Law Viewer

Back Home

ENFORCEMENT RULE OF THE ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES

Ordinance Of the Ministry of Environment No. 582, Dec. 24, 2014

Amended by Ordinance Of the Ministry of Environment No. 615, Oct. 30, 2015

Ordinance Of the Ministry of Environment No. 672, Aug. 4, 2016

Ordinance Of the Ministry of Environment No. 740, Jan. 15, 2018

Ordinance Of the Ministry of Environment No. 745, Jan. 17, 2018

Ordinance Of the Ministry of Environment No. 790, Dec. 28, 2018

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
The purpose of this Rule is to prescribe matters mandated by the Act on Registration, Evaluation, etc. of Chemicals and its Enforcement Decree and other matters necessary for the enforcement thereof.
 Article 2 Deleted. <by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016>
CHAPTER II REGISTRATION OF CHEMICAL SUBSTANCES
 Articles 3 and 4 Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 5 (Methods of Applying for Registration of Chemical Substances)
(1) Each person who intends to apply for registration of non-phase-in substances or phase-in substances pursuant to Article 10 (1) or (5) of the Act on Registration, Evaluation, etc. of Chemicals (hereinafter referred to as the "Act") shall submit a written application for registration in attached Form 2 to the President of the National Institute of Environmental Research, along with the following documents: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Data concerning the physical and chemical properties and hazards of the relevant chemical substance: Data submitted according to the methods for submission in attached Table 1: Provided, That in cases of the chemical substance referred to in Article 10 (5) of the Act, it shall be the data publicly notified by the Minister of Environment, which the Minister deems necessary as at the time of designation and public notification of the relevant chemical substance;
2. Data concerning the risks of the relevant chemical substance: Data compiled according to the methods in attached Table 2;
3. Data concerning the instructions for safe use of the relevant chemical substance: Data prepared according to the methods in attached Table 3;
4. Information on exposure from the uses of the relevant chemical substance: Data submitted under Article 12 (1);
4-2. Where the relevant chemical substance is an on-site isolated intermediate (referring to chemical substances that are produced in the course of manufacturing other chemical substances and do not correspond to a non-isolated intermediate and the whole quantity of which is used and extinguished in the subsequent process steps in the same manufacturing site under the conditions controlled according to the procedures and methods prescribed in attached Table 3-2 (hereafter in this subparagraph referred to as "controlled conditions"); hereinafter the same shall apply) or a transported isolated intermediate (referring to chemical substances that are produced in the course of manufacturing other chemical substances and then transferred to another manufacturing site under the controlled conditions, without corresponding to a non-isolated intermediate, the whole quantity of which is used and extinguished in the subsequent process steps in the relevant manufacturing site), documents proving its manufacture, transfer and use under the controlled conditions (in cases of on-site isolated intermediates, such documents shall be verified by manufacturers; and in cases of transported isolated intermediates, such documents shall be verified by manufacturers, importers or users);
5. Reasons for omitting data to apply for registration under the main sentence of Article 14 (1) of the Act (hereinafter referred to as "data to apply for registration") and evidentiary documents supporting such reasons (limited to where it is permitted to omit some of the data to apply for registration pursuant to the proviso of Article 14 (1) of the Act, with the exception of its subparagraphs, and Article 13 of the Enforcement Decree of the Act on Registration, Evaluation, etc. of Chemicals (hereinafter referred to as the "Decree"));
6. A testing plan under the former part of Article 14 (3) of the Act (limited to where it is permitted to submit a testing plan in lieu of some of the data to apply for registration pursuant to the former part of Article 14 (3) of the Act;
7. A copy of the written verification of individual submission (limited to where having obtained the verification of individual submission under the proviso of Article 15 (1) of the Act, with the exception of its subparagraphs);
8. A written opinion verifying a refusal to share vertebrate animal test data (limited to where having obtained verification under the main sentence of Article 17 (3) of the Act);
9. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to where the person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act applies for registration);
10. A written application for data protection (limited to requests for data protection pursuant to Article 45 (1) of the Act);
11. Documents evidencing outsourcing, such as a copy of a contract for outsourcing (limited to where a person who outsources the manufacture of a chemical substance applies for registration).
(2) Notwithstanding paragraph (1), the following documents need not be submitted pursuant to the proviso of Article 14 (1) of the Act, with the exception of its subparagraphs, in any of the following cases: <Amended by Ordinance of the Ministry of Environment No. 615, October 30, 2015; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. In cases of non-phase-in substances referred to in subparagraph 1 of Article 13 of the Decree or chemical substances referred to in subparagraph 1-2 of the same Article: Documents under paragraph (1) 1 through 4, 4-2, and 6 through 8: Provided, That any document possessed by the applicant for registration of the relevant chemical substances may be submitted among those under paragraph (1) 1 through 4 and 4-2;
1-2. In cases of phase-in substances referred to in subparagraph 1-3 of Article 13 of the Decree, documents satisfying the following classification: Provided, That any document possessed by the applicant for registration of the relevant chemical substances may be submitted:
(a) Phase-in substances referred to in subparagraph 1 of attached Table 3-3: Documents concerning items exempted from documentation under attached Table 1 among those prescribed in paragraph (1) 1, and documents prescribed in paragraph (1) 2;
(b) Phase-in substances referred to in subparagraph 2 of attached Table 3-3: Documents concerning items exempted from documentation under attached Table 1 among those prescribed in paragraph (1) 1;
2. In cases of on-site isolated intermediates referred to in subparagraph 2 of Article 13 of the Decree: Documents concerning hazards among those prescribed in paragraph (1) 1, and documents prescribed in subparagraphs 2 through 4 and 5 of the same paragraph: Provided, That any document possessed by the applicant for registration of the relevant on-site isolated intermediate may be submitted;
2-2. In cases of transported isolated intermediates under subparagraph 2-2 of Article 13 of the Decree: Documents prescribed in subparagraphs 2 through 4 and 5 of paragraph (1): Provided, That any document possessed by the applicant for registration of the relevant transported isolated intermediate may be submitted;
3. In cases of chemical substances referred to in subparagraphs 3 through 6, 6-2 and 7 of Article 13 of the Decree: Documents related to the relevant chemical substance among those under paragraph (1) 1;
4. In cases of chemical substances referred to in subparagraph 8 of Article 13 of the Decree: Documents related to the relevant chemical substance among test data under subparagraph 1 of attached Table 4.
(3) "Phase-in substance whose human health or environmental hazards, as contained in data submitted for the registration, etc. thereof, satisfy the level prescribed by Ordinance of the Ministry of Environment" in subparagraph 1-3 of Article 13 of the Decree means the phase-in substance in whose cases the items concerning hazards to health or the environment meet the criteria specified in attached Table 3-3 in the following data: <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Test data referred to in attached Table 1;
2. Data concerning the classification or labeling of chemical substances (limited to cases where data are submitted when a report or a report on changes under Article 10 (3) of the Act is filed).
(4) The President of the National Institute of Environmental Research upon receipt of an application for registration pursuant to paragraphs (1) and (2) shall verify the corporate registration certificate or the business registration certificate through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the applicant withholds consent to verify the business registration certificate, the President of the National Institute of Environmental Research shall require such person to attach the relevant certificate. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 6 (Notice of Registration and Notice Period)
(1) The President of the National Institute of Environmental Research shall assign a registration number and a registration date to a chemical substance and notify the applicant thereof by providing a notice of registration of a chemical substance in attached Form 4 by no later than 30 days from the date of receipt of an application for registration pursuant to Article 10 (6) of the Act: Provided, That where further review is required for the submitted data, the notice period may be extended twice, by a maximum of 30 days per period: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. and 2. Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) Where necessary to modify or supplement data to apply for registration, the President of the National Institute of Environmental Research shall give a notice to modify or supplement the data to apply for registration of chemical substances in attached Form 5, specifying the matters to be modified or supplemented and the period for submission. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(3) The applicant in receipt of a notice under paragraph (2) shall submit the modified or supplemented data to the President of the National Institute of Environmental Research within the period for submission.
 Article 6-2 (Report of Phase-In Substances during Registration Grace Period)
(1) "Matters prescribed by Ordinance of the Ministry of Environment, such as the trade name of the person who intends to manufacture or import" in Article 10 (3) 5 of the Act means the following matters:
1. The trade name, address and contact information of the person intending to report the manufacture or import of phase-in substances during the registration grace period;
2. The trade name, address and contact information of the person intending to import chemical substances (limited to cases where a report is filed by a person appointed by an overseas manufacturer or producer pursuant to Article 38 of the Act);
3. The trade name, address, and contact information of the person to whom the manufacture of chemical substances is outsourced (limited to cases where a report is filed by a person who intends to outsource the manufacture of chemical substances).
(2) Any person intending to report the manufacture or import of phase-in substances during the registration grace period referred to in Article 10 (3) of the Act shall submit to the President of the Korea Environment Corporation established under the Korea Environment Corporation Act (hereinafter referred to as the "Corporation") a report of the manufacture or import of phase-in substances in attached Form 5-2, along with the following documents:
1. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to cases where a report is filed by a person appointed by an overseas manufacturer or producer pursuant to Article 38 of the Act);
2. Documents evidencing outsourcing, such as a copy of the outsourcing contract (limited to cases where a report is filed by a person who outsources the manufacture of chemical substances).
(3) A person in charge who receives a report under paragraph (2) shall verify the corporate registration certificate or the business registration certificate through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the person who files the report withholds consent to verify the business registration certificate, such person shall be required to attach the relevant certificate.
(4) A person who intends to report any changes to the matters reported under Article 10 (3) of the Act shall submit a report of changes in the manufacture or import of phase-in substances in attached Form 5-2, along with documents evidencing the relevant changes, to the President of the Corporation by the following periods:
1. Where any change is made in any matter prescribed in subparagraph 1 or subparagraphs 4 through 6 of Article 10-2 of the Decree: Within one month from the date on which the relevant changes occur;
2. Where any change is made in any matter prescribed in subparagraph 2 or 3 of Article 10-2 of the Decree: Within one month from the date of becoming aware of the relevant changes.
