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ENFORCEMENT RULE OF THE CONSUMER CHEMICAL PRODUCTS AND BIOCIDES SAFETY CONTROL ACT

Ordinance Of the Ministry of Environment No. 794, Dec. 28, 2018

Amended by Ordinance Of the Ministry of Environment No. 805, Apr. 17, 2019

Ordinance Of the Ministry of Environment No. 901, Dec. 31, 2020

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
The purpose of this Rule is to prescribe matters mandated by the Consumer Chemical Products and Biocides Safety Control Act and the Enforcement Decree of the same Act, and other matters necessary for the enforcement thereof.
 Article 2 (Composition and Operation of Specialized Committees)
(1) Under Article 6 (6) of the Consumer Chemical Products and Biocides Safety Control Act (hereinafter referred to as the “Act”), the following specialized committees shall be established under the Consumer Chemical Products and Biocides Control Committee (hereinafter referred to as the "Control Committee") prescribed in Article 6 (1) of the Act:
1. A specialized committee for the control of consumer chemical products subject to safety verification;
2. A specialized committee for the control of biocides;
3. A specialized committee for the deliberation on information disclosure.
(2) A specialized committee shall consist of up to 10 members, including one chairperson, in consideration of the gender.
(3) Members of a specialized committee shall be appointed or commissioned by the chairperson of the Control Committee, from among those with extensive knowledge of and experience in such relevant fields as chemistry, environment, and health; and its chairperson shall be appointed by the chairperson of the Control Committee, from among the members of such specialized committee.
(4) The chairperson of each specialized committee shall report to the Control Committee the matters examined and reviewed by the relevant specialized committee.
(5) Except as provided in paragraphs (1) through (4), matters necessary for the composition and operation of the specialized committees shall be determined by the chairperson of the Control Committee, following a resolution made by the Control Committee.
CHAPTER II CONTROL OF CONSUMER CHEMICAL PRODUCTS
 Article 3 (Procedures for Fact-Finding Surveys)
(1) A fact-finding survey prescribed in Article 7 (1) of the Act (hereinafter referred to as "fact-finding survey") shall be conducted by means of a paper-based survey and, where necessary, by electronic means such as an information and communications network or e-mail.
(2) In making a request for data submission or reporting for the purposes of fact-finding surveys under Article 7 (2) of the Act, the President of the Korea Environmental Industry and Technology Institute under the Korea Environmental Industry and Technology Institute Act (hereinafter referred to as the “President of the Korea Environmental Industry and Technology Institute”) shall notify the following matters to the targets of the survey:
1. The grounds for requesting data submission or reporting;
2. The deadline for data submission or reporting, the methods therefor, and the place therefor;
3. The details of a request for data submission or reporting;
4. The details of disciplinary action for refusal to submit data or make a report.
 Article 4 (Methods and Procedures for Risk Assessment)
(1) In conducting a risk assessment of a consumer chemical product under Article 8 (1) of the Act (hereinafter referred to as “risk assessment”), the President of the Korea Environmental Industry and Technology Institute shall formulate an annual assessment plan and comply therewith. In such cases, an order of priority of the products subject to risk assessment may be set in consideration of such factors as concerns over risks associated with the relevant consumer chemical product and an urgent need for assessment.
(2) The President of the Korea Environmental Industry and Technology Institute shall conduct a risk assessment in the following order: Provided, That changes may be made to such order, where necessary, in consideration of the level of technology, properties of risk factors, and others:
1. Verifying the hazards of chemical substances in consumer chemical products;
2. Setting the permissible levels of human and environmental exposure to chemical substances in consumer chemical products;
3. Assessing the amounts and levels of human and environmental exposure to chemical substances in consumer chemical products;
4. Determining the levels of the risks of consumer chemical products;
5. Setting the direction for safety standards under Article 9 (1) of the Act and the labeling standards under Article 10 (6) of the Act for the relevant consumer chemical products (limited to cases where it is deemed to pose a risk under subparagraph 4).
(3) When conducting a risk assessment, the President of the Korea Environmental Industry and Technology Institute shall take the following into consideration:
1. Whether the product contains any of the following chemical substances and, if any, information on the relevant chemical substance:
(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) A chemical substance registered or reported under Article 10 of the Act on Registration and Evaluation of Chemical Substances;
(c) An active substance;
2. The findings from domestic and international research conducted on the hazards and risks of consumer chemical products and chemical substances therein.
(4) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 8 (5) of the Act means the following:
1. The name or trade name of the manufacturer or importer of the relevant product, and the location of the manufacturing facilities;
2. The names of the following chemical substances used in the relevant product:
(a) A hazardous chemical substance defined in subparagraph 10 of Article 2 of the Act on Registration and Evaluation of Chemical Substances;
(b) A substance subject to intensive control;
(c) An active substance;
3. Other matters determined and publicly notified by the Minister of Environment for the risk management for consumer chemical products.
(5) Once a risk assessment is complete, the President of the Korea Environmental Industry and Technology Institute shall prepare a report on the findings thereof and report the same to the Minister of Environment.
(6) Except as provided in paragraphs (1) through (5), matters necessary for guidelines and procedures for a risk assessment and others shall be determined and publicly notified by the President of the National Institute of Environmental Research.
 Article 5 (Verification of Consumer Chemical Products Subject to Safety Verification)
(1) "An application for verification of the consumer chemical product subject to safety verification in the Form prescribed by Ordinance of the Ministry of Environment and supporting documents" in Article 5 (1) of the Enforcement Decree of the Consumer Chemical Products and Biocides Safety Control Act (hereinafter referred to as the “Decree”) means an application for verification of a consumer chemical product subject to safety verification in attached Form 1 and the following documents:
1. Documents on product information, such as photographs and manuals of the product;
2. Documents on the ingredients, composition ratio, and uses of the chemical substances determined and publicly notified by the Minister of Environment, from among the chemical substances in the product;
3. Documents evidencing that a container has passed an inspection under Article 17 of the High-Pressure Gas Safety Control Act (limited to spray-type products using high-pressure gas);
4. Documents evidencing that the safety standards for a container or package for child protection are satisfied under Article 9 (2) 3 of the Act (limited to products required to use a container or package for child protection);
5. Documents evidencing outsourcing such as a copy of the outsourcing contract, where the manufacture of a consumer chemical product subject to safety verification is outsourced;
6. A copy of the corporate registration certificate or the business registration certificate;
7. A copy of the results of verification of a consumer chemical product subject to safety verification (limited to cases where an application for verification is filed under Article 10 (3) of the Act).
(2) Where a testing and inspection institution designated under Article 41 (1) of the Act (hereinafter referred to as "testing and inspection institution") determines whether the relevant product meets the safety standards under Article 5 (2) of the Decree, such institution shall provide the applicant with the results of verification of a consumer chemical product subject to safety verification in attached Form 2 and shall notify the President of the Korea Environmental Industry and Technology Institute of the verification results within 10 days from the completion of such testing and inspection. <Amended on Dec. 31, 2020>
(3) "Matters prescribed by Ordinance of the Ministry of Environment, including product information, ingredients, or content" in Article 10 (4) of the Act means the following: <Amended on Dec. 31, 2020>
1. The name or trade name, address, and contact information of a person who intends to manufacture or import a consumer chemical product subject to safety verification;
1-2. The name or trade name, address, and contact information of the outsourcee, where the manufacture of a consumer chemical product subject to safety verification is outsourced;
2. Product name, dosage form, weight, volume, and number of sheets;
3. Product information, such as photographs and manuals of the product;
4. Ingredients, composition ratio, and uses of all substances contained in the product (hereinafter referred to as "substances contained");
5. A sample of a consumer chemical product subject to safety verification, which indicates all the information listed in the subparagraphs of Article 10 (8) of the Act;
6. Effectiveness and efficacy of a consumer chemical product subject to safety verification (limited to cases where it is intended to state, indicate or advertise the effectiveness and efficacy of an active substance contained in a consumer chemical product subject to safety verification).
