Authorisation of production/use
For high resources, the steps proposed for the implementation of this element are:
- Information collection and data generation for selected chemicals producers and importers.
- Information transfer from industry to the government including identification and substantiation of CBI claims and (optional) fees. Use an electronic template for the information.
- Assessment of the received information and including review of CBI substantiation claims made.
- Authorisation decision and information of industry.
- Appeal by industry against “no authorisation or partial authorisation” decision.
- Storage of selected quality controlled information, for example, in a National Database for dissemination and use considering CBI aspects.
Relevant tools
Below is a list of tools relevant for implementing this topic :
- OECD Decision on the Minimum Pre-marketing set of Data in the Assessment of Chemicals
- OECD Recommendation on the Protection of Proprietary Rights to Data Submitted in Notifications of New Chemicals
- OECD Recommendation on the Exchange of Confidential Data on Chemicals
- Recommendation on the OECD List of Non-Confidential Data on Chemicals
- Guidance Document For Exposure Assessment Based On Environmental Monitoring, Series on Testing and Assessment No. 185, OECD 2013
- OECD Procedures for Notification of New Chemicals