(5) The President of the Corporation shall submit a quarterly report on the current status of the reports prescribed in paragraph (2) and reports on changes prescribed in paragraph (4) to the Minister of Environment by the 15th day of the month following the end of each quarter.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 6-3 (Report of Non-Phase-In Substances)
(1) Any person intending to report the manufacture or import of non-phase-in substances pursuant to Article 10 (4) of the Act shall submit to the President of the National Institute of Environmental Research a report of the manufacture or import of non-phase-in substances in attached Form 5-3, along with the following documents: Provided, That any document possessed by the person who reports the relevant non-phase-in substances may be submitted among the documents prescribed in Article 5 (1) 1 through 4 and 4-2:
1. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to cases where a report is filed by a person appointed by an overseas manufacturer or producer pursuant to Article 38 of the Act);
2. A written application for data protection (limited to cases where data protection is requested pursuant to Article 45 (1) of the Act);
3. Documents evidencing outsourcing, such as a copy of the outsourcing contract (limited to cases where a report is filed by a person who intends to outsource the manufacture of chemical substances);
4. A notice of verification of the exemption from a hazard review issued pursuant to Article 12 of the previous Toxic Chemical Substances Control Act (referring to the Toxic Chemical Substances Control Act prior to being amended by Act No. 11862) (limited to cases where non-phase-in substances prescribed in Article 10 (4) 2 of the Act are reported).
(2) A public official in charge who receives a report pursuant to paragraph (1) shall verify the corporate registration certificate or the business registration certificate through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the person who files a report withholds consent to verify the business registration certificate, such person shall be required to attach the relevant certificate.
(3) The President of the National Institute of Environmental Research shall issue a notice of the report of non-phase-in substances in attached Form 5-4 to the person who has filed the report within seven days from the date of receiving the report pursuant to paragraph (1) (when a detailed review is required regarding the submitted data, such notice shall be provided within 14 days).
(4) Where it is necessary to modify or supplement any report data, the President of the National Institute of Environmental Research shall notify the person who has filed the report by providing a notice to modify or supplement data to report non-phase-in substances in attached Form 5-5, specifying the matters to be modified or supplemented and the period for submission. In such cases, the period from the date of requesting modification or supplementation to the date of submitting data in response to such request shall be excluded from the period prescribed in paragraph (3).
(5) The person in receipt of the notice prescribed in paragraph (4) shall submit modified or supplemented data to the President of the National Institute of Environmental Research within the submission period.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 7 (Application for Confirmation of Exemption from Registration, etc.)
(1) Each person who intends to apply for confirmation of exemption from registration or reporting under Article 11 (1) 3 of the Act (hereinafter referred to as "confirmation of exemption from registration, etc.") shall submit a written application for confirmation of exemption from registration or reporting in attached Form 6 accompanied by the following documents, to the President of the Corporation prior to manufacturing or importing chemical substances. In such cases, with respect to chemical substances not directly related to sales in the market, such as reagents for test, research and examination and chemical substances for pilot production, such person may submit the above-mentioned written application and documents within 30 days from the manufacturing date or importing date: <Amended by Ordinance of the Ministry of Environment No. 615, Oct. 30, 2015; Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Data prepared according to the methods for preparation in attached Table 5;
2. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to where a person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act files an application);
3. A written application for data protection (limited to where data protection is requested pursuant to Article 45 (1) of the Act);
4. A document evidencing outsourcing, such as a copy of a contract for outsourcing (limited to where a person who outsources the manufacture of a chemical substance applies for confirmation of exemption from registration).
(2) The President of the Corporation in receipt of an application for confirmation of exemption from registration, etc. referred to in paragraph (1) shall verify the corporate registration certificate or the business registration certificate through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the applicant withholds consent to the verification of the business registration certificate, such person shall be required to attach the relevant certificate. <Amended by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(3) With respect to the matter applied pursuant to paragraph (1), the President of the Corporation may verify whether the relevant chemical substance is exempt from registration, etc. under Article 11 (1) 3 of the Act and Article 11 of the Decree in any such manner as the examination of the President of the National Institute of Environmental Research and on-site visits. <Amended by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) Exemption from registration, etc. under paragraph (2) shall be confirmed at the following intervals: <Amended by Ordinance of the Ministry of Environment No. 615, Oct. 30, 2015; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Chemical substances under Article 11 (1) 1 and 2 of the Decree: Confirmation of exemption from registration, etc. on an annual basis;
2. Chemical substances under Article 11 (1) 3 and 5 through 8 of the Decree: Confirmation of exemption from registration, etc. only once for the first confirmation;
3. Chemical substances under Article 11 (1) 4 of the Decree: Confirmation of exemption from registration, etc. for each plan for research and development of chemical substances.
(5) The President of the Corporation shall issue a notice of the results of an application for confirming exemption from registration or reporting of chemical substances in attached Form 7 to the relevant applicant within five days from the date of receiving the application for confirming exemption from registration, etc. referred to in paragraph (1) (where it is necessary to review whether the relevant chemical substance is exempt from registration, etc. pursuant to paragraph (3), it shall be within 14 days from the date of receiving the application). <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(6) "Controlled conditions complying with the procedure and manner prescribed by Ordinance of the Ministry of Environment" in Article 11 (1) 8 of the Decree means the controlled conditions specified in attached Table 3?2. <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 7-2 (Application for Changes to Confirmation of Exemption from Registration)
(1) "Where any change is made to the matters prescribed by Ordinance of the Ministry of Environment, such as a production or import amount of chemical substance" in Article 11 (3) of the Act means any of the following cases:
1. Where any change is made regarding a chemical substance for any research and development purpose referred to in Article 11 (1) 4 of the Decree, such as the period required for research and development, the estimated quantities of manufacture or import, or a research institute, among the matters exempted from registration, etc.;
2. Where a chemical substance prescribed in Article 11 (1) 6 of the Decree, which is a substance subject to surface treatment or another substance that treats the surface of the above-mentioned substance, is changed from a chemical substance falling under any item of the above-mentioned subparagraph to one falling under a different item of the same subparagraph;
3. Where the composition of the importers of the relevant chemical substance is changed (limited to cases where an application for confirmation of exemption from registration, etc. is filed by a person appointed by an overseas manufacturer or producer pursuant to Article 38 of the Act);
4. Where the composition of the manufacturers to whom the manufacture of the relevant chemical substance is outsourced is changed (limited to cases where an application for confirmation of exemption from registration, etc. is filed by the person who outsources the manufacture of the chemical substance).
(2) A person who intends to apply for any change to confirmation of exemption from registration, etc. pursuant to Article 11 (3) of the Act shall submit to the President of the Corporation a written application for changes to confirmation of exemption from registration or reporting of chemical substances in attached Form 6, along with the following documents, within 30 days from the date on which the relevant changes occur:
1. Documents evidencing the relevant changes;
2. Documents related to the relevant changes among the data prescribed in Article 7 (1) 1;
3. The original copy of the notice of the results of the application for confirmation of exemption from registration or reporting of chemical substances.
(3) The President of the Corporation shall return the notice of the results of the application for confirmation of exemption from registration or reporting of chemical substances to the relevant applicant within 14 days from the date of receiving the relevant application for changes under paragraph (2), by specifying the relevant changes on the back of such notice.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 8 (Notice of Results of Confirmation of Exemption from Registration)
(1) The President of the Corporation shall notify the President of the National Institute of Environmental Research on a quarterly basis of the following matters:
1. The current status of the applications for confirmation of exemption from registration, etc. under Article 7 (1) as well as the provision of notice under paragraph (5) of the same Article;
2. The current status of the applications for changes to confirmation of exemption from registration, etc. under Article 7-2 (2) as well as the results of the applications for changes under paragraph (3) of the same Article.
(2) The President of the National Institute of Environmental Research in receipt of the notification referred to in paragraph (1) shall notify the Minister of Employment and Labor of the data concerning the confirmation of exemption from registration of non-phase-in substances and any change thereto.
(3) The President of the Corporation shall report the records of the previous year concerning the matters under the subparagraphs of paragraph (1) to the Minister of Environment by March 31 of each year.
[This Article Wholly Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 9 (Methods for Registration of Change)
(1) Each person who intends to apply for registration of changes pursuant to Article 12 (1) of the Act shall submit a written application for registration of changes in attached Form 2 to the President of the National Institute of Environmental Research, along with the following documents: <Amended by Ordinance of the Ministry of Environment No. 615, Oct. 30, 2015; Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Documents evidencing the change;
2. Data related to the change of registration among the data prescribed in Article 5 (1) 1 through 4, 4-2, and 5 through 8;
3. The original copy of a notice of registration of the relevant chemical substance prescribed in Article 6 (1);
4. Deleted; <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
5. A written application for data protection (limited to where data protection is requested pursuant to Article 45 (1) of the Act);
6. Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) An application for registration of changes under paragraph (1) shall be filed within the following periods: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. In cases of a change referred to in Article 10 (1): One month from the date on which the change occurs;
2. In cases of a change referred to in Article 10 (2) 1: One month from the date of becoming aware of the change;
3. In cases of a change referred to in Article 10 (2) 2: Six months from the date of becoming aware of the change: Provided, That where the applicant requests an extension of the period, the period may, after the confirmation of the President of the National Institute of Environmental Research, be extended only once by six months.
