CONSUMER CHEMICAL PRODUCTS AND BIOCIDES SAFETY CONTROL ACT

영문법령 불러오는 중…

CONSUMER CHEMICAL PRODUCTS AND BIOCIDES SAFETY CONTROL ACT — 법갈피

Article 5(Scope of Application) #

(1) This Act shall not apply to any daily use consumer chemical product or biocide that falls under any of the following subparagraphs: Provided, That this Act shall apply where a daily use consumer chemical product or biocide is manufactured, imported, sold, or used not for the purpose or use prescribed in the following statutes: <Amended on Mar. 24, 2020; May 18, 2021>

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.

12. Organic food, organic processed product not intended for human consumption, processed food made with pesticide-free raw materials, organic agro-fishery materials, and permitted substances under subparagraphs 4, 5, 5-2, 6, and 7 of Article 2 of the Act on the Promotion of Environment-Friendly Agriculture and Fisheries and the Management of and Support for Organic Foods.

(2) Article 10 or Chapter III shall not apply to a daily use consumer chemical product or biocide that falls under any of the following subparagraphs: <Newly Inserted on Mar. 24, 2020>

1. Daily use consumer chemical products or biocides used for scientific experiments, analysis, or research;

2. Daily use consumer chemical products or biocides which are test products not designed for sale;

3. Daily use consumer chemical products or biocides to be exported in their entirety to a foreign country;

4. Daily use consumer chemical products or biocides used only for products falling under subparagraphs 1 through 3;

5. Other daily use consumer chemical products or biocides prescribed by Presidential Decree, such as products not sold in the Republic of Korea.

Article 6(Daily Use Consumer Chemical Products and Biocides Control Committee) #

(1) A Daily Use Consumer Chemical Products and Biocides Control Committee (hereinafter referred to as the "Control Committee") shall be established under the jurisdiction of the Minister of Environment to deliberate on the following matters concerning the control of daily use consumer chemical products and biocides: <Amended on Mar. 24, 2020; May 18, 2021>

1. Formulation of the comprehensive plans under Article 4 (1);

2. Designation of daily use 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 active 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 treated articles to be provided or perused under Article 30 (4);

7. Non-disclosure of data under Article 31 (2);

8. Deleted; <Mar. 19, 2024>

9. Other matters referred by the chairperson of the Control Committee for deliberation with regard to the safety control of daily use 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 daily use consumer chemical products and biocides.

(4) The Minister of Environment shall appoint or commission the members of the Control Committee from among the following persons: <Amended on May 18, 2021>

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;

4. Deleted; <Mar. 19, 2024>

5. Deleted. <Mar. 19, 2024>

(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.

Article 8(Risk Assessment) #

(1) The Minister of Environment may conduct a risk assessment of a daily use consumer chemical product in any of the following cases, as prescribed by Ordinance of the Ministry of Environment: <Amended on May 26, 2020>

1. Where the findings of a fact-finding survey of the daily use 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 daily use 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 daily use 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 daily use 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 daily use consumer chemical products subject to safety verification. <Amended on Mar. 24, 2020>

(4) Where the Minister of Environment deems that urgent action is necessary to prevent a daily use 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 daily use 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 10(Verification of Safety Standards and Labeling Standards) #

(1) Any person who intends to manufacture or import a daily use 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 daily use 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. <Newly Inserted on Mar. 24, 2020>

(6) Any person who intends to manufacture or import a daily use 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. <Amended on Mar. 24, 2020; May 25, 2020>

(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. <Newly Inserted on Mar. 24, 2020>

(8) Any person who intends to manufacture or import a daily use 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: <Amended on Mar. 24, 2020>

1. Name of the daily use consumer chemical products 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 daily use 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. <Amended on Mar. 24>

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 daily use consumer chemical product subject to safety verification, where its manufacturer or importer falls under any of the following cases: <Amended on Mar. 24, 2020>

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 daily use 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 daily use 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 daily use consumer chemical product subject to safety verification without reporting pursuant to Article 10 (4);

5. Where he or she manufactures or imports a daily use 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 daily use 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 daily use 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. <Amended on Mar. 24, 2020>

