ENFORCEMENT DECREE OF THE COSMETICS ACT
Presidential Decree No. 26452, Jul. 24, 2015
Amended by Presidential Decree No. 27827, Jan. 31, 2017
Presidential Decree No. 29621, Mar. 12, 2019
Presidential Decree No. 30245, Dec. 10, 2019
Presidential Decree No. 31655, Apr. 27, 2021
Presidential Decree No. 32445, Feb. 15, 2022
Presidential Decree No. 33913, Dec. 12, 2023
The purpose of this Decree is to prescribe matters mandated by the Cosmetics Act and other matters necessary for the enforcement thereof. <Amended on Feb. 3, 2012>
| Article 2 (Detailed types and scope of business) |
| 1. | Cosmetic manufacturing business: The following business: |
| (a) | Business of directly manufacturing cosmetics; |
| (b) | Business of manufacturing cosmetics by consignment; |
| (c) | Business of packaging cosmetics (limited to primary packaging); |
| 2. | Responsible cosmetic distribution business: The following business: |
| (a) | Business in which a cosmetic manufacturer (referring to a person whose cosmetic manufacturing business is registered pursuant to Article 3 (1) of the Act; hereinafter the same shall apply) directly manufactures, distributes, and sells cosmetics; |
| (b) | Business of distributing and selling cosmetics that a cosmetic manufacturer manufactures by consignment; |
| (c) | Business of distributing and selling imported cosmetics; |
| 3. | Customized cosmetic sales business: The following business: |
| (a) | Business of selling cosmetics made by mixing the contents of a manufactured or imported cosmetic with the contents of any other cosmetic or a raw material determined and publicly notified by the Minister of Food and Drug Safety; |
| (b) | Business of selling cosmetics repackaged by subdividing the contents of a manufactured or imported cosmetic into smaller amounts. |
[This Article Added on Mar. 12, 2019]
| Article 3 Deleted. <Feb. 3, 2012> |
| Article 4 Deleted. <Feb. 3, 2012> |
| Article 5 Deleted. <Feb. 3, 2012> |
| Article 6 Deleted. <Feb. 3, 2012> |
| Article 7 Deleted. <Feb. 3, 2012> |
| Article 8 Deleted. <Feb. 3, 2012> |
| Article 9 Deleted. <Feb. 3, 2012> |
| Article 10 Deleted. <Feb. 3, 2012> |
| Article 11 (Criteria for calculation of penalty surcharges) |
The amount of a penalty surcharge under Article 28 (1) of the Act shall be calculated by applying the criteria under Appendix 1 in accordance with the criteria for disposition to suspend business prescribed by Prime Ministerial Decree in consideration of the kind, severity of the relevant violation, but the total amount thereof shall not exceed 1 billion won. <Amended on Feb. 29, 2008; Mar. 15, 2010; Feb. 3, 2012; Mar. 23, 2013; Mar. 12, 2019; Dec. 10, 2019>
| Article 12 (Procedures for imposition and collection of penalty surcharges) |
| (1) | If the Minister of Food and Drug Safety intends to impose a penalty surcharge pursuant to Article 28 of the Act, he or she shall give written notice of the type of the relevant violation, the amount of the penalty surcharge, and other related matters. <Amended on Feb. 3, 2012; Mar. 23, 2013> |
| (2) | The procedures for collection of penalty surcharges shall be prescribed by Prime Ministerial Decree. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 12-2 (Extension of deadline for payment of penalty surcharge and installment payment) |
| (1) | The Minister of Food and Drug Safety may allow a person who has been imposed a surcharge under Article 28 (1) of the Act to defer the payment deadline for the penalty surcharge or to pay it in installments under the proviso of Article 29 of the Framework Act on Administrative Regulations, if the amount of the penalty surcharge payable is not less than 1 million won. <Amended on Dec. 12 2023> |
| (2) | Deleted. <Dec. 12, 2023> |
| (3) | If the deadline for payment of a penalty surcharge is extended under paragraph (1), the deadline shall be within 1 year from the day following the deadline for payment. |
| (4) | If payment in installments is allowed pursuant to paragraph (1), the interval between deadlines for payment in installments shall not exceed 4 months and the number of installments shall not exceed 3 times. |
| (5) | Deleted. <Dec. 12, 2023> |
[This Article Added on Apr. 27, 2021]
[Title Amended on Dec. 12, 2023]
[Previous Article 12-2 moved to Article 12-3 <Apr. 27, 2021>]
| Article 12-3 (Disposition against defaulters of penalty surcharges) |
| (1) | If a person obligated to pay a penalty surcharge fails to pay it by the specified deadline (Where a decision on installment payment is canceled under Article 12-2 (5), referring to the deadline for a lump sum payment), the Minister of Food and Drug Safety shall serve a reminder notice on him or her within 15 days after the elapse of such specified deadline. In such cases, the deadline for payment shall not exceed 10 days from the date of sending the reminder notice. <Amended on Feb. 3, 2012; Mar. 23, 2013; Mar. 12, 2019; Apr. 27, 2021> |
