New Chemicals in Korea Required to Comply with Both K-REACH and OSHA

1. Companies should register new chemical substances under OSHA as well as K-REACH. 2. Before 2020, data submission requirements for new chemical substances < 1t/y will vary hugely between OSHA and K-REACH. 3. MoEL may consider waiving some test data under OSHA to relieve the regulatory burden on potential registrants.

At present, new chemical substances should be notified separately under both TCCA and OSHA prior to manufacture or import activities. New chemical registration work previously conducted under TCCA will be transferred to K-REACH on 1 Jan 2015 and the companies should still notify their new chemical substances under OSHA without any delay.

In Korea’s OSHA, the notification types and tonnage bands are not divided. For new chemical substances in volumes greater than 0.1 tonne per year (substances<0.1t/y are exempt from notification), three test reports on toxicity should be submitted, including acute toxicity test (inhalation preferred, if not, Acute oral toxicity test can be substitute), Ames test and micronucleus test (in real practice micronucleus test is not mandatory required).

However, for K-REACH, before 2020, a simplified registration with less data requirements is applicable for new chemical substances in low volume below 1 t/y. There is no need to submit any test report and registration just requires the following information:

Registrant information
Substance information
Uses
Exposure information related to usage

According to an expert from Nam & Nam International, companies should also comply with OSHA for new chemical notification after the implementation of K-REACH. The ambiguity surrounding this issue has promoted the scheduling of meetings among related ministries, including Ministry of Environment (MoE), Ministry of Trade, Industry and Energy (MOTIE), MoEL, etc. with a focus on assessing the feasibility of waiving some of the test data requirements under OSHA. The MOTIE and MoEL are now still in a negotiation.

After 2020, simplified registration under K-REACH will only apply to new chemical substances in volume less than 0.1 t/y. Registrants of new chemical substances less than 1 t/y completed before 2020 do not need to supplement the testing data after 2020 (9 testing items will be required for 0.1-1t/y after 2020), according to experts from Nam & Nam International. However, re-registration will be necessary if there is any change in tonnage band or use, etc. For detailed data requirements under K-REACH, please see K-REACH Chempedia.