Raw Material Documents in Korean Cosmetics: What a Specification Sheet and a Test Report Actually Prove

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The short answer: the paperwork does not approve an ingredient, it records what was measured

Once an ingredient is chosen, a bundle of documents arrives from the supplier. Brands usually call these the specification sheet and the supplier certificate. A misreading follows almost every time: the documents are taken to mean that the material is cleared for use.

Korean law is built the other way around. Whether a material may be used at all is decided by the lists and usage limits that the Minister of Food and Drug Safety designates and publishes under Article 8 of the Cosmetics Act. The documents record what was measured, by which method, and whether the result met the stated specification. By themselves they do not establish permission under Article 8 or compliance with its usage limits. They are evidence, not permission.

One more thing is worth settling at the start. The words "specification sheet" do not appear in the articles of the Cosmetics Act or its Enforcement Rule as read for this article. That check covers the rendered articles and supplementary provisions, not the contents of the annexes and annexed forms. What the Rule does name, in Article 11(1)2, are the four documents a manufacturer must prepare and keep: the product standard document, the manufacturing control standard document, the manufacturing control record, and the quality control record. Other documents are named elsewhere, such as the quality control procedure document in Annex 1 and the import management record for imported cosmetics. The document whose issuer and required contents are prescribed in detail is the testing and inspection report, and that prescription sits in a different Act altogether. The gap between the document names the industry uses and the documents the law requires is where this article starts.

What follows is what a brand commissioning development should look for in ingredient-stage paperwork, taken from the provisions themselves. The scope is the law of the Republic of Korea, and every provision quoted here was read in the original on 29 September 2026. This is not legal advice on any specific matter.

Key takeaways

• What the law asks the manufacturing side for is not a document name but an act. Article 11(1)7 of the Enforcement Rule requires testing, inspection or verification as necessary from the receipt of raw materials and packaging materials through to the release of the finished product.
• Where a responsible distributor has received them from the manufacturer, the documents it must keep are specified, and there are two: the product standard document and the quality control record, under Article 12(3) of the Enforcement Rule. Neither a specification sheet nor a supplier certificate appears on that list.
• The manufacturer's duty to hand over what is needed for quality control carries two exceptions. One of them turns on a design-develop-produce arrangement and on trade secrecy.
• The body that issues a test report on the statutory form is a designated testing and inspection institution. A cosmetics testing and inspection institution is defined by reference to the inspection order in Article 20 of the Cosmetics Act, while the institutions to which quality testing may be outsourced are listed separately in Article 6(2)2 of the Enforcement Rule.
• The statutory report form carries two printed notices: the judgment covers only the items requested, and if the result is advertised or shown on a container or package, the entire content of the report must be shown.
• The document that describes ingredient-stage paperwork in the most concrete terms is the Good Manufacturing Practice notification. It is recommended under Article 11(2) of the Enforcement Rule, not mandatory.

1. What the law requires is testing and inspection, not a document

The starting point is Article 5 of the Cosmetics Act. Paragraph 1 requires a cosmetics manufacturer to observe the matters prescribed by Ordinance of the Prime Minister on two fronts. The first is how manufacturing records, facilities and equipment are managed. The second is the methods and duties for testing, inspecting and verifying raw materials, packaging materials, finished products and the like. Paragraph 2 requires a cosmetics responsible distributor to observe the matters prescribed by Ordinance of the Prime Minister concerning quality control standards, post-distribution safety management standards, and the methods and duty of quality testing.

Articles 11 and 12 of the Enforcement Rule carry that delegation. Article 11(1)7 tells the manufacturer to "conduct such testing, inspection or verification as is necessary from the receipt of raw materials and packaging materials through to the release of the finished product." The subject matter covers raw materials and packaging materials, not only the finished product, and the window runs from receipt to release. The sentence commands an act rather than a form. Nothing in it says which template to use or which fields to fill in.

A second provision runs in the same direction. Article 8(2)3 of the Enforcement Rule lists this as a duty of the responsible distribution manager. The manager must manage and supervise the manufacturer with respect to the testing, inspection or verification necessary from the receipt of raw materials and packaging materials through to the release of the finished product. The manufacturer performs the work over that stretch, and the responsible distributor, through its responsible distribution manager, manages and supervises it. Since a brand that commissions manufacturing is normally the responsible distributor, that provision is the statutory reason it has to look at ingredient paperwork at all.

