THE CONFERENCE PROCEEDINGS - IFEAT

It illustrates that REACH compliance is vital for doing business in the EU. Therefore REACH tasks incompanies are best assigned to a coordinator, who knows the Regulation and coordinates theimplementation by:• monitoring the company’sportfolio and identifying productsrequiring registration• coordination of productinformation and responses tocustomers• organising the dossier preparationand submission• participating in consortia andSIEFs• indicating budget needs forregistration• monitoring the REACH IT accountand ECHA’s messages.! REACH responsible/contact person(s)! Identify/monitor company REACH portfolio! Organise company dossier submissions! Monitor REACH-IT account & ECHA messages! Initiate timely actions for legal compliance by:! up-to-date product documentation (e.g. eSDS)! coverage of customer needs (e.g. uses and exposure scenarios)customer satisfaction! Consortium Representation in:! Steering Committee! Technical Committee! Quality control:! Substance identificationREACH registration isNOT A ONE-TIME EVENT,but needscontinuous monitoring and maintenanceIFEAT INTERNATIONAL CONFERENCE, Singapore, November, 2012, Dr. Hans van Bergen 18REACH registration is not a one-time event. Submitted dossiers must be maintained and kept up todate because of:• comments by ECHA• new knowledge ono properties impacting the hazardso exposure scenarios impacting the risk assessment• identification of new uses• an increase in volume band• a change in the registrant’s identificationThe Lead Registrant and co-registrants shall on their own initiative update their dossier, if abovechanges occur.! Fair and Proportinate to Level of Interest and depends on:! Number of Consortium Members! Number of NCSs per Member! Volume Band per NCS per Member! Cost Elements:! Existing Data evaluation! Letter of Access! New data collection! Exposure Assessment & CSR! Dossier preparation! Consortium Administration & Management! Company registration fee! Reimbursement of LRs and Other Active Members! Revenues:! Letters of Access to Data & Joint DossierIFEAT INTERNATIONAL CONFERENCE, Singapore, November, 2012, Dr. Hans van Bergen 19REACH compliance leads to costs andinvestments, which must be budgeted. Thesecosts include the fees for participation inconsortia giving rights to the lead dossier.Non-members can obtain access by payingthe consortium for a Letter of Access. Abasic rule of REACH is that costs should beshared in a proportionate and transparentmanner. The cost sharing for dossierpreparation in consortia is determined bythe agreed cost sharing key, which isderived from the number of members, thenumber of NCSs of a member’s interest andthe corresponding volume band.Administrative costs are shared equally. Main cost elements concern• data evaluation and data collection• fees for letters of access of data owners244