Base Formula vs Custom Formulation for Korean Private-Label Cosmetics

The short answer: deciding to write a new formulation changes the documents you have to produce, not the contract

Brands preparing a product often ask the same question. Should we start from a formulation the manufacturer already holds, or have a new one developed for our brand?

The question is usually discussed as a trade-off between development time and differentiation. That is true, but under Korea's Cosmetics Act the two paths divide something else as well: who has to have produced which documents before the product can be sold. An existing formulation may already carry part of that record. With a new formulation, the record for that product has to be built from the beginning.

The sections below separate those differences using the provisions currently in force.

AI-generated image.

1. First, a terminology check: statutory customised cosmetics are not custom formulation development

English-language material about custom formulation is sometimes read as if it matched Korea's statutory category of customised cosmetics. They are different things.

The Cosmetics Act (Act No. 20901, in force 2 April 2026), Article 2, subparagraph 3-2 defines customised cosmetics in two items. Item (a) is a cosmetic made by adding and mixing the contents of another cosmetic, or a raw material designated by the Minister of Food and Drug Safety, into the contents of a manufactured or imported cosmetic. Item (b) is a cosmetic made by subdividing the contents of a manufactured or imported cosmetic. Item (b) carries a proviso excluding cosmetics made by simply subdividing the contents of solid soap and other cosmetics prescribed by Ordinance of the Prime Minister, and Article 2-2 of the Enforcement Rule of the same Act (Ordinance of the Prime Minister No. 2109, in force 2 April 2026) identifies that cosmetic as solid-form facial cleansing soap, that is, toilet soap.

The customised cosmetics business is therefore a retail-stage mixing or subdividing business working from contents that have already been manufactured or imported. Article 3-2(1) of the Act makes the business subject to notification, and Article 3-2(2) requires the facility standards prescribed by Ordinance of the Prime Minister and a customised cosmetics preparation manager. Article 5(3) of the Act provides that a customised cosmetics seller must not arbitrarily mix or subdivide cosmetics that are distributed and sold to consumers.

Raw-material freedom does not widen either. Article 5 of the Regulation on Safety Standards for Cosmetics (Notice of the Ministry of Food and Drug Safety (MFDS) No. 2026-19, in force 18 March 2026) provides that raw materials other than those in its three subparagraphs may be used in customised cosmetics. Subparagraph 1 is the raw materials that may not be used in cosmetics under Attached Table 1, subparagraph 2 is the raw materials requiring restricted use under Attached Table 2, and subparagraph 3 is raw materials that produce the efficacy and effects of a functional cosmetic announced by the Minister of Food and Drug Safety. Subparagraph 3 carries a proviso: the restriction does not apply where the cosmetics responsible distributor supplying the raw material to the customised cosmetics seller has been reviewed for, or has filed a report on, a functional cosmetic including that raw material under Article 4 of the Cosmetics Act.

What brands mean by custom formulation development is something else: designing a formulation at the manufacturing stage. The business a brand registers for that is normally the cosmetics responsible distribution business, and a company that manufactures in-house must also register a cosmetics manufacturing business under Article 3(1) of the Act. How the statutory business types divide is set out separately in OEM, ODM, private label and brand sourcing compared.

2. For an ordinary cosmetic, no procedure reviews where the formulation came from

If the product is not a functional cosmetic, no procedure in the Cosmetics Act or its Enforcement Rule reviews in advance whether the formulation came from the manufacturer's library or was newly developed. One reporting duty does apply in both cases.

Article 5(5) of the Act requires a cosmetics responsible distributor to report to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister, its production or import performance, the list of raw materials used in the manufacturing process of the cosmetic and other such matters, and provides that the report on the list of raw materials must be made before the cosmetic is distributed and sold. Article 13(2) of the Enforcement Rule carries this through: the list of raw materials must be reported before the cosmetic is distributed and sold, and the same applies where a reported list changes.

This is where the practical difference between an existing and a new formulation first appears. The duty itself is identical, but the more the formulation is reworked during development, the more often the reported list has to be brought back into line. Under Article 13(3) of the Enforcement Rule, a cosmetics responsible distributor that imports after filing a standard customs clearance report as an electronic trade document under the Electronic Trade Facilitation Act may omit reporting its import performance and its list of raw materials.

3. For a functional cosmetic, this is where the paths separate

If the product is a functional cosmetic, the picture changes. Article 4(1) of the Act requires any of the following that intends to sell or otherwise handle a product recognised as a functional cosmetic, namely a cosmetics manufacturer, a cosmetics responsible distributor, or a university, research institute or similar body prescribed by Ordinance of the Prime Minister, to undergo review by the Minister of Food and Drug Safety, or to submit a report to the Minister, on the safety and efficacy of each item. The same applies when a submitted report or a reviewed matter is changed. Article 4(2) provides that the efficacy review is conducted only for the efficacy and effects specified in the items of Article 2, subparagraph 2 of the Act.

