphs 1–3 and 6–11, of the Enforcement Rule, solutions, lotions and creams are treated as the same dosage form.
For example, a previously reviewed lotion and a new cream may qualify for consideration under this dosage-form exception. That does not waive the remaining requirements concerning the functional ingredients, quantities, effects or directions of use.
There is a further condition for skin-brightening and wrinkle-improvement products: the efficacy of the previously reviewed product must have been demonstrated through a comparison with a control group. A control group, in this setting, is the comparator without the ingredients responsible for the claimed functional effect. The manufacturer should be able to identify how the efficacy of the original reviewed product was established.
The useful documents are therefore not limited to the earlier review result. The brand may also need records identifying the review holder and the parties responsible for design, development and production, plus the functional formula and information on the earlier efficacy comparison. Only then can it assess whether the earlier review offers a lawful reporting route for the new cream.
Does an exemption from supporting documents mean an exemption from review?
A manufacturer may say that certain testing materials are "exempt." This can be accurate while still leaving the brand with an individual review to complete.
Under Article 9(1) of the Enforcement Rule, where the MFDS has notified the functional ingredient and its quantity, documents specified in items 1 through 4 may be omitted from an individual review application. Where standards and testing methods have been notified, the document specified in item 5 may be omitted.
Omitting specified supporting documents from an individual review is not the same as qualifying to report a product instead of obtaining that review. The former concerns the content of a review application; the latter concerns eligibility under Article 10.
Article 10(1)(3) also provides a separate reporting category for certain combinations involving functional ingredients and quantities from previously reviewed sun-protection products and notified ingredients for brightening or other specified functions. For a cream intended only for brightening and wrinkle improvement, without such a sun-protection combination, it makes sense to examine the notified-category and existing-reviewed-product routes first.
If the factory says the product is exempt, ask whether it means that an individual review is replaced by a report, or merely that some documents can be omitted while the review is still required. The answer changes what the business must prepare.
If the factory handles the filing, can production start before review?
An OEM agreement may say that the factory handles regulatory filings. Even then, the brand should establish whose name will appear on the review or report and how that party relates to any earlier reviewed product. A general clause assigning "regulatory matters" to the factory does not automatically satisfy the statutory requirements for using an existing review.
Production timing needs similar attention. Article 15, item 1, of the Cosmetics Act prohibits selling functional cosmetics that have not undergone the required Article 4 review or report procedure. It also prohibits manufacturing, importing, storing or displaying such products for the purpose of sale.
There is, however, a specific and conditional rule concerning advance manufacture for a review. Article 8-2 of the MFDS regulation governing the review of functional cosmetics addresses products manufactured in advance for the purpose of obtaining an individual review or an amended review.
Under that rule, the products must be manufactured in compliance with Good Manufacturing Practice requirements, and the subsequent review or amended review must result in notification of a suitable outcome. The exception is limited to a maximum of three manufacturing units based on the manufacturing number. Where the conditions are met, the products manufactured in advance are treated as having been manufactured after the review.
This is not general permission to sell a functional cosmetic before completing its required procedure. Nor does the exception automatically apply to products proceeding through review-exempt reporting. If the factory proposes manufacturing in advance, the intended purpose, manufacturing standard, number of units and applicable review route must be checked before the production schedule is agreed.
When the formula changes, two different reporting questions may arise
A product can reach the final packaging stage before someone proposes a small change in fragrance or texture. The manufacturer may describe it as minor, but the legal question is what has actually changed.
First, compare the ingredient lists before and after the change. Under Article 5(5) of the Cosmetics Act and Article 13 of its Enforcement Rule, a change in the list of ingredients used to manufacture the product may require an updated ingredient-list report.
Second, consider the functional-cosmetics review or reporting record separately. If a functional ingredient, its quantity, the claimed effect or the directions and dosage have changed, the business must determine which procedure applies to the previously reviewed or reported particulars. A product reported by reference to an earlier reviewed item must still satisfy the relevant matching conditions after the change.
