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K-REACH: The Act on Registration and Evaluation of Chemicals

Min Cho

Feb 1, 2024

Korea

I. Inroduction of the Act on Registration and Evaluation of Chemicals (K-REACH)

The purpose of this Act is to promote production, 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 information of chemical substances.

1. The implementation and amendment of K-REACH

2. K-REACH registration bodies

South Korean manufacturers and importers have the obligations to fulfill pre-registration/registration/product notification in accordance with K-REACH. Foreign manufacturers may appoint an Only Representative (OR) to fulfill relevant obligations under K-REACH.

Note: Currently, OR transfer is not under K-REACH does not support OR transfer function. Therefore, when choosing an OR, it is important to assess the stability and capability of an OR.

II. Scope of K-REACH

K-REACH is not applicable to chemical substances in the following:

Radioactive materials defined in subparagraph 5 of Article 2 of the Nuclear Safety Act;
Drugs defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act and quasi-drugs defined in subparagraph 7 of the said Article;
Narcotics defined in subparagraph 1 of Article 2 of the Narcotics Control Act;
Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act and raw materials used for cosmetics;
Pesticides defined in subparagraph 1 of Article 2 of the Pesticide Control Act and active ingredients defined in subparagraph 3 of the said Article;
Fertilizers defined in subparagraph 1 of Article 2 of the Fertilizer Control Act;
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;
Feed defined in subparagraph 1 of Article 2 of the Control of Livestock and Fish Feed Act;
Explosives defined in Article 2 (3) of the Act on Control of Guns, Swords, and Explosives;
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);
Health functional foods defined in subparagraph 1 of Article 3 of the Health Functional Foods Act;
Medical devices defined in Article 2 (1) of the Medical Devices Act;
Hygiene products defined in subparagraph 1 of Article 2 of the Hygiene Products Control Act;
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.
Organic food, non-edible organic processed product, pesticide-free raw material processed food, organic fishery materials and permitted substances defined in subparagraph 4, 5, 5-2, 6, and 7 of Article 2 of the Act on the Promotion of Environment-friendly Agriculture and Fisheries and the Management of and Support for Organic Foods.

III. Exemption from K-REACH Registration or Notification without Additional Procedures

3.1 Substances falling under any of the following subparagraphs are subject to exemption from registration:

A chemical substance imported as imbedded into in the machine;
A chemical substance imported together with machine or equipment for test operation;
A chemical substance in a product in solid state with specific shape for a certain function and not discharged during its use;
Impurities, byproducts, minerals, ores, glass, hydrogen, and oxygen, etc.;
A substance itself existing in the nature and have not been chemically modified; and
Amino acids and its salts, the bases that make up DNA or RNA, nucleoside that base and sugar is combined, etc.

3.2 Apply for a confirmation of exemption from registration to the Korea Environment Corporation（KECO）prior to manufacture or import.

Information required to submit：

--Name, CAS No., and estimated volume of manufacture or import

Subject	Period	Documents to be submitted
1. A Chemical manufactured or imported to be wholly exported overseas	Annual unit	Exporting country and export volume
2. A chemical manufactured or imported in order to manufacture another chemical to be wholly exported overseas	Annual unit	Exporting country and export volume
3. A chemical for scientific experiment, analysis or research such as reagents	First time	Specific uses, duration of testing, analysis, research, photos or brochures of chemicals or products, etc.
4. A chemical for R&D -development, etc. of a chemical substance and product	R&D planning unit	Duration of R&D, research institute, safety management plan (submit the current status of safety managers, follow-up measures, and results of post-processing more than 0.1 ton), etc.
5. Some polymer compounds (PLC)	First time	Name of the monomers, CAS No. and content ratio (%), test data for number average molecular weight and molecular weight distributions
6. A substance which surface has been treated: -Both the target and surface treated materials of surface treatment under any of the following subparagraphs: For registered chemicals: When notified as non-phase-in substances less than 0.1 ton; For chemicals not subject to registration; In case of pre-registered phase-in substances within the registration grace period	First time	Registration on surface treated subject and surface treatment substance (registration number or receipt), phase-in substance notification (notification form), non-phase-in substance notification (notification number or receipt) or documents process diagrams, reaction structure formula and surface treatment rates that prove that they are not eligible for registration
7. Non-isolated intermediate	First time	Process diagram, etc.
8. Isolated intermediate whose outflow or leakage is blocked by technical means	First time	Process diagram, methods of blocking outflow and leakage, etc.

IV. Registration Procedure

Existing chemicals (non-PEC substances):

Existing chemicals manufactured or imported ≥1t/a will be given registration grace period based on their volume and toxicity, and shall be registered before 2030.

Companies applying for the registration of existing chemicals shall individually submit registration dossiers. But the data shall be submitted to the consortium for registration.

