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Act on Registration and Evaluation, etc. of Chemical Substances — “K-REACH”
At a conference organized by the National Institute of Environmental Research (NIER) on 14 July 2013, the scope of new chemical substances required to get registered under K-REACH is clarified. Although notified under TCCA, some of the chemical substances will still need to complete the mandatory registration pursuant to K-REACH if not published on the Official Gazette by 1 Jan 2015.
As specified in the legislative content of K-REACH, “new chemical substance” means all chemical substances other than existing chemical substances which are defined as either of the following,
A. Chemical substances published by the Minister of Environment (MoE) through the consultation with the Minister of Employment & Labor (MoEL) as chemical substances distributed for commercial uses in the country prior to February 2, 1991.
B. Chemical substances published by the MoE as the substances cleared of the new chemical notification under the Toxic Chemicals Control Act (TCCA) after February 2, 1991.
Clarified in this conference, the new chemical substances which have undergone hazard assessment under TCCA while not published on the Official Gazette by the effective date of K-REACH, will still be considered as new and subject to registration under K-REACH. It is customary that the publication of new chemical substances notified under TCCA on the Official Gazette is made 3 years since the assessment result is officially delivered to the notifer. Therefore, new chemical substances already assessed during 1 Jan 2012 and 31 Dec 2014 should register under K-REACH without delay theoretically.
On the other hand, new chemical substances gazetted before 31 Dec 2011 should be considered as existing chemical substances. For those included into the list of priority evaluation chemicals (PECs), they should be registered under K-REACH prior to manufacture and import (See the dark blue part in the figure below). However, the companies having previously completed the new chemical notification under TCCA, namely the original notifiers can obtain the registration number under K-REACH through notifying the MoE. The other potential registrants should register the gazetted substances based on the varied registration grace period for the priority 1, 2 and 3 chemical substances, which is said to be 2, 5 and 8 years respectively.
Note: The PECs, rather than all existing chemical substances, are subject to registration under K-REACH. They are classified as priority 1, 2 and 3 chemical substances with corresponding grace period.
It’s unfortunate that the Korean authority want to re-evaluate the new chemical substances already notified after the hazard assessment just because they are not published on the Official Gazette. The official explanation could only create more burden on the shoulder of the companies since to re-register the new chemical substance under K-REACH regime would be much more complicated with increasing data requirements compared with the current TCCA.
