Acceptable daily intake ADI

The ADI for humans is an estimate of J EC FA (Joint FAO/WHO Expert Committee on Food Additives) of the amount of a food additive and contaminants, expressed on a body weight basis, that can be ingested daily over a lifetime without health risk (standard man = 60 kg) (IPCS/JECFA 1987). 

The ADI is expressed in a range from 0 to an upper limit, which is considered to be the zone of acceptability of the substance. The ADI is expressed in this way to emphasize that the acceptable level is an upper limit. Substances that accumulate in the body are not suitable for use as food additives. Therefore, AD Is are established only for those compounds that are substantially cleared from the body within 24 h. There was a general consensus that chemicals found to be carcinogenic were not appropriate as food additives at any level whatsoever. 

Toxicological evaluation of metals in foods calls for carefully balanced consideration of the following factors  

The tentative tolerable daily intakes proposed for certain metals provide a guideline for maximum tolerable exposure. In the case of essential elements, these levels exceed the daily requirements, but this should not be construed as an indication of any change in the recommended daily requirements. In the case of both essential and nonessential metals, the tentative tolerable intake reflects permissible human exposures to these substances as a result of natural occurrence in foods or various food processing practices, as well as exposure from drinking water. 

The EU Directive 95/2/EC which covers the additives in this chapter limits the amount of certain additives to particular uses or quantities, usually based on the ADI. It also has special limits for foods intended for products for young children. For example, modified starches listed in Part 3 of Annex VI, although ADI Not specified , are restricted to 50g/kg in weaning foods for infants and young children. In the past a series of different and sometimes confusing expressions such as ADI Not limited or Acceptable were used instead of ADI Not specified , and older texts must, therefore, be read with caution Appendices 2 and 3 list the ADI allocated by the Scientific Committee for Food in the EU and by JECFA at an international level to the additives in this chapter. 

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The safety of lecithin is also confirmed by the World Health Organi2ation (WHO). WHO has not set any acceptable daily intake (ADI) to lecithin as... 

Aspartame (L-aspartyl-L-phenylalanine methyl ester [22839-47-0]) is about 200 times sweeter than sucrose. The Acceptable Daily Intake (ADI) has been estabUshed by JECFA as 40 mg/kg/day. Stmcture-taste relationship of peptides has been reviewed (223). Demand for L-phenylalanine and L-aspartic acid as the raw materials for the synthesis of aspartame has been increasing, d-Alanine is one component of a sweetener "Ahtame" (224). 

JECEA reviewed the safety studies of glutamate and endorsed its safety by allocating an Acceptable Daily Intake (ADI) for L-glutamic acid and its monosodium, potassium, ammonium, calcium, and magnesium salts as being "not specified." The scientific committee for food of EC concurred (40). 

Vanillin is Hsted in the Code of Federal Regulations by the FDA as a Generally Recogni2ed As Safe (GRAS) substance. The Council of Europe and the FAO/WHO Joint Expert Committee on Eood Additives have both given vanillin an unconditional Acceptable Daily Intake (ADI) of 10 mg/kg. 

Acceptable Daily Intake (ADI) An estimate similar in concept to the RfD, but derived using a less strictly defined methodology. RfDs have replaced ADIs as the USEPA s (Agency) preferred values for use in evaluating potential noiicarcinogenic health effects resulting from exposure to a chemical. 

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. ... 

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. 

Drinking water quality should be taken into account from a human toxicological viewpoint because the main source of drinking water is river water. Japanese regulatory procedures allocate 10% of the acceptable daily intake (ADI) in principle to the intake from drinking water. 

In September 1999, the United Nations World Health Organization (WHO) and the Food and Agriculture Organization (FAO) Joint Meeting on Pesticide Residues (JMPR) established an acute reference dose (RfD) of 0.1 mg/kg bw and a chronic RfD, or acceptable daily intake (ADI), of 0.01 mg/kg bw/day. (See FAO/WHO Report 153, Pesticide Residues in Pood, Section 4.7, Chlorpyrifos, 1999.)... 

Most countries restrict the maximum degree of amidation to a 25% maximum. High methoxyl pectins are naturally present in fruit and escape restrictions on use for that reason. Low methoxyl pectins are treated as additives and have restrictive acceptable daily intakes (ADIs). 

Dose-response characterisation. Different chemicals will be associated with different toxicological end-points and the risk of any individual experiencing toxicity is related to the dose that they receive. Very often it is possible to identify a dose level below which the probability of anyone experiencing an adverse effect is veiy low or zero. For additives this is usually referred to as the Acceptable Daily Intake (ADI). 

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... 

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

Toxicological studies are crucial in determining the safety of an antioxidant and also in determining the acceptable daily intake (ADI) levels. ADIs for widely used antioxidants such as BHA, BHT and gallates have changed over the years mainly because of their toxicological effects in various species.3 Table... 

The standards and limits adopted by the Codex Alimentarius Commission are intended for formal acceptance by governments in accordance with its general principles. Codex Alimentarius permits only those antioxidants which have been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for use in foods. Antioxidants may be used only in foods standardised by Codex. The antioxidant provisions of Codex Commodity Standards are included in and superseded by the provision of this Standard. Food categories or individual foods where the use of additives are not allowed or are restricted are defined by this Standard. The primary objective of establishing permitted levels of use of antioxidants in various food groups is to ensure that the intake does not exceed the acceptable daily intake (ADI). 

The 1988 Acceptable Daily Intake (ADI) established by the United Nation s Food and Agriculture Organization and the World Health Organization (FAO/WHO) for total heptachlor was 0.5 pg/kg/day (FDA 1989b). Total heptachlor intakes found in the Total Diet Analysis (1988) were 0.004 jg/kg/day for 6-11-month-old infants, 0.017 jg/kg/day for 14-16- year-old males, and 0.0007 jg/kg/day for 60-63-year-old females (FDA 1989b). 

The risk assessment comprises an effect assessment (hazard identification and hazard characterization) and an exposure assessment. The principles for the effect assessment of the active substances are in principle similar to those for existing and new chemicals and are addressed in detail in Chapter 4. Based on the outcome of the effect assessment, an Acceptable Daily Intake (ADI) and an Acceptable Operator Exposure Level (AOEL) are derived, usually from the NOAEL by applying an overall assessment factor addressing differences between experimental effect assessment data (usually from animal studies) and the real human exposure situation, taking into account variability and uncertainty for further details the reader is referred to Chapter 5. As a part of the effect assessment, classification and labeling of the active substance according to the criteria laid down in Directive 67/548/EEC (EEC 1967) is also addressed (Section 2.4.1.8). 

In 1961, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint Meeting of Experts on Pesticides Residues (JMPR) adopted this approach in a slightly modified form The safe level was called the Acceptable Daily Intake (ADI) and expressed in mg/kg body weight per day (Vermeire et al. 1999, ECETOC 2003). Usually, a safety factor of 100 is used by JECFA and JMPR for establishing ADIs by this ADI approach however, the procedures adopted by JECFA and JMPR do not generate a clear justification for deviation from the factor of 100, but in some individual cases, an expert explanation is given for the use of factors other than 100 (Vermeire et al. 1999). 

Implicit from the definition of the tolerable intake, i.e., an estimate of the intake of a substance over a lifetime that is considered to be without appreciable health risk, arises the question What are the health implications of exceeding the tolerable intake This issue has been discussed at an ELSI (International Life Science Instimte) Europe Workshop on the Significance of Excursions of Intake above the Acceptable Daily Intake (ADI) in 1999. The following questions were asked (Larsen and Richold 1999, Larsen 2006) ... 

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