New EU Guidance on Pesticide Products Requires ORE Studies
Are you ready to complete occupational and residential exposure studies to get approval on pesticide products and active ingredients?
Updated guidance on the approval and renewal process for plant protection products (PPP), their active ingredients and specific products, issued by the EU came into force on March 1, 2017. This means that to market a pesticide product you must now assess the risk of worker, bystander and resident a set of exposure and toxicological studies are required as well as modeling of the risk.
Why has the guidance been updated?
When PPP are applied to plants/crops it is possible that workers, bystanders and residents may be exposed to chemicals like pesticides or biocides. The EU has decided that these risks need to be assessed and fully understood.
SGS has been involved in the conduct of safety studies related to occupational, bystander and residential exposure for many years.
The general requirements for occupational and residential exposure (ORE) studies for pesticides in the EU are based on:
- Regulation 283/2013 (Active ingredient)
- Regulation 284/2013 (Formulated product), implementing Regulation 1107/2009
Further information is available in an EFSA guidance document published on October 17, 2014, as well as recent EU commission guidance document SANTE-10832-2015 rev. 1.7 published on January 24, 2017.
Experience & Expertise
SGS’s expertise in ORE studies includes passive dosimetry (full body and patch), inhalation monitoring by air sampling, biomonitoring in probands, and experience in most application techniques, as well as during loading, mixing and cleaning phases of pesticides and biocides.
Worker exposure, as well as dislodgeable foliar residue (DFR) studies are conducted all over Europe and supported by SGS field research teams in conjunction with our experienced GLP study directors. We operate in close communication with your study monitor or external consulting company.
With sound experience in GLP residue testing we apply all quality measures necessary to verify stability of the residue under field conditions (field spikes) and transportation. In DFR studies the extraction of the leave samples on the field site and shipment of the extract to the GLP laboratory is implemented as best practice.
Extensive Laboratory Network
SGS has a network of GLP residue laboratories established across Europe, with capacity to enable the rapid analysis of samples. Staff at our laboratories also contribute their experience to method development and validation in all kind of matrices including plant, tissues, dosimeters, air sampling probes and consumables.
SGS ORE Services
We can support your needs for ORE studies including:
- Inhalation monitoring
- Worker re-entry exposure
- Dislodgeable foliar residues (DFR)
- Turf transferable residues (TTR)
- Long term air sampling
- Residue – method development and validation
- Residue – storage stability
- Residue – magnitude of residue
For further information, please contact:
Seed and Crop Manager
m: +33 6 26 81 36 75
Test Facility Management
t: +49 6128 744-251
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.