
AI-generated image.
The short answer: there are two reports, and they fall due at different moments
A Korean cosmetics responsible distributor does not file one report but two. One is last year's production or import performance, due by the end of February each year. The other is the list of raw materials used in manufacturing the product, which is not an annual filing at all: it is due before that product is distributed or sold, and again whenever the reported list changes. One duty sits on the calendar; the other sits on your launch schedule.
The fields and the arithmetic are already fixed by notice. Production value is the production quantity multiplied by the unit production cost, entered in thousands of Korean won with anything below one thousand won truncated. Import value is the import quantity multiplied by the unit import price, entered in US dollars with decimals truncated. The product name must match the product name in the product standard document exactly, and the product type is entered as the item letter and number of the official type list. Samples, testers and giveaways that were not produced for sale are counted separately from saleable units.
This article reads the provisions directly: where each of the two reports comes from, who files which form with which body, what goes in each field and on what basis, how export-only and import-only cases differ, and the on-site inspection clause newly added in May 2026.
The scope is Korean law. The Act, Enforcement Decree, Enforcement Rule and MFDS notice cited here were all checked against the current text on the Korean Law Information Center on 16 October 2026. This is not legal advice for a specific matter, and it makes no claim about EVAS commercial terms, facilities or test records.
Key points
- The basis is Article 5(5) of the Cosmetics Act. Its first sentence requires the responsible distributor to report production or import performance and the list of raw materials used in manufacturing to the Minister of Food and Drug Safety; its second sentence separately requires that the report on the raw-material list be made before the cosmetic is distributed or sold.
- The deadlines are in Article 13 of the Enforcement Rule. Paragraph 1 sets last year's production or import performance at the end of February each year; paragraph 2 sets the raw-material list before distribution or sale, and adds that the same applies where a reported list has changed.
- The filing does not go directly to the MFDS. Article 3(1) of the notice sends production performance and the ingredient lists of domestically manufactured cosmetics to the Korea Cosmetic Association, and import performance and the ingredient lists of imported cosmetics to the Korea Pharmaceutical Traders Association.
- There are eight forms: Forms 1 and 2 for production performance, Forms 3 and 4 for import performance, Forms 5 and 6 for cosmetic ingredient lists, and Forms 7 and 8 for customised-cosmetics ingredient lists.
- The arithmetic is prescribed. Production value is quantity times unit production cost, in thousands of won, truncated below one thousand won. Import value is quantity times unit import price, in US dollars, with decimals truncated.
- The duty belongs to the responsible distributor. It is not a duty the manufacturer carries instead, and which form you use depends on your registered responsible-distribution type.
- Raw-material names are to be written using standard ingredient names as a recommendation, and for a compound raw material every individual constituent name is entered.
- Export-only products are still reported. Article 30 of the Act, which lists the provisions that do not apply to export-only products, does not include Article 5, and the form's purpose field marks export units as EXP.
- The amendment in force on 13 May 2026 inserted Article 3-2 into the notice. A regional MFDS commissioner may conduct an on-site inspection of a company that has not filed in order to check whether the registered site still exists or the business has closed, and where the company is found not to be actually operating, the commissioner must ask the competent tax office to cancel its business registration.
- Failure to report is an administrative fine. Article 40(1)3 of the Act sets a ceiling of KRW 1 million, and the individual standard in Attached Table 2 of the Enforcement Decree, item 2(c), is KRW 500,000.
1. Where each of the two reports comes from
The starting point is a single sentence, Article 5(5) of the Cosmetics Act:
"A cosmetics responsible distributor shall report to the Minister of Food and Drug Safety the production performance or import performance of cosmetics, the list of raw materials used in the manufacturing process of cosmetics, etc., as prescribed by Ordinance of the Prime Minister. In this case, the report on the list of raw materials shall be made before the cosmetics are distributed or sold."
One sentence, two duties. The first half is performance; the second half is the raw-material list, and only the second half carries a timing condition tied to distribution.
The Prime Minister's Ordinance that receives it is Article 13 of the Enforcement Rule. Paragraph 1 requires the responsible distributor to report last year's production or import performance by the end of February each year, as prescribed by notice of the Minister of Food and Drug Safety, through a cosmetics industry body established under Article 17 of the Act, such as the Korea Cosmetic Association, including the import-export association organised under Article 67 of the Pharmaceutical Affairs Act. Paragraph 2 requires the list of raw materials used in the manufacturing process to be reported before distribution or sale, and adds that the same applies where the reported list has changed.
