ARTIFICIALLY TOP-NOTED FLAVORS IN SPECIAL NATURAL WINES

Proprietors of Bonded Wine Cellars and Others Concerned:

Purpose. This circular is issued to advise the producers of special natural wine of the effect that regulatory changes made in 21 CFR 1.12 will have on labels and/or approved formulas for special natural wines.

Background. Amendments made to the Food and Drug Administration regulations under 21 CFR 1.12, effective June 30, 1975, establish a highly restrictive definition of the term "natural flavor" by stating that the term "artificial flavor" or "artificial flavoring" means any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf, or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Under 21 CFR 1.12(g)(3), a flavor containing both a natural and an artificial flavor must be labeled to show both natural and artificial flavors. In addition, a flavor supplier must certify, in writing that a flavor that he has supplied and which he has desig- nated as containing no artificial flavor does not, to the best of his knowledge and belief, contain any artificial flavor.

The Bureau of Alcohol, Tobacco and Firearms for many years has approved predominantly natural flavors which contain not more than 1/10 of one percent synthetic flavoring "topnotes" for use in special natural wine on the basis that such trace quantities of artificial ingredients merely replaced flavoring qualities unavoidably lost in the processing of natural products for the extraction of their natural flavor. It now becomes inappropriate, however, for the Bureau to recognize flavors as "natural" when they are labeled under Food and Drug regulations as being other than natural.

Compliance. The effect of FDA regulatory changes as applied to certain flavoring ingredients now listed on approved special natural wine formulas has been considered. It has been concluded that an additional period beyond the June 30, 1975, effective date of the amended FDA regulations will be required by those winemakers affected. Therefore, in order to avoid undue hardships which may otherwise result from immediate recognition of the aforementioned changes in the Food and Drug Regulations, flavors labeled under the new FDA regulations as "natural and artificial" may be used on bonded wine cellar premises in the production of special natural wines until June 30, 1976. Not later than June 30, 1976, such winemakers shall surrender approved Forms 698 Supplemental for cancellation if such formulas include flavors that will now be considered as "natural and artificial" unless they can be amended by rider in accordance with the proviso under 27 CFR 240.441(b) to include natural flavors in substitution for the flavors no longer recognized as completely natural. In such case, the rider shall show the replacement of the flavor now labeled as "natural and artificial" with a flavor eligible for a "natural" designation under the amended regulations, and new samples of products produced under the amended formulas must be submitted. Further, all approved labels related to the amended formulas must be examined. If they have been rendered inaccurate by the changes in formula, revised labels must be submitted for approval prior to the June 30, 1976, deadline.

Inquiries. Inquiries concerning this circular should refer to its number and be addressed to the Assistant Director, Regulatory Enforcement, Bureau of Alcohol, Tobacco and Firearms, 1200 Pennsylvania Avenue, N. W., Washington, D. C. 20226.

REX D. DAVIS

Director