(4) “Report on verification of compliance with the safety standards in the form specified by Ordinance of the Ministry of Environment and supporting documents” in Article 5 (3) of the Decree means a report on verification of compliance with the safety standards in attached Form 3 and the following documents: <Amended on Dec. 31, 2020>
1. A copy of the results of verification of a consumer chemical product subject to safety verification;
2. Documents on product information, such as photographs and manuals of the product;
3. Documents on the ingredients, composition ratio, and uses of substances contained;
4. A sample of a consumer chemical product subject to safety verification, which indicates all the information listed in the subparagraphs of Article 10 (8) of the Act;
5. Documents evidencing the effectiveness and efficacy of a consumer chemical product subject to safety verification under subparagraph 6 of paragraph (3) (limited to cases where it is intended to report the matters under subparagraph 6 of paragraph (3)).
(5) The President of the Korea Environmental Industry and Technology Institute shall issue to the applicant a certificate of a report on verification of compliance with the safety standards in attached Form 4, within 25 days from the receipt of an application under Article 5 (3) of the Decree. In such cases, if the data submitted require any correction or supplementation, the relevant applicant may be requested to make necessary correction or supplementation, and the time required therefor shall not be included in the period referred to in the former part. <Amended on Dec. 31, 2020>
(6) A person who intends to report any changes under Article 5 (4) of the Decree shall file with the President of the Korea Environmental Industry and Technology Institute a report on changes for verification of compliance with the safety standards in attached Form 3, accompanied by the following documents. In such cases, the President of the Korea Environmental Industry and Technology Institute shall return the report to the person after noting the changes made on the back of the certificate of the report on verification of compliance with the safety standards:
1. A certificate of the report on verification of compliance with the safety standards;
2. Documents evidencing the changes.
(7) The scope and preparation methods of the documents under paragraph (1) 1 through 4 and paragraph (4) 2 through 5 shall be determined and publicly notified by the Minister of Environment. <Amended on Dec. 31, 2020>
(8) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 10 (5) of the Act means the following: <Newly Inserted on Dec. 31, 2020>
1. Matters prescribed in paragraph (3) 1 and 1-2;
2. Matters prescribed in paragraph (3) 2 through 4 (limited to cases where changes are made to the matters not included in the safety standards under Article 9 of the Act).
 Article 6 (Approval of Consumer Chemical Products Subject to Safety Verification)
(1) "An application for approval of the consumer chemical product subject to safety verification in the form prescribed by Ordinance of the Ministry of Environment" in Article 6 (1) of the Decree means an application for approval of a consumer chemical product subject to safety verification in attached Form 5.
(2) "Documents prescribed by Ordinance of the Ministry of Environment" in Article 6 (1) of the Decree means the following documents:
1. Ingredients, composition ratio, and uses of the substances contained;
2. Manufacturer (including the outsourcee in the case of outsourced manufacturing) of the substances contained in the relevant consumer chemical product subject to safety verification responsible for its main functions (hereinafter referred to as "active ingredients”) and methods for manufacturing the product;
3. Validity of the consumer chemical product subject to safety verification, in terms of its effectiveness and efficacy;
4. Safety of the consumer chemical product subject to safety verification and its active ingredients;
5. Risks of the consumer chemical product subject to safety verification, including exposure information such as the channels and types of such exposure;
6. Methods and standards for testing and inspection to ensure quality control of the relevant consumer chemical product subject to safety verification and substances contained therein, and the results of such testing and inspection;
7. Usage and dosage of the relevant consumer chemical product subject to safety verification and precautions to take when using the product;
8. Emergency measures to take in the event of explosion of, fire to, or exposure to the relevant consumer chemical product subject to safety verification.
(3) A public official-in-charge who has received an application for approval of a consumer chemical product subject to safety verification under Article 10 (6) of the Act and Article 6 (1) of the Decree shall verify the applicant’s corporate registration certificate 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 such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(4) "Matters prescribed by Ordinance of the Ministry of Environment" in the main clause of Article 10 (7) of the Act means the following:
1. The names, composition ratio, and uses of the substances contained other than the active ingredients;
2. Matters falling under any of subparagraphs 2 through 8 of paragraph (2);
3. Product name, dosage form, weight, dosage, and number of sheets, as well as the location of the facilities for manufacturing and storage thereof.
(5) "Minor matters prescribed by Ordinance of the Ministry of Environment, such as name or trade name, address, and contact information" in the proviso of Article 10 (7) of the Act means any of the following:
1. The name or trade name of a person who has obtained approval, and address and contact information of the representative;
2. Simple misunderstanding, misspelling, omission or apparent errors equivalent thereto.
(6) "Application for approval for changes prescribed by Ordinance of the Ministry of Environment" in Article 6 (2) of the Decree means an application for approval for changes to a consumer chemical product subject to safety verification in attached Form 5-2.
(7) "Documents prescribed by Ordinance of the Ministry of Environment" in Article 6 (2) of the Decree means the following:
1. A notice of approval of a consumer chemical product subject to safety verification in attached Form 7;
2. Documents evidencing the changes.
(8) Where the data submitted under Article 6 (3) of the Decree require any correction or supplementation, the President of the National Institute of Environmental Research shall request the applicant to make necessary correction or supplementation in accordance with a request for correction or supplementation in attached Form 6.
(9) Once the President of the National Institute of Environmental Research has granted approval of a consumer chemical product subject to safety verification under Article 6 (4) of the Decree, he or she shall send to the applicant a notice of approval of a consumer chemical product subject to safety verification in attached Form 7.
(10) Once the President of the National Institute of Environmental Research has granted approval for changes to a consumer chemical product subject to safety verification under Article 6 (4) of the Decree, he or she shall return to the applicant a notice of approval of a consumer chemical product subject to safety verification in attached Form 7 after noting the details of approval for changes on the back of the notice.
(11) "Report on changes to an approved consumer chemical product subject to safety verification prescribed by Ordinance of the Ministry of Environment" in Article 6 (5) of the Decree means a report on changes to an approved consumer chemical product subject to safety verification in attached Form 5-3.
(12) "Documents prescribed by Ordinance of the Ministry of Environment" in Article 6 (5) of the Decree means the following:
1. A notice of approval of a consumer chemical product subject to safety verification in attached Form 7;
2. Documents evidencing the changes.
(13) The President of the National Institute of Environmental Research shall examine the changes reported within 10 days from the receipt of a report on changes under Article 6 (5) of the Decree, and shall return such report to the applicant after noting the changes on the back of the notice of approval of a consumer chemical product subject to safety verification in attached Form 7.
[This Article Wholly Amended on Dec. 31, 2020]
 Article 7 (Labeling Standards for Consumer Chemical Products Subject to Safety Verification)
(1) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 10 (8) 3 of the Act means the names of hazardous chemical substances, substances subject to intensive control, and active substances used in the relevant product. <Amended on Dec. 31, 2020>
(2) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 10 (8) 8 of the Act means the following matters: <Amended on Dec. 31, 2020>
1. The date of manufacture;
2. Labeling which shows that the product uses a container or package for the protection of children (limited to products subject to compliance with the safety standards for containers or packages designed to protect children under Article 9 (2) 3 of the Act);
3. Report number or approval number for verification of compliance with the safety standards;
4. Other matters to be included in the labeling as determined and publicly notified by the Minister of Environment in consideration of the characteristics of individual consumer chemical products subject to safety verification.
 Article 7-2 (Disclosure of Information on Consumer Chemical Products Subject to Safety Verification)
(1) The President of the National Institute of Environmental Research and the President of the Korea Environmental Industry and Technology Institute shall disclose information on consumer chemical products subject to safety verification under Article 10-2 (1) of the Act by posting such information on the information network under Article 47 (2) of the Act.
(2) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 10-2 (1) 4 of the Act means matters publicly notified by the Minister of Environment, from among those to be included in the product labeling such as the names of hazardous chemical substances, substances subject to intensive control, and active substances used in the relevant product.
[This Article Newly Inserted on Dec. 31, 2020]
CHAPTER III SAFETY CONTROL FOR BIOCIDES
 Article 8 (Active Substances Subject to Separate Period of Validity for Approval of Substances)
“An active substance prescribed by Ordinance of the Ministry of Environment such as a substance which causes respiratory sensitization” in Article 12 (4) 2 of the Act means any of the following active substances:
1. An active substance which causes respiratory sensitization;
2. An active substance with at least two of such features as persistence, bioaccumulation, and toxicity.
 Article 9 (Data to Apply for Approval of Substance)
(1) The types of biocidal products under Article 13 (1) 3 of the Act (hereinafter referred to as “biocidal product type”) shall be as specified in attached Table 1.