PEC substances：

The registration grace period for PEC substances has ended on June 30th, 2018, which means that PEC substances must be registered prior to its manufacture or import.

New chemical substances：

New chemical substances manufactured or imported ≤ 0.1t/a are required to be notified, while new chemical substances manufactured or imported ≥ 0.1t/a are required to be registered.

Note: New chemical substances and existing chemical substances can be searched through ChemRadar: ChemRadar

V. Data Submission

Data to be submitted when applying for registration:

	Information	Criteria for Registration	Details
1	Information on manufacturer or importer	Non-phase-in substance (for each company) (more than 0.1 t/y) Phase-in substance (more than 1 t/y for each company)	The name, location, and representative person who intends to manufacture or import the chemcial
2	Information on chemical substances		Identification of chemicals (such as the name, molecular formula, and structural formula of the chemical
3	Use of chemicals		Use classification system, confirmed use Uses not to be used
4	Classification and labelling of chemicals		Global classification and labelling standards (e.g. GHS)
5	Physical and chemical properties		Differentiation by tonnage band（up to 47 items） Submission of abstract of test data（in English and Korean） *submit full text if owned（in English and Korean）
6	Hazards
7	Guidance on safe use		·Personal protective equipment, first-aid measures, etc. in case of explosion, fire and leakage
8	Risks	Substances (more than 10 t/y) Substance that needs risk assessment as a result of hazard review	Exposure scenario describing handling, exposure controls, and management measures during the life-cycle of the chemical (substances more than 10t/a；substances that need risk assessment as a result

5.1 Existing substances

For existing substances, there are different data requirements based on the registration tonnage (1-10 t/a, 10-100 t/a, 100-1000 t/a, and 1000+t/a). According to hazard classifications, the competent authorities in South Korea may classify existing substances into three categories: unclassified, low hazard, and general substances, as shown in the table below.

Data	Since 2019
Chemicals unclassified	Substances not classified as "hazardous to human health and the environment" or classified as "Aquatic chronic 3 or 4" without any other classifications
Chemicals with low hazard	Substances classified as follows: Acute toxicity, Category 4; Skin irritation, Category 2; Eye irritation, Category 2; Skin sensitization, Category 1; Developmental or reproductive toxicity (excluding Categories 1 and 2); Specific target organ toxicity, Category 3; Hazardous to the ozone layer; (chronic) Aquatic hazard, Categories 3 or 4.
General substances	All substances that do not meet the criteria for unclassified or low hazard classification.

The above-mentioned classification may refer to：

EU CLP (Harmonized)；
EU REACH Registration (submitted data)；
Australia HCIS
Japan NITE
Korea KOSHA, NCIS

5.2 New chemical substance

New chemical substance can be submitted to competent authorities through notification or registration based on their tonnage.

Tonnage	Submission method	Data requirement
<0.1t/a	Notification	No mandatory data requirement
>0.1t/a	Registration	0.1~1t/a: After January 1, 2020, new chemical substances are required to submit mandatory data. Before data submission, existing data can be submitted, but the authorities can request further data from the registered companies.
>0.1t/a	Registration	Above 1t/a: Data requirements differ based on the tonnage of chemicals.

5.3 Data requirements for new substances and general substances registration

In addition, minimizing testing on vertebrate animals is adopted in the registration, hazard evaluation and risk assessment of chemicals. Competent authorities will develop and adopt alternative tests to minimize the use of vertebrate animals.

Data requirements for registration

Note:

Substances with volume of 0.1-1t/a and 1-10t/a are required to provide either data on acute oral or acute inhalation; substances whose volume above 10t/y are required to submit acute oral toxicity, and acute dermal or acute inhalation shall be submitted based on the exposure route;
If the bacterial mutation test result is positive, additional chromosome aberration and in vivo micronucleus tests are required;
Short-term toxicity to fish or to daphnia may be submitted for substances with volume of 0.1t/a~1t/a;
Data with "*" in the above Table shall be tested in an OECD GLP laboratory; Chemical Safety Assessment Report (CSR) shall be provided for substances above 10t/a.

5.4 Data requirements for unclassified and low hazard existing substances

Data requirements for unclassified substances: If an existing chemical has no hazard classification and no consumer use, then regardless of the registration tonnage, only the data requirements for substances of 1-10t/a need to be provided.

Data requirements for low hazard substances:

Data requirements for substances of 1-10 t/a and 10-100 t/a are consistent with the regular registration data requirements. For the registration of substances >100 t/a, most of the ecotoxicological data are not required.

5.5 Polymer registration

If a polymer does not meet the Polymer of Low Concern (PLC) exemptions, the registration of polymer itself is required. The data requirements for polymer registration differ based on tonnages and hazards.

