Food + Food Contact
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
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.