Whether a material may be used in the first place is outside the scope of this article. How to check the prohibited list and the materials whose use is restricted is covered in what a brand has to check when choosing ingredients.

2. The manufacturing side writes and keeps four documents

Article 11(1)2 of the Enforcement Rule requires the manufacturer to prepare and keep a manufacturing control standard document, a product standard document, a manufacturing control record and a quality control record. A parenthesis adds that electronic document form is included. The names look alike, but they split into two kinds. A standard document sets out in advance how something will be done; a record is proof that it was in fact done that way.

Where ingredient paperwork sits inside that structure is the practical question. A certificate sent by a supplier is none of those four documents. It is an input used to build the quality control record, and the standard and test method to be applied to that material belong in the product standard document. As we will see below, the requirement that a product standard document contain the standards and test methods for raw and packaging materials comes not from the Act or the Rule but from the Good Manufacturing Practice notification.

Other subparagraphs in the same paragraph connect to the ingredient stage as well. Subparagraph 1 requires the manufacturer to follow the guidance, supervision and requests of the responsible distributor under the quality control standards in Annex 1. Subparagraph 8 requires that, where manufacturing or quality testing is outsourced, the manufacturer supervise the contractor thoroughly and receive, maintain and manage records on manufacturing and quality control. That provision applies when ingredient testing is sent outside.

3. What is received from the manufacturer and kept is limited to two documents

The provision on the brand side is Article 12 of the Enforcement Rule. Subparagraph 3 reads: "keep the product standard document and the quality control record (including electronic document form) received from the manufacturer." The list has two entries, and the retention duty attaches to documents received from the manufacturer. The provision is not written as an unconditional duty to obtain both; what may be obtained is governed by Article 11(1)6, discussed next. The manufacturing control standard document and the manufacturing control record are not on the list, and neither the phrase "specification sheet" nor "supplier certificate" appears anywhere on it. Other subparagraphs of the same Article carry separate record duties, such as preparing and keeping an import management record.

So how far does the manufacturing side have to hand things over? Article 11(1)6 of the Enforcement Rule draws that boundary. It requires the manufacturer to submit to the responsible distributor those matters among the documents in subparagraph 2 that are necessary for quality control, and allows submission to be withheld in two cases. Item (a) is where the manufacturer and the responsible distributor are the same person. Item (b) is where the manufacturer manufactures the product by designing, developing and producing it, and where, within a range that does not affect quality and safety management, the matter constitutes a trade secret under a mutual contract between the manufacturer and the responsible distributor.

Item (b) attaches three conditions at once. The manufacturing arrangement must be of the design-develop-produce kind; the range must be one that does not affect quality and safety management; and the matter must qualify as a trade secret under a mutual contract. If any one of them is missing, the exception does not hold. And because the exception says submission "may be withheld," it widens what need not be handed over; it does not waive testing or inspection.

How ownership and access to the formula and technical data are settled in a contract is treated separately in who owns the formula. What matters here is narrower: not receiving a document is not always a failed negotiation. It can be a case the provision itself leaves open.

4. What the quality control standards ask of the brand

Article 7 of the Enforcement Rule sets the cosmetics quality control standards under Article 3(3) of the Act out in Annex 1, and the post-distribution safety management standards in Annex 2. Article 12(1) of the Enforcement Rule then requires the responsible distributor to comply with the quality control standards in Annex 1. The procedure inside which ingredient paperwork has to be handled is written in that annex.

Item (a) of paragraph 3 of Annex 1 lists seven matters that the quality control procedure document must contain: procedures for securing proper manufacturing control and quality control; procedures for handling information on quality and for handling poor quality; recall handling procedures; procedures on education and training; procedures for managing documents and records; procedures for recording market release; and any other procedures necessary for quality control work.

Item (b) of the same paragraph sets out six pieces of work to be performed under that procedure document. The first is to "confirm and record that the manufacturer has manufactured the cosmetic properly and smoothly." The sentence asks for a record, not only a confirmation. The everyday practice of collecting ingredient certificates connects to this provision.