Article 12(Approval of Active Substances) #

(1) A person who intends to manufacture or import an active substance to use such active substance for biocidal products shall obtain approval of the substance from the Minister of Environment: Provided, That the same shall not apply to active 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; <Mar. 24, 2010>

2. Deleted; <Mar. 24, 2010>

3. Deleted. <Mar. 24, 2020>

4. Deleted. <Mar. 24, 2010>

(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 active substance nor its residue shall adversely affect the health of people or animals or the environment;

2. An active substance shall have enough effect and efficacy for the removal, etc. of a harmful organism;

3. No active substance shall let a harmful organism, the removal, etc. of which is made by such substance, develop a tolerance thereto;

4. Where an active 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 active substance to be approved has 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 active substance to be approved needs to be used for the public health and the environment as no low-risk substance to replace such active substance exists.

(4) Approval of an active 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 active 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 active substances shall be valid for a period prescribed by Presidential Decree, not to exceed seven years:

1. An active substance to which relaxed standards for approval of a substance are applied pursuant to paragraph (3);

2. An active substance prescribed by Ordinance of the Ministry of Environment such as a substance which causes respiratory sensitization.

(5) A person who intends to continue manufacturing or importing the relevant active 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 active substance;

3. A biocidal product type for which the active 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 active substance:

(a) Physical, chemical, or biological properties;

(b) Exposure information such as the use, main routes of exposure, patterns of exposure of the active substance;

(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 active substance and the manufacturing process;

7. Comprehensive data on the safety of the active 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: <Amended on Mar. 24, 2020>

1. Where he or she proves that the effects of the relevant active substance on human bodies, animals, or the environment are insignificant as the exposure information is specified given the purposes of using such active substance and types of biocidal products for which the active 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: <Amended on May 26, 2020>

1. Purity range of the active substance to be maintained;

2. Properties and concentrations of impurities permitted to be contained in the active substance;

3. A biocidal product type for which the use of the active substance is permitted;

4. Categories of users of the active substance;

5. Valid term of approval of the active substance;

6. Other matters prescribed by Presidential Decree regarding approval of the active substance.

Article 16(Recognition of Technical Equivalence) #

(1) Any person who intends to obtain recognition of technical equivalence between an approved active substance (hereafter referred to as "reference active substance" in this Article) and another active substance shall file an application with the Minister of Environment for recognition of technical equivalence, along with data proving that the latter active substance has technical equivalence to the reference active 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) An active substance, technical equivalence of which to the reference active 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 active substance expires.

(5) Where any change to the reference active substance of an active 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 active 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 active 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 active 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 active 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 an active 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 active 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 active substance has any risk.

(2) Where the Minister of Environment has revoked approval, etc. of the reference active substance or ordered the suspension of manufacture or import thereof pursuant to paragraph (1), he or she may revoke recognition of technical equivalence of an active substance to the reference active substance or order the suspension of manufacture or import of such active 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 an active substance contained in any biocidal product or treated article distributed in the Republic of Korea prior to December 31, 2018 (hereinafter referred to as "existing active substance") may manufacture or import an existing active 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 active substance eligible for approval deferment after being reported pursuant to paragraph (2): <Amended on Mar. 24, 2020; May 26, 2020>

1. Deleted; <Mar. 24, 2010>

2. Deleted; <Mar. 24, 2010>

(2) A person who intends to manufacture or import an existing active 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: <Amended on Mar. 24, 2020>

1. Name or trade name, address, and contact information of a person who intends to manufacture or import the existing active substance;

2. Name, chemical composition, quantity manufactured or imported of the existing active substance;

3. A biocidal product type for which the existing active 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 active substance as an existing active substance eligible for approval deferment, taking into account the hazards and risks of the existing active substance, within six months from the date of reporting, and shall publicly notify the following: <Amended on Mar. 24, 2020>

1. Name of the existing active substance eligible for approval deferment;

2. A biocidal product type for which the existing active 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 active substance eligible for approval deferment and types of biocidal products for which such existing active substance is used.

