1. Roles, permissions and data responsibilities in an assessment certificate application

This page explains who can be involved in an assessment certificate application, what each participant is responsible for, and what information they can access. in AICIS Business Services.

Understanding this upfront will help avoid application processing delays.

Participants

There are 3 types of participants who may be involved in an assessment certificate application. These are:

• the applicant(s)
• third party data provider (if applicable)
• agent (if applicable)

A participant only provides information they have been nominated to supply.

Applicants

Applicants must always provide exposure and use information, even if other participants supply other technical data.

The initial applicant starts the application in AICIS Business Services and may nominate other participants, including joint applicants.

More than one applicant may submit a joint application for the same chemical. Alternatively, individuals may submit separate applications for the same chemical.

Chemical data providers

If applicants don't have access to - or permission to use - required chemical data, they must nominate a chemical data provider.

A chemical data owner must be nominated at the start of the application in AICIS Business Services.

Chemical data providers supply required data, such as:

• toxicological studies
• environmental fate studies
• physico‑chemical data.

This role is essential when the applicant does not own or have permission to use the required information.

Agents

Both applicants and chemical data providers may appoint agents to act on their behalf.

Agents will only have access to the information of the participant they represent.

A participant nominates their agent in AICIS Business Services. The agent must acknowledge their role before they can take part in the application process - this is an automated process with the agent receiving an emailed request from AICIS Business Services.

If there is more than one participant

Before starting an assessment certificate application in AICIS Business Services, all participants should communicate with each other to confirm:

• who is responsible for each part of the application
• who owns the required chemical data
• whether permission is needed to use any data
• what information each participant must provide.

Responsibilities by role

Responsibilities depend on whether you are the initial applicant, another applicant, a data provider, or an agent.

Initial applicant

• Assigns roles (agents, data providers)
• Coordinates completion of all application sections
• Marks sections as final in AICIS Business Services
• Submits the completed application

Chemical data provider

• Supplies required technical data
• Completes the information they are nominated to provide in the application

Agent

• Acts on behalf of the applicant or chemical data provider
• Must confirm their nomination through AICIS Business Services

Access to information in an application

• Each participant can only access the sections they are responsible for.
• Applicants cannot view any technical data submitted by a chemical data provider.

For example: if a data provider enters technical study data, applicants and agents cannot view or access that information unless the data provider nominates them.

Acknowledging a role

• When participants are nominated, they receive a notification and must acknowledge their role in AICIS Business Services.
• A participant only provides information they have been nominated to supply.

Data ownership rules

If you do not own the chemical data required for the application, you must obtain permission from the data owner.

This includes study reports and any references used to support technical claims.

If you do not have permission to use the data, you cannot legally submit it. Instead, the data owner must be nominated as the chemical data provider.

Read more about your obligations on our copyright page.

Submitting data to support your application

You must either:

• submit the data yourself, if you own it or have permission to use it, or
• nominate the data owner as the chemical data provider, who will then submit the information directly to AICIS.

All information submitted by a data provider is not visible to other participants, except to an agent acting on behalf of the chemical data provider.

Examples of how participant roles work in practice

These scenarios illustrate how the roles apply. They are examples only.

Example 1 

Who is involved

• Applicant – the business submitting the application
• Chemical data provider – the business that owns the technical chemical data

What happens

• The Applicant starts the application in AICIS Business Services.
• The Applicant does not own the technical chemical data, so they nominate a chemical data provider.
• The Chemical data provider enters the required data in their own instance of IUCLID and uploads the dossier file in AICIS Business Services.
• The Applicant cannot view or access any data uploaded by Chemical data provider.

Key point

The information is visible only to the chemical data provider.

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Example 2

Shared responsibilities in a multi‑participant application

Who is involved

• An application involves multiple applicants and one or more chemical data providers.
• The applicant does not own chemical identity information or study data and only has information about intended use and exposure.
• The chemical data provider (or another applicant) owns identity and study data.

What happens

• The chemical data provider submits an IUCLID dossier containing the required technical data.
• The applicant submits a separate IUCLID dossier containing use and exposure information.
• AICIS reviews both dossiers together.

Key points

• Each participant provides only the data they are responsible for.
• Applicants do not need to submit technical data if a nominated data provider submits it.