The retention period for records is in item (e) of paragraph 4 of the same annex. Records on quality control and on the management of the manufacturer must be prepared and kept for three years from the date of manufacture of the product concerned, counted from the date of import where the product is imported. Item (c) goes as far as the storage location: the original of the quality control procedure document must be kept where the responsible distribution manager performs their work, and copies checked against the original must be kept elsewhere.

There is one carve-out. Paragraph 8 of Annex 1 provides that, for a person registered for the cosmetics responsible distribution business under item (d) of Article 2(2) of the Enforcement Decree, which is the business of brokering or supplying cosmetics for import-agency transactions, items (a)1), 4) and 6), items (b)1), 4) and 5), item (e) of paragraph 4 and paragraph 6 do not apply. The three-year retention and the confirm-and-record duty described above are both on that list.

5. Per-batch quality testing, and when it is waived

Ingredient paperwork ultimately feeds per-batch quality testing of the finished product. Article 12(5) of the Enforcement Rule requires that quality testing be carried out thoroughly for each manufacturing batch number before distribution, with a proviso allowing quality testing to be omitted in two cases: where the manufacturer and the responsible distributor are the same person, and where quality testing has been outsourced to one of the institutions listed in Article 6(2)2 and a per-batch quality test result exists.

Article 6(2)2 lists four institutions: a health and environment research institute under Article 2 of the Health and Environment Research Institute Act; a manufacturer that has the laboratory described in Article 6(1)3; a cosmetics testing and inspection institution under Article 6 of the Act on Testing and Inspection in the Food and Drug Industry; and the Korea Pharmaceutical Traders Association, the incorporated association organised under Article 67 of the Pharmaceutical Affairs Act.

Two provisions are worth placing side by side here. The proviso in item (b)5) of paragraph 3 of Annex 1, which governs the same omission, describes the permitted recipients as "a cosmetics manufacturer, or a cosmetics testing and inspection institution designated by the Minister of Food and Drug Safety under Article 6 of the Act on Testing and Inspection in the Food and Drug Industry." That wording is not identical to the four-institution list in the proviso to Article 12(5). This article will not assert which wording prevails. It is simply safer to read both when choosing where to send the work.

Outsourcing does not dissolve the management duty either. Article 12(6) of the Enforcement Rule provides that, where manufacturing is outsourced or quality testing is outsourced to a manufacturer under item (b) of Article 6(2)2, the responsible distributor must supervise the contractor thoroughly as to whether manufacturing or quality testing is being carried out properly, receive, maintain and manage records on manufacturing and quality control, and carry out quality control of the final product thoroughly.

6. Who issues a test report on the statutory form

At this point a different Act takes over: the Act on Testing and Inspection in the Food and Drug Industry. Item (e) of Article 2(1) of that Act puts cosmetics under the Cosmetics Act and the raw materials used in cosmetics inside its scope together. Raw materials are covered by this Act.

Article 6(1) allows the Minister of Food and Drug Safety to designate institutions to perform testing and inspection work, and Article 6(2) divides them into six kinds. The fifth is the cosmetics testing and inspection institution, defined as "an institution that performs inspection of cosmetics pursuant to an inspection order under Article 20 of the Cosmetics Act." Article 20 of the Cosmetics Act is the provision that lets the Minister order a business operator to have cosmetics it has handled inspected by a cosmetics testing and inspection institution.

Read in reverse, the structure is this. The designation is defined by reference to an administrative procedure, the inspection order. The routine outsourcing of quality testing that a brand deals with rests instead on item (c) of Article 6(2)2 of the Enforcement Rule of the Cosmetics Act, which borrows that designation. "A designated testing and inspection institution" and "a place quality testing may be sent to" are therefore not the same set.

Article 6(7) of the same Act prohibits a designated institution from letting another person use its name to perform testing and inspection work, or from lending its designation certificate to another person. Checking that the institution named on a report is the institution that actually ran the test is not a formality.

7. What has to appear on a test report

Article 11(2) of the same Act requires a testing and inspection institution, once it has carried out testing or inspection, to issue a testing and inspection report to the person who requested it without delay. That report must contain the matters prescribed by Ordinance of the Prime Minister, and the provision adds that it may be issued as an electronic document.

That Ordinance is Article 12(4) of the Enforcement Rule of the same Act. A testing and inspection report means a report on the form in Annex Form 13, or a separate form that contains all of the matters stated in Annex Form 13. The template can change; the required contents cannot be dropped.

