ENFORCEMENT DECREE OF THE CONSUMER CHEMICAL PRODUCTS AND BIOCIDES SAFETY CONTROL ACT
Presidential Decree No. 31323, Dec. 29, 2020
Amended by Presidential Decree No. 32300, Dec. 31, 2021
Presidential Decree No. 32528, Mar. 8, 2022
Presidential Decree No. 33913, Dec. 12, 2023
Presidential Decree No. 34386, Apr. 2, 2024
CHAPTER I GENERAL PROVISIONS
Article 1-2 (Scope of Application) |
"Daily use consumer chemical products or biocides prescribed by Presidential Decree, such as products not sold in the Republic of Korea" in Article 5 (2) 5 of the Act means active substances or biocidal products used as raw materials of any of the following products that are manufactured, imported, sold, or used for the purposes and uses prescribed in the statutes provided in the subparagraphs of paragraph (1) of the same Article: 1. | Daily use consumer chemical products; |
[This Article Newly Inserted on Dec. 29, 2020]
Article 2 (Composition and Operation of Consumer Chemical Products and Biocides Control Committee) |
(1) | A member commissioned to the Consumer Chemical Products and Biocides Control Committee (hereinafter referred to as the "Control Committee") established under Article 6 (1) of the Daily Use Consumer Chemical Products and Biocides Safety Control Act (hereinafter referred as the "Act") shall hold office for three years and may be commissioned consecutively for only one further term. |
(2) | The chairperson of the Control Committee (hereinafter referred to as the "chairperson") shall represent the Control Committee and have general supervision and control of its affairs. |
(3) | Meetings of the Control Committee shall be classified into regular meetings and special meetings, which shall be called as follows: |
1. | Regular Meeting: Once a year; |
2. | Special meetings: At any time as the chairperson may deem necessary or upon the request of at least 1/5 of the members of the Control Committee (hereinafter referred to as "member"). |
(4) | To call a meeting under paragraph (3), the chairperson shall notify every member of the Control Committee in writing of the following seven days before the meeting: |
1. | The date, time, and place of the meeting; |
2. | The purpose and agenda of the meeting; |
3. | Others necessary matters in relation to the meeting. |
(5) | The chairperson may require a person relevant to an agenda or an expert to attend a meeting to ask questions or to have the person or expert speak at the meeting, if necessary for the deliberation and decision of the Control Committee. |
(6) | Except as provided in paragraphs (1) through (5), matters necessary for the composition and operation of the Control Committee shall be determined by the chairperson following decision by the Control Committee. |
Article 3 (Dismissal or Removal of Member) |
The Minister of Environment may dismiss or remove a member in any of the following cases:
1. | Where the member becomes unable to perform his or her duties due to a mental or physical disability; |
2. | Where the member is found to have engaged in misconduct in relation to his or her duties; |
3. | Where the member is deemed unfit as a member due to neglect of duty, injury to dignity, or any other reason; |
4. | Where the member fails to refrain voluntarily although any subparagraph of Article 4 (1) applies to him or her; |
5. | Where the member expresses that it is impracticable to perform his or her duties. |
Article 4 (Exclusion from, Challenge to, or Refrainment by Member) |
(1) | A member of the Control Committee shall be excluded from the its deliberation and decision in any of the following cases: |
1. | Where the member or current or former spouse of such member is a party (if a party is a corporation, organization, or similar entity, including executive officers thereof; hereafter in this subparagraph and subparagraph 2, the same shall apply) to the relevant agenda or is a joint right-holder or co-obligor with a party to the relevant agenda; |
2. | Where the member is or was a relative of a party to the relevant agenda; |
3. | Where the member, or the corporation to which the member belongs, is or was an agent of a party to the relevant agenda; |
4. | Where the member, or the corporation, etc. for which the member is working or has worked as an executive officer or employee in the most recent three years, provides consultation or service (including subcontract), or conducts research, appraisal, or investigation with regard to the agenda. |
(2) | Where a party to the relevant agenda finds it difficult to expect impartial deliberation or decision by a member, the party may file an application for challenge to the member with the Control Committee, which shall render a decision thereon by voting. In such cases, the member against whom the application for challenge is filed shall not participate in such voting. |
(3) | Where a member finds that he or she is subject to disqualification on any ground provided in the subparagraphs of paragraph (1), the member shall voluntarily refrain from deliberating or deciding on the relevant agenda. |
CHAPTER II CONTROL OF DAILY USE CONSUMER CHEMICAL PRODUCTS
Article 5 (Verification of Consumer Chemical Product Subject to Safety Verification) |
(1) | Any person who intends to obtain verification of a daily use consumer chemical product subject to safety verification under Article 10 (1) of the Act shall submit an application for verification of the daily use consumer chemical product subject to safety verification in the Form prescribed by Ordinance of the Ministry of Environment and supporting documents, along with such product, to any testing and inspection institution designated under Article 41 (1) of the Act (hereinafter referred to as "testing and inspection institution"). |
(2) | Upon receipt of an application for verification under paragraph (1), a testing and inspection institution shall verify whether the relevant product complies with the safety standards by testing and inspecting such product in accordance with the testing and inspection standards and guidelines specified and publicly notified by the Minister of Environment, and shall notify the applicant of the results thereof within 10 days from the date of completion of the test and inspection. |
(3) | A person who intends to file a report on the matters verified under Article 10 (4) of the Act shall submit to the Minister of Environment a report on verification of compliance with the safety standards prescribed by Ordinance of the Ministry of Environment and supporting documents within 30 days from the date of receipt of notification of the verification results under paragraph (2). |
(4) | A person who intends to file a report on changes under Article 10 (5) of the Act shall submit to the Minister of Environment a report on changes of verification of compliance with the safety standards prescribed by Ordinance of the Ministry of Environment, along with documents prescribed by Ordinance of the Ministry of Environment. <Amended on Dec. 29, 2020> |
(5) | Except as provided in paragraphs (1) through (4), matters necessary for the procedures for verification, reports, and reports on changes of compliance with the safety standards shall be prescribed by Ordinance of the Ministry of Environment. <Amended on Dec. 29, 2020> |
Article 6 (Approval of Daily Use Consumer Chemical Product Subject to Safety Verification) |
(1) | A person who intends to obtain approval of daily use consumer chemical products subject to safety verification under Article 10 (6) of the Act shall submit to the Minister of Environment an application for approval of the daily use consumer chemical products subject to safety verification prescribed by Ordinance of the Ministry of Environment, along with documents prescribed by Ordinance of the Ministry of Environment. |
(2) | A person who intends to obtain approval for changes pursuant to the main clause of Article 10 (7) of the Act shall submit to the Minister of Environment an application for approval for changes prescribed by Ordinance of the Ministry of Environment, along with documents prescribed by Ordinance of the Ministry of Environment. |
(3) | Where it is necessary to correct or supplement data submitted under paragraph (1) or (2), the Minister of Environment may request the person who applied for approval or approval for changes to correct or supplement the data, as prescribed by Ordinance of the Ministry of Environment. |
(4) | The Minister of Environment shall determine whether to grant approval or approval for changes in accordance with the standards and methods for granting approval or approval for changes that are determined and publicly notified by the Minister of Environment, and shall notify the applicant of the results of determination within the period classified as follows (excluding the period required for correction or supplementation referred to in paragraph (3)): |
1. | Where an application for approval is filed under paragraph (1): 90 days from the date of receipt of the application; |
2. | Where an application for approval for changes is filed under paragraph (2): 60 days from the date of receipt of such application. |
(5) | A person who intends to file a report on changes pursuant to the proviso of Article 10 (7) of the Act shall submit to the Minister of Environment a report on changes of approval of daily use consumer chemical products subject to safety verification prescribed by Ordinance of the Ministry of Environment, along with documents prescribed by Ordinance of the Ministry of Environment. |
