Acceptable daily intake consumer safety

With respect to veterinary medicines, the US-FDA establishes tolerances to include a safety factor to assure that the drug will have no harmful effects on consumers of the food product. The US-FDA first determines the level at which the dmg does not produce any measurable effect in laboratory animals. From this, the US-FDA determines an acceptable daily intake (ADI), and the drug tolerance and withdrawal times are then determined so that the concentrations of dmg residues in edible tissues are below the ADI. Depending on the dmg, safety factors of between 100-fold to 2000-fold are included in the calculations used to set the tolerances. 

In addressing consumer safety the VPC achieves this by consideration of the toxicological data and the no effect level (NEL = No observed Effect Level) for that substance in experimental animals. This, together with an additional safety factor to allow for any inter-species and intra-species variability, is used to calculate the acceptable daily intake (ADI). For an adult human the ADI is calculated from the NEL by using the following formula for a 60 kg person ... 

The most recently reported UK results on surveillance for veterinary drug residues in meat and animal products show that traces of these compounds can, and sometimes do, arise in food. As all of these compounds are biologically potent in order to be effective in use, it is necessary to ensure that any residual activity in a food product does not present a risk to the consumer. The use of veterinary medicines inevitably leads to the presence of trace residues in food and the purpose of toxicological safety evaluation is to determine at what concentration the residues of a particular compound becomes a cause for concern with regard to human health. Thus, dose-response relationships have to be established and used to determine the concentration of a dmg at which the risks to human health become acceptable and are outweighed by the benefits from the use of the drug. This is in essence the process involved in the setting of Acceptable Daily Intakes (ADIs) and... 

In general a food additive may be permitted in the EU if the European Food Safety Authority [74[ has found that it is harmless to the health of consumers and that it has an established ADI (acceptable daily intake). Besides this, there must be a technological need for the substance. 

For the reasons outlined earlier, effective control and regulation of the use of these preservatives in foods is very important to ensure consumer safety. The EFSA has established an acceptable daily intake (ADI) of nitrite, that is, the amount that can be ingested without adverse effects on human health (EFSA, 2003). The ADI of nitrite in a daily diet is up to 0.07 mg of nitrite per kg of body weight per day (equivalent to 3.6 mg/day for a person weighing 60 kg). Because some nitrate from food is converted to nitrite in our body, there is also an ADI for the amount of nitrate we eat. The acceptable daily limit of nitrate is up to 3.7 mg/kg of body weight per day (equivalent to 219 mg/day for a person weighing 60 kg), (FAO/WHO, 2003a,b,c lARC/WHO, 2010). 

The scientific committees mentioned earlier assess the safety for consumers of foods derived from animals treated with coccidiostats by assessing the available data from studies of the pharmacokinetics (including metabolism and residue depletion) in the target species and laboratory animals, toxicological studies and any available observations in exposed humans. Consumer safety is expressed numerically as an acceptable daily intake (ADI) and legal limits applied to concentrations of residues permitted in foods are established as a... 

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