South Korea Reach Regulation For Various Sectors

The Act on Registration and Evaluation, etc of Chemical Substances (K-REACH)

The Act on Registration and Evaluation, etc of Chemical Substances (known as K-REACH) aims to protect public health and the environment. This is achieved by four procedures, namely notification or registration, evaluation, authorization, and restriction of chemicals. K-REACH has been enforced since January 1, 2015 and the recent amendment has come into force on August 7, 2025.

Relevant documents are available at Menu > Regulatory Regions > South Korea > Compliance Library.

• The Act on Registration, Evaluation, etc. of Chemicals (Korean and English)
• A Guide on the Act on Registration, Evaluation, etc. of Chemicals (Korean)
• A Guide on the Amendment of the Act on Registration, Evaluation, etc. of Chemicals on January 1, 2019 (Korean/English)

Main Requirements of K-REACH

Under K-REACH, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance ("registration") according to the following requirement:

• New substances must be registered prior to manufacture or import. Below 100 kg per year (1t/year from January 1, 2025) (<100kg/y) new substances only require notification and do not need to go through hazard evaluation
• All over 1 ton per year (>=1t/y) existing chemical substances (excluding exempt substances) must be registered within given grace periods
• To benefit from the grace periods for existing substances, manufacturers and importers of >=1t/y existing chemical substances must pre-register their company info, substance name, volume, classification and use info to the Ministry of Environment in advance ("pre-registration")
  Substances over 1000 tons per year have passed deadlines, thus, need to be registered before placing them in Korea.

Foreign manufacturers who export chemical substances to South Korea may appoint a Korea-based Only Representative to submit pre-registration or registrations.

Besides, producers and importers of products containing priority control substances need to register their products to the Ministry of Environment before placing them in Korea.

Scope of K-REACH

(1) ‘New Substance’ is a substance that is not listed on Korean Existing Chemicals List (KECL)

(2) ‘Product’ is a mixture, or an article used by consumers or a component of the mixture or the article that may expose consumers to chemical substances

Only Representative (OR)

Ony Representative (OR) is an intermediary, and is mandatory for companies based outside of South Korea wishing to register the substance they export to South Korea. Foreign companies may appoint Korea-based ORs to fulfil relevant obligations under K-REACH.

As an OR, GPC Korea offers: 

• General consultancy and training
• Substance identification
• Application for exemption substance confirmation from Ministry of Environment
• K-REACH registration
• Risk assessment report
• Test monitoring/translation of study reports
• Preparation of Korean SDS and label
• Regulatory update monitoring

K-REACH Pre-registration

K-REACH pre-registration start from 1 Jan 2019 and end on 30 June 2019. It is required all >=1t/y existing chemical substances manufactured in or imported to South Korea. Only those pre-registered existing substances can benefit from registration grace periods, during which one can manufacture or import those pre-registered substances without full registrations.

1. Scope

K-REACH pre-registration is only required for >=1t/y existing chemical substances. New chemical substances do not require pre-registration and they must be registered before manufacture or import.

2. Object

A Korean manufacturer or importer of >=1t/y existing substances shall submit pre-notifications to the Ministry of Environment. This should be done between 1 Jan 2019 and 30 Jun 2019. Foreign manufacturers or formulators can appoint Korea-based Only Representatives (OR) to submit pre-registrations. Downstream users and foreign traders cannot submit pre-registrations.

Late pre-registration is possible for existing substances exceeding 1t/y for the first time after 30 June 2019. At least, 12 months before the relevant grace period deadline for registration.

3. Information requirements

Required information for K-REACH pre-registration is as follows:

• Substance identity information: name, CAS no.
• Estimated annual import/manufacture volume band
• GHS classification and labelling
• Use information (using K-REACH use descriptor system to describe uses)
• Legal entity information: name, address, contact info of Korean legal entity
• In case of using OR: OR appointment letter

It should be noted that one applicant shall update their pre-registrations within one month if there are changes with:

• Annual volume
• GHS classification and labelling
• Uses
• Manufacturer/Importer information

K-REACH registration

According to the article 10 of amended K-REACH regulation, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance before he or she manufactures or imports the substance.

1. Scope

K-REACH registration is required for >=1t/y existing chemical substance and >=1t/y new chemical substances. To find out if a substance is an existing substance or not, you shall search Korea Existing Chemicals List first.

