Who is this guide for?
Introduction
This guide is for applicants, agents and chemical data providers involved in an assessment certificate application. It explains how to prepare and submit the International Uniform Chemical Information Database (IUCLID) component of an assessment certificate application.
IUCLID software is integrated into the AICIS assessment certificate application process. You must use IUCLID to create a comprehensive chemical dossier that includes information about the chemical which AICIS requires to assess an application, such as manufacture, use, exposure and hazard properties.
Who completes chemical dossiers
Each participant submits their own IUCLID dossier. Participants do not all submit the same dossier. Instead, each participant provides only the information they are responsible for.
This depends on their role and the information they hold. These can be:
- applicant(s), including the initial applicant and any joint applicant
- nominated agent(s), acting on behalf of a single participant
- chemical data provider(s).
Before you begin, confirm your role in the application. This will determine what information you need to include in your IUCLID dossier.
We assess all dossiers together as part of a single assessment certificate application.
Read more about participants and their responsibilities
Example – multiple applicants
If there is more than one applicant, each applicant (or the applicant’s agent) will have to provide manufacture, use and exposure data based on their business in separate dossiers.
Example – chemical data providers
A chemical data provider (or their agent) submits a separate IUCLID dossier containing the chemical identity and hazard data that they own or are authorised to provide. If a data provider supports more than one participant, they submit separate dossiers for each participant they represent.
How AICIS uses dossiers
After submission, we consolidate all dossiers we receive for an application into a single dataset. We then validate the dataset to check that all information requirements for the application have been met.
You are only responsible for the information relevant to your role.