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 |