SIEF formation procedure
Based on the REACH Regulation and the recommendations from ECHA, the REVODS Consortium would like to propose a SIEF Formation Procedure to preSIEF members of the substances of interest. This procedure and related communication will rely on dedicated web communication tools. SIEF Communication will be fair and transparent. It will not be charged, and independent from the use of commercial tools. You will find following details for this procedure.
SIEF Formation steps
The substances covered by REVODS are UVCBs, which raises specific questions and makes the sameness discussions probably more technical. It appears indeed that SIEF splitting or merging may be necessary in certain cases, namely taking into consideration some nomenclature issues (See SDA Nomenclature section for further information). The proposed SIEF Formation Strategy takes these issues into account as a significant part dedicated to Sameness Discussions. Materials useful for the necessary Sameness Checks to be undertaken by preSIEF members are presented in the relevant SIEF pages of this website.
The main steps for the SIEF Formation Procedure (SFP) would be as follows:
Collection of SIEF Information
The first step is necessary to collect and/or update the contact details, registration intentions and CEFIC SIEF Activity Codes from members of the relevant preSIEFs.
PreSIEF members are invited to undertake sameness checks. In that respect, the technical sections of this website (SIEF pages, methods, etc.), and the guidance from ECHA will provide useful guidance on identification of the substances and nomenclature issues and opportunities. Merging and/or splitting of preSIEFs into the SIEFs under formation are proposed in the relevant SIEF pages of this website.
Based upon the assessment of composition and identification of substances manufactured by REVODS members, specifications are proposed to the SIEFs under formation. PreSIEFs members are invited to join the SIEFs under formations, and will be consulted to agree on the specification for the relevant substances. It is highly important that companies perform a careful assessment of their manufactured or imported substances.
Note: each registrant must ensure that the substance they register can be considered the same as the substance in the joint dossier and the data in the joint dossier can be applied to their substance.
Compilation of the results of the questionnaires
A company that does not reply to the questionnaire circulated in time will be considered as Dormant without intention to register in 2010, and not willing to take an active role in SIEF discussions. This status can be changed by companies at any time. Based on the results, a SIEF will be formed for companies that confirmed their interest and are willing to join the initiative.
Lead Registrant nomination
A member company within the REVODS Consortium having the closest deadline for Registration will apply to be a Lead Registrant. The nominated Lead Registrant will be proposed to the SIEF participants for their agreement. To formalise working in the SIEF and to ensure that a contractual basis is in place for collaboration, the Lead Registrant will enter into a formal arrangement with each registrant by means of a SIEF agreement.
Agreement on Classification & Labelling (C&L)
A preliminary C&L of the substance will be included in the specification. When the full set of physical, chemical and safety data is available, the REVODS consortium will propose either a classification for the substance, or absence of classification. The REVODS consortium will consult the other registrants in order to agree on the proposed classification.
Letter of Access (LoA)
When the final costs to develop the registration dossier are known, the REVODS consortium will provide each registrant with a calculation of the cost for access to the sections in the dossier needed for their own registration. Following agreement of the charge and payment to the consortium, when the joint dossier has been accepted by ECHA a “Letter of Access” and registration key will be provided for each registrant to meet his registration deadline.
Tools for a proper SIEF Communication
In order to ensure a fair and transparent communication, the REVODS Consortium have set in place a dedicated communication tool consisting of a website including public or private sections when necessary, and the possibility to use an online questionnaire tool. Histories of the questionnaires are kept in the system, allowing companies to display and print their own answers.
For each of the substances for which it intends to support a Joint Dossier, the REVODS Consortium will set up a SIEF Page where SIEF Communication will be available. The use of the online questionnaire tool will be proposed to discuss specific questions and ask for agreement when necessary. Access to this online questionnaire tool is private and SIEF member specific.