Act No. 14837, Apr. 18, 2017
Article 1 (Purpose) |
Article 2 (Definitions) |
1. | The term "cleansing and hygiene products" means products that require special hygiene control to ensure public health and hygiene, as classified as follows: |
(a) | Any of the following cleaning products: |
(i) | Cleaning agents used to wash vegetables, fruits, etc.; |
(ii) | Cleaning agents used to wash food containers, food processing equipment, cooking utensils, etc.; |
(b) | Dishwasher rinse aids: Preparations used for auxiliary roles such as removing residues on dishware, promoting drying, etc. during the final rinse cycle of an automatic dishwasher; |
(c) | Hygiene wet towels: Pre-packaged wet towels used to wipe hands, etc. at places of business providing food services prescribed in Article 36 (1) 3 of the Food Sanitation Act; |
(d) | Other cleansing and hygiene products: |
(i) | Disposable cups, spoons, chopsticks, forks, knives, and straws; |
(ii) | Toilet paper, disposable kitchen paper or towels, paper napkins, and pre-packaged wet towels to wipe hands, etc. at places of business providing food services prescribed in Article 36 (1) 3 of the Food Sanitation Act; |
(iii) | Disposable toothpicks, swabs, and diapers; |
(iv) | Other items prescribed by Presidential Decree; |
2. | The term "business manufacturing cleansing and hygiene products” means manufacturing, processing and subdividing (referring to dividing complete products and repackaging them for distribution; hereinafter the same shall apply) cleansing and hygiene products, excluding hygiene wet towels, for selling or using in business operations; |
3. | The term "business importing cleansing and hygiene products" means a business importing cleansing and hygiene products, excluding hygiene wet towels, for selling or using in business operations; |
4. | The term "business processing hygiene wet towels" means a business pre-packaging and renting hygiene wet towels by processing them by means of cleaning, sterilizing, disinfecting, etc. (hereinafter referred to as "hygiene treatment"). |
Article 3 (Report on Businesses) |
(1) | Any person who intends to conduct a business manufacturing cleansing and hygiene products or a business processing hygiene wet towels shall report to the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
(2) | Any person who intends to conduct a business importing cleansing and hygiene products shall report to the Minister of Food and Drug Safety after being equipped with facilities that meet the criteria prescribed by Ordinance of the Prime Minister. The foregoing shall also apply when he/she intends to change any matter prescribed by Ordinance of the Prime Minister among the matters he/she has already reported. |
(3) | Upon receipt of a report on business referred to in paragraph (1) or (2), the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, the head of a |
(4) | When a person who has submitted a report on a business manufacturing cleansing and hygiene products pursuant to paragraph (1) intends to manufacture or process items prescribed by Presidential Decree as requiring special control aimed at protecting public health due to certain dangers, such as exposing humans to chemical substances, etc., he/she shall file a report thereon, stating the product name, ingredients, etc. of the relevant item, with the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, and the head of a |
(5) | Necessary matters for the contents, methods, procedures, etc. concerning a reports provided for in paragraph (1) or (2) shall be prescribed by Ordinance of the Prime Minister. |
Article 4 (Report, etc. on Suspending, Closing or Resuming Businesses) |
(1) | When a person who has filed a report pursuant to paragraph (3) (hereinafter referred to as “business operator”) intends to suspend, close or resume his/her business, he/she shall report it to the Minister of Food and Drug Safety or to the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province or the head of a |
(2) | Notwithstanding paragraph (1), any person who has been subjected to any administrative disposition prescribed in Articles 15 through 19, including suspension of business, shall not be allowed to report the closure of business during the period of the relevant administrative disposition. |
(3) | Where a report filed pursuant to paragraph (1) meets the formality requirements without any deficiency in the submitted written report or its accompanying documents, the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province or the head of a |
(4) | Where a business operator reports the closure of his/her business to the head of the competent tax office or the head of the competent tax office revokes business registration pursuant to Article 8 of the Value-Added Tax Act, the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province or the head of a |
(5) | Where necessary for |
(6) | Necessary matters for the contents, methods, procedures, etc. concerning a reports provided for in paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
Article 5 (Restrictions on Business Reports) |
1. | A person subjected to an order to close the place of business referred to in Article 17 (1) who intends to engage in another business of the same type as one subjected to the order to close the place of business at the same place within six months lapse from the issuance of such order; |
2. | A person (in cases of a corporation, including its representative) subjected to an order to close the place of business referred to in Article 17 (1) who intends to engage in another business of the same type as one subjected to the order to close the place of business within two years lapse from the issuance of such order. |
