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Consumer Chemical Products and Biocides Safety Control Act
  • Date2022-06-09 13:53
  • TypeLaw
  • View341
Amended by Act No. 17103, Mar. 24, 2020

Lastly Amended by Act No. 17326, May 26, 2020

 


CHAPTER I GENERAL PROVISIONS
 
Article 1 (Purpose)
The purpose of this Act is to prescribe matters concerning the risk assessment of consumer chemical products, approval of biocidal substances and biocidal products, and standards for biocide-treated products, thereby protecting the public health and the environment and contributing to the public safety.
 
Article 2 (Basic Principles for Control of Consumer Chemical Products and Biocides)
Consumer chemical products and biocides shall be controlled in accordance with the following principles:
1. Even where the scientific correlation between consumer chemical products and biocides and human and animal health and damage to the environment has not been clearly demonstrated, such consumer chemical products and biocides shall be controlled safely in advance so as not to cause harm to human and animal health and the environment;
2. Priority shall be given to the groups vulnerable to exposure to chemical substances, etc. generated from consumer chemical products or biocides, such as children and pregnant women;
3. Information on the safety of consumer chemical products and biocides shall be provided accurately and promptly to prevent damage from misuse and abuse thereof.
 
Article 3 (Definitions)
The terms used in this Act are defined as follows:
1. The term "chemical substance" means any element, its compounds and substances obtained by an artificial chemical reaction thereto, and substances obtained by chemical modification, extraction or purification of substances in their natural state;
2. The term "risk" means the degree of damage to human health or the environment caused by exposure to chemical substances or biocidal substances;
3. The term "consumer chemical product" means any chemical product used in everyday living spaces such as houses, offices, or public use facilities, which is likely to cause exposure of chemical substances to humans or the environment;
4. The term "consumer chemical product subject to safety verification" means any consumer chemical product designated and publicly notified by the Minister of Environment pursuant to the main clause of Article 8 (3) as the relevant products are deemed to be risky from a risk assessment conducted under Article 8 (1);
5. The term "harmful organism" means any organism which directly or indirectly has harmful effects on humans or animals;
6. The term "biocide" means any biocidal substance, biocidal product, and biocide-treated product;
7. The term "biocidal substance" means any chemical substance, natural substance, or microbe used to remove, render harmless, or deter any harmful organism (hereinafter referred to as "removal, etc.");
8. The term "biocidal product" means any of the following products with the main purpose of removal, etc. of harmful organisms:
(a) A product composed of one or more biocidal substances, or a product with a mixture of a biocidal substance and a chemical substance, a natural substance, or a microbe which is not a biocidal substance;
(b) A product generating a biocidal substance from a chemical substance or a mixture of a chemical substance or natural substance or a microbe;
9. The term "biocide-treated product" means any product in which a biocidal product has been used for an ancillary purpose of removal, etc. of harmful organisms other than the main function of the product;
10. The term "nanomaterial" means any of the following materials:
(a) A material containing particles where, for 50 percent or more of the particles in the number size distribution, one or more external dimensions is in the size range of 1 nanometer to 100 nanometers;
(b) A fullerene, graphene flake, and single-wall carbon nanotubes with one or more external dimensions below 1 nanometer;
11. The term "technical equivalence" means the technical equality of mutually different biocidal substances with regard to their chemical composition, risks, and effects or efficacy of removal, etc. of harmful organisms;
12. The term "product similarity" means that mutually different biocidal products contain the identical biocidal substances (including the substances which are recognized to be technically equivalent) and that substances contained in biocidal products share the similar ingredients, composition ratio, and such products share the similar uses, risks, and effects or efficacy of removal, etc. of harmful organisms.
 
Article 4 (Formulation of Comprehensive Plan to Control Consumer Chemical Products and Biocides)
(1) The Minister of Environment shall formulate a comprehensive plan to control consumer chemical products and biocides (hereinafter referred to "comprehensive plan") every five years.
(2) To formulate a comprehensive plan, the Minister of Environment shall consult in advance with the heads of relevant central administrative agencies and have the comprehensive plan deliberated upon by the Consumer Chemical Products and Biocides Control Committee established under Article 6 (1). The foregoing shall also apply to amendments to such comprehensive plan.
(3) A comprehensive plan shall include the following:
1. Objectives of, and basic direction-setting for, policies on management of consumer chemical products and biocides;
2. Matters regarding methods and plans for fact-finding surveys, risk assessment, etc. of consumer chemical products;
3. Matters regarding methods and plans for managing biocides, such as approval of biocidal substances and biocidal products;
4. Matters regarding research and technological development of consumer chemical products and biocides;
5. Matters regarding cooperation with international organizations or foreign governments with regard to the safety control of consumer chemical products and biocides;
6. Other matters necessary to ensure the safety of consumer chemical products and biocides.
(4) Upon the formulation of a comprehensive plan, the Minister of Environment shall notify the heads of relevant central administrative agencies and the heads of local governments of the details of the comprehensive plan without delay.
(5) The heads of relevant central administrative agencies and the heads of local governments shall establish and implement policy measures under their jurisdiction in accordance with the comprehensive plan.
 
Article 5 (Scope of Application)
(1) This Act shall not apply to any consumer chemical product or biocide that falls under following categories: Provided, That this Act shall apply where a consumer chemical product or biocide is manufactured, imported, sold, or used not for a purpose or use prescribed in the following statutes:
1. Health functional foods defined in subparagraph 1 of Article 3 of the Health Functional Foods Act;
2. Munitions defined in Article 2 of the Act on the Management of Military Supplies and in subparagraph 2 of Article 3 of the Defense Acquisition Program Act (excluding conventional items under Article 3 of the Act on the Management of Military Supplies);
3. Pesticides defined in subparagraph 1 of Article 2 of the Pesticide Control Act, biopesticides under subparagraph 1-2 of the same Article, technical concentrate under subparagraph 3 of the same Article, and pest control equipment under subparagraph 3-2 of the same Article;
4. Water treatment chemicals defined in subparagraph 5 of Article 3 of the Drinking Water Management Act;
5. Single-compound feed defined in subparagraph 2 of Article 2 of the Control of Livestock and Fish Feed Act and supplementary feed under subparagraph 4 of the same Article;
6. Treatment substances defined in subparagraph 10 of Article 2 of the Ballast Water Management Act;
7. Foods defined in subparagraph 1 of Article 2 of the Food Sanitation Act, food additives under subparagraph 2 of the same Article, apparatus under subparagraph 4 of the same Article, containers and packages under subparagraph 5 of the same Article;
8. Drugs defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act, quasi-drugs under subparagraph 7 of the same Article, drugs and quasi-drugs for animals under Article 85 (1) of the same Act;
9. Hygiene products defined in subparagraph 1 of Article 2 of the Hygiene Products Control Act;
10. Medical devices defined in the main clause, with the exception of the subparagraphs, of Article 2 (1) of the Medical Devices Act;
11. Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act.
(2) Article 10 or Chapter III shall not apply to a consumer chemical product or biocide that falls under any of the following subparagraphs:
1. Consumer chemical products or biocides used for scientific experiments, analysis, or research;
2. Consumer chemical products or biocides which are test products not designed for sale;
3. Consumer chemical products or biocides to be exported in their entirety to a foreign country;
4. Consumer chemical products or biocides used only for products falling under subparagraphs 1 through 3;
5. Other consumer chemical products or biocides prescribed by Presidential Decree, such as products not sold in the Republic of Korea.
 
Article 6 (Consumer Chemical Products and Biocides Control Committee)
(1) A Consumer Chemical Products and Biocides Control Committee (hereinafter referred to as the "Control Committee") shall be established under the authority of the Minister of Environment to deliberate on the following matters concerning the control of consumer chemical products and biocides:
1. Formulation of the comprehensive plans under Article 4 (1);
2. Designation of consumer chemical products subject to safety verification under the main clause of Article 8 (3);
3. Safety standards under Article 9 (1) and labeling standards under Article 10 (8);
4. Approval of biocidal substances under the main clause of Article 12 (1), recognition of technical equivalence (hereinafter referred to as "recognition of technical equivalence") under the former part of Article 16 (2), and revocation of approval and recognition under Article 17 (1) and (2);
5. Approval of biocidal products under Article 20 (1), recognition of product similarity (hereinafter referred to as "recognition of product similarity") under the former part of Article 25 (2), and revocation of approval and recognition under Article 26 (1) and (2);
6. Orders requiring information on biocide-treated products to be provided or perused under Article 30 (4);
7. Non-disclosure of data under Article 31 (2);
8. Other matters referred by the chairperson of the Control Committee for deliberation with regard to the safety control of consumer chemical products and biocides.
(2) The Control Committee shall be composed of not more than 20 members, including one chairperson, giving due consideration to gender balance.
(3) The chairperson of the Control Committee shall be appointed by the Minister of Environment, from among the members of the Senior Executive Service of the Ministry of Environment responsible for controlling consumer chemical products and biocides.
(4) Members of the Control Committee shall be appointed or commissioned by the Minister of Environment from among the following persons:
1. A person recommended by the head of a relevant central administrative agency from among public officials belonging to the relevant central administrative agency responsible for the affairs related to chemical substances or products;
2. An expert with extensive knowledge and experiences in chemistry, the environment, health or other related fields or a person engaged in industries and private organizations related to chemical substances;
3. A person recommended by the head of any relevant central administrative agency from among the persons referred to in subparagraph 2.
(5) A majority of the members of the Control Committee shall constitute a quorum and any decision thereof shall require the concurring vote of a majority of those present.
(6) Where necessary for specialized research and review of the matters to be deliberated upon by the Control Committee, a specialized committee by each field comprised of the members of the Control Committee and experts from related fields may be separately established, as prescribed by Ordinance of the Ministry of Environment.
(7) Except as provided in paragraphs (1) through (6), matters necessary for the composition, operation, etc. of the Control Committee shall be prescribed by Presidential Decree.


