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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

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters delegated 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)
The detailed types and scope of cosmetic business under Article 2-2 (1) of the Cosmetics Act (hereinafter referred to as the “Act”) shall be as follows:
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 package);
2. Responsible cosmetic distribution business: The following business:
(a) Business in which a cosmetic manufacturer (referring to a person who registered his or her cosmetic manufacturing business 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;
(d) Business of offering or supplying cosmetics for import agency business (limited to electronic commerce transaction under subparagraph 1 of Article 2 of the Act on the Consumer Protection in Electronic Commerce);
3. Custom 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 prescribed by the Minister of Food and Drug Safety;
(b) Business of selling cosmetics repackaged by dividing the contents of a manufactured or imported cosmetic into smaller amounts.
[This Article Newly Inserted 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 attached Table 1 in accordance with the criteria for disposition to suspend business by Ordinance of the Prime Minister in consideration of the kind, severity, etc. of the relevant violation, but the total amount thereof shall not exceed one 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) Where 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 determined by Ordinance of the Prime Minister. <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) Where a person on whom a penalty surcharge is imposed under Article 28 (1) of the Act (hereinafter referred to as “person obliged to pay a penalty surcharge”) is required to pay an amount exceeding one million won and deemed unable to pay in lump sum due to any of the following grounds, the Minister of Trade, Industry and Energy may extend the deadline for payment or allow the person to pay such amount in installments. In such cases, he or she may require the person to provide security if deemed necessary:
1. Where the person suffers substantial property loss inflicted by a disaster, etc. as defined in subparagraph 1 of Article 2 of the Countermeasures against Natural Disasters Act;
2. Where his or her business faces serious crisis because business conditions have worsen;
3. Where a lump sum payment of the penalty surcharge is likely to result in considerable financial hardship;
4. Where the Minister of Food and Drug Safety acknowledges that there are other reasons corresponding to those prescribed in subparagraphs 1 through 3.
(2) A person who intends to be granted an extension of the deadline for payment of a penalty surcharge or to pay it in installments in accordance with paragraph (1) shall file an application with the Minister of Food and Drug Safety 10 days before the deadline, along with documents verifying the grounds for the extension of the deadline or the payment in installments.
(3) Where the deadline for payment of a penalty surcharge is extended under paragraph (1), the deadline shall be within one year from the day following the deadline for payment.
(4) Where payment in installments is allowed pursuant to paragraph (1), the interval between deadlines for payment in installments shall not exceed four months and the number of installments shall not exceed three times.
(5) Where a person liable to pay a penalty surcharge for whom a decision is made under paragraph (1) to extend the deadline for payment of the penalty surcharge or to permit payment in installments falls under any of the following cases, the Minister of Food and Drug Safety may cancel the decision to extend the deadline for payment or to permit payment in installments and collect the penalty surcharge in a lump sum:
1. Where such person fails to pay a penalty surcharge determined to be paid in installments by the deadline for payment;
2. Where such person fails to comply with a requirement to change security or any other measure taken for the preservation of security;
3. Where the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu deems it is deemed impractical to collect the full amount or remainder of a penalty surcharge, due to compulsory execution, commencement of an auction, declaration of bankruptcy, dissolution of a corporation, or disposition on delinquent national or local taxes;
4. Where such person is deemed capable of paying the penalty surcharge in lump sum as any of the grounds provided in the subparagraphs of paragraph (1) has ceased to exist.
[This Article Newly Inserted on Apr. 27, 2021]
[Previous Article 12-2 moved to Article 12-3 <Apr. 27, 2021>]
 Article 12-3 (Disposition against Payers in Arrears of Penalty Surcharges)
(1) Where an obligor of a penalty surcharge fails to pay it by the fixed deadline (where a decision on installment payment is revoked under Article 12-2 (5), referring to the deadline for a lump sum payment), the Minister of Food and Drug Safety shall serve a demand notice on him or her within 15 days after the elapse of such fixed deadline. In such case, the deadline for payment shall not exceed 10 days from the date of sending the demand notice. <Amended on Feb. 3, 2012; Mar. 23, 2013; Mar. 12, 2019; Apr. 27, 2021>
(2) Where a person who fails to pay a penalty surcharge fails to pay it by the deadline for payment after receiving a demand notice under paragraph (1), the Minister of Food and Drug Safety shall cancel the imposition of penalty surcharge and grant a disposition to suspend business: Provided, That 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) Where cancelling the imposition of penalty surcharge and granting 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 ground for changing the original disposition, the period of suspension of business operations, etc. shall be specified in the document. <Amended on Feb. 3, 2012; Nov. 4, 2014>
[This Article Newly Inserted 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. Ground 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 manufacturing 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 Newly Inserted 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 for modification of cosmetic manufacturing business or a responsible cosmetic distribution business under Article 3 of the Act;