Article 6 (Succession to Status of Business Operators) |
(1) | Any of the following persons shall succeed to the status of the relevant business operator: |
1. | When the business operator dies: His/her heir; |
2. | When the business operator transfers his/her business: The transferee; |
3. | When the business operator which is a corporation mergers with another corporation: The corporation surviving or established after such merger. |
(2) | A person who has acquired all of the business facilities of a certain business operator in accordance with any of the following procedures shall succeed to the status of the relevant business operator. In such cases, any business report made by the former business operator shall lose its effects: |
1. | An auction pursuant to the Civil Execution Act; |
2. | Realization pursuant to the Debtor Rehabilitation and Bankruptcy Act; |
3. | Sale of seized property pursuant to the National Tax Collection Act, the Customs Act, or the Framework Act on Local Taxes; |
4. | Other procedures corresponding to procedures prescribed in subparagraphs 1 through 3. |
(3) | A person who has succeeded to the status of a business operator under paragraph (1) or (2) shall report such fact to the Minister of Food and Drug Safety or to the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province or the head of a |
(4) | Upon receipt of a report prescribed in paragraph (3), the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
(5) | Article 5 shall apply |
Article 7 (Matters to be Observed by Business Operators, etc. and Report on Performance) |
(1) | Every business operator and its employees shall comply with the matters prescribed by Ordinance of the Prime Minister to control the quality of cleansing and hygiene products, such as the hygiene management of business facilities, the hygienic storage and management of cleansing and hygiene products and their ingredients, etc. |
(2) | Every business operator engaged in the manufacturing, processing, subdividing, or hygiene treatment of cleansing and hygiene products shall report its performance records concerning the production, hygiene treatment, etc. of cleansing and hygiene products to the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
Article 8 (Declaration on and Inspection of Imported Cleansing and Hygiene Products) |
(1) | An importer of cleansing and hygiene products shall declare cleansing and hygiene products it intends to import for selling or using in its business operations to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. |
(2) | Before completing customs procedures for cleansing and hygiene products declared pursuant to paragraph (1), the Minister of Food and Drug Safety shall have the relevant public official or inspection institution conduct necessary inspections on them. |
(3) | Notwithstanding paragraph (2), the Minister of Food and Drug Safety may omit all or some inspections on cleansing and hygiene products declared pursuant to paragraph (1) if a written inspection outcome or inspection certificate is submitted, being issued after inspections by an institution specializing in testing and inspecting cleansing and hygiene products referred to in Article 6 (2) 6 of the Act on Testing and Inspection in the Food and Drug Industry; a testing and inspection institution prescribed by Ordinance of the Prime Minister pursuant to the proviso to paragraph (4) of the aforesaid Article; or an overseas testing and inspection institution designated by the Minister of Food and Drug Safety pursuant to Article 8 of the aforesaid Act. |
(4) | Where certain cleansing and hygiene products are found to fail to meet the standards and specifications provided for in Article 10 (1) while inspecting them pursuant to paragraph (2), the Minister of Food and Drug Safety shall notify the relevant business operator of the outcomes of such inspection as prescribed by Presidential Decree. |
(5) | Matters necessary for the types, targets, methods, procedures, etc. of inspections provided for in paragraphs (2) and (3) shall be prescribed by Ordinance of the Prime Minister. |
Article 9 (Sanitation Education) |
(1) | Any business operator shall undergo sanitation education each year. |
(2) | Any person who intends to report pursuant to Article 3 (1) or (2) shall undergo sanitation education in advance. In such cases, such person shall be deemed to have undergone sanitation education prescribed in paragraph (1) for the corresponding year. |
(3) | Notwithstanding the former part of paragraph (2), where any person is unable to undergo sanitation education in advance due to any of the reasons prescribed by Ordinance of the Prime Minister, he/she shall undergo sanitation education within six months from the date of commencing his/her business operation, as prescribed by the Minister of Food and Drug Safety. |
(4) | Any of the following persons among those required to undergo sanitation education under paragraphs (1) through (3) may designate a responsible person from among his/her employees and have such person undergo sanitation education on his/her behalf: |
1. | A person who engages in business at least two places; |
2. | A person who does not directly engage in business; |
3. | A person who is unable to undergo education due to any of the reasons prescribed by Ordinance of the Prime Minister such as natural disaster, his/her disease or accident, overseas business trip, etc. |
