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Food and Drug Law Articles by Eric F. Greenberg

by Eric F. Greenberg

Packaging and its partners

When packagers speak of packaging, frequently they are referring to the physical structure holding a product. Of course, most packaging, and retail packaging in particular, is usually covered to some degree by label content, so sometimes people refer to a products packaging when what they are referring to is labeling. The best way to avoid potential confusion is to remember that packaging includes the physical structure as its labeling.

Its also been a longstanding contention, and not original with me, to note that packaging as such plays an important role in making a product safe, both in terms of the protective and preservative functions it can serve as well as the directions, warnings and other information that might be contained on the labeling. In fact, its most accurate to say that what makes a product safe for consumer use is often a combination of its physical characteristics (chemical formulation for example), plus the way it is packaged (unit dose is an example), plus the statements on its labeling (most notably directions for correct use and warnings about when not to use it). [A note about terminology: The legal definition of label refers to written, printed or graphic matter on a products immediate container, while labeling means the label, plus whats on any outer container or wrapper, or otherwise accompanying the article.]

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Eric F. Greenberg P.C. - Law Firm Practicing: Food & Drug Law, Packing Law, and Commercial Litigation


HACCP advice for packaging makers
March, 2010
Eric F. Greenberg, Attorney-at-Law

When the subject is HACCP, what’s a maker of food packaging to do? The Hazard Analysis and Critical Control Points concept has spread in recent years into more and more food processing realms, and new legislation might soon require it for essentially all foods. But that’s food. What about makers of food packaging? They have one foot in each world, since packaging is sometimes thought of like any other food ingredient, and sometimes not. What should be their stance on HACCP?

For many companies, the answer is easy: If the customer insists that I run my plant via a well-designed HACCP plan, then I do. Others might put HACCP in place voluntarily as a selling point, similar to getting ISO certification and the like.

But in recent years, as food safety has bubbled to the top of FDA’s list of concerns, and more food makers have been pressuring their packaging makers to provide assurances, it’s become clear that packaging makers need help in development of HACCP plans.

Enter the Food Safety Alliance for Pack-aging, a division of the Institute of Packaging Professionals. [The author is IoPP’s General Counsel] Wynn Wiksell, General Mills’ manager of packaging QRO, was a key driver, chairing the group and helping grow it. This recently formed group has issued model HACCP plans for a variety of packaging operations to help packaging makers create acceptable plans. FSAP was formed by consumer packaged goods companies, then added food safety associations in the U.S. and Canada and packaging trade groups and packaging suppliers themselves.

HACCP gives an operation a systematic way to impose controls against the most serious potential hazards. It calls for the company to analyze its processes to identify those most serious hazards and designate them critical control points, then create parameters to assure the hazard is averted, and document that the parameters are adhered to each time the process is undertaken. Regular reviews and improvements to the plan are part of the program, as well. It’s required for fruit and vegetable juices, seafood, and USDA-regulated meat and poultry. Low- and high-acid canned foods are regulated under a system that is conceptually similar to HACCP.

The basic design of all six of FSAP’s model HACCP plans is essentially the same. All include: assembling a multidisciplinary HACCP team; writing product descriptions; identifying target audiences; creating and verifying process flow diagrams; identifying hazards; performing hazard analyses; determining whether CCPs exist for the processes; using of CCP decision trees; if applicable, establishing CCPs, monitoring procedures for CCPs, corrective action for deviations; and verifying the HACCP plan.

FSAP’s models note that the most common area for packaging industry CCP’s is “allergen issues due to mixed labels or materials.” The models suggest programs to mitigate potential problems, such as: verifying label design/segregating varying label designs; keeping printing plates and other print media separate from other production orders; clearing the production line of materials, labels, and containers prior to beginning another production run; segregation of materials; and segregation of pallets and packing labels. Melissa Calicchia, M.S., of Food Safety Solutions, Inc., a California-based technical consulting firm and independent laboratory, frequently works with food companies and others to develop, validate and improve their HACCP programs. She is generally complimentary of the FSAP models for food packaging makers, noting that they are especially strong in addressing potential allergen issues. “The models are meaningful and would be very important for packaging manufacturers all over the country to refer to, to understand their risks, and control them,” she says.

Graham Packaging’s manager of global sustainability and regulatory compliance, Suzanne Matuszewski, was an early FSAP organizer and proponent of developing these plans. To her way of thinking, packaging suppliers are part of the food industry, and applying HACCP to packaging operations borrows a proven method of control from the food industry. “Packaging suppliers need to work with their food customers to make sure every link in the food supply chain is solid,” she says. She advises packaging makers who create HACCP plans to “Strive for continuous improvement once you do.” Her own company, which has followed HACCP in its own operations for some time, plans to revisit its plan with particular attention to the advice in the FSAP model plans.

Eric can be reached at greenberg@efg-law.com, and visit his firm’s Web site at www.ericfgreenbergpc.com.

FSAP’s model HACCP plans

  • A. Carton Model
  • B. Cut and Stack Label Model
  • C. Film: Extrusion Lamination Model
  • D. Film: Adhesive Lamination Model
  • E. Film: Blown Model (non-printed)
  • F. Rigid Plastics Model

To get the FSAP’s model plans, see www.iopp.org/fsap.

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