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ENFORCEMENT RULE OF THE COSMETICS ACT

Wholly Amended by Ordinance of the Prime Minister No. 110, Feb. 24, 2012

Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013

Ordinance of the Prime Minister No. 1046, Dec. 6, 2013

Ordinance of the Prime Minister No. 1074, Apr. 1, 2014

Ordinance of the Prime Minister No. 1088, Aug. 20, 2014

Ordinance of the Prime Minister No. 1097, Sep. 24, 2014

Ordinance of the Prime Minister No. 1120, Jan. 6, 2015

Ordinance of the Prime Minister No. 1154, Apr. 2, 2015

Ordinance of the Prime Minister No. 1182, Jul. 29, 2015

Ordinance of the Prime Minister No. 1297, jun. 30, 2016

Ordinance of the Prime Minister No. 1322, Sep. 9, 2016

Ordinance of the Prime Minister No. 1357, Jan. 12, 2017

Ordinance of the Prime Minister No. 1405, Jul. 31, 2017

 Article 1 (Purpose)
The purpose of these Rules is to prescribe matters delegated by the Cosmetics Act and its Decree, and other matters necessary for the enforcement thereof.
 Article 2 (Scope of Functional Cosmetics)
“Cosmetics determined by Ordinance of the Prime Minister” in subparagraph 2 of Article 2 of the Cosmetics Act (hereinafter referred to as "the Act"), other than its items, means the following: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1357, Jan. 12, 2017>
1. Cosmetics which have efficacy helpful in skin-whitening by curbing the formation of marks, freckles, etc. through prevention of skin pigmentation of melanin;
2. Cosmetics which have efficacy helpful in skin-whitening by fading melanin pigmentation in skin;
3. Cosmetics which have efficacy in smoothing or improving skin wrinkles by firming skin;
4. Cosmetics which have efficacy in tanning skin gently by screening strong sun light;
5. Cosmetics which have efficacy in protecting skin from ultraviolet rays by intercepting or scattering them;
6. Cosmetics with the function of changing (including the function of bleaching or removing) the color of hair: excluding: however, the products which temporarily change the color of hair;
7. Cosmetics with the function of removing body hair: excluding, however, products which remove body hair in a physical manner;
8. Cosmetics which help alleviate alopecia: excluding, however, products which make hair look thick in a physical manner such as coating;
9. Cosmetics which help alleviate acneiform skin conditions: limited, however, to kinds of products for cleaning human body;
10. Cosmetics which help alleviate dryness caused by atopic skin;
11. Cosmetics which help thinning red lines caused by striae distensa.
 Article 3 (Registration, etc. of Manufacturing Business)
(1) Persons required to be registered as a manufacturer under Article 3 (1) of the Act (hereinafter referred to as a "manufacturer") shall be as follows: <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. A person who intends to directly manufacture cosmetics;
2. A person who intends to manufacture cosmetics on consignment;
3. A person who intends to conduct packaging or labelling process only (excluding the secondary packaging or labelling process).
(2) A person who intends to make a registration of manufacturing business pursuant to paragraph (1) shall submit an application (including an application in the form of an electronic document) for cosmetic manufacturing business in Appendix 1 to the head of a local food and drug safety office having jurisdiction over the location of the manufacturing factory, together with the following documents (including electronic documents):
1. A diagnostic certificate of a specialized medical doctor, which evidences that the manufacturer (referring to the representative in cases of a corporation; hereafter the same shall apply in this paragraph) does not falls under the main sentence of Article 3 (2) 1 of the Act, or a diagnostic certificate of a medical doctor, which evidences that the manufacturer falls under the proviso of Article 3 (2) 1 of the Act;
2. A diagnostic certificate of a medical doctor, which evidences that the manufacturer does not fall under Article 3 (2) 3;
3. A document stating the specifications of facilities.
(3) The head of a local food and drug safety office in receipt of an application pursuant to paragraph (2) shall verify the certificate of registered matters of the corporation (limited to where the applicant is a corporation) through administrative data matching under Article 36 (1) of the Electronic Government.
(4) Where requirements for registration under paragraph (2) are satisfied, the head of a local food and drug safety office shall record the following matters in the register of cosmetics manufacturing business and issue a certificate of completed registration of cosmetics manufacturing business of Attached Table 'Form No. 2' (hereinafter referred to as a "certificate of completed registration of manufacturing business"): <Amended by Ordinance of the Prime Minister No. 1097, Sep. 24, 2014>
1. Registration number and registration date;
2. Name and birth date of the manufacturer (referring to the name and birth date of the representative where the applicant is a corporation);
3. Trade name of the manufacturer (referring to the name of the corporation where the applicant is a corporation);
4. Location of the manufacturing factory;
5. Type of manufacturing.
 Article 4 (Registration, etc, of Manufacturing and Sales Business)
(1) Persons required to be registered as a manufacturer-seller under Article 3 (1) of the Act (hereinafter referred to as “manufacturer-seller”) shall be as follows:
1. A person who intends to distribute and sell cosmetics directly manufactured;
2. A person who intends to distribute and sell cosmetics manufactured by outsourcing the manufacturing thereof;
3. A person who intends to distribute and sell imported cosmetics;
4. A person who intends to recommend or provide cosmetics for the purpose of vicarious importation (only for electronic transactions).
(2) Each person who intends to make a registration of a manufacturing and sales business pursuant to paragraph (1) shall submit an application (including an application in the form of electronic document) for cosmetic manufacturing and sales business in Appendix 3 to the head of a local food and drug safety office having jurisdiction over the location of the manufacturing and sales business place, together with the following documents (the following documents need not to be submitted in cases falling under paragraph (1) 4): <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. and 2 Deleted.; <by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
3. Regulations on the standards suitable for the quality control of cosmetics, and the safety management thereof after sale under Article 3 (4) of the Act;
4. A document through which it is possible to verify the qualification for a manufacture-sales manager under Article 3 (5) of the Act (hereinafter referred to as a "manufacture-sales manager").
(3) The head of a local food and drug safety office in receipt of an application under paragraph (2) shall verify the certificate of registered matters of the corporation (limited to where the applicant is a corporation) through administrative data matching under Article 36 (1) of the Electronic Government.
(4) Where requirements for registration under paragraph (2) are satisfied, the head of a local food and drug safety office shall record the following matters in the register of cosmetics manufacturing and sales business and issue a certificate of completed registration of cosmetics manufacturing and sales business in Appendix 4 (hereinafter referred to as a "certificate of completed registration of manufacturing and sales business“): <Amended by Ordinance of the Prime Minister No. 1097, Sep. 24, 2014>
1. Registration number and registration date;
2. Name and birth date of the manufacture the manufacturer (referring to the name and birth date of the representative where the applicant is a corporation);
3. Trade name of the manufacturer-seller (referring to the name of the corporation where the applicant is a corporation);
4. Location of the manufacturing and sales business place;
5. Name and birth date of the manufacture-sales manager;
6. Type of the manufacturing and sales.
 Article 5 (Registration of Changes in Manufacturing Business, etc.)
(1) The cases where a manufacturer or a manufacturer-seller is required to file for registration of a change pursuant to the latter part of Article 3 (1) of the Act shall be as follows: <Amended by Ordinance of the Prime Minister No. 1097, Sep. 24, 2014>
1. Where the manufacturer falls under any of the following:
(a) Change of the manufacturer (in cases of a corporation, change of the representative thereof);
(b) Change of the trade name of the manufacturer (in cases of a corporation, change of the name thereof);
(c) Change of the location of the manufacturing factory;
(d) Change of the type of manufacturing.
2. Where a manufacturer-seller falls under any of the following:
(a) Change of the manufacturer-seller (in cases of a corporation, change of the representative thereof);
(b) Change of the trade name of a manufacturer-seller (in cases of a corporation, change of the name thereof);
(c) Change of the location of the manufacturing and sales business place;
(d) Change of the manufacture-sales manager;
(e) Change of the type of manufacturing and sale.
