Chemical Regulation in South Korea
K-REACH: What You Need to Know to Do Business in South Korea [Webinar]
Questions & Answers from K-REACH webinar
Draft List of Chemicals for Registration under K-REACH*
English translation of "The Act" establishing K-REACH*
List of Priority Existing Substances
Chemical regulation in South Korea is in a state of transition. The Acta Group's (Acta®) experienced staff of professionals has been actively assessing the legislation and its implications since its inception and is well-suited to assist entities in managing the challenges occasioned by this transition.
The Toxic Chemicals Control Act (TCCA) of 1991 -- the key law addressing the basic management of industrial chemicals -- was divided, as of January 1, 2015, into two regulatory schemes: South Korea’s newly minted chemical management law, the Act on the Registration and Evaluation, etc. of Chemical Substance, that has come to be called K-REACH, and the Chemical Control Act (CCA). Provisions related to the registration and evaluation of new and existing substances now fall under the umbrella of K-REACH, and CCA activities focus principally on the control of hazardous substances. K-REACH’s adoption in 2013 is the latest example of the growing international significance of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) chemicals management framework. The adoption of REACH-like principles does not mean K-REACH is identical to European REACH. Significant differences exist and Acta professionals can assist in distinguishing them to ensure your commercial objectives are efficiently achieved.
There is no official transition date identified by which notifications under the existing TCCA should cease. Given the time frame to complete the notification process, however, the official submission date was October 22, 2014. TCCA has broad reach in terms of the array of chemicals it currently covers and the activities it affects. South Korea maintains an extensive chemical inventory and, as under other regulatory schemes, “new” chemicals -- those not listed on the inventory -- are subject to notification requirements unless otherwise exempt. The law provides differing notification options.
K-REACH requires that anyone who manufactures, imports, or sells new and existing chemicals in Korea, at greater than or equal to 1 ton per annum, must annually report volume and use details unless otherwise exempt. All new chemicals (unless otherwise exempt) and designated existing substances must be registered and must be reported annually under K-REACH. Companies must submit information regarding the manufacturer/importer, chemical identification, intended uses, classification and labeling, physical and chemical properties, hazard and risk information, safety data, and use-related exposure information when applying for registration.
Foreign manufacturers exporting chemical substances or products into South Korea may appoint an Only Representative. Qualification for Only Representative status is to be decided by the Ministry of Environment (MoE). An Only Representative’s obligations include annual reporting of use and tonnage of chemical substances, registration, notification of products, and other activities as set out in the presidential decree. The Only Representative must report to the MoE the appointment or release of the appointment by foreign manufacturers.
How, when, and by which entity are all strategic decisions that business entities need to consider carefully in reporting and registering their chemical products in South Korea. Acta, with offices in the U.S., EU, and China, is uniquely well-suited to provide guidance and assistance to companies affected by K-REACH. Our global team of scientists, regulatory consultants, and policy experts, augmented by our network of strategic partners, delivers the strategic business and technical know-how needed to register or maintain chemicals and chemical products on the global market, plus unparalleled access to experienced boots on the ground in South Korea.
Acta offers clients a uniquely seasoned and expansive group of regulatory consultants, scientists, and policy experts located in the U.S., EU, and Asia. Our team has tracked and has been engaged in the legislative and policy developments in South Korea’s adoption of K-REACH and can assist clients in gaining and maintaining competitive advantage as the new law takes effect.
Jane Vergnes, Ph.D., DABT®, an esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies before joining Acta, has particular expertise in toxicological testing required by global regulatory schemes, including K-REACH. Dr. Vergnes’ areas of focus include study design, laboratory practices, and data requirements for new chemical introductions; hazard characterization and risk assessment; and support for Globally Harmonized System of Classification and Labeling of Chemicals (GHS) implementation.
Brian Xu, M.D., Ph.D., DABT® is a board-certified toxicologist with an M.D. in pathology, a Ph.D. in pharmacology and toxicology, and over 15 years of experience developing and managing international safety testing, risk assessment, product safety, and regulatory compliance for consumer products, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Fluent in English and Mandarin, Dr. Xu works with clients to place, manage, and monitor toxicological and clinical tests and ensures Good Laboratory Practices (GLP) at laboratories in the U.S. and China; supports GHS classification and implementation; and oversees the preparation of dossiers in English or Chinese.
Acta's U.S.-based professionals also include regulatory consultant Karin Baron, MSPH, and scientist Lara Hall, MS, RQAP-GLP. Ms. Baron’s comprehensive grasp of the sometimes bewildering tangle of worldwide chemical control regulations is a powerful asset for clients bringing products to market in multiple jurisdictions. Her primary areas of practice include industrial hygiene and environmental health and safety (EHS) programs; hazard communication; and global GHS implementation, including compliant safety data sheets (SDS). Ms. Hall is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) who assists clients in placing and monitoring studies to assist with new chemicals, pesticides, biocides, and endocrine disruptor testing programs; developing testing plans for chemicals that are subject to regulatory approval; and assessing studies for conformance with testing guidelines, data compensation, and regulatory and GLP requirements.
In the EU, Emma Jackson, CBiol MSB, offers particular expertise in worldwide chemical notifications; data analysis; preparing test plans; hazard, exposure, and risk assessment; and managing to completion large and complex compliance projects quickly, cost-effectively, and harmoniously across multiple jurisdictions. Ms. Jackson is well-versed in TCCA, K-REACH, and CCA, and familiar with the governing agencies of South Korea and other Asian territories.
What We Do:
Acta professionals can provide strategic, cost-effective, and timely assistance in the following areas:
- Only Representative and Third Party Representative
- Data Gathering and Gap Analysis
- Relevant Data Search and Gathering
- Review Data Validation and Gap Analysis
- Review the Applicability of Quantitative Structure-Activity Relationship (QSAR), Read-Across
- Strategic Counseling/Business Planning
- Consortium/SIEF Activity and Data Sharing Negotiation
- Consortium or SIEF Activities
- Data Sharing Negotiation
- Supply Chain Management Considerations and Communications
- Registration Dossier Preparation
- Prepare and Review Hazard Data
- Prepare and Review Chemical Safety Report (Hazard Assessment, Exposure Assessment and Risk Characterization)
- SDS Preparation
- Consultation for Confirmation of Registration Exemption
- New Substance Manufactured or Imported in Amount Less Than 1 Ton Per Year
- Chemicals for Research and Development (R&D)
- Chemicals for Surface Coating
- Low Concern Polymer
- Supply Chain Communications
- Supply Chain Requirements Applicable to Product Manufacturers
*We provide these resources as a courtesy and cannot vouch for their accuracy.