(5) | Matters necessary for institutions for providing education, contents of education, collection of expenses, etc. provided for in paragraphs (1) through (4) shall be prescribed by Ordinance of the Prime Minister. |
Article 10 (Standards and Specifications) |
(1) | Where it is deemed necessary for public health, the Minister of Food and Drug Safety may determine the standards and specifications concerning the ingredients, manufacturing methods, purposes of use, etc. of cleansing and hygiene products and publicly notify them. |
(2) | Notwithstanding paragraph (1), the standards and specifications for cleansing and hygiene products to be exported may follow the standards and specifications requested by importers. |
(3) | cleansing and hygiene products for which the standards and specifications have been established pursuant to paragraph (1) shall be manufactured, processed, subdivided, imported and hygiene-treated in accordance with such standards; and no cleansing and hygiene products that fail to meet such standards and specifications shall be sold or rented, nor be manufactured, processed, subdivided, imported, hygiene-treated, stored, displayed, transported, or used for business operations for the purpose of sale or rental. |
Article 11 (Standards for Labeling) |
(1) | The requirements necessary for the labeling of cleansing and hygiene products intended for sale or rental, such as product name, company name, the date of manufacture, etc., shall be prescribed by Ordinance of the Prime Minister. |
(2) | No hygiene product subject to the standards for labeling established pursuant to paragraph (1) that fails to prescribe the labeling in compliance with such standards shall be sold or rented, nor be manufactured, processed, subdivided, imported, hygiene-treated, stored, displayed, transported, or used for business for the purpose of sale or rental. |
Article 12 (Prohibition of False Labelling, etc.) |
(1) | No one shall place any of the following labels or advertisements regarding the ingredients, purposes of use or effects of cleansing and hygiene products: |
1. | Untrue or exaggerated labels or advertisement; |
2. | Labels or advertisements that are likely to deceive or mislead consumers; |
3. | Labels or advertisements that slander other enterprises or their products. |
(2) | The scope of labels or advertisements prohibited under paragraph (1) and other necessary requirements shall be determined by Ordinance of the Prime Minister. |
Article 13 (Self-Quality Inspection and Inspection by Entrustment) |
(1) | Any business operator who manufactures cleansing and hygiene products or processes hygiene wet towels shall examine whether cleansing and hygiene products they have manufactured, processed, subdivided or hygiene-treated meet the standards and specifications provided for in Article 10 (1), as prescribed by Ordinance of the Prime Minister. |
(2) | Where it is not practical for a business operator who manufactures cleansing and hygiene products or processes hygiene wet towels to directly conduct an inspection prescribed in paragraph (1), it may entrust the relevant inspection to an institution specializing in testing and examining cleansing and hygiene products referred to in Article 6 (2) 6 of the Act on Testing and Inspection in the Food and Drug Industry. |
(3) | After conducting an inspection prescribed in paragraph (1) or (2), a business operator who manufactures cleansing and hygiene products or processes hygiene wet towels shall keep the records on such inspection for two years from the date of inspecting the relevant products. |
(4) | Necessary requirements for the items, procedures, etc. for inspections provided for in paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. |
Article 14 (Visits, Inspections, Collection, etc.) |
(1) | Where it is deemed necessary for safety management of cleansing and hygiene products and for maintaining business order, the Minister of Food and Drug Safety, the Mayor of a Special Metropolitan City, the Mayor of a Metropolitan City, the Mayor of a Special Self-Governing City, |
(2) | Where certain cleansing and hygiene products are found to fail to meet the standards and specifications provided for in Article 10 (1) while inspecting them pursuant to paragraph (1), the Minister of Food and Drug Safety, a Mayor/ |
(3) | Any public official who intends to make visits, conduct inspections, or perform collection under paragraph (1) shall carry a certificate indicating his/her authority and a document stating matters prescribed by Presidential Decree, such as the inspection period, the scope of inspection, persons in charge of inspection, related statutes, etc., and present them to related persons. |
Article 15 (Corrective Orders) |
Article 16 (Disposition for Discard, etc.) |
(1) | The Minister of Food and Drug Safety, a Mayor/ |
(2) | The Minister of Food and Drug Safety, a Mayor/ |
(3) | Any public official who seizes or discards cleansing and hygiene products pursuant to paragraph (1) or (2) shall carry a certificate indicating his/her authority and a document stating matters prescribed by Presidential Decree, such as the inspection period, the scope of inspection, persons in charge of inspection, related statutes, etc.; and shall produce them to related persons. |
(4) | Necessary matters for seizing or discarding provided for in paragraph (1) or (2) shall be prescribed by Ordinance of the Prime Minister. |
Article 17 (Business Suspension or Closure of Places of Businesses) |
