Acceptable Daily Intake basis

NOAEL (no-observed-adverse-effect level) is defined as the highest dose at which no adverse effects are observed in the most susceptible animal species. The NOAEL is used as a basis for setting human safety standards for acceptable daily intakes (ADIs), taking into account uncertainty factors for extrapolation from animals to humans and inter-individual variabilities of humans. The adequacy of any margin of safety or margin of exposure must consider the nature and quality of the available hazard identification and dose-response data and the reliability and relevance of the exposure estimations. In some cases, no adverse endpoint can be identified such as for many naturally occurring compounds that are widespread in foods. In that case, an ADI Not Specified is assigned. ... 

For many substances the body s own mechanisms for de-toxification and repair mean that low doses of some chemicals can be tolerated without experiencing any adverse effects. However, once a certain threshold has been exceeded then the degree of adverse effect is related to the dose. The highest dose at which no adverse effects are observed in the most susceptible animal species is identified as the No Observed Adverse Effect Level (NOAEL). The NOAEL is used as the basis for setting human safety standards for food additive Acceptable Daily Intakes (ADIs)4... 

Data on the safety studies were submitted to international agencies like the Joint Expert Committee for Food Additives of the WHO and FAO (JECFA), and the Scientific Committee on Food (SCF) of the EC. Both committees endorsed acesulfame K as a food additive. Initial acceptance was based on an NOEL of 900mg/kg in dogs which were considered to be the most sensitive species. Therefore Acceptable Daily Intake (ADI) values of 0-9 mg/kg of body weight were allocated.8 9 Evidence that rats would be an appropriate model for risk assessment was the reason for JECFA to change the ADI to 0-15 mg/kg of body weight on the basis of a no-effect level of 1500-3000 mg/kg in rats.10 Countries allocating their own ADI values like the USA and Canada have come to the same conclusion. The SCF still retains its 0-9 mg/kg ADI.11... 

ADI Acceptable daily intake - "The daily intake of chemical, which during an entire lifetime appears to be without appreciable risk on the basis of all known facts at that time" Food additives, pesticides... 

Acceptable Daily Intake (ADI) The dally intake of a chemical that is considered without appreciable risk on the basis of all the facts known at the time it is defined. 

WHO selects JECFA committee members (experts) to conduct the toxicological evaluation of food additives and contaminants and establishing an acceptable daily intake (ADI). FAO selects JECFA experts to establish specifications for the identity and purity of food additives and to assess their intake. Scientists are chosen for their expertise to serve on JECFA committees according to the types of compounds on the agenda, and membership is on an ad hoc basis using individual scientists from all regions of the world. 

Some critical differences in risk assessment procedure lead to confusing situations on a worldwide basis. These differences are due to some very controversial areas of safety issues including the calculation of the acceptable daily intake (ADI), the assignment of the ADI to maximum residue limit (MRL)/tolerance, the validation of the analytical methods needed to regulate drug residues, and the fitness of legislation to toxicology. 

The NOEL is the "no observed effect level" and it is determined from the dose-response curve when the toxic effect being measured is plotted against the dose. It is the highest dose where no toxicity is observed. The ADI is the "acceptable daily intake" and is usually determined as NOEL/100. The arbitrary factor of 100 is applied to account for individual differences between humans (factor of 10) and for species differences (factor of 10) as the NOEL is derived from animal toxicity studies. The ADI is the amount of a food additive that is felt to be safe to be ingested on a daily basis. 

Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) periodically considers food additives, including antioxidants, on the basis of all available scientific data to establish acceptable daily intake levels (92) and specifications on the identity and purity of the additives. The conclusions of JECFA are published in numerous reports and technological summaries by the World Health Organization (WHO) as the WHO Technical Report Series and WHO Food Additives Series. Such information provided by JECFA is used by the Joint FAO/ WHO Codex Alimentarius Commission in implementing the Joint FAO/WHO Standards Program, which was established to elaborate international standards for foods to protect the health of consumers, to ensure fair practices in food trade, and to facilitate international trade (90). 

Basically, these workers were attempting to determine the amounts of chemicals that the human body could ingest on a daily basis without undue risk and toxicity. In the process, they found that a level of acceptable daily intake could be calculated from the toxicity of the materials expressed as an LDS0. These data are widely available on material safety data sheets and other references on which toxicity data can be found. 

The risk to health from chemicals in food can be assessed by comparing estimates of dietary exposure with recommended safe levels of exposure. For most metals and other elements, these are the Provisional Tolerable Weekly Intakes (PTWIs) and the Provisional Tolerable Daily Intakes (PTDIs) recommended by the Joint Expert Committee on Food Additives of the Food and Agricultural Organisation of the United Nations and the World Health Organisation International Programme on Chemical Safety (JECFA). The European Commission s Scientific Committee on Food has established other relevant safe levels. These are Acceptable Daily Intakes (ADIs) for chemicals added to food, and Tolerable Daily Intakes (TDIs) for chemical contaminants. The use of the term tolerable implies permissibility rather than acceptability. All the above recommendations are estimates of the amount of substance that can be ingested over a lifetime without appreciable risk, expressed on a daily or weekly basis as appropriate. 