(5) Except as provided in paragraphs (1) through (4), procedures for filing reports on existing active 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 active substance is designated and publicly notified as an existing active substance eligible for approval deferment (hereinafter referred to as "existing active 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 active substance eligible for approval deferment. In such cases, approval of the substance shall be obtained to manufacture or import the aforesaid active substance.

(3) Where the Minister of Environment issues an order banning the manufacture or import of an existing active substance eligible for approval deferment to all persons who has reported such existing active substance pursuant to the former part of paragraph (2), the Minister may cancel the designation of such existing active substance as eligible for approval deferment.

(4) Where two or more persons submit a plan for applying for approval of an existing active 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: <Amended on Mar. 24, 2020>

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 active 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 active 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.

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: <Amended on Mar. 24, 2020>

1. Deleted; <Mar. 24, 2010>

2. Deleted; <Mar. 24, 2010>

3. Deleted. <Mar. 24, 2020>

(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: <Amended on Mar. 24, 2020; May 26, 2020>

1. Neither biocidal product nor its residue shall adversely affect the health of people or animals, or the environment;

2. Every active substance contained in a biocidal product shall be any of the following active substances:

(a) An active substance that is used to the extent that approval, etc. of such substance is obtained;

(b) An active substance publicly notified pursuant to the proviso of Article 12 (1);

(c) The existing active substances eligible for approval deferment used within the scope designated and publicly notified pursuant to Article 18 (3) (limited to where the biocidal product type under Article 18 (3) 2 are different from the biocidal product type 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): <Amended on May 26, 2020>

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 active substances contained in biocidal products cause in interaction with other active substances, chemical substances, etc.;

4. Whether kinds and methods of use of any treated article 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: <Amended on May 26, 2020>

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 active 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. <Mar. 24, 2020>

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: <Amended on May 26, 2020>

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 active substances, contained in the biocidal product;

(b) Name and address of a supplier of active substances contained in the biocidal product;

4. The following data on the biocidal product:

(a) Physical, chemical, or biological properties;

(b) Exposure information such as the use, main routes of exposure, and patterns of exposure of the biocidal product;

(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: <Amended on Mar. 24, 2020; May 26, 2020>

1. Where he or she proves that the effects of the biocidal product or an active substance contained therein on human bodies, animals, or the environment are insignificant as purpose of use of such biocidal product or an active 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.

(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: <Amended on May 26, 2020>

1. The name of the biocidal product and its type;

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 treated article, if the relevant biocidal product is used therein;

6. Other matters prescribed by Presidential Decree on approval of the biocidal product.

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: <Amended on Mar. 24, 2020; May 26, 2020>

1. Every active substance contained in the biocidal product shall be an active substance publicly notified under the proviso of Article 12 (1);

2. A substance other than active 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;

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: <Amended on May 26, 2020>

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 active 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 active 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: <Newly Inserted on Mar. 24, 2020; May 26, 2020>

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. <Newly Inserted on Mar. 24, 2020>

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. <Amended on May 26, 2020>

(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: <Amended on Mar. 24, 2020>

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 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.

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: <Amended on Mar. 24, 2020>

1. Any of the following daily use consumer chemical products:

(a) Daily use consumer chemical products the manufacture or import of which is banned pursuant to Article 8 (4) or 11 (1);

(b) Daily use consumer chemical products subject to safety verification the verification or approval of which under Article 10 (1) or (6) is not obtained;

(c) Daily use consumer chemical products subject to safety verification the report on which under Article 10 (4) is not filed;

(d) Daily use consumer chemical products subject to safety verification which fail to meet the labeling standards under Article 10 (8);

2. Any of the following active 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;

4. Treated articles not in compliance with the safety standards or labeling standards under Article 28.

(2) No sales broker or purchasing agent of daily use consumer chemical products subject to safety verification, biocidal products, or treated articles 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 38(Imposition of Penalty Surcharge) #

(1) The Minister of Environment may impose on a person a penalty surcharge equivalent to the sales of the daily use 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 daily use consumer chemical product subject to safety verification or biocide has no sales or it is impracticable to calculate its sales: <Amended on Mar. 24, 2020>

