South Korea Releases a List of New and Existing Substances Support Program Under K-REACH

To promote K-REACH registration and alleviate the pressure on registering companies, the South Korean government has introduced a series of government support programs. On April 11, 2024, the Korea Chemicals Management Association (KCMA) published three lists of substances that can be supported by the government during the registration.

The announcement is as follows:

List 1: List of new substances supported for the production of toxicological test data

Selected results: 34 substances (total of 172 test projects)

Eligibility: New chemical substances applied for registration in 2024

Registrations to be completed within 2024, and manufacturers and importers in South Korea must be small and medium-sized enterprises (SMEs).

Support details:

1. Support for testing fees for toxicological test data produced by domestic GLP laboratories in South Korea. Financial support is provided when companies sign contracts with GLP laboratories or complete testing (support for up to 25 test projects).
2. Support ranges from 80% to 95% of the total costs for alternative animal test projects, and from 60% to 70% for general test projects (priority given to projects that can perform alternative animal testing).

Timeline:

• Signing of the agreement and payment of support funds (around May 2024)
• Submission of the final version of the test plan (around August 2024)
• Submission of the chemical substance registration certificate (around December 2024)
• Submission of the test summary and final reports from GLP laboratories (in Korean and English).

※ Final report in Korean: by December 31, 2024/ Final report in English: by March 31, 2025

However, test plans for alternative test projects can be submitted within the corresponding regulatory deadlines.

※ Final report in Korean: by December 31, 2025/ Final report in English: by March 31, 2026

List 2: List of existing substances supported for the production of toxicological test data

Selected results: 22 substances (total of 120 test projects)

Eligibility: Existing substances with a registration deadline by the end of 2024 (annual production/import volume between 100 to 1000 tons)

Substances that can complete registration or have already completed registration before November 2024; substances that have selected a lead registrant and include at least two SMEs within South Korea.

Support details:

1. Support for testing fees for toxicological test data produced by domestic GLP laboratories in South Korea. Financial support is provided when companies sign contracts with GLP laboratories or complete testing (support for up to 25 test projects).
2. Support ranges from 80% to 95% of the total costs for alternative animal test projects, and from 60% to 70% for general test projects (priority given to projects that can perform alternative animal testing).

Timeline:

• Signing of the agreement and payment of support funds (around May 2024)
• Submission of the final version of the test plan (around August 2024)
• Submission of the chemical substance registration certificate (around November 2024)
• Submission of the test summary and final reports from GLP laboratories (in Korean and English).

※ Final report in Korean: by November 30, 2024/ Final report in English: by February 28, 2025

However, test plans for alternative test projects can be submitted within the corresponding regulatory deadlines.

※ Final report in Korean: by November 30, 2025/ Final report in English: by February 28, 2026

List 3: List of existing substances receiving registration consultation support

Selected results: 56 existing substances

Eligibility: Existing substances with a registration deadline by the end of 2024 (annual production/import volume between 100 to 1000 tons)

Substances that can complete registration or have already completed registration before November 2024; substances that have selected a lead registrant and include at least one active member from SMEs within South Korea.

Support details:

Partial support for the registration consultation fees for existing chemical substances, based on the maximum registered tonnage. A fixed amount of consultation fee support is provided according to the size of the SMEs included among the active members.

Timeline:

• Signing of a tripartite agreement and payment of support funds (around May 2024)
• Submission of the chemical substance registration notification (around November 2024)

Existing Substance Registration

Under K-REACH, existing substances have four grace periods for registration based on their pre-registered tonnage and hazardous characteristics. The details are as follows:

Existing substances produced/imported at 1000 tons or more per year, and substances of 1 ton or more that are classified as CMRs (Carcinogenic, Mutagenic, or toxic to Reproduction), must be registered by the end of 2021. Currently, these substances require registration before being exported.

• Substances produced/imported at 100 tons or more but less than 1000 tons per year must complete formal registration by December 31, 2024.
• Substances produced/imported at 10 tons or more but less than 100 tons per year must complete formal registration by December 31, 2027.
• Substances produced/imported at 1 ton or more but less than 10 tons per year must complete formal registration by December 31, 2030.

New Substance Registration

Currently, when the annual manufacture or import volume of a new substance reaches 0.1 tons or more, companies must complete the registration of the new substance before manufacturing or importing it. For new substances below 0.1 tons per year, a notification must be submitted.

From January 1, 2025, the registration threshold for new substances will be updated from 0.1 tons or more to 1 ton or more. For new substances below 1 ton, only a notification to the authorities is required, without the need for formal registration.

CIRS reminds that if your pre-registered substance under K-REACH has an annual production/import volume of 100 tons or more but less than 1,000 tons, you should confirm the registration obligations, registration tonnage, and intended uses with the importer in South Korea as soon as possible. Additionally, the CIRS Group Korea, as one of the officially designated consulting agencies for government support projects, has completed multiple government support projects.

If you need any assistance or have any questions, please get in touch with us via service@hfoushi.com.