2. Object

Only Korean manufacturers and importer are obligated to register chemical substances under K-REACH. Foreign manufacturers may appoint Korea-based Only Representatives to submit chemical registrations on their behalf.

3. Deadline

4. Information requirements

Required information for K-REACH registration is as follows:

• Legal entity information: name, address, contact info of Korean legal entity
• Substance identity information: name, CAS no.
• GHS classification/labelling
• Use information (using standard use descriptor)
• Test data: physico-chemical properties, toxicology and enviromental data
• Risk assessment report including exposure info and risk management measures
  (applicable only where the quantity of the chemical substance that the applicant intends to manufacture or import is at least 10 tons per year)
• Information on contents, etc. in case containing hazardous substance
• Safe use information such as handling method and emergency response measures

Joint submission of existing substance registration

Similar to SIEF in EU-REACH, CICO (Chemicals substance Information Communicative Organization) includes a group of potential registrants of one substance. The role of each participant is to strive for an efficient registration and communication process for the substance of concern.

The following information needs to be submitted jointly by all registrants of the same substance.

• GHS classification and labeling
• Test data: phsico-chemical properties
• Test data: toxicology data
• Test data: environmental hazard
• Testing plan that includes the details of and schedule for testing and other relevant matter can replace some of the test data under MOE’s supervision

1. CICO position

COMPARISON BETWEEN EU REACH AND K-REACH

DEADLINES & REMARKS

1) 31 Dec. 2021 Deadline: approximately 1,100 substances

Remark-CMR Substance (1t/a and above) and existing substances (1,000 t/a and above)

2) 24 Dec. 2024 Deadline: approximately 1,100 substances Remark-Existing Substance (100-1000t/a)

3) 27 Dec. 2027 Deadline: approximately 2,000 substance; Remark-Existing substance (10-100 t/a)

4) 30 Dec. 2030 Deadline: approximately 2,300 substances Remark-Existing substance (1-10t/a)

Nofication required in case of

1. New substances < 1 t/a
2. Substances that have received exemption approval under previous 'Toxic Chemical Control Act’ (TCCA)

• New substances under 1 t/a
• New polymers which is composed of existing monomers and meet one of below criteria:
• Polymer with mn over 10,000 d which contains oligomers with molecular weight of less than 1,000 is over 5%, or oligomers with molecular weight of less than 500 is over 2%.
• Polymer with mn between 1000-10,000 d which contains oligomers with molecular weight of less than 1,000 is over 25%, or oligomers with molecular weight of less than 500 is over 10%.
• Cationic
• Polymer with mn under 10,000, which contains residual monomer of hazardous chemical, or priority management chemical exceeding 1%.

Transional Period and Registraon Deadlines

According to the rules, companies were obliged to 'pre-notify’ the substances they manufacture or import by 30 June 2019. This will include information on Classification and labeling and anticipated volumes.

If a company does not do this it will, in effect, be banned from manufacturing or importing from 1 July 2019.

Substances completing pre-notification may benefit from a transitional period. The transitional periods are varied depending on the pre-notification tonnage band and hazards of substance.

K-REACH Pre-noficaon : Informaon Requirements

The following info is required for K-REACH pre-notification:

• Substance identity info: name, CAS
• Estimated annual import/manufacture volume band
• GHS Classification and labeling
• Use info (using K-REACH use descriptor system to describe uses) Ÿ Legal entity info: name, address, contact info of Korean legal entity. In case of using OR: OR appointment letter

It should be noted that applicant shall update their pre-notifications within one month if there are changes with:

• Annual volume
• GHS Classification and labeling

FEATURE OF CICO POSITION

There are four level of involvement which is available within CICO as described below

1) Lead Registrant

• Lead whole process of consortium operation as a consortium leader

Advantage: When additional members join the consortium, he/she obtains compensation for purchasing/producing test data and registration fee

Disadvantage: There is a burden of prior cost sharing as well as time investment.

