Registration / Notification / Exemption of Chemical Substances

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 manufacture/import/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 ISHA, 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 ISHA

 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 ISHA

- 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

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