Food Science L10 evaluation of food additive

Evaluation of food additive toxicology in the USARisk assessment is defined as the evaluation of the potential adverse effects on human & animal health due to additives, contaminants, toxins or pathogens in food and beverages.The centre for food safety and applied nutrition (CFSAN) deals with new type of product derived from bioengineering (e.g. rennet derived from bioengineered bacteria for cheese making).Risk assessment policy is a concept in establishing a risk analysis strategy. The establishment of the policy is the responsibility of the risk managers. It should be carried out by the risk assessors.Codex standards for additives & contaminantsAdditives are substances which are intentionally added to food products, therefore, can be limited or prohibited. Control over the presence of contaminants is more difficult & complete elimination is often impossible. contaminants are not intentionally added to food, they may happen during production, manufacturing, processing, packaging, transport or handling or as a result of environmental contamination.Examples of contaminants: Synthetic chemicals, metals, mycotoxins, bacterial toxins, naturally occurring toxins in food & feed.Purpose & scope of the risk assessmentThe risk managers to clearly define the risk management approach intended in the development of the general standards for additives, contaminants, and toxins and the end-point required from the risk assessors. For each evaluation referred to the risk assessors, the purpose, scope & expected form of the output of the risk assessment should be provided by the risk managers.Risk assessment policy should be included as a specific risk management task for the risk managers, in consultation with the risk assessors. This collaboration helps to protect the scientific integrity of the risk assessment.Adequacy of data setsThe adequacy of toxicological data must be determined on a case-by-case basis by the risk assessors. For additives, the risk assessment should be suspended if the data set is inadequate. For contaminants, if data is incomplete, risk assessors should communicate the consequences of this uncertainty for the risk assessment.Type of toxicityIn the case of food additives, the risk assessment should be based on the threshold of toxicity. For a contaminant, PTDI or PRWI (provisional tolerable daily/weekly intake) should be determined. Non-dietary sources – the risk assessment should take into account exposures from all sources, the exposure assessment should include a general consideration of non-dietary sources of exposureAcceptable riskThe risk managers should consider providing case-by-case guidanceto the risk assessors on levels of acceptable risk for use in quantitative risk management.Susceptible sub-groups - those with identified metabolic difference or with certain immunological differences. In such cases, the risk managers should be provided with information that will enable a suitable risk management decision to be taken.High level exposureThe risk characterisation should take into account high level exposure. The proportion of the population to be covered by the exposure assessment should be agreed, although the methodology will be dictated by the available data. If exposure estimates shows that certain subgroups might exceed the ADI, the risk assessors should evaluate the health concern, taking into account the toxicological profile, providing its advice to the risk managers.The risk assessment process is a scientifically based process including:-hazard identification,- hazard characterisation,-exposure assessment,-risk characterisationHazard identification- is defined as “the identification of biological, chemical, & physical agents which may be present if particular food (or group of foods) and are capable of causing adverse health effects”.The role of hazard identification as used by many risk assessors is to identify those inherent properties of a substance which may cause harm.Hazard characterisation- is the “qualitative &/or quant itative evaluation of the nature of the adverse health effects associated with biological, chemical & physical agents which may be present in food”. Dose-response relationship should be assessed for all adverse effects produced by the substance being evaluated. For contaminants use should be made of all available natural baseline exposure data relating to clinical effects in man. There are a number of uncertainties in the hazard characterization.Exposure assessment is “the qualitative and/ or quantitativeevaluation of the likely intake of biological, chemical and physical agents via food as well as exposures from other sources if relevant. Assessing the exposure to food additives & contaminants is a complex matter requiring:-specific expertise-information on food consumption-concentration distribution of the additive/ contaminant in a food-info about the effects of the production, processing, handling, distribution & preparation of the food.Risk characterisation should include a “ qualitative &/ or quantitative estimation, including attendant uncertainties of the probability of occurrence & severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment associated with biological, chemical, & physical agents which may be present in food.Risk assessors stated that occasional moves above the ADI may not be of toxicological concern. In this case, guidance should be provided in terms of the magnitude & duration of exposure, and should be based on information from the toxicological database on a case by case basis.Acceptance of new toxicological test methods by US government agenciesUnited state code 2000 was signed into law that authorized the formation of a permanent committee to provide a procedure to evaluate, validate & accept new and alternative toxicity testing methods for use by US government agencies. This committee will promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human & animal health & the environment while reducing, refining, or replacing animal tests & ensuring human safety & product effectiveness.More recently, ICCVAM (Interagency Coordinating Committee for Validation of Alternative Methods) has successfully assessed the validity of several alternative methods. Once validated, each new method is reviewed for:-Applicability-Safety assessment-Regulated products by organizations within each agency Once accepted by a regulatory agency, the method will be added to its list of applicable tests for that toxicological end-point.。