Introduction
Navigating South Korea’s complex chemical regulatory landscape presents significant challenges for overseas manufacturers and importers. Non-compliance with K-REACH regulations carries grave consequences, ranging from substantial financial penalties and supply chain disruptions to potential criminal liability.
This guide offers a definitive roadmap to K-REACH compliance. It details the scope of regulated entities, registration and notification, and critical supply chain mandates. Furthermore, we outline enforcement mechanisms and provide strategic insights to ensure your business maintains a seamless and compliant market presence in Korea.
What is K-REACH/Korea REACH?
K-REACH or Korea REACH, officially titled Act on Registration and Evaluation, etc. of Chemicals, is the Korean chemical registration and evaluation law that came into effect on January 1, 2015. A comprehensive amendment was approved by the Korean National Assembly on February 28, 2018, and enforced on January 1, 2019.
Further major revisions are scheduled for 2025, such as new substance notification thresholds, hazard determination standards, and interlinkages with the Chemical Control Act (K-CCA) and the Occupational Safety and Health Act (K-OSHA).
Under K-REACH, any new or existing chemical substance manufactured or imported at ≥1 ton per year (1 t/a) must be registered with the Ministry of Environment (MoE) before being placed on the Korean market.
Who Must Comply with K-REACH?
Entities subject to K-REACH include:
Domestic manufacturers and importers of chemical substances;
Foreign manufacturers exporting chemical substances to Korea (via an Only Representative, OR);
Manufacturers of products containing priority management chemicals.
Notification under K-REACH
Under K-REACH, "notification" is a distinct compliance obligation separate from "registration."
Notification mainly targets low-tonnage new chemical substances and certain new polymers. Failure to notify, or submission of incomplete/incorrect classification data, will result in the substance being designated by MOE as an Unknown Hazard Classification Substance.
New substances with an annual manufacturing or import volume < 1 t/a are not subject to registration; however, they must complete notification and obtain approval from the MoE before manufacture or import.
Korea REACH Registration
New Substance Registration
A new substance is defined as any substance not listed on the Korea Existing Chemicals List (KECL), the latest version of which was updated in August 2025 by the MoE. This definition covers substances that have never been manufactured, imported, or circulated in Korea, or substances that have not yet been officially recognized or classified by the MoE.
Tonnage Threshold:
New substances at ≥1 t/a must be registered before manufacture or import. The 2025 amendment raised the prior threshold from 0.1 t/a to 1 t/a.
Note: No grace period applies to new substances. Registration must be completed before production or import; non-compliance can result in fines up to 100 million KRW or imprisonment of up to 5 years.
Existing Chemicals Registration
An existing chemical substance refers to any substance already listed on the Korea Existing Chemicals List (KECL) and having a confirmed record of circulation in the Korean market. This includes hydrates of existing substances as well as multi‑component substances in which every constituent is an existing substance.
Tonnage Threshold:
Existing substances manufactured or imported at ≥ 1t/a are subject to registration. The registration schedule is phased according to annual tonnage and hazard classification, allowing companies to comply progressively.
Registration Types of Existing Chemicals Registration Under K‑REACH
K‑REACH applies a framework similar to that of the EU REACH Regulation for existing substances, encompassing three stages:
Pre‑registration: Existing substances with an annual quantity of more than 1 t/a (calculated based on the highest annual volume during 2016–2018) were required to complete pre‑registration by June 30, 2019, in order to obtain a grace period.
Late Pre‑registration: From July 1, 2019, companies manufacturing or importing relevant substances may still submit a late pre‑registration before the export volume surpasses 1 ton per year to secure the applicable grace period.
Registration: Enterprises must complete registration within the respective grace period defined for their tonnage and hazard band.
Registration of Specified Substances
Specified substances refer to those deemed “low-volume but high-risk” or “high-circulation but insufficiently regulated” under K-REACH. This category includes:
Newly manufactured or imported chemical substances whose total annual volume in Korea exceeds 1 ton, or
Existing chemical substances whose total annual volume exceeds 10 tons.
The identification of specified substances is based on the “Specified Substances Registration List” (officially announced by the MoE). The scope generally covers industrial sectors such as pharmaceutical intermediates, electronic chemicals, and food-contact material chemicals.
Although the individual enterprise’s annual tonnage may fall below 1 t/a, these substances are subject to enhanced regulatory oversight because of their high cumulative national circulation volume and potential risk to human health and the environment.
