K-REACH Legislation Further Amended: Law No. 15844

New amendments were passed and incorporated into the revised K-REACH as Law No. 15844 on 16 Oct 2018. New K-REACH legislation will come into effect on 1 Jan 2019. Corresponding K-REACH secondary rules are currently undergoing public consultation which will end on 26 Nov 2018.

Amendments regarding (1) the use of hazard testing data and (2) modification application for situations where the “Confirmation of Registration Exemption” has been obtained were incorporated into the revised version of K-REACH as Law No.15844 on 16 Oct 2018. The new requirements will come into force on 1 Jan 2019.

In current practice Korea MoE conducts hazard evaluation for the chemical substances registered under K-REACH. Any person who intends to use the result of hazard evaluation for the purpose of registration or hazard evaluation of chemical substance in other countries should obtain permission in advance from the MoE. The revised K-REACH updated the provisions associated with "the use of the result of hazard evaluation" to "the use of hazard testing data".

In addition, after revision, for substances for R&D purpose, if the manufacture/import volume is changed there is no need to re-apply for “Confirmation of Registration Exemption”. Instead, a modification application should be conducted.

History of the revised K-REACH:

Promulgated by the president on 20 Mar 2018 as Law No. 15512 (ChemLinked news)
Amendments regarding reduction of vertebrate animal testing during generation of registration data were incorporated into the revised K-REACH as Law No. 15584 on 17 Apr 2018 (ChemLinked news)
Amendments mentioned above were passed as Law No. 15844 on 16 Oct 2018

The MoE also has published the draft implementation decree (MoE Notice No.2018-772) and the draft implementation rules (MoE Notice No.2018-773) for the revised K-REACH legislation detailing the new amendments. For example,

Define the situations where to the modification of “Confirmation of Registration Exemption” should be applied for and corresponding fines for failure to comply.
Change the use of “the result of hazard evaluation” to “ the hazard testing data” used by the MoE for hazard evaluation;
Transfer the work of assessing hazard testing data away from the National Institute of Environmental Research (NIER) to the Korea Environment Corporation (KECO); and
Transfer the work of granting permission /cancelling permission for using hazard testing data for the purpose of registration or hazard evaluation of chemical substance in other countries away from the NIER to KECO.

Comments on the K-REACH secondary rules are welcome before 26 Nov 2018 and they are expected to be finalized in December.