1. Where the person manufactures or imports a daily use consumer chemical product subject to safety verification without obtaining verification or approval or with such verification or approval obtained by fraud or other improper means, in violation of Article 10 (1) or (6);

1-2. Where the person manufactures or imports a daily use 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 daily use 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 an active 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 an active substance, the valid term of approval of which expired, in violation of Article 12 (5);

4. Where the person manufactures or imports an active 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 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 daily use 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 daily use 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 daily use 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 48-2(Eligibility for Remedial Benefits) #

(1) Where a person's life or health is endangered (including aftereffects; hereinafter referred to as "damage from biocidal products") after he or she is exposed to biocidal products with defects prescribed in the Product Liability Act, which are approved by the Minister of Environment under Article 20 (1), and if the victim fails to receive compensation therefor or it is necessary to promptly provide remedy for such damage due to falling under any of the following cases, benefits for remedy for damage from biocidal products (hereinafter referred to as "remedial benefits") may be paid to the victim or his or her survivors, following the deliberation and determination by the Commission on Environmental Dispute Mediation and Damage Remedy under Article 4 of the Act on Environmental Dispute Mediation and Environmental Damage Remedy (hereinafter referred to as the "Commission"): <Amended on Mar. 19, 2024>

1. Where a person who has caused damage from biocidal products (hereafter referred to as "causer" in this Article) is insolvent;

2. Where it is necessary to take measures promptly due to considerable damage from biocidal products, such as collective damage;

3. Where it is necessary to take urgent medical treatment or convalescence due to severe damage from biocidal products is severe;

4. Where the cause of damage from biocidal products is not completely removed within a short period of time, which is expected to continue in the future;

5. Where it is deemed necessary by the Commission.

(2) Where the Minister of Environment pays remedial benefits to the victims regarding damage from biocidal products for which the causer is liable, the Minister of Environment may exercise the victim's right to claim compensation from the causer by subrogation to the extent of the remedial benefits paid (where the causer has paid the contributions to remedy for damage from biocidal products under Article 48-16, referring to the extent excluding the amount of contributions).

(3) In exercising the right to claim compensation by subrogation pursuant to paragraph (2), remedial benefits shall be construed as compensation for damage under the Civil Act.

[This Article Newly Inserted on May 18, 2021]

Article 48-4(Application for Payment of Remedial Benefits) #

(1) A person who intends to receive remedial benefits (hereinafter referred to as "applicant") shall file an application for payment of remedial benefits with the Commission, along with documents as prescribed by Ordinance of the Ministry of Environment. <Amended on Mar. 19, 2024>

(2) Where an application filed under paragraph (1) fails to meet the requirements prescribed in Article 48-2 (1), the Commission shall dismiss it after deliberation by the Control Committee within 30 days from the date of receipt of the application. <Amended on Mar. 19, 2024>

(3) Upon receipt of an application pursuant to paragraph (1), the Commission shall conduct an investigation, appraisal, etc. of the fact of damage, the causal relationship between the biocidal products and damage, the scope of remedial benefits, restrictions on the payment of remedial benefits, etc. <Amended on Mar. 19, 2024>

(4) The Commission shall make a decision as to whether the applicant is eligible for remedial benefits, and the degree of damage (hereinafter referred to as "degree of damage") after deliberation (hereinafter referred to as "decision on payment of remedial benefits") and shall notify the results of decision to the applicant and the Minister of Environment, within 90 days from the date of receipt of an application under paragraph (1): Provided, That the period may be extended by up to 30 days only once, if there is good cause, such as where it is impracticable to make a judgment due to medical reasons. <Amended on Mar. 19, 2024>

(5) Matters necessary for the standards for the degree of damage shall be prescribed by Ordinance of the Ministry of Environment.

(6) Where a person decided to be eligible for remedial benefits pursuant to paragraph (4) (hereinafter referred to as "person eligible for remedial benefits") requests remedial benefits during the effective period prescribed in Article 48-5 (1), the procedures for deliberation under paragraph (4) shall be omitted. <Amended on Mar. 19, 2024>

(7) Matters necessary for the procedures, methods, notice, etc. of decision on payment of remedial benefits pursuant to paragraphs (1) through (6) shall be prescribed by Ordinance of the Ministry of Environment.

