FDA’s Food Additive Regulations

The StepLadder Series is a Steptoe publication focused on discussing food contact regulatory topics in plain language.

Sometimes it’s nice to do things "by the book." Food packaging regulation is no different!

What Are the Food Additive Regulations?

The Food Additive Regulations describe, among other items, those substances that are lawfully permitted to be added "directly" to food (like food ingredients) or "indirectly" (like components of food packaging) in the United States, according to the US Food and Drug Administration (FDA). The Food Additive Regulations were first introduced following amendments to the Federal Food, Drug, and Cosmetic Act in 1958.

To understand the Food Additive Regulations, and how they work, we need to first need to review the definition of a "food additive:"¹

• Any substance the intended use of which results or may reasonably be expected to result — directly or indirectly — in its becoming a component [of] or otherwise affecting the characteristic of any food.

The definition continues on to state that food additives may include substances intended for "producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food…"²Therefore, it’s clear that food packaging may be considered a food additive in certain situations.

FDA's Food Additive Regulations appear in Title 21 of the Code of Federal Regulations (often abbreviated "21 C.F.R."). 21 C.F.R. is further subdivided into sections. "Indirect" food additives (like components of food packaging) appear in Sections 175-178 (with a few stragglers elsewhere), and describe the types of substances that may be used in the manufacture of certain types of food packaging.

While there are, of course, exceptions to every rule, the general approach to the Food Additive Regulations is that each clearance is application-specific. Remember from the definition of a food additive above, that "intended use" matters! Therefore, companies that want to market their products in accordance with one or more food additive regulations must demonstrate not only compositional compliance (e.g., the substance meets the description in a regulation), but also that the substance is listed in the appropriate regulation covering the intended use. When both criteria are met, the substance may be used as intended without the need for further sanction from FDA.

What Are Some Examples of Food Additive Regulations for Packaging?

Section 175.105 ("Adhesives")

Ironically, we start with one of the food additive regulations that reflects more of an exception to the rule! Substances listed in the adhesives regulation may, as one would expect, be used as a component of… adhesives! Interestingly, substances not listed in the adhesives regulation also may be used in certain circumstances too, because FDA assumes that most adhesives are used behind a functional barrier where they won’t directly contact food – a topic we will cover in the near future.

Section 175.125 ("Pressure-sensitive adhesives")

Unlike their adhesive counterparts, pressure-sensitive adhesives often are expected to be used in direct contact with food. Examples include stickers, labels, and tapes used to label fruits vegetables (like those UPC barcodes you find in the grocery store), poultry, and dry foods. You may not think of stickers as a food-contact material… but once you do, it kind of makes sense!

Section 175.300 ("Resinous and polymeric coatings")

This regulation covers two types of coatings: (1) films and enamels placed on metal substrates (think can coatings); and (2) any coating applied to a repeated-use article, to provide a barrier between the substrate and food. Coatings of this nature are used in a wide variety of applications, and are often intended to support certain types of packaging-food combinations that might not otherwise be possible – or might not be as ideal – without the coating applied.

Section 176.170 ("Components of paper and paperboard in contact with aqueous and fatty foods.")

There are a lot of paper-based food packaging products out there! Paper is versatile, lightweight, and sometimes recyclable, so it's no surprise that it’s there are near-infinite combinations of materials that go into the papermaking process. Common examples include mineral fillers, wet-strength agents, greaseproof coatings, and pigments. Many of these substances are listed for use in 176.170 subject to certain use level or application-based limitations, and most food-contact paper and paperboard must meet certain overall extractives limitations, with time, temperature, and solvents for measuring extractives based on the specific applications of interest.

Section 176.180 ("Components of paper and paperboard in contact with dry food")

Section 176.180 is both very similar and very different from its 176.170 neighbor in that it also lists substances that can be used in the manufacture of paper and paperboard, except that 176.180 represents a trade-off of listing substances that may be used without the need for extractives testing – but only in contact with dry (Type VIII) foods. (See our StepLadder article on FDA's Food Types and Conditions of Use)

Section 177.1520 ("Olefin polymers")

Olefin copolymers include polyethylene, polypropylene, and other versatile plastics that are ideal for application-specific uses. Modifications to the basic structure of these polymers incorporates desirable physical, chemical, and structural uses that make olefin copolymers highly customizable. While these polymers are sometimes limited in terms of functionality at higher temperatures, they represent a cost-effective, lightweight alternative to other materials that contact food.

Section 177.1630 ("Polyethylene phthalate polymers")

Polyethylene terephthalate (PET) has quickly become one of the most ubiquitous materials for holding food thanks to its broad resilience to high temperatures and acidic foods like soda. For this reason, PET is commonly used to hold foods during cooking, water, and many more. While there are only a few ways to make a basic PET homopolymer, there are many ways to produce modified PET copolymers. Most PET polymers are subject to extractives limitations.

Section 178.2010 ("Antioxidants and/or stabilizers for polymers")

Plastics are lightweight, resilient, and many of them are becoming more widely recycled. Each has a personality of its own! Certain types of plastic polymers are ideal for holding beverages, whereas others are well-suited for holding foods under high-temperatures for long durations of time. Like their paper and paperboard counterparts, plastics come in many different shapes, sizes, and compositions. In many cases, plastics that are otherwise less well suited for certain applications can be made more compatible by the addition of antioxidants and stabilizers that help to protect the substrate from the food, or the elements.

Section 178.3297 ("Colorants for polymers")

This lively food additive regulation brings a myriad number of colors into our lives and definitely makes food packaging more attractive. Many of the listed substances are classic examples of "a little goes a long way," and use level limitations similarly reflect that fact. Further, some colors have a greater affinity to migrate to different food types (or under higher temperature conditions), and are similarly-limited. (As a reminder – colors that migrate from packaging to food and inadvertently change the color of the food render the food adulterated… so that’s a no-go). Colors can be used together, and provided they don’t react with one another to form a new substance or compound, the most stringent limitation on all of the individual colorants applies to the finished packaging.

What About Substances That Aren’t Listed in the Food Additive Regulations?

The food additive regulations described above are only a small sample of the broad number of types of materials that are authorized for use in contact with food. For those materials that are not the subject of a food additive regulation, or are not listed for their intended use, alternatives such as a Food Contact Notification (FCN), as well as certain exemptions and exceptions may apply. These necessarily need to be evaluated on a case-by-case basis, and similarly, will be covered in future StepLadder discussions.

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¹ See Section 201(s) of the Federal Food, Drug and Cosmetic Act.

² Unless a specific exception or exemption applies – more on that another time!

About the Steptoe StepLadder Series

Steptoe & Johnson LLP is pleased to publish the StepLadder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.

This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn’t a ‘food additive,' in which case you’re not food packaging.