Open Annex Form 13 and the following fields are printed on it.

• MFDS designation number, issue number, receipt number
• Test completion date, date of receipt
• Product name, product type, material and item name, date of manufacture or import with the batch number
• The client's name, company name, address and contact details
• The manufacturer's company name, country of manufacture and address
• Purpose of testing and inspection. In the cosmetics row there are exactly two choices: inspection under an inspection order, and quality testing.
• Test items, specifications, test results, judgment, and remarks including limit of detection and limit of quantitation
• Final judgment, testing personnel, testing manager, and the seal of the head of the testing and inspection institution

Several notices are printed below the form. Two of them are what practice runs into most often. First: "the judgment above shall be only subject to the requested test items." A pass covers the items written on that report and nothing beyond them. Second: "when advertising test results or indicating test results on containers or packages, the entire content of the test report shall be indicated." Lifting one favourable line out of a report is blocked by the form itself.

What a claim can be proved with, and by which kind of evidence, is covered further in what you must be able to prove.

8. Where the testing standards and methods come from

If the "specifications" column of a report is empty or its origin is unclear, what the report can confirm shrinks. The provision that fixes those specifications is Article 11 of the Enforcement Rule of the same Act, and subparagraph 5 lists the four that apply to a cosmetics testing and inspection institution.

• The ingredients, content, standards and test items for functional cosmetics published by the Minister of Food and Drug Safety under the proviso to the part of Article 9(1) of the Enforcement Rule of the Cosmetics Act other than its subparagraphs
• The standards for the use of cosmetic colourants published by the Minister under Article 8(2) of the Cosmetics Act
• The safety management standards for cosmetics in distribution
• Other standards and methods determined and published by the Minister

The third entry has a cross-reference worth checking. This Enforcement Rule cites the basis for the safety management standards for cosmetics in distribution as Article 8(5) of the Cosmetics Act, whereas in the current Cosmetics Act the paragraph that allows the Minister to determine and publish those standards is Article 8(8). Article 8(5) is the provision on the periodic safety review of usage standards for designated and published raw materials. Because the cited paragraph number does not match the current text, it is safer in practice to identify the standard by its name rather than by a paragraph number.

The test method side carries a more consequential proviso. Article 6(1) of the Regulations on Safety Standards for Cosmetics requires cosmetics in distribution to meet the safety management standards, then adds that testing shall follow Annex 4, but that a company's own standard may be used for testing where it is otherwise recognised as scientifically and reasonably valid. So two things have to be read off a report: which specification the judgment was made against, and whether the test method was Annex 4 or an in-house method. If it was in-house, the basis for its validity should be on record alongside it.

9. When a result is non-conforming, the report is not just an internal company document

Handling paperwork with only a pass in mind misses one provision. Article 11(3) of the Act on Testing and Inspection in the Food and Drug Industry requires a testing and inspection institution, where a result is judged non-conforming, to report that result without delay to the Minister of Food and Drug Safety and to the institutions prescribed by Ordinance of the Prime Minister, and to notify the requesting party of that fact without delay. Article 11(4) provides that paragraph 3 does not apply to the results described in item (b) of Article 6(2)1 and item (b) of Article 6(2)2. Those two items cover not only labelling-standard tests but also tests needed for food or food-additive manufacturing and processing reports, for food safety management certification, and for livestock safety management certification or item manufacturing reports.

Which authority receives the report is split by subject matter in Article 12(5) of the Enforcement Rule of the same Act. Subparagraph 3 covers cosmetics under the Cosmetics Act and the raw materials used in cosmetics, and the recipient is the Minister of Food and Drug Safety.

Samples must also be retained. Article 12(3) of the same Enforcement Rule requires the institution, where a requested sample is found non-conforming with the specifications under Article 11, to keep all or part of that sample for 60 days from the date the testing and inspection ended. Samples that are difficult to keep or liable to spoil are excluded.

The institution's own filing is prescribed as well. Article 14(1) of the same Enforcement Rule lists copies of testing and inspection reports, testing and inspection logs, printouts from testing and inspection equipment, and other documents determined by the Minister; Article 14(2) sets the period at three years, extended to five years for medical device testing and inspection institutions.