2) Active Member

• Participate in every consortium management process
• Submit opinion and participate in prior cost sharing

Advantage: When additional members join the consortium, lead registrant (LR) obtains compensation for test data and registration fee

Disadvantage: There is a burden of prior cost sharing as well as time investment

3) Passive Member

• Not participated in every consortium management process
• Register with a share of finally determined cost; Need to purchase only Letter of Access (LoA)

Advantage: Pre-investment of money or time is not required

Disadvantage: There is no right to submit opinion about burden sharing and consortium management or data selection when additional members join the consortium, he/she does not obtain compensation for registration fee

3) Passive Member

• Not participated in every consortium management process
• Register with a share of finally determined cost; Need to purchase only Letter of Access (LoA)

Advantage: Pre-investment of money or time is not required

Disadvantage: There is no right to submit opinion about burden sharing and consortium management or data selection when additional members join the consortium, he/she does not obtain compensation for registration fee

Dormant

Not currently registered member in consortium or CICO system but prospective participant in the future

NEW CHEMICAL REGISTRATION

Registration of new chemical substances was transferred from TCCA to K-REACH from 1 Jan 2015. All new chemical substances regardless of tonnage are required to be registered.

However, a Simplified registration with less data requirements is applicable for new chemical substances in low volume below 1 t/y (threshold will be reduced to 0.1 t/y after 2020).

In addition, OSHA should also be complied with as before, which means under OSHA new substances<0.1t/y are exempt from registration.

Relevant documents

GHS Status

South Korea implemented the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in 2013. Currently, the fourth revised edition of the GHS (GHS4) is applied in South Korea under different regulations including the Korea Occupational Safety and Health Act (K-OSHA) and the Standards for Classification and Labeling of Chemicals and Safety Data Sheets. K-OSHA, last updated in 2024, imposes a duty on manufacturers and importers of chemicals supplied to Korea to correctly classify the chemical according to GHS4, label hazardous chemicals in the workplace, and provide Material Safety Data Sheets (MSDSs). Different authorities implement GHS in South Korea are summarised below:

Local Adaption of GHS

The following GHS hazard categories are exempt from classification under K-OSHA:

• Flammable gases – Chemically Unstable Gases, Category 1A and 1B
• Chemicals Under Pressure, all categories
• Desensitized Explosives, all categories
• Skin Corrosion/Irritation, Category 3
• Acute Hazards to the Aquatic Environment, Category 2 and 3

The following GHS hazard categories are not mandatory to separate categories under K-OSHA:

• Skin Corrosion/Irritation, Category 1A, 1B, and 1C (To separate them, the total sum of 1A, !B, 1C, each should be more than 5%)
• Serious Eye Damage/Eye Irritation, Category 2A and 2B
• Respiratory Sensitization, Category 1A and 1B
• Skin Sensitization, Category 1A and 1B

GHS Labeling Requirements

Like many other countries, South Korea also has its own GHS labeling requirements. The requirements are set by the Standards for Classification and Labeling of Chemicals and Safety Data Sheets. Any classified chemical is correctly labelled if the label includes the following in Korean:

• The product name
• Any hazard pictogram(s) that is consistent with the correct classification(s) of the chemical.
• Any signal word that is consistent with the correct classification(s) of the chemical.
• Any hazard statement(s) that is consistent with the correct classification(s) of the chemical.
• Any precautionary statement(s) that is consistent with the correct classification(s) of the chemical.
• The information (name and contact) of either the manufacturer or importer

The label must comply with the following size requirements:

The pictogram in the label must comply with the following size requirements

• The size of each pictogram must be over 1/40 of the entire label size
• The size of pictogram must be over at least 0.5c㎡

The following requirements should also be considered:

• Maximum number of hazard pictogram: 4
• Similar or repetitive hazard statement can be omitted or combined
• Similar or precautionary statement can be omitted or combined

Safety Data Sheets

Since 16 January 2021, Korean authorities require that manufacturers, importers, or Only Representatives (ORs) appointed by non-Korean manufacturers submit a Material Safety Data Sheet (MSDS) before manufacturing or importing chemical substances. The MSDS must be submitted in Korean Language and follow the fourth revision of UN GHS. If a chemical substance has been placed in the Korean market and an MSDS has been prepared before 16 January 2021, there are grace periods given to submit MSDSs based on the quantity of the substances, as follows:

The format and content of an MSDS in South Korea are set by K-OSHA and the Standards for Classification and Labeling of Chemicals and Safety Data Sheets. The requirements for a Korean MSDS are:

• It must be in Korean (a proper noun such as chemical substance name can be in English).
• It should contain the 16 standard sections.
• Additional sections can be added if necessary.
• For Section 1, the substance can be omitted if its content is under 1% limit concentration.
• For Section 3, content of ingredients can be in a range of +/- 5% P.
• For Section 10, GLP (Good Laboratory Practice) or KOLAS (Korea Laboratory Accreditation Scheme) study results should be prioritized.