(2) "An application for approval of an active substance in the form prescribed by Ordinance of the Ministry of Environment" in the main clause, with the exception of the subparagraphs, of Article 10 (2) of the Decree means an application for approval of an active substance in attached Form 8.
(3) The scope and preparation methods of the data to accompany an application for approval of a substance under the subparagraphs of Article 13 (1) of the Act (hereinafter referred to as “data to apply for approval of a substance”) shall be determined and publicly notified by the President of the National Institute of Environmental Research. <Amended on Dec. 31, 2020>
 Article 10 (Procedures for Approval of Substance)
(1) In accordance with Article 10 (2) of the Decree, a public official-in-charge who has received an application for approval under the main clause, with the exception of the subparagraphs, of Article 12 (1) of the Act (hereinafter referred to as "approval of a substance") shall verify the applicant’s corporate registration certificate or business registration certificate through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where a person who has applied for approval of a substance (hereinafter referred to as "applicant for approval of a substance") does not consent to such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(2) The President of the National Institute of Environmental Research shall confirm whether the data to apply for approval of the substance have been prepared appropriately within 30 days from the receipt of an application for approval of a substance; and shall send to the applicant for approval of a substance a notice of the commencement of evaluation for granting approval of a substance in attached Form 9.
(3) Where the data to apply for approval of a substance submitted require any supplementation under the latter part of Article 14 (1) of the Act, the President of the National Institute of Environmental Research shall request the applicant for approval of a substance to make supplementation in accordance with a request for correction or supplementation in attached Form 6. In such cases, the time required for supplementation shall not be included in the period referred to in paragraph (2) or (4). <Amended on Dec. 31, 2020>
(4) The President of the National Institute of Environmental Research shall prepare a draft assessment report for approval of a substance within any of the periods as classified in the following subparagraphs, counting from the date the applicant for approval of a substance is notified of the commencement of evaluation for granting approval of a substance under paragraph (2):
1. Where an application for approval of a substance is filed under Article 13 (1) of the Act: One year;
2. Where an application for approval of a substance is filed under Article 13 (3) of the Act: Six months.
(5) Once the President of the National Institute of Environmental Research has completed a draft assessment report for approval of a substance under paragraph (4), he or she shall inform the applicant of the period and place for perusal under the former part of Article 14 (3) of the Act.
(6) Where the applicant for approval of a substance intends to request the extension of a period for submitting opinions under the latter part of Article 14 (3) of the Act, he or she shall prepare an application for the extension of a period for submitting opinions in attached Form 10 and shall submit it to the President of the National Institute of Environmental Research seven days prior to the expiration of the period for perusal specified in the former part of the same paragraph. In such cases, a request may be made to have the period for submitting opinions extended once by up to 30 days.
(7) Where the period for submitting opinions is extended under the latter part of Article 14 (3) of the Act, the President of the National Institute of Environmental Research shall notify the applicant for approval of a substance by providing a notice of extension of the period for submitting opinions in attached Form 11.
(8) Where the period for determining whether to grant approval of a substance is extended under Article 14 (5) of the Act, the President of the National Institute of Environmental Research shall notify the applicant for approval of a substance by providing a notice of extension of the period for deciding on the approval of a substance in attached Form 12.
(9) Where the President of the National Institute of Environmental Research decides to grant approval of a substance, he or she shall issue a notice of approval of an active substance in attached Form 13 to the applicant for approval of a substance under Article 14 (6) of the Act.
 Article 11 (Approval for Changes to Approved Substance)
(1) A person who intends to obtain approval for changes to an approved substance under the main clause of Article 15 of the Act shall submit to the President of the National Institute of Environmental Research an application for approval for changes to an approved substance in attached Form 14, accompanied by the following documents: <Amended on Dec. 31, 2020>
1. Documents evidencing the changes;
2. The notice of approval of an active substance.
(2) The President of the National Institute of Environmental Research shall note the approved changes on the back of the notice of approval of an active substance and return it to the applicant within 90 days from the receipt of the application for approval for changes to an approved substance under paragraph (1): Provided, That the period prescribed in the main clause may be extended once by up to 90 days where the changes are made to the matters referred to in subparagraph 7 of Article 12 of the Decree.
(3) Where the data submitted under paragraph (1) require any supplementation, the President of the National Institute of Environmental Research shall request the applicant to make supplementation in accordance with a request for correction or supplementation in attached Form 6. In such cases, the time required for supplementation shall not be included be in the period referred to in the main clause of paragraph (2). <Amended on Dec. 31, 2020>
 Article 12 (Report on Changes to Approved Substances)
(1) A person who intends to file a report on changes to an approved substance under the proviso of Article 15 of the Act shall submit to the President of the National Institute of Environmental Research a report on changes to an approved substance in attached Form 15, accompanied by the following documents:
1. Documents evidencing the changes;
2. The notice of approval of an active substance.
(2) The President of the National Institute of Environmental Research shall note the reported changes on the back of the notice of approval of an active substance and return it to the applicant within 10 days from the receipt of such report on changes to an approved substance under paragraph (1).
 Article 13 (Procedures and Methods for Recognizing Technical Equivalence)
(1) “Application for recognition of technical equivalence in the form prescribed by Ordinance of the Ministry of Environment” in the part other than the subparagraphs of Article 13 (1) of the Decree means an application for recognition of technical equivalence in attached Form 16.
(2) A public official-in-charge who has received an application for recognition of technical equivalence under the former part of Article 16 (1) of the Act and Article 13 (1) of the Decree shall verify the applicant’s corporate registration certificate 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 such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(3) The President of the National Institute of Environmental Research shall determine whether to grant recognition of technical equivalence and notify the applicant by providing a notice of recognition of technical equivalence in attached Form 17 within 180 days from the receipt of an application for recognition of technical equivalence: Provided, That such period may be extended by up to 60 days (excluding the time required for additional data submission) where a request for additional data is made under Article 13 (2) of the Decree.
(4) Where the data submitted under Article 16 (1) of the Act require any supplementation, the President of the National Institute of Environmental Research shall request the applicant to make supplementation in accordance with a request for correction or supplementation in attached Form 6 under the latter part of Article 16 (2) of the Act. In such cases, the time required for supplementation shall not be included in the period referred to in the main clause of paragraph (3). <Amended on Dec. 31, 2020>
(5) Matters regarding the scope and preparation methods of the data to apply for recognition of technical equivalence under the subparagraphs of Article 13 (1) of the Decree shall be determined and publicly notified by the President of the National Institute of Environmental Research. <Amended on Dec. 31, 2020>
 Article 14 (Report on Existing Active Substances)
(2) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 18 (2) 4 of the Act means any of the following:
1. A range of purity of existing active substances according to Article 18 (1), with the exception of the subparagraphs, of the Act (hereinafter referred to as “existing active substance”);
2. The specific uses of existing active substances;
3. Deleted. <Dec. 31, 2020>
(2) A person who intends to file a report on the manufacturing or import of an existing active substance under Article 18 (2) of the Act shall submit to the President of the National Institute of Environmental Research a report on manufacturing or import of an existing active substance in attached Form 18, accompanied by the following documents: <Amended on Dec. 31, 2020>
1. Documents evidencing outsourcing, such as a copy of the outsourcing contract, where a report is filed by a person who has outsourced the manufacturing of an existing active substance;
2. A certificate of a report on appointment by an overseas manufacturer in attached Form 49, where a report is filed by a person who manufactures, or intends to manufacture, an active substance imported to the Republic of Korea under Article 54-2 of the Act (hereinafter referred to as "overseas manufacturer").