| (2) | If a person obligated to pay a penalty surcharge fails to pay it by the deadline for payment after receiving a reminder notice under paragraph (1), the Minister of Food and Drug Safety shall cancel the imposition of penalty surcharge and issue a disposition to suspend business; provided, in cases falling under the proviso of Article 28 (4) of the Act, such penalty surcharge shall be collected in the same manner as delinquent national taxes. <Amended on Nov. 4, 2014; Mar. 12, 2019; Apr. 27, 2021> |
| (3) | In order to cancel the imposition of penalty surcharge and issue a disposition to suspend business pursuant to the main clause of paragraph (2), the details of the disposition shall be notified in writing to the person subject to the disposition, and the grounds for changing the original disposition, the period of suspension of business operations shall be specified in the document. <Amended on Feb. 3, 2012; Nov. 4, 2014> |
[This Article Added on Jul. 3, 2007]
[Moved from Article 12-2 <Apr. 27, 2021>]
| Article 13 (Publication of relevant violations) |
| (1) | "Matters prescribed by Presidential Decree" in Article 28-2 (1) of the Act means the following matters: |
| 1. | Grounds for the disposition; |
| 2. | Content of the disposition; |
| 3. | Name and address of the person subject to the disposition, and the name of the representative of such person; |
| 4. | Name and batch number of the relevant item. |
| (2) | The publication under Article 28-2 (1) of the Act shall be made by posting the relevant fact on the website of the Ministry of Food and Drug Safety. |
[This Article Added on Jul. 24, 2015]
| Article 14 (Delegation of authority) |
The Minister of Food and Drug Safety shall delegate the following authority to the heads of the Regional Offices of Food and Drug Safety, pursuant to Article 34 (1) of the Act: <Amended on Feb. 3, 2012; Mar. 23, 2013; Nov. 4, 2014; Jul. 24, 2015; Jan. 31, 2017; Mar. 12, 2019; Apr. 27, 2021; Feb. 15, 2022> | 1. | To file for registration or registration of change of cosmetic manufacturing business or responsible cosmetic distribution business under Article 3 of the Act; |
| 1-2. | To accept a report on customized cosmetic sales business or a report on change thereof under Article 3-2 (1) of the Act; |
| 1-3. | To order cosmetic manufacturers, responsible cosmetic distributors, and customized cosmetic sellers (hereinafter referred to as "business operators") to attend education under Article 5 (8) of the Act; |
| 1-4. | Receipt of a report on a recall plan under Article 5-2 (2) of the Act, and mitigation or remission of administrative disposition under Article 5-2 (3) of the Act; |
| 2. | The following authority regarding reporting on business closure, under Article 6 of the Act: |
| (a) | To accept reports filed pursuant to the subparagraphs of Article 6 (1) of the Act; |
| (b) | To cancel registration pursuant to Article 6 (2) of the Act; |
| (c) | To make a request for the provision of information under Article 6 (3) of the Act; |
| (d) | To give notice under Article 6 (4) of the Act; |
| 2-2. | The following authority regarding the substantiation of the claims of labeling and advertisements under Article 14 of the Act: |
| (a) | To request the submission of data under Article 14 (2) of the Act; |
| (b) | To extend a period for the acceptance or submission of data under Article 14 (3) of the Act; |
| (c) | To issue an order to suspend pursuant to Article 14 (4) of the Act; |
| (d) | To reply to other agencies' requests for data pursuant to Article 14 (6) of the Act; |
| 3. | To issue a reporting order, access, inspection, inquiry, and collection under Article 18 of the Act; |
| 3-2. | To appoint, dismiss, or educate consumer watchdogs for cosmetics safety management under Article 18-2 of the Act; |
| 3-3. | To issue a corrective order under Article 19 of the Act in any of the following cases: |
| (a) | In cases of a failure to file a registration for change under the latter part of Article 3 (1) of the Act; |
| (b) | In cases of a failure to file a report on change under the latter part of Article 3-2 (1) of the Act; |
| (c) | In cases of a violation of an order to attend education under Article 5 (8) of the Act; |
| (d) | In cases of a failure to file a report on business closure or suspension or a report on resuming business after suspension under Article 6 (1) of the Act; |