[This Article Newly Inserted on May 18, 2021]

Article 48-14(Account for Remedy for Damage from Biocidal Products) #

(1) The Minister of Environment may establish and operate an account for remedy for damage from biocidal products (hereinafter referred to as "remedy account") to be used for each of the following purposes including payment of remedial benefits:

1. Payment of remedial benefits;

2. Repayment of the principal and interest accrued therefrom of borrowings under paragraph (3);

3. Disbursement of expenses (including expenses for entrustment) incurred in the management and operation of the remedy account;

4. Investigation and research for the evaluation of damage from biocidal products, mitigation of damage, etc.;

5. Disbursement of other expenses deemed necessary to maintain and improve the remedial system for damage from biocidal products.

(2) The remedy account shall be operated with the following financial resources:

1. Borrowings under paragraph (3);

2. Penalty surcharges under Article 38;

3. Compensation for damage paid by exercising the right of subrogation under Article 48-2 (2);

4. Amount recovered from remedial benefits under Article 48-9 (3);

5. Contributions to remedy for damage from biocidal products under Article 48-16;

6. Commissions under Article 52;

7. Administrative fines under Article 60;

8. Donations from individuals, corporations, or organizations;

9. Proceeds from the operation of the remedy account and other revenues.

(3) If deemed necessary for operating the remedy account, the Minister of Environment may take loans from financial institutions at the expense of the remedy account.

(4) Notwithstanding Article 5 (2) of the Act on Collection and Use of Donations, the Minister of Environment may receive voluntarily donated money and goods within the scope of serving the purpose of remedy for damage from biocidal products.

(5) The Minister of Environment shall set up a separate account in the remedy account for the management of donations referred to in paragraph (4).

[This Article Newly Inserted on May 18, 2021]

Article 48-16(Contributions to Remedy for Damage from Biocidal Products) #

(1) The Minister of Environment shall impose and collect contributions to remedy for damage from biocidal products (hereinafter referred to as "contributions") on and from the manufacturers and importers of biocidal products that have caused damage from biocidal products (hereinafter referred to as "product of cause"), as prescribed by Presidential Decree, to secure funds necessary for the remedy for damage from biocidal products. In such cases, the Minister of Environment may entrust the imposition and collection of contributions to the head of an operating institution.

(2) Contributions to be imposed on and collected from individual manufacturers or importers under paragraph (1) shall be calculated as follows:

(3) "Ratio of use of products of cause" in paragraph (2) means the share of individual manufacturers or importers out of the whole products of cause used by persons eligible for remedial benefits verified through an investigation conducted by the investigation team, and the detailed methods of calculation shall be prescribed by Presidential Decree.

(4) "Ratio of sale of products of cause" in paragraph (2) means the share of sales by individual manufacturers or importers in the total sales of products of cause, and the detailed methods of calculation shall be prescribed by Presidential Decree.

(5) Notwithstanding paragraph (1), the Minister of Environment may exempt the manufacturers or importers prescribed by Presidential Decree, such as manufacturers, importers, etc. who are not capable of paying the contributions or who falls under Article 2 (1) of the Framework Act on Small and Medium Enterprises, from the obligation to pay contributions or may reduce their contributions.

(6) The head of an operating institution entrusted with the affairs of imposition and collection of contributions pursuant to the latter part of paragraph (1) shall keep the accounting of contributions separately from other accounting.

(7) If a person liable to pay contributions fails to pay it by the payment deadline, the Minister of Environment or the head of an operating institution shall demand the person to pay it for a specified period of at least 30 days. In such cases, an additional charge of up to 3/100 of the contributions in arrears shall be imposed for a period from the day immediately following the payment deadline to the day immediately preceding the payment date, and the rate of the additional charge shall be prescribed by Presidential Decree.

(8) If a person upon receipt of a demand notice pursuant to paragraph (7) fails to pay the contributions and additional charge within the specified period, such contributions and additional charge shall be collected in the same manner as delinquent national taxes are collected.