CHAPTER II CONTROL OF CONSUMER CHEMICAL PRODUCTS
 
Article 7 (Fact-Finding Survey)
(1) In order to prevent risks posed by consumer chemical products to the public health or the environment and to collect data necessary for deciding whether to designate consumer chemical products as those subject to safety verification pursuant to the main clause of Article 8 (3), the Minister of Environment shall conduct a fact-finding survey of manufacturers, importers, sellers, or distributors of consumer chemical products with respect to the following matters:
1. Types and uses of consumer chemical products, quantities of manufacture, import, and sale thereof;
2. Ingredients, composition ratio, and hazards of consumer chemical products;
3. Other matters deemed necessary by the Minister of Environment for safety control of consumer chemical products.
(2) Where necessary for a fact-finding survey conducted under paragraph (1), the Minister of Environment may request manufacturers, importers, sellers, or distributors of consumer chemical products to submit or report data on the matters provided in the subparagraphs of paragraph (1).
(3) Necessary matters for procedures for fact-finding surveys conducted under paragraphs (1) and (2) and other matters shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 8 (Risk Assessment)
(1) The Minister of Environment may conduct a risk assessment of a consumer chemical product in any of the following cases, as prescribed by Ordinance of the Ministry of Environment:
1. Where the findings of a fact-finding survey of the consumer chemical product under Article 7 (1) suggest that such product is likely to pose a risk;
2. Where concerns are raised domestically and internationally about a high risk chemical substance contained in a consumer chemical product.
(2) Upon conducting a risk assessment pursuant to paragraph (1), the Minister of Environment shall notify the head of any relevant central administrative agency the results thereof.
(3) Where the risk assessment of a consumer chemical product conducted under paragraph (1) suggests that such product is deemed likely to pose a risk, the Minister of Environment shall consult the head of any relevant central administrative agency and shall, following deliberation by the Control Committee, designate and publicly notify the product as a consumer chemical product subject to safety verification: Provided, That biocidal products approved by the Minister of Environment pursuant to Article 20 (1) are excluded from designation as consumer chemical products subject to safety verification.
(4) Where the Minister of Environment deems that urgent action is necessary to prevent a consumer chemical product from posing a risk as the risk assessment conducted under paragraph (1) determines that such product is highly risky, the Minister may order a ban on the manufacture or import of the product before designating and publicly notifying it as a consumer chemical product subject to safety verification pursuant to the main clause of paragraph (3).
(5) Upon completion of a risk assessment, the Minister of Environment may disclose the name, risks of the relevant product, and other matters prescribed by Ordinance of the Ministry of Environment.
(6) Except as provided in paragraphs (1) through (5), the guidelines and procedures for risk assessments and other necessary matters shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 9 (Safety Standards for Consumer Chemical Product Subject to Safety Verification)
(1) The Minister of Environment may prescribe and publicly notify safety standards on risks, etc. of each type of consumer chemical product subject to safety verification. In such cases, the Minister shall consult with the head of any relevant central administrative agency on the safety standards and have them deliberated upon by the Control Committee before public notification.
(2) The safety standards shall include the following:
1. Chemical substances not permitted to be contained in a consumer chemical product subject to safety verification;
2. Standards for the content, yield, or evaporation amount of chemical substances contained in a consumer chemical product subject to safety verification;
3. Standards for a container or package (including the details necessary to prevent a safety accident that may occur to children, pregnant women, or other groups vulnerable to exposure to chemical substances, etc. from the relevant product), where such container or package, or leakage of the content is likely to pose a risk;
4. Other matters deemed necessary by the Minister of Environment for safety control of consumer chemical products subject to safety verification.
 
Article 10 (Verification of Safety Standards and Labeling Standards)
(1) Any person who intends to manufacture or import a consumer chemical product subject to safety verification for which the safety standards are publicly notified pursuant to Article 9 (1) shall obtain verification as to whether such product complies with the safety standards from any testing and inspection institution designated under Article 41 (1).
(2) Verification under paragraph (1) shall be valid for three years from the date of receipt of the verification.
(3) Any person who intends to continue manufacturing or importing a consumer chemical product subject to safety verification even after the valid term of verification specified under paragraph (2) expires shall obtain re-verification under paragraph (1).
(4) A person who has obtained verification under paragraph (1) shall file a report with the Minister of Environment on the matters prescribed by Ordinance of the Ministry of Environment, including product information, ingredients, or content.
(5) Where a person who has filed a report under paragraph (4) intends to change any reported matters which are prescribed by Ordinance of the Ministry of Environment, he or she shall file a report on changes with the Minister of Environment.
(6) Any person who intends to manufacture or import a consumer chemical product subject to safety verification, the safety standards for which are not publicly notified, shall submit data on the uses, hazards, or exposure information of chemical substances contained in such product to the Minister of Environment to obtain approval, as prescribed by Presidential Decree.
(7) Where a person who has obtained approval pursuant to paragraph (6) intends to change any approved matters which are prescribed by Ordinance of the Ministry of Environment, he or she shall obtain approval for changes from the Minister of Environment: Provided, That where the person intends to change any minor matters prescribed by Ordinance of the Ministry of Environment, such as the name or trade name, address, and contact information, he or she shall file a report on changes with the Minister of Environment.
(8) Any person who intends to manufacture or import a consumer chemical product subject to safety verification for sale or distribution in the Republic of Korea shall label the following information (hereinafter referred to as "labeling standards") in Korean on the surface or package of such product. In such cases, Chinese characters or a foreign language may also be stated therein:
1. Name of the consumer chemical product subject to safety verification;
2. Name or trade name, address, and contact information of the manufacturer or importer;
3. Matters prescribed by Ordinance of the Ministry of Environment on chemical substances used in the consumer chemical product subject to safety verification;
4. Weight or volume;
5. Precautions for use;
6. Matters reported pursuant to paragraph (4);
7. Matters approved pursuant to paragraph (6);
8. Other matters prescribed by Ordinance of the Ministry of Environment.
(9) Matters necessary for the procedures, etc. for verification under paragraph (1), reporting under paragraph (4), reporting on changes under paragraph (5), approval under paragraph (6), approval for changes and reporting on changes under paragraph (7), and labeling standards under paragraph (8) shall be prescribed by Presidential Decree.
Article 10-2 (Disclosure of Information on Consumer Chemical Products Subject to Safety Verification)
(1) The Minister of Environment shall disclose the following information on consumer chemical products subject to safety verification reported pursuant to Article 10 (4) or approved pursuant to paragraph (6) of the same Article:
1. Name of the consumer chemical products subject to safety verification;
2. Name or trade name, address, and contact information of the manufacturer or importer of the consumer chemical products subject to safety verification;
3. Major ingredients used in the relevant consumer chemical product subject to safety verification;
4. Other matters prescribed by Ordinance of the Ministry of Environment.
(2) Matters necessary for the methods, procedures, etc. for disclosure of information under paragraph (1) shall be prescribed by Ordinance of the Ministry of Environment.
[This Article Newly Inserted on Mar. 24, 2020]
 
Article 11 (Ban on Manufacture or Import of Consumer Chemical Product Subject to Safety Verification)
(1) The Minister of Environment may issue an order banning the manufacture or import of a consumer chemical product subject to safety verification, where its manufacturer or importer falls under any of the following cases:
1. Where he or she fails to obtain verification under Article 10 (1) or approval under Article 10 (6) or obtains verification or approval by fraud or other improper means;
2. Where he or she manufactures or imports a consumer chemical product subject to safety verification not in accordance with the details of the verification or approval obtained under Article 10 (1) or (6);
3. Where he or she continues to manufacture or import a consumer chemical product subject to safety verification without obtaining re-verification pursuant to Article 10 (3) even after the term of validity for verification under Article 10 (2) expires;
4. Where he or she manufactures or imports a consumer chemical product subject to safety verification without reporting pursuant to Article 10 (4);
5. Where he or she manufactures or imports a consumer chemical product subject to safety verification without filing a report on changes under Article 10 (5) or obtaining approval for changes under the main clause of paragraph (7) of the same Article;
6. Where he or she manufactures or imports a consumer chemical product subject to safety verification which fails to meet the labeling standards under Article 10 (8);
7. Where he or she fails to comply with a corrective order under Article 36-2 (2).
(2) No person subject to an order banning the manufacture or import of a consumer chemical product subject to safety verification under paragraph (1) may apply for either verification under Article 10 (1) or approval under Article 10 (6) until the expiry of six months from the date of issuance of such order.


CHAPTER III SAFETY CONTROL OF BIOCIDES
 
SECTION 1 Approval of Biocidal Substances
 
Article 12 (Approval of Biocidal Substance)
(1) A person who intends to manufacture or import a biocidal substance to use such biocidal substance for biocidal products shall obtain approval of the substance from the Minister of Environment: Provided, That the same shall not apply to biocidal substances publicly notified by the Minister of Environment following deliberation by the Control Committee, as such substances are deemed to be a low risk:
1. Deleted;
2. Deleted;
3. Deleted;
4. Deleted.
(2) The standards for approval required under the main clause, with the exception of the subparagraphs, of paragraph (1) (hereinafter referred to as "approval of a substance") shall be as follows, and further details shall be specified and publicly notified by the Minister of Environment:
1. Neither biocidal substance nor its residue shall adversely affect the health of people or animals or the environment;
2. A biocidal substance shall be effective and functional enough for the removal, etc. of a harmful organism;
3. No biocidal substance shall let a harmful organism, the removal, etc. of which is made by such substance, develop a tolerance thereto;
4. Where a biocidal substance is used for the removal, etc. of a vertebrate, such substance shall not cause unnecessary pain thereto in the process of removal, etc.
(3) Where a person who intends to obtain approval of a substance falls under any of the following cases, the Minister of Environment may fully or partially relax the standards provided in the subparagraphs of paragraph (2):
1. Where the biocidal substance to be approved has a little chance of being exposed to a person or the environment as the purpose of using it or its use is limited;
2. Where the biocidal substance to be approved needs to be used for the public health and the environment as no low-risk substance to replace such biocidal substance exists.
(4) Approval of a biocidal substance shall be valid for a period prescribed by Presidential Decree, not to exceed 10 years, taking into account the hazards or risks of the biocidal substance, regardless of whether approval for changes is granted or any change is reported pursuant to Article 15: Provided, That approval of any of the following biocidal substances shall be valid for a period prescribed by Presidential Decree, not to exceed seven years:
1. A biocidal substance to which relaxed standards for approval of a substance are applied pursuant to paragraph (3);
2. A biocidal substance prescribed by Ordinance of the Ministry of Environment such as a substance with acute respiratory impacts.
(5) A person who intends to continue manufacturing or importing the relevant biocidal substance even after the valid term of approval of that substance under paragraph (4) expires shall obtain re-approval of such substance before the valid term expires.
 
Article 13 (Application for Approval of Substance)
(1) A person who intends to obtain approval of a substance shall file an application therefor with the Minister of Environment along with the following data:
1. Name or trade name, address, and contact information of an applicant for approval of the substance;
2. Identification information, such as the name, molecular formula, and chemical composition of the biocidal substance;
3. Types of biocidal products for which the biocidal substance can be used (referring to biocidal products classified by type based on the purpose of use or the use, as prescribed by Ordinance of the Ministry of Environment; hereinafter referred to as "types of biocidal products");
4. The following data on the biocidal substance:
(a) Physical, chemical, or biological features;
(b) Exposure information such as the use, main routes of exposure, patterns of exposure of the biocidal substance;
(c) Information on hazards and risks to human bodies, animals, and the environment;
(d) Effects and efficacy;
(e) Classification and labeling;
5. In any of the cases provided in the subparagraphs of Article 12 (3), data to prove the relevant facts;
6. Other data prescribed by Presidential Decree, such as ingredients used for manufacturing the biocidal substance and the manufacturing process;
7. Comprehensive data on the safety of the biocidal substance evaluated on the basis of the data provided in subparagraphs 1 through 6.
(2) A person who applies for approval of a substance pursuant to paragraph (1) need not submit the data referred to in the subparagraphs of paragraph (1) in any of the following cases:
1. Where he or she proves that the effects of the relevant biocidal substance on human bodies, animals, or the environment are insignificant as the exposure information is specified given the purposes of using such biocidal substance and types of biocidal products for which the biocidal substance can be used;
2. Where he or she scientifically proves that it is unnecessary to submit data;
3. Where the relevant data is submitted for registration under Article 10 of the Act on Registration and Evaluation of Chemical Substances.
(3) A person who intends to obtain re-approval of a substance pursuant to Article 12 (5) shall apply for approval of the substance with the Minister of Environment one year before the expiry of the valid term specified in paragraph (4) of the same Article, along with the data provided in the subparagraphs of paragraph (1): Provided, That where the relevant data have the same content with that of the data already submitted when applying for approval of that substance, he or she need not submit the data.
(4) Matters necessary for the methods of applying for approval of substances and of preparing data pursuant to paragraphs (1) and (3) shall be prescribed by Presidential Decree.
 
