Yes--FDA Regulatory Framework Provides for Their Use

Misconceptions about the use of UV/EB coatings in food contact applications abound. The good news is that the U.S. Food and Drug Administration (FDA), the agency responsible for regulating such applications, permits the use of UV/EB coatings as components of food packaging under certain conditions and in compliance with certain regulations. The bad news is that attempting to understand the complex regulation of food packaging can be a frustrating and disheartening experience.

FDA's regulatory scheme is one under which most coatings substances intended for use in food packaging applications are either covered by an applicable FDA regulation or are "exempt" from the pre-clearance requirements of the Federal Food, Drug and Cosmetic Act (FFDCA). Knowledge of the exemptions is a UV/EB coatings manufacturer's best defense against the Agency's absolutes -- especially its favorite refrain, "File a Food Additive Petition." The exemptions, however, are not all codified in Parts 174 through 179 of Title 21 of the Code of Federal Regulations (CFR). Knowledge about some of them is sometimes considered more like folklore than codified law.

How is a "Food Additive" defined?

FDA's regulation of food packaging is based on Section 201(s) of the FFDCA, which defines a food additive, in relevant part, as:

[A]ny substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component . . . of any food . . . if such substance is not generally recognized . . . to be safe under the conditions of its intended use; except that such term does not include -- (4) any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this Act.

This definition is repeated in Section 170.3(e) of the Food Additive Regulations which adds other explanatory information:

A material used in the production of containers and packages is subject to the definition if it may reasonably be expected to become a component . . . directly or indirectly of the food packed in the container . . . . If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive.

Section 409 of the Act requires that a food additive, as defined above, must be the subject of an applicable food additive regulation. Thus, substances which, under their intended conditions of use, may reasonably be expected to become components of food are "food additives" and can be used only in accordance with an applicable food additive regulation unless they are either: (1) the subject of a prior sanction or approval granted by FDA or the U.S. Department of Agriculture (USDA) prior to the enactment of the Food Additives Amendment of 1958; or (2) generally recognized as safe (GRAS). If the substance is not reasonably expected to become a component of food under the intended conditions of use, however, it is not a food additive within the meaning of Section 201(s) of the Act, and may be used as intended without the need for consultation with or prior action by FDA.

Overview of Parts 170 - 197 of the Food Additive Regulations

FDA's food additive regulations, found in Title 21, Parts 170 - 197 of the CFR, cover both direct and indirect additives. "Direct food additives" are materials directly and intentionally added to foods to perform a functional effect in food, including, among others, ingredients, preservatives, colors, stabilizers, and texturizers. "Indirect food additives" generally refer to substances that are not intended to, but nevertheless become, components of food as a result of use in articles that contact food (e.g., substances used on food machinery and in packaging materials).

Over the years, the indirect food additives regulations have been issued, in response to food additive petitions, without any overall regulatory structure. Where a UV/EB coatings company can establish that the subject material is exempt from the definition of a food additive and, thus, from the requirements for filing a petition, it should do so. The petition process takes an average of a year and a half after the petition has been submitted to the Agency before promulgation of a food additive regulation in response to the food additive petition. This does not account for the time spent in developing appropriate analytical data, and sometimes toxicology data, to support the petition, nor for the time spent in drafting the petition.

The "No-Migration" Exemption

One of the most important means of establishing satisfactory FDA status for an indirect additive is to establish a rational basis on which to conclude that there is no reasonable expectation of the substance becoming a component of food. If a substance is not expected to become a component of food under its intended conditions of use, it is not a food additive by definition and, therefore, may be so used without the need to obtain any FDA clearance.

For most substances, a finding of "non-detected" in a properly conducted migration study is considered to be a sound basis for concluding that the substance is not a food additive. A properly conducted migration study is one which accurately simulates the conditions of actual use, utilizing analytical methods sensitive to the equivalent of 50 parts per billion (ppb) of the substance in food. In some cases, however, it may be necessary to base a "no-migration" determination on being able to say "non-detected" with a method sensitive to 10 or even 1 ppb because of the toxicological nature of the material being used, such as a heavy metal, or because of the high exposure of the end product, such as soda or milk containers. Of course, carcinogenic constituents must be evaluated separately using risk assessment techniques.

The Functional Barrier Doctrine

This doctrine simply recognizes that substances separated from food by a functional barrier which prevents their migration to food are not reasonably expected to become components of food and, thus, are not properly considered to be food additives, as that term is defined under the Act. This doctrine often serves as the basis for determining the regulatory status of interior layers of laminates and outer layers of packages. The most significant question is whether a true barrier exists. This question may be resolved by considering the packaging structure, the exposure conditions anticipated for the package, or, where necessary, by conducting appropriate extraction testing.

Threshold of Regulation Policy

FDA's recently promulgated "threshold of regulation" provides further support for the proposition that substances can be considered safe on the basis of low dietary exposure (60 FR 36582, July 17, 1995). This rule exempts from regulation as food additives, food-contact substances that may migrate to food at low levels, provided that certain criteria are met. In particular, under the threshold of regulation, substances that are not known to be carcinogens, and do not contain known carcinogenic constituents that have a Toxic Dose (TD) 50 value less than 6.25 mg/kg body weight per day, are eligible for exemption from regulation as food additives if the dietary concentration of the substance is 0.5 ppb or below, or if the substance is currently regulated for direct addition to food and the dietary exposure to the substance resulting from the proposed indirect use is less than 1 percent of the dietary intake from the direct additive uses.

The threshold of regulation represents at least an implied acknowledgement that the presence of a substance in the diet at extremely low levels is GRAS. Accordingly, although it is intended as a mechanism for FDA to consider the suitability of food additives present in the diet at de minimis levels, this regulation also provides guidance for the private sector's evaluation of food-contact materials.

Summarizing, substances used in food contact articles must be the subject of a food additive regulation if they are reasonably expected to migrate to food under the intended conditions of use unless the quantity migrating is insignificant, or the substance is GRAS, or the subject of a prior sanction. As noted above, if the substance is not reasonably expected to become a component of food under the intended conditions of use, it is not considered to be a food additive, and may be used without the need for a permissive food additive regulation.