An unlabelled ivory ceramic cream jar with its lid leaning beside it, a stainless steel tray holding an empty glass beaker and folded white cotton gloves, and a blank cream paper card on a brushed stainless steel work surface in natural light, with small white flowers by the window at the left

AI-generated image.

The short answer: a conformity assessment judges an establishment, it does not approve a product

The first thing a brand hears when choosing a Korean manufacturer is that the establishment is a CGMP conforming establishment. Search results and AI answers generally say the same thing: check the certification first. Yet the brand that hears it can verify very little. A photograph of a certificate does not say what was assessed, when it was assessed, or whether that assessment reaches as far as the product you are about to make.

This article reads the scheme in its own words. Its basis is a Ministry of Food and Drug Safety notification, the Regulations on Good Manufacturing Practice for Cosmetics, and CGMP is the abbreviation the industry commonly uses for it, although the notification does not use that abbreviation of itself. Three conclusions come first. The standard is recommended rather than mandatory. What is assessed is an establishment, and depending on the application category, the assessment may cover only part of that establishment's processes. And the main text of the notification sets no validity period for the assessment, offering instead a periodic on-site inspection, a corrective order and the power to revoke.

The scope is the law of the Republic of Korea, and every provision quoted here was read in the original on the Korean Law Information Center on 1 October 2026. Manufacturing standards required by an importing country are outside this article. It is not legal advice on a specific matter. It explains a public scheme, and it makes no claim that EVAS holds any particular assessment or certification.

Key takeaways

1. The standard is recommended, not mandatory

The starting point is Article 5(1) of the Cosmetics Act. It provides that a cosmetics manufacturer shall observe the matters prescribed by Ordinance of the Prime Minister concerning methods of managing records, facilities and equipment related to manufacture, and the methods of and obligation to carry out testing, inspection and verification of raw materials, packaging materials and finished products. That much is mandatory.

That Ordinance is the Enforcement Rule of the Cosmetics Act, and the provision is Article 11. Article 11(1) lists the eight obligations a manufacturer must observe. Article 11(2) then continues: the Minister of Food and Drug Safety may recommend that a manufacturer observe the good manufacturing practice standard published by the Minister, in addition to the obligations under Article 11(1). The name the Enforcement Rule gives that standard is not identical to the title of the notification, but Article 1 of the notification cites Article 11(2) of the Enforcement Rule as its basis, so the two refer to the same standard.

The operative verb is "may recommend". The notification says the same of itself. Article 1 states its purpose as prescribing the details of the standard under Article 5(1) of the Cosmetics Act and Article 11(2) of its Enforcement Rule and, "by recommending that they be implemented", contributing to consumer protection and public health through the manufacture, management, storage and supply of good cosmetics by cosmetics manufacturers.

The next provision confirms the same character. Article 11(3) of the Enforcement Rule provides that the Minister may support a manufacturer that observes this standard in three ways: specialist technology and education on applying the standard, advice on applying it, and the repair and improvement of facilities and equipment needed to apply it. That is a structure for helping those who follow, not for imposing on those who do not.

A provision higher up the hierarchy points the same way. Article 29 of the Cosmetics Act, titled support for voluntary management, provides that the Minister may give administrative and financial support so that a voluntary management system, in which business operators make their own efforts on labelling and advertising, quality control, domestic and foreign certifications and other obligations, can take root and spread. The phrase "domestic and foreign certifications" appears in the Act inside this support provision.

So an establishment without the assessment is not, on that ground alone, operating unlawfully. Nor does holding the assessment remove any other obligation under the Cosmetics Act. The two layers rest on different provisions.

2. Registration and facility requirements are the mandatory part

Before discussing the assessment it helps to fix what is compulsory. Article 3(1) of the Cosmetics Act provides that a person who intends to run a cosmetics manufacturing business or a cosmetics responsible distribution business shall register with the Minister of Food and Drug Safety as prescribed by Ordinance of the Prime Minister. It adds that the same applies when changing important registered particulars prescribed by that Ordinance.

Article 3(2) attaches facility requirements to manufacturing registration. The main text requires a person registering a cosmetics manufacturing business to have the facilities prescribed by Ordinance of the Prime Minister, and the proviso allows some of those facilities to be dispensed with where the case falls within a category prescribed by that Ordinance, such as manufacturing only part of the processes of a cosmetic.

