If data submitted for toxicity examination is technically or commercially sensitive of a company and can cause disadvantage should the information be disclosed to a third party, the applicant can submit an application for confidential protection.
However without application for confidentiality, the National Institute of Environmental Research (NIER) has a general principle of keeping all information obtained from Toxicity Examination of New Chemicals confidential to a third party. Therefore only chemical names and CAS numbers are announced in the official gazette and any other information is unlikely to be disclosed to the general public.
The application for confidential protection must be filed together with an application for notification, and the following documents are required to be submitted.
- An application for confidentiality protection
- A statement of reasons for confidentiality protection
- Data for confidentiality protection
Unless there is a specific reason, confidentiality protection is valid for 5 years. If a notifier applies for an extension one month prior to the expiry date, confidentiality protection can be extended twice, each time for a further 5 years (maximum of 15 years in total).
For more information on regulations in Korea, please feel free to post your question or send an e-mail to ehcho@namandnam.com. Thank you.
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