IUCLID/R4BP

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Your challenge – our solution

Our Biocides Business Unit has submitted numerous BPD dossiers on more than 20 existing biocidal active substances, including substances of key importance for the biocide sector.

Since the dossier deadline for the fourth and last list was in October 2008, the current focus of our work on active substances is on the defense of submitted dossiers. This also includes dossiers which have not been prepared by SCC.

Do not hesitate to contact us if, during the evaluation of your dossiers, critical issues are raised by the Rapporteur Member State or if a refinement of your exposure and risk assessments is required. For new active substances, we can help you on any aspect of dossier preparation, from data gap analysis through planning and monitoring of studies to dossier writing including the performance of risk assessments.

 

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Environmental exposure and risk assessment

We have been involved in the development of official Emission Scenario Documents (ESDs) and have broad experience in the performance of environmental exposure and risk assessments, covering nearly all product types:

  • We have established the performance of exposure and risk assessments as a routine procedure: the assessments are done in a fast and cost-effective way.
  • We are familiar with the latest versions of the ESDs and other relevant guidance documents.
  • We are experienced in working with all relevant models such as EUSES, SimpleTreat, FOCUS PELMO and PEARL, GREAT-er and TOXSWA.
  • We offer a proven expertise in standard ESDs to non-standard applications and to create new ESDs.
The performance of environmental exposure and risk assessments is usually done as part of dossier preparation. However, it can also be done as a stand-alone task.

In product dossiers, read across to the exposure and risk assessment of the respective active substance dossier(s) may be sufficient if the following conditions apply:



  • The use pattern of the product is fully covered by the exposure and risk assessment in the active substance dossier(s).

  • The product does not contain any substances of concern requiring additional exposure and risk assessments.

  • The product does not contain any components which may influence the toxicological, environmental fate and eco-toxicological properties of the active substance(s).
  • The exposure scenarios and models used in the active substance dossier(s) for the performance of exposure and risk assessments are still valid.

In all other cases, the applicant is likely required to submit adapted, refined or extended exposure and risk assessments.

Environmental exposure and risk assessments
Human health exposure and risk assessments

 

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Human health exposure and risk assessments

We have broad experience in the performance of human-health exposure and risk assessments:

  • We have established the performance of exposure and risk assessment as a routine procedure: the assessments are done in a fast and cost-effective way.
  • We are familiar with all relevant exposure models including TNsG (2007), BEAT, ConsExpo and RiskOfDerm.
  • We are experts in adapting standard models to non-standard uses.
The performance of human health exposure and risk assessments is usually done as part of dossier preparation. However, it can also be done as a stand-alone task.