E.1.1. Identification

Chemical name: The name of the Substance dataset given by the user when he created the dataset is displayed. If necessary, this name can be changed by clicking the Wizard button .

Note

The Substance dataset is identified by its chemical name given when the dataset is created. Any chemical identifier can be used. It is however suggested to select an identifier which is commonly used for that substance within the company. This can be for instance an internal name or a CAS number.

Legal entity flag: Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.

Legal entity: The Legal entity name owning the Substance dataset and assigned during the creation process of the dataset is displayed. The Goto buttonallows to directly access the Legal entity stored in the Legal entity inventory, where it is possible to add or modify the information. All modifications will be automatically updated by clicking the Save button . The Back button button will lead back to section 1.1 Identification.

Note

The Wizard button allows changing the Legal entity owner of the substance (see chapter D.17 user management). It is not possible to create a Substance dataset without establishing a relation to a Legal entity assigned to the current User account.

Third party flag: Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.

Third party: Indicate the name of the Third party representative appointed by the Company/organisation. Click the Link button to select the Third party representative and establish the link. If the desired Third party is not present in your database, click the New button. It will trigger the opening of the Legal entity creation dialogue. Follow the instructions as described in chapter D.9.2 Feature "Legal entity - New": How to create a Legal entity). The Legal entity of the Third party representative is created and simultaneously linked to the Substance or Mixture dataset. To complete the information of this newly created Legal entity, click the Goto button and follow the instructions given in chapter D.9.3 Feature "Legal entity - Update": How to update (edit) a Legal entity). The modifications will be automatically updated by clicking the Save button . The Back button button will lead back to section 1.1 Identification. The link can be deleted by clicking the Delete button .

Note

The Third party is the point of contact to represent the Legal entity in all aspects of data sharing under the REACH regulation.

Role in the supply chain

Role flags: Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.

Role: Select the role of the Legal entity in the supply chain for the Substance under consideration.

Note

More than one role can be selected, however certain roles are exclusive: A manufacturer can also be an importer and/or an only representative at the same time, but cannot be also a downstream user. A downstream user cannot simultaneously be a manufacturer, and/or importer, and/or only representative.

- Manufacturer: The manufacturer is any natural or legal person who manufactures a Substance (in the EU under REACH).

- Importer: Any natural or legal person who is responsible for import (in the EU under REACH).

- Only representative: Any EU-based representative of a non EU-manufacturer. (The "only representative" needs to have sufficient background in the practical handling of substances and information related to them. The only representative has to be designated by the non-EU manufacturer). The official assignment documentation from a non EU manufacturer may be indicated in chapter 1.8 Suppliers. The other importers of the same substance from the same non-EU manufacturer are considered to be downstream users for the only representative, and if necessary, they can be specified in chapter 1.8 Suppliers.

- Downstream user: Any natural or legal person other than the manufacturer or the importer or the Only representative, who uses a Substance.

Note

The importer of a substance which is exported from the European Union, and re-imported into the same supply chain is considered to be a downstream user.

Reference Substance

Specify the Reference substance for fully identifying the Substance under consideration. This is done by creating a link with the desired Reference substance element stored in the Reference substance inventory (see chapter D.11 Reference substance (create and update Reference substance related information)). Click the Link button to select the Reference substance and establish the link. If the desired Reference substance is not present in your database, click the New button. It will trigger the opening of the Reference substance creation dialogue. Follow the instructions as described in chapter D.11.4 Feature "Reference substance - Update": How to update (edit) a Reference substance. The Reference substance is created and simultaneously linked to the Substance dataset. To complete the information of this newly created Reference substance, click the Goto button . The modifications will be automatically updated by clicking the Save button . The Back button button will lead back to section 1.1 Identification. The link can be deleted by clicking the Delete button .

Note

Only active Reference substances can be assigned.

Note

For Mixture datasets, the link to a Reference substance cannot be created in the identification section, but only in the Composition section where identification of the components of the Mixture is done.

Type of substance

Composition: Indicate the type of the substance by selecting a value in the picklist. Picklist options: || mono constituent substance || multi constituent substance || UVCB || polymer || other: ||. If none of pre-defined items applies, select other:. A text field is then activated next to the list field in which you can enter any free text.

Origin: Define the origin (or the status) of the substance, using the picklist. Picklist options: || element || inorganic || organic || organometallic || petroleum product || other: ||. If none of pre-defined items applies, select other:. A text field is then activated next to the list field in which you can enter any free text.

Trade names

Role flags: Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.

Name: Insert all commercial names or trademarks by which the substance is known. For each entry add a new row in the table by clicking the green Plus button .

Contact person

Insert all information related to the person responsible for the Substance and the future Dossier to be submitted. The following fields are available:

Role flags: Set the confidentiality flag and regulatory purpose.

Organisation: Name of the organisation.

Department: Name of contact person (e.g. Scientific Department).

Title: Title of the contact person (e.g. Mr.).

First name: Of the contact person (e.g. Henri).

Last name: Of the contact person (e.g. Smith).

Phone: Of the contact person (e.g. 39 332 785241).

Mobile: Of the contact person.

Fax: Of the contact person (e.g. 39 332 785240).

E-mail: Of the contact person (e.g. henri.smith@legalentity.it).

Address: Enter the address of the contact person (e.g. Umkomaas Road 28).

Address: Use this second address line, if necessary.

Postal code: Enter the postal code (e.g. 01234).

Town: Enter the town.

Region/State: Enter the Region/State of the contact person.

Country: Select the country in which the contact person is located from the drop-down list. If none of the pre-defined items applies, select other. A text field is then activated next to the list field in which you can enter any free text.

Remarks: If necessary provide any additional comments here.