Packaging Manufacturing Regulations: Compliance, Science, and Change
Kevin Lee
Packaging manufacturers are faced with the challenge of balancing regulations, available materials, cost, and function to demand. This article will discuss packaging manufacturing regulations, the Fair Packaging and Labeling Act, and FDA compliance to shed light on the many regulations that dictate the packaging industry.
Let’s begin with a breakdown of packaging requirements and who is involved.
What Federal Agency Regulates Packaging?
The FTC: Both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) regulate food packaging materials and manufacturing. Two sweeping acts form the basic platform for modern food packaging regulations. Since 1958, the FDA has enforced the Federal Food, Drug, and Cosmetic Act (FFDCA). And enacted in 1967, the Fair Packaging and Labeling Act (FPLA) enables both agencies to issue regulations regarding the labeling of the commodity, the net contents, and the name and place of business of the distributor, packer, or manufacturer.
The FDA: The FDA regulates food contact substances (FCS), which are any materials that come into contact with food. These materials can range from manufacturing machinery to packaging components. Molecules from packaging materials can migrate into the food or beverage they contain, so it is essential to monitor the food to ensure it remains safe for consumption. Overall, most packaging manufacturers encounter the FDA in packaging compliance.
NIST: The National Institute of Standards and Technology (NIST) under the US Department of Commerce plays a supportive role by upholding equitable standards and developing measurement solutions. In 1952, NIST developed the Uniform Packaging and Labeling Regulation (UPLR), now encompassed by the NIST Handbook 130 and adopted by nearly every state in the US.
What Are Packaging Requirements?
Multiple laws and agencies govern packaging requirements, from the raw materials of the packaging to the appearance and labeling of a package. The FDA administers the FPLA concerning foods, drugs, cosmetics, and medical devices. The FTC administers the FPLA for other “consumer commodities” consumed or expended in the household. Many products that are exempt from the FPLA nevertheless fall under the Weights and Measures laws of the individual states.
While there is some overlap, the UPLR can apply to a broader range of packaging. However, five states have not adopted the UPLR, including Louisiana, Rhode Island, Wyoming, Minnesota, and North Dakota.
Some states and municipalities have Bag Suffocation Warning requirements that determine the labeling requirements, size, and thickness of plastic bags used in packaging. Federal regulations require that products imported to the US contain a stamp with the country of origin.
California Packaging Manufacturing Requirements
In addition to federal packaging requirements, California has additional requirements in place for packaging. While it is not the only state with additional regulations, it is often at the forefront of evolving packaging guidelines. In addition to requiring a Bag Suffocation Warning and regulating the opening size of plastic bags, it also has passed the Rigid Plastic Packaging Container Law (RPPC), enacted in 1991. Food packaging is exempt from RPPC, but recently California passed the California Safer Food Packaging & Cookware Act of 2021 (AB 1200), focusing on materials containing per-and poly-fluoroalkyl substances (PFAS) or other hazardous chemicals.
Additionally, California’s Prop 65, under the administration of the California Office of Environmental Health Hazard Assessment (OEHHA), places restrictions on over 900 heavy metals and chemicals in all consumer products sold within the state. The proposition requires that importers lab test products, and if they contain excessive amounts of certain chemicals, the state will ban the products from sale. Instead of or in addition to third-party testing, a product may carry a warning label.
What Is Required on Food Packaging?
Basic labeling requirements of the FPLA and UPLR include:
Declaration of identity: A clear statement of what the commodity is
Declaration of responsibility: The place of business and name of the distributor, packager, or manufacturer
Declaration of net quantity or use: The net quantity of contents in terms of weight, measure, or numerical count, and the measurement must be in both metric and inch or pound units
Fair Packaging and Labeling Act: Regulations Under Section 4 of the Fair Packaging and Labeling Act
Additional FPLA requirements include:
The labeling should be visible and easily distinguishable from other packaging parts.
Font and typeface must be consistent and run horizontally when the package is oriented how a manufacturer has designed it to be viewed.
Food Contact Substance Exemptions
There are three ways in which a food packaging manufacturer can seek an exemption for a food contact material:
Prior sanction: Prior to 1958, the FDA and the US Department of Agriculture (USDA) had already approved several substances based on inquiries from individual manufacturers, issuing letters of approval called “no objection letters.” Those substances are covered by prior sanction. However, manufacturers must still demonstrate the product is safe.
GRAS: Generally recognized as safe (GRAS) substances can also be exempt from the food contact notification process. Scientists and scientific analysis have determined that these substances are identified as safe for common use with food products. The FDA rules on GRAS, and manufacturers can submit a request for GRAS determination. The regulations list many GRAS substances, but there are also options for manufacturers to demonstrate a food contact substance is GRAS.