(3) A public official-in-charge who has received a report under paragraph (2) shall verify the corporate registration certificate or the business registration certificate through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where the person who filed a report does not consent to such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(4) Where the data submitted under paragraph (2) require any supplementation, the President of the National Institute of Environmental Research shall request the person who filed a report to make supplementation in accordance with a request for correction or supplementation in attached Form 6. <Amended on Dec. 31, 2020>
 Article 15 (Submission of Plan for Applying for Approval of Substance)
(1) A person who intends to submit a plan for applying for approval of a substance under Article 19 (1) of the Act shall submit to the President of the National Institute of Environmental Research an application therefor in attached Form 18-2, accompanied by the following documents: <Amended on Dec. 31, 2020>
1. A specific schedule and methods for preparing data to apply for approval of a substance under the subparagraphs of Article 13 (1) of the Act;
2. Documents evidencing outsourcing, such as a copy of the outsourcing contract, where an application is filed by a person who outsources the manufacturing of the existing active substance;
3. A certificate of a report on the appointment by an overseas manufacturer in attached Form 49, where an application is filed by a person appointed by an overseas manufacturer.
(2) Persons required to jointly submit data to apply for approval of a substance under the main clause, with the exception of the subparagraphs, of Article 19 (4) of the Act shall select a representative by mutual agreement of the parties involved.
(3) The representative selected under paragraph (2) (hereafter in this Article referred to as "representative") shall perform the following business affairs upon consultation with the relevant parties who jointly submit data to apply for approval of a substance: <Amended on Dec. 31, 2020>
1. Business affairs regarding the selection and production of data to be jointly submitted;
2. Business affairs regarding the sharing of expenses required for such joint submission;
3. Other business affairs regarding joint preparation and submission of the data to apply for approval of a substance.
(4) Where an agreement on the sharing of expenses under paragraph (3) 2 is not reached between the parties required to jointly submit the data to apply for approval of a substance, the expenses shall be split in consideration of the respective quantities of an active substance manufactured or imported by the individual parties.
(5) The representative shall submit data to apply for approval of a substance before those required to jointly submit such data individually apply for approval of a substance. <Amended on Dec. 31, 2020>
(6) The Minister of Environment may provide support in the matters necessary for executing the agreement of the parties under paragraph (3).
 Article 16 (Joint Submission of Data to Apply for Approval of Substance)
"Data prescribed by Ordinance of the Ministry of Environment" in the main clause, with the exception of the subparagraphs, of Article 19 (4) of the Act means the following data: <Amended on Dec. 31, 2020>
1. The data according to the following classification:
(a) Where a plan for applying for approval of a substance is filed for an existing active substance subject to approval deferment, with the identical name, chemical composition, and a biocidal product type in which an active substance may be used: Data listed in subparagraphs 2 through 5 and 7 of Article 13 (1) of the Act (excluding data on raw materials used in manufacturing and the process thereof; hereafter in this Article the same shall apply);
(b) Where a plan for applying for approval of a substance is filed for an existing active substance subject to approval deferment, with the identical name and chemical composition: Data listed in Article 13 (1) 2, 4 (a), (c), (limited to information on hazards) and (e), 5, and 7 of the Act;
2. The data listed in Article 10 (1) 2 and 3 of the Decree.
 Article 17 (Confirmation of Separate Submission of Data to Apply for Approval of Substance)
(1) A person who intends to separately submit data to apply for approval of a substance under the proviso, with the exception of the subparagraphs, of Article 19 (4) of the Act shall file with the President of the National Institute of Environmental Research an application for confirmation of separate submission of data to apply for approval of a substance in attached Form 19, accompanied by the following documents: <Amended on Dec. 31, 2020>
1. Documents evidencing that the case falls under the grounds for separate submission specified in the subparagraphs of Article 19 (4) of the Act;
2. Documents evidencing outsourcing, such as a copy of the outsourcing contract, where an application is filed by a person who outsources the manufacturing of an active substance;
3. A certificate of a report on the appointment by an overseas manufacturer in attached Form 49, where an application is filed by a person appointed by an overseas manufacturer.
(2) The President of the National Institute of Environmental Research shall notify the applicant by providing a confirmation of separate submission of data in attached Form 20 to apply for approval of a substance within 14 days from the receipt of such application under paragraph (1).
 Article 18 (Provision of Data to Apply for Approval of Substance)
(1) “Data prescribed by Ordinance of the Ministry of Environment” in the former part of Article 19 (5) of the Act means the following:
1. Data on the physical, chemical, or biological properties of an active substance;
2. Data on the information about the hazards and risks of an active substance as to the human body, animals and the environment.
(2) A person provided with the data to apply for approval of a substance under the former part of Article 19 (5) of the Act shall pay the amount, not exceeding the actual expenses incurred, as determined by the CEO of Korea Environment Corporation under the Korea Environment Corporation Act (hereinafter referred to as "Korea Environment Corporation”) upon considering the expenses incurred in securing such data to apply for approval of a substance (hereafter in this Article referred to as “cost for provision of the data”). In such cases, where the person provided with the data to apply for approval of a substance is a small or medium enterprise under Article 2 of the Framework Act on Small and Medium Enterprises, a full or partial discount of the cost for provision of the data may be given. <Amended on Dec. 31, 2020>
(3) Except as provided in paragraphs (1) and (2), matters regarding the procedures for providing the data to apply for approval of a substance, calculation of the amount for provision of the data, and others shall be determined and publicly notified by the Minister of Environment. <Amended on Dec. 31, 2020>
 Article 19 (Safety Standards for Containers and Package for Biocidal Products)
“Standards prescribed by Ordinance of the Ministry of Environment” in Article 20 (2) 6 of the Act shall be as follows:
1. The contents shall not leak out;
2. It shall not be easily damaged due to its contents; neither shall it produce any hazardous chemical compound in response to its contents;
3. It shall not be deformed due to normal use;
4. It shall prevent any safety accident to those vulnerable to the exposure to chemical substances generated by the product in question, such as children and pregnant women;
5. It shall comply with the safety standards for containers and packages determined and publicly notified by the Minister of Environment.
 Article 20 Deleted. <Dec. 31, 2020>
 Article 21 (Procedures for Approval of Product)
(1) “An application for approval of a biocidal product in the form prescribed by Ordinance of the Ministry of Environment” in Article 18 (2), with the exception of the subparagraphs, of the Decree means an application for approval of a biocidal product in attached Form 21.
(2) In accordance with Article 18 (2) of the Decree, a public official-in-charge who has received an application for approval under the main clause, with the exception of the subparagraphs, of Article 20 (1) of the Act (hereinafter referred to as “approval of a product”) shall verify the applicant's corporate registration certificate or business registration certificate through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where the person who has applied for approval of a product (hereinafter referred to as “applicant for approval of a product”) does not consent to such verification of the business registration certificate, the applicant shall have the relevant document attached thereto.
(3) The President of the National Institute of Environmental Research shall verify whether the data to apply for approval of a product under the subparagraphs of Article 21 (1) of the Act (hereinafter referred to as “data to apply for approval of a product”) are properly prepared within 30 days from the receipt of an application for approval of a product, and shall notify the applicant by providing a notice of commencement of assessment for product approval in attached Form 22.
(4) Where the data to apply for approval of a product require any supplementation, the President of the National Institute of Environmental Research shall request the applicant for approval of a product to make supplementation in accordance with a request for correction or supplementation in attached Form 6, under the latter part of Article 22 (1) of the Act. In such cases, the time required for supplementation shall not be included in the period referred to in paragraphs (3) or (5). <Amended on Dec. 31, 2020>
(5) The President of the National Institute of Environmental Research shall prepare a draft assessment report for approval of a product within any of the periods as classified in the following subparagraphs, counting from the date a notice of commencement of assessment for product approval is given in accordance with paragraph (3): Provided, That where the applicant for approval of a product also files an application for approval of a substance, either of the following periods may be added to the period specified in Article 10 (4) 1:
1. Where an application for approval of a product is filed under Article 21 (1) of the Act: Six months;
2. Where an application for approval of a product is filed under Article 21 (3) of the Act: Four months.
(6) Once a draft assessment report for approval of a product is complete under paragraph (5), the President of the National Institute of Environmental Research shall inform the applicant of the period and place for perusal under the former part of Article 22 (3) of the Act.