(3) Within 30 days from the date of receipt of an application for registration of changes pursuant to paragraph (1), the President of the National Institute of Environmental Research shall provide the applicant with the notice of registration of the relevant chemical substance submitted under paragraph (1) by stating the changed matters thereon: Provided, That where further review is required for the submitted data, the notice period may be extended up to twice by a maximum of 30 days per period: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. and 2. Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 10 (Grounds for Registration of Change)
(1) "Where any change is made ... beyond the range prescribed by Ordinance of the Ministry of Environment" in Article 12 (1) 1 of the Act refers to cases where the annual quantity of a chemical substance manufactured or imported is changed from the tonnage band of the quantities of the chemical substance manufactured or imported which is classified pursuant to the subparagraphs of attached Table 6 to the tonnage band above such band. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) "Where any change is made to the matters prescribed by Ordinance of the Ministry of Environment" in Article 12 (1) 2 of the Act refers to any of the following cases: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Any of the following cases in which the uses of a registered chemical substance are changed:
(a) Where the chemical substances classifications by uses in attached Table 2 of the Decree are changed;
(b) Where the detailed uses of a chemical substance are changed or the new use thereof is identified;
2. Any of the following cases in which the hazards, risks, etc. of a registered chemical substance are changed:
(a) Where new information on properties and hazards of the chemical substance, which does not exist at the time of registration and causes a change to the classification and labeling of such chemical substance under Article 14 (1) 4 of the Act, becomes available;
(b) Where new information on risks of the chemical substance, which does not exist at the time of registration and affects human health or the environment, becomes available.
(3) Details of classification and labeling of chemical substances under paragraph (2) 2 (a) shall be as listed in attached Table 7.
 Article 11 (Report on Changes by Persons Who Have Made Registration)
(1) "Matters prescribed by Ordinance of the Ministry of Environment" in Article 12 (2) 3 of the Act means the following: <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The composition of the importers of the relevant chemical substance (limited to cases where the registration is filed by a person appointed by an overseas manufacturer or producer pursuant to Article 38 of the Act);
2. The composition of the manufacturers to whom the manufacture of the relevant chemical substance is outsourced (limited to cases where the registration is filed by the person who outsources the manufacture of the chemical substance).
(2) A person who intends to report changes pursuant to Article 12 (2) of the Act shall submit to the President of the National Institute of Environmental Research a report on changes in attached Form 8, along with the documents evidencing such changes, within one month from the date on which the relevant changes occur. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
[This Article Wholly Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018]
 Article 11-2 (Report on Changes by Persons Who Have Filed Reports)
(1) A person who has reported the manufacture or import of a non-phase-in substance pursuant to Article 10 (4) of the Act shall report the relevant change pursuant to Article 12 (3) 3 of the Act in any of the following cases:
1. Where the change of the chemical substances classifications by uses in attached Table 2 of the Decree causes any change in the use of the reported chemical substance;
2. Where the consumer use of the reported chemical substance is changed among the uses of such chemical substance or when a new consumer use is identified;
3. In any of the following cases where the properties, hazards or risks of the reported chemical substance are changed:
(a) Where new information on the properties or hazards of the chemical substance becomes available, causing a change to the classification and labeling of such chemical substance;
(b) Where new information on risks of the chemical substance that affect human health or the environment becomes available;
4. Where the composition of the importers of the relevant chemical substance is changed (limited to cases where the report is filed by a person appointed by an overseas manufacturer or producer pursuant to Article 38 of the Act);
5. Where the composition of the manufacturers to whom the manufacture of the relevant chemical substance is outsourced is changed (limited to cases where the report is filed by the person who outsources the manufacture of the chemical substance).
(2) Any person who intends to report changes pursuant to Article 12 (3) of the Act shall submit to the President of the National Institute of Environmental Research a report on changes in the manufacture or import of non-phase-in substances in attached Form 5-3 accompanied by the following documents, within one month from the date on which the relevant changes occur (referring to the date on which such person becomes aware of the relevant changes in any case falling under paragraph (1) 1 through 3):
1. Documents evidencing the changes;
2. Documents related to the changes among the data prescribed in Article 5 (1) 1 through 4 and 4-2 (limited to cases where the relevant documents are submitted pursuant to the proviso of Article 6-3 (1), with the exception of its subparagraphs);
3. The original copy of a notice of the report of a non-phase-in substance;
4. A written application for data protection (limited to cases where data protection is requested pursuant to Article 45 (1) of the Act).
(3) The President of the National Institute of Environmental Research shall return the submitted notice of the report of a non-phase-in substance to the person who has filed such report within seven days from the date of receiving a report on changes pursuant to paragraph (2) (when further review is required regarding the submitted data, it shall be within 14 days), by specifying the relevant changes on the back of such notice.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 12 (Data to Apply for Registration of Chemical Substances)
(1) "Data prescribed by Ordinance of the Ministry of Environment" in Article 14 (1) 9 of the Act refers to data concerning information on exposure from the uses of the relevant chemical substance prepared according to the methods for preparation under attached Table 8: Provided, That any person who has submitted data regarding risks of the chemical substance pursuant to Article 14 (1) 7 of the Act need not submit the data referred to in the main sentence. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) "Data prescribed by Ordinance of the Ministry of Environment" in Article 14 (2) of the Act, with the exception of its subparagraphs, refers to data stipulated in subparagraph 2 of attached Table 4.
 Article 13 (Verification by Foreign Testing Institution)
(1) When submitting documents stating the result of a test conducted by a foreign testing institution pursuant to Article 14 (2) 2 of the Act, either of the following materials shall also be submitted:
1. A written authentication issued by a member state of the Organization for Economic Cooperation and Development (OECD);
2. A written statement that the result of a test conducted by the foreign testing institution conforms to OECD Principles of Good Laboratory Practice.
(2) Upon receipt of materials falling under any of the subparagraphs of paragraph (1), the President of the National Institute of Environmental Research shall verify whether the relevant foreign testing institution complies with OECD Principles of Good Laboratory Practice.
 Article 14 (Alternative Submission of Testing Plan)
(1) Each person who intends to apply for registration pursuant to the former part of Article 14 (3) of the Act may submit a testing plan in lieu of data stipulated in subparagraph 3 of attached Table 4 related to the matters pursuant to Article 14 (1) 5 and 6 of the Act.
(2) A testing plan under paragraph (1) shall be formulated containing the following matters: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
1. The name of the test data;
2. Deleted; <by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
3. Reasons for submitting the testing plan;
4. Detailed methods for the test;
5. Expected schedules for the test;
6. The date when the test data can be submitted.
 Article 15 (Examination of Testing Plan and Notice Thereof)
(1) The President of the National Institute of Environmental Research shall examine the appropriateness, etc. of the test details and schedules stated in a testing plan pursuant to the latter part of Article 14 (3) of the Act and shall notify the person who has submitted the testing plan of the result of examination and the deadline for submission of the test data.
(2) Where it is deemed necessary to modify or supplement a testing plan as a result of examination under paragraph (1), the President of the National Institute of Environmental Research shall notify the person who has submitted the relevant testing plan of the following matters:
1. Conditions and methods of the test;
2. Deadline for submission of the test data;
3. Other matters to be modified or supplemented.
(3) Each person notified of the result of examination of a testing plan pursuant to paragraph (1) shall submit test data to the President of the National Institute of Environmental Research by the deadline for submission: Provided, That where the President of the National Institute of Environmental Research deems, after on-site verification, that the testing institution referred to in Article 14 (2) of the Act, with the exception of its subparagraphs, cannot submit test data by the deadline due to extenuating circumstances, the deadline for submission may be extended.
 Article 15-2 (Expenses for Using Data to Apply for Registration of Chemical Substances)
Any person provided with data to apply for registration pursuant to the former part of Article 14 (4) of the Act shall pay the expense for acquiring the data to apply for registration pursuant to the latter part of the same paragraph within the limit of the actual expense, as determined by the President of the Corporation.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 15-3 (Data to Report Non-Phase-In Substances)
"Data prescribed by Ordinance of the Ministry of Environment" in Article 14 (6) 2 of the Act means data possessed by a person who intends to file a report pursuant to Article 10 (4) of the Act among the data prescribed in Article 14 (1) 5 through 9 of the Act.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 16 (Data to Apply for Registration to Be Jointly Submitted)
(1) "Data to apply for registration prescribed by Ordinance of the Ministry of Environment" in the main sentence of Article 15 (1) of the Act, with the exception of its subparagraphs, refers to the following data:
1. Data concerning classification and labeling of chemical substances referred to in Article 14 (1) 4 of the Act;
2. Data concerning the physical and chemical properties of chemical substances referred to in Article 14 (1) 5 of the Act;
3. Data concerning hazards of chemical substances referred to in Article 14 (1) 6 of the Act;
4. A testing plan referred to in the former part of Article 14 (3) of the Act.
(2) Notwithstanding paragraph (1), where all applicants for registration under Article 10 (6) of the Act reach an agreement on the joint submission of the following data, joint submissions may be undertaken: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Data concerning risks of chemical substances referred to in Article 14 (1) 7 of the Act;
2. Data concerning the instructions for safe use referred to in Article 14 (1) 8 of the Act.
 Article 17 (Methods and Procedures for Joint Submission of Data to Apply for Registration)
(1) Persons required to jointly submit data to apply for registration pursuant to the main sentence of Article 15 (1) of the Act, with the exception of its subparagraphs, shall form a consultative body for joint submission (hereinafter referred to as "consultative body") and select a representative by agreement among the members of such consultative body. <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
(2) Notwithstanding paragraph (1), a separate consultative body may be formed for the relevant chemical substance in any of the following cases: <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Where a report or report on changes is filed regarding the relevant chemical substance for consumer uses pursuant to Article 10 (3) of the Act;
2. Where the relevant chemical substance is a polymer, for which it is difficult to regard such chemical substance as a single one despite a same name or identification information due to clear characteristic differences, in terms of the number average molecular weight range, the degree of melting in water, etc., and where the classification or labeling information of such chemical substance or its data to apply for registration to be submitted are different.
