This part is a repeatable block subsection. It enables to specify different groupings of Companies to prepare Joint submission registration dossiers under REACH and consortium dossiers for the OECD HPV Chemicals Programme.
Under the REACH regulation, Companies have to share information on the same substance. One of them acts as the Lead, i.e. he is responsible for submitting on behalf of the other registrants information on the intrinsic properties of the substance and its effects on the environment and human health (i.e. (robust) study summaries) and the classification and labelling. He may also be in charge to submit information on guidance on safe use and the Chemical Safety Report.
The lead Legal entity creates the joint submission in his local IUCLID installation and therefore needs to request from the other participants their Legal entity information so that data consistency may be ensured between IUCLID installations. Each participant exports his own Legal entity object and sends the export file electronically to the lead Legal entity.
It is recommended that all other participants create the Joint submission in their own IUCLID installation for better traceability later on of their Joint submission dossiers.
Each participant in the Joint submission other than the Lead must submit individually in addition to their Company identification, all confidential information, i.e. the identification of their Substance and its composition, and information on manufacture and use, including a description of the technological process, the manufacture and/or import volumes per year, the volumes for own use per year.
Click the green Plus button to open the repeatable block. If more than one Joint submission has to be specified, add a new block for each one.
Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.
Joint submission name:
Insert the name assigned to
the Joint submission or Consortium.
Remarks:
If necessary introduce any additional
information/comments.
Regulatory programme:
Indicate for which regulatory
programme the Joint submission is prepared. Select a value in the picklist.
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.
Picklist options: || EU: BPD Biocidal Products Directive 98/8/EC || EU: PPP Plant Protection Products Directive 91/414/EEC || EU: REACH Registration, Evaluation and Authorisation of Chemicals || ... ||other: ||.
Indicate the name of the Lead. Click the Link button to select the Lead and establish the link. If the desired Legal entity is not present in your database, you should request it from your partners in the Joint submission. It is strongly requested not to use the New button to create locally the Legal entity information. It would lead to having the same Legal entities differently identified in the various IUCLID installations and would compromise data exchange.
Add the name of all members of the Joint submission or consortium. Click the Link button to select the member and establish the link. The same recommendations as those provided for assigning the Lead apply.