(9) A person who has any objection to the imposition of contributions may file an objection to the Minister of Environment or the head of an operating institution, by the method prescribed by Presidential Decree, within 30 days from the date of receipt of a notice for payment of contributions. In such cases, the Minister of Environment or the head of an operating institution shall notify the applicant of the results thereof within 30 days from the date of receipt of an objection.

(10) Except as provided in paragraph (9), Article 36 of the Framework Act on Administration (excluding the proviso of paragraph (2) of that Article) shall apply to matters concerning filing of objections to the imposition of contributions. <Newly Inserted on Jan. 30, 2024>

(11) The methods for collecting contributions, the payment deadline, the payment procedures, and other matters necessary for imposition and collection shall be prescribed by Presidential Decree. <Amended on Jan. 30, 2024>

[This Article Newly Inserted on May 18, 2021]

Article 49(Recording and Reporting) #

(1) A manufacturer or importer of a daily use 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: <Amended on Mar. 24, 2020; May 26, 2020>

1. Name and quantity of the daily use consumer chemical product subject to safety verification manufactured or imported;

2. Ingredients and composition ratio of substances contained in the daily use 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 active substances contained in biocidal products;

5. Names and quantities of biocidal products used for treated articles;

6. Matters concerning the quality control of daily use consumer chemical products subject to safety verification or biocidal products.

(2) A manufacturer or importer of a daily use consumer chemical product subject to safety verification or biocide shall report to the Minister of Environment every two years the data classified below: <Amended on Mar. 24, 2020; May 26, 2020>

1. A manufacturer or importer of an active substance: Name and quantity of the active substance manufactured or imported;

2. A manufacturer or importer of a daily use 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 active substances contained in such product.

(3) The Minister of Environment may exempt a manufacturer or importer of a daily use 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 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: <Amended on Mar. 24, 2020>

1. A person who manufactures or imports a daily use 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 daily use 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 daily use 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 daily use 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 daily use 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 daily use 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 an active substance without approval of the active substance or with approval of the active substance obtained by fraud or other improper means (excluding approval of the active 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 an active substance not in accordance with the details of approval of the active substance (excluding approval of the active 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 an active 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 daily use 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 an active 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 active substance or biocidal product has been imported not in accordance with the details of notification. <Newly Inserted on Mar. 24, 2020>

(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. <Amended on Mar. 24, 2020>

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: <Amended on Mar. 24, 2020>

1. A person who manufactures or imports a daily use 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 daily use 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 daily use 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 daily use 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 an active 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 an active 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 an active 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 an active 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 treated article not in compliance with the safety standards in violation of Article 28 (1);

13. A person who manufactures or imports a treated article 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 an active 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 active substance or biocidal product has been imported not in accordance with the details of notice. <Newly Inserted on Mar. 24, 2020>

(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. <Amended on Mar. 24, 2020>

Article 60(Administrative Fines) #

(1) Any of the following persons shall be subject to an administrative fine not more than 10 million won: <Amended on Mar. 24, 2020>

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 treated article 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) A person who fails to submit requested data without good cause or submits false data, in violation of the latter part of Article 48-3 (2), shall be subject to an administrative fine not exceeding five million won. <Newly Inserted on May 18, 2021>

(3) Administrative fines under paragraphs (1) and (2) shall be imposed and collected by the Minister of Environment, as prescribed by Presidential Decree. <Amended on May 18, 2021>

CONSUMER CHEMICAL PRODUCTS AND BIOCIDES SAFETY CONTROL ACT

Article 1(Purpose) #

Article 2(Basic Principles for Control of Daily Use Consumer Chemical Products and Biocides) #

Article 3(Definitions) #

Article 4(Formulation of Comprehensive Plan to Control Daily Use Consumer Chemical Products and Biocides) #

Article 5(Scope of Application) #

Article 6(Daily Use Consumer Chemical Products and Biocides Control Committee) #

Article 7(Fact-Finding Survey) #

Article 8(Risk Assessment) #

Article 9(Safety Standards for Consumer Chemical Product Subject to Safety Verification) #

