Lead Registrant. 1. The Lead Registrant(s) shall be designated by the Steering Committee; the Lead Registrant shall accept such designation. The Lead Registrant is accountable to the Steering Committee. 2. If appointed as the Lead Registrant in the relevant SIEF, the Lead Registrant, with the assistance of the Consortium Manager and other Committees of the Consortium, shall prepare and submit to the Agency, in the agreement of and on behalf of the Consortium Members and their Affiliates and other members of the respective SIEF, and in the format specified by the Agency the Joint Registration Dossier [optional: Chemical safety Report/ Guidance on safe use] for the purpose of registering the substance at least two months before the deadline for registration applicable to the Member(s) within the highest tonnage band. The Lead Registrant shall make available the Technical Dossier in IUCLID format, i5z file or updated formats (i.e. data referred to in Article 11 (1) paragraph 2 [optional - if CSR is included in joint submission: and paragraph 4] REACH that have to be submitted in the joint submission) [and when applicable the CSR as defined according to Article I of this Agreement], to the other Members of the Consortium, provided that they share the costs in accordance with the cost allocation method agreed upon under Section X and Annex 4 of this Agreement. The Lead Registrant(s) shall pay its/their fee as invoiced by the Agency after submission of the Joint Registration Dossier without undue delay. The Lead Registrant(s) shall further inform without undue delay the other Members of the Consortium of the creation of the joint submission object in REACH-IT and shall provide the valid security token number and the name of the joint submission.
Appears in 1 contract
Sources: Consortium Agreement
Lead Registrant.
1. The Lead Registrant(s) shall be designated by the Steering Committee; the Lead Registrant shall accept such designation. The Lead Registrant is accountable to the Steering Committee.
2. If appointed as the Lead Registrant in the relevant SIEF, the Lead Registrant, with the assistance of the Consortium Manager and other Committees of the Consortium, shall prepare and submit to the Agency, in the agreement of and on behalf of the Consortium Members and their Affiliates and other members of the respective SIEF, and in the format specified by the Agency the Joint Registration Dossier [optional: Chemical safety Report/ Guidance on safe use] for the purpose of registering the substance at least two months before the deadline for registration applicable to the Member(s) within the highest tonnage band. The Lead Registrant shall make available the Technical Dossier in IUCLID format, i5z file or updated formats (i.e. data referred to in Article 11 (1) paragraph 2 [optional - if CSR is included in joint submission: and paragraph 4] REACH that have to be submitted in the joint submission) [and when applicable the CSR as defined according to Article I of this Agreement], to the other Members of the Consortium, provided that they share the costs in accordance with the cost allocation method agreed upon under Section X and Annex 4 of this Agreement. The Lead Registrant(s) shall pay its/their fee as invoiced by the Agency after submission of the Joint Registration Dossier without undue delay. The Lead Registrant(s) shall further inform without undue delay the other Members of the Consortium of the creation of the joint submission object in REACH-IT and shall provide the valid security token number and the name of the joint submission.
Appears in 1 contract
Sources: Consortium Agreement