Been undertaken in support of this project are

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.