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: So far LR election has been completed for 334 PECs. 38 LRs have submitted dossiers, of which 11 have been approved by the authority and obtained a registration No.
- South Korea’s National Institute of Environmental Research (NIER) issued the updates of hazard evaluation results for new chemical substances registered under K-REACH by NIER Announcement No. 2017-52 on 23 Nov 2017. The updates took effect immediately.
- Takehome: 22 new toxic chemical substances will be listed into the TCSL. Additional transitional measures will be provided. Published on 23 Nov 2017 by MoE Notice No. 2017-784, South Korea's Ministry of Environment (MoE) is now consulting on supplementation of...
- South Korea's Cabinet passed a new biocides law named K-BPR in Aug of 2017, which is still awaiting final approval from the National Assembly. If approved it will come into force on January 1, 2019. Manufacturers or importers should submit relevant documents to...
- On 22 Nov 2017, Korea MoE issued an announcement, urging the manufacturers and importers of hazardous chemicals to voluntarily notify breaches of the previous TCCA (the precursor of CCA) and the current CCA regulation.
- Risk assessment of risk concerned products is necessary under K-REACH to prevent risk to human health and the environment which may occur due to hazardous chemical substances contained in products. To assess exposure and risk for consumers, the exposure factors of the risk concerned...