Dossier Development

  • Fera has vast experience of preparing and submitting REACH and BPR dossiers to the European Chemicals Agency (ECHA).
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Dossier Development

Our regulatory specialists understand the specific requirements of each regulatory framework, so we can ensure the data and risk assessments you supply are fully compliant and that nothing is left out – giving your application the best chance of a trouble-free registration process.

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  • Preparation of robust study summaries (RSS)
  • Completion of risk assessments to demonstrate safe use
  • Preparation of expert statements
  • Entry of all data into IUCLID 6 for submission

Fera's dossier development service

We will work closely with you to prepare your dossier. This involves preparing robust data summaries and completing human health and environmental risk assessments, where necessary, using appropriate modelling scenarios to demonstrate safe use. We can prepare expert statements, where required, to plug any gaps in your data. Where possible, we can write scientific and technical arguments to explain why testing is not required in some cases. Finally, we will enter all of the data and summaries into IUCLID 6 for submission submission to ECHA in order to comply with REACH or BPR, as appropriate.

Dossier development: full scope

The full scope of our dossier development and submission service covers:

  • Preparation of Robust Study Summaries (RSS) for all required endpoints in IUCLID 6.
  • Preparation of expert statements to fill in data gaps and avoid testing where possible, and summarising these into IUCLID 6.
  • Preparation of waivers where possible: Preparation of technical and scientific arguments justifying that the substance does not need to be tested (based on nature, properties, use of substance).
  • Derivation of the CLP classification from data available.
  • Deciding critical endpoints (PNECs, OELs) to be used in the risk assessments.
  • Human health and environmental risk assessments: applying appropriate modelling and refining scenarios to demonstrate safe use.
  • Preparation of Summary of Product Characteristics (SPC) in the case of biocidal product authorisations.
  • Submission of dossiers via R4BP or REACH-IT, as appropriate.

For more information on our dossier development service, please get in touch.

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