Cosmetics Act

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법령, 판례 등 모든 법령정보를 한 번에 검색 OK !

COSMETICS ACT

[Enforcement Date 29. Jul, 2015.] [Act No.13117, 28. Jan, 2015., Partial
Amendment]

식품의약품안전처 (화장품정책과)043-719-3415

법제처 국가법령정보센터
www.law.go.kr
2016.03.07
「COSMETICS ACT 」

COSMETICS ACT
[Enforcement Date 29. Jul, 2015.] [Act No.13117, 28. Jan, 2015., Partial Amendment]
식품의약품안전처 (화장품정책과) 043-719-3415

CHAPTER I GENERAL PROVISIONS

Article 1 (Purpose)
The purpose of this Act is to contribute to improving national health and developing
the cosmetics industry by prescribing matters concerning the manufacture,
importation, sale, etc. of cosmetics.

Article 2 (Definitions)
The terms used in this Act shall be defined as follows:<Amended by Act No. 11690, Mar.
23, 2013>

1. The term "cosmetic" means any item intended to be used by means of spreading,
rubbing, spraying on or otherwise applied to the human body for cleansing,
beautifying, promoting attractiveness or brightening the appearance, or maintaining
or improving the health of skin and hair, which have light effects on the human
body: Provided, That goods constituting medicines defined in subparagraph 4 of
Article 2 of the Pharmaceutical Affairs Act shall be excluded herefrom;
2. The term "functional cosmetics" means cosmetics prescribed by Ordinance of the
Prime Minister, falling under any of the following:
(a) Products aiding in the whitening of the skin;
(b) Products aiding in improving wrinkles in the skin;
(c) Products aiding in tanning skin gently or protecting skin from ultraviolet rays;
3. The term "organic cosmetics" means cosmetics manufactured from organic
materials, plants and animals, or materials, etc. derived therefrom, which comply
with standards prescribed by the Minister of Food and Drug Safety;
4. The term "safe containers or packaging" means containers or packaging designed
or planned with child-proof lids for children under the age of five;
5. The term "use-by date" means the minimum period from date of manufacture
during which consumers can safely use a cosmetic with its unique characteristics
preserved in appropriate storage conditions;

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6. The term "primary package" means packaging containers which come into direct
contact with the contents of cosmetics at the time of manufacturing;
7. The term "secondary package" means one or more packages, protecting materials,
and packages for the purpose of labeling (including attached documents, etc.) that
encase the primary package;
8. The term "labeling" means letters, numbers or figures written on the containers
and packages of cosmetics;
9. The term "advertisement" means conduct to display or notify information on
cosmetics by means of radio, television, newspapers, magazines, voice, sound,
videos, the Internet, printings or billboards, or by other means.

CHAPTER II MANUFACTURE AND DISTRIBUTION OF COSMETICS

Article 3 (Registration, etc. of Manufacture or Sales Business) (1) Each person who
intends to manufacture whole or part of cosmetics (including the process of
packaging or labeling only), (hereinafter referred to as "manufacturer"), and who
intends to distribute or sell, or supply or award, for the purpose of import agency
business, the manufactured cosmetics (including manufactured cosmetics by
consignment) and imported cosmetics (hereinafter referred to as "manufacturer-
seller") shall file for registration with the Minister of Food and Drug Safety, as
prescribed by Ordinance of the Prime Minister. The same shall apply to any revision
to important matters prescribed by Ordinance of the Prime Minister, among the
registered matters. <Amended by Act No. 11690, Mar. 23, 2013>
(2) None of the following persons shall be registered as a seller or manufacturer:
<Amended by Act No. 12497, Mar. 18, 2014>

1. A mentally ill person defined in subparagraph 1 of Article 3 of the Mental Health


Act: Provided, That the foregoing shall not apply to a person determined suitable as
a seller or manufacturer by a specialized medical doctor;
2. An incompetent person under the adult guardianship or a person declared bankrupt
and not yet reinstated;
3. An addict to drugs or other harmful substances;
4. A person for whom his/her imprisonment without labor or greater punishment
declared by a court for violating this Act or the Act on Special Measures for the