Which products count as functional cosmetics is set out in eleven subparagraphs in Article 2 of the Enforcement Rule: two forms of skin whitening, improvement or relief of wrinkles, tanning, ultraviolet protection, changing hair colour, removing body hair, relief of hair-loss symptoms, relief of acne-prone skin, restoration of the skin-barrier function, and lightening the red lines caused by stretch marks. Subparagraph 6 carries a proviso excluding products that change hair colour only temporarily, subparagraph 7 excludes products that remove body hair physically, and subparagraph 8 excludes products that make hair look thicker by physical means such as coating. Subparagraph 9 is limited to human cleansing products.

Where the review route applies, Article 9(1) of the Enforcement Rule, which excludes functional cosmetics that must be reported under Article 10, requires an application for review of a functional cosmetic to be submitted for each item to the President of the National Institute of Food and Drug Safety Evaluation, with five categories of documents attached: material on the origin and development history, material on safety, material on efficacy or function, material supporting the sun protection factor and the protection grade of ultraviolet A, and material on the standards and test methods. The fourth document applies only to cosmetics with a function of protecting the skin from ultraviolet rays by blocking or scattering them. Under the proviso to Article 9(1), an applicant for an item for which the Minister of Food and Drug Safety has announced the ingredients and content that produce the product's efficacy and effects may omit the first through fourth documents, and an applicant for an item for which the standards and test methods have been announced may omit the fifth.

The distance between building that list from scratch and filing a report on the strength of results that already exist is the real difference between an existing and a new formulation. What changes the moment a particular expression is used in labelling or advertising is covered, for one product type, in claiming hair-loss relief on a shampoo.

4. The conditions that open the report route are written into the provision

Article 10(1) of the Enforcement Rule sets out three subparagraphs of items that must be reported instead of reviewed.

• Subparagraph 1 covers a functional cosmetic in which the type and content of the ingredients producing the efficacy and effects, the efficacy and effects, the dosage and administration, and the standards and test methods are the same as those of an item announced by the Minister of Food and Drug Safety.
• Subparagraph 2 covers an item for which five matters are all the same as those of a functional cosmetic that has already been reviewed. Those five are, in item (a), the type, specification and content of the raw material producing the efficacy and effects, meaning its concentration where the raw material is liquid; in item (b), the efficacy and effects; in item (c), the standards and test methods; in item (d), the dosage and administration; and in item (e), the dosage form.
• Subparagraph 3 covers a combined item that shares the same matters when compared with a functional cosmetic already reviewed and one announced by the Minister. It applies only to an item combining the ingredients and content of an already-reviewed functional cosmetic under Article 2, subparagraphs 4 and 5 of the Enforcement Rule with those of an announced functional cosmetic under subparagraphs 1 through 3 of the same Article.

Subparagraph 2 carries a bracketed limit that any brand intending to use an existing formulation must read. A functional cosmetic that has already been reviewed qualifies only where the cosmetics manufacturer is the same, or the cosmetics responsible distributor is the same, or the university, research institute or similar body reviewed under Article 9(1) of the Enforcement Rule is the same. The manufacturer branch is then narrowed again: it applies only where the cosmetics manufacturer manufactured the product by designing, developing and producing it. The bracket closes by stating that the same shall apply in subparagraph 3, so that party-sameness limit carries over to subparagraph 3 as well.

In practice, the bracket means something quite specific. Where the existing formulation is one the manufacturer designed and developed itself, the report route can stay open for a different brand because the cosmetics manufacturer is the same. Where a new formulation is written to a brand's request and any one of the five matters changes, the subparagraph 2 route closes, and unless the item falls under subparagraph 1 or subparagraph 3, it goes back to review.

The proviso to the same subparagraph has to be read with it. For functional cosmetics under Article 2, subparagraphs 1 through 3 and subparagraphs 8 through 11 of the Enforcement Rule, the subparagraph applies only where the already-reviewed item had its efficacy demonstrated through a comparative test against a control group, meaning a preparation from which the ingredient producing the efficacy and effects has been excluded.

The five matters also contain rules that widen what counts as the same. On the efficacy and effects in item (b), for functional cosmetics under Article 2, subparagraphs 4 and 5 of the Enforcement Rule, a measured sun protection factor within a range of minus 20 percent or less is treated as the same efficacy and effects. The standards in item (c) exclude the standard for acidity. On the dosage form in item (e), for functional cosmetics under Article 2, subparagraphs 1 through 3 and subparagraphs 6 through 11, a solution, a lotion and a cream are treated as the same dosage form. Whether moving from a lotion to a cream for sensory reasons stays inside that allowance therefore depends on which subparagraph the product falls under, and subparagraph 3, item (e) contains no such dosage-form equivalence.

