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The short answer: outsourcing production does not outsource the registration

In a development conversation, formula and packaging come up first. Registration usually comes up when launch is close. That order is backwards. Under the Cosmetics Act, a person who intends to distribute and sell cosmetics has to go through the registration or notification route set for that type of business. Commissioning all of the manufacturing does not by itself remove the responsible distribution registration duty.

This article reads the registration scheme in its own words. It sets out which registrations exist, which one a brand normally has to hold, what each one requires, who is barred from holding one, and what follows once a registration is in place. Every earlier article in this series was written on the assumption that the registration already exists. This one takes that assumption as its subject.

The scope is the law of the Republic of Korea, and every provision quoted here was read in the original on the National Law Information Center on 5 October 2026. Local registration or approval required by an export destination is outside the scope, and this is not legal advice on any particular matter. The article explains the scheme only, and makes no claim about EVAS's own registrations or commercial terms.

Key takeaways

1. The Act divides business into three kinds

Article 2-2(1) of the Cosmetics Act provides that the kinds of business under the Act are the cosmetics manufacturing business, the cosmetics responsible distribution business, and the customised cosmetics sales business. Article 2-2(2) delegates their detailed types and scope to Presidential Decree.

The three are not treated alike. Article 3(1) of the Act requires a person who intends to run a cosmetics manufacturing business or a cosmetics responsible distribution business to register each of them. The registration is made with the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. Article 3-2(1), by contrast, provides that a person who intends to run a customised cosmetics sales business shall file a notification. Registration and notification differ in procedure, and they differ in which provision applies when something goes wrong.

One point is worth settling at the outset. Manufacturing and responsible distribution are not alternatives. Article 3(1) says each of them is registered, so a company that makes its own products and distributes them itself holds both registrations. Where the line between making and distributing falls is set out separately in what the brand owner still has to do.

2. Each registration splits into types

Article 2 of the Enforcement Decree of the Cosmetics Act sets out the detailed types. The cosmetics manufacturing business has three. Item (a) is manufacturing cosmetics directly. Item (b) is manufacturing cosmetics under a commission from another party. Item (c) is packaging cosmetics, and a parenthesis in item (c) limits this to primary packaging only.

The cosmetics responsible distribution business has four. Item (a) is a registered cosmetics manufacturer distributing and selling cosmetics it has made itself. Item (b) is distributing and selling cosmetics manufactured under commission by a registered cosmetics manufacturer. Item (c) is distributing and selling imported cosmetics. Item (d) is brokering or supplying cosmetics for the purpose of agency-import transactions, and a parenthesis limits those to electronic commerce under Article 2, subparagraph 1 of the Act on Consumer Protection in Electronic Commerce.

The customised cosmetics sales business has two. Item (a) is selling cosmetics made by adding to the contents of a manufactured or imported cosmetic either the contents of another cosmetic or a raw material designated and published by the Minister of Food and Drug Safety. Item (b) is selling cosmetics made by subdividing those contents.

Where a person registered as a cosmetics manufacturer makes the product under commission, and the brand then distributes and sells it under its own name, the business falls under item (b) of the responsible distribution business. The type is recorded on the registration certificate, and changing it later becomes a ground for change registration, so the type chosen at the start is a question about the shape of the business rather than about paperwork. Which commercial route to take is compared in OEM, ODM, private label and brand sourcing.

3. Manufacturing registration asks about facilities first

The main text of Article 3(2) of the Act provides that a person who intends to register a cosmetics manufacturing business shall have the facilities prescribed by Ordinance of the Prime Minister. Those facilities are listed in Article 6(1) of the Enforcement Rule.

There are four. The first is a work area in which manufacturing operations are carried out. That one carries three sub-items: facilities that can keep out rats, pests and dust; work benches and other facilities and equipment needed for manufacturing; and, where a work room generates airborne powder, facilities to remove it. The second is a storage area for raw materials, packaging materials and products. The third is a testing laboratory needed for quality testing of those same items. The fourth is the facilities and equipment needed for quality testing.

The procedure is in Article 3(2) of the Enforcement Rule. The applicant submits the registration application in Form 1 of the attached forms, with the three documents described next, to the head of the Regional Office of the Ministry of Food and Drug Safety having jurisdiction over the location of the manufacturing site. The first is a physician's certificate showing that the applicant does not fall under the main text of Article 3-3, subparagraph 1 of the Act, or a specialist's certificate showing that the applicant falls under the proviso to that subparagraph. The second is a physician's certificate showing that the applicant does not fall under Article 3-3, subparagraph 3. The third is a facility specification. For a corporation these certificates concern its representative. A corporate registration certificate is not submitted: under Article 3(3) of the Enforcement Rule the head of the Regional Office confirms it through the shared use of administrative information.