K-REACH Registration Exemption
The following cases may be exempt from Korea REACH registration; however, an application for registration exemption must be submitted, including:
• Chemical substances imported/manufactured for export-only use, including substances imported/manufactured to make export-only products
• Chemical reagents
• Surface-treated substances
• Non-isolated intermediates or on-site isolated intermediates that can be technically blocked from leakage or exposure
• Polymers of low concern (PLC)
• Substances for R&D use:
1. Development of chemical substances or their products
2. Improvement or development of processes
3. Testing of chemical applications
4. Trial production or pilot manufacturing of products
K-REACH's Grace Period
The K-REACH registration grace period refers to the transitional compliance period granted to existing chemical substances, allowing companies sufficient time to complete testing, prepare dossiers, and complete registration.
Different categories of substances are assigned different grace period deadlines. The 2025 K-REACH revision does not change the existing grace period timeline; however, it significantly strengthens compliance supervision during the grace period.
New Chemical Substances – No Grace Period
New substances do not benefit from any grace period. Companies must complete:
registration for ≥1 t/a, or
new substance notification for <1 t/a
before manufacturing in Korea or importing into Korea for the first time.
If a company manufactures or imports a new substance without prior registration/notification, it will be subject to the heaviest penalties, and shipments may be detained or destroyed under K-REACH.
510 Priority Existing Chemicals (PECs) – Grace Period Already Expired
The grace period for the 510 Priority Existing Chemical Substances (PECs) ended on June 30, 2018.
For these substances, companies must complete registration before manufacture or import, with no remaining grace period available.
Other Existing Substances (Excluding 510 PECs)
For other existing chemical substances, the grace period is determined based on annual manufacture/import volume and hazard classification. Companies must carefully assess their tonnage band and risk category to identify the applicable registration deadline.
Failure to complete registration within the grace period will result in a ban on manufacture or import in Korea.
Grace period deadlines are as follows:
PMC Notification under K-REACH
Consumer products containing Priority Management Chemicals (PMC) must be notified before manufacture or import.
What is PMC?
Priority Management Chemicals (PMC) are risk-posing chemical substances that fall under any of the criteria indicated below:
May cause, or are suspected of causing cancer, gene mutations, reproductive toxicity, or endocrine disruption in humans or animals;
Have high bioaccumulation potential and are persistent in the environment;
May cause damage to major human organs, such as lungs, liver, or kidneys, upon exposure;
Exhibit hazard levels equivalent to or higher than those listed in categories 1 to 3 above.
Currently, the MoE has designated 699 substances as PMCs.
What Consumer Products are Subject to PMC Notification?
A consumer product is subject to PMC notification only if both of the following conditions are met:
The concentration of a PMC in an individual product exceeds 0.1%; and
When considering all products together, the total quantity of the PMC substance with more than 0.1% concentration exceeds 1 tonne.
Information Requirements for PMC Notification
The following information must be submitted as part of the PMC notification:
Notifier information;
Name of the PMCs;
Concentration of the PMC in the product and total annual tonnage placed on the market;
Product photographs and instructions for use;
Intended product use and major human exposure routes;
Product classification and labeling information.
Supply Chain Communication
The K-REACH regulation establishes clear obligations for information communication along the entire supply chain, creating a full lifecycle safety management system for chemical substances. These requirements apply to every stage of a chemical substance’s journey, from manufacture and import to distribution and end-use.
Key obligations include:
Downstream Use Information: Downstream users must provide accurate information on the actual uses of substances to assist upstream companies in meeting their K-REACH compliance obligations.
Safety Data Sheets (SDS): Both substances and products exported to Korea must be accompanied by a Safety Data Sheet compliant with Korean GHS requirements, ensuring that all hazards are properly communicated.
Safety Labeling: Appropriate safety labels must be provided on substances and products.
How Overseas Companies Can Comply with Korea REACH?
Overseas companies exporting chemical substances or consumer products to Korea have two main compliance strategies under K-REACH:
Strategy 1: Appoint an Only Representative (OR) or Establish a Korean Subsidiary
This approach is suitable for overseas companies seeking to actively manage their Korean market presence and maintain long-term control over their business operations.
Strategy 2: Fully Delegate Compliance to a Korean Importer
This strategy may be suitable for companies prioritizing short-term cost savings, but it carries higher operational and legal risks, particularly regarding control over the supply chain and market access.
Enforcement and Penalties under Korea REACH
K-REACH establishes strict penalties to ensure compliance, as outlined in Articles 50, 51, 52, and 54. The severity of penalties depends on the nature and seriousness of the violation.
