Statutes of the Republic of Korea

Article 1 (Purpose)

The purpose of this Decree is to prescribe matters mandated by the Cleansing and Hygiene Products Control Act and matters necessary for the enforcement thereof.

Article 2 (Types of Cleansing and Hygiene Products)

"Items prescribed by Presidential Decree" in subparagraph 1 (d) (iv) of Article 2 of the Cleansing and Hygiene Products Control Act (hereinafter referred to as the "Act") means the products specified in attached Table 1.

Article 3 (Items Subject to Reporting Manufacturing)

"Items prescribed by Presidential Decree" in the former part of Article 3 (4) of the Act means any of the following:

1.	Cleaning products under subparagraph 1 (a) of Article 2 of the Act;

2.	Dishwasher rinse aids under subparagraph 1 (b) of Article 2 of the Act;

3.	Wet towels under subparagraph 1 (d) (ii) of Article 2 of the Act;

4.	Disposable diapers under subparagraph 1 (d) (iii) of Article 2 of the Act;

5.	Disposable panty liners under subparagraph 1 of attached Table 1 (excluding quasi-drugs prescribed in subparagraph 7 (a) of Article 2 of the Pharmaceutical Affairs Act).

Article 4 (Notification of Outcomes of Inspecting Imported Cleansing and Hygiene Products)

When the Minister of Food and Drug Safety notifies the outcomes of an inspection pursuant to Article 8 (4) of the Act, he or she shall notify the importer of cleansing and hygiene products of the outcomes of the inspection without delay, including the following matters:

1.	The name of a product subject to the inspection;

2.	The items, standards, and specifications of the inspection;

3.	The outcomes of the inspection by item of inspection;

4.	Procedures for disposing of products determined to be non-compliant;

5.	Methods to raise an objection to non-compliant results.

Article 5 (Visits, Inspections, and Collection)

(1)

When the Minister of Food and Drug Safety, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, a Special Self-Governing Province Governor (hereinafter referred to as "Mayor/Do Governor"), or the head of a Si/Gun/Gu (the head of a Gu refers to the head of an autonomous Gu; hereinafter the same shall apply) notifies the outcomes of an inspection pursuant to Article 14 (2) of the Act, he or she shall notify the relevant business operator of the methods of the inspection, and methods of collecting and handling specimens that are applied to the relevant inspection, and the outcomes of the inspection within seven days from the date of confirmation of such outcomes.

(2)	"Matters prescribed by Presidential Decree, such as the inspection period, the scope of inspections, persons in charge of inspections, and related statutes or regulations" in Article 14 (3) of the Act means the following matters:

1.	The objectives of inspections;

2.	The period and subject matters of inspections;

3.	The scope and details of inspections;

4.	The name and division of a person in charge of inspections;

5.	A list of materials subject to inspections;

6.	Statutes or regulations pertaining to inspections;

7.	Other matters necessary for the relevant inspection.

Article 6 (Matters to Be Stated in Documents Presented for Seizure or Discard)

"Matters prescribed by Presidential Decree, such as the inspection period, the scope of inspections, persons in charge of inspections, and related statutes or regulations" in Article 16 (3) of the Act means the following matters:

1.	The objectives of seizure and discard;

2.	The subject matters and period of seizure and discard;

3.	The name and division of a person in charge of seizure and discard;

4.	Matters concerning products subject to seizure and discard;

5.	Statutes or regulations pertaining to seizure and discard;

6.	Other matters necessary for seizure and discard.

Article 7 (Matters to Be Stated in Documents Presented When Taking Measures, Such as Removing Business Markings, Posting Notices, or Affixing Seals)

"Matters prescribed by Presidential Decree, such as the inspection period, the scope of inspections, persons in charge of inspections, and related statutes or regulations" in Article 19 (4) of the Act means the following matters:

1.	The objectives of taking measures, such as removing business markings, posting notices, etc., or affixing seals;

2.	The period and targets of taking measures, such as removing business markings, posting notices, etc., or affixing seals;

3.	The scope and details of taking measures, such as removing business markings, posting notices, etc., or affixing seals;

4.	The name and division of a person in charge of taking measures, such as removing business markings, posting notices, etc., or affixing seals;

5.	Statutes or regulations pertaining to taking measures, such as removing business markings, posting notices, etc., or affixing seals;

6.	Other matters necessary for taking measures, such as removing business markings, posting notices, etc., or affixing seals.

Article 8 (Standards for Calculating Penalty Surcharges Imposed in Lieu of Suspension of Business)

Standards for calculating the amounts of penalty surcharges by type of violation, degree of violation, etc., which are imposed pursuant to the main clause of Article 22 (1) of the Act, shall be as specified in attached Table 2.

Article 9 (Imposition and Payment of Penalty Surcharges)

(1)

When the Minister of Food and Drug Safety, a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu (hereinafter referred to as "imposing authority") imposes a penalty surcharge pursuant to Article 22 (1) of the Act, he or she shall give a written notice to the person subject to the imposition of a penalty surcharge to pay the penalty surcharge, specifying the type of the violation, the amount of the relevant penalty surcharge, etc.

(2)

A person notified pursuant to paragraph (1) shall pay the penalty surcharge to the receiving agency determined by the imposing authority, within 20 days from the date of receipt of the notice: Provided, That where it is impossible to pay a penalty surcharge within such period due to a natural disaster or other unavoidable causes, the penalty surcharge shall be paid within seven days from the date such cause ceases to exist.

(3)	A receiving agency in receipt of penalty surcharges pursuant to paragraph (2) shall issue receipts to the payers.

(4)	A receiving agency in receipt of a penalty surcharge pursuant to paragraph (2) shall notify the imposing authority of such fact without delay.