(2) In cases of filing for registration of change under paragraph (1), a manufacturer or a manufacturer-seller shall submit an application for registration of change in a cosmetics manufacturing business in Appendix 5 (including an application in the form of an electronic document) or an application for registration of change in cosmetics manufacturing and sales business in Appendix 6 (including an electronic document) to the head of a local food and drug safety office, together with the certificate of completed registration of manufacturing business or the certificate of completed registration of manufacturing and sales business and other relevant document categorized in the following. In such cases, where the location of the manufacturing factory or manufacturing and sales business place is changed, resulting in the change of the competent registration office, they shall be submitted to the head of a local food and drug safety office having jurisdiction over the new location: <Amended by Ordinance of the Prime Minister No. 1097, Sep. 24, 2014; Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. The following documents, in cases of change (in cases of a corporation, change of the representative thereof) of a manufacturer or a manufacturer-seller:
(a) A document falling under Article 3 (2) 1 (only manufacturers shall submit it);
(b) A document falling under Article 3 (2) 2 (only manufacturers shall submit it);
(c) A document evidencing the transfer and acquisition in cases of the transfer and acquisition of the rights;
(d) A certificate of family relations under Article 15 (1) 1 of the Act on the Registration, etc, of Family Relationship, in cases of succession;
2. In cases of change of the location of the manufacturing factory (excluding where administrative districts are restructured): a document falling under Article 3 (2) 3;
3. In cases of change of a manufacturer-seller, a document falling under Article 4 (2) 4 (excluding a manufacture-sales manager assigned by a manufacturer-seller under Article 4 (1) 4);
4. In cases of change of the type of manufacturing or the type of manufacturing and sales falling under the following:
(a) Where a person who has obtained registration of the type of manufacturing prescribed in Article 3 (1) 3 changes such type into the type of manufacturing prescribed in subparagraph 1 or 2 of the same paragraph or add the type of manufacturing prescribed in subparagraph 1 or 2 of the same paragraph: a document falling under Article 3 (2) 3;
(b) Where a person who has obtained registration of the type of manufacturing and sales falling under Article 4 (1) 4 changes such type into the type of manufacturing and sales prescribed in subparagraph 1, 2 or 3 of the same paragraph or add the type of manufacturing and sales prescribed in subparagraph 1, 2 or 3 of the same paragraph: documents falling under Article 4 (2) 3 and 4.
(3) The head of a local food and drug safety office in receipt of an application for change of registration in manufacturing business or an application for change of registration in manufacturing and sales business pursuant to paragraphs (1) and (2) shall verify the certificate of the registered matters of the corporation (limited to where the applicant is a corporation) through administrative data matching under Article 36 (1) of the Electronic Government.
(4) The head of a local food and drug safety office shall, after verifying the subject-matters of the application for change of registration under paragraphs (2) and (3), record the respective changed matters in the registration edger of cosmetics manufacturing business or the register of cosmetics manufacturing and sales business, and shall issue a certificate of completed registration of manufacturing business or a certificate of completed registration of manufacturing and sales business after entering such changed matters on the backside of such certificate.
 Article 6 (Standards for Facilities, etc.)
(1) The facilities with which a manufacturer is required to be equipped pursuant to the main sentence of Article 3 (3) of the Act shall be as follows:
1 A manufacturing factory equipped with the following, in which manufacturing works are performed:
(a) Facilities for preventing rats, vermin, and dust;
(b) Facilities and apparatuses necessary for manufacturing, such as worktables, etc.;
(c) Facilities removing powder, in cases of a workroom where powder scatters;
2. A storage place in which raw materials, other materials and products are stored;
3. A Laboratory necessary for the quality inspection of raw materials, other materials and products;
4. Facilities and apparatuses necessary for quality inspections.
(2) Notwithstanding paragraph (1), in any of the following cases, a part of the facilities may be omitted as categorized as follows: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1088, Aug. 20, 2014>
1. Where a manufacturer only performs a part of manufacturing process, facilities and apparatuses other than those necessary for the relevant process;
2. In cases of outsourcing quality inspections of raw materials, other materials and products to any of the following institutions, etc., facilities and apparatuses falling under paragraph (1) 3 and 4:
(a) The Public Health and Environment Research Institute under Article 2 of the Public Health and Environment Research Institute Act;
(b) A manufacturer equipped with a laboratory under paragraph (1) 3;
(c) A cosmetics test and inspection institution under Article 6 of the Act on Testing and Inspection in the Food and Drug Industry;
(d) The Korea Pharmaceutical Traders Association, being an incorporated association incorporated pursuant to Article 67 of the Pharmaceutical Affairs Act.
(3) A manufacturer may manufacture any products other than cosmetics, by using the facilities for manufacturing cosmetics: Provided, that this shall not apply where the contamination among products is liable to occur.
 Article 7 (Standards for Quality Control of Cosmetics and other Related Matters)
Standards for quality control of cosmetics under Article 3 (4) of the Act shall be as listed in attached Table 1, and standards for safety management after manufacturing and sales shall be as listed in attached Table 2.
 Article 8 (Standards for Qualifications for Manufacture-Sales Manager, and other Related Matters)
(1) A manufacture-sales manager whom an operator pf manufacturing and sales business (excluding a manufacturer-seller under Article 4 (1) 4) is required to assign pursuant to Article 3 (4) of the Act shall be any of the following persons: <Amended by Ordinance of the Prime Minister No. 1046, Dec. 6, 2013; Ordinance of the Prime Minister No. 1097, Sep. 24, 2014; Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. A medical doctor under the Medical Service Act or a pharmacist under the Pharmaceutical Affairs;
2. A person who obtained a bachelor's degree or higher (including persons who are recognized to have academic background equivalent to or higher than a bachelor's degree pursuant to any Act or subordinate statute; hereinafter the same shall apply in this Article) in a school under each subparagraph of Article 2 of the Higher Education Act (excluding a junior college under subparagraph 4 of the same Article; hereafter referred to as "a college, university, etc." in this Article) and who majored in a field of science and engineering (referring to a field of science and engineering under subparagraph 1 of Article 2 of the Special Act on Support of Scientists and Engineers for Strengthening National Science and Technology Competitiveness) or in cosmeticology, cosmetic science, Korean traditional medicine, or Korean traditional pharmacy;
3. A person who is a graduate from a junior college (including a person recognized to have academic background corresponding to or higher than such graduate in any Act or subordinate statute) under subparagraph 4 of Article 2 of the Higher Education (hereafter referred to as "a junior college" in this Article) and has at least one year’s experience in the affairs of the manufacture, or quality management of cosmetics; who majored in a cosmetics-related field, such as chemistry, biology, chemical engineering, biological engineering, microbiology, biochemistry, life science, biomedical engineering, genetic engineering, cosmeticology, cosmetic science, Korean traditional medicine, and Korean traditional pharmacy (hereinafter referred to as a "cosmetic-related field");
4. Other person who has at least two years’ experience in the affairs of the manufacture, or quality control of cosmetics;
5. and 6. Deleted. <by Ordinance of the Prime Minister No. 1097, Sep. 24, 2014>
(2) A manufacture-sales manager shall perform the following affairs:
1. Affairs of quality control in conformity with standards for quality control under attached Table 1;
2. Affairs for ensuring safety under standards for safety management under Attached Table 2;
3. Affairs for managing and supervising a manufacturer with respect to necessary tests, inspections, or examinations from the warehousing of raw materials and other materials to the release of finished products.