Article 14 (Procedures for Approval of Substance)
(1) Upon receipt of an application for approval of a substance under Article 13 (1) or (3), the Minister of Environment shall evaluate the application for approval of the substance, as prescribed by Presidential Decree. In such cases, if supplementation is necessary for the data submitted, the Minister may request the relevant applicant (hereinafter referred to as “applicant for approval of the substance”) to supplement such data, specifying the content of and period for supplementation.
(2) Where a test or an inspection is necessary for the evaluation referred to in the former part of paragraph (1), the Minister of Environment may require a testing and inspection institution designated pursuant to Article 41 (1) to perform such tasks as an agent.
(3) Upon completion of an evaluation under the former part of paragraph (1), the Minister of Environment shall draft an evaluation statement, as prescribed by Ordinance of the Ministry of Environment, and allow the applicant for approval of a substance to peruse the statement for at least 30 days. In such cases, the applicant for approval of that substance may submit his or her opinions on the draft of such evaluation statement within 30 days after the end of the perusal period, and may request the submission deadline to be extended by up to 30 days, as prescribed by Ordinance of the Ministry of Environment, if any unavoidable cause exists.
(4) The Minister of Environment shall decide whether to approve a substance after deliberation on the evaluation statement by the Control Committee within 30 days after the date when opinions are submitted pursuant to the latter part of paragraph (3) (referring to the closure date for submission in the absence of opinions).
(5) Where it is impracticable to decide within 30 days whether to approve a substance for good cause, such as cases that would take the Minister of Environment a significant amount of time to review and reflect the opinions submitted, he or she may extend the period for decision by up to 30 days. In such cases, the Minister shall without delay notify the applicant for approval of that substance of an extension of the period and grounds therefor.
(6) Where the Minister of Environment decides to approve a substance pursuant to paragraph (4), he or she shall notify the applicant of the following matters without delay, as prescribed by Ordinance of the Ministry of Environment:
1. Purity level of the biocidal substance to be maintained;
2. Features and content level of impurities permitted to be contained in the biocidal substance;
3. Types of biocidal products for which the use of the biocidal substance is permitted;
4. Categories of users of the biocidal substance;
5. Valid term of approval of the biocidal substance;
6. Other matters prescribed by Presidential Decree regarding approval of the biocidal substance.
 
Article 15 (Changes to Approval of Substance)
Where a person who has obtained approval of a biocidal substance intends to change the significant matters prescribed by Presidential Decree, such as information on the hazards or risks and the effects or efficacy of the biocidal substance, the person shall obtain approval for such change, as prescribed by Ordinance of the Ministry of Environment: Provided, That where such person intends to change other approved matters, such as the trade name, his or her name, address or contact information, he or she shall file a report on the change with the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment.
 
Article 16 (Recognition of Technical Equivalence)
(1) Any person who intends to obtain recognition of technical equivalence between an approved biocidal substance (hereafter referred to as a “reference biocidal substance” in this Article) and another biocidal substance shall file an application with the Minister of Environment for recognition of technical equivalence, along with data proving that the latter biocidal substance has technical equivalence to the reference biocidal substance. In such cases, he or she shall obtain consent to use data pursuant to Article 32 (1).
(2) Upon receipt of an application under paragraph (1), the Minister of Environment shall decide whether to recognize technical equivalence following deliberation by the Control Committee. In such cases, if supplementation is necessary for the data submitted pursuant to paragraph (1) in the process of such decision-making, the Minister may ask the applicant to supplement such data, specifying the content of and the period for supplementation.
(3) Where the Minister of Environment decides to recognize technical equivalence, he or she shall notify the applicant under paragraph (1) thereof without delay.
(4) A biocidal substance, technical equivalence of which to the reference biocidal substance is recognized, shall be deemed approved. In such cases, the recognition of technical equivalence shall be valid until the valid term of approval of the reference biocidal substance expires.
(5) Where any change to the reference biocidal substance of a biocidal substance, technical equivalence of which is recognized, is approved pursuant to the main clause of Article 15, the Minister of Environment shall notify the details of such approval to the manufacturer or importer of such biocidal substance.
(6) A person notified pursuant to paragraph (5) shall re-obtain recognition of technical equivalence by submitting data proving the technical equivalence to the reference biocidal substance for which approval for changes is granted: Provided, That the foregoing shall not apply to the cases prescribed by Presidential Decree, such as where no change is made in the chemical composition of the reference biocidal substance for which approval for changes is granted.
(7) Except as provided in paragraphs (1) through (6), matters necessary for the criteria of, procedure for, and methods of recognizing technical equivalence shall be prescribed by Presidential Decree.
 
Article 17 (Revocation of Approval of Substance)
(1) Where a person who has obtained approval of a substance or approval for changes under the main clause of Article 15 (hereinafter referred to as “approval, etc. of a substance”) or recognition of technical equivalence falls under any of the following cases, the Minister of Environment may revoke approval, etc. of the relevant biocidal substance or recognition of technical equivalence or order the suspension of manufacture or import thereof for up to one year after deliberation by the Control Committee: Provided, That in cases falling under subparagraph 1, the Minister shall revoke approval, etc. of the substance or recognition of technical equivalence:
1. Where he or she obtains approval, etc. of the substance or recognition of technical equivalence by fraud or other improper means;
2. Where he or she manufactures or imports a biocidal substance not in accordance with the details of approval, etc. of the substance or recognition of technical equivalence that he or she has obtained;
3. Where he or she continues manufacturing or importing the biocidal substance without obtaining approval of the substance or recognition of technical equivalence even after the valid term of approval of the substance under Article 12 (4) or of recognition of technical equivalence under the latter part of Article 16 (4) expires;
4. Where any risk that was unknown as at the time of approval, etc. of the substance or recognition of technical equivalence is newly identified;
5. Where a foreign government, an international agency, etc. deems that the relevant biocidal substance has any risk.
(2) Where the Minister of Environment has revoked approval, etc. of the reference biocidal substance or ordered the suspension of manufacture or import thereof pursuant to paragraph (1), he or she may revoke recognition of technical equivalence of a biocidal substance to the reference biocidal substance or order the suspension of manufacture or import of such biocidal substance for up to one year after deliberation by the Control Committee.
 
Article 18 (Approval Deferment of Existing Biocidal Substance)
(1) A person who intends to manufacture or import a biocidal substance contained in any biocidal product or biocide-treated product distributed in the Republic of Korea prior to December 31, 2018 (hereinafter referred to as “existing biocidal substance”) may manufacture or import an existing biocidal substance without obtaining approval of that substance, notwithstanding the main clause of Article 12 (1), , where such substance is designated and publicly notified as the existing biocidal substance eligible for approval deferment after being reported pursuant to paragraph (2):
1. Deleted;
2. Deleted.
(2) A person who intends to manufacture or import an existing biocidal substance without obtaining approval of such substance by the last day of the period of approval deferment under paragraph (1) shall file a report on the following matters with the Minister of Environment before manufacturing or importing such substance:
1. Name or trade name, address, and contact information of a person who intends to manufacture or import the existing biocidal substance;
2. Name, chemical composition, quantity manufactured or imported of the existing biocidal substance;
3. Types of biocidal products for which the existing biocidal substance can be used;
4. Other matters prescribed by Ordinance of the Ministry of Environment.
(3) Upon receipt of a report under paragraph (2), the Minister of Environment shall designate an existing biocidal substance as an existing biocidal substance eligible for approval deferment, taking into account the hazards and risks of the existing biocidal substance, within six months from the date of reporting, and shall publicly notify the following:
1. Name of the existing biocidal substance eligible for approval deferment;
2. Types of biocidal products for which the existing biocidal substance eligible for approval deferment can be used;
3. The period of approval deferment.
(4) The period of approval deferment referred to in paragraph (3) 3 shall be prescribed by Presidential Decree, not to exceed 10 years, taking into account the hazards and risks of an existing biocidal substance eligible for approval deferment and types of biocidal products for which such existing biocidal substance is used.
(5) Except as provided in paragraphs (1) through (4), procedures for filing reports on existing biocidal substances and other necessary matters shall be prescribed by Ordinance of Ministry of Environment.
 
Article 19 (Submission of Plan for Applying for Approval of Substance)
(1) A person who has filed a report under Article 18 (2) shall submit a plan on the procedure and method for preparing the data to apply for approval of a substance listed in the subparagraphs of Article 13 (1) (hereafter in this Article referred to as “plan for applying for approval of a substance”) within one year from the date on which the relevant existing biocidal substance is designated and publicly notified as an existing biocidal substance eligible for approval deferment (hereinafter referred to as “existing biocidal substance eligible for approval deferment”) under Article 18 (3).
(2) Where it is deemed impracticable for a person who has filed a report under Article 18 (2) to submit data to apply for approval of a substance within the period of approval deferment as such person fails to submit a plan for applying for approval of the substance by the deadline or fails to prepare the data to apply for approval of the substance listed in the subparagraphs of Article 13 (1) (hereafter in this Article referred to as “data to apply for approval of a substance”) in accordance with the plan, the Minister of Environment may issue the person an order banning the manufacture or import of the relevant existing biocidal substance eligible for approval deferment. In such cases, approval of the substance shall be obtained to manufacture or import the aforesaid biocidal substance.
(3) Where the Minister of Environment issues an order banning the manufacture or import of an existing biocidal substance eligible for approval deferment to all persons who has reported such existing biocidal substance pursuant to the former part of paragraph (2), the Minister may cancel the designation of such existing biocidal substance as eligible for approval deferment.
(4) Where two or more persons submit a plan for applying for approval of an existing biocidal substance eligible for approval deferment with the same names and chemical compositions, such persons shall file applications for approval of the substance separately but the data prescribed by Ordinance of the Ministry of Environment among the data to apply for approval of the substance shall be submitted jointly by a representative chosen by them: Provided, That the persons may separately submit such data with the confirmation of the Minister of Environment in any of the following cases:
1. Where joint submission is likely to lead to the disclosure of business secrets of an enterprise, subsequently incurring substantial loss;
2. Where joint submission costs more than separate submission;
3. Where the grounds prescribed by Presidential Decree arise in relation to separate submission.
(5) The Minister of Environment may obtain the data prescribed by Ordinance of the Ministry of Environment among the data to apply for approval of an existing biocidal substance eligible for approval deferment and may provide such data to a person who has filed a report pursuant to Article 18 (2). In such cases, the Minister may collect the expenses incurred in obtaining the data to apply for approval of that existing biocidal substance from the recipient of such data, as prescribed by Ordinance of the Ministry of Environment.
(6) Except as provided in paragraphs (1) through (5), the procedure for submission of plans for applying for approval of substances and for confirmation of joint submission or separate submission of data to apply for approval of substances and other necessary matters shall be prescribed by Ordinance of the Ministry of Environment.
 