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Control of Public Health Crimes was not completed or the non-execution of the
sentence has not become final;
5. A person for whom one year has not elapsed since the date registration was
revoked pursuant to Article 24.
(3) A manufacturer who intends to file for registration pursuant to paragraph (1)
shall be equipped with proper facilities, as prescribed by Ordinance of the Prime
Minister: Provided, That he/she may be allowed to be equipped with only part of the
facilities in cases prescribed by Ordinance of the Prime Minister, such as partial
engagement in the process of manufacturing cosmetics.<Amended by Act No. 11690, Mar.
23, 2013>

(4) A seller referred to in paragraph (1) who intends to file for registration of
manufacture-sale business shall meet appropriate standards prescribed by
Ordinance of the Prime Minister for quality control and post-manufacture and sale
safety control and shall assign a manager capable of managing such standards
(hereinafter referred to as "manufacture-sales manager"). <Amended by Act No.
11690, Mar. 23, 2013>
(5) Matters necessary for procedures for registration, etc. or qualification
requirements, duties, etc. of manufacture-sales managers under paragraphs (1)
through (4) shall be prescribed by Ordinance of the Prime Minister.<Amended by Act
No. 11690, Mar. 23, 2013>

Article 4 (Examination, etc. of Functional Cosmetics) (1) A person who intends to


manufacture or sell functional cosmetics by manufacturing or importing them shall
undergo an examination by the Minister of Food and Drug Safety or shall submit a
report to the Minister of Food and Drug Safety for safety and effectiveness of each
product. The same shall apply to any revision to the examined matters. <Amended by
Act No. 11690, Mar. 23, 2013>

(2) Examinations of effectiveness under paragraph (1) shall be limited to the


efficacy and effects provided for in the items of subparagraph 2 of Article 2.
(3) A person who intends to undergo an examination under paragraph (1) shall
submit data necessary for such examination to the Minister of Food and Drug Safety,
as prescribed by Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar. 23,
2013>

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(4) Matters necessary for the scope of and procedures, etc. for examinations or
submission of reports under paragraphs (1) and (2) shall be prescribed by Ordinance
of the Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>

Article 5 (Obligations, etc. of Manufacturer-Sellers, etc.) (1) A manufacturer-seller


shall conform to matters prescribed by Ordinance of the Prime Minister concerning
the quality control, post-manufacture and sale safety control of cosmetics and other
issues related to manufacture-sale. <Amended by Act No. 11690, Mar. 23, 2013>
(2) A manufacturer shall observe matters prescribed by Ordinance of the Prime
Minister concerning manufacturing of cosmetics.<Amended by Act No. 11690, Mar. 23,
2013>

(3) A manufacturer-seller shall report data, such as a track record of manufacturing


or importing cosmetics and a list of raw materials used in the process of
manufacturing cosmetics, to the Minister of Food and Drug Safety, as prescribed by
Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>
(4) If deemed necessary for preventing public health risks, the Minister of Food and
Drug Safety may require manufacturers, manufacturer-sellers and manufacture-
sales managers to undergo training for securing safety and quality management of
cosmetics.<Amended by Act No. 11690, Mar. 23, 2013>
(5) Necessary matters concerning institutions providing training, details of training,
and persons required to undergo training shall be determined by Ordinance of the
Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>

Article 5-2 (Recall of Hazardous Cosmetics) (1) Where cosmetics currently in market
violate Article 7, 9, 15 or 16 (1) and are likely to cause harm to national health, the
manufacturer or manufacturer-seller shall, without delay, recall or take necessary
measures to recall the relevant cosmetics.
(2) A manufacturer or manufacturer-seller who intends to recall or take necessary
measures to recall the relevant cosmetics pursuant to paragraph (1) shall report a
recall plan to the Minister of Food and Drug Safety in advance.
(3) The Minister of Food and Drug Safety may reduce or remit the administrative
disposition set forth under Article 24 to be imposed on the manufacturer or
manufacturer-seller who has carried out conscientiously the recall or necessary
measures for recall set forth under paragraph (1) because of the relevant cosmetics,

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as prescribed by Ordinance of the Prime Minister.


(4) Matters necessary for the cosmetics subject to the recall, reporting of a recall
plan, recall procedures, etc. set forth under paragraph (1) and (2) shall be
prescribed by Ordinance of the Prime Minister.
[This Article Newly Inserted by Act No. 13117, Jan. 28, 2015]

Article 6 (Reporting on Business Closure, etc.)


