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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

 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>
 Articles 2 through 10 Deleted. <by Presidential Decree No. 23614, Feb. 3, 2012>
 Article 11 (Standards for Calculation of Penalty Surcharge)
The amount of a penalty surcharge under Article 28 (2) of the Cosmetics Act (hereinafter referred to as "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>
 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 Payer in Arrears of Penalty Surcharge)
(1) Where an obligor of a penalty surcharge pursuant to the main sentence of Article 28 (3) 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 cases, the deadline for payment shall not exceed ten 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>
(2) Where a person who fails to pay the 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 to Article 28 (3) 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>
(3) Where cancelling the disposition of imposing the penalty surcharge and taking a disposition for suspending business pursuant to the main sentence of paragraph (2), the content 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 Ministry 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>
1. Registration or registration for change of a manufacturing business or manufacturing and sale business under Article 3 of the Act;
1-2. An order for training under Article 5 (5) of the Act;
1-3. Receipt 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. Receipt of a report on the closure, suspension, etc. of business under Article 6 of the Act;
3. An order for report, entry, inspection, questioning and collection under Article 18 of the Act;
3-2. An order for correction under Article 19 of the Act (limited to where failing to make a registration for change in violation of the latter part of Article 3 (1) of the Act, violating an order for training under Article 5 (5) of the Act and failing to make a report on the suspension of business under Article 6 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 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 certificates of registration completion under Article 31 of the Act;
11. Imposition and collection of administrative fines under Article 40 of the Act (excluding where failing to undergo a review of change in violation of the latter part of Article 4 (1) of the Act or failing to report the records of manufacturing or importing cosmetics or the materials of cosmetics in violation of Article 5 (3) of the Act).
[This Article Newly Inserted by Presidential Decree No. 20158, Jul. 3, 2007]
 Article 15 (Treatment of Sensitive Information and Unique identifiable information)
The Ministry of Food and Drug Safety (including persons to whom is delegated with the relevant authority of the Ministry of Food and Drug Safety) shall, if inevitable for conducting the following affairs, process data containing information concerning health under Article 23 of the Personal Information Protection Act, information equivalent to data of criminal record under the subparagraph 2 of Article 18 of the Decree of the same Act, and resident registration numbers or foreigner registration numbers under the subparagraph 1 or 4 of Article 18 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>
1. Affairs concerning registration or registration for change of a manufacturing business or manufacturing and sale business under Article 3 of the Act;
2. Affairs concerning examination, etc. of functional cosmetics under Article 4 of the Act;
3. Affairs concerning the 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 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 completion under Article 31 of the Act.
[This Article Newly Inserted by Presidential Decree No. 23488, Jan. 6, 2012]
 Article 16 (Standards for Imposition of Administrative Fines)
Standards for imposition of administrative fines under Article 40 of the Act shall be as listed in Attached Table 2.
[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.