Active and Intelligent Packaging: A U.S. and EU Perspective
Many of today's more interesting advances in the packaging arena are being developed in the area of active and intelligent packaging systems.
The marketing requirements for new active and intelligent packaging technologies in the United States are not very different from the requirements for conventional packaging materials; the only additional necessity is for manufacturers to pay close scrutiny to the formation of any byproducts or degradation products that may be formed during the "functioning" of the material.
In the EU, certain inherent constraints in the law, such as the overall migration limit, result in a different set of regulatory hurdles for the clearance of active packaging materials. Recognizing the benefits of bringing safe, new materials into European markets, the EU is currently developing a regulatory standard to address the appropriate regulation of active packaging and remove barriers in the Member States that prevent the use of active packaging.
The purpose of this article is to provide an overview of how the United States and the European Union regulate active and intelligent packaging systems, and to highlight which regulations (in the United States) and which directives (in the European Union) should be considered before going to market.
FDA Regulation of Active and Intelligent Packaging
In the United States, the term "active packaging" generally describes any packaging system that protects food from contamination or degradation by creating a barrier to outside conditions while interacting with the internal environment to control the atmosphere within the package. Active packaging systems typically involve packaging materials that contain a variety of active substances that are incorporated into the packaging material's formulation; these substances improve the packaging material's ability to extend the shelf life of the food contained inside.
An example of an active packaging system might be a polymer-based packaging that possesses barrier and protective qualities, such as oxygen scavenging, moisture scavenging, or microbial control. In an oxygen scavenging system, the addition of an oxygen-absorbing additive to the polymer used to manufacture the packaging creates a package that will absorb oxygen and improve the stability, preservation, convenience, and quality of the packaged food products. Foods such as vegetables, bread, and beverages are commonly packaged in an active packaging film containing an oxygen absorber.
Intelligent packaging materials, on the other hand, have no effect in the food, but are designed to convey information about the condition of the food to the consumer. For example, an intelligent packaging system can use color sensors or other methods of warning to indicate when food is stored under inappropriate temperature conditions or has spoiled.
Materials used in food-contact applications are subject to premarket regulatory clearance by the U.S. Food and Drug Administration if they are deemed "food additives" under the Federal Food, Drug, and Cosmetic Act (the Act). Section 201(s) of the Act defines a "food additive" as a substance that is reasonably expected to become a component of food under the intended conditions of use. Statutory exemptions are provided for substances that are generally recognized as safe (GRAS) or are the subject of a sanction or approval issued by the FDA or U.S. Department of Agriculture prior to the enactment of the Food Additives Amendment in 1958. Food that contains an "unsafe" food additive is deemed adulterated, per se, under Section 402(a)(2)(C) of the Act, the so-called "automatic adulteration" standard. The adulteration standard requires that a substance of interest be safe in that it does not add anything unsafe to food, and that it does not physically contaminate the food or cause it to have an unacceptable taste or odor.
Because the safety of a substance used in a packaging material is based on the dietary exposure resulting from the intended use, it is irrelevant whether the material is designed to create a protective barrier to prevent against external source contamination; is active in promoting oxygen scavenging, microbial control, or moisture scavenging; or monitors the conditions of packaged foods to give information when the food contained inside is spoiled or has been overexposed to improper temperatures. In fact, as long as the material in the active or intelligent packaging system is intended neither to add any substance to the food, nor to have a technical effect in the food (so-called "indirect additives") there are no special regulatory concerns for substances that are used in such systems; thus, they are simply regulated like all other food-contact substances. If, on the other hand, the active packaging material is added directly to food, or has a technical effect in the food, the material would constitute a "direct additive" and would be subject to much stricter FDA regulatory requirements (most likely, a food additive petition would have to be filed with FDA unless another exemption could be claimed).
While no additional regulatory concerns exist for additives used in active packaging, it is important that manufacturers account for any additional migrants, decomposition byproducts, or impurities that may occur as a result of the chemical activity in the active packaging material during its storage and shelf life. This information is needed before one can assess whether the material in the active packaging system constitutes a "food additive." Put simply, one cannot determine whether a substance is reasonably expected to become a component of food under the intended conditions of use, nor can one calculate the dietary exposure to a substance used or created in the active packaging system, unless any substances that may be produced and may get into food are analyzed and quantified. Accordingly, residual and migration testing in active packaging systems must take into account the possible formation of these additional migrants and decomposition byproducts.
While active and intelligent packaging is not subject to any special regulatory concern in the United States, the regulation of such packaging material in Europe is still evolving.