(6) | Except as provided in paragraphs (1) through (5), matters necessary for the procedures for approval, approval for changes, and a report on changes of daily use consumer chemical products subject to safety verification shall be prescribed by Ordinance of the Ministry of Environment. |
[This Article Wholly Amended on Dec. 29, 2020]
Article 7 (Labeling of Consumer Chemical Product Subject to Safety Verification) |
Labeling on the surface or package of a daily use consumer chemical product subject to safety verification under Article 10 (8) of the Act shall be placed conspicuously compared with other texts or graphic matters and shall be comprehensible and accurate in compliance with the following requirements: <Amended on Dec. 29, 2020> 1. | Where the labeling text appears in Chinese character or other languages, along with the Korean language, the size of the Korean font shall be larger than that of Chinese character or other languages; |
2. | The labeling shall appear on a clear contrasting background (not applicable where it is etched or stamped); |
3. | The labeling shall be non-erasable and be securely attached; |
4. | Other matters specified and publicly notified by the Minister of Environment regarding labeling of daily use consumer chemical products subject to safety verification shall be complied with. |
CHAPTER III SAFETY CONTROL OF BIOCIDES
SECTION 1 Approval of Active Substances
Article 8 Deleted. <Dec. 29, 2020> |
Article 9 (Valid Term of Approval of Active Substance) |
(1) | "Period prescribed by Presidential Decree" in the main clause, with the exception of its subparagraphs, of Article 12 (4) of the Act means 10 years. |
(2) | "Period prescribed by Presidential Decree in the proviso, with the exception of its subparagraphs, of Article 12 (4) of the Act means the period specified in the following: |
1. | An active substance (excluding an active substance referred to in subparagraph 2) that falls under either of the subparagraphs of Article 12 (4) of the Act: Seven years; |
2. | An active substance that falls under both subparagraphs of Article 12 (4) of the Act: Five years. |
Article 10 (Application for Approval of Substance) |
(1) | "Data prescribed by Presidential Decree, such as ingredients used for manufacturing the active substance and the manufacturing process" in Article 13 (1) 6 of the Act means the following: |
1. | Data on the ingredients used for manufacturing the active substance and the manufacturing process; |
2. | Precautions for the use of the active substance and the method of destruction; |
3. | Information on the use and regulation of the active substance domestically and internationally; |
4. | A written confirmation on separate submission of data (only where separate submission of data is confirmed by the Minister of Environment under the proviso, with the exception of its subparagraphs, of Article 19 (4) of the Act); |
5. | A document proving outsourcing, such as a copy of an outsourcing contract, where a person outsources the manufacture of the active substance. |
(2) | A person who intends to apply for approval under the main clause of Article 12 (1) of the Act (hereinafter referred to as "approval of a substance"), in accordance with Article 13 (1) or (3) of the Act, shall submit to the Minister of Environment an application for approval of an active substance prescribed by Ordinance of the Ministry of Environment, along with data referred to in the subparagraphs of Article 13 (1) of the Act: Provided, That such person need not submit the data under the relevant provisions, where he or she also submits data proving any of the following cases: <Amended on Dec. 29, 2020> |
1. | The active substance falls under any subparagraph of Article 13 (2) of the Act; |
2. | The applicant falls under the proviso of Article 13 (3) of the Act; |
3. | The applicant has obtained confirmation under the main clause of Article 33 (5) of the Act. |
(3) | The guidelines for testing and evaluation determined and publicly notified by the Minister of Environment shall be complied with in preparing the data referred to in Article 13 (1) 4 (a) and (c) of the Act. <Amended on Dec. 29, 2020> |
(4) | Upon receipt of an application for approval of a substance under paragraph (2), the Minister of Environment shall evaluate whether the active substance satisfies the standards provided in the subparagraphs of Article 12 (2) of the Act in accordance with Article 14 (1) of the Act and shall also ascertain whether such active substance falls under each subparagraph of Article 12 (3) of the Act. |
(5) | Except as provided in paragraphs (1) through (4), procedures for approval of substances and other necessary matters shall be prescribed by Ordinance of the Ministry of Environment. |
Article 11 (Matters to Be Notified regarding Approval of Substance) |
"Matters prescribed by Presidential Decree" in Article 14 (6) 6 of the Act means the following: 1. | Name of the active substance; |
2. | Approval number of the active substance; |
3. | Name or trade name, address, and contact information of a person who obtains approval of the active substance; |
4. | Location of the manufacturing facility of the active substance; |
5. | Uses of the active substance; |
6. | Manufacturing method of the active substance, including the manufacturing process; |
Article 12 (Approval for Changes to Approval of Substance) |
"Significant matters prescribed by Presidential Decree, such as information on the hazards or risks and the effects or efficacy of the active substance" in the main clause of Article 15 of the Act means the following: <Amended on Dec. 29, 2020> 1. | Information on the hazards and risks of the active substance; |
2. | Effects and efficacy of the active substance; |
3. | Name of the active substance; |
4. | Location of the manufacturing facility of the active substance; |
5. | Uses of the active substance; |
6. | Manufacturing method of the active substance, including the manufacturing process; |
7. | Matters regarding Article 14 (6) 1, 2, and 4 of the Act. |
Article 13 (Procedures for Recognition of Technical Equivalence) |
(1) | Any person who intends to obtain recognition of technical equivalence between an approved active substance (hereafter in this Article referred to as "reference active substance") and another active substance under the former part of Article 16 (1) of the Act shall submit to the Minister of Environment an application for recognition of technical equivalence in the Form prescribed by Ordinance of the Ministry of Environment, which shall be accompanied by the following: |
1. | Identification information, such as the name, molecular formula, and chemical composition of the active substance, technical equivalence of which is to be recognized; |
2. | Ingredients used for manufacturing the active substance, technical equivalence of which is to be recognized, and the manufacturing process; |
3. | Data proving that the applicant has obtained consent to use data required under Article 32 (1) of the Act. |
(2) | Where the Minister of Environment deems it impracticable to decide whether to recognize technical equivalence based on the data submitted under paragraph (1), the Minister may request the applicant for recognition of technical equivalence to submit additional data necessary to decide on recognition of technical equivalence, such as information on hazards to human bodies, animals, and the environment. |
(3) | The testing guidelines specified and publicly notified by the Minister of Environment shall be complied with in preparing the data requested under paragraph (2). |
(4) | The Minister of Environment shall take into account the following criteria to decide whether to recognize technical equivalence under Article 16 (2) of the Act: |
1. | The chemical composition of the active substance, technical equivalence of which is to be recognized, shall be similar to that of the reference active substance; |
2. | Effects and efficacy of the active substance, technical equivalence of which is to be recognized, in removing, rendering harmless, or inhibiting risks and any harmful organism shall be technically equivalent to those of the reference active substance; |
3. | Other criteria for recognition of technical equivalence specified and publicly notified by the Minister of Environment shall be complied with. |
(5) | "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" in the proviso of Article 16 (6) of the Act means the following cases: |
1. | Where no change is made in the chemical composition of the reference active substance for which approval for changes is granted under the main clause of Article 15 of the Act; |
2. | Where the scope of a change in the chemical composition of the reference active substance includes the scope of the chemical composition of an active substance, technical equivalence of which is recognized. |
(6) | Except as provided in paragraphs (1) through (5), matters necessary for procedures for recognition of technical equivalence shall be prescribed by Ordinance of the Ministry of Environment. |
Article 14 (Periods for Approval Deferment of Existing Active Substance) |
Periods for which approval of an existing active substance eligible for approval deferment under the provisions, with the exception of the subparagraphs, of Article 18 (3) of the Act (hereinafter referred to as "existing active substance eligible for approval deferment"), with the exception of its subparagraphs, can be deferred shall be as specified in attached Table 1.
