Dossier Preparation and Risk Assessment II

Kerona provides the following range of services for Biocidal Product dossiers:

• Preparation of all required risk assessments:
  • Human health risk assessment using ConsExpo and other suitable models based on the proposed uses, users and likely exposed groups (professional/non-professional, adults, children)
  • Environmental risk assessment using available emission scenario documents (ESD) and guidance for the relevant product type and suitable risk assessment models (e.g. EUSES) based on the proposed uses and users
  • Dietary risk assessment (DRA)
• Screening of supported label uses for all risk assessments to identify passing/failing scenarios and options for refinement
• Management of the programme for renewal of the active substance approval at EU level, including addressing comments from the ECA and BPC, comprehensive literature searches according to the EFSA 2011 criteria and identification of endocrine disrupting properties according to the EFSA guidance (June, 2018)

• Preparation of Biocidal Product dossiers with summaries, risk assessments and evaluation in the required format:
  • Preparation of the BPR dossier summaries of individual studies and other dossier data points in IUCLID
  • Preparation of the draft PAR (Product Authorisation Report
  • Preparation of the Summary of Product Characteristics (SPC)
• Preparation of Biocidal Product Family (BPF) dossiers, taking into consideration the notes for guidance e.g. CA-July-19-Doc4.2-Final
• Comparative assessment where the active substance is a candidate for substitution (CfS)
• Peer review of draft dossiers
• Assistance with submission to the ECHA and eCA using the R4BP3 platform