This article will provide food processors relevant information related to the safety of food contact substances (FCSs) present in food packaging, including plastics, glass, and metal containers.
For clarity, the following are terms and definitions directly extracted from the U.S. Food and Drug Administration (FDA).[1] This terminology is critically important, not only to the manufacturer of FCSs but also to food processors to better understand the methodology applied to ensure compliance with the right standards.
Food Additive: A food additive is defined in Section 201(s) of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives.
Food Contact Substance: Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.
Food Contact Material (FCM): An FCM is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable.
Food Contact Article: A food contact article is the finished film, bottle, dough hook, tray, or whatever item that is formed out of the FCM.
GRAS: GRAS is an acronym for the phrase “generally recognized as safe.” Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, which is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise exempted from the definition of a food additive.
CEDI/ADI Database: For many FCSs, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) maintains a database of cumulative estimated daily intakes (CEDIs) and acceptable daily intakes (ADIs). The CEDIs and ADIs are based on currently available information and may be revised when information is submitted or made available to the CFSAN Office of Food Additive Safety (OFAS). The CEDI/ADI database is updated approximately twice annually.
Prior Sanctioned Substance: A substance whose use in or on food is the subject of a letter issued by FDA or the U.S. Department of Agriculture (USDA) offering no objection to a specific use. The prior sanction exists only for a specific use of a substance in food delineating level(s), condition(s), and product(s) set forth by explicit approval by FDA or USDA prior to September 6, 1958.
Threshold of Regulation (TOR) Exemption: A substance used in a food contact article may be exempted from the requirement of a food additive listing regulation if the use in question has been shown to meet the requirements in 21 C.F.R. 170.39. For details, see 21 C.F.R. 170.39. For a complete listing of the TOR exemptions, consult the TOR inventory on the CFSAN Internet.
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Use miniDART™ to Tell Your Product Story with Conviction and Evidence
Daily headlines about environmental destruction, foodborne illnesses, fraud, and adulteration have consumers worried when deciding which brands to trust and which products to buy for their families. Chocolate production destroying the rain forest? Produce not sourced locally? Organic bread not made with organic wheat? Olive oil not pure?
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The IoT miniDART solution is part of SafeTraces’ solution suite created for a more digital, transparent, and safer food system. It gives quick access to information about where foods come from, how they were produced, and whether the food is the subject of an ongoing recall.
Who Uses miniDART?
Any facility producing, processing, preparing or packaging foods including bulk good (grains, beans, cereals fresh produce) or liquids (juices, oils, etc.) can use the miniDART solution, which is easily retrofitted into legacy production systems.
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Item-level traceability without packaging and in real-time revolutionizes fresh produce and commodity food traceability where packaging is typically absent and product is often commingled. The miniDART can encode traceability data for multiple supply chain events (e. g., harvest, shipping, product transformation, etc.). Use miniDART to tell your story about source, authenticity, and purity.