Indirect food additive

Indirect Food Additives Subpart B Substances for Use as Basic Components of Single and Repeat Use Food Contact Surfaces," Code of Federal KegulationSs Tide 21, Part 177, U.S. Government Printing Office, Washington, D.C., 1994. 

Dipropylene glycol is produced in the manufacture of propylene glycol and finds utiUty as an indirect food additive, in brake-fluid formulations, cutting oils, soaps, and solvents. Tripropylene glycol also finds use as a solvent, as textile soaps, and as lubricants (273). 

Accepted by the PDA as an indirect food additive in April 1990. Tide 21 of the Code of Pederal Regulations provides details. 

Are any of the toll products sold under Food and Drug Administration (FDA) regulations as direct or indirect food additives ... 

FDA Indirect food additive for use only as a component of adhesives Yes FDA 1977a (21 CFR 175.105), 1977b... 

FDA. 1977a. Indirect food additives Adhesives and components of coatings. U.S. Food and Drug Administration. Code of Federal Regulations. 21 CFR 175.105. 

It should be mentioned that the Food Additives Analytical Manual (FAAM) [75] provides analysts with FDA evaluated methodology (partly subjected to collaborative study) needed to determine compliance with food additive regulations, including procedures for indirect food additives, such as butylated hydroxy-anisole (BHA), butylated hydroxytoluene (BHT), t-butylhydroxyquinone (TBHQ), dilaurylthiopropionate (DLTDP), fatty acid methyl esters (FAME), sodium benzoate, sorbitol, and others. 

C12 to C20, primarily Ci6 to ( is), used as surface lubricants in the manufacture of food-contact articles. The method, which uses ethyl palmitate (Eastman Chemicals No. 1575 Red Label) as an internal standard, has been validated at 200 ppm total FAME [185]. Other FAME standards (methyl palmitate, methyl stearate, methyl oleate, methyl linoleate and methyl linolenate) are available (Applied Science Laboratories) [116], Worked out examples of additive determinations are given in the Food Additives Analytical Manual [116], which also describes a great many of indirect food additives, such as BHA, BHT, TBHQ, l-chloro-2-propanol, DLTDP, fatty acid methyl esters, w-heptyl-p-hydroxybenzoate, propyl-gallate, sodium benzoate, sodium stearoyl-2-lactylate, sorbitol and phenolic antioxidants. EPA methods 606 and 8060 describe the CGC separation of phthalate esters (direct injection) (cf. Figure 4.2). 

Lidding substrates are required to be sealed to the preformed blister materials. An essential component of lidding material is a coating suitable for heat sealing. The heat sealing lacquers used must comply with FDA standards set forth in the Code of Federal Regulations (CFR) for indirect food additives. 

Part 174—Indirect food additives General provisions... 

Part 175—Indirect food additives Adhesives and components of coatings... 

Part 176—Indirect food additives Paper and paperboard components... 

Part 178—Indirect food additives Adjuvants, production aids, and sanitizers... 

Indigoid soluble dyes, 7 373t Indigo vat dye, 9 181 Indirect-arc furnaces, 12 297—298 Indirect coal liquefaction, 6 858-867 Indirect cooler evaporators, 21 537 Indirect extrusion, copper, 7 693 Indirect food additives, 12 29, 34 categories of, 12 31 Indirect-gap semiconductors, 14 837 ... 

The US Food and Drug Administration (FDA) allows PVA for use as an indirect food additive in products which are in contact with food [11], For example, under 21 CFR 73.1, PVA is approved as a diluent in color additive mixtures for coloring shell eggs and under 21 CFR 349.12, PVA is approved as an ophthalmic demulcent at 0.1-4.0 %. 

Recommendations for chemistry data for indirect food additive petitions, June, 1995... 

These recommendations are intended to amplify and explain the statutory chemistry requirements for indirect food additive petitions. The science and technology of food-packaging and food-contact articles as well as the scientific basis for evaluating exposure to indirect food additives are continually evolving. Therefore, for the most current information go directly to http // vm.cfsan.fda. gov/ drns/opa-cg5. html... 

Indirect food additives, which are the most frequent sources of poisoninglike diseases, are not natural food components. They enter food as... 

It is furthermore noted that the TTC concepts, including the structure-based approaches, are derived from databases covering substances used as direct and indirect food additives, pesticides, and industrial chemicals, and cover toxic effects related to systemic exposure to these chemicals. In addition, it is underlined that TTC has not been developed for endpoints associated with direct contact such as irritation or sensitization. 

Munro, l.C. 1990. Safety assessment procedures for indirect food additives An overview. Report of a workshop. Regul. Toxicol. Pharmacol., 12 2-12. 

The term food additive is used to cover any substance that is expected to become a component of human food. This covers substances intentionally added to food for their nutritional, chemical, or physical benefits (e.g., colorants and gelling agents) and substances used in the manufacture or packaging of foods (i.e., food contact substances, formerly known as indirect food additives ). The US Federal Food, Drug, and Cosmetic Act defines food additives as substances whose intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food or otherwise affecting the characteristics of food. ... 

The Food and Drug Administration permits the use of diethanolamine as a component of adhesives in food packaging, as an indirect food additive, as a component of the uncoated or coated food contact surface of paper and paperboard for use with dry solid foods with no free fat or oil on the surface, and for use only as an adjuvant to control pulp absorbance and pitch content in the manufacture of paper and paperboard or for use only in paper mill boilers in the United States (Food and Drug Administration, 1999). 

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