Sep 2012, K-REACH has been introduced to the National Assembly. However, the passage of Korea REACH in the National Assembly within this year has little possibility and the legislation is expected to pass the Plenary Session next Feb, claimed by Dr. Sanghee Park from Chemtopia.
As one of the major changes since the 2011 K-REACH draft, “the articles will be exempted from registration under K-REACH”, introduced by Dr. Park in the International Chemical Regulatory Workshop 2012 in Hangzhou.
Other significant updates include,
- The tonnage threshold for registration is increased from 0.5t/y to 1t/y;
- Even less than 1 ton/year, registration required for substance with high concern about human health and environment designated by the MOE through the discussion of relevant ministries;
- The pre-registration process is deleted.
Dr. Park also mentioned that recent consecutive environmental accidents could lead to the modification of the final version of K-REACH.
As for polymers, Dr. Park explained that only polymers included in the priory substance list or considered as new chemical substances are covered under the K-REACH. Unlike the EU REACH, polymer will be registered as a whole instead of the monomer.
K-REACH also stress the prohibition on repetitive generation of test data in the article 16, in which,
- If vertebrate test data already exist, repetitive generation for registration shall be prohibited; (However, K-REACH only concerns the tests conducted in Korea, therefore, the vertebrate test proposal in Korea will not be considered as “repetitive” despite the existence of test data obtained in other countries, i.e. EU.) ;
- In cases of refusal of test data sharing without justification, the submission of data for registration can be prohibited.
The qualification of testing institutes is always a crucial concern for industry registers. The physico-chemical data from non-GLP labs could be accepted, claimed by Dr. Park. Nevertheless, with respect to the toxicological and eco-toxicological data, Dr. Park remained a conservative tone over the GLP certification when being asked if test data generated from non-OCED member countries could be recognized under the K-REACH.
About the Speaker
Sanghee Park, Ph.D
Senior researcher, National Institute of Environmental Research, Ministry of Environment
New Chemical Notification Section
The Representative, Chemtopia Co. Ltd.