영문법령 불러오는 중…

ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES — 법갈피

영문법령 / ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES

ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES

법률일부개정시행 2024-01-04기후에너지환경부,기후에너지환경부,기후에너지환경부 · 제19172호 · 공포 2023-01-03

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

The purpose of this Act is to protect public health and the environment by providing for matters regarding the registration and reporting of chemical substances, the review and assessment of hazards and risks of chemical substances, and the designation of hazardous chemical substances, and by producing and utilizing information on chemical substances. <Amended on Mar. 20, 2018>

Article 2(Definitions) #

The terms used in this Act are defined as follows: <Amended on Mar. 20, 2018; Apr. 17, 2018>

1. The term "chemical substance" means an element, its compounds and substances obtained by artificial chemical reaction thereto, and substances obtained by chemical modification, extraction or purification of substances in their natural state;

2. The term "mixture" means a substance or solution composed of at least two substances;

3. The term "phase-in substance" means any of the following chemical substances:

(a) Chemical substances publicly notified by the Minister of Environment in consultation with the Minister of Employment and Labor, which were domestically distributed for commercial purposes before February 2, 1991;

(b) Chemical substances publicly notified by the Minister of Environment and where the hazard reviews thereof have been conducted pursuant to the previous Toxic Chemical Substances Control Act after February 2, 1991;

4. The term "non-phase-in substance" means all chemical substances excluding phase-in substances;

5. Deleted; <Mar. 20, 2018>

6. The term "toxic substance" means a hazardous chemical substance designated and publicly notified by the Minister of Environment according to the standards prescribed by Presidential Decree;

7. The term "substance subject to permission" means a chemical substance likely to pose a risk, which is publicly notified by the Minister of Environment after consultation with the heads of relevant central administrative agencies in accordance with Article 25 and deliberation by the Chemicals Evaluation Committee prescribed in Article 7 to be manufactured, imported, or used with permission of the Minister of Environment;

Article 3(Scope of Application) #

This Act shall not apply to any of the following chemical substances: <Amended on Mar. 20, 2018; Apr. 13, 2021>

1. Radioactive materials defined in subparagraph 5 of Article 2 of the Nuclear Safety Act;

2. Drugs defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act and quasi-drugs defined in subparagraph 7 of the said Article;

3. Narcotics defined in subparagraph 1 of Article 2 of the Act on the Narcotics Control Act;

4. Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act and raw materials used for cosmetics;

5. Pesticides defined in subparagraph 1 of Article 2 of the Pesticide Control Act and active ingredients defined in subparagraph 3 of the said Article;

6. Fertilizers defined in subparagraph 1 of Article 2 of the Fertilizer Control Act;

7. Foods defined in subparagraph 1 of Article 2 of the Food Sanitation Act, food additives defined in subparagraph 2 of the said Article, apparatus defined in subparagraph 4 of the said Article, containers and packages defined in subparagraph 5 of the said Article;

8. Feed defined in subparagraph 1 of Article 2 of the Control of Livestock and Fish Feed Act;

9. Explosives defined in Article 2 (3) of the Act on Control of Guns, Swords, and Explosives;

10. Munitions defined in Article 2 of the Act on the Management of Military Supplies and subparagraph 2 of Article 3 of the Defense Acquisition Program Act (excluding ordinary commodities prescribed in Article 3 of the Act on the Management of Military Supplies);

11. Health functional foods defined in subparagraph 1 of Article 3 of the Health Functional Foods Act;

12. Medical devices defined in Article 2 (1) of the Medical Devices Act;

13. Hygiene products defined in subparagraph 1 of Article 2 of the Hygiene Products Control Act;

14. Biocidal substances and biocidal products defined in subparagraphs 7 and 8 of Article 3 of the Act on Safety Control of Consumer Chemical Products and Biocides;

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

Article 6(Master Plan for Evaluation of Chemical Substance) #

(1) The Minister of Environment shall formulate a master plan for registering, reporting, and evaluating chemical substances, and reporting substances subject to intensive control contained in products, etc. (hereinafter referred to as "master plan") every five years. <Amended on Mar. 20, 2018; May 26, 2020>

(2) Where the Minister of Environment formulates a master plan, prior consultations shall be undertaken with the heads of relevant central administrative agencies and the master plan shall be subject to deliberation by the Chemicals Evaluation Committee prescribed in Article 7. The same shall also apply to the revision of the master plan.

