Plant Protection Products
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
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