(3) In accordance with Article 15 (2) of the Act, among the matters on which a report or report on changes has been filed pursuant to Article 10 (3) of the Act for the purpose of forming a consultative body referred to in paragraphs (1) and (2), the Minister of Environment may provide the contact information of the person who has filed the report, information concerning the classification, labeling and use of the relevant chemical substance, etc. to persons required to jointly submit data to apply for registration pursuant to the main sentence of Article 15 (1) of the Act, with the exception of its subparagraphs. <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) Where a consultative body is likely to face difficulties in registering chemical substances due to its failure to select its representative one year prior to the expiration of the registration grace period, the Minister of Environment may recommend that a person who manufactures or imports the greatest quantities of phase-in substances be selected as the representative of the consultative body among the members thereof; and in extenuating circumstances where the person recommended by the Minister of Environment cannot be selected as the representative, the relevant consultative body may be advised to select as its representative a person who manufactures or imports the second greatest quantities of phase-in substances. <Newly Inserted by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(5) The representative selected pursuant to paragraph (1) or (4) (hereafter in this Article referred to as "representative") shall perform the following affairs upon consultation with the members who jointly submit data to apply for registration: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Affairs related to the selection and production of data to be jointly submitted;
2. Affairs related to apportioning expenses incurred in the joint submission;
3. Other affairs related to joint preparation and submission of data to apply for registration.
(6) Where the representative is unable to efficiently perform the affairs prescribed in the subparagraphs of paragraph (5) due to such reasons as delays in consensus among the members of the consultative body, which is likely to cause a failure in the registration of phase-in substances, such representative may request the mediation of the Minister of Environment. <Newly Inserted by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(7) Where an agreement on the apportionment of expenses prescribed in paragraph (5) 2 fails to be reached among the members who jointly submit data to apply for registration, expenses shall be allocated in consideration of the quantities of phase-in substances the respective members have manufactured or imported. <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(8) The representative shall submit data to apply for registration referred to in Article 16 before each member who jointly submits data to apply for registration respectively applies for registration. <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(9) The Minister of Environment may provide support concerning matters necessary for agreement among the members prescribed in paragraph (5). <Newly Inserted by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016; Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(10) Where the representative receives notice of registration regarding the relevant chemical substance pursuant to Article 6 (1), such fact shall be informed to the members of the consultative body within 15 days from the date of receiving such registration notice. <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 18 (Confirmation of Individual Submission of Data to Apply for Registration)
(1) Any person who intends to individually submit data to apply for registration pursuant to the proviso of Article 15 (1) of the Act, with the exception of its subparagraphs, shall obtain confirmation from the President of the National Institute of Environmental Research with respect to such individual submission. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) Any person who intends to obtain confirmation under paragraph (1) shall submit a written application for confirmation concerning individual submission in attached Form 10 to the President of the National Institute of Environmental Research, along with the following documents: <Amended by Ordinance of the Ministry of Environment No. 615, Oct. 30, 2015; Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. A document evidencing that the person has any ground for individual submission under Article 15 (1) of the Act and Article 14 of the Decree;
2. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to where the person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act files an application);
3. A document evidencing outsourcing, such as a copy of a contract for outsourcing (limited to cases where a person who outsources the manufacture of a chemical substance applies for confirmation);
4. A written consent to data provision in attached Form 10-2 (limited to cases where an application for confirmation of individual submission is filed pursuant to subparagraph 3 of Article 14 of the Decree).
(3) The President of the National Institute of Environmental Research in receipt of an application under paragraph (2) shall examine the details of the application after interviews with the applicant, on-site visits, etc. and shall give a notice of confirmation of individual submission in attached Form 11 within 14 days from the date of application. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 19 (Joint Use of Existing Data to Apply for Registration)
(1) "Data to apply for registration prescribed by Ordinance of the Ministry of Environment" in the main sentence of Article 16 (1) of the Act refers to the following data:
1. Data concerning the physical and chemical properties of chemical substances referred to in Article 14 (1) 5 of the Act;
2. Data concerning hazards of chemical substances referred to in Article 14 (1) 6 of the Act.
(2) Where a person uses data referred to in paragraph (1) to apply for registration after obtaining consent to such use from the owner pursuant to Article 16 (1) of the Act, the written consent from the owner shall be submitted to the President of the National Institute of Environmental Research when applying for registration under Article 10 (6) of the Act. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 20 (Inquiry of Whether Chemical Substance Has Been Registered)
(1) Each person who intends to make an inquiry under Article 16 (2) of the Act shall submit to the President of the National Institute of Environmental Research a written inquiry in attached Form 12 accompanied by the following documents: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to cases where the person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act makes an inquiry);
2. A document evidencing outsourcing, such as a copy of a contract for outsourcing (limited to cases where a person who outsources the manufacture of a chemical substance makes an inquiry).
(2) The President of the National Institute of Environmental Research shall notify whether the relevant chemical substance is registered by giving a notice of verification in attached Form 13 within 14 days from the date of receipt of the written inquiry under paragraph (1). In such cases, the President of the National Institute of Environmental Research shall notify the person who has submitted existing data to apply for registration of the information on the person who submits a written inquiry under paragraph (1).
 Article 21 (Consent to Use Vertebrate Animal Test Data)
(1) Any person who intends to obtain confirmation that the owner of vertebrate test data refuses to give consent under the main sentence of Article 17 (3) of the Act shall submit a written application for confirmation in attached Form 14 to the President of the National Institute of Environmental Research, along with the following documents: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. A document evidencing the refusal of the owner to provide vertebrate test data;
2. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to where the person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act files an application);
3. A document evidencing outsourcing, such as a copy of a contract for outsourcing (limited to cases where a person who outsources the manufacture of a chemical substance files an application).
(2) The President of the National Institute of Environmental Research shall give a written opinion concerning verification in attached Form 15 to the applicant within 14 days from the date of receipt of an application under paragraph (1). <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 22 (Period for Submission of Vertebrate Animal Test Data)
"Period prescribed by Ordinance of the Ministry of Environment" in the proviso of Article 17 (3) of the Act refers to such period required to produce the relevant vertebrate animal test data as notified by the President of the National Institute of Environmental Research when ordering the submission of the relevant vertebrate animal test data. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 22-2 (Imposition of Penalty Surcharges)
(1) Where the head of a river basin environmental office or the head of a regional environmental office (hereinafter referred to as "head of a regional environmental agency") intends to impose a penalty surcharge pursuant to Article 17-2 (1) of the Act, he or she shall give a penalty surcharge payment notice in attached Form 15-2 specifying the type of the violation, the amount of the penalty surcharge, etc.
(2) Any person who intends to apply for extending the payment deadline of a penalty surcharge pursuant to the former part of Article 15-3 (4) of the Decree, with the exception of its subparagraphs, shall submit to the head of the competent regional environmental agency a written application for extension of penalty surcharge payment deadline in attached Form 15-3 accompanied by documents evidencing the satisfaction of the requirements for extension of the payment deadline. In such cases, the head of the regional environmental agency shall provide a notice of the outcome of application for extension of the penalty surcharge payment deadline in attached Form 15-4 to the relevant applicant.
(3) Any person who intends to apply for installment payments of a penalty surcharge pursuant to the former part of Article 15-3 (4) of the Decree, with the exception of its subparagraphs, shall submit to the head of the competent regional environmental agency a written application for installment payments of a penalty surcharge in attached Form 15-5 accompanied by documents evidencing the satisfaction of the requirements for installment payments of the penalty surcharge. In such cases, the head of the regional environmental agency shall provide a notice of the outcome of the application for installment payments of the penalty surcharge in attached Form 15-6 to the relevant applicant.
(4) Except as otherwise provided in paragraphs (1) through (3), the Enforcement Rule of the Management of the National Funds Act shall apply mutatis mutandis to the procedures for imposing penalty surcharges.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
CHAPTER III HAZARD REVIEW AND RISK ASSESSMENT OF CHEMICAL SUBSTANCES
 Article 23 (Method for Hazard Review)
(1) The President of the National Institute of Environmental Research shall conduct a hazard review pursuant to Article 18 of the Act (hereinafter referred to as "hazard review") from the date of notifying registration under Article 6 (1) or registration of change under Article 9 (3) to the applicant. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) Notwithstanding paragraph (1), where a representative is designated and data to apply for registration of a phase-in substance are jointly submitted within the registration grace period pursuant to the main sentence of Article 15 (1) of the Act, with the exception of its subparagraphs, a hazard review shall be conducted from the earliest date of the following dates: <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The expiration date of the registration grace period;
2. The date on which the notice of registration to all the members of a consultative body including the representative is completed pursuant to Article 6 (1).
(3) A period for a hazard review referred to in paragraphs (1) and (2) shall not exceed the periods classified as follows. In such cases, the period from the date of issuing an order to submit data under Article 25 to the date of submitting the relevant data according to such order shall not be included therein: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. A non-phase-in substance: Six months: Provided, That where further review is required regarding the submitted data, the period may be extended two times by up to six months each time;
2. A phase-in substance: One year: Provided, That where further review is required regarding the submitted data, the period may be extended two times by up to one year each time.
(4) Where the President of the National Institute of Environmental Research conducts a hazard review, priorities may be determined in consideration of the following matters: <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The quantities of domestic manufacture or import;
2. The hazards of the relevant chemical substance;
3. Whether any damage has been caused to human health or the environment due to the relevant chemical substance.
(5) Methods for a hazard review shall be as listed in attached Table 9. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 24 (Notice of Findings of Hazard Review)
When a hazard review is completed, the President of the National Institute of Environmental Research shall notify the findings thereof to the person who has applied for registration under Article 10 (1) and (5) of the Act or for registration of changes under Article 12 of the Act by giving a notice of findings in attached Form 16; and in cases of non-phase-in substances, the President of the National Institute of Environmental Research shall give a written notification of results in attached Form 17 to the Minister of Employment and Labor. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 25 (Order to Submit Data Necessary for Hazard Review)
(1) In any of the following cases, the President of the National Institute of Environmental Research may order a person who has applied for registration or registration of change to submit data necessary for a hazard review by a fixed deadline by providing a written order for submission of data in attached Form 18, pursuant to Article 18 (2) of the Act. In such cases, the deadline for submission of such data shall be determined in consideration of the period required to produce the relevant data as deemed appropriate by the President of the National Institute of Environmental Research: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Where it is necessary to add other data or supplement the initial data based on the results of examining the data submitted to apply for either registration under Article 10 (1) and (5) of the Act or registration of change under Article 12 of the Act;
2. Where it is necessary to identify the hazards of the relevant chemical substance on the ground of likelihood of exposure to human health and the environment based on the results of examining the use of and information on exposure to a chemical substance registered pursuant to Article 10 (1) and (5) of the Act;
3. Where a chemical substance registered pursuant to Article 10 (1) and (5) of the Act is likely to be designated as a hazardous chemical substance;
4. Where it is necessary to submit the whole text of the test data which describes the test results without manipulating the processes, procedures, etc. applied to produce data concerning the physical and chemical properties and hazards of a chemical substance referred to in Article 5 (1) 1.
