Regulatory Risk Assessment

Assessing the risks to human health or the environment of any chemical product is an essential part of the regulatory registration process.

Regulatory Risk Assessment

Preparing a detailed and thorough dossier of evidence and data is essential for a hassle-free product approval. We can help to ensure that you provide all the necessary evidence, compliance data and risk assessments to satisfy the requirements of the regulatory authority – whether for BPR or REACH registration.

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  • Analysis of existing data to identify gaps
  • Advice on testing strategy to provide missing data
  • Risk assessment study design and results monitoring
  • Provision of regulatory risk assessment laboratory services

Fera's regulatory risk assessment service

Our regulatory consultants and scientists have vast experience of submitting complete documentation for chemical product registration, so we know exactly what is required. To support your approval process, we will assess your existing data to check for validity, completeness and regulatory compliance. If we identify gaps in your data, we can advise you on how to fill those gaps.

That could mean commissioning tests to produce the missing data, or completing human health or environmental risk assessments. We have the expertise to design and monitor these studies, to ensure they produce the data you need.

We can introduce you to the laboratories able to carry out the required tests – and in many cases, the work can be completed by Fera scientists in our own laboratories. We specialise in regulatory risk assessment studies using the most appropriate modelling scenarios to help you demonstrate safe use of your product in line with stringent regulatory requirements.

Service scope

Our regulatory risk-assessment services include:

Data gap analysis

  • Expert review of existing data and identification of data gaps against regulatory requirements.
  • Advice on risk-assessment testing.
  • Cost estimates for commissioning studies where gaps identified.
  • Advice on where gaps can be filled with expert statements and data-waiving arguments.

Study design and monitoring

  • Study design.
  • Selection of contract laboratories to commission studies.
  • Monitoring experimental phase.
  • Review of draft study reports.
  • Guidance on interpretation of results and conclusions.

If you have any questions about our regulatory risk assessment service, please get in touch.

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With the 2018 deadline for submission of IUCLID dossiers approaching, it is important to have a clear understanding of the obligations under REACH (Regulation (EC) No 1907/2006). This is where our experts can help. At Fera, we help our clients navigate through the REACH registration process, from providing advice on specific issues to full support packages. We are experienced working with difficult chemicals and have a wide range of analytic equipment and experience to ensure this happens.

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