Specifications for food additives

Specifications for food additives are established by JECFA to ensure that the commercially used product is of consistent quality and is equivalent to the product evaluated in the toxicological studies. 

Workshop on Criteria for Establishing Microbiological Specifications for Food Additives (April 25,2000)... 

In Canada, the current edition of the Food Chemicals Codex, including its supplements, is officially recognized in the Canadian Food and Drug Regulations under Section B.01.045(b) as the reference for specifications for food additives. The new Australia New Zealand Food Authority recognizes the Food Chemicals Codex as a primary source of identity and purity specifications in its Food Standards Code, Chapter 1 General Food Standards, Part 1.3 Substances Added to Food, Standard 1.3.4 Identity and Purity. 

As of 2004, a total of 63 meetings of JECFA have been held and over 2100 food additives including more than 1500 flavoring agents, 40 contaminants, and 93 veterinary drugs evaluated. The reports are published in the WHO Technical Report Series. The comprehensive toxicological evaluations, which review the data that serve as the basis for the safety assessments, are published in the WHO Food Additives Series. The specifications for food additives and residue evaluations of veterinary drugs are published in the FAO Food and Nutrition Paper Series. 

Several FAO/WHO expert groups have made general and specific recommendations as to the type of information that is required and how this information should be obtained. Such recommendations are contained in various reports resulting from the activities of these various expert groups, specifically for food additives , pesticide chemicals , drugs and chemicals in generaF". ... 

In Europe, the formation of the European Economic Community has created a requirement to bring food additive approvals of the member nations into alignment, so as to eliminate differences in laws that hinder the movement of foodstuffs among these nations. Historically the member countries have differed widely in approaches to food additive approval and their tendency to approve new additives. At the time of this writing, a framework directive for food additives and several specific directives for various categories of additives are nearing completion (3). 

JSSFA = Japan s Specifications and Standards for Food Additives 7th edition, 2000 with page number (p. ..). 

In conclusion, the JECFA evaluation process for food additives is a thorough, comprehensive review of safety, intake, and specifications resulting in an assignment of an ADI. An evaluation by JECFA could serve as a credible review of the safety of a new excipient. Likewise, the safety evaluation by FDA or the EFSA of an ingredient for use as a food additive could also be very useful to support the potential use of a new excipient for the oral route of administration. 

The international consensus is largely that, in principle, authorization for food additives should be given only if justified technologically. This means that without such additives, the required effect could only be achieved either uneconomically or not at all. In every country, food additives are subject to purity specifications which are fixed by law. 

The nutritional, chemical, biological, and toxicological properties of a chemical element are known to be critically dependent on the form in which it occurs in food. The recognition of this fact has spurred the development of species-selective (speciation) analytical methods for food additives and contaminants. According to the IUPAC s dehnition, speciation analysis deals with the analytical activities of identification and/or measurement of the quantities of one or more individual chemical species in a given sample [1], The analytical approach is usually based on the combination of a chromatographic separation technique with an element-specif>c detection technique. The former ensures that the analyte compound leaves the column unaccompanied by other species of the analyte element, whereas the latter enables a sensitive and specil>c detection of the target element. Coupled (also called hyphenated) techniques have become a fundamental tool for speciation analysis and have been discussed in many published reviews [2D6]. 

The UEL for reproductive and developmental toxicity is derived by applying uncertainty factors to the NOAEL, LOAEL, or BMDL. To calculate the UEL, the selected UF is divided into the NOAEL, LOAEL, or BMDL for the critical effect in the most appropriate or sensitive mammalian species. This approach is similar to the one used to derive the acute and chronic reference doses (RfD) or Acceptable Daily Intake (ADI) except that it is specific for reproductive and developmental effects and is derived specifically for the exposure duration of concern in the human. The evaluative process uses the UEL both to avoid the connotation that it is the RfD or reference concentration (RfC) value derived by EPA or the ADI derived for food additives by the Food and Drug Administration, both of which consider all types of noncancer toxicity data. Other approaches for more quantitative dose-response evaluations can be used when sufficient data are available. When more extensive data are available (for example, on pharmacokinetics, mechanisms, or biological markers of exposure and effect), one might use more sophisticated quantitative modeling approaches (e.g., a physiologically based pharmacokinetic or pharmacodynamic model) to estimate low levels of risk. Unfortunately, the data sets required for such modeling are rare. 

For food additives, JECFA normally establishes ADIs on the basis of available toxicological and other relevant information. Specifications of purity are also developed for food additives, which help to ensure that the product in commerce is of appropriate quality, can be manufactured consistently, and is equivalent to the material that was subjected to toxicological testing. 

Specialists invited to serve as members of JECFA are independent scientists who serve in their individual capacities as experts and not as representatives of their governments or employers. They also understand that the discussions at the meetings are confidential. The goal is to establish acceptable daily intakes (ADIs) (or equivalent tolerable intakes) for food chemicals and to develop specifications for identity and purity for food additives or maximum residue limits (MRLs) when veterinary drugs are used in accordance with good practice in the use of veterinary drugs. 

Notes INS = international numbering system prepared by the Codex Committee for Food Additives for the purpose of providing an agreed upon international numerical system for identifying food additives in an ingredient list as an alternative to the declaration of the specific name (Codex Alimen-tarius, 2nd ed., Vol. 1, Sec. 5.1, 1992). 

JAPAN EXTERNAL TRADE ORGANISATION (JETRO), Specifications and Standards for Food Additives etc. under the Food Sanitation Law, March 2001. 

The European Union also has regnlations in place for food additives, novel foods, and genetically modified organisms. However the Enropean regnlations are not specific for adding new ingredients to infant formnlas. 

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