Where the application meets the requirements, Article 3(4) of the Enforcement Rule requires five particulars to be entered in the manufacturing business register, and the registration certificate in Form 2 to be issued. The five are the registration number and date, the manufacturer's name and resident registration number or equivalent, the trade name, the location of the manufacturing site, and the manufacturing type.

4. Two situations allow part of the facilities to be left out

The proviso to Article 3(2) of the Act allows part of the facilities to be left out where a person manufactures only part of the cosmetics process, or in other cases prescribed by Ordinance of the Prime Minister. Those cases are the two subparagraphs of Article 6(2) of the Enforcement Rule.

Subparagraph 1 covers a cosmetics manufacturer that manufactures only part of the process. What may be left out is the facilities and equipment other than those needed for that part. Subparagraph 2 covers a manufacturer that commissions quality testing of raw materials, packaging materials and products. What may be left out here is the testing laboratory under Article 6(1)3 and the testing facilities and equipment under Article 6(1)4.

Subparagraph 2 limits the permitted testing bodies to four. Two of them are a health and environment research institute under Article 2 of the Health and Environment Research Institute Act, and a manufacturer that has a testing laboratory meeting Article 6(1)3. The other two are 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. Whether the facility exemption holds therefore depends on where the testing goes. What those test reports actually prove is examined in raw material documents.

Article 6(3) of the Enforcement Rule adds that a manufacturer may use its cosmetics manufacturing facilities to make goods other than cosmetics, with a proviso excluding cases where there is a risk of cross-contamination between products.

5. Responsible distribution registration turns on two documents

Article 3(3) of the Act requires a person who intends to register a cosmetics responsible distribution business to have the standards for quality control and for post-distribution safety management prescribed by Ordinance of the Prime Minister. The same paragraph requires that person to appoint a manager able to administer them. That manager is called the responsible distribution manager. Article 7 of the Enforcement Rule identifies the standards: the quality control standards are Annex 1 and the post-distribution safety management standards are Annex 2.

The procedure is Article 4(2) of the Enforcement Rule. The applicant submits the registration application in Form 3 with two documents to the head of the Regional Office having jurisdiction over the location of the responsible distribution premises. The documents are the rules on the standards under Article 3(3) of the Act, and a document by which the responsible distribution manager's qualifications can be confirmed. It is worth noticing that no facility specification and no physician's certificate appear here, unlike the manufacturing application.

The same paragraph carries an important parenthetical limitation. Where the applicant falls under Article 2, subparagraph 2, item (d) of the Enforcement Decree, meaning a responsible distribution business for agency-import transactions, those two documents are not submitted. Of the four responsible distribution types, only item (d) is treated differently.

Where the application meets the requirements, Article 4(4) of the Enforcement Rule requires six particulars to be entered in the register, and the registration certificate in Form 4 to be issued. The first four are the registration number and date, the responsible distributor's name and resident registration number or equivalent, the trade name, and the location of the premises. The last two are the responsible distribution manager's name and resident registration number or equivalent, and the responsible distribution type. Unlike the manufacturing register, this one records a second named person, which is why a change in that person changes a registered particular.

6. Who can serve as the responsible distribution manager?

Article 8(1) of the Enforcement Rule lists the qualifications. A parenthetical limitation at the front excludes operators registered under Article 2, subparagraph 2, item (d) of the Enforcement Decree from the duty to appoint such a manager at all.

A person must fall under one of six categories. The first is a doctor under the Medical Service Act or a pharmacist under the Pharmaceutical Affairs Act. The second is a person who has obtained a bachelor's degree or higher by majoring in a natural science or engineering discipline, or in fields such as cosmetic science, cosmetics science, Korean medicine, Korean pharmacy, nursing, nursing science or health nursing. The third is a person who has obtained an associate degree by majoring in a cosmetics-related field and has then worked for at least one year in cosmetics manufacturing or quality control. The fourth is a person who has completed a specialised training course designated and published by the Minister of Food and Drug Safety, and that category applies only to the items the Minister designates and publishes. The fifth is a person who has passed the qualifying examination for customised cosmetics preparation managers. The sixth is a person who has otherwise worked for at least two years in cosmetics manufacturing or quality control.

