The "No Migration" Position

• Published date: 01 August 2023
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law
• Law Firm: Steptoe LLP
• Author: Mr Daniel C. Rubenstein and Caleb Holland

The StepLadder Series is a Steptoe publication focused on discussing food contact regulatory topics in plain language.

There's no such thing as zero.

"Functional Barrier" is a Subset of "No Migration"

In our recent StepLadder article on Functional Barriers, we discussed how food-contact materials that are completely separated from food are not considered "food additives" subject to premarket approval by the US Food and Drug Administration (FDA), because they aren't reasonably expected to become a component of food under their intended conditions of use.¹ The logic behind the functional barrier approach is straightforward: if a substance can't get into food, then by definition, it's not a food additive. The principles underlying a "No Migration" position introduce a further variation on this theme: how much of a food contact substance could potentially migrate into food, when used as intended, before we would consider it to be a food additive subject to premarket approval by FDA? The answer (usually) isn't zero!

How Low Can You Go?

We begin by observing that a "No Migration" position is a self-determination that's made by taking into consideration the identity, intended use, safety profile, and the upper-bound potential (or actual - if measured) migration of a substance from packaging to food. Substances that are properly the subject of a "No Migration" position are, therefore, outside the scope of the definition of a food additive, and do not require premarket approval by FDA. These substances still must be safe when used as intended, however, in keeping with FDA's General Safety Clause and Good Manufacturing Practice (GMP) requirements.

FDA has not provided definitive criteria on how to determine at what specific level of migration a substance may reasonably be expected to become a component of food, so a "No Migration" determination must be made carefully, by taking into consideration the available sources of guidance, including case law in this area. A well-known example of this question was addressed in the Monsanto v. Kennedy case in 1979.² Here, FDA argued that the mere existence of contact between food packaging and food would result in some conceivable amount of migration of the food-contact substance to food (no matter how small), thereby potentially requiring the need for a food additive regulation for every intentionally added food-contact substance. The court disagreed with FDA's position, and stated instead that, to meet the definition of a...