(3) A master plan shall include the following: <Amended on Mar. 20, 2018; May 26, 2020>

1. Methods and plans for registering and reporting chemical substances, hazard reviews and risk assessments, reporting substances subject to intensive control contained in products, etc.;

2. Matters relating to registering and reporting chemical substances, reporting substances subject to intensive control contained in products, developing technology necessary for hazard reviews and risk assessments, etc.;

3. Matters relating to surveys and research, safety management, and international cooperation related to hazards and risks of chemical substances;

4. Matters relating to industrial activities to prevent any harm caused by chemical substances to public health or the environment, safety support and education for workers and consumers;

5. Other matters necessary for registering and reporting chemical substances, hazard reviews, risk assessments, etc.

(4) Where the Minister of Environment formulates a master plan, he or she shall notify the heads of relevant central administrative agencies and the heads of local governments of the details thereof without delay.

(5) The head of each relevant central administrative agency and the head of each local government shall formulate and implement policies regarding matters under his or her jurisdiction in accordance with the master plan.

Article 7(Chemicals Evaluation Committee) #

(1) The Chemicals Evaluation Committee (hereinafter referred to as the "Evaluation Committee") shall be established under the jurisdiction of the Minister of Environment to deliberate on the following related to registering and reporting chemical substances, reporting substances subject to intensive control contained in products, hazard reviews, risk assessments, etc.: <Amended on Mar. 20, 2018; May 26, 2020>

1. Matters relating to the formulation of master plans;

2. Matters relating to the designation of substances subject to intensive control;

3. Matters relating to substances subject to permission, restricted substances, or prohibited substances;

4. Matters relating to the designation of chemical substances to be registered pursuant to Article 10 (5);

4-2. Matters relating to the designation of chemical substances exempted from registration, etc. pursuant to Article 11 (1) 2;

5. Deleted; <Mar. 20, 2018>

6. Other matters prescribed by Presidential Decree regarding registration and reporting of chemical substances and the hazard review, risk assessment, safety management, etc. of chemical substances.

(2) The Evaluation Committee shall be composed of up to 30 members, including 1 chairperson and 1 vice chairperson.

(3) The Vice Minister of Environment shall be the chairperson of the Evaluation Committee and the vice chairperson shall be elected from among, and by, the members.

(4) The Minister of Environment shall appoint or commission members of the Evaluation Committee from among the following persons: <Amended on Mar. 20, 2018>

1. Persons recommended by the head of the relevant central administrative agency in charge of affairs relating to chemical substances from among public officials belonging to such agency;

2. Experts with profound knowledge and experience in relevant fields, such as chemistry, the environment and public health, and relevant persons in the industry and non-governmental organizations related to chemical substances;

3. Persons recommended by the heads of relevant central administrative agencies from among the persons referred to in subparagraph 2.

(5) A majority of the members of the Evaluation Committee shall constitute a quorum, and any decision thereof shall require the concurring vote of a majority of those present.

(6) Where it is necessary to conduct professional research and examination of matters to be deliberated by the Evaluation Committee, expert committees for each area may be established, such as a risk assessment committee composed of members of the Evaluation Committee and experts in the relevant fields. <Amended on Mar. 20, 2018>

(7) Except as provided in paragraphs (1) through (6), matters necessary for the composition and operation of the Evaluation Committee and expert committees shall be prescribed by Presidential Decree.

Article 10(Registration of Chemical Substance) #

(1) Any person who intends to manufacture or import at least 100 kilograms of a non-phase-in substance per year or at least 1 ton of a phase-in substance per year (excluding a person falling under paragraph (4) 2) shall register the chemical substance with the Minister of Environment before it is manufactured or imported. <Amended on Mar. 20, 2018>

(2) Notwithstanding paragraph (1), any person who intends to manufacture or import a phase-in substance may manufacture or import such substance without registration thereof during a registration grace period (hereinafter referred to as "registration grace period") provided in the following: <Amended on Mar. 20, 2018>

1. Where he or she intends to manufacture or import at least 1 ton of a phase-in substance per year designated and publicly notified by the Minister of Environment following deliberation by the Evaluation Committee, which causes or is likely to cause cancer, mutation or reproductive disorders to humans or animals, or at least 1,000 tons of a phase-in substance per year: By December 31, 2021;

2. Where he or she intends to manufacture or import at least 100 tons and less than 1,000 tons of a phase-in substance per year: By December 31, 2024;

3. Where he or she intends to manufacture or import at least 1 ton and less than 100 tons of a phase-in substance per year: Period prescribed by Presidential Decree but by no later than December 31, 2030.