Article 8(2) sets three duties. The first is quality control work under the quality control standards in Annex 1. The second is safety assurance work under the post-distribution safety management standards in Annex 2. The third is supervising the manufacturer in respect of the testing, inspection or verification needed from the receipt of raw materials and packaging materials through to the release of finished products. It is worth noting that the third duty names the manufacturer as the party supervised.

A route exists for small operators. Article 8(3) applies where a responsible distributor runs a business with 10 or fewer regularly employed workers and is itself a person falling under one of the subparagraphs of Article 8(1). That person may then perform the duties in Article 8(2), and in that case the operator is deemed to have appointed a responsible distribution manager. For a corporation, the operator here means its representative. This lets a qualified representative hold the role; it does not waive the qualification.

Article 8(4) adds that a responsible distribution manager who ceases to work in that role at the premises may submit a notification of non-engagement in Form 6-2, with a statement of reasons. The wording is permissive, so that filing is not written as a duty. A change of responsible distribution manager is, however, a ground for change registration, as the next section shows.

7. Some people are barred from registering

Article 3-3 of the Act lists the grounds for disqualification and provides that a person falling under any of them may not register a cosmetics manufacturing business or a cosmetics responsible distribution business, or file a customised cosmetics sales notification. A proviso follows: subparagraphs 1 and 3 apply to the cosmetics manufacturing business only.

The provision in force today has six numbered entries. Subparagraph 1 covers a person with a mental illness under Article 3, subparagraph 1 of the Act on the Improvement of Mental Health and the Support for Welfare Services for Mental Patients. A proviso excludes a person whom a specialist recognises as fit to be a cosmetics manufacturer. Subparagraph 2 covers a person under adult guardianship, or a person declared bankrupt and not yet reinstated. Subparagraph 3 covers a narcotics addict under Article 2, subparagraph 1 of the Narcotics Control Act. Subparagraph 4 covers a person sentenced to imprisonment without labour or a heavier punishment for violating this Act or the Act on Special Measures for the Control of Public Health Crimes. That person remains covered while the execution of the sentence has neither ended, including cases deemed to have ended, nor been exempted. Subparagraph 4-2 covers a person serving the suspension period of a suspended sentence of imprisonment without labour or a heavier punishment. Subparagraph 5 covers a person for whom one year has not passed since a registration was revoked or premises were closed under Article 24 of the Act. A parenthesis excludes revocations and closures based on subparagraphs 1 through 3 of this Article.

One date belongs here. The National Law Information Center also carries a version of Article 3-3 marked as taking effect on 8 October 2026, and in that version subparagraph 2 reads simply as a person under adult guardianship. The bankruptcy limb now in subparagraph 2 drops out on that date. The provision described above is the one that applies as this article is written, and anyone checking after 8 October 2026 should read the amended text instead.

Disqualification does not operate only at the application stage. Article 24(1)3 of the Act makes falling under any subparagraph of Article 3-3 a ground for disposition, and the proviso to Article 24(1) requires the registration to be revoked or the premises closed in that case. It is mandatory, not discretionary.

8. Changes to a registration are filed within 30 days

The second sentence of Article 3(1) of the Act provides that registration is also required when an important registered particular prescribed by Ordinance of the Prime Minister is changed. Those particulars are in Article 5(1) of the Enforcement Rule.

For a cosmetics manufacturer there are four. Two of them are a change of the manufacturer, which for a corporation means a change of representative, and a change of trade name, which for a corporation means a change of corporate name. The other two are a change in the location of the manufacturing site and a change of manufacturing type. For a responsible distributor there are five: the same first three, plus a change of responsible distribution manager and a change of responsible distribution type. That a change of responsible distribution manager triggers a filing is the limb most often missed in practice.

The deadline is in Article 5(2): within 30 days from the day the ground for the change arises, and 90 days only where the change of location results from an administrative district reorganisation. The filing uses Form 5 for a manufacturing change or Form 6 for a responsible distribution change, attaches the relevant registration certificate, and adds documents according to the change. A change of representative requires the physician's certificates from the manufacturer only, and a transfer requires documents evidencing it. A change in the location of the manufacturing site requires the facility specification, excluding changes arising from an administrative district reorganisation. A change of responsible distribution manager requires the qualification document. Where the change of location moves the business to a different registering authority, the filing goes to the head of the Regional Office having jurisdiction over the new location.

Failing to file a change leads to an administrative disposition rather than a penalty. Article 24(1)1 of the Act lists the failure to register a change under the second sentence of Article 3(1) as a ground for disposition.

