Batelle

 

Battelle Memorial Institute – Research and Services for the registration of active substances and products

 

Battelle is the world’s largest non-profit independent research and development organization. Battelle’s AgriBusiness provides comprehensive registration services for agrochemicals, biopesticides, biocides and chemicals from individual hazard assessment studies to turn-key projects and regulatory support. Battelle is distinguished through its technology offering, including the development of new formulations, sensors, or Agbiotech research.


In order to provide high-level experience in all scientific areas relevant for biocides Battelle joined forces with competent partners (ECT, FoBiG Hydrotox) to form RegisGate.
Battelle can provide complete registration support for agrochemicals and biocides including database evaluation, data gap identification, testing strategies, study monitoring, project management, dossier preparation and post-submission support. Battelle has experience with the management of Task Forces.


Although Battelle has a particular expertise in environmental fate, including ground and surface water modelling, our toxicology and ecotoxicology experts are able to perform higher tier risk assessments for human health and the environment. Our analytical methodology and phys-chem experts can provide the required information and analytical tools for the approval of active substances and the authorisation of their products. Battelle’s Regulatory Affairs team have experience in communicating with the regulatory authorities, compiling active substance and product dossiers, for both plant protection products and biocides, and in responding to post-submission technical enquiries. 


Battelle have provided EU regulatory environmental fate, metabolism and modelling support to the plant protection and biocide industry since early 2000.  Support includes; dossier preparation and negotiation of registration strategies with authorities; providing advice on demand for the design and conduction of new studies and actively participates in project teams for compounds involved. 


The regulatory affairs team and key support staff have acquired a combined experience of over 100 years by working in industry, other consultancies and for regulatory authorities prior to working for Battelle.
In the area of biocides, Battelle is experienced in preparing and reviewing dossier documents, including IUCLID datasets, of various product types (PT). For biocidal dossiers, Battelle have specialised in the areas of phys-chem, methods, and chemical fate and behaviour. Another area of extensive experience is the theoretical assessment of pesticide and biocidal active ingredients and their impurities and metabolites by means of accredited QSAR models.


In its GLP-certified laboratories in the US and Europe Battelle conducts a broad range of studies, including physical-chemical properties testing, method development and validation, toxicology (in-vivo) and laboratory and field testing of metabolism and environmental fate.

Further information can be found on our website (www.battelle.org) and can be provided upon request.
www.batelle.org