(2) The submission of data which may be ordered pursuant to paragraph (1) shall be as follows:
1. Data concerning the physical and chemical properties of the relevant chemical substance;
2. Data concerning the hazards of the relevant chemical substance.
 Article 26 (Methods for Hazard Assessment)
(1) The President of the National Institute of Environmental Research shall conduct a hazard assessment under Article 19 (1) of the Act of chemical substances listed in Article 16 of the Decree after determining the priority order thereof upon consideration of the following matters: Provided, That the chemical substances which urgently require a hazard assessment may be assessed with priority:
1. The quantities of the relevant chemical substance domestically manufactured, imported and exported;
2. Hazard level of the relevant chemical substance;
3. Whether the relevant chemical substance damages human health or the environment, etc.
(2) Relevant domestic and foreign statutes and regulations or systems regarding the registration, hazard review, etc. of chemical substances shall be considered in conducting a hazard assessment under paragraph (1).
(3) Attached Table 9 shall apply mutatis mutandis to the method for hazard assessment under paragraph (1).
 Article 27 (Method for Approval for Use)
(1) Any person who intends to obtain approval for using hazard assessment data referred to in Article 19 (2) of the Act (hereinafter referred to as "hazard data") shall submit a written application for approval for use in attached Form 19 to the President of the Corporation. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(2) The President of the Corporation in receipt of a written application under paragraph (1) shall issue a written approval for use in attached Form 20, where deemed appropriate in consideration of the purpose of approval for use. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(3) A person in receipt of a written approval for use pursuant to paragraph (2) may submit such written approval for use or a copy thereof to the relevant authority of a foreign country, where necessary for the registration of a chemical substance, the application for a hazard review, or any other purpose under statutes and regulations of the relevant foreign country.
(4) Deleted. <by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016>
(5) Except as otherwise provided in paragraphs (1) through (3), matters necessary for the methods of granting approval for the use of hazard data, etc. shall be determined and publicly notified by the Minister of Environment. <Amended by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 28 (Public Notification of Results of Hazard Review)
"Matters prescribed by Ordinance of the Ministry of Environment" in Article 21 (1) of the Act refers to the following matters:
1. The identification number of the relevant chemical substance;
2. Classification and labeling of the relevant chemical substance;
3. Other matters necessary for the safety control of the relevant chemical substance.
 Article 29 (Procedures for Designation of Testing Institutions)
(1) The head of a research institute who intends to apply for designation as a testing institution referred to in the former part of Article 22 (1) of the Act (hereinafter referred to as "testing institution") pursuant to the former part of paragraph (2) of the same Article shall submit a written application for designation in attached Form 21 to the Minister of Environment, along with the following documents: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. A detailed statement of the current status of facilities;
2. A detailed statement of the current status of operation;
3. Data proving testing capability.
(2) The Minister of Environment shall examine the written application for designation and data submitted under paragraph (1) and shall then issue a written designation in attached Form 22 to the applicant if such written application and documents satisfy the standards for designation under paragraph (5).
(3) "Important matter prescribed by Ordinance of the Ministry of Environment" in the latter part of Article 22 (2) of the Act refers to the following matters:
1. The name and representative of a testing institution;
2. Location of a testing institution or facility;
3. Detailed testing areas or detailed test items.
(4) The head of a research institute who intends to apply for change of designation pursuant to the latter part of Article 22 (2) of the Act shall submit a written application for change of designation in attached Form 23 to the Minister of Environment, along with the following documents. In such cases, the Minister of Environment shall modify a written designation in attached Form 22 and issue it to the applicant, if such written application and documents satisfy the standards for change of designation under paragraph (5):
1. The original copy of a written designation under paragraph (2);
2. Documents evidencing the changed matters.
(5) The head of a research institute who intends to obtain its designation as a testing institution or intends to change such designation pursuant to Article 22 of the Act shall satisfy the standards determined and publicly notified by the Minister of Environment, such as the exclusive organization and staff members, and research facilities and equipment necessary for performing the tasks of a testing institution.
 Article 30 (Evaluation of Testing Institutions)
(1) The President of the National Institute of Environmental Research shall conduct a regular evaluation of the business performance and follow-up management of a testing institution biannually from the date of designation pursuant to Article 22 (3) of the Act.
(2) The President of the National Institute of Environmental Research shall occasionally evaluate a testing institution to verify the propriety and creditability of the details and result of tests performed by the testing institution.
(3) The President of the National Institute of Environmental Research may establish and operate an investigative team comprised of the relevant public officials and experts to efficiently conduct the evaluation under paragraphs (1) and (2).
(4) Matters necessary for the standards for the evaluation concerning a testing institution under paragraphs (1) and (2), the details of the establishment and operation of an investigative team under paragraph (3), the management of a testing institution, etc. shall be determined and publicly notified by the Minister of Environment.
 Article 30-2 (Report by Testing Institutions)
In accordance with Article 22 (4) of the Act, a testing institution shall report its operational performance of the preceding year in attached Form 23-2 to the President of the National Institute of Environmental Research by January 31 of each year.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 31 (Criteria for Administrative Dispositions)
The criteria for administrative dispositions under Article 23 (5) of the Act shall be as listed in attached Table 10.
 Article 32 (Methods for Risk Assessment)
(1) The President of the National Institute of Environmental Research shall conduct risk assessments of chemical substances listed in each subparagraph of Article 24 (1) of the Act, after determining the priority thereof in consideration of the following:
1. The quantities of the relevant chemical substance domestically manufactured and imported;
2. Hazards of the relevant chemical substance;
3. Uses of and ways of using the relevant chemical substance;
4. Likelihood to damage human health or the environment;
5. Other available data concerning the risks of the relevant chemical substance.
(2) A risk assessment referred to in paragraph (1) shall be conducted based on the following data: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Data submitted to apply for registration under Article 10 (1) or (5) of the Act and registration of change under Article 12 of the Act;
2. Other recognized domestic and international information concerning the relevant chemical substance.
(3) Where the President of the National Institute of Environmental Research conducts a risk assessment under paragraph (1), he or she shall prepare a report on risk assessment, including the following matters:
1. The name of the chemical substance subject to the risk assessment;
2. The period of the risk assessment;
3. Assessment of the physical and chemical properties of the relevant chemical substance with respect to human health;
4. Hazard assessment of the relevant chemical substance with respect to human health and the environment;
5. Dose-response assessment of the relevant chemical substance;
6. Exposure assessment of the relevant chemical substance;
7. Risk level of the relevant chemical substance.
(4) Except as otherwise provided in paragraphs (1) through (3), matters necessary for detailed methods for risk assessments, such as selection of chemical substances subject to a risk assessment, shall be determined and publicly notified by the President of the National Institute of Environmental Research.
 Article 33 (Notice of Findings of Risk Assessment)
When completing a risk assessment under Article 32, the President of the National Institute of Environmental Research shall notify the findings thereof to the person who has applied for registration under Article 10 (1) or (5) of the Act or registration of change under Article 12 of the Act. In such cases, if any measure under Article 18 (1) of the Decree has been taken in relation to the relevant chemical substance, such measure shall be notified. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 34 (Order to Submit Data Necessary for Risk Assessment)
(1) In any of the following cases, the President of the National Institute of Environmental Research may order a person who has filed a registration or registration of change pursuant to Article 24 (2) of the Act to submit data necessary for a risk assessment by a fixed deadline by providing a written order for data submission in attached Form 24. In such cases, the deadline for data submission shall be determined in consideration of the period required to produce the relevant data as deemed appropriate by the President of the National Institute of Environmental Research: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Where it is necessary to add other data or supplement the initial data based on the result of examining data submitted to apply for either registration under Article 10 (1) or (5) of the Act or registration of change under Article 12 of the Act;
2. Where a chemical substance registered pursuant to Article 10 of the Act is likely to be designated as a hazardous chemical substance.
(2) The submission of data which may be ordered pursuant to paragraph (1) shall be as follows:
1. Data concerning the uses of the relevant chemical substance under Article 14 (1) 3 of the Act;
2. Data concerning the risks of the relevant chemical substance under Article 14 (1) 7 of the Act;
3. Data concerning the instructions for safe use under Article 14 (1) 8 of the Act;
4. Data under Article 12 (1);
5. Data concerning downstream users of the relevant chemical substance.
CHAPTER IV PROVISION OF INFORMATION ON CHEMICAL SUBSTANCES
 Article 35 (Provision of Information on Chemical Substances)
(1) "Information prescribed by Ordinance of the Ministry of Environment, such as the registration number, name, information on hazards and risks, and information on the safe use of the relevant chemical substance" in the main sentence of Article 29 (1) of the Act refers to the following information (hereinafter referred to as "chemical substance safety information"): <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The name or trade name, location and contact information of the provider of chemical substance safety information;
2. The name of product, and name or generic name of the relevant chemical substance;
3. The registration number, report number and identification number of the relevant chemical substance: Provided, That in cases of chemical substances falling under Article 29 (1) 2 of the Act, the registration number may be omitted;
4. Classification and labeling of the relevant chemical substance;
5. Permissible uses or restricted uses of the relevant chemical substance;
6. Information concerning the physical and chemical properties and health and environmental hazards of the relevant chemical substance;
7. Information concerning risks, such as summarized information of an exposure scenario, and measures to reduce risks;
8. Information on the content, etc. of any hazardous chemical substance, if any;
9. Information concerning the safe use of the relevant chemical substance, including handling methods, emergency response guidelines for a fire, etc., leakage control methods, protective equipment and disposal methods;
10. Information concerning regulation of the relevant chemical substance.
(2) Notwithstanding paragraph (1), trade secrets defined in subparagraph 2 of Article 2 of the Unfair Competition Prevention and Trade Secret Protection Act, such as ingredients and contents of the relevant chemical substance, shall be excluded from chemical substance safety information provided in paragraph (1): Provided, That this shall not apply where the relevant chemical substance is hazardous.