In any of the following cases, a manufacturer-seller or manufacturer of cosmetics
shall report the event to the Minister of Food and Drug Safety within 20 days from
the date of occurrence of the relevant event: Provided, That the same shall not apply
where he/she suspends his/her business for less than one month or resumes his/her
business after suspension for less than one month:<Amended by Act No. 11690, Mar. 23,
2013>

1. Where he/she closes or suspends the business;


2. Where he/she resumes the business after suspension;
3. Where any other matter prescribed by the Ordinance of the Prime Minister are
revised.

Article 7 (International Trade, etc. in Endangered Species of Wild Fauna and Flora)
When a person who intends to import or bring in or export cosmetics or raw
materials for cosmetics containing processed products of animals or plants
prescribed in the Convention on International Trade in Endangered Species of Wild
Fauna and Flora shall obtain permission from the Minister of Food and Drug Safety,
as prescribed by Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar. 23,
2013>

CHAPTER III HANDLING OF COSMETICS


SECTION 1 STANDARDS

Article 8 (Safety Standards, etc. for Cosmetics) (1) The Minister of Food and Drug
Safety shall designate and publicly announce raw materials which cannot be used for
manufacturing cosmetics. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety shall designate and publicly announce
standards for usage regarding raw materials, such as sterilization preservatives,

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coloring and sunblocks which require a specific restriction on usage, and no


sterilization preservatives, coloring and sunblocks whose standards for usage are not
designated and publicly announced shall be used.<Amended by Act No. 11690, Mar. 23,
2013>

(3) As for raw materials of cosmetics, etc. that are likely to pose risks to public
health, such as those known to contain harmful materials in Korea or overseas, the
Minister of Food and Drug Safety shall promptly assess the hazards of such materials
and determine whether such materials are hazardous, as prescribed by Ordinance of
the Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>
(4) After completing hazard assessment under paragraph (3), the Minister of Food
and Drug Safety shall designate the relevant raw materials of cosmetics as unusable
in manufacturing cosmetics or shall prescribe the standards for usage of such
materials. <Amended by Act No. 11690, Mar. 23, 2013>
(5) The Minister of Food and Drug Safety may publicly announce other safety
control standards for distributed cosmetics.<Amended by Act No. 11690, Mar. 23, 2013>

Article 9 (Safe Containers, Packaging, etc.) (1) When a manufacturer-seller sells


manufactured or imported cosmetics, he/she shall use child-proof containers and
packages to prevent children from being poisoned by misuse.
(2) Items requiring child-proof containers and packages under paragraph (1) and
standards, etc. for containers and packages shall be prescribed by Ordinance of the
Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>

SECTION 2 LABELING, ADVERTISEMENTS AND HANDLING

Article 10 (Matters Required to be Stated in Packages of Cosmetics) (1) Each of the


following matters shall be stated and labeled on the primary or secondary package of
cosmetics, as prescribed by the Ordinance of the Prime Minister: Provided, That in
cases of packages prescribed by Ordinance of the Prime Minister, such matters,
other than the name of a cosmetic, the trade name of a manufacturer-seller, and the
price need not be stated and labeled thereon: <Amended by Act No. 11690, Mar. 23, 2013>
1. Name of a cosmetic;

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2. Trade name and address of a manufacturer or manufacturer-seller;


3. All ingredients used in manufacturing the relevant cosmetic (excluding ingredients
prescribed by Ordinance of the Prime Minister, such as trace ingredients that are
not harmful to the human body);
4. Volume or weight of contents;
5. Manufacturing number;
6. Use-by date or best-before date after opening (the date of manufacture shall be
also entered when the best-before date after opening is entered; hereafter the
same shall apply in paragraph (2) 4);
7. Price;
8. The words "functional cosmetics" in cases of functional cosmetics;
9. Cautions for use;
10. Other matters prescribed by Ordinance of the Prime Minister.
(2) Notwithstanding the main body, other than the subparagraphs of paragraph (1),
each of the following matters shall be stated in the primary package:
1. Name of the cosmetic;
2. Trade name of the manufacturer or manufacturer-seller;
3. Manufacturing number;
4. Use-by date and best-before date after opening.
(3) The name of a product and the trade name of a manufacturer or manufacturer-
seller may be also stated in Braille for visually-impaired persons when placing
matters required to be stated under paragraph (1) on the containers and packages of
cosmetics.
(4) Standards for and methods of labeling and other matters shall be determined by
Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>