(3) Where a manufacturer-seller (in cases of a corporation, referring to the representative thereof) who conducts a manufacturing and sales business with not more than 10 full-time workers falls under any of the subparagraphs of paragraph (1), he/she may directly perform affairs of a manufacture-sales manager. In such cases, a manufacture-sales manager under Article 3 (4) of the Act shall be deemed to be assigned. <by Ordinance of the Prime Minister No. 1046, Dec. 6, 2013; Ordinance of the Prime Minister No. 1297, Jun. 30, 2016>
 Article 9 (Examination of Functional Cosmetics)
(1) An manufacturer-seller who intends to sell functional cosmetics (excluding those functional cosmetics subject to reporting pursuant to Article 10; hereafter the same shall apply in this Article) after manufacturing or importing them pursuant to Article 4 (1) of the Act shall undergo an examination by the Director General of the National Institute of Food and Drug Safety Evaluation, by submitting a written request for examination of functional cosmetics in Appendix 7 (including a written request for examination in the form of an electronic document) for each item of such cosmetic thereof, together with the following documents (including electronic documents): Provided, That in cases of items for which the Minister of Food and Drug Safety determines and publicly notifies the ingredients and contents expressing efficacy and effects of the following products, data under subparagraph 5 need not be submitted: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1046, Dec. 6, 2013>
1. Data concerning the origin and explanations on development;
2. Data concerning the safety:
(a) Data of single dose toxicity tests;
(b) Data of primary skin irritation tests;
(c) Data of eye mucous membrane irritation or other mucous membrane irritation tests;
(d) Data of skin sensitization tests;
(e) Data of phototoxicity and photosensitization tests;
(f) Data of human insult patch tests;
3. Data concerning efficacy or functions:
(a) Data of effects tests;
(b) Data of human trials;
4. Evidential data for establishing ultraviolet ray-protection factor and the protection grade of ultraviolet A (limited to those cosmetics which have efficacy in protecting skin against ultraviolet rays by screening or scattering them);
5. Data (including clinical specimen) concerning standards and testing methods.
(2) Notwithstanding paragraph (1), where intending to undergo an examination under paragraph (1) as a result of the transfer and acquisition of the rights concerning any functional cosmetics for which an examination has been completed pursuant to Article 4 (1) of the Act, the contract for such transfer and acquisition may be submitted in lieu of documents to be attached pursuant to the subparagraphs of paragraph (1).
(3) A person who intends to change any matter examined pursuant to paragraph (1) submit a written request for examination of change concerning any functional cosmetics in Appendix 8 (including a written request in the form of an electronic document) to the Director General of the National Institute of Food and Drug Safety Evaluation, together with the following documents (including electronic documents):<Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. The initially issued written notification of the findings from examination of functional cosmetics;
2. Documents proving the clause for the relevant change.
(4) The Director General of the National Institute of Food and Drug Safety Evaluation, in receipt of a written request for examination or a written request for examination of change pursuant paragraph (1) or (3), shall conduct the examination on the basis of the following standards for examination: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. The raw materials and their doses of functional cosmetics shall be reasonable and appropriate when taking into consideration the data concerning the efficacy and effects of such raw materials, and the significance of the compounding of respective ingredients shall be recognized;
2. The efficacy and effects of functional cosmetics shall be suitable for each item of subparagraph 2 of Article 2 of the Act;
3. The methods of use and optimal dosage of functional cosmetics shall be definitely expressed so as not to be misused.
(5) After conducting an examination pursuant to paragraphs (1) through (4), the Director General of the National Institute of Food and Drug Safety Evaluation shall record the following matters in an examination ledger and issue a written notification of the result of the examination or examination of change concerning functional cosmetics in Appendix 9: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. The examination number and the examination date or the date of examination of change;
2. The trade name (for a corporation, referring to its name) and location of the manufacturer-seller;
3. The name of the product;
4. Efficacy and effects.
(6) Detailed matters concerning the scope, requirements, methods of preparing attached documents under paragraphs (1) through (4), the scope of exemption from submission and the standards for examination shall be determined by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1046, Dec. 6, 2013>
 Article 10 (Functional Cosmetics, etc. Requiring the Submission of Report)
(1) The functional cosmetics, etc. subject to submission of a report to the Director General of the National Institute of Food and Drug Safety Evaluation in lieu of an examination of functional cosmetics pursuant to Article 4 (1) shall be as follows: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1046, Dec. 6, 2013; Ordinance of the Prime Minister No. 1405, Jul. 31, 2017>
1. Functional cosmetics whose kinds and ingredients, efficacy and effects, methods of use and optimal dosage, standards and testing methods are the same as those of any item publicly notified by the Minister of Food and Drug Safety;
2. Items the same as any functional cosmetics having already undergone an examination [only limited to functional cosmetics whose manufacturer-sellers are one and the same or whose manufacturers (limited to where the manufacturers have manufactured them in a manner of designing, developing and producing them) are one and the same] with respect to the following matters: Provided, That with respect to any functional cosmetics falling under any of subparagraphs 1 through 3 and 8 through 11 of Article 2, this shall apply only where the efficacy of the already examined items is proven through the experiments comparing with the control group (referring to those things from which the ingredients displaying the efficacy and effects of such functional cosmetics are removed):
(a) The kinds, standards, and contents (densities in cases of liquids) of those raw materials displaying the efficacy and effects;
(b) The efficacy and effects (in cases of functional cosmetics falling under any of subparagraphs 4 and 5 of Article 2, if their measured values of sun protection factor (SPF) are within the band not exceeding minus 20 percent, they are deemed to have the same efficacy and effects);
(c) Standards (excluding pH-related standards) and testing methods;
(d) Methods of use and optimal dosage;
(e) The dosage form (in cases of functional cosmetics falling under any of subparagraphs 1 through 3 and 6 through 11 of Article 2, liquid form and lotion form shall be deemed the same form).
(2) a manufacturer-seller who intends to manufacture or import and sell functional cosmetics under paragraph (1) shall submit a report of those items excluded from the examination of functional cosmetics in Appendix 10 (including a report in the form of an electronic document) for respective items to the Director General of the National Institute of Food and Drug Safety Evaluation. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
(3) After confirming the satisfaction of requirements under paragraph (1), the Director General of the National Institute of Food and Drug Safety Evaluation in receipt of a report pursuant to paragraph (2) shall record the following matters in the ledger of reports of functional cosmetics: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. Reporting number and reporting date;
2. The trade name (in cases of a corporation, the name thereof) and location of the manufacturer-seller;
3. The product name;
4. Efficacy and effects.
 Article 11 (Matters to be Observed by Manufacturer-Sellers)
Those matters to be observed by manufacturer-sellers pursuant to Article 5 (1) of the Act shall be as follows (in cases of manufacturer-sellers under Article 4 (1) 4, only subparagrph 1, 2, 4 (a), (c), (g) and (j) and 10 shall apply): <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1046, Dec. 6, 2013; Ordinance of the Prime Minister No. 1154, Apr. 2, 2015>
1. To comply with standards for quality control prescribed in attached Table 1;
2. To comply with standards for safety management after manufacturing and sales prescribed in attached Table 2:
3. To preserve the written product standards and the written quality control record (including an electronic form) received from the manufacturer;
4. To state the following matters on imported cosmetics or prepare and preserve the attached written import and management record:
(a) The product name, and the name intended to be used in selling the imported cosmetics;
(b) The standards and ingredients;
(c) The manufacturing country and the name and location of the manufacturing company;
(d) A copy of the written notification of the findings from examination of the functional cosmetics;
(e) The certificate of manufacturing and sales: Provided, That it may be omitted where having received the confirmation that the said imported cosmetics are the same as those cosmetics imported by a manufacturer-seller who has a certificate of manufacturing and sales, from an institution confirming the requirements for export and import in the consolidated public notice under Article 12 (2) of the Foreign Trade Act, and having been issued a test record from an institution under Article 6 (2) 2 (a), (c), or (d) after having received from such institution, an inspection based on the standards for quality control which are established by the manufacturer-seller;
(f) A copy of the product guide written in the Korean language;
(g) The initial importing date (referring to the date of customs clearance hereafter the same shall apply in this subparagraph);
(h) Dates and quantities of importation by manufacturer serial number;
(i) Quality inspection dates and results by manufacturer serial number;
(j) Selling stores, and the date and quantities of sale;
5. To distribute products after conducting a quality inspection by manufacturer serial numbers: Provided, That the a quality inspection may be omitted in cases where the manufacturer and the manufacturer-seller are one and the same or where having obtained the results of quality inspections by outsourcing the quality inspections to any institute falling under any of the items of Article 6 (2) 2;
6. Where outsourcing the manufacture of the cosmetics or outsourcing the quality inspections to the manufacturer under Article 6 (2) 2 (b), to thoroughly manage and supervise a consignee for securing that the manufacture or quality inspection of cosmetics is properly performed, to receive, keep and manage the records of the manufacture or quality inspections, and to thoroughly control the quality of the end products;
7. Notwithstanding subparagraph 5, a manufacturer-seller under Article 4 (1) 3 may omit a quality inspection in the Republic of Korea where it is recognized that the standards for quality control of the manufacturing company in the manufacturing country have been mutually certified between the Republic of Korea and the manufacturing country, or that such standards are equal to or higher than the standards for manufacture management publicly announced by the Minister of Food and Drug Safety pursuant to Article 12 (2). In such cases, the results of quality inspection shall be replaced by the written record of quality management;
8. A manufacturer-seller under Article 4 (1) 3 shall, whee choosing not to undergo a quality inspection for imported cosmetics pursuant to subparagraph 7, file an application for the performance of on-site verification concerning the manufacturer of the imported cosmetics with the Minister of Food and Drug Safety as prescribed by the Minister of Food and Drug Safety. Application procedures, documents to be submitted, assessment methods, etc. necessary for the on-site verification shall be determined and publicly notified by the Minister of Food and Drug Safety;
8-2. Where the certification under subparagraph 7 is cancelled owing to the fact that the standards for quality control of the manufacturing company of the cosmetics certified pursuant to subparagraph 7 is not recognized to be at least equal to the standards for manufacture management of good cosmetics under Article 12 (2), the quality inspection under the main sentence of subparagraph 5 shall be conducted. In such cases, the detailed matters necessary for the cancellation of the certification shall be determined and publicly notified by the Minister of Food and Drug Safety;
9. To comply with the guidances on the export and import under the Foreign Trade Act and to make a standard customs clearance forecast report as an electronic trade document under the Electronic Trade Facilitation Act, in cases of a manufacturer-seller falling under Article 4 (1) 3;
10. To make a report and prepare necessary safety countermeasures as determined and publicly notified by the Minister of Food and Drug Safety upon becoming aware of the new data, information (including the occurrences of side effects caused by the uses of the cosmetics), etc. concerning safety and efficacy, which is liable to directly effect the citizens' health with respect to the product;
11. In cases of a product containing any of the following ingredient, the content of which is at least 0.5 percent, to preserve test data on safety of the relevant item for one year from the expiry date of the usable period of the finally manufactured product:
(a) Retinol (Vitamin A) and its derivatives;
(b) Ascorbic acid (Vitamin C) and its derivatives;
(c) Tocopherol (Vitamin E);
(d) Hydrogen peroxide;
(e) Enzyme.
