Cosmetics Act
Cosmetics Act
Cosmetics Act
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
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.
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>
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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>
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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 5-2 (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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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>
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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(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>
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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>
(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>
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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.
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>
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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]
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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>
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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]
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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>
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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.
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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>
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