The following assessments were conducted to present human health hazard and risk assessments for insecticide-treated nets (ITNs). This includes factory-coated or incorporated ITNs. These assessments may be used by applicants, regulatory authorities and other stakeholders as examples of the implementation of the Generic risk assessment model for insecticide-treated nets, 2nd edition (WHO, 2018).

The product characteristics utilized in the assessments, including the fabric weight (g/m2) and concentration of formulants (g active ingredient/kg net), were selected as representative values which exemplify currently prequalified ITN products.

The assessments are not intended to place a limit on the possible concentration of insecticide or synergist formulants in an ITN, nor are the selected values intended to represent the maximum concentration of formulants at which the assessed risks may become unacceptable.

In support of new product applications or change applications submitted to PQT/VCP, applicants may include reference to these document as part of the product dossier; however, applicants must determine if the design of their product or certain characteristics would require altering the presented risk assessment to properly reflect and assess the proposed product.