Thursday, April 9, 2015

It is likely ; Deregulation in the required data for KOSHA registration.

▪ 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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