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CEHTRA - Consultancy for Environmental & Human Toxicology and Risk AssessmentREACH Registration Dossier with the expertise of CEHTRA
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REACH

REACH Registration Dossier with the expertise of CEHTRA CEHTRA worked on over 3% of submitted substances in the first Phase of REACH Registration, and 6% in the second - a rich experience which can be a real asset to industry faced with the challenge of managing and completing dossiers for the next phases.

REACH deadline 2018

As we approach the third phase of the REACH Regulation (EC) No 1907/2006, with provisions for substances manufactured or imported into the EU at quantities of 1-100 tonnes per year, rigorous project management is required. You need to anticipate traffic jams in laboratories while maintaining the high quality of tests.

Our strong scientific and regulatory experience ensures your company meets the challenge of managing and fulfilling the REACH requirement.

CEHTRA offers the following solutions but is not limited to:

  • Regulatory Strategy and expert advice - going beyond standard technical services; 
  • Technical dossiers preparation and submission in IUCLID 5;
  • Chemical Safety Reports (CSR) and Exposure Scenarios (using CHESAR and other tools);
  • Chemical Safety Assessments: DNEL/PNEC derivation, PBT/vPvB risk characterisation;
  • Identification of realistic Risk Management Measures (RMM);
  • Intelligent Testing Strategies: reduction of testing obligations by Read-across, chemical grouping, QSAR modelling and exposure dependent data waivers;
  • Data Evaluation, Data Gap Analysis, Literature Searches and Archiving;
  • Project/Programme Management - Impartial study placement and monitoring to ensure all hazard and exposure data gaps are fulfilled with valid and scientifically rigorous studies;
  • SIEF and Consortia Management;
  • Post Submission Support: dossier evaluation, substance evaluation, defence of dossiers.

CEHTRA’s experience, proof of our commitment

During REACH Phase 1 & 2, CEHTRA provided technical and regulatory support on well over 300 dossiers, either on specific tasks or full preparation work and we’re already working on a similar number for Phase 3. That equates to over 3% of submitted substances in the first Phase of REACH Registration and 6% in the second Phase.  An extensive experience which can be a real asset to industry faced with the challenge of managing and completing dossiers for 2018 deadline.

REACH is not just the biggest regulation that the EU has created, it is as complicated and as nuanced as it is long. While much of the dossier verification work of ECHA has focussed on issues such as substance ID, they are also preparing algorithms for QC checks across the board. Lower tonnages will be registered in Phase 3, but that doesn’t necessarily mean that the substances are easier to assess. Up to the end of 2013, CEHTRA has scientifically assessed the risk of well over 200 substances, from dozens of different chemical groups for REACH. Benefit from our experience to help you register your dossier with confidence.
 
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®Cehtra • July 2017