	0.1-1&1-10t/a	10-100t/a	100-1000t/a	1000+: Scenario 1	1000+: Scenario 2
Physico-chemical properties	1)Physical state 2)Water Solubility 3)Melting Point/Freezing Point	1)Physical state 2)Water Solubility 3)Melting Point/Freezing Point	1) Physical state 2)Water Solubility 3)Melting Point/Freezing Point 4)Relative Density 5)Granulometry	1) Physical state 2)Water Solubility 3)Melting Point/Freezing Point 4)Relative Density 5)Granulometry	1) Physical state 2)Water Solubility 3)Melting Point/Freezing Point 4)Relative Density 5)Granulometry
Toxicological information		1)Acute oral toxicity /Acute Inhalation Toxicity 2)Bacterial reverse mutation	1)Acute oral toxicity/Acute Inhalation 2)Bacterial reverse mutation 3)Skin irritation/ corrosion 4)Skin sensitization	1)Acute oral toxicity/Acute Inhalation 2)Bacterial reverse mutation 3)Skin irritation/ corrosion 4)Skin sensitization	1)Acute oral toxicity/Acute Inhalation 2)Bacterial reverse mutation 3)Skin irritation/ corrosion 4)Skin sensitization 5)Acute dermal toxicity/ acute inhalation toxicity 6)Eye irritation/ corrosion 7)In vitro mammalian chromosome aberration test 8)In vivo micronucleus test 9)28-day repeated dose toxicity 10)Reproductive/developmental toxicity screening test
Enviromental fate and pathways, Ecotoxicological information		1)*Short-term toxicity to fish/daphnia	1)Short-term toxicity to fish 2)Short-term toxicity to daphnia	1)Short-term toxicity to fish 2)Acute daphnia toxicity	1)Short-term toxicity to fish 2)Acute daphnia toxicity 3)*Algae growth inhibition test 4)Hydrolysis as a function of pH

5.6 Intermediates registration

Intermediates	Compliance obligations under K-REACH	Requirements
Non-isolated intermediates	Exempted from registration	Process flow
On-site isolated intermediates	Exempted under strictly controlled conditions (SCC)	Process flow Detailed description of SCC
Transported isolated intermediate (TII)	Registration (data can be reduced)	A complete process flow that meets strict controlled requirements; Individual using TII substances must undergo specialized training; the usage of TII must be documented.

Data requirements of TII registration

	0.1-1t/a	1-10t/a	10-100t/a	100-1000t/a	1000+t/a
Physico-chemical properties	(1)Physical and chemical state (2)Water solubility (3)Melting point/freezing point (4)Vapor pressure (5)Boiling point	(1)Physical and chemical state (2)Water solubility (3)Melting point/freezing point (4)Vapor pressure (5)Boiling point (6)*Partition coefficient n-Octanol/water (7)Relative Density (8)Granulometry	(1)Physical and chemical state (2)Water solubility (3)Melting point/freezing point (4)Vapor pressure (5)Boiling point (6)*Partition coefficient n-Octanol/water (7)Relative Density (8)Granulometry (9)Flammability (10)Explosive property (11)Oxidizing property	(1)Physical and chemical state (2)Water solubility (3)Melting point/freezing point (4)Vapor pressure (5)Boiling point (6)*Partition coefficient n-Octanol/water (7)Relative Density (8)Granulometry (9)Flammability (10)Explosive property (11)Oxidizing property (12)Viscosity (13)Dissociation constant	(1)Physical and chemical state (2)Water solubility (3)Melting point/freezing point (4)Vapor pressure (5)Boiling point (6)*Partition coefficient n-Octanol/water (7)Relative Density (8)Granulometry (9)Flammability (10)Explosive property (11)Oxidizing property (12)Viscosity (13)Dissociation constant
Toxicological information	/	/	/	/	(1)Acute oral toxicity/Acute inhalation toxicity (2)Bacterial reverse mutation (3)Skin irritation/ corrosion (4)Skin sensitization
Enviromental fate and pathways, Ecotoxicological information	/	/	/	/	(1)Short-term toxicity testing to fish (2)Ready biodegradability (3)*Short-term toxicity to daphnia

Data with “*” mark in the above Table shall be tested in an OECD GLP laboratory.

VI. Notification of Hazardous Substances in Products

Similar to the Substances of Very High Concern（SVHC）notification under the EU REACH, the Korean MOE will designate and publish priority substances. Manufacturers or importers are required to notify the Korean authorities if their products containing priority substances and its content exceeds 0.1t/a with its total tonnage over 1t/a.

Priority substances can be searched through our ChemRadar.

VII. Transmission and management of supply chain

If appointing an OR, it is necessary to inform downstream users in advance. After registration, the MSDS + Form 26 (or Form 25) shall be passed to downstream. The intended use and exposure detail of substances shall be specified in this Form. Suppliers are required to transfer the hazard information of the substance during the supply chain. If there are new importers or new uses after pre-registration or registration, it is mandatory to update this information in time.

Min Cho

ChemRadar Regulatory Analyst