This article will provide food processors relevant information related to the safety of food contact substances (FCSs) present in food packaging, including plastics, glass, and metal containers.

For clarity, the following are terms and definitions directly extracted from the U.S. Food and Drug Administration (FDA).[1] This terminology is critically important, not only to the manufacturer of FCSs but also to food processors to better understand the methodology applied to ensure compliance with the right standards.  

Food Additive: A food additive is defined in Section 201(s) of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives.

Food Contact Substance: Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.

Food Contact Material (FCM): An FCM is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable.

Food Contact Article: A food contact article is the finished film, bottle, dough hook, tray, or whatever item that is formed out of the FCM.

GRAS: GRAS is an acronym for the phrase “generally recognized as safe.” Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, which is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise exempted from the definition of a food additive.

CEDI/ADI Database: For many FCSs, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) maintains a database of cumulative estimated daily intakes (CEDIs) and acceptable daily intakes (ADIs). The CEDIs and ADIs are based on currently available information and may be revised when information is submitted or made available to the CFSAN Office of Food Additive Safety (OFAS). The CEDI/ADI database is updated approximately twice annually.

Prior Sanctioned Substance: A substance whose use in or on food is the subject of a letter issued by FDA or the U.S. Department of Agriculture (USDA) offering no objection to a specific use. The prior sanction exists only for a specific use of a substance in food delineating level(s), condition(s), and product(s) set forth by explicit approval by FDA or USDA prior to September 6, 1958.

Threshold of Regulation (TOR) Exemption: A substance used in a food contact article may be exempted from the requirement of a food additive listing regulation if the use in question has been shown to meet the requirements in 21 C.F.R. 170.39. For details, see 21 C.F.R. 170.39. For a complete listing of the TOR exemptions, consult the TOR inventory on the CFSAN Internet.


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Claims and Counterclaims on Food Packaging Safety
Plenty of general information is available on the Internet, creating confusion about the safety of food packaging. Simply searching terms such as “microwaveable foods,” “plastic bottled water,” and “canned foods” will result in various statements ranging from informative to alarming.[2,3] Some information arrives from public opinion, while some other information may be traced to commercial or scientific sources. Regardless of the content or the source, it is imperative that food processing and packaging professionals be adequately informed and prepared to present information about the safety of FCSs being used. Whether an FCS exists in finished products or contacts equipment during processing, storage, and transportation, this information should be presented and summarized via packaging labeling, a website, or other means. The following example of Internet searches can provide insight into the gravity of how important it is to understand FCSs.

A recent Internet search about food packaging safety yielded a 2018 report[4] by the American Academy of Pediatrics (AAP) about a policy statement published online in July 2018. According to the AAP report, an “increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development, according to the policy statement and accompanying technical report. Some may also increase the risk of childhood obesity, rates of which have tripled since the 1970s.”

This report, which cites scientific evidence, also states the potential health hazards as follows:

Bisphenols, such as BPA [bisphenol A], used to harden plastic containers and line metal cans, can act like estrogen in the body and potentially change the timing of puberty, decrease fertility, increase body fat, and affect the nervous and immune systems. BPA is now banned in baby bottles and sippy cups.

Phthalates, which are used to make plastic and vinyl tubes in industrial food production, may affect male genital development, increase childhood obesity, and contribute to cardiovascular disease. In 2017, the Consumer Product Safety Commission banned the use of some phthalates in child-care products such as teething rings.

Perfluoroalkyl chemicals (PFCs), used in grease-proof paper and cardboard food packaging, may reduce immunity, birth weight, and fertility. Research also shows PFCs may affect the thyroid system, key to metabolism, digestion, muscle control, brain development, and bone strength.

Perchlorate, added to some dry food packaging to control static electricity, is known to disrupt thyroid function, early life brain development, and growth.

The AAP report was challenged by the American Chemistry Council through a response,[5] clarifying the positive role of FDA and the benefits of the FCS regulations.

Industry Initiatives on Safer, “Greener” Packaging
From a commercial point of view, it is good to know that some packaging manufacturers as well as commercial food processors are reviewing the status of packaging materials to make the necessary improvements. Nestlé, for example, in January 2019,[6] announced it will stop using the following plastic materials in new packaging or will be phasing them out due to problems with recycling: polyvinyl chloride, polystyrene (PS), regenerated cellulose, polyvinylidene chloride, expanded PS, nonrecyclable plastics/paper combinations, paper/plastic laminates, and laminated paper cups. Some packaging applications include sleeves, labels, trays, printing inks, sealing layers trays, yogurt pots, lids for ice cream cones, coffee cups, and twist wraps.

