South Korea’s chemical regulations are undergoing significant changes

This article was originally published on Chemical Weekly on 16 April 2024.

South Korea’s chemical industry stands as a cornerstone of the country’s economic growth, driving innovation, trade, and technological advancements. Behind this success story, however, lies a complex web of regulations and policies designed to ensure the sustainability and safety of chemical production, distribution, and usage. This year, we will see significant shifts in South Korea’s major chemical regulations, driven by a steadfast commitment to protect public health and the environment. Understanding these changes is crucial for stakeholders to ensure compliance, mitigate risks, and seize emerging business opportunities in this ever-evolving regulatory environment of South Korea.

Chemical regulations in South Korea

The Act on the Registration and Evaluation of Chemicals, widely known as K-REACH, came into effect on 1 January 2015. This regulation was promulgated by the Ministry of Environment of Korea (MoE) and plays a crucial role in improving the safe management and control of chemical substances in the country. Similar to EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), K-REACH is based on the principles of scientific knowledge and accurate data. It aims to establish a comprehensive framework for the control of chemical substances based on a thorough understanding of their physicochemical properties, hazards and risks.

Meanwhile, the Chemical Substances Control Act (K-CCA), which came into force on the same date as K-REACH, replaced the Toxic Chemicals Control Act. While K-REACH focuses on the identification of hazardous chemical substances, the regulatory provisions of K-CCA mainly focus on controlling the entire process from market access, distribution, handling and disposal of chemicals to prevent chemical accidents at the sites.

Major regulatory changes

Please note that a limited number of changes have been introduced in this article. Therefore, in order to be fully compliant with K-REACH and K-CCA, it is highly recommended that you review all changes. Also, please note that all of the changes listed below have already been officially announced by MoE, but will enter into force August 2025.

(1) One of the most important changes regarding K-REACH is that the annual manufacturing/importing volume threshold for new chemical substance notification changes from < 0.1 t/a to < 1 t/a. General registration (> 1 t/a) requires a full dossier including data on hazards, risks and uses of substances. However, manufacturers/ importers of new chemical substances < 1 t/a will only be required to notify with the chemical name, CAS#, use and Classification & Labelling (C&L) of the substance. This change will reduce the administrative burden for both regulators and the industry, and promote more active trade by reducing barriers to market entry or compliance. In order to ensure public safety in relation to new chemical substances, the name of chemical substances subject to notification and their hazard data will be made public, and MoE will review the notified C&L to check the propriety after the notification is completed.

(2) The term ‘toxic substances’ under K-REACH refers to designated substances that have been determined to be hazardous as a result of hazard assessment by MoE. As shown in Figure 1, ‘toxic substances’ are divided into three different groups based on toxicity characteristics, namely acute toxicity for human health, chronic toxicity for human health and ecotoxicity.

Such classification will allow a more targeted risk assessment and management strategy by the responsible authority. For acute toxic substances for human health the focus will be on the prevention of chemical accidents, while for chronic toxic substances for human health the focus will be on the reduction of long-term exposure. Substances which are toxic to the environment will be managed by focusing on the reduction of environmental release.

Companies will need to update labelling and Safety Datasheets (SDS) accordingly and pay attention to the further amendment plan for new facility standards that will be set under K-CCA, taking into account the characteristics for each group.

(3) Chemical substances without hazard data are assumed to be hazardous chemicals until the hazard is classified. This is to prevent any health/environmental risks. Hazard data should be made available to the supply chain and in this case it is foreseen to state ‘reason for non-classification’. This approach is in line with the precautionary principle, ‘no data, no market’, which prioritises taking preventive action in the face of uncertainty to avoid potential harm. This change will require additional efforts when placing a ‘substance without hazard data’ on the market to prove that the substance will be safe for users. However, MoE has not yet decided which data will be accepted as evidence. Industry will not be able to make decisions until MoE announces the type and quality of data required to prove ‘non-classification’ and how this data should be generated, collected and evaluated.

(4) There will be a change in regulatory bodies for K-REACH and K-CCA. While MoE is responsible for developing and implementing policies, the National Institute of Environmental Research (NIER) plays a crucial role in providing scientific data and expertise to support environmental policy and management. Under K-REACH, NIER took on the important role of implementing and overseeing the chemical registration and notification process and managing the protection of confidential business information related to hazardous substances. And under K-CCA, NIER has the authority to legislate the labelling of hazardous substances. This work will be transferred to the National Institute of Chemical Safety (NICS). NICS focuses mainly on chemical accident prevention and response; as such it has a role in facility management under K-CCA. In order to ensure consistency in these tasks and to facilitate the use of resources already available, MoE decided to establish a single point of contact for all types of chemical accidents where they have information on chemical substances distributed in Korea. Some of the responsibilities will be transferred to NIER for evaluation of testing facilities, development of alternative testing methods, risk assessment and socio-economic analysis, and management of substances subject to permission, restricted substances and prohibited substances.

Key messages

These revisions represent a comprehensive overhaul of the regulatory framework, introducing new requirements for registration, evaluation, and risk management of chemical substances. Furthermore, it aligns South Korea’s chemical regulations more closely with international standards, facilitating trade while bolstering efforts to address emerging risks posed by hazardous substances. However, obligations under K-REACH and K-BPR to register existing substances in line with the tonnage band related deadlines remain unchanged.

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