Those facilities are set out in Article 6(1) of the Enforcement Rule, and there are four. A workplace for manufacturing operations, equipped with facilities that keep out rodents, insects and dust, with work benches and other facilities and equipment needed for manufacture, and with dust-removal facilities in any room where powder is dispersed. A storage area for raw materials, packaging materials and products. A laboratory needed for quality testing of raw materials, packaging materials and products. And the facilities and equipment needed for quality testing.

Article 6(2) opens two routes to dispensing with some of those. Subparagraph 1 covers a manufacturer that makes only part of the processes of a cosmetic, which may dispense with facilities and equipment other than those needed for that process. Subparagraph 2 covers a manufacturer that entrusts quality testing to one of four bodies, which may dispense with the laboratory in subparagraph 3 and the facilities and equipment in subparagraph 4 of Article 6(1). The four are listed in items (a) to (d). They are the Institute of Health and Environment under Article 2 of the Institutes of Health and Environment Act; a manufacturer that has a laboratory under subparagraph 3 of Article 6(1); a cosmetics testing and inspection body under Article 6 of the Act on Testing and Inspection in the Food and Drug Industry; and the Korea Pharmaceutical Traders Association, an incorporated association organised under Article 67 of the Pharmaceutical Affairs Act.

It is worth noting that the phrase "part of the processes" already appears here. The same division carries straight through to the assessment and the logo below. The point where the duties of a manufacturer and those of a responsible distributor divide is covered separately in what the brand owner still has to do.

3. How an establishment applies for the assessment

Article 30(1) of the notification sets out the application. An establishment seeking a conformity assessment submits an application in the form of Annex Form 1, and that application may be an electronic document. The materials attached to it are a self-assessment record showing the standard applied and operated at least three times, the organisation that operates the cosmetics manufacturing and quality control standard, the facility details of the establishment, the state of manufacturing control and the state of quality control. The application goes to the Minister of Food and Drug Safety. Subparagraph 1 of that paragraph was deleted on 16 October 2012.

The heaviest item on that list is the first. This is not a matter of reading the standard once and applying; there must be a record of the standard having been applied and operated at least three times, in the form of a self-assessment record. It is a procedure for showing a system that was already running, not for producing new paperwork at the point of application.

A proviso is attached to the same paragraph. An establishment that carries out only part of the processes shall enter the process concerned, as listed in Annex 1, on the Annex Form 1 application. The division between all processes and part of the processes therefore appears at the application stage.

4. What is assessed

Article 30(4) of the notification sets out the decision. The Minister of Food and Drug Safety evaluates the materials submitted and carries out an on-site inspection under Annex 2. Where the Minister makes a conformity assessment, the Minister shall issue a certificate of a conforming establishment in the form of Annex Form 3. It is not a paper exercise alone; a visit to the site is part of it.

Annex 2 is the implementation status assessment table. Read in the original it has two parts. Part I is the establishment profile. It carries the establishment's name and address, the applicant's representative and date of birth, and the contact details of the quality manager and of the person handling the application. It then has boxes for the plant area, broken down into manufacturing workplace, storage, quality control laboratory, other and total; a box for the application category; boxes for staff numbers, broken down into manufacturing departments, quality department, other workers and total; and boxes for the name, representative, address and contact details of any contractor.

Part II is the assessment table proper. It has three columns: the item and assessment content, the conformity decision, and remarks; the conformity decision column takes an O or an X. The items follow the order of the notification's own provisions. They begin with Article 3 on the composition of the organisation in Chapter 2 on human resources, run through Chapter 3 on manufacturing, continue into Chapter 4 on quality assurance, and end with Article 29 on document control.

The subject of assessment is therefore Articles 3 to 29 of the notification. Organisation, the responsibilities and training of staff, hygiene, buildings and facilities, maintenance, incoming, outgoing and storage control, water quality, the written standards, weighing, in-process control, packaging operations, testing control, the sampling and storage of specimens, disposal, outsourcing contracts, deviation control, complaint handling, product recall, change control, internal audit and document control all appear as items. No item asks about the formula or the efficacy of any particular product. What this table asks about is the way an establishment works.

Where ingredient paperwork sits inside that system is set out in detail in what a specification sheet and a test report actually prove.

