Speaking at the Open Seminar on Chemicals Management Policies among China, Japan and Korea, in Hangzhou of China in 31 Oct 2012, Mr. Pilje Kim confirmed that the South Korea’s proposed Act on Registration and Evaluation of Chemicals (K-REACH) has been submitted to National Assembly and will be released in the first half of 2013. The K-REACH is expected to come into force since 2015.
120 officials from the Environmental Protection Departments of China, Korea and Japan and more than 160 representatives from the industry and non-government organizations have attended the seminar. In the seminar, responsible officials of the three countries proclaimed the chemical management prospect and regulatory concerns in their own countries. The seminar, held annually with location rotating among cities in China, Korea and Japan, is committed to set up a platform for the experts and representatives from chemical industry to communicate with the competent authorities.
Stipulated in the K-REACH, the manufacturers or importers of new chemicals and priority evaluation chemicals (PECs) shall submit registration to the Ministry of Environmental (MOE) prior to manufacture and import. The PECs are screened out among the existing chemicals concerning the exposure, hazard and trading volume, etc., including about 2000 to 2500 chemicals. The PECs list is planned to be released in 2014. The registration grace periond for the PECs varies across the priority 1, 2 and 3 chemicals, which is 2, 5 and 8 year respectively.
In the previous draft version, manufacturers or importers of existing chemicals manufactured or imported in quantities above 0.5 ton per year must submit a registration. However, the final draft has changed the criterion from 0.5 ton/yr to 1 ton/yr, which is consistent with the requirements of the EU REACH and Japan CSCL. The pre-registration process has been deleted earlier this year, and the reporting frequency has been changed from once a year to once every two years.
Similar to the EU REACH, the K-REACH also allows foreign companies to apply for notification to authorities through the appointment of a only representative in Korea. Any foreign-invested entities which officially registered in Korea are qualified as ORs without overall size limit.
In cases of modification on volume (manufacture or import), usage or hazardous properties, dossiers with updated information should be submitted. Companies can make joint submissions on the same substance. In the K-REACH, there’s a prohibition on repetitive generation of vertebrate animal test data. In cases of refusal of vertebrate test data sharing without justification, the submission of such data for registration can be prohibited.
Since South Korea is a member state of OECD, the test data generated from the GLP laboratories overseas will be acceptable under K-REACH. However, the complete test report should be submitted for registration under the K-REACH.
As for the chemicals management in Japan, Ms Keiko Segawa introduced the Chemical Substance Control Law (CSCL), the Pollutant Release and Transfer Register (PRTR) and the other pollution control laws. In 2011, the number of notifications of new chemical substances counts for 684, and 28,519 notifications of the low volume of new chemical substances have been approved which is increased over 10% compared to the previous year.
Japan’s PRTR system is a registration and announcement system for hazardous chemicals' release and transfer into the environment. In Japan, the PRTR system is voluntarily managed by business operators and the information is disclosed to the public. According to statistics from 2003 to 2010, the emission and transfer amount has been significantly reduced.