 Article 12 (Matters to be Observed by Manufacturer, etc.)
(1) Those matters to be observed by a manufacturer of cosmetics pursuant to Article 5 (2) of the Act shall be as follows:
1. To comply with the guidance, supervision and requests of a manufacturer-seller in accordance with the standards for quality control under attached Table 1;
2. To prepare and preserve written manufacture management standards, a written manufacture management record and a written quality control record (including forms of an electronic document);
3. To hygienically manage and keep uncontaminated the manufacturing factory, facilities and apparatuses so as not to cause injuries to health and hygiene;
4. To periodically check the facilities and apparatuses necessary for the manufacture of cosmetics to prevent impeding the operations;
5. Not to leave in a workplace, any articles likely to cause injury, and not to leak or emit any substance hazardous to citizens' health and the environment from a manufacturing factory;
6. To submit, to a manufacturer-seller, matters necessary for quality control, among matters falling under subparagraph 2: Provided, That in any of the following cases, such matters may be omitted to be submitted:
(a) Where the manufacturer and the manufacturer-seller are identical;
(b) Where the manufacturer manufactures a product by designing, developing and producing it and such manufacturing methods falls under trade secrets in accordance with a mutual contract between the manufacturer and the manufacturer-seller to the extent not effecting the quality and safety management;
7. To conduct necessary tests, inspections or examinations, from the warehousing of raw materials and other materials to the release of finished products;
8. To thoroughly manage and supervise the consignee to secure that the manufacture or quality inspections are properly performed, and to receive, keep and manage the records of the manufacture or quality inspections, in cases of outsourcing the manufacture or quality inspections.
(2) In addition to matters to be observed pursuant to paragraph (1), the Minister of Food and Drug Safety may recommend manufacturers to comply with such standards for managing manufacturing good cosmetics as determined and publicly notified by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
(3) The Minister of Food and Drug Safety may provide any of the following support to the manufacturers who comply with the standards for managing manufacturing good cosmetics pursuant to paragraph (2): <Newly Inserted by Ordinance of the Prime Minister No. 1097, Sept. 24, 2014.>
1. Specialized techniques and education on applying standards for managing manufacturing good cosmetics;
2. Consultation for the purpose of applying standards for managing manufacturing good cosmetics;
3. Improvement and repair of the facilities, equipments, etc. for the purpose of applying standards for managing manufacturing good cosmetics.
 Article 13 (Report of Production Result, etc. of Cosmetics)
(1) A manufacturer-seller shall make a report to the Minister of Food and Drug Safety by the end of February every year as prescribed by the Minister of Food and Drug Safety with respect to the production result or import result of the previous year, such as the number of produced or imported items, the production or import quantity, and value produced or imported, as well as the list, etc. of raw materials used in the manufacturing process in the previous year. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
(2) Notwithstanding paragraph (1), a manufacturer-seller who conducts imports after having made a report standard customs clearance forecast report by an electronic trade document need not report the import results or the list of raw material pursuant to paragraph (1).
 Article 14 (Education to Operators of Manufacturing and Sales Business)
(1) Persons subject to an order for education under Article 5 (5) of the Act shall be manufacturers and manufacturer-sellers falling under any of the following subparagraphs: <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. Manufacturers or manufacturer-sellers who violate Article 15 of the Act;
2. Manufacturer or manufacturer-sellers who are subject to an order for correction under Article 19 of the Act;
3. Manufacturer-sellers who violate any matter to be observed referred to in Article 11;
4. Manufacturers who have violated any matter to be observed referred to in Article 12 (1).
(2) Where a person subject to an order for education under paragraph (1) is unable to undergo such education due to natural disaster, disease, pregnancy, childbirth, accident, business tour, etc., the Minister of Food and Drug Safety may suspend the requirement to undergo the relevant education.
(3) A person who intends to be granted the suspension of the requirement for undergoing education pursuant to paragraph (2) submit an application for the suspension, as prescribed by the head of a local food and drug safety office, together with documents evidencing the cause for such suspension.
(4) After examining the applications for the suspension of education submitted pursuant to paragraph (3), the head of a local food and drug safety office shall issue a written confirmation of the suspension of education, as prescribed by the Minister of Food and Drug Safety.
(5) “Person prescribed by Ordinance of the Prime Minister” referred to in Article 5 (6) of the Act means the a person falling under ant of the following subparagraphs: <Newly Inserted by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. A manufacture-sales manager;
2. An employee engaged in affairs of quality control pursuant to the standards for quality control under attached Table 1.