5. What the certificate says

Annex Form 3 contains four entries: the establishment's name, its representative, its address and the application category. The body is a single sentence certifying that the cosmetics manufacturing establishment named above has been assessed as a conforming establishment under Article 30 of the Regulations on Good Manufacturing Practice for Cosmetics, followed by the date of issue and the seal of the Minister of Food and Drug Safety.

The reverse of the form carries a table headed changes and dispositions, with two columns, one for the date and one for the content. The form is designed so that later changes and dispositions are written onto the certificate itself.

What the form tells a brand is plain. What is recorded is the identity of the establishment and the application category; no product name is recorded. When a certificate arrives, the things to check are whether the establishment name and address are in fact those of the establishment that will make your product, and what the application category says.

6. All processes and part of the processes are not the same

This is the most practical distinction in the scheme. Annex 1 is headed processes concerned and has two parts. Part 1, classification by cosmetics group, has been deleted. Part 2, classification by process, leaves two entries: number 1, bulk manufacturing, and number 2, filling and packaging (primary packaging).

The division appears in three places. At the application stage, the proviso to Article 30(1) makes an establishment that carries out only part of the processes enter the process concerned on the application. At the decision stage, the proviso to Article 30(4) makes the process concerned appear on the certificate of such an establishment. And the application category box in Annex 2 separates all processes from part of the processes, listing bulk manufacturing and filling and packaging (primary packaging) under the latter.

The logo follows the same split. Annex 3 sets out two logo designs as its marking standard: item (a) for all processes and item (b) for part of the processes. As its marking method it provides that the size of the design shall be adjusted at the same ratio according to its use and the size of the packaging material, and that the design shall be marked legibly by printing, engraving or a similar method. Part 3 of the same Annex was deleted on 16 October 2012.

One question therefore follows directly from hearing that an establishment is a conforming establishment: is it all processes or part of the processes, and if the latter, is it bulk manufacturing or filling and packaging (primary packaging)? This is not a commercial term to be negotiated but a fact already written on the certificate, so it can be asked without asking for a single number.

7. What changes once the assessment is granted

Article 31 of the notification is titled preferential measures and has three surviving paragraphs. Article 31(1) was deleted on 16 October 2012.

Article 31(2) concerns raw and packaging materials. It provides that for raw and packaging materials supplied by a business certified to an international standard (CGMP, ISO9000) or otherwise recognised as having quality assurance capability, the inspection method and test items may be adjusted in light of the documentary evidence of conformity supplied with them. Two things deserve care here: the subject of the provision is material arriving from a supplier rather than the assessment of an establishment, and the operative verb is "may be adjusted", not "shall be exempted".

Article 31(3) is the effect that attaches to the assessed establishment itself. The Minister of Food and Drug Safety may exclude an establishment that has received a conformity assessment under Article 30 from routine sample collection and testing and from routine surveillance. Here too the verb is "may exclude". The power to collect and inspect sits in Article 18 of the Cosmetics Act. Article 18(1) covers orders to report and the entry, inspection and questioning carried out by public officials. Article 18(2) covers collecting the minimum quantity necessary to inspect whether quality or safety standards and the particulars marked on the packaging are met.

Article 31(4) covers marking and advertising. An establishment that has received a conformity assessment under Article 30 may mark the logo under Annex 3 on the manufacturing establishment concerned and on cosmetics manufactured at that establishment, or advertise that fact. The permitted scope is written into the sentence: the cosmetics that may carry the logo are those manufactured at that establishment.

8. There is no validity period, but there is follow-up management

A common question is how long the assessment lasts. Read from beginning to end, the main text and the addenda of the notification contain no provision setting a validity period or a renewal. There is no provision on fees either. That search covers the provisions and the addenda, not the contents of the Annexes and Annex Forms. What they contain instead is Article 32 on follow-up management.

Article 32(1) provides that the Minister of Food and Drug Safety shall carry out an on-site inspection of an establishment assessed under Article 30 at least once every three years. The inspection follows the implementation status assessment table in Annex 2. The operative verb is "shall".

Article 32(2) attaches to the result. Where follow-up management finds an establishment non-conforming, the Minister may order it to make corrections within a set period, or may revoke the designation as a conforming establishment. Correction and revocation are alternatives.

