The Act on Registration and Evaluation, etc., of Chemical Substances (ARECS), commonly known as K-REACH, managed by South Korea’s Ministry of Environment (MoE), is a key chemical regulation that ensures the safe management of chemical substances. K-REACH came into force on 1 January 2015 and is in line with South Korea’s commitment to protect public health and the environment. Its most recent update, implemented on 10 July 2024, reflects evolving regulatory needs and underscores the importance of robust chemical oversight.

K-REACH regulates chemicals through four key procedures:

• Notification or registration of chemical substances.
• Evaluation of hazards and risks.
• Authorization of substances of concern.
• Restriction of certain chemicals to reduce risks to humans and the environment.

The Act provides a legal framework for the management both new substances and existing substances to ensure their safe manufacture, import and use in South Korea.

Registration for New Substances

Under K-REACH, any manufacturer or importer that intends to manufacture or import new chemical substances must register these substances before commencing activities. A new substance is defined as a substance that isnot listed on the Korean Existing Chemicals List (KECL).

• Substances in quantities under 1 tonne per year are exempt from registration and hazard evaluation and only require notification.
• Substances in quantities above 1 tonne per year must undergo full registration, including hazard evaluation.

Registration for Existing Substances

Existing substances, defined as those already listed on the KECL, have distinct registration requirements:

• Only companies that completed pre-registration during the designated period (1 January to 30 June 2019) are eligible to use these grace periods.
• The grace periods vary by tonnage band, with higher volume substances requiring earlier registration (see below).

Failure to register existing substances within the assigned deadlines will prohibit their continued manufacture or import into South Korea.

The grace periods under K-REACH provide manufacturers and importers with additional time to comply with registration requirements. These grace periods are based on the quantity of the substance produced or imported annually. For substances that exceed the grace period deadline, full registration must be completed before the product is placed on the Korean market.

The deadlines for existing substances are as follows:

• 510 designated existing substances (PEC): Deadline passed 1 July 2018
• Quantities ≥1000 tonnes per year and designated CMR substances ≥1 tonne per year: Deadline passed 31 December 2021.
• 100-1000 tonnes per year: Deadline is 31 December 2024.
• 10-100 tonnes per year: Deadline is 31 December 2027.
• 1-10 tonnes per year: Deadline is 31 December 2030.

This structured approach ensures a phased compliance process that balances regulatory rigor with practical timelines for businesses.

Pre-registration was a cornerstone of K-REACH implementation, applicable only to existing substances in quantities above 1 tonne per year. Conducted between 1 January and 30 June 2019, pre-registration allowed companies to manufacture or import substances within the grace period while deferring full registration requirements. Late pre-registration is still possible for existing substances in quantities exceeding 1 tonne per year placed on the Korean market for the first time after 30 June 2019.

Key Information for Pre-Registration

During pre-registration, applicants were required to provide the following information:

• Substance identity: Chemical name and CAS number.
• Estimated annual quantity: Import or manufacture quantity.
• GHS Classification and labeling
• Use information: Descriptions using the K-REACH Use Descriptor System.
• Legal entity details: Contact information for the Korean entity or the appointed Only Representative (OR).

Companies were also required to update pre-registration details within one month if there were changes in:

• Annual quantity.
• GHS classification and labeling.
• Intended uses.
• Manufacturer/importer information or change of OR.

K-REACH applies to a wide range of chemicals and products, while exempting others based on specific criteria.

Substances and Products Covered

• Individual chemical substances

• Existing substances listed on the KECL.
• New substances.

• Substances in mixtures
• Products containing Priority Control Substances:

• Articles or components that may expose consumers to hazardous chemicals.

Exemptions from K-REACH

• Naturally occurring substances: Exempt unless chemically modified.
• Substances subject to other regulations, including:

• Cosmetics and their raw materials.
• Pesticides.
• Pharmaceuticals and medical devices.
• Fertilizers.

For exempt substances, companies may seek official confirmation from the Korea Environment Corporation (K-ECO) to avoid regulatory misunderstandings.

Companies that manufacture or import products containing substances subject to intensive control are required to notify the Minister of Environment prior to commencing such activities if both of the following conditions are met:

• The weight of the individual priority control substances in the product exceeds 0.1 percent by weight.
• The gross weight of the individual substances of priority control in the total products exceeds 1 tonne per year.

Substances of Intensive Control

Substances classified as substances of intensive control have one or more of the following characteristics:

• Toxicity to humans and animals: Includes substances suspected or confirmed to be carcinogenic, mutagenic, reprotoxic (CMR), or endocrine disrupting.
• Bioaccumulation and Persistence: Substances that accumulate in the bodies of humans, animals, or plants and remain in the environment for extended periods of time.
• Organ-Specific Toxicity: Substances that may cause damage human organs (e.g. lungs, liver, kidneys) after prolonged or repeated exposure.
• High Risk: Substances that pose risks to humans, animals, or plants that are comparable to or greater than those of the above categories.