Article 15 (Separate Submission of Data to Apply for Approval of Substance) |
"Where the grounds prescribed by Presidential Decree arise" in Article 19 (4) 3 of the Act means any of the following: 1. | Where the classifications and labeling of existing active substances eligible for approval deferment are different; |
2. | Where applicants have a conflicting opinion on the preparation of data to apply for approval of the relevant substance. |
SECTION 2 Approval of Biocidal Products and Control of Treated Articles
Article 16 Deleted. <Dec. 29, 2020> |
Article 17 (Valid Term of Approval of Biocidal Product) |
(1) | "Period prescribed by Presidential Decree" in the main clause, with the exception of its subparagraphs, of Article 20 (5) of the Act means 10 years. |
(2) | "Period prescribed by Presidential Decree" in the proviso, with the exception of its subparagraphs, of Article 20 (5) of the Act means the period specified in the following: |
1. | A biocidal product that falls under either of the subparagraphs of Article 20 (5) of the Act (excluding a biocidal product referred to in subparagraph 2): Five years; |
2. | A biocidal product that fall under both subparagraphs of Article 20 (5) of the Act: Three years. |
Article 18 (Application for Approval of Product) |
(1) | "Data prescribed by Presidential Decree, such as raw materials used in manufacturing the biocidal product and the manufacturing process" in Article 21 (1) 6 of the Act means the following: <Amended on Dec. 29, 2020> |
1. | Data on the ingredients used in manufacturing the biocidal product and the manufacturing process; |
2. | Precautions for the use of the biocidal product and the method of destruction; |
3. | Information on the use and regulation of the biocidal product domestically and internationally; |
4. | Data proving that the applicant uses a safe container or package that complies with the standards provided in Article 20 (2) 6 of the Act; |
5. | The current status of or a plan for compliance with the standards, including the manufacturing and storage facilities and safety control under Article 36-2 (1) of the Act; |
6. | A document proving outsourcing, such as a copy of an outsourcing contract, where the applicant outsources the manufacturing of biocidal products. |
(2) | A person who intends to apply for approval under Article 20 (1) of the Act (hereinafter referred to as "approval of a product"), in accordance with Article 21 (1) or (3) of the Act, shall submit to the Minister of Environment an application for approval of a biocidal product prescribed by Ordinance of the Ministry of Environment, along with the data referred to in the subparagraphs of Article 21 (1) of the Act: Provided, That such person need not submit the data under the relevant provisions, where he or she also submits data proving any of the following cases: <Amended on Dec. 29, 2020> |
1. | The biocidal product falls under any subparagraph of Article 21 (2) of the Act; |
2. | The applicant falls under the proviso of Article 21 (3) of the Act; |
3. | The applicant has obtained confirmation under the main clause of Article 33 (5) of the Act. |
(3) | The guidelines for testing and evaluation determined and publicly notified by the Minister of Environment shall be complied with in preparing the data referred to in Article 21 (1) 4 (a) and (c) of the Act. <Amended on Dec. 29, 2020> |
(4) | Upon receipt of an application for approval of a biocidal product under paragraph (2), the Minister of Environment shall evaluate whether the biocidal product satisfies the standards provided in the subparagraphs of Article 20 (2) of the Act in accordance with Article 22 (1) of the Act and shall also ascertain whether such biocidal product falls under each subparagraph of Article 20 (4) of the Act. |
(5) | Except as provided in paragraphs (1) through (4), procedures for approval of products and other necessary matters shall be prescribed by Ordinance of the Ministry of Environment. |
Article 19 (Matters to Be Notified regarding Approval of Product) |
"Matters prescribed by Presidential Decree" in Article 22 (6) 6 of the Act means the following: 1. | Approval number of the biocidal product; |
2. | Name or trade name, address, and contact information of the person granted approval of the product; |
3. | Location of the manufacturing facility of the biocidal product; |
4. | Effects and efficacy of the biocidal product; |
5. | Manufacturing method of the biocidal product, including the manufacturing process; |
6. | Names and addresses of suppliers of active substances contained in the biocidal product; |
7. | Following information on the biocidal product: |
(b) | Standard usage and instructions for use; |
Article 20 (Approval for Changes to Approval of Product) |
"Significant matters prescribed by Presidential, such as information on the hazards or risks and the effects or efficacy of the biocidal product" in the main clause of Article 23 of the Act means the following: 1. | Information on the hazards and risks of the biocidal product; |
2. | Effects and efficacy of the biocidal product; |
3. | Matters referred to in Article 22 (6) 1, 3, and 5 of the Act; |
4. | Ingredients and composition ratio of any of the following substances contained in the biocidal product: |
5. | Ingredients and composition ratio of substances, other than the substances referred to in any of the items of subparagraph 4, contained in the biocidal product (only applicable where the biocidal product’s classification and labeling referred to in Article 21 (1) 4 (e) of the Act are also changed); |
6. | Matters referred to in any of the items of subparagraph 7 of Article 19. |
Article 21 (Special cases concerning Approval of Product) |
(1) | "Data prescribed by Presidential Decree" in Article 24 (2) 5 of the Act means the following: |
1. | Data referred to in Article 21 (1) 3 (a) and (b) of the Act; |
2. | Data referred to in Article 18 (1) 1, 2, and 4 through 6. |
(2) | Upon receipt of an application for approval of a biocidal product under Article 24 (2) of the Act, the Minister of Environment shall evaluate whether the biocidal product satisfies the standards provided in the subparagraphs of Article 20 (2) of the Act and shall also ascertain whether such biocidal product falls under each subparagraph of paragraph (3) and (4) of the same Article. |
(3) | Upon deciding to grant approval of a product under paragraph (2), the Minister of Environment shall without delay notify the applicant for approval of that product of the matters referred to each subparagraph of Article 22 (6) of the Act, as prescribed by Ordinance of the Ministry of Environment. |
Article 22 (Procedures for Recognition of Product Similarity) |
(1) | Any 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 under the former part of Article 25 (1) of the Act shall submit to the Minister of Environment an application for recognition of product similarity in the Form prescribed by Ordinance of the Ministry of Environment, which shall be accompanied by the following data: |
1. | Data referred to in Article 21 (1) 3 (a) and (b) of the Act; |
2. | Data referred to in Article 18 (1) 1 and 4 through 6; |
3. | Data proving that the applicant has obtained consent to use data required under Article 32 (1) of the Act. |
(2) | The Minister of Environment shall take into account the following criteria to decide whether to recognize product similarity under Article 25 (2) of the Act: |
1. | Ingredients, composition ratio of all substances, including active substances, contained in the biocidal product, product similarity of which is to be recognized, and its purposes of use and uses shall be similar to those of the reference biocidal product; |
2. | Purposes of use, uses, formulation, risks, hazards, effects, and efficacy of the biocidal product, product similarity of which is to be recognized, shall be similar to those of the reference biocidal product; |
3. | Other criteria specified and publicly notified by the Minister of Environment regarding recognition of product similarity shall be complied with. |
(3) | "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" in the proviso of Article 25 (6) of the Act means any of the following: |
1. | Where no change is made in the ingredients and composition ratio of substances contained in the reference biocidal product for which approval for changes is granted under the main clause of Article 23 of the Act; |
2. | Where the scope of a change in the ingredients and composition of substances contained in the reference biocidal product includes the scope of the ingredients and composition ratio of substances contained in the biocidal product whose similarity to the reference biocidal product is recognized. |
(4) | Except as provided in paragraphs (1) through (3), matters necessary for procedures for recognition of product similarity shall be prescribed by Ordinance of the Ministry of Environment. |
Article 23 (Safety Standards for Treated Articles) |
"Standards for similarity prescribed by Presidential Decree" in Article 28 (1) 1 of the Act means the following standards: <Amended on Dec. 29, 2020> 1. | All active substances contained in a biocidal product shall be any of the following: |
(a) | Active substances approved under Article 12 (1) of the Act, which are used for the types of biocidal products, for which such active substances can be used as approved (hereinafter referred to as "biocidal product type"); |
(b) | Active substances publicly notified by the Minister of Environment under the proviso of Article 12 (1) of the Act; |
(c) | Active substances approved, confirmed, etc. by a foreign government, the safety of which is officially recognized for its use in the relevant biocidal product type; |
2. | Safety of a biocidal product used for a treated article shall be recognized by approval, verification, etc. of a foreign government. |
SECTION 3 Information Disclosure and Data Protection
Article 24 (Provision of Information on Treated Article) |