(3) Details of chemical substance safety information provided in paragraph (1) shall be consistent with those of data to apply for registration of the relevant chemical substance or data to report the relevant chemical substance. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) "Level prescribed by Ordinance of the Ministry of Environment" in Article 20-2 (2) of the Decree means the content criteria for classification as having physical risks, health hazards or environmental hazards pursuant to attached Table 7. <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 35 (Provision of Information on Chemical Substances)
(1) "Information prescribed by Ordinance of the Ministry of Environment, such as the registration number, name, information on hazards and risks, instructions for safe use of the relevant chemical substance" in the main sentence of Article 29 (1) of the Act refers to the following information (hereinafter referred to as "chemical substance safety information"): <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The name or trade name, location and contact information of the provider of chemical substance safety information;
2. The name of the product, and name or generic name of the relevant chemical substance;
3. The registration number, report number and identification number of the relevant chemical substance: Provided, That in cases of chemical substances falling under Article 29 (1) 2 of the Act, the registration number may be omitted;
4. Classification and labeling of the relevant chemical substance;
5. Permissible uses or restricted uses of the relevant chemical substance;
6. Information concerning the physical and chemical properties and health and environmental hazards of the relevant chemical substance;
7. Information concerning risks, such as summarized information of an exposure scenario, and measures to reduce risks;
8. Information on the content, etc. of any hazardous chemical substance, if any;
9. Information concerning the safe use of the relevant chemical substance, including handling methods, emergency response guidelines for a fire, etc., leakage control methods, protective equipment and disposal methods;
10. Information concerning regulation of the relevant chemical substance.
(2) Notwithstanding paragraph (1), trade secrets defined in subparagraph 2 of Article 2 of the Unfair Competition Prevention and Trade Secret Protection Act, such as ingredients and contents of the relevant chemical substance shall be excluded from chemical substance safety information provided in paragraph (1) in any of the following cases: Provided, That the relevant information shall be provided where the relevant chemical substance is a hazardous chemical substance or a chemical substance designated and publicly notified by the Minister of Environment pursuant to Article 10 (2) 1 of the Act, exceeding the content criteria for classification as having physical risks, health hazards or environmental hazards pursuant to attached Table 7: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Where chemical substances classified as being hazardous to health or the environment under attached Table 7 are approved by the Minister of Environment for exclusion from chemical substance safety information pursuant to Article 35-2;
2. In cases of chemical substances not classified as being hazardous to health and the environment under attached Table 7.
(3) Details of chemical substance safety information provided in paragraph (1) shall be consistent with those of data to apply for registration of the relevant chemical substance or data to report the relevant chemical substance. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) "Level prescribed by Ordinance of the Ministry of Environment" in Article 20-2 (2) of the Decree means the content criteria for classification as having physical risks, health hazards or environmental hazards pursuant to attached Table 7. <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
[Enforcement Date: Jan. 1, 2020] Article 35 (2)
 Article 35-2 (Approval of Scope of Provision of Chemical Substance Safety Information)
(1) A person who intends to exclude the composition, contents, etc. of a chemical substance from chemical substance safety information pursuant to Article 35 (2) 1 shall apply to the Minister of Environment for approval concerning the scope of exclusion from chemical substance safety information, including the following matters:
1. The identification information of the chemical substance, including its name and registration number;
2. Application information for approval of exclusion from chemical substance safety information and the grounds for such application.
(2) Upon receipt of an application for approval prescribed in paragraph (1), the Minister of Environment shall determine whether information on the composition, contents, etc. of the relevant chemical substance can be excluded from the chemical substance safety information, after deliberation by the information provision review committee under Article 7 of the Decree, and he or she shall notify the relevant applicant of the results thereof.
(3) Where it is necessary to determine the scope of exclusion from the chemical substance safety information pursuant to paragraph (2), the Minister of Environment may request cooperation from related organizations, such as the Corporation.
(4) The Minister of Environment may revoke the relevant approval, where any person who has obtained an approval as to the scope of exclusion from the chemical safety substance information under paragraph (2) falls under any of the following cases:
1. Where the approval has been obtained by fraud or other improper means;
2. Where information on the hazards or risks of the approved chemical substance is newly found, which is likely to cause harm to the public health.
(5) Except as otherwise provided in paragraphs (1) through (4), matters necessary for the application for approval, approval procedures, etc. shall be determined and publicly notified by the Minister of Environment.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
[Enforcement Date: Jan. 1, 2020] Article 35-2
 Article 36 (Methods for Providing Information on Chemical Substances)
(1) Chemical substance safety information shall be prepared based on information included in the data sheet in attached Form 25: Provided, That where a material safety data sheet referred to in Article 41 of the Occupational Safety and Health Act is required to be prepared and provided pursuant to the proviso of Article 29 (1) of the Act, such data sheet shall be provided, along with the chemical substance safety information (on risks) data sheet prepared in attached Form 26.
(2) A chemical substance safety information data sheet prepared under paragraph (1) shall be provided in writing or by electronic means before or at the same time as the transfer of either the relevant chemical substance or any mixture containing such chemical substance. <Amended by Ordinance of the Ministry of Environment No. 615, Oct. 30, 2015; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(3) Matters necessary for methods for preparing a chemical substance safety information data sheet shall be determined and publicly notified by the President of the National Institute of Environmental Research.
 Article 37 (Methods for Providing Changed Information)
"Change determined by Ordinance of the Ministry of Environment" in Article 29 (3) of the Act refers to the following:
1. Where new information on physical and chemical properties and hazards of the relevant chemical substance is provided by a notice of findings of a hazard review under Article 18 (1) of the Act;
2. Where new information on risks of the relevant chemical substance is provided by a notice of findings of a risk assessment under Article 24 (1) of the Act;
3. Where new uses of the relevant chemical substance transferred pursuant to Article 29 (1) of the Act or of a mixture containing such chemical substance become available;
4. Where information on new regulation of the relevant chemical substance becomes available.
 Article 38 (Provision of Information by Downstream Users)
(1) Chemical substance safety information to be provided by the downstream user and the seller of a chemical substance or a mixture thereof pursuant to Article 30 (1) of the Act shall be as follows:
1. Names or trade names of the downstream users and sellers;
2. The name or generic name of the relevant chemical substance and the product name thereof;
3. Quantities of the relevant chemical substance used and sold;
4. Detailed uses of the relevant chemical substance;
5. Information on the exposure to the relevant chemical substance;
6. Details of any measure taken for the safe use of the relevant chemical substance.
(2) Chemical substance safety information to be provided by the manufacturer and importer of a chemical substance or a mixture thereof pursuant to Article 30 (2) of the Act shall be as follows:
1. Names or trade names of the manufacturers and importers;
2. The name or generic name of the relevant chemical substance and the product name thereof;
3. Quantities of the relevant chemical substance manufactured and imported;
4. Permissible uses or restricted uses of the relevant chemical substance;
5. Information concerning the safe use of the relevant chemical substance including handling methods, emergency response guidelines for a fire, etc., leakage control methods, protective equipment and disposal methods;
6. Information on physical and chemical properties and hazards of the relevant chemical substance;
7. Information on regulation of the relevant chemical substance.
(3) Notwithstanding paragraphs (1) and (2), trade secrets defined in subparagraph 2 of Article 2 of the Unfair Competition Prevention and Trade Secret Protection Act, such as ingredients and contents of the relevant chemical substance or a mixture thereof, shall be excluded from chemical substance safety information under paragraphs (1) and (2): Provided, That the relevant information shall be provided if the relevant chemical substance or a mixture thereof is a hazardous chemical substance or a chemical substance designated and publicly notified by the Minister of Environment pursuant to Article 10 (2) 1 of the Act, exceeding the content criteria for classification as having physical risks, health hazards or environmental hazards under attached Table 7. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) Matters necessary for the methods for preparing a chemical substance safety information data sheet referred to in paragraphs (1) and (2) shall be determined and publicly notified by the President of the National Institute of Environmental Research.
 Article 39 (Methods for Providing Information by Downstream Users)
(1) Chemical substance safety information referred to in Article 30 (1) and (2) of the Act shall be provided by submitting a chemical substance safety information data sheet in attached Form 27.
(2) Any person who shall provide chemical substance safety information pursuant to Article 30 (1) and (2) of the Act shall submit a chemical substance safety information data sheet to the person requesting such information within one month from the date of such request.
 Article 40 (Methods and Procedures for Notification to Provide Information)
(1) In any of the following cases, the President of the National Institute of Environmental Research shall notify the person registered under Article 10 of the Act and the person who has submitted a report pursuant to Article 32 of the Act pursuant to Article 31 of the Act:
1. Where new information becomes available as a result of a hazard review under Article 18 (1) of the Act;
2. Where new information becomes available as a result of a risk assessment under Article 24 (1) of the Act;
3. Where the relevant chemical substance is designated, or is designated after modification, as a hazardous chemical substance.
(2) Notwithstanding paragraph (1), the President of the National Institute of Environmental shall be deemed to have notified pursuant to paragraph (1) where any of the following actions has been taken:
1. Notice of the findings of a hazard review under Article 18 (1) of the Act or a risk assessment under Article 24 (1) of the Act;
2. Designation and public notification of a toxic substance, substance subject to permission, restricted substance or prohibited substance under Article 20, 25 (1) or 27 (1) of the Act;
3. Disclosure of the findings of a hazard review under Article 21 of the Act;
4. Cancellation of the designation of a substance subject to permission, restricted substance or prohibited substance under Article 26 or 28 of the Act.
