How does Exponent's expertise and footprint provide unique global support for REACH?
REACH — the Registration, Evaluation, Authorization, and Restriction of Chemical substances — is the EU law governing chemicals substances supplied at one or more tonnes per year to be registered. Exponent's REACH team comprises regulatory affairs professionals, project managers, risk assessors, socioeconomic analysts, and technical specialists in all relevant scientific disciplines directly relevant to REACH. Our consultants have been following REACH since its inception and were involved in the consultation process that helped to shape the legislation in its final form. Several members of our multidisciplinary team have also contributed to the scientific and regulatory content in the official guidance documents. Our scientists have varying backgrounds in industry, government and contract research giving us unparalleled expertise in solving complex regulatory problems.
- Regulatory strategy and advice — tailored to the individual requirements of the client
- Program and project management — efficient communication and regular updates
- SIEF and consortia management — SIEF Formation Facilitator services and full SIEF/consortium management or participation
- Data evaluation and gap analysis — determination of available data held within the SIEF and in the public domain; evaluation of their suitability (including Klimisch rating) and identification of data gaps
- Use of integrated testing strategies (ITS) — consideration of grouping and read across, exposure based and technical data waivers, expert statements and QSAR modelling
- Study placement and monitoring — independent advice on choice of laboratory
- Dossier preparation and submission — complete dossier in IUCLID including preparation of robust study summaries, end point summaries, inquiry dossiers, testing proposals, classification, and labelling and toxicokinetics assessment
- Chemical safety reports (CSR) — identification of uses and exposure routes including development of use descriptors, hazard assessment, DNEL/PNEC derivation, PBT/vPvB assessment, exposure assessment and development of exposure scenarios, risk characterization and recommendations on risk management measures
- Evaluation and authorization services — post submission support, negotiation with European Chemicals Agency, socio-economic analysis
- CLP — Notification, harmonized classification dossiers
- Extended safety data sheets — incorporating exposure scenarios
- Only representative and third-party representative services