(1) | A person who intends to request provision or perusal of information on biocidal products used in a treated article under Article 30 (1) of the Act shall submit to the manufacturer or importer of the treated article a request for provision or perusal of information in the Form prescribed by Ordinance of Ministry of Environment, which shall be accompanied by a document proving the purchase of such treated article. |
(2) | A person who has received a request for provision or perusal of information under paragraph (1) shall provide the requester with the relevant information or permit the perusal of such information by giving the requester a notice of decision on information request in the Form prescribed by Ordinance of Ministry of Environment within 45 days from the date of receipt of the request. In such cases, such person shall inform the requester of the date, time, and place of perusal three days before the date of perusal when permitting the perusal of information. |
(3) | Notwithstanding paragraph (2), a person who intends to refuse provision or perusal of information on the grounds that such information constitutes his or her management or trade secrets shall give the requester a notice of decision on information request in the Form prescribed by Ordinance of Ministry of Environment stating his or her refusal and grounds therefor within 45 days from the date of receipt of the request. |
(4) | Notwithstanding paragraphs (2) and (3), a person who has received a request for provision or perusal of information under paragraph (1) may extend the period specified in the former part of paragraph (2) or paragraph (3) by up to 10 days only once, where any unavoidable cause exists. In such cases, such person shall inform the requester of the grounds for and period of extension. |
Article 25 (Data Protection) |
(1) | "Protection period prescribed by Presidential Decree" in the main clause, with the exception of its subparagraphs, of Article 31 (1) of the Act means five years: Provided, That where a person who has submitted data requests an extension (up to two extensions with a five-year period each) of the protection period, as prescribed by Ordinance of Ministry of Environment, and the Minister of Environment recognizes the necessity for protection of the data, the protection period includes such extension. |
Article 25-2 (Grounds for Repeated Testing on Vertebrate Animals) |
"Cases prescribed by Presidential Decree, such as where new findings suggest that the relevant daily use consumer chemical products, active substances, or biocidal products pose a risk on humans, animals, or the environment" in Article 32-2 (1) of the Act means any of the following cases: 1. | Where new findings suggest that the relevant daily use consumer chemical products (including any chemical substances contained in such daily use consumer chemical products; hereafter the same shall apply in this Article), active substances, or biocidal products pose a hazard or risk on humans, animals, or the environment; or where internationally recognized test results, etc. are likely to identify a newly discovered hazard or risk, in which cases the data on alternative 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 "alternative to vertebrate animal test data") are not sufficient to assess the hazards or risks; |
2. | Where it is impracticable to assess the risks to humans, animals, or the environment due to the low reliability of data recording the test results of vertebrate animals (hereinafter referred to as "vertebrate animal test data"); |
3. | Where it is impracticable to determine the hazards or risks of the relevant daily use consumer chemical products, active substances, or biocidal products solely with the alternative to vertebrate animal test data; |
4. | Where it is deemed appropriate to generate and retain new vertebrate animal test data for the management of information on the hazards or risks of the relevant daily use consumer chemical products, active substances, or biocidal products, in light of the cost and terms and conditions of purchase of the vertebrate animal test data available at home and abroad; |
5. | Where the Minister of Environment issues an order to produce and submit vertebrate animal test data pursuant to the proviso of Article 33 (5) of the Act. |
[This Article Newly Inserted on Dec. 29, 2020]
Article 26 (Grounds for Refusal to Consent to Use of Vertebrate Animal Test Data) |
"Good cause prescribed by Presidential Decree" in Article 33 (4) of the Act means where the price to be paid by a person who requests a consent to use vertebrate animal test data under the same paragraph to the owner of data for its use is not reasonable, in light of the cost incurred in producing the data. <Amended on Dec. 29, 2020>
CHAPTER IV EX-POST CONTROL OF DAILY USE CONSUMER CHEMICAL PRODUCTS AND BIOCIDES
Article 27 (Recommendation on Measures regarding New Risks) |
(1) | To make a recommendation that a daily use consumer chemical product subject to safety verification or biocide should be collected, destroyed, repaired, exchanged, refunded, or improved or other necessary measures should be taken under Article 36 (2) of the Act, the Minister of Environment shall do so in writing (including an electronic document) specifying the following: |
1. | Name of the daily use consumer chemical product subject to safety verification or biocide subject to the recommendation; |
2. | Grounds for, and details of, the recommendation; |
3. | Name of the person subject to the recommendation (the names of a corporation and its representative, in the case of a corporation); |
4. | Time limit for notifying acceptance or rejection of the recommendation; |
5. | Actions to be taken when the relevant entity or person rejects the recommendation; |
6. | Other matters deemed necessary by the Minister of Environment to make the recommendation. |
(2) | A person who has received a recommendation under paragraph (1) shall notify the Minister of Environment in writing (including an electronic document) of acceptance or rejection of the recommendation within seven days from the date of receipt of the recommendation, specifying the following: |
1. | Name of the daily use consumer chemical product subject to safety verification or biocide subject to the recommendation; |
2. | Name of the person subject to the recommendation (the names of a corporation and its representative, in the case of a corporation); |
3. | Acceptance or rejection of the recommendation; |
4. | Grounds for rejection, if such person rejects the recommendation. |
(3) | A person who has notified the Minister of Environment of acceptance of a recommendation under paragraph (2) shall submit an action plan and the outcomes of taking measures to the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment. |
Article 28 (Order to Take Measures, Such as Recall) |
(1) | To issue an order requiring necessary measures to be taken, such as recall or destruction of a daily use consumer chemical product or biocide under Article 37 of the Act, the Minister of Environment shall do so in writing, specifying the following: |
1. | Name of the daily use consumer chemical product or biocide; |
2. | Name and address of a person subject to the order to take measures (the name of a corporation and the name and address of its representative, in the case of a corporation); |
3. | Details of, and grounds for, the order to take measures; |
4. | Period by which the order to take measures shall be implemented; |
5. | Other matters deemed necessary by the Minister of Environment to issue the order to take measures. |
(2) | A person subject to an order to take measures issued under paragraph (1) shall submit an action plan and the outcomes of taking measures to the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment. |
Article 29 (Calculation of Penalty Surcharge) |
(1) | Sales referred to in the main clause, with the exception of its subparagraphs, of Article 38 (1) of the Act shall be calculated by multiplying the selling price of the relevant daily use consumer chemical product subject to safety verification or biocide by its sales volume. |
(2) | The sales volume referred to in paragraph (1) means the volume of manufacture or import less the volume remaining unsold from the time a daily use consumer chemical product subject to safety verification or biocide is sold (or from the time approval or recognition of such product or biocide is revoked or an order banning or suspending its manufacture or import is issued, in the case of Article 38 (1) 2, 4, or 6 of the Act) in violation of any of the subparagraphs of Article 38 (1) of the Act to the time such violation is discovered. |
(3) | The selling price referred to in paragraph (1) means the selling price during the period of sale specified in paragraph (2). |
(4) | "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" in the proviso, with the exception of its subparagraphs, of Article 38 (1) of the Act means any of the following: |
1. | Where such product or biocide has no sales as its sale has not started or is suspended; |
2. | Where it is impracticable to calculate sales as the times or volume specified in paragraph (2) cannot be fixed; |
3. | Where it is impracticable to objectively calculate sales as supporting data for calculating sales is destroyed or damaged due to a natural disaster or any other unavoidable cause. |
(5) | To impose a penalty surcharge under Article 38 (1) of the Act, the Minister of Environment may take into account the following: |
1. | Type and severity of the relevant violation; |
2. | Period and frequency of the relevant violation; |
3. | Profits earned by the relevant violation; |
4. | Level of efforts expended by a person subject to a penalty surcharge to prevent or compensate for consumer damage. |
(6) | Except as provided in paragraphs (1) through (5), calculation of penalty surcharges and other necessary matters shall be specified and publicly notified by the Minister of Environment. |