| 4. | To issue an inspection order under Article 20 of the Act; |
| 5. | To issue an order to repair facilities, or an order to prohibit the use of all or part of facilities under Article 22 of the Act; |
| 6. | To issue an order to recall, destroy; to accept reports on recall plans; to destroy goods; and to take other necessary measures pursuant to Article 23 of the Act; |
| 6-2. | To issue an order for publication under Article 23-2 of the Act; |
| 7. | To cancel registration; issue an order to close a place of business; issue an order to prohibit manufacture, import, or sale of items, or issue an order to suspend the whole or part of business under Article 24 of the Act; |
| 8. | To hold a hearing pursuant to Article 27 of the Act; |
| 9. | To impose and collect penalty surcharges pursuant to Article 28 of the Act; |
| 10. | To reissue certificates of registration or certificates of completion of report under Article 31 of the Act; |
| 11. | To impose or collect administrative fines under Article 40 (1) of the Act. |
[This Article Added on Jul. 3, 2007]
| Article 15 (Management of sensitive information and personally identifiable information) |
The Minister of Food and Drug Safety (including a person to whom the authority of the Minister of Food and Drug Safety is delegated under Article 14, or a person entrusted with duties regarding the administration of qualification tests and the issuance of qualification certificates, etc. under Article 3-4 (3) of that Act) may, if unavoidable for performing any of the following duties, process information on health under Article 23 of the Personal Information Protection Act (hereinafter referred to as “health information”), information falling under criminal history records under Article 18 (2) 2 of the Enforcement Decree of that Act (hereinafter referred to as “criminal history information”), and data including resident registration numbers or alien registration numbers under Article 19 (1) 1 or 4 of that Decree; provided, criminal history information shall be excluded for the business affairs under subparagraphs 2, 5, and 6, and both health information and criminal history information shall be excluded for the business affairs under subparagraphs 3 and 11. <Amended on Feb. 3 2012; Mar. 23 2013; Jul. 24 2015; Mar. 12 2019; Dec. 10 2019; Feb. 15 2022; Dec. 20 2022> | 1. | Business affairs relating to registration of or registration for change of a cosmetic manufacturing business or a responsible cosmetic distribution business under Article 3 of the Act; |
| 1-2. | Business affairs relating to reports on customized cosmetic sales businesses or reports on change thereof under Article 3-2 (1) of the Act; |
| 1-3. | Business affairs relating to the management of the qualification test for a customized cosmetic compounding manager and the issuance and re-issuance of a qualification certificate under Article 3-4 (1) and (4) of the Act; |
| 2. | Business affairs relating to examination of functional cosmetics under Article 4 of the Act; |
| 3. | Business affairs relating to business closure under Article 6 of the Act; |
| 4. | Business affairs relating to reporting, inspection under Article 18 of the Act; |
| 4-2. | Business affairs relating to corrective orders under Article 19 of the Act; |
| 5. | Business affairs relating to inspection orders under Article 20 of the Act; |
| 6. | Business affairs relating to orders to repair, and orders for prohibition of the use of all or part of facilities under Article 22 of the Act; |
| 7. | Business affairs relating to orders for recall, destruction; and destruction or other necessary dispositions under Article 23 of the Act; |
| 8. | Business affairs relating to the cancellation of registration; orders for the closure of a place of business; orders for prohibition of the manufacture, import, and sale of any items; and orders for the suspension of the whole or part of business affairs under Article 24 of the Act; |
| 9. | Business affairs relating to hearings under Article 27 of the Act; |
| 10. | Business affairs relating to the imposition and collection of penalty surcharges under Article 28 of the Act; |
| 11. | Business affairs relating to re-issuance of certificates of registration under Article 31 of the Act. |
[This Article Added on Jan. 6, 2012]
| Article 16 (Criteria for imposition of administrative fines) |
The criteria for the imposition of administrative fines under Article 40 (1) of the Act shall be as listed in Appendix 2. <Amended on Mar. 12, 2019> [This Article Wholly Amended on Feb. 3, 2012]
[Moved from Article 13 <Feb. 3, 2012>]
ADDENDUM <Presidential Decree No. 16869, Jun. 27, 2000>
This Decree shall enter into force on July 1, 2000.