CHAPTER V CONTROL OF PRODUCTS CONTAINING CHEMICAL SUBSTANCES
 Article 41 (Methods for Reporting Substances Subject to Intensive Control Contained in Products)
(1) Each producer or importer of a product containing a substance subject to intensive control shall submit a report on the substances subject to intensive control contained in the products in attached Form 28 for each substance subject to intensive control to the head of a regional environmental agency, along with the following documents, before such product is produced or imported from the next day after it is confirmed that the total quantities of respective chemical substances contained (referring to where the weight ratio of a substance subject to intensive control to the relevant product exceeds 0.1 percent) therein exceed one ton per year: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. A manual of the relevant product;
2. A photograph of the relevant product;
3. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to where the person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act submits a report);
4. A written application for data protection (limited to where the data protection pursuant to Article 45 (1) of the Act is requested);
5. A document evidencing outsourcing, such as a copy of a contract for outsourcing (limited to where the person who outsources the manufacture of a chemical substance submits a report).
(2) Notwithstanding paragraph (1), where a person has an extenuating circumstance preventing confirmation of the total quantities of respective chemical substances contained in a product and it is estimated that such total quantities exceed one ton per year, he or she shall submit personal identification information and the reasons for such circumstance to the head of a regional environmental agency before producing or importing the relevant product and shall submit a report and documents under paragraph (1) by April 30 of the following year.
(3) The head of a regional environmental agency in receipt of a report under paragraphs (1) and (2) shall verify the corporate registration certificate or the business registration certificate through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the reporting person withholds consent to the verification of the business registration certificate, the head of the regional environmental agency shall require such person to attach the relevant certificate. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) Where it is necessary to modify or supplement any data submitted pursuant to paragraph (1) or (2), the head of a regional environmental agency shall request the modification or supplementation. In such cases, the person in receipt of such request shall immediately modify and supplement such data and submit them. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(5) The head of a regional environmental agency shall issue a report certificate in attached Form 29 within seven days from the date of receipt of a report on a product containing substances subject to intensive control pursuant to paragraph (1) or (2). In such cases, the period from the date of requesting the modification or supplementation pursuant to paragraph (4) to the date of submission of modified or supplemented data shall be excluded from the seven days. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(6) Except as otherwise provided in paragraphs (1) through (5), matters necessary for the methods of reporting, etc. shall be determined by the Minister of Environment. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Articles 42 through 44 Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 45 (Provision of Information on Chemical Substances Contained in Products)
(1) "Information prescribed by Ordinance of the Ministry of Environment, such as the name, uses and conditions of the substance subject to intensive control" in Article 35 (1) of the Act refers to the following information: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The trade name of the relevant product;
2. Names and contents of substances subject to intensive control contained in the relevant product;
3. Permissible uses or restricted uses of the relevant product;
4. Methods for proper use of the relevant product and conditions of use thereof;
5. Precautionary measures in handling the relevant product, such as exposure response guidelines.
(2) Where the customer of a product requests the provision of information thereon, the person who transfers such product pursuant to Article 35 (2) of the Act shall provide the information under paragraph (1).
(3) Notwithstanding paragraph (1), trade secrets defined in subparagraph 2 of Article 2 of the Unfair Competition Prevention and Trade Secret Protection Act, such as ingredients and contents of chemical substances contained in the relevant product, shall be excluded from the information under paragraph (1): Provided, That this shall not apply to consumer chemical products subject to safety verification prescribed in subparagraph 4 of Article 3 of the Act on Safety Control of Consumer Chemical Products and Biocides. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) Details of information under paragraph (1) shall correspond with those reported pursuant to Article 32 (1) of the Act. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 46 (Methods for Providing Information on Chemical Substances Contained in Product)
(1) Information described in Article 45 (1) and (2) shall be provided by issuing a data sheet in attached Form 32.
(2) A data sheet prepared pursuant to paragraph (1) shall be issued before or at the same time as the transfer of a product containing substances subject to intensive control reported pursuant to Article 32 (1) of the Act: Provided, That where the customer of the product requests the provision of information pursuant to Article 35 (2) of the Act, such information shall be provided free of charge within 45 days from the date of receipt of such request. <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(3) Matters necessary for the methods of compiling data sheets under paragraph (1) shall be determined and publicly notified by the President of the National Institute of Environmental Research.
 Articles 47 and 48 Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
CHAPTER VI SUPPLEMENTARY PROVISIONS
 Article 49 (Requirements, etc. for Persons Appointed by Overseas Manufacturer or Producer)
(1) "Person meeting the requirements prescribed by Ordinance of the Ministry of Environment" in Article 38 (1) of the Act, with the exception of its subparagraphs, refers to a person qualified as follows:
1. A citizen of the Republic of Korea;
2. A person domiciled (referring to a place of business in cases of a corporation) in the Republic of Korea.
(2) Each person who intends to report appointment or dismissal pursuant to Article 38 (2) of the Act shall submit a written appointment or written dismissal in attached Form 33 to the head of the relevant regional environmental agency, the President of the National Institute of Environmental Research, or the President of the Corporation, along with the following documents: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
1. A document evidencing the requirements described in paragraph (1);
2. A document evidencing the appointment or dismissal, such as a copy of an agreement on appointment.
(3) Upon receipt of a report pursuant to paragraph (2), the head of a regional environmental agency, the President of the National Institute of Environmental Research or the President of the Corporation shall verify the corporate registration certificate or the business registration certificate through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the reporting person withholds consent to the verification of the business registration certificate, such person shall be required to attach the relevant certificate. <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
(4) Within seven days from the date of receipt of a report under paragraph (2), the head of the relevant regional environmental agency, the President of the National Institute of Environmental Research or the President of the Corporation shall issue a report certificate in attached Form 34. <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
(5) Deleted. <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 50 (Application for Designation of Green Chemical Center)
(1) Each institution which intends to apply for designation pursuant to Article 26 (2) of the Decree shall submit a written application for designation in attached Form 35 to the Minister of Environment, along with the documents listed in Article 26 (2) of the Decree.
(2) The Minister of Environment in receipt of a written application for designation under paragraph (1) shall verify the certificate of incorporation or business registration certificate of the applicant through administrative information sharing under Article 36 (1) of the Electronic Government Act: Provided, That where the reporting person withholds consent to the verification of his or her certificate of incorporation or business registration certificate, he or she shall require such person to attach the relevant certificate.
(3) A written designation as a green chemical center under Article 26 (3) of the Decree shall be in attached Form 36.
 Article 51 (Disclosure of Information on Chemical Substances)
(1) The President of the National Institute of Environmental Research shall disclose the following information on the website of the National Institute of Environmental Research, etc. pursuant to Article 42 of the Act: Provided, That where the name of a chemical substance is subject to the data protection under Article 45 (1) of the Act, the generic name of such chemical substance shall be disclosed in lieu of the name thereof until the period for such data protection expires: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. The name and identification number of the relevant chemical substance;
2. Uses of the relevant chemical substance according to the use classification system of chemical substances;
3. Classification and labeling of the relevant chemical substance;
4. Whether the chemical substance constitutes a toxic substance, substance subject to permission, restricted substance or prohibited substance;
5. Physical and chemical properties of the relevant chemical substance;
6. Hazards and risks of the relevant chemical substance;
7. Details of safe use of the relevant chemical substance, such as precautions in handling.
(2) In accordance with Article 42 of the Act, the President of the Corporation shall disclose on the website of the Corporation, etc. information regarding the name of chemical substances for which a report or a report on changes has been filed pursuant to Article 10 (3) of the Act, the range of the maximum manufacture or import quantities per chemical substance, the classification and labeling of a chemical substance, whether the uses of a chemical substance include consumer uses, etc. <Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
 Article 52 (Access and Inspection)
(1) Access and inspection under Article 43 of the Act shall be conducted where any of the following grounds exists: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Where access and inspection are conducted according to a plan for regular guidance and inspection as provided by the head of a regional environmental agency to ensure the proper management of chemical substances and products containing chemical substances;
2. Where the risks of chemical substances and products containing chemical substances have caused or are likely to cause harm to public health or the environment;
3. Where any other agency requests access and inspection with legitimate authority or a civil petition therefor is filed;
4. Where it is necessary to verify whether any duty under the Act has been fulfilled regarding chemical substances, such duties as applying for registration or registration of changes; filing a report or a report on changes; confirming exemption from registration, etc.; and reporting any substance subject to intensive control contained in products;
5. Where it is necessary to verify whether any data to be protected under Article 45 (1) of the Act is appropriately managed to a level that the protection thereof may be requested.
(2) Where the Minister of Environment, the President of the National Institute of Environmental Research or the head of the relevant regional environmental agency accesses a place of business, etc. for inspections pursuant to Article 43 of the Act, he or she shall collectively conduct access and inspection if the facilities or places of business subject to the following access and inspection are identical: Provided, That the same shall not apply where such integrated access and inspection are deemed impracticable due to civil petitions, environmental pollution, wide-area monitoring activities or operation of human resources: <Amended by Ordinance of the Ministry of Environment No. 745, Jan. 17, 2018; Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Access and inspection under Article 41 (1) or (2) of the Act on the Management and Use of Livestock Excreta;
2. Access and inspection under Article 82 (1) of the Clean Air Conservation Act;
2-2. Access and inspection under Article 50 (1) of the Act on Safety Control of Consumer Chemical Products and Biocides;
3. Access and inspection under Article 47 (1) of the Noise and Vibration Control Act;
4. Access and inspection under Article 68 (1) of the Water Environment Conservation Act;
5. Access and inspection under Article 39 (1) of the Wastes Control Act;
6. Access and inspection under Article 69 (1) or (2) of the Sewerage Act;
7. Access and inspection under Article 49 (1) of the Chemical Substances Control Act;
8. Access and inspection under Article 30 (1) of the Act on the Integrated Control of Pollutant-Discharging Facilities.
 Article 53 (Inspection Institutions)
Where the head of a regional environmental agency sampled chemical substances pursuant to Article 43 (1) of the Act, he or she may request verification, testing or inspection of such chemical substances or products containing such chemical substances to any of the following entities: <Amended by Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016>
1. The National Institute of Environmental Research;
2. The Corporation;
3. Public health and environment research institutes established in the Special Metropolitan City, Metropolitan Cities, Dos and the Special Self-Governing Province pursuant to the Public Health and Environment Research Institute Act;
4. The Korea Environmental Industry and Technology Institute under the Act on the Korea Environmental Industry and Technology Institute;
5. Testing and inspection institutions recognized under Article 23 (2) of the Framework Act on National Standards.
 Article 54 (Recording and Retaining Documents)
(1) Any person required to record and retain documents pursuant to Article 44 of the Act shall record and retain the following documents related to the manufacturing, import, sale and use of the relevant chemical substances for five years. In such cases, the documents referred to in subparagraph 8 shall be recorded and retained for five years from the date the period for data protection under Article 30 of the Decree expires: <Amended by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
1. Deleted; <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
2. Data related to registration and registration of changes and a report and a report on changes of a chemical substance under Articles 10 and 12 of the Act;
2-2. Management register of transported isolated intermediates in attached Form 3 related to the registration of transported isolated intermediates under Article 10 of the Act and subparagraph 2-2 of Article 13 of the Decree;
3. Data related to confirmation of exemption from registration, etc. of a chemical substance under Article 11 of the Act;
4. Data related to the report on substances subject to intensive control contained in products under Article 32 (1) of the Act;
5. and 6. Deleted; <by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
7. Data concerning information provided under Articles 29, 30 and 35 of the Act;
8. Data subject to data protection under Article 45 (1) of the Act.
(2) Documents concerning the affairs under Article 22 of the Decree among documents to be recorded and retained pursuant to paragraph (1) may be electronically recorded and retained.