Article 30 (Imposition and Payment of Penalty Surcharge) |
(1) | To impose a penalty surcharge under Article 38 (1) of the Act, the Minister of Environment shall issue a payment notice specifying the type of the relevant violation and the amount of a penalty surcharge. |
(2) | A person who has received a payment notice under paragraph (1) shall pay a penalty surcharge to any receiving agency specified by the Minister of Environment within 60 days from the date of receipt of the payment notice. <Amended on Dec. 12, 2023> |
(3) | A receiving agency that has received the payment of a penalty surcharge under paragraph (2) shall give the payer a receipt and notify the Minister of Environment its receipt of the payment of the penalty surcharge without delay. |
(4) | The Minister of Environment may extend the deadline for payment of a penalty surcharge or allow the payment of a penalty surcharge in installments pursuant to the proviso of Article 29 of the Framework Act on the Administration. <Amended on Dec. 12, 2023> |
(5) | Where the Minister of Environment extends the deadline for payment of a penalty surcharge pursuant to paragraph (4), the extended period shall not exceed two years from the day following the original payment deadline. <Amended on Dec. 12, 2023> |
(6) | Where the Minister of Environment allows the payment of a penalty surcharge in installments pursuant to paragraph (4), the interval between each installment payment deadline shall not exceed six months, and the number of installment payments shall not exceed six. <Amended on Dec. 12, 2023> |
(7) | Deleted. <Dec. 12, 2023> |
Article 31 (Additional Charge for Penalty Surcharge and Demand) |
(1) | An additional charge collected under the former part of Article 39 (1) of the Act equals 3/100 of an overdue penalty surcharge. |
(2) | A demand under Article 39 (2) of the Act shall be made in writing within seven days after the due date. |
(3) | Where a demand notice is issued under paragraph (2), the due date for an overdue penalty surcharge shall be within 10 days from the date of issuance of the demand notice. |
(4) | An additional payment of refund made under Article 39 (3) of the Act equals a penalty surcharge to be refunded, multiplied by the interest rate specified in Article 43-3 (2) of the Enforcement Decree of the Framework Act on National Taxes (if the imposition of a penalty surcharge is revoked by a judgment of the court and a new penalty surcharge is imposed based on the grounds for such judgment, a penalty surcharge to be refunded means the penalty surcharge already paid less the new penalty surcharge). |
Article 32 (Publication of Violation) |
The Minister of Environment shall publish the following matters on any general daily newspaper registered to be circulated nationwide under Article 9 (1) of the Act on the Promotion of Newspapers or the website of the Ministry of Environment in accordance with Article 40 of the Act: 1. | Title "Publication of Violation of the Daily Use Consumer Chemical Products and Biocides Safety Control Act"; |
2. | Name of the relevant daily use consumer chemical product or biocide; |
3. | Name or trade name, address, and contact information of a person on whom an administrative disposition is finally and conclusively imposed; |
4. | Details of the violation; |
5. | Person having authority to impose dispositions, and date and details of the disposition. |
CHAPTER V LAYING FOUNDATION FOR SAFETY CONTROL OF DAILY USE CONSUMER CHEMICAL PRODUCTS AND BIOCIDES
Article 33 (Requirements for Designation of Testing and Inspection Institution) |
(1) | "Requirements for facilities, equipment, and technical personnel prescribed by Presidential Decree" in the former part of Article 41 (2) of the Act means the following: <Amended on Dec. 29, 2020> |
1. | Facilities: An applicant shall have a separate laboratory necessary for conducting testing and inspection to verify whether daily use consumer chemical products comply with the safety standards or to approve biocides; |
2. | Equipment: An applicant shall have the measuring equipment and analysis devices determined and publicly notified by the Minister of Environment, such as local ventilation system, sample preconditioning modules, and quantitative analysis device; |
3. | Technical personnel: An applicant shall have both of the following engineers: |
(a) | At least two professional engineers who have at least three years of testing and inspection experiences in the environment, chemistry, or other related fields after acquiring a bachelor’s or higher degree in the environment, chemistry, or other related majors at any schools referred to in subparagraphs 1 through 6 of Article 2 of the Higher Education Act or any graduate schools referred to in Article 29 of the same Act or after having an equivalent academic qualification under the relevant statutes or regulations; |
(b) | At least five testing engineers with at least one year of testing and inspection experiences in the environment, chemistry, or other related fields after graduating from a high school or a vocational high school referred to in subparagraph 3 of Article 2 of the Elementary and Secondary Education Act or after having an equivalent academic qualification under the relevant statutes or regulations. |
(2) | Fields of testing and inspection referred to in the latter part of Article 41 (2) of the Act means the following: |
1. | Verification as to whether daily use consumer chemical products subject to safety verification comply with the safety standards under Article 10 (1) of the Act; |
2. | Testing and inspection provided in Articles 14 (2) and 22 (2) of the Act as agency. |
(3) | Detailed standards for the facilities, equipment, and technical personnel of testing and inspection institutions under paragraph (1) and testing and inspection fields under paragraph (2) shall be determined and publicly notified by the Minister of Environment. <Amended on Dec. 29, 2020> |
Article 34 (Procedures for Designation of Testing and Inspection Institution) |
(1) | A person that intends to be designated or re-designated as a testing and inspection institution under the former part of Article 41 (2) of the Act or the latter part of paragraph (6) of the same Article shall submit to the Minister of Environment an application for designation of a testing and inspection institution in the Form prescribed by Ordinance of the Ministry of Environment, which shall be accompanied by the following: |
1. | An operational plan of the testing and inspection institution; |
2. | Data proving that the applicant meets the requirements provided in the subparagraphs of Article 33 (1). |
(2) | Upon receipt of an application under paragraph (1), a public official in charge shall verify the applicant’s corporation registration certificate (only applicable if the applicant is a corporation) or business registration certificate through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where the applicant does not consent to verification of his or her business registration certificate, the public official shall require the applicant to submit the relevant document. |
(3) | "Important matters prescribed by Presidential Decree" in Article 41 (4) of the Act means the following: <Amended on Dec. 29, 2020> |
1. | Name of a testing and inspection institution; |
2. | Representative of a testing and inspection institution; |
3. | Location of a testing and inspection institution; |
4. | Technical personnel in a testing and inspection institution; |
5. | Fields of testing and inspection. |
(4) | A testing and inspection institution that intends to modify any of the matters referred to in the subparagraphs of paragraph (3) under Article 41 (4) of the Act shall submit to the Minister of Environment an application for designation modifications of a testing and inspection institution in the Form prescribed by Ordinance of Ministry of Environment, which shall be accompanied by the following documents: |
1. | A certificate of designation as a testing and inspection institution issued under Article 41 (5) of the Act; |
2. | A document proving that any of the matters referred to in the subparagraphs of paragraph (3) is modified. |
(5) | Upon permitting a designation modification of a testing and inspection institution under Article 41 (4) of the Act, the Minister of Environment shall state the relevant modification on the reverse side of the certificate of designation submitted by such testing and inspection institution under paragraph (4) and shall return it to the applicant for the designation modification. |
(6) | Except as provided in paragraphs (1) through (5), procedures and methods for designation and re-designation of testing and inspection institutions and for designation modifications, and other necessary matters shall be specified and publicly notified by the Minister of Environment. |
Article 35 (Support for Small and Medium Enterprise) |
"Matters prescribed by Presidential Decree" in subparagraph 5 of Article 45 of the Act means the following: <Amended on Dec. 29, 2020> 1. | Technical support for compliance with the safety and labeling standards for daily use consumer chemical products subject to safety verification; |
2. | Technical support for recognition of technical equivalence; |
3. | Technical support for recognition of product similarity; |
4. | Support in preparing data to apply for approval of substances, if jointly submitted under Article 19 (4) of the Act; |
5. | Utilization of the information network for the control of daily use consumer chemical products and biocides established under Article 47 of the Act. |
Article 36 (Designation of Household Chemical Products and Biocides Safety Center) |
"Specialized institute prescribed by Presidential Decree" in Article 46 (1) of the Act means the Korea Environmental Industry and Technology Institute established under the Korea Environmental Industry and Technology Institute Act (hereinafter referred to as the "Korea Environmental Industry and Technology Institute").