SECTION 2 Approval of Biocidal Products and Control of Biocide-Treated Products
 
Article 20 (Approval of Biocidal Product)
(1) Any person who intends to manufacture or import a biocidal product for sale or distribution in the Republic of Korea shall obtain approval of such biocidal product from the Minister of Environment:
1. Deleted;
2. Deleted;
3. Deleted.
(2) The standards for approval obtained under paragraph (1) (hereinafter referred to as "approval of a product") shall be as follows, and further details shall be specified and publicly notified by the Minister of Environment:
1. Neither biocidal product nor its residue shall adversely affect the health of people or animals, or the environment;
2. Every biocidal substance contained in a biocidal product shall be any of the following biocidal substances:
(a) A biocidal substance that is used to the extent that approval, etc. of such substance is obtained;
(b) A biocidal substance publicly notified pursuant to the proviso of Article 12 (1);
(c) The existing biocidal substances eligible for approval deferment used within the scope designated and publicly notified pursuant to Article 18 (3) (limited to where the types of biocidal products under Article 18 (3) 2 are different from the types of biocidal products subject to approval);
3. A biocidal product shall be effective and functional enough for the removal, etc. of a harmful organism;
4. No biocidal product shall let a harmful organism, the removal, etc. of which is made by such product, develop a tolerance thereto;
5. Where a biocidal product is used for the removal, etc. of a vertebrate, such product shall not cause unnecessary pain thereto in the process of removal, etc.;
6. Safe containers or packages in compliance with the standards prescribed by Ordinance of the Ministry of Environment shall be used to prevent any safety accident attributable to handling or use of biocidal products.
(3) The Minister of Environment shall take into account the following matters in application of the standards provided in the subparagraphs of paragraph (2):
1. The maximum extent of risks of biocidal products;
2. Possible adverse impacts on the environment in the process of using or discarding biocidal products;
3. Effects that biocidal substances contained in biocidal products cause in interaction with other biocidal substances, chemical substances, etc.;
4. Whether kinds and methods of use of any biocide-treated product are appropriate, if biocidal products are used therein.
(4) The Minister of Environment may partially or wholly relax the standards provided in the subparagraphs of paragraph (2), where a person who intends to obtain approval of a product meets the following criteria:
1. The biocidal product to be approved shall be used only for industrial purposes;
2. The biocidal product to be approved needs to be used for the public health and the environment as no low-risk product to replace such biocidal product exists.
(5) Approval of a biocidal product shall be valid for a period prescribed by Presidential Decree, not to exceed 10 years, taking into account the risks or hazards of the biocidal product, regardless of whether approval for changes is granted or any change is reported under Article 23: Provided, That approval of any of the following biocidal products shall be valid for a period prescribed by Presidential Decree, not to exceed five years:
1. A biocidal product to which relaxed standards for approval of products apply pursuant to paragraph (4);
2. A biocidal product which contains any of the biocidal substances referred to in the subparagraphs of Article 12 (4).
(6) A person who intends to continue manufacturing or importing a biocidal product even after the expiry of the valid term of approval of such product under paragraph (5) shall obtain re-approval of the product prior to the expiry of the valid term.
(7) Deleted.
 
Article 21 (Application for Approval of Product)
(1) Any person who intends to obtain approval of a product shall submit an application to the Minister of Environment along with the following data:
1. Name or trade name, address, and contact information of an applicant for approval of the product;
2. Name and type of the biocidal product;
3. The following data on substances contained in the biocidal product:
(a) Ingredients, composition ratio, purposes of use, and uses of all the substances including biocidal substances, contained in the biocidal product;
(b) Name and address of a supplier of biocidal substances contained in the biocidal product;
(c) Name, purpose of use, and use of a nanomaterial, if it is intentionally contained in the biocidal product;
4. The following data on the biocidal product:
(a) Physical, chemical, or biological features;
(b) Exposure information such as the use, main routes of exposure, and patterns of exposure of the biocidal product;
(c) Information on hazards and risks to human bodies, animals, and the environment;
(d) Effects and efficacy;
(e) Classification, labeling, and package;
5. In any of the cases provided in the subparagraphs of Article 20 (4), data proving the relevant facts;
6. Other data prescribed by Presidential Decree, such as ingredients used in manufacturing the biocidal product and the manufacturing process;
7. Comprehensive data on the safety of the biocidal product evaluated on the basis of the data referred to in the subparagraphs 1 through 6.
(2) A person who applies for approval of a product under paragraph (1) need not submit the data provided in the subparagraphs of paragraph (1) in any of the following cases:
1. Where he or she proves that the effects of the biocidal product or a biocidal substance contained therein on human bodies, animals, or the environment are insignificant as and purpose of use of such biocidal product or a biocidal substance contained therein and the exposure information are specified;
2. Where he or she scientifically proves that it is unnecessary to submit data;
3. Where the relevant data is submitted for registration under Article 10 of the Act on Registration and Evaluation of Chemical Substances.
(3) A person who intends to obtain re-approval of a product pursuant to Article 20 (6) shall apply for approval of the product to the Minister of Environment one year before the term of validity under paragraph (5) of the same Article expires, along with the data referred to in each subparagraph of paragraph (1): Provided, That where the relevant data have the same content with that of the data already submitted when applying for approval of the product, he or she need not submit the data.
(4) Matters necessary for the methods of applying for approval of products and of preparing data pursuant to paragraphs (1) and (3) shall be prescribed by Presidential Decree.
 
Article 22 (Procedures for Approval of Product)
(1) Upon receipt of an application for approval of a product under Article 21 (1) or (3), the Minister of Environment shall evaluate the application for approval of the product, as prescribed by Presidential Decree. In such cases, if supplementation is necessary for the data submitted, the Minister may request the applicant for approval of the product (hereinafter referred to as “applicant for approval of the product”) to supplement such data, specifying the content of and period for supplementation.
(2) Where a test or an inspection is necessary for the evaluation referred to in the former part of paragraph (1), the Minister of Environment may require a testing and inspection institution designated pursuant to Article 41 (1) to perform such tasks as an agent.
(3) Upon completion of an evaluation under the former part of paragraph (1), the Minister of Environment shall draft an evaluation statement, as prescribed by Ordinance of the Ministry of Environment, and allow the applicant for approval of the product to peruse the statement for at least 30 days. In such cases, the applicant for approval of the product may submit his or her opinions on the draft of such evaluation statement within 30 days after the perusal period ends, and may request the submission deadline to be extended the by up to 30 days, as prescribed by Ordinance of the Ministry of Environment, if any unavoidable reason exists.
(4) The Minister of Environment shall decide whether to approve a product after deliberation on the evaluation statement by the Control Committee within 30 days after the date when opinions are submitted pursuant to the latter part of paragraph (3) (referring to the closure date for submission in the absence of opinions).
(5) Where it is impracticable to decide within 30 days whether to approve a product for good cause, such as cases that would take the Minister of Environment a significant amount of time to review and reflect the opinions submitted, he or she may extend the period for decision by up to 30 days. In such cases, the Minister shall without delay notify the applicant for approval of the product of an extension of the period and grounds therefor.
(6) Where the Minister of Environment decides to approve a product pursuant to paragraph (4), he or she shall notify the applicant of the following matters without delay, as prescribed by Ordinance of the Ministry of Environment:
1. Names and types of the biocidal product;
2. Valid term of approval of the product;
3. Prospective users of the biocidal product and scope of their use;
4. Ingredients and composition ratio of all the substances contained in the biocidal product;
5. Kinds and methods of use of a biocide-treated product, if the relevant biocidal product is used therein;
6. Other matters prescribed by Presidential Decree on approval of the biocidal product.
 
Article 23 (Changes to Approval of Product)
Where a person granted approval of a biocidal product intends to change the significant matters prescribed by Presidential Decree, such as information on the hazards or risks and the effects or efficacy of the biocidal product, the person shall obtain approval for such change, as prescribed by Ordinance of the Minister of Environment: Provided, That where such person intends to change other matters, such as the name or trade name, address, or contact information, he or she shall file a report on changes, as prescribed by Ordinance of the Minister of Environment.
 
Article 24 (Special Cases concerning Approval of Product)
(1) Articles 21 and 22 and the main clause of Article 23 shall not apply to approval of any biocidal product that satisfies all the following requirements:
1. Every biocidal substance contained in the biocidal product shall be a biocidal substance publicly notified under the proviso of Article 12 (1);
2. A substance other than biocidal substances from among substances contained in the biocidal product shall not be the following:
(a) A substance subject to intensive control defined in subparagraph 10-2 of Article 2 of the Act on Registration and Evaluation of Chemical Substances (hereinafter referred to as "substance subject to intensive control");
(b) Nanomaterials;
(c) A hazardous or risky substance prescribed by Ordinance of the Ministry of Environment;
3. The biocidal product shall be effective and functional enough for the removal, etc. of a harmful organism;
4. The handling of the biocidal product and its intended use do not require personal protective equipment.
(2) A person who intends to obtain approval of a biocidal product that satisfies the requirements provided in the subparagraphs of paragraph (1) shall file an application therefor with the Minister of Environment, as prescribed by Ordinance of the Ministry of Ordinance, along with the following data:
1. Name or trade name, address, and contact information of an applicant for approval of the biocidal product;
2. Name of the biocidal product;
3. Ingredients and composition ratio of all substances, including biocidal substances, contained in the biocidal product;
4. Data proving that the biocidal product satisfies the requirements provided in the subparagraphs of paragraph (1);
5. Data prescribed by Presidential Decree on approval of the biocidal product.
(3) Upon receipt of an application under paragraph (2), the Minister of Environment shall decide whether to approve the relevant product and notify the applicant of the decision, as prescribed by Presidential Decree.
(4) Where a biocidal product falls under both of the following cases, the Minister of Environment may permit the manufacture or import of the relevant product or biocidal substances contained in such product without approval for a limited period pursuant to Ordinance of the Ministry of Environment, at the request of the head of the relevant central administrative agency:
1. Where it is urgently needed for public health, etc.;
2. Where there is no product to replace such biocidal product.
(5) Upon receipt of a request under paragraph (4), the Minister of Environment may conduct a risk assessment, if necessary to verify the negative impacts on the health of humans and animals or the environment.
 
Article 25 (Recognition of Product Similarity)
(1) A person who intends to obtain recognition of product similarity between an approved biocidal product (hereafter in this Article referred to as "reference biocidal product") and another biocidal product shall file an application for recognition of product similarity with the Minister of Environment, along with data proving that the relevant biocidal product has similarity with the reference biocidal product. In such cases, such person shall obtain consent to use data required under Article 32 (1).
(2) Upon receipt of an application under paragraph (1), the Minister of Environment shall decide whether to recognize product similarity following deliberation by the Control Committee. In such cases, if supplementation is necessary for the data submitted under paragraph (1) in the process of deciding whether to recognize product similarity, the Minister may request the applicant to supplement such data, specifying the details of and period for supplementation.
(3) Upon deciding whether to recognize product similarity, the Minister of Environment shall notify the applicant under paragraph (1) of the decision without delay.
(4) A biocidal product, product similarity of which to the reference biocidal product is recognized, shall be deemed approved. In such cases, recognition of product similarity shall remain valid until the valid term of approval of the reference biocidal product expires.
(5) Where any change to the reference biocidal product of a biocidal product, product similarity of which is recognized, is approved pursuant to the main clause of Article 23, the Minister of Environment shall notify the manufacturer or importer of the biocidal product of the details of such approval.
(6) A person notified under paragraph (5) shall obtain re-recognition of product similarity by submitting data proving that the biocidal product has similarity to the reference biocidal product for which approval for changes is granted: Provided, That the same shall not apply to the cases prescribed by Presidential Decree, such as where no change is made in the ingredients or composition ratio of substances contained in the reference biocidal product for which approval for changes is granted.
(7) Except as provided in paragraphs (1) through (6), standards, procedures, and methods for recognition of product similarity and other necessary matters shall be prescribed by Presidential Decree.
 
