Korean Cosmetic Batch Release: Which Safety Standards Should the Test Report Cover?

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The short answer: one set of standards applies to everything, and product type adds more

When the finished goods arrive, a brand usually says "send us the test report." Far fewer brands decide in advance what that report has to contain. Cosmetics distributed in Korea are held to safety management standards that apply to every product, and product type stacks further standards on top of them. You have to know which of the two layers catches your product before you can read the report.

This article reads those standards as the provisions are written. Where the standards come from, what applies to every product, what gets added by product type, how the testing is done, and who actually owes the duty to test. Raw-material documents and the manufacturing site's quality system are already covered in other articles, so this one looks at what comes after them, on the finished product.

The scope is Korean law, and every provision quoted here was read in the original on the Korea Law Information Center on 6 October 2026. Testing items or limits required by an export market are out of scope. This is not legal advice on a specific matter. The article explains the regime only, and makes no claim about EVAS's testing facilities or commercial terms.

Key takeaways

• Distribution safety management standards are a matter Article 8(8) of the Cosmetics Act allows the Minister of Food and Drug Safety to set by notification, and that notification is currently the Regulation on Safety Standards for Cosmetics.
• Article 2 of the Regulation states that it applies to every cosmetic manufactured, imported or distributed in Korea.
• Article 6(1) of the Regulation splits the structure into two layers. Paragraphs (2) to (5) bind every distributed cosmetic; paragraphs (6) to (9) must additionally be met by product type.
• The common layer has four parts: detection limits for unintentionally derived substances, risk assessment where no limit exists, microbial limits, and content volume.
• The type layer covers pH 3.0 to 9.0 for the liquid product types within paragraph (6), the active-ingredient content of functional cosmetics, the standards for permanent wave and hair straightener products, and free alkali in soap.
• Test methods follow Attached Table 4 under the same paragraph, except that a company's own method may be used where it is otherwise recognised as scientifically and rationally valid.
• Subparagraph 5 of Article 12 of the Enforcement Rule requires responsible distributors, except those registered under item (d) of subparagraph 2 of Article 2 of the Enforcement Decree, to test quality thoroughly by batch before distribution, and its proviso permits testing to be omitted in two situations.
• Where a manufacturer entrusts quality testing of raw materials, packaging materials and products to a body under the items of subparagraph 2 of Article 6(2) of the Enforcement Rule, it may omit the laboratory and quality testing facilities and equipment under subparagraphs 3 and 4 of Article 6(1).
• Subparagraph 6 of Article 12 of the Enforcement Rule requires supervision and maintenance of records where manufacture is entrusted or quality testing is entrusted to a manufacturer under item (b) of subparagraph 2 of Article 6(2).

1. Where do the standards come from?

The starting point is Article 8 of the Cosmetics Act. Paragraph (1) has the Minister of Food and Drug Safety designate and publish the raw materials that may not be used in manufacturing cosmetics, and paragraph (2) does the same for the usage standards of raw materials needing particular restriction, such as preservatives, colourants and UV filters. Then paragraph (8) says the Minister "may set and publish other distribution cosmetics safety management standards."

The wording in Article 8(8) of the Act is "may." The provision empowers the Minister of Food and Drug Safety to set and publish distribution cosmetics safety management standards. The specific standards checked in this article are in the Regulation on Safety Standards for Cosmetics (MFDS Notification No. 2026-19, in force 18 March 2026).

Article 1 of the Regulation says it does three things. It designates the raw materials usable in customised cosmetics under Article 2, subparagraph 3-2 of the Act, it designates under Article 8 of the Act the usage standards for raw materials that may not be used in cosmetics and for raw materials needing restriction, and it sets the matters concerning distribution cosmetics safety management standards. This article looks at the third.

The reach is wide. Article 2 states that the Regulation applies to every cosmetic manufactured, imported or distributed within Korea. Domestic manufacture or import, the standards start from the same place.

2. The standards are stacked in two layers

Article 6(1) of the Regulation carries the whole structure in a single sentence. A distributed cosmetic shall conform to the safety management standards in paragraphs (2) through (5), and shall additionally conform, by type of distributed cosmetic, to the safety management standards in paragraphs (6) through (9).

That fixes the reading order. Check the four that catch every product first, then see which type your product falls into and check what is added. The two layers are cumulative, not alternative. Meeting a type standard does not excuse the common ones.

The second half of the same paragraph sets the test method. Testing shall follow Attached Table 4, except that a company's own standard may be used for testing where it is otherwise recognised as scientifically and rationally valid. That proviso is taken up separately below.

