We are the leading consulting company in Europe in the field of Biopesticides and have submitted dossiers for 27 strains or isolates from 17 microbial species for approval as active substances in the EU. We are also engaged in the revision of Guidance Documents for dossier preparation for biocides containing microorganisms as active substances and frequently participate in the OECD BioPesticide Steering Group, EU Commission Working groups, IOBC and IBMA - ensuring that we are always at the forefront of knowledge in regulations for biopesticide registration.
Biopesticides differ considerably from conventional chemicals used in plant protection products or biocides. Therefore, study protocols often need to be adapted to the specific needs of the particular product or active ingredient. Differences when compared to chemicals exist in particular in the determination of the active substances, and in efficacy trials. We provide competent scientific support during all stages of physical-chemical, toxicological and environmental tests and efficacy trials. We are in contact with the best laboratories and together with them we will design experiments and produce high quality reports which will prevent unnecessary investments of time and money.
Our extensive expertise in the preparation of dossiers for biopesticides and our work with the EU in the development of the current data requirements for microorganisms in plant protection products and biocidal products means that we know exactly what is required to get your biopesticide registered.
Our One-Stop Service concept provides our clients with high-quality regulatory services. Clients may choose the services that meet their specific needs best – in packages or stand-alone.
Biopesticides are regulated either as plant protection products under Regulation (EC) No 1107/2009 or as biocides under Regulation (EU) 528/2012 depending on the use of the product.
In both systems, the active ingredients have to be registered at the EU level before product registrations can be obtained. Data requirements for plant extracts and pheromones are the same as for chemicals, whereas seperate ones exist for microorganisms.
Follow-up Activities & Dossier Defence (selected services)
- Review and commenting of authorities‘ assessments on EU and national level
- Risk refinements
- Expert discussions and negotiations with authorities
Dossier Preparation (selected services)
- Active substance dossiers for EU approval
(agrochemicals under Regulation (EC) No 1107/2009 and biocides under Regulation (EU) 528/2012)
- Product dossiers for national / EU authorisation (agrochemicals under Reg. 1107/2009/EC and biocides under Reg. 528/2012/EC)
- Preliminary or stand-alone risk assessments
- Documentation & submission on CDs, PDF-files and CADDY
- Expert statements
- Literature research
General Consultancy & Project Management (selected services)
- Identification and evaluation of data gaps in the data package according to current EU requirements (check of completeness) for biopesticides and preliminary risk assessments
(human & environmental exposure, risk characterisation human health & environment)
- Cost analysis for completion of the data package (including statements) and preparation of a registration dossier
- Time schedule for study conduction and dossier preparation
- Support in the selection of contract laboratories,
contracting of studies
- Scientific support and study monitoring