Falsifying a report carries criminal liability. Article 28(1)2 of the same Act provides that a person who, at a designated institution, intentionally issues or communicates a false testing and inspection report may be punished by imprisonment for up to five years or a fine of up to 50 million won, and the two may be imposed together. Article 28(2)1 provides that a person who, at a designated institution, issues a report inconsistent with the facts through gross negligence may be punished by imprisonment for up to three years or a fine of up to 30 million won, again with the possibility of both.

10. The Good Manufacturing Practice notification is recommended, but it shows what the paperwork looks like

The document that sets out ingredient paperwork in the most detail is the Regulations on Good Manufacturing Practice for Cosmetics. Its status has to be stated plainly first. Article 11(2) of the Enforcement Rule provides that the Minister of Food and Drug Safety may recommend that manufacturers observe that standard, in addition to the duties in paragraph 1. Article 1 of the notification itself describes its purpose as "recommending that it be implemented." It is not mandatory.

Even so, it is a useful reference point for reading paperwork. Article 11 covers incoming material control. Paragraph 1 requires the manufacturer to evaluate and select suppliers of raw and packaging materials and to supervise them appropriately. Paragraph 2 requires that, on receipt, the purchase requisition, the supplier certificate and the physical goods agree with one another, and allows transport-related documents to be checked additionally where necessary. Paragraph 5 requires received materials to be labelled with a status such as conforming, non-conforming or under test, unless another system offering the same level of assurance is in place.

Paragraph 6 of the same Article sets four fields as mandatory on the container of raw or packaging material and on the test record: the product name set by the supplier, the supplier's name, the date of receipt, and the batch number or control number assigned by the supplier. Checking those four against the physical goods is the first line of review on a supplier certificate.

The standard documents are in Article 15. Among the matters that must be included in the product standard document under paragraph 2, subparagraph 8 is the standards and test methods for raw and packaging materials, semi-finished products, bulk products and finished products. The manufacturing control standard document under paragraph 3 includes, on materials, the method of checking the name, specification, quantity and any damage to packaging on receipt together with the handling procedure if damage is found, the storage location and method, and the handling of items found non-conforming. The quality control standard document under paragraph 4 includes sampling methods for test samples, management of retention samples, management of reference standards and reagents, and, where testing or manufacturing is outsourced, the method of sending samples and of judging results.

The testing stage is Article 20. Paragraph 2 requires conformity criteria to be established for raw and packaging materials, semi-finished products, bulk products and finished products, and test records to be prepared and maintained for each batch. Paragraph 4 allows only items judged conforming to be used or released. Paragraph 5 allows raw materials, semi-finished products and bulk products whose storage period has passed to be used in manufacturing if re-evaluation finds them within the quality standard. Paragraph 6 requires test records to be reviewed and then judged conforming, non-conforming or held. Paragraph 7 requires an out-of-specification result to be reported to the responsible person and then investigated. Article 2(6) of the same notification defines out-of-specification as "a result of inspection, measurement or testing that does not conform to the prescribed acceptance criteria."

One more provision deserves attention: Article 31(2). It provides that, for raw and packaging materials supplied by a company certified to an international standard, or by a company recognised as having quality assurance capability, the inspection method and test items may be adjusted in light of the documented evidence of conformity provided. Note, though, that the Article is titled preferential measures and sits inside a notification that is itself a recommendation. It is not a general rule that supplier certification waives testing.

11. Retention periods for records and samples

Retention is not a single number; it is scattered across provisions. Gathering what has appeared above:

• Records on quality control and on management of the manufacturer: three years from the date of manufacture of the product, or from the date of import where imported (item (e) of paragraph 4 of Annex 1 to the Enforcement Rule)
• Report copies, testing logs and equipment printouts held by a testing and inspection institution: three years (Article 14 of the Enforcement Rule of the Act on Testing and Inspection in the Food and Drug Industry)
• A sample judged non-conforming: 60 days from the date testing and inspection ended (Article 12(3) of the same Enforcement Rule)

A further duty applies to certain ingredients. Article 12(11) of the Enforcement Rule covers a product containing 0.5 per cent or more of any of retinol (vitamin A) and its derivatives, ascorbic acid (vitamin C) and its derivatives, tocopherol (vitamin E), peroxide compounds, or enzymes. For such a product, the stability test data for that item must be kept for one year from the date on which the shelf life of the last manufactured product expires. The clock starts at the expiry of the shelf life, not at the date of manufacture.

