The Company/organisation is the main actor in IUCLID. All information created or imported in a IUCLID installation, e.g. a Substance dataset is always associated to one Company/organisation which is the owner of the dataset. In general, it represents the Company which will register the Substance to the regulatory authorities.

IUCLID provides the necessary format and functionality to identify the Company or Organisation as requested by the different regulatory programmes. In the context of the REACH Regulation, it provides the format referred to in Article 10(a)(i) and further specified in section 1 of Annex VI.

All information describing a Company/organisation is maintained in a specific IUCLID element called a Legal entity.

In this chapter, the concept of Legal entity is further explained. The terms Legal entity, Legal entity object, LEO, official Legal entity, non-official Legal entity, Legal entity local inventory, Legal entity owner are defined. A short overview behind the rationale of managing official Legal entities centrally at the IUCLID web site is given.

Legal entity

A Legal entity is either a Company/organisation or a natural person capable and having the right to engage into contracts or commercial transactions. In IUCLID, the term Legal entity however describes a variety of organisations that may want/need to use the application or need to be identified in the application. It covers business organisations, chemical companies, consultants, regulatory authorities, test houses, third parties, universities, etc.

The information stored in the Legal entity includes the name, the address and other contact details, the contact person(s), and Legal entity specific identification numbers which may help identifying it in an unambiguous manner such as VAT or DUNS numbers. It also encompasses information on the location of its production and own use sites (see chapter D.10 Legal entity sites (Create and update Legal entity sites)).

The Legal entity is the principal actor in IUCLID. It is not even possible to start the application before specifying at least one Legal entity, in general the one running the application (see chapter D.9.2.1 How to create your official Legal entity). Once the application has been installed, all information created (e.g. Substance datasets) will be associated to a Legal entity, considered as the Legal entity owner.

Legal entity local inventory

Each individual Company/organisation should ideally be represented in IUCLID by only one single Legal entity, i.e. duplicates in the database should be avoided to ensure data consistency. This is facilitated by the storage and the management of all Legal entity information in a local inventory enabling to enter the information only once in the IUCLID database and re-use it as often as necessary without re-typing anything. Query functionality exists to easily retrieve the Legal entity in the local inventory when necessary. When multiple Substance datasets belong to the same Legal entity, they all relate to the same Legal entity element stored in the inventory.

When datasets are exchanged by using the import/export functionality (see chapters D.4.13 Importing a Substance dataset and D.4.12 Exporting a Substance) or a Dossier is created, the associated Legal entity is automatically included in the import/export file or in the Dossier.

Official vs. Non official Legal entity

Legal entities are critical in the registration of Substances: a Substance is registered for a Company (Legal entity) which is legally responsible. Since Legal entity information is exchanged with the regulatory authorities (e.g. the European Chemicals Agency, Member States Competent Authorities) as well as between companies, it is essential that the Legal entity may be unambiguously identified by a unique identifier and that related information be consistent across the stakeholder"s systems and databases.

To facilitate this authentication process, each Legal entity in IUCLID is identified by a Universal Unique IDentifier (UUID). Moreover, IUCLID makes the distinction between:

In any creation process of a Substance , a Mixture , a Category , or a Template dataset, a Legal entity site or a Dossier , at least one official Legal entity must exist in the IUCLID installation and be assigned to the user account in charge of creating the dataset, the site or the Dossier. This official Legal entity is not necessarily always the one running the application. For instance a service provider preparing a dossier for a client will need to get his client's official Legal entity and import it into his own IUCLID installation to be able to act on his behalf. This can be done by using the IUCLID export/import functionality (see chapters D.9.7 Exporting a Legal entity and D.9.8 Importing a Legal entity). If the client does not have an installation of IUCLID and cannot supply his official Legal entity, the service provider can create one for him at the IUCLID web site (see chapter D.9.2.1.2 How to manage official trade partner Legal entity).

For detailed guidance on Legal entity, including "How to" instructions, see chapter D.9 Legal entity (Create and update Company/organistation-related information).