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HOW TO GET ACCESS TO REACH DOSSIER SIG Partnership meeting, Special seminar on REACH Brussels, 11 February 2010

HOW TO GET ACCESS TO REACH DOSSIER SIG Partnership meeting, Special seminar on REACH Brussels, 11 February 2010. Vincent Navez, Cefic. Agenda. SIEF AGREEMENT & LETTERS OF ACCESS DATA SHARING ON JOINT DOSSIER COST SHARING PRACTICAL PROCESS. SIEF agreement. SIEF. SIEF

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HOW TO GET ACCESS TO REACH DOSSIER SIG Partnership meeting, Special seminar on REACH Brussels, 11 February 2010

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  1. HOW TO GET ACCESS TO REACH DOSSIER SIG Partnership meeting, Special seminar on REACH Brussels, 11 February 2010 Vincent Navez, Cefic

  2. Agenda • SIEF AGREEMENT & LETTERS OF ACCESS • DATA SHARING ON JOINT DOSSIER • COST SHARING • PRACTICAL PROCESS

  3. SIEF agreement SIEF SIEF Leadership Team/consortium Lead Registrant Passive Involved Dormant = SIEF agreement: between the SIEF Leadership Team and each signatory SIEF participant

  4. SIEF agreement & letter of access • -The grant of access rights by the Lead Members to the entire Joint submission to a Non-Lead Members is secured preferably via the SIEF agreement. The SIEF agreement (between the consortium/SLT and the SIEF member) is the extended contract agreed and signed between 2 parties (recommended contractual arrangements on compensation, payment term, liabilities, scope of the rights, etc). • -The letter of access is the reduced and simplified form that proves the data sharing and the subsequent legitimate possession. • The letter of access is a unilateral declaration and formal commitment by the LR on behalf of the SLT/consortium and formalising the data sharing on the full dossier (kind of formal certificate signed by the LR).

  5. Requirement of legitimate possession (art 10) • There is no legal requirement in REACH that the letters of access should have to be attached by the Joint Registrant to the Registration dossier: no strict need of a physical letter of access. • But the letter of access is especially useful for enforcement purposes, in case national authorities ask to the registrant for evidence of his legitimate possession on data.

  6. SIEF agreement + letter of access • The signature of the SIEF agreement cannot act as a sufficient proof of the legitimate possession: if a Non Lead Member signs the SIEF Agreement but doesn’t pay the compensation when he is invoiced, the LR won’t grant the right to use/to refer: an additional letter of access is needed as proof: • The SIEF agreement and the letter of access don’t substitute each other  but both are complementary: • the SIEF agreement (to be preferably signed at the beginning of the SIEF process). • the letter of access, to be delivered following the payment of the due compensation as certificate of grant of the access rights.

  7. Agenda • SIEF AGREEMENT & LETTERS OF ACCESS • DATA SHARING ON JOINT DOSSIER • COST SHARING • PRACTICAL PROCESS

  8. Data sharing: access rights to joint dossier • Obligations of the Lead Registrant • Grant of right to use the (robust) studies summaries in the Joint Registration Dossier Use of (robust) study summaries included in the IUCLID; a copy of these summaries might be needed by the Non-Lead Member, e.g. if Chemical Safety Assessment is done individually • Right to refer to the full study reports Right to refer to full study reports is required by Art. 10 (a) last sentence of REACH (no copy is normally passed on to Non-Lead Member) • + Information on the submission of the Joint Registration Dossier Lead Registrant is required to inform the Non-Lead Member immediately of the submission of the Joint Registration Dossier

  9. You get what you pay • It is recommended the rights that are entailed in each case are defined very clearly - they should be described in the SIEF agreement and in the Letter of access. • Options: • access rights (right to use/to refer)* / co-ownership • data rights for REACH only* / any regulatory purposes / for any purposes • non-transferable rights* / transferable rights • with copy of (robust) studies summaries* / with copy of full study reports * Recommended options under the SIEF agreement • Cost compensation should be fixed according to the extent of the rights granted.

  10. Agenda • SIEF AGREEMENT & LETTERS OF ACCESS • DATA SHARING ON JOINT DOSSIER • COST SHARING • PRACTICAL PROCESS

  11. Cost sharing • Obligations of the Non-Lead Member: • Financial compensation for the Joint Registration Dossier: Payment of a «Joint Registration Compensation» • 1. Administrative and technical work • 2. Data costs • Requirement to allocate expenses to all SIEF participants in a transparent, fair and non discriminatory manner, taking into account the following exceptions: • Applicable tonnage band of Non-Lead Member • Possible Opt-Out from parts of the Joint Registration Dossier

  12. 1.Consortium costs 3.1.Consortium data • Expenses reasonably incurred: • All administrative expenses by the Management • of the Consortium, incl. costs for Secretariat; • management of confidential data,operational costs • Technical works: IUCLID 5 dossier preparation, • experts, etc • All existing relevant data collected for processing • in the Registration dossier and owned by one or • more Consortium Members • newly generated relevant data jointly developed 2.Historical pre-Consortium costs (done before operational Consortium) 3.2.Non-Consortium data • Any existing relevant data owned by one or more • non-Consortium Members (e.g. via SIEF) evaluated • for processing in the Registration dossier • All administrative expenses of founding companies • that are claimed to provide added value for the • Consortium (e.g. pre-Consortium work; industry • sector activities; etc) Cost factors of the dossier

  13. Cost sharing mechanisms Different options for Payment of «Joint Registration Compensation»: • Calculation of costs before each deadline • 2010: Partial advance payment (e.g. provision in February 2010) + adjustment at the moment of submission of Joint Registration Dossier • Lump-sum per category of registrants fixed from the beginning • + possible reimbursement in 2013 to 2010 registrants and in 2018 to 2010/2013 registrants • + optional threshold for reimbursement • + share per LE/per group of LEs (concept of affiliates)

  14. Agenda • SIEF AGREEMENT & LETTERS OF ACCESS • DATA SHARING ON JOINT DOSSIER • COST SHARING • PRACTICAL PROCESS

  15. Combined process • It is recommended that the SLT/consortium puts in place a practical process that combines data sharing on full dossier and organisation of the participation to the Joint Submission: • 1. Conclusion of the SIEF agreement • + communication of invoicing details by the SIEF member to the SLT/consortium • 2. Invoicing of the joint registration compensation when final price has been determined • 3. Disclosure of the token by the LR and delivery of the letter of access on full dossier.

  16. LoA Collective route   Announce the process SIEF agreement defined To all Potential Registrants    Indicate price of LoA(what it represents) Request for registrant information Invoicing   Payments follow up Issue of Joint Submission token number + LoA Participation to Joint submission LR registration

  17. WWW.CEFIC.EU Thank you

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