Efficacy

One of the pre-requirements for the approval of a biocidal active substance or product is that the efficacy claimed against the relevant target organisms is adequately demonstrated. The variety of indications and application methods for biocides means that the appropriate efficacy studies must be specifically selected.

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Since the 1st of September 2013, biocidal products are regulated through the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), which aims to control the market launch and use of biocides in the European Union.

One of the prerequisites for successful biocidal product authorization according to the BPR is a proof of sufficient efficacy, showing that claims made on the product label will be fulfilled during the specific use of the product. With the emerging knowledge about the potential influence of co-formulants on a product’s efficacy, evaluation of the function of co-formulants in the formulation, such as pH-regulators, surfactants or cleaning additives, can be further requested by the evaluating Competent Authority and should be included in the efficacy assessment of a product.

Moreover the efficacy assessment and establishment of efficacious in-use concentrations lays the foundation for the assessment of possible risks arising for humans, animals and environment during the use of the product. After all, efficacy data are the basis for the Competent Authorities to evaluate a product’s performance with regard to its effectiveness  for a specific use and whether arising risks to people, animals and environment are acceptable or not.

At knoell, our experts combine their experience (gained at knoell and/or past work within Competent Authorities, Industry and research) in knoell’s internal Efficacy team to offer full service with regard to efficacy evaluation and the development of testing strategies for biocidal products and product families.

We offer the following services, with regards to efficacy:

  • Development of a customised efficacy test strategies for single products or biocidal product families (incl. test product selection, worst-case testing and bridging strategies)
  • Data gap analysis according to the latest requirements
  • Evaluation of efficacy study reports in the context of regulatory requirements, applications and label claims
  • Management and monitoring of efficacy studies with external laboratories
  • Assessment of the potential influence of co-formulants and preparation of justifications
  • Report-writing and dossier compilation (IUCLID and dRAR)
  • Communication with competent authorities (pre- and post-submission support)
  • In-house trainings in efficacy 

 

Our services with regard to efficacy

  • Development of product type-specific test strategies for testing efficacy
  • Management and monitoring of efficacy studies
  • Evaluating and summarizing study data, and
  • Report-writing and dossier compilation in IUCLID 6
Deirdre Lawler Head of Business Unit Industrial Chemicals & Biocides - Biocides
+49 214 20658-220 +49 214 20658-200 send mail

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