(7) If the applicant for approval of a product intends to request the extension of the period for submitting opinions under the latter part of Article 22 (3) of the Act, he or she shall prepare an application for the extension of the period for submitting opinions in attached Form 10 and shall submit it to the President of the National Institute of Environmental Research seven days prior to the expiration of the period for perusal under the former part of that paragraph. In such cases, a request may be made to have the period for submitting opinions extended once by up to 30 days.
(8) Where the period for submitting opinions is extended under the latter part of Article 22 (3) of the Act, the President of the National Institute of Environmental Research shall notify the applicant for approval of a product by providing a notice of extension of the period for submitting opinions in attached Form 11.
(9) Where the period for decision on approval of a product is extended under the latter part of Article 22 (5) of the Act, the President of the National Institute of Environmental Research shall notify the applicant for approval of a product by providing a notice of extension of the period for decision on approval of a product in attached Form 23.
(10) Where the President of the National Institute of Environmental Research decides to approve a product, he or she shall issue to the applicant for approval of a product a notice of approval of a biocidal product in attached Form 24 under Article 22 (6) of the Act.
(11) Matters regarding the scope and preparation methods of the data to apply for a product shall be determined and publicly notified by the President of the National Institute of Environmental Research. <Amended on Dec. 31, 2020>
 Article 22 (Approval for Changes to Approved Product)
(1) A person who intends to obtain approval for changes to an approved product under the main clause of Article 23 of the Act shall submit to the President of the National Institute of Environmental Research an application for approval for changes to an approved product in attached Form 25, accompanied by the following documents:
1. Documents evidencing the changes;
2. A notice of approval of a biocidal product.
(2) The President of the National Institute of Environmental Research shall note the changes on the back of the notice of approval of a biocidal product and return it to the applicant within 90 days from the receipt of the application for approval for changes to an approved product under paragraph (1): Provided, That the period prescribed in the main clause may be extended once by up to 90 days where the changes are made to the biocidal product type.
(3) Where the data submitted under paragraph (1) require any supplementation, the President of the National Institute of Environmental Research shall request the applicant to make supplementation in accordance with a request for correction or supplementation in attached Form 6. In such cases, the time required for supplementation shall not be included in the period referred to in the main clause of paragraph (2). <Amended on Dec. 31, 2020>
 Article 23 (Report on Changes to Approved Product)
(1) A person who intends to file a report on changes to an approved product under the proviso of Article 23 of the Act shall submit to the President of the National Institute of Environmental Research a report on changes to an approved product in attached Form 15, accompanied by the following documents:
1. Documents evidencing the changes;
2. A notice of approval of a biocidal product.
(2) The President of the National Institute of Environmental Research shall note the reported changes on the back of the notice of approval of a biocidal product and return it to the applicant within 10 days from the receipt of such report on changes to an approved product under paragraph (1).
 Article 24 (Special Cases regarding Product Approval)
(1) "Substance prescribed by Ordinance of the Ministry of Environment" in Article 24 (1) 2 (c) of the Act means hazardous chemicals or persistent pollutants defined in subparagraph 1 of Article 2 of the Persistent Pollutants Control Act. <Amended on Apr. 17, 2019>
(2) A person who intends to obtain approval of a product under Article 24 (2) of the Act shall submit to the President of the National Institute of Environmental Research an application for special case approval of a product in attached Form 26, accompanied by the data listed in the subparagraphs of Article 24 (2) of the Act.
(3) A public official-in-charge who has received an application for special case approval of a product under paragraph (2) shall verify the applicant's corporate registration certificate 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 such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(4) The President of the National Institute of Environmental Research shall determine whether to grant approval of a product within 90 days from the receipt of an application therefor under paragraph (2) and shall notify the applicant by providing a notice of approval of a biocidal product in attached Form 24.
(5) Where the data submitted under paragraph (2) require any supplementation, the President of the National Institute of Environmental Research shall request the applicant to make supplementation in accordance with a request for correction or supplementation in attached Form 6. In such cases, the time required for supplementation shall not be included in the period referred to in paragraph (4). <Amended on Dec. 31, 2020>
(6) Where the head of a relevant central administrative agency intends to request a temporary approval exemption for the biocidal product in question and an active substance therein under Article 24 (4) of the Act, he or she shall submit the following data to the President of the National Institute of Environmental Research: <Newly Inserted on Dec. 31, 2020>
1. The data on the following information on the relevant biocidal product:
(a) The name of the product and its biocidal product type;
(b) The name or trade name, address, and contact information of the manufacturer or importer;
2. The data on the following information on the active substance in the relevant biocidal product:
(a) Composition, the purpose of use, and uses;
(b) Effectiveness and efficacy;
3. Data on the grounds for an urgent need of public health, etc. and the minimum period for such urgent use;
4. Data showing that there is no substitute for the product;
5. The data necessary for a risk assessment of the relevant biocidal product including:
(a) Samples of the product;
(b) Information on exposure;
(c) Other data determined and publicly notified by the President of the National Institute of Environmental Research.
(7) Upon receipt of the data under paragraph (6), the President of the National Institute of Environmental Research shall examine the necessity of a temporary approval exemption, determine whether to grant exemption, and notify the head of the relevant central administrative agency of the results thereof. <Newly Inserted on Dec. 31, 2020>
 Article 25 (Recognition Procedures and Methods for Product Similarity)
(1) “An application for recognition of product similarity in the form prescribed by Ordinance of the Ministry of Environment” in Article 22 (1), with the exception of the subparagraphs, of the Decree means an application for recognition of product similarity in attached Form 27.
(2) A public official-in-charge who has received an application for recognition of product similarity under the former part of Article 25 (1) of the Act and Article 22 (1) of the Decree shall verify the applicant’s corporate registration certificate 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 such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(3) The President of the National Institute of Environmental Research shall determine whether to recognize product similarity and notify the applicant by providing a notice of recognition of product similarity in attached Form 28, within 90 days from the receipt of an application for recognition of product similarity.
(4) Where the data submitted under paragraph (1) of that Article require any supplementation, the President of the National Institute of Environmental Research shall request the applicant to make supplementation in accordance with a written request for correction and supplementation in attached Form 6 under the latter part of Article 25 (2) of the Act. In such cases, the time required for supplementation shall not be included in the period referred to in paragraph (3). <Amended on Dec. 31, 2020>
(5) Matters regarding the scope and preparation methods of the data to apply for recognition of product similarity under the subparagraphs of Article 22 (1) of the Decree shall be determined and publicly notified by the President of the National Institute of Environmental Research. <Amended on Dec. 31, 2020>
 Article 26 (Labeling of Biocidal Products)
(1) Labeling information required to appear on the surface of a biocidal product under Article 27 of the Act shall be displayed in a spot making such information more visible than other letters or graphics in an easily understandable and clear manner, in compliance with the following standards:
1. The labeling shall be in Korean characters; and where they are accompanied by Chinese or other foreign characters, the Korean font sizes shall be larger than those of such Chinese or other foreign characters;
2. The labeling shall be made in colors distinguishable from the background color (excluding the cases of engraving or stamping);
3. The labeling shall not be erasable or removable.
(2) "Matters prescribed by Ordinance of the Ministry of Environment" in subparagraph 6 of Article 27 of the Act means the following:
1. The name of the biocidal product and its type;
2. Weight or dosage;
3. An approval number for the biocidal product;
4. Hazards of the biocidal product;
5. Effectiveness and efficacy of the biocidal product;
6. The standard volume of consumption of the biocidal product, the methods of use, and precautions for the use;
7. The names of the hazardous chemical substances or substances subject to intensive control contained in the biocidal product.
(3) Except as provided in paragraphs (1) and (2), matters regarding labeling of biocidal products shall be determined and publicly notified by the Minister of Environment.
 Article 27 (Labeling Standards for Treated Articles)
Labeling information required to appear on the surface of a treated article under Article 28 (2) of the Act shall be displayed in a spot making such information more visible than other letters or graphics in an easily understandable and clear manner, in compliance with the following standards:
1. The labeling shall be in Korean characters; and where they are accompanied by Chinese or other foreign characters, the Korean font sizes shall be larger than those of such Chinese or other foreign characters;
2. The labeling shall be made in colors distinguishable from the background color (excluding the cases of engraving or stamping);
3. The labeling shall not be erasable or removable;
4. The labeling shall not use any expression that might mislead readers to mistaken a treated article for a biocidal product.
