Our work
Plant Protection Products Regulation (PPPR) consulting is crucial for the protection of our food supply, against the harmful action of organisms like fungi and insects. The formulations designed to achieve this are not perfect and it is important to assess the risks to humans, other non-target animals, or to the environment.
A high-quality assessment of the toxicology of a plant protection product is a cornerstone of any submission for approval. Our extensive experience in identifying, interpreting and summarising toxicological data makes us an ideal partner for this aspect of your Plant Protection Products Regulation submissions.
Literature searching
Pesticide active substances are approved in the EU for a defined period of up to 15 years. As part of the renewal process, companies are required to submit data published since the previous evaluation. We have years of experience in performing tailored, sector-specific literature searches. Our skills in pesticide toxicology make us a valuable partner in the preparation of plant protection product authorisation and renewal dossiers.
Exposure Estimation
Once a chemical’s toxicological hazards have been characterised, it is crucial to understand what the potential human exposure might be. This is always difficult, particularly so for plant protection products, where very different tribes might be at risk (e.g. professional users, bystanders and even inadvertently-exposed children).
We always treat exposure estimation as a collaborative process, guiding our clients to identify the information necessary for a robust health risk assessment. We are, though, familiar with many of the key software tools for exposure estimation, including ECHA’s Chesar, EasyTRA, BEAT, EUSES and ConsExpo, as well as the key guidance relating to modelling of biocide exposures.
Helpful link
Regulation (EC) 1107/2009 concerning the placing of plant protection products on the market
Some of our case studies in this area
A human health risk assessment of API-related impurities
Case study
Whilst developing an inhalation spray drug product, the client identified two impurities with chemical structures related to the Active Pharmaceutical Ingredient (API). Click through to read more about how we dealt with this interesting project.
Human health risk assessment of unknown contamination
Case study
The client reported that small “brown spots” had been observed on the inside surface of a batch of aluminium tubes that contain a topical drug product. The source and chemical composition of the brown spots was unknown. Click through to read more about how we dealt with this interesting project.
Toxicological risk assessment of a disinfecting agent in a syringe medical device
Case study
The client manufactures a product which is used as part of a syringe line medical device. The connection set-up has the potential to introduce a disinfectant chemical into the line and be injected into patients. Click through to read more about how we dealt with this interesting project.