(3) Any person who intends to manufacture or import a phase-in substance without registration thereof during the registration grace period pursuant to paragraph (2) shall report the following to the Minister of Environment before he or she manufactures or imports the phase-in substance, as prescribed by Ordinance of the Ministry of Environment, and where the matters prescribed by Presidential Decree are changed among the matters reported, he or she shall report such change to the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment: <Newly Inserted on Mar. 20, 2018>

1. Name of the chemical substance;

2. Annual quantity of manufacture or import;

3. Classification and labelling of the chemical substance;

4. Uses of the chemical substance;

5. Other matters prescribed by Ordinance of the Ministry of Environment, such as the trade name of the person who intends to manufacture or import the chemical substance.

(4) Any of the following persons shall report the Minister of Environment before he or she manufactures or imports the following relevant non-phase-in substances: <Newly Inserted on Mar. 20, 2018>

1. A person who intends to manufacture or import less than 100 kilograms of a non-phase-in substance per year;

2. A person who has obtained confirmation of exemption from hazard reviews of any of the following non-phase-in substances pursuant to Article 10 (1) 3 of the previous Toxic Chemical Substances Control Act (referring to the aforesaid Act before amended by Act No. 11862) and who, accordingly, intends to manufacture or import the relevant non-phase-in substance:

(a) A non-phase-in substance manufactured or imported in quantities of not more than 100 kilograms per year;

(b) A non-phase-in substance designated and publicly notified by the Minister of Environment, which is a polymer only composed of chemical substances other than non-phase-in substances.

(5) Any person who intends to manufacture or import a chemical substance which is designated and publicly notified by the Minister of Environment following deliberation by the Evaluation Committee because the chemical substance is deemed highly likely to inflict serious damage on human health and the environment though not subject to registration under paragraph (1) or because the total quantity of such chemical substance domestically manufactured or imported per year exceeds the criteria prescribed by Presidential Decree, shall register the relevant chemical substance with the Minister of Environment within a period prescribed by Presidential Decree. <Newly Inserted on Mar. 20, 2018>

(6) Any person who intends to register pursuant to paragraphs (1) and (5) or make a report pursuant to paragraph (4) shall apply for registration with or make a report to the Minister of Environment, as prescribed by Ordinance of the Ministry of Environment. <Amended on Mar. 20, 2018>

(7) The Minister of Environment shall decide whether to accept a registration or report, and shall notify an applicant of his or her decision within a period prescribed by Ordinance of the Ministry of Environment from the date of receipt of an application for such registration or report pursuant to paragraph (6). <Amended on Mar. 20, 2018>

(8) Except as provided in paragraphs (1) through (7), matters necessary for registering and reporting chemical substances shall be prescribed by Ordinance of the Ministry of Environment. <Amended on Mar. 20, 2018>

[Title Amended on Mar. 20, 2018]

Article 11(Exemption from Registration of Chemical Substance) #

(1) Any of the following persons may manufacture or import a chemical substance without registration under Article 10 (1) and (5) or reporting under paragraph (4) of the aforesaid Article: <Amended on Mar. 20, 2018; May 26, 2020>

1. A person who intends to manufacture or import any of the following chemical substances:

(a) A chemical substance contained in a machine imported;

(b) A chemical substance imported along with a machine or device used for a test run;

(c) A chemical substance contained in a product performing a certain function in a specific solid form, which does not leak in the process of using the product;

2. A person who intends to manufacture or import a chemical substance of very low risk designated and publicly notified by the Minister of Environment following deliberation by the Evaluation Committee;

3. A person who intends to manufacture or import other chemical substances prescribed by Presidential Decree, such as a chemical substance manufactured or imported to export the whole quantity thereof, in which case he or she has obtained confirmation of exemption from registration or reporting (hereinafter referred to as "confirmation of exemption from registration, etc.") from the Minister of Environment.

