Apparently, the Center for Veterinary Medicine of the US Food and Drug Administration (FDA) is making progress on its "to-do" list! In September, the agency published two guidance documents (one proposed, one final) regarding additives for use in animal feed, including petfood. The subject matter that is covered by these documents is not particularly new; however, the guidance they offer to the petfood industry is very helpful.
One means of obtaining acceptance of a new petfood ingredient is through the submission of a Food Additive Petition (FAP) to FDA. This method has been available for a number of decades. As evidenced by the relatively few food additives that have been approved for use in animal feeds over the years, it is not an easy process. As a result, the preference of the industry has been to pursue a less burdensome, albeit informal, pathway to ingredient acceptance; i.e., an Association of American Feed Control Officials (AAFCO) Feed Ingredient Definition.
However, because the continued legal status of the AAFCO definition process is tenuous, and the Generally Recognized As Safe (GRAS) Notification process (instituted for animal feeds in 2010) has proven to be more arduous than first presumed, the submission of FAPs may become the preferred route in the future.
Although FDA regulations do provide information as to the required content of a FAP [21 CFR 571.1], they can be a bit cryptic. The proposed guidance document goes far in explaining what the agency expects a properly constructed FAP to contain. Recommendations in the guidance include:
- What to do prior to submitting a petition
- Recommendations on general format of the petition
- Providing information on additive identity and composition
- What information is needed regarding intended use, use level and labeling
- What type of data are needed to establish intended effect
- Explanation of analytical methods
- How to evaluate safety
- Providing proposed tolerances
- Constructing a proposed regulation
- When you need an environmental assessment
This document is now in draft form. Comments on the proposal may be submitted electronically to www.regulations.gov, citing docket number FDA-2013-D-0928, by November 12, 2013.
The Nutrition Labeling and Education Act of 1990 brought many changes to human food labeling, including requirements for the Nutrition Facts box and a means for approval of label health claims. However, the law did not affect petfood labeling, with one exception. The requirement in the act to declare certified color additives by their common or usual names, not just by a vague "artificial color" designation, applies to both human foods and animal feeds, including petfoods. It took a little while for FDA to promulgate regulations to put the law into effect as it applied to petfoods and other animal feeds, but that was finally accomplished in 2011.
All color additives used in food are subject to an approval process by FDA, but some are also required to obtain certification of each batch to ensure it consistently conforms to the required specifications. Certified color additives are generally chemically synthesized and recognized by a name consisting of a color and a number; e.g., "FD&C Blue No. 1," "FD&C Red No. 40 Lake." Effective November 18, 2013, the regulations for petfoods will require that these color additives be declared in the label ingredient statement by their specific names, although the "FD&C" and "No." parts of the name are optional. For example, "Blue 1" or "Red 40 Lake" would also be acceptable on a petfood label.
Many approved color additives are not subject to certification, such as caramel and titanium dioxide. A food color in this category may be declared by its common or usual name, provided its intended use in the petfood product as a color is clear to the consumer (e.g., "caramel color" or "colored with titanium dioxide"). However, the regulations retain the option for color additives not subject to certification to be declared in the ingredient statement (individually or collectively) simply as "artificial color," "color added" or equally informative words.
Frankly, though, use of the common or usual names of these food colors would probably evoke less negative reaction to the reader than nondescript references to color that do not identify its source or nature. In any event, while many (but not all) colors in this category are from plant, mineral or other "natural" sources, they can't be declared as "natural color."
Although the guidance document for color additive labeling is now final, comments may still be submitted to www.regulations.gov at any time. The docket number for this document is FDA-2013-D-1088.
