Non-phase-in substances: Registration, Reporting, or Exemption

Under the ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES (화학물질의 등록 및 평가 등에 관한 법률), chemical substances are classified into phase-in substances or non-phase-in substances.

Phase-in substance means any of the following chemical substance:

-       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, or

-       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.

Non-phase-in substance means any chemical substance other than phase-in substances.

Relating to the method of confirming the classification of a chemical substance, please refer to my blog “Detailed statement of verification on chemical product”.

 

In the case of a phase-in substance, obligations arise when its import volume is 1 ton or more. Meanwhile, registration, reporting, or exemption shall be processed for a non-phase-in substance, depending on its features, import volume, and purpose of import, even if a small amount is imported.  




Under Article 11 (1) of the ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES, the following chemical substances are exempted from registration or reporting without additional procedures. However, companies importing such chemical substances shall retain documentary evidence and be able to prove the applicability of the exemption whenever it is requested by authorities.

1.       A chemical substance imported as imbedded into the machine

2.       A chemical substance imported together with machine or equipment used for test operation

3.       A chemical that is contained in a product that performs a certain function in a particular solid form and is not leaked during its use

4.       A chemical substance with very low risk declared and publicly announced by the Minister of Environment after deliberation by the Chemical Substance Evaluation Committee:

-       Impurities, by-products, minerals, ores, glass, vegetable fat/oil, hydrogen, and oxygen, charcoal, activated carbon (water treatment agents according to the Drinking Water Management Act), etc.

-       Substances existing in nature as themselves or obtained from the nature by using manpower/ machinery/gravity, by dissolving in water, flooring, or by removing moisture by means of heat

-       Amino acids and its salts, the bases that make up DNA or RNA, nucleoside that base and sugar is combined, etc.

 

In the case of the following chemical substances, the application for confirmation of exemption from registration or reporting (depending on its annual import volume estimate) shall be filed with the Korea Environment Corporation prior to import (in the case of chemicals not directly related to market release, such as reagents for testing, research, analysis, or demonstration production, within 30 days from the date of import):

1.       A chemical substance imported to be wholly exported overseas

2.       A chemical substance imported in order to manufacture another chemical substance to be wholly exported overseas

3.       A chemical substance for scientific experiment, analysis or research, such as reagents

4.       A chemical substance for any of the following research and development purposes:

(a)     Developing chemical substances, products, etc.;

(b)    Improving or developing manufacturing processes;

(c)     Testing application fields of chemical substances at the place of business;

(d)    Pilot manufacturing of chemical substances or pilot production of products, etc.;

5.       Any of the following polymers:

(a)     A polymer whose number average molecular weight is at least 10,000, in which the content of molecules whose weight is less than 1,000 is less than 5 percent and the content of molecules whose weight is less than 500 is less than 2 percent;

(b)    A polymer whose number average molecular weight is at least 1,000 but less than 10,000, in which the content of molecules whose weight is less than 1,000 is less than 25 percent and the content of molecules whose weight is less than 500 is less than 10 percent;

6.       A chemical substance formed by reacting functional groups on the surface of a substance subject to surface treatment with another substance that treats the surface of the substance where both the substance subject to surface treatment and another substance that treats the surface of the substance fall under any of the following:

(a)     A chemical substance registered pursuant to Article 10 (1) or (5) of the Act;

(b)    A chemical substance reported pursuant to Article 10 (3) of the Act, which is a phase-in substance and where the registration grace period of which has not expired under Article 10 (2) of the Act;

(c)     A chemical substance reported pursuant to Article 10 (4) of the Act;

(d)    A chemical substance not subject to registration pursuant to Article 10 (1) or (5) of the Act or not subject to reporting pursuant to Article 10 (4) of the Act;

7.       A non-isolated intermediate;

8.       An on-site isolated intermediate (which means a chemical substance that does not meet the criteria of a non-isolated intermediate and is created in the manufacturing process of another chemical substance and is used and completely consumed in the subsequent process on the same manufacturing site under controlled conditions complying with the procedure and manner prescribed by Ordinance of the Ministry of Environment), the leakage or exposure of which is blocked by technical means.

 

The obligation of such application is fulfilled when it is filed for the first import of relevant chemical substances, except for the chemical substances to be wholly exported overseas (which shall be filed annually) and the chemical substances for research and development (which shall be filed per R&D planning unit).

 

The application for confirmation of exemption from registration or reporting shall be filed through the Chemical Substance Data Processing System (https://kreach.me.go.kr/), along with the documents proving that such a specific category of exemption is applicable. Registration as a user and a digital identity certificate is required to use the system.

 

In registering a chemical substance, the following data shall be submitted (in the case of reporting, data 1 through 4):

1.       The name, location, and representative of a person who intends to 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 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.

Test reports required for the data of physical and chemical properties and hazards are different depending on the import volume.

 

To ensure proper processing of registration, reporting, or exemption under the ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES and timely response to statistical surveys under the CHEMICAL SUBSTANCES CONTROL ACT, importers of chemical products subject to the control of these Acts shall keep track of the import weight of each chemical substance contained in the imported chemical products.


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