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New chemicals notified under TCCA which have already undergone hazard assessment under TCCA but have not been published in the Official Gazette prior to 1st of Jan 2015 are still considered new chemicals under K-REACH. Korean authorities are now offering a chance for them to be included into the Korean Existing Chemicals Inventory (KECI) as existing chemical substances under K-REACH.
Under the current regulatory framework the publication of new chemical substances notified under TCCA on the Official Gazette is made every 3 years after the assessment results are officially delivered to the notifier. In line with this rule new chemical substances already assessed between 1st Jan 2012 up until the 31st of Dec 2014 under TCCA are consider new chemicals. Only the original registration applicant will be exempt from new chemical registration under K-REACH.
However to allay industry’s burden, MoE will update the KECI in April to include more new chemical substances already assessed under TCCA that have never been published Official Gazette as existing chemical substances. For new chemical substances already assessed between 1 Apr 2012 and 31 Dec 2014 (subject to the date of receiving hazard examination result), original notifiers can inform authorities via E-mail ([email protected]) or by fax (032-568-2038) before 17 Mar 2015 that they wish to change the status of a notified new chemical substances from “new” to “existing”.
Table 1. Information to be submitted to the authority before 17 Mar 2015
| Hazard assessment No. | Chemical name (Generic name) | Date of receiving hazard examination result | Agree for publication in April of 2015 | |
| Agree | Disagree | |||
| … | … | … | … | … |
| … | … | … | … | … |
It will be assumed that notifiers are opposed to any change in regulatory status if failing to inform authorities of their wish to change the status of a notified chemical before this deadline. If so, the substance will not be published as an existing chemical substance and will still be regarded as a new chemical substance. Substances not published during this period will be announced three years later. For these substances, only the original applicants under TCCA will be exempt from new chemical registration under K-REACH. All other potential registrants should register under K-REACH without delay.
The original applicant is required to notify to the NIER that the substance has been notified under TCCA before 30 Jun 2015 with the following information:
Hazard examination results
Manufacture and import amount in the past three years
Usage classified according to Korean use category (at present 55 categories)
In addition, in cases of modification of volume (manufacture or import), usage or hazardous properties, re-registration reflecting all updates and amendments should be submitted. As for the change of applicant information, e.g. name of registrant, address, representative, the original notifiers under TCCA should also notify changes to MoE under K-REACH.
If the original notifiers agree to include their new substance into KECI in advance, the status of the substances will change from “new” to “existing”. There is no need to comply with new chemical registration under K-REACH for any company handling these substances thereafter. However, considering K-REACH registration is a significant regulatory barrier, exemption from registration represents a distinct competitive advantage for original notifiers and as such not all original notifiers will agree to publish their substances.