That notice is the Regulation on Reporting of Cosmetics Production and Import Performance and Ingredient Lists (MFDS Notice No. 2026-38, in force 13 May 2026). The forms, the drafting instructions, the receiving bodies and the submission method are all in it.
What goes wrong in practice is simple. If the duty is filed away as an annual February task, the ingredient-list report that falls due in the month of a product launch gets missed. Ingredient-list reporting belongs on the pre-launch checklist.
2. The duty sits with the responsible distributor
The duty holder is the cosmetics responsible distributor, whether the product was manufactured in-house, made under contract, or imported. The fact that the manufacturer holds the production data and the question of who owes the report are two separate things. How the manufacturer's role and the responsible distributor's role divide is set out in what the brand owner is responsible for.
Which form you use follows your registered type. Article 2(1) of the notice has responsible distributors under Article 2, item 2(a) and (b) of the Enforcement Decree file production performance, and those under item 2(c) file import performance.
The four types in Article 2, item 2 of the Enforcement Decree are:
- (a) a manufacturer distributing and selling cosmetics it manufactured itself
- (b) distributing and selling cosmetics manufactured under contract by a registered manufacturer
- (c) distributing and selling imported cosmetics
- (d) brokering or supplying cosmetics for import-agency transactions, limited to electronic commerce
The most common brand arrangement, contracting a Korean manufacturer to produce your product, is type (b), which means the production-performance route. Because the February form depends on the type you registered, the fastest check is the responsible-distribution category printed on your registration certificate. Choosing that type in the first place is covered in business registration and comparing manufacturing routes.
3. The filing goes to an association, which then reports to the MFDS
The point that trips up first-time filers is that the report is not submitted to the MFDS directly.
Article 3(1) of the notice splits the receiving bodies in two:
- production performance, and the ingredient lists of domestically manufactured cosmetics and of customised cosmetics: the Korea Cosmetic Association
- import performance, and the ingredient lists of imported cosmetics: the Korea Pharmaceutical Traders Association
Paragraph 2 of the same article allows the head of each body to provide education, guidance and publicity on filing methods so that reporting is carried out diligently.
What happens next is in Article 2(6) of the notice. The head of the relevant body must report the production and import performance and the ingredient lists it has received to the Minister of Food and Drug Safety through an information network within three months after the end of the year concerned. In doing so, the body may contact companies that have not filed, by post, telephone, email, text message or fax, to establish why, so that filings are not omitted.
The submission method is Article 2(4): the completed forms are recorded on electronic media (a CD or diskette) or submitted over an information network. In practice this means each association's reporting system. Note that association guidance screens sometimes still cite the old paragraph numbers for this duty; verify the basis against the current Article 5(5) of the Act and Article 13 of the Enforcement Rule.
4. The production report form carries company-level numbers
Production performance is filed on two forms. Form 1 is the company-level summary; Form 2 is the per-product schedule. The drafting instructions in Attached Table 1 of the notice carry the note "prepared as at the end of December" on the report forms themselves, Form 1 and its import counterpart Form 3, and on Form 5 for the ingredient list. The per-product schedules, Forms 2 and 4, carry no such note.
Form 1 contains:
- Year: the year of production.
- Responsible distributor, registration number, registration date, address and responsible-distribution category: all entered exactly as printed on the cosmetics responsible-distribution registration certificate.
- Reporting contact: the name, telephone number, fax number and email address of the person who prepared the report.
- Headcount: total employees broken down by function, counting only staff actually engaged in cosmetics-related work. The form's columns are sales, administration, research, production and other, each split by gender.
- Total number of products produced during the year.
- Total production quantity and total production value: entered separately for saleable units and samples, and these must match the totals in Form 2.
That last item matters most in practice. Because the summary has to agree with the per-product schedule, the right order is to complete the product table first and carry its totals up. Writing the summary first and then forcing the detail to match makes verification difficult.
5. How each column of the per-product production record is filled
Form 2 takes one product per line, and the drafting instructions set a basis for each column.
- Year: the year of production.
- Responsible distributor: the trade name on the registration certificate.
- Manufacturer: the trade name of that cosmetic's manufacturer. For contract manufacturing, this is the contract manufacturer.
- Month of manufacture: entered where necessary, such as where the product has changed. The example given formats 5 January 2012 as 2012-1.
- Type indication: the item letter and number from section 1, Types of Cosmetics, of Attached Table 1 to the Regulation on Precautions for Use and Labelling of Allergenic Fragrance Ingredients in Cosmetics. The worked example enters a baby shampoo as 가1 (item (a), number 1).