The notification system ensures that the use of these hazardous substances in products is closely monitored to minimize potential risks to human health and the environment.

The management of chemical substances in South Korea under K-REACH is anchored in a series of regulatory inventories. These inventories provide a structured framework for tracking, evaluating, and managing chemicals used, manufactured, or imported into the country. The Korean Existing Chemicals List (KECL) is the cornerstone of these inventories, complemented by specialized lists for hazardous and high-risk substances.

The Korean Existing Chemicals List

The Korean Existing Chemicals List (KECL) is South Korea’s most comprehensive chemical inventory, containing 47,418 substances. KECL serves as the basis for determining whether a substance is classified as "existing" or "new" under K-REACH.

The KECL is divided into two categories:

• Pre-1991 chemicals: Substances that were in commercial circulation in South Korea before 2 February 1991.
• Post-1991 chemicals: Substances that underwent hazard review under the former Toxic Chemicals Control Act and were subsequently listed by the Ministry of Environment after 2 February 1991.

This inventory allows manufacturers and importers to check the regulatory status of their substances. If a substance is not listed on the KECL, it is classified as a new substance and is subject to registration before its manufacture or import.

In addition to KECL, K-REACH maintains several specialized inventories tailored to specific categories of chemical substances:

• Toxic Chemical Substances Inventory: Includes 2,310 substances identified as hazardous because of their potential to cause significant harm to human health or the environment.
• Inventory of Substances Subject to Intensive Control: Lists 830 substances that require strict control due to their high risk during use or handling.
• Inventory of CMR Substances: Lists 364 substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR), requiring additional controls to minimize exposure.
• Inventory of Substances Requiring Preparation for Accidents: This inventory lists 99 substances that require emergency preparedness measures to mitigate risks associated with accidental releases.
• Inventory of Hazardous (Restricted/Prohibited/Permitted) Substances: Includes 207 substances that are subject to restrictions, prohibitions, or specific permissions under South Korea’s chemical regulations.

All these inventories are publicly accessible through the following platforms:

• National Chemicals Information System (NCIS): ncis.nier.go.kr
• Chemical Substance Information Processing System: kreach.me.go.kr

These databases are regularly updated to reflect new scientific data, hazard evaluations, and regulatory changes. The Chemicals Evaluation Committee reviews proposed additions or removals based on hazard and risk assessments, followed by a period of public consultation. Final updates are published by the Ministry of Environment.

The KECL and the other inventories are important tools under K-REACH that enable regulators, companies and stakeholders to:

• Determine the regulatory status of substances.
• Meet registration and hazard evaluation requirements.
• Manage the risks associated with hazardous and high-priority substances.

By maintaining transparency and accessibility, these inventories ensure that chemical management in South Korea is consistent with public health, environmental protection, and global regulatory standards.

Foreign manufacturers exporting chemical substances to South Korea must rely on Korea-based Only Representatives (ORs) to fulfill their K-REACH obligations. The OR acts as a compliance intermediary, ensuring smooth interaction with regulatory authorities.

Services Offered by ORs

• Registrationof substances: Handling notification and registration processes.
• Regulatory compliance: Monitoring updates and ensuring compliance with new requirements.
• Risk assessments: Preparing exposure and hazard assessments.

Korean SDS and labels: Ensuring documentation meets local standards.

The registration process under K-REACH is highly structured and requires extensive data submission. Companies must determine the type of substance (new or existing) and its volume before initiating registration.

Registration Steps

1. Identify the substance:

• Determine whether the substance is new or existing by consulting KECL.

2. Collect required information

When registering a chemical substance under K-REACH, the following information must be provided:

• Legal entity information: Name, address, and contact information of the Korean legal entity responsible for the registration.
• Substance identity information: Includes substance name, CAS number, and other identifiers.
• GHS classification and labeling: Details of the Globally Harmonized System (GHS) classification and labeling requirements.
• Use information: Description of the intended uses of the substance using the standardized K-REACH Use Descriptor System.
• Test data:
  • Physicochemical properties.
  • Toxicological data.
  • Environmental hazard information.
• Risk assessment report: Required for substances manufacture or imported in quantities of ≥10 tonnes per year. This report includes:
  • Exposure assessment.
  • Risk management measures.
• Additional information:
  • Information on the hazardous content of the substance, if applicable.
  • Guidelines for safe use, including handling methods and emergency response.

3. Joint submission:
   • Registrants of the same substance may form a Chemical Substance Information Communicative Organization (CICO) to share data and reduce duplication.

