Section 1 – General information

Substance name

This is a unique name in the IUCLID instance and relates to your application in an AICIS working context. You can link this later to reference substance(s) that identifies the substances to be assessed under Identification of substance below and under 1.2 Composition.

Public name

This is the name for publication of the AICIS Assessment Statement. The working legal entity is the legal entity that created the substance dataset or filled in the fields for substance name and legal entity (the 2 mandatory fields in this section). 

Other substance identifiers table

• Select New item to provide other information about the identity of your substance. 
• You can use the table to flag CBI, with justification. 
• Select the type of identifier, (e.g., CAS number, CAS name, trade name) and type the identifier in the free text field.

Legal entity

You can select the legal entity that already exists (created under the inventory manager), or you can create a new one.

Third party

Includes agents and chemical data providers acting on behalf of the applicant. When a third-party legal entity is created, associated contact persons can also be recorded.

Contact persons

Select a contact person created under the Inventory manager or create a new one. 

You can set a CBI flag for each contact person.

Identification of substance

• Select a reference substance from the list or create a new one if needed.
• You can flag this as CBI, unlike the substance name.

Type of substance

Select from pick lists – for example, mono or multi-constituent, UVCB, polymer, etc) and origin (e.g., element, inorganic, organic, etc). 

You cannot flag these as CBI.

Role in the supply chain

The checkbox under this heading is:

• Manufacturer
• Importer
• Only representative
• Downstream user.

Roles in the supply chain can be flagged as CBI.

Note the distinction between an only representative, a downstream user and an importer in IUCLID:

• Only representative is a natural or legal person established in a certain region, appointed by a manufacturer outside that region to meet the regulatory obligations on importers.
• The importers in the same supply chain are downstream users of the only representative.

Section 1.2 – Composition

This section describes the composition of your substance. You must provide details of the different compositions (if applicable), including constituents, impurities and additives, and their relative proportions. 

Your substance may have one or more compositions (for example, multi-constituent substances or UVCBs).

This information defines what your substance is and supports its identification, classification and assessment throughout your application.

Create composition records

Create a document for each composition (for example, Composition.001).

Complete the General information fields:

• Name (actual composition)
• Type of composition (for example, legal entity composition)
• State/form of the substance.

If you select solid: nanoform, an additional section for nanoform characterisation will appear. You will be able to flag confidentiality when you get to this stage.

Multiple compositions

If your substance has more than one composition:

• link related compositions using Related composition(s)
• provide the purity for each composition
• the information can be flagged as confidential where appropriate.

Constituents, impurities and additives

For each composition:

• provide details of constituents, impurities and additives
• include their relative proportions.  

Each composition must include at least one constituent.  

To add a constituent:

• select New item
• select or create a reference substance
• enter the concentration of the constituent.

You should:

• complete impurity and additive information where relevant
• indicate whether impurities/additives affect classification and labelling.

Unknown impurities

You can report unknown impurities by:

• creating a reference substance named Unknown impurity
• describing the impurity under Remarks.  

Polymers (if applicable)

If your substance is a polymer, complete the Characterisation of polymers section.

You can flag this information as confidential where appropriate.

Composition information needed for polymers

Constituents table

Provide identity and percentage of all polymer starting materials.

Impurities table

Provide the percentage residual of each starting material remaining (by weight) following completion of the polymerisation.

Characterisation of polymers

Provide the following:

• molecular weight range
• number average molecular weight (NAMW)
• weight average molecular weight (WAMW)
• the percentage by mass of molecules with molecular weight that are < 1,000 g/mol, and < 500 g/mol
• identity of any moderate or high concern reactive functional groups contained in the polymer
• the functional group equivalent weight (FGEW) (if applicable).

Section 1.4 – Analytical information

This section provides analytical information to confirm the identity of your substance. You must include the methods and results used to characterise the substance.

This information supports and verifies the composition described in Section 1.2.

• Create a document (e.g. Analytical information.001) and include the information for each method performed to characterise the identity of your substance in the analytical determination table.
• You must provide enough information to sufficiently characterise the chemical, such as nuclear magnetic resonance (NMR) spectroscopy, liquid chromatography-mass spectrometry (LC-MS) or Fourier-transform infrared (FT-IR) spectroscopy analytical report. 
• If introducing a polymer, you must provide a gel permeation chromatography (GPC) or equivalent analytical report.

Methods and results of analysis 

• Provide all analytical information in the table. Select New item to add a new entry and set the values of the analytical determination. 
• If the purpose is for identification and quantification, make sure you reflect these in the pick list choice. 
• Provide more information in Remarks, if needed. 

Related composition

You can link a composition (created in Section 1.2 Composition) to this field. 

If you are introducing a chemical with multiple compositions, create one analytical information document for each chemical composition.