(6) An institution providing education under Article 5 (7) of the Act (hereafter referred to as an "educational institution") shall be designated and publicly notified by the Minister of Food and Drug Safety, from among institutions and associations related to cosmetics and associations established pursuant to Article 17 of the Act. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
(7) An educational institution shall establish an educational plan including content concerning persons subject to the education, and curriculum and hours thereof every year and shall submit such education plan to the Minister of Food and Drug Safety by November 30 of the immediately preceeding year before such educations is provided. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
(8) The educational hours under paragraph (7) shall be not less than four hours, but not more than eight hours. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
(9) The curriculum of the education under paragraph (7) shall be matters concerning cosmetics-related Acts and subordinate statutes and systems, matters concerning the securing of cosmetics safety and the quality control of cosmetics, and other related matters, and detailed matters concerning the curriculum thereof shall be subject to approval by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
(10) An educational institution shall issue a certificate of education completion to persons who have completed the education, report the result of the education of the previous year to the Minister of Food and Drug Safety by January 31 every year, prepare records of the periods of education, the list of those persons having undergone education, the curriculum of education and other related matters, and preserve them for two years together with documents evidencing them. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
(11) An educational institution may collect from those persons who receive education actual expenses incurred in education, such as expenses for educational materials, expenses incurred in practical training, allowances for instructors. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
(12) In addition to the matters provided in paragraphs (1) through (11), other detailed matters necessary for education shall be determined and publicly notified by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
[This Article Wholly Amended by Ordinance of the Prime Minister No. 1120, Jan. 6, 2015]
 Article 14-2 (Standards for Cosmetics Subject to Recall)
Cosmetics subject to recall under Article 5-2 (1) of the Act (hereinafter referred to as "cosmetics subject to recall") shall be the following cosmetics in circulation:
1. Cosmetics which violates Article 7, 15 or 16 (1) of the Act and fall under any of the following:
(a) Cosmetics falling under subparagraph 2 or 3 of Article 15 of the Act;
(b) Cosmetics likely to cause risks to health and hygiene among cosmetics falling under subparagraph 4 of Article 15 of the Act;
(c) Cosmetics which fall under any of the following, among those falling under subparagraph 5 of Article 15 of the Act:
1) Cosmetics using any raw materials prohibited to be used in cosmetics under Article 8 (1) or (2) of the Act;
2) Cosmetics not meeting the standards (excluding standards for net contents) for safety management of cosmetics in circulation under Article 8 (5) of the Act;
(d) Cosmetics falling under subparagraph 9 of Article 15 of the Act;
(e) Other cosmetics which a manufacturer or a manufacturer-seller decides at his/her/its own discretion are necessary to be recalled because of the likeliness to cause risk to citizens' health;
2. Cosmetics which violate Article 9 of the Act.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1182, Jul. 29, 2015]
 Article 14-3 (Recall Plan, Recall Procedures, etc. of Hazardous Cosmetics)
(1) A manufacturer or manufacturer-seller who intends to recall, or take a measure necessary to recall, any cosmetics pursuant to Article 5-2 (1) of the Act (hereinafter referred to as a "obligator for recall") shall immediately take necessary measures against the relevant cosmetics and submit, within five days after becoming aware of the fact that such cosmetics are subject to recall, a recall plan prescribed in Appendix 10 to the head of a local food and drug safety office, together with the following documents: Provided, That where it is deemed difficult to submit a recall plan by the deadline for submission, such manufacturer or manufacturer-seller shall request the head of a local food and drug safety office to extend the submission deadline, clarifying the reason for such request:
1. A copy of the record of manufacture or import of the relevant item;
2. The record of the quantities and dates of sales for each selling store;
3. A document specifying the reasons for recall.
(2) If the recall plan submitted pursuant to paragraph (1) is deemed unsatisfactory, the head of a local food and drug safety office may order the relevant obligor for recall to complement the recall plan.
(3) An obligor for recall shall notify the sellers of the cosmetics subject to recall (referring to sellers under Article 11 (1) of the Act), and other persons who handle the relevant cosmetics in the course of performing their business of the recall plan by means of visit, mail, telephone, telegram, electronic mail, fax or public announcement through a media source; and the obligor for recall shall preserve the materials demonstrating the fact of such notification for two year from the last date of recall.
(4) A person notified of the recall plan pursuant to paragraph (3) shall return cosmetics subject to recall to the obligor for recall, prepare a written confirmation of recall prescribed in Appendix 10-3, and send it to the obligor for recall.
(5) Where intending to discard recalled cosmetics, an obligor for recall shall submit an application for disposal prescribed in Appendix 10-4 to the head of a local food and drug safety office, together with the following documents, and, in the presence of the relevant public officials, dispose of the said cosmetics as prescribe by environment-related Acts and subordinate statutes:
1. A copy of the recall plan prescribed in Appendix 10-2;
2. A copy of the written confirmation prescribed in Appendix 10-3.
(6) An obligor for recall who completes the disposal pursuant to paragraph (5) shall prepare a written confirmation prescribed in Appendix 10-5 and preserve it for two years.
(7) Where completing the recall of the cosmetics subject to recall, an obligor for recall shall submit a report of recall completion prescribed in Appendix 10-6 to the head of a local food and drug safety office, together with the following documents:
1. A copy of the written confirmation of recall prescribed in Appendix 10-3;
2. A copy of the written confirmation of disposal prescribed in Appendix 10-5 (limited to cases of disposal);
3. A copy of the report of assessment prescribed in Appendix 10-7.
(8) Where receiving a report of recall completion pursuant to paragraph (7), the head of a local food and drug safety office shall take measures as provided in the following subparagraph:
1. To confirm the completion of recall and notify the obligor for recall in writing thereof, where it is deemed that the recall of the cosmetics subject to recall has been properly conducted in compliance with the recall plan;
2. To order the obligor for recall to take additional measure necessary for the recall, where it is deemed that the recall has not been conducted effectively.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1182, Jul. 29, 2015]
 Article 14-4 (Mitigation or Remission of Administrative Dispositions)
Where mitigating or remitting an administrative disposition under Article 24 of the Act pursuant to Article 5-2 (3) of the Act, the standards therefor shall be as categorized as follows:
1. Where not less than 4/5 of the planned recall quantity under the recall plan of Article 5-2 (2) of the Act (hereafter referred to as "the planned recall quantity") has been recalled, an administrative disposition against the violation shall be withdrawn;
2. Where some of the planned recall quantity has been recalled, an administrative disposition shall be mitigated according to the following standards:
(a) Where not less than 1/3 of the planned recall quantity has been recalled (excluding a case falling under subparagraph 1);
1) If the standard for an administrative disposition under Article 24 (2) of the Act (hereafter referred to as “standard for an administrative disposition” in this paragraph) is the cancellation of registration, the suspension of business for not less than two months but not more than six months shall be taken;
2) If the standard for an administrative disposition is the suspension of business or the suspension of manufacturing business, import or sale of any item, the administrative disposition shall be mitigated by up to 2/3 of the period of the disposition of suspension;
(b) Where not less than 1/4 but less than 1/3 of the planned recall quantity has been recalled:
1) If the standard for an administrative disposition is the cancellation of registration, the suspension of business for not less than three months but not more than six months shall be taken;
2) If the standard for an administrative disposition is the suspension of business or the suspension of manufacturing business, import or sale of any item, the administrative disposition shall be mitigated by up to 1/2 of the period of the disposition of suspension;
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1182, Jul. 29, 2015]
 Article 15 (Report of Permanent Closure of Business)
A manufacturer or manufacturer-seller intends to permanently close the business or suspend the business, or resume the business after the suspension of business pursuant to Article 6 of the Act shall submit a report prescribed in Appendix 11 (including a report in the form of an electronic document) to the head of a local food and drug safety office, together with a registration certificate of a manufacturing and sales business or a registration certificate of manufacturing business (limited to the permanent closure of business or the suspension of business).
 Article 16 (Permission for Export, Import, etc. of Endangered Species of Wild Fauna and Flora)
(1) A person who intends to obtain permission pursuant to Article 7 of the Act for the export, import or introduction of any cosmetics or raw materials thereof containing any processed product of the fauna and flora (excluding those artificially propagated or cultivated; hereinafter referred to as an "internationally endangered species") under the Convention on International Trade in Endangered Species of Wild Fauna and Flora shall, whenever he/she exports, imports, or introduces them, submit an application prescribed in Appendix 12 (including an application in the form of an electronic document) to the Minister of Food and Drug Safety, together with the relevant documents (including electronic documents) as categorized in the following: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. In cases of exportation, the following documents:
(a) Where re-exporting any cosmetics or raw materials thereof containing a processed product of the internationally endangered species of foreign origin, a copy of an export certificate issued by the country exporting the cosmetics or raw materials thereof, containing a processed product of such internationally endangered species in accordance with the Convention on International Trade in Endangered Species of Wild Fauna and Flora;
(b) Where exporting any cosmetics or raw materials thereof containing a processed product of an internationally endangered species of domestic origin, a note explaining the acquisition of the said internationally endangered species and evidential documents therefor;
2. In cases of importation, the following documents:
(a) A copy of an export certificate issued by the country exporting the cosmetics or raw materials thereof, containing a processed product of an internationally endangered species in accordance with the Convention on International Trade in Endangered Species of Wild Fauna and Flora;
(b) An affirmation certificate of sale of goods or a copy of the contract for import;
3. In cases of introduction, a note explaining the acquisition of any cosmetics or raw materials thereof, containing a processed product of an internationally endangered species of domestic origin, and evidential documents therefor.
