Is it Possible to Use a Colorant if it is Not on FDA Compliant Lists, but is Used by European Competitors in the US?

September 30, 2008

We are producing a new produce packaging product that will compete against incumbent products from Europe. These products contain a barium-based red colorant that is not on any FDA compliant lists, it doesn't appear to have an FCN or be on the TOR list. But, the products have been sold in the U.S. for produce packaging for over 5 years. What would we need to do to use this same colorant on our product that will be made and sold in the US?




Substances that are reasonably be expected to become components of food under their intended conditions of use, either directly or indirectly, are regulated as "food additives" under the Federal Food, Drug, and Cosmetic Act. Materials such as colorants used in your packaging product—to the extent the product is used to package food—must therefore comply with a food additive regulation or be exempt from regulation on some other basis. To understand more about how a suitable regulatory status may be established for a product used in food packaging, either through a determination that it is generally recognized as safe (GRAS) or not expected to become a component of food under the intended conditions of use, or through a Food Contact Notification (FCN), we suggest you take a look at the following article on – Fathoming Food Packaging Regulation Revisited. This article provides a very good overview of the regulation of food packaging in the United States and the relationships among its various components, such as GRAS and the FCN process.

To establish a suitable status for the use in food packaging of the specific barium-based red colorant identified in your question, you would need to consult with qualified legal counsel. If you are interested in retaining regulatory assistance in this regard, someone at Keller and Heckman LLP would be glad to speak with you.