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

Companies wishing to market any chemical products, including biocides, in the EU need to register the products with relevant regulatory frameworks. These include BPR for biocides, covering insecticides, preservatives, disinfectants and rodenticides, and REACH for all other chemicals, excluding medicines, food additives and plant-protection products.  Our chemical regulation team have helped customers develop and defend safe and effective new plant protection products that have made a real difference to people’s lives around the world. We offer a comprehensive range of high quality consulting services to the crop protection industry developing and registering both chemical and biological based crop protection solutions for the global marketplace. Access to senior scientists with experience in the industry and across all scientific disciplines, we understand the relevant legislative frameworks and are uniquely positioned to assist you and help you meet the regulatory requirements for crop protection registrations in whichever market you need to register your plant protection product. 

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. Fera has the scientific and regulatory expertise to provide consultancy services to help you with every step of the process. Our experience derives from working in government, industry, contract research organisations and in regulatory consultancies. We have well-established working relationships with many competent authorities, which means we can support you to achieve product registrations effectively and efficiently. Our flexible approach means you can choose the consultancy service that best suits your needs. This could range from providing advice on specific issues to delivering a full package of consultancy support – including everything from data gap analysis, study design and dossier preparation and submission, through to post-submission query handling.

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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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Dossier Development

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

Full scope

  • 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.

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