Regulatory Science

Technical & Scientific Support

No data, no market! We ensure that your product information is always up-to-date and that you are using quality data.

knoell Technical and Scientific Support

Data are the backbone of each submission. The more reliable the data, the better presented your assessment, the higher the probability of a successful approval or authorisation.

Our regulatory scientists support you in this endeavour by first of all making sure that your submission is based on the right assumptions: thorough data analysis, including gap analysis, check of completeness, technical equivalence as well as identity and physical-chemical parameter determination is therefore essential. Our more specific support is described below.

Literature search & evaluation

Literature search is essential for most registration processes.  At knoell, we have our own dedicated Literature Search Team, already established in 2011, when it became apparent  that open source searches for "all available data"  according to Regulation (EC) No 1907/2006 form an essential but time consuming part of the EU REACH data requirements. Literature search became also an important part of the submission preparations under other regulations, e.g. Regulation (EC) No 1107/2009 dealing with Plant Protection Products and their active substances, or for more general topics like endocrine disrupting properties. The increasing relevance of Endocrine Disruptor (ED) assessments for registrations required the development of new European Food Safety Authority (EFSA)-conform search strategies.

Typically information related to ecotox and toxicological data, environmental fate and physico-chemical data are required. Our team is perfectly set-up to support you with searches for, e.g.

  • REACH (open source and STN-database)
  • EFSA-conform searches for Crop Protection and Endocrine Disruptor (ED) Assessments (open source and STN-database)
  • CAS identification
  • OEL (Occupational Exposure Limit) and PDE (Permitted Daily Exposure) targeted searches (open sources only)

Subsequently, the evaluation part of this task is performed by our scientific experts in a tiered approach: a) screening for relevance based on title and abstract, followed by b)  the detailed assessment, e.g. according to Klimisch (1997) or Schneider (2009) .

Environmental fate of active ingredients and their metabolites

Depending on the regulation, environmental fate, i.e. the behaviour of your active ingredient and metabolites in the environment, plays an important role in your submission. The environmental compartments that need to be considered when it comes to investigation the behaviour of your ingredient are, e.g. for pesticides, soil, surface water and sediment, groundwater and air. 

Sorption and degradation are the most important processes defining the environmental fate of a substance. These parameters are typically investigated by a set of studies (laboratory and/or field) performed according to certain standards, e.g. OECD or US EPA guidelines.

Our team of environmental fate specialists will evaluate available studies for you in order to identify potential data gaps that need to be addressed before the next submission. They can also point you into the direction of reliable CROs, help you to develop an appropriate testing strategy and take over study management and monitoring for you.

In order to be able to use the obtained data in your exposure and risk assessments, most data need to be processed further. Our experts are well versed e.g. in performing kinetic evaluations in order to determine degradation data that can be further used in the soil, surface water and groundwater models required for the respective submissions.

Efficacy of your products

Efficacy means the ability of a product to fulfil its label claims, i.e. the product is effective against the organisms and conditions specified on the product label.

Proof of sufficient efficacy of a biocidal product, pesticide or biocontrol agent is one of the prerequisites for successful authorisation in most countries. Furthermore, establishing efficacy of a biocidal product provides the basis for balancing benefits against risks to humans, animals and the environment that arise from the use of the product. Thereby, the results from efficacy testing provide the data that are required for the exposure assessment of a biocidal product.

Our team supports you with

  • Planning and monitoring of your trial programme as well as design of test strategies (incl. study plan preparation)
  • Data management and evaluation (evaluation of mode of action (MOA))
  • Development of strategies for integrated pest management (IPM)
  • "Agronomic equivalence" evaluation (evaluation of genetically-modified plants (GMOs) in comparison to conventional varieties)

Specifically for the EU

  • Comparative assessment (EPPO 1/271) for Plant Protection Products containing candidates for substitution active substances (CfS)
  • Resistance management strategies and risk analysis (EPPO 1/213)

Hazard, risk and exposure assessments

When it comes to the use of chemicals, human, environmental and ecological safety are key. Therefore, depending on the active ingredient, product and country of use, complex assessments form the core of most sets of documents required to obtain and maintain market access. Find out how our scientific experts can support you to present a robust assessment.