ADDENDUM <Presidential Decree No. 20158, Jul. 3, 2007>
This Decree shall enter into force on July 4, 2007.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on March 19, 2010. (Proviso omitted.)
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso omitted.)
ADDENDA <Presidential Decree No. 23614, Feb. 3, 2012>
Article 1 (Enforcement date)
This Decree shall enter into force on February 5, 2012.
Article 2 (Transitional measures concerning standards for calculation of penalty surcharges)
Notwithstanding the amended provisions of Appendix 1, the application of standards for calculation of penalty surcharges against violations committed before this Decree enters into force shall be governed by the previous provisions.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso omitted.)
ADDENDA <Presidential Decree No. 25705, Nov. 4, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional measures concerning disposition against defaulter of penalty surcharge)
A person who fails to pay a penalty surcharge by the specified deadline for payment even after receiving a reminder notice pursuant to Article 12-2 (1) before this Decree enters into force shall be governed by the previous provisions.
ADDENDUM <Presidential Decree No. 26452, Jul. 24, 2015>
This Decree shall enter into force on the date of its promulgation; provided, the amended provisions of subparagraphs 3, 6 and 6-2 of Article 14 and subparagraph 7 of Article 15 shall enter into force on July 29, 2015.
ADDENDUM <Presidential Decree No. 27827, Jan. 31, 2017>
This Decree shall enter into force on February 4, 2017.
ADDENDUM <Presidential Decree No. 29621, Mar. 12, 2019>
This Decree shall enter into force on March 14, 2019; provided, the amended provisions of subparagraph 3 of Article 2, subparagraph 1-2 of Article 14, and subparagraph 1-2 of Article 15 and the amended provisions of subparagraph 1-3, 2, 3-3, 7, 10, and 11 of Article 14, subparagraph 8 of Article 15, and Appendixes 1 and 2 regarding customized cosmetic sales business and customized cosmetic sellers shall enter into force on March 14, 2020.
ADDENDA <Presidential Decree No. 30245, Dec. 10, 2019>
Article 1 (Enforcement date)
Article 2 (Transitional measures concerning criteria for calculation of penalty surcharges)
Notwithstanding the amended provisions of subparagraph 2 of Appendix 1, the previous provisions shall govern in applying the criteria for the calculation of penalty surcharges to violations committed before this Decree enters into force.
ADDENDA <Presidential Decree No. 31655, Apr. 27, 2021>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Applicability to extension of deadline for payment of penalty surcharge and to installment payment)
The amended provisions of Article 12-2 shall also apply where a penalty surcharge has been imposed before this Decree enters into force, and the deadline for payment of the penalty surcharge remains at least 10 days as of the enforcement date of this Decree.
ADDENDA <Presidential Decree No. 32445, Feb. 15, 2022>
Article 1 (Enforcement date)
This Decree shall enter into force on February 18, 2022.
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into force on the date of its promulgation.