United States Food Additives Amendment

In the United States, food additives are regulated by the Food and Drug Administration (FDA), which limits the conditions of use of substances that are reasonably expected to become food components, including artificial sweeteners. The European Union through EU Directive 94/35/CE amended by EU Directive 2003/115/CE and EU Directive 2006/52/CE... 

United States government passes food additives amendments that require manufacturers to establish safety and to eliminate additives demonstrated to cause cancer. 

In the United States, safety is often expressed as the principle of reasonable certainty of no harm. This principle has replaced the earlier idea of zero tolerance for toxic substances. The idea of zero tolerance is incorporated in the Delaney clause of the Food Additives Amendment. 

United States food law is codified in the Eederal Eood Drug Cosmetic Act (EEDCA) with amendments and further clarification in the Code of Eederal Regulations, (CER), Title 21. This deals with food and food additives. 

The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 of the United States of America was completed in 1958 by the Food Additives Amendment. This amendment established the requirement of safety , which led to a major change in the Food and Drug Administration s (FDA) approach to its activities. The US Congress applied the term safe as the criterion for action, thereby supplementing, but not replacing, the use of the term adulteration . The result was a shift in focus - from an approach which emphasised evaluation of the food in its entirety to one which emphasised evaluation of individual food components. 

Delaney amendment Amendment to the Food, Drug, and Cosmetic Act of the Food and Drug Administration of the United States. The amendment states that food additives that cause cancer in humans or animals at any level shall not be considered safe and are, therefore, prohibited. 

In the United States two classes of color additives are recognized colorants exempt from certification and colorants subject to certification. The former are obtained from vegetable, animal, or mineral sources or are synthetic forms of naturally occurring compounds. The latter group of synthetic dyes and pigments is covered by the Color Additives Amendment of the U.S. Food, Drug and Cosmetic Act. In the United States these color compounds are not known by their common names but as FD C colors (Food, Drug and Cosmetic colors) with a color and a number (Noonan 1968). As an example,... 

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 (United States Public Law 103-417) amended the Federal Food, Drug and Cosmetic Act by defining as a dietary supplement any product (other than tobacco) that contains a vitamin, mineral, herb or other botanical, or amino acid and is intended as a supplement to the diet. Food is considered safe by definition, but new foods or food additives must be demonstrated to be generally recognized as... 

Copper Chlorophyll. Current efforts to improve the green color of processed foods include the use of copper complexes of chlorophyll derivatives. Copper complexes of pheophytin and pheophorbide are available commercially under the names copper chlorophyll and copper chlorophyllin, respectively. Their use in canned foods, soups, candy, and dairy products is permitted in most European countries under regulatory control of the European Economic Community (47). The Food and Agriculture Organization (FAO) of the United Nations (48) has certified their safe use in foods provided that no more than 200 ppm of free ionizable copper is present. Use of copper-containing chlorophyll derivatives in foods is not allowed in the United States under the Color Additive Amendment to the Food, Drug, and Cosmetic Act of 1938. 

Food irradiation has been defined in the United States as a food additive according to the 1958 Miller amendment of the Federal Food, Drug, and Cosmetic Act. Each food item allowed for commercial irradiation must first be petitioned to the FDA for clearance on the basis of data and evidence supporting technical effects, safety and sometimes user interest. A regulation permitting the use is issued by the FDA, and in some cases, by other government agencies. 

Much of this regulatory zeal was driven by the Delaney Clause, which amended the Food, Drug and Cosmetic Act of 1938. This clause forbids the addition of any amount of animal carcinogen to the food supply. This was originally based on our belief at the time that even one molecule of a carcinogen could cause cancer in humans. This concept was largely influenced by theories of radiation-induced cancer. Thresholds were not allowed. As we discussed, this is no longer considered valid since the processes of absorption, distribution, elimination, metabolism and cellular defense, and repair mechanisms make this possibility far less than remote. However, the United States... 

The amendment removed labeling exemptions for allergens in spices, flavorings, colors, and food additives, and also requiring all packaged foods to declare the major food allergens or their protein derivatives. In the United States, the major food allergens include ... 

There are two classes of color additives, those that must be certified and those that are exempt from certification. Both are strictly controlled in the United States by regulatory statutes (Food Color Additives Amendments), but an official certificate is required for each commercial batch of color of the first group, while no such certificate is necessary for the second group. For certification the manufacturer must submit a sample of the batch to the Food Drug Administration for chemical analysis. The results of the analysis are compared with the specifications for certified colors published in the Code of Federal Regulations. If the compliance is complete, a certificate is issued for that particular batch of color. 

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