Article 32(3) opens inspection outside that cycle. Notwithstanding Article 32(1), the Minister may at any time carry out an inspection of how the standard is being operated at an establishment considered to have a problem in its manufacturing or quality control.

In short, the notification puts a periodic on-site inspection, a corrective order and revocation where a fixed term and a renewal might otherwise sit. What a brand actually wants to know is therefore not the date the certificate was issued but the date of the most recent on-site inspection. That is also why the reverse of Annex Form 3, seen above, carries a table for changes and dispositions.

The notification also has a review cycle of its own. Article 33 provides that the Minister shall review the validity of the notification every three years from 1 January 2016 under the Regulations on the Issuance and Management of Directives and Established Rules, and take measures such as improvement.

9. ISO 22716 does not appear in the main text of this notification

Manufacturer profiles often print CGMP and ISO 22716 on the same line, which makes the two names read as the domestic and international editions of one scheme. Measured against the text of the notification, they are not.

In the main text and addenda of this notification, an international standard is named in exactly one place, Article 31(2) as seen above, and the names written there are CGMP and ISO9000. The number 22716 appears nowhere in the main text or the addenda. This check covers the provisions and addenda of the notification; it does not extend to the contents of the Annexes and Annex Forms.

The position of Article 31(2) is worth noting again as well. It is not a provision that grants an assessment to a plant; it says that the inspection method and test items for raw and packaging materials may be adjusted in light of a supplying business's certification.

The content of the ISO 22716 standard itself was not examined for this article. The verification scope here is Korean legislation and administrative rules readable on the Korean Law Information Center, and an ISO standard document is not among them. This article therefore does not compare the requirements of the two standards; it records only that the procedure this notification lays down is a conformity assessment by the Minister of Food and Drug Safety, and that the procedure for an international standard certification is not inside this notification. Where a manufacturer names both, the more accurate move is to ask separately who made each decision and how far its subject matter reaches.

10. Some certifications have been abolished

The reason to ask whether a named certification is still a live scheme lies in a recent amendment. Articles 14-2, 14-3, 14-4 and 14-5 of the Cosmetics Act were all deleted with effect from 31 January 2025. They were the certification scheme for natural cosmetics and organic cosmetics.

The addenda of the same date provide transitional measures. Article 2 of the Addenda to Act No. 20767 provides that natural and organic cosmetics for which certification had been applied for and the procedure was under way at the time of entry into force remain subject to the previous provisions, and that where certification had already been granted, it is deemed valid until the expiry of the validity period stated on the certificate. It also provides that where a case falls under any subparagraph of the former Article 14-2(3), the certification shall be revoked under the previous provisions. Under Article 1 of those Addenda, the Act entered into force six months after promulgation.

One further provision was tidied up at the same time. Subparagraph 3 of Article 13(1) of the Cosmetics Act, on prohibited labelling and advertising, was also deleted with effect from 31 January 2025.

So when the word certification appears in a company profile, two things are worth checking: whether the scheme is still in operation, and who makes the decision. The decision discussed in this article is made by the Minister of Food and Drug Safety.

11. When the assessment moves into labelling and advertising

What Article 31(4) of the notification permits, as seen above, is for an assessed establishment to mark the Annex 3 logo on the manufacturing establishment concerned and on cosmetics manufactured at that establishment, or to advertise that fact. The permission presupposes an establishment that has received the assessment, and its subject matter is written as cosmetics manufactured at that establishment.

The general rules on labelling and advertising are in Article 13 of the Cosmetics Act. Article 13(1) provides that a business operator or a seller shall not engage in three kinds of labelling or advertising. The first is labelling or advertising likely to be mistaken for a medicine. The second is labelling or advertising likely to make a cosmetic that is not a functional cosmetic be mistaken for one, or that differs from the outcome of the review of a functional cosmetic. The third is any other labelling or advertising likely to deceive consumers contrary to the facts or to cause them to be mistaken. Article 13(2) leaves the scope of such labelling and advertising and other necessary matters to Ordinance of the Prime Minister.

The point where these two provisions meet is the person they address. Article 31(4) of the notification permits marking and advertising by an establishment that has received the assessment, while Article 13(1) of the Act writes its prohibition against a business operator or a seller. When an assessment granted to an establishment is copied onto a brand's own product page, that sentence becomes labelling or advertising done by the brand. What a claim generally has to be backed by is covered in what you must be able to prove.