(2) Any person who intends to obtain confirmation of exemption from registration, etc. shall file an application for confirmation of exemption from registration, etc. with the Minister of Environment. In such cases, the Minister of Environment shall confirm whether a chemical substance is eligible for exemption from registration or reporting under paragraph (1) 3 and notify the applicant of the eligibility determination, as prescribed by Ordinance of the Ministry of Environment. <Amended on Mar. 20, 2018>

(3) Any person who is informed of confirmation of exemption from registration, etc. from the Minister of Environment under paragraph (2) shall file an application for changes with the Minister of Environment, where any change is made to the matters prescribed by Ordinance of the Ministry of Environment, such as a manufacturing or import quantity of chemical substance for which he or she has received confirmation of exemption from registration, etc. <Newly Inserted on Oct. 16, 2018>

(4) Except as provided in paragraphs (1) and (3), matters necessary for confirmation of exemption from registration, etc., such as criteria for confirmation of exemption from registration, etc., and for application of changes shall be prescribed by Ordinance of the Ministry of Environment. <Amended on Mar. 20, 2018; Oct. 16, 2018>

[Title Amended on Mar. 20, 2018]

Article 14(Data to Be Submitted When Applying for Registration of Chemical Substance) #

(1) Any person who intends to register pursuant to Article 10 (1) or (5) shall submit data on the following matters (hereinafter referred to as "data to apply for registration"), as prescribed by Ordinance of the Ministry of Environment: Provided, That in the case of a phase-in substance or non-phase-in substance prescribed by Presidential Decree, he or she need not submit some of the relevant data, as prescribed by Ordinance of the Ministry of Environment: <Amended on Mar. 20, 2018>

1. The name, location, and representative of a person who intends to manufacture or import the chemical substance;

2. Information on the identification of the chemical substance, such as the name, molecular formula, and structural formula of such chemical substance;

3. Uses of the chemical substance;

4. Classification and labelling of the chemical substance;

5. Physical and chemical properties of the chemical substance;

6. Hazards of the chemical substance;

7. Risks of the chemical substance, including an exposure scenario describing handling, exposure controls, and management measures during the life-cycle of the chemical substance (applicable only where the quantity of the chemical substance that the applicant intends to manufacture or import is at least 10 tons per year);

8. Guidance on safe use (personal protections, first-aid measures, etc. in case of explosion, fire or leakage);

9. Other data prescribed by Ordinance of the Ministry of Environment.

(2) Among the data to apply for registration regarding the matters referred to in paragraph (1) 5 and 6, the data prescribed by Ordinance of the Ministry of Environment shall be submitted in documents stating the results of a test conducted by any of the following testing institutions:

1. A Korean testing institution prescribed in Article 22 (1);

2. A confirmed foreign testing institution pursuant to Ordinance of the Ministry of Environment to comply with the Principles of Good Laboratory Practice of the Organization for Economic Cooperation and Development.

(3) Any person who intends to register pursuant to Article 10 (1) or (5) may submit a plan that includes the details of and schedule for testing and other relevant matters (hereafter referred to as "testing plan" in this Article) in lieu of some of the data to apply for registration on the matters referred to in paragraph (1) 5 and 6, as prescribed by Ordinance of the Ministry of Environment. In such cases, the Minister of Environment shall review the appropriateness, etc. of the details of and schedule for testing in such testing plan, as prescribed by Ordinance of the Ministry of Environment, and shall inform a manufacturer or importer of the specific details of such testing, the deadline for such data submission, and other relevant matters. <Amended on Mar. 20, 2018>

(4) The Minister of Environment may acquire the data to apply for registration relating to the matters prescribed in paragraph (1) 5 and 6 for some phase-in substances and may provide such data to a person who intends to register under paragraph (1). In such cases, the Minister of Environment may receive the expenses incurred in acquiring the data to apply for registration from a person who intends to register, as prescribed by Ordinance of the Ministry of Environment. <Newly Inserted on Mar. 20, 2018>

