U. S. Pharmacopeial Convention (USP) recently announced a host of newly proposed standards to the Food Chemicals Codex (FCC). This Q&A with Markus Lipp, Ph.D., director of food standards for USP, offers insight into the proposed standards and their potential impact on the food industry.
1) Please provide a brief explanation of what FCC is—what sorts of ingredients does it provide standards for, and what are contained in these standards?
The FCC is a compendium of quality standards for food ingredients published by the U.S. Pharmacopeial Convention (USP). The FCC is unique among compendia in that it accommodates any food ingredients or additives that can legally be added to food (in the United States or elsewhere)—including functional ingredients, colorings, flavorings, nutrients, preservatives, emulsifiers, and thickeners, among others. FCC standards designate an ingredient’s chemical formula, structure and molecular weight; function and definition; identity tests, assays, impurity limits and tests; and packaging, storage and labeling information. In addition to these written quality standards, FCC cites corresponding analytical reference materials to ensure that the analytical procedures are performing reliably and appropriately. The combination of quality criteria, suitable analytical methods (included within the FCC standards), and reference materials offers all parties along the food supply chain an independent means to agree on an ingredient’s identity, quality, and purity criteria—which can be used to ascertain the authenticity of ingredients. This is particularly important today as ingredients are sourced from suppliers all over the world and from companies that may vary significantly in their size and sophistication. With global markets being so competitive, low-cost ingredients present tempting but often too-good-to-be-true offers, and companies should insist that their suppliers use a resource like FCC to authenticate food ingredients and additives.
2) One of the recent proposals was a new bio-based method that would help food companies quantify the “natural" content of ingredients? This is a hot-button issue right now. Please explain how this method does this, and what types of ingredients it would apply to?
We certainly see a trend in consumer—and in turn manufacturer—interest in “natural" foods and ingredients. But how does one really know that something is natural and not synthetic? The new FCC method provides a way to determine the amount of a food ingredient that is derived from renewable carbon sources such as plant- or animal-based versus other raw materials commonly used to produce food additives (e.g., petroleum wax and mineral oil). The method uses carbon isotope signatures, which is one of the most accurate ways to make such quantitative determinations. Results obtained from this new FCC method would allow parties to verify the labeled percentage of a food ingredient that is bio-based—something not commonly done today but useful to companies seeking to instill confidence in consumers that may be skeptical of such claims. The method proposed in FCC is suggested for the bio-based content analysis of 1,3-propanediol (a new food ingredient), but is suitable for analysis of all carbon-based materials.
Besides this application, this technique can also be used for counterfeit detection, as in detecting the fraudulent addition of a synthetic compound to an expensive natural extract. For example, the new method would be able to detect the addition of synthetically produced vanillin to natural vanilla extract—something that other anti-counterfeiting methods are not specific enough to do. USP intends to expand on authenticity methods in the future and is encouraging industry partners to submit such methods for consideration.
3) Other proposals focus on some ingredients emerging in popularity, such as monk fruit (luo han guo) extract. Tell us a little bit more about these standards—and why USP is focusing on them specifically.
New standards for FCC are often focused on those ingredients that are innovative and/or emerging in popularity. Such ingredients may be more likely to be at risk for counterfeiting, particularly in cases of natural ingredients where there is limited supply coupled with high demand. Monk fruit is one of a number of natural sweeteners that is generating a lot of interest within the food industry, and we have developed a standard for the flavor enhancer and table-top sweetener. Another example is the plant-based sweetener rebaudioside A (stevia), for which FCC provides written and corresponding reference standards. In addition to high market demand, there are compositional complexities and analytical challenges associated with rebaudioside A that further necessitate standards to confirm the authenticity, quality and purity of the substance.
Another area in which FCC has recently developed new standards—and is continuing to do so —is infant formula ingredients. Specifically, we have proposed new standards for arachidonic acid (ARA) from fungal (Mortierella alpina) oil, a source of omega-6 fatty acids that is approved for use in infant formulas. Also proposed was a standard for ferrous ammonium phosphate, a source of iron used in infant formulas and other foods. In November 2010, standards for three nucleotides, present in breast milk and commonly added to infant formula, and two docosahexaenoic acid (DHA) oils, essential omega-3 fatty acids present in fish and often added to both infant formula and a host of functional foods, became effective in FCC. For ingredients used in infant formula, quality is of paramount importance, given the many unique considerations at play (e.g., a particularly vulnerable population and the single source of nutrition for many babies).
4) USP makes a point of saying these standards are "proposed"—what are the next steps?
FCC standards are developed through an open and transparent public process. A proposed standard is first published in the FCC Forum, the free online, open-access mechanism through which USP provides for public review of—and accepts comment on—its proposed food ingredient standards. After a three-month comment period, USP’s scientific staff reviews comments submitted to the Forum and incorporates modifications where appropriate. If a standard is altered significantly, it may go back into the FCC Forum for another round of public comment. Following this, USP’s Food Ingredients Expert Committee—a group of outside, independent food experts—reviews and approves the final standard. It is then published in the next edition of FCC or its supplement.
http://www.usp.org/fcc/forum/
5) Are FCC standards enforceable? How do they apply to industry?
FCC standards are largely voluntary standards designed to serve as a resource for the food industry (though the compendium is recognized in law in some form in Australia, Canada, Israel, and New Zealand, and some individual U.S. FDA regulations for ingredients).
