Food additives are highly regulated at global level. (i.e. EFSA, FAs etc. etc.) No food additive can be used without safety assessment and approval Safety assessment is undertaken PRIOR to approval The applicant (industry) provides the safety data, which have to be performed to defined quality standards (GLP, QA, OECD, UE guidelines……) The assessment Panels – which include scientists and regulators with a wide range of expertise – are responsible for safety assessments RISK ANALYSIS
Hazard identification Inherent biological activity Hazard assessment Assessment of relevance for humans Dose-response analysis HAZARD IDENTIFICATION Identification of adverse health effects In silico methodologies In vitro toxicology data Animal-based toxicological studies Human observation HAZARD ASSESSMENT Quantification of adverse health effects Kinetic variability Dynamic variability Mode/mechanism of action Selection of critical data Dose-response for critical effect EXPOSURE ASSESSMENT Active principle Dose of food additives Dose in individuals Dose in special population groups Max/min chronically/occasionally
Principle 1Risk management should follow a structured approach Principle 2Protection of human health should be the primary consideration in risk management decisions Principle 3Risk management decisions and practices should be transparent Principle 4Determination of risk assessment policy should be included as a specific component of risk management Principle 5Risk management should ensure the scientific integrity of the risk assessment process by maintaining the functional separation or risk assessment and risk management Principle 6Risk management decisions should include clear, interactive communication with consumers and other interested parties in all aspects of the process Principle 7Risk management should be a continuing process that takes into account all newly generated data in the evaluation and review of risk management decisions
ADI (Acceptable Daily Intake) ARfD (Acute Reference Dose) TMDI (Tolerable Maximum daily Intake) XYZ ……………………………………………………… etc. etc
ADI represents the amount of a food additive, a pesticide or a veterinary drug residue, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk. ARfD represents the amount of a pesticide, expressed on a body weight basis, that can be ingested over a short period of time (one day) without appreciable health risk T(M)DI represents permissible human daily exposure to those contaminants, expressed on a body weight basis, unavoidably associated with the consumption of nutritious foods.
TOXICOLOGICAL PROTOCOL ADI – ARfD -TMDI– xxz….. ALLOCATION
The greatest concentration or amount of an agent, found by study or observation that causes detectable, usually adverse (or toxic?) alteration of morphology, functional capacity, growth, development or lifespan of the target
response dose mg/kg bw 10010 1 HUMANS sensitive subjects HUMANS HUMANS population average HUMANS
NOAEL = No Observed Adverse Effect Level (mg/kg b.w.) SF = Safety Factor (10, 100, n) NOAEL SF ADI = ADI = Admissible Daily Intake mg/kg b.w.
Log Concentration -∞ +∞ Frequency of the phenomenon
Exposure assessment is a key element of risk assessment and a tool for risk management It’s theoretically simple but practically complex due to data deficiencies Examples of exposure models: ILSI Europe’s ‘ GUIDEA ‘ and FACET
Which substances are present in what amounts in a given food/diet: including information concerning factors influencing their levels and qualities such as bioavailability How much of the foods containing these substances are consumed and what is the consumption of potentially relevant risk groups, including high users? What are the conditions and the probabilities of consuming occasionally or regularly high amounts of such foods which at the same time contain high levels of the substance(s) in question?