9. Training comes round every year

Article 5(7) of the Act provides that responsible distribution managers and customised cosmetics preparation managers shall receive annual training on securing the safety of cosmetics and on quality control. Article 14(1) of the Enforcement Rule splits the cycle in two. Initial training falls within six months from the day the person takes up the role, with a proviso treating it as completed where the person passed the qualifying examination within one year before that day. Refresher training is once a year measured from the day the initial training was received, or, where that proviso applies, once a year measured from the first anniversary of passing the examination.

A separate instrument sits beside this. Article 5(8) of the Act provides that the Minister of Food and Drug Safety may, where this is considered necessary to prevent harm to public health, order a business operator to receive training on cosmetics law and policy. Article 14(2) of the Enforcement Rule sets five categories of addressee. Two of them are an operator that has violated Article 15 of the Act, and an operator that has received a corrective order under Article 19 of the Act. The other three are manufacturers, responsible distributors and customised cosmetics sellers that have violated the compliance duties in Article 11(1), Article 12 and Article 12-2 of the Enforcement Rule respectively. The standing annual duty and the training order are therefore two different things.

Where a person required to receive training under Article 5(8) runs the business at two or more locations, Article 5(9) of the Act allows an employee to be designated as the person in charge and to receive the training. Article 14(6) of the Enforcement Rule identifies that employee as a responsible distribution manager, a customised cosmetics preparation manager, or an employee engaged in quality control work under the quality control standards in Annex 1. Article 14(9) sets the training at not less than four hours and not more than eight.

10. Closure, suspension and resumption are also filed

Article 6(1) of the Act requires a business operator to file a notification when it intends to close or suspend the business, and when it intends to resume after a suspension. A proviso removes the requirement where the suspension period is shorter than one month, or where the operator resumes after suspending for such a period. The procedure is Article 15(1) of the Enforcement Rule: the notification in Form 11, attaching the registration certificate or the notification certificate, with that attachment required for closure or suspension only.

Article 6(2) of the Act deserves attention. The Minister of Food and Drug Safety may revoke the registration of a cosmetics manufacturer or responsible distributor on either of two grounds. One is that the operator has filed a business closure report with the competent head of a tax office under Article 8 of the Value-Added Tax Act. The other is that the head of the tax office has cancelled its business registration. A tax-side step can therefore reach the cosmetics registration. A procedural safeguard follows: Article 15(5) of the Enforcement Rule requires the head of the Regional Office to notify the operator in advance and to give at least 10 days' public notice on the Regional Office website before such a revocation.

Processing has its own deadline. Article 6(4) of the Act requires the Minister to notify the person who filed of whether the closure or suspension notification is accepted within seven days of receiving it. Article 6(5) provides that where no notice of acceptance or of an extension of the processing period is given within that period, the notification is deemed accepted on the day after the period ends.

11. What follows when a registration is missing or shaken?

The penalty is in Article 36(1) of the Act. Subparagraph 1 covers a person who violates the first sentence of Article 3(1), and the statutory range is up to three years' imprisonment or a fine of up to 30 million won. Article 36(2) allows imprisonment and a fine to be imposed together. The phrase "first sentence" matters. Not registering at all violates the first sentence; failing to file a change violates the second sentence, which this penalty provision does not cover. As noted above, that route runs through Article 24(1)1 instead.

Registering, filing a change registration, notifying, or filing a change notification by false or otherwise improper means is listed separately as Article 36(1)1-2. It is at the same time a ground for disposition under Article 24(1)1-2. Because the proviso to Article 24(1) requires revocation or closure where subparagraph 1-2 applies, that case is mandatory too.

The main text of Article 24(1) gives the authority a wide range. It may revoke the registration or order the closure of the premises. It may also prohibit the manufacture, import and sale of items, or suspend all or part of the business for a fixed period within one year. A parenthesis limits closure of premises to businesses notified under Article 3-2(1). The registration-related grounds are subparagraph 1 for an unfiled change, subparagraph 1-2 for a false or improper registration, subparagraph 2 for failing to have the facilities under Article 3(2), and subparagraph 3 for disqualification. Subparagraph 2 shows that the facility standard is not a one-off entry requirement.

What follows a recall or a reporting failure is set out separately in who has to act when a product goes wrong.