Article 11 (Price Indication of Cosmetics) (1) Prices referred to in Article 10 (1) 7


shall be indicated by a person who directly sells cosmetics to consumers (hereinafter
referred to as "seller").
(2) Methods of indication prescribed in paragraph (1) and other necessary matters
shall be determined by Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar.
23, 2013>

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Article 12 (Cautions for Statements or Labeling)


Matters prescribed in Articles 10 and 11 shall be stated or labeled in a more
conspicuous place than a place where other characters or sentences are and shall be
accurately stated or labeled in easily readable and comprehensible Korean
characters, as prescribed by Ordinance of the Prime Minister, and scripts in Chinese
characters and foreign languages may also be placed.<Amended by Act No. 11690, Mar.
23, 2013>

Article 13 (Prohibition of Wrongful Labeling and Advertisements) (1) No manufacturer,


manufacturer-seller or seller shall make any of the following labeling or
advertisements:
1. Labeling or advertisements likely to mislead consumers into thinking the
cosmetics are medicines;
2. Labeling or advertisements exceeding the scope of the examination undergone on
the safety and effectiveness of functional cosmetics, or labeling or advertisements
different from such examination results;
3. Labeling or advertisements likely to mislead consumers into thinking the
cosmetics are functional cosmetics or organic cosmetics;
4. Other labeling or advertisements likely to deceive or mislead consumers by
misrepresentation.
(2) The scope of labeling and advertisements under paragraph (1) or other
necessary matters shall be determined by Ordinance of the Prime Minister.<Amended
by Act No. 11690, Mar. 23, 2013>

Article 14 (Demonstration of Contents of Labeling and Advertisements) (1) A


manufacturer, manufacturer-seller or seller shall be able to demonstrate matters of
relevant factors in labeling and advertisements which he/she has placed.
(2) If the Minister of Food and Drug Safety deems it necessary to demonstrate
labeling or advertisements placed by a manufacturer, manufacturer-seller or seller
pursuant to paragraph (1) as it or they fall under Article 13 (1) 4, he/she may
request the manufacturer, manufacturer-seller or seller to submit relevant data
specifying the details thereof.<Amended by Act No. 11690, Mar. 23, 2013>
(3) A manufacturer, manufacturer-seller or seller in receipt of a request to submit
the demonstration data under paragraph (2) shall submit it to the Minister of Food

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and Drug Safety within 15 days after receipt of such request: Provided, That the
period for submission may be extended when the Minister of Food and Drug Safety
deems extenuating circumstances exist.<Amended by Act No. 11690, Mar. 23, 2013>
(4) When a manufacturer, manufacturer-seller or seller continues placing labeling or
advertisements without submitting the demonstration data within the period for
submission prescribed in paragraph (3) even after having been requested to do so
under paragraph (2), the Minister of Food and Drug Safety shall issue an order to
suspend the labeling or advertisements until he/she submits such verification data.
<Amended by Act No. 11690, Mar. 23, 2013>

(5) A manufacturer, manufacturer-seller or seller may refuse the submission of


verification data requested by other organizations under other Acts, such as the Act
on Fair Labeling and Advertising when he/she has submitted verification data
requested by the Minister of Food and Drug Safety pursuant to paragraphs (2) and
(3).<Amended by Act No. 11690, Mar. 23, 2013>
(6) The Minister of Food and Drug Safety shall comply with other organizations'
request for the submitted verification data, made under other Acts, such as the Act
on Fair Labeling and Advertising, except in extenuating circumstances.<Amended by
Act No. 11690, Mar. 23, 2013>

(7) Necessary matters concerning those subject to verification, scopes of, and
requirements for verification data, and methods of submission under paragraphs (1)
through (4) shall be determined by Ordinance of the Prime Minister.<Amended by Act
No. 11690, Mar. 23, 2013>

SECTION 3 PROHIBITION ON MANUFACTURE, IMPORTATION, SALE, ETC.

