Introduction — Food Law
This web page provides numerous links to regulations, statutes, FDA U.S. federal food law applies to all food in "interstate commerce"; foods. The General Food Law Regulation ensures a high level of protection of human life and consumers' interests in relation to food, while ensuring the effective. National legal frameworks are a key pillar in an effective food control system. In all countries, food is governed by a complexity of laws and regulations which set .
It is not the responsibility of government to prove the substance or its intended use is safe or unsafe. The primary differences between a substance that would be considered GRAS or a food additive is "GRAS substances are distinguished from food additives by the type of information that supports the GRAS determination, that it is publicly available and generally accepted by the scientific community, but should be the same quantity and quality of information that would support the safety of a food additive.
Information about food additives may not be as publicly available as information about GRAS substances. A substance that does not reach the level of GRAS will be treated as a food additive. The consequence of this program is that 1 the GRAS review effort is not being completed but that review process was moving slowly anyway and may have been a reason for this proposal and 2 petitions for food additive regulations are not being pursued by food businesses if the notification program moves more quickly.
A concern, however, is that agency oversight of the substances is not as strict; see http: Substances can be directly or indirectly added to food if there is a regulation identifying the use of the substance as prior-sanctioned, GRAS or a food additive. See subsequent sections titled Contact Surfaces and Packaging for more discussion of indirect food additives. Certifying each batch of color additive is different than the oversight process used for food additives.
Also see 21 CFR parts Color additives are used for products other than food; for example, they are added to drugs, cosmetics, etc. Supplier Verification Congress, in the Food Safety Modernization Act, imposed greater expectations on food processors in terms of assessing the safety of the raw ingredients using in food manufacturing.
The question is "food processors, have you assessed the safety of the ingredients your firm is receiving and using in food processing? The strategy then is to implement a supply-chain-applied control.
The law also requires that if a receiving facility determines that the supplier is not controlling hazards, the receiving facility must take prompt action and document its prompt action to ensure the ingredients from the supplier do not cause food the receiving firm is processed to be adulterated.
The law allows the receiving facility to rely on audits conducted by third-party auditors. The FDA regulation lists numerous documents the receiving firm must maintain, for example: Contact Surfaces, Water and Air U. For example, materials used in constructing food-contact surfaces of food-processing equipment can migrate into food 21 CFR Accordingly, all plant equipment and utensils must be designed and made of material to be cleanable.
The design, construction, and use of equipment and utensils also must prevent lubricants, fuel, metal fragments, contaminated water, or other contaminants from adulterating the food.
Food safety and quality: Food regulations
Food-contact surfaces should be corrosion-resistant and made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, cleaning compounds and sanitizing agents. Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.
See 21 CFR Any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality Packaging Food packaging also raises the question of indirect food additives.
If the substance e. See 21 CFRand The other broad prohibition in U. An early concern was that food was packaged in a way to mislead the consumer, such as disguising the quantity in the container or not filling the container.
The next section addresses product labeling which is primarily directed at assuring the food product is not misbranded. Labeling Food products must be labeled so consumers have the information they need to make decisions based on nutrition and safety, such as allergens.
This information is to be available to the consumer at time of purchase so the consumer can consider the information in deciding which food to purchase and consume. This section introduces the basics of food labeling. For products regulated by FDA, the food business does its best to develop a label but it is only after it has begun to use the label that the business will learn whether FDA considers the label adequate.
The PDP must include the name of the product, net quantity of contents, the official inspection legend, number of the official establishment, and, if necessary, a handling statement. All information required to appear on the label of a package must appear either on the PDP or the information panel unless otherwise specified by regulation.
Other label information that may be placed on the information panel unless on the PDP includes an ingredients statement, name and address of the manufacturer or distributor, and nutrition labeling, if required. The safe handling instructions may be placed anywhere on the label.
Food safety standards (Australia only)
The "country of origin" statement must be immediately under the name of the product. Because of the impasse, Vilsack says there are two possibilities moving forward: The remainder of the package can be used for other information, such as preparation steps and promotion as long as the promotion is not misleading.
If a calendar date is shown, immediately adjacent to the date must be a phrase explaining the meaning of that date such as "sell-by" or "use before. Nutrient Content and Health Claims Food businesses, like any business, seek opportunities to promote their product, such as "the benefit of eating our product is??? Accordingly, Congress has included misleading statements in the definition of "misbranded"; that is, a food promotion or advertisement that misleads consumers will render the food misbranded and thus prohibit the food from being sold.
Quality is generally left for the food business to consider. Many food businesses, however, do not draw a distinction between quality and safety that emerges from food law.
As discussed on other pages, food manufacturers are sometimes interested in making claims about their product in an effort to attract customers. Such claims, however, are regulated to prevent the food from being misbranded. This is an appropriate time for the food business to begin considering what claims it may want to make as part of promoting the food product.
Regulation of the U.S. Food Processing Sector
Refining these claims, based on federal law, is addressed subsequently. Understanding the food product, its ingredients, how it will be processed, packaged, handled, stored, and transported also contributes to understanding the risks or hazards that may impact the food, which, in turn, provides the foundation for developing and implementing a HACCP plan or a food safety plan, whichever applies to the food product.
Businesses that take the time to thoroughly describe their food product and their processing system will be better prepared to comply with their legal mandates. Oversight by Various Levels of Government The food industry in the United States is regulated by several levels of government. Even though the federal government often receives the most attention, members of the food industry cannot overlook the role of state and local governments, as well as the impact of international standards for food that is traded among nations.