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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

 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 by Presidential Decree No. 23614, 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 cometic manufacturer (referring to a person who registered his/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 cometic 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 by Presidential Decree No. 29621, Mar. 12, 2019]
[Enforcement Date: Mar. 14, 2020] Subparagraph 3 of Article 2
 Articles 3 through 10 Deleted. <by Presidential Decree No. 23614, Feb. 3, 2012>
 Article 11 (Standards for Calculation of Penalty Surcharges)
The amount of a penalty surcharge under Article 28 (2) of the Act shall be calculated by applying the standards unde attached Table 1 in accordance with the standards for dispositions of the suspension of business determined by Ordinance of the Prime Minister in consideration of the types, severity, etc. of the relevant violation, but the total amount thereof shall not exceed 50 million won. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 29621, Mar. 12, 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/she shall give written notice of the type of the relevant violation, the amount of the penalty surcharge, and other related matters. <Amended by Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 24454, Mar. 23, 2013>
(2) The procedures for collection of penalty surcharges shall be determined by Ordinance of the Prime Minister. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24454, Mar. 23, 2013>
 Article 12-2 (Disposition against Payers in Arrears of Penalty Surcharges)
(1) Where an obligor of a penalty surcharge pursuant to the main sentence of Article 28 (4) of the Act fails to pay it by the fixed deadline, the Minister of Food and Drug Safety shall serve a demand notice on him/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 by Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 29621, Mar. 12, 2019>
(2) Where a person who fails to pay a penalty surcharge pursuant to paragraph (1) fails to pay it by the deadline for payment after receiving the demand notice, the Minister of Food and Drug Safety shall cancel the disposition of imposing the penalty surcharge and take a disposition for suspending 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 are collected. <Amended by Presidential Decree No. 25705, Nov. 4, 2014; Presidential Decree No. 29621, Mar. 12, 2019>
(3) Where cancelling the disposition of imposing a penalty surcharge and taking a disposition for suspending business pursuant to the main sentence of paragraph (2), the details of the disposition shall be notified in writing to the person subject thereto, and the ground for changing the disposition, the period of the disposition for suspending business, etc. shall be specified in the document. <Amended by Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 25705, Nov. 4, 2014>
[This Article Newly Inserted by Presidential Decree No. 20158, Jul. 3, 2007]
 Article 13 (Publication of Relevant Violations)
(1) “Matters prescribed by Presidential Decree” in Article 28-2 (1) of the Act refers to 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 homepage of the Ministry of Food and Drug Safety.
[This Article Newly Inserted by Presidential Decree No. 26452, Jul. 24, 2015]
 Article 14 (Delegation of Authority)
In accordance with Article 34 (1) of the Act, the Minister of Food and Drug Safety shall delegate the following authority to the heads of local food and drug safety offices: <Amended by Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 25705, Nov. 4, 2014; Presidential Decree No. 26452, Jul. 24, 2015; Presidential Decree No. 27827, Jan. 31, 2017; Presidential Decree No. 29621, Mar. 12, 2019>
1. Registration or registration for change of cosmetic manufacturing business or responsible cosmetic distribution business under Article 3 of the Act;
1-2. Acceptance of a report on custom cosmetic sales business or a report on changes thereof under Article 3-2 (1) of the Act;
1-3. An order for training for a cosmetic manufacturer, a responsible cosmetic distributor, and a custom cosmetic seller (hereinafter referred to as “business operator”) under Article 5 (6) of the Act;
1-4. Acceptance of a report on a recall plan under Article 5-2 (2) of the Act and mitigation and revocation of administrative dispositions under paragraph (3) of the same Article;
2. Acceptance of a report on business closure, business suspension, etc. of a business operator under Article 6 (1) of the Act;
3. An order for report, entry, inspection, questioning, and collection under Article 18 of the Act;
3-2. Appointment or dismissal of and education for consumer watchdogs for cosmetics safety control under Article 18-2 of the Act;
3-3. A corrective order issued under Article 19 of the Act in any of the following cases:
(a) In cases of failing to file a registration for change pursuant to the latter part of Article 3 (1) of the Act;
(b) In cases of failing to file a report on changes pursuant to the latter part of Article 3-2 (1) of the Act;
(c) In cases of violating an order for training under Article 5 (6) of the Act;
(d) In cases of failing 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. An order for inspection under Article 20 of the Act;
5. An order for repair, and an order for prohibiting the use of all or part of facilities under Article 22 of the Act;
6. An order for collection, disposal, etc., receipt and disposal of reports of a recall plan, or other necessary dispositions under Article 23 of the Act;
6-2. An order for publication under Article 23-2 of the Act;
7. Revocation of registration, an order for the closure of a place of business, an order for prohibiting manufacture, import and sale of items, and an order for the suspension of the whole or part of business under Article 24 of the Act;
8. Hearings under Article 27 of the Act;
9. Imposition and collection of penalty surcharges under Article 28 of the Act;
9-2. Publication under Article 28-2 of the Act;