No migration exemption: One other group excepted from food packaging regulations includes those substances that are not reasonably expected to become components of the food even if they are in contact or part of the packaging. This exception can consist of materials separated from the food by a functional barrier. The no migration exemption can be complicated and require significant testing to demonstrate. For this exception to apply by means of the functional barrier, the manufacturer must establish that the functional barrier does prevent the migration of the substances. Manufacturers do not have to notify the FDA of the testing as long as the packaging ends up meeting the no migration exemption criteria. This exemption is based on reasonable expectations, and there is some dispute as to what level constitutes migration. Fifty parts per billion (ppb) is the accepted threshold for most foods. For milk and soft drinks, the threshold is ten ppb. This exemption cannot apply to substances with significant toxicological concerns like carcinogens.
What Are the Three Types of Packaging that Manufacturers Recognize Today?
There are three types or levels of packaging that manufacturers use today to ensure the safe transport and storage of food. These levels include:
Primary packaging: Also known as the consumer unit, this is the packaging that comes into direct contact with the food. This first layer is intended for the consumer, and manufacturers design this packaging to protect the food from contamination and be attractive and appealing to consumers. An example of the first layer would be a pasta box.
Secondary packaging: Secondary packaging groups multiples of a product and makes it easier to handle them by placing them in a single pack. It can also provide additional protection to the individual products inside and may also be the shipping container. This packaging can include several components, including the corrugated cardboard box and padding inside to protect the primary packaging of the products.
Tertiary packaging: Tertiary packaging is also known as transit or bulk packaging. This is the packaging that helps ensure the safe transport of large quantities of products. These distribution units are easier and safer to handle over long distances and store in large warehouses. An example of tertiary packaging is a shrink-wrapped pallet containing multiple secondary packages of products.
FDA Regulation of Food Contact Materials
The FDA introduced an amendment to the Food Drug and Cosmetic Act (FD&C Act) in 1997 called the Food and Drug Administration Modernization Act (FDAMA). This Act developed a notification method for food contact substances. In the amended Act, the FDA defined 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 amendment is intended to replace the petition process used to authorize food additives that are also food contact substances. Still, the FDA retains the power to use the petition process when it feels it is more appropriate.
The FDA regulates each food contact substance that makes up a food contact material. Food contact substance manufacturers ensure that the food contact materials comply with all authorizations. Every authorization should include three components:
Identity of the substance
Specifications such as the physical properties
Limitations for how manufacturers can use the material
Under section 303 of the FFDCA, manufacturers of food contact materials may seek to obtain a “letter of guaranty” from a food contact substance manufacturer that allows the FCS manufacturer to assume the responsibility if a substance is found to be adulterated or misbranded.
The Food Contact Notification System
Since 2000, companies that supply or manufacture a food contact material can submit a food contact notification (FCN) to the FDA that describes the chemical identity of the substance and information supporting its use as safe. In January of 2022, the FDA proposed a new rule on when and how it can determine that an FCN is no longer effective, with the goal of maintaining a more accurate and current list based on safety and use.
Manufacturers submitting a food contact notification to the FDA should consider several factors, including the chemistry, toxicology, and environmental impact and implications of the substance. The environmental impact of food contact substances is facing increasing scrutiny. A notification must meet the requirements set forth by the National Environmental Policy Act (NEPA) and include an environmental assessment or claim for an exclusion. Title 21 of the Code of Federal Regulations governs both the environmental assessment process and the exclusion process.
Three Routes to FDA Compliance
A manufacturer has three main routes to FDA compliance for a food contact material. The three steps are:
The established route: Manufacturers can go with FCS that is already approved by the FDA and have existing regulations in place.
Exploring new materials: Manufacturers can seek authorization from the FDA by submitting an FCN. In some instances, manufacturers may also need to submit a Food Additive Petition (FAP) or a Threshold of Regulation Submission (ToR).
Exemption: A packaging manufacturer may not have to meet requirements for authorizing a material if the material is exempt.
The Threshold of Regulation Program
FCS submissions through the ToR program follow a much faster and more straightforward route. ToR requests are considered a more efficient way of establishing FCS compliance. In this program, the focus of the determination is whether the FCS meets specific criteria and would pose negligible health risks when used for its intended purposes. The food-contact notification process requires a 120-day review period, but the manufacturers can receive ToR exemptions much more quickly. Finally, ToR submissions apply to the intended use of the FCS regardless of the manufacturer, whereas an FCN is proprietary to the manufacturer submitting the notification.
Possible Changes for Packaging Manufacturers
In January of 2022, the FDA proposed a new rule for the process of delisting an FCN. The rule’s goal is to make it easier for the FDA to determine whether an FCN is no longer effective if a manufacturer stops using the material for a reason other than safety. Manufacturers would also have the ability to weigh in on the determination sooner in the process.
Manufacturers of food contact substances and materials continue to work within the industry and with state and federal regulations to develop packaging materials and methods. Targeting the intersection of safety, durability, and food integrity mean that manufacturers and regulatory agencies must become more flexible and adaptive.
