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New Revision of K-REACH Regulations in South Korea - Adjusting Compliance Requirements for New Substances


Time:

2024-03-01

On February 6th, the South Korean Ministry of Environment issued Decree No. 20232, proposing to revise regulations on the registration and evaluation of chemical substances. The main revision content of the K-REACH regulation in South Korea this time mainly includes four parts:

01 Add the following terms

✍️ Acute harmful substances in the human body:

Chemical substances that may have adverse effects on human health in a short period of time through single or short-term exposure, as designated and notified by the Minister of Environment in accordance with the standards set by the Presidential Decree.

✍️ Chronic harmful substances in the human body:

Chemical substances that may have adverse effects on human health through repeated exposure or incubation period after exposure, as designated and notified by the Minister of Environment in accordance with the standards set by the Presidential Decree.

✍️ Ecological harmful substances:

Chemical substances designated and notified by the Minister of Environment in accordance with the standards set forth in the Presidential Decree that may have adverse effects on the environment (such as aquatic organisms) due to short-term or long-term exposure.

✍️ Undetermined hazardous substances:

Refers to substances that have been registered/reported to the Ministry of Environment in accordance with Article 10 of the Regulations on Registration and Evaluation of Chemical Substances, but due to the lack of hazardous data, it is difficult to determine their hazardous nature, and they belong to the standards set by the Ministry of Environment.

02 Increase the reported tonnage of new chemical substances

The South Korean government has raised the reported tonnage limit for new chemical substances from 0.1 tons per year to 1 ton per year,

👉 Enterprises that import/produce new chemical substances below 1 ton/year

Notification is required before import/production.

👉 Enterprises that import/produce new chemical substances exceeding 1 ton/year

Registration is required before import/production.

At the same time, when reporting new chemical substances, enterprises must submit materials in accordance with regulatory requirements and explain the reasons when providing the classification and labeling of chemical substances.

03 Newly added regulations on the disclosure of chemical substance data

In order to facilitate the public's access and use of information on the dangers and hazards of chemical substances, the Minister of Environment shall, in accordance with the regulations of the Ministry of Environment, disclose the names, hazards, and other information of chemical substances that belong to any of the following categories.

Chemical substances registered or notified in accordance with Article 10 (including changes in registration or notification under Article 12);

Chemical substances that undergo hazard or risk assessments in accordance with regulations;

Other chemical substances specified by the Ministry of Environment.

Anyone who needs to modify or supplement the hazard information of the chemical substances disclosed above can apply to the Director of the Ministry of Environment, accompanied by supporting documents.

After receiving a modification application, the Minister of Environment shall review the hazard information of the relevant substance and may take the following measures if necessary:

Conduct hazard or risk assessments in accordance with regulations;

◇ Modify public information about substances;

In addition, necessary matters such as standards, methods, and procedures for the disclosure and modification of chemical substance information shall be stipulated by the Ministry of Environment.

 

04 Newly added data breach regulations and penalties

If any of the following accidents occur (hereinafter referred to as "data leakage accidents"), the informed party shall immediately notify the Minister of Environment of the time, location, accident details, and measures to be taken.

◇ The leakage or loss of data required to be protected under Article 45 (1) (hereinafter referred to as "protected data");

◇ Damaging or damaging storage facilities and equipment for protected data;

Other accidents determined by the Minister of Environment.

If a data leakage accident occurs, the Minister of Environment should conduct an investigation to determine the cause of the accident and develop preventive measures.

The Minister of Environment shall take necessary measures based on the investigation results of data leakage incidents, such as replacing the equipment of protected data storage facilities or suspending or canceling the effectiveness of protected data.

Those who fail to report data leakage accidents shall be fined no more than 3 million Korean won.

Revision effective time

The revision of K-REACH regulations in South Korea will take effect from August 6, 2025. The adjustment of the reported tonnage for new chemical substances and the requirements for submission of materials will take effect from January 1, 2025.

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