12. The notification lists what an outsourcing party checks

This notification is a recommended standard addressed to cosmetics manufacturers. Article 23 nevertheless deals with outsourcing contracts and sets out what a person intending to outsource manufacturing operations, and the outsourcing party, are to do. These are not sentences a brand commissioning development or production can claim as its own obligations, but they do show what this standard treats as the things to check.

Article 23(1) provides that where part of a process or a test in cosmetics manufacturing and quality control is to be outsourced, a documented procedure shall be established and maintained.

Article 23(2) touches this article's subject directly. A person intending to outsource manufacturing operations is recommended to have the manufacturing carried out by an establishment that has received a conformity assessment from the Minister of Food and Drug Safety under Article 30. The provision recommends rather than requires, so it does not mean that outsourcing to an establishment without the assessment is prohibited. The same point appears among the assessment items in Annex 2, where one of the Article 23 items asks whether, when outsourcing manufacturing operations, an assessed establishment is being chosen first.

Article 23(3) onwards sets out the substance of the checking. The outsourcing party shall assess the contractor's capability to perform the contract and confirm that the contractor has the facilities and other resources needed to perform it. Article 23(4) requires a written contract and the transmission of relevant information so that the work can be done accurately. Article 23(5) provides that the outsourcing party shall carry out the audit provided for in the contract, and that the contractor shall accept it. Article 23(6) provides that the outsourcing records generated by the contractor shall be maintained and made available to the outsourcing party.

What those four paragraphs point at in common is the contract. The notification writes the capability assessment and facility check, the written contract, the audit and the availability of records all on the assumption that a contract exists. Without a clause providing for an audit and a clause on receiving records, the ways left to check shrink, whatever the assessment status. How formulas and technical data are settled at the contract stage is covered separately in who owns the formula.

13. What can be checked without asking for numbers

These questions follow directly from the provisions read above. Each asks about a fact that already exists in a document or a contract rather than about the other side's commercial terms, so each can be asked before any discussion of unit price or quantity.

EVAS carries out planning, design, research, manufacturing, logistics and brand content in house. Which of the questions above actually matters on a given project depends on the product and the processes involved, so the accurate place to settle specific conditions is a consultation. How a development project is sequenced is set out on the process page.

14. Frequently asked questions

Is it unlawful to use a manufacturer without a CGMP conformity assessment?

No. Article 11(2) of the Enforcement Rule of the Cosmetics Act says only that observance of the standard may be recommended, and Article 1 of the notification likewise describes its purpose as recommending that the standard be implemented. What is mandatory is registration under Article 3(1) of the Cosmetics Act and the facility requirements under Article 3(2). That said, Article 23(2) of the notification does recommend that a person intending to outsource manufacturing operations have them carried out by an assessed establishment.

If the establishment has the assessment, does that mean my product has been approved?

No. What Article 30(4) of the notification assesses is an establishment, and the certificate in Annex Form 3 records only the establishment's name, representative, address and application category. The assessment items in Annex 2 ask about organisation, facilities, processes and documents, that is, about how the establishment works, and they include no item reviewing the formula or the efficacy of any particular product.

Does the assessment have a validity period?

The main text and the addenda of the notification contain no provision setting a validity period or a renewal. Instead, Article 32(1) makes an on-site inspection at least once every three years mandatory. Article 32(2) allows a corrective order or revocation of the designation where follow-up management finds non-conformity, and Article 32(3) leaves open an inspection at any time of an establishment considered to have a problem.

What is different when a conforming establishment covers only part of the processes?

Annex 1 classifies processes into exactly two: bulk manufacturing, and filling and packaging (primary packaging). Under the proviso to Article 30(1) of the notification, an establishment carrying out only part of the processes enters the process concerned on the application, and under the proviso to Article 30(4) that process is also entered on the certificate. Annex 3 likewise provides a separate logo design for all processes and for part of the processes.

Does an ISO 22716 certification take the place of the domestic conformity assessment?

Nothing examined for this article supports that reading. The number 22716 does not appear in the main text or the addenda of the Regulations on Good Manufacturing Practice for Cosmetics. Article 31(2), the one place an international standard is named there, concerns suppliers of raw and packaging materials and names CGMP and ISO9000. The ISO 22716 standard itself was not examined here, so the requirements of the two standards are not compared.

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