Article 15 (Prohibition of Manufacture-Sale)


No person shall sell any of the following cosmetics or manufacture, import, store or
display them for the purpose of sale:
1. Functional cosmetics that fail to undergo an examination or no report on which has
not been submitted, as prescribed in Article 4;
2. Fully or partially deteriorated cosmetics;
3. Cosmetics contaminated by pathogens;

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4. Cosmetics mixed or mingled with foreign substances;


5. Cosmetics using raw materials that cannot be used for cosmetics as prescribed in
Article 8 (1) and (2), or cosmetics that fail to meet safety control standards for
distributed cosmetics under paragraph (5) of the same Article;
6. Cosmetics using the horns of rhinoceros or bones of tigers, or the extracts
thereof;
7. Cosmetics manufactured either under unsanitary conditions which are likely to
cause harm to health and sanitation, or in facilities which fail to satisfy facility
standards under Article 3 (3);
8. Cosmetics which are likely to cause harm to health and sanitation due to poor
containers and packages;
9. Cosmetics which have forged or falsified the use-by date or best-before date
after opening (including the date of manufacture stated) prescribed in Article 10
(1) 6.

Article 16 (Prohibition of Sale, etc.) (1) No person shall sell any of the following
cosmetics, or store or display them for the purpose of sale: Provided, That this shall
be limited to cosmetics to be sold to consumers in the case of subparagraph 3:
1. Cosmetics sold after being manufactured (including manufacturing by
consignment) or imported by a person, other than registered manufacturer-sellers;
2. Cosmetics in violation of Articles 10 through 12 or cosmetics with statements or
labeling likely to mislead consumers into thinking the cosmetics are medicines;
3. Cosmetics manufactured or imported for consumers to test and use in advance not
for the purpose of sale but for publicity and sales promotions;
4. Cosmetics, the package of which or statements or labeling on which have been
damaged, forged or falsified.
(2) No one shall sell contents divided from a container of a cosmetic.

SECTION 4 COSMETICS INDUSTRY ASSOCIATION

Article 17 (Establishment)
Manufacturer-sellers or manufacturers may establish an association to guarantee
their independent activities and common interests and to contribute to improving

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national health.

CHAPTER IV SUPERVISION

Article 18 (Reporting, Inspections, etc.) (1) When the Minister of Food and Drug Safety
deems it necessary, he/she may order manufacturer-sellers, manufacturers, sellers
or other persons who handle cosmetics for their business to file necessary reports,
or order the relevant public officials to enter the places of manufacturing cosmetics,
places of business, warehouses, stores or other places handling cosmetics in order to
inspect relevant facilities, books, documents or other goods, or to ask questions to
relevant persons. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety may collect the minimum amount of a
cosmetic necessary to inspect the propriety of quality or safety standards, or
statements or labeling on packages, etc.<Amended by Act No. 11690, Mar. 23, 2013>
(3) The Minister of Food and Drug Safety may operate a monitoring system on sale
of products, as prescribed by Ordinance of the Prime Minister.<Amended by Act No.
11690, Mar. 23, 2013>

(4) In the case of paragraph (1), a relevant public official shall produce an identity
card indicating his/her authority to relevant persons.
(5) Qualification of relevant public officials under paragraphs (1) and (2) and other
necessary matters shall be prescribed by Ordinance of the Prime Minister.<Amended
by Act No. 11690, Mar. 23, 2013>

Article 19 (Corrective Orders)


If deemed necessary, the Minister of Food and Drug Safety may issue a corrective
order to persons who fail to comply with this Act.<Amended by Act No. 11690, Mar. 23,
2013>

Article 20 (Inspection Orders)


If deemed necessary, the Minister of Food and Drug Safety may order
manufacturer-sellers or manufacturers to undergo an inspection performed by a
cosmetics testing and inspection institution prescribed in Article 6 (2) 5 of the Act
on Testing and Inspection in the Food and Drug Industry, on cosmetics they have
handled.<Amended by Act No. 11690, Mar. 23, 2013; Act No. 11985, Jul. 30, 2013>

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Article 21 Deleted. <by Act No. 11985, Jul. 30, 2013>

Article 22 (Orders to Repair Facilities)


If the Minister of Food and Drug Safety deems that facilities held by a manufacturer
are likely to compromise the safety and quality of cosmetics because such facilities
fail to satisfy the facility standards referred to in Article 3 (3) paragraph 3 or are
decrepit or damaged, he/she may order the manufacturer to repair the facilities or
prohibit the use of all or part of the facilities until finishing repair.<Amended by Act No.
11690, Mar. 23, 2013>

