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VANILLA EXTRACT is the only flavoring material with a U.S.FDA standard of identity. It is included in the Code of Federal Regulations (21-CFR-169). The standard was developed and promulgated concurrent, and in close relationship, with the ice cream standard (21-CFR-135.110)

This coordination was necessary since vanilla extract and related flavorings are ice cream's most widely used flavorants; and the labeling of ice cream is dependent on the type of flavoring used. Category I (21-CFR-135) vanilla ice cream contains only pure vanilla components and no artificial flavors. This product can be labeled "Vanilla Ice Cream." Category II (21-CFR-135) vanilla ice cream can beflavored with up to one ounce of synthetic vanillin per unit (defined below) of vanilla extract.

This natural and artificial product, where the natural is the characterizing and predominant contributor to the flavor, must be labelled "Vanilla Flavored Ice Cream." Finally, Category III (21-CFR-135) ice cream contains predominantly or exclusively an artificial vanilla flavoring which includes primarily synthetic vanillin. This product must be labelled "Artificially Flavored" or "Artificial Vanilla."

Both the ice cream standard and the vanilla standard nomenclatures rely heavily on the definition of a unit of vanilla constituent. This term is defined by the Vanilla Standard 21-CFR-169.3. The types of vanilla beans are identified as "the properly cured and dried fruit pods of Vanilla planifolia Andrews and of Vanilla Tahitensis Moore." But the term properly cured and dried is not defined. The quantity of beans necessary to make a unit weight of vanilla beans is also identified. This last part has led to confusion in that the definition of quantity was set at 13.35 oz of 25% moisture vanilla beans. This is 10 oz of dry weight solids. If the beans contain greater than 25% moisture, logic states (as does the standard) that the quantity of beans in a unit be based on 10 oz of dry weight solids, although the wording refers again to the 25% moisture vanilla beans. 

However, when the moisture content of the beans used is below 25% moisture, the standard requires 13.35 oz regardless of the dry weight solids. No guidance is given concerning when the moisture content should be measured, when packed, when purchased, when received, or when used. There has been much discussion within the industry recently concerning the relationship between moisture content of the beans and the flavor of the extract. A positive correlation (eg, increase in moisture accompanies an increase or improvement in flavor) would be necessary to require an adjustment in the quantity and quality of bean usage in the extraction.

The intent of the regulation was to provide a consistent product to the consumer, and therefore, an analytically valid dry weight standard would be more appropriate and defendable. This debate will probably go on for several more years. Until resolution, the government is evaluating and approving appropriate industrial permits as requested by vanilla extract producers. Because the moisture content is so important to policing the standards (and will be regardless of which refinement prevails), the standard goes on to define how moisture should be analyzed—azeotropic distillation with toluene/benzene. This, also, leads to a concern in that most, if not all, extraction companies and analytical labs no longer permit the use of benzene in their facilities. Therefore, the moisture analysis needs to be revised as the entire standard is being overhauled. Currently, the Technical Committee of the Flavor Extract Manufacturer's Association of the United States (FEMA) has undertaken this task. In addition, alternative methods to the wet technique should be investigated and incorporated as appropriate. These include near infrared (NIR), electroconductivity, nuclear magnetic resonance (MMR), etc.
The remainder of the standard is involved with describing in general terms how the extract is made and what
other ingredients can be used. The standard also defines other products related to pure vanilla extract—what constitutesthem and how they can be labeled:

• Concentrated vanilla extract
• Vanilla flavoring
• Concentrated vanilla flavoring
• Vanilla powder
• Vanilla-vanillin extract
• Vanilla-vanillin flavoring
• Vanilla-vanillin powder

The more significant statements in the standard, which should be noted, require that the finished extract have not less than 35% ethyl alcohol and contain no less than one unit of vanilla beans per gallon.
As a result of this unique standard, the manufacture of vanilla extract is tightly controlled and requires a means for assuring compliance via analytically supported criteria.

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