Dr. Sanghee Park from Chemtopia at Shanghai CRAC on 21 Oct, 2013.
Korea’s existing chemical inventory contains 37,021 chemicals which have been domestically circulated in Korea prior to Feb 2, 1991 and those assessed and published by MoE through hazard evaluation under TCCA after Feb 2, 1991 (assumed 6,878 as of Dec 2012). All chemicals falling outside of these criteria are regarded as new chemical substances subject to new chemical registration.
Whether a low-volume exemption for new chemicals will be applied to K-REACH registration is a crucial concern for industry. Current information indicates that apart from the special exemptions specified in K-REACH regulations, all new chemical substance regardless of tonnage should be registered, according to Dr. Sanghee Park from Chemtopia speaking at the REACH24H Chemical Regulatory Annual Conference (CRAC 2013) on 22nd of Oct.
New chemical substances assessed under TCCA will be published on the Official Gazette 3 years after the assessment result is officially delivered to the applicant. Those unpublished by 1 Jan 2015 will still be considered as new. (* see case studies below for further clarification)
Case 1: New chemicals assessed between Jan 1, 2012 and Dec 31, 2014 but unpublished are considered new chemicals under K-REACH. Only the original applicants will be exempted from new chemical registration under K-REACH.
Case 2: If a new chemical registration dossier is submitted but does not receive an assessment result by 1 Jan 2015, the substance will be considered new under K-REACH. New chemical registration under K-REACH is required for everyone who wants to manufacture or import the new substance.
Case 3: For new chemicals assessed and already published under TCCA, the status changes from “new” to “existing”. There is still a chance chemicals will be included into the priority list which are subject to existing chemical registration. In this case, only the original applicant can be exempted or granted a more simplified registration under K-REACH.
The IT tool for K-REACH is also of critical concern, however it is unclear how similar this system will be to the UCLIDE5 system used in EU REACH and the cross compatibility of the data use in both. Industry is hoping that dossiers submitted under EU REACH can be accepted under K-REACH with minimal adjustments. Another major stumbling block in the realization of this goal is the development of a bilingual platform capable of handling both Korean and English data sources.
Toxicological and eco-toxicological data should be produced by GLP or government approved testing laboratories. Authorities are adopting a conservative stance regarding acceptance of test data generated from non-OCED member countries, even if the test institute is GLP certified.
K-REACH will come into force on 1 Jan 2015. The upcoming deadline has placed Korean authorities under tremendous pressure to address many of the unforeseen problems that have arisen. The major problems are being addressed in four guidance documents relating to cost sharing, chemical identification, test data, post-registration obligations, etc. The priority list of chemicals which will be subject to existing chemical registration has also yet to be published. With D-day approaching and many things still uncertain, if the guidance documents, priority list and IT tool, due to be published next year are delayed there will be no time for potential registrants to figure out productive strategies to comply with K-REACH.