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Food Packaging Inks – Navigating a Complex Regulatory Landscape

Over the last few years, a consumer battle was launched and subsequently raged over straws. Yes, drinking straws. This battle was part of the larger ‘paper versus plastic’ war, which has carried on for decades.

Straws, it turns out, are not only on the front lines of the environment debate, but also illustrate issues surrounding food packaging and safety.

When it comes to nutrition and food quality, consumers are more educated and aware than ever before – but food packaging by and large still tends to dodge attention.

One reason? It’s ubiquitous. Printing ink is found on nearly all food packaging – and not just on the outside of containers and boxes, but in direct contact with your food. For example:

  • Colorful or printed straws directly contact both the beverage and your mouth.
  • Printing on a piece of paper is placed inside a fortune cookie.
  • Printed contest information or codes on the underside of a yogurt container lid.

The use of ink in close proximity to food can be problematic, as the chemicals that comprise the ink may not be safe for human consumption. Contaminants can potentially migrate from the packaging of a food item to the food itself. Thus, the safety of packaging components – such as printing ink – must always be considered.

Direct vs. Indirect Food Contact

Some packaging inks have indirect food contact (IFC). Others have direct food contact (DFC). To identify the type of ink you need, it’s a good idea to review the definitions of IC and DFC:

  • Indirect Food Contact (IFC)
    Indirect food contact occurs when the printed area of the packaging is not expected to make contact with the food under normal foreseeable conditions. Still, for indirect contact, the printing ink used on the packaging should be deemed low-migration or food packaging-compliant. In addition, when the ink has indirect contact with food, regulations require a functional barrier in order to provide an added layer of protection for consumers.
  • Direct Food Contact (DFC)
    Direct Food Contact occurs when printed portions of the food packaging have intentional direct contact with the food item or will likely make contact with the foodstuff. Additionally, DFC takes place when the components of the packaging print are transferred to the food item under typical-use conditions. In these instances, the ink used in the packaging must be FDA compliant. Some companies try using a compliant OPV (Overprint varnish) atop conventional inks, believing it will offer enough protection and meet regulatory standards for direct food, drug and medical applications. We believe this is a risky approach, since pinholes in the coating, chemical resistance issues and other factors can bring components of the inks into direct contact with the product.

    The FDA’s position is that they will only consider a coating an effective (functional) barrier if it is of sufficient thickness and uniformity (no pinholes or voids) and is completely chemically resistant to the food/drug/medical products under the conditions of use.

Once you’ve identified the type of ink you need for your application, there are a number of regulatory requirements you must be aware of across geographies.

Man holding a creative business box

FDA-Compliant Ink Materials

In the U.S., the Food and Drug Administration (FDA) regulates the ingredients found in most foods. Additionally, the FDA offers a list of materials that are approved for contact with food.

Although the regulations do not directly address packaging ink, if an ink material is likely to become a component of food, specific restrictions still apply. These restrictions are listed in Title 21 of the U. S. Code of Federal Regulations (21 CFR).

The regulatory guidelines include:

  • Inclusion in the inventory of food contact substances. The FDA authorizes the use of specific substances listed in 21 CFR—including direct and indirect additives.
  • Safe for the intended use. The FDA requires the submission of a food contact substance notification that indicates an environmental assessment or a categorical exclusion under 21 CFR 25.15.
  • Generally recognized as safe (GRAS). Some substances, such as certain spices, essential oils, and seasonings, are considered safe when used under approved conditions.
  • Exempted by a prior sanction. The U.S. Department of Agriculture and the FDA approved the specific use of certain substances before the inception of the Food, Drug, and Cosmetic Act of 1958.

European Union (EU)-Compliant Ink Materials

For countries in the European Union, when it comes to Food Contact Materials (FCMs), there are general safety principles defined by Regulation (EC) No 1935/2004. The Regulation requires that:

  • FCMs do not release contaminants at levels deemed harmful to the consumers’ health.
  • FCMs do not negatively impact the composition, odor, or taste of the food.

Additionally, migration limits are in place for plastic materials that are expected to come in direct contact with food items. Nevertheless, today there are no specific requirements for ink. Still, if the constituents of the packaging ink are listed in the regulations, any applicable restrictions – such as migration and concentration limits – must be met. New ink regulations (for example, Germany’s recently adopted Printing Inks Ordinance) are expected to impose further requirements on manufacturers.

Swiss Ordinance-Compliant Ink Materials

In 2010, the Swiss Federal Office of Public Health (FOPH) introduced an ordinance that affects inks used for the packaging of food. The ordinance, Swiss Ordinance SR 817.023.21, requires that ink materials only include those referenced in the Ordinance. The Swiss Ordinance, although voluntarily adopted by many manufacturers, is only mandatory in Switzerland, and addresses only those inks used on non-direct contact surfaces of food packaging materials.

Choosing the Right No-Tox Ink Product

While you may prioritize consumer health and regulatory compliance, you might still have questions about selecting the best ink product for your indirect or direct food contact packaging needs. Experienced regulatory consultants can be indispensable to the success of a packaging project.

To learn more or discuss your latest food packaging printing project, contact us today!

LeynaLeyna Force has a BS in Chemistry from Kutztown University and an MBA from DeSales University.  Leyna joined the No-Tox Products Division of Colorcon in 2006 as a Research Scientist. Over the past fifteen years she has held many technical positions within the company.  Her current role is the Manager of Laboratory Services where she oversees the No-Tox Technical Services, Quality Control, and New Product Development laboratories.

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