(2) The Minister of Food and Drug Safety shall verify the content of the application which has been submitted pursuant paragraph (1) and, where permitting the exportation, importation, or introduction, shall issue a permit for exportation, importation, or introduction prescribed in Appendix 13. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 17 (Hazard Assessment of Raw Materials, etc. of Cosmetics)
(1) A hazard assessment under Article 8 (3) of the Act shall be conducted by undergoing the processes of the identification, decision, assessment, etc. of the following:
1. The process of identifying the danger, through which toxicity of hazardous elements within the human body is identified;
2. The process of determining the danger, through which the permissible amount of exposure of hazardous elements to the human body is calculated;
3. The process of assessing the exposure, through which the exposed amount of hazardous elements to the human body is calculated;
4. The process of assessing the severity of hazard, through which the hazardous effect on the human body is determined by comprehensively considering the results of subparagraphs 1 through 3.
(2) The Minister of Food and Drug Safety shall determine whether any hazard exists according to the standards established by the Minister of Food and Drug Safety on the basis of the results under paragraph (1): Provided, That where any research and inspection institution, whether domestic or overseas, has already conducted a hazard assessment of the relevant raw materials etc. of the cosmetics or any scientific test and analysis data exists concerning hazardous elements, he/she may, on the basis of such data, determine whether any hazard exists. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
(3) Detailed matters concerning the standards, methods, etc. for risk assessments under paragraphs (1) and (2) shall be determined and publicly notified by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 18 (Items Requiring Use of Safe Container and Packaging, and Standards therefor)
(1) Items requiring the use of safe containers and packaging shall be as follows: Provided, That disposable products, products with a spray container, the nozzle of which is operated by a pump or trigger, and products with compression spray container (such as aerosol products) shall be excluded therefrom:
1. Nail enamel removers and nail polish removers containing acetone;
2. Products in liquid state of non-emulsion which contain hydrocarbons (PAHs) whose content in each package is not less than ten percent and whose kinematic viscosity is not higher than 21 centistokes (at 40° C);
3. Products in liquid state containing methyl salicylate whose content in each package is not less than five percent.
(2) A safe container and packaging is readily openable by an adult to open, but difficult for a child under the age of five to open. In such cases, the specific standards and methods of testing for the degree of difficulty of opening shall be determined and publicly notified by the Minister of the Minister of Trade, Industry and Energy. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 19 (Marking, Labelling, etc. on Package of Cosmetics)
(1) Pursuant to the proviso to Article 10 (1), only the name of cosmetics, only trade name of a manufacturer-seller, the price, the manufacturing number, the usage time-limt or the usage period after opening (the manufacturing date shall also be entered together in case of entering the usage period after opening) may be marked and labelled on the primary or secondary package falling under any of the following: Provided, That in cases of the secondary package, the term "price" shall be deemed to refer to the labelling 'sample', 'not for sale', etc.: <Amended by Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
1. A package of cosmetics the net contents is not less than 10ml or 10g;
2. A package of cosmetics manufactured or imported so as for customers to try and use them in advance to choose, etc. a product, not for sale.
(2) Ingredients which need not be marked or labeled pursuant to Article 10 (1) 3 of the Act refers to the following ingredients: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. Ingredients eliminated in the course of manufacture and do not remain in a final product;
2. Ingredients which are incidental ingredients, such as a stabilizer and a preservative, and are present in any raw materials themselves, and contained in amounts of less than the amounts displaying their effects;
3. Ingredients excluding the following ingredients in cases of a package of cosmetics, the net content of which is more than 10ml but not more than 50ml or the weight of which is more than 10g but not more than 50g:
(a) Tar colors;
(b) Gold foils;
(c) Kinds of phosphates contained in shampoo and rinse;
(d) Alpha hydroxy acid (AHA);
(e) Raw materials displaying efficacy and effects in cases of functional cosmetics;
(f) Raw materials, the compound limits of which are publicly notified by the Minister of Food and Drug Safety.
(3) Matters requiring attention in using the cosmetics as labelled on a package of such cosmetics pursuant to Article 10 (1) 9 of the Act shall be as listed in attached Table 3.
(4) Matters required to be marked and labelled on a package of cosmetics pursuant to Article 10 (1) 10 of the Act shall be as follows: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
1. Bar codes determined by the Minister of Food and Drug Safety;
2. In cases of functional cosmetics, the efficacy and effects, and method of use and optimal dosages reviewed or reported;
3. Where the name of any ingredient is used as a part of the name of a product, the name and the ingredient (excluding Aromatic products);
4. Where human cell or tissue material is contained in any cosmetics, their content;
5. In cases of labeling "organic farming" on any cosmetics and advertising the cosmetics to that effect, the content of such materials;
6. In cases of imported cosmetics, the name of the manufacturing country (in cases of marking the country of origin under the Foreign Trade Act, the name of the manufacturing country may be omitted), and the name and location of manufacturing company.
(5) Where intending to omit to mark and label the ingredients used in manufacturing the relevant cosmetics pursuant to paragraph (1) and (2) 3, it must be possible to verify such omitted ingredients as follows:
1. To mark the telephone number or homepage address so as for customers to immediately confirm all ingredients under Article 10 (1) 3 of the Act;
2. To always keep, in selling stores, printed materials marking all ingredients under Article 10 (1) 3 of the Act, such as a manual.
(6) Standards and methods for marking on packages under Article 10 (1) 3 of the Act shall be as listed in attached Table 4.
 Article 20 (Marking of Price of Cosmetics)
A person who directly sells the relevant cosmetics to customers pursuant to Article 11 (1) of the Act (hereinafter referred to a "seller") shall mark the price on the package of the cosmetics for customers in general to easily confirm such price, and the detailed marking methods shall be determined and publicly notified by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 21 (Matters Requiring Attention in Marking and Labelling)
Matters Requiring attention in marking and labelling on the package of cosmetics and marking the price thereof shall be as follows:
1. To make marks and labels easy to be readable in the Korean language: Provided, That Chinese characters or foreign languages may be used together, and in cases of a product for export, the language of the export target country may be used;
2. To use standardized common names in labelling ingredients of cosmetics.
 Article 22 (Scope, etc. of Labelling and Advertisements)
The scope of labelling and advertisements under Article 13 (2) of the Act and other matters to be observed shall be as listed in attached Table 5.
 Article 23 (Subjects, etc. of Demonstration of Contents of Labelling and Advertisements)
(1) The Subjects of demonstration of contents of labelling and advertisements under Article 14 (1) of the Act shall be the labelling and advertisements, the demonstration of which the Minister of Food and Drug Safety is deemed necessary to conduct due to the likeliness to deceive customers by exaggerating facts or misleading customers, from among the packages of cosmetics, or labelling and advertisements by media or tools of advertisements of cosmetics under subparagraph 1 of attached Table 5. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
(2) The scope and requirements of the evidentiary data to be submitted by a manufacturer, manufacturer-seller or seller shall be as follows:
1. Test results: the demonstration data shall be human applying test data, non-human test data, or the investigation data whose level is equal to or higher than that of the former two test data;
2. Investigation results: the sample selection, questionnaire and question strategies shall coincide with the purpose or statistical methods of such investigation;
3. Demonstration methods: the methods of testing or investigations used for demonstration shall be either widely known in the academic circle or generally recognized in the relevant industrial sector, and shall be scientific and objective methods.
(3) Where submitting demonstration data, a manufacturer, manufacturer-seller, or seller shall submit them to the Minister of Food and Drug Safety, specifying the following matters and attaching materials demonstrating them: <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
(a) Methods of proof;
(b) Name, representative's name, address and telephone number of the test and investigation institution;
(c) Demonstration content and results;
(d) Where not wishing to disclose any part of demonstration data because that part belongs to trade secrets, the content of such part and the reason for disclosure.
(4) In addition to those matters provided for in paragraphs (1) through (3), other matters necessary for the demonstration of labelling and advertisements shall be determined and publicly notified by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 24 (Qualifications, etc. of Relevant Public Officials)
(1) A public official who conducts affairs concerning the inspection, etc. of cosmetics under Article 18 (1) of the Act (hereinafter referred to as the "public official in charge of the supervision of cosmetics") shall be a person appointed by the head of a local food and drug safety office from among the following persons:
1. Persons who have obtained an academic degree at least a bachelor's degree in the area of pharmacy or cosmetics in a school under Article 2 of the Higher Education Act (including persons who are recognized to have the academic background corresponding to or higher than a bachelor's degree in such area by any Act or subordinate statute);
2. Persons who is recognized by the head of a local food and drug safety office as having affluent knowledge and experience concerning cosmetics or persons who are recommended by the Special Metropolitan City Mayor, other Metropolitan City Mayor, Do Governor, the Special Self-Governing Province Governor or the head of a Si/Gun/Gu (the head of a Gu refers to the head of a autonomous Gu).
