By Sarah Foradori | May 2, 2016

Food and nutrition labeling can be extremely confusing — for both consumers and manufacturers. While consumers may wonder what exactly constitutes a serving size, label manufacturers have to know what kinds of materials and inks are approved for food labeling and packaging. How do they know what kind of materials to use to create labels that are safe for food?

What is food-safe labeling?

Labeling is only considered food-safe if it meets stringent Food and Drug Administration (FDA) regulations regarding label materials and content. The labeling components — the label facestock, adhesives, and inks that display the required nutrition facts, barcodes, dates, lot codes, etc. — are classified as Food Contact Substances (FCS).

Section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act defines FCS as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” The FDA further categorizes FCS—printing inks included—as direct contact substances or indirect contact substances. Understanding the difference between direct and indirect food contact is just as important for labeling solution providers as it is to food manufacturers and packagers.

Direct contact substances are categorized as those that make direct contact with food. Some common examples of direct food contact are product look-up (PLU) labels printed with barcodes and applied to fresh produce and placed in a bin, or pouch-in-bag applications (like salad & dressing kits) where print on the pouch may come in direct contact with the contents of the bag.

Indirect contact substances are classified as FCS that may or may not come into contact with food — such as printing on labels placed outside of food cartons, bags, or pouches.

What are the challenges for food-safe labeling?

There are extensive FDA labeling requirements for most prepared foods — such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, and more. Newer initiatives for produce, like the Produce Traceability Initiative (PTI), and seafood are underway.

The FDA has also created food label requirements that determine which adhesives, labeling materials, and inks are considered safe when applied directly to food or the packaging it comes in. However, the rules about materials are not always as clear as the rules about label content, which leads to two challenges:

  1. The lack of clarity creates a gray area that can lead to more confusion for label printers and food manufacturers, packagers, and distributors who are ultimately responsible for complying with the FDA’s food label requirements.
  2. It also leads to misleading claims that inks and other print components are “FDA Approved” — when in fact, the FDA does not approve nor endorse any product.

How can manufacturers make sure they meet food label requirements?

The FDA states that “it is the responsibility of the manufacturer of an FCS to ensure that food contact materials comply with the specifications and limitations in all applicable authorizations.”

To ensure that packaging components meet FCS labeling requirements, manufacturers can consult the FDA’s published Code of Federal Regulations (CFR), Section 21. 21 CFR 174-199 will cover labeling & packaging materials and inks, and includes some substances that have been categorized as Generally Recognized as Safe (GRAS) for direct or indirect food contact.

Partnering with label solution providers who understand the FDA labeling requirements for food contact labeling and printing takes the guesswork and heavy lifting out of compliance. The most reliable partners are ready and able to provide documentation and Letters of Guaranty that support claims of meeting the FDA labeling requirements for indirect and direct food contact.

In partnership with ITW Thermal Films for thermal transfer printing ribbons, Lowry Solutions is able to provide a comprehensive portfolio of printing solutions that are FDA-compliant for direct and indirect food contact.

Check out this Flexible Packaging Solutions brochure for more information on how we can help.


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