10. Re-issuance of a certificate of registration or a certificate of completion of report under Article 31 of the Act;
11. Imposition and collection of administrative fines under Article 40 (1) of the Act.
[This Article Newly Inserted by Presidential Decree No. 20158, Jul. 3, 2007]
[Enforcement Date: Mar. 14, 2020] Amendments to subparagraphs 1-3, 2, 3-3, 7, 10, and 11 of Article 14 regarding custom cosmetic sales business and custom cosmetic sellers
 Article 15 (Treatment of Sensitive Information and Personally Identifiable information)
If inevitable for conducting the following affairs, the Minister of Food and Drug Safety (including persons to whom the relevant authority of the Minister of Food and Drug Safety is delegated under Article 14) may process data containing information concerning health under Article 23 of the Personal Information Protection Act, information equivalent to data of criminal record under subparagraph 2 of Article 18 of the Enforcement Decree of the same Act, and resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the same Decree: <Amended by Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 26452, Jul. 24, 2015; Presidential Decree No. 29621, Mar. 12, 2019>
1. Affairs concerning registration or registration for change of cosmetic manufacturing business or responsible cosmetic distribution business under Article 3 of the Act;
2. Affairs concerning examination, etc. of functional cosmetics under Article 4 of the Act;
3. Affairs concerning business closure, etc. under Article 6 of the Act;
4. Affairs concerning reporting, inspection, etc. under Article 18 of the Act;
4-2. Affairs concerning orders for correction under Article 19 of the Act;
5. Affairs concerning orders for inspection under Article 20 of the Act;
6. Affairs concerning orders for repair, and orders for prohibiting the use of all or part of facilities under Article 22 of the Act;
7. Affairs concerning an order for collection, disposal, etc., and a disposition of discard or other necessary dispositions under Article 23 of the Act;
8. Affairs concerning revocation of registration, orders for the closure of a place of business, orders for prohibiting manufacture, import and sale of any items, and orders for the suspension of the whole or part of business under Article 24 of the Act;
9. Affairs concerning hearings under Article 27 of the Act;
10. Affairs concerning imposition and collection of penalty surcharges under Article 28 of the Act;
11. Affairs concerning re-issuance of certificates of registration, etc. under Article 31 of the Act.
[This Article Newly Inserted by Presidential Decree No. 23488, Jan. 6, 2012]
[Enforcement Date: Mar. 14, 2020] Amendments to subparagraph 8 of Article 15 regarding custom cosmetic sales business and custom cosmetic sellers
 Article 15 (Treatment of Sensitive Information and Personally Identifiable information)
If inevitable for conducting the following affairs, the Minister of Food and Drug Safety (including persons to whom the relevant authority of the Minister of Food and Drug Safety is delegated under Article 14) may process data containing information concerning health under Article 23 of the Personal Information Protection Act, information equivalent to data of criminal record under subparagraph 2 of Article 18 of the Enforcement Decree of the same Act, and resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the same Decree: <Amended by Presidential Decree No. 23614, Feb. 3, 2012; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 26452, Jul. 24, 2015; Presidential Decree No. 29621, Mar. 12, 2019>
1. Affairs concerning registration or registration for change of cosmetic manufacturing business or responsible cosmetic distribution business under Article 3 of the Act;
1-2. Affairs concerning a report on custom cosmetic sales business or a report on changes therof under Article 3-2 (1) of the Act;
2. Affairs concerning examination, etc. of functional cosmetics under Article 4 of the Act;
3. Affairs concerning business closure, etc. under Article 6 of the Act;
4. Affairs concerning reporting, inspection, etc. under Article 18 of the Act;
4-2. Affairs concerning orders for correction under Article 19 of the Act;
5. Affairs concerning orders for inspection under Article 20 of the Act;
6. Affairs concerning orders for repair, and orders for prohibiting the use of all or part of facilities under Article 22 of the Act;
7. Affairs concerning an order for collection, disposal, etc., and a disposition of discard or other necessary dispositions under Article 23 of the Act;
8. Affairs concerning revocation of registration, orders for the closure of a place of business, orders for prohibiting manufacture, import and sale of any items, and orders for the suspension of the whole or part of business under Article 24 of the Act;
9. Affairs concerning hearings under Article 27 of the Act;
10. Affairs concerning imposition and collection of penalty surcharges under Article 28 of the Act;
11. Affairs concerning re-issuance of certificates of registration, etc. under Article 31 of the Act.
[This Article Newly Inserted by Presidential Decree No. 23488, Jan. 6, 2012]
[Enforcement Date: Mar. 14, 2020] Amendments to subparagraph 8 of Article 15 regarding custom cosmetic sales business and custom cosmetic sellers
 Article 16 (Standards for Imposition of Administrative Fines)
Standards for imposition of administrative fines under Article 40 (1) of the Act shall be as listed in attached Table 2. <Amended by Presidential Decree No. 29621, Mar. 12, 2019>
[This Article Wholly Amended by Presidential Decree No. 23614, Feb. 3, 2012]
ADDENDUM
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. (Provison 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.