Migration and Compliance Testing Issues

Published: April 01, 2002, By Sheila A. Millar, Attorney-at-Law, Keller & Heckman, Washington, DC

One issue of perennial interest to members of the converting industry involves the differences between migration testing, conducted prior to needed regulatory clearances to determine whether a food-contact substance migrates to the food, and compliance testing, which generally is required to ensure the material conforms with applicable regulations or notifications. While there are many nuances involved, this is a brief review of the differences.

In the US food contact substances that are anticipated, or have been shown, to become components of food when used as intended must be the subject of either an applicable Food and Drug Administration (FDA) regulation (found in Title 21 of the Code of Federal Regulations); an FDA Threshold of Regulation (TOR) exemption; or an effective Food Contact Notification (FCN).

Thus, any use of a new food contact substance first requires migration studies be conducted, under the intended conditions of use, to determine if and to what extent the substance may become a component of food.

Designing a migration study requires, first of all, an understanding of the chemical identity of the substance and the manufacturing process involved (including possible contaminants). Second, it requires a thorough evaluation of the intended conditions of use. For example, you should assess whether the substance is a food contact item per se, like a plastic film; a component of a food-contact item, like a colorant or plasticizer; or an aid in the manufacturing of a food contact item, like an emulsifier.

Other key elements of the study design include the types of food likely to be contacted (dry or aqueous) and maximum and minimum contact times and temperatures involved in the application. Products that must withstand a host of conditions (freezer-to-oven types of products) should be evaluated appropriately. Other relevant factors that should be considered include whether the product is intended for multiple or single use.

Developing the appropriate migration study can thus involve significant effort and analyses before the tests even are initiated.

A compliance test is performed only for a substance that either is explicitly cleared in a Food Additive Regulation or is the subject of a Threshold of Regulation Exemption or an effective FCN.

If a substance is listed specifically in a Food Additive Regulation, TOR exemption, or effective FCN, and testing is needed to determine compliance with the conditions set forth in the listing (as a specification on the substance or article in which the substance is used as a component), the end test must be satisfied. In such a case, the compliance testing must be performed strictly as set forth in the regulation, TOR, or notification.

The situation, not surprisingly, is different in the EU. There, compliance testing to determine whether the use of a food contact article, after it is cleared, meets the necessary specifications involves the use of food-simulating solvents and conditions of time and temperature identical to those used during migration testing to evaluate the substance, so the data can be put in a “technical dossier” prior to the clearance of the substance in a Directive. The compliance tests require total migration to be determined, and frequently also require a specific determination for many substances.

As converters and their suppliers strive to achieve global clearances and ongoing compliance with differing food contact regulations, proper design of migration and compliance testing becomes increasingly critical to assure applicable legal requirements are met most efficiently.

Sheila A. Millar, a partner with Keller and Heckman LLP, counsels both corporate and association clients. Contact her at 202/434-4143; This email address is being protected from spambots. You need JavaScript enabled to view it.; PackagingLaw.com