Under K-REACH, hazard/risk reviews are obligated for all existing chemical substances that are manufactured or imported in excess of 1 ton annually and for all new chemical substances newly introduced into the Korean market, and all manufactures/imports/uses/sales of chemical substances which fail to comply with established standards may be suspended and/or recalled.
K-REACH determines if chemical substances are subject to registration, notification and/or exemption processes, based on their status of existing or new substance and on their yearly manufacture/import quantity. In case of existing chemical substances, individuals who wish to domestically manufacture or import said substance in excess of 1 ton annually must register before manufacturing/importing begins, or go through a pre-registration process and then register the substance within a given grace period.
Under OSHA, when manufacturing/importing new chemical substances in excess of 100kg annually, the manufacturer/importer must submit a hazard/risk report and receive its review results beforehand. Such obligations do not apply for existing chemical substances.
Major services provided in regards with K-REACH and OSHA
Pre-registration
- Preparation and submission of pre-registration dossiers for existing chemical substances
(Pre-registration completed by 2019.06.30. Existing chemical substances newly manufactured/imported afterwards undergo late pre-registration processes)
Joint registration of existing chemical substances
- Joining and managing CICO
- Data gap analysis
- Generation or purchase of joint submission data
- Preparation and submission of registration application dossier
- Follow-up monitoring
Registration/Notification of new chemical substances
- Searching the Korean chemical substance list
- Confirming the homogeneity of substances, and searching/using scientific and technological data such as academical literature
- Taking steps for sharing data from prior registrants(submit questionnaires, etc.)
- Data gap analysis
- Setting testing strategies, arranging and monitoring tests
- Preparation and submission of registration application dossier
- Follow-up monitoring
Exemption of registration/notification
- Confirming whether substance is subject to exemption
- Preparation and submission of exemption application dossier
Performing representative roles and services
- Reporting on manufacture/import of chemical substances and any alterations therein
- Registration/notification of chemical substances and notification of alterations
- Application for confirmation of exemption from registration/notification, and application for alterations therein
- Alteration registration/notification for registered/notified chemical substances
- Notification of priority substances contained in products
- Confirmation of individual submission of registration application data for existing substances(opt-out)
- Inquiry into whether chemical substance has already been registered by prior registrants
- Confirmation of approval for use from owners of vertebrate test data
- Providing information on chemical substances after registration/notification
- Providing information to downstream users
- Application for confidentiality claim and for its cancellation
Test monitoring
- Data gap analysis
- Designing test methods
- Recommendation of Korean and overseas GLP or accredited labs
- Setting test strategy
- Test arrangement and monitoring
QSAR and Read Across
- Providing strategies for submission of non-test (predicted) data
- Read Across approach via data on substances with analogous structures
Registration of new chemical substances under OSHA
- Representing clients in legal/administrative obligations for submission of hazard/risk reports
- Submitting hazard/risk reports and suggesting strategies to optimize testing time/costs
- Reviewing and suggesting methods to maintain confidentiality of chemical substance information
Chemical Safety Reports
- Preparation and updates of report
Translation services in English/Japanese