One of the most important tools for commercial food packaging and processing is accessibility to the most recent FDA recalls finding any potential problems related to food packaging. For example, a recent review, from January 2018 to February 2019, shows that, indeed, none of the about 200 food and dietary supplement recalls were related to FCSs as defined by FDA. Most of the recalls concerned undeclared food ingredients, allergens, and microbial contaminations. Only three recalls were related to foreign particles such as metal, glass, and plastic.[7]

Food and packaging manufacturers should be updated on any controversial issues related to health hazards from FCSs. An analysis of the recall reviews can provide critical insight into emerging problems about FCSs in food packaging containers in finished products but also in processing, storing, holding, or transporting operations.

FCS information updates have also been provided by professional organizations such as Chemical Watch[8] devoted to disseminating relevant and current information on issues such as potential health hazards derived from food packaging materials. As an example, and to address the potential effect on human health and the environment, Chemical Watch organizes an annual Food Contact Materials Regulations conference. The goal is to offer guidance on the latest developments in food contact materials, including compliance issues with plastics and packaging, nonintentionally added substances, product labeling and inks, and emerging issues with perfluoroalkyl substances and perfluorooctanoic acid.

Food processors need to be asking packaging suppliers for letters of guarantee as related to FCSs as well as any other documentation as evidence of safety. Packaging specifications including factors such as pH, temperature applications, and levels of fats, oils, and alcohol are of critical importance as a first step assisting food processors and packaging suppliers to make sure the right FCSs are being properly used in the finished food packaging, storage, holding, or transportation containers.

Ideally, a food processor in the U.S. needs awareness of the protocols FCS manufacturers and packaging converters follow to comply with FDA regulations. In general, commercial food processing and packaging need to comply with fundamental laws and regulations to ensure the safety of foods and their packaging. The safety baseline is described in laws and regulations such as the Food Safety Modernization Act, Current Good Manufacturing Practices, food additive rules, and FCSs.[1,9,10]

The CFSAN OFAS ensures the safety of FCS components, including food packaging and processing. These substances are composed of FCMs that contain or are made of FCSs that are described in Table 1.[11]

Factors such as acids, oils, fats, alcohol, and the moisture content (aqueous or dry foods) play an important role in the conditions of use of FCSs. Another critical factor is temperature. Heating and cooling through sterilization, pasteurization, refrigeration, freezing, and irradiation or cooking are conditions required to be known in order to properly use FCSs. For all practical purposes, this means that FCSs would not migrate, diffuse, leach, or otherwise enter into the food being contained. It also means an insignificant impact on humans and the environment as demonstrated by chemical, toxicological, and environmental scientific evidence.

FCSs typically include coatings, plastics, papers, adhesives, colorants, antimicrobials, and antioxidants. FCSs are evaluated primarily through the food contact notification program;12 furthermore, depending on the substance, it may fit into one of the following categories:

•    Prior Sanctioned

•    GRAS

•    Food Additive

•    TOR Exemption

•    Indirect Food Additive

•    FCS

A notification for an FCS must contain enough information to demonstrate that the substance is safe for the intended use that is the subject of the notification [21 U.S.C. 348(h)(1)]. For guidance on the data and information recommended for inclusion in an FCS notification, potential notifiers should consult FDA’s guidance on chemistry, toxicology, and environmental information recommended in notifications and FDA’s administrative guidance concerning formatting of such information.

To ensure that the appropriate information is submitted for an FCS notification, FDA has provided access to an electronic form or a PDF format for notifiers to submit their notification. FDA Form 3480 may be printed and mailed to CFSAN’s OFAS.

In summary, it is critically important that food packaging processors maintain current and verifiable information about emerging issues related to FCSs, especially chemicals used in food packaging materials including processing, storage, and transportation equipment. Food processors need to be aware that there are creditable U.S. laws and regulations created to ensure the safety of FCSs.   

Felix Barron, Ph.D., is principal of Felix Barron & Associates LLC.

4. Trasande, L, RM Shaffer, S Sathyanarayana, and Council on Environmental Health. 2018. “Food Additives and Child Health.” Pediatrics 142(2): e20181408.