The European Union's perspective on active and intelligent packaging recently came to light in a series of draft recommendations for legislative amendments under the so-called FAIR-project "Actipak" (CT 98-4170). The report was developed by a government/industry task force group, headed by TNO Nutrition and Food Research, that was asked to examine and report on how active and intelligent packaging should be regulated in the EU.
The Actipak task force defined "active packaging" as packaging systems that "actively change the conditions of the packed food to extend shelf-life or to improve food safety or sensory properties while maintaining the quality of the food." "Intelligent packaging" systems were defined as those that "monitor the conditions of packed foods to give information about the quality of the packed food during transport and storage." The task force reviewed active and intelligent packaging as it relates to food contact materials, food additives, flavoring, hygiene, biocides, pesticides, labeling, product safety, weight and volume, and waste.
The conclusions of the Actipak task force led the Commission to propose modifications to the Framework Directive (89/109/EEC) and to propose the promulgation of a specific directive setting forth or regulating requirements for these materials, as summarized below.
Our discussion below is limited to summarizing how active and intelligent packaging would affect EU legislation as it relates to food-contact materials, food additives, and labeling.
Food Contact Materials
The Actipak report discusses how active and intelligent packaging fits within the EU Commission's Framework Directive (89/109/EEC). The Framework Directive applies to "materials and articles which, in their finished state, are intended to be brought into contact with foodstuffs." Because active packaging systems (and, often, intelligent packaging systems) are intended to come into contact with food, such systems must comply with the Framework Directive. For example, Article 2 of the Framework Directive states that food contact materials and articles must not transfer their constituents to foodstuffs in quantities that could endanger human health and should not result in an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof.
In addition to the Framework Directive, the so-called Monomers Directive (Directive 90/128/EEC) and its seven amendments, regulates food contact articles composed entirely of plastic; because many active and intelligent packaging systems are used in packaging materials composed entirely of plastic, the requirements set forth in the Monomers Directive must be met. For example, the Monomers Directive establishes a purity standard by requiring that no more than 60 mg/kg of substances from the finished plastic article can migrate to food. This is known as an overall migration limit (OML). Many of the monomers in the Monomers Directive and subsequent amendments include what is known as specific migration limits (SMLs) and, like the 60 mg/kg OML, these limitations must be met in active packaging systems. Because active packaging systems may be designed to release substances into the package of the food, the migration may exceed the OML. Thus, the Actipak task force has recommended amending EU legislation so that such systems would not be out of compliance.
If the food contact article or material is composed of plastic and non-plastic components, the Monomers Directive does not apply; however, Article 2 of the Framework Directive still must be observed, i.e., the potential transfer of constituents to food must not be at levels that could endanger human health or result in an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof. When active and intelligent packaging systems are used in plastic and non-plastic materials, existing national regulations should be looked at to determine compliance. However, this could change as a result of the specific directive for these materials, which the European Commission may decide to develop.
The Actipak report also addresses needed changes to migration testing protocols to allow for active and intelligent packaging systems in the European Union. Migration testing is provided for in Directives 82/711/EEC and 85/572/EEC. Plastic packaging containing active or intelligent packaging systems should be tested in accordance with these directives. The task force recommended that dedicated protocols for active and intelligent packaging systems be developed to address unique issues raised by this type of packaging.
Another Framework Directive (89/107/EEC) addresses the regulation of (direct) food additives. This legislation applies to active and intelligent packaging to the extent that substances are intentionally released from the packaging system or have a technical effect on the food. Active packaging systems that intentionally release substances into the package must comply with the (direct) food additives directives, i.e., the released substance must be listed in the positive lists of additives reproduced in these directives and the use of the substance must accomplish a technological need. As long as intelligent packaging systems are not designed to intentionally release substances into or onto food, Directive 89/107/EEC does not apply to such systems. Since Directive 89/107/EEC, as it currently stands, already applies to active packaging that is intended to release substances into food, no amendments to that legislation were recommended by the Actipak task force.
Directive 2000/13/EC on the labeling of foodstuffs requires food additives, used in the manufacture or preparation of food and present in the finished product, to be listed on the label. An additive intentionally released to the food via its packaging should be listed on the food label consistent with Directive 2000/13/EC.
The task force recommended labeling requirements at the retail stage to disclose the presence of a non-food component (for example, a sachet used in intelligent packaging systems), the function of the system, and the fact that the system is inedible. While these are labeling requirements that typically would be included in the food labeling directive, the task force notes that they may be more appropriately placed in the food contact directives.