Discover your next big idea at PACK EXPO Las Vegas this September
Experience a breakthrough in packaging & processing and transform your business with solutions from 2,300 suppliers spanning all industries.
REGISTER NOW & SAVE

Food contact chemistry guidance document gets adjustments

One common place that packaging meets law is where packaging touches food.

The materials that contact food might get into food in tiny amounts, so the law requires that food contact polymers, paperboard, aluminum, glass, inks, coatings, adjuvants, adhesives, colorants, and other components all need to have some legal status if they might get into the food they package, or in legal parlance, if they are reasonably expected to become components of the food.

FDA has a complex and elaborate legal and regulatory framework in place for the regulation of food packaging substances. Late last year, FDA announced a change in their recommendations for parts of the program. For those of us who work closely in this arena, this is a big event.

But first, some context. In a nutshell, the realm of U.S. regulation of food contact materials concerns itself with the safety of potential exposures to food contact materials by determining how much of the material, if any, is reasonably expected to get into the daily diet of consumers, and then with whether that exposure level is safe. This commonly involves mathematical modeling, or laboratory testing that simulates the specific end use conditions and types of food involved in a proposed new use of a food contact substance.

The law requires that food makers assure that any food contact material that is reasonably expected to become a component of the food, and is thus a “food additive” under the law, be safe and not adulterate that food. FDA and industry have, over recent decades, developed a series of important conventional practices and formulas to standardize these scientific evaluations. Depending on the circumstances, these evaluations might be used to support a Food Contact Notification, Food Additive Petition, or Threshold of Regulation submission to FDA, or an evaluation that establishes that a use is Generally Recognized As Safe and therefore does not need approval as a food additive.
FDA has worked up a series of guidance documents to help attorneys and scientists evaluate food packaging materials with recommendations on the administrative procedures involved, as well as the chemistry considerations, toxicology issues, and environmental evaluations. FDA also tweaks them now and then.

In December 2007, it tweaked the chemistry guidance document, formally called “Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations.” These are the first alterations since 2002.
Some of the changes reflect what has been FDA’s thinking for some time and merely formalize the recommendation by putting it into the document. But some changes were a bit of a surprise.

For example, FDA created new food use categories, “I” for irradiation uses and “J” for cooking at temperatures over 121°C (250°F). They had been listed for some time on the FDA’s web site, but now join the list in the guidance document, too. These refine the categories of end uses, which are relevant chiefly to the design of migration studies to simulate actual use.

Conveying Innovations Report
Editors report on distinguishing characteristics that define each new product and collected video demonstrating the equipment or materials as displayed at the show. This topical report, winnowed from nearly 300 PACK EXPO collective booth visits, represents a categorized, organized account of individual items that were selected based on whether they were deemed to be both new, and truly innovative, based on decades of combined editorial experience in experiencing and evaluating PACK EXPO products.
Take me there
Conveying Innovations Report
Researched List: Engineering Services Firms
Looking for engineering services? Our curated list features 100+ companies specializing in civil, process, structural, and electrical engineering. Many also offer construction, design, and architecture services. Download to access company names, markets served, key services, contact information, and more!
Download Now
Researched List: Engineering Services Firms