12. The customised cosmetics sales business is notified, not registered

Article 3-2(1) of the Act requires a person who intends to run a customised cosmetics sales business to file a notification with the Minister of Food and Drug Safety. The same applies when a notified particular prescribed by Ordinance of the Prime Minister is changed. Article 3-2(2) requires the person to have the facilities prescribed by Ordinance of the Prime Minister. It also requires the appointment of a person engaged in quality and safety management work such as mixing and subdividing customised cosmetics, who is called the customised cosmetics preparation manager.

This article also carries a future date. The National Law Information Center shows a version of Article 3-2 marked as taking effect on 29 April 2027. That version adds a proviso to paragraph 2. The proviso lets an employee who has completed training on subdividing cosmetics stand in for the preparation manager, where the seller handles only cosmetics that fall within the main text of Article 2, subparagraph 3-2, item (b) of the Act and are prescribed by Ordinance of the Prime Minister. New paragraphs 3 and 4 then set what that training must cover, and the training bodies and methods. The pre-amendment text applies for now, so anyone building this into a plan should check it again against the effective date.

For a brand, this business type becomes relevant where the activity is one of the two in Article 2, subparagraph 3 of the Enforcement Decree: selling cosmetics whose contents have been mixed, or selling cosmetics whose contents have been subdivided. Planning finished products and distributing them is not written into either of those two types.

13. What to check during development

  1. Write down which type in Article 2 of the Enforcement Decree your intended activity falls under. Agency-import transactions under Article 2, subparagraph 2, item (d) differ from the other types in the documents required and in the responsible distribution manager requirement, so separate them out.
  2. Confirm that the responsible distribution registration is yours to hold even when all manufacturing is commissioned. Who registers is settled by the Act, not by the contract.
  3. Decide who will serve as responsible distribution manager. With 10 or fewer regularly employed workers, a qualified representative can take the role.
  4. Prepare the rules on the required standards for submission. Those rules are the document referred to in Article 4(2)1 of the Enforcement Rule, and Annexes 1 and 2 set their content; the provisions do not say who has to draft them.
  5. Check in advance which particulars appear on the registration certificate. Trade name, location, responsible distribution manager and responsible distribution type all become 30-day filings when they change.
  6. If an office move or a change of representative is planned, read it against the registration calendar. The clock starts on the day the ground for the change arises.
  7. Put the training dates in the calendar. Initial training falls within six months from the day the person takes up the role.
  8. When choosing a manufacturer, check whether its manufacturing type covers the process your product needs. Some establishments are registered for part of the process only.

What to settle at the planning stage is covered in how to write a product brief, and quantities and production planning in small-batch production and MOQ. If you would like the registration structure read against your own launch schedule, tell us through contact, and the other articles are on insights.

14. Frequently asked questions

If we commission all of the manufacturing, do we need no registration at all?

No. Article 3(1) of the Act places the registration duty on a person who intends to run a cosmetics responsible distribution business. Article 2, subparagraph 2, item (b) of the Enforcement Decree lists distributing and selling cosmetics manufactured under commission as one of its types, so commissioning production does not remove the duty. Operating without registration falls under Article 36(1)1 of the Act.

Do we have to register both the manufacturing business and the responsible distribution business?

It depends on what you intend to do. Article 3(1) of the Act requires each of the two to be registered, so a company that manufactures and then distributes its own products holds both. A company that commissions manufacturing and only distributes holds the responsible distribution registration alone.

Do we have to hire a responsible distribution manager separately?

Not necessarily. Article 8(3) of the Enforcement Rule applies where a responsible distributor runs a business with 10 or fewer regularly employed workers. That operator must itself be a person falling under one of the subparagraphs of Article 8(1). The operator may then perform the duties, and is deemed to have appointed a manager. For a corporation this means its representative. The qualification requirement itself is not waived.

What do we have to do if we move the responsible distribution premises?

Under Article 5(1)2(c) of the Enforcement Rule, a change in the location of the responsible distribution premises is a ground for change registration. Article 5(2) sets the deadline at 30 days from the day the ground arises, or 90 days where the change results from an administrative district reorganisation. If the move puts you under a different registering authority, the filing goes to the head of the Regional Office having jurisdiction over the new location.

Does a registration have a validity period?

Within Article 3 of the Act and Articles 3 through 6 of the Enforcement Rule, which this article read, there is no wording setting a validity period or a renewal for the registration. That does not mean a registration lasts indefinitely. Article 24(1) of the Act provides grounds for revocation and suspension, and Article 6(2) allows revocation where a closure report is filed with the tax office or the business registration is cancelled. This check is limited to the provisions named here, and the contents of the annexes and attached forms were not searched.

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