been undertaken in support of this project are identification of data gaps use

Been undertaken in support of this project are

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been undertaken in support of this project are identification of data gaps, use of intelligent testing strategies to address gaps and, where necessary, placing and monitoring of studies. In addition Exponent is responsible for the preparation and update of the registration dossiers in Iuclid 5 and for the production of CSRs. To complete the CSRs, we work with the consortium members and external parties to identify downstream uses that need to be considered and proposing use descriptor codes for exposure assessments and the production of exposure scenarios. Due to the properties of the substances, creative yet pragmatic solutions have been necessary to demonstrate safe use. In addition we have also provided support for post registration activities and have been involved with compliance checks as part of a dossier evaluation and also substance evaluations. CASE STUDY 2: product stewardship service for an SME Exponent has provided ongoing product stewardship support for a catalyst manufacturer, covering REACH and all other global chemical regulatory regimes for over five years. Taking a holistic approach, we provide global regulatory strategy and advice to ensure that legislative requirements from a number of countries can be effectively overlapped. Exponent also provides more technical support by preparing and submitting regulatory documentation for worldwide chemical notifications, including higher tier notifications in countries such as China and Japan. We prepare and review European safety data sheets and determine the classification and labelling of the substances for GHS inside and outside of the EU. We also act as a sole representative for their Swiss notifications. CASE STUDY 3: Exponent has provided assistance from data package development right through to active substance approval and product authorisation. This involved providing initial strategic advice, data gap analysis, data interpretation, study placement and monitoring, devising robust waiving strategies and bridging argumentation, exposure modelling, human health and environmental risk assessments, preparation and submission of the dossier and attending working group and competent authority meetings during the evaluation process. Discussions were held with the evaluating competent authority to confirm acceptance of the proposed product families, prior to Exponent’s specialists compiling the dossiers in Iuclid. Our team also performed technical equivalence assessments. This is just one example where Exponent’s expertise has contributed towards a positive outcome for our clients. Overall, our highly trained scientists have written over 30 active substance dossiers and numerous representative product dossiers across 17 product types, within the ongoing EU biocides review and for new biocidal active substances.
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  • Spring '14
  • ErickE.Barnes
  • Chemical industry, Registration, Evaluation, Authorisation and Restriction of Chemicals, Chemical Watch

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