▪ With regards to KOSHA registration with
tonnage band of ‘over 0.1t/y’, the hazard studies which required to submit
would be reduced from three(3) end points at present to one(1) end point.
For the substance registration under
KOSHA, it is required in principle to submit the 3 end points of toxicity(acute
toxicity test-oral / inhalation, Ames test, and micronucleus test), even though
micronucleus test is usually waived. But Korea Ministry of Employment and Labor(MoEL)
has a plan to substitute those requirement with only the acute toxicity test.
Also other genotoxicity studies like Ames test, micronucleus test could be
ordered to submit by MoEL for the chemical substance that is expected to cause
harmful risk to the health like mutagenicity.
▪ In addition, MoEL has a plan to
shorten the duration for examination of registration dossier with tonnage band
of ‘over 0.1t/y’ from 45 days at present to 14 days, i.e. MoEL will respond to
each application of substance registration within 14 days.
▪ Expected schedule by MoEL
- 2015.4 : Preparation for amendment of
the enforcement rule
- 2015.5 : Legislative notice
- 2015.7 : Review for regulatory and
legislative purpose
- 2015.9 : Enactment and enforcement.
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