Benefit from CEHTRA’s rich experience in the first Phase of REACH Registration to successfully manage and complete your dossier for the next phases.

REACH Challenges: 

 

· Coordinating and completing multiple dossiers in a timely manner for 2013 requires urgent attention and rigorous project management.

· Our prognostic is that for 2013/2018 more experimental data will need to be produced. You will want to anticipate traffic jams in laboratories while maintaining the high quality of your tests to avoid false positives.

· You will need to juggle chronic studies from the first phase and acute testing from the next phases simultaneously.
· You may want to adapt your dossier management according to ECHA feedback and anticipate new guidance documents and methodologies.

· You may need to closely follow technical issues in the SIEF/Consortia, either as a lead registrant or passive member.

 

CEHTRA can offer you all the solutions you need:

 

Prepare for the next Phases of REACH: 

 

· Deliver expert advice reducing your work effort and using good science to intelligently prepare dossiers; 

· CEHTRA goes beyond standard technical services by offering a strategy of support all along the preparation of your dossiers.

· We can help you evaluate the overall impact of REACH on your business. 

Prepare and follow up your dossier(s): 

 

· CEHTRA prepares and submits Technical dossiers and Chemical Safety Reports on behalf of our clients; 

· We perform complete, traceable, literature searches and archiving;

· Use our experience to scrutinise the quality of the data supported by Read-across approaches (QSAR, modelling, and exposure dependent data waivers where possible), to reduce substance testing obligations; 

· CEHTRA has close links with some of the best laboratories in the world. We will monitor laboratory tests to ensure all hazard and exposure data gaps are fulfilled with fully valid and scientifically rigorous studies; 

· We prepare complete Hazard Assessment, from IUCLID5 summaries to DNEL/PNEC derivation;

· We prepare complete Chemical Safety Assessments covering Human Health and Environmental risk, including PBT/vPvB risk characterisation; 

· CEHTRA provides potential risk management measures for your chemical substances, where required while taking the steps to make measures proposed intelligent and realistic.

 

We have the experience:

 

During REACH Phase 1, CEHTRA provided technical and regulatory support on well over 100 dossiers, either on specific tasks or full preparation work. CEHTRA dealt with big consortia (Solvents, Styrene, ClO2, Polyamide) as well as fine chemistry companies (Aluminum (bis)sulfate, limonene, fine fragrances). CEHTRA had to deal with complex scientific and regulatory issues, sometimes in a very short time frame as shown in the Case Study below.

 

---

CASE STUDY: REACH dossier rescue

Late summer 2010, CEHTRA was asked to help on a problematic incomplete and flawed R50/53 dossier.

Issues:

• Environmental and Human Health studies of limited value

• Re-work needed for environmental ES

• Failed consumer and environment Risk Characterisation Ratios

CEHTRA response:

• Total review of available studies, WOE approach, July

• Short-term Ecotoxicological study performed to declassify, August

• All ES completely re-worked and taken to Tier 2, August/September

• Dossier compiled, draft CSR sent early September

• Consortium comments addressed, submitted end September.,,,

---