Article 26 (Revocation of Approval of Product)
(1) Where a person who has obtained approval of a product or approval for changes under the main clause of Article 23 (hereinafter referred to as “approval, etc. of a product”) or recognition of product similarity falls under any of the following cases, the Minister of Environment may revoke approval, etc. of the relevant biocidal product or recognition of product similarity, or order the suspension of manufacture or import thereof for up to one year after deliberation by the Control Committee: Provided, That in cases falling under subparagraph 1, the Minister shall revoke approval, etc. of the product or recognition of product similarity:
1. Where he or she obtains approval, etc. of the product or recognition of product similarity by fraud or other improper means;
2. Where he or she manufactures or imports a biocidal product not in accordance with the details of approval, etc. of the product or recognition of technical equivalence that he or she has obtained;
3. Where he or she continues manufacturing or importing the biocidal product without obtaining approval of the product or recognition of product similarity even after the term of validity for approval of the product under Article 20 (5) or of recognition of product similarity under the latter part of Article 25 (4) expires;
4. Where he or she fails to comply with a corrective order under Article 36-2 (2);
5. Where any risk that was unknown as at the time of approval, etc. of the product or recognition of product similarity is newly identified;
6. Where a foreign government, an international agency, etc. deems that the relevant biocidal product has any risk.
(2) Where the Minister of Environment has revoked approval, etc. of the reference biocidal product or ordered the suspension of manufacture or import thereof pursuant to paragraph (1), he or she may revoke recognition of product similarity of a biocidal product to the reference biocidal product or order the suspension of manufacture or import of such biocidal product for up to one year after deliberation by the Control Committee.
 
Article 27 (Labeling of Biocidal Product)
A manufacturer or importer of an approved biocidal product (including approval of a product deemed granted pursuant to the former part of Article 25 (4)) for sale or distribution in the Republic of Korea shall label the following matters on the surface of the relevant biocidal product in a clear and legible manner for consumers, as prescribed by Ordinance of the Ministry of Environment:
1. Ingredients and composition ratio of all the biocidal substances used in the biocidal product;
2. Name or trade name, address, and contact information of the manufacturer or importer of the biocidal product;
3. Dangers of, and first-aid methods of, using the biocidal product;
4. Shelf life of, and methods of discarding, the biocidal product;
5. Name, purpose of use, and use of a nanomaterial, if it is intentionally contained in the biocidal product;
6. Other matters prescribed by Ordinance of the Ministry of Environment as those deemed necessary by the Minister of Environment for the safe use of the biocidal product.
 
Article 28 (Safety and Labeling Standards for Biocide-Treated Product)
(1) A manufacturer or an importer of a biocide-treated product for sale or distribution in the Republic of Korea shall comply with the following safety standards for biocidal products used in the biocide-treated product:
1. A biocidal product used in the biocide-treated product shall be approved (including approval of a product deemed granted pursuant to the former part of Article 25 (4); hereafter the same shall apply in this subparagraph) (in cases of importing a biocide-treated product, the one in which an approved biocidal product and a biocidal product satisfying the standards for similarity prescribed by Presidential Decree are used) and shall be used to the extent that approval for such biocidal product is granted;
2. The manufacturer or an importer shall comply with the matters prescribed by Ordinance of the Ministry of Environment for the safety control of biocide-treated products.
(2) Where a manufacturer or an importer of a biocide-treated product for sale or distribution in the Republic of Korea notifies consumers of its effects and efficacy of the removal, etc. of harmful organisms, he or she shall label the following matters on the surface of the relevant biocide-treated product in a clear and legible manner for consumers, as prescribed by Ordinance of the Ministry of Environment:
1. Statement indicating that biocidal products are used;
2. Names and functions of all the biocidal substances contained in biocide-treated products used in the biocide-treated product;
3. The fact that nanomaterials are contained in biocidal products used in the biocide-treated product, if they are intentionally contained;
4. Dangers of biocidal products used in the biocide-treated product and precautions in handling thereof.
 
SECTION 3 Information Disclosure and Data Protection
 
Article 29 (Disclosure of Information on Biocidal Substance and Product)
(1) The Minister of Environment shall disclose the following information on an approved biocidal substance (including approval of a substance deemed granted pursuant to the former part of Article 16 (4); hereafter the same shall apply in this paragraph):
1. Name of the biocidal substance and the valid term of approval;
2. Degrees of the hazards and risks of the biocidal substance;
3. Name or trade name, address, and contact information of a person who obtains approval of the biocidal substance;
4. Types of biocidal products in which the relevant biocidal substance can be used;
5. Other matters prescribed by Ordinance of the Ministry of Environment regarding disclosure of information on the approved biocidal substance.
(2) The Minister of Environment shall disclose the following information on an approved biocidal product (including approval of a product deemed granted pursuant to the former part of Article 25 (4); hereafter the same shall apply in this paragraph):
1. Name of the biocidal product and the valid term of approval;
2. Degrees of the hazards and risks of the biocidal product;
3. Name or trade name, address, and contact information of a person who obtains approval of the product;
4. Types of and methods of using biocide-treated products, if the biocidal product can be used in such biocide-treated products;
5. Other matters prescribed by Ordinance of the Ministry of Environment regarding disclosure of information on the approved biocidal product.
(3) Matters necessary for the method and procedure for information disclosure under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 30 (Provision of Information on Biocide-Treated Product)
(1) A person who has purchased a biocide-treated product may request the manufacturer or importer of such biocide-treated product to provide or permit perusal of information on the biocidal products used in the biocide-treated product, as prescribed by Presidential Decree.
(2) A person requested to provide or permit perusal of information pursuant to paragraph (1) shall provide or permit perusal of such information, except where business or operational secrets exist.
(3) A person whose request for provision or perusal of information pursuant to paragraph (1) is refused pursuant to paragraph (2) may apply with the Minister of Environment for ordering provision or perusal of such information, as prescribed by Ordinance of the Ministry of Environment.
(4) Upon receipt of an application pursuant to paragraph (3), the Minister of Environment may order the manufacturer or the importer of the relevant biocide-treated product to provide or permit perusal of such information after deliberation by the Control Committee.
(5) No person who is provided with or peruses information pursuant to paragraph (2) or (4) shall use such information for a purpose other than the intended purpose of requesting the information nor for an unlawful purpose such as provision of the information to a third party.
(6) Except as provided in paragraphs (1) through (5), matters necessary for the procedure, etc. for requesting, providing, or perusing information shall be prescribed by Presidential Decree.
 
Article 31 (Data Protection)
(1) The Minister of Environment shall not disclose any data submitted by each applicant for approval of a substance, approval of a product, and recognition of technical equivalence under the former part of Article 16 (1), or for recognition of product similarity under the former part of Article 25 (1) for a protection period prescribed by Presidential Decree not to exceed 15 years: Provided, That the same shall not apply to any of the following data:
1. Data already published domestically and internationally;
2. Data that shall be published pursuant to Article 29 (1) or (2);
3. Other data prescribed by Presidential Decree regarding data disclosure.
(2) The Minister of Environment may not disclose certain data after deliberation by the Control Committee even after the protection periods under the main clause, with the exception of the subparagraphs, of paragraph (1) elapse in any of the following cases:
1. Where data disclosure is likely to significantly disrupt the national security, order maintenance, or public welfare;
2. Where data constitute the trade secrets defined in subparagraph 2 of Article 2 of the Unfair Competition Prevention and Trade Secret Protection Act and a person who has submitted such data requests protection thereof.
(3) Except as provided in paragraphs (1) and (2), matters necessary for data protection, etc. shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 32 (Consent to Data Use)
(1) A person who shall submit data to file any of the following applications may use the data already submitted by another person to the Minister of Environment, if such person obtains consent to use such data from the owner thereof:
1. An application for approval, etc. of a substance pursuant to the Article 13 (1) and (3) or the main clause of Article 15;
2. An application for recognition of technical equivalence pursuant to Article 16 (1);
3. An application for approval, etc. of a product pursuant to Article 21 (1) and (3), the main clause of Article 23, or Article 24 (2);
4. An application for recognition of product similarity pursuant to Article 25 (1).
(2) The procedure for obtaining consent to use data pursuant to paragraph (1) and other necessary matters shall be prescribed by Ordinance of the Ministry of Environment.
Article 32-2 (Principle of Minimizing Vertebrate Animal Testing)
(1) Vertebrate animal testing to assess the risk of consumer chemical products and to approve biocidal substances or biocidal products shall be conducted within the minimum scope through alternatives to vertebrate animal testing defined in subparagraph 19 of Article 2 of the Act on Registration and Evaluation of Chemical Substances (hereinafter referred to as "alternatives to vertebrate animal testing"); and except in cases prescribed by Presidential Decree, such as where the risks of the relevant consumer chemical products, biocidal substances, or biocidal products to the health of humans and animals and the environment are newly identified, vertebrate animal testing shall not be conducted repeatedly on the same consumer chemical products, biocidal substances, or biocidal products.
(2) The Minister of Environment shall formulate and implement policies for the development and use of alternatives to vertebrate animal testing in order to minimize vertebrate animal testing in the process of the risk assessment of consumer chemical products, approval of biocidal substances or biocidal products, etc.
[This Article Newly Inserted on Mar. 24, 2020]
 
Article 33 (Special cases concerning Vertebrate Animal Test Data)
(1) A person who is required to submit data under the provisions, with the exception of the subparagraphs, of Article 32 (1) shall endeavor to secure data prepared in accordance with a method to replace animal testing and, if animal testing is needed, the person shall request the Minister of Environment to verify whether data recording the result of testing on vertebrates (hereafter referred to as “vertebrate animal test data” in this Article) exist.
(2) Where the Minister of Environment upon receipt of a request under paragraph (1) has verified the existence of vertebrate animal test data, the Minister shall without delay notify the requester under paragraph (1) of the matters prescribed by Ordinance of the Ministry of Environment with the consent of the owner of such vertebrate animal test data, including the name of the owner.
(3) Upon receipt of a notice under paragraph (2), the requester under paragraph (1) shall obtain consent to use vertebrate animal test data from its owner and use such data for the intended purpose of the request to minimize animal testing: Provided, That where 15 years have elapsed since vertebrate animal test data was submitted, he or she may use it without obtaining consent to use such data from its owner.
(4) Upon receipt of a request for consent to use vertebrate animal test data pursuant to the main clause of paragraph (3), the owner of such data shall comply therewith unless there is good cause prescribed by Presidential Decree.
(5) Where the owner of vertebrate animal test data refuses to give consent to use such data notwithstanding paragraph (4), the requester under paragraph (1) may obtain confirmation from the Minister of Environment to omit submission of the data: Provided, That where it is deemed that vertebrate animal test data needs to be submitted for any reason such as that an assessment of the hazards, etc. of a chemical substance is impracticable without such data, the Minister may order the owner to produce and submit the data by a period prescribed by Ordinance of the Ministry of Environment.
(6) Except as provided in paragraphs (1) through (5), consent to use vertebrate animal test data and other necessary matters shall be prescribed by Ordinance of the Ministry of Environment.


