ADI-value

Thus the ADI in mg per kg per day is an estimate of the daily pesticide dietary intake that appears to be without risk over the entire human lifetime. ADI values are estabHshed and periodically reviewed by joint committees of the Eood and Agricultural Organization (EAO) and WHO of the United Nations. 

The quantitative measurement of toxicity level is expressed by parameters like NOEL (no observed effect level), NOAEL (no observed adverse effect level), and ADI (acceptable daily intake). The NOEL values are divided by 100 to obtain ADI values. The 100 safety factor derives from 10 x 10, where the 10s represent the animal-to-human conversion rate and the human variability factor. Currently, the most useful index of safety is the ADI, expressed as milligrams of test substance per kilogram of body weight (ppm), with the recommendation not to eat more than the ADI per day. The FDA, EU, and WHO agree on the ADI principle. 

AOELinhaiative Can be substituted by the AOELsystemic In the case that neither acceptable operator exposure level (AOEL) values are available, the proposed or established acceptable daily intake (ADI) value can be considered. 

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... 

The ADI value for cyclamate of 0-11 mg/kg as allocated by JECFA17 is based on the no-effect level for cyclohexylamine, a 63% availability of cyclohexylamine for conversion due to absorption of 37% and an average conversion rate of 30%. The SCF has meanwhile reduced the ADI to 0-7 mg/kg assuming a higher conversion rate.18... 

As bulk sweeteners have not specified ADI values, a similar range of intake studies is not available, and laxative properties more or less exclude excessive intake. 

ADI values and source details organised by additive category (Appendix 2) and by additive name (Appendix 3). 

Appendix 2 Acceptable daily intake (ADI) values and references by additive category... 

SCF ADI Acceptable Daily Intake allocated by the Scientific Committee on Food, formerly known as the Scientific Committee for Food. (The SCF has often considered and then adopted JECFA ADI values.) Numbers in this column are the numerical ADI in mg per kg body weight, (mg/kg b.w.) expressed as 0—X, because 0 mg/kg b.w. is also acceptable NS = Not specified. This implies that the no-effect level and conditions of use have been assessed to be such as to cause no toxicological concern. It does not mean that no ADI could be allocated, because of, for instance, lack of submitted evidence. 

At least two attempts have been made to calculate ADI values for chloroform. These attempts assumed the existence of a threshold for the carcinogenicity of chloroform. Roe (39) suggested an ADI of 300 /zg/L in drinking water. He used the no observed effect level of 17 mg/kg/day in the mouse and a margin of safety of 2000 and assumed consumption of 2 L per person per day. 

Table IV lists the results of risk calculations provided in the preliminary proposal for the substances that were proposed as potential carcinogens in the regulatory context at that time (44). 1,1-Dichloroethylene was later converted to a listing of equivocal evidence of carcinogenicity. The table includes calculations made by the USEPA CAG and the NAS Safe Drinking Water Committee. These calculations attempt to project concentrations of each chemical in drinking water that, if consumed for a lifetime (70 years) at the rate of 2 L of water per day would contribute an excess lifetime cancer risk of up to 1 in 100,000 and up to 1 in 1,000,000. The quality of evidence of carcinogenicity ranging from sufficient in humans to limited in animals is also included for each chemical. Provisional ADI values calculated from chronic toxicity data only are included for the sake of comparison.

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. 

Based on the residue studies and ADI values, maximum residue level (MRL) values for the substance or critical metabolites are defined. Methods must be developed and validated to detect these under practical conditions. Withdrawal periods will be set to ensure that no unacceptable residues occur in human food. 

The toxicological evaluations related to human safety of chemical substances are a very complex process involving the determination of the intrinsic toxicity and hazard of the test chemicals. Subsequently, this evaluation leads to determining and establishing a no observed effect level (NOEL) the highest dose level tested experimentally that did not produce any adverse effects. This dose level then is divided by a safety factor to establish an acceptable daily intake (ADI) of the candidate chemical substance. The ADI value is normally based on current research and... 

ADI values are typically calculated from NOAEL values by dividing by uncertainty (UF) and/or modifying factors (MFs) ... 

The reference dose (RfD) and acceptable daily intake (ADI) for fipronil are both 0.0002 mg kg day RfD and ADI values for fipronil-desulfinyl are about an order of magnitude lower, 0.00003 and 0.0002, respectively. 

In 1987 the World Health Organization (WHO + FAO) specified an Accepted Daily Intake (ADI) value for soluble polyvinylpyrrolidone (povidone) in food of 0-50 mg/kg body weight [372]. For Crospovidone the ADI value is not specified and therefore no limit is given for the application in foods [215]. 

Name Sweetening power ADI value US limit EU limit Solubility at 20°C... 

Sweetening power as compared to a 10% sucrose solution in water ADI value acceptable daily intake in mg per kg of body weight (bw) per day US limit maximum amount permitted in soft drinks in the USA EU limit maximum amount permitted in soft drinks in the EU solubility maximum solubility of the raw material in water. 

All those flavouring material that have been suggested for approval by WHO or of which ADI values have been established or that have been approved by either two organisations such as FEMA, CoE, lOFI can be used in China. In case a test is required, generally an acute toxicological test is sufficient, and the evaluation will be made according to published data. ... 

Artificial or intense sweeteners are often used not only to restrict the sugar intake in food and beverages but also to boost the degree of sweetness to mask bitter notes. Only few are approved for use in over 80 countries (e.g., saccharin, aspartame, sucralose, and acesulfame potassium). There is some ongoing controversy over whether artificial sweeteners are health risks despite lack of scientifically controlled peer-reviewed studies in general consistently to produce clear evidence. It is to be noted that if an acceptable daily intake (ADI) value is available, most of the time it is for a general adult population and not specifically for pediatric and geriatric population. 

Characteristically, their mammalian and fish toxicity are very low, and they have rather high acceptable daily intake (ADI) values. Tripathi et al. (2002) have made an extensive review on the chitin synthesis-inhibiting insecticides, including 156 references. 

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