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.
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
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.
Acta’s U.S.-based professionals also include Regulatory Consultant Karin Baron, MSPH, whose 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); Scientist Lara Hall, MS, RQAP-GLP, who is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) and 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; and Regulatory Consultant Karen Lorusso, who prepares data sheets and labels that are GHS compliant and assists clients with complex regulatory compliance projects.
In the EU, Emma Jackson 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.