CHAPTER IV EX POST CONTROL OF CONSUMER CHEMICAL PRODUCTS AND BIOCIDES
 
Article 34 (Restrictions on Labeling and Advertisement)
(1) Where a person who manufactures, imports, sells, or distributes consumer chemical products subject to safety verification or biocidal products packs or advertises the products, such person shall comply with all of the following:
1. He or she shall not use a phrase prescribed by Ordinance of the Ministry of Environment such as “non-toxic” or “environment-friendly” or any similar expression so as not to mislead consumers about negative impacts on the health of humans and animals and the environment: Provided, That where consumer chemical products subject to safety verification obtain an eco-label certification pursuant to Article 17 of the Environmental Technology and Industry Support Act, he or she may affix the label;
2. He or she shall ensure that a phrase prescribed by Ordinance of the Ministry of Environment is stated clearly and legibly in advertisements of the relevant products to prevent any risk caused by the use thereof.
(2) No manufacturer, importer, seller, or distributor of any product other than an approved biocidal product or biocide-treated product (including products deemed approved pursuant to the former part of Article 25 (4)) shall label or advertise such product as a biocidal product or biocide-treated product or conduct labeling or advertisement with a potentially misleading implication to that effect.
 
Article 35 (Prohibition of Sale)
(1) No one shall sell or donate, or display, keep, or store for sale or donation, any of the following substances or products:
1. Any of the following consumer chemical products:
(a) Consumer chemical products the manufacture or import of which is banned pursuant to Article 8 (4) or 11 (1);
(b) Consumer chemical products subject to safety verification the verification or approval of which under Article 10 (1) or (6) is not obtained;
(c) Consumer chemical products subject to safety verification the report on which under Article 10 (4) is not filed;
(d) Consumer chemical products subject to safety verification which fail to meet the labeling standards under Article 10 (8);
2. Any of the following biocidal substances:
(a) Biocidal substances approval, etc. of which is not obtained;
(b) Biocidal substances, the approval, etc. or recognition of technical equivalence of which is revoked or the suspension of manufacture or import of which is ordered pursuant to Article 17;
3. Any of the following biocidal products:
(a) Biocidal products approval, etc. of which is not obtained;
(b) Biocidal products, the approval, etc. or recognition of product similarity of which is revoked or the manufacture or import of which is suspended pursuant to Article 26;
(c) Biocidal products the labels to which under Article 27 are not affixed;
4. Biocide-treated products not in compliance with the safety standards or labeling standards under Article 28.
(2) No sales broker or purchasing agent of consumer chemical products subject to safety verification, biocidal products, or biocide-treated products shall intermediate or purchase by proxy any product provided in the subparagraphs of paragraph (1) (excluding where mail order brokers under the Act on the Consumer Protection in Electronic Commerce shall immediately delete any relevant product at an online shopping website that they operate and take a technical action to enable consumers to check such information; hereinafter the same shall apply).
 
Article 36 (Report on New Risks and Recommendation on Measures)
(1) Where a manufacturer or importer of a consumer chemical product subject to safety verification, a person granted approval of a substance or approval of a product (including approval of a substance deemed granted pursuant to the former part of Article 16 (4) or approval of a product deemed granted pursuant to the former part of Article 25 (4)), or a manufacturer or importer of a biocide-treated product for sale or distribution in the Republic of Korea becomes aware of any of the following information, he or she shall file a report thereon with the Minister of Environment without delay, as prescribed by Ordinance of the Ministry of Environment:
1. Information on hazards and risks of consumer chemical products subject to safety verification or biocides;
2. Information that effects or efficacy of biocidal substances or biocidal products is not sufficient.
(2) If necessary to prevent risks to the life, body, or property posed by any consumer chemical product subject to safety verification or biocide reported under paragraph (1), the Minister of Environment may recommend its manufacturer or importer to collect, destroy, repair, exchange, refund, or improve such product or biocide or to take any other necessary measures, as prescribed by Presidential Decree.
Article 36-2 (Obligation of Quality Control)
(1) A manufacturer or importer of a consumer chemical product subject to safety verification or biocidal product, approval of which is granted, shall comply with the standards prescribed by Ordinance of the Ministry of Environment, such as manufacturing and storage facilities and safety control, to maintain and manage the quality of the relevant product as approved.
(2) The Minister of Environment may order a person who fails to comply with the standards under paragraph (1) to correct the same for a specified period, as prescribed by Ordinance of the Ministry of Environment.
[This Article Newly Inserted on Mar. 24, 2020]
 
Article 37 (Recall Order)
(1) The Minister of Environment may order a manufacturer, importer, seller, or distributor of a consumer chemical product or biocide to recall or destroy such product or biocide, or to take other necessary measures, as prescribed by Presidential Decree, in any of the following cases:
1. Where any of Article 35 (1) 1 through 4 applies to such consumer chemical product or biocide;
2. Where a person subject to a recommendation under Article 36 (2) fails to comply therewith without good cause.
(2) A person subject to an order to take a measure under paragraph (1) shall take the measure and report the results thereof, etc. to the Minister of Environment.
(3) Where a person subject to an order to take a measure under paragraph (1) fails to comply with the order, such as recall or destruction, the Minister of Environment shall directly take necessary measures on the relevant consumer chemical product or biocide. In such cases, the expense incurred in the recall, destruction, etc. thereof shall be borne by its manufacturer, importer, seller, or distributor.
(4) Matters necessary for issuing orders, including recall and destruction under paragraph (1), and for reporting under paragraph (2) shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 38 (Imposition of Penalty Surcharge)
(1) The Minister of Environment may impose on a person a penalty surcharge equivalent to the sales of the consumer chemical product subject to safety verification or biocide manufactured or imported by the person, in any of the following cases: Provided, That the Minister may impose on such person a penalty surcharge not to exceed one billion won in cases prescribed by Presidential Decree, including where such consumer chemical product subject to safety verification or biocide has no sales or it is impracticable to calculate its sales:
1. Where the person manufactures or imports a consumer chemical product subject to safety verification without obtaining verification or approval or with such verification or approval obtained by other improper means, in violation of Article 10 (1) or (6);
1-2. Where the person manufactures or imports a consumer chemical product subject to safety verification, the valid term of verification of which expired, in violation of Article 10 (3);
2. Where the person manufactures or imports a consumer chemical product subject to safety verification, which is under an order banning its manufacture or import in violation of Article 11 (1);
3. Where the person manufactures or imports a biocidal substance without obtaining approval or with approval obtained by fraud or other improper means, in violation of the main clause, with the exception of the subparagraphs, of Article 12 (1);
3-2. Where the person manufactures or imports a biocidal substance, the valid term of approval of which expired, in violation of Article 12 (5);
4. Where the person manufactures or imports a biocidal substance, approval, etc. or recognition of technical equivalence of which was revoked, or the manufacture or import of which is suspended under Article 17 (1);
5. Where the person manufactures or imports a biocidal product without obtaining approval or with approval obtained by fraud or other improper means, in violation of Article 20 (1);
5-2. Where the person manufactures or imports a biocidal product, the valid term of approval of which expired, in violation of Article 20 (6);
6. Where the person manufactures or imports a biocidal product, approval, etc. or recognition of product similarity of which was revoked, or the manufacture or import of which is suspended under Article 26 (1).
(2) Where any corporation that is a business operator falling under each subparagraph of paragraph (1) merges with another corporation, the Minister of Environment impose a penalty surcharge on a corporation surviving or established by the merger, deeming the violation by the first-mentioned corporation to be committed by the corporation surviving or established following the merger.
(3) Matters necessary to calculate the sales and to impose and collect penalty surcharges under paragraph (1) shall be prescribed by Presidential Decree.
 
Article 39 (Collection of Penalty Surcharges and Disposition on Overdue Penalty Surcharges)
(1) Where a person liable to pay a penalty surcharge under Article 38 (1) (hereafter in this Article referred to as “person liable to pay a penalty surcharge”) fails to pay it by the due date, the Minister of Environment may collect an additional charge from such person for a period that begins on the following day of the due date and ends on the date of payment of the penalty surcharge, taking into account the overdue interest rate applied by a bank defined in Article 2 (1) 2 of the Banking Act, as prescribed by Presidential Decree. In such cases, the period for collecting an additional charge shall not exceed 60 months.
(2) Where a person liable to pay a penalty surcharge fails to pay it by the due date, the Minister of Environment shall demand the person to pay the penalty surcharge within a specified period; and where such person fails to pay the penalty surcharge and an additional charge assessed under paragraph (1) within the specified period, the Minister may collect such penalty surcharge and additional charge in the same manner as delinquent national taxes are collected.
(3) Where the Minister of Environment refunds a penalty surcharge based on a judgment of the court or for any other reason, the Minister shall make an additional payment of refund for a period that begins on the date of payment of the penalty surcharge and ends on the date of refund, as prescribed by Presidential Decree.
(4) Except as provided in paragraphs (1) through (3), matters necessary to collect penalty surcharges and to take dispositions on overdue penalty surcharges shall be prescribed by Presidential Decree.
 
Article 40 (Publication of Violation)
If a person on whom an administrative disposition is finally and conclusively imposed under Article 8 (4), 11 (1), 17, the former part of Article 19 (2), 26, 37, 38 (1), or 43 (1), the Minister of Environment shall publish the details of such administrative disposition and other information on the disposition, including the name of the relevant consumer chemical product or biocide, as prescribed by Presidential Decree.
 


CHAPTER V LAYING FOUNDATION FOR SAFETY CONTROL OF CONSUMER CHEMICAL PRODUCTS AND BIOCIDES
 
Article 41 (Designation of Testing and Inspection Institution)
(1) The Minister of Environment may designate each of the following institutions as a testing and inspection institution to verify the safety of consumer chemical products and to approve biocides:
1. The Korea Environment Corporation established under the Korea Environment Corporation Act;
2. The Korea Environmental Industry and Technology Institute established under the Korea Environmental Industry and Technology Institute Act;
3. Other institutions deemed by the Minister of Environment capable of testing and inspecting consumer chemical products and biocides.
(2) An institution referred to in paragraph (1) 3 that intends to be designated as a testing and inspection institution shall satisfy the requirements for facilities, equipment, and technical personnel prescribed by Presidential Decree and shall apply for designation as a testing and inspection institution with the Minister of Environment. In such cases, the Minister shall determine the fields of testing and inspection that can be conducted by such institution when designating it as a testing and inspection institution.
(3) Every testing and inspection institution designated under paragraph (1) (hereinafter referred to as “testing and inspection institution”) shall perform the following tasks:
1. Verifying whether consumer chemical products subject to safety verification comply with the safety standards under Article 10 (1);
2. Conducting testing and inspection as an agent under Articles 14 (2) and 22 (2).
(4) An institution designated as a testing and inspection institution under paragraph (1) 3 shall seek a designation modification from the Minister of Environment to change the significant matters prescribed by Presidential Decree.
(5) Upon designating an institution referred to in each subparagraph of paragraph (1) as a testing and inspection institution or upon permitting a designation modification, the Minister of Environment shall issue a certificate of designation to the relevant institution and shall publicly announce the facts by publishing them on the Official Gazette or website of the Ministry of Environment.
(6) Designation of an institution referred to in paragraph (1) 3 as a testing and inspection institution shall be valid for five years from the date of the designation, regardless of whether a designation modification is made or not under paragraph (4). In such cases, such testing and inspection institution shall apply for re-designation at least three months prior to the expiry date of the initial designation, if it intends to continue performing testing and inspection tasks even after the expiry date of the initial designation.
(7) The Minister of Environment shall periodically evaluate whether testing and inspection institutions properly operate, as prescribed by Ordinance of the Ministry of Environment.
(8) Except as provided in paragraphs (1) through (7), procedures and methods for designation and re-designation of testing and inspection institutions and for designation modifications, and other necessary matters shall be prescribed by Presidential Decree.
 
