To improve the registration efficiency of new chemical registration under K-REACH, as well as optimize the preparation and transmission of hazard information to be aligned with EU standards, South Korea’s MoE is considering updating the critical tonnage band (0.1 t/y → 1 t/y) for new chemical registration under K-REACH in 2024. Accordingly, data submission requirements for low tonnage bands may be updated. That is to say, for new chemicals manufactured or imported at a volume of 0.1 t/y ~ 1 t/y, relevant requirements under K-REACH may be changed in the coming future. However, a detailed proposal is not released so far.
In most countries and regions that implement REACH-like regulations for chemical registration, registration obligations apply to new substances manufactured or imported in quantity of 1 t/y or more. As for new substances less than 1 t/y, notification applies. South Korea’s MoE may take this into consideration to reduce the compliance burden for SMEs. As per the current K-REACH, it adopts levels of tonnage bands with higher tonnage bands requiring more information for data submission. More specifically,
For new chemical substances < 0.1 t/y, they only require notification rather than registration. Only very simple information is required for data submission, including manufacturer/importer information, chemical name and identity, uses, classification and labeling, etc.
For new chemical substances ≥ 0.1 t/y, the require registration. The information below is required for data submission (higher tonnage bands requiring more information):
Company information (name, address, representative of the manufacturer or the importer, etc.),
Chemical identification information (chemical name, molecular formula, chemical structure, etc.),
Use information,
Classification and labeling,
Physicochemical properties,
Toxicological information,
Risk assessment information for substances at or above 10 t/y,
Guidance on safe use (including personal protective devices and measures for explosion, fire, or leak), etc.
Recently, South Korea’s MoE announced many supporting programs to help SMEs complete the compliance works under K-REACH (CL news). On July 12, 2023, a pilot project of free consultancy regarding new chemical registration was initiated in South Korea, which applies to domestic SMEs handling new chemicals less than 0.1 t/y. The application deadline is September 30, 2023. Details can be accessed here.
