Food Additive Amendment

Action to compile standards for food-grade chemicals did not take place until after the enactment of the Food Additives Amendment to the Food, Dmg, and Cosmetic Act in 1958 (13). This amendment stated that substances added to foods should be of food-grade quaUty, but it contained no criteria by which such quahty could be determined (see also Colorants forfood, drugs, cosmetics, and medicaldevices). The Food Protection Committee of the National Academy of Sciences—National Research Council (NAS—NRC) therefore undertook the project of producing a Food Chemicals Codex. 

Bread and flour are specifically regulated in the UK, at the time of writing, by the Bread and Flour Regulations 1998, The Food Labelling (Amendment) regulations 1998, and the Miscellaneous Food Additives (Amendment) Regulations 1999. 

Miscellaneous Food Additives (Amendment) Regulations 1999 lays down the levels of propionates that can be added to bread. It also notes that propionates can form naturally in the fermentation of bread. 

Food, Drug Cosmetic (FD C) Act, 11 581 18 682. See also FD C color additives Food Additives Amendment Food Additives Amendment to, 12 34 Food, Drug, and Insecticide Administration, 18 682 Food enzymes, 10 309-310 functions of, 12 64... 

Food laws, British, 23 160-161. See also Food Additives Amendment of 1958 Food and Drug Administration Modernization Act of 1997 (FDAMA) Food Chemicals Codex (FCC) Food Quality Protection Act of 1996 (FQPA) Food manufacturing aids, 12 66-67... 

In contrast, the Food Additive Amendments of 1958 to the Food, Drug and Cosmetic Act presented a different type of law, a "zero-risk" law. Under the thrust of the zero-risk law, it said "if a food additive is a carcinogen, we cannot permit any exposure since we cannot live with any such risk." Risk is the evaluation of severity of toxicity or hazardous properties... 

It is important to note that not only are directly added (intentional) substances, such as preservatives, considered food additives, but indirectly added (unintentional) substances, such as sanitizers used on processing equipment, may also be categorized as food additives. There are four groups of substances that are exempted from the Food Additives Amendment. They are ... 

The Food Additives Amendment to the Federal Food, Drag, and Cosmetic Act of 1938, which was adopted in 1958, requires that proof of safety of a new food additive be furnished by the manufacturer based on extensive scientific research. Since it is impossible to conclusively prove the safety of a new food additive through animal and clinical trials, manufacturers routinely conduct postmarketing surveillance and long-term follow-up studies to monitor adverse events. 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

To further improve the general safety standards, the Delaney Clause was included in the Food Additives Amendment of 1958. The Delaney Clause states that no food additive or color additive can be deemed safe if it has been found to induce cancer when ingested by humans or animals (23). The Clause acts as an absolute prohibition on the use of any additive found to cause cancer without any regard for whether, or to what extent, the substance is hazardous to human health. As scientific advances continue, both in the realm of food technology and analysis of previously undetected contaminants, the... 

Under the terms of the US Food Regulations, flavourings fall under the definition of food additives. The respective definition was implemented in the Federal Food Drug and Cosmetic Act by the Food Additives Amendment of 1958. With this amendment, the general requirement of safety became the major topic for food additives. 

In the 1950s, the increased use of food additives in foods became a concern to the U.S. government. Prior to 1958, the burden of proof was on the FDA to show that a food was adulterated by the misuse of food additives and, therefore, unsafe for consumption. As a result of this concern, Congress passed the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (Act). A premarket clearance system was set up requiring that a food additive be shown to be safe for its intended use and that the food additive be approved by the FDA before it could be used in food. 

Federal Food, Drug, and Cosmetic Act, As Amended, the Food Additives Amendments of 1958, 72 Stat. 1784, 85th Cong., 2nd session, p. 331 (1958). 

The Food Additives Amendment was added in 1958, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibited the approval of any food additive shown to induce cancer in humans or animals, and the FDA published the first list of substances, including herbs and spices, as Generally Recognized As Safe (GRAS) in the Federal Register. The list contained nearly 200 substances. This list is now compiled under Title 21 of the Code of Federal Regulations. 

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

Prior to the 1958 Food Additives Amendment, the safety of additives in food was based on a harmless per se concept. Regardless of the level of animal testing or exposure, if an additive in food could cause harm or injury, it was considered unsafe. That a substance must be nontoxic at any test level was an absolute and impractical concept. This concept does not recognize that chemicals have thresholds for inducing toxicity. 

The safety of foods—including food additives, food contaminants, and even some of the major natural components of foods—is becoming an increasingly complex issue. Prior to the enactment of the Food Additives Amendment to the FDCA, food additive control required that a food additive be non-deceptive and that an added substance be... 

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. 

The Food Additives Amendment to the FDCA (see Chapter 11) recognizes the following three classes of intentional additives ... 

Two acts are pertinent to any discussion regarding the regulation of food contact materials in the US. These are the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) and the National Environmental Policy Act (NEPA) of 1969. A brief discussion of the authority granted the Pood and Drug Administration (PDA) under each follows. 

The US Congress granted authority to the FDA to regulate food additives in the 1958 Food Additives Amendment to the FFDCA. A food additive is... 

In 1954, Congress enacted the Miller Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA), which required that a maximum acceptable level (tolerance) be established for pesticide residues in foods and animal feed (for example, 10.0 ppm carbaryl in lettuce, or 1.0 ppm ethyl parathion on string beans). In 1958, congress enacted the Food Additives Amendment to FFDCA, which regulated pesticide residues in processed foods. 

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