Chemicals / REACH
Chemicals /REACH
Chemicals Registration - worldwide

WTC and its network are in the position to compile and submit chemicals notification/ registration dossiers according to existing chemical regulatory schemes:

  • European Union
  • Switzerland
  • USA
  • Canada
  • Japan
  • Korea
  • China
  • Australia
  • Others on request
Regulatory Affairs Services
  • Consulting on notification / registration strategies and test program
  • Scientific and regulatory evaluation of test data
  • Compilation and submission of registration dossier to regulatory authorities
  • Negotiations with regulatory agencies
Safety Testing Services
  • Conception, execution and management of experimental studies (physical-chemical properties, eco-toxicity, toxicology, mutagenicity, analytic - as needed) at the CRO of our clients’ choice. The tests will be performed according to the relevant international test guidelines, e.g. OECD, METI, OPPTS, EC, etc.
  • Under certain regulatory schemes, it is necessary to perform specific tests in an appropriate (accredited) laboratory located in the country of registration, as e.g. China.
  • Project management and scientific monitoring of studies.

 

Chemicals Registration in the European Union
Regulatory Affairs Services
  • Advice on registration strategy (grouping, etc.)
  • Collection, review and evaluation (e.g. Klimisch coding, monetary value) of data available
  • Literature search and evaluation of data
  • Gap analysis
  • Recommendations for filling / handling data gaps
  • Expert statements, bridging and waiving concepts, QSAR-modeling
  • Conception, execution and management of experimental studies with CROs
  • Robust summaries
  • Data entry into IUCLID 5 database
  • Environmental exposure assessments
  • Occupational - and human exposure assessments
  • Hazard assessment
  • Classification and Labeling
  • Compilation of exposure scenarios
  • Compilation of the registration dossier (IUCLID 5)
  • Compilation of the chemical safety report
  • Compilation of extended safety data sheets (e-SDS)
  • Management / coaching of consortia
  • Third party Representative
  • Only Representative service for non-EU-suppliers