Article 37 (Affairs of Handling Daily Use Consumer Chemical Products in Information Network) |
(1) | "Affairs prescribed by Presidential Decree" in Article 47 (1) of the Act means the following: <Amended on Dec. 29, 2020> |
1. | Reporting, reporting on changes, approval, or approval for changes of daily use consumer chemical products subject to safety verification under Article 10 (4) through (7) of the Act; |
2. | Approval of substances, approval for changes, and reporting on changes under Articles 12 and 15 of the Act; |
3. | Recognition of technical equivalence under Article 16 of the Act; |
4. | Report on existing active substances under Article 18 (2) of the Act; |
5. | Submission of a plan for applying for approval of substances under Article 19 (1) of the Act; |
6. | Approval of products, approval for changes, and reporting on changes under Articles 20 and 23 of the Act; |
7. | Special cases concerning approval of products under Article 24 of the Act; |
8. | Recognition of product similarity under Article 25 of the Act; |
9. | Disclosure of information on active substances and biocidal products under Article 29 of the Act; |
9-3. | Confirmation under the main clause of Article 33 (5) of the Act; |
10. | Reports on new risks, etc., recommendation on measures, and issuance of orders to take measures under Articles 36 and 37 of the Act; |
11. | Publication of violations under Article 40 of the Act; |
13. | Succession to rights and obligations under Article 51 of the Act; |
14. | Reporting appointment or dismissal under Article 54-2 (2) of the Act. |
(2) | In order to establish an information network under Article 47 (2) of the Act, the Minister of Environment may request the following information from the heads of relevant central administrative agencies pursuant to paragraph (3) of the same Article: <Newly Inserted on Dec. 29, 2020> |
1. | Name or trade name of the manufacturer or importer of chemical substances and products containing chemical substances; |
2. | The following matters regarding chemical substances and products containing chemical substances: |
(a) | Name, ingredients, and content; |
(b) | Purpose of use, usage, capacity, effects, and efficacy; |
(c) | Hazard and risk Information; |
(d) | Information on safe use, such as precautions for use; |
3. | Other information determined and publicly notified by the Minister of Environment as deemed necessary for the establishment of an information network. |
(3) | "Matters prescribed by Presidential Decree" in Article 47 (4) of the Act means the following: <Newly Inserted on Dec. 29, 2020> |
1. | Name, hazards, and risks of the chemical substance, and a safe way to use; |
2. | The following matters regarding products containing chemical substances: |
(a) | Name of products containing chemical substances; |
(b) | Hazards, risks, and a safe way to use; |
(c) | Name or trade name, address, and contact information of manufacturers or importers; |
3. | Other information disclosed pursuant to the statutes and regulations governing each product. |
Article 37-2 (Monetary Awards) |
(1) | The payment standards for monetary awards under Article 52-2 (1) of the Act shall be as specified in attached Table 1-2. |
(2) | The annual limit for monetary awards payable per capita in accordance with paragraph (1) shall be three million won. |
(3) | Except as provided in paragraphs (1) and (2), matters necessary for the methods, procedures, etc. for payment of monetary awards shall be determined and publicly notified by the Minister of Environment. |
[This Article Newly Inserted on Dec. 29, 2020]
CHAPTER V-2 REMEDY FOR DAMAGE FROM BIOCIDAL PRODUCTS
Article 37-3 (Composition of Biocidal Product Damage Investigation Team) |
(1) | A biocidal product damage investigation team referred to in Article 48-3 (1) of the Act (hereinafter referred to as "biocidal product damage investigation team") shall consist of up to 20 team members, including one chief. |
(2) | The chief of a biocidal product damage investigation team shall be nominated by the Minister of Environment from among the team members. |
(3) | The members of a biocidal product damage investigation team shall be appointed or commissioned by the Minister of Environment from among the following persons: |
1. | Persons specified in the subparagraphs of Article 6 (4) of the Act; |
2. | Executive officers and employees of the Korea Environmental Industry and Technology Institute. |
(4) | Where a professional judgment or an epidemiological investigation is necessary, the Minister of Environment may commission and operate non-standing professional investigators under the jurisdiction of the biocidal product damage investigation team. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-4 (Request for Submission of Data) |
(1) | "Persons prescribed by Presidential Decree, such as the relevant central administrative agencies, local governments, victims and their survivors, or manufacturers and importers of products causing damage under Article 48-16 of the Act" in the former part of Article 48-3 (2) of the Act means the following persons: |
3. | A person who has filed an application for payment of remedial benefits pursuant to Article 48-4 (1) of the Act and his or her survivors, and a person determined eligible for remedial benefits pursuant to paragraph (4) of the same Article (hereinafter referred to as "person eligible for remedial benefits") and his or her survivors; |
4. | A manufacturer or importer of biocidal products and a seller or distributor of biocidal products; |
7. | Other institutions, corporations, or organizations that possess data that the Minister of Environment deems required for investigations, appraisals, etc. under Article 48-4 (3) of the Act. |
(2) | "Data prescribed by Presidential Decree, such as resident registration, family relation registration, medical records, health insurance, and biocidal product information" in the former part of Article 48-3 (2) of the Act means the following: |
2. | Computerized information data on registered matters concerning family relations under Article 9 of the Act on the Registration of Family Relationships and certificates specified in the subparagraphs of Article 15 (1) of the same Act; |
6. | Data on products and sales, including ingredients, mixing ratio, hazards, volume of manufacture or import, and sales volume of the biocidal products; |
9. | Other data deemed necessary by the Minister of Environment for conducting an investigation, appraisal, etc. under Article 48-4 (3) of the Act. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-5 (Effective Period for Decisions on Payment of Remedial Benefits for Damage from Biocidal Products) |
(1) | The effective period for a decision on payment of remedial benefits for damage from biocidal products under Article 48-5 (1) of the Act shall be five years. |
(2) | A person eligible for remedial benefits who intends to apply for renewal of the effective period for a decision on payment of remedial benefits pursuant to Article 48-5 (2) of the Act shall submit an application for renewal of the effective period to the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment. |
(3) | The Minister of Environment shall determine whether to renew the effective period within 60 days from the date of receipt of an application filed pursuant to paragraph (2), and if the application filed pursuant to paragraph (2) is deemed incomplete, the Minister of Environment may send the applicant a written request to supplement the application, stating the details of and period for supplementation. In such cases, the period required for supplementation shall be excluded from the period for decision on whether to renew the effective period. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-6 (Management and Operation of Account for Remedy for Damage from Biocidal Products) |
(1) | The Minister of Environment shall keep an account for remedy for damage from biocidal products under Article 48-14 (1) of the Act (hereinafter referred to as "account for remedy for damage from biocidal products") in accordance with the principles of corporate accounting. |
(2) | "Manners prescribed by Presidential Decree" in Article 48-15 (3) of the Act means the following: |
1. | Deposit or money trust into a financial institution or postal service agency; |
2. | Purchase of securities which are directly issued or the redemption of which is guaranteed, by the State, a local government, or a financial institution; |
(3) | The Minister of Environment shall, pursuant to Article 48-15 (4) of the Act, entrust the president of the Korea Environmental Industry and Technology Institute with the duties specified in each subparagraph of Article 48-14 (1) of the Act. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-7 (Composition of Remedy Account Operating Committee) |
(1) | The remedy account operating committee established under Article 48-15 (5) of the Act (hereinafter referred to as "remedy account operating committee") shall be comprised of not more than 10 members, including one chairperson. |
(2) | The chairperson of the remedy account operating committee shall be elected by and from among the committee members. |
(3) | The members of the remedy account operating committee shall be selected from among the following persons: |
1. | Persons nominated by the Minister of Environment from among public officials belonging to the Ministry of Environment; |
2. | Persons commissioned by the president of the Korea Environmental Industry and Technology Institute from among the following persons. In such cases, the members of any particular gender shall not exceed 6/10 of the total number of commissioned members: |
(a) | A person in charge of the affairs related to damage from biocidal products under Article 48-2 (1) of the Act (hereinafter referred to as "damage from biocidal products"), among the executive officers and employees of the Korea Environmental Industry and Technology Institute; |
(b) | A person who has served as a judge, prosecutor, or attorney at law for at least five years; |
(c) | A person with extensive knowledge of and experience in asset management, financial management, or insurance science. |
(4) | A member under paragraph (3) 2 (b) and (c) shall hold office for a term of two years and may be appointed consecutively for only two terms. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-8 (Imposition and Collection of Contributions to Remedy for Damage from Biocidal Products) |