- Functional-cosmetic category: for functional cosmetics only, entered as whitening, wrinkle improvement, UV protection, combination type and so on, with every category listed for a combination product.
- Classification: saleable units and samples are distinguished. The instructions define a sample as a product produced as a specimen, tester or giveaway rather than for sale to consumers.
- Product name: must be identical to the product name in the product standard document.
- Packaging unit: the volume and the unit of the packaging produced, entered separately.
- Production record: quantity is entered on a packaging-unit basis, and production value is quantity multiplied by unit production cost, in thousands of won, truncated below one thousand won.
- Purpose: domestic and export are distinguished, with export entered as EXP.
Three of these connect straight back to development and production records. First, because the product name must match the product standard document, a marketing name that differs from the standard-document name needs one more check at filing. Second, the type indication follows the official type scheme, so the product type has to be settled; how the type then drives label wording is covered in precautions on the label. Third, if samples are aggregated together with saleable units, the saleable/sample split in the summary form will not reconcile.
6. Importers use different forms and a different currency
A responsible distributor that distributes and sells imported cosmetics files import performance on Forms 3 and 4, with the Korea Pharmaceutical Traders Association as the receiving body.
Form 3, the import performance report, mirrors the production summary. The total number of products is the number of product items imported during the year, while total import quantity and total import value are entered separately for saleable units and samples and must match the totals in Form 4. The fields that differ on Form 4 are:
- Month of import: the month in which the goods were imported.
- Product name: as declared in the standard customs clearance report. The Korean product name declared there is entered; where the Korean name is not yet fixed, only the name declared in the standard customs clearance report may be entered.
- Import record: quantity on a packaging-unit basis, and import value as quantity multiplied by unit import price, in US dollars, with decimals truncated.
- Country of manufacture.
The exemption also exists only on the import side. Article 13(3) of the Enforcement Rule provides that a responsible distributor that imports after making a standard customs clearance report by electronic trade document under the Electronic Trade Facilitation Act need not report import performance or the raw-material list under paragraphs 1 and 2, and Article 2(5) of the notice sets the same exemption in different words: it covers a person who imported after making a standard customs clearance report "by electronic document interchange" under that Act, and identifies what falls away as the import-performance report under Article 2(1)2 and the ingredient-list report under Article 2(2). Read the scope precisely: what is exempted is import performance and the ingredient list. Production performance for domestically manufactured goods was never within this exemption.
7. The ingredient list is filed before distribution, and again whenever it changes
Ingredient-list reporting has two distinguishing features. Its deadline hangs on the launch schedule rather than the calendar, and filing once is not the end of it: it is refiled whenever the list changes.
The forms are Form 5 (cosmetic ingredient list report) and Form 6 (cosmetic ingredient list record). The drafting instructions set these bases:
- Raw-material names: every ingredient name of the raw material is entered, with standard ingredient names recommended. For a compound raw material, the names of all individual constituents are entered.
- Product name and type indication: entered identically to Form 2 or Form 4.
- Manufacturer: the trade name of that cosmetic's manufacturer. For an imported cosmetic, the trade name of the foreign manufacturer declared in the standard customs clearance report.
- Purpose: export units are entered as EXP.
- The ingredient-list field on Form 5: completed on Form 6, with standard ingredient names recommended.
The requirement to name every constituent of a compound raw material reaches straight into supply. If a raw-material supplier provides documentation only at trade-name level, the form cannot be completed, and full-ingredient labelling hits the same wall. Which documents to secure at the raw-material stage is set out in raw-material documents and choosing raw materials.
The sentence "the same shall apply where the reported list has changed" should also be read as it stands. Touch the formula and the filing has to be brought back into line. The more a project reworks its formula, the more this becomes recurring work. How a stock formula and a new formula differ at exactly this point is covered in base formula versus custom formulation.
8. Export-only products are still reported
Brands often ask whether a product that is not sold domestically and exists only for export drops out of reporting as well. On the text, it does not.
Article 30 of the Act lists the provisions that do not apply to products not sold domestically and intended solely for export. The current text names Article 4, Articles 8 through 12, Article 14, Article 15 items 1 and 5, Article 16(1) items 2 and 3, and Article 16(2). Article 5 is not on that list.
The drafting instructions point the same way. The purpose column on Form 2 distinguishes domestic from export and has export entered as EXP. The structure is not to remove export products from reporting, but to mark their purpose inside the report. Which provisions genuinely fall away for export-only products is set out in the export-only exception.