3. Common layer one: detection limits for unintentionally derived substances

Article 6(2) of the Regulation sets detection limits for ten substances. The paragraph attaches conditions before it reaches the numbers. The substance must not have been added artificially during manufacture; the fact that it was derived unintentionally, such as by migration from the packaging material during manufacture or storage, must be confirmed by objective data; and complete removal must be technically impossible. The three are conditions to be satisfied together, not alternatives. Because the text reads "such as by migration from the packaging material," packaging is also not presented as the only route.

Where the conditions hold, the limits are as follows.

• Lead: 50㎍/g or less for powder products using clay as a raw material, 20㎍/g or less for other products
• Nickel: 35㎍/g or less for eye make-up products, 30㎍/g or less for colour make-up products, 10㎍/g or less for other products
• Arsenic: 10㎍/g or less
• Mercury: 1㎍/g or less
• Antimony: 10㎍/g or less
• Cadmium: 5㎍/g or less
• Dioxane: 100㎍/g or less
• Methanol: 0.2(v/v)% or less, and 0.002%(v/v) or less for wet wipes
• Formaldehyde: 2000㎍/g or less, and 20㎍/g or less for wet wipes
• Phthalates (limited to dibutyl phthalate, butyl benzyl phthalate and diethylhexyl phthalate): 100㎍/g or less as a total sum

Three things stand out. Lead and nickel split by product type. Methanol and formaldehyde carry separate, far lower numbers for wet wipes alone. And the phthalate entry is limited to three substances and is judged as a total sum rather than individually.

4. Common layer two: when a substance with no set limit is detected

Attached Table 1 of the Regulation is the list of raw materials that may not be used in cosmetics. Such a raw material may be detected for the reason given in Article 6(2), that is, unintentionally, in a case where no detection limit has been set. Article 6(3) of the Regulation then requires that the risk be determined after a risk assessment under Article 17 of the Enforcement Rule of the Cosmetics Act.

Article 17(1) of the Enforcement Rule says that assessment runs through four processes: hazard identification, which confirms the toxicity of the hazardous factor in the human body; hazard characterisation, which calculates the tolerable human exposure; exposure assessment, which calculates the amount to which the body has been exposed; and risk characterisation, which combines the first three results to judge the effect on the human body.

Paragraph (2) of the same Article has the Minister of Food and Drug Safety determine the risk on the basis of that result, according to standards the Minister sets, and attaches a proviso. Where a domestic or foreign research or testing institution has already carried out a risk assessment on the raw material concerned, or where scientific testing and analysis data on the hazardous factor exist, the risk may be determined on the basis of that data. It is worth being explicit that the assessing party is not the brand.

5. Common layer three: microbial limits

Article 6(4) of the Regulation splits microbial limits into four subparagraphs.

• Total aerobic microbial count: 500 CFU/g(mL) or less for products for infants and young children and for eye make-up products
• For wet wipes, bacteria and fungi counts of 100 CFU/g(mL) or less each
• 1,000 CFU/g(mL) or less for other cosmetics
• Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus: not detected

The first three are numeric limits; the last one is a different kind of requirement. Those three specified organisms carry no limit, only non-detection. Wet wipes are also not judged on a combined count: bacteria and fungi are each held to 100 CFU/g(mL) or less.

6. Common layer four: content volume

Article 6(5) of the Regulation sets the content volume standard in three subparagraphs. Subparagraph 1 requires that, when three units of the product are tested, the average content be at least 97% of the labelled amount, except that for soap the dry weight is taken as the content. Subparagraph 2 covers falling outside that figure. Six more units are taken, and it is enough if the average content of the nine meets or exceeds the figure in subparagraph 1. Subparagraph 3 covers other special products, which follow the Korean Pharmacopoeia (an MFDS notification).

This is where practice often slips. Three units below 97% is not an immediate failure, because the structure has a second stage that takes six more and reads the average across nine. It is therefore sensible to secure a sample quantity from the start that also allows for the additional testing.

7. The type layer: what gets added to your product?

Article 6(6) of the Regulation sets pH. It covers products for infants and young children (excluding infant shampoos, infant rinses, infant body cleansing products and infant bath products), eye make-up products, colour make-up products, hair products (excluding shampoos and rinses), shaving products (excluding shaving creams and shaving foams) and basic skincare products (excluding make-up remover products such as cleansing waters, cleansing oils, cleansing lotions and cleansing creams), among them the liquid products in solution, lotion, cream and similar formulation forms, and the standard is pH 3.0 to 9.0. Products containing no water and products rinsed off with water immediately after use are excluded. The bracketed exclusions and the closing proviso have to be read together before the scope is accurate.

Paragraph (7) of the same Article looks at functional cosmetics. The content of the active raw material producing the function shall conform to the standard reviewed or reported under Article 4 of the Cosmetics Act and Article 9 or Article 10 of its Enforcement Rule. The active-ingredient content should therefore be checked against the reviewed or reported standard.