(2) The certificate evidencing the status of the public official in charge of the supervision of cosmetics under Article 18 (1) of the Act shall be prescribed in Appendix 13.
 Article 25 (Collection, etc.)
Where collecting any goods or cosmetics, a public official in charge of the supervision of cosmetics shall issue a collection certificate prescribed in Appendix 15 to the person whose articles or cosmetics are collected.
 Article 26 (Monitering of Sale of Cosmetics)
The Minister of Food and Drug Safety may, pursuant to Article 18 (2) of the Act, designate an association under Article 17 of the Act or an institution conducting the business engaging in monitoring the sales, labelling, advertisements, qualities, etc, of cosmetics. <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 27 (Orders, etc. to Recall or Dispose)
Article 14-3 shall apply mutatis mutandis to the procedures, plans, ex post facto measures for recall and disposal of goods under Article 23 (1) of the Act.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1182, Jul. 29, 2015]
 Article 28 (Publication of Hazardous Cosmetics)
(1) A business operator subject to an order for publication pursuant to Article 23-2 (1) of the Act shall publish the following matters in at least one general daily newspapers (referring to the whole version of the relevant newspapers printed and distributed on the relevant date) which are registered pursuant to Article 9 (1) of the Act on the Promotion of Newspapers, Etc. and are distributed nationwide, and shall also request the publication on the homepage of the Ministry of Food and Drug Safety:
1. Title stating collection of the relevant cosmetics;
2. Name of the relevant product;
3. Serial numbers of the cosmetics subject to collection;
4. Time limit of use or period of use after opening of the cosmetics (including the manufacturing date which is marked together);
5. Causes for collection;
6. Methods for collection;
7. Name of the collecting business operator;
8. Telephone number and address of the collecting business operator, and other matter necessary for collection.
(2) The detailed methods for stating the matters falling under the subparagraphs of paragraph (1) shall be as listed in attached Table 6.
(3) The business operator who has published the matters pursuant to paragraph (1) shall, without delay, notify the head of a local food and drug safety office of the results of publication including the following matters:
1. The publication date;
2. The media for publication;
3. The number of publication;
4. A copy of the published statement or the content thereof.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1182, Jul. 29, 2015]
 Article 29 (Standards for Administrative Disposition)
(1) Standards for Administrative Dispositions under Article 24 (1) of the Act shall be as listed in attached Table 7.
(2) Deleted. <by Ordinance of the Prime Minister No. 1088, Aug. 20, 2014>
 Article 30 (Procedures for Collection of Penalty Surcharges)
The Enforcement Rules of the Management of the National Funds Act shall apply mutatis mutandis to procedures for the collection of penalty surcharges under Article 12 (1) of the Decree of the Cosmetics Act. In such cases, methods and period for raising objections shall be specified in a notice of payment together.
 Article 31 (Re-issuance, etc. of Registration Certificates, etc.)
(1) A person who intends to be re-issued a certificate of registration of manufacturing and sales business, a certificate of registration of manufacturing business ,or a notice of the findings from examination of functional cosmetics (hereinafter referred to as "a registration certificate, etc.") shall submit an application for re-issuance prescribed in Appendix 18 or 19 (including an application in the form of an electronic document) to the head of a local food and drug safety office or to the Director General of the National Institute of Food and Drug Safety Evaluation, respectively, together with the following documents (including electronic documents). <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013; Ordinance of the Prime Minister No. 1405, Jul. 31, 2017>
1. Where a registration certificate, etc. is unusable because it is contaminated, damaged, or otherwise in poor condition;
2. Where a registration certificate, etc. is lost, an explanatory statement.
(2) Where a lost registration certificate, etc. is discovered after the re-issuance of the registration certificate, etc., the former shall be returned to the head of the relevant issuing agency, without delay.
(3) A person who intends to receive the confirmation or certification of the registration, etc. of a manufacturer or manufacturer-seller under Article 3 of the Act shall submit a written application for confirmation or a written application for certification (including an application in the form of an electronic document, respectively, and including a translation of an application in cases of an application in a foreign language). <Amended by Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
 Article 32 (Fees)
In accordance with Article 32 of the Act, where applying for the registration of changed registration or applying for an examination or examination of change of any functional cosmetics, a manufacturer or manufacturer-seller shall pay fees under attached Table 9 in cash or by means of certification verifying the payment in cash or by means of the electronic money or electronic settlement system using an information and communications network.
 Article 33 (Re-examination of Restrictions)
The the Minister of Food and Drug Safety shall, with the dates referred to in the following as the reference dates, examine the validity of the following matters every three years (referring to the period ending immediately before the third anniversary from the relevant reference date) and shall then take measures for improvement, etc. thereof:
1. Registration of a manufacturing business of cosmetics under Article 3: January 1, 2014;
2. Registration of a manufacturing and sales business under Article 4: January 1, 2014;
3. Registration for change of a manufacturing business and a manufacturing and sales business under Article 5: January 1, 2014.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1074, Apr. 1, 2014]
ADDENDA
Article 1 (Enforcement Date)
These Rules shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 6 (2) 2 (c), 27, 28, and 29 (2), and attached Tables 6 and 8 shall enter into force on August 5, 2012.
Article 2 (Applicability to Marking, Labelling, etc. on Package of Cosmetics)
The amended provisions of Article 19 shall apply to cosmetics manufactured or imported first after these rules enter into force.
Article 3 (Transitional Measures concerning Registration of Manufacturing and Sales Business)
(1) A person who intends to be registered as a manufacturer-seller pursuant to the amended provisions of Article 4 from persons importing cosmetics (including persons who import cosmetics on consignment) under the former provisions at the time these Rules enter into force shall be registered by February 4, 2013, by meeting the relevant requirements.
(2) A person who intends to be registered as a manufacturer-seller pursuant to the amended provisions of Article 4 among persons who distribute and sell cosmetics manufactured by outsourcing the manufacturing to a manufacturer registered pursuant to the former provisions of Article 3 (1) as at the time these Rules enter into force shall be registered by February 4, 2013, by meeting the relevant requirements.
Article 4 (Transitional Measures concerning Examination or Reporting of Functional Cosmetics)
Functional cosmetics examined or reported pursuant to the former provisions at the time these Rules enter into force shall be deemed examined or reported pursuant to the amended provisions of Articles 9 and 10.
Article 5 (Transitional Measures concerning Report of Production or Import Results of Cosmetics)
Notwithstanding the amende provisions of Article 13, the report of production or import results of cosmetics in 2011 shall be governed by the former provisions.
Article 6 (Transitional Measures concerning Permission for Export, Import, etc. of Endangered Species of Wild Fauna and Flora)
A person who has obtained permission for the export, import or introduction of any cosmetics or raw materials containing any processed product of internationally endangered species pursuant the former provisions at the time these Rules enter into force shall be deemed to have obtained permissions pursuant to the amended provisions of Article 16.
Article 7 (Transitional Measures concerning Change in Name)
A public official in charge of the examination of cosmetics under the former provisions at the time these Rules enter into force shall be deemed a public official in charge of the supervision of cosmetics under the amended provisions of Article 24.
Article 8 (Transitional Measures concerning Standards for Administrative Disposition)
Notwithstanding the amended provisions of attached Table 7, violations committed before these Rules enter into force shall be governed by the former provisions.
Article 9 (Transitional Measures concerning Forms)
Forms under the former provisions as the time these Enforcement Provisions enter into force may be used concurrently with the forms under the amended provisions: Provided, That the former shall be used by apply the amended provisions.
Article 10 (Relations with other Acts)
Where other Acts and subordinate statues cite the former Enforcement Regulations on the Cosmetics Act or the provisions thereof at the time these Rules enter into force, it shall, if any provisions corresponding to such provisions in these Rules exist, be deemed to cite these Rules or the corresponding provisions of these Rules in lieu of the former provisions.