 Article 28 (Disclosure of Information on Active Substances and Biocidal Products)
(1) “Matters prescribed by Ordinance of the Ministry of Environment” in Article 29 (1) 5 of the Act means the following:
1. The physical, chemical, or biological properties of an active substance;
2. The classification and labeling of an active substance.
(2) “Matters prescribed by Ordinance of the Ministry of Environment” in Article 29 (2) 5 of the Act means the following:
1. The biocidal product type;
2. The ingredients and composition ratio of all the active substances contained in the biocidal product;
3. The names of the hazardous chemical substances or substances subject to intensive control contained in a biocidal product;
4. The physical, chemical, or biological properties of a biocidal product;
5. Effectiveness and efficacy of a biocidal product;
6. Classification, labeling, and package of a biocidal product;
7. Matters regarding the safe use of a biocidal product, such as the methods of use and precautions for the use.
(3) The President of the National Institute of Environmental Research shall disclose information referred to in the subparagraphs of Article 29 (1) and (2) of the Act by posting them on the website of the National Environmental Science Institute or by other means.
 Article 29 (Provision of Information on Treated Articles)
(1) "A request for provision or perusal of information in the form prescribed by Ordinance of Ministry of Environment” in Article 24 (1) of the Decree means a request for provision or perusal of information in attached Form 29.
(2) "A notice of decision on information request in the form prescribed by Ordinance of Ministry of Environment” in Article 24 (2) and (3) of the Decree both means a notice of decision on information request in attached Form 30.
 Article 30 (Request for Order for Provision or Perusal of Information on Treated Articles)
(1) A person who intends to apply for an order for the provision or perusal of information under Article 30 (3) of the Act shall submit to the Minister of Environment an application for an order of information provision or perusal in attached Form 31, accompanied by the following data:
1. A copy of the request for provision or perusal of information and documents evidencing the purchase of the relevant treated article;
2. A copy of the notice of decision on the information request.
(2) The Minister of Environment shall determine whether to issue an order for provision or perusal of information, the scope thereof, and the methods therefor within 120 days from the receipt of an application under paragraph (1), and shall notify the applicant by providing a notice of decision on the request for information provision or perusal in attached Form 32.
(3) Where reasonable grounds exist, such as where a decision on the provision or perusal of information takes a considerable period of time, the Minister of Environment may extend the period for notice once by up to 30 days. In such cases, the Minister of Environment shall notify the applicant of the grounds for such extension and the period of extension within 100 days from the receipt of the application.
(4) Where the Minister of Environment issues an order for provision or perusal of information under Article 30 (4) of the Act, he or she shall do so using an order for information provision or perusal in attached Form 33. In such cases, the details of such order shall be entered in the ledger for orders for information provision or perusal in attached Form 34.
 Article 31 (Extension of Period for Data Protection)
(1) A person who intends to request the extension of the period for data protection under the proviso of Article 25 (1) of the Decree shall file with the President of the National Institute of Environmental Research an application for the extension of the period for data protection in attached Form 35 by not later than three months before such period expires. In such cases, where any notice of decision on the extension of the period of data protection has been given, a copy of such notice shall be attached thereto.
(2) Upon receipt of an application under paragraph (1), the President of the National Institute of Environmental Research shall notify the applicant by providing a notice of decision on the extension of the period for data protection in attached Form 36.
 Article 32 (Consent to Use of Data)
A person who intends to utilize the data already submitted by another person under Article 32 (1) of the Act shall prepare a written consent to the use of such data in agreement with the owner of the relevant data.
 Article 33 (Consent to Use of Vertebrate Animal Test Data)
(1) "Matters prescribed by Ordinance of the Ministry of Environment ... the owner of such vertebrate animal test data, including the name of the owner" in Article 33 (2) of the Act means the following information:
1. The name or trade name of the owner of vertebrate animal test data referred to in Article 33 (1) of the Act (hereinafter referred to as "vertebrate animal test data”);
2. Address and contact information of the owner of the vertebrate animal test data.
(2) A person who intends to obtain confirmation on the refusal to the use of data from the owner of the vertebrate animal test data under the main clause of Article 33 (5) of the Act shall file with the President of the National Institute of Environmental Research an application for confirmation on the refusal to the use of vertebrate animal test data in attached Form 37, accompanied by the data evidencing such fact.
(3) The President of the National Institute of Environmental Research shall notify the applicant by providing a notice of decision to confirm the refusal to the use of vertebrate animal test data in attached Form 38 within 14 days from the receipt of such application under paragraph (2).
(4) “Period prescribed by Ordinance of the Ministry of Environment” in the proviso of Article 33 (5) of the Act means a period of up to two years as specified in the notice for order for submission of the vertebrate animal test data, which is set by the President of the National Institute of Environmental Research in consideration of the time required for the production of vertebrate animal test data.
CHAPTER IV FOLLOW-UP CONTROL OF CONSUMER CHEMICAL PRODUCTS AND BIOCIDES
 Article 34 (Restrictions on Labeling and Advertisement)
(1) "Phrase prescribed by Ordinance of the Ministry of Environment" in Article 34 (1) 1 of the Act means the following:
1. Nontoxic;
2. Environment- and nature-friendly;
3. Non-harmful;
4. Human and animal-friendly.
(2) "Phrase prescribed by Ordinance of the Ministry of Environment" in Article 34 (1) 2 of the Act means the following: <Amended on Dec. 31, 2020>
1. A phrase by which the name or type of the product can be identified;
2. A phrase recommending compliance with the methods of using the product and precautions for use;
3. A phrase regarding the effectiveness and efficacy of the product (limited to those stated in a certificate of a report on verification of compliance with the safety standards referred to in Article 5 (5), a notice of approval of a consumer chemical product subject to safety verification referred to in Article 6 (9), or a notice of approval of a biocidal product referred to in Article 21 (10)).
 Article 35 (Report on New Risks)
(1) A person who intends to report information on new risks under Article 36 (1) of the Act shall submit a report, including all the following matters, to the head of the competent river basin environmental office or the head of the competent regional environmental office:
1. Basic information on the relevant consumer chemical product subject to safety verification or biocide, such as the name and photographs thereof;
2. The details of the information falling under any subparagraph of Article 36 (1) of the Act;
3. The measures to be taken.
(2) A public official-in-charge who has received an application under paragraph (1) shall verify the applicant’s corporate 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 such verification of the business registration certificate, the person shall have a copy of the relevant document attached thereto.
 Article 36 (Recommendation on Measures regarding New Risks)
(1) In accordance with Article 27 (2) of the Decree, a person who has given a notice of acceptance of recommendation of measures under Article 36 (2) of the Act shall submit to the head of a river basin environmental office or the head of a regional environmental office a plan for measures, containing the following matters, within 10 days from the date such notice is given:
1. The name, manufacturing volume, import volume, and sales volume of the relevant consumer chemical product subject to safety verification or biocide, and the name of the business counterpart;
2. Planned volume subject to measures (to be calculated according to such factors as the distribution quantity of the relevant consumer chemical product subject to safety verification or biocide at the time a plan for measures is submitted);
3. Expected period of time necessary for implementing the measures;
4. Place where such measures are to be implemented and the specific methods therefor;
5. Methods for informing the public of the measures to be taken.
(2) A person who has submitted a plan for measures under paragraph (1) shall submit to the head of the river basin environmental office or the head of the regional environmental office a report on the results of the measures taken, including the following matters, within seven days from the end of the period referred to in paragraph (1) 3 after taking such measures:
1. The name, manufacturing volume, import volume, and sales volume of the relevant consumer chemical product subject to safety verification or biocide, and the performance in taking measures including the volume for which measures have been taken and volume for which measures have yet to be taken;
2. The details of the volume for which measures have yet to be taken and the plan for taking measures;
3. The measures for preventing a recurrence.
(3) Where a plan for measures under paragraph (1) or a report on the results of the measures taken under paragraph (2) requires any supplementation, the head of the river basin environmental office or the head of the regional environmental office may make a written request for supplementation.
