Information waivers for assessment certificate applications
Who should read this and when?
Anyone who wishes to submit a certificate application is required to provide information related to their chemical. This guidance is to assist anyone planning to submit an assessment certificate application in understanding when it is appropriate to request an information waiver and justifications that we would accept.
What are information waivers?
Information waiving refers to omitting certain required information about the chemical in a certificate application.
When applying for an assessment certificate, you need to provide information on the:
- physical and chemical properties
- environment-related endpoints
- human health-related endpoints
of the chemical you wish to introduce. We need this information for risk assessment of your chemical. The type of information you’ll need to give us depends on your application type. If requesting an information waiver on certain properties or endpoints, you will need to provide a reason or justification for not submitting the required information about your chemical. You can choose a justification from the lists below (see ‘Information waiver justifications in IUCLID6’ and ‘Information justifications not in IUCLID6’ below). Alternatively, you can provide your own justification.
Please note for specified class of introductions, the information requirements may override the information waivers in this guidance.
When we assess an application, we will consider all available information from:
- in vitro tests
- in vivo tests
- human evidence/studies
- data from suitable analogues
- valid Quantitative Structure-Activity Relationship (QSAR) data on a case-by-case basis.
Any information you provide must also comply with our policy on animal test data.