(5) Where the Minister of Environment intends to acquire the data to apply for registration pursuant to the former part of paragraph (4), he or she shall first acquire test data in which the results of tests conducted by testing institutions prescribed in the subparagraphs of paragraph (2) using vertebrate animals are recorded (hereinafter referred to as "vertebrate animal test data") to minimize animal testing or data prepared in accordance with alternatives to animal testing. <Newly Inserted on Mar. 20, 2018>

(6) Any person who intends to report pursuant to Article 10 (4) shall submit the following data, as prescribed by Ordinance of the Ministry of Environment: <Newly Inserted on Mar. 20, 2018>

1. Data relating to the matters referred to in paragraph (1) 1 through 4;

2. Other data prescribed by Ordinance of the Ministry of Environment.

(7) Matters necessary for the details of data prescribed in paragraph (1), testing methods to produce data to apply for registration on the matters referred to in paragraph (1) 5 and 6, methods for preparing data on the risks referred to in paragraph (1) 7, methods for preparing testing plans, and the securing of data prescribed in paragraph (4) shall be prescribed by Ordinance of the Ministry of Environment. <Amended on Mar. 20, 2018>

[Title Amended on Mar. 20, 2018]

Article 17(Special Case on Vertebrate Animal Test Data) #

(1) Any person who intends to register pursuant to Article 10 (1) or (5) shall check if vertebrate animal test data already exist, to minimize vertebrate animal testing. <Amended on Mar. 20, 2018; Apr. 17, 2018>

(2) Where the check under paragraph (1) finds that vertebrate animal test data already exist, any person who intends to apply for registration shall use the relevant vertebrate animal test data for the purpose of his or her own application for registration with the consent to use of the relevant animal test data from the owner thereof: Provided, That where at least 15 years have passed since vertebrate animal test data were registered as data to apply for registration, he or she may use such data without consent to use from the owner thereof. <Newly Inserted on Apr. 17, 2018>

(3) Notwithstanding paragraph (2), where the owner of vertebrate animal test data does not consent to their use, a person who intends to apply for registration need not submit the relevant data to apply for registration with confirmation from the Minister of Environment: Provided, That where deemed necessary to submit vertebrate animal test data, such as where it is difficult to determine hazards, etc. of chemical substances without the relevant vertebrate animal test data, the Minister of Environment may order him or her to produce and submit the relevant data within a period prescribed by Ordinance of the Ministry of Environment. <Amended on Apr. 17, 2018>

(4) Any person requested to consent to use of vertebrate animal test data pursuant to paragraph (2) shall comply with such request, unless there are good reasons prescribed by Presidential Decree. <Amended on Apr. 17, 2018>

(5) No person who refuses to consent to use of vertebrate animal test data without good cause prescribed in paragraph (4) shall submit the relevant vertebrate animal test data for the purpose of applying for registration. <Amended on Apr. 17, 2018>

(6) Except as provided in paragraphs (1) through (5), matters necessary for consent to use, etc. of vertebrate animal test data shall be prescribed by Ordinance of the Ministry of Environment. <Amended on Apr. 17, 2018>

[Title Amended on Apr. 17, 2018]

Article 17-2(Imposition of Penalty Surcharge) #

(1) Where any person who manufactures or imports a chemical substance commits any of the following offenses, the Minister of Environment may impose a penalty surcharge equivalent to not more than 5/100 of the sales on the person who manufactures or imports the relevant chemical substance , as prescribed by Presidential Decree: Provided, That in cases prescribed by Presidential Decree, such as where there is no sales or it is difficult to calculate sales, the Minister of Environment may impose a penalty surcharge not exceeding 1 billion won, and in the case of an enterprise that has one place of business, the amount of a penalty surcharge shall not exceed 25/1,000 of its sales:

1. Where he or she fails to register, in violation of Article 10 (1) or (5), or manufactures or imports a chemical substance different from the details he or she has registered;

2. Where he or she fails to register changes, in violation of Article 12 (1), or manufactures or imports a chemical substance different from the details of any change he or she has registered.

(2) Where the Minister of Environment collects penalty surcharges pursuant to paragraph (1), he or she shall take the following into consideration:

1. The details and gravity of the offense;

2. The period during which a person commits an offense and the number of times he or she commits such offense;

3. The size of profits an offender has gained from having committed the offense.

(3) Where a corporation that has committed an offense falling under any of the subparagraphs of paragraph (1) effects a merger, the Minister of Environment may impose a penalty surcharge on such corporation considering an offense the corporation has committed to be an offense committed by a corporation that survives the merger or is incorporated following the merger.