(1) | Where a business operator falls under any of the following, the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province or the head of a |
1. | When it has violated the facility criteria prescribed in Article 3 (1) or (2); |
2. | When it has failed to report on an alteration under the latter part of Article 3 (1) or the latter part of Article 3 (2); |
3. | When it has failed to report items prescribed in Article 3 (4); |
4. | When it has violated the matters to be observed by business operators provided for in Article 7 (1); |
5. | When it has failed to report imported cleansing and hygiene products provided for in Article 8 (1); |
6. | When it has sold or rented cleansing and hygiene products that fail to meet a relevant standard and specification; or has manufactured, processed, subdivided, imported, hygiene-treated, stored, displayed, transported, or used for business operations such cleansing and hygiene products for the purpose of sale or rental, in violation of Article 10 (3); |
7. | When it has sold or rented cleansing and hygiene products that fail to meet the labeling standards or has manufactured, processed, subdivided, imported, hygiene-treated, stored, displayed, transported, or used for business operations such cleansing and hygiene products for the purpose of sale or rental, in violation of Article 11 (2); |
8. | When it has violated its obligation not to affix false labeling, etc. provided for in Article 12 (1); |
9. | When it has failed to conduct an inspection provided for in Article 13 (1) or (2); |
10. | When it has failed to implement a corrective order prescribed in Article 15; |
11. | When it has violated an order for collection or discard prescribed in Article 16 (2); |
12. | When it has continued to operate its business in violation of an order for suspension of business. |
(2) | The detailed standards for suspending business or closing places of business pursuant to paragraph (1) shall be prescribed by Ordinance of the Prime Ministerial Decree, in consideration of the types, severity, etc. of violations. |
Article 18 (Suspension of Manufacturing Products, etc.) |
(1) | Where a business operator falls under any of the following, the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province or the head of a |
1. | When it has sold or rented cleansing and hygiene products that fail to meet the relevant standards and specifications or has manufactured, processed, subdivided, hygiene-treated, stored, displayed, transported, or used for business operations such cleansing and hygiene products for the purpose of sale or rental, in violation of Article 10 (3); |
2. | When it has sold or rented cleansing and hygiene products that fail to meet the labeling standards or has manufactured, processed, subdivided, hygiene-treated, stored, displayed, transported, or used for business operations such cleansing and hygiene products for the purpose of sale or rental, in violation of Article 11 (2); |
3. | When it has violated its obligation not to affix false labeling, etc. provided for in Article 12 (1); |
4. | When it has failed to conduct an inspection provided for in Article 13 (1) or (2). |
(2) | The detailed standards for suspending manufacturing products or kinds of products pursuant to paragraph (1) shall be prescribed by Ordinance of the Prime Ministerial Decree, in consideration of the types, severity, etc. of violations. |
Article 19 (Measures for Closure, etc.) |
(1) | Where any business operator continues to conduct its business after receiving an order to close its place of business prescribed in Article 17 (1), the Minister of Food and Drug Safety, the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
1. | Removing the signboard or other business markings of the relevant place of business; |
2. | Posting notice, etc. indicating that the relevant place of business is not a lawful place of business; |
3. | Sealing for making facilities of the relevant place of business or its apparatuses, etc. used for its business operations unavailable. |
(2) | After taking any measure provided for in paragraph (1) 2 or 3, the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
1. | When the posted notice, etc. or seal is deemed no longer necessary; |
2. | When the relevant business operator or its agent requests the elimination of the post, seal, etc. based on justifiable grounds. |
(3) | Where the Minister of Food and Drug Safety, the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
(4) | Every public official who takes any measure prescribed in paragraph (1), such as removing business markings, posting notice, etc., and affixing seals, shall carry a certificate indicating his/her authority and a document stating matters prescribed by Presidential Decree, such as the inspection period, the scope of inspection, persons in charge of inspection, related statutes, etc., and produce them to related persons. |
Article 20 (Succession to Effects of Administrative Sanctions) |
Article 21 (Hearings) |
Article 22 (Imposition of Penalty Surcharges in Lieu of Dispositions such as Business Suspension, etc.) |
(1) | Where a business operator falls under any subparagraph of Article 17 (1) or any subparagraph of 18 (1), the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
(2) | The amount of penalty surcharges depending on the types, severity, etc. of violations subject to penalty surcharges under paragraph (1), and other necessary matters shall be prescribed by Presidential Decree. |
(3) | Where necessary to collect penalty surcharges, the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
