Food packaging offers a variety of benefits to manufacturers and consumers alike. It is a vital element of food safety because it protects food products from outside contamination and prolongs shelf life. It also has significant marketing advantages since a familiar or exciting design quickly catches the eye and leads to purchase. Moreover, detailed nutrition labeling offers invaluable information about the product to potential consumers, such as which major food allergens it contains, nutrition facts, an ingredient list, how it should be prepared and consumed, etc.

In the United States, the Food and Drug Administration (FDA) is in charge of regulating the safety of substances added to food. Substances in food include antimicrobial substances, food contact material, recycled plastics in food packages, and similar. The main goal of these FDA regulations is to minimize the migration of chemicals and material substances from the packaging into food and reduce food safety concerns.

Understanding this consumer safety guidance is crucial to package your frozen food in a safe, effective, and legally compliant manner.

Basic Requirements

In food manufacturing, general safety requirements are shaped in a way to protect the physical, chemical, and sanitary integrity of the food ingredients and product. The requirements focus on prohibiting the transfer of substances from the food packaging to the product itself. This transfer might result in a change of taste, odor, or composition of food and could negatively impact human health, which is why it is undesirable.

A substance can be cleared for food packaging based on its analytical chemistry data and how likely it is to present a public health concern. If a substance represents no cause for toxicological concern (as judged by the FDA), it can be incorporated into food packaging.

Overall, frozen food packaging should have the following essential characteristics:

  • Resistance to low and high temperatures (especially if the food is cooked in its original packaging)
  • Have a particular mechanical strength
  • Resistance to acid, oil, and other degrading chemicals in the food product
  • A specific level of hygiene, and similar

Food Contact Substances

To ensure that food contact articles, including food processing and packaging equipment, are safe for use, FDA established the Division of Food Contact Substances. This division is within the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN).

A food contact substance is “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.” FCSs are usually part of plastics, coatings, paper, colorants, adhesives, antimicrobials, and antioxidants. FDA set up a program called the food contact notification program to evaluate FCSs.

Federal food laws dictate that any company that wishes to supply or manufacture an FCS must submit a Food Contact Substance Notification (FCN) to the FDA. “Supply” in this case includes any organization or individual supplying the FCS, even those that are supplying it only for themselves for manufacturing food contact material.

Once an FCN has been filed, the FDA has 120 days to respond to it. If it doesn’t object to the substance or fails to respond in the given time period, the FCS can legally be used in food product manufacturing. Once an FCN is in effect, it applies only to the FCS the Notification was for, as well as only to the food processor listed in the notification.

FCSs vs. Food Additives

The FDA’s definition of an FCS includes a wider variety of substances that come in contact with food than those regulated as food additives.

In the past, the FDA had several categories of food additives:

  • Direct food additives – those with an intended technical effect in food.
  • Secondary direct food additives – with an intended technical effect during processing but not in the finished food product.
  • Indirect food additives – with an intended technical effect in food contact material (not the food).

This is largely an informal classification of food additives. These definitions don’t exist in the codified regulations or the statute, though they are mentioned separately in the Code of Federal Regulations. Only FCSs that are also food additives (of any category) require approval from the FDA before they reach the market. Most FCNs submitted will be about substances that belong in the third category – indirect additives. Sometimes, FCNs about secondary direct additives are also possible, seeing as some substances added during processing but not after processing may fall under the definition of FCSs.

Other FCSs

Food contact substances can also be compounds that are not food additives in any way. They are sorted into several groups.

  • GRAS

GRAS stands for “generally recognized as safe.” GRAS substances reach their status based on the type of information available about them and the general opinion of the scientific community. The information that supports the GRAS conclusion must be the same in quality and quantity as information that would support the safety of a food additive.

Direct food additives covered by the GRAS category can also be used for indirect food contact applications, such as in packaging materials. Examples of that include zinc stearate and zinc oxide.

  • Prior Sanctioned

Food packaging was included in the Food and Drugs Act back in 1958. Before this, the FDA had already approved many substances for use in food contact materials. All substances that have received this letter of FDA approval before 1958 fall in the ‘prior sanctioned’ group of substances.

A well-known example of this is PVC. However, food manufacturers should still be careful even when using prior sanctioned FCSs. Many other FDA sections require guaranteed safety of product packaging material before placing it on the market.

  • No-Migration Substances

If a substance does not become a food component (in reasonable quantities), it is not considered a food additive but could still be approved as an FCS.

However, proving that a substance does not migrate into food is not an easy task. The consensus is that the migration threshold level is less than 50 ppb (parts per billion). High-exposure applications, such as the material of milk and carbonated beverage bottles, have a limit of 10 ppb.

The no-migration substances category does not apply to known carcinogens or toxic substances, such as heavy metals. It also does not apply to substances that are toxic to humans or animals in levels equal to or lower than 40 ppb.

Sanitary Regulations

Regardless of whether you are a frozen food producer or supplier of food packaging products, you must keep in mind the strict sanitary regulations that apply. Food contamination has to be avoided at all costs. The responsibility for the integrity and sanitation of the packaging does not stop with its production.

Your food containers and packaging materials must be stored away from cleaning chemicals, odorous materials, pesticides, or any other type of compound that is not safe for food.

The utmost care must be taken to ensure that transferring food packaging substances and materials from one side of the production facility to another is contamination-free. The conveyor belts you use must not have metal parts, loose pieces, string, rope, clips, or anything else that might find its way into the final food product. Enclosed conveyor systems for transporting food material are the most efficient way of keeping your product ingredients safe from outside contamination.


The FDA regulations regarding food contact substances and materials can be tricky to navigate. There are dozens of different sections and codes to keep track of, and it is difficult to discern whether the substances your packaging is made from are food additives or not.

A significant difference between food additives and food contact substances is that the former can be added intentionally into the food product. The latter end up in the product either unintentionally or are meant to be there just during the processing phase. There are also FCSs that don’t have to be additives at all. They include GRAS substances, those that have been previously sanctioned, and substances that do not migrate into food.

Whether you’re a manufacturer or supplier of food packaging (even if only for your own company), you should file a Food Contact Substance Notification (FCN) with the FDA for substances that you’re not sure are up to FDA’s standards. It is also a good idea to consult with the FDA before you fill in the FCN to know precisely what information they expect you to provide.

What type of packaging you will use depends explicitly on your product. Your materials must withstand the product type and its contents, as well as any physical influences (such as transporting, storing, cooking, or microwaving the food in the packaging).

Don’t hesitate to reach out to Cablevey for more information on sanitary, non-toxic, food-grade transportation of food materials from one side of the production plant to another.