Article 10 (Persons Subject to Revocation of Imposition of Penalty Surcharge)

Persons for whom the imposing authority shall revoke the imposition of a penalty surcharge and suspend all or part of business or manufacturing or shall collect penalty surcharges in arrears in the same manner as delinquent national taxes are collected or pursuant to the Act on the Collection of Local Non-Tax Revenue under the main clause of Article 22 (4) of the Act shall be those who have received a reminder once for the failure to pay a penalty surcharge within the deadline but fail to pay the penalty surcharge within 15 days from the date of receipt of the reminder.

Article 11 (Publication of Violation)

Where the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu falls under any of the subparagraphs of Article 23 of the Act, he or she shall, without delay, publish the following matters in the website of the relevant agency or general daily newspapers registered pursuant to Article 9 (1) of the Act on the Promotion of Newspapers and distributed nationwide:

1.	A title indicating the publication of a violation of the Cleansing and Hygiene Products Control Act;

2.	The type of business;

3.	The name and location of a place of business and the name of the representative;

4.	The name of a product;

5.	A controlling agency, and the date of control or the date of detection;

6.	The details of a violation (including specific details of such violation and statutes or regulations serving as a legal basis);

7.	The details of administrative dispositions, and the date and period of dispositions;

8.	Other matters the Minister of Food and Drug Safety deems necessary.

Article 12 (Qualifications, Appointment, and Scope of Duties of Cleansing and Hygiene Products Sanitation Supervisors)

(1)

The Minister of Food and Drug Safety, Mayors/Do Governors, or the heads of Sis/Guns/Gus shall appoint cleansing and hygiene products sanitation supervisors prescribed in Article 26 of the Act from among their public officials having work experience in food sanitation administration, health and sanitary administration, medical care administration, pharmaceutical affair administration, etc.

(2)	The scope of duties of cleansing and hygiene products sanitation supervisors prescribed in Article 26 of the Act shall be as follows:

1.	Verification and inspection as to whether business operators comply with the criteria for facilities under Article 3 (1) and (2) of the Act;

2.	Verification as to whether business operators fulfill the obligation for compliance under Article 7 (1) of the Act;

3.	Inspection of imported cleansing and hygiene products under Article 8 (2) of the Act;

4.	Verification as to whether business operators receive sanitation education under Article 9 of the Act and provision of guidance thereon;

5.	Control of violation of labeling standards under Article 11 of the Act and prohibition of false labeling, etc. under Article 12 of the Act;

6.	Visits, inspections, and collection of products necessary for inspections under Article 14 of the Act;

7.	Seizure or discard of cleansing and hygiene products under Article 16 of the Act;

8.	Verification as to whether administrative dispositions under Articles 17 and 18 of the Act are implemented;

9.	Measures for removing business markings, etc. for the closure of places of business under Article 19 of the Act;

10.	Other duties concerning the management of cleansing and hygiene products, such as verification as to whether orders and obligations under this Act are complied with.

Article 13 (Delegation of Authority)

The Minister of Food and Drug Safety may delegate the following authority to the heads of regional offices of food and drug safety pursuant to Article 29 (1) of the Act:

1.	Receipt of reports on business importing cleansing and hygiene products, and notification of the grounds for delay in processing such reports under Article 3 of the Act;

2.	Receipt, etc. of reports on suspension of business, closure of business, and resumption of business under Article 4 of the Act;

3.	Receipt of reports on succession to status, and notification of the grounds for delay in processing such reports under Article 6 of the Act;

4.	Receipt of declarations on imported cleansing and hygiene products and inspection of such products under Article 8 of the Act;

5.	Reporting, visits, inspections, collection, etc. under Article 14 (1) of the Act;

6.	Notification of the outcomes of inspections under Article 14 (2) of the Act;

7.	Corrective orders under Article 15 of the Act;

8.	Seizure, discard, or orders for discard under Article 16 (1) and (2) of the Act;

9.	Orders for business suspension or closure of places of business under Article 17 of the Act;

10.	Measures for closure, etc. under Article 19 of the Act;

11.	Hearings under Article 21 of the Act;

12.	Imposition and collection of penalty surcharges under Article 22 of the Act;

13.	Matters concerning the operation of cleansing and hygiene products sanitation supervisors under Article 26 of the Act;

14.	Matters concerning the commissioning and operation of customer cleansing and hygiene products sanitation supervisors under Article 27 of the Act;

15.	Collection of fees under Article 30 of the Act;

16.	Imposition and collection of administrative fines under Article 34 (1) 1 and 4 of the Act.

Article 14 (Processing of Personally Identifiable Information)

Where inevitable to handle the following administrative affairs, the Minister of Food and Drug Safety (including the heads of regional offices of food and drug safety), Mayors/Do Governors, or the heads of Sis/Guns/Gus may process materials including resident registration numbers prescribed in subparagraph 1 of Article 19 of the Enforcement Decree of the Personal Information Protection Act and alien registration numbers prescribed in subparagraph 4 of that Article:

1.	Administrative affairs concerning reports on business under Article 3 of the Act;

2.	Administrative affairs concerning succession to the status of business operators under Article 6 of the Act;

3.	Administrative affairs concerning visits, inspections, collection, etc. under Article 14 of the Act;

4.	Administrative affairs concerning administrative dispositions under Articles 15 through 19 of the Act;

5.	Administrative affairs concerning hearings under Article 21 of the Act;

6.	Administrative affairs concerning the imposition and collection of penalty surcharges under Article 22 of the Act.

Article 15 (Standards for Imposing Administrative Fines)

Standards for imposing administrative fines under Article 34 (1) of the Act shall be as specified in attached Table 3.

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ENFORCEMENT DECREE OF THE CLEANSING AND HYGIENE PRODUCTS CONTROL ACT