1. | Personal information of taxpayers; |
2. | Purpose of use; |
3. | Amount of sales which serves as the basis for the imposition of penalty surcharges. |
(4) | Where a business operator fails to pay a penalty surcharge prescribed in paragraph (1) by a deadline, the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing City, the Governor of a Special Self-Governing Province, or the head of a |
(5) | The amount of penalty surcharges imposed and collected under paragraph (1) or (4) shall revert to the State or the local government where the relevant imposition and collection authority belongs. |
Article 23 (Publication of Violations) |
1. | When cleansing and hygiene products have been seized or discarded pursuant to Article 16 (1) or (2); |
2. | When an order to suspend business or an order to close the place of business has been issued pursuant to Article 17 (1). |
Article 24 (Establishment of Business Operators’ Organization) |
(1) | Business operators may establish an business operators’ organization (hereinafter referred to as "organization") for the purpose of promoting sound development of their business and improving public health. |
(2) | Any organization established under paragraph (1) shall be a body corporate. |
(3) | The provisions regarding the incorporated association in the Civil Act shall apply |
Article 25 (Reinspection of Cleansing and Hygiene Products) |
Article 26 ( Cleansing and Hygiene Products Sanitation Supervisors) |
Article 27 (Customer Cleansing and Hygiene Products Sanitation Supervisors) |
Article 28 (State Subsidies) |
1. | Expenses incurred in conducting education prescribed in Article 9 (1) through (3); |
2. | Expenses incurred in collection prescribed in Article 14 (1); |
3. | Expenses incurred in discarding products prescribed in Article 16 (1) or (2). |
Article 29 (Delegation or Entrustment of Authority) |
(1) | The authority of the Minister of Food and Drug Safety vested under this Act may be partially delegated to the head of an institution under his/her jurisdiction, a Mayor/ |
(2) | The Minister of Food and Drug Safety may partially entrust his/her duties prescribed in this Act to a relevant specialized institution as prescribed by Presidential Decree. |
Article 30 (Fees) |
1. | A person who files a report or an alteration report pursuant to Article 3 (1) or (2); |
2. | A person who files a report pursuant to Article 6 (3); |
3. | A person inspected pursuant to Article 8 (2). |
Article 31 (Legal Fiction as Public Official in Applying Penalty Provisions) |
Article 32 (Penalty Provisions) |
1. | A person who has conducted business without facilities prescribed in Article 3 (1) or (2); |
2. | A person who has conducted business without reporting prescribed in the former part of Article 3 (1) or the former part of Article 3 (2); |
3. | A person who has failed to report the succession to the status of a business operator prescribed in Article 6 (3); |
4. | A person who has violated any of the matters to be observed by business operators provided for in Article 7 (1): |
5. | A person who has imported cleansing and hygiene products without filing a report prescribed in Article 8 (1); |
6. | A person who has sold or rented cleansing and hygiene products that fail to meet the relevant standards or specifications, or has manufactured, processed, subdivided, imported, hygiene-treated, stored, displayed, transported, or used for business operations such cleansing and hygiene products for sale or rental, in violation of Article 10 (3); |
7. | A person who has sold or rented hygiene product that fails to meet any of the labeling standards, or has manufactured, processed, subdivided, imported, hygiene-treated, stored, displayed, transported, or used for business operations such cleansing and hygiene products for the purpose of sale or rental, in violation of Article 11 (2); |
8. | A person who has violated the obligation not to affix false labels, etc. prescribed in Article 12 (1): |
9. | A person who has failed to conduct an inspection provided for in Article 13 (1) or (2); |
10. | A person who has refused, obstructed or evaded the visit, inspection, collection, etc. by the relevant public officials provided for in Article 14 (1); |
11. | A person who has refused, obstructed or evaded the seizure or discarding products by the relevant public officials provided for in Article 16 (1) or (2); |
12. | A person who has failed to comply with an order for collection or discard provided for in Article 16 (2); |
13. | A person who has conducted business in violation of an order to suspend business or close the place of business provided for in Article 17 (1); |
14. | A person who has removed or damaged notice or seal, etc. provided for in Article 19 (1). |
Article 33 (Joint Penalty Provisions) |
Article 34 (Administrative Fines) |
(1) | Any of the following persons shall be punished by an administrative fine not exceeding one million won: |
1. | A person who has failed to alter report in violation of the latter part of Article 3 (1) or the latter part of Article 3 (2); |
2. | A person who has failed to report or made a false report in violation of Article 3 (4); |
3. | A person who has failed to report or made a false report in violation of Article 7 (2); |
4. | A person who has failed to receive sanitation education in violation of Article 9 (1) through (3); |
5. | A person who has failed to retain records in violation of Article 13 (3). |
(2) | Administrative fines prescribed in paragraph (1) shall be imposed and collected by the Minister of Food and Drug Safety, a Mayor/ |