Article 42 (Grounds for Disqualification as Testing and Inspection Institution)
None of the following persons are eligible for designation as a testing and inspection institution:
1. A person under adult guardianship or limited guardianship;
2. A person declared bankrupt and not yet reinstated;
3. A person in whose case two years have not passed since his or her imprisonment without labor or greater punishment declared by a court for a violation of this Act was completely executed (or deemed to be completely executed) or exempted;
4. A person in whose case two years have not passed since designation as a testing and inspection institution was revoked under Article 43 (1) (excluding revocation of a designation on the grounds referred to in subparagraph 1 or 2 of this Article);
5. A corporation, an executive officer of which is any of the persons referred to in subparagraphs 1 through 4.
 
Article 43 (Revocation of Designation as Testing and Inspection Institution)
(1) The Minister of Environment may revoke the designation of a testing and inspection institution or may order such testing and inspection institution to suspend the whole or part of its business for a specified period not to exceed one year in any of the following cases: Provided, That the Minister shall revoke the designation of a testing and inspection institution in the case of subparagraph 1 or 3:
1. Where the testing and inspection institution obtained designation under Article 41 (1) 3 by fraud or other improper means;
2. Where the testing and inspection institution fails to satisfy the requirements for facilities, equipment, and technical personnel provided in the former part of Article 41 (2);
3. Where the testing and inspection institution conducts a test and inspection during the period of business suspension;
4. Where the results of an evaluation conducted under Article 41 (7) fail to meet the criteria prescribed by Ordinance of Ministry of Environment;
5. Where any of subparagraphs 1 through 3 or 5 of Article 42 applies to the testing and inspection institution: Provided, That the foregoing shall not apply if a new executive officer is appointed to replace the executive officer in question within six months in the case of subparagraph 5 of Article 42;
6. Where the testing and inspection institution falsifies test or inspection results intentionally or by gross negligence;
7. Where the testing and inspection institution suspends its business consecutively for three years or more without good cause after obtaining designation.
(2) Detailed standards for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Ministry of Environment, taking into account the type and severity of each violation.
 
Article 44 (Educational Training and Campaign)
(1) The Minister of Environment may provide educational training to manufactures or importers of consumer chemical products or biocides and their employees and may conduct a campaign for consumers to improve their understanding of the safety control of consumer chemical products and biocides and to have them voluntarily practice safety control in the course of manufacturing, importing, selling, or using such products or biocides.
(2) Matters necessary for educational training and campaigns under paragraph (1) shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 45 (Support for Small and Medium Enterprises)
For the safety control, etc. of consumer chemical products and biocides, the Minister of Environment may establish and implement a scheme to support small and medium enterprises defined in Article 2 of the Framework Act on Small and Medium Enterprises regarding the following matters:
1. Technical support for approval of substances and approval of products;
2. Mutual cooperation among small and medium enterprises for the safety control of consumer chemical products and biocides;
3. Securing and use of the existing vertebrate animal test data;
4. Development and dissemination of alternatives to vertebrate animal testing;
5. Other matters prescribed by Presidential Decree regarding support for small and medium enterprises.
 
Article 46 (Designation of Household Chemical Products and Biocides Safety Center)
(1) The Minister of Environment may designate a specialized institute prescribed by Presidential Decree as the Household Chemical Products and Biocides Safety Center (hereinafter referred to as the “Household Chemical Products and Biocides Safety Center”) to provide technical support for the following duties:
1. Fact-finding surveys under Article 7 (1);
2. Risk assessments under Article 8 (1);
3. Review of the safety standards for consumer chemical products subject to safety verification;
4. Review of the data to apply for approval, etc. of substances and preparation of evaluation statements;
5. Review of the data to apply for recognition of technical equivalence;
6. Review of the data to apply for approval, etc. of products and preparation of evaluation statements;
7. Review of the data to apply for recognition of product similarity;
8. Other duties prescribed by Ordinance of the Ministry of Environment regarding the safety of consumer chemical products and biocides.
(2) The Minister of Environment may provide subsidies for the expenses incurred in the operation, etc. of the Household Chemical Products and Biocides Safety Center within the budgetary limits.
 
Article 47 (Establishment of Information Network on Consumer Chemical Products)
(1) The Minister of Environment may establish and operate an information network for the control of consumer chemical products and biocides to electronically process the affairs prescribed by Presidential Decree, such as applications for approval, etc. of substances, applications for approval, etc. of products, and reports on new risks, etc. filed under Article 36 (1).
(2) The Minister of Environment may establish and operate an information network to comprehensively manage information on the safety of chemical substances and products containing chemical substances secured by the relevant central administrative agency.
(3) In order to establish the information network under paragraph (2), the Minister of Environment may request the provision of information on the safety of chemical substances and products containing chemical substances secured by the head of related central administrative agency pursuant to his or her respective statutes. In such cases, the head of the relevant central administrative agency in receipt of such request shall comply therewith, unless there is a compelling reason not to do so.
(4) The Minister of Environment may disclose matters prescribed by Presidential Decree, such as the hazards and risks of chemical substances and products containing chemical substances secured pursuant to paragraph (3) and the methods for safe use thereof.
(5) Matters necessary for the establishment, operation, etc. of the information network under paragraph (1) shall be prescribed by Ordinance of the Ministry of Environment, and matters necessary for the establishment, operation, etc. of the information network under paragraph (2) shall be prescribed by Presidential Decree.
 
Article 48 (Cooperation with Related Organizations)
(1) To prevent accidents related to consumer chemical products and biocides, the Minister of Environment may implement a project on the matters prescribed by Ordinance of the Ministry of Environment, including market monitoring, in cooperation with corporations or organizations engaged in activities related to consumers and product safety.
(2) To improve the safety of consumer chemical products and biocides, the Minister of Environment may establish and implement policy necessary to help enterprises, related academic fields, and specialized institutes mutually cooperate in such activities as research, development of technology, and campaigns in relation to control of the consumer chemical products and biocides.


CHAPTER VI SUPPLEMENTARY PROVISIONS
 
Article 49 (Recording and Reporting)
(1) A manufacturer or importer of a consumer chemical product subject to safety verification or biocide shall record (including electronic documents) the following matters and shall preserve the records for 10 years, as prescribed by Ordinance of the Ministry of Environment:
1. Name and quantity of the consumer chemical product subject to safety verification manufactured or imported;
2. Ingredients and composition ratio of substances contained in the consumer chemical product subject to safety verification;
3. Name, product name, and quantity of the biocide manufactured or imported;
4. Ingredients and composition ratio of biocidal substances contained in biocidal products;
5. Names and quantities of biocidal products used for biocide-treated products;
6. Matters concerning the quality control of consumer chemical products subject to safety verification or biocidal products.
(2) A manufacturer or importer of a consumer chemical product subject to safety verification or biocide shall report to the Minister of Environment every two years the data classified below:
1. A manufacturer or importer of a biocidal substance: Name and quantity of the biocidal substance manufactured or imported;
2. A manufacturer or importer of a consumer chemical product subject to safety verification or biocidal product: Name and quantity of the product manufactured or imported, and names and quantities of substances subject to intensive control and biocidal substances contained in such product.
(3) The Minister of Environment may exempt a manufacturer or importer of a consumer chemical product subject to safety verification or biocide from reporting under paragraph (2) in the cases prescribed by Ordinance of Ministry of Environment, such as where the manufacturer or importer reported the data referred to in the subparagraphs of paragraph (2) under any other statute or regulation.
(4) Except as provided in paragraphs (1) through (3), matters necessary for recording and reporting, including the timing and methods of reporting, shall be prescribed by Ordinance of the Ministry of Environment.
 
Article 50 (Entry, Inspection, and Collection)
(1) If deemed necessary to safely control a consumer chemical product or biocide, the Minister of Environment may require a manufacturer, importer, distributor, or testing and inspection institution of the consumer chemical product or biocide, or other related person to file a necessary report, or may require a relevant public official to enter such entity’s place of business, the testing and inspection institution, or other similar place to take the following actions, as prescribed by Ordinance of the Ministry of Environment:
1. Inspecting the safety, container, package, manufacturing and storage facility, etc. of the consumer chemical product or biocide manufactured or imported;
2. Collecting free of charge the minimum quantity of the consumer chemical product or biocide necessary for an inspection under subparagraph 1, and a chemical substance, container, package, etc. deemed related thereto;
3. Perusing ledgers and documents or requesting the submission of data in relation to the consumer chemical product or biocide or testing and inspection tasks.
(2) A relevant public official who intends to enter, inspect, collect, or peruse under paragraph (1) shall carry identification verifying his or her authority and present it to interested persons.
 
Article 51 (Succession to Rights and Obligations)
(1) If a person who obtained verification or approval of a consumer chemical product subject to safety verification under Article 10 (1) or (6), approval, etc. of a substance, or approval, etc. of a product (including approval of a substance deemed granted under the former part of Article 16 (4) and approval of a product deemed granted under the former part of Article 25 (4); hereafter the same shall apply in this Article) deceases, transfers his or her status to another person, or conducts a merger, all rights and obligations occurring in relation to the approval, etc. of the substance or approval, etc. of the product shall be succeeded to by an heir, transferee, or corporation surviving or established by the merger.
(2) Any person who succeeds to the status of a person who obtained verification or approval of a consumer chemical product subject to safety verification under Article 10 (1) or (6), approval, etc. of a substance, or approval, etc. of a product under paragraph (1) shall notify the Minister of Environment of such succession within one month from the date of succession, as prescribed by Ordinance of the Ministry of Environment.
 
Article 52 (Fees)
Any of the following persons shall pay a fee, as prescribed by Ordinance of Ministry of Environment:
1. A person who intends to apply for approval, etc. of a substance under Article 13 (1) or (3) or the main clause of Article 15;
2. A person who intends to apply for recognition of technical equivalence under Article 16 (1);
3. A person who intends to apply for approval, etc. of a product under Article 21 (1) or (3), the main clause of Article 23, or Article 24 (2);
4. A person who intends to apply for recognition of product similarity under Article 25 (1);
5. A person who intends to apply for an order requiring provision or perusal of information under Article 30 (3).
Article 52-2 (Monetary Awards)
(1) The Minister of Environment may grant a monetary award, within the budget, to a person who reports any of the following persons:
1. A person who sells or donates, or displays, keeps, or stores for sale or donation, the products falling under any subparagraph of Article 35 (1);
2. A person who manufactures, imports, sells, or distributes the relevant consumer chemical product or biocide, notwithstanding an order to recall or destroy the product, or to take other necessary measures under Article 37 (1).
(2) Matters necessary for the standards, methods, and procedures for granting monetary awards under paragraph (1), detailed amounts thereof, etc. shall be prescribed by Presidential Decree.
[This Article Newly Inserted on Mar. 24, 2020]
 
Article 53 (Hearings)
The Minister of Environment shall hold a hearing to render any of the following dispositions:
1. Revoking approval, etc. of a substance or recognition of technical equivalence under Article 17 (1) or (2);
2. Revoking approval, etc. of a product or recognition of product similarity under Article 26 (1) or (2);
3. Imposing a penalty surcharge under Article 38 (1);
4. Revoking designation of a testing and inspection institution under Article 43 (1).
 