 Article 36-2 (Duty of Quality Control)
(1) "Standards prescribed by Ordinance of the Ministry of Environment, in terms of manufacturing and storage facilities, safety management, and other factors" in Article 36-2 (1) of the Act means the standards prescribed in attached Table 2.
(2) Where the manufacturer or importer of an approved consumer chemical product subject to safety verification or a biocidal product fails to meet the standards referred to in paragraph (1), the head of a river basin environmental office or the head of a regional environmental office may order the person to comply within a specified period of up to six months.
[This Article Newly Inserted on Dec. 31, 2020]
 Article 37 (Order for Measures, Such as Recall)
(1) A person who has received an order for measures such as recall under Article 37 (1) of the Act shall, within 10 days from the receipt of such order, submit to the head of a river basin environmental office or the head of a regional environmental office a plan therefor, including the following information:
1. The name, manufacturing volume, import volume, and sales volume of the relevant consumer chemical product or biocide, and the name of the business counterpart;
2. Planned volume subject to measures (to be calculated in consideration of such factors as the distribution quantity of the relevant consumer chemical product or biocide at the time a plan for measures is submitted);
3. Expected period of time necessary for implementing the measures;
4. Place where such measures are to be implemented and the specific methods therefor;
5. Methods for informing the public of the measures taken.
(2) A person who has submitted a plan for measures under paragraph (1) shall, within seven days from the end of the period referred to in paragraph (1) 3 upon taking such measures, submit to the head of the river basin environmental office or the head of the regional environmental office a report on the results of the measures taken, including the following matters:
1. The name, manufacturing volume, import volume, and sales volume of the relevant consumer chemical product subject to safety verification or biocide, and the performance in taking measures including the volume for which measures have been taken and volume for which measures have yet to be taken;
2. The details of the volume for which measures have yet to be taken and the plan for taking measures;
3. The measures for preventing a recurrence.
(3) Where a plan for measures under paragraph (1) or a report on the results of the measures taken under paragraph (2) requires any supplementation, the head of the river basin environmental office or the head of the regional environmental office may make a written request for supplementation.
 Article 38 (Imposition of Penalty Surcharges)
(1) Where a penalty surcharge is imposed under Article 38 (1) of the Act, the head of a river basin environmental office or the head of a regional environmental office shall notify such fact by means of a notice of payment of penalty surcharges in attached Form 39, specifying the type of a violation and the amount of the penalty surcharge.
(2) A person who intends to apply for the extension of the deadline for paying a penalty surcharge under the former part, with the exception of the subparagraphs, of Article 30 (4) of the Decree shall submit to the head of the river basin environmental office or the head of the regional environmental office an application for the extension of penalty surcharge payment deadline in attached Form 40, accompanied by the documents evidencing that the case satisfies the grounds for such extension. In such cases, the head of the river basin environmental office or the head of the regional environmental office shall notify the applicant by providing a notice of decision on the extension of penalty surcharge payment deadline in attached Form 41.
(3) A person who intends to apply for payment of a penalty surcharge in installments under the former part, with the exception of the subparagraphs, of Article 30 (4) of the Decree shall submit to the head of the river basin environmental office or the head of the regional environmental office an application for penalty surcharge payment in installments in attached Form 42, accompanied by the documents evidencing that the case satisfies the grounds for payment in installments. In such cases, the head of the river basin environmental office or the head of the regional environmental office shall notify the applicant by providing a notice of decision on penalty surcharge payment in installments in attached Form 43.
CHAPTER V LAYING FOUNDATION FOR SAFETY CONTROL FOR CONSUMER CHEMICAL PRODUCTS AND BIOCIDES
 Article 39 (Designation of Testing and Inspection Institutions)
(1) "Application for designation of a testing and inspection institution in the form prescribed by Ordinance of the Ministry of Environment" in Article 34 (1), with the exception of the subparagraphs, of the Decree means an application for designation of a testing and inspection institution in attached Form 44.
(2) A public official-in-charge who has received an application for designation under paragraph (1) shall verify the applicant’s corporate registration certificate 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 such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(3) "Application for designation modifications of a testing and inspection institution in the form prescribed by Ordinance of Ministry of Environment" in Article 34 (4), with the exception of the subparagraphs, of the Decree means an application for designation modifications of a testing and inspection institution in attached Form 45.
(4) A certificate of designation of a testing and inspection institution under Article 41 (5) of the Act shall be as specified in attached Form 46.
 Article 40 (Evaluation of Testing and Inspection Institutions)
(1) The President of the National Institute of Environmental Research shall evaluate testing and inspection institutions according to the following classification under Article 41 (7) of the Act:
1. Periodic evaluation: An evaluation of testing and inspection institutions in terms of operation status and follow-up control is to be conducted every two years from the date of such designation;
2. On-demand evaluation: To be conducted whenever deemed necessary to confirm the adequacy and reliability of the details and findings of testing and inspection by testing and inspection institutions.
(2) The evaluation standards referred to in paragraph (1) shall be as follows: <Amended on Dec. 31, 2020>
1. Appropriateness of operation of the facilities and equipment under Article 33 (1) 1 and 2 of the Decree;
2. The skills in analyzing the standard samples;
3. Whether an institution is operated in accordance with the operational plan referred to in Article 34 (1) 1 of the Decree.
(3) The President of the National Institute of Environmental Research may operate an evaluation team consisting of relevant public officials and experts so as to efficiently conduct evaluation under paragraph (1).
(4) Except as provided in paragraphs (1) through (3), matters necessary for conducting an evaluation of testing and inspection institutions shall be determined and publicly notified by the President of the National Institute of Environmental Research. <Newly Inserted on Dec. 31, 2020>
 Article 41 (Specific Criteria for Administrative Dispositions)
(1) "Fail to meet the criteria prescribed by Ordinance of the Ministry of Environment” in Article 43 (1) 4 of the Act means cases where the results of a periodic or on-demand evaluation conducted under Article 40 (1) fall short of the evaluation standards referred to in paragraph (2) of that Article.
(2) The specific criteria for administrative dispositions under Article 43 (2) of the Act shall be as specified in attached Table 3.
 Article 42 (Educational Training and Campaign)
(1) Educational training and campaign referred to in Article 44 (1) of the Act shall be focused on the following:
1. Improving understanding of the safety control of consumer chemical products and biocides;
2. Making voluntary efforts to put safety control of consumer chemical products and biocides into action.
(2) Educational training under Article 44 (1) of the Act shall be provided in a face-to-face or on-line learning environment using an information and communications network.
(3) A campaign under Article 44 (1) of the Act shall be conducted using the following methods:
1. Utilizing an information and communications network;
2. Using experiential activities, such as field experience opportunities;
3. Utilizing non-commercial, public interest advertisements referred to in Article 73 (4) of the Broadcasting Act;
4. Providing support to consumer organizations in their public relations activities.
 Article 43 (Duties of Consumer Chemical Products Safety Center)
"Duties prescribed by Ordinance of the Ministry of Environment” in Article 46 (1) 8 of the Act means the following: <Amended on Dec. 31, 2020>
1. Examining data on reports on consumer chemical products subject to safety verification and reports on changes under Article 10 (4) and (5) of the Act;
2. Deleted; <Dec. 31, 2020>
3. Deleted; <Dec. 31, 2020>
4. Cooperating with the related organizations under Article 48 of the Act.
 Article 44 (Operation of Information Network on Consumer Chemical Products)
Where the duties listed in the subparagraphs of Article 37 of the Decree are performed using an information network for the control of consumer chemical products and biocides under Article 47 (1) of the Act, electronic documents or other means may replace documents to be attached. In such cases, an electronic signature of a person who handles electronic documents may replace his or her name-writing and seal impression or signature.
 Article 45 (Cooperation with Related Organizations)
"Matters prescribed by Ordinance of the Ministry of Environment, including market monitoring" in Article 48 (1) of the Act means the following:
1. Conducting surveys on the status of consumer chemical products and biocides in the market and collecting such information;
2. Conducting surveys on the safety of consumer chemical products and biocides in the market;
3. Conducting surveys on whether consumer chemical products and biocides in the market are in compliance with the labeling requirements, collecting relevant data, and filing a report thereon;
4. Other matters that the Minister of Environment deems necessary for the prevention of accidents related to consumer chemical products and biocides.
