K-REACH and Chemical Control Act came into simultaneous effect on the 1 Jan 2015 replacing their predecessor the TCCA. These new regulatory frameworks establish a more effective chemical regulatory management scheme in Korea. The OSHA mainly regulates chemical substances that pose risks to employees to ensure workers’ health and safety in workplace.
The Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH) was passed by the National Assembly on 30 Apr 2013 as Law No.11789. It came into force on 1 Jan 2015. K-REACH follows the basic concept of EU REACH which South Korea has adapted to meet the demands of its own chemical management program regulating the registration and evaluation of new and existing chemical substances.
The K-REACH subordinate statutes, the Presidential Decree (also known as the Enforcement Decree) and the Ministerial Decree (also known as the Enforcement Rules) detail management of chemicals and downstream products, and specify and elucidate the registration requirements and any possible registration exemptions, etc.
South Korea’s Chemicals Control Act (CCA) was issued as Presidential Decree No. 11862 on 4 June 2013 and came into force on 1 Jan 2015. The CCA Enforcement Decree and Enforcement Rules, known as the main supporting documents, specify the regulatory provisions throughout the chemical chain of custody including initial market access, distribution, handling and disposal of chemicals. The CCA strengthens the licensing management for businesses including risk management and preparation of off-site impact analysis report.
South Korea’s Occupational Safety and Health Act (OSHA) ensure proper compliance with workers’ health and safety in workplace. Companies should register new chemical substances under OSHA as well as K-REACH. The new requirements for new chemical management under Korea OSHA have been effective on 1 May 2016. OSHA also requires any person who transfers or supplies a chemical substance or preparations to classify the chemical if classification criteria are applicable and to prepare SDS and labels accordingly.
Korean Ministry of Employment and Labor (MOEL) on April 6 of 2016 published the revised Standards for Classification and Labeling of Chemical Substances and Material Safety Data Sheet by Public Notice No.2016-19, which entered into force immediately. Transitional measures are granted under which classification, labeling and SDS prepared in accordance with the previous version of Public Notice No.2013-37 are acceptable until April 6, 2017.
By adopting the hazard category “hazardous to the ozone layer” and revising some of the hazard statements and precautionary statements, the new standards update the 2013 standards (MOEL Public Notice No.2013-37) to align with UN GHS Rev.4 (2011).
- Takehome: 510 PECs need to be registered under K-REACH before 30 June 2018. Only 315 PECs have finished the lead registration (LR) election. More than 100 PECs had no manufacture or importation records thus there is no one voting for LR.
- South Korea’s National Institute of Environmental Research (NIER) published on 4 May 2017 guidelines for acceptance of alternative data that can be used instead of test reports generated by a GLP laboratory for chemical registration under K-REACH.
- Published on 8 May 2017 by MoE Notice No. 2017-369, South Korea’s Ministry of Environment (MoE) is now consulting on (1) supplementation of 23 toxic chemical substances (Given No. 2017-1-773~2017-1-795) into South Korea’s Toxic Chemical Substance List (TCSL); (2...
- Updated on 28 Apr 2017, 316 priority existing chemical substances (PECs) have finished LR election, of which 8 PECs newly completed the election process.
- On 14 Apr 2017, South Korea’s Ministry of Environment (MoE) announced the addition of 23 substances (No. 2017-1-750~ 2017-1-772) into the Toxic Chemical Substance List (TCSL) by MoE Announcement No. 2017-76. The updates are effective immediately, which are...
- Note: Updated on 10 May by MoE Announcement No. 2017-91, the 278 non-toxic chemical substances were officially published with chemical names disclosed. South Korea’s Ministry of Environment (MoE) issued the MoE Notice No. 2017-291 on 7 Apr 2017, consulting on...