(4) Except as provided in paragraphs (1) through (3), matters necessary to impose penalty surcharges, such as criteria for imposing penalty surcharges, shall be prescribed by Presidential Decree.

[This Article Newly Inserted on Mar. 20, 2018]

Article 23(Revocation of Designation of Testing Institution) #

(1) Where any person designated as a testing institution pursuant to Article 22 falls under any of the following, the Minister of Environment shall revoke the designation of a testing institution:

1. Where it is designated by fraud or other improper means;

2. Where the testing institution has conducted testing during a period of business suspension;

3. Where the testing institution has falsified test results by intention or gross negligence;

(2) Where any person designated as a testing institution pursuant to Article 22 falls under any of the following, the Minister of Environment may revoke the designation of such testing institution or the designation of a test field or test item, or may order the testing institution to suspend business on the test field or test item for a fixed period not exceeding six months: <Amended on Apr. 17, 2018>

1. Where the testing institution has failed to meet the designation standards under Article 22 (4) or violates management standards as a result of evaluation under paragraph (3) of the said Article;

2. Where the testing institution has failed to commence testing on the designated test field or test item within two years after being designated as a testing institution without just cause or has no business performance for more than two consecutive years;

3. Where the testing institution has conducted a testing or issued a test report other than on the designated test field or test item;

4. Where the testing institution has failed to report under Article 22 (4) or submitted a falsified report.

(3) Where two years have not passed since the designation of a testing institution was revoked pursuant to paragraph (1) or (2), no such testing institution shall be designated as a testing institution under Article 22.

(4) Where six months have not passed since the designation of a test field or test item was revoked pursuant to paragraph (2), no such testing institution shall be designated for a test field or test item under Article 22 on the same test field or test item.

(5) Criteria for administrative dispositions under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Environment.

Article 27(Designation of Restricted Substance or Prohibited Substance) #

(1) Where a chemical substance falls under any of the following, the Minister of Environment shall designate and publicly notify the relevant chemical substance as a restricted substance or prohibited substance after consultation with the heads of relevant central administrative agencies and deliberation by the Evaluation Committee, as prescribed by Presidential Decree: <Amended on Mar. 20, 2018>

1. Where the chemical substance is deemed to pose a risk based on the results of a hazard review and a risk assessment:

2. Where a foreign government, international organization, etc. deems that the chemical substance poses a risk;

3. Where manufacture, import or use of the chemical substance is prohibited or restricted in accordance with an international agreement, etc.;

4. Where the chemical substance falls under substances subject to permission that the designation of which has been terminated due to the ground under subparagraph 1 of Article 26.

(2) Where the Minister of Environment intends to designate a chemical substance as a restricted substance or prohibited substance, he or she shall notify beforehand the name of the chemical substance to be designated, the timing of designation, and other similar matters in the Official Gazette or on the website: Provided, That this shall not apply where urgent response is required because the relevant chemical substance poses or is likely to pose a critical risk to human health or the environment.

(3) Where the Minister of Environment designates and publicly notifies a chemical substance as a restricted substance or prohibited substance, he or she shall include the name of the restricted substance or prohibited substance, details of prohibition depending on its use, and similar matters.

(4) Except as provided in paragraphs (1) through (3), matters necessary for the designation and public notice of restricted substances or prohibited substances shall be prescribed by Presidential Decree.

Article 29(Provision of Information on Chemical Substance) #

(1) Any person who transfers any of the following chemical substances or a mixture containing such chemical substance shall, where the content of the relevant chemical substance reaches the level prescribed by Presidential Decree, prepare and provide information prescribed by Ordinance of the Ministry of Environment, such as information on the registration number, name, hazards, and risks of the relevant chemical substance, and information on the safe use thereof, to a person who acquires the chemical substance: Provided, That where the transferor shall prepare and provide a material safety data sheet pursuant to Article 110 (1) and (3) or 111 of the Occupational Safety and Health Act, he or she shall record and provide the relevant information in the material safety data sheet: <Amended on Mar. 20, 2018; Jan. 15, 2019; May 26, 2020>

1. A chemical substance registered or reported under Article 10 (1), (4), or (5);

2. A hazardous chemical substance, among phase-in substances not registered during the registration grace period under Article 10 (2).