A plant following the Good Manufacturing Practice notification has a retention-sample rule as well. Article 21(3) of the notification requires retention samples of finished products to be kept by manufacturing batch under appropriate storage conditions in a designated area until the end of the shelf life. Where a period after opening is stated instead, they must be kept for three years from the date of manufacture. Which of the two dates a label carries changes how long a physical sample, not only a document, has to be kept. The difference between the two is covered in shelf life and period after opening.

12. What to check on ingredient paperwork

Separately from the statutory duties, the documents and procedures that support them can be settled early in development. Here is what to look for at the ingredient stage.

• Are the specification and test method for this material written into the product standard document? It is safer not to assume that the items on a supplier certificate and the specification applied to the product are the same.
• Who issued the report? Distinguish a supplier's own test result from a report issued by a designated testing and inspection institution on Annex Form 13 or on a form containing all of its required contents.
• Does the judgment cover the items you actually need? As the notice on the form says, the judgment covers only the items requested.
• What do the specifications point to: the safety management standards for cosmetics in distribution, the functional-cosmetics standards and test items, the colourant usage standards, or an in-house standard?
• Do the batch number and the date of receipt match the physical goods? This is the point at which Article 11(2) of the Good Manufacturing Practice notification requires the purchase requisition, the supplier certificate and the goods to agree.
• Who performs per-batch quality testing, and if the omission applies, under which provision and at which institution? Read the proviso to Article 12(5) of the Enforcement Rule together with the proviso in item (b)5) of paragraph 3 of Annex 1.
• Has it been settled where quality control records will be kept, and from when the three years run? Item (e) of paragraph 4 of Annex 1 sets the period, and item (c) of paragraph 3 prescribes where the original and the copies belong.
• Does the product contain 0.5 per cent or more of any of the five specified ingredient groups? If so, the duty to retain stability test data comes with it.

Which materials accumulate at which stage of development is set out in our development process, and formulation-side material is collected in formulation development. If a review against a project already in progress would help, get in touch.

13. Frequently asked questions

If the supplier provided a certificate, may we use the ingredient?

Paperwork does not decide whether a material may be used. Materials that may not be used are designated under Article 8(1) of the Cosmetics Act, and the usage standards for materials requiring restriction are designated under Article 8(2) of the same Article, in both cases by published notification. A certificate records a measurement made against those standards.

Is there a statutory form for a raw material specification?

The term "specification sheet" does not appear in the articles of the Cosmetics Act or its Enforcement Rule as read for this article. The four documents Article 11(1)2 names are the product standard document, the manufacturing control standard document, the manufacturing control record and the quality control record, and what requires the standards and test methods for raw and packaging materials to sit in the product standard document is Article 15(2)8 of the Regulations on Good Manufacturing Practice for Cosmetics. That notification is a recommendation.

Where is checking a material quality certificate an express statutory duty?

In item (a) of Article 12-2(2) of the Enforcement Rule. As part of the safety management standards for mixing and repackaging that apply to a custom cosmetics seller, it requires the quality certificate for the contents or raw material used to be checked before mixing or repackaging. The duties of manufacturers and responsible distributors contain no sentence in that shape; they require testing and inspection to be performed and recorded instead.

If a supplier holds an international certification, can incoming testing be reduced?

Article 31(2) of the Regulations on Good Manufacturing Practice for Cosmetics provides that, for raw and packaging materials from a company certified to an international standard or recognised as having quality assurance capability, the inspection method and test items may be adjusted in light of the documented evidence of conformity provided. The Article is titled preferential measures and the notification as a whole is a recommendation, so it cannot be used as a basis for waiving a testing or inspection duty set by law.

Our manufacturer calls ingredient information a trade secret and will not share it. Is that a problem?

Item (b) of Article 11(1)6 of the Enforcement Rule addresses that situation directly. Where the manufacturer manufactures by designing, developing and producing the product, and where, within a range that does not affect quality and safety management, the matter constitutes a trade secret under a mutual contract, submission of the matters necessary for quality control may be withheld. Because the three conditions apply together, the practical safeguard is to separate in the contract what counts as a trade secret from what counts as information needed for quality and safety management.