 Article 55 (Application for Data Protection)
(1) Any person who intends to apply for data protection pursuant to the main sentence of Article 45 (1) of the Act shall submit a written application for data protection in attached Form 37 to the President of the National Institute of Environmental Research, the head of the relevant regional environmental agency or the President of the Corporation, along with the following documents. The same shall apply to the application for the extension of the period for data protection pursuant to the proviso of Article 30 (1) of the Decree: <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
1. A copy of notice of the receipt and result of processing an application for data protection (limited to where an application for the extension of the period for data protection is filed);
2. A certificate of reporting the appointment by an overseas manufacturer or producer (limited to where the person appointed by the overseas manufacturer or producer pursuant to Article 38 of the Act files an application).
(2) Upon receipt of a written application for data protection under paragraph (1), the President of the National Institute of Environmental Research, the head of the relevant regional environmental agency or the President of the Corporation shall examine whether the relevant data is subject to protection and notify the applicant of the result by providing a notice of the receipt and results of processing an application in attached Form 38. <Amended by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
(3) Matters necessary for the methods for preparing a written application for data protection under paragraph (1), methods for managing protected data, etc. shall be determined and publicly notified by the Minister of Environment.
 Article 55-2 (Requests for Cancellation of Data Protection)
(1) Any person who intends to request cancellation of data protection pursuant to Article 45 (3) of the Act shall submit a written request for cancellation of data protection in attached Form 38-2 to the President of the National Institute of Environmental Research, the head of a regional environmental agency or the President of the Corporation.
(2) The President of the National Institute of Environmental Research, the head of a regional environmental agency or the President of the Corporation shall notify the results of the request for cancellation of data protection submitted pursuant to paragraph (1) to the person who has made such request by providing a notice of the results of cancellation of data protection in attached Form 38-3.
[This Article Newly Inserted by Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018]
 Article 56 (Fees)
(1) Fees provided in Article 46 of the Act shall be as listed in attached Table 11.
(2) Fees referred to in paragraph (1) shall be payable either by means of revenue stamps or by means of electronic currencies, electronic settlement, etc. through an information and communication network.
ADDENDA
Article 1 (Enforcement Date)
This Rule shall enter into force on January 1, 2015.
Article 2 (Documents to Be Submitted by Persons Who Have Completed Hazard Review at Time of Reporting)
(1) "Form prescribed by Ordinance of the Ministry of Environment" in Article 3 (1) of the Addenda to the Decree refers to a report in attached Form 39.
(2) "Data prescribed by Ordinance of the Ministry of Environment" in Article 3 (1) of the Addenda to the Decree refers to the following data:
1. A notice of the findings of a hazard review under Article 12 of the previous Toxic Chemical Substances Control Act;
2. Information concerning manufacturers or importers who have given a notice under subparagraph 1 (referring to information concerning the intial owner where a notice is given);
3. Data verifying the quantities of the relevant chemical substance manufactured and imported for the preceeding three years including the relevant year.
(3) The President of the National Institute of Environmental Research shall review the appropriateness of data submitted pursuant to paragraphs (1) and (2) and provide a notice of report in attached Form 40 to the reporting person.
Article 3 Deleted. <by Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
Article 4 (Transitional Measures concerning Non-Phase-In Substances for Which Exemption from Hazard Review Has Been Confirmed)
Notwithstanding Article 5 (1), any person who intends to manufacture or import a non-phase-in substance for which confirmation of exemption from a hazard review is notified under Article 12 of the previous Toxic Chemical Substances Control Act and Article 8 (1) of the Rule of the same Act shall apply for registration by the following dates:
1. A non-phase-in substance referred to in Article 10 (1) 3 of the previous Toxic Chemical Substances Control Act and subparagraph 1 of Article 9 of the previous Enforcement Decree of the Toxic Chemical Substances Control Act: December 31, 2015;
2. A non-phase-in substance referred to in Article 10 (1) 3 of the previous Toxic Chemical Substances Control Act and subparagraph 5 of Article 9 of the previous Enforcement Decree of the Toxic Chemical Substances Control Act: December 31, 2017.
ADDENDUM <Ordinance of the Ministry of Environment No. 615, Oct. 30, 2015>
This Rule shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Ministry of Environment No. 672, Aug. 4, 2016>
Article 1 (Enforcement Date)
This Rule shall enter into force on January 28, 2017: Provided, That the amended provisions of the latter part of Article 7 (1), with the exception of its subparagraphs, Articles 17 (5) and 27 (4) and (5) and attached Form 27 shall enter into force on the date of promulgation and the amended provisions of subparagraph 4 of Article 53 shall enter into force on December 2, 2016.
Article 2 (Transitional Measures concerning Reporting Results of Confirmation of Exemption from Registration)
Notwithstanding the amended provisions of Articles 8 (3) and 42 (5), the previous provisions shall apply to reporting the records of current status and the performance of notifications concerning applications for confirmation of exemption from registration or applications for confirmation of exemption from reporting a product containing hazardous chemical substances which are received by the head of the relevant association pursuant to the previous Article 7 (1) or 42 (1) before this Rule enters into force.
ADDENDA <Ordinance of the Ministry of Environment No. 740, Jan. 15, 2018>
Article 1 (Enforcement Date)
This Rule shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures concerning Period of Notice of Whether Non-Phase-In Substances Have Been Registered)
Where an application for registration is filed pursuant to Article 10 (3) of the Act before this Rule enters into force, notwithstanding the amended provisions of Article 6 (1) 2, the previous provisions shall apply to the period of notice of whether the registration has been filed.
Article 3 (Transitional Measures concerning Period of Notice of Whether Exemption from Registration Is to Be Granted)
Notwithstanding the amended provisions of Article 8 (1), the previous provisions shall apply where an application for confirming exemption from registration is filed pursuant to Article 11 (2) of the Act before this Rule enters into force.
Article 4 (Transitional Measures concerning Registration of Changes in Chemical Substances)
Notwithstanding the amended provisions of Article 9 (1) and (3), the previous provisions shall apply where an application for registration of changes is filed pursuant to Article 12 (1) of the Act before this Rule enters into force.
ADDENDA <Ordinance of the Ministry of Environment No. 745, Jan. 17, 2018>
Article 1 (Enforcement Date)
This Rule shall enter into force on January 18, 2018.
Articles 2 through 4 Omitted.
ADDENDA <Ordinance of the Ministry of Environment No. 790, Dec. 28, 2018>
Article 1 (Enforcement Date)
This Rule shall enter into force on January 1, 2019: Provided, That the amended provisions of Articles 35 (2) and 35-2 shall enter into force on January 1, 2020.
Article 2 (Transitional Measures concerning Standards for Administrative Dispositions)
Any administrative disposition imposed for violations committed before this Rule enters into force shall not be counted when calculating the number of violations under the amended provisions of subitems (iv) through (vi) of subparagraph 2 of attached Table 10.
Article 3 (Transitional Measures concerning Report by Persons Who Have Undergone Hazard Review)
(1) "Report prescribed by Ordinance of the Ministry of Environment" in the main sentence of Article 2 (1) of the Addenda to the Enforcement Decree of the Act on Registration and Evaluation of Chemical Substances (Presidential Decree No. 29413), with the exception of its subparagraphs, means a report in attached Form 39.
(2) "Data prescribed by Ordinance of the Ministry of Environment" in the main sentence of Article 2 (1) of the Addenda to the Enforcement Decree of the Act on Registration and Evaluation of Chemical Substances (Presidential Decree No. 29413), with the exception of its subparagraphs, means the following data:
1. A notice of the findings of a hazard review prescribed in Article 12 of the previous Toxic Chemical Substances Control Act;
2. Data verifying the manufacture or import quantities of the relevant chemical substance over the recent three years including the relevant year.
(3) The President of the National Institute of Environmental Research shall review the appropriateness of data submitted pursuant to paragraphs (1) and (2) and notify the results thereof to the person who has filed the report by providing a notice of report in attached Form 40.
Article 4 (Transitional Measures concerning Registration of Non-Phase-In Substances)
Any person who intends to submit data regarding the manufacture or import quantities of non-phase-in substances pursuant to Article 3 (1) of the Addenda to the Enforcement Decree of the Act on Registration and Evaluation of Chemical Substances (Presidential Decree No. 29413) shall submit to the President of the National Institute of Environmental Research a report on the manufacture or import quantities of non-phase-in substances in attached Form 41, along with documents verifying the manufacture or import quantities of the relevant chemical substances from the year in which the notice of registration is received pursuant to Article 10 (4) of the previous Act on Registration and Evaluation of Chemical Substances (referring to the Act on Registration and Evaluation of Chemical Substances prior to its amendment by Act No. 15512) to the year 2018.