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The Enforcement Decree of the Act on Registration and Evaluation, etc. of Chemical Substances (hereafter referred to as K-REACH Enforcement Decree) was revised on 26 Dec 2017 by Presidential Decree No. 28502. The updates came into effect immediately except for Article 31 Paragraph 4 and 5 which took effect since 1 Jan 2018.
K-REACH was revised on 27 Jan 2016 and the updates came into effect on 28 Jan 2017. Major changes have been summarized by ChemLinked (CL news). The Enforcement Decree was revised accordingly to corporate with K-REACH’s revisions.
Compared to the previous version (Presidential Decree No. 27434, fully implemented on 28 Jan 2017), major changes are summarized as below:
Article 2 (definitions)
Adding definition of a “nanomaterial”
-- A Nanomaterial means (1) more than half of the particles have one or more external dimensions between 1 nm and 100 nm; or (2)fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm
Article 11 (registration exemption of chemical substances)
For Polymer with Mn less than 10,000 Daltons, which contains more than 2% of monomers that are new chemical substance, hazardous chemical substance or specific chemical substance prescribed by Presidential Decree due to its hazard or risk are inapplicable to PLC exemption. The “new chemical substance” are further specified as “new chemical substance (expect for those manufactured/imported more than 1t/a and have been assessed by NIER according to article 18 of K-REACH)”
Article 13 (omit of materials submitted for chemical registration)
Adding one condition (point 6.2) subject to omitting of materials submitted for chemical registration
-- Chemical substances of which their health hazards and environmental hazards can be determined by public hazard assessment results from overseas government or international organization.
Article 14 (reasons for individual submission for PEC registration)
Except for the reasons in Article 15 Paragraph 1 of K-REACH, if the registrant owns all data and is willing to share with other registrants of the same substance without charge, an individual submission can be made.
Article 19 (designation and publication of substances subject to authorization)
Before designation of an authorized substance, a social economy analysis report should be completed to analyze the impact of using the substance in question on the social economy. In such case, if risk assessment has not been conducted, it should be conducted in the meantime. In the updated version, it is further explicated that if the substance to be designated for authorization has been controlled or is to be controlled by the overseas government or international organization, according to Article 25 Paragraph 1 of K-REACH, the social economy analysis report and risk assessment can be omitted since it already has sufficient hazard data for designation.
Article 20 (designation and publication of restricted or prohibited substances)
For designation of restricted or prohibited substances, the update is also considering issues applicable to omit the social economy analysis report and risk assessment which is the same as Article 19 specified above.
Article 31 (delegation and entrustment of authority)
Delegating one more task (point 7.2) to the National Institute of Environmental Research (NIER)
--The designation and publication of toxic chemical substances is delegated to the NIER.
In addition, the tasks delegated to the Basin/ Regional Environmental Office, Korea Environmental Industry & Technology Institute (KEITI), Korea Environment Corporation (KECO) and associations have been updated.
The translation of the updated K-REACH Enforcement Decree is being prepared and will soon be available on ChemLinked E-book store. Please stay tuned to our site.