Article 54 (Delegation of Authority and Entrustment of Duties)
(1) The Minister of Environment may delegate part of the authority vested in him or her under this Act to the heads of agencies under his or her authority, as prescribed by Presidential Decree.
(2) The following duties, among the duties of the Minister of Environment provided in this Act, may be entrusted to related corporations or organizations, as prescribed by Presidential Decree:
1. Fact-finding surveys under Article 7 (1);
2. Risk assessments under Article 8 (1);
3. Other duties prescribed by Presidential Decree regarding the safety of consumer chemical products and biocides.
Article 54-2 (Application for Approval by Persons Appointed by Overseas Manufacturers)
(1) A person who manufactures or intends to manufacture biocides overseas that are imported to the Republic of Korea may appoint a person satisfying the requirements prescribed by Ordinance of the Ministry of Environment and require him or her to perform the following affairs in lieu of a person who imports or intends to import the biocides:
1. Application, etc. for approval of a substance under Article 13;
2. Application for approval for changes to approval of a substance or reporting on changes under Article 15;
3. Application for recognition of technical equivalence under Article 16;
4. Reporting on approval deferment of the existing biocidal substances under Article 18;
5. Submission of a plan for applying for approval of a substance, etc. under Article 19;
6. Application for approval of a product under Article 21;
7. Application for approval for changes to approval of a product or reporting on changes under Article 23;
8. Application for special cases concerning approval of a product under Article 24;
9. Application for recognition of product similarity under Article 25;
10. Reporting on and measures for new risks, etc. under Article 36;
11. Other affairs prescribed by Presidential Decree.
(2) A person appointed pursuant to paragraph (1) shall report his or her appointment or dismissal to the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment.
(3) A person appointed pursuant to paragraph (1) shall notify a person who imports or intends to import biocides under paragraph (1) of the matters prescribed by Presidential Decree, such as his or her appointment or the affairs entrusted, as prescribed by Ordinance of the Ministry of Environment.
[This Article Newly Inserted on Mar. 24, 2020]
 
Article 55 (Legal Fiction as Public Officials for Purposes of Penalty Provisions)
Any of the following persons shall be deemed public officials for purposes of applying Articles 127 through 129 and 132 of the Criminal Act:
1. Members of the Control Committee, who are not public officials;
2. Executive officers and employees of the testing and inspection institutions designated under Article 41 (1);
3. Executive officers and employees of the related corporations or organizations engaging in the duties entrusted under Article 54 (2).


CHAPTER VII PENALTY PROVISIONS
 
Article 56 (Penalty Provisions)
(1) Any of the following persons shall be punished by imprisonment with labor for not more than seven years or by a fine of not more than 70 million won. In such cases, imprisonment with labor and a fine may be concurrently imposed:
1. A person who manufactures or imports a consumer chemical product subject to safety verification, the safety standards for which are publicly notified, without verification or with verification obtained by fraud or other improper means in violation of Article 10 (1);
2. A person who manufactures or imports a consumer chemical product subject to safety verification not in accordance with the details of verification in violation of Article 10 (1);
3. A person who obtains verification of a consumer chemical product subject to safety verification required under Article 10 (1) by fraud or other improper means;
4. A person who manufactures or imports a consumer chemical product subject to safety verification without approval or with approval obtained by fraud or other improper means in violation of Article 10 (6);
5. A person who manufactures or imports a consumer chemical product subject to safety verification not in accordance with the details of approval in violation of Article 10 (6);
6. A person who manufactures or imports a consumer chemical product subject to safety verification, which is under an order banning its manufacture or import, in violation of Article 11 (1);
7. A person who manufactures or imports a biocidal substance without approval of the biocidal substance or with approval of the biocidal substance obtained by fraud or other improper means (excluding approval of the biocidal substance deemed granted under the former part of Article 16 (4)) in violation of the main clause of Article 12 (1);
8. A person who manufactures or imports a biocidal substance not in accordance with the details of approval of the biocidal substance (excluding approval of the biocidal substance deemed granted under the former part of Article 16 (4)) in violation of the main clause of Article 12 (1);
9. A person who manufactures or imports a biocidal substance, approval, etc. of which or recognition of technical equivalence of which is revoked, or which is subject to an order suspending its manufacture or import under Article 17 (1);
10. A person who manufactures or imports a biocidal product without approval of the biocidal product or with approval of the biocidal product obtained by fraud or other improper means (excluding approval of the biocidal product deemed granted under the former part of Article 25 (4)) in violation of Article 20 (1);
11. A person who manufactures or imports a biocidal product not in accordance with the details of approval of the biocidal product (excluding approval of the biocidal product deemed granted under the former part of Article 25 (4)) in violation of Article 20 (1);
12. A person who manufactures or imports a biocidal product, approval, etc. of which or recognition of product similarity of which is revoked, or which is subject to an order suspending its manufacture or import under Article 26 (1);
13. A person who fails to comply with an order to take a measure, such as recall or destruction, in violation of Article 37;
14. A person who verifies a consumer chemical product subject to safety verification required under Article 10 (1) without designation as a testing and inspection institution or with designation obtained by fraud or other improper means under Article 41 (1).
(2) Where a person appointed under Article 54-2 files an application for approval of a biocidal substance or biocidal product or approval for changes thereto, recognition of technical equivalence, or recognition of product similarity in lieu of a person falling under any of paragraph (1) 7 through 12, the appointed person shall be deemed the person falling under any of paragraph (1) 7 through 12, and paragraph (1) shall apply only to the appointed person: Provided, That the same shall not apply where the appointed person proves that the relevant biocidal substance or biocidal product has been imported not in accordance with the details of notification.
(3) Any person engaged in any of the acts provided in paragraph (1) that results in a death or an injury of another person shall be punished by imprisonment with labor for not more than 10 years or by a fine of not more than 100 million won. In such cases, imprisonment with labor and a fine may be imposed concurrently.
 
Article 57 (Penalty Provisions)
(1) Any of the following persons shall be punished by imprisonment with labor for not more than five years or by a fine of not more than 50 million won. In such cases, imprisonment with labor and a fine may be imposed concurrently:
1. A person who manufactures or imports a consumer chemical product, which is under an order banning its manufacture or import, in violation of Article 8 (4);
1-2. A person who manufactures or imports a consumer chemical product subject to safety verification without obtaining approval for changes or with approval for changes obtained by fraud or other improper means, in violation of the main clause of Article 10 (7);
1-3. A person who manufactures or imports a consumer chemical product not in accordance with the details of approval for changes, in violation of the main clause of Article 10 (7);
2. A person who manufactures or imports a consumer chemical product subject to safety verification without labeling the matters required under the subparagraphs of Article 10 (8) thereon or falsely labeling the same in violation of Article 10 (8);
3. A person who manufactures or imports a biocidal substance without obtaining approval for changes or with approval for changes obtained by fraud or other improper means in violation of the main clause of Article 15;
4. A person who manufactures or imports a biocidal substance not in accordance with the details of approval for changes in violation of the main clause of Article 15;
5. A person who manufactures or imports a biocidal substance with recognition of technical equivalence obtained by fraud or other improper means or not in accordance with the details of recognition of technical equivalence in violation of Article 16 (1);
6. A person who manufactures or imports a biocidal substance without re-obtaining recognition of technical equivalence in violation of the main clause of Article 16 (6);
7. A person who manufactures or imports a biocidal product without obtaining approval for changes or with approval for changes obtained by fraud or other improper means in violation of the main clause of Article 23;
8. A person who manufactures or imports a biocidal product not in accordance with the details of approval for changes in violation of the main clause of Article 23;
9. A person who manufactures or imports a biocidal product with recognition of product similarity obtained by fraud or other improper means or not in accordance with the details of recognition of product similarity in violation of Article 25 (1);
10. A person who manufactures or imports a biocidal product without re-obtaining recognition of product similarity in violation of the main clause of Article 25 (6);
11. A person who manufactures or imports a biocidal product without labeling or falsely labeling the matters required under the subparagraphs of Article 27 in violation of Article 27;
12. A person who manufactures or imports a biocide-treated product not in compliance with the safety standards in violation of Article 28 (1);
13. A person who manufactures or imports a biocide-treated product without labeling or falsely labeling the matters required under the subparagraphs of Article 28 (2) in violation of Article 28 (2);
14. A person who conducts a test and inspection during the period of business suspension in violation of Article 43 (1).
(2) Where a person appointed under Article 54-2 files an application for approval for changes to a biocidal substance or biocidal product, recognition of technical equivalence, or recognition of product similarity in lieu of a person falling under any of paragraph (1) 3 through 10, the appointed person shall be deemed the person falling under any of paragraph (1) 3 through 10, and paragraph (1) shall apply only to the appointed person: Provided, That the same shall not apply where the appointed person proves that the relevant biocidal substance or biocidal product has been imported not in accordance with the details of notification.
(3) Any person engaged in any of the acts provided in paragraph (1) that results in a death or an injury of another person shall be punished by imprisonment with labor for not more than seven years or by a fine of not more than 70 million won. In such cases, imprisonment with labor and a fine may be imposed concurrently.
 
Article 58 (Penalty Provisions)
Any of the following persons shall be punished by imprisonment with labor for not more than three years or by a fine of not more than 30 million won:
1. A person who manufactures or imports a consumer chemical product subject to safety verification without filing a report or upon filing a report by fraud or other improper means in violation of Article 10 (4);
2. A person who fails to comply with an order requiring him or her to provide or permit perusal of information in violation of Article 30 (4);
3. A person who uses information provided or perused for an unlawful purpose in violation of Article 30 (5);
4. A person who fails to comply with the requirements for packaging or labeling of a consumer chemical product subject to safety verification or biocidal product in violation of Article 34 (1);
5. A person who labels or advertises a product in violation of Article 34 (2);
6. A person who sells or donates, or displays, keeps, or stores for sale or donation, a consumer chemical product or biocidal product in violation of Article 35 (1) 1 or 2;
7. A person who refuses, interferes with, or evades entry, inspection, collection, etc., in violation of Article 50 (1).
 
Article 59 (Joint Penalty Provisions)
If the representative of a corporation, or an agent or employee of, or any other person employed by, the corporation or an individual commits any violation described in Articles 56 through 58 in conducting the business affairs of the corporation or individual, the corporation or individual shall be punished by a fine prescribed in the relevant Article, in addition to punishing the violators accordingly: Provided, That the foregoing 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 60 (Administrative Fines)
(1) Any of the following persons shall be subject to an administrative fine not more than 10 million won:
1. A person who fails to submit or report, or falsely submits or report, data required under Article 7 (2);
2. A person who fails to file a report on changes in violation of Article 10 (5);
3. A person who fails to file a report on changes in violation of the proviso of Article 10 (7);
4. A person who fails to file a report on changes in violation of the proviso of Article 15 or the proviso of Article 23: Provided, That where a person appointed pursuant to Article 54-2 has performed the affairs prescribed in Article 15 or 23, the same shall apply only to such appointed person;
5. A person who sells or donates, or imports, displays, keeps, or stores for sale or donation, a biocide-treated product in violation of Article 35 (1) 4;
6. A person who intermediates or purchases by proxy a product in violation of Article 35 (2);
7. A person who fails to file a report without delay or files a false report, in violation of Article 36 (1);
8. A person who fails to comply with the standards under Article 36-2 (1);
9. A person who fails to file a report under Article 37 (2) or files a false report;
10. A person who fails to obtain a designation modification in violation of Article 41 (4) although significant matters are modified;
11. A person who fails to record or preserve, or falsely records, in violation of Article 49 (1);
12. A person who fails to report, or falsely reports, data in violation of Article 49 (2).
(2) Administrative fines under paragraph (1) shall be imposed and collected by the Minister of Environment, as prescribed by Presidential Decree.