K-REACH: The Act on the Registration and Evaluation of Chemical Substances
The main industrial chemical regulation in South Korea is the Act on the Registration and Evaluation of Chemicals (AREC), commonly known as “K-REACH”. The main revision to the regulation entered into force on 1 January 2019.
K-REACH places significant obligations on manufacturers, importers, users and sellers of chemicals. Companies failing to comply can face large penalties, including penalty surcharges of up to 5% of sales and prison sentences of up to 5 years.
K-REACH Registration deadlines for existing substances:
The Main Regulatory Obligations
Late Pre-notification of existing substances manufactured or imported ≥1 tonne/year
Registration of existing substances manufactured or imported ≥1 tonne/year (approximately 7000 substances) before specified registration deadlines
Registration of new substances before manufacture or import ≥0.1 t/y
Notification of new substances before manufacture or import <0.1 t/y
Where relevant, application for “Confirmation of Exemption from Registration”
Notification of priority control substances to the Ministry of Environment if manufactured/imported at >1 t/y and present in consumer products at > 0.1%.
Compliance with requirements for information provisions in the supply chain
Compliance with authorisation requirements for the candidate substances subject to authorisation.
Restriction requirements: K-REACH restricts the use of certain hazardous substances in consumer products and articles.
Please also be aware of the obligations under the Chemical Control Act (CCA) and K-OSHA.
Frequently Asked Questions
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Non-Korean companies can appoint an Only Representative (OR) based in South Korea to submit pre-registrations and registrations. Several importers can be covered by a single registration of the OR, but these importers must be known to the OR and included in the pre-registration/registration submission. The tonnages of all importers must be aggregated and any new importers should be added within 1 month. Yordas provides OR services through our dedicated partner.
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Although there are some similarities (for example, non-isolated intermediates and substances obtained from natural sources are exempt from registration under both regulations), there are significant differences.
For example, “confirmation of exemption from registration” is required from the regulator before importing non-isolated intermediates above notification/registration thresholds, and the exemption criteria for substances obtained from natural sources are different.
The following are exempt from K-REACH registration (ref: K-REACH Article 11):
Exempt - no confirmation required
A chemical substance contained in a machine imported;
A chemical substance imported along with a machine or device used for a test run;
A chemical substance contained in a product performing a certain function in a specific solid form, which does not leak in the process of using the product;
Exempt - “confirmation of exemption from registration” required
Export only substances
Chemical substance for scientific experiments, analysis or research such as reagents, etc.
Chemical substance for R&D
Surface Treated Substances
Polymers of Low Concern (PLC)
Non-isolated intermediates, and;
Isolated intermediates whose leakage is blocked by technical means (does not apply to foreign companies)
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Some of the data for EU-REACH can be used for K-REACH registration, however it is important to perform a data gap analysis to identify any missing data before preparing the K-REACH dossier. It is also essential to ensure you have legitimate rights to use the endpoint data for K-REACH before submission.
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Those companies with a pre-registration (for general existing substances) will have a grace period for registration. There are deadlines in 2021, 2024, 2027 and 2030 depending on the tonnage band and CMR status. During the grace period, they can keep importing the chemical substance into South Korea as long as they are within their tonnage limits. Companies must register the substance before the deadline if they intend to import/manufacture above the tonnage threshold after the relevant deadline.