Benefits to conducting a Preliminary Risk Assessment for biocidal products
Benefits to conducting a Preliminary Risk Assessment for biocidal products
Recent biocidal projects completed at Kerona have once again emphasised the importance of conducting a preliminary risk assessment (PRA) for a biocidal product or biocidal product family (BPF) once the final agreed EU end-points are available from the CAR. A PRA considers a “worst case” scenario to establish whether the use of a biocidal product results in acceptable levels of exposure.
The risk assessment required is based on the actual product being investigated. The assessment should follow the latest BPR guidance documents, exposure scenarios and other available literature, using the worst-case approach. If no specific scenarios have been defined for the mode of use of your product, it may be useful to discuss the risk assessment approach with the competent authority beforehand. If the risk assessment is not passing, risk mitigation measures can be introduced which can limit the product uses but can save the product if there is no other option. Due to this, it is important not to begin efficacy testing until a safe use for the product has been demonstrated.
It is important to remember that if the product fails any of the PRA parts, it must be redefined again so that it can be shown to present an acceptable level of risk. Once a passing preliminary risk fits with the intended uses, required data must be generated. The efficacy data is crucial, because if the product cannot be shown to be effective against the target organism, it must be redefined. Once this step is completed, the full BPR authorisation dossier may be compiled and submitted.
Performing a PRA prior to submission has several benefits and can help a registrant save time and money. Sometimes a registrant will assume the submission will be successful due to the biocidal product being comparable to an already authorised reference product. However, as is the nature of regulation, the endpoints and thresholds pertaining to the time of the reference product submission would have likely changed (become more conservative). The PRA will demonstrate if the intended uses of the product are passing and if additional data is needed as part of the BPR authorisation data package.
For assistance with conducting a preliminary risk assessment for biocidal products, please do not hesitate to contact Kerona at info@kerona.ie or call us at +353 (0)1 849 5284.