The report itself is filed under Article 10(2) of the Enforcement Rule, by submitting to the President of the National Institute of Food and Drug Safety Evaluation, for each item, a report on a functional-cosmetic item exempt from review.

5. Raw-material rules set the limits on a new formulation

Developing a new formulation does not mean raw materials can be chosen freely.

Article 8(1) of the Act requires the Minister of Food and Drug Safety to designate and announce raw materials that may not be used in the manufacture of cosmetics or otherwise. Article 8(2) requires the Minister to designate and announce standards of use for raw materials that particularly require restricted use, such as preservatives, colourants and ultraviolet filters, and provides that preservatives, colourants, ultraviolet filters and similar raw materials other than those whose standards of use have been designated and announced may not be used. Those lists are Attached Table 1, referred to in Article 3 of the Regulation on Safety Standards for Cosmetics, and Attached Table 2, referred to in Article 4. Article 4 repeats in its own words that preservatives, ultraviolet filters and similar raw materials other than those in Attached Table 2 may not be used.

The route is not a dead end, though. Article 8(6) of the Act allows a cosmetics manufacturer, a cosmetics responsible distributor, or a university, research institute or similar body prescribed by Ordinance of the Prime Minister to apply for three things: release from or change to a designated and announced prohibited raw material, designation and announcement of standards of use for a raw material that has not been designated and announced, and a change to the standards of use of a designated and announced raw material. Article 8(7) requires the Minister to examine whether the application is well founded and, where it is, to grant the release, change, designation or announcement, and to notify the applicant of the examination result in writing.

That such a procedure exists is a different matter from whether a given raw material is actually accepted. Neither the time it takes nor the outcome is fixed by the provision, so it is safer not to build a development schedule on that procedure.

6. Stability data attaches to the formulation, the dosage form and the container together

The practical advantage of an existing formulation often shows up less in the legal procedure than in the history of the data.

The MFDS Guideline on Stability Testing of Cosmetics (civil-petitioner guide, guide number 0332-01, approved 1 May 2017) states, on lot selection for long-term preservation testing, that the same formulation, dosage form and packaging container as the product to be distributed on the market are used. It adds that testing three or more lots is the default rule, with a proviso allowing an exception where it is judged that stability will not be affected, and that the test period is six months or longer by default, though it may be set differently according to the characteristics of the cosmetic.

In its general provisions, the same guide explains that where an approved specification exists the test standards and methods follow that specification, and that otherwise test methods and related standards are selected additionally for each preparation on the basis of each manufacturer's experience, after which stability testing is performed at one or more temperature conditions. On test conditions it says evaluation should take place under scientific and reasonable conditions based on predictions about variables such as the characteristics of the dosage form and the ingredients, the storage container and the storage conditions, and on data and experience already evaluated.

Read against that lot-selection wording, stability data is built not on the formulation alone but on the combination of formulation, dosage form and packaging container. Change the formulation, and data built on the earlier combination is hard to carry over; keep the formulation but change the container, and the same problem appears. When the container has to be fixed is covered in packaging and formulation compatibility, and how that data becomes a printed date is covered in shelf life and period after opening.

In its opening notice, though, the guide states that it has no external legal force, so despite the phrasing used in its body it is not something petitioners must comply with, and it adds that it was written on the basis of the scientific and technical facts and the legislation in force as of September 2011. The revision of 1 May 2017 changed only its title and registration number. It should be read as reference guidance, not as an obligation.

7. A product for infants or children adds one more record

Article 4-2(1) of the Act requires a cosmetics responsible distributor that intends to label or advertise a cosmetic as usable by infants or children to prepare and keep, for each product, material capable of proving its safety and quality. That product-specific safety material comprises three documents: explanatory material on the product and its manufacturing method, material on the safety evaluation of the cosmetic, and material proving the product's efficacy and effects. Article 4-2(4) delegates to Ordinance of the Prime Minister the ages of infants and children, the scope of the labelling and advertising, the scope of preparation and retention period of the product-specific safety material, and other such matters.

The point is that this material is product-specific. Article 10-3(1) of the Enforcement Rule requires a cosmetics responsible distributor intending such labelling or advertising to prepare in advance all of the product-specific safety material under Article 4-2(1), subparagraphs 1 through 3 of the Act, so material from another product of the same brand is hard to substitute. If the formulation is new, the record for that product has to be built new as well. If this labelling is planned, it is better raised while the formulation route is still being decided.

