Within the framework of the consumer, environmental and operator risk assessment studies are requested for your agrochemical product registration. Staphyt is GLP compliant and able to conduct GLP field studies to help you meet your regulatory requirements.
We can ensure the realization of multi-site studies in all regulatory areas in the north and south of the European Union and on any type of crop.
Our Study Directors and Principal Investigators monitor the studies continuously, together with all the specialists involved in the projects and so comply with the GLP requirements for multi-site studies (OECD N°13).
Commission Regulation (EU) No. 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No. 1107/2009, requires soil dissipation studies data to be presented in section 7 (« Fate and behavior in the environment »). These studies allow the estimation of the amount of time required to dissipate 50% and 90% of active ingredient as well as the amount of time required to degrade 50% and 90% of the same ingredient under natural conditions (in field).
These tests cover a range of representative soils, generally at least 4, and must be carried out until up to 90% of active ingredients has been dissipated or degraded. If the 90% dissipation time exceeds one year and theoretical calculations do not rule out the risk, soil accumulation studies will be considered.
Staphyt is equipped with brand new borers that are capable of generating soil samples to a depth of 1 meter. We can achieve sampling with cores of 1 meter or several cores of 25-30 cm. If needed, it is also possible to fragment the 1 meter soil cores into smaller sections, which means that our organization is flexible enough to cope with different situations.
Do not hesitate to contact us, so we can discuss your program further.
In North & South Europe and Australasia, Staphyt conducts residue studies at its GLP accredited experimental stations. DFR studies are intended to evaluate the risk of re-entry to workers and how this risk will decrease over time after the pesticide application (eg. an indoor tomatoes picker, who would regularly be in contact with treated leaves during his daily working tasks). The general requirements are based on Regulations 283/2013 and 284/2013, implementing R 1107/2009 – Reference to US EPA Guideline OPPTS 875.2100 and guidance document EFSA (17.10.2014).
Active ingredient collection: Any chemical residues are immediately and gently dislodged on site by shaking the leaf samples into a detergent solution. These solutions will then be sent to the laboratory for subsequent analysis.In regard to stability during freezer storage and shipment, the analytical results are secured with field Quality Control sets. The QC samples are prepared with matrix loaded dislodging solutions and fortification solutions prepared by the analytical site.
Once the amount of active ingredient is known in the washing solution, the DFR can be calculated and reported as µg/ cm².
Over the years Staphyt has conducted numerous DFR studies (on different crops and with different designs), and has gained real expertise and recognition by its sponsors. Our field stations are well spread out over Europe and trialists are equipped and trained to perform the DFR trials.
Do not hesitate to contact us, so we can discuss your program further together with the DFR techniques and associated sampling strategies.
• Rotational crop and Post-Harvest trials
• Turf Transferable Residue (TTR)
• Operator (OPEX), Workers (re-entry) and Bystander Exposure
• Ambient, chilled, frozen storage and transportation
• Specimen shipment: Specific or scheduled collections, door to door (fleet of purpose built freezer trucks)
• In-house and state of the art processing laboratory
• Honey bee & bumble bee field and semi field testing, Sub product sampling and Brood studies
• Bee larvae tests