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
 Article 46 (Recording and Reporting)
(1) A person who intends to file a report pursuant to Article 49 (2) of the Act shall submit the data referred to in each subparagraph of the same paragraph to the head of a river basin environmental office or the head of a regional environmental office by the following respective dates:
1. Initial reporting: Mar. 31, 2020;
2. Reporting thereafter: Mar. 31 of every other year from the year in which the initial reporting date under subparagraph 1 falls.
(2) "Cases prescribed by Ordinance of the 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” in Article 49 (3) of the Act means cases where the data falling under any subparagraph of Article 49 (2) of the Act are reported or submitted to the Minister of Environment under other statutes or regulations. <Amended on Dec. 31, 2020>
 Article 47 (Access, Inspection, and Collection)
(1) A public official who has access to conduct an inspection under Article 50 (1) of the Act shall notify, in advance, the relevant manufacturer or importer of the purpose and date of such access and inspection as well as the details of such inspection: Provided, That this shall not apply to cases where urgent inspection is required or where the purpose of inspection cannot be attained due to the destruction of evidence or other concerns if a prior notice is given.
(2) Where a place of business, etc. subject to the access and inspection by the President of the National Institute of Environmental Research, the head of a river basin environmental office, or the head of a regional environmental office, under Article 50 (1) of the Act is also subjected to access and inspection under the provisions of other statutes as listed in the following subparagraphs, such access and inspection shall not be made or conducted separately: Provided, That this shall not apply to cases where it is inevitable due to civil petitions, environmental pollution, wide-range monitoring activities, or issues of human resources:
1. Article 41 (1) or (2) of the Act on the Management and Use of Livestock Excreta;
2. Article 82 (1) of the Clean Air Conservation Act;
3. Article 68 (1) of the Water Environment Conservation Act;
4. Article 47 (1) of the Noise and Vibration Control Act;
5. Article 39 (1) of the Wastes Control Act;
6. Article 69 (1) or (2) of the Sewerage Act;
7. Article 49 (1) of the Chemical Substances Control Act;
8. Article 43 (1) of the Act on Registration and Evaluation of Chemicals;
9. Article 30 (1) of the Act on the Integrated Control of Pollutant-Discharging Facilities.
(3) Where the head of a river basin environmental office or the head of a regional environmental office has collected a consumer chemical product or biocide, he or she may request the following institutions to verify its information or conduct a test or inspection of such consumer chemical product or biocide:
1. The National Institute of Environmental Research;
2. Testing and inspection institutions.
 Article 48 (Notification of Succession to Rights and Obligations)
(1) A person who succeeds to the rights and obligations arising from approval of a consumer chemical product subject to safety verification, approval of a substance, or approval of a product under Article 51 (1) of the Act shall submit to the President of the National Institute of Environmental Research a notice of succession to rights and obligations in attached Form 47, accompanied by the following documents, under paragraph (2) of that Article: <Amended on Dec. 31, 2020>
1. Documents evidencing the following:
(a) Approval of a consumer chemical product subject to safety verification under Article 10 of the Act;
(b) Approval of a substance under Article 12 of the Act and approval for changes under the main clause of Article 15 of the Act;
(c) Approval of a product under Article 20 of the Act and approval for changes under the main clause of Article 23 of the Act;
2. Documents evidencing that the person is the heir (limited to inheritances);
3. Documents evidencing the transfer or merger such as a copy of the agreement (limited to transfers or mergers).
(2) A person who succeeds to the rights and obligations arising from verification of a consumer chemical product subject to safety verification under Article 51 (1) of the Act shall submit to the President of the Korea Environmental Industry and Technology Institute a notice of succession to rights and obligations in attached Form 47, accompanied by the following documents, under paragraph (2) of that Article: <Newly Inserted on Dec. 31, 2020>
1. Documents evidencing verification of a consumer chemical product subject to safety verification under Article 10 of the Act;
2. Documents falling under paragraph (1) 2 or 3.
(3) A public official-in-charge who has received a notice under paragraph (1) shall verify a corporate registration certificate (limited to corporations) or business registration certificate through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where the person who filed an application does not consent to such verification of the business registration certificate, the person shall have a copy of the relevant document attached thereto. <Amended on Dec. 31, 2020>
[Title Amended on Dec. 31, 2020]
 Article 49 (Fees)
(1) Fees to be paid under Article 52 of the Act shall be as prescribed in attached Table 4.
(2) Fees under paragraph (1) may be paid by a revenue stamp or by such means as electronic money or electronic payment using the information and communications network.
 Article 49-2 (Issue of Certificates in English)
(1) The President of the Korea Environmental Industry and Technology Institute or the President of the National Institute of Environmental Research may issue to a person who intends to export a consumer chemical product subject to safety verification or biocide an English version of a document evidencing that the relevant consumer chemical product subject to safety verification or biocide is legally in the market for sale.
(2) Matters necessary for issuing a certificate under paragraph (1) shall be determined and publicly notified by the Minister of Environment.
[This Article Newly Inserted on Dec. 31, 2020]
 Article 50 (Requirements for Person Appointed by Overseas Manufacturer)
(1) "Person who meets the requirements prescribed by Ordinance of the Ministry of Environment” in Article 54-2 (1) of the Act means any of the following persons:
1. A national of the Republic of Korea;
2. A person domiciled (in the case of a corporation, referring to the seat of its place of business) in the Republic of Korea.
(2) Where a person appointed under Article 54-2 (1) of the Act (hereinafter referred to as "appointed person") intends to report appointment or dismissal under paragraph (2) of that Article, he or she shall submit to the President of the National Institute of Environmental Research a report on appointment or dismissal by an overseas manufacturer in attached Form 48, accompanied by the following documents:
1. Documents evidencing that the person falls under any subparagraph of paragraph (1);
2. Documents evidencing appointment or dismissal such as a copy of the appointment contract or the notice of dismissal.
(3) A public official-in-charge who has received a report under paragraph (2) shall verify the corporate registration certificate or business registration certificate of an appointed person through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where the person appointed or dismissed does not consent to such verification of the business registration certificate, the person shall have the relevant document attached thereto.
(4) The President of the National Institute of Environmental Research shall issue a certificate of a report on appointment or dismissal by an overseas manufacturer in attached Form 49, within seven days from the receipt of the report under paragraph (2).
(5) An appointed person shall notify, without delay, a person who imports, or intends to import, biocides of the matters referred to in the subparagraphs of Article 39-2 (2) of the Decree, under Article 54-2 (3) of the Act.
[This Article Newly Inserted on Dec. 31, 2020]
ADDENDUM <Ordinance of the Ministry of Environment No. 794, Dec. 28, 2018>
This Rule shall enter into force on January 1, 2019.
ADDENDA <Ordinance of the Ministry of Environment No. 805, Apr. 17, 2019>
Article 1 (Enforcement Date)
This Rule shall enter into force on the date the Minamata Convention on Mercury takes effect on the Republic of Korea. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDA <Ordinance of the Ministry of Environment No. 901, Dec. 31, 2020>
Article 1 (Enforcement Date)
This Rule shall enter into force on January 1, 2021: Provided, That the amended provisions of Articles 5 (3) 6, (4) 5 and 34 (2) 3 shall enter into force on July 1, 2021.
Article 2 (Applicability to Disclosure of Information on Consumer Chemical Products Subject to Safety Verification)
The amended provisions of Article 7-2 shall also apply to consumer chemical products subject to safety verification that have been reported or approved before this Rule enters into force.
Article 3 (Applicability to Submission of Plan for Applying for Approval of Substance)
The amended provisions of Article 15 shall also apply to a person who has submitted a plan for applying for approval of a substance before this Rule enters into force.
Article 4 (Transitional Measures concerning Duty of Quality Control)
A manufacturer or importer of a consumer chemical product subject to safety verification that has been approved before this Rule enters into force shall satisfy the standards required under the amended provisions of Article 36-2 (1) by June 30, 2021.