Polymers have specific registration requirements under K-REACH. While the registration process for polymers is similar to that for non-polymer substances, it requires less data and focuses on certain key tests, such as:

• Acid/base stability tests.
• Residual monomer content tests.

According to Paragraph 3, Article 2 of the K-REACH Enforcement Decree, a polymer is defined as a substance that meets the following criteria:

• Repetitive monomer units: The polymer must consist of molecules in which at least one type of monomer unit is continuously repeated.
• Molecular weight distribution: It must have a characteristic molecular weight distribution based on the number of repetitive monomer units in each molecule.
• Covalent bonds: At least 50% of its molecules must consist of at least three monomer units covalently bonded to at least one monomer unit or other reactants.
• Molecular weight uniformity: Molecules of the same molecular weight must not exceed 50% of the weight ratio.

These specific criteria distinguish polymers from other chemical substances and allow for more tailored regulatory approaches under K-REACH.

Similar to the EU-REACH system, K-REACH allows joint submissions for existing substances. Registrants work together through CICO to streamline the process, with roles divided into Lead Registrant, Active Members and Passive Members.

Benefits of joint submission

• Cost sharing: Participants share the financial burden of data generation.
• Reduced duplication: Fewer redundant tests are performed.
• Efficient communication: Centralized data management ensures consistency.

Information Required

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

• GHS classification and labeling
• Test data: physicochemical properties
• Test data: toxicology data
• Test data: environmental hazard

A test plan including details and schedule of testing and other relevant matters, may replace some of the test data under the supervision of the MOE.

K-REACH establishes a robust framework for the safe management of chemical substances in South Korea. By requiring thorough registration, notification and evaluation processes, it aims to protect public health and the environment while aligning with international standards such as EU-REACH.

For companies navigating K-REACH, understanding the scope, requirements, and deadlines of the regulation is essential for compliance. Partnering with experienced Only Representatives and leveraging joint submission mechanisms can further streamline the compliance journey and enable safe and compliant market access in South Korea.

Although K-REACH shares many similarities with EU-REACH, including registration requirements and the use of ORs, there are notable differences:

These differences reflect South Korea's tailored approach to chemical management, taking into account local industry needs and the regulatory framework.

In addition to chemical registration, K-REACH requires manufacturers or importers of products containing Priority Control Substances to register their products with the Ministry of Environment. This requirement ensures consumer safety and environmental protection by addressing the risks of exposure to hazardous substances.

For companies navigating the complexities of K-REACH compliance, GPC (Global Product Compliance) offers a comprehensive range of services. These services are tailored to help companies efficiently and effectively meet their K-REACH obligations.

Key Services Offered by GPC

1. Consultancy and training:
• Providing expert guidance on K-REACH requirements and processes.
• Offering training programs to enhance understanding of regulatory obligations.
2. Substance identification:
• Determining whether a chemical substance is classified as new or existing by consulting the Korean Existing Chemicals List (KECL).
• Identifying the regulatory status of substances and preparing for registration or notification.
3. Exemption Applications:
• Assisting in applying for exemption confirmations from the Ministry of Environment for substances that may not require full registration.
4. K-REACH Registration Services:
• Preparing and submitting registration dossiers for new and existing substances.
• Managing joint submissions through participation in Chemical substance Information Communicative Organization (CICO).
5. Risk Assessments:
• Conducting exposure assessments and preparing risk management reports for substances manufactured or imported in volumes of ≥10 tonnes per year.
6. Preparation of Korean MSDS and Labels:
• Developing compliant Material Safety Data Sheets (MSDS) and product labels according to South Korean standards.
7. Test Monitoring and Translation:
• Monitoring of study processes and translation of study reports to meet regulatory requirements.
8. Regulatory Update Monitoring:
• Keeping clients informed of updates to K-REACH and associated chemical inventories.
• Providing proactive compliance strategies to adapt to regulatory changes.

Role as an Only Representative (OR)

GPC also acts as a Korea-based Only Representative (OR) for foreign manufacturers exporting chemical substances to South Korea. Acting as an intermediary, GPC ensures that foreign companies meet their K-REACH obligations without having to establish a local presence. This includes:

• Handling pre-registration and registration submissions.
• Representing foreign companies in interactions with South Korean regulatory authorities.
• Maintaining compliance documentation and records on behalf of the client.

Benefits of Partnering with GPC

• Expertise: In-depth knowledge of K-REACH ensures accurate and efficient compliance.
• Cost-Effectiveness: Streamlined processes and joint submissions reduce overall compliance costs.
• Peace of Mind: Proactive monitoring and updates eliminate the risk of regulatory non-compliance.