For instance, changing a fragrance may change the ingredient list without changing the product's functional ingredients or quantities. Conversely, the name of a functional ingredient might stay the same while its quantity changes, requiring a fresh assessment under the functional-cosmetics rules.
One filing does not substitute for the other. To identify the required next step, compare the final manufacturing record both with the previously reported ingredient list and with the existing functional-cosmetics review result or report.
When may the packaging say "brightening and wrinkle improvement"?
By the time a brand finalizes packaging and an online product page, it may already have drafted a dual-function claim. That wording must still reflect the effects actually covered by the completed review or report.
Article 13 of the Cosmetics Act prohibits labeling or advertising that could mislead consumers into believing a product is a functional cosmetic when it is not, or that differs from the product's functional-cosmetics review result. The mere presence of a brightening ingredient does not permit an unreviewed or unreported cream to be advertised as a recognized functional cosmetic.
Likewise, if the product has qualified only for the skin-brightening function, the addition of a wrinkle-related ingredient does not automatically justify a dual-function claim. The brand needs to confirm that the necessary review or reporting procedure covers both effects and that the actual label and online claims remain within the recognized scope. Claims that suggest disease treatment or effects beyond what has been recognized can raise separate advertising concerns.
These points concern products intended for domestic sale in Korea. Article 30 of the Cosmetics Act provides for the non-application of certain provisions, including Article 4, to products manufactured solely for export and not sold domestically, with the importing country's rules governing those products. A genuine export-only product should therefore be assessed with its destination market and export-only status in mind rather than automatically treated as a domestic-sale product.
What should the brand request from its OEM manufacturer before launch?
The starting point is to turn the factory's explanation into documents that can be compared. The brand does not need to pretend every record is already complete. Reviewing what is available will help identify what else should be requested.
- Final manufacturing and formulation information: Identify the types and amounts of functional ingredients, the claimed effects, and the formula of the product that will actually be sold.
- Previous review result or reporting record, if available: Check which business filed the earlier review or report and how the earlier product relates to the new one. Records on design, development, production and the method used to demonstrate efficacy may also be needed.
- OEM agreement, sales name and packaging draft: Compare the parties named in the contract and registration information, their responsibilities for providing documents, the manufacturer's internal product name and the name planned for sale.
Technical testing and the scientific assessment of safety and efficacy depend on materials from the manufacturer or qualified testing and research institutions. The brand's own task is to check whether those materials concern the product it plans to sell, whether the company and product identities match across records, and whether required attachments are missing.
Within the scope permitted by Article 2 of the Administrative Attorneys Act (「행정사법」) and other applicable laws, an Administrative Attorney can prepare prescribed documents for submission to administrative agencies and carry out submission work where legally permitted. In this context, the work may involve comparing the business names in responsible-distributor registration records and the OEM agreement, then organizing product names, claimed effects and supporting materials for an individual functional-cosmetics review application or a review-exempt reporting document. The exact drafting and submission scope depends on the procedure and authorization. It is distinct from conducting efficacy tests or guaranteeing a regulatory outcome, and any document preparation or permitted submission service is separately paid.
If you are preparing to launch an OEM brightening or wrinkle-improvement cosmetic in Korea, send the final formulation information you have, any existing review or reporting records, the OEM agreement, and the intended product name or packaging draft; Ethos Administrative Attorney Office can provide a free preliminary assessment of potentially applicable reporting conditions, differences between the documents and the additional records you may need from the manufacturer.
Three key takeaways
- Functional cosmetics for domestic sale in Korea require product-specific review or a report under a qualifying review-exempt category; using an OEM factory does not remove this requirement.
- Reporting eligibility depends on the notified product category or the legal relationship to a previously reviewed product, together with matching functional ingredients, quantities, effects and other statutory conditions.
- Before launch, compare the final formula, prior review or reporting records, OEM agreement and packaging draft, and keep scientific testing distinct from administrative document preparation.