FCC revisions proposed for omega-3s, natural sweeteners, caffeine

January 3, 2013

To help ensure the quality of popular food ingredients increasingly being incorporated into products sold in the United States and worldwide, standards for omega 3-rich krill oil and natural, low-calorie stevia sweeteners are among the latest proposed revisions to the Food Chemicals Codex (FCC). FCC is an internationally recognized compendium of food ingredient quality standards published by the U.S. Pharmacopeial Convention (USP).

“Public standards defining the identity, quality, and purity of ingredients incorporated into finished products can be an important resource for manufacturers as they source ingredients from suppliers around the world, offering some assurance that they are receiving the ingredients they expect by providing public specifications to which they can be compared,” said V. Srini Srinivasan, Executive Vice President, Global Science and Standards at USP. “While important for all ingredients, it is especially crucial for high-value ingredients, including those linked to health benefits such as krill oil and so-called natural ingredients such as stevia, which manufacturers and consumers pay a premium for and are in high public demand.”

Some of the proposals in the FCC Forum include the following.

Krill Oil—Originally proposed in 2010, a draft FCC monograph for the popular omega-3 fatty acids source was deferred from advancement into final monograph status based on public comments received that indicated the monograph needed to be strengthened with quantitative test requirements for phospholipids. Phospholipids are important biological chemicals—and krill phospholipids contain the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Considerable outside research is being conducted on these types of phospholipids and their potential health benefits in the areas of heart and cardiovascular health, joint health, women’s health, and brain health. Many of these purported benefits are associated with the specific DHA and EPA fatty acids that are attached to phospholipids in krill oil. The revised version of this monograph, reflective of comments received, proposes both qualitative (fingerprint) and quantitative tests for total phospholipid content as well as one of the key phospholipids—phosphatidylcholine—which is believed to be linked to certain health benefits.

Steviol Glyosides—First proposed in the December 2011 FCC Forum, a revised monograph proposal incorporating comments and suggestions from stakeholders for the naturally derived sweetener provides a more simplified approach for separating and measuring all nine glycosides present in the stevia leaf. USP also has a monograph for high purity Rebaudioside A, the first stevia-based sweetener widely used in the United States and Europe. A range of steviol glycosides, including mixtures of different glycosides, are now being used in a variety of products in addition to Rebaudioside A. For regulatory compliance, formulation considerations (e.g., different glycosides may have different sweetener profiles) and other reasons, it is critical for manufacturers to be able to accurately identify the material they have sourced.

Caffeine—As part of ongoing efforts to keep FCC monographs current and reflective of the latest available analytical techniques, the revised monograph that is being offered for public comment includes a more discriminating liquid chromatography test for both identity and quantitative determination of the purity of caffeine content. For manufacturers and suppliers, the ability to properly identify and measure caffeine content will be more critical than ever given the broader use of the ingredient in products marketed to increase energy beyond traditional beverages such as soft drinks.

The proposed standards are available for public review for a 90-day comment period, which closes March 31, 2013. To make comments, go to www.usp.org/fcc/fccForum.html.

Press release