When packagers go international, compliance comes along

August, 2011

Eric F. Greenberg | Attorney-at-Law

Packaging makers and users who take advantage of worldwide markets have long recognized the importance of confirming regulatory compliance in foreign countries. Food-contact materials are regulated in a range of ways in countries around the world.

Two recent developments affect packagers with an international perspective. One is in China, which has recently taken the next important step in putting in place a new system for clearance of food-contact materials that will affect packagers who want to sell there. Second, back home, a new energy for scrutiny of imported foods and other products will increase packagers’ incentives to be careful with regulatory compliance issues.

Let’s first look at the U.S. side of the equation.

Particularly after 9/11, both unintentional microbial contamination and intentional contamination of the food supply were suddenly a greater concern. Industry groups such as the Grocery Manufacturers’ Association and federal agencies like the Food and Drug Administration quickly put assurance of food safety on the top of their lists. And packaging companies know it, as measures aimed at giving extra attention to quality assurance for food ingredients have increasingly fallen on packaging materials makers as well, a trend that has been noted in this space in the past.

During the Bush Administration, FDA announced an Import Safety Plan in which it called for a series of measures aimed at (1) prevention, (2) intervention, and (3) response. The prevention concept got a further boost when the Food Safety Modernization Act was signed into law in January of this year, with its conceptual emphasis on preventing food contamination before it occurs most notably by requiring more food companies to implement HACCP plans.

Well, FDA added further emphasis to the attention it pays to food imports when, in June, it announced a new approach to safety and quality of imported products of all kinds.

In a report called the “Pathway to Global Product Safety and Quality,” FDA announced its conclusion that it needs a wholesale conceptual change in approach to imports. FDA commissioner Dr. Margaret A. Hamburg announced, “Global production of FDA-regulated products has exploded over the past ten years,” and the U.S. now imports many finished products and also many materials and ingredients. FDA says that in order to more effectively assure safety and quality, it will have to do things like partner-up with its counterpart regulators in other countries and generate and share more data internationally. This emphasis on partnerships echoes a theme in the new Food Safety Modernization Act, under which FDA will arrange for third parties to certify the compliance of foreign food facilities.

Watch for such themes in coming months and years as FDA implements this new philosophy.

As for China’s food-contact materials program, let’s start with a nod to context. With all due respect to the many fine and reputable Chinese manufacturers and suppliers, certainly most observers would agree that in recent years, that nation has suffered from what is, at the very least, a public relations problem. The concept of “food safety” in China has been a matter of “insert-your-joke-here,” as troubling and sometimes bizarre stories seem to be working against the idea that China is effectively entering the modern world. Melamine contamination of pet food products was only the most notorious of a variety of issues, which also included contaminated toothpaste, concerns about seafood, and substandard infant formula and honey.

But China continues to implement changes. Chinese officials say they are moving forward with tougher enforcement of food safety requirements, and they recently passed a detailed food labeling system. Just as important, it continues phasing in a new food-contact materials program.

China’s system essentially grandfathers in older substances that can be supported by safety information, and puts in place a system for approving new substances. Approximately 116 resins and 196 additives have already been cleared by China’s Ministry of Health. Coming soon are listings of additional substances submitted before June 2010 but not included in the original positive list, as a so-called “clean up” submission. As well, there will be a “negative list” coming out, of substances prohibited from food packaging.

In terms of getting new substances cleared, the data required in the ‘dossier’ include what you’d expect: physical and chemical information; technical details about the substance; manufacturing process; quality specifications; test methods and test reports; toxicology; migration or residue and estimated dietary exposure; and other details.

New products would also have to be supported by a Certificate of Free Sale, and Certificate of Good Standing in the country of origin, as well as Chinese translation of the documents, notarized by a Chinese agency.

Once the dossier is submitted, the Ministry of Health will let the applicant know if it is complete within 5 business days. Once complete, they will be reviewed within 60, a relatively quick process.

Whether the issue is the safety of foods imported into the U.S., food contact materials in China, or sales and marketing in other nations around the world, packagers need to continue to be vigilant about international regulatory compliance and safety issues. PW

Eric Greenberg can be reached at [email protected], and visit his firm’s Web site at www.ericfgreenbergpc.com.

This article is informational only and is not intended as, and should not be considered to be, legal advice.

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GRAS Goes to Congress

GRAS Goes to Congress

By Eric F. Greenberg, Attorney-at-law

Remember that whole business involving NGOs and other folks objecting to the legal system that allows companies to self-determine that their uses of substances are Generally Recognized As Safe (“GRAS”)? And remember how some groups had gone to court to get the system declared unlawful, but late last year the court ruled against them? Well, there’s a new chapter to this story. Now, some members of Congress have proposed a bill that would make changes to the law to address those very same objections.

The GRAS pathway to clearance of the use of substances in packaging and in food is crucially important, and this proposed law has the potential to make enormous changes in various legal obligations. For that reason, packagers should keep a close eye on this latest chapter in the ongoing debate over the policy issues surrounding the GRAS system.

In my view, addressing the complaints we’ve heard for years about the GRAS program required changes in the law, so at least the objectors are in the correct forum. There’s been so much criticism of the Food and Drug Administration lately, what with its slow reaction to the infant formula contamination problem, on top of its handling of issues relating to heavy metals in baby food and various complaints about its handling of COVID and other drug approvals, for some examples. But when it comes to the GRAS program, it’s always seemed that most of the objectors’ objections were better directed at Congress than at FDA.

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