Food additive definition

Evidence of GRAS must relate to the conditions of intended use general recognition of the safe use of a substance in a different product or at a different level would not suffice to escape the food additive definition. The exception turns not on safety itself so much as on recognition of safety by scientific experts. Testimony of an absence of any evidence of a health hazard would not suffice to establish GRAS status, at least not unless coupled with evidence of common prior use. If GRAS status is premised on common use prior to 1958, then such use must have been fairly extensive. 

Use of yarrow as a food additive in the United States is subject to a limitation that the finished food or beverage is thu-jone-free (CFR 2011). Dietary ingredients for use in dietary supplements, however, are specifically excluded from the federal food additive definition (U.S.C. 2010). 

These two examples illustrate that different food additive definitions tend to be very similar because a general consensus has been reached among the majority of countries as to what an additive is. It should also be pointed out that a special statute is normally reserved for dietetic products, nutritive substances added to food products (e.g., vitamins, amino acids, minerals, etc.), technological processing aids, and aromas. 

According to the U.S. Code of Federal Regulations, food additives may be defined as "substances. .. the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food" (1). Canada and the European Community have adopted similar definitions. According to this broad definition, a food additive is synonymous to a food ingredient. In practice, however, the word additive is limited to substances that are used in small quantities. 

An ingredient used in food prior to January 1, 1958 can be considered GRAS under the conditions of its intended use based on common use in food. PDA prior approval generally is not necessary. A post-1958 food ingredient that is generally recognized by qualified experts as safe, under the conditions of its intended use based on scientific tests, is GRAS by definition and therefore is not a food additive and does not require PDA approval prior to use. 

Analytical procedures sensitive to 2 ppm for styrene and 0.05 ppm or less for other items were used for examining the extracts. Even under these exaggerated exposure conditions no detectable levels of the monomers, of the polymer, or of other potential residuals were observed. The materials are truly non-food-additive by the FDA definitions. Hydrogen cyanide was included in the list of substances for analysis since it can be present at low levels in commercial acrylonitrile monomer, and it has been reported as a thermal decomposition product of acrylonitrile polymers. As shown here, it is not detectable in extracts by tests sensitive to... 

Council Directive 89/107/EEC, as amended by Directive 94/34/EC ° — This framework directive provides umbrella legislation under which the individual additives directives are developed. It includes a definition of a food additive, exclusions from the scope of the definition, and a list of food additive categories, one of which is colors. Additionally, general criteria for use of food additives are described. ... 

After all the answers from the interviews had been uploaded, an expert analysed each supply chain for each of the seven defined criteria for quality and safety microbial toxins and abiotic contaminants potential pathogens natural plant toxicants freshness and taste nutrient content and food additives fraud social and ethical aspects. For example, an expert on freshness and taste would check each major step in a supply chain for tomatoes to determine if it fulfilled the definition of a CCP (HACCP, Principle 2) in relation to freshness and taste for this commodity. If the step was considered to be a CCP, the answers in the questionnaire that related to relevant substeps at this step would be reviewed, to assess the control procedures that were in use for this CCP. The expert would then fill in the text field, structuring the input to consist of the following points ... 

Directive 89/107/EEC,1 sometimes known as a framework directive, contains a number of general safety and authorising measures concerning food additives. There is a definition of food additive as follows ... 

The definition of a food additive in Section 201(s) of the Federal Food, Drug, and Cosmetic Act, as amended ( the Act ) refers to substances whose intended use results directly or indirectly in the substance becoming a component of food. The FDA refers to direct food additives as those added to a food to accomplish an intended effect. Indirect additives are those that unintentionally, though predictably, become components of food. Components of plastic packaging materials that can migrate to food are indirect additives. 

Sweeteners are food additives by definition in almost all countries and need approval for use by food laws, food regulations, decrees or certificates released and issued by the national government or other responsible governmental institutions. Generally three prerequisites must be fulfilled to obtain an approval for use ... 

The term acceptable is used widely to describe safe levels of intake and is apphed for chemicals to be used in food production such as, e.g., food additives, pesticides, and veterinary dmgs. The term tolerable is applied for chemicals unavoidably present in a media such as contaminants in, e.g., drinking water and food. The term PTWI (Provisional Tolerable Weekly Intake) is generally used for contaminants that may accumulate in the body, and the weekly designation is used to stress the importance of limiting intake over a period of time for such substances. The tolerable intake is similar in definition and intent to terms such as Reference Dose and Reference Concentration (RfD/RfC), which are widely used by, e.g., the US-EPA. For some substances, notably pesticides, the ARID (Acute Reference Dose), is also established, often from shorter-term studies than those that would support the ADI. The ARfD is defined as the amount of a substance in food that can be consumed in the course of a day or at a single meal with no adverse effects. 

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. 

The use of microcapsules in food is generally that of an additive. By regulatory definition, a food additive is any substance which becomes added to food either intentionally or unintentionally other than food itself. This includes both compounds added directly and those that are added indirectly such as migrating from packaging materials. We will limit our discussion here to direct, intentional additives. This means, for example, that the Vitamin C in orange juice is not an additive but the Vitamin C added to orange juice is. 

To better appreciate why reading the specification definitions is so important, let s consider the following example. Imagine a chemist has discovered a tris-phenolic compound (Figure 5.10) and is particularly excited about its antioxidant activity, which will be useful as a food additive due to the compound s apparent lack of toxicity. 

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