Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 97
10.1.2 File format validation
The file format validation checks that the submitted dossier file is of the appropriate format
(.i5z file format) and is compliant with the XML schema used by IUCLID 5.
10.1.3 Internal structure validation
This verification ensures that the submitted dossier file does not contain attachments for which
the format is not supported or recognised by REACH-IT.
10.1.4 Business rule validation
The business rules are a set of pre-requisites that must be fulfilled before ECHA can establish
that the dossier can be accepted for processing. They are checked using the REACH-IT
software.
A dossier can be accepted for processing only if all of the relevant business rules are satisfied.
After that, the submission can proceed to the next steps (technical completeness check and
invoicing). If the dossier submission fails at the business rule level, the dossier cannot be
accepted for processing and a new submission is required before any regulatory processes
can be initiated.
10.2 Assigning submission number
The REACH-IT system automatically assigns a submission number and submission date to
any submission which is accepted for processing after successful business rule validation. The
REACH-IT system without delay communicates this submission number and date to the
concerned registrant. The submission number is to be used for all correspondence regarding
the relevant dossier type (e.g. pre-registration, registration or PPORD notification). In the case
of registration (including registration of on-site isolated intermediates and transported isolated
intermediates) and PPORD notification the submission number is to be used until the
registration/notification is deemed to be complete (Article 20 (1)). It will then be replaced by
the registration/notification number.
10.3 Completeness check and invoicing procedures
The completeness check process comprises two distinct sub-processes:
Technical completeness check
Financial completeness check
The technical completeness check is performed for the following dossier types: registration
(including intermediates), updated registration and PPORD notification. The Financial
completeness check is performed for those dossier types for which a fee is required.
10.3.1 Technical completeness check
This process is aimed at checking the technical completeness of the dossier. The main purpose
of this check is to make sure that all information as required in REACH has been provided.
After being accepted for processing, each received dossier is screened for technical
completeness using a specially created algorithm that is specific for each dossier type
depending on the legal requirements. The system checks if all required fields are filled and all
testing proposals, derogation statements, waving statements etc. are included. In the case of
a negative result, ECHA will verify the outcome of the completeness check to make sure that
the decision is fully correct.
Registrants are strongly encouraged to verify the technical completeness of their dossiers
before submission by applying the IUCLID Technical Completeness Check (TCC) plug-in.The
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