9. Customised-cosmetics sellers file under a separate provision
Customised-cosmetics sellers carry a different duty. Article 5(6) of the Act requires them to report the list of all raw materials used in customised cosmetics to the Minister of Food and Drug Safety once a year, and Article 13(4) of the Enforcement Rule sets that as the list of raw materials used in customised cosmetics sold in the previous year, by the end of February each year, through a cosmetics industry body.
The forms are Form 7 (customised-cosmetics ingredient list report) and Form 8 (customised-cosmetics ingredient list record), and the drafting instructions are Attached Table 2 of the notice. The amendment in force on 13 May 2026 added a sentence here. Article 2(3) of the notice has the seller complete the forms product by product, with the proviso that where products are made by adding the contents of another cosmetic, or a raw material designated by the Minister, to the same contents of a manufactured or imported cosmetic, those products form a product group and may be reported together.
Who files what also differs. A responsible distributor supplying the contents used for mixing or repackaging reports those volumes as its own production performance, while the store reports the list of raw materials used in the customised cosmetics it sold. The wider structure is in mixing and repackaging customised cosmetics.
10. The May 2026 amendment added on-site inspection of non-filers
One thing changed in this regime this year. MFDS Notice No. 2026-38 inserted Article 3-2, on-site inspection, and it has been in force since 13 May 2026.
The article has three paragraphs:
- Paragraph 1: a regional MFDS commissioner may conduct an on-site inspection of responsible distributors and customised-cosmetics sellers that have not reported production or import performance or ingredient lists, in order to check matters such as whether the registered site has ceased to exist or the business has closed.
- Paragraph 2: where the inspection finds that the company is not actually operating, for instance because another business occupies the registered address or the lease has been terminated, the commissioner must request the competent head of the tax office to cancel the business registration. The verb in the provision is "shall request", not "may request".
- Paragraph 3: the Minister and regional commissioners may grant preferential measures, such as exemption from on-site inspection or commendation, to companies that report diligently.
Two practical readings follow. First, a missed filing is no longer a single fine in isolation; it can be the trigger for a site check. If an address or lease changed and the registration was left as it was, a missed filing and an address mismatch arrive together. Second, it is now plain that the filing survives even where a company has registered but not yet launched.
11. Failure to report is a KRW 500,000 administrative fine
The sanction is an administrative fine. Article 40(1) of the Act sets a ceiling of KRW 1 million, and within it item 3 covers "a person who fails to report the production performance or import performance of cosmetics or the list of cosmetic raw materials, etc. in violation of Article 5(5)", while item 3-2 covers failure to report the customised-cosmetics raw-material list in violation of Article 5(6). Paragraph 2 of the same article has the Minister impose and collect the fine as prescribed by Presidential Decree.
The amount is in Attached Table 2 of the Enforcement Decree, the standards for imposing administrative fines. In the individual standards under item 2, sub-item (c) for a violation of Article 5(5) and sub-item (d) for a violation of Article 5(6) are each KRW 500,000.
The amount is not fixed. The general standards in item 1 let the imposing authority reduce it by up to one half where the violation is found to stem from minor negligence or error, where its content and degree are minor so that the resulting harm is small, or where the violator is found to have made efforts to correct or resolve the state of violation, except for a violator in arrears on an administrative fine. Conversely it may be increased by up to one half where the content and degree are serious so that the harm is large, or where the state of violation has lasted six months or more, and even then it cannot exceed the ceiling in Article 40(1).
We also checked the administrative-disposition side. Article 24(1)6 of the Act lists "failure to comply with the obligations of a business operator in violation of Article 5" as a ground for registration cancellation or business suspension. However, the sub-items of item 2(j) of Attached Table 7 to the Enforcement Rule, which sets those standards, enumerate the obligations in Articles 11, 12 and 12-2 of the Enforcement Rule and a violation of Article 5(3) of the Act, and no line corresponding to production-performance or ingredient-list reporting under Article 13 of the Enforcement Rule was found. In other words, the direct sanction for this reporting duty is designed as an administrative fine. How any individual case is handled is for the competent authority.
12. Practical checklist
- Have you checked the responsible-distribution category on your registration certificate? Is this the production-performance form or the import-performance form?
- Have you confirmed the receiving body? Production performance and domestic ingredient lists go to the Korea Cosmetic Association; import performance and imported-cosmetic ingredient lists go to the Korea Pharmaceutical Traders Association.
- Is ingredient-list reporting on the launch schedule for each new product? It is due before distribution or sale.