ADDENDA <Ordinance of the Prime Minister No. 1010, Mar. 23, 2013>
Article 1 (Enforcement Date)
These Rules shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDUM <Ordinance of the Prime Minister No. 1046, Dec. 6, 2013>
These Rules shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Prime Minister No. 1074, Apr. 1, 2014>
These Rules shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Prime Minister No. 1088, Aug. 20, 2014>
Article 1 (Enforcement Date)
These Rules shall enter into force on the date of its promulgation.
Articles 2 through 10 Omitted.
ADDENDUM <Ordinance of the Prime Minister No. 1097, Sep. 24, 2014>
These Rules shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Prime Minister No. 1120, Jan. 6, 2015>
These Rules shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Prime Minister No. 1154, Apr. 2, 2015>
Article 1 (Enforcement Date)
These Rules shall enter into force on the date of its promulgation: Provided, That the amended provisions of subparagraph 1 (c) 5 of attached Table 3 shall enter into force on July 1, 2015.
Article 2 (Applicability to Wet Tissues)
The amended provisions of subparagraph 1 (c ) 5 of attached Table 3 shall apply to wet tissues imported or manufactured first after July 1, 2015.
Article 3 (Transitional Measures concerning Registration of Manufacturer, etc. of Wet Tissues)
(1) Where a manufacturer, importer or seller of wet tissues under the Quality Control and Safety Management of Industrial Products Act intends to manufacture wet tissues pursuant to the amended provisions of subparagraph 1 (c) 5 of attached Table 3 or to distribute and sell, or to recommend or provide wet tissues pursuant to each subparagraph of Article 4 (1) after July 1, 2015, he/she shall be registered as a manufacturer or manufacturer-seller to the head of a local food and drug safety office by June 30, 2015, by meeting the registration requirements under Article 3 of the Act.
(2) Where registered as a manufacturer or manufacturer-seller pursuant to paragraph (1), the date of registration shall be July 1, 2015.
Article 4 (Transitional Measures concerning Standards for Administrative Disposition)
Notwithstanding the amended provisions of subparagraph 2 (d) 2 e) through g), administrative dispositions against violations committed before these Rules enter into force shall be governed by the former provisions.
ADDENDA <Ordinance of the Prime Minister No. 1182, Jul. 29, 2015>
Article 1 (Enforcement Date)
These Rules shall enter into force on July 29, 2015: Provided, the amended provisions of subparagraph 2 of attached Table 1, subparagraph 2 of attached Table 2, and subparagraph 2 (f) of attached Table 7 shall enter into force one month after the date of its promulgation, and the amended provisions of subparagraph 2 (b) of attached Table 3 shall enter into force six months after the date of its promulgation.
Article 2 (Transitional Measure concerning Matters to be Entered in Package of Cosmetics)
The package of cosmetics on which matters requiring attention is marked and labelled pursuant to the former provisions at the time the amended provisions of subparagraph 2 (b) of attached Table 3 under the proviso to Article 1 of the Addenda enter into force may, notwithstanding the amended provisions of subparagraph 2 (b) of attached Table 3, continue to be used until six months after the same amended provisions enter into force.
ADDENDA <Ordinance of the Prime Minister No. 1297, Jun. 30, 2016>
Article 1 (Enforcement Date)
These Rules shall enter into force on the date of their promulgation.
Articles 2 through 3 Omitted.
Article 4 (Applicability to Amendment of Enforcement Rules of the Cosmetics Act)
The amended provisions of subparagraph 2 (o) 5) of the attached Table 7 shall also apply in cases of taking administrative measures against violations committed before this Rules enter into force.
Article 5 Omitted.
ADDENDA <Ordinance of the Prime Minister No. 1322, Sep. 9, 2016>
Article 1 (Enforcement Date)
These Rules shall enter into force on the date of their promulgation: Provided, That the amended provisions of Articles 14 and 19 shall enter into force on February 4, 2017.
Article 2 (Transitional Measure concerning Use of Packages of Cosmetics)
Notwithstanding the amended provisions of subparagraph 2 of attached Table 3 the packages of cosmetics in which matters requiring attention are entered may be used for one year from the date on which this Rules enter into force.
ADDENDA <Ordinance of the Prime Minister No. 1357, Jan. 12, 2017>
Article 1 (Enforcement Date)
These Rules shall enter into force on May 30, 2017.
Article 2 (Transitional Measures concerning Registration of Cosmetics Manufacturing Business, etc.)
A manufacturer of quasi-drugs and an importer of quasi-drugs, who, at the time these Rules enter into force, have manufactured or imported any items falling under either any of the amended provisions of subparagraphs 6 through 9 of Article 2 or subparagraph 1 (a) or (c) of attached Table 3 after having obtained permission by item for items or made report on items pursuant to Article 31 (4) of the Pharmaceutical Affairs Act, shall be deemed a cosmetics manufacturer or cosmetics manufacturer-seller, and a cosmetics manufacturer-seller, respectively: Provided, that such manufacturer and importer shall file a report on cosmetics manufacturing business or cosmetics manufacturing and sales business according to the following classifications within six months after these Rules enter into force:
1. In case of intending to continue to manufacture the relevant items: registration of cosmetics manufacturing business;
2. In case of intending to continue to manufacture (including the outsourcing of the manufacture) or import, and distribute or sell the relevant items, or to recommend or provide the relevant items for the purpose of vicarious importation.
Article 3 (Transitional Measures concerning Examination, etc. of Functional Cosmetics)
(1) With respect to any items referred to in the amended provisions of subparagraphs 6 through 9 of Article 2, where any person has obtained permission for such items or has made report thereon pursuant to Article 31 (4) of the Pharmaceutical Affairs Act at the time these Rules enter into force, he/she/it shall be deemed to have undergone an examination of such items or have submitted a report thereon pursuant to Article 4 of the Act: Provided, That a manufacturer-seller who intends to manufacture (including the outsourcing of the manufacture) or import, and distribute or sell such items, or to recommend or provide such items for the purpose of vicarious importation shall prepare a list of the relevant functional cosmetics and submit it to the Minister of Food and Drug Safety within six months after these Rules enter into force.
(2) With respect to any item referred to in the amended provisions of subparagraphs 6 through 9 of Article 2, where any person has applied for permission for such item and the relevant procedures are underway at the time these Rules enter into force, he/she/it shall be deemed to have made a request for examination of functional cosmetics under Article 9 on the date of application for permission for such item.
(3) Notwithstanding paragraph (1), the items with respect to which reevaluation of quasi-drugs is underway pursuant to Article 33 (1) of the Pharmaceutical Affairs Act, among items referred to in the amended provisions of subparagraph 8 of Article 2, shall, if their efficacy and effectiveness fails to be proved as a result of reevaluation, shall be deemed as if they had not undergone examination or written reports on them had not been submitted pursuant to Article 4 of the Act, since the date when such reevaluation is completed.
(4) Notwithstanding paragraph (1), the items with respect to which reevaluation of quasi-drugs is underway pursuant to Article 33 (1) of the Pharmaceutical Affairs Act, among items referred to in the amended provisions of subparagraph 8 of Article 2, shall not fall under categories of functional cosmetics under the main sentence Article 10 (1) 2 until their efficacy and effectiveness are proved as a result of reevaluation.
Article 4 (Transitional Measure concerning Matters to be Entered in Package of Cosmetics)
With respect to items which fall under the amended provisons of any of subparagraphs 6 through 9 of Article 2 or any of subpagraph 1 (a) or (c) of attached Table 3 at the time these Rules enter into force, the matters entered in their containers, packages or package inserts pursuant to Article 65 (1) of the Pharmaceutical Affairs Act may be used as the matters to be entered with respect to the relevant items until the date when one and half year has elapsed after these Rules enter into force.
Article 5 (Transitional Measure concerning standards for Administrative Measures)
Notwithstanding the amended provisions of the attached Table 7, the former provisons shall also apply to administrative measures against violations committed before this Rules enter into force.
ADDENDUM <Ordinance of the Prime Minister No. 1405, Jul. 31, 2017>
These Rules shall enter into force on the date of their promulgation.