Article 23 (Orders, etc. to Recall or Discard Goods) (1) The Minister of Food and Drug
Safety shall order manufacturer-sellers, manufacturers, sellers or other persons
handling cosmetics for business to take measures such as recalling and discarding
the relevant goods, where the cosmetics that they have sold, stored, displayed,
manufactured, or imported in violation of Article 7, 9, 15 or 16 (1), or the raw
materials, ingredients, etc. (hereinafter referred to as "goods") are likely to cause
harm to national health. The manufacturer-seller, manufacturer, seller or any other
person handling cosmetics for business who has received a recall order shall report a
recall plan to the Minister of Food and Drug Safety in advance. <Amended by Act No.
11690, Mar. 23, 2013; Act No. 13117, Jan. 28, 2015>

(2) The Minister of Food and Drug Safety may order relevant public officials to
discard the relevant goods or take other necessary measures in any of the following
cases:<Amended by Act No. 11690, Mar. 23, 2013>
1. When a person who has received an order prescribed in paragraph (1) fails to
comply with it;
2. When other urgent measures are necessary for national health.
(3) Matters necessary for the recall or discard procedures and plans, follow-up
measures, etc. set forth under paragraph (1) shall be prescribed by Ordinance of the
Prime Minister. <Newly Inserted by Act No. 13117, Jan. 28, 2015>

Article 23-2 (Publication of Hazardous Cosmetics) (1) In any of the following cases,
the Minister of Food and Drug Safety may order the relevant business entity to make
the fact public:

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1. Where the cosmetics violating Article 7, 9, 15, or 16 (1) are likely to cause harm
to national health;
2. Where a recall plan set forth under Article 5-2 (2) has been received.
(2) Matters necessary for the method of and the procedures, etc. for the publication
set forth under paragraph (1) shall be prescribed by Ordinance of the Prime
Minister.
[This Article Newly Inserted by Act No. 13117, Jan. 28, 2015]

Article 24 (Revocation of Registration and Suspension, etc. of Manufacturing Products)


(1) If a manufacturer-seller or manufacturer falls under any of the following, the
Minister of Food and Drug Safety may revoke the registration thereof or order
him/her to prohibit manufacturing, importing and selling products, or order him/her to
suspend all or part of the business for a prescribed period not exceeding one year:
Provided, That if he/she falls under subparagraph 1, the Minister of Food and Drug
Safety shall revoke the registration thereof: <Amended by Act No. 11690, Mar. 23, 2013;
Act No. 13117, Jan. 28, 2015>

1. When he/she falls under any subparagraph of Article 3 (2);


2. When he/she fails to equip the facilities under Article 3 (3);
3. When he/she manufactures or imports cosmetics that caused or are likely to cause
harm to national health;
4. When he/she fails to file for registration of cosmetics manufacture-sale or
manufacture business, any revision thereto, or to report business closure, etc.
required under Article 3 or 6;
5. When he/she sells, upon manufacturing or importation, functional cosmetics over
which he fails to undergo an examination or submit a report, in violation of Article
4;
6. When he/she fails to comply with matters to be observed, in violation of Article 5;
7. When he/she imports, or brings into Korea, cosmetics containing processed animal
or plant products prescribed in the Convention on International Trade in
Endangered Species of Wild Fauna and Flora, in violation of Article 7;
8. When he/she violates the standards for safety containers and packages under
Article 9;

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9. When he/she places statements or labeling on the containers or packages of


cosmetics and attached documents, in violation of Articles 10 through 12;
10. When he/she labels or advertises cosmetics, in violation of Article 13 or any
suspension order issued under Article 14 (4);
11. When he/she sells cosmetics, or manufactures, imports, stores, or displays
cosmetics for the purpose of sale, in violation of Article 15;
12. When he/she refuses or interferes with an inspection, questioning, collection, etc.
pursuant to Article 18 (1) and (2);
13. When he/she fails to comply with a corrective order, inspection order, repair
order, recall order, discard order or publication order issued under Article 19, 20,
22, the former part of Article 23 (1), or Article 23-2.
13-2. When he/she fails to or falsely report the recall plan set forth under the latter
part of Article 23 (1).
(2) Standards for administrative dispositions under paragraph (1) shall be
determined by Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar. 23,
2013>

Article 25 Deleted. <by Act No. 11985, Jul. 30, 2013>

Article 26 (Succession to Status of Manufacturers, etc.)


