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: The highly anticipated K-REACH CICO (analogous to EU REACH’s substance information exchange forum -SIEF) finally opened on 7th October. Companies that want to complete joint-registration need to join CICO first. Enterprises willing to play the role of LR...
- Takehome: South Korea’s Common Safety Standards for Children’s Products is under revision. The concentration limits of nitrosamines and nitrosatable substances will be set for oral use children's product. The concentration of...
- Takehome: South Korea’s MoE approved the amendments on K-REACH Enforcement Rules to simplify and accelerate new chemical registration and approvals of exemptions for R&D purposes. However, only new chemical substances affected by the Japan’s trade dispute are...
- Takehome: 15 new substances have been designated as toxic chemicals and provided with classification and labeling information. They are still considered new chemicals and require new chemical registration under K-REACH.
- Takehome: The first batch of priority management substances under K-REACH took effect on 1st July 2019. Products containing these substances over a specified level are required to be notified to the local authority. On 26th August 2019, KCMA published FAQs on the...
- Takehome: Purchasing data for use in Taiwan REACH or K-REACH registration from EU REACH data owners is hindered by communication difficulties and lack of cross regional data sharing standards. Big companies may decline joint registration in Taiwan as many of their potential co-...