Online Exclusive: Inside the Food Chemicals Codex

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 iswhat 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 ingredients 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 ingredients identity, quality, and purity criteriawhich 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 consumerand in turn manufacturerinterest 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-basedsomething 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 extractsomething 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 standardsand 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 standardsand 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 ofand accepts comment onits proposed food ingredient standards. After a three-month comment period, USPs 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, USPs Food Ingredients Expert Committeea group of outside, independent food expertsreviews 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).

FCC is used by finished food and beverage manufacturers, food chemical and ingredient suppliers, food quality control professionals, and regulatory bodies around the world for managing supply chains, maintaining regulatory compliance, developing national legislation, and conducting day-to-day business transactions between food manufacturers and ingredient suppliers.

is used by finished food and beverage manufacturers, food chemical and ingredient suppliers, food quality control professionals, and regulatory bodies around the world for managing supply chains, maintaining regulatory compliance, developing national legislation, and conducting day-to-day business transactions between food manufacturers and ingredient suppliers.

Such standards are one of the largely overlooked yet absolutely essential components of helping to ensure a quality product. Coupled with quality systems complying with GMPs and other components, these standards can help ensure the overall qualityand in turn, safetyof food ingredients and products.

6) Looking ahead, what can manufacturers and suppliers expect in future editions of FCC?

Future FCC standards/projects include those focused on natural colors and pre- and probiotics and other functional foods, as well as work on methods for detecting economically motivated adulteration of food and food ingredients (employing non-targeted approaches that can assist in detecting the next, unknown adulterant as opposed to detecting specific adulterants, e.g., melamine).

USP is interested in working with manufacturers of food ingredients to develop more standards for food ingredients marketed in the United States or elsewhere. These include U.S. GRAS-Notified and GRAS-self-determined ingredients. Please visit usp.org/fcc to learn more about the compendium and the benefits of working with USP to develop standards.

Markus Lipp, Ph.D., joined USP in 2008 as Director for Food Standards with the main responsibility to further develop the Food Chemicals Codex. Prior to this position, he worked as the Director for Science and Research at the International Bottled Water Association and as the Global Lead for GMO Detection Methods and Reference Materials at Monsanto Co. Furthermore, his experiences include working for Unilever at their Dutch Research facility and for the Joint Research Center of the European Commission in their facility in Italy. Both positions focused on ensuring food authenticity and safety, including the presence of genetically modified organisms in food.  Lipp holds a Ph.D. in analytical chemistry from the University of Karlsruhe, Germany.