When a manufacturer-seller or manufacturer dies or transfers his/her business, or a
merger between corporate manufacturer-sellers or manufacturers takes place, the
successor, transferee, corporation surviving such merger or corporation incorporated
in the course of such merger shall succeed to the status of the manufacturer, etc.

Article 27 (Hearings)
The Minister of Food and Drug Safety shall hold a hearing when he/she intends to
issue an order to revoke registration or prohibit manufacturing and importing
products or suspend all business under Article 24.<Amended by Act No. 11690, Mar. 23,
2013>

Article 28 (Penalty Surcharges) (1) When a manufacturer-seller or manufacturer is


subject to a disposition of business suspension under Article 24, the Minister of Food
and Drug Safety may impose penalty surcharges not exceeding 50 million won in lieu
of a disposition of business suspension. <Amended by Act No. 11690, Mar. 23, 2013>

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(2) Amounts of penalty surcharges, based on the types, degrees, etc. of violations
subject to penalty surcharges under paragraph (1), and other necessary matters
shall be prescribed by Presidential Decree.
(3) When a person required to pay a penalty surcharge under paragraph (1) fails to
pay it by a payment deadline, the Minister of Food and Drug Safety may revoke the
imposition of the penalty surcharge under paragraph (1), as prescribed by
Presidential Decree, and order the relevant person to suspend business under Article
24 (1) or collect the said penalty surcharge in the same manner as delinquent
national taxes are collected: Provided, That when the Minister of Food and Drug
Safety cannot order the relevant person to suspend business under Article 24 (1)
due to business closure, etc. under Article 6, the penalty surcharge shall be collected
in the same manner as delinquent national taxes are collected.<Amended by Act No.
11690, Mar. 23, 2013>

Article 28-2 (Publication of Violations) (1) The Minister of Food and Drug Safety may
release to the public matters related to dispositions and prescribed by Presidential
Decree concerning the person against whom an administrative disposition has been
determined pursuant to Article 22, 23, 23-2, 24 or 28, such as the reason for and
details of the disposition, the name, address and name of representative of the
person subject to the disposition and the name of the relevant items.
(2) Matters necessary for the publication such as the methods of the publication set
forth under paragraph (1) shall be prescribed by Presidential Decree.
[This Article Newly Inserted by Act No. 13117, Jan. 28, 2015]

Article 29 (Support for Voluntary Management)


The Minister of Food and Drug Safety may provide administrative or financial
support to manufacturer-sellers or manufacturers in order for them to settle and
spread a voluntary management system under which they voluntarily endeavor to
comply with criteria for labeling, advertisements, quality control.<Amended by Act No.
11690, Mar. 23, 2013>

Article 30 (Exception to Products for Exportation)


Products for exportation only that are not sold domestically may comply with
provisions of any importing country, notwithstanding Articles 8 through 16.

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CHAPTER V SUPPLEMENTARY PROVISIONS

Article 31 (Re-issuance of Certificate of Registration Completion)


When a manufacturer-seller or manufacturer loses his/her certificate of registration
or a notice on the examination results of functional cosmetics, or such certificate or
notice becomes unusable, he/she may be re-issued such certificate, as prescribed
by Ordinance of the Prime Minister.<Amended by Act No. 11690, Mar. 23, 2013>

Article 32 (Fees)
A person who intends to register or undergo an examination under this Act shall pay
fees, as prescribed by Ordinance of the Prime Minister. The same shall apply to
revisions to registered or examined matters.<Amended by Act No. 11690, Mar. 23, 2013>

Article 33 (Support for Cosmetics Industry)


The Minister of Health and Welfare and the Minister of Food and Drug Safety shall
establish the foundation for promoting the cosmetic industry and formulate and
implement policies necessary for enhancing competitiveness, and he/she shall secure
finances thereof and grant support necessary for developing technology, survey and
research projects, and building an international cooperation system.<Amended by Act
No. 11690, Mar. 23, 2013>

Article 34 (Entrustment or Delegation of Authority) (1) Part of the authority of the


Minister of Food and Drug Safety vested under this Act may be delegated to the
Commissioner of the local Korea Food and Drug Administration, the Special
Metropolitan City Mayor, a Metropolitan City Mayor, or a Do Governor, as prescribed
by Presidential Decree. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety may entrust some of his/her duties related
to cosmetics vested under this Act to an association established pursuant to Article
17, as prescribed by Presidential Decree.<Amended by Act No. 11690, Mar. 23, 2013>

CHAPTER VI GENERAL PROVISIONS

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Article 35 (Penalty Provisions) (1) Any person who violates Article 7 shall be punished
by imprisonment with labor for not more than five years or by a fine not exceeding
50 million won. <Amended by Act No. 12497, Mar. 18, 2014>
(2) Imprisonment with labor and fines under paragraph (1) may be imposed
concurrently.