(1) | Where the Minister of Environment (including the president of the Korea Environmental Industry and Technology Institute entrusted with the imposition and collection of contributions pursuant to paragraph (3); hereafter the same shall apply in Articles 37-10 and 37-11) intends to impose contributions to remedy for damage from biocidal products (hereinafter referred to as "contributions") pursuant to the former part of Article 48-16 (1) of the Act, he or she shall give a notice of contributions payment to the manufacturers and importers of the products of cause that are specified in the former part of the same paragraph (hereinafter referred to as "product of cause), stating the amount of and deadline for payment, a receiving agency, etc., as prescribed by Ordinance of the Ministry of Environment. |
(2) | The deadline for payment of contributions shall be 30 days from the date of giving a notice of contributions payment under paragraph (1). |
(3) | The Minister of Environment shall entrust the duties of imposition and collection of contributions to the president of the Korea Environmental Industry and Technology Institute pursuant to the latter part of Article 48-16 (1) of the Act. |
(4) | The ratio of use of products of cause under Article 48-16 (2) of the Act shall be calculated excluding the products of cause used by any of the following persons: |
1. | A person exposed to the products of cause, all or part of which are unidentifiable; |
2. | A person exposed to products of cause that are manufactured or imported and sold by the manufacturer or importer of a product of cause for which contributions are reduced pursuant to paragraph (7). In such cases, the number of persons shall be calculated by multiplying the number of persons exposed to products of cause by the rate of reduction of contributions under paragraph (7). |
(5) | The ratio of rale of products of cause pursuant to Article 48-16 (2) of the Act shall be calculated according to the following standards: |
1. | The total sales volume of products of cause shall be the sales volume of products of cause that are verified through investigations, appraisals, etc. under Article 48-4 (3) of the Act; |
2. | The sales volume calculated by multiplying the reduction rate of contributions shall be excluded from the sales volume of the manufacturers or importers of products of cause under paragraph (7). |
(6) | The Minister of Environment may, pursuant to Article 48-16 (5) of the Act, exempt the manufacturers or importers of the following products of cause from the obligation to pay contributions: |
2. | Manufacturers or importers of products of cause that are practically incapable of paying contributions due to the business closure, bankruptcy, insolvency, etc. |
(7) | Pursuant to Article 48-16 (5) of the Act, the Minister of Environment may reduce the amount specified in the relevant subparagraphs for the following manufacturers or importers of products of cause: |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-9 (Additional Charges) |
An additional charge imposed pursuant to Article 48-16 (7) of the Act shall be calculated by multiplying an amount equivalent to 1/1,000 of the contributions in arrears, by the number of days from the day immediately after the payment deadline to the day immediately before the actual payment date. [This Article Newly Inserted on Dec. 31, 2021]
Article 37-10 (Filing Objections) |
(1) | "Method prescribed by Presidential Decree" in the former part of the Article 48-16 (9) of the Act means a written form, e-mail, facsimile, or other equivalent means. |
(2) | A person who intends to file an objection against the imposition of contributions pursuant to the former part of Article 48-16 (9) of the Act shall submit a written application prescribed by Ordinance of the Ministry of Environment to the Minister of Environment, along with data proving the grounds for filing an objection. |
(3) | Upon receipt of an objection filed under paragraph (2), the Minister of Environment shall examine the details of the objection and notify the relevant applicant of the results thereof. In such cases, the period from the date of receipt of an objection to the date of notification of the results shall not be included in the period for calculation of additional charges under Article 37-9. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-11 (Payment of Contributions in Installments) |
(1) | Where the manufacturer or importer of products of cause falls under any of the following cases, the Minister of Environment may, pursuant to Article 48-16 (10) of the Act, require him or her to pay the contributions in installments as specified in the relevant subparagraph: |
1. | Where contributions imposed on the manufacturer or importer of products of cause (excluding the manufacturer or importer referred to in subparagraph 2) exceed one billion won: Up to eight installments within a two-year period; |
(2) | A person who intends to pay the contributions in installments pursuant to paragraph (1) shall submit an application for installment payments of the contributions to the Minister of Environment within seven days from the date of receipt of a notice of payment under Article 37-8 (1), as prescribed by Ordinance of the Ministry of Environment. |
(3) | The Minister of Environment shall notify whether to accept an application for installment payment of contributions within 30 days from the date of receipt of an application filed pursuant to paragraph (2), as prescribed by Ordinance of the Ministry of Environment. |
(4) | If a person upon receipt of a notice of installment payment pursuant to paragraph (3) falls under any of the following cases, the Minister of Environment may revoke the decision on the payment of contributions in installments and collect the contributions in lump sum. In such cases, the Minister of Environment shall give a prior written notice thereof to the person liable to pay: |
1. | Where the person fails to pay an installment by the specified deadline; |
2. | Where it is deemed impossible to collect the whole amount of installment by the deadline for installment payment due to the causes provided for in any of the subparagraphs of Article 9 (1) of the National Tax Collection Act or any other cause equivalent thereto. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 37-12 (Request for Medical Examination) |
Where the Minister of Environment requests a medical examination, inspection, investigation, etc. pursuant to Article 48-17 of the Act, he or she shall give a written notice thereof for a specified period not exceeding 30 days. [This Article Newly Inserted on Dec. 31, 2021]
Article 37-13 (Temporary Suspension of Remedial Benefits) |
(1) | "Cases prescribed by Presidential Decree" in Article 48-18 (1) 2 of the Act means where a person eligible for remedial benefits is deemed to have aggravated his or her disease or interfered with his or her treatment, by intent or gross negligence. |
(2) | Where the Minister of Environment intends to temporarily suspend the payment of medical expenses under Article 48-18 (1) of the Act, the Minister shall request in writing a person to be paid the medical expenses to correct matters specified in the subparagraphs of the same paragraph for a specified period not exceeding 30 days. |
(3) | Where a person upon receipt of a request for correction under paragraph (2) fails to make a correction within the period specified in the same paragraph, the Minister of Environment may temporarily suspend the payment of medical expenses. |
(4) | The period for temporary suspension of the payment of medical expenses shall be from the day following the end of the period for a request for correction under paragraph (2) to the day before the date of making a correction under the same paragraph. |
[This Article Newly Inserted on Dec. 31, 2021]
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
Article 38 (Delegation of Authority) |
(1) | The Minister of Environment shall delegate the following authority to the president of the National Institute of Chemical Safety pursuant to Article 54 (1) of the Act: <Amended on Dec. 29, 2020; Apr. 2, 2024> |
1. | Receipt of approval, approval for changes, and a report on changes of daily use consumer chemical products subject to safety verification under Article 10 (6) and the main clause of Article (7) of the Act and the proviso of the same paragraph; |
1-2. | Disclosure of information under Article 10-2 of the Act (limited to the information on daily use consumer chemical products subject to safety verification, which are approved pursuant to Article 10 (6) of the Act); |
1-3. | Public notice of active substances referred to in the proviso of Article 12 (1) of the Act; |
1-4. | Public notice of details of the standards for approval of active substances under Article 12 (2) of the Act; |
2. | Approval of substances under Articles 13 and 14 of the Act; |
3. | Receipt of applications for approval for changes and granting approval for changes under the main clause of Article 15 of the Act and receipt of reports on changes under the proviso of the same Article; |
4. | Recognition of technical equivalence under Article 16 of the Act; |
5. | Revocation of approval, etc. of substances or of recognition of technical equivalence under Article 17 of the Act; |
6. | Receipt of reports on existing active substances eligible for approval deferment under Article 18 (2) of the Act; |
6-2. | Designation and public notice of existing active substances eligible for approval deferment under Article 18 (3) of the Act; |
7. | Receipt of plans for applying for approval of substances under Article 19 (1) of the Act, cancellation of designation of existing active substances eligible for approval deferment under paragraph (3) of the same Article, and confirmation of separate submission under the proviso of paragraph (4) of the same Article; |
7-2. | Public notice of the details of the standards for approval of a product under Article 20 (2) of the Act; |
8. | Approval of products under Articles 21 and 22 of the Act; |
9. | Receipt of applications for approval for changes and granting approval for changes under the main clause of Article 23 of the Act and receipt of reports on changes under the proviso of the same Article; |
10. | Approval of products under Article 24 of the Act; |
11. | Recognition of product similarity under Article 25 of the Act; |
12. | Revocation of approval, etc. of products or recognition of product similarity under Article 26 of the Act; |
13. | Disclosure of information on active substances and biocidal products under Article 29 of the Act; |
14. | Protection and disclosure of data under Article 31 of the Act; |
15. | Receipt of requests for verifying whether vertebrate animal test data exists, giving notice of the results of verification, confirmation as to whether owners of vertebrate animal test data give consent to their use, and issuing orders to submit vertebrate animal test data under Article 33 of the Act; |
16. | Designation of testing and inspection institutions, designation modifications, and evaluation of testing and inspection institutions under Article 41 of the Act; |