Paragraph (8) distinguishes permanent wave and hair straightener products in subparagraphs 1 through 9 and sets the composition and standards for each product. Under subparagraph 1, for instance, the cold two-bath permanent wave product whose principal ingredient is thioglycolic acid or its salts has a first agent read on pH 4.5 to 9.6, alkali, reducing substances after boiling in acid, reducing substances other than those, reducing substances after reduction, heavy metals at 20㎍/g or less, arsenic at 5㎍/g or less and iron at 2㎍/g or less. The second agent splits into sodium bromate preparations and hydrogen peroxide preparations, each also checked on oxidising power.

Paragraph (9) is one line. Free alkali at 0.1% or less, limited to soap.

8. The test methods are Attached Table 4, and a company method is the proviso

Attached Table 4 is the Test Methods for Distribution Cosmetics Safety Management, the table related to Article 6. It is divided into Ⅰ General Cosmetics, Ⅱ Test Methods for Permanent Wave and Hair Straightener Products, and Ⅲ General Matters.

Part Ⅰ holds fourteen items: 1. lead, 2. nickel, 3. arsenic, 4. mercury, 5. antimony, 6. cadmium, 7. dioxane, 8. methanol, 9. formaldehyde, 10. phthalates, 11. microbial limits, 12. content volume, 13. pH test method, and 14. free alkali test method. They can be read alongside the corresponding standard items in the provisions above.

Some items carry more than one method. Lead states that "testing shall follow a suitable method among the following" and lines up the dithizone method, atomic absorption spectrophotometry and a method using inductively coupled plasma spectrometry. Microbial limits consist of sample pre-treatment, the total aerobic microbial count test and the specified bacteria test, with a proviso that automated equipment for microbial detection, microbial identification instruments and kits may also be used in addition to the stated methods.

Part Ⅲ, General Matters, holds a definition that matters more than it looks when you read a report. The "sample" is the contents of the cosmetic excluding accessory materials (for example, the non-woven fabric in a sheet mask), and where accessory material is mixed with the contents it is removed by a suitable method (for example, pressing or centrifugation) before the sample is tested. For a product with a sheet, this is what decides which thing the number describes. For an aerosol product, the product is sprayed into a separating funnel and left for at least an hour with the stopper opened occasionally, and the separated liquid is taken as the sample. Where the sample is too viscous to be taken accurately by volume, it may be taken by weight, in which case 1g is regarded as 1mL.

Then there is the proviso in Article 6(1). A company's own standard may be used for testing where it is otherwise recognised as scientifically and rationally valid. This wording concerns test methods. It should be read separately from the conformity requirements for the safety management standards in Article 6(2) through (9) imposed by Article 6(1).

9. So whose duty is this testing?

The standards and the test methods are in the notification, but the duty to test is in the Enforcement Rule of the Cosmetics Act.

On the responsible distributor's side it is Article 12. Subparagraph 5 applies within the scope of the main text, excluding those registered under item (d) of subparagraph 2 of Article 2 of the Enforcement Decree, and requires that quality be thoroughly tested by batch before the product is distributed. A proviso then removes two situations. Where the manufacturer and the responsible distributor are the same, or where quality testing has been entrusted to one of the bodies under the items of subparagraph 2 of Article 6(2) and a batch-by-batch quality test result exists, the quality testing need not be carried out. The proviso sets when quality testing may be omitted. The conformity requirements in Article 6(1) of the Regulation should be checked separately from this testing duty.

The main text of the same Article also carries a scope limit. A person who has registered the responsible distribution business under item (d) of subparagraph 2 of Article 2 of the Enforcement Decree is subject only to subparagraphs 1 and 2, items (a), (c), (g) and (j) of subparagraph 4, and subparagraph 10, as the bracketed text says. Subparagraph 5 is not on that list.

On the manufacturer's side it is Article 11(1). Subparagraph 7 requires the testing, inspection or verification needed from the receipt of raw materials and packaging materials through to the release of the finished product, and subparagraph 8 requires that, where manufacture or quality testing is entrusted, the entrusted party be thoroughly supervised and the records on manufacture and quality control be received and maintained. Subparagraph 2 requires that the manufacturing control standard document, product standard document, manufacturing control record and quality control record be prepared and kept, electronic form included.

