All food packaging is heavily regulated by the U.S. Food and Drug Administration (FDA). The rules and regulations imposed by the FDA control what types of packaging can be used for food applications. It affects the materials that can be used, including which papers, plastics or adhesives are considered safe for food contact. The FDA also looks at the environmental impacts of food packaging and requires certain steps be taken to ensure compliance with environmental protections. In this article, we’re going to discuss a few of the important regulations enforced by the FDA and how they affect packaging for food products.
The Federal Food, Drug, and Cosmetic Act (FD&C Act)
In 1938, Congress recognized the need for federal regulations in the food, drug, and cosmetic industries after incidents involving unsafe products intensified. They passed the Federal Food, Drug, and Cosmetic Act (FD&C Act), which tightened control over drugs and food, as well as their packaging. It also gave the government more ability to enforce the laws surrounding food, drugs, and cosmetics.
Eventually the amended FD&C Act (United States, 1998a) would come to define a food-contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food." This is how the act has control over food packaging.
Many of the main regulations affecting food packaging can be found under CFR 174-179 within Title 21 of the United States Code of Regulations. The different sections we’ll be covering are outlined below.
General Indirect Food Additives (21 CFR 174)
Under this section, the general rules and definitions are listed for indirect food additives, which includes packaging. Essentially, this section defines that indirect food additives should be used only for their intended uses under the conditions of good manufacturing practices. Substances used for indirect food additives, including those used for packaging, should not exceed the reasonable amount necessary to perform the required tasks. This section also clarifies that should a material be compliant with one provision of the act but fails to comply with another provision, it is not considered approved. It must still comply with other provisions within the full FD&C Act unless given an exemption for a specific section.
Adhesives and Components of Coatings (21 CFR 175)
This provision confirms that adhesives may be used in packaging, transporting, or holding food if they meet certain conditions that are outlined in the section. Some of those conditions are mentioned below.
The adhesive is manufactured from one of the approved materials listed in paragraph c of this section within the stated limitations.
The adhesive is separated from the food by some type of barrier; or: The adhesive will keep packaging seams bonded under normal conditions without visible separation.
○ In dry foods, adhesives do not exceed safe quantities of good manufacturing practices
○ In fatty foods, the quantity of the adhesive doesn’t exceed trace amounts at seam or edge exposures
The finished adhesive container must be labeled with the statement “food-packaging adhesive.”
Paperboard and Paperboard Components (21 CFR 176)
This section breaks down the acceptable substances that can be used in conjunction with paper and paperboard components. There’s a lot of different chemicals or additives listed in this section that are approved within limitations for use on paper or paperboard packaging.
These chemicals and additives are commonly used either to manufacture the paper used for packaging or to enhance the finished paper product. Some chemicals are used to ensure printed words remain sealed in the paper rather than being able to bleed into the food. Others are used to make sure the packaging keeps food preserved, such as an additive that enhances paper’s ability to keep food dehydrated and free of moisture.
Many of the chemicals listed are used in coatings added to paper and paperboard products that help packaging preserve food products better. We aren’t going to list them all out because it’s quite a long list, but here’s a link to check out this section of the FD&C Act for yourself.
Polymers (21 CFR 177)
This section is another one jam-packed with different materials and components that are approved for use in single or repeated use food packaging and contact surfaces. This section discusses what is considered safe when working with many plastics, including acrylics, polyethylene, polystyrene, polyurethane, vinyl, and more.
Plastic packaging is very common in the food industry because it helps preserve and protect food better than most other options. The plastic used for food packaging must be in accordance with these rules and regulations for polymers.
Again, it’s a long list of different materials and the uses they are approved for under certain limitations in food contact applications. Here’s a link to check out the regulations regarding polymers.
Adjuvants, Production Aids, and Sanitizers (21 CFR 178)
In this section, you’ll find another long list of approved chemicals and substances that are considered safe for food contact surfaces. This specifically highlights chemicals used for sanitizing or enhancing production. This section affects what chemicals and substances you can use to create or clean packaging supplies for food contact. It includes substances like castor oil, emulsifiers, corrosion inhibitors, lubricants, and waxes.
During the manufacturing process, packaging can be enhanced with certain materials. It can also come into contact with chemicals that are designed to sanitize or prepare it for food products. These chemicals are regulated by the FD&C Act to ensure they are safe for indirect or direct food contact. Here’s a link to the list of approved chemicals and their limitations regarding sanitizers and production aids.
Irradiation in the Production, Processing and Handling of Food (21 CFR 179)
This final section defines what is considered safe or appropriate when using radiation around food. It outlines regulations for sourcing radiation used in food inspection or processing, ionizing radiation for treating food, radiofrequency radiation for heating food, ultraviolet radiation for processing food, pulsed light for treating food, and carbon dioxide laser for etching food.
Radiation is used in the production, processing, and handling of many food products. It is limited by this section of the act in terms of what types of radiation are acceptable and how much radiation can be used for any food processes. Some packaging may be subject to irradiation treatment and processes, especially if the packaging is used for pre-packaged foods. This means that packaging must also comply with the rules unless given an exemption.
Some common uses of radiation in the food industry include controlling the growth and maturation of fresh foods, the disinfestation of pests in food, disinfecting dry or dehydrated vegetables, controlling food-borne pathogens, sterilizing frozen packaged goods, and much more.
Environmental Regulations (21 CFR Part 25)
The National Environmental Policy Act of 1969 (NEPA) states that policies and regulations created by the United States must be interpreted and administered in accordance with the policies outlined in NEPA to the fullest extent. This means that all agencies of the Federal Government, including the FDA, should comply with procedures described in NEPA, except where compliance would go against other legal requirements.
Because the FDA controls packaging regulations for food and must follow the NEPA policies, they are required to evaluate the environmental impact of food packaging. This also means that the FDA must ensure that packaging materials are compliant with regulations imposed by the Environmental Protection Agency (EPA).
The FDA aims to follow these policies by requiring all food packaging clearances to include and Environmental Assessment (EA) followed by a Finding of No Significant Impact (FONSI). Food packaging must receive full clearance by the FDA in terms of environmental impact.
The FDA mainly looks at the way packaging materials are used and disposed of in terms of their environmental impact. In particular, they look closely at the recyclability of the packaging being used. In order to gain approval for materials in packaging that are not easily recycled, a company must present reasonable evidence for why their product requires something specific. Should the company fail to provide reasonable evidence, the FDA will require them to redesign their packaging using more eco-friendly materials due to NEPA policies.
We hope this article has helped you understand where food packaging regulations come from and how the government is involved in creating rules for safe practices. There are obviously other packaging regulations that come into play, but the Federal Food, Drug, and Cosmetic Act (FD&C Act) is one of the major players involved in regulating packaging. Feel free to explore the links below to look at the different sections of the FD&C Act we discussed. If you have any questions about a product on our site and whether it complies with government regulations, feel free to call or send us a message.