Article 36 (Penalty Provisions) (1) Any of the following persons shall be punished by
imprisonment with labor for not more than three years or by a fine not exceeding 30
million won: <Amended by Act No. 12497, Mar. 18, 2014>
1. A person who violates the former part of Article 3 (1);
2. A person who violates the former part of Article 4 (1);
3. A person who violates Article 15;
4. A person who violates Article 16 (1) 1 or 4.
(2) Imprisonment with labor and fines under paragraph (1) may be imposed
concurrently.

Article 37 (Penalty Provisions) (1) Any person who violates Article 9, 13, or 16 (1) 2
or 3 or Article 16 (2), or who fails to comply with a suspension order issued under
Article 14 (4) shall be punished by imprisonment with labor for not more than one
year or by a fine not exceeding ten million won. <Amended by Act No. 11985, Jul. 30, 2013;
Act No. 12497, Mar. 18, 2014>

(2) Imprisonment with labor and fines under paragraph (1) may be imposed
concurrently.

Article 38 (Penalty Provisions)


Any of the following persons shall be punished by a fine not exceeding two million
won:
1. A person who violates Article 5 (1) and (2);
2. A person who violates Article 10 (1), (2) and Article 11;
3. A person who violates any order issued under Articles 18 through 20, Article 22
or 23, or refuses, interferes with or evades an inspection, collection or disposition
by a relevant public official.

Article 39 (Joint Penalty Provisions)

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If the representative of a corporation or an agent or employee of, or any other


person employed by, a corporation or an individual commits any violation under
Articles 35 through 38 in connection with the business affairs of the corporation or
individual, not only shall the violator be punished, but also the corporation or
individual shall be punished by a fine under the relevant provisions: Provided, That
the same shall not apply where such corporation or individual has not been negligent
in giving due attention and supervision concerning the relevant business affairs to
prevent such violation.

Article 40 (Administrative Fines) (1) Any of the following persons shall be subject to an
administrative fine not exceeding one million won:
1. A person who fails to file for registration of any revision, in violation of the latter
part of Article 3 (1);
2. A person who fails to undergo an examination of revised matters, in violation of
the latter part of Article 4 (1);
3. A person who fails to report the track record of producing or importing cosmetics
or a list of materials of cosmetics, in violation of Article 5 (3);
4. A person who violates any order issued under Article 5 (4);
5. A person who fails to report business closure, in violation of Article 6;
6. A person who fails to file a report, in violation of Article 18.
(2) Administrative fines under paragraph (1) shall be imposed and collected by the
Minister of Food and Drug Safety, as prescribed by Presidential Decree.<Amended by
Act No. 11690, Mar. 23, 2013>

ADDENDA <No. 11690, 23. Mar, 2013>


Article 1 (Enforcement Date)
(1) This Act shall enter into force on the date of its promulgation.
(2) Omitted.
Articles 2 through 7 Omitted.

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ADDENDA <No. 12497, 18. Mar, 2014>


Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures concerning Incompetent Persons)
Incompetent persons under the adult guardianship referred to in the amended
provisions of Article 3 (2) 2 shall be deemed to include persons for whom a
declaration of incompetency remains in effect under Article 2 of the Addenda to the
Civil Act (Act No. 10429).
Article 3 (Transitional Measures concerning Quasi-Incompetent Persons)
Notwithstanding the amended provisions of Article 3 (2) 2, the previous provisions
shall apply to persons for whom a declaration of quasi-incompetency remains in
effect under Article 2 of the Addenda to the Civil Act (Act No. 10429).

ADDENDA <No. 13117, 28. Jan, 2015>


This Act shall enter into force six months after the date of its promulgation:
Provided, That the amended provisions of Article 28-2 shall enter into force on the
date of its promulgation.

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