Who the work can be entrusted to is in the items under subparagraph 2 of Article 6(2) of the Enforcement Rule. Item (a) is a health and environment research institute under Article 2 of the Health and Environment Research Institute Act, item (b) is a manufacturer equipped with the laboratory under subparagraph 3 of paragraph (1) of the same Article, item (c) is a cosmetics testing and inspection institution under Article 6 of the Act on Testing and Inspection in the Food and Drug Industry, and item (d) is the Korea Pharmaceutical Traders Association, an incorporated association organised under Article 67 of the Pharmaceutical Affairs Act. Where quality testing of raw materials, packaging materials and products is entrusted to one of these bodies, subparagraph 2 of Article 6(2) permits the laboratory and quality testing facilities and equipment under subparagraphs 3 and 4 of Article 6(1) to be omitted.

Entrusting the work is not letting go of it. Subparagraph 6 of Article 12 of the Enforcement Rule requires that, where manufacture is entrusted or quality testing is entrusted to a manufacturer under item (b) of subparagraph 2 of Article 6(2), the entrusted party be thoroughly supervised as to whether manufacture or quality testing is being carried out properly, that the records on manufacture and quality control be received and maintained, and that the quality of the final product be thoroughly controlled. Subparagraph 3 of the same Article requires the product standard document and quality control record received from the manufacturer to be kept, electronic form again included.

It reaches the people too. Subparagraph 3 of Article 8(2) of the Enforcement Rule puts into the responsible distribution manager's duties the supervision of the manufacturer as to the testing, inspection or verification needed from the receipt of raw materials and packaging materials through to the release of the finished product.

10. What to check during development

• Check whether your product falls into the pH types in Article 6(6) of the Regulation, with the bracketed exclusions and the proviso included.
• For a functional cosmetic, check the reviewed or reported active-ingredient content standard. Article 6(7) of the Regulation requires conformity to that standard.
• Look for the batch number on the report. The duty in subparagraph 5 of Article 12 of the Enforcement Rule runs batch by batch.
• Check who ran the test. Whether it was the manufacturer's laboratory or another body under subparagraph 2 of Article 6(2) of the Enforcement Rule changes how the proviso applies.
• Check whether content volume stopped at three units or went to nine. A retest history is not visible from the number alone.
• For a product with a sheet, ask what was taken as the sample. Part Ⅲ of Attached Table 4 takes the contents excluding accessory material.
• If a method other than Attached Table 4 was used, keep a record of how the validity is explained.

How far raw-material paperwork actually proves anything is set out in raw material specifications and test reports, and the manufacturing site's quality system in CGMP conformity. The recall procedure when a problem arises with a product already on the market is in recalls, and the numbers on the shelf-life side are in shelf life and period after opening. If you would rather start from the registration structure, see business registration, and for the planning stage see how to write a product brief. If you would like to go through which items catch your particular product, tell us through contact, and the other articles are at insights.

11. Frequently asked questions

Does having a test report mean the product meets the standards?

A report speaks only to the items it tested. Article 6(1) of the Regulation requires conformity to the common standards in paragraphs (2) to (5) and the type standards in paragraphs (6) to (9). The provisions checked in this article do not, by themselves, establish that every applicable item must be tested as a complete panel for every batch. In practice, it is sensible to compare the applicable product standards with the items in the report and ask what evidence supports the items that the report alone does not confirm.

Can we test by a method other than Attached Table 4?

Article 6(1) of the Regulation has testing follow Attached Table 4, except that a company's own standard may be used where it is otherwise recognised as scientifically and rationally valid. This wording concerns test methods and is separate from the conformity requirements for the safety management standards in paragraphs (2) through (9) of Article 6. The provision does not say how that validity is to be recognised, so keeping the grounds on record is the safer course.

We outsourced manufacturing. Do we still have to run quality testing?

The proviso to subparagraph 5 of Article 12 of the Enforcement Rule says quality testing need not be carried out where the manufacturer and the responsible distributor are the same, or where testing has been entrusted to one of the bodies under the items of subparagraph 2 of Article 6(2) and a batch-by-batch quality test result exists. Subparagraph 6 of the same Article separately requires supervision of the entrusted party, maintenance of records and quality control of the final product where manufacture is entrusted or quality testing is entrusted to a manufacturer under item (b) of subparagraph 2 of Article 6(2).

If nickel or lead is detected, is the product immediately non-conforming?

Article 6(2) of the Regulation sets detection limits only where the substance was not added artificially, where the unintentional derivation is confirmed by objective data, and where complete removal is technically impossible. When those three conditions hold together, a result within the limit is permitted to that extent. If the conditions do not hold, the discussion never reaches the limit.

If the notification is amended, what happens to product already made?

Article 2 of the Addenda to Notification No. 2026-19 applies it to cosmetics manufactured or imported (on the basis of the customs clearance date) by a manufacturer or a responsible distributor after the notification enters into force, and Article 3 of the Addenda applies the previous provisions to cosmetics manufactured or imported under them before that date. This check is limited to the Addenda to Notification No. 2026-19; the addenda to earlier amendments have to be read separately.