Cefic Sief Agreement Model

10 Comparison with a simple access letter is a collective and standardized possibility for lead members (for example. B the consortium), in order to provide data rights and to be compensated for the costs of developing the file. this means that lead members have already set up all types of SIEF participants and have legally covered them from the date of the FSRSE agreement (no negotiations in 2010/2013/2018), the SIEF agreement already includes, in a single agreement, all types of sied participants who have access to the data (TPR, Or representation of several producers from non-EU countries, LE with related companies in the same FONDS, etc.) 4 Legal uncertainties without a regulatory framework of the FSRSE Example of issues dealt with in the SIEF FR agreement: What happens when a FRSE participant has access to the information he receives from executives, abuses it and transmits it to another company? What happens when a non-member of the consortium files a complaint against the consortium for lack of expertise in the preparation process? What is the basis for a senior filer to inform other SIEF members of the conclusion of the joint registration file? As a SIEF participant, do I need bilateral data exchange agreements with all data owners? What are the debts of the lead registrant if things go wrong with registration? 11 D, the right of the public administration to enter into agreements in accordance with the Italian civil code; Law enforcement. 7 Common benefits of the SIEF standardized data exchange process, which avoid the need for bilateral data exchange agreements with any data owner Lead Registrant Centralized Approach Access to Data Needed for Individual Submission, agreements on cost-sharing principles and cost-sharing mechanisms at the beginning of SIEF`s activities Facilitates the calculation and allocation of costs for the lead members SIEF agreement is proof for the authorities of the agreement as part of the documentation sief requirement decisions within the SIEF 2 SIEF Consortium/other cooperations) Dormant passive SIEF LEAD Registrant participates in SIEF Accord: link between SIEF Leadership Team and other participants in SIEF (potential registrants) – SIEF agreement : bilateral agreement between the SLT represented by LR and each siEF participant. 11 Alignment with the consortium agreement In the case of a consortium within the SIEF, the consortium preferably proposes the SIEF agreement in accordance with the provisions of the consortium agreement, particularly with regard to the terms of cost-sharing. For example, if the consortium agreement includes a down payment, it is fully transferable to the agreement of the F SIEF, in accordance with the principle of fair, transparent and non-discriminatory compensation. The model`s 3 cost-sharing options are indicative and can be combined and mixed (. B for example, no down payment and no refund as a risk premium / all filers (2010/2013/2018) pay 50% of their costs in 2009/2010 to LR and they compensate the LR for the remaining 50% just before the expiry of the deadline, etc.). Other cost-sharing factors can be added legally. 8 SIEF Agreement: Benefits for Lead Members – Contractual Rights and Obligations: Secetic Confidentiality To Comply with Competition Law Structured Communication and Information Flow – Proactive Behaviour of Non-Lead Members Cost Sharing / Compensation – Several Options – Payment Terms Limiting Liability – Facilitating the Appointment of a Lead Filers 3 ACCORD SIEF: REACH Starting Point: Legal Requirements: Cooperation and Communication in the Joint Submission of SIEF Data Sharing Cost Compensations (excluding opt-out) Significant number of SIEF participants Many SIEF participants are not really familiar with REACH requirements, which will create a great deal of legal uncertainty.

This is why SIEF`s operating rules are established according to ECHA Guidance, the sief leadership team (z.B.

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