- Has any product's formula changed? If so, has the reported ingredient list been brought back into line?
- Does each product name match the product name in the product standard document?
- Is the type indication entered as the item letter and number of the official type list?
- Were saleable units and samples counted separately, and does the summary reconcile with the per-product schedule?
- Was production value calculated as quantity times unit production cost and truncated to thousands of won? For imports, calculated in US dollars with decimals truncated?
- Is EXP entered in the purpose column for export units?
- Were all raw-material names entered, including the individual constituents of compound raw materials?
- Do your address and registration details match your current situation?
- If there was no production or import last year, have you confirmed the handling with the receiving body?
Items 3 and 10 are the ones that most often fail. Both depend on the launch schedule and on raw-material documentation, which means neither can be solved by the person filing alone.
What this article did not verify
- The screens and account-issuing procedure of each association's reporting system are out of scope. Check each association's own guidance.
- Handling for a year with no activity has in practice been operated as a nil report, in past MFDS regional-office guidance and association guidance. Those notices, however, cite earlier paragraph numbers for this duty, so this article states only what the current provisions support. Confirming with the receiving body before filing is the safer course.
- The field-by-field bases in Attached Table 2 of the notice, the drafting instructions for the customised-cosmetics ingredient list, are not reproduced in full.
- The procedure for imposing an administrative fine, submitting an opinion, or objecting is not covered.
- Internal association and MFDS procedures for handling and using reported information were not verified.
- Comparable reporting regimes in export markets are out of scope. If you are exporting, the destination country's rules have to be checked separately.
- Other articles are listed in the insights index.
Frequently asked questions
The manufacturer holds the production data. Doesn't the manufacturer file?
Under Article 5(5) of the Act the duty belongs to the cosmetics responsible distributor. The fact that Form 2 has a field for the manufacturer's trade name shows the structure: the manufacturer's information is content of the report, and the brand is the filer. Operational support can be arranged by contract, but that does not move where the duty sits.
We filed the ingredient list before launch and then changed only the fragrance. Do we refile?
Article 13(2) of the Enforcement Rule says "the same shall apply where the reported list has changed". If the content of the reported list differs, it is refiled. There is no sentence in the provision creating an exception based on how small the change was.
Do samples have to be reported?
The drafting instructions split the classification column into saleable units and samples, defining a sample as a product produced as a specimen, tester or giveaway rather than for sale to consumers. They are not excluded; they are reported separately. Total production quantity and value on the summary form are likewise entered with the two distinguished.
Our product is export-only, with no domestic sales. Are we outside reporting?
No. Article 5 is not in the list of provisions excluded by Article 30 of the Act, and the drafting instructions have export units entered as EXP in the purpose column.
If we import after a standard customs clearance report, do we file nothing at all?
Read the scope of the exemption precisely. Article 13(3) of the Enforcement Rule speaks of an electronic trade document and Article 2(5) of the notice of electronic document interchange, and both confine the exemption to the import-performance report and the raw-material list. Production performance for domestically manufactured products has nothing to do with that exemption.
Does failure to report mean business suspension?
The direct sanction we can confirm for this duty is an administrative fine: Article 40(1)3 of the Act with item 2(c) of Attached Table 2 of the Enforcement Decree sets KRW 500,000, and no corresponding administrative-disposition line was found in Attached Table 7 of the Enforcement Rule. That said, under Article 3-2 of the notice, in force 13 May 2026, a company that has not filed may become the subject of a regional on-site inspection, and where it is found not to be actually operating, the tax office is asked to cancel its business registration.
Can you help us map our own filing calendar and form preparation?
What has to be prepared depends on product type, launch timing and formula-change history. If you would like to go through which documents are needed at which stage, tell us through the enquiry page.
Sources
- Cosmetics Act (Act No. 21525, in force 8 October 2026) ↗
- Enforcement Decree of the Cosmetics Act (Presidential Decree No. 36176, in force 2 April 2026) ↗
- Enforcement Rule of the Cosmetics Act (Ordinance of the Prime Minister No. 2109, in force 2 April 2026) ↗
- Regulation on Reporting of Cosmetics Production and Import Performance and Ingredient Lists (MFDS Notice No. 2026-38, in force 13 May 2026) ↗
- Attached Table 1: Instructions for Completing the Production and Import Performance and Ingredient List Report Forms (MFDS Notice No. 2026-38) ↗
- Attached Table 7: Standards for Administrative Dispositions (Enforcement Rule of the Cosmetics Act) ↗