8. What does not change whichever path you take

Some duties remain in place however the route is decided.

• The cosmetics manufacturer's obligations under Article 5(1) of the Act and the cosmetics responsible distributor's obligations under Article 5(2) apply regardless of where the formulation came from.
• The raw-material list report under Article 13(2) of the Enforcement Rule must be filed before distribution and sale in both cases, except for the imports covered by Article 13(3), that is, imports made after a standard customs clearance report has been filed as an electronic trade document.
• What may be said in labelling and advertising does not depend on whether the formulation is new. What you must be able to produce as evidence for a given expression is set out in substantiating advertising claims.
• Shelf life and the period after opening are best set on the basis of supporting data on either route. That reflects the guideline above as reference guidance, not a duty imposed by the provisions cited here.

9. What to check before deciding

• Confirm first whether the product falls under any of the eleven subparagraphs of Article 2 of the Enforcement Rule. If it does not, the next three checks can be skipped.
• If it does, confirm whether the route is review or report, and if report, which subparagraph of Article 10(1) of the Enforcement Rule supports it.
• If an existing formulation is under consideration, confirm whether it has already been reviewed, and whether the match is on the cosmetics manufacturer, the cosmetics responsible distributor, or the university, research institute or similar body.
• Confirm which of the five matters a requested change would touch: the raw material's type, specification and content, the efficacy and effects, the standards and test methods, the dosage and administration, or the dosage form.
• Confirm whether any raw material you want is caught by Attached Table 1 or Attached Table 2.
• Confirm whether the container can be fixed at the same time. The guideline's lot-selection wording presumes a combination of formulation, dosage form and packaging container.
• Confirm whether you plan to label or advertise the product as usable by infants or children.
• Confirm at the contract stage who files the raw-material list report, and when.

10. Frequently asked questions

Does using an existing formulation let us skip the functional-cosmetic review?

It does not skip anything; it changes whether a report can be submitted instead of a review. Article 4(1) of the Act requires either a review or a report, and Article 10(1) of the Enforcement Rule sets out what may be reported. An existing formulation that does not meet those requirements still goes through review.

Can we report, under our own brand, a formulation the manufacturer already had reviewed?

The bracketed limit in Article 10(1), subparagraph 2 of the Enforcement Rule governs that case. An already-reviewed functional cosmetic qualifies only where the cosmetics manufacturer is the same, or the cosmetics responsible distributor is the same, or the reviewed university, research institute or similar body is the same, and the manufacturer branch is confined to a manufacturer that manufactured the product by designing, developing and producing it. All five matters in that subparagraph must also be the same, and for functional cosmetics under Article 2, subparagraphs 1 through 3 and subparagraphs 8 through 11 of the Enforcement Rule, the proviso to that subparagraph additionally requires that the already-reviewed item had its efficacy demonstrated by comparative testing against a control group.

Can a reviewed functional cosmetic be transferred to us?

Article 9(3) of the Enforcement Rule requires a person seeking to change a reviewed matter to submit an application for review of changes to a functional cosmetic, with documents attached, to the President of the National Institute of Food and Drug Safety Evaluation. Article 9(3), subparagraph 2 states that where the reviewed party is to be changed because parties that have been reviewed transfer and acquire rights between themselves, the document capable of proving the reason for the change means the transfer and acquisition contract.

Does changing only the dosage form break the sameness?

It depends on which subparagraph the product falls under. Article 10(1), subparagraph 2, item (e) of the Enforcement Rule treats a solution, a lotion and a cream as the same dosage form only for functional cosmetics under Article 2, subparagraphs 1 through 3 and subparagraphs 6 through 11 of the Enforcement Rule. A change outside that range is treated as a different dosage form.

Does a custom formulation mean we can use the raw materials we want?

Freedom in designing a formulation and freedom in choosing raw materials are different things. Article 8(2) of the Act provides that preservatives, colourants, ultraviolet filters and similar raw materials other than those whose standards of use have been designated and announced may not be used. If a raw material you need is not on the list, the application procedure in Article 8(6) exists, but neither its outcome nor how long it takes is guaranteed by the provision.

11. Next steps

Whether an existing formulation or a new one is the right starting point depends on whether the product is a functional cosmetic, what you plan to say on the label, and when the container can be fixed. Settling those three before comparing quotations makes the rest of the schedule much simpler.

EVAS runs planning, design, research, manufacturing, logistics and brand content in-house. Even if the route has not been decided yet, we can work through it with you against the goals and material you already have. Start with the development concepts in the formula library, see how to compare samples in turning sample preferences into criteria, and follow the overall flow in our development process. If you have a concrete plan, tell us through a project enquiry, and the other articles are in insights.