Food additives, regulations Delaney clause

The FDA also regulates food additives - substances, such as antioxidants, emulsifiers and non-nutritive sweeteners, that are intentionally and directly added to food to achieve some desired technical quality in the food. As noted, the Delaney clause prohibits the deliberate addition to food of any amount of a carcinogen. These additives, if they are threshold agents (not carcinogenic), can be allowed as long as the human intake does not exceed a well-documented ADI. Those who would seek approval for an additive need to supply the FDA with all of the toxicity information needed to establish a reliable ADI, and all of the product-use data that would permit the agency to assure itself that the ADI will not be exceeded when the additive is used. 

Finally it should be noted that prior to the FQPA in 1996, the Delaney clause prohibited the establishment of tolerances or maximum allowable levels for food additives if it has been shown to induce cancer in human or animal. This is an important change in regulations because pesticide residues were considered as food additives. Because of the FQPA, pesticide residues are no longer regarded as food additives, and there is no prohibition against setting tolerances for carcinogens. 

When sufficient information has been accumulated this is assessed by the FDA in the USA or the Committee on Toxicity (COT) and other committees in the UK. The committees, consisting of various scientifically and medically qualified individuals, determine whether the substance is safe to be used as an additive as well as the level at which it can be added to food. This level is known as the acceptable daily intake, or ADI. How this is determined will be discussed in the next chapter (see pp. 299-301). In the USA an amendment to the Food and Drug regulations, known as the Delaney Clause, was introduced which specified that no additive shall be deemed safe if it is found to induce cancer when ingested by man or animal or it is found, after tests which are appropriate for the evaluation... 

The first legislation that comes to mind is the Delaney clause because it deals with carcinogens, but when the clause is closely examined one finds that it deals only with food additives. Thermal processing adds nothing to the product other than heat. Heat processing could possibly be compared to food irradiation in that both are different types of food processing techniques and food irradiation is considered an "additive" by FDA and subject to its regulations on additives. 

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