ADI Acceptable Daily Intake the amount of a specific food additive or contaminant (e.g., pesticide) thought to be the maximum level that should be consumed on a daily basis. ADI values are normally determined by experts of WHO and FAO Codex Alimentarius Committee. 

Acceptable Daily Intake (ADI) The ADI of a chemical is the estimate of the amount of a substance in food and/or drinking water, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk to the consumer on the basis of all of the known facts at the time of the evaluation. It is usually expressed in mg of the chemical per kg of body weight (EAO/WHO, 1997). 

The health and environmental effects profile for antimony oxides was prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH, USA Acceptable daily intakes, defined as the amount of a chemical to which humans can he exposed on a daily basis over an extended period of time (usually a lifetime) without suffering deleterious effects, were 24.5, 29.3, 30.9 and 32.5 /ig day for oral exposure, for antimony, antimony trioxide, antimony tetroxide and antimony pentoxide, respectively. 

On the basis of metabolic and toxicological data, the WHO has set an acceptable daily intake of propylene glycol at up to 25 mg/kg body-weight. Formulations containing 35% propylene glycol can cause hemolysis in humans. 

The dose-response relationship is the basis by which regulatory bodies define under what limits humans can be exposed to potentially toxic chemicals and yet not suffer adverse effects. A number of different government bodies establish regulations to define safe exposure conditions. The acceptable daily intake (ADI) is... 

Acceptable Daily Intake (ADI) aldicarb, 455 atrazine, 534-535 basis, 438 oxamyl, 539... 

The recommended daily intake values as estimated by the United States Environmental Protection Agency (EPA) (4) and the Centers for Disease Control (CDC) (5,6) have been used for the present calculations. For the EPA the "Acceptable Daily Intake" (ADI) for 2,3,7,8-TCDD is 1 x 10" g/kg/day. This value is based on the lowest-observed-adverse-effect-level (LOAEL) of 1 X 10 g/kg/day for a reproductive effect in rats (7,8), a 10-fold uncertainty factor because a LOAEL is used as the basis of the calculation rather than a no-observed adverse effect level (NOAEL), and an additional uncertainty factor of 100 based on the existence of lifetime animal studies and lack of knowledge of the effects in man. (4). For a 10" (1/1,000,000) cancer risk, the EPA has estimated a 95% lower-limit criteria for a lifetime intake of... 

In 1954, the Food and Drug Administration published a paper that defined the basis for the acceptable daily intake (ADI). The ADI was a threshold for intake of a chemical for a large population, below which there should be no significant toxic risks. The paper not only defined a procedure for the ADI, but also described the use of safety factors and how animal data could be used to estimate risk to humans. A no effect level was determined from animal studies and a safety factor of 100 was used to establish a safe level. Tolerances for chemical additives and pesticides were calculated, comparing the safe level to the residue concentration of these chemicals in crops (e.g., wheat) and that crop s contribution to the individual s daily diet. 

The No Observable Adverse Effect Level (NOAEL) of 70 mg SO2 kg body weight is the basis for the postulation of the acceptable daily intake of 0-0.7 mg SO2 kg body weight and day. This means that, for an adult person of 70 kg body weight, an acceptable daily intake of S02 is about 49 mg. These amounts can be ignored due to an endogenous sulfite formation of 1680 mg (Holland 1996). 

All provisions in respect of food additives will require to be endorsed by the Codex Committee on Food Additives and Contaminants, on the basis of technological justification submitted by the commodity committees and of the recommendations of the Joint FAO/WHO Expert Committee on Food Additives concerning the safety-in-use (acceptable daily intake (ADI) and other restrictions) and an estimate of the potential and, where possible, the actual intake of the food additives, ensuring conformity with the General Principles for the Use of Food Additives . 

The Additive and Food Contaminants (AFC) Panel of the European Food Safety Authority has evaluated the new long-term study on the carcinogenicity of aspartame conducted by the European Ramazzini Foundation (European Foundation of Oncology and Environmental Sciences) in Bologna, Italy. In its opinion, the Panel concluded, on the basis of aU the evidence currently available, that there is neither need to further review the safety of aspartame nor to revise the previously established Acceptable Daily Intake (ADI) for aspartame (40mg/kg body weight). 

Acceptable daily intake (ADI) The amount of a food additive that can be ingested daily in the diet without appreciable risk, determined on the basis of all facts known at the time. Without appreciable risk refers to the practical certainty that injury will not result, even after a lifetime of experience. The ADI is a practical approach to determining the safety of food additives and is a means of achieving some uniformity of approach in regulatory control. It serves to ensure that the actual human intake of a substance is well below toxic levels. In the United States, ADIs are determined by the U.S. Food and Drug Administration (FDA). 

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