1-2. To accept a report on custom cosmetic sales business or a report on modification thereof under Article 3-2 (1) of the Act;
1-3. To order cosmetic manufacturers, responsible cosmetic distributors, and custom cosmetic sellers (hereinafter referred to as “business operators”) to receive education under Article 5 (8) of the Act;
1-4. To accept a report on a recall plan under Article 5-2 (2) of the Act and to mitigate administrative disposition or to grant and exemption from administrative disposition pursuant to paragraph (3) of that Article;
2. The following authority regarding reporting on business closure, under Article 6 of the Act:
(a) To accept reports filed pursuant to each subparagraph of Article 6 (1) of the Act;
(b) To revoke 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 facts about labeling and advertisements required 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 required 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 entities' requests for data pursuant to Article 14 (6) of the Act;
3. To issue an order to make a report, to access to relevant places, to conduct inspections, to make inquiries, and to collect under Article 18 of the Act;
3-2. To appoint or dismiss and to provide training for consumer watchdogs for cosmetics safety control 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 modification under the latter part of Article 3 (1) of the Act;
(b) In cases of a failure to file a report on modification under the latter part of Article 3-2 (1) of the Act;
(c) In cases of a violation of an order to receive 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, etc.; to accept or destroy reports on recall plans; 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 revoke 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;
9-2. To publish under Article 28-2 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 Newly Inserted on Jul. 3, 2007]
 Article 15 (Management of Sensitive Information and Personally Identifiable information)
If unavoidable for conducting the following affairs, the Minister of Food and Drug Safety (including persons delegated with the authority of the Minister of Food and Drug Safety under Article 14 or persons entrusted with the affairs relating to the management of qualification tests and issuance of qualification certificates pursuant to Article 3-4 (3) of the Act) may manage data containing health information under Article 23 of the Personal Information Protection Act, information equivalent to criminal history records referred to in subparagraph 2 of Article 18 of the Enforcement Decree of that Act, and resident registration numbers or alien registration numbers referred to in subparagraph 1 or 4 of Article 19 of that Decree: <Amended on Feb. 3, 2012; Mar. 23, 2013; Jul. 24, 2015; Mar. 12, 2019; Dec. 10, 2019; Feb. 15, 2022>
1. Affairs relating to registration of or registration for modification of a cosmetic manufacturing business or a responsible cosmetic distribution business under Article 3 of the Act;
1-2. Affairs relating to reports on custom cosmetic sales businesses or reports on modification thereof under Article 3-2 (1) of the Act;
1-3. Affairs relating to the management of the qualification test for a custom cosmetic compounding manager and the issuance and re-issuance of a qualification certificate under Article 3-4 (1) and (4) of the Act;
2. Affairs relating to examination, etc. of functional cosmetics under Article 4 of the Act;
3. Affairs relating to business closure, etc. under Article 6 of the Act;
4. Affairs relating to reporting, inspection, etc. under Article 18 of the Act;
4-2. Affairs relating to corrective orders under Article 19 of the Act;
5. Affairs relating to Inspection orders under Article 20 of the Act;
6. Affairs relating to orders for repair, and orders for prohibition of the use of all or part of facilities under Article 22 of the Act;
7. Affairs relating to orders for recall, destruction, etc.; and destruction or other necessary dispositions under Article 23 of the Act;
8. Affairs relating to revocation 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. Affairs relating to hearings under Article 27 of the Act;
10. Affairs relating to the imposition and collection of penalty surcharges under Article 28 of the Act;
11. Affairs relating to re-issuance of certificates of registration, etc. under Article 31 of the Act.
[This Article Newly Inserted 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 attached Table 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.
Articles 2 through 9 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 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.)
Article 2 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 attached Table 1, the application of standards for calculation of penalty surcharges against violations committed before this Decree enters into force shall be governed by the former 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.)
Articles 2 through 4 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 Payer in Arrears of Penalty Surcharge)
A person who fails to pay a penalty surcharge by the fixed deadline for payment even after receiving a demand notice pursuant to Article 12-2 (1) before this Decree enters into force shall be governed by the former provisions.
ADDENDUM <Presidential Decree No. 26452, Jul. 24, 2015>
This Decree shall enter into force on the date of its promulgation: Provided, That 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, That 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 attached Tables 1 and 2 regarding custom cosmetic sales business and custom cosmetic sellers shall enter into force on March 14, 2020.
ADDENDUM <Presidential Decree No. 30245, Dec. 10, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 12, 2019: Provided, That the amended provisions, with the exception of the subparagraphs, of Article 15 and those of subparagraph 1-3 of Article 15 of the Enforcement Decree of the Cosmetics Act (Presidential Decree No. 29621) shall enter into force on March 14, 2020.
Article 2 (Transitional Measures concerning Criteria for Calculation of Penalty Surcharges)
Notwithstanding the amended provisions of subparagraph 2 of attached Table 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.
Article 2 Omitted.