Up to 5 Years Imprisonment or KRW 100 Million Fine
Applicable in cases of:
Failure to register or submit false registration/notification;
Failure to submit or false submission of registration amendments;
Failure to notify or false notification of consumer products containing PMCs.
Up to 3 Years Imprisonment or KRW 50 Million Fine
Applicable in cases of:
Failure to submit or false submission of registration exemption applications;
Use or sale of unregistered chemical substances.
Up to 1 Year Imprisonment or KRW 30 Million Fine
Applicable in cases of:
Failure to communicate information downstream or providing false information;
Obtaining registration data through improper means.
Up to KRW 10 Million Fine
Applicable in cases of:
Failure to amend or false amendment of exemption-related information;
Failure to conduct a joint registration without obtaining approval for individual registration
Failure to notify or submitting false information regarding changed data;
Failure to maintain required registration dossiers and records.
Our Compliance Services
We provide a comprehensive range of services to help companies ensure compliance with Korea K-REACH regulations:
Only Representative (OR) Appointment Services – Acting as the legal representative for overseas companies in Korea.
Lead Registrant Services (Joint Submission) – Coordinating joint registrations under K-REACH.
Data Retrieval and Quality Assessment – Searching for existing data and evaluating its reliability for regulatory submission.
Data Sharing Agency Services – Facilitating lawful sharing of data among registrants.
Chemical Risk Assessment Report Preparation and Submission – Preparing risk assessment dossiers in compliance with K-REACH requirements.
Product Notification Services – Assisting companies in preparing and submitting notifications for products, particularly those containing Priority Management Chemicals.
Exemption Documentation Preparation and Submission – Drafting and submitting registration or notification exemption materials.
Annual K-REACH Regulatory Consulting – Providing ongoing regulatory updates and guidance.
Safety Data Sheets (SDS) and Labeling – Preparing Korean GHS-compliant SDS and labels.
New Substance Notification and Registration Services – Handling all steps for new chemical substances under K-REACH.
Data Gap Analysis – Identifying missing or insufficient data required for compliance.
Laboratory Supervision – Overseeing testing procedures to meet K-REACH standards.
Compliance Strategy Development – Crafting actionable regulatory compliance plans.
Regulatory Training – Providing training sessions on K-REACH requirements and compliance best practices.
For more information and inquiries about K-REACH, please feel free to contact us at customer@reach24h.com.
FAQ
Q1: What are the key changes in the 2025 K-REACH revision?
A1: The main change is the adjustment of the notification threshold for new substances. The threshold for new substance notification has been raised from 0.1 t/a to 1 t/a, clearly distinguishing “notification” (<1 t/a) from “registration” (≥1 t/a).
Additionally, the amendment refines the classification of hazardous substances, strengthening interlinked regulatory oversight with K-CCA (Chemical Control Act) and K-OSHA (Occupational Safety and Health Act) based on toxicological properties. The revision also clarifies Only Representative (OR) transfers, ensuring legal continuity for previously compliant registrants and defining the rules for OR succession.
Q2: Do overseas companies exporting chemicals to Korea need to appoint an Only Representative (OR)?
A2: Yes. Under K-REACH, overseas manufacturers cannot directly submit registration or notification dossiers to the Korean MoE. They must appoint an OR located in Korea to fulfill compliance obligations. The OR acts as the official liaison with Korean regulatory authorities and assumes legal responsibility. Alternatively, overseas companies may establish a Korean subsidiary, which can act as the direct compliance entity.
Q3: Are additional compliance documents required for substances claiming registration exemptions?
A3: Yes. Even if a substance qualifies for an exemption, companies must submit a Registration Exemption Application Form along with supporting evidence (e.g., proof of use as a reagent, for research purposes, exclusively for export, or low-concern PLC polymers). Exemption is only granted after review and approval by the MoE.
Q4: How long does it typically take to register a new substance without a grace period?
A4: The registration timeline depends on substance tonnage and availability of global data. Typically:
Use data collection and dossier preparation: 3 months
Human and ecological toxicology testing: 6 to 18 months, depending on experimental complexity
Overseas companies are strongly advised to plan in advance and complete the registration process before the first export to Korea.
Q5: What happens if an existing substance that was pre-registered is not formally registered after the grace period?
A5: Once the grace period ends, existing substances that have not completed formal registration are prohibited from manufacture or import in Korea. Continued distribution of such substances will be treated as “unregistered substances”, subject to substantial fines, and responsible individuals may face criminal penalties.
