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Two subordinate statutes of K-REACH have been issued for public consultation (Chemlinked news 21 Feb 2014). The statutes were drafted based on conclusions made by a task force consisting of industry stakeholders, government officials, experts and NGOs. The development of this program is different from traditional legislative procedures where authorities engage in talks prior to drafting legislative documents, before finally opening them to public consultation. This new legislative method is less likely to face resistance from industry and ultimately more likely to be successfully passed.
The registration of new chemicals will undergo a devolutionary process where regulatory responsibility will be shifted from TCCA to K-REACH. The measures during this transitional period are a major concern for original and potential registrants. As clarified in the draft Presidential Decree and Ministerial Decree, the following scenarios are a useful reference.
Case 1: New chemicals having received hazard examination results under TCCA but unpublished on the Official Gazette by 1 Jan 2015 are still considered new chemicals under K-REACH. Only the original applicants will be exempt from new chemical registration under K-REACH. However, the original applicant is required to notify to the NIER before 30 Jun 2015 and submit the following information:
Hazard examination results
Manufacture and import amount in the past three years
Usage classified according to Korean use category (at present 65 categories)
Case 2: For new chemicals assessed and already published under TCCA, the status changes from “new” to “existing”. There is no need to comply with new chemical registration under K-REACH. Though unlikely, there is still a chance the chemicals will be included in the priority list which are subject to existing chemical registration. In this case, the original applicant can be exempt from the existing chemical registration under K-REACH. For priority substances, original applicants are required to notify to the NIER within 6 months after the publication of priority list providing the information mentioned in case 1.
Hazard examination exemptions under TCCA for new chemical substances manufactured or imported in quantities of less than 0.1 ton per year will not be available under K-REACH. K-REACH requires all the new chemical substances to be registered except for chemicals that meet the registration exemption conditions specified in Table 1 below. However, a one-year grace period will be granted for low-volume substances until the end of 2015.
As for the data protection under TCCA, it will still be valid under K-REACH until the protection period expires.
Table 1. K-REACH Registration
| Registration Exemption | Simplified Registration
| Registration |
Applicable Scope | 1. R&D substance manufacture or import each year 2. R&D substance manufactured or imported one-off
3. Low-concerned polymer(LCP)
4. Surface treated chemical in which both the base and the treated chemical do not contain new chemical or existing substance that is subject to registration | New chemical substances manufactured or imported below 1 tonne per year (2015-2020); tonnage threshold will be reduced to 0.1 tonne from 2020
| priority evaluation chemicals (PECs) over 1 tonne per year and all new chemicals |
Authority | Korea Chemical Management Association (KCMA) | National Institute of Environmental Research (NIER) | NIER |
Processing period | Review and issue the Confirmation of Exemption within 3 days (10 days if further consultation with NIER required) | Review and issue the Registration No. within 3 days (7 days if further review required) | - Review and issue the Registration No. within 30 days - Carry out hazard assessment and issue the assessment result within 6 months for new chemical substance; within 1 year for PECs |