(2) Where a transferor prescribed in paragraph (1) continuously and repeatedly transfers the same chemical substance or a mixture containing such chemical substance to the same person, the transferor may provide information prescribed in paragraph (1) only for the first transfer of such information. <Amended on May 26, 2020>

(3) Where any change prescribed by Ordinance of the Ministry of Environment is made to information provided, any person who has provided information pursuant to paragraphs (1) and (2) or any person who has been provided with such information shall inform the other party of such change within one month from the date he or she becomes aware of the change, as prescribed by Ordinance of the Ministry of Environment.

(4) Information shall be provided under paragraphs (1) through (3) only when the relevant chemical substance or mixture is transferred or acquired to be used or consumed as a raw material of a product in a place of business.

(5) Except as provided in paragraphs (1) through (4), matters necessary to provide information on chemical substances shall be prescribed by Ordinance of the Ministry of Environment.

ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Scope of Application) #

Article 4(Responsibilities of the State) #

Article 5(Responsibilities of Business Entity) #

Article 6(Master Plan for Evaluation of Chemical Substance) #

Article 7(Chemicals Evaluation Committee) #

Article 8 #

Article 9 #

Article 10(Registration of Chemical Substance) #

Article 11(Exemption from Registration of Chemical Substance) #

Article 12(Registration and Reporting of Change) #

Article 13(Measures against Non-Compliance of Duty to Register) #

Article 14(Data to Be Submitted When Applying for Registration of Chemical Substance) #

Article 15(Method for Submitting Data When Applying for Registration of Phase-In Substance) #

Article 16(Joint Use of Existing Data to Apply for Registration) #

Article 16-2(Principle of Minimizing Vertebrate Animal Testing) #

Article 17(Special Case on Vertebrate Animal Test Data) #

Article 17-2(Imposition of Penalty Surcharge) #

Article 17-3(Collection of Penalty Surcharge and Disposition on Default Thereof) #

Article 18(Hazard Review) #

Article 19(Hazard Assessment) #

Article 20(Designation of Toxic Substance) #

Article 21(Disclosure of Results of Hazard Review) #

Article 22(Designation of Testing Institution) #

Article 23(Revocation of Designation of Testing Institution) #

Article 24(Risk Assessment) #

Article 25(Designation of Substance Subject to Permission) #

Article 26(Termination of Designation of Substance Subject to Permission) #

Article 27(Designation of Restricted Substance or Prohibited Substance) #

Article 28(Termination of Designation of Restricted Substance or Prohibited Substance) #

Article 29(Provision of Information on Chemical Substance) #

Article 30(Provision of Information by Downstream User) #

Article 31(Notification to Provide Information on Chemical Substance) #

Article 32(Reporting of Substance Subject to Intensive Control Contained in Product) #

Article 33(Reporting of Change in Substance Subject to Intensive Control Contained in Product) #

Article 34 #

Article 35(Provision of Information on Chemical Substance Contained in Product) #

Article 36 #

Article 37 #

Article 38(Application for Registration by Person Appointed by Overseas Manufacturer or Producer) #

Article 39(Establishment and Operation of Chemical Data Processing System) #

Article 40(Designation and Operation of Green Chemical Center) #

Article 41(Revocation of Designation of Green Chemical Center) #

Article 42(Disclosure of Information on Chemical Substance) #

Article 42-2(Support for Small and Medium Enterprise for Registration and Assessment of Chemical Substance) #

Article 43(Reporting and Inspection) #

Article 43-2(Requests for Data) #

Article 44(Recording and Retaining Document) #

Article 45(Data Protection) #

Article 45-2(Succession to Rights and Obligations) #

Article 46(Fee) #

Article 47(Hearing) #

Article 48(Delegation or Entrustment of Authority) #

Article 48-2(Legal Fiction as Public Officials in Application of Penalty Provisions) #

Article 49 #

Article 50(Penalty Provisions) #

Article 51(Penalty Provision) #

Article 52(Penalty Provisions) #

Article 53(Joint Penalty Provision) #

Article 54(Administrative Fines) #