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
Determining a Specific Migration Limit (SML) for a data-deficient compound identified in food labels
Case study
The client was informed by a supplier that a chemical compound with a worrying structure was present within a food label ink. Click to find out how we dealt with it.
Pod-based ENDS device PMTA assessments
Case study
As part of a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device, bibra was asked to provide support preparing non-clinical and human health impact assessments.
ISO 18562 evaluation of a medical device in contact with the breathing gas pathway
Case study
As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.