17. | Issuance of orders requiring testing and inspection institutions to suspend business or revocation of designation of such institutions under Article 43 of the Act; |
18. | Entry, inspection, collection, etc. (limited to the same to exercise the authority delegated to the president of the National Institute of Chemical Safety) under Article 50 of the Act; |
18-2. | Receipt of notification of succession to the rights and obligations regarding approval of daily use consumer chemical products subject to safety verification, approval, etc. of a substance, or approval, etc. of a product under Article 51 (2) of the Act; |
19. | Hearings under subparagraphs 1, 2 and 4 of Article 53 of the Act; |
19-2. | Receipt of reports on appointment or dismissal under Article 54-2 (2) of the Act; |
19-3. | Imposition and collection of administrative fines under Article 60 (1) 3, 4, 8, and 10 of the Act; |
20. | Public notice of the testing and inspection standards and guidelines under Article 5 (2); |
21. | Public notice of the standards and methods for granting approval under Article 6 (4); |
22. | Public notice of the guidelines for testing and evaluation under Articles 10 (3), 13 (3), and 18 (3); |
22-2. | Public notice of the criteria for recognition of technical equivalence under Article 13 (4) 3; |
22-3. | Public notice of the criteria for recognition of product similarity under Article 22 (2) 3; |
23. | Granting of extensions of the data protection period under the proviso of Article 25 (1); |
24. | Public notice of the detailed standards for designation of testing and inspection institutions, and the procedures, methods, etc. for designation, designation modification, and re-designation thereof under Articles 33 (3) and 34 (6). |
(2) | The Minister of Environment shall delegate the following authority to the heads of river basin environmental offices or the heads of regional environmental offices, pursuant to Article 54 (1) of the Act: <Amended on Dec. 29, 2020> |
1. | Issuance of orders banning the manufacture or import of daily use consumer chemical products subject to safety verification under Articles 8 (4) and 11 (1) of the Act; |
2. | Issuance of orders suspending the manufacture or import of active substances under Article 17 of the Act; |
3. | Issuance of orders banning the manufacture or import of existing active substances eligible for approval deferment under Article 19 (2) of the Act; |
4. | Issuance of orders suspending the manufacture or import of biocidal products under Article 26 of the Act; |
5. | Receipt of reports on new risks and recommendation on measures under Article 36 of the Act; |
5-2. | Issuance of corrective orders under Article 36-2 (2) of the Act; |
6. | Issuance of orders to take measures, such as recall or destruction, receipt of reports on results, and taking measures, such as recall or destruction under Article 37 of the Act; |
7. | Imposition and collection of penalty surcharges and disposition on overdue penalty surcharges under Articles 38 and 39 of the Act; |
8. | Receipt of reports under Article 49 (2) of the Act; |
9. | Entry, inspection, collection, etc. (limited to the same to exercise the authority delegated to the heads of river basin environmental offices or the heads of regional environmental offices) under Article 50 of the Act; |
10. | Hearings under subparagraph 3 of Article 53 of the Act; |
11. | Imposition and collection of administrative fines under Article 60 (1) 1, 2, 5, 6, 7, 9, 11, and 12 of the Act. |
Article 39 (Entrustment of Affairs) |
(1) | The Minister of Environment shall entrust the following affairs to the Korea Environmental Industry and Technology Institute in accordance with Article 54 (2) and (4) of the Act: <Amended on Dec. 29, 2020; Dec. 31, 2021> |
1. | Fact-finding surveys and requests for submission or reporting of data under Article 7 of the Act; |
2. | Risk assessments of daily use consumer chemical products and notification and disclosure of assessment findings under Article 8 (1), (2), and (5) of the Act; |
3. | Receipt of reports under Article 10 (4) of the Act; |
3-2. | Receipt of reports on changes under Article 10 (5) of the Act; |
3-3. | Disclosure of information under Article 10-2 of the Act (limited to information on daily use consumer chemical products subject to safety verification notified under Article 10 (4) of the Act); |
4. | Educational training and campaigns under Article 44 of the Act: Provided, That the affairs specified in paragraph (3) 1 shall be excluded herefrom; |
5. | Support for small and medium enterprises under Article 45 of the Act: Provided, That the affairs specified in paragraph (3) 2 shall be excluded herefrom; |
6. | Establishment and operation of an information network for the management of daily use consumer chemical products and biocides under Article 47 (1) and (2) of the Act; |
7. | Receipt of an application for payment of remedial benefits and review of the details of application pursuant to Article 48-4 (1) of the Act; |
8. | Investigation, appraisal, etc. under Article 48-4 (3) of the Act; |
9. | Receipt of an application for renewal of the period of validity under Article 48-5 (2) of the Act and notice of the results of renewal of the effective period under paragraph (4) of the same Article; |
10. | Payment of remedial benefits and payment of unpaid medical expenses under Articles 48-7 and 48-8 of the Act; |
11. | Support for review of the suspension of payment of remedial benefits under Article 48-9 of the Act; |
12. | Receipt of a request for re-examination and review of the details of such request pursuant to Article 48-13 of the Act; |
13. | Requests for medical examination, inspection, investigation, etc. under Article 48-17 of the Act; |
14. | Support for review of temporarily suspension of remedial benefits under Article 48-18 of the Act; |
15. | Receipt of notification of succession to the rights and obligations regarding the verification of daily use consumer chemical products subject to safety verification under Article 51 (2) of the Act; |
16. | Payment of monetary awards under Article 52-2 of the Act. |
(2) | Pursuant to Article 54 (2) of the Act, the Minister of Environment shall entrust the Korea Environment Corporation established under the Korea Environment Corporation Act with the affairs to secure and provide data to apply for approval of substances and to collect expenses thereof under Article 19 (5) of the Act. <Amended on Dec. 29, 2020> |
1. | Educational training and campaigns (limited to educational training and campaigns for persons who manufacture or import active substances and their employees) pursuant to Article 44 of the Act; |
2. | Support under Article 45 of the Act, which is specified in any of the following subparagraphs: |
(a) | Technical support for approval of substances; |
(b) | Technical support for recognition of technical equivalence under subparagraph 2 of Article 35; |
(c) | Support for preparation of data in cases of joint submission of data to apply for approval of substances under subparagraph 4 of Article 35. |
(4) | Pursuant to Article 54 (3) of the Act, the Minister of Environment shall entrust the affairs of requesting the submission of data under the former part of Article 48-3 (2) of the Act to a biocidal product damage investigation team. <Newly Inserted on Dec. 31, 2021> |
Article 39-2 (Affairs of Persons Appointed by Overseas Manufacturers) |
(1) | "Affairs prescribed by Presidential Decree" in Article 54-2 (1) 11 of the Act means the following: |
1. | Submission of a plan for applying for approval of substances under Article 19 (1) of the Act; |
2. | Separation submission of data to apply for approval of substances under the proviso of Article 19 (4) of the Act; |
3. | Consent to use data from the owner of relevant data under Article 32 (1) of the Act. |
(2) | "Matters prescribed by Presidential Decree, such as his or her appointment and the assigned affairs" in Article 54-2 (3) of the Act means the following: |
1. | The fact of appointment and assigned duties; |
2. | Results of performance of relevant affairs; |
3. | Other information on biocides, such as the name, use, hazard, and risk of the biocides. |
[This Article Newly Inserted on Dec. 29, 2020]
Article 39-3 (Processing of Sensitive Information and Personally Identifiable Information) |
1. | Administrative affairs related to making a decision on the payment of remedial benefits under Article 48-4 of the Act; |
2. | Administrative affairs related to the renewal of the effective period under Article 48-5 of the Act; |
3. | Administrative affairs related to the payment of remedial benefits under Article 48-7 of the Act; |
4. | Administrative affairs related to the payment of unpaid medical expenses under Article 48-8 of the Act; |
5. | Administrative affairs related to examination and decision on a request for re-examination under Article 48-13 of the Act. |
[This Article Newly Inserted on Dec. 31, 2021]
Article 39-4 (Re-Examination of Regulations) |
The Minister of Environment shall examine the appropriateness of the standards for designation of a testing and inspection institution referred to in Article 33 (1) every three years, counting from January 1, 2022 (referring to the period that ends on the day before the base date of every third year) and shall take measures, such as making improvements. [This Article Newly Inserted on Mar. 8, 2022]
CHAPTER VII PENALTY PROVISIONS
Article 40 (Criteria for Imposition of Administrative Fines) |
Criteria for the imposition of administrative fines prescribed in Article 60 (1) and (2) of the Act shall be as specified in attached Table 2. <Amended on Dec. 31, 2021>
ADDENDUM <Presidential Decree No. 29417, Dec. 24, 2018>
This Decree shall enter into force on January 1, 2019.
ADDENDA <Presidential Decree No. 31323, Dec. 29, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2021.
Article 2 (Applicability to Safety Standards for Treated Articles)
(1) | The amended provisions of item (c) of subparagraph 1 of Article 23 shall begin to apply to treated articles that are manufactured or imported after this Decree enters into force. |
Article 3 (Applicability to Persons Entitled to Monetary Awards)
The amended provisions of Article 37-2 and attached Table 1-2 shall also apply where a person who falls under any subparagraph of Article 52-2 (1) of the Act before this Decree enters into force is reported after this Decree enters into force.
ADDENDUM <Presidential Decree No. 32300, Dec. 31, 2021>
This Decree shall enter into force on December 31, 2021.
ADDENDUM <Presidential Decree No. 32528, Mar. 8, 2022>
This Decree shall enter into on the date of its promulgation.
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into on the date of its promulgation.
ADDENDUM <Presidential Decree No. 34386, Apr. 2, 2024>
This Decree shall enter into force on April 30, 2024.