Our work
The assessment and evaluation of food chemical toxicology was at the core of our company when it was founded in 1961, and remains a central activity today. Our team has a broad range of experience considering the health effects of food components, including flavourings and other additives, novel ingredients and unexpected contaminants.
We are also ideally placed to assist with the assessment of food packaging and other food-contact materials. Together with expert analytical partners, we can determine health risks associated with the migration of the components of these food-contact materials, including printing inks.
Safety Benchmarks
Our health risk assessments of food ingredients and food-contact materials compare the key toxicological hazards of these chemicals with the worst-case estimates of exposure. This involves the identification – or derivation – of a health-based guidance value. Such a value is an estimate of the maximum exposure, generally qualified by route, that will pose no significant threat to human health. It will usually be based on data from laboratory animal experiments, adjusted to account for the likely differences in how humans and the other species (usually a rodent) is likely to respond to chemicals in general or (much more rarely) to that specific test chemical.
TTC
The Threshold of Toxicological Concern (TTC) approach provides a default value against which a risk assessment can be carried out. The TTC values represent low levels of exposure to an untested or data-poor chemical that is highly unlikely to pose any significant toxicological risk. The TTC concept is the scientific foundation of the risk assessment of food additives and flavourings by several regulatory bodies including the US FDA, JECFA and EFSA.
Our expertise in this area
Hazard Characterisation
Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities.
Risk Assessment
Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.
Safety Benchmarks
Identifying or deriving a safety benchmark is a critical step in determining the risk of a chemical to human health. These values are estimates of the maximum exposure, generally qualified by route, that will pose no significant threat.
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.
