Food Chemicals Codex to Focus on Natural Colors and Flavors, and Functional Ingredients in the First Supplement to the Tenth Edition


CONTACT: Claudia Costabile

Rockville, Md., January 18, 2016 — The U.S. Pharmacopeial Convention (USP) is proposing new monographs to be included in its Food Chemicals Codex (FCC), First Supplement to the Tenth Edition.  Among them are new and revised monographs focusing on color and spice additives that are vulnerable to adulteration and contamination and functional ingredients used in a variety of food formulations including popular sports nutritional supplements.

“The ingredients proposed for the FCC are reflective of industry stakeholder needs in meeting consumers’ expectations for particular food ingredients. We have seen a demand for quality standards for spice extracts used as color and flavor additives for foods as well as functional ingredients, as manufacturers look to quality as a way of distinguishing their products on the market,” said Jaap Venema, Ph.D., executive vice president and chief science officer at USP.

Turmeric oleoresin is widely used as a coloring and flavoring agent. USP seeks comments on this proposed monograph, particularly as to how the FCC monograph should approach the issue of potential adulteration or contamination of turmeric oleoresin with non-declared colors such as Sudan dyes, including appropriate methods and specifications.

Another monograph going through a major revision for the first supplement of FCC 10 is Anise Oil. It is used as a flavoring agent in various food preparations. The proposed revision provides test limits for the possibility of anise oil adulteration with Japanese star anise (Illicium anisatum), which is highly toxic. Also proposed is a labeling requirement indicating the botanical origin of the oil as either Pimpinella anisum (native of the Mediterranean and Southwest Asia regions) or Illicium verum (Chinese star anise).

Two functional ingredients are also part of the proposed standards in the first supplement of FCC 10.  Gamma Aminobutyric Acid (GABA) is a popular functional food ingredient used for its purported calming, anti-anxiety effects.

Widely used as a “sports” nutritional supplement under claims of better recovery from physical exertion, L-Carnitine L-Tartrate is another functional ingredient monograph proposed for inclusion in the first supplement of FCC 10. The ingredient is GRAS for use at defined levels in specific food items such as fruit juices, fruit-flavored drinks, protein bars, meal replacements, breakfast bars and carbonated soft drinks. USP requests comments on how to limit potential contamination with D-carnitine, an impurity that lacks the biochemical function of L-carnitine and is reported to be antagonistic to L-carnitine.

Manufacturers and other interested parties are encouraged to comment on the proposed monographs through USP’s FCC Forum, a free, online tool, available for the public to review food ingredients quality standards.  The comment period for these new and revised FCC monographs is from December 31, 2015 to March 31, 2016. For a list of all new and revised monograph proposals, visit  

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