Article 10(Verification of Safety Standards and Labeling Standards) #

Article 10-2(Disclosure of Information on Daily Use Consumer Chemical Products Subject to Safety Verification) #

Article 11(Ban on Manufacture or Import of Consumer Chemical Product Subject to Safety Verification) #

Article 12(Approval of Active Substances) #

Article 13(Application for Approval of Substance) #

Article 14(Procedures for Approval of Substance) #

Article 15(Changes to Approval of Substance) #

Article 16(Recognition of Technical Equivalence) #

Article 17(Revocation of Approval of Substance) #

Article 18(Approval Deferment of Existing Biocidal Substance) #

Article 19(Submission of Plan for Applying for Approval of Substance) #

Article 20(Approval of Biocidal Product) #

Article 21(Application for Approval of Product) #

Article 22(Procedures for Approval of Product) #

Article 23(Changes to Approval of Product) #

Article 24(Special Cases concerning Approval of Product) #

Article 25(Recognition of Product Similarity) #

Article 26(Revocation of Approval of Product) #

Article 27(Labeling of Biocidal Product) #

Article 28(Safety and Labeling Standards for Treated Articles) #

Article 29(Disclosure of Information on Biocidal Substance and Product) #

Article 30(Provision of Information on Treated Articles) #

Article 31(Data Protection) #

Article 32(Consent to Data Use) #

Article 32-2(Principle of Minimizing Vertebrate Animal Testing) #

Article 33(Special cases concerning Vertebrate Animal Test Data) #

Article 34(Restrictions on Labeling and Advertisement) #

Article 35(Prohibition of Sale) #

Article 36(Report on New Risks and Recommendation on Measures) #

Article 36-2(Obligation of Quality Control) #

Article 37(Recall Order) #

Article 38(Imposition of Penalty Surcharge) #

Article 39(Collection of Penalty Surcharges and Disposition on Overdue Penalty Surcharges) #

Article 40(Publication of Violation) #

Article 41(Designation of Testing and Inspection Institution) #

Article 42(Grounds for Disqualification as Testing and Inspection Institution) #

Article 43(Revocation of Designation as Testing and Inspection Institution) #

Article 44(Educational Training and Campaign) #

Article 45(Support for Small and Medium Enterprises) #

Article 46(Designation of Household Chemical Products and Biocides Safety Center) #

Article 47(Establishment of Information Network on Daily Use Consumer Chemical Products) #

Article 48(Cooperation with Related Organizations) #

Article 48-2(Eligibility for Remedial Benefits) #

Article 48-3(Establishment and Operation of Biocidal Product Damage Investigation Team) #

Article 48-4(Application for Payment of Remedial Benefits) #

Article 48-5(Effective Period for Decision on Payment of Remedial Benefits) #

Article 48-6(Type of Remedial Benefits) #

Article 48-7(Payment of Remedial Benefits) #

Article 48-8(Payment of Unpaid Medical Expenses) #

Article 48-9(Suspension of Payment of Remedial Benefits and Recovery of Unjust Enrichment) #

Article 48-10(Compensation for Damage and Relationship with Other Remedy) #

Article 48-11(Protection of Entitlement to Remedial Benefits) #

Article 48-12(Exemption of Public Charges) #

Article 48-13(Requests for Re-Examination) #

Article 48-14(Account for Remedy for Damage from Biocidal Products) #

Article 48-15(Management and Operation of Remedy Account) #

Article 48-16(Contributions to Remedy for Damage from Biocidal Products) #

Article 48-17(Request for Medical Examination) #

Article 48-18(Temporary Suspension of Remedial Benefits) #

Article 49(Recording and Reporting) #

Article 50(Entry, Inspection, and Collection) #

Article 51(Succession to Rights and Obligations) #

Article 52(Fees) #

Article 52-2(Monetary Awards) #

Article 53(Hearings) #

Article 54(Delegation of Authority and Entrustment of Affairs) #

Article 54-2(Application for Approval by Persons Appointed by Overseas Manufacturers) #

Article 55(Legal Fiction as Public Officials for Purposes of Penalty Provisions) #

Article 56(Penalty Provisions) #

Article 57(Penalty Provisions) #